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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒ QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2024
Or
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _____________ to _____________
Qualigen
Therapeutics, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-37428 |
|
26-3474527 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
No.) |
5857
Owens Avenue, Suite 300, Carlsbad, California 92008
(Address
of principal executive offices) (Zip Code)
(760)
452-8111
(Registrant’s
telephone number, including area code)
n/a
(Former
name or former address, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol |
|
Name
of each exchange on which registered |
Common
Stock, par value $.001 per share |
|
QLGN |
|
The
Nasdaq Capital Market of The Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). ☒ Yes ☐ No
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
|
|
Emerging
growth company |
☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No
As
of August 9, 2024, there were 12,155,830 shares of the registrant’s common stock, par value $0.001 per share, outstanding.
TABLE
OF CONTENTS
ITEM
1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
QUALIGEN
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
ASSETS | |
| | | |
| | |
Current assets | |
| | | |
| | |
Cash | |
$ | 118,685 | | |
$ | 401,803 | |
Prepaid expenses and other current assets | |
| 415,725 | | |
| 764,964 | |
Total current assets | |
| 534,410 | | |
| 1,166,767 | |
Other assets | |
| — | | |
| 866,481 | |
Total Assets | |
$ | 534,410 | | |
$ | 2,033,248 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ DEFICIT | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
$ | 1,853,896 | | |
$ | 2,222,983 | |
Accrued expenses and other current liabilities | |
| 986,806 | | |
| 560,006 | |
Warrant liabilities | |
| 260,276 | | |
| 54,600 | |
Convertible debt | |
| 1,080,294 | | |
| — | |
Convertible debt - related party | |
| 589,717 | | |
| 1,299,216 | |
Convertible debt | |
| 589,717 | | |
| 1,299,216 | |
Derivative liabilities | |
| 23,588 | | |
| — | |
Derivative liabilities - related party | |
| 17,696 | | |
| — | |
Derivative liabilities | |
| 17,696 | | |
| — | |
Total current liabilities | |
| 4,812,273 | | |
| 4,136,805 | |
Commitments and Contingencies (Note 10) | |
| - | | |
| - | |
Stockholders’ Deficit | |
| | | |
| | |
Qualigen Therapeutics, Inc. stockholders’ equity (deficit): | |
| | | |
| | |
Common stock, $0.001 par value; 225,000,000 shares authorized; 9,613,899 and 5,362,128 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | |
| 47,514 | | |
| 43,262 | |
Additional paid-in capital | |
| 116,086,316 | | |
| 114,655,565 | |
Accumulated deficit | |
| (120,411,693 | ) | |
| (116,802,384 | ) |
Total Stockholders’ Deficit | |
| (4,277,863 | ) | |
| (2,103,557 | ) |
Total Liabilities & Stockholders’ Deficit | |
$ | 534,410 | | |
$ | 2,033,248 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
QUALIGEN
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND OTHER COMPREHENSIVE LOSS
(Unaudited)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended
June 30, | | |
For the Six Months Ended
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
EXPENSES | |
| | | |
| | | |
| | | |
| | |
General and administrative | |
$ | 986,484 | | |
$ | 2,427,066 | | |
$ | 2,047,419 | | |
$ | 3,796,068 | |
Research and development | |
| 754,287 | | |
| 1,174,646 | | |
| 1,118,672 | | |
| 2,456,463 | |
Total expenses | |
| 1,740,771 | | |
| 3,601,712 | | |
| 3,166,091 | | |
| 6,252,531 | |
| |
| | | |
| | | |
| | | |
| | |
LOSS FROM OPERATIONS | |
| (1,740,771 | ) | |
| (3,601,712 | ) | |
| (3,166,091 | ) | |
| (6,252,531 | ) |
| |
| | | |
| | | |
| | | |
| | |
OTHER EXPENSE (INCOME), NET | |
| | | |
| | | |
| | | |
| | |
Gain on change in fair value of warrant liabilities | |
| (493,206 | ) | |
| (440,294 | ) | |
| (359,906 | ) | |
| (1,478,967 | ) |
Gain on change in fair value of derivative liabilities | |
| (10,116 | ) | |
| — | | |
| (174,613 | ) | |
| — | |
Interest expense | |
| 263,560 | | |
| 377,416 | | |
| 400,117 | | |
| 921,652 | |
Loss on issuance of convertible debt | |
| — | | |
| — | | |
| 358,279 | | |
| — | |
(Gain) loss on voluntary conversion of convertible debt into common stock | |
| (83,800 | ) | |
| — | | |
| (83,800 | ) | |
| 1,077,287 | |
Loss on monthly redemptions of convertible debt into common stock | |
| 61,655 | | |
| — | | |
| 208,852 | | |
| — | |
Other income, net | |
| (1,094 | ) | |
| (5,509 | ) | |
| (2,713 | ) | |
| (5,509 | ) |
Total other expense (income), net | |
| (263,001 | ) | |
| (68,387 | ) | |
| 346,216 | | |
| 514,463 | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
(BENEFIT) PROVISION FOR INCOME TAXES | |
| (1,212 | ) | |
| 4,036 | | |
| (2,998 | ) | |
| 5,429 | |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS FROM CONTINUING OPERATIONS | |
| (1,476,558 | ) | |
| (3,537,361 | ) | |
| (3,509,309 | ) | |
| (6,772,423 | ) |
| |
| | | |
| | | |
| | | |
| | |
DISCONTINUED OPERATIONS | |
| | | |
| | | |
| | | |
| | |
Income (loss) from discontinued operations, net of tax | |
| — | | |
| 29,672 | | |
| — | | |
| (842,515 | ) |
Loss on disposal of discontinued operations, net of tax | |
| (100,000 | ) | |
| — | | |
| (100,000 | ) | |
| — | |
GAIN (LOSS) FROM DISCONTINUED OPERATIONS | |
| (100,000 | ) | |
| 29,672 | | |
| (100,000 | ) | |
| (842,515 | ) |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS | |
| (1,576,558 | ) | |
| (3,507,689 | ) | |
| (3,609,309 | ) | |
| (7,614,938 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss attributable to non-controlling interest from discontinued operations | |
| — | | |
| (43,484 | ) | |
| — | | |
| (304,512 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss available to Qualigen Therapeutics, Inc. | |
$ | (1,576,558 | ) | |
$ | (3,464,205 | ) | |
$ | (3,609,309 | ) | |
$ | (7,310,426 | ) |
Deemed dividend arising from warrant down-round provision | |
$ | — | | |
$ | — | | |
$ | (60,017 | ) | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Net loss attributable to Qualigen Therapeutics, Inc | |
$ | (1,576,558 | ) | |
$ | (3,464,205 | ) | |
$ | (3,669,326 | ) | |
$ | (7,310,426 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per common share, basic and diluted - continuing operations | |
$ | (0.20 | ) | |
$ | (0.70 | ) | |
$ | (0.53 | ) | |
$ | (1.35 | ) |
Net income (loss) per common share, basic and diluted - discontinued operations | |
$ | (0.01 | ) | |
$ | 0.01 | | |
$ | (0.01 | ) | |
$ | (0.11 | ) |
Total net loss per common share, basic and diluted | |
$ | (0.21 | ) | |
$ | (0.69 | ) | |
$ | (0.54 | ) | |
$ | (1.46 | ) |
Weighted-average number of shares outstanding, basic and diluted | |
| 7,603,252 | | |
| 5,052,463 | | |
| 6,773,533 | | |
| 5,006,050 | |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive loss, net of tax | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (1,576,558 | ) | |
$ | (3,507,689 | ) | |
$ | (3,609,309 | ) | |
$ | (7,614,938 | ) |
Foreign currency translation adjustment from discontinued operations | |
| — | | |
| (56,747 | ) | |
| — | | |
| 119,473 | |
Other comprehensive loss | |
| (1,576,558 | ) | |
| (3,564,436 | ) | |
| (3,609,309 | ) | |
| (7,495,465 | ) |
Comprehensive loss attributable to noncontrolling interest from discontinued operations | |
| — | | |
| (43,484 | ) | |
| — | | |
| (304,512 | ) |
Comprehensive loss attributable to Qualigen Therapeutics, Inc. | |
$ | (1,576,558 | ) | |
$ | (3,520,952 | ) | |
$ | (3,609,309 | ) | |
$ | (7,190,953 | ) |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
QUALIGEN
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(Unaudited)
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Deficit | |
| |
Common Stock | | |
Additional Paid-In | | |
Accumulated | | |
Total
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Deficit | |
Balance at December 31, 2023 | |
| 5,362,128 | | |
$ | 43,262 | | |
$ | 114,655,565 | | - |
$ | (116,802,384 | )- | - |
$ | (2,103,557 | ) |
Monthly redemptions of convertible debt into common stock | |
| 1,138,535 | | |
| 1,138 | | |
| 545,094 | |
- |
| — | - | - |
| 546,232 | |
Fair value of warrant modification for professional services | |
| — | | |
| — | | |
| 9,737 | | - |
| — | - | - |
| 9,737 | |
Stock-based compensation | |
| — | | |
| — | | |
| 58,651 | | - |
| — | - | - |
| 58,651 | |
Net loss | |
| — | | |
| — | | |
| — | | - |
| (2,032,751 | )- | - |
| (2,032,751 | ) |
Balance at March 31, 2024 | |
| 6,500,663 | | |
$ | 44,400 | | |
$ | 115,269,047 | | - |
$ | (118,835,135 | )- | - |
$ | (3,521,688 | ) |
Voluntary conversion of convertible debt into common stock | |
| 1,400,000 | | |
| 1,400 | | |
| 278,801 | | - |
| — | | - |
| 280,201 | |
Monthly redemptions of convertible debt into common stock | |
| 1,136,312 | | |
| 1,137 | | |
| 355,959 | | - |
| — | - | - |
| 357,096 | |
Stock issued upon partial exercise of warrants | |
| 576,924 | | |
| 577 | | |
| 149,423 | | - |
| — | -
| - |
| 150,000 | |
Stock-based compensation | |
| — | | |
| — | | |
| 33,086 | | - |
| — | | -- |
| 33,086 | |
Net loss | |
| — | | |
| — | | |
| — | | - |
| (1,576,558 | )- | - |
| (1,576,558 | ) |
Balance at June 30, 2024 | |
| 9,613,899 | | |
$ | 47,514 | | |
$ | 116,086,316 | | - |
$ | (120,411,693 | )- | - |
$ | (4,277,863 | ) |
| |
| | |
| | |
Additional | | |
Accumulated
Other | | |
| | |
Total
Qualigen
Therapeutics, Inc. | | |
| | |
Total | |
| |
Common Stock | | |
Paid-In | | |
Comprehensive | | |
Accumulated | | |
Stockholders’ | | |
Noncontrolling | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Income | | |
Deficit | | |
Equity | | |
Interest | | |
Equity | |
Balance at December 31, 2022 | |
| 4,210,737 | | |
$ | 42,110 | | |
$ | 110,528,050 | | |
$ | 50,721 | | |
$ | (103,385,172 | ) | |
$ | 7,235,709 | | |
$ | 1,530,881 | | |
$ | 8,766,590 | |
Voluntary conversion of convertible debt into common stock | |
| 841,726 | | |
| 842 | | |
| 1,111,740 | | |
| — | | |
| — | | |
| 1,112,582 | | |
| — | | |
| 1,112,582 | |
Stock-based compensation | |
| — | | |
| — | | |
| 247,657 | | |
| — | | |
| — | | |
| 247,657 | | |
| 4,569 | | |
| 252,226 | |
Foreign currency translation adjustment | |
| — | | |
| — | | |
| — | | |
| 119,723 | | |
| — | | |
| 119,723 | | |
| 56,497 | | |
| 176,220 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| (3,846,221 | ) | |
| (3,846,221 | ) | |
| (261,028 | ) | |
| (4,107,249 | ) |
Balance at March 31, 2023 | |
| 5,052,463 | | |
$ | 42,952 | | |
$ | 111,887,447 | | |
$ | 170,444 | | |
$ | (107,231,393 | ) | |
$ | 4,869,450 | | |
$ | 1,330,919 | | |
$ | 6,200,369 | |
Balance | |
| 5,052,463 | | |
$ | 42,952 | | |
$ | 111,887,447 | | |
$ | 170,444 | | |
$ | (107,231,393 | ) | |
$ | 4,869,450 | | |
$ | 1,330,919 | | |
$ | 6,200,369 | |
Stock-based compensation | |
| — | | |
| — | | |
| 667,383 | | |
| — | | |
| — | | |
| 667,383 | | |
| 4,728 | | |
| 672,111 | |
Foreign currency translation adjustment | |
| — | | |
| — | | |
| — | | |
| (38,553 | ) | |
| — | | |
| (38,553 | ) | |
| (18,194 | ) | |
| (56,747 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| (3,464,205 | ) | |
| (3,464,205 | ) | |
| (43,484 | ) | |
| (3,507,689 | ) |
Balance at June 30, 2023 | |
| 5,052,463 | | |
$ | 42,952 | | |
$ | 112,554,830 | | |
$ | 131,891 | | |
$ | (110,695,598 | ) | |
$ | 2,034,075 | | |
$ | 1,273,969 | | |
$ | 3,308,044 | |
Balance | |
| 5,052,463 | | |
$ | 42,952 | | |
$ | 112,554,830 | | |
$ | 131,891 | | |
$ | (110,695,598 | ) | |
$ | 2,034,075 | | |
$ | 1,273,969 | | |
$ | 3,308,044 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
QUALIGEN
THERAPEUTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| |
2024 | | |
2023 | |
| |
For the Six Months Ended
June 30, | |
| |
2024 | | |
2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |
| | | |
| | |
Net loss | |
$ | (3,609,309 | ) | |
$ | (7,614,938 | ) |
Loss from discontinued operations, net of tax | |
| (100,000 | ) | |
| (842,515 | ) |
Loss from continuing operations | |
| (3,509,309 | ) | |
| (6,772,423 | ) |
Adjustments to reconcile loss from continuing operations to net cash used in operating activities: | |
| | | |
| | |
Stock-based compensation | |
| 91,737 | | |
| 886,442 | |
Change in fair value of warrant liabilities | |
| (359,906 | ) | |
| (1,478,967 | ) |
Change in fair value of derivative liabilities | |
| (174,613 | ) | |
| — | |
(Gain) loss on voluntary conversion of convertible debt | |
| (83,800 | ) | |
| 1,077,287 | |
Loss on monthly redemptions of convertible debt into common stock | |
| 208,852 | | |
| — | |
Accretion of discount on convertible debt | |
| 322,717 | | |
| 787,517 | |
Loss on issuance of convertible debt | |
| 358,279 | | |
| — | |
Fair value of warrant modification for professional services | |
| 9,737 | | |
| — | |
| |
| | | |
| | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other assets | |
| 765,720 | | |
| 185,308 | |
Accounts payable | |
| (369,088 | ) | |
| 630,288 | |
Accrued expenses and other current liabilities | |
| 481,556 | | |
| 321,973 | |
Net cash used in operating activities - continuing operations | |
| (2,258,118 | ) | |
| (4,362,575 | ) |
Net cash used in operating activities - discontinued operations | |
| — | | |
| (1,199,841 | ) |
Net cash used in operating activities | |
| (2,258,118 | ) | |
| (5,562,416 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
Net cash provided by (used in) investing activities - discontinued operations | |
| 350,000 | | |
| (246,418 | ) |
Net cash provided by (used in) investing activities | |
| 350,000 | | |
| (246,418 | ) |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Net proceeds from the issuance of convertible notes payable | |
| 1,475,000 | | |
| — | |
Proceeds from warrant exercises | |
| 150,000 | | |
| — | |
Net cash provided by financing activities - continuing operations | |
| 1,625,000 | | |
| — | |
Net cash provided by financing activities - discontinued operations | |
| — | | |
| — | |
Net cash provided by financing activities | |
| 1,625,000 | | |
| — | |
| |
| | | |
| | |
Net change in cash and restricted cash | |
| (283,118 | ) | |
| (5,808,834 | ) |
Effect of exchange rate changes on cash and restricted cash | |
| — | | |
| 115,803 | |
Cash and restricted cash from continuing operations- beginning of period | |
| 401,803 | | |
| 3,165,985 | |
Cash and restricted cash from discontinued operations - beginning of period | |
| — | | |
| 3,874,139 | |
Less: cash and restricted cash from discontinued operations - end of period | |
| — | | |
| (756,456 | ) |
Cash from continuing operations - end of period | |
$ | 118,685 | | |
$ | 590,636 | |
| |
| | | |
| | |
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION | |
| | | |
| | |
Cash paid during the year for: | |
| | | |
| | |
Interest | |
$ | 1,020 | | |
$ | — | |
Taxes | |
$ | 2,860 | | |
$ | — | |
| |
| | | |
| | |
NONCASH FINANCING AND INVESTING ACTIVITIES: | |
| | | |
| | |
Monthly redemption of convertible debt into common stock | |
$ | 903,329 | | |
$ | — | |
Voluntary conversion of convertible debt into common stock | |
$ | 280,200 | | |
$ | 1,112,582 | |
Deemed dividend arising from warrant down-round provision | |
$ | 60,017 | | |
$ | — | |
Exchange of derivative liability for warrant and convertible debt | |
$ | 675,625 | | |
$ | — | |
Net transfers to equipment held for lease from inventory | |
$ | — | | |
$ | 35,971 | |
The
accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
QUALIGEN
THERAPEUTICS, INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
NOTE
1 — ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES
Organization
Ritter
Pharmaceuticals, Inc. (the Company’s predecessor) was formed as a Nevada limited liability company on March 29, 2004 under the
name Ritter Natural Sciences, LLC. In September 2008, this company converted into a Delaware corporation under the name Ritter Pharmaceuticals,
Inc. On May 22, 2020, upon completing a “reverse recapitalization” transaction with Qualigen, Inc., Ritter Pharmaceuticals,
Inc. was renamed Qualigen Therapeutics, Inc. (the “Company”). Qualisys Diagnostics, Inc. was formed as a Minnesota corporation
in 1996, reincorporated to become a Delaware corporation in 1999, and then changed its name to Qualigen, Inc. in 2000. Qualigen, Inc.
was a wholly-owned subsidiary of the Company. On July 20, 2023, the Company sold all of the issued and outstanding shares of common stock
of Qualigen, Inc. to Chembio Diagnostics, Inc. (“Chembio”), a wholly-owned subsidiary of Biosynex, S.A. (“Biosynex”).
Following the consummation of this transaction, Qualigen, Inc. became a wholly-owned subsidiary of Chembio (see Note 5 – Discontinued
Operations).
On
May 26, 2022, the Company acquired 2,232,861 shares of Series A-1 Preferred Stock of NanoSynex, Ltd. (“NanoSynex”) from Alpha
Capital Anstalt (“Alpha”), a related party, in exchange for 350,000 reverse split adjusted shares of the Company’s
common stock and a prefunded warrant to purchase 331,464 reverse split adjusted shares of the Company’s common stock at an exercise
price of $0.001 per share. These warrants were subsequently exercised on September 13, 2022. Concurrently with this transaction, the
Company also entered into a Master Funding Agreement for the Operational and Technology Funding of NanoSynex Ltd., dated May 26, 2022,
with NanoSynex (the “NanoSynex Funding Agreement”), to, among other things, provide for the further funding of NanoSynex,
and purchased 381,786 shares of Series B preferred stock from NanoSynex for a total purchase price of $600,000. The transactions resulted
in the Company acquiring a 52.8% interest in NanoSynex (the “NanoSynex Acquisition”). NanoSynex is a nanotechnology diagnostics
company domiciled in Israel. On July 20, 2023, the Company entered into an Amendment and Settlement Agreement with NanoSynex (the “NanoSynex
Amendment”), which amended the NanoSynex Funding Agreement, to, among other things, eliminate most of the Company obligation for
the further funding of NanoSynex. Pursuant to the terms of the NanoSynex Amendment, the Company lost its controlling interest in NanoSynex
(see Note 5 -Discontinued Operations).
Basis
of Presentation
Certain information or footnote disclosures normally included in financial statements prepared in accordance with
GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they
do not include all the information and footnotes necessary for a complete presentation of financial position, results of operations, or
cash flows. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments,
consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results, and
cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements should be read in conjunction
with the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which contains the audited financial statements
and notes thereto. The financial information as of December 31, 2023 is derived from the audited financial statements presented in the
Company’s Annual Report on Form 10-K for the year ended December 31, 2023. The interim results for the three and six months ended
June 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any future periods.
Principles
of Consolidation
The
accompanying condensed consolidated financial statements include the accounts of the Company and its former wholly-owned and majority
owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to
applicable guidance is meant to refer to U.S. GAAP. The Company views its operations and manages its business in one operating segment.
In general, the functional currency of the Company and its subsidiaries is the U.S. dollar. For NanoSynex, the functional currency was
the local currency, New Israeli Shekels (NIS). As such, assets and liabilities for NanoSynex were translated into U.S. dollars with the
effects of foreign currency translation adjustments reflected as a component of accumulated other comprehensive loss within the Company’s
condensed consolidated statements of changes in stockholders’ equity (deficit).
As
of July 20, 2023, NanoSynex was deconsolidated from these financial statements as the transactions contemplated by the NanoSynex Amendment
resulted in a loss of control of a subsidiary that constitutes a business under ASC 810. The retained investment in NanoSynex is accounted
for prospectively as an equity method investment. See Note 5 – Discontinued Operations for further information.
Discontinued
Operations
On
July 20, 2023, the Company completed the sale of Qualigen, Inc. to Chembio Diagnostics, Inc. The sale of Qualigen Inc. constituted a
significant disposition and as such, the Company concluded that the disposition of ownership in Qualigen, Inc. represented a strategic
shift that had a major effect on its operations and financial results. Therefore, Qualigen, Inc. is classified as discontinued operations
for all periods presented herein.
On
July 20, 2023, the Company entered into the NanoSynex Amendment, which amended the Master Funding Agreement for the Operational and Technology
Funding of NanoSynex Ltd., dated May 26, 2022, by and between the Company and NanoSynex (the “NanoSynex Funding Agreement”),
a former majority owned subsidiary of the Company, to, among other things, forfeit 281,000 Series B Preferred Shares of NanoSynex held
by the Company, resulting in the deconsolidation of NanoSynex. The disposition represents a strategic shift that will have a material
effect on the Company’s operations and financial results. Accordingly, the business of NanoSynex is classified as discontinued
operations for all periods presented herein.
See
Note 5 - Discontinued Operations for further information.
Equity
Method Investments
Following
deconsolidation of NanoSynex on July 20, 2023, the Company accounts for its retained investment under the equity method of accounting
as it retained the ability to exercise significant influence over the operating and financial policies of the investee. Under the equity
method, the Company recognizes its proportionate share earnings or losses each reporting period with an adjustment to the carrying value
of the investment. As of December 31, 2023, the carrying value of the retained investment was zero, and therefore the Company has suspended
application of the equity method as the Company is not liable for the obligations of the investee nor otherwise committed to provide
financial support. Future equity method earnings, if any, will not be recognized until the amount exceeds the unrecognized net losses
in prior periods. See Note 5 – Discontinued Operations for further information.
Accounting
Estimates
Management
uses estimates and assumptions in preparing its condensed consolidated financial statements in accordance with U.S. GAAP. Those estimates
and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported
revenues and expenses. The most significant estimates relate to the estimated fair value of in-process research and development, goodwill,
warrant liabilities, and stock-based compensation. Actual results could materially vary from the estimates that were used.
Cash
The
Company considers all highly liquid investments purchased with an initial maturity of 90 days or less and money market funds to be cash
equivalents.
The
Company maintains the majority of its cash in government money market mutual funds and in accounts at banking institutions in the U.S.
that are of high quality. Cash held in these accounts often exceed the Federal Deposit Insurance Corporation (FDIC) insurance limits.
If such banking institutions were to fail, the Company could lose all or a portion of amounts held in excess of such insurance limitations.
In March 2023, Silicon Valley Bank and Signature Bank, and more recently in May 2023, First Republic Bank, were closed due to liquidity
concerns and taken over by the FDIC. While the Company did not have an account at any of these banks, in the event of failure of any
of the financial institutions where the Company maintains its cash and cash equivalents, there can be no assurance that the Company would
be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely
affect the Company’s business and financial position.
Impairment
of Long-Lived Assets
The
Company assesses potential impairments to its long-lived assets when there is evidence that events or changes in circumstances indicate
that assets may not be recoverable. An impairment loss would be recognized when the sum of the expected future undiscounted cash flows
is less than the carrying amount of the assets. The amount of impairment loss, if any, will generally be measured as the difference between
the net book value of the assets and their estimated fair values. During the six months ended June 30, 2024 and 2023, no such impairment
losses have been recorded.
Segment
Reporting
Operating
segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation
by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company
has viewed its operations and managed its business as one segment operating primarily within the United States (and in Israel prior to
the NanoSynex deconsolidation).
Research
and Development
Except
for acquired in process research and development (IPR&D), the Company expenses research and development costs as incurred including
therapeutics license costs.
Patent
Costs
The
Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting
expenses related to making such applications) and such costs are included in general and administrative expenses in the condensed consolidated
statement of operations.
Derivative
Financial Instruments and Warrant Liabilities
The
Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates
all of its financial instruments, including issued stock purchase warrants, to determine if such instruments are derivatives or contain
features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative
instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported
in the condensed consolidated statements of operations and comprehensive loss. Depending on the features of the derivative financial
instrument, the Company uses either the Black-Scholes option-pricing model or a Monte-Carlo simulation to value the derivative instruments
at inception and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should
be recorded as liabilities or as equity, is re-assessed at the end of each reporting period (See Note 7-Warrant Liabilities and Note
8- Convertible Debt).
Fair
Value Measurements
The
Company determines the fair value measurements of applicable assets and liabilities based on a three-tier fair value hierarchy established
by accounting guidance and prioritizes the inputs used in measuring fair value. The Company discloses and recognizes the fair value of
its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy
gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level
1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements).
The guidance establishes three levels of the fair value hierarchy as follows:
|
● |
Level
1 - Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability
to access at the measurement date; |
|
|
|
|
● |
Level
2 - Inputs other than quoted prices that are observable for the assets or liability either directly or indirectly, including inputs
in markets that are not considered to be active; and |
|
|
|
|
● |
Level
3 - Inputs that are unobservable. |
Fair
Value of Financial Instruments
Cash,
accounts receivable, prepaids, accounts payable, and accrued liabilities are carried at cost, which management believes approximates
fair value due to the short-term nature of these instruments.
Comprehensive
Loss
Comprehensive
loss consists of net income and foreign currency translation adjustments related to the discontinued operations of NanoSynex. Comprehensive
gains (losses) have been reflected in the statements of operations and comprehensive loss and as a separate component in the statements
of stockholders’ equity (deficit) for all periods presented.
Stock-Based
Compensation
Stock-based
compensation cost for equity awards granted to employees and non-employees is measured at the grant date based on the calculated fair
value of the award using the Black-Scholes option-pricing model, and is recognized as an expense, under the straight-line method, over
the requisite service period (generally the vesting period of the equity grant). If the Company determines that other methods are more
reasonable, or other methods for calculating these assumptions are prescribed by regulators, the fair value calculated for the Company’s
stock options could change significantly. Higher volatility, lower risk-free interest rates, and longer expected lives would result in
an increase to stock-based compensation expense to employees and non-employees determined at the date of grant.
Income
Taxes
Deferred
income taxes are recognized for temporary differences in the basis of assets and liabilities for financial statement and income tax reporting
that arise due to net operating loss carry forwards, research and development credit carry forwards and from using different methods
and periods to calculate depreciation and amortization, allowance for doubtful accounts, accrued vacation, research and development expenses,
and state taxes. A provision has been made for income taxes due on taxable income and for the deferred taxes on the temporary differences.
Deferred
tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all
of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws
and rates on the date of enactment. Realization of the deferred income tax asset is dependent on generating sufficient taxable income
in future years.
In
December 2023, the FASB issued Accounting Standards Update 2023-09, Improvements to Income Tax Disclosures, which requires more detailed
income tax disclosures. The guidance requires entities to disclose disaggregated information about their effective tax rate reconciliation
as well as expanded information on income taxes paid by jurisdiction. The disclosure requirements will be applied on a prospective basis,
with the option to apply them retrospectively. The standard is effective for fiscal years beginning after December 15, 2024, with early
adoption permitted. The Company is evaluating the disclosure requirements related to the new standard.
Foreign
Currency Translation
The
functional currency for the Company is the U.S. dollar. The functional currency for the discontinued operations of NanoSynex was the
New Israeli Shekel (NIS). The financial statements of NanoSynex were translated into U.S. dollars using exchange rates in effect at each
period end for assets and liabilities; using exchange rates in effect during the period for results of operations; and using historical
exchange rates for certain equity accounts. The adjustment resulting from translating the financial statements of NanoSynex was reflected
as a separate component of other comprehensive income (loss) (see Note 5 - Discontinued Operations).
Global
Economic Conditions
Ongoing
Wars in Ukraine and Israel
In
February 2022, Russia invaded Ukraine. While the Company has no direct exposure in Russia and Ukraine, the Company continues to monitor
any broader impact to the global economy, including with respect to inflation, supply chains and fuel prices. The full impact of the
conflict on the Company’s business and financial results remains uncertain and will depend on the severity and duration of the
conflict and its impact on regional and global economic conditions.
In
October 2023, Hamas conducted terrorist attacks in Israel resulting in ongoing war. There continue to be hostilities between Israel and
Hezbollah in Lebanon and Hamas in the Gaza Strip, both of which have resulted in rockets being fired into Israel, causing casualties
and disruption of economic activities. In early 2023, there were a number of changes proposed to the political system in Israel by the
current government which, if implemented as planned, could lead to large-scale protests and additional uncertainty, negatively impacting
the operating environment in Israel. Popular uprisings in various countries in the Middle East over the last few years have also affected
the political stability of those countries and have led to a decline in the regional security situation. Such instability may also lead
to deterioration in the political and trade relationships that exist between Israel and these countries. Any armed conflicts, terrorist
activities or political instability involving Israel or other countries in the region could adversely affect the Company’s minority
interest in NanoSynex, its results of operations, financial condition, cash flows and prospects (see Note 5 – Discontinued Operations).
Inflation
and Global Economic Conditions
During
the year ended 2023 and continuing into the current fiscal year, global commodity and labor markets experienced significant inflationary
pressures attributable to government stimulus and recovery programs, government deficit spending and supply chain issues. The Company
cannot provide assurance that it will be successful in fully offsetting increased costs resulting from inflationary pressure. In addition,
the global economy suffers from slowing growth and rising interest rates, and some economists believe that there may be a global recession
in the near future. If the global economy slows, the Company’s business may be adversely affected.
Impact
of COVID-19 Pandemic
The
COVID-19 pandemic has had a dramatic impact on businesses globally and on the Company’s business as well. During the height of
the pandemic, sales of diagnostic products decreased significantly and the Company’s net loss increased significantly, as clinics
and small hospitals’ demand for Qualigen, Inc.’s FastPack™ diagnostic test kits was reduced sharply, largely due to
deferral of patients’ non-emergency visits to physician offices. In July 2023 the Company sold Qualigen, Inc., its wholly-owned
subsidiary, to Chembio (see Note 5 - Discontinued Operations).
Accounting
Standards
Other
accounting standard updates are either not applicable to the Company or are not expected to have a material impact on the Company’s
condensed consolidated financial statements.
NOTE
2 — LIQUIDITY AND GOING CONCERN
As
of June 30, 2024, we had approximately $119,000 in
cash and an accumulated deficit of $120.4
million. For the six months ended June 30, 2024
and year ended December 31, 2023, we used cash of $2.3
million and $10.3
million, respectively, in operations.
The
Company’s cash balances as of the date that these financial statements were issued, without additional financing, are expected
to fund operations into the fourth quarter of 2024. The Company expects to continue to have net losses and negative cash flow from operations,
which will challenge its liquidity. These factors raise substantial doubt about the Company’s ability to continue as a going concern
for the one-year period following the date that these financial statements were issued. There is no assurance that profitable operations
will ever be achieved, or, if achieved, could be sustained on a continuing basis.
Historically,
the Company’s principal sources of cash have included proceeds from the issuance of common and preferred equity and proceeds from
the issuance of debt. In December 2022 the Company raised $3.0 million from the sale of an 8% Senior Convertible Debenture to Alpha and
between February 2024 and April 2024 the Company raised $1.5 million from the sale of Convertible Debentures (see Note 8 - Convertible
Debt - Related Party). In July 2024 the Company raised an additional $2.0 million from the sale of a nonconvertible 18% Senior Note.
There can be no assurance that further financing can be obtained on favorable terms, or at all. If the Company is unable to obtain funding,
the Company could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future
commercialization efforts, which could adversely affect the Company’s business prospects.
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The financial statements
do not include any adjustments that would be necessary should the Company be unable to continue as a going concern, and therefore, be
required to liquidate its assets and discharge its liabilities in other than the normal course of business and at amounts that may differ
from those reflected in the accompanying financial statements.
NOTE
3 — PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets consisted of the following at June 30, 2024 and December 31, 2023:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Prepaid insurance | |
$ | 382,229 | | |
$ | 566,011 | |
Other prepaid expenses | |
| 33,496 | | |
| 25,053 | |
Prepaid research and development expenses | |
| — | | |
| 173,900 | |
Prepaid expenses and
other current assets | |
$ | 415,725 | | |
$ | 764,964 | |
NOTE
4 — OTHER NON-CURRENT ASSETS
Other
non-current assets consisted of the following at June 30, 2024 and December 31, 2023:
SCHEDULE
OF OTHER NON CURRENT ASSETS
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Funds held in escrow | |
$ | — | | |
$ | 450,000 | |
Long-term research and development deposits | |
| — | | |
| 416,481 | |
Other non-current assets | |
$ | — | | |
$ | 866,481 | |
NOTE
5 — DISCONTINUED OPERATIONS
The
summary of gain (loss) from discontinued operations, net of tax, for the three and six months ended June 30, 2023 are as follows:
SCHEDULE
OF GAIN (LOSS) FROM DISCONTINUED OPERATIONS
| |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total |
| |
Three
Months Ended
June 30,
2024 | |
Six Months
Ended
June 30,
2024 | |
Three
Months Ended
June 30,
2023 | |
Six Months
Ended
June 30,
2023 |
| |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
|
Loss on disposal of discontinued operations, net of tax | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | 113,694 | | |
$ | (84,022 | ) | |
$ | 29,672 | | |
$ | (262,478 | ) | |
$ | (580,037 | ) | |
$ | (842,515 | ) |
Income (loss) from discontinued operations, net of tax | |
| (100,000 | ) | |
| — | | |
| (100,000 | ) | |
| (100,000 | ) | |
| — | | |
| (100,000 | ) | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
GAIN (LOSS) FROM DISCONTINUED OPERATIONS | |
$ | (100,000 | ) | |
$ | — | | |
$ | (100,000 | ) | |
$ | (100,000 | ) | |
$ | — | | |
$ | (100,000 | ) | |
$ | 113,694 | | |
$ | (84,022 | ) | |
$ | 29,672 | | |
$ | (262,478 | ) | |
$ | (580,037 | ) | |
$ | (842,515 | ) |
Sale
of Qualigen Inc.
On
July 20, 2023, the Company completed the sale of Qualigen, Inc., its formerly wholly-owned subsidiary, to Chembio Diagnostics, Inc. for
net cash consideration of $5.4 million, of which $4.9 million was received during the year ended December 31, 2023, and $450,000 is being
held in escrow until January 20, 2025 to satisfy certain Company indemnification obligations. On June 4, 2024, the escrow account was
settled early by mutual agreement of the Company and the buyer resulting in cash proceeds to the Company of $350,000 and a loss on disposal
of discontinued operations of $100,000 for the three and six months ending June 30, 2024. There was no other activity related to Qualigen,
Inc. during the three and six months ended June 30, 2024.
There
were no assets and liabilities remaining related to Qualigen, Inc. as of June 30, 2024 or December 31, 2023.
The
Company reclassified the following statement of operations items to discontinued operations for the three and six months ended June 30,
2023:
SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS
| |
For the Three
Months Ended June 30, | | |
For the Six
Months June 30, | |
| |
2023 | | |
2023 | |
REVENUES | |
| | | |
| | |
Net product sales | |
$ | 1,627,031 | | |
$ | 3,234,201 | |
Total revenues | |
| 1,627,031 | | |
| 3,234,201 | |
| |
| | | |
| | |
EXPENSES | |
| | | |
| | |
Cost of product sales | |
| 1,016,543 | | |
| 2,281,368 | |
General and administrative | |
| 238,782 | | |
| 584,214 | |
Research and development | |
| 25,657 | | |
| 204,207 | |
Sales and marketing | |
| 169,223 | | |
| 368,337 | |
Total expenses | |
| 1,450,204 | | |
| 3,438,126 | |
| |
| | | |
| | |
OTHER EXPENSE (INCOME), NET | |
| | | |
| | |
Loss on disposal of equipment held for lease | |
| 63,302 | | |
| 63,302 | |
Other expense (income), net | |
| (169 | ) | |
| (5,049 | ) |
Loss on fixed asset disposal | |
| — | | |
| 300 | |
Total other expense (income), net | |
| 63,133 | | |
| 58,553 | |
| |
| | | |
| | |
INCOME (LOSS) FROM DISCONTINUED OPERATIONS OF QUALIGEN, INC. | |
$ | 113,694 | | |
$ | (262,478 | ) |
Amendment
and Settlement Agreement with NanoSynex Ltd.
On
July 20, 2023, the Company entered into and effectuated the NanoSynex Amendment, reducing its ownership from approximately 52.8% to approximately
49.97% of the voting equity of NanoSynex, and deconsolidation of the subsidiary. On November 22, 2023, the Company further agreed to
eliminate the Company’s obligations to lend additional funds to NanoSynex by surrendering shares of Series A-1 Preferred Stock
of NanoSynex in an amount that reduced the Company’s ownership in NanoSynex voting equity from approximately 49.97% to 39.90%.
On
the date of deconsolidation, the Company recognized its retained investment at fair value, which during the preparation of these financial
statements was determined to be de minimis based on various economic, industry, and other factors. As a result, the Company has discontinued
recognition of its proportionate share of equity method losses following the date of initial recognition. Future equity method earnings,
if any, will not be recognized until the amount exceeds the unrecognized net losses in prior periods.
There
were no assets and liabilities recognized related to NanoSynex as of June 30, 2024 or December 31, 2023.
There
was no activity related to NanoSynex during the three and six months ended June 30, 2024. The Company reclassified the following statement
of operations items to discontinued operations for the three and six months ended June 30, 2023:
SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS
| |
For the Three
Months Ended March 30, | | |
For the Six
Months June 30, | |
| |
2023 | | |
2023 | |
EXPENSES | |
| | | |
| | |
Research and development | |
$ | 126,240 | | |
$ | 787,425 | |
Total expenses | |
| 126,240 | | |
| 787,425 | |
| |
| | | |
| | |
(BENEFIT) PROVISION FOR INCOME TAXES | |
| (42,218 | ) | |
| (207,388 | ) |
| |
| | | |
| | |
LOSS FROM DISCONTINUED OPERATIONS OF NANOSYNEX, LTD. | |
| (84,022 | ) | |
| (580,037 | ) |
| |
| | | |
| | |
Loss attributable to noncontrolling interest | |
| (43,484 | ) | |
| (304,512 | ) |
| |
| | | |
| | |
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS | |
$ | (40,538 | ) | |
$ | (275,525 | ) |
NOTE
6 — ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued
expenses and other current liabilities consisted of the following at June 30, 2024 and December 31, 2023:
SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Board compensation | |
$ | 251,999 | | |
| 129,499 | |
Interest (Convertible debt) | |
| 51,909 | | |
| 10,004 | |
License fees | |
| — | | |
| 32,975 | |
Payroll | |
| 300,481 | | |
| 1,215 | |
Professional fees | |
| 144,528 | | |
| 121,775 | |
Research and development | |
| 17,500 | | |
| 104,402 | |
Vacation | |
| 162,665 | | |
| 151,286 | |
Other | |
| 57,725 | | |
| 8,850 | |
Accrued expenses and
other current liabilities | |
$ | 986,806 | | |
$ | 560,006 | |
NOTE
7 — WARRANT LIABILITIES
In
2004, the Company issued warrants to various investors and brokers for the purchase of Series C preferred stock in connection with a
private placement (the “Series C Warrants”). The Series C Warrants were subsequently extended and, upon closing of the reverse
recapitalization transaction with Ritter, exchanged for warrants to purchase common stock of the Company. The Series C Warrants were
determined to be liability-classified pursuant to the guidance in ASC 480 and ASC 815-40, based on the inclusion of a leveraged ratchet
provision for subsequent dilutive issuances. As of December 31, 2022 there were 1,349,570 Series C Warrants outstanding with an exercise
price of $1.32 per share.
On
December 22, 2022, in conjunction with the issuance of the Debenture to Alpha (see Note 8 – Convertible Debt),
the Company issued to Alpha a warrant to purchase 2,500,000 shares of the Company’s common stock (the “Alpha Warrant”).
The exercise price of the Alpha Warrant was $1.65 (equal to 125% of the conversion price of the Debenture on the closing date). The Alpha
Warrant may be exercised by Alpha, in whole or in part, on or after June 22, 2023 and at any time before June 22, 2028, subject to certain
terms and conditions described in the Alpha Warrant. The fair value of this Alpha Warrant was included in Warrant liabilities-related
party on the Company’s consolidated balance sheet as of December 31, 2022. On December 5, 2023, the Company entered into an Amendment
No. 1 with regard to a Securities Purchase Agreement, with Alpha. This Amendment eliminated certain adjustment provisions of the Warrant.
The Company determined the event resulted in equity classification for the Warrant and, accordingly, the Company remeasured the warrant
liabilities to fair value, and reclassified to noncompensatory equity classified warrants (see Note 12 - Stockholders Equity).
On
November 24, 2023, 1,097,599 Series C Warrants expired, and on December 5, 2023 the remaining Series C Warrants were repriced from an
exercise price of $1.32 per share to an exercise price of $0.73 per share, with 203,652 additional ratchet Series C Warrants issued,
resulting in 455,623 of these Series C Warrants outstanding and exercisable as of December 31, 2023.
On
February 27, 2024, these Series C Warrants were repriced again as a result of a down-round provision triggered by a Securities Purchase
Agreement with Alpha for the purchase of the February 2024 Debenture, from an exercise price of $0.73 per share to an exercise price
of $0.26 per share, with 823,633 additional ratchet Series C Warrants issued, resulting in 1,279,256 of these Series C Warrants outstanding
and exercisable, and on June 26, 2024 the remaining 1,279,256 Series C Warrants expired.
On
April 12, 2024, in connection with an 8%
Convertible Debenture in the principal amount of $1,100,000
issued to Yi Hua Chen (“Chen”) (see Note 8 – Convertible Debt), we issued a liability classified warrant to Chen
purchase 1,800,032
shares of our common stock, exercisable until February 27, 2029, which remains outstanding and exercisable as of June 30, 2024. The warrant is liability classified due to an insufficient number of authorized shares to settle the warrant prior
to the receipt of shareholder approval, which has not yet been obtained. The fair value of the warrant was $565,582 on the issuance date and $260,276 at June 30, 2024. During the three months
ended June 30, 2024, the Company recorded a gain on change in fair value of warrant liabilities of $305,306 for this warrant.
The
following table summarizes the activity in liability classified warrants for the six months ended June 30, 2024:
SCHEDULE OF WARRANTS ACTIVITY
| |
Common Stock Warrants | |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2023 | |
| 455,623 | | |
$ | 0.73 | | |
$ | 0.73 - $0.73 | | |
| 0.49 | |
Granted | |
| 2,623,665 | | |
$ | 0.26 | | |
$ | 0.26 - $0.26 | | |
| 4.67 | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| (1,279,256 | ) | |
$ | 0.26 | | |
$ | 0.26 - $0.26 | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Total outstanding – June 30, 2024 | |
| 1,800,032 | | |
$ | 0.26 | | |
$ | 0.26 - $0.26 | | |
| 4.67 | |
Exercisable | |
| 1,800,032 | | |
$ | 0.26 | | |
$ | 0.26 - $0.26 | | |
| 4.67 | |
The
following table summarizes the activity in liability classified warrants for the six months ended June 30, 2023:
| |
Common Stock Warrants | |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding –December 31, 2022 | |
| 3,849,571 | | |
$ | 1.53 | | |
| $1.32 - $1.65 | | |
| 3.9 | |
Granted | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| — | | |
| — | | |
| — | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Total outstanding – June 30, 2023 | |
| 3,849,571 | | |
$ | 1.53 | | |
| $1.32 - $1.65 | | |
| 3.41 | |
Exercisable | |
| 3,849,571 | | |
$ | 1.53 | | |
| $1.32 - $1.65 | | |
| 3.41 | |
The
following table presents the Company’s fair value hierarchy for its liabilities measured at fair value on a recurring basis as
of June 30, 2024:
SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES
| |
Quoted | | |
| | |
| | |
| |
| |
Market | | |
Significant | | |
| | |
| |
| |
Prices for | | |
Other | | |
Significant | | |
| |
| |
Identical | | |
Observable | | |
Unobservable | | |
| |
| |
Assets | | |
Inputs | | |
Inputs | | |
| |
Common Stock Warrant liabilities | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
Balance as of December 31, 2023 | |
$ | — | | |
$ | — | | |
$ | 54,600 | | |
$ | 54,600 | |
Granted | |
| — | | |
| — | | |
| 565,582 | | |
| 565,582 | |
Exercises | |
| — | | |
| — | | |
| — | | |
| — | |
Gain on change in fair value of warrant liabilities | |
| — | | |
| — | | |
| (359,906 | ) | |
| (359,906 | ) |
Balance as of June 30, 2024 | |
$ | — | | |
$ | — | | |
$ | 260,276 | | |
$ | 260,276 | |
| |
Quoted | | |
| | |
| | |
| |
| |
Market | | |
Significant | | |
| | |
| |
| |
Prices for | | |
Other | | |
Significant | | |
| |
| |
Identical | | |
Observable | | |
Unobservable | | |
| |
| |
Assets | | |
Inputs | | |
Inputs | | |
| |
Derivative Liabilities Arising From Issuance of Convertible Debt | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
Balance as of December 31, 2023 | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | |
Granted | |
| — | | |
| — | | |
| 215,897 | | |
| 215,897 | |
Gain on change in fair value of derivative liabilities | |
| — | | |
| — | | |
| (174,613 | ) | |
| (174,613 | ) |
Balance as of June 30, 2024 | |
$ | — | | |
$ | — | | |
$ | 41,284 | | |
$ | 41,284 | |
There were no transfers of financial assets or liabilities
between category levels for the three and six months ended June 30, 2024.
The
value of the warrant liabilities was based on a valuation received from an independent valuation firm determined using a Monte-Carlo
simulation. For volatility, the Company considers comparable public companies as a basis for its expected volatility to calculate the
fair value of common stock warrants and transitions to its own volatility as the Company develops sufficient appropriate history as a
public company. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected term of the common
stock warrant. The Company uses an expected dividend yield of zero based on the fact that the Company has never paid cash dividends and
does not expect to pay cash dividends in the foreseeable future. Any significant changes in the inputs may result in significantly higher
or lower fair value measurements.
The
following are the weighted average and the range of assumptions used in estimating the fair value of warrant liabilities (weighted average
calculated based on the number of outstanding warrants on each issuance) as of June 30, 2024 and 2023:
SCHEDULE
OF ASSUMPTIONS OF WARRANT LIABILITIES
| |
June 30, 2024 | | |
June 30, 2023 | |
| |
Actual | | |
Range | | |
Weighted Average | |
Risk-free interest rate | |
| 4.38 | % | |
| 4.05% — 5.31% | | |
| 4.49 | % |
Expected volatility (peer group) | |
| 125 | % | |
| 66.3% — 134% | | |
| 110.55 | % |
Term of warrants (in years) | |
| 4.7 | | |
| .39 — 4.98 | | |
| 3.41 | |
Expected dividend yield | |
| 0.00 | % | |
| 0.00 | % | |
| 0.00 | % |
NOTE
8 — CONVERTIBLE DEBT
2022
Convertible Debenture (Related party)
On
December 22, 2022, we issued to Alpha an 8%
Senior Convertible Debenture in the aggregate principal amount of $3,300,000
for a purchase price of $3,000,000
pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022 (the “2022 Securities Purchase
Agreement”). The 2022 Debenture has a maturity date of December
22, 2025 and is convertible, at any time, and from time to time, until the 2022 Debenture is no longer outstanding, at
Alpha’s option, into shares of our common stock (the “Conversion Shares”), at a price initially equal to $1.32
per share, subject to adjustment as described in the 2022 Debenture and other terms and conditions described in the 2022 Debenture.
On July 13, 2023, we obtained stockholder approval, for purposes of complying with Nasdaq Listing Rule 5635(d), for the issuance to
Alpha of more than 20%
of our issued and outstanding shares of common stock pursuant to the terms and conditions of (a) the 2022 Debenture, and (b) the
common stock purchase warrant dated December 22, 2022 issued by us to Alpha. Between January 9 and 12, 2023, we issued 841,726
shares of common stock upon Alpha’s partial conversion of the 2022 Debenture at $1.32
per share for a total of $1,111,078
principal. In October and December 2023, we issued 309,665
shares of common stock to Alpha in lieu of cash for monthly redemption payments on the 2022 Debenture at a weighted average price of
$0.71
per share. During the three months ending March 31, 2024, we issued 1,138,535
shares of common stock to Alpha in lieu of cash for monthly redemption payments on the 2022 Debenture at a weighted average
conversion price of $0.33
per share, with a weighted average fair value of $0.48 per share. During the three months ending June 30, 2024, we issued 2,536,312
shares of common stock to Alpha in lieu of cash for monthly redemption payments on the 2022 Debenture at a weighted average
conversion price of $0.26
per share, with a weighted fair value price of $0.25 per share.
As
of June 30, 2024, approximately 1,518,929 shares of common stock were issuable under the 2022 Debenture, based on the $0.26 per share
figure. The 2022 Debenture includes a beneficial ownership blocker of 9.99%, which may only be waived by Alpha upon 61 days’ notice
to us. Except in respect of an Exempt Issuance (as defined in the 2022 Securities Purchase Agreement), the 2022 Debenture contains a
“ratchet” antidilution provision, with a $0.26 floor.
Commencing
June 1, 2023 (the “Initial Monthly Redemption Date”) and continuing on the first day of each month thereafter until the earlier
of (i) December 22, 2025 and (ii) the full redemption of the 2022 Debenture (each such date, a “Monthly Redemption Date”),
we must redeem $110,000 plus accrued but unpaid interest, liquidated damages and any amounts then owing under the 2022 Debenture (the
“Monthly Redemption Amount”). The Monthly Redemption Amount must be paid in cash; provided that after the first two
monthly redemptions, we may elect to pay all or a portion of a Monthly Redemption Amount in shares of our common stock, based on a conversion
price equal to the lesser of (i) the then conversion price of the 2022 Debenture and (ii) 85% of the average of the VWAPs (as defined
in the 2022 Debenture) for the five consecutive trading days ending on the trading day that is immediately before the applicable Monthly
Redemption Date, subject to the Equity Conditions (as defined in the 2022 Debenture) having been satisfied or waived.
The
2022 Debenture accrues interest at the rate of 8% per annum, which did not begin accruing until December 1, 2023, and will be payable
on a monthly or quarterly basis. Interest may be paid in cash or shares of our common stock or a combination thereof at our option; provided
that interest may only be paid in shares if the Equity Conditions have been satisfied or waived.
In
December 2022, pursuant to the terms of the 2022 Securities Purchase Agreement, we entered into a registration rights agreement with
Alpha (the “Registration Rights Agreement”), pursuant to which we agreed to file one or more registration statements, as
necessary, and to the extent permissible, to register under the Securities Act the resale of the remaining shares (underlying the 2022
Debenture and the 2022 Warrant) not otherwise registered under the Company’s registration statement on Form S-3 (File No. 333-266430).
The Registration Rights Agreement requires that the Company file, within 30 days after signing, a resale registration statement and use
commercially reasonable efforts to cause the resale registration statement to be declared effective by the SEC on or before the 60th
calendar day following the date of signing of the Registration Rights Agreement (or 120 days if such registration statement is
subject to full review by the SEC). We filed a resale registration statement on Form S-3 pursuant to the requirements of the Registration
Rights Agreement on December 2022 (File Number 333-269088), which registration statement was declared effective by the SEC on January
5, 2023. On September 1, 2023, we filed a Post-Effective Amendment No. 1 to Form S-3 on Form S-1 (File No. 333-269088), which Post-Effective
Amendment was declared effective by the SEC on September 7, 2023. On May 1, 2024, we filed a Post-Effective Amendment No. 2 to Form S-1
on Form S-3 (File No. 333-269088), which Post-Effective Amendment was declared effective by the SEC on May 2, 2024.
The
Company evaluated the 2022 Debenture and the 2022 Warrant and determined that the 2022 Warrant is a freestanding financial instrument.
Initially, the 2022 Warrant is not considered indexed to the Company’s own stock, because the settlement amount would not equal
the difference between the fair value of a fixed number of the Company’s equity shares and a fixed strike price and all of the
adjustment features in Section 3(b) of the Alpha Warrant are not down round provisions, as defined in ASU 2017-11. Accordingly, the 2022
Warrant was classified as a liability and recognized at fair value, with subsequent changes in fair value recognized in earnings.
The
proceeds from the 2022 Debenture were allocated to the initial fair value of the 2022 Warrant, with the residual balance allocated to
the initial carrying value of the 2022 Debenture. The Company has not elected the fair value option for the 2022 Debenture. The 2022
Debenture was recognized as proceeds received after allocating the proceeds to the 2022 Warrant, and then allocating remaining proceeds
to a suite of bifurcated embedded derivative features (conversion option, contingent acceleration upon an Event of Default, and contingent
interest upon an Event of Default), with the resulting difference, if any, allocated to the loan host instrument. The suite of derivative
features was measured and determined to have no fair value.
The
original issue discount of $0.3 million, the initial fair value of the 2022 Warrant of $2.8 million, the initial fair value of the suite
of bifurcated embedded derivative features of $0, and the fees and costs paid to Alpha and other third parties of $0.1 million comprised
the debt discount upon issuance. The debt discount is amortized to interest expense over the expected term of the 2022 Debenture using
the effective interest method, in accordance with ASC 835-30. The debt host instrument of the 2022 Debenture will subsequently be measured
at amortized cost using the effective interest method to accrete interest over its term to bring the 2022 Debenture’s initial carrying
value to the principal balance at maturity.
On
December 5, 2023, the Company and Alpha executed Amendment No. 1 with regard to Securities Purchase Agreement (the “SPA Amendment”),
pursuant to which the Company and Alpha agreed to, among other things, reduce the Conversion Price of the 2022 Debenture from $1.32 per
share to $0.73 per share and reduce the exercise price of the 2022 Warrant from $1.65 per share to $0.73 per share, in each case subject
to certain adjustments. In addition, the SPA Amendment revised certain provisions of the 2022 Warrant to (i) limit the circumstances
which would trigger a potential adjustment to the exercise price of the 2022 Warrant and (ii) clarify the treatment of the 2022 Warrant
upon a Fundamental Transaction. The purpose of these revisions was to remove the terms that caused the 2022 Warrant to be liability-classified
under U.S. GAAP. The Company performed an assessment and concluded that all remaining adjustment features in the revised language meet
the FASB’s definition of a down-round feature. In addition, the 2022 Warrant was determined to meet all of the additional requirements
for equity classification. Accordingly, as of December 5, 2023, the Company remeasured the 2022 Warrant to its fair value immediately
prior to the modification and recognized the change in fair value in earnings. The incremental fair value impact from the 2022 Warrant
modification of $0.09 million was included in the Company’s evaluation of the 2022 Debenture modification under ASC 470, discussed
further below. The Company then reclassified the 2022 Warrant liability to equity at its post-modification fair value of $1.6 million.
In
accordance with ASC 470-50, the Company determined that the modified terms of the 2022 Debenture were substantially different when compared
to the original terms that existed prior to the SPA Amendment, and thus the event was required to be accounted for as a debt extinguishment.
Accordingly, the Company derecognized the net carrying value of the original Debenture, and recorded the new debt instrument at its fair
value of $1.4 million, and recorded a $0.6 million loss on debt extinguishment. The difference between the remaining 2022 Debenture principal
and its fair value on December 5, 2023 was recorded as a debt discount and will be amortized to interest expense over the expected term
of the Debenture using the effective interest method, in accordance with ASC 835-30.
During
the three and six months ended June 30, 2024, the Company recognized a gain of approximately $22,000,
and a loss of approximately $125,000
respectively, upon debenture share redemptions, and recorded interest expense of approximately $65,000
and $134,000 (of which
approximately $49,000 and $92,000 was attributable to discount accretion, respectively) for the three and six months ended
June 30, 2024 respectively, in other expenses in the condensed consolidated statements of operations related to the 2022
Debenture. As of June 30, 2024, the fair value of the suite of bifurcated
embedded derivative features related to the 2022 Debenture was approximately $6,000.
During the three and six months ended June 30, 2023, the Company recognized a loss upon voluntary conversion of convertible
debt of approximately $1.1 million, and recorded accrued interest of approximately $383,000 and $945,000, respectively (of which
approximately $364,000 and $898,000 was attributable to discount accretion, respectively) in other expenses in the condensed
consolidated statements of operations related to the 2022 Debenture. As of June 30, 2023, the fair value of the suite of bifurcated embedded
derivative features related to the 2022 Debenture was $0.
2024
Convertible Debenture (Related party)
On
February 27, 2024, upon our receipt of a cash purchase price payment of $500,000
less expenses, we issued to Alpha an 8%
Convertible Debenture (the “2024 Alpha Debenture”) in the principal amount of $550,000.
The 2024 Alpha Debenture matures no later than December 31, 2024 and is convertible, at any time, and from time to time, at
Alpha’s option, into shares of common stock of the Company, at $0.6111
per share, subject to adjustment as described in the 2024 Alpha Debenture. Except in respect of an Exempt Issuance, the 2024 Alpha
Debenture contains a “ratchet” antidilution provision, with an $0.1164
floor. The 2024 Alpha Debenture accrues interest on its outstanding principal balance at the rate of %
per annum, payable at maturity. In connection with this issuance, we also issued to Alpha a noncompensatory equity classified 5-year
common stock purchase warrant to purchase (at $0.26
per share) 900,016
shares of our common stock (see Note 12 - Stockholders Equity (Deficit)).
We
also granted to Alpha an option, exercisable until July 1, 2024, to purchase from us additional 8%
Convertible Debentures, of like tenor, with face amounts of up to an aggregate of $1,100,000
(and with a proportional number of accompanying
common stock warrants of like tenor, up to a total of 1,800,032
additional warrants).
During the three and six months ending June 30, 2024
in connection with the 2024 Alpha Debenture, the Company recorded initial derivative liabilities with a fair value of $858,279, and recorded
interest expense of approximately $173,000 and $238,000, respectively (of which approximately $162,000 and
$222,000 was attributable to discount accretion, respectively) in other expenses in the condensed consolidated statements
of operations related to the 2024 Alpha Debenture. As of June 30, 2024, the fair value of the suite of bifurcated
embedded derivative features related to the 2024 Alpha Debenture was approximately $12,000.
The Securities Purchase Agreement related to the issuance of 2024 Alpha Debenture resulted in down-round provisions
of various warrants being triggered which resulted in reductions of the exercise price of these warrants from $0.73 per share to
$0.26 per share (see Note 7 - Warrant Liabilities and Note 12 - Stockholders Equity (Deficit).
2024
Convertible Debenture
In
April 2024, Alpha assigned its option to Chen and Chen exercised the option in full, in exchange for $1,000,000, less expenses, we
issued to Chen an 8%
Convertible Debenture (the “2024 Chen Debenture”) with a principal amount of $1,100,000.
The 2024 Chen Debenture matures no later than December 31, 2024 and is convertible, at any time, and from time to time, at
Chen’s option, into shares of common stock of the Company, at $0.6111 per
share, subject to adjustment as described in the 2024 Chen Debenture. Except in respect of an Exempt Issuance, the 2024 Chen
Debenture contains a “ratchet” antidilution provision, with an $0.1164 floor.
The 2024 Chen Debenture accrues interest on its outstanding principal balance at the rate of 8%
per annum, payable at maturity. In connection with this issuance, we also issued to Chen a 5-year
liability classified common stock purchase warrant to purchase 1,800,032 shares
of our common stock at $0.26 per
share with an initial fair value of $565,582 (see Note 7 - Warrant Liabilities).
During
the three and six months ending June 30, 2024 in connection with the 2024 Chen Debenture, the Company recorded initial derivative liabilities
with a fair value of $33,243,
and recorded interest expense of approximately $28,000 (of which approximately $8,000 was attributable to discount accretion) in other
expenses in other expenses in the condensed consolidated statements of operations related to the 2024 Chen Debenture.
As of June
30, 2024, the fair value of the suite of bifurcated embedded derivative features related to the 2024 Alpha Debenture was approximately
$24,000. The fair value of the warrant issued
in connection with the 2024 Chen Debenture was approximately $260,000 at June 30, 2024, and during the three and six months ended
June 30, 2024, the Company recorded a gain on change in fair value of warrant liabilities of approximately $305,000
for this warrant.
Convertible
debt is comprised of the following as of June 30, 2024 and December 31, 2023:
SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT
| |
June 30,
2024 | | |
December 31, 2023 | |
Convertible debt | |
$ | 1,100,000 | | |
$ | — | |
Discount on convertible debt | |
| (19,706 | ) | |
| — | |
Total convertible debt | |
$ | 1,080,294 | | |
$ | — | |
| |
June 30,
2024 | | |
December 31, 2023 | |
Convertible debt - related party | |
| 944,922 | | |
| 1,418,922 | |
Convertible debt | |
| 944,922 | | |
| 1,418,922 | |
Discount on convertible debt - related party | |
| (355,205 | ) | |
| (119,706 | ) |
Discount on convertible debt | |
| (355,205 | ) | |
| (119,706 | ) |
Total convertible debt - related party | |
$ | 589,717 | | |
$ | 1,299,216 | |
Total convertible debt | |
$ | 589,717 | | |
$ | 1,299,216 | |
As
of June 30, 2024, there were no events of default or violation of any covenants under our financing obligations.
NOTE
9 — EARNINGS (LOSS) PER SHARE
Basic
loss per share (“EPS”) is computed by dividing net loss by the weighted-average number of common shares outstanding. Diluted
EPS is computed based on the sum of the weighted-average number of common shares and potentially dilutive common shares outstanding during
the period. Potentially dilutive common shares consist of shares issuable from stock options and warrants.
The
following potentially dilutive securities have been excluded from diluted net loss per share as of June 30, 2024 and 2023 because their
effect would be anti-dilutive:
SCHEDULE
OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE
| |
As of June 30, | |
| |
2024 | | |
2023 | |
Shares of common stock subject to outstanding options | |
| 755,715 | | |
| 445,163 | |
Shares of common stock subject to outstanding warrants | |
| 4,741,957 | | |
| 4,119,934 | |
Shares of common stock subject to outstanding convertible debt | |
| 4,218,978 | | |
| — | |
Total common stock equivalents | |
| 9,716,650 | | |
| 4,565,097 | |
NOTE
10 — COMMITMENTS AND CONTINGENCIES
Litigation
and Other Legal Proceedings
From time to time, the Company may be involved in litigation relating to claims arising out of operations in the
normal course of business. As of June 30, 2024, there were no pending or threatened lawsuits that could reasonably be expected to have
a material effect on the results of the Company’s operations.
NOTE
11 — RESEARCH AND LICENSE AGREEMENTS
UCL
Business Limited
In
January 2022, the Company entered into a License Agreement with UCL Business Limited to obtain an exclusive worldwide in-license of a
genomic quadruplex (G4)-selective transcription inhibitor drug development program which had been developed at University College London,
including lead and back-up compounds, preclinical data and a patent estate. (UCL Business Limited is the commercialization company for
University College London.) The program’s lead compound is now being developed at the Company under the name QN-302 as a candidate
for treatment for pancreatic ductal adenocarcinoma, which represents the vast majority of pancreatic cancers. The License Agreement required
a $150,000 upfront payment, reimbursement of past patent prosecution expenses of approximately $160,000, and (if and when applicable)
tiered royalty payments in the low to mid-single digits, clinical/regulatory/sales milestone payments and a percentage of any non-royalty
sublicensing consideration paid to the Company.
For
both the three months ended June 30, 2024 and 2023, there were license costs of $0, and for the six months ended June 30, 2024 and 2023,
there were license costs of approximately $2,000 and $0, respectively, related to this agreement which are included in research and development
expenses in the condensed consolidated statements of operations and other comprehensive loss.
QN-302
Phase 1 Study
In
June 2023, the Company entered into a Master Clinical Research Services Agreement with Translational Drug Development, LLC (“TD2”)
whereby TD2 agreed to perform certain clinical research and development services for the Company including but not limited to trial management,
side identification and selection, site monitoring/management, medical monitoring, project management, data collection, statistical programming
or analysis, quality assurance auditing, scientific and medical communications, regulatory affairs consulting and submissions, strategic
consulting, and/or other related services. From time to time, the Company shall enter into statements of work with TD2 for the performance
of specific services under this Master Clinical Research Services Agreement.
In
June 2023, the Company entered into a Master Laboratory Services Agreement with MLM Medical Labs, LLC (“MLM”) whereby MLM
agreed to perform certain clinical research and development services for the Company including but not limited to laboratory, supply,
testing, validation, data management, and storage services. From time to time, the Company shall enter into work orders with MLM for
the performance of specific services under this Master Laboratory Services Agreement.
In
June 2023, the Company entered into a Master Services Agreement with Clinigen Clinical Supplies Management, Inc. (“Clinigen”)
whereby Clinigen agreed to provide certain pharmaceutical products and/or services. From time to time, the Company shall enter into statements
of work with Clinigen for the performance of specific services under this Master Services Agreement.
In
July 2023, pursuant to the above agreements, the Company entered into work orders and statements of work for clinical trial services
for the conduct of the QN-302 Phase 1 study.
The
University of Louisville Research Foundation
In
March 2019, the Company entered into a sponsored research agreement and an option for a license agreement with University of
Louisville Research Foundation, Inc. (“ULRF”) for development of several small-molecule RAS interaction inhibitor drug
candidates. Under the terms of this agreement, the Company agreed to reimburse ULRF for sponsored research expenses of initially up
to $693,000
for this program. This agreement was amended in February 2021, March 2022 and August 2023, with the current term of this agreement
expired in December 2023 and the aggregate amount that the Company would reimburse ULRF for sponsored research expenses increased to
approximately $2.9
million. In
July 2020, the Company entered into an exclusive license agreement with ULRF for RAS interaction inhibitor drug candidates. Under
the agreement, the Company took over development, regulatory approval and commercialization of the candidates from ULRF and is
responsible for maintenance of the related intellectual property portfolio. In return, ULRF received approximately $112,000 for an
upfront license fee and reimbursement of prior patent costs. In addition, the Company has agreed to pay ULRF (i) royalties, on
patent-covered net sales associated with the commercialization, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net
sales above a cumulative $250,000,000), until expiration of the licensed patent, and 2.5% (on net sales for any sales not covered by
Licensed Patents), (ii) 30% to 50% of any non-royalty sublicensee income received (50% for sublicenses granted in the first two
years of the ULRF license agreement, 40% for sublicenses granted in the third or fourth years of the ULRF license agreement, and 30%
for sublicenses granted in the fifth year of the ULRF license agreement or thereafter), (iii) reimbursements for ongoing costs
associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred prior to July 2020, and (iv)
payments ranging from $50,000
to $5,000,000
upon the achievement of certain regulatory and commercial milestones. Milestone payments for the first therapeutic indication
would be $50,000
for first dosing in a Phase 1 clinical trial, $100,000
for first dosing in a Phase 2 clinical trial, $150,000
for first dosing in a Phase 3 clinical trial, $300,000
for regulatory marketing approval and $5,000,000
upon achieving a cumulative $500,000,000
of Licensed Product sales. The Company also must pay ULRF shortfall payments if the total amounts actually paid with respect to
royalties and non-royalty sublicensee income for any year is less than the applicable annual minimum (ranging from $20,000
to $100,000)
for such year.
Sponsored
research expenses related to these agreements for the three months ended June 30, 2024 and 2023 were both $0, and for the six months
ended June 30, 2024 and 2023 were both $0. License costs were approximately $28,000 and $1,000 related to these agreements for the three
months ended June 30, 2024 and 2023, respectively, and approximately $53,000 and $22,000 related to these agreements for the six months
ended June 30, 2024 and 2023, respectively, and are included in research and development expenses in the condensed consolidated statements
of operations and other comprehensive loss.
Between
June 2018 and April 2022, the Company entered into license and sponsored research agreements with ULRF for QN-247, a novel aptamer-based
compound that has shown promise as an anticancer drug. Under the agreements, the Company took over development, regulatory approval and
commercialization of the compound from ULRF and is responsible for maintenance of the related intellectual property portfolio. In return,
ULRF received a $50,000 convertible promissory note in payment of an upfront license fee, which was subsequently converted into the Company’s
common stock, and the Company agreed to reimburse ULRF for sponsored research expenses of up to approximately $805,000 and prior patent
costs of up to $200,000. In addition, the Company agreed to pay ULRF (i) royalties, on patent-covered net sales associated with the commercialization
of anti-nucleolin agent-conjugated nanoparticles, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net sales above a cumulative
$250,000,000), until expiration of the last to expire of the licensed patents, (ii) 30% to 50% of any non-royalty sublicensee income
received (50% for sublicenses granted in the first two years of the ULRF license agreement, 40% for sublicenses granted in the third
or fourth years of the ULRF license agreement, and 30% for sublicenses granted in the fifth year of the ULRF license agreement or thereafter),
(iii) reimbursements for ongoing costs associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred
prior to June 2018, and (iv) payments ranging from $100,000 to $5,000,000 upon the achievement of certain regulatory and commercial milestones.
Milestone payments for the first therapeutic indication would be $100,000 for first dosing in a Phase 1 clinical trial, $200,000 for
first dosing in a Phase 2 clinical trial, $350,000 for first dosing in a Phase 3 clinical trial, $500,000 for regulatory marketing approval
and $5,000,000 upon achieving a cumulative $500,000,000 of Licensed Product sales. The Company also agreed to pay another $500,000 milestone
payment for any additional regulatory marketing approval for each additional therapeutic (or diagnostic) indication. The Company must
also pay ULRF shortfall payments if the total amounts actually paid with respect to royalties and non-royalty sublicensee income for
any year is less than the applicable annual minimum (ranging from $10,000 to $50,000) for such year.
Sponsored
research expenses related to these agreements for the three months ended June 30, 2024 and 2023 were approximately $0 and $333,000, respectively,
and for the six months ended June 30, 2024 and 2023 were approximately $0 and $556,000, respectively, and are recorded in research and
development expenses in the condensed consolidated statements of operations and other comprehensive loss. License costs related to these
agreements for the three months ended June 30, 2024 and 2023 were approximately $0 and $15,000, respectively, and for the six months
ended June 30, 2024 and 2023 were approximately $1,000 and $29,000, respectively, and are included in research and development expenses
in the condensed consolidated statements of operations and other comprehensive loss.
Marizyme
On
April 11, 2024, we entered into a Co-Development Agreement with Marizyme. Under the Co-Development Agreement (as amended on August 6, 2024), we agreed to pay
Marizyme a Funding Payment of up to $1,750,000
and an Exclusivity Fee of $200,000.
The Exclusivity Fee of $200,000
and a Funding Payment of $500,000
was paid to Marizyme on April 12, 2024. The Exclusivity Fee entitles us to an exclusivity period until May 31, 2024 for purposes of
proposing and outlining a broader strategic relationship with Marizyme with regard to Marizyme’s DuraGraft business. The
Funding Payment is designed to provide financial support for commercialization of Marizyme’s DuraGraft™ vascular conduit
solution, which is indicated for adult patients undergoing coronary artery bypass grafting surgeries and is intended for the
flushing and storage of the saphenous vein grafts used in coronary artery bypass grafting surgery. In
return for the Funding Payment we will receive quarterly a 33% payment in the nature of royalties on any Net Sales (as defined with
a meaning tantamount to gross profit on net sales) of DuraGraft, capped at double the amount of the Funding Payment cash
provided. No such payments-in-the-nature-of-royalties would accrue until after DuraGraft has been launched in the United
States and a cumulative total of $500,000
of DuraGraft Net Sales have been made in the United States.
NOTE
12 — STOCKHOLDERS’ EQUITY
As
of June 30, 2024 and December 31, 2023, the Company had two classes of authorized capital stock: common stock and preferred stock.
Common
Stock
Holders
of common stock generally vote as a class with the holders of the preferred stock and are entitled to one vote for each share held. Subject
to the rights of the holders of the preferred stock to receive preferential dividends, the holders of common stock are entitled to receive
dividends when and if declared by the Board of Directors. Following payment of the liquidation preference of the preferred stock, any
remaining assets will be distributed ratably among the holders of the common stock and, on an as-if-converted basis, the holders of any
preferred stock upon liquidation, dissolution or winding up of the affairs of the Company. The holders of common stock have no preemptive,
subscription or conversion rights and there are no redemption or sinking fund provisions.
At
June 30, 2024, the Company has reserved 9,716,650 shares of authorized but unissued common stock for possible future issuance. At June
30, 2024, shares were reserved in connection with the following:
SCHEDULE
OF RESERVED SHARES
| |
| | |
Exercise of issued and future grants of stock options | |
| 755,715 | |
Conversion of convertible debt | |
| 4,218,978 | |
Exercise of stock warrants | |
| 4,741,957 | |
Total | |
| 9,716,650 | |
Preferred
Stock
At
June 30, 2024 and December 31, 2023, there were no shares of preferred stock outstanding.
Stock
Options and Warrants
Stock
Options
The
Company recognizes all compensatory share-based payments as compensation expense over the service period, which is generally the vesting
period.
In
April 2020, the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which provides for the granting of incentive
or non-statutory common stock options and other types of awards to qualified employees, officers, directors, consultants and other service
providers. At June 30, 2024 and December 31, 2023, there were 337,286 and 398,924 outstanding stock options, respectively, under the
2020 Plan and on such dates there were 418,429 and 356,791 shares reserved under the 2020 Plan, respectively, for future grant.
The
following represents a summary of the options granted (under the 2020 Plan and otherwise) to employees and non-employee service providers
that were outstanding at June 30, 2024, and changes during the six-month period then ended:
SCHEDULE
OF STOCK OPTION ACTIVITY
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2023 | |
| 398,924 | | |
$ | 35.21 | | |
$ | 5.14 — $51.30 | | |
| 7.06 | |
Granted | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| — | | |
| — | | |
| — | | |
| — | |
Forfeited | |
| (61,638 | ) | |
$ | 14.88 | | |
$ | 5.14 — $49.70 | | |
| — | |
Total outstanding – June 30, 2024 | |
| 337,286 | | |
$ | 38.92 | | |
$ | 5.14 — $51.30 | | |
| 6.47 | |
Exercisable (vested) | |
| 283,634 | | |
$ | 45.21 | | |
$ | 5.14 — $51.30 | | |
| 6.18 | |
Non-Exercisable (non-vested) | |
| 53,652 | | |
$ | 5.67 | | |
$ | 5.14 — $12.40 | | |
| 7.99 | |
There
was approximately $92,000 and $0.9 million of compensation cost related to outstanding stock options for the six months ended June 30,
2024 and 2023, respectively. As of June 30, 2024, there was approximately $120,000 of total unrecognized compensation cost related to
unvested stock-based compensation arrangements. This cost is expected to be recognized over a weighted average period of 0.93 years.
The
exercise price for an option issued under the 2020 Plan is determined by the Board of Directors, but will be (i) in the case of an incentive
stock option (A) granted to an employee who, at the time of grant of such option, is a 10% stockholder, no less than 110% of the fair
market value per share on the date of grant; or (B) granted to any other employee, no less than 100% of the fair market value per share
on the date of grant; and (ii) in the case of a non-statutory stock option, no less than 100% of the fair market value per share on the
date of grant. The options awarded under the 2020 Plan will vest as determined by the Board of Directors but will not exceed a
ten-year period. A forfeiture is recognized as incurred if the option holder does not exercise after 90 days following termination
of service.
Fair
Value of Equity Awards
The
Company utilizes the Black-Scholes option pricing model to value awards under its equity plans. Key valuation assumptions include:
● |
Expected
dividend yield. The expected dividend is assumed to be zero, as the Company has never paid dividends and has no current plans
to pay any dividends on the Company’s common stock. |
|
|
● |
Expected
stock-price volatility. The Company’s expected volatility is derived from the average historical volatilities of publicly
traded companies within the Company’s industry that the Company considers to be comparable to the Company’s business
over a period approximately equal to the expected term, because the Company does not have sufficient stock price history over the expected term. |
|
|
● |
Risk-free
interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon
U.S. Treasury notes with maturities approximately equal to the expected term. |
|
|
● |
Expected
term. The expected term represents the period that the stock-based awards are expected to be outstanding. The Company’s
historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because of
a lack of sufficient data. Therefore, the Company estimates the expected term by using the simplified method provided by the SEC.
The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the options. |
The
Company recorded share-based compensation expense and classified it in the unaudited condensed consolidated statements of operations
as follows:
SCHEDULE
OF SHARE-BASED COMPENSATION EXPENSE
| |
2024 |
|
|
2023 |
|
|
2024 | | |
2023 | |
| |
For the Three Months Ended June 30, |
|
|
For the Six Months Ended June
30, | |
| |
2024 |
|
|
2023 |
|
|
2024 | | |
2023 | |
General and administrative | |
$ |
33,042 |
|
|
$ |
604,259 |
|
|
$ | 67,057 | | |
$ | 807,980 | |
Research and development | |
|
44 |
|
|
|
39,641 |
|
|
| 24,680 | | |
| 78,462 | |
Total | |
$ |
33,086 |
|
|
$ |
643,900 |
|
|
$ | 91,737 | | |
$ | 886,442 | |
Equity
Classified Compensatory Warrants
As
part of the May 2020 reverse recapitalization transaction, the Company issued equity classified compensatory common stock warrants to
an advisor and its designees. In addition, various service providers hold equity classified compensatory common stock warrants issued
in 2017 and earlier (originally exercisable to purchase Series C convertible preferred stock, and now instead exercisable to purchase
common stock). These are to be differentiated from the Series C Warrants described in Note 7- Warrant Liabilities.
On
February 27, 2024, as a result of a down-round provision triggered by a Securities Purchase Agreement with Alpha for the purchase of
the February 2024 Debenture, 67,620 warrants were repriced from $0.73 per share exercise price to $0.26 per share exercise price. The
increase in fair value of $9,737 for the modification of these warrants was charged to general and administrative expenses in the Company’s
condensed consolidated statements of operations and comprehensive loss.
No
compensatory warrants were issued during the six months ended June 30, 2024 and June 30, 2023.
The
following table summarizes the activity in the common stock equity classified compensatory warrants for the six months ended June 30,
2024:
SCHEDULE
OF COMPENSATORY WARRANT ACTIVITY
| |
Common Stock | |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2023 | |
| 119,046 | | |
$ | 10.69 | | |
$ | 0.73—$25.40 | | |
| 1.25 | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| (7,261 | ) | |
$ | 20.66 | | |
$ | 20.66—$20.66 | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Total outstanding –June 30, 2024 | |
| 111,785 | | |
$ | 9.40 | | |
$ | 0.26—$25.40 | | |
| 0.83 | |
Exercisable | |
| 111,785 | | |
$ | 9.40 | | |
$ | 0.26—$25.40 | | |
| 0.83 | |
Non-Exercisable | |
| — | | |
| — | | |
| — | | |
| — | |
The
following table summarizes the activity in the common stock equity classified compensatory warrants for the six months ended June 30,
2023:
| |
Common Stock |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2022 | |
| 179,046 | | |
$ | 9.12 | | |
$ | 1.32 — $25.40 | | |
| 1.73 | |
Exercised | |
| — | | |
| | | |
| | | |
| | |
Expired | |
| — | | |
| | | |
| | | |
| | |
Forfeited | |
| — | | |
| | | |
| | | |
| | |
Total outstanding – June 30, 2023 | |
| 179,046 | | |
$ | 9.12 | | |
$ | 1.32 — $25.40 | | |
| 1.24 | |
Exercisable | |
| 179,046 | | |
$ | 9.12 | | |
$ | 1.32 — $25.40 | | |
| 1.24 | |
Non-Exercisable | |
| — | | |
| — | | |
| — | | |
| — | |
There
was $9,737 in compensation cost related to outstanding equity classified compensatory warrants for the six months ended June 30, 2024
and $0 for the six months ended June 30, 2023. As of June 30, 2024 and June 30, 2023, there was no unrecognized compensation cost related
to nonvested warrants.
Noncompensatory
Equity Classified Warrants
On
May 22, 2020, as a commitment fee, the Company issued noncompensatory equity classified warrants to Alpha (a related party) for the purchase
of common stock. 7,048 of these warrants remain outstanding and exercisable as of June 30, 2024 and may be exercised in whole or in part,
at any time before May 22, 2025. On December 22, 2022, in conjunction with the issuance of a debenture to Alpha (see Note 8 – Convertible
Debt), the Company issued to Alpha a warrant to purchase 2,500,000 shares of the Company’s common stock.
The exercise price of this warrant was initially $1.65, and may be exercised in whole or in part, on or after June 22, 2023 and at any
time before June 22, 2028. On December 5, 2023, the Company entered into an Amendment No. 1 with regard to the related Securities Purchase
Agreement, with Alpha. This Amendment reduced the Exercise Price of the December 22, 2022 warrant from $1.65 per share to $0.73 per share.
The Amendment also revised certain provisions of the warrant which resulted in reclassification of the warrant from liabilities to equity.
On
February 27, 2024 the Company entered into a new Securities Purchase Agreement with Alpha for the purchase of the February 2024 Debenture
(see Note 8 – Convertible Debt). This Securities Purchase Agreement resulted in the reduction of the exercise
price of the December 22, 2022 warrant and the May 2020 warrant from $0.73 per share to $0.26 per share. The company recognized a deemed
dividend of $60,017, which represents the incremental fair value of the outstanding warrants as a result of the down-round provision.
As the Company has an accumulated deficit, the deemed dividend was recorded as a reduction in additional paid-in capital, resulting in
a net impact of zero to additional paid-in capital in the condensed consolidated statements of changes in stockholders’ equity.
In addition, on February 27, 2024, the Company issued to Alpha a warrant to purchase 900,016 shares of the Company’s common stock
at an exercise price of $0.26 per share, which may be exercised in whole or in part, at any time before February 27, 2029.
The
following table summarizes the noncompensatory equity classified warrant activity for the six months ended June 30, 2024:
SCHEDULE
OF NON COMPENSATORY WARRANT ACTIVITY
| |
Common Stock |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2023 | |
| 2,507,050 | | |
$ | 0.73 | | |
$ | 0.73 — $0.73 | | |
| 4.47 | |
Granted | |
| 900,016 | | |
$ | 0.26 | | |
| $0.26 — $0.26 | | |
| 4.67 | |
Exercised | |
| (576,924 | ) | |
$ | 0.26 | | |
$ | 0.26 — $0.26 | | |
| — | |
Expired | |
| — | | |
| — | | |
| — | | |
| — | |
Forfeited | |
| (2 | ) | |
$ | 0.26 | | |
$ | 0.26 — $0.26 | | |
| — | |
Total outstanding – June 30, 2024 | |
| 2,830,140 | | |
$ | 0.26 | | |
$ | 0.26 — $0.26 | | |
| 4.19 | |
Exercisable | |
| 2,830,140 | | |
$ | 0.26 | | |
$ | 0.26 — $0.26 | | |
| 4.19 | |
Non-Exercisable | |
| — | | |
| — | | |
| — | | |
| — | |
The
following table summarizes the noncompensatory equity classified warrant activity for the six months ended June 30, 2023:
| |
Common Stock | |
| |
Shares | | |
Weighted–
Average Exercise Price | | |
Range
of Exercise Price | | |
Weighted–
Average Remaining Life (Years) | |
Total outstanding – December 31, 2022 | |
| 547,003 | | |
$ | 19.76 | | |
$ | 1.32
— $20.00 | | |
| 0.33 | |
Legacy Ritter warrants | |
| — | | |
| — | | |
| — | | |
| — | |
Granted | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| (455,685 | ) | |
$ | 20.00 | | |
$ | 20.00
— $20.00 | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Total outstanding – June 30, 2023 | |
| 91,318 | | |
$ | 18.56 | | |
$ | 1.32
— $20.00 | | |
| — | |
Exercisable | |
| 226,150 | | |
$ | 18.56 | | |
$ | 1.32
— $20.00 | | |
| 0.58 | |
Non-Exercisable | |
| — | | |
$ | — | | |
$ | — | | |
| — | |
NOTE
13 — RELATED PARTY TRANSACTIONS
Convertible
Debt
On
December 22, 2022, the Company issued to Alpha, an 8% Senior Convertible Debenture in the aggregate principal amount of $3,300,000 for
a purchase price of $3,000,000 pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022. As of June 30, 2024
the Debenture had a remaining principal balance of $394,921, and was convertible, at any time, and from time to time, at Alpha’s
option, into shares of common stock of the Company, at a price equal to $0.26 per share, subject to adjustment as described in the Debenture
and other terms and conditions described in the Debenture.
Between
July 3 - July 5, 2024, Alpha subsequently converted the remaining principal balance of $394,921 of this Debenture into 1,518,931 shares
of common stock of the Company, at a price equal to $0.26 per share (see Note 14 - Subsequent Events).
On
February 27, 2024, the Company issued to Alpha, an 8% Convertible Debenture in the principal amount of $550,000 for a purchase price
of $500,000 less expenses pursuant to the terms of a Securities Purchase Agreement dated February 26, 2024. As of June 30, 2024 the Debenture
had a remaining principal balance of $550,000, and was convertible, at any time, and from time to time, at Alpha’s option, into
shares of common stock of the Company, at a price equal to $0.6111 per share, subject to adjustment as described in the Debenture and
other terms and conditions described in the Debenture.
See
Note 8 – Convertible Debt for additional information concerning convertible debt – related party transactions.
Warrants
On
May 22, 2020, as a commitment fee, the Company issued warrants to Alpha for the purchase of common stock. As of June 30, 2024, 7,048
of these warrants remain outstanding and exercisable, and may be exercised in whole or in part, at any time before May 22, 2025.
On
December 22, 2022, in conjunction with the issuance of a debenture to Alpha, the Company issued to Alpha a warrant to purchase 2,500,000
shares of the Company’s common stock. As of June 30, 2024, the exercise price of this warrant was $0.26. This warrant may be exercised
by Alpha, in whole or in part, on or after June 22, 2023 and at any time before June 22, 2028, subject to certain terms and conditions
described in the warrant. On May 16, 2024, Alpha partially exercised this warrant to purchase 288,462 shares of the Company’s common
stock at an exercise price of $0.26, and on June 4, 2024, Alpha partially exercised this warrant to purchase 288,462 shares of the Company’s
common stock at an exercise price of $0.26, for total cumulative proceeds to the Company of $ from both exercises.
On
February 27, 2024, in conjunction with the issuance of a debenture to Alpha, the Company issued to Alpha a warrant to purchase 900,016
shares of the Company’s common stock. As of June 30, 2024, the exercise price of the Alpha Warrant was $0.26. The Alpha Warrant
may be exercised by Alpha, in whole or in part, at any time before February 27, 2029, subject to certain terms and conditions described
in the warrant.
The
above warrants are included in equity on the Company’s condensed consolidated balance sheets (see Note 12 – Stockholders’
Equity (Deficit)).
NOTE
14 — SUBSEQUENT EVENTS
Debt
Conversion and Warrant Exercises
Between
July 3 and July 5, 2024, Alpha voluntarily converted the remaining principal balance of $394,921 of the December 2022 8% Senior Convertible
Debenture into 1,518,931 shares of common stock of the Company, at a conversion price of $0.26 per share.
Between
July 5 and July 12, 2024, Alpha partially exercised an equity-classified noncompensatory warrant to purchase 1,023,000 shares of the
Company’s common stock at an exercise price of $0.26 per share, resulting in total cumulative proceeds to the Company of $266,000.
Nonconvertible
Debt and Changes to Board of Directors
The
Company and an institutional investor entered into a Securities Purchase Agreement dated July 5, 2024 (the “Agreement”),
providing for the Company to issue to the investor at par an unsecured, nonconvertible $2,000,000 18% senior note (the “Senior
Note”) with a scheduled maturity date of July 8, 2025. The Senior Note includes a requirement for partial prepayments from a percentage
of any future Company financings. Otherwise, principal and interest on the Senior Note is not payable until maturity. On July 5, 2024,
four independent directors resigned from the Company’s Board of Directors, and the Company’s Board of Directors appointed
three new directors to the Board effective upon the Company’s receipt of the $2,000,000 pursuant to the Agreement, which occurred
on July 12, 2024.
Marizyme
On July 15, 2024, the Company advanced to Marizyme, Inc., a Nevada corporation (“Marizyme”), against which Marizyme had previously
delivered its demand promissory note to the Company of like principal amount dated July 12, 2024 (the “Marizyme Note”). The
Marizyme Note bears interest the rate of eighteen percent (18%) per annum. Marizyme may pre-pay all or any part of the outstanding principal
or interest of the Marizyme Note at any time and from time to time, in whole or in part, without premium or penalty.
Possible
Nasdaq Delisting
On May 23, 2024, the Company received written notice (the “Delist Notice”) from The Nasdaq Stock Market (“Nasdaq”)
indicating the Company’s continued non-compliance with the minimum bid price requirement, pursuant to Listing Rule 5550(b)(2).
As
previously reported, on November 20, 2023, the Company received a letter (the “Bid Price Deficiency Notice”) from Nasdaq
notifying the Company that, because the closing bid price for its common stock has been below $1.00 per share for 30 consecutive business
days, it no longer complies with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. Nasdaq Listing
Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share (the “Bid Price Rule”),
and Listing Rule 5810(c)(3)(A) provides that a failure to meet the Minimum Bid Price Requirement exists if the deficiency continues for
a period of 30 consecutive business days.
Further,
as previously reported, on November 21, 2023, the Company also received a letter from Nasdaq notifying the Company that it did not comply
with the $2,500,000 minimum stockholders’ equity requirement, as set forth in Listing Rule 5550(a)(2) (the “Equity Rule”).
On January 12, 2024, Nasdaq granted the Company an extension of time until May 21, 2024, to regain compliance with the Equity Rule. The
Company has not done so to date. As such, the Delist Notice states that this matter also serves as a separate and additional basis for
delisting the Company’s securities from The Nasdaq Stock Market.
On
July 16, 2024, the Company attended a hearing before the Nasdaq Hearings Panel (the “Panel”) regarding the Company’s potential delisting from The Nasdaq Stock Market due to non-compliance
with the bid price requirement pursuant to the Bid Price Rule and the shareholder equity requirement pursuant to the Equity Rule. On August
2, 2024, the Company received the Panel decision which granted the Company until October 31, 2024 to regain compliance with the Bid Price
Rule and the Equity Rule. If the Company is unable to regain compliance with the listing standards of the Nasdaq Capital Market by October
31, 2024, the Company’s securities may be delisted from The Nasdaq Stock Market.
Settlement
of Outstanding Accounts Payable
On
August 9, 2024, the Company fully settled accounts payable to certain creditors totaling approximately $319,000
for cash payments of approximately $50,000.
Public Offering
On August 7, 2024 and August 9, 2024 the Company filed Amendments to its
Form S-1 Registration Statement for an offering on a “reasonable best efforts” basis of up to $4 million of shares of common
stock.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The
following discussion and analysis should be read in conjunction with our interim unaudited condensed consolidated financial statements
and related notes included in this Quarterly Report on Form 10-Q (this “Quarterly Report”) and the audited financial statements
and notes thereto as of and for the twelve months ended December 31, 2023, which are contained in our Annual Report on Form 10-K filed
with the Securities and Exchange Commission (“SEC”) on April 5, 2024. As used in this Quarterly Report, unless the context
suggests otherwise, “we,” “us,” “our,” or “Qualigen” refer to Qualigen Therapeutics,
Inc. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties
and assumptions.
Cautionary
Note Regarding Forward Looking Statements
This
Quarterly Report contains forward-looking statements by the Company that involve risks and uncertainties and reflect the Company’s
judgment as of the date of this Report. These statements generally relate to future events or the Company’s future financial or
operating performance. In some cases, you can identify forward-looking statements because they contain words such as “may,”
“will,” “should,” “expects,” “plans,” “anticipates,” “could,”
“intends,” “target,” or “continue” or the negative of these words or other similar terms or expressions
that concern the Company’s expectations, strategy, plans or intentions. Such forward-looking statements may relate to, among other
things, potential future development, testing and launch of products and product candidates. Actual events or results may differ from
our expectations due to a number of factors.
Some
of the factors that we believe could cause actual results to differ from those anticipated or predicted include:
| ● | our
ability to procure sufficient working capital to continue and complete the development, testing
and launch of our prospective drug products; |
| ● | our
ability to successfully develop any drugs; |
| ● | our
ability to progress our drug candidates through preclinical and clinical development; |
| ● | our
ability to obtain the requisite regulatory approvals for our clinical trials and to begin
and complete such trials according to any projected timeline; |
| ● | our
ability to complete enrollment in our clinical trials as contemplated by any projected timeline; |
| ● | the
likelihood that future clinical trial data will be favorable or that such trials will confirm
any improvements over other products or lack negative impacts; |
| ● | our
ability to successfully commercialize any drugs; |
| ● | the
likelihood that patents will issue on our in-licensed patent applications; |
| ● | our
ability to protect our intellectual property; and |
By
their nature, forward-looking statements involve risks and uncertainties because they relate to events, competitive dynamics, and healthcare,
regulatory and scientific developments and depend on the economic circumstances that may or may not occur in the future or may occur
on longer or shorter timelines than anticipated. In light of the significant uncertainties in these forward-looking statements, you should
not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each
forward-looking statement contained in this Quarterly Report, we caution you that forward-looking statements are not guarantees of future
performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which
we operate may differ materially from the forward-looking statements contained in this Quarterly Report. In addition, even if our results
of operations, financial condition and liquidity, and the development of the industry in which we operate, are consistent in some future
periods with the forward-looking statements contained in this Quarterly Report, they may not be predictive of results or developments
in other future periods. Any forward-looking statement that we make in this Quarterly Report speaks only as of the date of this Quarterly
Report, and we disclaim any intent or obligation to update these forward-looking statements beyond the date of this Quarterly Report,
except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Future
filings with the Securities and Exchange Commission (the “SEC”), future press releases and future oral or written statements
made by us or with our approval, which are not statements of historical fact, may also contain forward-looking statements. Because such
statements include risks and uncertainties, many of which are beyond our control, actual results may differ materially from those expressed
or implied by such forward-looking statements. The forward-looking statements speak only as of the date on which they are made, and we
undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they
are made.
Overview
We
are an early-clinical-stage therapeutics company focused on developing treatments for adult and pediatric cancer. Our business now consists
of one early-clinical-stage therapeutic program (QN-302) and one preclinical therapeutic program (Pan-RAS).
Our
lead program, QN-302, is an investigational small molecule G-quadruplexes (G4)-selective transcription inhibitor with strong binding
affinity to G4s prevalent in cancer cells (such as pancreatic cancer). Such binding could, by stabilizing the G4s against DNA “unwinding,”
help inhibit cancer cell proliferation. QN-302 is undergoing a Phase 1a clinical trial at START Midwest in Grand Rapids, Michigan, and
HonorHealth in Scottsdale, Arizona.
Our
Pan-RAS program, which is currently at the preclinical stage, consists of a family of RAS oncogene protein-protein interaction inhibitor
small molecules believed to inhibit or block mutated RAS genes’ proteins from binding to their effector proteins thereby leaving
the proteins from the mutated RAS unable to cause further harm. In theory, such mechanism of action may be effective in the treatment
of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers. The investigational compounds
within our Pan-RAS portfolio are designed to suppress the interaction of endogenous RAS with c-RAF, upstream of the KRAS, HRAS and NRAS
effector pathways.
We
do not expect to be profitable before products from our therapeutics pipeline are commercialized. To experience losses while therapeutic
products are still under development is, of course, typical for biotechnology companies.
In
addition, under a Co-Development Agreement dated April 11, 2024 with Marizyme, Inc. (“Marizyme”), we are entitled to receive
quarterly a 33% payment in the nature of royalties (capped at double the amount of Funding Payment cash we provide to Marizyme) on any
Net Sales (as defined with a meaning tantamount to gross profit on net sales) of Marizyme’s DuraGraft™ vascular conduit solution,
which is indicated for adult patients undergoing coronary artery bypass grafting surgeries and is intended for the flushing and storage
of the saphenous vein grafts used in coronary artery bypass grafting surgery. No such payments-in-the-nature-of-royalties would accrue
until after DuraGraft has been launched in the United States and a cumulative total of $500,000 of DuraGraft Net Sales have been made
in the United States. To date we have provided $1,750,000 of Funding Payments to Marizyme (inclusive of a $1,250,000 demand promissory
note dated July 15, 2024 which bears interest at 18% per annum).
Recent
Developments
Phase
1 Clinical Trial of QN-302
On
August 1, 2023, we announced that the FDA has cleared our IND application for QN-302. Based on this clearance, we chose Translational
Drug Development, LLC (“TD2”) to serve as our contract research organization to conduct a Phase 1 clinical trial in patients
with advanced or metastatic solid tumors. The Phase 1 trial (NCT06086522) is designed as a multicenter, open-label, dose escalation,
safety, pharmacokinetic, and pharmacodynamic study with dose expansion to evaluate safety, tolerability, and antitumor activity of QN-302
in patients with advanced solid tumors that have not responded to or that have recurred following treatment with available therapies.
On November 7, 2023, we announced that the first patient had been enrolled and dosed in the dose escalation (Phase 1a) portion of the
study. The exact number of patients to be enrolled in the trial will depend on the observed safety profile, which will determine the
number of patients per dose level, as well as the number of dose escalations required to meet the Maximum Tolerated Dose (“MTD”).
Once the MTD has been established in dose escalation, dose expansion will begin.
Sale
of Diagnostics Business
On
July 20, 2023, we sold all of the issued and outstanding shares of common stock of Qualigen, Inc., a wholly-owned subsidiary and the
legal entity operating our FastPack™ diagnostic business, to Chembio Diagnostics, Inc. (“Chembio”), a subsidiary of
Biosynex, S.A. As consideration for the shares of Qualigen, Inc., we received cash payments of approximately $4.9 million, which payment
is subject to post-closing adjustments. An additional $450,000 was delivered by Chembio to an escrow account to satisfy our indemnification
obligations. The escrow account was closed on June 4, 2024 by mutual agreement; $350,000 was paid to us, and $100,000 was paid to Chembio.
Upon the consummation of the July 2023 transaction, Qualigen, Inc. became a wholly-owned subsidiary of Chembio.
Amendment
and Settlement Agreement with NanoSynex Ltd.
On
July 20, 2023, we entered into and effectuated the NanoSynex Amendment, by which we agreed to, among other things, forfeit 281,000 Series
B Preferred Shares of NanoSynex held by us, resulting in our ownership in NanoSynex being reduced from approximately 52.8% to approximately
49.97% of the voting equity of NanoSynex. In addition, we agreed to cancel approximately $3.0 million of promissory notes which NanoSynex
had issued to us under the NanoSynex Funding Agreement, relieving NanoSynex of any repayment obligations to us with respect to such notes.
The NanoSynex Amendment superseded any NanoSynex Funding Agreement obligations to provide funding to NanoSynex, except we agreed to provide
future loans as follows: (i) $560,000 on or before November 30, 2023, and (ii) $670,000 on or before March 31, 2024. However, on November
22, 2023, in full settlement of any additional funding obligations to NanoSynex, we forfeited certain of our shares of Series A-1 Preferred
Stock of NanoSynex in an amount that reduced our ownership in NanoSynex from approximately 49.97% to 39.90%. Accordingly, NanoSynex was
deconsolidated from our financial statements as of July 20, 2023, and is reported as Discontinued Operations in this Quarterly Report.
Our investment in NanoSynex will be accounted for in the future as an equity method investment.
Marizyme
On
April 11, 2024, we entered into a Co-Development Agreement with Marizyme. Under the Co-Development Agreement (as amended on August 6, 2024), we agreed to pay
Marizyme a Funding Payment of up to $1,750,000 and an Exclusivity Fee of $200,000. The Exclusivity Fee of $200,000 and a Funding
Payment of $500,000 was paid to Marizyme on April 12, 2024. The Exclusivity Fee entitles us to an exclusivity period until May 31,
2024 for purposes of proposing and outlining a broader strategic relationship with Marizyme with regard to Marizyme’s
DuraGraft business. The Funding Payment is designed to provide financial support for commercialization of Marizyme’s
DuraGraft™ vascular conduit solution, which is indicated for adult patients undergoing coronary artery bypass grafting
surgeries and is intended for the flushing and storage of the saphenous vein grafts used in coronary artery bypass grafting surgery.
In return for the Funding Payment we will receive quarterly a 33% payment in the nature of royalties on any Net Sales (as defined
with a meaning tantamount to gross profit on net sales) of DuraGraft, capped at double the amount of the Funding Payment cash
provided. No such payments-in-the-nature-of-royalties would accrue until after DuraGraft has been launched in the United States and
a cumulative total of $500,000 of DuraGraft Net Sales have been made in the United States.
On
July 15, 2024, the Company advanced $1,250,000 to Marizyme, Inc., a Nevada corporation (“Marizyme”), against which Marizyme
had previously delivered its demand promissory note to the Company of like principal amount dated July 12, 2024 (the “Marizyme
Note”). The Marizyme Note bears interest the rate of eighteen percent (18%) per annum. Marizyme may pre-pay all or any part of
the outstanding principal or interest of the Marizyme Note at any time and from time to time, in whole or in part, without premium or
penalty.
Critical
Accounting Policies and Estimates
Our
condensed consolidated financial statements historically have not separated our diagnostics-related activities from our therapeutics-related
activities. All of our historically reported revenue was diagnostics-related. Before the third quarter of 2023, our reported expenses
represented the total of our diagnostics-related and therapeutics-related expenses. In this Quarterly Report, all diagnostics-related
revenues and expenses have been reclassified to discontinued operations (See Note 5 - Discontinued Operations).
This
discussion and analysis is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S.
GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the
reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our condensed
consolidated financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to impairment
of goodwill and other intangible assets, fair value of warrant liabilities, and stock-based compensation. We base our estimates on historical
experience, known trends and events and various other factors we believe to be reasonable under the circumstances, the results of which
form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
Actual results may differ from these estimates under different assumptions or conditions.
While
our significant accounting policies are more fully described in Note 1 to our condensed consolidated financial statements, we believe
that the following accounting policies are the most critical to aid you in fully understanding and evaluating our financial condition
and results of operations:
| ● | Research
and development |
| ● | Derivative
financial instruments and warrant liabilities |
| ● | Stock-based
compensation |
Derivative
Financial Instruments and Warrant Liabilities
On
April 12, 2024, in connection with an 8% Convertible Debenture in the principal amount of $1,100,000 issued to Yi Hua Chen (“Chen”)
(see Note 7 Warrant Liabilities), we issued a liability classified warrant to Chen purchase 1,800,032 shares of our common stock, exercisable
until February 27, 2029, which remains outstanding and exercisable as of June 30, 2024.
The fair value of liability classified warrants will be determined each quarter on a “mark-to-market”
basis, it could result in significant variability in our future quarterly and annual consolidated statement of operations and consolidated
balance sheets based on changes in our public market common stock price. Pursuant to U.S. GAAP, a quarter-to-quarter increase in our stock
price would result in an increase in the fair value of the warrant liabilities and a quarter-to-quarter decrease in our stock price would
result in a decrease in the fair value of the warrant liabilities.
Results
of Operations
Comparison
of the Three Months Ended June 30, 2024 and 2023
The
following table summarizes our results of operations for the three months ended June 30, 2024 and 2023:
| |
For the Three Months June 30, | |
| |
2024 | | |
2023 | |
EXPENSES | |
| | |
| |
General and administrative | |
$ | 986,484 | | |
$ | 2,427,066 | |
Research and development | |
| 754,287 | | |
| 1,174,646 | |
Total expenses | |
| 1,740,771 | | |
| 3,601,712 | |
| |
| | | |
| | |
LOSS FROM OPERATIONS | |
| (1,740,771 | ) | |
| (3,601,712 | ) |
| |
| | | |
| | |
OTHER EXPENSE (INCOME), NET | |
| | | |
| | |
Gain on change in fair value of warrant liabilities | |
| (493,206 | ) | |
| (440,294 | ) |
Gain on change in fair value of derivative liabilities | |
| (10,116 | ) | |
| — | |
Interest expense, net | |
| 263,560 | | |
| 377,416 | |
Loss on issuance of convertible debt | |
| — | | |
| — | |
Gain on voluntary conversion of convertible debt into common stock | |
| (83,800 | ) | |
| — | |
Loss on monthly redemptions of convertible debt into common stock | |
| 61,655 | | |
| — | |
Other income, net | |
| (1,094 | ) | |
| (5,509 | ) |
Total other expense (income), net | |
| (263,001 | ) | |
| (68,387 | ) |
| |
| | | |
| | |
LOSS BEFORE PROVISION FOR INCOME TAXES | |
| (1,477,770 | ) | |
| (3,533,325 | ) |
| |
| | | |
| | |
(BENEFIT) PROVISION FOR INCOME TAXES | |
| (1,212 | ) | |
| 4,036 | |
| |
| | | |
| | |
NET LOSS FROM CONTINUING OPERATIONS | |
| (1,476,558 | ) | |
| (3,537,361 | ) |
| |
| | | |
| | |
DISCONTINUED OPERATIONS | |
| | | |
| | |
Income from discontinued operations, net of tax | |
| — | | |
| 29,672 | |
Loss on disposal from discontinued operations, net of tax | |
| (100,000 | ) | |
| — | |
GAIN (LOSS) FROM DISCONTINUED OPERATIONS | |
| (100,000 | ) | |
| 29,672 | |
| |
| | | |
| | |
NET LOSS | |
| (1,576,558 | ) | |
| (3,507,689 | ) |
| |
| | | |
| | |
Net loss attributable to non-controlling interest from discontinued operations | |
| — | | |
| (43,484 | ) |
| |
| | | |
| | |
Net loss available to Qualigen Therapeutics, Inc. | |
$ | (1,576,558 | ) | |
$ | (3,464,205 | ) |
Deemed dividend arising from warrant down-round provision | |
$ | — | | |
$ | — | |
| |
| | | |
| | |
Net loss attributable to Qualigen Therapeutics, Inc | |
| (1,576,558 | ) | |
| (3,464,205 | ) |
| |
| | | |
| | |
Net loss per common share, basic and diluted - continuing operations | |
$ | (0.20 | ) | |
$ | (0.70 | ) |
Net loss per common share, basic and diluted - discontinued operations | |
$ | (0.01 | ) | |
$ | 0.01 | |
Total net loss per common share, basic and diluted | |
$ | (0.21 | ) | |
$ | (0.69 | ) |
Weighted—average number of shares outstanding, basic and diluted | |
| 7,603,252 | | |
| 5,052,463 | |
| |
| | | |
| | |
Other comprehensive loss, net of tax | |
| | | |
| | |
Net loss | |
$ | (1,576,558 | ) | |
$ | (3,507,689 | ) |
Foreign currency translation adjustment from discontinued operations | |
| — | | |
| (56,747 | ) |
Other comprehensive loss | |
| (1,576,558 | ) | |
| (3,564,436 | ) |
Comprehensive loss attributable to noncontrolling interest from discontinued operations | |
| — | | |
| (43,484 | ) |
Comprehensive loss attributable to Qualigen Therapeutics, Inc. | |
$ | (1,576,558 | ) | |
$ | (3,520,952 | ) |
Expenses
General
and Administrative Expenses
General
and administrative expenses decreased from $2.4 million for the three months ended June 30, 2023, to $1.0 million for the three months
ended June 30, 2024, a decrease of $1.4 million or 59%. This is primarily due to decreases in stock-based compensation of $0.6 million,
payroll of $0.4 million, professional fees of $0.3 million and insurance of $0.1 million.
Research
and Development Costs
Research and development expenses decreased from $1.2 million for the three months ended June 30, 2023, to $0.8 million
for the three months ended June 30, 2024, a decrease of $0.4 million or 36%. This was primarily due to decreases in QN-302 program expenses of $0.6 million, a decrease in RAS program expenses
of $0.3 million, a decrease in payroll of $0.1 million and a decrease in stock-based compensation of $0.1 million, offset by an increase
of $0.7 million in expenses under the Marizyme co-development agreement.
Other
Expense (Income), Net
Gain
on Change in Fair Value of Warrant Liabilities
During
the three months ended June 30, 2024 and 2023, we experienced a gain of approximately $493,000 million and a gain of approximately $440,000 million,
respectively, on change in fair value of warrant liabilities, primarily due to changes in our stock price and expiration of warrants during the current period,
and changes in our stock price in the prior period. Typically, a decline in our stock price would result in a decline in the fair value
of our warrant liabilities, generating a gain, while an increase in our stock price would result in an increase in the fair value of
our warrant liabilities, generating a loss.
Gain
on Change in Fair Value of Derivative Liabilities
During
the three months ended June 30, 2024 we experienced a gain of approximately $10,000 on change in fair value of derivative liabilities, compared to $0 for the three months ended June 30, 2023. The fair
value of derivative liabilities declined during the current period due to changes in our stock price and a reduction in the remaining term of the
underlying instruments. Derivative liabilities in the prior period had no fair value.
Interest
Expense, Net
Interest
expense during the three months ended June 30, 2024 was approximately $264,000 compared to interest expense of approximately
$377,000 during the three months ended June 30, 2023. The decrease was primarily due to reduced accretion of discount on convertible
debt during the current period.
Gain
on Voluntary Conversion of Convertible Debt Into Common Stock
During
the three months ended June 30, 2024, we issued 1,400,000 shares of common stock with a fair value of approximately $280,000, upon Alpha’s
partial voluntary conversion of the 2022 Alpha Debenture at a weighted average share price of $0.26. Upon conversion to shares, we recognized
a gain on voluntary conversion of convertible debt into common stock of approximately $84,000. There were no voluntary conversions of
convertible debt for the three months ended June 30, 2023.
Loss on Monthly Redemptions of Convertible Debt into Common Stock
During
the three months ended June 30, 2024, we issued 1,136,312 shares of common stock with a fair value of approximately $357,000, in lieu
of cash for monthly redemptions of $280,000 principal and approximately $15,000 accrued interest redeemed, pursuant to the terms of the
2022 Alpha Debenture at a weighted average share price of $0.26. Upon redemption in shares, we recognized a loss on monthly redemptions
of convertible debt into common stock of approximately $62,000.
Other
Income, Net
Other
income, net was immaterial during the three months ended June 30, 2024 and 2023.
Discontinued
Operations
There
was a $100,000 loss from discontinued operations during the three months ended June 30, 2024, compared to income from discontinued
operations of approximately $30,000 during the three months ended June 30, 2023. The $100,000 loss from discontinued operations
during the current period was generated from the early settlement of an escrow account from the sale of Qualigen, Inc. The income of
$30,000 from discontinued operations during the three months ended June 30, 2023 consisted of approximately $114,000 in net
income from our former Qualigen, Inc. subsidiary and approximately a net loss of approximately $84,000 from NanoSynex. (See Note 5 -
Discontinued Operations).
There
was no loss attributable to non-controlling interest from discontinued operations during the three months ended June 30, 2024, compared
to a loss attributable to non-controlling interest from discontinued operations of approximately $43,000 during the three months ended
June 30, 2023 (See Note 5 - Discontinued Operations).
Comparison
of the Six Months Ended June 30, 2024 and 2023
The
following table summarizes our results of operations for the six months ended June 30, 2024 and 2023:
| |
For the Six Months June 30, | |
| |
2024 | | |
2023 | |
EXPENSES | |
| | |
| |
General and administrative | |
$ | 2,047,419 | | |
$ | 3,796,068 | |
Research and development | |
| 1,118,672 | | |
| 2,456,463 | |
Total expenses | |
| 3,166,091 | | |
| 6,252,531 | |
| |
| | | |
| | |
LOSS FROM OPERATIONS | |
| (3,166,091 | ) | |
| (6,252,531 | ) |
| |
| | | |
| | |
OTHER EXPENSE (INCOME), NET | |
| | | |
| | |
Gain on change in fair value of warrant liabilities | |
| (359,906 | ) | |
| (1,478,967 | ) |
Gain on change in fair value of derivative liabilities | |
| (174,613 | ) | |
| — | |
Interest expense, net | |
| 400,117 | | |
| 921,652 | |
Loss on issuance of convertible debt | |
| 358,279 | | |
| — | |
(Gain) loss on voluntary conversion of convertible debt into common stock | |
| (83,800 | ) | |
| 1,077,287 | |
Loss on monthly redemptions of convertible debt into common stock | |
| 208,852 | | |
| — | |
Other income, net | |
| (2,713 | ) | |
| (5,509 | ) |
Total other expense (income), net | |
| 346,216 | | |
| 514,463 | |
| |
| | | |
| | |
LOSS BEFORE PROVISION FOR INCOME TAXES | |
| (3,512,307 | ) | |
| (6,766,994 | ) |
| |
| | | |
| | |
(BENEFIT) PROVISION FOR INCOME TAXES | |
| (2,998 | ) | |
| 5,429 | |
| |
| | | |
| | |
NET LOSS FROM CONTINUING OPERATIONS | |
| (3,509,309 | ) | |
| (6,772,423 | ) |
| |
| | | |
| | |
DISCONTINUED OPERATIONS | |
| | | |
| | |
Loss from discontinued operations, net of tax | |
| — | | |
| (842,515 | ) |
Loss on disposal from discontinued operations, net of tax | |
| (100,000 | ) | |
| — | |
LOSS FROM DISCONTINUED OPERATIONS | |
| (100,000 | ) | |
| (842,515 | ) |
| |
| | | |
| | |
NET LOSS | |
| (3,609,309 | ) | |
| (7,614,938 | ) |
| |
| | | |
| | |
Net loss attributable to non-controlling interest from discontinued operations | |
| — | | |
| (304,512 | ) |
| |
| | | |
| | |
Net loss available to Qualigen Therapeutics, Inc. | |
$ | (3,609,309 | ) | |
$ | (7,310,426 | ) |
Deemed dividend arising from warrant down-round provision | |
$ | (60,017 | ) | |
$ | — | |
| |
| | | |
| | |
Net loss attributable to Qualigen Therapeutics, Inc | |
| (3,669,326 | ) | |
| (7,310,426 | ) |
| |
| | | |
| | |
Net loss per common share, basic and diluted - continuing operations | |
$ | (0.53 | ) | |
$ | (1.35 | ) |
Net loss per common share, basic and diluted - discontinued operations | |
$ | (0.01 | ) | |
$ | (0.11 | ) |
Total net loss per common share, basic and diluted | |
$ | (0.54 | ) | |
$ | (1.46 | ) |
Weighted—average number of shares outstanding, basic and diluted | |
| 6,773,533 | | |
| 5,006,050 | |
| |
| | | |
| | |
Other comprehensive loss, net of tax | |
| | | |
| | |
Net loss | |
$ | (3,609,309 | ) | |
$ | (7,614,938 | ) |
Foreign currency translation adjustment from discontinued operations | |
| — | | |
| 119,473 | |
Other comprehensive loss | |
| — | | |
| (7,495,465 | ) |
Comprehensive loss attributable to noncontrolling interest from discontinued operations | |
| (3,609,309 | ) | |
| (304,512 | ) |
Comprehensive loss attributable to Qualigen Therapeutics, Inc. | |
$ | — | | |
$ | (7,190,953 | ) |
Expenses
General
and Administrative Expenses
General
and administrative expenses decreased from approximately $3.8 million, during the six months ended June 30, 2023 to approximately
$2.0 million during the six months ended June 30, 2024, a decrease of approximately $1.8 million or 46%. This decrease was primarily
due to a $0.8 million decrease in stock-based compensation expense, a $0.6 million decrease in professional fees and a $0.4 million
decrease in payroll expenses.
Research
and Development Costs
Research
and development expenses decreased from approximately $2.5 million for the six months ended June 30, 2023, to approximately $1.1
million for the six months ended June 30, 2024, a decrease of $1.4 million or 54%. This was primarily due to an decrease in
QN-302 program costs of $1.2 million, a decrease in RAS program expenses of $0.7 million, and a decrease in wages of $0.2 million,
offset by an increase of $0.7 million in expenses under the Marizyme co-development agreement.
Other
Expense (Income), Net
Gain
on Change in Fair Value of Warrant Liabilities
During
the six months ended June 30, 2024 and 2023, we experienced a gain of approximately $0.4 million, and a gain of approximately $1.5 million,
respectively, on change in fair value of warrant liabilities, primarily due to changes in our stock price and expiration of warrants during the current period,
and changes in our stock price in the prior period. Typically, a decline in our stock price would result in a decline in the fair value
of our warrant liabilities, generating a gain, while an increase in our stock price would result in an increase in the fair value of
our warrant liabilities, generating a loss.
Gain
on Change in Fair Value of Derivative Liabilities
During
the six months ended June 30, 2024, we experienced a gain of approximately $0.2 million on change in fair value of derivative liabilities, compared to $0 for the six months ended June 30, 2023. The fair
value of derivative liabilities declined during the current period due to changes in our stock price and a reduction in the remaining term of the
underlying instruments. Derivative liabilities in the prior period had no fair value.
Interest
Expense
Interest expense during the six months ended June 30,
2024 was approximately $400,000, compared to interest expense of approximately $922,000 during the six months ended June 30, 2023, The
decrease was primarily due to reduced accretion of discount on convertible debt during the current period.
Loss on Issuance of Convertible Debt
During the six months ended June 30, 2024 we incurred
a loss on issuance of convertible debt of approximately $358,000 due to the fair value of the 2024 Alpha Debenture and derivative liabilities
exceeding the cash proceeds.
Gain
on Voluntary Conversion of Convertible Debt Into Common Stock
During
the six months ended June 30, 2024, we issued 1,400,000 shares of common stock with a fair value of approximately $280,000, upon partial voluntary conversion of the 2022 Alpha Debenture at a weighted average share price of $0.26. Upon redemption in shares, we recognized
a gain on voluntary conversion of convertible debt into common stock of approximately $84,000.
During
the six months ended June 30, 2023, we recognized a $1.1 million loss due to a voluntary conversion by Alpha of approximately $1.1 million
of convertible debt into 841,726 shares of common stock.
Loss on Monthly Redemptions of Convertible Debt into Common Stock
During
the six months ended June 30, 2024, we issued 2,274,847 shares of common stock with a fair value of approximately $903,000, in lieu of
cash for monthly redemptions of $660,000 principal and approximately $34,000 accrued interest redeemed, pursuant to the terms of the
2022 Alpha Debenture at a weighted average share price of $0.29. Upon redemption in shares, we recognized a loss on monthly redemptions
of convertible debt into common stock of approximately $209,000.
Other
Income, Net
Other
income, net was immaterial during the six months ended June 30, 2024 and 2023.
Discontinued
Operations
There was a loss from discontinued operations of $0.1
million during the six months ended June 30, 2024, compared to a loss from discontinued operations of approximately $0.8 million during
the six months ended June 30, 2023. The $0.1 million loss from discontinued operations during the six months ended June 30, 2024 was generated
from the early settlement of an escrow account from the sale of Qualigen, Inc. The $0.8 million loss from discontinued operations during
the six months ended June 30, 2023 consisted of approximately a $0.2 million loss from our former Qualigen, Inc. subsidiary and approximately
a $0.6 million loss from NanoSynex (See Note 5 - Discontinued Operations).
There was no loss attributable to non-controlling
interest from discontinued operations during the six months ended June 30, 2024, compared to a loss attributable to non-controlling interest
from discontinued operations of approximately $0.3 million during the six months ended June 30, 2023 (See Note 5 - Discontinued Operations).
Liquidity
and Capital Resources
As
of June 30, 2024, we had approximately $119,000 in cash and an accumulated deficit of $120.4 million. For the six months ended June 30,
2024 and year ended December 31, 2023, we used cash of $2.3 million and $10.3 million, respectively, in operations.
We
currently expect our cash balances to fund operations into the fourth quarter of 2024. We expect to continue to have net losses and negative
cash flow from operations, which will challenge our liquidity. These factors raise substantial doubt regarding our ability to continue
as a going concern for the one-year period following the date that the financial statements in this Quarterly Report were issued. There
is no assurance that we will ever achieve profitable operations, or, if achieved, could be sustained on a continuing basis.
Historically,
our principal sources of cash have, in addition to previous revenue from product sales and license revenues from the FastPack product
of line of Qualigen, Inc. (which we divested in July 2023), included proceeds from the issuance of common and preferred equity and proceeds
from the issuance of debt. There can be no assurance that further financing can be obtained on favorable terms, or at all. If we are
unable to obtain funding, we could be required to delay, reduce or eliminate research and development programs, product portfolio expansion
or future commercialization efforts, and we could be unable to continue operations.
During
the six months ended June 30, 2024 we raised approximately $1.5 million less expenses, in convertible debt. In February 2024 we issued
to Alpha Capital Anstalt (“Alpha”) an 8% Convertible Debenture (the “2024 Alpha Debenture”) with a principal
amount of $550,000; in connection with this issuance, we also issued to Alpha a 5-year common stock purchase warrant to purchase (at
$0.26 per share) 900,016 shares of our common stock. We also granted to Alpha an option, exercisable until July 1, 2024, to purchase
from us additional 8% Convertible Debentures, of like tenor, with face amounts of up to an aggregate of $1,100,000 (and with a proportional
number of accompanying common stock warrants of like tenor, up to a total of 1,800,032 additional warrants). In April 2024, Alpha assigned
this option to Yi Hua Chen (“Chen”) and Chen exercised the option in full; in exchange for $1,000,000 (less expenses) we
issued to Chen an 8% Convertible Debenture with a principal amount of $1,100,000; in connection with this issuance, we also issued to
Chen a 5-year common stock purchase warrant to purchase (at $0.26 per share) 1,800,032 shares of our common stock.
To
the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our
common stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect
the rights of our common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting
our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise
additional funds through third-party funding, commercialization, marketing and distribution arrangements or other collaborations, strategic
alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue
streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. In addition, any future
financing (depending on the terms and conditions) may be subject to the approval of Alpha and Chen under the terms of the Debentures
and/or trigger certain adjustments to the Debentures or warrants held by Alpha and Chen.
In
June 2024, by way of a negotiated early release of escrow, we received $350,000 from the $450,000 escrow account established in connection
with our July 2023 sale of Qualigen, Inc. The escrow account had originally been subject to release in January 2025. In exchange for
the early release, $100,000 from the escrow account was paid to Chembio Diagnostics, Inc., the buyer of Qualigen, Inc.
The
Company and an institutional investor entered into a Securities Purchase Agreement dated July 5, 2024 (the “Agreement”),
providing for the Company to issue to the investor at par an unsecured, nonconvertible $2,000,000 18% senior note (the “Senior
Note”) with a scheduled maturity date of July 8, 2025. The Senior Note includes a requirement for partial prepayments from a percentage
of any future Company financings. Otherwise, principal and interest on the Senior Note is not payable until maturity. On July 12, 2024,
the investor funded the $2,000,000 loan to the Company and the Company issued the Senior Note to the investor.
Delisting of our common stock from Nasdaq would have
a serious negative effect on any future financing efforts. As described in Note 14 in our condensed consolidated financial statements,
a hearing before a Nasdaq Hearing Panel was held on July 16, 2024. On August 2, 2024, the Company received the Panel decision which granted
the Company until October 31, 2024 to regain compliance with the Bid Price Rule and the Equity Rule. If the Company is unable to regain
compliance with the listing standards of Nasdaq by October 31, 2024, the Company’s securities may be delisted from The Nasdaq Stock
Market.
The accompanying financial statements have been prepared
assuming that we will continue as a going concern. The financial statements do not include any adjustments that would be necessary should
we be unable to continue as a going concern, and therefore, be required to liquidate its assets and discharge its liabilities in other
than the normal course of business and at amounts that may differ from those reflected in the accompanying financial statements.
Our current liabilities at June 30, 2024 include approximately
$1.9 million of accounts payable, $1.7 million of convertible debt and derivative liabilities, $1.0 million of accrued expenses and other
current liabilities, $0.3 million in warrant liabilities.
Contractual
Obligations and Commitments
We
have no material contractual obligations that are not fully recorded on our condensed consolidated balance sheets or fully disclosed
in the notes to the financial statements.
License
and Sponsored Research Agreements
We
have obligations under various license and sponsored research agreements to make future payments to third parties that become due and
payable on the achievement of certain development, regulatory and commercial milestones (such as the start of a clinical trial, filing
for product approval with the FDA or other regulatory agencies, product approval by the FDA or other regulatory agencies, product launch
or product sales) or on the sublicense of our rights to another party. We have not included these commitments on our balance sheet because
the achievement and timing of these events is not determinable. Certain milestones are in advance of receipt of revenue from the sale
of products and, therefore, we may require additional debt or equity capital to make such payments.
We
have multiple license agreements with ULRF. Under these agreements, we have taken over development, regulatory
approval and commercialization of various drug compounds from ULRF and are responsible for maintenance of the related intellectual property
portfolio. Under the terms of these agreements, we are required to make patent maintenance payments and payments based upon development,
regulatory and commercial milestones for any products covered by the in-licensed intellectual property. The maximum aggregate milestone
payments we may be obligated to make per product are $5 million. We will also be required to pay a royalty on net sales of products covered
by the in-licensed intellectual property in the low single digits. The royalty is subject to reduction for any third-party payments required
to be made, with a minimum floor in the low single digits. We have the right to sublicense our rights under these agreements, but we
will be required to pay ULRF a percentage of any sublicense income.
In
January 2022, we entered into a License Agreement with UCL Business Limited to obtain an exclusive worldwide in-license of a genomic
quadruplex (G4)-selective transcription inhibitor drug development program which had been developed at University College London, including
lead and back-up compounds, preclinical data and a patent estate. (UCL Business Limited is the commercialization company for University
College London.) We are further developing the program’s lead compound under the name QN-302. The License Agreement requires (if
and when applicable) tiered royalty payments in the low to mid-single digits, clinical/regulatory/sales milestone payments, and sharing
of a percentage of any non-royalty sublicensing consideration paid to the Company. In November 2023, we became obligated to pay $100,000
to UCL Business Limited upon the first patient dosing of QN-302, which was paid in January 2024.
2022
Convertible Debenture
On
December 22, 2022, we issued to Alpha an 8% Senior Convertible Debenture in the aggregate principal amount of $3,300,000 for a
purchase price of $3,000,000 pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022 (the “2022
Securities Purchase Agreement”). The 2022 Debenture has a maturity date of December 22, 2025 and is convertible, at any time,
and from time to time, until the 2022 Debenture is no longer outstanding, at Alpha’s option, into shares of our common stock
(the “Conversion Shares”), at a price initially equal to $1.32 per share, subject to adjustment as described in the 2022
Debenture and other terms and conditions described in the 2022 Debenture. On July 13, 2023, we obtained stockholder approval, for
purposes of complying with Nasdaq Listing Rule 5635(d), for the issuance to Alpha of more than 20% of our issued and outstanding
shares of common stock pursuant to the terms and conditions of (a) the 2022 Debenture, and (b) the common stock purchase warrant
dated December 22, 2022 issued by us to Alpha. Between January 9 - 12, 2023, we issued 841,726 shares of common stock upon
Alpha’s partial conversion of the 2022 Debenture at $1.32 per share for a total of $1,111,078 principal. In October and
December 2023, we issued 309,665 shares of common stock to Alpha in lieu of cash for monthly redemption payments on the 2022
Debenture at a weighted average price of $0.71 per share. During the three months ending March 31, 2024, we issued 1,138,535 shares
of common stock to Alpha in lieu of cash for monthly redemption payments of the 2022 Debenture at a weighted average conversion
price of $0.33 per share, and a weighted average fair value of $0.49 per share, and during the three months ending June 30, 2024, we
issued 2,536,312 shares of common stock to Alpha in lieu of cash for monthly redemption payments of the 2022 Debenture at a weighted
average conversion price of $0.26 per share, and a weighted average fair value of $0.25 per share.
As
of June 30, 2024, approximately 1,518,929 shares of common stock were issuable under the 2022 Debenture, based on the $0.26 per share
figure.
Between
July 3 - 5, 2024, Alpha voluntarily converted the remaining principal balance of $394,921 of the December 2022 8% Senior Convertible
Debenture into 1,518,931 shares of common stock of the Company, at the conversion price of $0.26 per share.
2024
Convertible Debentures
On
February 27, 2024, upon our receipt of a cash purchase price payment of $500,000 (less expenses), we issued to Alpha an 8% Convertible
Debenture (the “2024 Alpha Debenture”) in the principal amount of $550,000. The 2024 Alpha Debenture matures no later than
December 31, 2024 and is convertible, at any time, and from time to time, at Alpha’s option, into shares of common stock of the
Company, at $0.6111 per share, subject to adjustment as described in the 2024 Alpha Debenture. Except in respect of an Exempt Issuance,
the 2024 Alpha Debenture contains a “ratchet” antidilution provision, with an $0.1164 floor. The 2024 Alpha Debenture accrues
interest on its outstanding principal balance at the rate of 8% per annum, payable at maturity. In connection with this issuance, we
also issued to Alpha a 5-year common stock purchase warrant to purchase (at $0.26 per share) 900,016 shares of our common stock.
We also
granted to Alpha an option, exercisable until July 1, 2024, to purchase from us additional 8% Convertible Debentures, of like tenor,
with face amounts of up to an aggregate of $1,100,000 (and with a proportional number of accompanying common stock warrants of like tenor,
up to a total of 1,800,032 additional warrants). On April 11, 2024, Alpha assigned this option to Yi Hua Chen, who exercised it in full
on April 12, 2024 (see Note 8 - Convertible Debt to the Company’s condensed consolidated financial statements).
NanoSynex
Funding Agreement
As
a condition to our acquisition of a majority voting equity interest in NanoSynex from Alpha and NanoSynex, we entered into a Master Agreement
for the Operational and Technological Funding of NanoSynex (the “Funding Agreement”), on May 26, 2022, pursuant to which
we agreed to fund NanoSynex up to an aggregate of approximately $10.4 million, subject to NanoSynex’s achievement of certain performance
milestones specified in the Funding Agreement and the satisfaction of other terms and conditions described in the Funding Agreement.
On
July 20, 2023, we entered into the NanoSynex Amendment, which amended the Funding Agreement, pursuant to which the Company agreed to,
among other things, forfeit 281,000 Series B Preferred Shares of NanoSynex held by the Company, resulting in our ownership in NanoSynex
being reduced from approximately 52.8% to approximately 49.97% of the voting equity of NanoSynex. In addition, we agreed to cancel approximately
$3.0 million of promissory notes which NanoSynex had issued to us under the NanoSynex Funding Agreement, relieving NanoSynex of any repayment
obligations to us with respect to such notes. The surrender of shares reducing our interest in NanoSynex from approximately 52.8% to
approximately 49.97% occurred on July 20, 2023. Accordingly, NanoSynex was deconsolidated from our financial statements as of July 20,
2023, and is reported as Discontinued Operations in this Quarterly Report.
The
NanoSynex Amendment superseded any payment obligations contemplated by the original Funding Agreement and amended our obligations to
provide funding to NanoSynex, except we agreed to provide future funding as follows: (i) $560,000 on or before November 30, 2023, and
(ii) $670,000 on or before March 31, 2024, in each case issued in the form of a promissory note to the Company with a face value in the
amount of such funding. However, on November 22, 2023, in full settlement of any additional funding obligations to NanoSynex, we forfeited
certain of our shares of Series A-1 Preferred Stock of NanoSynex in an amount that reduced our ownership in NanoSynex from approximately
49.97% to 39.90%. Our investment in NanoSynex will be accounted as an equity method investment prospectively from the July 20, 2023 deconsolidation
date.
Marizyme
On
April 11, 2024, we entered into a Co-Development Agreement with Marizyme, Inc. (“Marizyme”). Under the Co-Development
Agreement (as amended on August 6, 2024), we agreed to pay Marizyme a Funding Payment of up to $1,750,000 and an Exclusivity Fee of $200,000. The Exclusivity Fee
of $200,000 and a Funding Payment of $500,000 was paid to Marizyme on April 12, 2024. The Exclusivity Fee entitled us to an
exclusivity period until May 31, 2024 for purposes of proposing and outlining a broader strategic relationship with Marizyme with
regard to Marizyme’s DuraGraft business. The Funding Payment is designed to provide financial support for commercialization of
Marizyme’s DuraGraft™ vascular conduit solution, which is indicated for adult patients undergoing coronary artery bypass
grafting surgeries and is intended for the flushing and storage of the saphenous vein grafts used in coronary artery bypass grafting
surgery. In return for the Funding Payment we will receive quarterly a 33% payment in the nature of royalties on any Net Sales (as
defined with a meaning tantamount to gross profit on net sales) of DuraGraft, capped at double the amount of the Funding Payment
cash provided. No such payments-in-the-nature-of-royalties would accrue until after DuraGraft has been launched in the United States
and a cumulative total of $500,000 of DuraGraft Net Sales have been made in the United States.
On
July 15, 2024, the Company advanced to Marizyme, Inc., a Nevada corporation (“Marizyme”) $1,250,000 against which Marizyme
had previously delivered its demand promissory note to the Company of like principal amount dated July 12, 2024 (the “Marizyme
Note”). The Marizyme Note bears interest the rate of eighteen percent (18%) per annum. Marizyme may pre-pay all or any part of
the outstanding principal or interest of the Marizyme Note at any time and from time to time, in whole or in part, without premium or
penalty.
Other
Service Agreements
We
enter into contracts in the normal course of business, including with clinical sites, contract research organizations, and other professional
service providers for the conduct of clinical trials, contract manufacturers for the production of our product candidates, contract research
service providers for preclinical research studies, professional consultants for expert advice and vendors for the sourcing of clinical
and laboratory supplies and materials. These contracts generally provide for termination on notice, and therefore are cancelable contracts.
Cash
Flows
The
following table sets forth the significant sources and uses of cash for the periods set forth below:
| |
For the Six Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
Net cash (used in) provided by: | |
| | | |
| | |
Operating activities | |
$ | (2,258,118 | ) | |
$ | (5,562,416 | ) |
Investing activities | |
| 350,000 | | |
| (246,418 | ) |
Financing activities | |
| 1,625,000 | | |
| — | |
Effect of exchange rate on cash | |
| — | | |
| 115,803 | |
Net decrease in cash and restricted cash | |
$ | (283,118 | ) | |
$ | (5,693,031 | ) |
Net
Cash Used in Operating Activities
During
the six months ended June 30, 2024, operating activities used $2.3 million of cash, primarily resulting from a loss from continuing
operations of $3.5 million. Cash flows from operating activities for the six months ended June 30, 2024 were positively impacted by
adjustments for $0.4 million loss on issuance of convertible debt, $0.1 million in stock-based compensation expense, $0.3 million in
accretion of discount on convertible debt, $0.2 million loss on monthly redemptions of convertible debt into common stock, and a
$0.8 million decrease in prepaid expenses and other assets and a $0.5 million increase in accrued expenses and other current
liabilities. Cash flows from operating activities for the six months ended June 30, 2024 were negatively impacted by adjustments for
a $0.4 million gain on change in fair value of warrant liabilities, a $0.2 million gain
on change in fair value of derivative liabilities, a $0.1 million gain on voluntary conversion of convertible
debt into common stock and a $0.4 million decrease in accounts payable.
During
the six months ended June 30, 2023, operating activities used $5.6 million of cash, primarily resulting from a loss from continuing
operations of $6.8 million. Cash flows from operating activities for the six months ended June 30, 2023 were positively impacted by
adjustments for $0.9 million in stock-based compensation expense, a $1.1 million loss on voluntary conversion of convertible debt,
accretion of discount of $0.8 million on convertible debt, and a $0.6 million increase in accounts payable, a $0.2 million decrease
in prepaid expenses and other assets and a $0.3 million increase in accrued expenses and other current liabilities. Cash flows from
operating activities for the six months ended June 30, 2023 were negatively impacted by an adjustment for a $1.5 million decrease in
fair value of warrant liabilities and net cash used in discontinued operations of $1.2 million.
Net Cash Provided by (Used in) Investing Activities
During
the six months ended June 30, 2024, net cash provided by investing activities from disposal of discontinued operations was $350,000, due to the early release of escrow from the sale of Qualigen,
Inc.
During
the six months ended June 30, 2023, net cash used in investing activities from discontinued operations was approximately $246,000,
due to purchase of property and equipment.
Net
Cash Provided by Financing Activities
Net
cash provided by financing activities for the six months ended June 30, 2024 was $1,625,000, of which $1,475,000 was due to
issuances of convertible debt, and $150,000 was due to warrant exercises.
Net
cash provided by financing activities for the six months ended June 30, 2023 was $0.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We
are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise
required under this Item.
ITEM
4. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of
our disclosure controls and procedures as of June 30, 2024, the end of the period covered by this Quarterly Report.
Based
on this evaluation, our principal executive officer and principal financial officer have concluded that, due to the material weakness
described below, our disclosure controls and procedures as of June 30, 2024 were not effective to provide reasonable assurance that the
information required to be disclosed by us in reports filed under the Securities Exchange Act of 1934, as amended (the “Exchange
Act’), is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and
that such information is accumulated and communicated to our management, including our principal executive officer and principal financial
officer, as appropriate, to allow timely decisions regarding required disclosure. We believe that a disclosure controls system, no matter
how well designed and operated, cannot provide absolute assurance that the objectives of the disclosure controls system are met, and
no evaluation of disclosure controls can provide absolute assurance that all disclosure control issues, if any, within a company have
been detected.
Changes
in Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f)
and 15d-15(f) under the Securities Exchange Act. Internal control over financial reporting is a process designed under the supervision
and with the participation of our management, including our principal executive officer and principal financial officer, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes
in accordance with U.S. GAAP. As of December 31, 2023, our management assessed the effectiveness of our internal control over financial
reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated
Framework, or 2013 Framework. In connection with the audit of our financial statements as of and for the year ended December 31, 2023,
we identified material weaknesses related to a lack of sufficient number of personnel within our accounting function to adequately segregate
duties, and we have not designed and implemented effective Information Technology General Controls (“ITGC”) related to access
controls to financial accounting systems. We lack the resources to employ additional personnel to help mitigate these material weaknesses
and we foresee that these material weaknesses will not be remediated until we receive additional funding to support our accounting department.
We cannot assure you that these or other measures will fully remediate the material weakness in a timely manner.
There was no change in our internal control over financial reporting in the second quarter of 2024.
Notwithstanding
the identified material weakness, our management believes that the condensed consolidated financial statements included in this Quarterly
Report fairly represent in all material respects our financial condition, results of operations and cash flows at and for the periods
presented in accordance with U.S. GAAP. Nonetheless, we also believe that an internal control system, no matter how well designed and
operated, cannot provide absolute assurance that the objectives of the internal control system are met, and no evaluation of internal
control can provide absolute assurance that all internal control issues and instances of fraud, if any, within a company are detected.
PART
II - OTHER INFORMATION
ITEM
1. LEGAL PROCEEDINGS
We
are not currently involved in any legal matters. From time to time, we could become involved in disputes and various litigation matters
that arise in the normal course of business. These may include disputes and lawsuits related to intellectual property, licensing, contract
law and employee relations matters.
ITEM
1A. RISK FACTORS
The
Company’s business, reputation, results of operations and financial condition, as well as the price of its stock, can be affected
by a number of factors, whether currently known or unknown, including those described in Part I, Item 1A of the Company’s 2023
Annual Report under the heading “Risk Factors.” When any one or more of these risks materialize, the Company’s business,
reputation, results of operations and financial condition, as well as the price of its stock, can be materially and adversely affected.
Except as described below, there have been no material changes to the Company’s risk factors since the 2023 Annual Report.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Unregistered
Sales of Equity Securities
During
the six months ended June 30, 2024, we issued to Alpha Capital Anstalt 1,604,612 shares of unregistered common stock in lieu of cash
for monthly redemptions of $440,000 principal and $24,532 accrued interest redeemed, pursuant to the terms of the 2022 Debenture at a
weighted average share price of $0.29.
Purchases
of Equity Securities by the Issuer and Affiliated Purchasers
None
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM
4. MINE SAFETY DISCLOSURES
Not
Applicable
ITEM
5. OTHER INFORMATION
None
ITEM
6. EXHIBITS
|
|
|
|
Incorporated
by Reference |
Exhibit
No. |
|
Description |
|
Form |
|
File
No. |
|
Exhibit |
|
Filing
Date |
|
|
|
|
|
|
|
|
|
|
|
2.1 |
|
Contingent Value Rights Agreement, dated May 22, 2020, among the Company, John Beck in the capacity of CVR Holders’ Representative and Andrew J. Ritter in his capacity as a consultant to the Company. |
|
8-K |
|
001-37428 |
|
2.4 |
|
5/29/2020 |
|
|
|
|
|
|
|
|
|
|
|
3.1 |
|
Amended and Restated Certificate of Incorporation |
|
8-K |
|
001-37428 |
|
3.1 |
|
7/1/2015 |
|
|
|
|
|
|
|
|
|
|
|
3.2 |
|
Certificate of Amendment to the Amended and Restated Certificate of Incorporation |
|
8-K |
|
001-37428 |
|
3.1 |
|
9/15/2017 |
|
|
|
|
|
|
|
|
|
|
|
3.3 |
|
Certificate of Amendment to the Amended and Restated Certificate of Incorporation |
|
8-K |
|
001-37428 |
|
3.1 |
|
3/22/2018 |
|
|
|
|
|
|
|
|
|
|
|
3.4 |
|
Certificate of Designation of Preferences, Rights and Limitations of Series Alpha Preferred Stock of the Company, filed with the Delaware Secretary of State on May 20, 2020 |
|
8-K |
|
001-37428 |
|
3.1 |
|
5/29/2020 |
|
|
|
|
|
|
|
|
|
|
|
3.5 |
|
Certificate of Amendment to the Certificate of Incorporation of the Company, filed with the Delaware Secretary of State on May 22, 2020 [reverse stock split] |
|
8-K |
|
001-37428 |
|
3.2 |
|
5/29/2020 |
|
|
|
|
|
|
|
|
|
|
|
3.6 |
|
Certificate of Merger, filed with the Delaware Secretary of State on May 22, 2020 |
|
8-K |
|
001-37428 |
|
3.3 |
|
5/29/2020 |
|
|
|
|
|
|
|
|
|
|
|
3.7 |
|
Certificate of Amendment to the Certificate of Incorporation of the Company, filed with the Delaware Secretary of State on May 22, 2020 [name change] |
|
8-K |
|
001-37428 |
|
3.4 |
|
5/29/2020 |
|
|
|
|
|
|
|
|
|
|
|
3.8 |
|
Amended and Restated Bylaws of the Company, through August 10, 2021 |
|
10-Q |
|
001-37428 |
|
3.1 |
|
8/13/2021 |
|
|
|
|
|
|
|
|
|
|
|
3.9 |
|
Certificate of Amendment to the Amended and Restated Certificate of Incorporation, as amended |
|
8-K |
|
001-37428 |
|
3.1 |
|
11/22/2022 |
|
|
|
|
|
|
|
|
|
|
|
4.1 |
|
Warrant, issued by the Company in favor of Alpha Capital Anstalt, dated May 22, 2020 |
|
8-K |
|
001-37428 |
|
10.13 |
|
5/29/2020 |
|
|
|
|
|
|
|
|
|
|
|
4.2 |
|
Form of Warrant, issued by the Company in favor of GreenBlock Capital LLC and its designees, dated May 22, 2020 [post-Merger] |
|
8-K |
|
001-37428 |
|
10.10 |
|
5/29/2020 |
|
|
|
|
|
|
|
|
|
|
|
4.3 |
|
Common Stock Purchase Warrant in favor of Alpha Capital Anstalt, dated July 10, 2020 |
|
8-K |
|
001-37428 |
|
10.2 |
|
7/10/2020 |
|
|
|
|
|
|
|
|
|
|
|
4.4 |
|
Common Stock Purchase Warrant in favor of Alpha Capital Anstalt, dated August 4, 2020 |
|
8-K |
|
001-37428 |
|
10.3 |
|
8/4/2020 |
|
|
|
|
|
|
|
|
|
|
|
4.5 |
|
“Two-Year” Common Stock Purchase Warrant for 1,348,314 shares in favor of Alpha Capital Anstalt, dated December 18, 2020 |
|
8-K |
|
001-37428 |
|
10.3 |
|
12/18/2020 |
4.6 |
|
“Deferred” Common Stock Purchase Warrant for 842,696 shares in favor of Alpha Capital Anstalt, dated December 18, 2020 |
|
8-K |
|
001-37428 |
|
10.4 |
|
12/18/2020 |
|
|
|
|
|
|
|
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|
|
|
4.7 |
|
Form of liability classified Warrant to Purchase Common Stock |
|
10-K |
|
001-37428 |
|
4.13 |
|
3/31/2021 |
|
|
|
|
|
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4.8 |
|
Form of “service provider” compensatory equity classified Warrant |
|
10-K |
|
001-37428 |
|
4.14 |
|
3/31/2021 |
|
|
|
|
|
|
|
|
|
|
|
4.9 |
|
Description of Common Stock |
|
10-K/A |
|
001-37428 |
|
4.9 |
|
7/7/2023 |
|
|
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|
|
|
|
|
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|
|
4.10 |
|
Amended and Restated Common Stock Purchase Warrant to GreenBlock Capital LLC, dated April 25, 2022 |
|
10-Q |
|
001-37428 |
|
4.15 |
|
5/13/2022 |
|
|
|
|
|
|
|
|
|
|
|
4.11 |
|
Amended and Restated Common Stock Purchase Warrant to Christopher Nelson, dated April 25, 2022 |
|
10-Q |
|
001-37428 |
|
4.16 |
|
5/13/2022 |
|
|
|
|
|
|
|
|
|
|
|
4.12 |
|
Common Stock Purchase Warrant for 2,500,000 shares in favor of Alpha Capital Anstalt, dated December 22, 2022 |
|
8-K |
|
001-37428 |
|
4.1 |
|
12/22/2022 |
|
|
|
|
|
|
|
|
|
|
|
4.13 |
|
Common Stock Purchase Warrant for 900,016 shares in favor of Alpha Capital Anstalt, dated February 27, 2024 |
|
8-K |
|
001-37428 |
|
10.3 |
|
2/27/2024 |
|
|
|
|
|
|
|
|
|
|
|
10.1 |
|
Option Exercise dated April 11, 2024 by Yi Hua Chen, acknowledged by Alpha Capital Anstalt and by us |
|
8-K |
|
001-37428 |
|
10.1 |
|
4/16/2024 |
|
|
|
|
|
|
|
|
|
|
|
10.2 |
|
8% Convertible Debenture dated April 12, 2024, issued by us to Yi Hua Chen. |
|
8-K |
|
001-37428 |
|
10.2 |
|
4/16/2024 |
|
|
|
|
|
|
|
|
|
|
|
10.3 |
|
Common Stock Purchase Warrant dated April 12, 2024, issued by us to Yi Hua Chen. |
|
8-K |
|
001-37428 |
|
10.3 |
|
4/16/2024 |
|
|
|
|
|
|
|
|
|
|
|
10.4 |
|
Co-Development Agreement dated April 11, 2024 between Marizyme, Inc. and us. |
|
8-K |
|
001-37428 |
|
10.4 |
|
4/16/2024 |
|
|
|
|
|
|
|
|
|
|
|
31.1* |
|
Certificate of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
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|
|
|
|
|
|
|
|
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|
|
|
|
|
|
31.2* |
|
Certificate of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
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|
|
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|
32.1* |
|
Certificate of principal executive officer and principal financial officer pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
|
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|
|
|
|
|
|
101.INS# |
|
Inline
XBRL Instance Document. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.SCH# |
|
Inline
XBRL Taxonomy Extension Schema Document. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.CAL# |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase Document. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.DEF# |
|
Inline
XBRL Taxonomy Extension Definition Linkbase Document. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.LAB# |
|
Inline
XBRL Taxonomy Extension Label Linkbase Document. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.PRE# |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase Document. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
104 |
|
Cover
page Interactive Data File (embedded within the Inline XBRL document) |
|
|
|
|
|
|
|
|
*
Filed or furnished herewith.
+
Indicates management contract or compensatory plan or arrangement.
#
XBRL (Extensible Business Reporting Language) information is furnished and not filed herewith, is not a part of a registration statement
or Prospectus for purposes of sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of section 18 of the
Securities Exchange Act of 1934, and otherwise is not subject to liability under these sections.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its
behalf by the undersigned thereunto duly authorized.
August
14, 2024 |
QUALIGEN
THERAPEUTICS, INC. |
|
|
|
|
By: |
/s/
Michael S. Poirier |
|
Name: |
Michael
S. Poirier |
|
Title: |
Chief
Executive Officer |
Exhibit
31.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO
SECTION
302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Michael S. Poirier, certify that:
1. |
I
have reviewed this quarterly report on Form 10-Q of Qualigen Therapeutics, Inc., a Delaware corporation; |
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
3. |
Based
on my knowledge, the condensed consolidated financial statements, and other financial information included in this report, fairly
present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for,
the periods presented in this report; |
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant is made known to us by others within those entities, particularly
during the period in which this report is being prepared; |
|
b) |
Designed
such control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of condensed consolidated financial
statements for external purposes with generally accepted accounting principles; |
|
c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
d) |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions): |
|
a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
August
14, 2024 |
By: |
/s/
Michael S. Poirier |
|
Name: |
Michael
S. Poirier |
|
Title: |
Chief
Executive Officer |
Exhibit
31.2
CERTIFICATION
OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO
SECTION
302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Christopher L. Lotz, certify that:
1. |
I
have reviewed this quarterly report on Form 10-Q of Qualigen Therapeutics, Inc., a Delaware corporation; |
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
3. |
Based
on my knowledge, the condensed consolidated financial statements, and other financial information included in this report, fairly
present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for,
the periods presented in this report; |
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant is made known to us by others within those entities, particularly
during the period in which this report is being prepared; |
|
b) |
Designed
such control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of condensed consolidated financial
statements for external purposes with generally accepted accounting principles; |
|
c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
d) |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a) |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
August
14, 2024 |
By: |
/s/
Christopher L. Lotz |
|
Name: |
Christopher
L. Lotz |
|
Title: |
Chief
Financial Officer (Principal Financial Officer) |
Exhibit
32.1
CERTIFICATIONS
PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
Each
of the undersigned, Michael S. Poirier, Chief Executive Officer of Qualigen Therapeutics, Inc., a Delaware corporation (the “Company”),
and Christopher L. Lotz, Chief Financial Officer of the Company, do hereby certify, pursuant to 18 U.S.C. Section 1350 as adopted pursuant
to Section 906 of the Sarbanes- Oxley Act of 2002, that, to his knowledge (1) the quarterly report on Form 10-Q of the Company for the
three months ended June 30, 2024, as filed with the Securities and Exchange Commission on the date hereof (the “Report”),
fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, and (2) the information
contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
August
14, 2024
|
By: |
/s/
Michael S. Poirier |
|
Name: |
Michael
S. Poirier |
|
Title: |
Chief
Executive Officer (Principal Executive Officer) |
August
14, 2024
|
By: |
/s/
Christopher L. Lotz |
|
Name: |
Christopher
L. Lotz |
|
Title: |
Chief
Financial Officer (Principal Financial Officer) |
These
certifications accompanying and being “furnished” with this Report, shall not be deemed “filed” by the Company
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability under that Section and
shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the
Securities Exchange Act of 1934, as amended, whether made before or after the date of this Report, irrespective of any general incorporation
language contained in such filing.
v3.24.2.u1
Cover - $ / shares
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6 Months Ended |
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Jun. 30, 2024 |
Aug. 09, 2024 |
Cover [Abstract] |
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|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-37428
|
|
Entity Registrant Name |
Qualigen
Therapeutics, Inc.
|
|
Entity Central Index Key |
0001460702
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|
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Common
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NASDAQ
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets |
|
|
Cash |
$ 118,685
|
$ 401,803
|
Prepaid expenses and other current assets |
415,725
|
764,964
|
Total current assets |
534,410
|
1,166,767
|
Other assets |
|
866,481
|
Total Assets |
534,410
|
2,033,248
|
Current liabilities |
|
|
Accounts payable |
1,853,896
|
2,222,983
|
Accrued expenses and other current liabilities |
986,806
|
560,006
|
Warrant liabilities |
260,276
|
54,600
|
Total current liabilities |
4,812,273
|
4,136,805
|
Commitments and Contingencies (Note 10) |
|
|
Qualigen Therapeutics, Inc. stockholders’ equity (deficit): |
|
|
Common stock, $0.001 par value; 225,000,000 shares authorized; 9,613,899 and 5,362,128 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively |
47,514
|
43,262
|
Additional paid-in capital |
116,086,316
|
114,655,565
|
Accumulated deficit |
(120,411,693)
|
(116,802,384)
|
Total Stockholders’ Deficit |
(4,277,863)
|
(2,103,557)
|
Total Liabilities & Stockholders’ Deficit |
534,410
|
2,033,248
|
Nonrelated Party [Member] |
|
|
Current liabilities |
|
|
Convertible debt |
1,080,294
|
|
Derivative liabilities |
23,588
|
|
Related Party [Member] |
|
|
Current liabilities |
|
|
Convertible debt |
589,717
|
1,299,216
|
Derivative liabilities |
$ 17,696
|
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
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$ 0.001
|
$ 0.001
|
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225,000,000
|
225,000,000
|
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9,613,899
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v3.24.2.u1
Condensed Consolidated Statements of Operations and Other Comprehensive Loss (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
EXPENSES |
|
|
|
|
General and administrative |
$ 986,484
|
$ 2,427,066
|
$ 2,047,419
|
$ 3,796,068
|
Research and development |
754,287
|
1,174,646
|
1,118,672
|
2,456,463
|
Total expenses |
1,740,771
|
3,601,712
|
3,166,091
|
6,252,531
|
LOSS FROM OPERATIONS |
(1,740,771)
|
(3,601,712)
|
(3,166,091)
|
(6,252,531)
|
OTHER EXPENSE (INCOME), NET |
|
|
|
|
Gain on change in fair value of warrant liabilities |
(493,206)
|
(440,294)
|
(359,906)
|
(1,478,967)
|
Gain on change in fair value of derivative liabilities |
(10,116)
|
|
(174,613)
|
|
Interest expense |
263,560
|
377,416
|
400,117
|
921,652
|
Loss on issuance of convertible debt |
|
|
358,279
|
|
(Gain) loss on voluntary conversion of convertible debt into common stock |
(83,800)
|
|
(83,800)
|
1,077,287
|
Loss on monthly redemptions of convertible debt into common stock |
61,655
|
|
208,852
|
|
Other income, net |
(1,094)
|
(5,509)
|
(2,713)
|
(5,509)
|
Total other expense (income), net |
(263,001)
|
(68,387)
|
346,216
|
514,463
|
LOSS BEFORE PROVISION FOR INCOME TAXES |
(1,477,770)
|
(3,533,325)
|
(3,512,307)
|
(6,766,994)
|
(BENEFIT) PROVISION FOR INCOME TAXES |
(1,212)
|
4,036
|
(2,998)
|
5,429
|
NET LOSS FROM CONTINUING OPERATIONS |
(1,476,558)
|
(3,537,361)
|
(3,509,309)
|
(6,772,423)
|
DISCONTINUED OPERATIONS |
|
|
|
|
Income (loss) from discontinued operations, net of tax |
|
29,672
|
|
(842,515)
|
Loss on disposal of discontinued operations, net of tax |
(100,000)
|
|
(100,000)
|
|
GAIN (LOSS) FROM DISCONTINUED OPERATIONS |
(100,000)
|
29,672
|
(100,000)
|
(842,515)
|
NET LOSS |
(1,576,558)
|
(3,507,689)
|
(3,609,309)
|
(7,614,938)
|
Net loss attributable to non-controlling interest from discontinued operations |
|
(43,484)
|
|
(304,512)
|
Net loss available to Qualigen Therapeutics, Inc. |
(1,576,558)
|
(3,464,205)
|
(3,609,309)
|
(7,310,426)
|
Deemed dividend arising from warrant down-round provision |
|
|
(60,017)
|
|
Net loss attributable to Qualigen Therapeutics, Inc |
$ (1,576,558)
|
$ (3,464,205)
|
$ (3,669,326)
|
$ (7,310,426)
|
Net loss per common share, basic - continuing operations |
$ (0.20)
|
$ (0.70)
|
$ (0.53)
|
$ (1.35)
|
Net loss per common share, diluted - continuing operations |
(0.20)
|
(0.70)
|
(0.53)
|
(1.35)
|
Net loss per common share, basic - discontinued operations |
(0.01)
|
0.01
|
(0.01)
|
(0.11)
|
Net loss per common share, diluted - discontinued operations |
(0.01)
|
0.01
|
(0.01)
|
(0.11)
|
Total net loss per common share, basic |
(0.21)
|
(0.69)
|
(0.54)
|
(1.46)
|
Total net loss per common share, diluted |
$ (0.21)
|
$ (0.69)
|
$ (0.54)
|
$ (1.46)
|
Weighted-average number of shares outstanding, basic |
7,603,252
|
5,052,463
|
6,773,533
|
5,006,050
|
Weighted-average number of shares outstanding, diluted |
7,603,252
|
5,052,463
|
6,773,533
|
5,006,050
|
Other comprehensive loss, net of tax |
|
|
|
|
Net loss |
$ (1,576,558)
|
$ (3,507,689)
|
$ (3,609,309)
|
$ (7,614,938)
|
Foreign currency translation adjustment from discontinued operations |
|
(56,747)
|
|
119,473
|
Other comprehensive loss |
(1,576,558)
|
(3,564,436)
|
(3,609,309)
|
(7,495,465)
|
Comprehensive loss attributable to noncontrolling interest from discontinued operations |
|
(43,484)
|
|
(304,512)
|
Comprehensive loss attributable to Qualigen Therapeutics, Inc. |
$ (1,576,558)
|
$ (3,520,952)
|
$ (3,609,309)
|
$ (7,190,953)
|
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v3.24.2.u1
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
AOCI Attributable to Parent [Member] |
Retained Earnings [Member] |
Parent [Member] |
Noncontrolling Interest [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 42,110
|
$ 110,528,050
|
$ 50,721
|
$ (103,385,172)
|
$ 7,235,709
|
$ 1,530,881
|
$ 8,766,590
|
Balance, shares at Dec. 31, 2022 |
4,210,737
|
|
|
|
|
|
|
Stock-based compensation |
|
247,657
|
|
|
247,657
|
4,569
|
252,226
|
Net loss |
|
|
|
(3,846,221)
|
(3,846,221)
|
(261,028)
|
(4,107,249)
|
Voluntary conversion of convertible debt into common stock |
$ 842
|
1,111,740
|
|
|
1,112,582
|
|
1,112,582
|
Voluntary conversion of convertible debt into common stock, shares |
841,726
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
119,723
|
|
119,723
|
56,497
|
176,220
|
Balance at Mar. 31, 2023 |
$ 42,952
|
111,887,447
|
170,444
|
(107,231,393)
|
4,869,450
|
1,330,919
|
6,200,369
|
Balance, shares at Mar. 31, 2023 |
5,052,463
|
|
|
|
|
|
|
Balance at Dec. 31, 2022 |
$ 42,110
|
110,528,050
|
50,721
|
(103,385,172)
|
7,235,709
|
1,530,881
|
8,766,590
|
Balance, shares at Dec. 31, 2022 |
4,210,737
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
(7,614,938)
|
Balance at Jun. 30, 2023 |
$ 42,952
|
112,554,830
|
131,891
|
(110,695,598)
|
2,034,075
|
1,273,969
|
3,308,044
|
Balance, shares at Jun. 30, 2023 |
5,052,463
|
|
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 42,952
|
111,887,447
|
170,444
|
(107,231,393)
|
4,869,450
|
1,330,919
|
6,200,369
|
Balance, shares at Mar. 31, 2023 |
5,052,463
|
|
|
|
|
|
|
Stock-based compensation |
|
667,383
|
|
|
667,383
|
4,728
|
672,111
|
Net loss |
|
|
|
(3,464,205)
|
(3,464,205)
|
(43,484)
|
(3,507,689)
|
Foreign currency translation adjustment |
|
|
(38,553)
|
|
(38,553)
|
(18,194)
|
(56,747)
|
Balance at Jun. 30, 2023 |
$ 42,952
|
112,554,830
|
131,891
|
(110,695,598)
|
2,034,075
|
1,273,969
|
3,308,044
|
Balance, shares at Jun. 30, 2023 |
5,052,463
|
|
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 43,262
|
114,655,565
|
|
(116,802,384)
|
|
|
(2,103,557)
|
Balance, shares at Dec. 31, 2023 |
5,362,128
|
|
|
|
|
|
|
Monthly redemptions of convertible debt into common stock |
$ 1,138
|
545,094
|
|
|
|
|
546,232
|
Monthly redemptions of convertible debt into common stock, shares |
1,138,535
|
|
|
|
|
|
|
Fair value of warrant modification for professional services |
|
9,737
|
|
|
|
|
9,737
|
Stock-based compensation |
|
58,651
|
|
|
|
|
58,651
|
Net loss |
|
|
|
(2,032,751)
|
|
|
(2,032,751)
|
Balance at Mar. 31, 2024 |
$ 44,400
|
115,269,047
|
|
(118,835,135)
|
|
|
(3,521,688)
|
Balance, shares at Mar. 31, 2024 |
6,500,663
|
|
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 43,262
|
114,655,565
|
|
(116,802,384)
|
|
|
(2,103,557)
|
Balance, shares at Dec. 31, 2023 |
5,362,128
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
(3,609,309)
|
Balance at Jun. 30, 2024 |
$ 47,514
|
116,086,316
|
|
(120,411,693)
|
|
|
(4,277,863)
|
Balance, shares at Jun. 30, 2024 |
9,613,899
|
|
|
|
|
|
|
Balance at Mar. 31, 2024 |
$ 44,400
|
115,269,047
|
|
(118,835,135)
|
|
|
(3,521,688)
|
Balance, shares at Mar. 31, 2024 |
6,500,663
|
|
|
|
|
|
|
Monthly redemptions of convertible debt into common stock |
$ 1,137
|
355,959
|
|
|
|
|
357,096
|
Monthly redemptions of convertible debt into common stock, shares |
1,136,312
|
|
|
|
|
|
|
Stock-based compensation |
|
33,086
|
|
|
|
|
33,086
|
Net loss |
|
|
|
(1,576,558)
|
|
|
(1,576,558)
|
Voluntary conversion of convertible debt into common stock |
$ 1,400
|
278,801
|
|
|
|
|
280,201
|
Voluntary conversion of convertible debt into common stock, shares |
1,400,000
|
|
|
|
|
|
|
Stock issued upon partial exercise of warrants |
$ 577
|
149,423
|
|
|
|
|
150,000
|
Stock issued upon exercise of warrants, shares |
576,924
|
|
|
|
|
|
|
Balance at Jun. 30, 2024 |
$ 47,514
|
$ 116,086,316
|
|
$ (120,411,693)
|
|
|
$ (4,277,863)
|
Balance, shares at Jun. 30, 2024 |
9,613,899
|
|
|
|
|
|
|
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v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
NET LOSS |
$ (3,609,309)
|
$ (7,614,938)
|
Loss from discontinued operations, net of tax |
(100,000)
|
(842,515)
|
Loss from continuing operations |
(3,509,309)
|
(6,772,423)
|
Adjustments to reconcile loss from continuing operations to net cash used in operating activities: |
|
|
Stock-based compensation |
91,737
|
886,442
|
Change in fair value of warrant liabilities |
(359,906)
|
(1,478,967)
|
Change in fair value of derivative liabilities |
(174,613)
|
|
(Gain) loss on voluntary conversion of convertible debt |
(83,800)
|
1,077,287
|
Loss on monthly redemptions of convertible debt into common stock |
208,852
|
|
Accretion of discount on convertible debt |
322,717
|
787,517
|
Loss on issuance of convertible debt |
358,279
|
|
Fair value of warrant modification for professional services |
9,737
|
|
Changes in operating assets and liabilities: |
|
|
Prepaid expenses and other assets |
765,720
|
185,308
|
Accounts payable |
(369,088)
|
630,288
|
Accrued expenses and other current liabilities |
481,556
|
321,973
|
Net cash used in operating activities - continuing operations |
(2,258,118)
|
(4,362,575)
|
Net cash used in operating activities - discontinued operations |
|
(1,199,841)
|
Net cash used in operating activities |
(2,258,118)
|
(5,562,416)
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
Net cash provided by (used in) investing activities - discontinued operations |
350,000
|
(246,418)
|
Net cash provided by (used in) investing activities |
350,000
|
(246,418)
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
Net proceeds from the issuance of convertible notes payable |
1,475,000
|
|
Proceeds from warrant exercises |
150,000
|
|
Net cash provided by financing activities - continuing operations |
1,625,000
|
|
Net cash provided by financing activities - discontinued operations |
|
|
Net cash provided by financing activities |
1,625,000
|
|
Net change in cash and restricted cash |
(283,118)
|
(5,808,834)
|
Effect of exchange rate changes on cash and restricted cash |
|
115,803
|
Cash and restricted cash from continuing operations- beginning of period |
401,803
|
3,165,985
|
Cash and restricted cash from discontinued operations - beginning of period |
|
3,874,139
|
Less: cash and restricted cash from discontinued operations - end of period |
|
(756,456)
|
Cash from continuing operations - end of period |
118,685
|
590,636
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION |
|
|
Interest |
1,020
|
|
Taxes |
2,860
|
|
NONCASH FINANCING AND INVESTING ACTIVITIES: |
|
|
Monthly redemption of convertible debt into common stock |
903,329
|
|
Voluntary conversion of convertible debt into common stock |
280,200
|
1,112,582
|
Deemed dividend arising from warrant down-round provision |
60,017
|
|
Exchange of derivative liability for warrant and convertible debt |
675,625
|
|
Net transfers to equipment held for lease from inventory |
|
$ 35,971
|
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v3.24.2.u1
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES |
NOTE
1 — ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES
Organization
Ritter
Pharmaceuticals, Inc. (the Company’s predecessor) was formed as a Nevada limited liability company on March 29, 2004 under the
name Ritter Natural Sciences, LLC. In September 2008, this company converted into a Delaware corporation under the name Ritter Pharmaceuticals,
Inc. On May 22, 2020, upon completing a “reverse recapitalization” transaction with Qualigen, Inc., Ritter Pharmaceuticals,
Inc. was renamed Qualigen Therapeutics, Inc. (the “Company”). Qualisys Diagnostics, Inc. was formed as a Minnesota corporation
in 1996, reincorporated to become a Delaware corporation in 1999, and then changed its name to Qualigen, Inc. in 2000. Qualigen, Inc.
was a wholly-owned subsidiary of the Company. On July 20, 2023, the Company sold all of the issued and outstanding shares of common stock
of Qualigen, Inc. to Chembio Diagnostics, Inc. (“Chembio”), a wholly-owned subsidiary of Biosynex, S.A. (“Biosynex”).
Following the consummation of this transaction, Qualigen, Inc. became a wholly-owned subsidiary of Chembio (see Note 5 – Discontinued
Operations).
On
May 26, 2022, the Company acquired 2,232,861 shares of Series A-1 Preferred Stock of NanoSynex, Ltd. (“NanoSynex”) from Alpha
Capital Anstalt (“Alpha”), a related party, in exchange for 350,000 reverse split adjusted shares of the Company’s
common stock and a prefunded warrant to purchase 331,464 reverse split adjusted shares of the Company’s common stock at an exercise
price of $0.001 per share. These warrants were subsequently exercised on September 13, 2022. Concurrently with this transaction, the
Company also entered into a Master Funding Agreement for the Operational and Technology Funding of NanoSynex Ltd., dated May 26, 2022,
with NanoSynex (the “NanoSynex Funding Agreement”), to, among other things, provide for the further funding of NanoSynex,
and purchased 381,786 shares of Series B preferred stock from NanoSynex for a total purchase price of $600,000. The transactions resulted
in the Company acquiring a 52.8% interest in NanoSynex (the “NanoSynex Acquisition”). NanoSynex is a nanotechnology diagnostics
company domiciled in Israel. On July 20, 2023, the Company entered into an Amendment and Settlement Agreement with NanoSynex (the “NanoSynex
Amendment”), which amended the NanoSynex Funding Agreement, to, among other things, eliminate most of the Company obligation for
the further funding of NanoSynex. Pursuant to the terms of the NanoSynex Amendment, the Company lost its controlling interest in NanoSynex
(see Note 5 -Discontinued Operations).
Basis
of Presentation
Certain information or footnote disclosures normally included in financial statements prepared in accordance with
GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they
do not include all the information and footnotes necessary for a complete presentation of financial position, results of operations, or
cash flows. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments,
consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results, and
cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements should be read in conjunction
with the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which contains the audited financial statements
and notes thereto. The financial information as of December 31, 2023 is derived from the audited financial statements presented in the
Company’s Annual Report on Form 10-K for the year ended December 31, 2023. The interim results for the three and six months ended
June 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any future periods.
Principles
of Consolidation
The
accompanying condensed consolidated financial statements include the accounts of the Company and its former wholly-owned and majority
owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to
applicable guidance is meant to refer to U.S. GAAP. The Company views its operations and manages its business in one operating segment.
In general, the functional currency of the Company and its subsidiaries is the U.S. dollar. For NanoSynex, the functional currency was
the local currency, New Israeli Shekels (NIS). As such, assets and liabilities for NanoSynex were translated into U.S. dollars with the
effects of foreign currency translation adjustments reflected as a component of accumulated other comprehensive loss within the Company’s
condensed consolidated statements of changes in stockholders’ equity (deficit).
As
of July 20, 2023, NanoSynex was deconsolidated from these financial statements as the transactions contemplated by the NanoSynex Amendment
resulted in a loss of control of a subsidiary that constitutes a business under ASC 810. The retained investment in NanoSynex is accounted
for prospectively as an equity method investment. See Note 5 – Discontinued Operations for further information.
Discontinued
Operations
On
July 20, 2023, the Company completed the sale of Qualigen, Inc. to Chembio Diagnostics, Inc. The sale of Qualigen Inc. constituted a
significant disposition and as such, the Company concluded that the disposition of ownership in Qualigen, Inc. represented a strategic
shift that had a major effect on its operations and financial results. Therefore, Qualigen, Inc. is classified as discontinued operations
for all periods presented herein.
On
July 20, 2023, the Company entered into the NanoSynex Amendment, which amended the Master Funding Agreement for the Operational and Technology
Funding of NanoSynex Ltd., dated May 26, 2022, by and between the Company and NanoSynex (the “NanoSynex Funding Agreement”),
a former majority owned subsidiary of the Company, to, among other things, forfeit 281,000 Series B Preferred Shares of NanoSynex held
by the Company, resulting in the deconsolidation of NanoSynex. The disposition represents a strategic shift that will have a material
effect on the Company’s operations and financial results. Accordingly, the business of NanoSynex is classified as discontinued
operations for all periods presented herein.
See
Note 5 - Discontinued Operations for further information.
Equity
Method Investments
Following
deconsolidation of NanoSynex on July 20, 2023, the Company accounts for its retained investment under the equity method of accounting
as it retained the ability to exercise significant influence over the operating and financial policies of the investee. Under the equity
method, the Company recognizes its proportionate share earnings or losses each reporting period with an adjustment to the carrying value
of the investment. As of December 31, 2023, the carrying value of the retained investment was zero, and therefore the Company has suspended
application of the equity method as the Company is not liable for the obligations of the investee nor otherwise committed to provide
financial support. Future equity method earnings, if any, will not be recognized until the amount exceeds the unrecognized net losses
in prior periods. See Note 5 – Discontinued Operations for further information.
Accounting
Estimates
Management
uses estimates and assumptions in preparing its condensed consolidated financial statements in accordance with U.S. GAAP. Those estimates
and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported
revenues and expenses. The most significant estimates relate to the estimated fair value of in-process research and development, goodwill,
warrant liabilities, and stock-based compensation. Actual results could materially vary from the estimates that were used.
Cash
The
Company considers all highly liquid investments purchased with an initial maturity of 90 days or less and money market funds to be cash
equivalents.
The
Company maintains the majority of its cash in government money market mutual funds and in accounts at banking institutions in the U.S.
that are of high quality. Cash held in these accounts often exceed the Federal Deposit Insurance Corporation (FDIC) insurance limits.
If such banking institutions were to fail, the Company could lose all or a portion of amounts held in excess of such insurance limitations.
In March 2023, Silicon Valley Bank and Signature Bank, and more recently in May 2023, First Republic Bank, were closed due to liquidity
concerns and taken over by the FDIC. While the Company did not have an account at any of these banks, in the event of failure of any
of the financial institutions where the Company maintains its cash and cash equivalents, there can be no assurance that the Company would
be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely
affect the Company’s business and financial position.
Impairment
of Long-Lived Assets
The
Company assesses potential impairments to its long-lived assets when there is evidence that events or changes in circumstances indicate
that assets may not be recoverable. An impairment loss would be recognized when the sum of the expected future undiscounted cash flows
is less than the carrying amount of the assets. The amount of impairment loss, if any, will generally be measured as the difference between
the net book value of the assets and their estimated fair values. During the six months ended June 30, 2024 and 2023, no such impairment
losses have been recorded.
Segment
Reporting
Operating
segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation
by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company
has viewed its operations and managed its business as one segment operating primarily within the United States (and in Israel prior to
the NanoSynex deconsolidation).
Research
and Development
Except
for acquired in process research and development (IPR&D), the Company expenses research and development costs as incurred including
therapeutics license costs.
Patent
Costs
The
Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting
expenses related to making such applications) and such costs are included in general and administrative expenses in the condensed consolidated
statement of operations.
Derivative
Financial Instruments and Warrant Liabilities
The
Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates
all of its financial instruments, including issued stock purchase warrants, to determine if such instruments are derivatives or contain
features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative
instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported
in the condensed consolidated statements of operations and comprehensive loss. Depending on the features of the derivative financial
instrument, the Company uses either the Black-Scholes option-pricing model or a Monte-Carlo simulation to value the derivative instruments
at inception and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should
be recorded as liabilities or as equity, is re-assessed at the end of each reporting period (See Note 7-Warrant Liabilities and Note
8- Convertible Debt).
Fair
Value Measurements
The
Company determines the fair value measurements of applicable assets and liabilities based on a three-tier fair value hierarchy established
by accounting guidance and prioritizes the inputs used in measuring fair value. The Company discloses and recognizes the fair value of
its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy
gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level
1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements).
The guidance establishes three levels of the fair value hierarchy as follows:
|
● |
Level
1 - Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability
to access at the measurement date; |
|
|
|
|
● |
Level
2 - Inputs other than quoted prices that are observable for the assets or liability either directly or indirectly, including inputs
in markets that are not considered to be active; and |
|
|
|
|
● |
Level
3 - Inputs that are unobservable. |
Fair
Value of Financial Instruments
Cash,
accounts receivable, prepaids, accounts payable, and accrued liabilities are carried at cost, which management believes approximates
fair value due to the short-term nature of these instruments.
Comprehensive
Loss
Comprehensive
loss consists of net income and foreign currency translation adjustments related to the discontinued operations of NanoSynex. Comprehensive
gains (losses) have been reflected in the statements of operations and comprehensive loss and as a separate component in the statements
of stockholders’ equity (deficit) for all periods presented.
Stock-Based
Compensation
Stock-based
compensation cost for equity awards granted to employees and non-employees is measured at the grant date based on the calculated fair
value of the award using the Black-Scholes option-pricing model, and is recognized as an expense, under the straight-line method, over
the requisite service period (generally the vesting period of the equity grant). If the Company determines that other methods are more
reasonable, or other methods for calculating these assumptions are prescribed by regulators, the fair value calculated for the Company’s
stock options could change significantly. Higher volatility, lower risk-free interest rates, and longer expected lives would result in
an increase to stock-based compensation expense to employees and non-employees determined at the date of grant.
Income
Taxes
Deferred
income taxes are recognized for temporary differences in the basis of assets and liabilities for financial statement and income tax reporting
that arise due to net operating loss carry forwards, research and development credit carry forwards and from using different methods
and periods to calculate depreciation and amortization, allowance for doubtful accounts, accrued vacation, research and development expenses,
and state taxes. A provision has been made for income taxes due on taxable income and for the deferred taxes on the temporary differences.
Deferred
tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all
of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws
and rates on the date of enactment. Realization of the deferred income tax asset is dependent on generating sufficient taxable income
in future years.
In
December 2023, the FASB issued Accounting Standards Update 2023-09, Improvements to Income Tax Disclosures, which requires more detailed
income tax disclosures. The guidance requires entities to disclose disaggregated information about their effective tax rate reconciliation
as well as expanded information on income taxes paid by jurisdiction. The disclosure requirements will be applied on a prospective basis,
with the option to apply them retrospectively. The standard is effective for fiscal years beginning after December 15, 2024, with early
adoption permitted. The Company is evaluating the disclosure requirements related to the new standard.
Foreign
Currency Translation
The
functional currency for the Company is the U.S. dollar. The functional currency for the discontinued operations of NanoSynex was the
New Israeli Shekel (NIS). The financial statements of NanoSynex were translated into U.S. dollars using exchange rates in effect at each
period end for assets and liabilities; using exchange rates in effect during the period for results of operations; and using historical
exchange rates for certain equity accounts. The adjustment resulting from translating the financial statements of NanoSynex was reflected
as a separate component of other comprehensive income (loss) (see Note 5 - Discontinued Operations).
Global
Economic Conditions
Ongoing
Wars in Ukraine and Israel
In
February 2022, Russia invaded Ukraine. While the Company has no direct exposure in Russia and Ukraine, the Company continues to monitor
any broader impact to the global economy, including with respect to inflation, supply chains and fuel prices. The full impact of the
conflict on the Company’s business and financial results remains uncertain and will depend on the severity and duration of the
conflict and its impact on regional and global economic conditions.
In
October 2023, Hamas conducted terrorist attacks in Israel resulting in ongoing war. There continue to be hostilities between Israel and
Hezbollah in Lebanon and Hamas in the Gaza Strip, both of which have resulted in rockets being fired into Israel, causing casualties
and disruption of economic activities. In early 2023, there were a number of changes proposed to the political system in Israel by the
current government which, if implemented as planned, could lead to large-scale protests and additional uncertainty, negatively impacting
the operating environment in Israel. Popular uprisings in various countries in the Middle East over the last few years have also affected
the political stability of those countries and have led to a decline in the regional security situation. Such instability may also lead
to deterioration in the political and trade relationships that exist between Israel and these countries. Any armed conflicts, terrorist
activities or political instability involving Israel or other countries in the region could adversely affect the Company’s minority
interest in NanoSynex, its results of operations, financial condition, cash flows and prospects (see Note 5 – Discontinued Operations).
Inflation
and Global Economic Conditions
During
the year ended 2023 and continuing into the current fiscal year, global commodity and labor markets experienced significant inflationary
pressures attributable to government stimulus and recovery programs, government deficit spending and supply chain issues. The Company
cannot provide assurance that it will be successful in fully offsetting increased costs resulting from inflationary pressure. In addition,
the global economy suffers from slowing growth and rising interest rates, and some economists believe that there may be a global recession
in the near future. If the global economy slows, the Company’s business may be adversely affected.
Impact
of COVID-19 Pandemic
The
COVID-19 pandemic has had a dramatic impact on businesses globally and on the Company’s business as well. During the height of
the pandemic, sales of diagnostic products decreased significantly and the Company’s net loss increased significantly, as clinics
and small hospitals’ demand for Qualigen, Inc.’s FastPack™ diagnostic test kits was reduced sharply, largely due to
deferral of patients’ non-emergency visits to physician offices. In July 2023 the Company sold Qualigen, Inc., its wholly-owned
subsidiary, to Chembio (see Note 5 - Discontinued Operations).
Accounting
Standards
Other
accounting standard updates are either not applicable to the Company or are not expected to have a material impact on the Company’s
condensed consolidated financial statements.
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v3.24.2.u1
LIQUIDITY AND GOING CONCERN
|
6 Months Ended |
Jun. 30, 2024 |
Liquidity And Going Concern |
|
LIQUIDITY AND GOING CONCERN |
NOTE
2 — LIQUIDITY AND GOING CONCERN
As
of June 30, 2024, we had approximately $119,000 in
cash and an accumulated deficit of $120.4
million. For the six months ended June 30, 2024
and year ended December 31, 2023, we used cash of $2.3
million and $10.3
million, respectively, in operations.
The
Company’s cash balances as of the date that these financial statements were issued, without additional financing, are expected
to fund operations into the fourth quarter of 2024. The Company expects to continue to have net losses and negative cash flow from operations,
which will challenge its liquidity. These factors raise substantial doubt about the Company’s ability to continue as a going concern
for the one-year period following the date that these financial statements were issued. There is no assurance that profitable operations
will ever be achieved, or, if achieved, could be sustained on a continuing basis.
Historically,
the Company’s principal sources of cash have included proceeds from the issuance of common and preferred equity and proceeds from
the issuance of debt. In December 2022 the Company raised $3.0 million from the sale of an 8% Senior Convertible Debenture to Alpha and
between February 2024 and April 2024 the Company raised $1.5 million from the sale of Convertible Debentures (see Note 8 - Convertible
Debt - Related Party). In July 2024 the Company raised an additional $2.0 million from the sale of a nonconvertible 18% Senior Note.
There can be no assurance that further financing can be obtained on favorable terms, or at all. If the Company is unable to obtain funding,
the Company could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future
commercialization efforts, which could adversely affect the Company’s business prospects.
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The financial statements
do not include any adjustments that would be necessary should the Company be unable to continue as a going concern, and therefore, be
required to liquidate its assets and discharge its liabilities in other than the normal course of business and at amounts that may differ
from those reflected in the accompanying financial statements.
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v3.24.2.u1
PREPAID EXPENSES AND OTHER CURRENT ASSETS
|
6 Months Ended |
Jun. 30, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
PREPAID EXPENSES AND OTHER CURRENT ASSETS |
NOTE
3 — PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets consisted of the following at June 30, 2024 and December 31, 2023:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Prepaid insurance | |
$ | 382,229 | | |
$ | 566,011 | |
Other prepaid expenses | |
| 33,496 | | |
| 25,053 | |
Prepaid research and development expenses | |
| — | | |
| 173,900 | |
Prepaid expenses and
other current assets | |
$ | 415,725 | | |
$ | 764,964 | |
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v3.24.2.u1
OTHER NON-CURRENT ASSETS
|
6 Months Ended |
Jun. 30, 2024 |
Investments, All Other Investments [Abstract] |
|
OTHER NON-CURRENT ASSETS |
NOTE
4 — OTHER NON-CURRENT ASSETS
Other
non-current assets consisted of the following at June 30, 2024 and December 31, 2023:
SCHEDULE
OF OTHER NON CURRENT ASSETS
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Funds held in escrow | |
$ | — | | |
$ | 450,000 | |
Long-term research and development deposits | |
| — | | |
| 416,481 | |
Other non-current assets | |
$ | — | | |
$ | 866,481 | |
|
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v3.24.2.u1
DISCONTINUED OPERATIONS
|
6 Months Ended |
Jun. 30, 2024 |
Discontinued Operations and Disposal Groups [Abstract] |
|
DISCONTINUED OPERATIONS |
NOTE
5 — DISCONTINUED OPERATIONS
The
summary of gain (loss) from discontinued operations, net of tax, for the three and six months ended June 30, 2023 are as follows:
SCHEDULE
OF GAIN (LOSS) FROM DISCONTINUED OPERATIONS
| |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total |
| |
Three
Months Ended
June 30,
2024 | |
Six Months
Ended
June 30,
2024 | |
Three
Months Ended
June 30,
2023 | |
Six Months
Ended
June 30,
2023 |
| |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
|
Loss on disposal of discontinued operations, net of tax | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | 113,694 | | |
$ | (84,022 | ) | |
$ | 29,672 | | |
$ | (262,478 | ) | |
$ | (580,037 | ) | |
$ | (842,515 | ) |
Income (loss) from discontinued operations, net of tax | |
| (100,000 | ) | |
| — | | |
| (100,000 | ) | |
| (100,000 | ) | |
| — | | |
| (100,000 | ) | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
GAIN (LOSS) FROM DISCONTINUED OPERATIONS | |
$ | (100,000 | ) | |
$ | — | | |
$ | (100,000 | ) | |
$ | (100,000 | ) | |
$ | — | | |
$ | (100,000 | ) | |
$ | 113,694 | | |
$ | (84,022 | ) | |
$ | 29,672 | | |
$ | (262,478 | ) | |
$ | (580,037 | ) | |
$ | (842,515 | ) |
Sale
of Qualigen Inc.
On
July 20, 2023, the Company completed the sale of Qualigen, Inc., its formerly wholly-owned subsidiary, to Chembio Diagnostics, Inc. for
net cash consideration of $5.4 million, of which $4.9 million was received during the year ended December 31, 2023, and $450,000 is being
held in escrow until January 20, 2025 to satisfy certain Company indemnification obligations. On June 4, 2024, the escrow account was
settled early by mutual agreement of the Company and the buyer resulting in cash proceeds to the Company of $350,000 and a loss on disposal
of discontinued operations of $100,000 for the three and six months ending June 30, 2024. There was no other activity related to Qualigen,
Inc. during the three and six months ended June 30, 2024.
There
were no assets and liabilities remaining related to Qualigen, Inc. as of June 30, 2024 or December 31, 2023.
The
Company reclassified the following statement of operations items to discontinued operations for the three and six months ended June 30,
2023:
SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS
| |
For the Three
Months Ended June 30, | | |
For the Six
Months June 30, | |
| |
2023 | | |
2023 | |
REVENUES | |
| | | |
| | |
Net product sales | |
$ | 1,627,031 | | |
$ | 3,234,201 | |
Total revenues | |
| 1,627,031 | | |
| 3,234,201 | |
| |
| | | |
| | |
EXPENSES | |
| | | |
| | |
Cost of product sales | |
| 1,016,543 | | |
| 2,281,368 | |
General and administrative | |
| 238,782 | | |
| 584,214 | |
Research and development | |
| 25,657 | | |
| 204,207 | |
Sales and marketing | |
| 169,223 | | |
| 368,337 | |
Total expenses | |
| 1,450,204 | | |
| 3,438,126 | |
| |
| | | |
| | |
OTHER EXPENSE (INCOME), NET | |
| | | |
| | |
Loss on disposal of equipment held for lease | |
| 63,302 | | |
| 63,302 | |
Other expense (income), net | |
| (169 | ) | |
| (5,049 | ) |
Loss on fixed asset disposal | |
| — | | |
| 300 | |
Total other expense (income), net | |
| 63,133 | | |
| 58,553 | |
| |
| | | |
| | |
INCOME (LOSS) FROM DISCONTINUED OPERATIONS OF QUALIGEN, INC. | |
$ | 113,694 | | |
$ | (262,478 | ) |
Amendment
and Settlement Agreement with NanoSynex Ltd.
On
July 20, 2023, the Company entered into and effectuated the NanoSynex Amendment, reducing its ownership from approximately 52.8% to approximately
49.97% of the voting equity of NanoSynex, and deconsolidation of the subsidiary. On November 22, 2023, the Company further agreed to
eliminate the Company’s obligations to lend additional funds to NanoSynex by surrendering shares of Series A-1 Preferred Stock
of NanoSynex in an amount that reduced the Company’s ownership in NanoSynex voting equity from approximately 49.97% to 39.90%.
On
the date of deconsolidation, the Company recognized its retained investment at fair value, which during the preparation of these financial
statements was determined to be de minimis based on various economic, industry, and other factors. As a result, the Company has discontinued
recognition of its proportionate share of equity method losses following the date of initial recognition. Future equity method earnings,
if any, will not be recognized until the amount exceeds the unrecognized net losses in prior periods.
There
were no assets and liabilities recognized related to NanoSynex as of June 30, 2024 or December 31, 2023.
There
was no activity related to NanoSynex during the three and six months ended June 30, 2024. The Company reclassified the following statement
of operations items to discontinued operations for the three and six months ended June 30, 2023:
SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS
| |
For the Three
Months Ended March 30, | | |
For the Six
Months June 30, | |
| |
2023 | | |
2023 | |
EXPENSES | |
| | | |
| | |
Research and development | |
$ | 126,240 | | |
$ | 787,425 | |
Total expenses | |
| 126,240 | | |
| 787,425 | |
| |
| | | |
| | |
(BENEFIT) PROVISION FOR INCOME TAXES | |
| (42,218 | ) | |
| (207,388 | ) |
| |
| | | |
| | |
LOSS FROM DISCONTINUED OPERATIONS OF NANOSYNEX, LTD. | |
| (84,022 | ) | |
| (580,037 | ) |
| |
| | | |
| | |
Loss attributable to noncontrolling interest | |
| (43,484 | ) | |
| (304,512 | ) |
| |
| | | |
| | |
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS | |
$ | (40,538 | ) | |
$ | (275,525 | ) |
|
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- DefinitionThe entire disclosure related to a disposal group. Includes, but is not limited to, a discontinued operation, disposal classified as held-for-sale or disposed of by means other than sale or disposal of an individually significant component.
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v3.24.2.u1
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES |
NOTE
6 — ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued
expenses and other current liabilities consisted of the following at June 30, 2024 and December 31, 2023:
SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Board compensation | |
$ | 251,999 | | |
| 129,499 | |
Interest (Convertible debt) | |
| 51,909 | | |
| 10,004 | |
License fees | |
| — | | |
| 32,975 | |
Payroll | |
| 300,481 | | |
| 1,215 | |
Professional fees | |
| 144,528 | | |
| 121,775 | |
Research and development | |
| 17,500 | | |
| 104,402 | |
Vacation | |
| 162,665 | | |
| 151,286 | |
Other | |
| 57,725 | | |
| 8,850 | |
Accrued expenses and
other current liabilities | |
$ | 986,806 | | |
$ | 560,006 | |
|
X |
- DefinitionThe entire disclosure for accounts payable, accrued expenses, and other liabilities that are classified as current at the end of the reporting period.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/disclosureRef -Topic 720 -SubTopic 30 -Name Accounting Standards Codification -Section 45 -Paragraph 1 -Publisher FASB -URI https://asc.fasb.org/1943274/2147483384/720-30-45-1
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v3.24.2.u1
WARRANT LIABILITIES
|
6 Months Ended |
Jun. 30, 2024 |
Warrant Liabilities |
|
WARRANT LIABILITIES |
NOTE
7 — WARRANT LIABILITIES
In
2004, the Company issued warrants to various investors and brokers for the purchase of Series C preferred stock in connection with a
private placement (the “Series C Warrants”). The Series C Warrants were subsequently extended and, upon closing of the reverse
recapitalization transaction with Ritter, exchanged for warrants to purchase common stock of the Company. The Series C Warrants were
determined to be liability-classified pursuant to the guidance in ASC 480 and ASC 815-40, based on the inclusion of a leveraged ratchet
provision for subsequent dilutive issuances. As of December 31, 2022 there were 1,349,570 Series C Warrants outstanding with an exercise
price of $1.32 per share.
On
December 22, 2022, in conjunction with the issuance of the Debenture to Alpha (see Note 8 – Convertible Debt),
the Company issued to Alpha a warrant to purchase 2,500,000 shares of the Company’s common stock (the “Alpha Warrant”).
The exercise price of the Alpha Warrant was $1.65 (equal to 125% of the conversion price of the Debenture on the closing date). The Alpha
Warrant may be exercised by Alpha, in whole or in part, on or after June 22, 2023 and at any time before June 22, 2028, subject to certain
terms and conditions described in the Alpha Warrant. The fair value of this Alpha Warrant was included in Warrant liabilities-related
party on the Company’s consolidated balance sheet as of December 31, 2022. On December 5, 2023, the Company entered into an Amendment
No. 1 with regard to a Securities Purchase Agreement, with Alpha. This Amendment eliminated certain adjustment provisions of the Warrant.
The Company determined the event resulted in equity classification for the Warrant and, accordingly, the Company remeasured the warrant
liabilities to fair value, and reclassified to noncompensatory equity classified warrants (see Note 12 - Stockholders Equity).
On
November 24, 2023, 1,097,599 Series C Warrants expired, and on December 5, 2023 the remaining Series C Warrants were repriced from an
exercise price of $1.32 per share to an exercise price of $0.73 per share, with 203,652 additional ratchet Series C Warrants issued,
resulting in 455,623 of these Series C Warrants outstanding and exercisable as of December 31, 2023.
On
February 27, 2024, these Series C Warrants were repriced again as a result of a down-round provision triggered by a Securities Purchase
Agreement with Alpha for the purchase of the February 2024 Debenture, from an exercise price of $0.73 per share to an exercise price
of $0.26 per share, with 823,633 additional ratchet Series C Warrants issued, resulting in 1,279,256 of these Series C Warrants outstanding
and exercisable, and on June 26, 2024 the remaining 1,279,256 Series C Warrants expired.
On
April 12, 2024, in connection with an 8%
Convertible Debenture in the principal amount of $1,100,000
issued to Yi Hua Chen (“Chen”) (see Note 8 – Convertible Debt), we issued a liability classified warrant to Chen
purchase 1,800,032
shares of our common stock, exercisable until February 27, 2029, which remains outstanding and exercisable as of June 30, 2024. The warrant is liability classified due to an insufficient number of authorized shares to settle the warrant prior
to the receipt of shareholder approval, which has not yet been obtained. The fair value of the warrant was $565,582 on the issuance date and $260,276 at June 30, 2024. During the three months
ended June 30, 2024, the Company recorded a gain on change in fair value of warrant liabilities of $305,306 for this warrant.
The
following table summarizes the activity in liability classified warrants for the six months ended June 30, 2024:
SCHEDULE OF WARRANTS ACTIVITY
| |
Common Stock Warrants | |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2023 | |
| 455,623 | | |
$ | 0.73 | | |
$ | 0.73 - $0.73 | | |
| 0.49 | |
Granted | |
| 2,623,665 | | |
$ | 0.26 | | |
$ | 0.26 - $0.26 | | |
| 4.67 | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| (1,279,256 | ) | |
$ | 0.26 | | |
$ | 0.26 - $0.26 | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Total outstanding – June 30, 2024 | |
| 1,800,032 | | |
$ | 0.26 | | |
$ | 0.26 - $0.26 | | |
| 4.67 | |
Exercisable | |
| 1,800,032 | | |
$ | 0.26 | | |
$ | 0.26 - $0.26 | | |
| 4.67 | |
The
following table summarizes the activity in liability classified warrants for the six months ended June 30, 2023:
| |
Common Stock Warrants | |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding –December 31, 2022 | |
| 3,849,571 | | |
$ | 1.53 | | |
| $1.32 - $1.65 | | |
| 3.9 | |
Granted | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| — | | |
| — | | |
| — | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Total outstanding – June 30, 2023 | |
| 3,849,571 | | |
$ | 1.53 | | |
| $1.32 - $1.65 | | |
| 3.41 | |
Exercisable | |
| 3,849,571 | | |
$ | 1.53 | | |
| $1.32 - $1.65 | | |
| 3.41 | |
The
following table presents the Company’s fair value hierarchy for its liabilities measured at fair value on a recurring basis as
of June 30, 2024:
SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES
| |
Quoted | | |
| | |
| | |
| |
| |
Market | | |
Significant | | |
| | |
| |
| |
Prices for | | |
Other | | |
Significant | | |
| |
| |
Identical | | |
Observable | | |
Unobservable | | |
| |
| |
Assets | | |
Inputs | | |
Inputs | | |
| |
Common Stock Warrant liabilities | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
Balance as of December 31, 2023 | |
$ | — | | |
$ | — | | |
$ | 54,600 | | |
$ | 54,600 | |
Granted | |
| — | | |
| — | | |
| 565,582 | | |
| 565,582 | |
Exercises | |
| — | | |
| — | | |
| — | | |
| — | |
Gain on change in fair value of warrant liabilities | |
| — | | |
| — | | |
| (359,906 | ) | |
| (359,906 | ) |
Balance as of June 30, 2024 | |
$ | — | | |
$ | — | | |
$ | 260,276 | | |
$ | 260,276 | |
| |
Quoted | | |
| | |
| | |
| |
| |
Market | | |
Significant | | |
| | |
| |
| |
Prices for | | |
Other | | |
Significant | | |
| |
| |
Identical | | |
Observable | | |
Unobservable | | |
| |
| |
Assets | | |
Inputs | | |
Inputs | | |
| |
Derivative Liabilities Arising From Issuance of Convertible Debt | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
Balance as of December 31, 2023 | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | |
Granted | |
| — | | |
| — | | |
| 215,897 | | |
| 215,897 | |
Gain on change in fair value of derivative liabilities | |
| — | | |
| — | | |
| (174,613 | ) | |
| (174,613 | ) |
Balance as of June 30, 2024 | |
$ | — | | |
$ | — | | |
$ | 41,284 | | |
$ | 41,284 | |
There were no transfers of financial assets or liabilities
between category levels for the three and six months ended June 30, 2024.
The
value of the warrant liabilities was based on a valuation received from an independent valuation firm determined using a Monte-Carlo
simulation. For volatility, the Company considers comparable public companies as a basis for its expected volatility to calculate the
fair value of common stock warrants and transitions to its own volatility as the Company develops sufficient appropriate history as a
public company. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected term of the common
stock warrant. The Company uses an expected dividend yield of zero based on the fact that the Company has never paid cash dividends and
does not expect to pay cash dividends in the foreseeable future. Any significant changes in the inputs may result in significantly higher
or lower fair value measurements.
The
following are the weighted average and the range of assumptions used in estimating the fair value of warrant liabilities (weighted average
calculated based on the number of outstanding warrants on each issuance) as of June 30, 2024 and 2023:
SCHEDULE
OF ASSUMPTIONS OF WARRANT LIABILITIES
| |
June 30, 2024 | | |
June 30, 2023 | |
| |
Actual | | |
Range | | |
Weighted Average | |
Risk-free interest rate | |
| 4.38 | % | |
| 4.05% — 5.31% | | |
| 4.49 | % |
Expected volatility (peer group) | |
| 125 | % | |
| 66.3% — 134% | | |
| 110.55 | % |
Term of warrants (in years) | |
| 4.7 | | |
| .39 — 4.98 | | |
| 3.41 | |
Expected dividend yield | |
| 0.00 | % | |
| 0.00 | % | |
| 0.00 | % |
|
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v3.24.2.u1
CONVERTIBLE DEBT
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
CONVERTIBLE DEBT |
NOTE
8 — CONVERTIBLE DEBT
2022
Convertible Debenture (Related party)
On
December 22, 2022, we issued to Alpha an 8%
Senior Convertible Debenture in the aggregate principal amount of $3,300,000
for a purchase price of $3,000,000
pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022 (the “2022 Securities Purchase
Agreement”). The 2022 Debenture has a maturity date of December
22, 2025 and is convertible, at any time, and from time to time, until the 2022 Debenture is no longer outstanding, at
Alpha’s option, into shares of our common stock (the “Conversion Shares”), at a price initially equal to $1.32
per share, subject to adjustment as described in the 2022 Debenture and other terms and conditions described in the 2022 Debenture.
On July 13, 2023, we obtained stockholder approval, for purposes of complying with Nasdaq Listing Rule 5635(d), for the issuance to
Alpha of more than 20%
of our issued and outstanding shares of common stock pursuant to the terms and conditions of (a) the 2022 Debenture, and (b) the
common stock purchase warrant dated December 22, 2022 issued by us to Alpha. Between January 9 and 12, 2023, we issued 841,726
shares of common stock upon Alpha’s partial conversion of the 2022 Debenture at $1.32
per share for a total of $1,111,078
principal. In October and December 2023, we issued 309,665
shares of common stock to Alpha in lieu of cash for monthly redemption payments on the 2022 Debenture at a weighted average price of
$0.71
per share. During the three months ending March 31, 2024, we issued 1,138,535
shares of common stock to Alpha in lieu of cash for monthly redemption payments on the 2022 Debenture at a weighted average
conversion price of $0.33
per share, with a weighted average fair value of $0.48 per share. During the three months ending June 30, 2024, we issued 2,536,312
shares of common stock to Alpha in lieu of cash for monthly redemption payments on the 2022 Debenture at a weighted average
conversion price of $0.26
per share, with a weighted fair value price of $0.25 per share.
As
of June 30, 2024, approximately 1,518,929 shares of common stock were issuable under the 2022 Debenture, based on the $0.26 per share
figure. The 2022 Debenture includes a beneficial ownership blocker of 9.99%, which may only be waived by Alpha upon 61 days’ notice
to us. Except in respect of an Exempt Issuance (as defined in the 2022 Securities Purchase Agreement), the 2022 Debenture contains a
“ratchet” antidilution provision, with a $0.26 floor.
Commencing
June 1, 2023 (the “Initial Monthly Redemption Date”) and continuing on the first day of each month thereafter until the earlier
of (i) December 22, 2025 and (ii) the full redemption of the 2022 Debenture (each such date, a “Monthly Redemption Date”),
we must redeem $110,000 plus accrued but unpaid interest, liquidated damages and any amounts then owing under the 2022 Debenture (the
“Monthly Redemption Amount”). The Monthly Redemption Amount must be paid in cash; provided that after the first two
monthly redemptions, we may elect to pay all or a portion of a Monthly Redemption Amount in shares of our common stock, based on a conversion
price equal to the lesser of (i) the then conversion price of the 2022 Debenture and (ii) 85% of the average of the VWAPs (as defined
in the 2022 Debenture) for the five consecutive trading days ending on the trading day that is immediately before the applicable Monthly
Redemption Date, subject to the Equity Conditions (as defined in the 2022 Debenture) having been satisfied or waived.
The
2022 Debenture accrues interest at the rate of 8% per annum, which did not begin accruing until December 1, 2023, and will be payable
on a monthly or quarterly basis. Interest may be paid in cash or shares of our common stock or a combination thereof at our option; provided
that interest may only be paid in shares if the Equity Conditions have been satisfied or waived.
In
December 2022, pursuant to the terms of the 2022 Securities Purchase Agreement, we entered into a registration rights agreement with
Alpha (the “Registration Rights Agreement”), pursuant to which we agreed to file one or more registration statements, as
necessary, and to the extent permissible, to register under the Securities Act the resale of the remaining shares (underlying the 2022
Debenture and the 2022 Warrant) not otherwise registered under the Company’s registration statement on Form S-3 (File No. 333-266430).
The Registration Rights Agreement requires that the Company file, within 30 days after signing, a resale registration statement and use
commercially reasonable efforts to cause the resale registration statement to be declared effective by the SEC on or before the 60th
calendar day following the date of signing of the Registration Rights Agreement (or 120 days if such registration statement is
subject to full review by the SEC). We filed a resale registration statement on Form S-3 pursuant to the requirements of the Registration
Rights Agreement on December 2022 (File Number 333-269088), which registration statement was declared effective by the SEC on January
5, 2023. On September 1, 2023, we filed a Post-Effective Amendment No. 1 to Form S-3 on Form S-1 (File No. 333-269088), which Post-Effective
Amendment was declared effective by the SEC on September 7, 2023. On May 1, 2024, we filed a Post-Effective Amendment No. 2 to Form S-1
on Form S-3 (File No. 333-269088), which Post-Effective Amendment was declared effective by the SEC on May 2, 2024.
The
Company evaluated the 2022 Debenture and the 2022 Warrant and determined that the 2022 Warrant is a freestanding financial instrument.
Initially, the 2022 Warrant is not considered indexed to the Company’s own stock, because the settlement amount would not equal
the difference between the fair value of a fixed number of the Company’s equity shares and a fixed strike price and all of the
adjustment features in Section 3(b) of the Alpha Warrant are not down round provisions, as defined in ASU 2017-11. Accordingly, the 2022
Warrant was classified as a liability and recognized at fair value, with subsequent changes in fair value recognized in earnings.
The
proceeds from the 2022 Debenture were allocated to the initial fair value of the 2022 Warrant, with the residual balance allocated to
the initial carrying value of the 2022 Debenture. The Company has not elected the fair value option for the 2022 Debenture. The 2022
Debenture was recognized as proceeds received after allocating the proceeds to the 2022 Warrant, and then allocating remaining proceeds
to a suite of bifurcated embedded derivative features (conversion option, contingent acceleration upon an Event of Default, and contingent
interest upon an Event of Default), with the resulting difference, if any, allocated to the loan host instrument. The suite of derivative
features was measured and determined to have no fair value.
The
original issue discount of $0.3 million, the initial fair value of the 2022 Warrant of $2.8 million, the initial fair value of the suite
of bifurcated embedded derivative features of $0, and the fees and costs paid to Alpha and other third parties of $0.1 million comprised
the debt discount upon issuance. The debt discount is amortized to interest expense over the expected term of the 2022 Debenture using
the effective interest method, in accordance with ASC 835-30. The debt host instrument of the 2022 Debenture will subsequently be measured
at amortized cost using the effective interest method to accrete interest over its term to bring the 2022 Debenture’s initial carrying
value to the principal balance at maturity.
On
December 5, 2023, the Company and Alpha executed Amendment No. 1 with regard to Securities Purchase Agreement (the “SPA Amendment”),
pursuant to which the Company and Alpha agreed to, among other things, reduce the Conversion Price of the 2022 Debenture from $1.32 per
share to $0.73 per share and reduce the exercise price of the 2022 Warrant from $1.65 per share to $0.73 per share, in each case subject
to certain adjustments. In addition, the SPA Amendment revised certain provisions of the 2022 Warrant to (i) limit the circumstances
which would trigger a potential adjustment to the exercise price of the 2022 Warrant and (ii) clarify the treatment of the 2022 Warrant
upon a Fundamental Transaction. The purpose of these revisions was to remove the terms that caused the 2022 Warrant to be liability-classified
under U.S. GAAP. The Company performed an assessment and concluded that all remaining adjustment features in the revised language meet
the FASB’s definition of a down-round feature. In addition, the 2022 Warrant was determined to meet all of the additional requirements
for equity classification. Accordingly, as of December 5, 2023, the Company remeasured the 2022 Warrant to its fair value immediately
prior to the modification and recognized the change in fair value in earnings. The incremental fair value impact from the 2022 Warrant
modification of $0.09 million was included in the Company’s evaluation of the 2022 Debenture modification under ASC 470, discussed
further below. The Company then reclassified the 2022 Warrant liability to equity at its post-modification fair value of $1.6 million.
In
accordance with ASC 470-50, the Company determined that the modified terms of the 2022 Debenture were substantially different when compared
to the original terms that existed prior to the SPA Amendment, and thus the event was required to be accounted for as a debt extinguishment.
Accordingly, the Company derecognized the net carrying value of the original Debenture, and recorded the new debt instrument at its fair
value of $1.4 million, and recorded a $0.6 million loss on debt extinguishment. The difference between the remaining 2022 Debenture principal
and its fair value on December 5, 2023 was recorded as a debt discount and will be amortized to interest expense over the expected term
of the Debenture using the effective interest method, in accordance with ASC 835-30.
During
the three and six months ended June 30, 2024, the Company recognized a gain of approximately $22,000,
and a loss of approximately $125,000
respectively, upon debenture share redemptions, and recorded interest expense of approximately $65,000
and $134,000 (of which
approximately $49,000 and $92,000 was attributable to discount accretion, respectively) for the three and six months ended
June 30, 2024 respectively, in other expenses in the condensed consolidated statements of operations related to the 2022
Debenture. As of June 30, 2024, the fair value of the suite of bifurcated
embedded derivative features related to the 2022 Debenture was approximately $6,000.
During the three and six months ended June 30, 2023, the Company recognized a loss upon voluntary conversion of convertible
debt of approximately $1.1 million, and recorded accrued interest of approximately $383,000 and $945,000, respectively (of which
approximately $364,000 and $898,000 was attributable to discount accretion, respectively) in other expenses in the condensed
consolidated statements of operations related to the 2022 Debenture. As of June 30, 2023, the fair value of the suite of bifurcated embedded
derivative features related to the 2022 Debenture was $0.
2024
Convertible Debenture (Related party)
On
February 27, 2024, upon our receipt of a cash purchase price payment of $500,000
less expenses, we issued to Alpha an 8%
Convertible Debenture (the “2024 Alpha Debenture”) in the principal amount of $550,000.
The 2024 Alpha Debenture matures no later than December 31, 2024 and is convertible, at any time, and from time to time, at
Alpha’s option, into shares of common stock of the Company, at $0.6111
per share, subject to adjustment as described in the 2024 Alpha Debenture. Except in respect of an Exempt Issuance, the 2024 Alpha
Debenture contains a “ratchet” antidilution provision, with an $0.1164
floor. The 2024 Alpha Debenture accrues interest on its outstanding principal balance at the rate of %
per annum, payable at maturity. In connection with this issuance, we also issued to Alpha a noncompensatory equity classified 5-year
common stock purchase warrant to purchase (at $0.26
per share) 900,016
shares of our common stock (see Note 12 - Stockholders Equity (Deficit)).
We
also granted to Alpha an option, exercisable until July 1, 2024, to purchase from us additional 8%
Convertible Debentures, of like tenor, with face amounts of up to an aggregate of $1,100,000
(and with a proportional number of accompanying
common stock warrants of like tenor, up to a total of 1,800,032
additional warrants).
During the three and six months ending June 30, 2024
in connection with the 2024 Alpha Debenture, the Company recorded initial derivative liabilities with a fair value of $858,279, and recorded
interest expense of approximately $173,000 and $238,000, respectively (of which approximately $162,000 and
$222,000 was attributable to discount accretion, respectively) in other expenses in the condensed consolidated statements
of operations related to the 2024 Alpha Debenture. As of June 30, 2024, the fair value of the suite of bifurcated
embedded derivative features related to the 2024 Alpha Debenture was approximately $12,000.
The Securities Purchase Agreement related to the issuance of 2024 Alpha Debenture resulted in down-round provisions
of various warrants being triggered which resulted in reductions of the exercise price of these warrants from $0.73 per share to
$0.26 per share (see Note 7 - Warrant Liabilities and Note 12 - Stockholders Equity (Deficit).
2024
Convertible Debenture
In
April 2024, Alpha assigned its option to Chen and Chen exercised the option in full, in exchange for $1,000,000, less expenses, we
issued to Chen an 8%
Convertible Debenture (the “2024 Chen Debenture”) with a principal amount of $1,100,000.
The 2024 Chen Debenture matures no later than December 31, 2024 and is convertible, at any time, and from time to time, at
Chen’s option, into shares of common stock of the Company, at $0.6111 per
share, subject to adjustment as described in the 2024 Chen Debenture. Except in respect of an Exempt Issuance, the 2024 Chen
Debenture contains a “ratchet” antidilution provision, with an $0.1164 floor.
The 2024 Chen Debenture accrues interest on its outstanding principal balance at the rate of 8%
per annum, payable at maturity. In connection with this issuance, we also issued to Chen a 5-year
liability classified common stock purchase warrant to purchase 1,800,032 shares
of our common stock at $0.26 per
share with an initial fair value of $565,582 (see Note 7 - Warrant Liabilities).
During
the three and six months ending June 30, 2024 in connection with the 2024 Chen Debenture, the Company recorded initial derivative liabilities
with a fair value of $33,243,
and recorded interest expense of approximately $28,000 (of which approximately $8,000 was attributable to discount accretion) in other
expenses in other expenses in the condensed consolidated statements of operations related to the 2024 Chen Debenture.
As of June
30, 2024, the fair value of the suite of bifurcated embedded derivative features related to the 2024 Alpha Debenture was approximately
$24,000. The fair value of the warrant issued
in connection with the 2024 Chen Debenture was approximately $260,000 at June 30, 2024, and during the three and six months ended
June 30, 2024, the Company recorded a gain on change in fair value of warrant liabilities of approximately $305,000
for this warrant.
Convertible
debt is comprised of the following as of June 30, 2024 and December 31, 2023:
SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT
| |
June 30,
2024 | | |
December 31, 2023 | |
Convertible debt | |
$ | 1,100,000 | | |
$ | — | |
Discount on convertible debt | |
| (19,706 | ) | |
| — | |
Total convertible debt | |
$ | 1,080,294 | | |
$ | — | |
| |
June 30,
2024 | | |
December 31, 2023 | |
Convertible debt - related party | |
| 944,922 | | |
| 1,418,922 | |
Convertible debt | |
| 944,922 | | |
| 1,418,922 | |
Discount on convertible debt - related party | |
| (355,205 | ) | |
| (119,706 | ) |
Discount on convertible debt | |
| (355,205 | ) | |
| (119,706 | ) |
Total convertible debt - related party | |
$ | 589,717 | | |
$ | 1,299,216 | |
Total convertible debt | |
$ | 589,717 | | |
$ | 1,299,216 | |
As
of June 30, 2024, there were no events of default or violation of any covenants under our financing obligations.
|
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.24.2.u1
EARNINGS (LOSS) PER SHARE
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
EARNINGS (LOSS) PER SHARE |
NOTE
9 — EARNINGS (LOSS) PER SHARE
Basic
loss per share (“EPS”) is computed by dividing net loss by the weighted-average number of common shares outstanding. Diluted
EPS is computed based on the sum of the weighted-average number of common shares and potentially dilutive common shares outstanding during
the period. Potentially dilutive common shares consist of shares issuable from stock options and warrants.
The
following potentially dilutive securities have been excluded from diluted net loss per share as of June 30, 2024 and 2023 because their
effect would be anti-dilutive:
SCHEDULE
OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE
| |
As of June 30, | |
| |
2024 | | |
2023 | |
Shares of common stock subject to outstanding options | |
| 755,715 | | |
| 445,163 | |
Shares of common stock subject to outstanding warrants | |
| 4,741,957 | | |
| 4,119,934 | |
Shares of common stock subject to outstanding convertible debt | |
| 4,218,978 | | |
| — | |
Total common stock equivalents | |
| 9,716,650 | | |
| 4,565,097 | |
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
COMMITMENTS AND CONTINGENCIES |
NOTE
10 — COMMITMENTS AND CONTINGENCIES
Litigation
and Other Legal Proceedings
From time to time, the Company may be involved in litigation relating to claims arising out of operations in the
normal course of business. As of June 30, 2024, there were no pending or threatened lawsuits that could reasonably be expected to have
a material effect on the results of the Company’s operations.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.2.u1
RESEARCH AND LICENSE AGREEMENTS
|
6 Months Ended |
Jun. 30, 2024 |
Research And License Agreements |
|
RESEARCH AND LICENSE AGREEMENTS |
NOTE
11 — RESEARCH AND LICENSE AGREEMENTS
UCL
Business Limited
In
January 2022, the Company entered into a License Agreement with UCL Business Limited to obtain an exclusive worldwide in-license of a
genomic quadruplex (G4)-selective transcription inhibitor drug development program which had been developed at University College London,
including lead and back-up compounds, preclinical data and a patent estate. (UCL Business Limited is the commercialization company for
University College London.) The program’s lead compound is now being developed at the Company under the name QN-302 as a candidate
for treatment for pancreatic ductal adenocarcinoma, which represents the vast majority of pancreatic cancers. The License Agreement required
a $150,000 upfront payment, reimbursement of past patent prosecution expenses of approximately $160,000, and (if and when applicable)
tiered royalty payments in the low to mid-single digits, clinical/regulatory/sales milestone payments and a percentage of any non-royalty
sublicensing consideration paid to the Company.
For
both the three months ended June 30, 2024 and 2023, there were license costs of $0, and for the six months ended June 30, 2024 and 2023,
there were license costs of approximately $2,000 and $0, respectively, related to this agreement which are included in research and development
expenses in the condensed consolidated statements of operations and other comprehensive loss.
QN-302
Phase 1 Study
In
June 2023, the Company entered into a Master Clinical Research Services Agreement with Translational Drug Development, LLC (“TD2”)
whereby TD2 agreed to perform certain clinical research and development services for the Company including but not limited to trial management,
side identification and selection, site monitoring/management, medical monitoring, project management, data collection, statistical programming
or analysis, quality assurance auditing, scientific and medical communications, regulatory affairs consulting and submissions, strategic
consulting, and/or other related services. From time to time, the Company shall enter into statements of work with TD2 for the performance
of specific services under this Master Clinical Research Services Agreement.
In
June 2023, the Company entered into a Master Laboratory Services Agreement with MLM Medical Labs, LLC (“MLM”) whereby MLM
agreed to perform certain clinical research and development services for the Company including but not limited to laboratory, supply,
testing, validation, data management, and storage services. From time to time, the Company shall enter into work orders with MLM for
the performance of specific services under this Master Laboratory Services Agreement.
In
June 2023, the Company entered into a Master Services Agreement with Clinigen Clinical Supplies Management, Inc. (“Clinigen”)
whereby Clinigen agreed to provide certain pharmaceutical products and/or services. From time to time, the Company shall enter into statements
of work with Clinigen for the performance of specific services under this Master Services Agreement.
In
July 2023, pursuant to the above agreements, the Company entered into work orders and statements of work for clinical trial services
for the conduct of the QN-302 Phase 1 study.
The
University of Louisville Research Foundation
In
March 2019, the Company entered into a sponsored research agreement and an option for a license agreement with University of
Louisville Research Foundation, Inc. (“ULRF”) for development of several small-molecule RAS interaction inhibitor drug
candidates. Under the terms of this agreement, the Company agreed to reimburse ULRF for sponsored research expenses of initially up
to $693,000
for this program. This agreement was amended in February 2021, March 2022 and August 2023, with the current term of this agreement
expired in December 2023 and the aggregate amount that the Company would reimburse ULRF for sponsored research expenses increased to
approximately $2.9
million. In
July 2020, the Company entered into an exclusive license agreement with ULRF for RAS interaction inhibitor drug candidates. Under
the agreement, the Company took over development, regulatory approval and commercialization of the candidates from ULRF and is
responsible for maintenance of the related intellectual property portfolio. In return, ULRF received approximately $112,000 for an
upfront license fee and reimbursement of prior patent costs. In addition, the Company has agreed to pay ULRF (i) royalties, on
patent-covered net sales associated with the commercialization, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net
sales above a cumulative $250,000,000), until expiration of the licensed patent, and 2.5% (on net sales for any sales not covered by
Licensed Patents), (ii) 30% to 50% of any non-royalty sublicensee income received (50% for sublicenses granted in the first two
years of the ULRF license agreement, 40% for sublicenses granted in the third or fourth years of the ULRF license agreement, and 30%
for sublicenses granted in the fifth year of the ULRF license agreement or thereafter), (iii) reimbursements for ongoing costs
associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred prior to July 2020, and (iv)
payments ranging from $50,000
to $5,000,000
upon the achievement of certain regulatory and commercial milestones. Milestone payments for the first therapeutic indication
would be $50,000
for first dosing in a Phase 1 clinical trial, $100,000
for first dosing in a Phase 2 clinical trial, $150,000
for first dosing in a Phase 3 clinical trial, $300,000
for regulatory marketing approval and $5,000,000
upon achieving a cumulative $500,000,000
of Licensed Product sales. The Company also must pay ULRF shortfall payments if the total amounts actually paid with respect to
royalties and non-royalty sublicensee income for any year is less than the applicable annual minimum (ranging from $20,000
to $100,000)
for such year.
Sponsored
research expenses related to these agreements for the three months ended June 30, 2024 and 2023 were both $0, and for the six months
ended June 30, 2024 and 2023 were both $0. License costs were approximately $28,000 and $1,000 related to these agreements for the three
months ended June 30, 2024 and 2023, respectively, and approximately $53,000 and $22,000 related to these agreements for the six months
ended June 30, 2024 and 2023, respectively, and are included in research and development expenses in the condensed consolidated statements
of operations and other comprehensive loss.
Between
June 2018 and April 2022, the Company entered into license and sponsored research agreements with ULRF for QN-247, a novel aptamer-based
compound that has shown promise as an anticancer drug. Under the agreements, the Company took over development, regulatory approval and
commercialization of the compound from ULRF and is responsible for maintenance of the related intellectual property portfolio. In return,
ULRF received a $50,000 convertible promissory note in payment of an upfront license fee, which was subsequently converted into the Company’s
common stock, and the Company agreed to reimburse ULRF for sponsored research expenses of up to approximately $805,000 and prior patent
costs of up to $200,000. In addition, the Company agreed to pay ULRF (i) royalties, on patent-covered net sales associated with the commercialization
of anti-nucleolin agent-conjugated nanoparticles, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net sales above a cumulative
$250,000,000), until expiration of the last to expire of the licensed patents, (ii) 30% to 50% of any non-royalty sublicensee income
received (50% for sublicenses granted in the first two years of the ULRF license agreement, 40% for sublicenses granted in the third
or fourth years of the ULRF license agreement, and 30% for sublicenses granted in the fifth year of the ULRF license agreement or thereafter),
(iii) reimbursements for ongoing costs associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred
prior to June 2018, and (iv) payments ranging from $100,000 to $5,000,000 upon the achievement of certain regulatory and commercial milestones.
Milestone payments for the first therapeutic indication would be $100,000 for first dosing in a Phase 1 clinical trial, $200,000 for
first dosing in a Phase 2 clinical trial, $350,000 for first dosing in a Phase 3 clinical trial, $500,000 for regulatory marketing approval
and $5,000,000 upon achieving a cumulative $500,000,000 of Licensed Product sales. The Company also agreed to pay another $500,000 milestone
payment for any additional regulatory marketing approval for each additional therapeutic (or diagnostic) indication. The Company must
also pay ULRF shortfall payments if the total amounts actually paid with respect to royalties and non-royalty sublicensee income for
any year is less than the applicable annual minimum (ranging from $10,000 to $50,000) for such year.
Sponsored
research expenses related to these agreements for the three months ended June 30, 2024 and 2023 were approximately $0 and $333,000, respectively,
and for the six months ended June 30, 2024 and 2023 were approximately $0 and $556,000, respectively, and are recorded in research and
development expenses in the condensed consolidated statements of operations and other comprehensive loss. License costs related to these
agreements for the three months ended June 30, 2024 and 2023 were approximately $0 and $15,000, respectively, and for the six months
ended June 30, 2024 and 2023 were approximately $1,000 and $29,000, respectively, and are included in research and development expenses
in the condensed consolidated statements of operations and other comprehensive loss.
Marizyme
On
April 11, 2024, we entered into a Co-Development Agreement with Marizyme. Under the Co-Development Agreement (as amended on August 6, 2024), we agreed to pay
Marizyme a Funding Payment of up to $1,750,000
and an Exclusivity Fee of $200,000.
The Exclusivity Fee of $200,000
and a Funding Payment of $500,000
was paid to Marizyme on April 12, 2024. The Exclusivity Fee entitles us to an exclusivity period until May 31, 2024 for purposes of
proposing and outlining a broader strategic relationship with Marizyme with regard to Marizyme’s DuraGraft business. The
Funding Payment is designed to provide financial support for commercialization of Marizyme’s DuraGraft™ vascular conduit
solution, which is indicated for adult patients undergoing coronary artery bypass grafting surgeries and is intended for the
flushing and storage of the saphenous vein grafts used in coronary artery bypass grafting surgery. In
return for the Funding Payment we will receive quarterly a 33% payment in the nature of royalties on any Net Sales (as defined with
a meaning tantamount to gross profit on net sales) of DuraGraft, capped at double the amount of the Funding Payment cash
provided. No such payments-in-the-nature-of-royalties would accrue until after DuraGraft has been launched in the United
States and a cumulative total of $500,000
of DuraGraft Net Sales have been made in the United States.
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v3.24.2.u1
STOCKHOLDERS’ EQUITY
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
STOCKHOLDERS’ EQUITY |
NOTE
12 — STOCKHOLDERS’ EQUITY
As
of June 30, 2024 and December 31, 2023, the Company had two classes of authorized capital stock: common stock and preferred stock.
Common
Stock
Holders
of common stock generally vote as a class with the holders of the preferred stock and are entitled to one vote for each share held. Subject
to the rights of the holders of the preferred stock to receive preferential dividends, the holders of common stock are entitled to receive
dividends when and if declared by the Board of Directors. Following payment of the liquidation preference of the preferred stock, any
remaining assets will be distributed ratably among the holders of the common stock and, on an as-if-converted basis, the holders of any
preferred stock upon liquidation, dissolution or winding up of the affairs of the Company. The holders of common stock have no preemptive,
subscription or conversion rights and there are no redemption or sinking fund provisions.
At
June 30, 2024, the Company has reserved 9,716,650 shares of authorized but unissued common stock for possible future issuance. At June
30, 2024, shares were reserved in connection with the following:
SCHEDULE
OF RESERVED SHARES
| |
| | |
Exercise of issued and future grants of stock options | |
| 755,715 | |
Conversion of convertible debt | |
| 4,218,978 | |
Exercise of stock warrants | |
| 4,741,957 | |
Total | |
| 9,716,650 | |
Preferred
Stock
At
June 30, 2024 and December 31, 2023, there were no shares of preferred stock outstanding.
Stock
Options and Warrants
Stock
Options
The
Company recognizes all compensatory share-based payments as compensation expense over the service period, which is generally the vesting
period.
In
April 2020, the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which provides for the granting of incentive
or non-statutory common stock options and other types of awards to qualified employees, officers, directors, consultants and other service
providers. At June 30, 2024 and December 31, 2023, there were 337,286 and 398,924 outstanding stock options, respectively, under the
2020 Plan and on such dates there were 418,429 and 356,791 shares reserved under the 2020 Plan, respectively, for future grant.
The
following represents a summary of the options granted (under the 2020 Plan and otherwise) to employees and non-employee service providers
that were outstanding at June 30, 2024, and changes during the six-month period then ended:
SCHEDULE
OF STOCK OPTION ACTIVITY
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2023 | |
| 398,924 | | |
$ | 35.21 | | |
$ | 5.14 — $51.30 | | |
| 7.06 | |
Granted | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| — | | |
| — | | |
| — | | |
| — | |
Forfeited | |
| (61,638 | ) | |
$ | 14.88 | | |
$ | 5.14 — $49.70 | | |
| — | |
Total outstanding – June 30, 2024 | |
| 337,286 | | |
$ | 38.92 | | |
$ | 5.14 — $51.30 | | |
| 6.47 | |
Exercisable (vested) | |
| 283,634 | | |
$ | 45.21 | | |
$ | 5.14 — $51.30 | | |
| 6.18 | |
Non-Exercisable (non-vested) | |
| 53,652 | | |
$ | 5.67 | | |
$ | 5.14 — $12.40 | | |
| 7.99 | |
There
was approximately $92,000 and $0.9 million of compensation cost related to outstanding stock options for the six months ended June 30,
2024 and 2023, respectively. As of June 30, 2024, there was approximately $120,000 of total unrecognized compensation cost related to
unvested stock-based compensation arrangements. This cost is expected to be recognized over a weighted average period of 0.93 years.
The
exercise price for an option issued under the 2020 Plan is determined by the Board of Directors, but will be (i) in the case of an incentive
stock option (A) granted to an employee who, at the time of grant of such option, is a 10% stockholder, no less than 110% of the fair
market value per share on the date of grant; or (B) granted to any other employee, no less than 100% of the fair market value per share
on the date of grant; and (ii) in the case of a non-statutory stock option, no less than 100% of the fair market value per share on the
date of grant. The options awarded under the 2020 Plan will vest as determined by the Board of Directors but will not exceed a
ten-year period. A forfeiture is recognized as incurred if the option holder does not exercise after 90 days following termination
of service.
Fair
Value of Equity Awards
The
Company utilizes the Black-Scholes option pricing model to value awards under its equity plans. Key valuation assumptions include:
● |
Expected
dividend yield. The expected dividend is assumed to be zero, as the Company has never paid dividends and has no current plans
to pay any dividends on the Company’s common stock. |
|
|
● |
Expected
stock-price volatility. The Company’s expected volatility is derived from the average historical volatilities of publicly
traded companies within the Company’s industry that the Company considers to be comparable to the Company’s business
over a period approximately equal to the expected term, because the Company does not have sufficient stock price history over the expected term. |
|
|
● |
Risk-free
interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant for zero coupon
U.S. Treasury notes with maturities approximately equal to the expected term. |
|
|
● |
Expected
term. The expected term represents the period that the stock-based awards are expected to be outstanding. The Company’s
historical share option exercise experience does not provide a reasonable basis upon which to estimate an expected term because of
a lack of sufficient data. Therefore, the Company estimates the expected term by using the simplified method provided by the SEC.
The simplified method calculates the expected term as the average of the time-to-vesting and the contractual life of the options. |
The
Company recorded share-based compensation expense and classified it in the unaudited condensed consolidated statements of operations
as follows:
SCHEDULE
OF SHARE-BASED COMPENSATION EXPENSE
| |
2024 |
|
|
2023 |
|
|
2024 | | |
2023 | |
| |
For the Three Months Ended June 30, |
|
|
For the Six Months Ended June
30, | |
| |
2024 |
|
|
2023 |
|
|
2024 | | |
2023 | |
General and administrative | |
$ |
33,042 |
|
|
$ |
604,259 |
|
|
$ | 67,057 | | |
$ | 807,980 | |
Research and development | |
|
44 |
|
|
|
39,641 |
|
|
| 24,680 | | |
| 78,462 | |
Total | |
$ |
33,086 |
|
|
$ |
643,900 |
|
|
$ | 91,737 | | |
$ | 886,442 | |
Equity
Classified Compensatory Warrants
As
part of the May 2020 reverse recapitalization transaction, the Company issued equity classified compensatory common stock warrants to
an advisor and its designees. In addition, various service providers hold equity classified compensatory common stock warrants issued
in 2017 and earlier (originally exercisable to purchase Series C convertible preferred stock, and now instead exercisable to purchase
common stock). These are to be differentiated from the Series C Warrants described in Note 7- Warrant Liabilities.
On
February 27, 2024, as a result of a down-round provision triggered by a Securities Purchase Agreement with Alpha for the purchase of
the February 2024 Debenture, 67,620 warrants were repriced from $0.73 per share exercise price to $0.26 per share exercise price. The
increase in fair value of $9,737 for the modification of these warrants was charged to general and administrative expenses in the Company’s
condensed consolidated statements of operations and comprehensive loss.
No
compensatory warrants were issued during the six months ended June 30, 2024 and June 30, 2023.
The
following table summarizes the activity in the common stock equity classified compensatory warrants for the six months ended June 30,
2024:
SCHEDULE
OF COMPENSATORY WARRANT ACTIVITY
| |
Common Stock | |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2023 | |
| 119,046 | | |
$ | 10.69 | | |
$ | 0.73—$25.40 | | |
| 1.25 | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| (7,261 | ) | |
$ | 20.66 | | |
$ | 20.66—$20.66 | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Total outstanding –June 30, 2024 | |
| 111,785 | | |
$ | 9.40 | | |
$ | 0.26—$25.40 | | |
| 0.83 | |
Exercisable | |
| 111,785 | | |
$ | 9.40 | | |
$ | 0.26—$25.40 | | |
| 0.83 | |
Non-Exercisable | |
| — | | |
| — | | |
| — | | |
| — | |
The
following table summarizes the activity in the common stock equity classified compensatory warrants for the six months ended June 30,
2023:
| |
Common Stock |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2022 | |
| 179,046 | | |
$ | 9.12 | | |
$ | 1.32 — $25.40 | | |
| 1.73 | |
Exercised | |
| — | | |
| | | |
| | | |
| | |
Expired | |
| — | | |
| | | |
| | | |
| | |
Forfeited | |
| — | | |
| | | |
| | | |
| | |
Total outstanding – June 30, 2023 | |
| 179,046 | | |
$ | 9.12 | | |
$ | 1.32 — $25.40 | | |
| 1.24 | |
Exercisable | |
| 179,046 | | |
$ | 9.12 | | |
$ | 1.32 — $25.40 | | |
| 1.24 | |
Non-Exercisable | |
| — | | |
| — | | |
| — | | |
| — | |
There
was $9,737 in compensation cost related to outstanding equity classified compensatory warrants for the six months ended June 30, 2024
and $0 for the six months ended June 30, 2023. As of June 30, 2024 and June 30, 2023, there was no unrecognized compensation cost related
to nonvested warrants.
Noncompensatory
Equity Classified Warrants
On
May 22, 2020, as a commitment fee, the Company issued noncompensatory equity classified warrants to Alpha (a related party) for the purchase
of common stock. 7,048 of these warrants remain outstanding and exercisable as of June 30, 2024 and may be exercised in whole or in part,
at any time before May 22, 2025. On December 22, 2022, in conjunction with the issuance of a debenture to Alpha (see Note 8 – Convertible
Debt), the Company issued to Alpha a warrant to purchase 2,500,000 shares of the Company’s common stock.
The exercise price of this warrant was initially $1.65, and may be exercised in whole or in part, on or after June 22, 2023 and at any
time before June 22, 2028. On December 5, 2023, the Company entered into an Amendment No. 1 with regard to the related Securities Purchase
Agreement, with Alpha. This Amendment reduced the Exercise Price of the December 22, 2022 warrant from $1.65 per share to $0.73 per share.
The Amendment also revised certain provisions of the warrant which resulted in reclassification of the warrant from liabilities to equity.
On
February 27, 2024 the Company entered into a new Securities Purchase Agreement with Alpha for the purchase of the February 2024 Debenture
(see Note 8 – Convertible Debt). This Securities Purchase Agreement resulted in the reduction of the exercise
price of the December 22, 2022 warrant and the May 2020 warrant from $0.73 per share to $0.26 per share. The company recognized a deemed
dividend of $60,017, which represents the incremental fair value of the outstanding warrants as a result of the down-round provision.
As the Company has an accumulated deficit, the deemed dividend was recorded as a reduction in additional paid-in capital, resulting in
a net impact of zero to additional paid-in capital in the condensed consolidated statements of changes in stockholders’ equity.
In addition, on February 27, 2024, the Company issued to Alpha a warrant to purchase 900,016 shares of the Company’s common stock
at an exercise price of $0.26 per share, which may be exercised in whole or in part, at any time before February 27, 2029.
The
following table summarizes the noncompensatory equity classified warrant activity for the six months ended June 30, 2024:
SCHEDULE
OF NON COMPENSATORY WARRANT ACTIVITY
| |
Common Stock |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2023 | |
| 2,507,050 | | |
$ | 0.73 | | |
$ | 0.73 — $0.73 | | |
| 4.47 | |
Granted | |
| 900,016 | | |
$ | 0.26 | | |
| $0.26 — $0.26 | | |
| 4.67 | |
Exercised | |
| (576,924 | ) | |
$ | 0.26 | | |
$ | 0.26 — $0.26 | | |
| — | |
Expired | |
| — | | |
| — | | |
| — | | |
| — | |
Forfeited | |
| (2 | ) | |
$ | 0.26 | | |
$ | 0.26 — $0.26 | | |
| — | |
Total outstanding – June 30, 2024 | |
| 2,830,140 | | |
$ | 0.26 | | |
$ | 0.26 — $0.26 | | |
| 4.19 | |
Exercisable | |
| 2,830,140 | | |
$ | 0.26 | | |
$ | 0.26 — $0.26 | | |
| 4.19 | |
Non-Exercisable | |
| — | | |
| — | | |
| — | | |
| — | |
The
following table summarizes the noncompensatory equity classified warrant activity for the six months ended June 30, 2023:
| |
Common Stock | |
| |
Shares | | |
Weighted–
Average Exercise Price | | |
Range
of Exercise Price | | |
Weighted–
Average Remaining Life (Years) | |
Total outstanding – December 31, 2022 | |
| 547,003 | | |
$ | 19.76 | | |
$ | 1.32
— $20.00 | | |
| 0.33 | |
Legacy Ritter warrants | |
| — | | |
| — | | |
| — | | |
| — | |
Granted | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| (455,685 | ) | |
$ | 20.00 | | |
$ | 20.00
— $20.00 | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Total outstanding – June 30, 2023 | |
| 91,318 | | |
$ | 18.56 | | |
$ | 1.32
— $20.00 | | |
| — | |
Exercisable | |
| 226,150 | | |
$ | 18.56 | | |
$ | 1.32
— $20.00 | | |
| 0.58 | |
Non-Exercisable | |
| — | | |
$ | — | | |
$ | — | | |
| — | |
|
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v3.24.2.u1
RELATED PARTY TRANSACTIONS
|
6 Months Ended |
Jun. 30, 2024 |
Related Party Transactions [Abstract] |
|
RELATED PARTY TRANSACTIONS |
NOTE
13 — RELATED PARTY TRANSACTIONS
Convertible
Debt
On
December 22, 2022, the Company issued to Alpha, an 8% Senior Convertible Debenture in the aggregate principal amount of $3,300,000 for
a purchase price of $3,000,000 pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022. As of June 30, 2024
the Debenture had a remaining principal balance of $394,921, and was convertible, at any time, and from time to time, at Alpha’s
option, into shares of common stock of the Company, at a price equal to $0.26 per share, subject to adjustment as described in the Debenture
and other terms and conditions described in the Debenture.
Between
July 3 - July 5, 2024, Alpha subsequently converted the remaining principal balance of $394,921 of this Debenture into 1,518,931 shares
of common stock of the Company, at a price equal to $0.26 per share (see Note 14 - Subsequent Events).
On
February 27, 2024, the Company issued to Alpha, an 8% Convertible Debenture in the principal amount of $550,000 for a purchase price
of $500,000 less expenses pursuant to the terms of a Securities Purchase Agreement dated February 26, 2024. As of June 30, 2024 the Debenture
had a remaining principal balance of $550,000, and was convertible, at any time, and from time to time, at Alpha’s option, into
shares of common stock of the Company, at a price equal to $0.6111 per share, subject to adjustment as described in the Debenture and
other terms and conditions described in the Debenture.
See
Note 8 – Convertible Debt for additional information concerning convertible debt – related party transactions.
Warrants
On
May 22, 2020, as a commitment fee, the Company issued warrants to Alpha for the purchase of common stock. As of June 30, 2024, 7,048
of these warrants remain outstanding and exercisable, and may be exercised in whole or in part, at any time before May 22, 2025.
On
December 22, 2022, in conjunction with the issuance of a debenture to Alpha, the Company issued to Alpha a warrant to purchase 2,500,000
shares of the Company’s common stock. As of June 30, 2024, the exercise price of this warrant was $0.26. This warrant may be exercised
by Alpha, in whole or in part, on or after June 22, 2023 and at any time before June 22, 2028, subject to certain terms and conditions
described in the warrant. On May 16, 2024, Alpha partially exercised this warrant to purchase 288,462 shares of the Company’s common
stock at an exercise price of $0.26, and on June 4, 2024, Alpha partially exercised this warrant to purchase 288,462 shares of the Company’s
common stock at an exercise price of $0.26, for total cumulative proceeds to the Company of $ from both exercises.
On
February 27, 2024, in conjunction with the issuance of a debenture to Alpha, the Company issued to Alpha a warrant to purchase 900,016
shares of the Company’s common stock. As of June 30, 2024, the exercise price of the Alpha Warrant was $0.26. The Alpha Warrant
may be exercised by Alpha, in whole or in part, at any time before February 27, 2029, subject to certain terms and conditions described
in the warrant.
The
above warrants are included in equity on the Company’s condensed consolidated balance sheets (see Note 12 – Stockholders’
Equity (Deficit)).
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.24.2.u1
SUBSEQUENT EVENTS
|
6 Months Ended |
Jun. 30, 2024 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
14 — SUBSEQUENT EVENTS
Debt
Conversion and Warrant Exercises
Between
July 3 and July 5, 2024, Alpha voluntarily converted the remaining principal balance of $394,921 of the December 2022 8% Senior Convertible
Debenture into 1,518,931 shares of common stock of the Company, at a conversion price of $0.26 per share.
Between
July 5 and July 12, 2024, Alpha partially exercised an equity-classified noncompensatory warrant to purchase 1,023,000 shares of the
Company’s common stock at an exercise price of $0.26 per share, resulting in total cumulative proceeds to the Company of $266,000.
Nonconvertible
Debt and Changes to Board of Directors
The
Company and an institutional investor entered into a Securities Purchase Agreement dated July 5, 2024 (the “Agreement”),
providing for the Company to issue to the investor at par an unsecured, nonconvertible $2,000,000 18% senior note (the “Senior
Note”) with a scheduled maturity date of July 8, 2025. The Senior Note includes a requirement for partial prepayments from a percentage
of any future Company financings. Otherwise, principal and interest on the Senior Note is not payable until maturity. On July 5, 2024,
four independent directors resigned from the Company’s Board of Directors, and the Company’s Board of Directors appointed
three new directors to the Board effective upon the Company’s receipt of the $2,000,000 pursuant to the Agreement, which occurred
on July 12, 2024.
Marizyme
On July 15, 2024, the Company advanced to Marizyme, Inc., a Nevada corporation (“Marizyme”), against which Marizyme had previously
delivered its demand promissory note to the Company of like principal amount dated July 12, 2024 (the “Marizyme Note”). The
Marizyme Note bears interest the rate of eighteen percent (18%) per annum. Marizyme may pre-pay all or any part of the outstanding principal
or interest of the Marizyme Note at any time and from time to time, in whole or in part, without premium or penalty.
Possible
Nasdaq Delisting
On May 23, 2024, the Company received written notice (the “Delist Notice”) from The Nasdaq Stock Market (“Nasdaq”)
indicating the Company’s continued non-compliance with the minimum bid price requirement, pursuant to Listing Rule 5550(b)(2).
As
previously reported, on November 20, 2023, the Company received a letter (the “Bid Price Deficiency Notice”) from Nasdaq
notifying the Company that, because the closing bid price for its common stock has been below $1.00 per share for 30 consecutive business
days, it no longer complies with the minimum bid price requirement for continued listing on The Nasdaq Capital Market. Nasdaq Listing
Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per share (the “Bid Price Rule”),
and Listing Rule 5810(c)(3)(A) provides that a failure to meet the Minimum Bid Price Requirement exists if the deficiency continues for
a period of 30 consecutive business days.
Further,
as previously reported, on November 21, 2023, the Company also received a letter from Nasdaq notifying the Company that it did not comply
with the $2,500,000 minimum stockholders’ equity requirement, as set forth in Listing Rule 5550(a)(2) (the “Equity Rule”).
On January 12, 2024, Nasdaq granted the Company an extension of time until May 21, 2024, to regain compliance with the Equity Rule. The
Company has not done so to date. As such, the Delist Notice states that this matter also serves as a separate and additional basis for
delisting the Company’s securities from The Nasdaq Stock Market.
On
July 16, 2024, the Company attended a hearing before the Nasdaq Hearings Panel (the “Panel”) regarding the Company’s potential delisting from The Nasdaq Stock Market due to non-compliance
with the bid price requirement pursuant to the Bid Price Rule and the shareholder equity requirement pursuant to the Equity Rule. On August
2, 2024, the Company received the Panel decision which granted the Company until October 31, 2024 to regain compliance with the Bid Price
Rule and the Equity Rule. If the Company is unable to regain compliance with the listing standards of the Nasdaq Capital Market by October
31, 2024, the Company’s securities may be delisted from The Nasdaq Stock Market.
Settlement
of Outstanding Accounts Payable
On
August 9, 2024, the Company fully settled accounts payable to certain creditors totaling approximately $319,000
for cash payments of approximately $50,000.
Public Offering
On August 7, 2024 and August 9, 2024 the Company filed Amendments to its
Form S-1 Registration Statement for an offering on a “reasonable best efforts” basis of up to $4 million of shares of common
stock.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.24.2.u1
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization |
Organization
Ritter
Pharmaceuticals, Inc. (the Company’s predecessor) was formed as a Nevada limited liability company on March 29, 2004 under the
name Ritter Natural Sciences, LLC. In September 2008, this company converted into a Delaware corporation under the name Ritter Pharmaceuticals,
Inc. On May 22, 2020, upon completing a “reverse recapitalization” transaction with Qualigen, Inc., Ritter Pharmaceuticals,
Inc. was renamed Qualigen Therapeutics, Inc. (the “Company”). Qualisys Diagnostics, Inc. was formed as a Minnesota corporation
in 1996, reincorporated to become a Delaware corporation in 1999, and then changed its name to Qualigen, Inc. in 2000. Qualigen, Inc.
was a wholly-owned subsidiary of the Company. On July 20, 2023, the Company sold all of the issued and outstanding shares of common stock
of Qualigen, Inc. to Chembio Diagnostics, Inc. (“Chembio”), a wholly-owned subsidiary of Biosynex, S.A. (“Biosynex”).
Following the consummation of this transaction, Qualigen, Inc. became a wholly-owned subsidiary of Chembio (see Note 5 – Discontinued
Operations).
On
May 26, 2022, the Company acquired 2,232,861 shares of Series A-1 Preferred Stock of NanoSynex, Ltd. (“NanoSynex”) from Alpha
Capital Anstalt (“Alpha”), a related party, in exchange for 350,000 reverse split adjusted shares of the Company’s
common stock and a prefunded warrant to purchase 331,464 reverse split adjusted shares of the Company’s common stock at an exercise
price of $0.001 per share. These warrants were subsequently exercised on September 13, 2022. Concurrently with this transaction, the
Company also entered into a Master Funding Agreement for the Operational and Technology Funding of NanoSynex Ltd., dated May 26, 2022,
with NanoSynex (the “NanoSynex Funding Agreement”), to, among other things, provide for the further funding of NanoSynex,
and purchased 381,786 shares of Series B preferred stock from NanoSynex for a total purchase price of $600,000. The transactions resulted
in the Company acquiring a 52.8% interest in NanoSynex (the “NanoSynex Acquisition”). NanoSynex is a nanotechnology diagnostics
company domiciled in Israel. On July 20, 2023, the Company entered into an Amendment and Settlement Agreement with NanoSynex (the “NanoSynex
Amendment”), which amended the NanoSynex Funding Agreement, to, among other things, eliminate most of the Company obligation for
the further funding of NanoSynex. Pursuant to the terms of the NanoSynex Amendment, the Company lost its controlling interest in NanoSynex
(see Note 5 -Discontinued Operations).
|
Basis of Presentation |
Basis
of Presentation
Certain information or footnote disclosures normally included in financial statements prepared in accordance with
GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they
do not include all the information and footnotes necessary for a complete presentation of financial position, results of operations, or
cash flows. In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments,
consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results, and
cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements should be read in conjunction
with the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which contains the audited financial statements
and notes thereto. The financial information as of December 31, 2023 is derived from the audited financial statements presented in the
Company’s Annual Report on Form 10-K for the year ended December 31, 2023. The interim results for the three and six months ended
June 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024 or for any future periods.
|
Principles of Consolidation |
Principles
of Consolidation
The
accompanying condensed consolidated financial statements include the accounts of the Company and its former wholly-owned and majority
owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to
applicable guidance is meant to refer to U.S. GAAP. The Company views its operations and manages its business in one operating segment.
In general, the functional currency of the Company and its subsidiaries is the U.S. dollar. For NanoSynex, the functional currency was
the local currency, New Israeli Shekels (NIS). As such, assets and liabilities for NanoSynex were translated into U.S. dollars with the
effects of foreign currency translation adjustments reflected as a component of accumulated other comprehensive loss within the Company’s
condensed consolidated statements of changes in stockholders’ equity (deficit).
As
of July 20, 2023, NanoSynex was deconsolidated from these financial statements as the transactions contemplated by the NanoSynex Amendment
resulted in a loss of control of a subsidiary that constitutes a business under ASC 810. The retained investment in NanoSynex is accounted
for prospectively as an equity method investment. See Note 5 – Discontinued Operations for further information.
|
Discontinued Operations |
Discontinued
Operations
On
July 20, 2023, the Company completed the sale of Qualigen, Inc. to Chembio Diagnostics, Inc. The sale of Qualigen Inc. constituted a
significant disposition and as such, the Company concluded that the disposition of ownership in Qualigen, Inc. represented a strategic
shift that had a major effect on its operations and financial results. Therefore, Qualigen, Inc. is classified as discontinued operations
for all periods presented herein.
On
July 20, 2023, the Company entered into the NanoSynex Amendment, which amended the Master Funding Agreement for the Operational and Technology
Funding of NanoSynex Ltd., dated May 26, 2022, by and between the Company and NanoSynex (the “NanoSynex Funding Agreement”),
a former majority owned subsidiary of the Company, to, among other things, forfeit 281,000 Series B Preferred Shares of NanoSynex held
by the Company, resulting in the deconsolidation of NanoSynex. The disposition represents a strategic shift that will have a material
effect on the Company’s operations and financial results. Accordingly, the business of NanoSynex is classified as discontinued
operations for all periods presented herein.
See
Note 5 - Discontinued Operations for further information.
|
Equity Method Investments |
Equity
Method Investments
Following
deconsolidation of NanoSynex on July 20, 2023, the Company accounts for its retained investment under the equity method of accounting
as it retained the ability to exercise significant influence over the operating and financial policies of the investee. Under the equity
method, the Company recognizes its proportionate share earnings or losses each reporting period with an adjustment to the carrying value
of the investment. As of December 31, 2023, the carrying value of the retained investment was zero, and therefore the Company has suspended
application of the equity method as the Company is not liable for the obligations of the investee nor otherwise committed to provide
financial support. Future equity method earnings, if any, will not be recognized until the amount exceeds the unrecognized net losses
in prior periods. See Note 5 – Discontinued Operations for further information.
|
Accounting Estimates |
Accounting
Estimates
Management
uses estimates and assumptions in preparing its condensed consolidated financial statements in accordance with U.S. GAAP. Those estimates
and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported
revenues and expenses. The most significant estimates relate to the estimated fair value of in-process research and development, goodwill,
warrant liabilities, and stock-based compensation. Actual results could materially vary from the estimates that were used.
|
Cash |
Cash
The
Company considers all highly liquid investments purchased with an initial maturity of 90 days or less and money market funds to be cash
equivalents.
The
Company maintains the majority of its cash in government money market mutual funds and in accounts at banking institutions in the U.S.
that are of high quality. Cash held in these accounts often exceed the Federal Deposit Insurance Corporation (FDIC) insurance limits.
If such banking institutions were to fail, the Company could lose all or a portion of amounts held in excess of such insurance limitations.
In March 2023, Silicon Valley Bank and Signature Bank, and more recently in May 2023, First Republic Bank, were closed due to liquidity
concerns and taken over by the FDIC. While the Company did not have an account at any of these banks, in the event of failure of any
of the financial institutions where the Company maintains its cash and cash equivalents, there can be no assurance that the Company would
be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely
affect the Company’s business and financial position.
|
Impairment of Long-Lived Assets |
Impairment
of Long-Lived Assets
The
Company assesses potential impairments to its long-lived assets when there is evidence that events or changes in circumstances indicate
that assets may not be recoverable. An impairment loss would be recognized when the sum of the expected future undiscounted cash flows
is less than the carrying amount of the assets. The amount of impairment loss, if any, will generally be measured as the difference between
the net book value of the assets and their estimated fair values. During the six months ended June 30, 2024 and 2023, no such impairment
losses have been recorded.
|
Segment Reporting |
Segment
Reporting
Operating
segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation
by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company
has viewed its operations and managed its business as one segment operating primarily within the United States (and in Israel prior to
the NanoSynex deconsolidation).
|
Research and Development |
Research
and Development
Except
for acquired in process research and development (IPR&D), the Company expenses research and development costs as incurred including
therapeutics license costs.
|
Patent Costs |
Patent
Costs
The
Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting
expenses related to making such applications) and such costs are included in general and administrative expenses in the condensed consolidated
statement of operations.
|
Derivative Financial Instruments and Warrant Liabilities |
Derivative
Financial Instruments and Warrant Liabilities
The
Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates
all of its financial instruments, including issued stock purchase warrants, to determine if such instruments are derivatives or contain
features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative
instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported
in the condensed consolidated statements of operations and comprehensive loss. Depending on the features of the derivative financial
instrument, the Company uses either the Black-Scholes option-pricing model or a Monte-Carlo simulation to value the derivative instruments
at inception and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should
be recorded as liabilities or as equity, is re-assessed at the end of each reporting period (See Note 7-Warrant Liabilities and Note
8- Convertible Debt).
|
Fair Value Measurements |
Fair
Value Measurements
The
Company determines the fair value measurements of applicable assets and liabilities based on a three-tier fair value hierarchy established
by accounting guidance and prioritizes the inputs used in measuring fair value. The Company discloses and recognizes the fair value of
its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy
gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level
1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements).
The guidance establishes three levels of the fair value hierarchy as follows:
|
● |
Level
1 - Inputs that reflect unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability
to access at the measurement date; |
|
|
|
|
● |
Level
2 - Inputs other than quoted prices that are observable for the assets or liability either directly or indirectly, including inputs
in markets that are not considered to be active; and |
|
|
|
|
● |
Level
3 - Inputs that are unobservable. |
|
Fair Value of Financial Instruments |
Fair
Value of Financial Instruments
Cash,
accounts receivable, prepaids, accounts payable, and accrued liabilities are carried at cost, which management believes approximates
fair value due to the short-term nature of these instruments.
|
Comprehensive Loss |
Comprehensive
Loss
Comprehensive
loss consists of net income and foreign currency translation adjustments related to the discontinued operations of NanoSynex. Comprehensive
gains (losses) have been reflected in the statements of operations and comprehensive loss and as a separate component in the statements
of stockholders’ equity (deficit) for all periods presented.
|
Stock-Based Compensation |
Stock-Based
Compensation
Stock-based
compensation cost for equity awards granted to employees and non-employees is measured at the grant date based on the calculated fair
value of the award using the Black-Scholes option-pricing model, and is recognized as an expense, under the straight-line method, over
the requisite service period (generally the vesting period of the equity grant). If the Company determines that other methods are more
reasonable, or other methods for calculating these assumptions are prescribed by regulators, the fair value calculated for the Company’s
stock options could change significantly. Higher volatility, lower risk-free interest rates, and longer expected lives would result in
an increase to stock-based compensation expense to employees and non-employees determined at the date of grant.
|
Income Taxes |
Income
Taxes
Deferred
income taxes are recognized for temporary differences in the basis of assets and liabilities for financial statement and income tax reporting
that arise due to net operating loss carry forwards, research and development credit carry forwards and from using different methods
and periods to calculate depreciation and amortization, allowance for doubtful accounts, accrued vacation, research and development expenses,
and state taxes. A provision has been made for income taxes due on taxable income and for the deferred taxes on the temporary differences.
Deferred
tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all
of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws
and rates on the date of enactment. Realization of the deferred income tax asset is dependent on generating sufficient taxable income
in future years.
In
December 2023, the FASB issued Accounting Standards Update 2023-09, Improvements to Income Tax Disclosures, which requires more detailed
income tax disclosures. The guidance requires entities to disclose disaggregated information about their effective tax rate reconciliation
as well as expanded information on income taxes paid by jurisdiction. The disclosure requirements will be applied on a prospective basis,
with the option to apply them retrospectively. The standard is effective for fiscal years beginning after December 15, 2024, with early
adoption permitted. The Company is evaluating the disclosure requirements related to the new standard.
|
Foreign Currency Translation |
Foreign
Currency Translation
The
functional currency for the Company is the U.S. dollar. The functional currency for the discontinued operations of NanoSynex was the
New Israeli Shekel (NIS). The financial statements of NanoSynex were translated into U.S. dollars using exchange rates in effect at each
period end for assets and liabilities; using exchange rates in effect during the period for results of operations; and using historical
exchange rates for certain equity accounts. The adjustment resulting from translating the financial statements of NanoSynex was reflected
as a separate component of other comprehensive income (loss) (see Note 5 - Discontinued Operations).
|
Global Economic Conditions |
Global
Economic Conditions
Ongoing
Wars in Ukraine and Israel
In
February 2022, Russia invaded Ukraine. While the Company has no direct exposure in Russia and Ukraine, the Company continues to monitor
any broader impact to the global economy, including with respect to inflation, supply chains and fuel prices. The full impact of the
conflict on the Company’s business and financial results remains uncertain and will depend on the severity and duration of the
conflict and its impact on regional and global economic conditions.
In
October 2023, Hamas conducted terrorist attacks in Israel resulting in ongoing war. There continue to be hostilities between Israel and
Hezbollah in Lebanon and Hamas in the Gaza Strip, both of which have resulted in rockets being fired into Israel, causing casualties
and disruption of economic activities. In early 2023, there were a number of changes proposed to the political system in Israel by the
current government which, if implemented as planned, could lead to large-scale protests and additional uncertainty, negatively impacting
the operating environment in Israel. Popular uprisings in various countries in the Middle East over the last few years have also affected
the political stability of those countries and have led to a decline in the regional security situation. Such instability may also lead
to deterioration in the political and trade relationships that exist between Israel and these countries. Any armed conflicts, terrorist
activities or political instability involving Israel or other countries in the region could adversely affect the Company’s minority
interest in NanoSynex, its results of operations, financial condition, cash flows and prospects (see Note 5 – Discontinued Operations).
Inflation
and Global Economic Conditions
During
the year ended 2023 and continuing into the current fiscal year, global commodity and labor markets experienced significant inflationary
pressures attributable to government stimulus and recovery programs, government deficit spending and supply chain issues. The Company
cannot provide assurance that it will be successful in fully offsetting increased costs resulting from inflationary pressure. In addition,
the global economy suffers from slowing growth and rising interest rates, and some economists believe that there may be a global recession
in the near future. If the global economy slows, the Company’s business may be adversely affected.
|
Impact of COVID-19 Pandemic |
Impact
of COVID-19 Pandemic
The
COVID-19 pandemic has had a dramatic impact on businesses globally and on the Company’s business as well. During the height of
the pandemic, sales of diagnostic products decreased significantly and the Company’s net loss increased significantly, as clinics
and small hospitals’ demand for Qualigen, Inc.’s FastPack™ diagnostic test kits was reduced sharply, largely due to
deferral of patients’ non-emergency visits to physician offices. In July 2023 the Company sold Qualigen, Inc., its wholly-owned
subsidiary, to Chembio (see Note 5 - Discontinued Operations).
|
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v3.24.2.u1
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS |
Prepaid
expenses and other current assets consisted of the following at June 30, 2024 and December 31, 2023:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Prepaid insurance | |
$ | 382,229 | | |
$ | 566,011 | |
Other prepaid expenses | |
| 33,496 | | |
| 25,053 | |
Prepaid research and development expenses | |
| — | | |
| 173,900 | |
Prepaid expenses and
other current assets | |
$ | 415,725 | | |
$ | 764,964 | |
|
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OTHER NON-CURRENT ASSETS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Investments, All Other Investments [Abstract] |
|
SCHEDULE OF OTHER NON CURRENT ASSETS |
Other
non-current assets consisted of the following at June 30, 2024 and December 31, 2023:
SCHEDULE
OF OTHER NON CURRENT ASSETS
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Funds held in escrow | |
$ | — | | |
$ | 450,000 | |
Long-term research and development deposits | |
| — | | |
| 416,481 | |
Other non-current assets | |
$ | — | | |
$ | 866,481 | |
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v3.24.2.u1
DISCONTINUED OPERATIONS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS |
The
summary of gain (loss) from discontinued operations, net of tax, for the three and six months ended June 30, 2023 are as follows:
SCHEDULE
OF GAIN (LOSS) FROM DISCONTINUED OPERATIONS
| |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total |
| |
Three
Months Ended
June 30,
2024 | |
Six Months
Ended
June 30,
2024 | |
Three
Months Ended
June 30,
2023 | |
Six Months
Ended
June 30,
2023 |
| |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total | |
Qualigen, Inc. | |
NanoSynex | |
Total |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
| |
|
Loss on disposal of discontinued operations, net of tax | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | 113,694 | | |
$ | (84,022 | ) | |
$ | 29,672 | | |
$ | (262,478 | ) | |
$ | (580,037 | ) | |
$ | (842,515 | ) |
Income (loss) from discontinued operations, net of tax | |
| (100,000 | ) | |
| — | | |
| (100,000 | ) | |
| (100,000 | ) | |
| — | | |
| (100,000 | ) | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | |
GAIN (LOSS) FROM DISCONTINUED OPERATIONS | |
$ | (100,000 | ) | |
$ | — | | |
$ | (100,000 | ) | |
$ | (100,000 | ) | |
$ | — | | |
$ | (100,000 | ) | |
$ | 113,694 | | |
$ | (84,022 | ) | |
$ | 29,672 | | |
$ | (262,478 | ) | |
$ | (580,037 | ) | |
$ | (842,515 | ) |
|
NanoSynex [Member] |
|
SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS |
SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS
| |
For the Three
Months Ended March 30, | | |
For the Six
Months June 30, | |
| |
2023 | | |
2023 | |
EXPENSES | |
| | | |
| | |
Research and development | |
$ | 126,240 | | |
$ | 787,425 | |
Total expenses | |
| 126,240 | | |
| 787,425 | |
| |
| | | |
| | |
(BENEFIT) PROVISION FOR INCOME TAXES | |
| (42,218 | ) | |
| (207,388 | ) |
| |
| | | |
| | |
LOSS FROM DISCONTINUED OPERATIONS OF NANOSYNEX, LTD. | |
| (84,022 | ) | |
| (580,037 | ) |
| |
| | | |
| | |
Loss attributable to noncontrolling interest | |
| (43,484 | ) | |
| (304,512 | ) |
| |
| | | |
| | |
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS | |
$ | (40,538 | ) | |
$ | (275,525 | ) |
|
Parent [Member] |
|
SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS |
The
Company reclassified the following statement of operations items to discontinued operations for the three and six months ended June 30,
2023:
SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS
| |
For the Three
Months Ended June 30, | | |
For the Six
Months June 30, | |
| |
2023 | | |
2023 | |
REVENUES | |
| | | |
| | |
Net product sales | |
$ | 1,627,031 | | |
$ | 3,234,201 | |
Total revenues | |
| 1,627,031 | | |
| 3,234,201 | |
| |
| | | |
| | |
EXPENSES | |
| | | |
| | |
Cost of product sales | |
| 1,016,543 | | |
| 2,281,368 | |
General and administrative | |
| 238,782 | | |
| 584,214 | |
Research and development | |
| 25,657 | | |
| 204,207 | |
Sales and marketing | |
| 169,223 | | |
| 368,337 | |
Total expenses | |
| 1,450,204 | | |
| 3,438,126 | |
| |
| | | |
| | |
OTHER EXPENSE (INCOME), NET | |
| | | |
| | |
Loss on disposal of equipment held for lease | |
| 63,302 | | |
| 63,302 | |
Other expense (income), net | |
| (169 | ) | |
| (5,049 | ) |
Loss on fixed asset disposal | |
| — | | |
| 300 | |
Total other expense (income), net | |
| 63,133 | | |
| 58,553 | |
| |
| | | |
| | |
INCOME (LOSS) FROM DISCONTINUED OPERATIONS OF QUALIGEN, INC. | |
$ | 113,694 | | |
$ | (262,478 | ) |
|
X |
- DefinitionTabular disclosure of information related to a disposal group. Includes, but is not limited to, a discontinued operation, disposal classified as held-for-sale or disposed of by means other than sale or disposal of an individually significant component.
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v3.24.2.u1
ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES |
Accrued
expenses and other current liabilities consisted of the following at June 30, 2024 and December 31, 2023:
SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Board compensation | |
$ | 251,999 | | |
| 129,499 | |
Interest (Convertible debt) | |
| 51,909 | | |
| 10,004 | |
License fees | |
| — | | |
| 32,975 | |
Payroll | |
| 300,481 | | |
| 1,215 | |
Professional fees | |
| 144,528 | | |
| 121,775 | |
Research and development | |
| 17,500 | | |
| 104,402 | |
Vacation | |
| 162,665 | | |
| 151,286 | |
Other | |
| 57,725 | | |
| 8,850 | |
Accrued expenses and
other current liabilities | |
$ | 986,806 | | |
$ | 560,006 | |
|
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v3.24.2.u1
WARRANT LIABILITIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Warrant Liabilities |
|
SCHEDULE OF WARRANTS ACTIVITY |
The
following table summarizes the activity in liability classified warrants for the six months ended June 30, 2024:
SCHEDULE OF WARRANTS ACTIVITY
| |
Common Stock Warrants | |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2023 | |
| 455,623 | | |
$ | 0.73 | | |
$ | 0.73 - $0.73 | | |
| 0.49 | |
Granted | |
| 2,623,665 | | |
$ | 0.26 | | |
$ | 0.26 - $0.26 | | |
| 4.67 | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| (1,279,256 | ) | |
$ | 0.26 | | |
$ | 0.26 - $0.26 | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Total outstanding – June 30, 2024 | |
| 1,800,032 | | |
$ | 0.26 | | |
$ | 0.26 - $0.26 | | |
| 4.67 | |
Exercisable | |
| 1,800,032 | | |
$ | 0.26 | | |
$ | 0.26 - $0.26 | | |
| 4.67 | |
The
following table summarizes the activity in liability classified warrants for the six months ended June 30, 2023:
| |
Common Stock Warrants | |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding –December 31, 2022 | |
| 3,849,571 | | |
$ | 1.53 | | |
| $1.32 - $1.65 | | |
| 3.9 | |
Granted | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| — | | |
| — | | |
| — | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Total outstanding – June 30, 2023 | |
| 3,849,571 | | |
$ | 1.53 | | |
| $1.32 - $1.65 | | |
| 3.41 | |
Exercisable | |
| 3,849,571 | | |
$ | 1.53 | | |
| $1.32 - $1.65 | | |
| 3.41 | |
|
SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES |
The
following table presents the Company’s fair value hierarchy for its liabilities measured at fair value on a recurring basis as
of June 30, 2024:
SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES
| |
Quoted | | |
| | |
| | |
| |
| |
Market | | |
Significant | | |
| | |
| |
| |
Prices for | | |
Other | | |
Significant | | |
| |
| |
Identical | | |
Observable | | |
Unobservable | | |
| |
| |
Assets | | |
Inputs | | |
Inputs | | |
| |
Common Stock Warrant liabilities | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
Balance as of December 31, 2023 | |
$ | — | | |
$ | — | | |
$ | 54,600 | | |
$ | 54,600 | |
Granted | |
| — | | |
| — | | |
| 565,582 | | |
| 565,582 | |
Exercises | |
| — | | |
| — | | |
| — | | |
| — | |
Gain on change in fair value of warrant liabilities | |
| — | | |
| — | | |
| (359,906 | ) | |
| (359,906 | ) |
Balance as of June 30, 2024 | |
$ | — | | |
$ | — | | |
$ | 260,276 | | |
$ | 260,276 | |
| |
Quoted | | |
| | |
| | |
| |
| |
Market | | |
Significant | | |
| | |
| |
| |
Prices for | | |
Other | | |
Significant | | |
| |
| |
Identical | | |
Observable | | |
Unobservable | | |
| |
| |
Assets | | |
Inputs | | |
Inputs | | |
| |
Derivative Liabilities Arising From Issuance of Convertible Debt | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | | |
Total | |
Balance as of December 31, 2023 | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | |
Granted | |
| — | | |
| — | | |
| 215,897 | | |
| 215,897 | |
Gain on change in fair value of derivative liabilities | |
| — | | |
| — | | |
| (174,613 | ) | |
| (174,613 | ) |
Balance as of June 30, 2024 | |
$ | — | | |
$ | — | | |
$ | 41,284 | | |
$ | 41,284 | |
|
SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES |
The
following are the weighted average and the range of assumptions used in estimating the fair value of warrant liabilities (weighted average
calculated based on the number of outstanding warrants on each issuance) as of June 30, 2024 and 2023:
SCHEDULE
OF ASSUMPTIONS OF WARRANT LIABILITIES
| |
June 30, 2024 | | |
June 30, 2023 | |
| |
Actual | | |
Range | | |
Weighted Average | |
Risk-free interest rate | |
| 4.38 | % | |
| 4.05% — 5.31% | | |
| 4.49 | % |
Expected volatility (peer group) | |
| 125 | % | |
| 66.3% — 134% | | |
| 110.55 | % |
Term of warrants (in years) | |
| 4.7 | | |
| .39 — 4.98 | | |
| 3.41 | |
Expected dividend yield | |
| 0.00 | % | |
| 0.00 | % | |
| 0.00 | % |
|
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- DefinitionTabular disclosure of warrants or rights issued. Warrants and rights outstanding are derivative securities that give the holder the right to purchase securities (usually equity) from the issuer at a specific price within a certain time frame. Warrants are often included in a new debt issue to entice investors by a higher return potential. The main difference between warrants and call options is that warrants are issued and guaranteed by the company, whereas options are exchange instruments and are not issued by the company. Also, the lifetime of a warrant is often measured in years, while the lifetime of a typical option is measured in months. Disclose the title of issue of securities called for by warrants and rights outstanding, the aggregate amount of securities called for by warrants and rights outstanding, the date from which the warrants or rights are exercisable, and the price at which the warrant or right is exercisable.
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v3.24.2.u1
CONVERTIBLE DEBT (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT |
Convertible
debt is comprised of the following as of June 30, 2024 and December 31, 2023:
SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT
| |
June 30,
2024 | | |
December 31, 2023 | |
Convertible debt | |
$ | 1,100,000 | | |
$ | — | |
Discount on convertible debt | |
| (19,706 | ) | |
| — | |
Total convertible debt | |
$ | 1,080,294 | | |
$ | — | |
| |
June 30,
2024 | | |
December 31, 2023 | |
Convertible debt - related party | |
| 944,922 | | |
| 1,418,922 | |
Convertible debt | |
| 944,922 | | |
| 1,418,922 | |
Discount on convertible debt - related party | |
| (355,205 | ) | |
| (119,706 | ) |
Discount on convertible debt | |
| (355,205 | ) | |
| (119,706 | ) |
Total convertible debt - related party | |
$ | 589,717 | | |
$ | 1,299,216 | |
Total convertible debt | |
$ | 589,717 | | |
$ | 1,299,216 | |
|
X |
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v3.24.2.u1
EARNINGS (LOSS) PER SHARE (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE |
The
following potentially dilutive securities have been excluded from diluted net loss per share as of June 30, 2024 and 2023 because their
effect would be anti-dilutive:
SCHEDULE
OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE
| |
As of June 30, | |
| |
2024 | | |
2023 | |
Shares of common stock subject to outstanding options | |
| 755,715 | | |
| 445,163 | |
Shares of common stock subject to outstanding warrants | |
| 4,741,957 | | |
| 4,119,934 | |
Shares of common stock subject to outstanding convertible debt | |
| 4,218,978 | | |
| — | |
Total common stock equivalents | |
| 9,716,650 | | |
| 4,565,097 | |
|
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v3.24.2.u1
STOCKHOLDERS’ EQUITY (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
SCHEDULE OF RESERVED SHARES |
SCHEDULE
OF RESERVED SHARES
| |
| | |
Exercise of issued and future grants of stock options | |
| 755,715 | |
Conversion of convertible debt | |
| 4,218,978 | |
Exercise of stock warrants | |
| 4,741,957 | |
Total | |
| 9,716,650 | |
|
SCHEDULE OF STOCK OPTION ACTIVITY |
The
following represents a summary of the options granted (under the 2020 Plan and otherwise) to employees and non-employee service providers
that were outstanding at June 30, 2024, and changes during the six-month period then ended:
SCHEDULE
OF STOCK OPTION ACTIVITY
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2023 | |
| 398,924 | | |
$ | 35.21 | | |
$ | 5.14 — $51.30 | | |
| 7.06 | |
Granted | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| — | | |
| — | | |
| — | | |
| — | |
Forfeited | |
| (61,638 | ) | |
$ | 14.88 | | |
$ | 5.14 — $49.70 | | |
| — | |
Total outstanding – June 30, 2024 | |
| 337,286 | | |
$ | 38.92 | | |
$ | 5.14 — $51.30 | | |
| 6.47 | |
Exercisable (vested) | |
| 283,634 | | |
$ | 45.21 | | |
$ | 5.14 — $51.30 | | |
| 6.18 | |
Non-Exercisable (non-vested) | |
| 53,652 | | |
$ | 5.67 | | |
$ | 5.14 — $12.40 | | |
| 7.99 | |
The
exercise price for an option issued under the 2020 Plan is determined by the Board of Directors, but will be (i) in the case of an incentive
stock option (A) granted to an employee who, at the time of grant of such option, is a 10% stockholder, no less than 110% of the fair
market value per share on the date of grant; or (B) granted to any other employee, no less than 100% of the fair market value per share
on the date of grant; and (ii) in the case of a non-statutory stock option, no less than 100% of the fair market value per share on the
date of grant. The options awarded under the 2020 Plan will vest as determined by the Board of Directors but will not exceed a
ten-year period. A forfeiture is recognized as incurred if the option holder does not exercise after 90 days following termination
of service.
|
SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE |
The
Company recorded share-based compensation expense and classified it in the unaudited condensed consolidated statements of operations
as follows:
SCHEDULE
OF SHARE-BASED COMPENSATION EXPENSE
| |
2024 |
|
|
2023 |
|
|
2024 | | |
2023 | |
| |
For the Three Months Ended June 30, |
|
|
For the Six Months Ended June
30, | |
| |
2024 |
|
|
2023 |
|
|
2024 | | |
2023 | |
General and administrative | |
$ |
33,042 |
|
|
$ |
604,259 |
|
|
$ | 67,057 | | |
$ | 807,980 | |
Research and development | |
|
44 |
|
|
|
39,641 |
|
|
| 24,680 | | |
| 78,462 | |
Total | |
$ |
33,086 |
|
|
$ |
643,900 |
|
|
$ | 91,737 | | |
$ | 886,442 | |
|
Compensatory Warrant Activity [Member] |
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
SCHEDULE OF NON COMPENSATORY WARRANT ACTIVITY |
The
following table summarizes the activity in the common stock equity classified compensatory warrants for the six months ended June 30,
2024:
SCHEDULE
OF COMPENSATORY WARRANT ACTIVITY
| |
Common Stock | |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2023 | |
| 119,046 | | |
$ | 10.69 | | |
$ | 0.73—$25.40 | | |
| 1.25 | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| (7,261 | ) | |
$ | 20.66 | | |
$ | 20.66—$20.66 | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Total outstanding –June 30, 2024 | |
| 111,785 | | |
$ | 9.40 | | |
$ | 0.26—$25.40 | | |
| 0.83 | |
Exercisable | |
| 111,785 | | |
$ | 9.40 | | |
$ | 0.26—$25.40 | | |
| 0.83 | |
Non-Exercisable | |
| — | | |
| — | | |
| — | | |
| — | |
The
following table summarizes the activity in the common stock equity classified compensatory warrants for the six months ended June 30,
2023:
| |
Common Stock |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2022 | |
| 179,046 | | |
$ | 9.12 | | |
$ | 1.32 — $25.40 | | |
| 1.73 | |
Exercised | |
| — | | |
| | | |
| | | |
| | |
Expired | |
| — | | |
| | | |
| | | |
| | |
Forfeited | |
| — | | |
| | | |
| | | |
| | |
Total outstanding – June 30, 2023 | |
| 179,046 | | |
$ | 9.12 | | |
$ | 1.32 — $25.40 | | |
| 1.24 | |
Exercisable | |
| 179,046 | | |
$ | 9.12 | | |
$ | 1.32 — $25.40 | | |
| 1.24 | |
Non-Exercisable | |
| — | | |
| — | | |
| — | | |
| — | |
|
Non Compensatory Warrant Activity [Member] |
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
SCHEDULE OF NON COMPENSATORY WARRANT ACTIVITY |
The
following table summarizes the noncompensatory equity classified warrant activity for the six months ended June 30, 2024:
SCHEDULE
OF NON COMPENSATORY WARRANT ACTIVITY
| |
Common Stock |
| |
Shares | | |
Weighted– Average Exercise Price | | |
Range of Exercise Price | | |
Weighted– Average Remaining Life (Years) | |
Total outstanding – December 31, 2023 | |
| 2,507,050 | | |
$ | 0.73 | | |
$ | 0.73 — $0.73 | | |
| 4.47 | |
Granted | |
| 900,016 | | |
$ | 0.26 | | |
| $0.26 — $0.26 | | |
| 4.67 | |
Exercised | |
| (576,924 | ) | |
$ | 0.26 | | |
$ | 0.26 — $0.26 | | |
| — | |
Expired | |
| — | | |
| — | | |
| — | | |
| — | |
Forfeited | |
| (2 | ) | |
$ | 0.26 | | |
$ | 0.26 — $0.26 | | |
| — | |
Total outstanding – June 30, 2024 | |
| 2,830,140 | | |
$ | 0.26 | | |
$ | 0.26 — $0.26 | | |
| 4.19 | |
Exercisable | |
| 2,830,140 | | |
$ | 0.26 | | |
$ | 0.26 — $0.26 | | |
| 4.19 | |
Non-Exercisable | |
| — | | |
| — | | |
| — | | |
| — | |
The
following table summarizes the noncompensatory equity classified warrant activity for the six months ended June 30, 2023:
| |
Common Stock | |
| |
Shares | | |
Weighted–
Average Exercise Price | | |
Range
of Exercise Price | | |
Weighted–
Average Remaining Life (Years) | |
Total outstanding – December 31, 2022 | |
| 547,003 | | |
$ | 19.76 | | |
$ | 1.32
— $20.00 | | |
| 0.33 | |
Legacy Ritter warrants | |
| — | | |
| — | | |
| — | | |
| — | |
Granted | |
| — | | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | | |
| — | |
Expired | |
| (455,685 | ) | |
$ | 20.00 | | |
$ | 20.00
— $20.00 | | |
| — | |
Forfeited | |
| — | | |
| — | | |
| — | | |
| — | |
Total outstanding – June 30, 2023 | |
| 91,318 | | |
$ | 18.56 | | |
$ | 1.32
— $20.00 | | |
| — | |
Exercisable | |
| 226,150 | | |
$ | 18.56 | | |
$ | 1.32
— $20.00 | | |
| 0.58 | |
Non-Exercisable | |
| — | | |
$ | — | | |
$ | — | | |
| — | |
|
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v3.24.2.u1
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES (Details Narrative) - USD ($)
|
|
|
6 Months Ended |
Jul. 20, 2023 |
May 26, 2022 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Impairment losses on construction-in-progress |
|
|
$ 0
|
$ 0
|
Pre-funded Warrant [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Warrants to purchase common stock |
|
331,464
|
|
|
Warrants exercise price |
|
$ 0.001
|
|
|
Series B Preferred Stock [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Stock issued during period shares acquisitions |
|
381,786
|
|
|
Series B Preferred Stock [Member] | Amendment and Settlement Agreement [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Number of shares surrender |
281,000
|
|
|
|
NanoSynex Ltd [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Stock issued during period shares acquisitions |
|
350,000
|
|
|
Voting interests acquired |
|
52.80%
|
|
|
NanoSynex Ltd [Member] | Series A-1 Preferred Stock [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Stock issued during period shares acquisitions |
|
2,232,861
|
|
|
NanoSynex Ltd [Member] | Series B Preferred Stock [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Stock issued during period, value, acquisitions |
|
$ 600,000
|
|
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v3.24.2.u1
LIQUIDITY AND GOING CONCERN (Details Narrative) - USD ($)
|
|
1 Months Ended |
6 Months Ended |
12 Months Ended |
Apr. 30, 2024 |
Jul. 31, 2024 |
Dec. 31, 2022 |
Jun. 30, 2024 |
Dec. 31, 2023 |
Subsequent Event [Line Items] |
|
|
|
|
|
Cash |
|
|
|
$ 118,685
|
$ 401,803
|
Retained Earnings (Accumulated Deficit) |
|
|
|
120,411,693
|
116,802,384
|
Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents, Period Increase (Decrease), Including Exchange Rate Effect |
|
|
|
$ 2,300,000
|
$ 10,300,000
|
Proceeds from issuance of debt |
$ 1,500,000
|
|
$ 3,000,000.0
|
|
|
Subsequent Event [Member] |
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
Proceeds from issuance of debt |
|
$ 2,000,000.0
|
|
|
|
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SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
|
Prepaid insurance |
$ 382,229
|
$ 566,011
|
Other prepaid expenses |
33,496
|
25,053
|
Prepaid research and development expenses |
|
173,900
|
Prepaid expenses and other current assets |
$ 415,725
|
$ 764,964
|
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SCHEDULE OF GAIN (LOSS) FROM DISCONTINUED OPERATIONS (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Loss on disposal of discontinued operations, net of tax |
|
$ 29,672
|
|
$ (842,515)
|
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(100,000)
|
|
(100,000)
|
|
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(100,000)
|
29,672
|
(100,000)
|
(842,515)
|
Parent Company [Member] |
|
|
|
|
Loss on disposal of discontinued operations, net of tax |
|
113,694
|
|
(262,478)
|
Income (loss) from discontinued operations, net of tax |
(100,000)
|
|
(100,000)
|
|
GAIN (LOSS) FROM DISCONTINUED OPERATIONS |
(100,000)
|
113,694
|
(100,000)
|
(262,478)
|
NanoSynex [Member] |
|
|
|
|
Loss on disposal of discontinued operations, net of tax |
|
(84,022)
|
|
(580,037)
|
Income (loss) from discontinued operations, net of tax |
|
|
|
|
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|
$ (84,022)
|
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$ (580,037)
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SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
(BENEFIT) PROVISION FOR INCOME TAXES |
$ 100,000
|
|
$ 100,000
|
|
Loss attributable to noncontrolling interest |
|
(43,484)
|
|
(304,512)
|
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS |
(100,000)
|
29,672
|
(100,000)
|
(842,515)
|
NanoSynex [Member] |
|
|
|
|
Research and development |
|
126,240
|
|
787,425
|
Total expenses |
|
126,240
|
|
787,425
|
LOSS FROM DISCONTINUED OPERATIONS OF NANOSYNEX, LTD. |
|
(84,022)
|
|
(580,037)
|
(BENEFIT) PROVISION FOR INCOME TAXES |
|
(42,218)
|
|
(207,388)
|
Loss attributable to noncontrolling interest |
|
(43,484)
|
|
(304,512)
|
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS |
|
(40,538)
|
|
(275,525)
|
Parent Company [Member] |
|
|
|
|
Net product sales |
|
1,627,031
|
|
3,234,201
|
Total revenues |
|
1,627,031
|
|
3,234,201
|
Cost of product sales |
|
1,016,543
|
|
2,281,368
|
General and administrative |
|
238,782
|
|
584,214
|
Research and development |
|
25,657
|
|
204,207
|
Sales and marketing |
|
169,223
|
|
368,337
|
Total expenses |
|
1,450,204
|
|
3,438,126
|
Loss on disposal of equipment held for lease |
|
63,302
|
|
63,302
|
Other expense (income), net |
|
(169)
|
|
(5,049)
|
Loss on fixed asset disposal |
|
|
|
300
|
Total other expense (income), net |
|
63,133
|
|
58,553
|
LOSS FROM DISCONTINUED OPERATIONS OF NANOSYNEX, LTD. |
|
113,694
|
|
(262,478)
|
(BENEFIT) PROVISION FOR INCOME TAXES |
100,000
|
|
100,000
|
|
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$ (100,000)
|
$ 113,694
|
$ (100,000)
|
$ (262,478)
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v3.24.2.u1
DISCONTINUED OPERATIONS (Details Narrative) - USD ($)
|
|
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
|
Jun. 04, 2024 |
Jul. 20, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
May 26, 2022 |
Escrow deposits related to property sales |
$ 350,000
|
|
|
|
|
|
|
|
Loss on disposal of discontinued operations |
|
|
$ 100,000
|
|
$ 100,000
|
|
|
|
NanoSynex Ltd [Member] |
|
|
|
|
|
|
|
|
Business acquisition, percentage of voting interests acquired |
|
|
|
|
|
|
|
52.80%
|
NanoSynex Ltd [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
Business acquisition, percentage of voting interests acquired |
|
49.97%
|
|
|
|
|
|
|
NanoSynex Ltd [Member] | Maximum [Member] | Series B Preferred Stock [Member] |
|
|
|
|
|
|
|
|
Business acquisition, percentage of voting interests acquired |
|
52.80%
|
|
|
|
|
|
|
NanoSynex Ltd [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
Business acquisition, percentage of voting interests acquired |
|
39.90%
|
|
|
|
|
|
|
NanoSynex Ltd [Member] | Minimum [Member] | Series B Preferred Stock [Member] |
|
|
|
|
|
|
|
|
Business acquisition, percentage of voting interests acquired |
|
49.97%
|
|
|
|
|
|
|
Until January 20, 2025 [Member] |
|
|
|
|
|
|
|
|
Escrow deposit |
|
$ 450,000
|
|
|
|
|
|
|
Chembio diagnostics [Member] |
|
|
|
|
|
|
|
|
Cash consideration |
|
$ 5,400,000
|
|
|
|
|
$ 4,900,000
|
|
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v3.24.2.u1
SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Payables and Accruals [Abstract] |
|
|
Board compensation |
$ 251,999
|
$ 129,499
|
Interest (Convertible debt) |
51,909
|
10,004
|
License fees |
|
32,975
|
Payroll |
300,481
|
1,215
|
Professional fees |
144,528
|
121,775
|
Research and development |
17,500
|
104,402
|
Vacation |
162,665
|
151,286
|
Other |
57,725
|
8,850
|
Accrued expenses and other current liabilities |
$ 986,806
|
$ 560,006
|
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v3.24.2.u1
SCHEDULE OF WARRANTS ACTIVITY (Details) - Series C Warrants [Member] - Common Stock Warrants [Member] - $ / shares
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Number of Shares, Warrants Outstanding Beginning |
455,623
|
3,849,571
|
3,849,571
|
|
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning |
$ 0.73
|
$ 1.53
|
$ 1.53
|
|
Weighted-Average Remaining Life (Years) Outstanding |
4 years 8 months 1 day
|
3 years 4 months 28 days
|
5 months 26 days
|
3 years 10 months 24 days
|
Number of Shares, Warrants Granted |
2,623,665
|
|
|
|
Weighted Average Exercise Price Per Share Warrants Granted |
$ 0.26
|
|
|
|
Weighted-Average Remaining Life (Years) Outstanding, Granted |
4 years 8 months 1 day
|
|
|
|
Number of Shares, Warrants Exercised |
|
|
|
|
Weighted Average Exercise Price Per Share Warrants Exercised |
|
|
|
|
Number of Shares, Warrants Expired |
(1,279,256)
|
|
|
|
Weighted Average Exercise Price Per Share Warrants Expired |
$ 0.26
|
|
|
|
Number of Shares, Warrants Forfeited |
|
|
|
|
Weighted Average Exercise Price Per Share Warrants Forfeited |
|
|
|
|
Number of Shares, Warrants Outstanding Ending |
1,800,032
|
3,849,571
|
455,623
|
3,849,571
|
Weighted Average Exercise Price Per Share Warrants Outstanding Ending |
$ 0.26
|
$ 1.53
|
$ 0.73
|
$ 1.53
|
Number of Shares, Warrants Exercisable |
1,800,032
|
3,849,571
|
|
|
Weighted Average Exercise Price Per Share Exercisable |
$ 0.26
|
$ 1.53
|
|
|
Weighted-Average Remaining Life (Years) Exercisable |
4 years 8 months 1 day
|
3 years 4 months 28 days
|
|
|
Minimum [Member] |
|
|
|
|
Range of Exercise Price, Beginning |
$ 0.73
|
$ 1.32
|
1.32
|
|
Range of Exercise Price, Granted |
0.26
|
|
|
|
Range of Exercise Price, Expired |
0.26
|
|
|
|
Range of Exercise Price, Ending |
0.26
|
1.32
|
0.73
|
1.32
|
Range of Exercise Price, Exercisable |
0.26
|
1.32
|
|
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Maximum [Member] |
|
|
|
|
Range of Exercise Price, Beginning |
0.73
|
1.65
|
1.65
|
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Range of Exercise Price, Granted |
0.26
|
|
|
|
Range of Exercise Price, Expired |
0.26
|
|
|
|
Range of Exercise Price, Ending |
0.26
|
1.65
|
$ 0.73
|
$ 1.65
|
Range of Exercise Price, Exercisable |
$ 0.26
|
$ 1.65
|
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v3.24.2.u1
SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES (Details) - USD ($)
|
|
6 Months Ended |
Apr. 12, 2024 |
Jun. 30, 2024 |
Platform Operator, Crypto Asset [Line Items] |
|
|
Fair value for warrant liabilities |
|
$ 54,600
|
Common Stock Warrant liabilities, Granted |
$ 565,582
|
565,582
|
Common Stock Warrant liabilities, Exercises |
|
|
Gain on change in fair value of warrant liabilities |
|
(359,906)
|
Fair value for warrant liabilities |
|
260,276
|
Balance as of December 31, 2023 |
|
|
Granted |
|
215,897
|
Gain on change in fair value of derivative liabilities |
|
(174,613)
|
Balance as of June 30, 2024 |
|
41,284
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Platform Operator, Crypto Asset [Line Items] |
|
|
Fair value for warrant liabilities |
|
|
Common Stock Warrant liabilities, Granted |
|
|
Common Stock Warrant liabilities, Exercises |
|
|
Gain on change in fair value of warrant liabilities |
|
|
Fair value for warrant liabilities |
|
|
Balance as of December 31, 2023 |
|
|
Granted |
|
|
Gain on change in fair value of derivative liabilities |
|
|
Balance as of June 30, 2024 |
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Platform Operator, Crypto Asset [Line Items] |
|
|
Fair value for warrant liabilities |
|
|
Common Stock Warrant liabilities, Granted |
|
|
Common Stock Warrant liabilities, Exercises |
|
|
Gain on change in fair value of warrant liabilities |
|
|
Fair value for warrant liabilities |
|
|
Balance as of December 31, 2023 |
|
|
Granted |
|
|
Gain on change in fair value of derivative liabilities |
|
|
Balance as of June 30, 2024 |
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Platform Operator, Crypto Asset [Line Items] |
|
|
Fair value for warrant liabilities |
|
54,600
|
Common Stock Warrant liabilities, Granted |
|
565,582
|
Common Stock Warrant liabilities, Exercises |
|
|
Gain on change in fair value of warrant liabilities |
|
(359,906)
|
Fair value for warrant liabilities |
|
260,276
|
Balance as of December 31, 2023 |
|
|
Granted |
|
215,897
|
Gain on change in fair value of derivative liabilities |
|
(174,613)
|
Balance as of June 30, 2024 |
|
$ 41,284
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v3.24.2.u1
SCHEDULE OF ASSUMPTIONS OF WARRANT LIABILITIES (Details)
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Measurement Input, Risk Free Interest Rate [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Fair value assumptions, measurement input, percentages |
4.38
|
|
Measurement Input, Risk Free Interest Rate [Member] | Minimum [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Fair value assumptions, measurement input, percentages |
|
4.05
|
Measurement Input, Risk Free Interest Rate [Member] | Maximum [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Fair value assumptions, measurement input, percentages |
|
5.31
|
Measurement Input, Risk Free Interest Rate [Member] | Weighted Average [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Fair value assumptions, measurement input, percentages |
|
4.49
|
Measurement Input, Price Volatility [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Fair value assumptions, measurement input, percentages |
125
|
|
Measurement Input, Price Volatility [Member] | Minimum [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Fair value assumptions, measurement input, percentages |
|
66.3
|
Measurement Input, Price Volatility [Member] | Maximum [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Fair value assumptions, measurement input, percentages |
|
134
|
Measurement Input, Price Volatility [Member] | Weighted Average [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Fair value assumptions, measurement input, percentages |
|
110.55
|
Measurement Input, Expected Term [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Fair value assumptions, measurement input, term |
4 years 8 months 12 days
|
|
Measurement Input, Expected Term [Member] | Minimum [Member] |
|
|
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|
|
Fair value assumptions, measurement input, term |
|
4 months 20 days
|
Measurement Input, Expected Term [Member] | Maximum [Member] |
|
|
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|
|
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|
4 years 11 months 23 days
|
Measurement Input, Expected Term [Member] | Weighted Average [Member] |
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
Fair value assumptions, measurement input, term |
|
3 years 4 months 28 days
|
Measurement Input, Expected Dividend Rate [Member] |
|
|
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|
|
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0.00
|
0.00
|
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|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
|
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|
0.00
|
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v3.24.2.u1
WARRANT LIABILITIES (Details Narrative) - USD ($)
|
|
|
|
3 Months Ended |
6 Months Ended |
|
|
|
|
|
|
|
|
Apr. 12, 2024 |
Nov. 24, 2023 |
Dec. 22, 2022 |
Jun. 30, 2024 |
Jun. 30, 2024 |
Jun. 26, 2024 |
Feb. 27, 2024 |
Feb. 26, 2024 |
Dec. 31, 2023 |
Dec. 05, 2023 |
Dec. 04, 2023 |
Dec. 31, 2022 |
Dec. 21, 2022 |
Fair value of warrants on grant date |
$ 565,582
|
|
|
|
$ 565,582
|
|
|
|
|
|
|
|
|
Warrant liabilities |
$ 260,276
|
|
|
$ 260,276
|
$ 260,276
|
|
|
|
$ 54,600
|
|
|
|
|
Gain on change in fair value of warrant liabilities |
|
|
|
$ 305,306
|
|
|
|
|
|
|
|
|
|
Alpha Capital [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
$ 0.73
|
|
|
|
$ 0.26
|
$ 0.73
|
|
|
|
|
$ 1.65
|
Alpha Capital [Member] | Securities Purchase Agreement [Member] | 2024 Debenture [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate |
8.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt principal amount |
$ 1,100,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Series C Warrants [Member] | Alpha Capital [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
$ 1.65
|
|
|
|
|
|
|
|
|
|
|
Warrant to purchase shares |
|
|
2,500,000
|
|
|
|
|
|
|
|
|
|
|
Conversion price percentage |
|
|
125.00%
|
|
|
|
|
|
|
|
|
|
|
Series C Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants outstanding |
|
|
|
|
|
|
|
|
|
|
|
1,349,570
|
|
Warrant exercise price |
|
|
|
|
|
|
|
|
|
|
|
$ 1.32
|
|
Warrants expired |
|
1,097,599
|
|
|
|
|
|
|
|
|
|
|
|
Series C Warrants [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
|
|
|
|
$ 0.26
|
$ 0.73
|
|
$ 0.73
|
$ 1.32
|
|
|
Series C Warrants [Member] | Alpha Capital [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant to purchase shares |
|
|
|
|
|
|
823,633
|
|
|
203,652
|
|
|
|
Warrants outstanding |
|
|
|
|
|
1,279,256
|
1,279,256
|
|
455,623
|
|
|
|
|
Warrants exercisable |
|
|
|
|
|
1,279,256
|
1,279,256
|
|
455,623
|
|
|
|
|
Common Stock [Member] | Alpha Capital [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant to purchase shares |
1,800,032
|
|
|
|
|
|
|
|
|
|
|
|
|
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v3.24.2.u1
SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Nonrelated Party [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Total convertible debt |
$ 1,080,294
|
|
Related Party [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Total convertible debt |
589,717
|
1,299,216
|
2024 Senior Convertible Debenture [Member] | Nonrelated Party [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Convertible debt |
1,100,000
|
|
2024 Senior Convertible Debenture [Member] | Related Party [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Convertible debt |
944,922
|
1,418,922
|
2024 Discount On Convertible Debenture [Member] | Nonrelated Party [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Discount on convertible debt |
(19,706)
|
|
2024 Discount On Convertible Debenture [Member] | Related Party [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Discount on convertible debt |
$ (355,205)
|
$ (119,706)
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v3.24.2.u1
CONVERTIBLE DEBT (Details Narrative) - USD ($)
|
|
|
|
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
|
|
|
Apr. 12, 2024 |
Feb. 27, 2024 |
Dec. 05, 2023 |
Jul. 13, 2023 |
Jan. 12, 2023 |
Dec. 22, 2022 |
Apr. 30, 2024 |
Oct. 31, 2023 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Feb. 26, 2024 |
Dec. 31, 2023 |
Dec. 04, 2023 |
Dec. 21, 2022 |
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair value of warrant liability |
|
|
|
|
|
|
|
|
|
|
|
$ (359,906)
|
$ (1,478,967)
|
|
|
|
|
Common Stock Warrant liabilities, Granted |
$ 565,582
|
|
|
|
|
|
|
|
|
|
|
565,582
|
|
|
|
|
|
2022 Senior Convertible Debenture [Member] | Related Party [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable debt |
|
|
|
|
|
$ 110,000
|
|
|
|
|
|
|
|
|
|
|
|
Conversion rate |
|
|
|
|
|
85.00%
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate |
|
|
|
|
|
8.00%
|
|
|
|
|
|
|
|
|
|
|
|
Gain loss on extinguishment |
|
|
|
|
|
|
|
|
$ 22,000
|
|
$ 1,100,000
|
125,000
|
1,100,000
|
|
|
|
|
Interest expense |
|
|
|
|
|
|
|
|
65,000
|
|
383,000
|
134,000
|
945,000
|
|
|
|
|
Accretion expense |
|
|
|
|
|
|
|
|
49,000
|
|
|
92,000
|
|
|
|
|
|
Bifurcated embedded derivative |
|
|
|
|
|
|
|
|
6,000
|
|
0
|
6,000
|
0
|
|
|
|
|
Accretion expense |
|
|
|
|
|
|
|
|
|
|
$ 364,000
|
|
$ 898,000
|
|
|
|
|
2024 Senior Convertible Debenture [Member] | Related Party [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount |
|
|
|
|
|
|
|
|
944,922
|
|
|
944,922
|
|
|
$ 1,418,922
|
|
|
Gain loss on extinguishment |
|
|
|
|
|
|
|
|
858,279
|
|
|
858,279
|
|
|
|
|
|
Interest expense |
|
|
|
|
|
|
|
|
173,000
|
|
|
238,000
|
|
|
|
|
|
Bifurcated embedded derivative |
|
|
|
|
|
|
|
|
12,000
|
|
|
12,000
|
|
|
|
|
|
Accretion expense |
|
|
|
|
|
|
|
|
$ 162,000
|
|
|
$ 222,000
|
|
|
|
|
|
2024 Senior Convertible Debenture [Member] | Related Party [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
|
|
|
|
|
|
$ 0.73
|
|
|
$ 0.73
|
|
|
|
|
|
2024 Senior Convertible Debenture [Member] | Related Party [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
|
|
|
|
|
|
$ 0.26
|
|
|
$ 0.26
|
|
|
|
|
|
2024 Senior Convertible Debenture [Member] | Nonrelated Party [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount |
|
|
|
|
|
|
|
|
$ 1,100,000
|
|
|
$ 1,100,000
|
|
|
|
|
|
Interest expense |
|
|
|
|
|
|
|
|
28,000
|
|
|
28,000
|
|
|
|
|
|
Bifurcated embedded derivative |
|
|
|
|
|
|
|
|
24,000
|
|
|
24,000
|
|
|
|
|
|
Accretion expense |
|
|
|
|
|
|
|
|
8,000
|
|
|
8,000
|
|
|
|
|
|
Common Stock Warrant liabilities, Granted |
|
|
|
|
|
|
$ 565,582
|
|
|
|
|
|
|
|
|
|
|
Warrants fair value |
|
|
|
|
|
|
|
|
260,000
|
|
|
260,000
|
|
|
|
|
|
Alpha Capital [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount |
|
|
|
|
|
|
|
|
$ 550,000
|
|
|
$ 550,000
|
|
|
|
|
|
Conversion price |
|
|
|
|
|
|
|
|
$ 0.6111
|
|
|
$ 0.6111
|
|
|
|
|
|
Exercise price |
|
$ 0.26
|
|
|
|
$ 0.73
|
|
|
|
|
|
|
|
$ 0.73
|
|
|
$ 1.65
|
Alpha Capital [Member] | Common Stock [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of warrants for shares |
1,800,032
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alpha Capital [Member] | 2022 Senior Convertible Debenture [Member] | Related Party [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Senior convertible debenture rate |
|
|
|
|
|
8.00%
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount |
|
|
|
|
|
$ 3,300,000
|
|
|
|
|
|
|
|
|
|
|
|
Purchase price |
|
|
|
|
|
$ 3,000,000
|
|
|
|
|
|
|
|
|
|
|
|
Maturity date |
|
|
|
|
|
Dec. 22, 2025
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price |
|
|
|
|
$ 1.32
|
$ 1.32
|
|
|
|
|
|
|
|
|
|
|
|
Issued and outstanding shares percentage |
|
|
|
20.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares of common stock conversion |
|
|
|
|
841,726
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount |
|
|
|
|
$ 1,111,078
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
|
|
|
309,665
|
|
|
|
1,518,929
|
|
|
|
|
|
Weighted average exercise price |
|
|
|
|
|
$ 0.26
|
|
$ 0.71
|
0.26
|
|
|
$ 0.26
|
|
|
$ 0.71
|
|
|
Debenture beneficial ownership blocker percentage |
|
|
|
|
|
9.99%
|
|
|
|
|
|
|
|
|
|
|
|
Alpha Capital [Member] | 2022 Senior Convertible Debenture [Member] | Related Party [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price |
|
|
$ 0.73
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 1.32
|
|
Fair value of warrant liability |
|
|
$ 90,000.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
$ 0.73
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 1.65
|
|
Warrant liability to equity |
|
|
$ 1,600,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument fair value |
|
|
1,400,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain loss on extinguishment |
|
|
$ 600,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alpha Capital [Member] | 2022 Senior Convertible Debenture [Member] | Related Party [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price |
|
|
|
|
|
|
|
|
$ 0.26
|
$ 0.33
|
|
0.26
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
|
|
|
|
2,536,312
|
1,138,535
|
|
|
|
|
|
|
|
Weighted average fair value |
|
|
|
|
|
|
|
|
$ 0.25
|
$ 0.48
|
|
$ 0.25
|
|
|
|
|
|
Alpha Capital [Member] | 2024 Senior Convertible Debenture [Member] | Related Party [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate |
|
8.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt term |
|
5 years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alpha Capital [Member] | 2024 Senior Convertible Debenture [Member] | Related Party [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price |
|
$ 0.1164
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount |
|
$ 550,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate |
|
8.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash purchase price payment |
|
$ 500,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share price per share |
|
$ 0.6111
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alpha Capital [Member] | 2024 Senior Convertible Debenture [Member] | Related Party [Member] | Securities Purchase Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount |
|
$ 1,100,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alpha Capital [Member] | 2024 Senior Convertible Debenture [Member] | Related Party [Member] | 2024 Convertible Debenture [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
$ 0.26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of warrants for shares |
|
900,016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alpha Capital [Member] | 2024 Senior Convertible Debenture [Member] | Related Party [Member] | 2024 Convertible Debenture [Member] | Securities Purchase Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Issued During Period, Shares, Period Increase (Decrease) |
|
1,800,032
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alpha Capital [Member] | 2024 Senior Convertible Debenture [Member] | Nonrelated Party [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate |
|
|
|
|
|
|
8.00%
|
|
|
|
|
|
|
|
|
|
|
Debt term |
|
|
|
|
|
|
5 years
|
|
|
|
|
|
|
|
|
|
|
Derivative, Fair Value, Net |
|
|
|
|
|
|
|
|
$ 33,243
|
|
|
$ 33,243
|
|
|
|
|
|
Derivative fair value of warrants |
|
|
|
|
|
|
|
|
305,000
|
|
|
305,000
|
|
|
|
|
|
Alpha Capital [Member] | 2024 Senior Convertible Debenture [Member] | Nonrelated Party [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price |
|
|
|
|
|
|
$ 0.1164
|
|
|
|
|
|
|
|
|
|
|
Share price per share |
|
|
|
|
|
|
$ 0.6111
|
|
|
|
|
|
|
|
|
|
|
Alpha Capital [Member] | 2024 Senior Convertible Debenture [Member] | Nonrelated Party [Member] | Securities Purchase Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount |
|
|
|
|
|
|
$ 1,100,000
|
|
|
|
|
|
|
|
|
|
|
Alpha Capital [Member] | 2024 Senior Convertible Debenture [Member] | Nonrelated Party [Member] | 2024 Chen Convertible Debenture [Member] | Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price |
|
|
|
|
|
|
$ 0.26
|
|
|
|
|
|
|
|
|
|
|
Purchase of warrants for shares |
|
|
|
|
|
|
1,800,032
|
|
|
|
|
|
|
|
|
|
|
2022 Senior Convertible Debenture [Member] | 2022 Senior Convertible Debenture [Member] | Related Party [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
|
|
|
309,665
|
|
|
|
|
|
|
|
|
|
Alpha Capital Other Third Parties [Member] | 2022 Senior Convertible Debenture [Member] | Related Party [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt discount |
|
|
|
|
|
|
|
|
|
|
|
300,000
|
|
|
|
|
|
Fair value of warrant liability |
|
|
|
|
|
|
|
|
|
|
|
2,800,000
|
|
|
|
|
|
Fair value of embedded derivative features |
|
|
|
|
|
|
|
|
$ 0
|
|
|
0
|
|
|
|
|
|
Fees and costs paid |
|
|
|
|
|
|
|
|
|
|
|
$ 100,000
|
|
|
|
|
|
X |
- DefinitionAccretion discount inculded in interest expense.
+ References
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X |
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+ References
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Namespace Prefix: |
QLGN_ |
Data Type: |
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|
X |
- DefinitionDebt instrument fair value per share.
+ References
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Namespace Prefix: |
QLGN_ |
Data Type: |
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Balance Type: |
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Period Type: |
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|
X |
- DefinitionDerivative fair value of warrants.
+ References
+ Details
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QLGN_ |
Data Type: |
xbrli:monetaryItemType |
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X |
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+ References
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Namespace Prefix: |
QLGN_ |
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X |
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+ References
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X |
- DefinitionAmount recognized for the passage of time, typically for liabilities, that have been discounted to their net present values. Excludes accretion associated with asset retirement obligations.
+ ReferencesReference 1: http://www.xbrl.org/2003/role/exampleRef -Topic 420 -SubTopic 10 -Name Accounting Standards Codification -Section 35 -Paragraph 4 -Publisher FASB -URI https://asc.fasb.org/1943274/2147481639/420-10-35-4
Reference 2: http://www.xbrl.org/2009/role/commonPracticeRef -Topic 420 -SubTopic 10 -Name Accounting Standards Codification -Section 50 -Paragraph 1 -Subparagraph (b)(2) -Publisher FASB -URI https://asc.fasb.org/1943274/2147482017/420-10-50-1
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|
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v3.24.2.u1
SCHEDULE OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE (Details) - shares
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total common stock equivalents |
9,716,650
|
4,565,097
|
Share-Based Payment Arrangement, Option [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total common stock equivalents |
755,715
|
445,163
|
Warrant [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total common stock equivalents |
4,741,957
|
4,119,934
|
Convertible Debt [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total common stock equivalents |
4,218,978
|
|
X |
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v3.24.2.u1
RESEARCH AND LICENSE AGREEMENTS (Details Narrative) - USD ($)
|
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
47 Months Ended |
Apr. 30, 2024 |
Apr. 12, 2024 |
Apr. 11, 2024 |
Dec. 31, 2022 |
Jan. 31, 2022 |
Jul. 31, 2020 |
Mar. 31, 2019 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Apr. 30, 2022 |
Research and development expense |
|
|
|
|
|
|
|
$ 754,287
|
$ 1,174,646
|
$ 1,118,672
|
$ 2,456,463
|
|
Proceeds from convertible debt |
$ 1,500,000
|
|
|
$ 3,000,000.0
|
|
|
|
|
|
|
|
|
License Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursement of patent |
|
|
|
|
$ 160,000
|
|
|
|
|
|
|
|
License cost |
|
|
|
|
|
|
|
0
|
0
|
2,000
|
0
|
|
Sponsored Research and License Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
License cost |
|
|
|
|
|
|
|
0
|
15,000
|
1,000
|
29,000
|
|
Research and development expense |
|
|
|
|
|
|
|
0
|
333,000
|
0
|
556,000
|
|
Sponsored Research and License Agreement [Member] | University of Louisville Research Foundation [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursement of research expenses |
|
|
|
|
|
|
$ 693,000
|
|
|
2,900,000
|
|
|
Agreement term payment, description |
|
|
|
|
|
In
July 2020, the Company entered into an exclusive license agreement with ULRF for RAS interaction inhibitor drug candidates. Under
the agreement, the Company took over development, regulatory approval and commercialization of the candidates from ULRF and is
responsible for maintenance of the related intellectual property portfolio. In return, ULRF received approximately $112,000 for an
upfront license fee and reimbursement of prior patent costs. In addition, the Company has agreed to pay ULRF (i) royalties, on
patent-covered net sales associated with the commercialization, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net
sales above a cumulative $250,000,000), until expiration of the licensed patent, and 2.5% (on net sales for any sales not covered by
Licensed Patents), (ii) 30% to 50% of any non-royalty sublicensee income received (50% for sublicenses granted in the first two
years of the ULRF license agreement, 40% for sublicenses granted in the third or fourth years of the ULRF license agreement, and 30%
for sublicenses granted in the fifth year of the ULRF license agreement or thereafter), (iii) reimbursements for ongoing costs
associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred prior to July 2020, and (iv)
payments ranging from $50,000
to $5,000,000
upon the achievement of certain regulatory and commercial milestones.
|
|
|
|
|
|
|
Marketing approval expenses |
|
|
|
|
|
$ 300,000
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
500,000,000
|
|
|
|
|
|
$ 500,000,000
|
Sponsored Research and License Agreement [Member] | University of Louisville Research Foundation [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Upfront license fee |
|
|
|
|
|
20,000
|
|
|
|
|
|
|
Sponsored Research and License Agreement [Member] | University of Louisville Research Foundation [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Upfront license fee |
|
|
|
|
|
100,000
|
|
|
|
|
|
|
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursement of research expenses |
|
|
|
|
|
|
|
|
|
|
|
$ 805,000
|
Agreement term payment, description |
|
|
|
|
|
|
|
|
|
|
|
In addition, the Company agreed to pay ULRF (i) royalties, on patent-covered net sales associated with the commercialization
of anti-nucleolin agent-conjugated nanoparticles, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net sales above a cumulative
$250,000,000), until expiration of the last to expire of the licensed patents, (ii) 30% to 50% of any non-royalty sublicensee income
received (50% for sublicenses granted in the first two years of the ULRF license agreement, 40% for sublicenses granted in the third
or fourth years of the ULRF license agreement, and 30% for sublicenses granted in the fifth year of the ULRF license agreement or thereafter),
(iii) reimbursements for ongoing costs associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred
prior to June 2018, and (iv) payments ranging from $100,000 to $5,000,000 upon the achievement of certain regulatory and commercial milestones.
|
Marketing approval expenses |
|
|
|
|
|
|
|
|
|
|
|
$ 500,000
|
Proceeds from convertible debt |
|
|
|
|
|
|
|
|
|
|
|
50,000
|
Patent costs |
|
|
|
|
|
|
|
|
|
|
|
200,000
|
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Licensed Product Sales [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative sales |
|
|
|
|
|
5,000,000
|
|
|
|
|
|
5,000,000
|
Regulatory marketing approval, expenses |
|
|
|
|
|
|
|
|
|
|
|
500,000
|
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Milestone payment |
|
|
|
|
|
50,000
|
|
|
|
|
|
100,000
|
Shortfall payments |
|
|
|
|
|
|
|
|
|
|
|
10,000
|
License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Milestone payment |
|
|
|
|
|
5,000,000
|
|
|
|
|
|
5,000,000
|
Shortfall payments |
|
|
|
|
|
|
|
|
|
|
|
50,000
|
Sponsored Research Agreements And License [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
License cost |
|
|
|
|
|
|
|
28,000
|
1,000
|
53,000
|
22,000
|
|
Research and development expense |
|
|
|
|
|
|
|
$ 0
|
$ 0
|
$ 0
|
$ 0
|
|
Co Development Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Funding payment |
|
|
$ 1,750,000
|
|
|
|
|
|
|
|
|
|
Exclusivity fee |
|
|
$ 200,000
|
|
|
|
|
|
|
|
|
|
Payment for funding |
|
$ 500,000
|
|
|
|
|
|
|
|
|
|
|
Agreements under research and development |
|
In
return for the Funding Payment we will receive quarterly a 33% payment in the nature of royalties on any Net Sales (as defined with
a meaning tantamount to gross profit on net sales) of DuraGraft, capped at double the amount of the Funding Payment cash
provided
|
|
|
|
|
|
|
|
|
|
|
Net sales |
|
$ 500,000
|
|
|
|
|
|
|
|
|
|
|
Upfront Payment [Member] | License Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Reimbursement of patent |
|
|
|
|
$ 150,000
|
|
|
|
|
|
|
|
Phase 1 Clinical Trial [Member] | License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Milestone payment |
|
|
|
|
|
50,000
|
|
|
|
|
|
100,000
|
Phase 2 Clinical Trial [Member] | License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Milestone payment |
|
|
|
|
|
100,000
|
|
|
|
|
|
200,000
|
Phase 3 Clinical Trial [Member] | License and Sponsored Research Agreements [Member] | University of Louisville Research Foundation [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Milestone payment |
|
|
|
|
|
$ 150,000
|
|
|
|
|
|
$ 350,000
|
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SCHEDULE OF STOCK OPTION ACTIVITY (Details) - $ / shares
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
Weighted- Average Remaining Contractual Life (in Years), Outstanding at Ending |
11 months 4 days
|
|
Employees and Non-employee Service Provider [Member] |
|
|
Number of shares, options outstanding, beginning |
398,924
|
|
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$ 35.21
|
|
Weighted- Average Remaining Contractual Life (in Years), Outstanding at Ending |
6 years 5 months 19 days
|
7 years 21 days
|
Number of shares, options granted |
|
|
Weighted average exercise price, options granted |
|
|
Number of shares, options expired |
|
|
Weighted average exercise price, options expired |
|
|
Number of shares, options forfeited |
(61,638)
|
|
Weighted average exercise price, options forfeited |
$ 14.88
|
|
Number of Shares, Options Outstanding at Ending |
337,286
|
398,924
|
Range of Exercise price, Options Outstanding |
$ 38.92
|
$ 35.21
|
Number of shares, options exercisable (vested) |
283,634
|
|
Range of exercise price, options exercisable (vested) |
$ 45.21
|
|
Weighted- Average Remaining Contractual Life (in Years), Options Exercisable (vested) |
6 years 2 months 4 days
|
|
Number of shares, options non-exercisable (non-vested) |
53,652
|
|
Weighted average exercise price, options non-exercisable (non-vested) |
$ 5.67
|
|
Weighted- Average Remaining Contractual Life (in Years), Options Non-exercisable (non-vested) |
7 years 11 months 26 days
|
|
Employees and Non-employee Service Provider [Member] | Minimum [Member] |
|
|
Range of Exercise price, Options Outstanding |
$ 5.14
|
|
Range of Exercise price, Options Forfeited |
5.14
|
|
Range of Exercise price, Options Outstanding |
5.14
|
5.14
|
Range of exercise price, options exercisable (vested) |
5.14
|
|
Range of exercise price, options non-exercisable (non-vested) |
5.14
|
|
Employees and Non-employee Service Provider [Member] | Maximum [Member] |
|
|
Range of Exercise price, Options Outstanding |
51.30
|
|
Range of Exercise price, Options Forfeited |
49.70
|
|
Range of Exercise price, Options Outstanding |
51.30
|
$ 51.30
|
Range of exercise price, options exercisable (vested) |
51.30
|
|
Range of exercise price, options non-exercisable (non-vested) |
$ 12.40
|
|
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v3.24.2.u1
SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Total |
$ 33,086
|
$ 91,737
|
$ 643,900
|
$ 886,442
|
General and Administrative Expense [Member] |
|
|
|
|
Total |
33,042
|
67,057
|
604,259
|
807,980
|
Research and Development Expense [Member] |
|
|
|
|
Total |
$ 44
|
$ 24,680
|
$ 39,641
|
$ 78,462
|
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SCHEDULE OF COMPENSATORY WARRANT ACTIVITY (Details) - Compensatory Warrant Activity [Member] - $ / shares
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
Number of Shares, Warrants Outstanding Beginning |
119,046
|
179,046
|
179,046
|
|
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning |
$ 10.69
|
$ 9.12
|
$ 9.12
|
|
Weighted Average Remaining Life (Years) - outstanding |
9 months 29 days
|
1 year 2 months 26 days
|
1 year 3 months
|
1 year 8 months 23 days
|
Number of Shares, Warrants Exercised |
|
|
|
|
Weighted average exercise price per share warrants exercised |
|
|
|
|
Number of Shares, Warrants Expired |
(7,261)
|
|
|
|
Weighted average exercise price per share warrants expired |
$ 20.66
|
|
|
|
Number of Shares, Warrants Forfeited |
|
|
|
|
Weighted average exercise price per share warrants forfeited |
|
|
|
|
Number of Shares, Warrants Outstanding Ending |
111,785
|
179,046
|
119,046
|
179,046
|
Weighted Average Exercise Price Per Share Warrants Outstanding Ending |
$ 9.40
|
$ 9.12
|
$ 10.69
|
$ 9.12
|
Number of Shares, Warrants Exercisable |
111,785
|
179,046
|
|
|
Weighted Average Exercise Price Per Share Exercisable |
$ 9.40
|
$ 9.12
|
|
|
Weighted Average Remaining Life (Years) Exercisable |
9 months 29 days
|
1 year 2 months 26 days
|
|
|
Number of shares, warrants non-exercisable |
|
|
|
|
Weighted Average Exercise Price Per Share Non-Exercisable |
|
|
|
|
Range of Exercise Price, Non-Exercisable |
|
|
|
|
Minimum [Member] |
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
Range of exercise price - beginning |
0.73
|
1.32
|
1.32
|
|
Range of exercise price, expired |
20.66
|
|
|
|
Range of exercise price - ending |
0.26
|
1.32
|
0.73
|
1.32
|
Range of exercise price, exercisable |
0.26
|
1.32
|
|
|
Maximum [Member] |
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
Range of exercise price - beginning |
25.40
|
25.40
|
25.40
|
|
Range of exercise price, expired |
20.66
|
|
|
|
Range of exercise price - ending |
25.40
|
25.40
|
$ 25.40
|
$ 25.40
|
Range of exercise price, exercisable |
$ 25.40
|
$ 25.40
|
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v3.24.2.u1
SCHEDULE OF NON COMPENSATORY WARRANT ACTIVITY (Details) - Non Compensatory Warrant Activity [Member] - $ / shares
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Number of Shares, Warrants Outstanding Beginning |
2,507,050
|
547,003
|
547,003
|
|
Weighted Average Exercise Price Per Share Warrants Outstanding Beginning |
$ 0.73
|
$ 19.76
|
$ 19.76
|
|
Weighted average remaining life (Years) exercisable |
4 years 2 months 8 days
|
|
4 years 5 months 19 days
|
3 months 29 days
|
Number of shares, warrants granted |
900,016
|
|
|
|
Weighted Average Exercise Price, warrants granted |
$ 0.26
|
|
|
|
Weighted average remaining life (Years) exercisable granted |
4 years 8 months 1 day
|
|
|
|
Number of Shares, Warrants Exercised |
(576,924)
|
|
|
|
Weighted Average Exercise Price, warrants exercised |
$ 0.26
|
|
|
|
Number of Shares, Warrants Expired |
|
(455,685)
|
|
|
Weighted Average Exercise Price, warrants expired |
|
$ 20.00
|
|
|
Number of Shares, Warrants Forfeited |
(2)
|
|
|
|
Weighted Average Exercise Price, warrants forfeited |
$ 0.26
|
|
|
|
Number of Shares, Warrants Outstanding Ending |
2,830,140
|
91,318
|
2,507,050
|
547,003
|
Weighted Average Exercise Price Per Share Warrants Outstanding Ending |
$ 0.26
|
$ 18.56
|
$ 0.73
|
$ 19.76
|
Number of Shares, Warrants Exercisable |
2,830,140
|
226,150
|
|
|
Weighted Average Exercise Price, exercisable |
$ 0.26
|
$ 18.56
|
|
|
Weighted average remaining life (Years) exercisable |
4 years 2 months 8 days
|
6 months 29 days
|
|
|
Number of Shares, Warrants Exercisable |
|
|
|
|
Weighted Average Exercise Price, exercisable |
|
|
|
|
Number of shares legal ritter warrants |
|
|
|
|
Weighted Average Exercise Price, legal ritter warrants |
|
|
|
|
Minimum [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Range of exercise price - beginning |
0.73
|
1.32
|
1.32
|
|
Range of exercise price, granted |
0.26
|
|
|
|
Range of exercise price, excercised |
0.26
|
|
|
|
Range of exercise price, expired |
0.26
|
20.00
|
|
|
Range of exercise price - ending |
0.26
|
1.32
|
0.73
|
1.32
|
Range of exercise price, exercisable |
0.26
|
1.32
|
|
|
Maximum [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Range of exercise price - beginning |
0.73
|
20.00
|
20.00
|
|
Range of exercise price, granted |
0.26
|
|
|
|
Range of exercise price, excercised |
0.26
|
|
|
|
Range of exercise price, expired |
0.26
|
20.00
|
|
|
Range of exercise price - ending |
0.26
|
20.00
|
$ 0.73
|
$ 20.00
|
Range of exercise price, exercisable |
$ 0.26
|
$ 20.00
|
|
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v3.24.2.u1
STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($)
|
|
3 Months Ended |
6 Months Ended |
|
|
|
|
|
|
Feb. 27, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 04, 2024 |
May 16, 2024 |
Feb. 26, 2024 |
Dec. 31, 2023 |
Dec. 22, 2022 |
Dec. 21, 2022 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Shares reserved for future issuance |
|
9,716,650
|
|
9,716,650
|
|
|
|
|
|
|
|
Preferred stock, shares outstanding |
|
0
|
|
0
|
|
|
|
|
0
|
|
|
Compensation cost |
|
|
|
$ 91,737
|
$ 886,442
|
|
|
|
|
|
|
Unrecognized compensation cost |
|
$ 120,000
|
|
$ 120,000
|
|
|
|
|
|
|
|
Cost is expected to be recognized over a weighted average period |
|
|
|
11 months 4 days
|
|
|
|
|
|
|
|
Fair value of warrants |
|
|
|
$ (359,906)
|
(1,478,967)
|
|
|
|
|
|
|
Compensation cost |
|
$ 33,086
|
$ 91,737
|
643,900
|
886,442
|
|
|
|
|
|
|
Alpha Capital [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise price |
$ 0.26
|
|
|
|
|
|
|
$ 0.73
|
|
$ 0.73
|
$ 1.65
|
Deemed dividend |
$ 60,017
|
|
|
|
|
|
|
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Warrant to purchase shares |
67,620
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise price |
$ 0.26
|
|
|
|
|
|
|
$ 0.73
|
|
|
|
Fair value of warrants |
$ 9,737
|
|
|
|
|
|
|
|
|
|
|
Compensatory Warrant Activity [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Compensation cost |
|
|
|
$ 9,737
|
$ 0
|
|
|
|
|
|
|
Warrants exercisable |
|
111,785
|
179,046
|
111,785
|
179,046
|
|
|
|
|
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Shares reserved for future issuance |
|
755,715
|
|
755,715
|
|
|
|
|
|
|
|
Compensation cost |
|
|
|
$ 92,000
|
$ 900,000
|
|
|
|
|
|
|
Share-Based Payment Arrangement, Option [Member] | 2020 Stock Incentive Plan [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Shares reserved for future issuance |
|
418,429
|
|
418,429
|
|
|
|
|
356,791
|
|
|
Options outstanding |
|
337,286
|
|
337,286
|
|
|
|
|
398,924
|
|
|
Noncompensatory Equity Classified Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise price |
$ 0.26
|
$ 0.26
|
|
$ 0.26
|
|
|
|
|
|
|
|
Warrants outstanding |
|
7,048
|
|
7,048
|
|
|
|
|
|
|
|
Warrants exercisable |
|
7,048
|
|
7,048
|
|
|
|
|
|
|
|
Warrant to purchase shares of common stock |
900,016
|
|
|
|
|
|
|
|
|
|
|
Noncompensatory Equity Classified Warrants [Member] | Alpha Capital [Member] |
|
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Warrant to purchase shares |
|
|
|
|
|
288,462
|
288,462
|
|
|
2,500,000
|
|
Warrants exercise price |
|
$ 0.26
|
|
$ 0.26
|
|
$ 0.26
|
$ 0.26
|
|
|
$ 1.65
|
|
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v3.24.2.u1
RELATED PARTY TRANSACTIONS (Details Narrative) - USD ($)
|
|
|
|
|
3 Months Ended |
|
|
|
|
Jul. 05, 2024 |
Jun. 04, 2024 |
Feb. 27, 2024 |
Dec. 22, 2022 |
Jun. 30, 2024 |
Mar. 31, 2023 |
Jul. 12, 2024 |
May 16, 2024 |
Feb. 26, 2024 |
Dec. 21, 2022 |
Share conversion, value |
|
|
|
|
$ 280,201
|
$ 1,112,582
|
|
|
|
|
Noncompensatory Equity Classified Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
Warrants outstanding |
|
|
|
|
7,048
|
|
|
|
|
|
Warrants exercisable |
|
|
|
|
7,048
|
|
|
|
|
|
Warrant exercise price |
|
|
$ 0.26
|
|
$ 0.26
|
|
|
|
|
|
Warrant to purchase shares of common stock |
|
|
900,016
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Noncompensatory Equity Classified Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
|
|
|
|
$ 0.26
|
|
|
|
Warrant to purchase shares of common stock |
|
|
|
|
|
|
1,023,000
|
|
|
|
Alpha Capital [Member] |
|
|
|
|
|
|
|
|
|
|
Principal amount |
|
|
|
|
$ 550,000
|
|
|
|
|
|
Conversion price |
|
|
|
|
$ 0.6111
|
|
|
|
|
|
Warrant exercise price |
|
|
$ 0.26
|
$ 0.73
|
|
|
|
|
$ 0.73
|
$ 1.65
|
Alpha Capital [Member] | Noncompensatory Equity Classified Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
Warrant to purchase shares |
|
288,462
|
|
2,500,000
|
|
|
|
288,462
|
|
|
Warrant exercise price |
|
$ 0.26
|
|
$ 1.65
|
$ 0.26
|
|
|
$ 0.26
|
|
|
Proceeds from warrants exercises |
|
$ 150,000
|
|
|
|
|
|
|
|
|
Alpha Capital [Member] | Senior Convertible Debenture [Member] |
|
|
|
|
|
|
|
|
|
|
Senior convertible debenture rate |
|
|
8.00%
|
8.00%
|
|
|
|
|
|
|
Principal amount |
|
|
$ 550,000
|
$ 3,300,000
|
$ 394,921
|
|
|
|
|
|
Purchase Price |
|
|
$ 500,000
|
$ 3,000,000
|
|
|
|
|
|
|
Conversion price |
|
|
|
|
$ 0.26
|
|
|
|
|
|
Alpha Capital [Member] | Senior Convertible Debenture [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
Senior convertible debenture rate |
8.00%
|
|
|
|
|
|
|
|
|
|
Conversion price |
$ 0.26
|
|
|
|
|
|
|
|
|
|
Share conversion, value |
$ 394,921
|
|
|
|
|
|
|
|
|
|
Share conversion |
1,518,931
|
|
|
|
|
|
|
|
|
|
X |
- DefinitionThe number of shares into which fully or partially vestednon-option equity outstanding as of the balance sheet date can be currently converted under the non-option equity plan.
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v3.24.2.u1
SUBSEQUENT EVENTS (Details Narrative) - USD ($)
|
|
|
|
|
3 Months Ended |
|
|
|
|
|
|
|
|
|
Aug. 09, 2024 |
Jul. 05, 2024 |
Jul. 05, 2024 |
Feb. 27, 2024 |
Dec. 22, 2022 |
Jun. 30, 2024 |
Mar. 31, 2023 |
Jul. 15, 2024 |
Jul. 12, 2024 |
Jun. 04, 2024 |
May 16, 2024 |
Feb. 26, 2024 |
Dec. 31, 2023 |
Nov. 21, 2023 |
Nov. 20, 2023 |
Dec. 21, 2022 |
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share conversion, value |
|
|
|
|
|
$ 280,201
|
$ 1,112,582
|
|
|
|
|
|
|
|
|
|
Bid price |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 1.00
|
|
Minimum stockholders equity requirement nasdaq amount |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 2,500,000
|
|
|
Cash |
|
|
|
|
|
118,685
|
|
|
|
|
|
|
$ 401,803
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share conversion, value |
|
|
|
|
|
$ 1,400
|
$ 842
|
|
|
|
|
|
|
|
|
|
Share conversion |
|
|
|
|
|
1,400,000
|
841,726
|
|
|
|
|
|
|
|
|
|
Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bid price |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 1.00
|
|
Noncompensatory Equity Classified Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant to purchase shares of common stock |
|
|
|
900,016
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise price |
|
|
|
$ 0.26
|
|
$ 0.26
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Offering of shares |
$ 4,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Marizyme Note [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate |
|
|
|
|
|
|
|
18.00%
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Noncompensatory Equity Classified Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant to purchase shares of common stock |
|
|
|
|
|
|
|
|
1,023,000
|
|
|
|
|
|
|
|
Warrants exercise price |
|
|
|
|
|
|
|
|
$ 0.26
|
|
|
|
|
|
|
|
Warrant to purchase shares of common stock, value |
|
|
|
|
|
|
|
|
$ 266,000
|
|
|
|
|
|
|
|
Senior Note [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Senior convertible debenture rate |
|
18.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non convertible debt |
|
$ 2,000,000
|
$ 2,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non convertible debt, maturity date |
|
Jul. 08, 2025
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alpha Capital [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price per share |
|
|
|
|
|
0.6111
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise price |
|
|
|
$ 0.26
|
$ 0.73
|
|
|
|
|
|
|
$ 0.73
|
|
|
|
$ 1.65
|
Alpha Capital [Member] | Noncompensatory Equity Classified Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercise price |
|
|
|
|
$ 1.65
|
0.26
|
|
|
|
$ 0.26
|
$ 0.26
|
|
|
|
|
|
Alpha Capital [Member] | Senior Convertible Debenture [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Senior convertible debenture rate |
|
|
|
8.00%
|
8.00%
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price per share |
|
|
|
|
|
$ 0.26
|
|
|
|
|
|
|
|
|
|
|
Alpha Capital [Member] | Senior Convertible Debenture [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share conversion, value |
|
|
$ 394,921
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Senior convertible debenture rate |
|
|
8.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share conversion |
|
|
1,518,931
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price per share |
|
$ 0.26
|
$ 0.26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Director [Member] | Senior Note [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non convertible debt |
|
$ 2,000,000
|
$ 2,000,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Creditor [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts Payable |
319,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash |
$ 50,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Qualigen Therapeutics (NASDAQ:QLGN)
Gráfica de Acción Histórica
De Jul 2024 a Ago 2024
Qualigen Therapeutics (NASDAQ:QLGN)
Gráfica de Acción Histórica
De Ago 2023 a Ago 2024