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United
States
Securities
and Exchange Commission
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ |
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 ____ |
Commission
File Number 001-39531
Processa
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
45-1539785 |
(State
or other jurisdiction of incorporation or organization) |
|
(IRS
Employer Identification No.) |
7380
Coca Cola Drive, Suite 106,
Hanover,
Maryland 21076
(443)
776-3133
Securities
registered pursuant to Section 12(b) of the Exchange Act:
Title
of Each Class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, $0.0001 par value per share |
|
PCSA |
|
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 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 emerging growth company. See definition 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 ☒
The
number of outstanding shares of the registrant’s common stock at August 1, 2024 was 3,256,944.
PROCESSA
PHARMACEUTICALS, INC.
TABLE
OF CONTENTS
Part
I: Financial Information
Item
1: Financial Statements
Processa
Pharmaceuticals, Inc.
Condensed
Consolidated Balance Sheets
(Unaudited)
| |
June 30, 2024 | | |
December 31, 2023 | |
ASSETS | |
| | | |
| | |
Current Assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 5,571,120 | | |
$ | 4,706,197 | |
Prepaid expenses and other | |
| 1,906,854 | | |
| 926,300 | |
Total Current Assets | |
| 7,477,974 | | |
| 5,632,497 | |
| |
| | | |
| | |
Property and Equipment, net | |
| 2,276 | | |
| 2,554 | |
| |
| | | |
| | |
Other Assets | |
| | | |
| | |
Lease right-of-use assets, net of accumulated amortization | |
| 115,191 | | |
| 146,057 | |
Security deposit | |
| 5,535 | | |
| 5,535 | |
Total Other Assets | |
| 120,726 | | |
| 151,592 | |
Total Assets | |
$ | 7,600,976 | | |
$ | 5,786,643 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current Liabilities | |
| | | |
| | |
Current maturities of lease liabilities | |
$ | 93,181 | | |
$ | 83,649 | |
Accounts payable | |
| 953,086 | | |
| 311,617 | |
Due to licensor | |
| - | | |
| 189,000 | |
Due to related parties | |
| - | | |
| 39 | |
Accrued expenses | |
| 505,397 | | |
| 146,274 | |
Total Current Liabilities | |
| 1,551,664 | | |
| 730,579 | |
Non-current Liabilities | |
| | | |
| | |
Non-current lease liabilities | |
| 25,648 | | |
| 66,905 | |
Total Liabilities | |
| 1,577,312 | | |
| 797,484 | |
| |
| | | |
| | |
Commitments and Contingencies | |
| - | | |
| - | |
| |
| | | |
| | |
Stockholders’ Equity | |
| | | |
| | |
Common stock, par value $0.0001, 100,000,000 shares authorized: 2,873,883 issued and 2,868,883 outstanding at June 30, 2024; and 1,291,000 issued and 1,286,000 outstanding at December 31, 2023 | |
| 287 | | |
| 129 | |
Additional paid-in capital | |
| 87,429,165 | | |
| 80,658,111 | |
Treasury stock at cost — 5,000 shares at June 30, 2024 and December 31, 2023 | |
| (300,000 | ) | |
| (300,000 | ) |
Accumulated deficit | |
| (81,105,788 | ) | |
| (75,369,081 | ) |
Total Stockholders’ Equity | |
| 6,023,664 | | |
| 4,989,159 | |
Total Liabilities and Stockholders’ Equity | |
$ | 7,600,976 | | |
$ | 5,786,643 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
Processa
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Operating Expenses | |
| | | |
| | | |
| | | |
| | |
Research and development expenses | |
$ | 1,730,444 | | |
$ | 1,688,164 | | |
$ | 3,269,555 | | |
$ | 3,342,509 | |
General and administrative expenses | |
| 1,351,580 | | |
| 1,026,301 | | |
| 2,622,067 | | |
| 3,477,490 | |
| |
| | | |
| | | |
| | | |
| | |
Operating Loss | |
| (3,082,024 | ) | |
| (2,714,465 | ) | |
| (5,891,622 | ) | |
| (6,819,999 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other Income (Expense), net | |
| 71,698 | | |
| 101,900 | | |
| 154,915 | | |
| 185,361 | |
| |
| | | |
| | | |
| | | |
| | |
Income Tax Benefit | |
| - | | |
| - | | |
| - | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
Net Loss | |
$ | (3,010,326 | ) | |
$ | (2,612,565 | ) | |
$ | (5,736,707 | ) | |
$ | (6,634,638 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net Loss per Common Share - Basic and Diluted | |
$ | (1.01 | ) | |
$ | (1.94 | ) | |
$ | (2.11 | ) | |
$ | (5.34 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted Average Common Shares Used to Compute Net Loss Applicable to Common Shares - Basic and Diluted | |
| 2,983,283 | | |
| 1,346,808 | | |
| 2,724,903 | | |
| 1,243,475 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
Processa
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Changes in Stockholders’ Equity
(Unaudited)
| |
Shares | | |
Amount | | |
Capital | | |
Shares | | |
Amount | | |
Deficit | | |
Total | |
| |
| | |
| | |
Additional | | |
| | |
| | |
| | |
| |
| |
Common Stock | | |
Paid-In | | |
Treasury Stock | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Capital | | |
Shares | | |
Amount | | |
Deficit | | |
Total | |
Balance at January 1, 2023 | |
| 806,774 | | |
$ | 80 | | |
$ | 72,018,222 | | |
| (5,000 | ) | |
$ | (300,000 | ) | |
$ | (64,247,561 | ) | |
$ | 7,470,741 | |
Stock-based compensation | |
| 3,195 | | |
| 1 | | |
| 341,503 | | |
| - | | |
| - | | |
| - | | |
| 341,504 | |
Shares issued in connection with capital raises, net of transaction costs | |
| 421,611 | | |
| 42 | | |
| 6,352,035 | | |
| - | | |
| - | | |
| - | | |
| 6,352,077 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,022,073 | ) | |
| (4,022,073 | ) |
Balance, March 31, 2023 | |
| 1,231,580 | | |
| 123 | | |
| 78,711,760 | | |
| (5,000 | ) | |
| (300,000 | ) | |
| (68,269,634 | ) | |
| 10,142,249 | |
Stock-based compensation | |
| - | | |
| - | | |
| 319,123 | | |
| - | | |
| - | | |
| - | | |
| 319,123 | |
Warrants issued in connection with a consulting agreement | |
| - | | |
| - | | |
| 1,310,875 | | |
| - | | |
| - | | |
| - | | |
| 1,310,875 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,612,565 | ) | |
| (2,612,565 | ) |
Balance, June 30, 2023 | |
| 1,231,580 | | |
$ | 123 | | |
$ | 80,341,758 | | |
| (5,000 | ) | |
$ | (300,000 | ) | |
$ | (70,882,199 | ) | |
$ | 9,159,682 | |
| |
| | |
| | |
Additional | | |
| | |
| | |
| | |
| |
| |
Common Stock | | |
Paid-In | | |
Treasury Stock | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Capital | | |
Shares | | |
Amount | | |
Deficit | | |
Total | |
Balance at January 1, 2024 | |
| 1,291,000 | | |
$ | 129 | | |
$ | 80,658,111 | | |
| (5,000 | ) | |
$ | (300,000 | ) | |
$ | (75,369,081 | ) | |
$ | 4,989,159 | |
Stock-based compensation | |
| 13,176 | | |
| 1 | | |
| 167,642 | | |
| - | | |
| - | | |
| - | | |
| 167,643 | |
Shares issued in connection with capital raise, net of transaction costs | |
| 1,555,555 | | |
| 156 | | |
| 6,282,274 | | |
| - | | |
| - | | |
| - | | |
| 6,282,430 | |
Shares issued in connection with license agreement | |
| 5,000 | | |
| 1 | | |
| 188,999 | | |
| - | | |
| - | | |
| - | | |
| 189,000 | |
Settlement of stock award | |
| - | | |
| - | | |
| (8,561 | ) | |
| - | | |
| - | | |
| - | | |
| (8,561 | ) |
Shares withheld to pay income taxes on stock-based compensation | |
| (3,750 | ) | |
| (1 | ) | |
| (9,923 | ) | |
| - | | |
| - | | |
| - | | |
| (9,924 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,726,381 | ) | |
| (2,726,381 | ) |
Balance, March 31, 2024 | |
| 2,860,981 | | |
| 286 | | |
| 87,278,542 | | |
| (5,000 | ) | |
| (300,000 | ) | |
| (78,095,462 | ) | |
| 8,883,366 | |
Balance | |
| 2,860,981 | | |
| 286 | | |
| 87,278,542 | | |
| (5,000 | ) | |
| (300,000 | ) | |
| (78,095,462 | ) | |
| 8,883,366 | |
Stock-based compensation | |
| 14,167 | | |
| 1 | | |
| 152,631 | | |
| - | | |
| - | | |
| - | | |
| 152,632 | |
Shares withheld to pay income taxes on stock-based compensation | |
| (1,265 | ) | |
| - | | |
| (2,008 | ) | |
| - | | |
| - | | |
| - | | |
| (2,008 | ) |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,010,326 | ) | |
| (3,010,326 | ) |
Balance, June 30, 2024 | |
| 2,873,883 | | |
$ | 287 | | |
$ | 87,429,165 | | |
| (5,000 | ) | |
$ | (300,000 | ) | |
$ | (81,105,788 | ) | |
$ | 6,023,664 | |
Balance | |
| 2,873,883 | | |
$ | 287 | | |
$ | 87,429,165 | | |
| (5,000 | ) | |
$ | (300,000 | ) | |
$ | (81,105,788 | ) | |
$ | 6,023,664 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
Processa
Pharmaceuticals, Inc.
Condensed
Consolidated Statements of Cash Flows
(Unaudited)
| |
2024 | | |
2023 | |
| |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
Cash Flows From Operating Activities | |
| | | |
| | |
Net loss | |
$ | (5,736,707 | ) | |
$ | (6,634,638 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation | |
| 278 | | |
| - | |
Non-cash lease expense for right-of-use assets | |
| 42,670 | | |
| 39,982 | |
Stock-based compensation | |
| 320,275 | | |
| 660,627 | |
Warrant issued to purchase 158,007 shares of common stock in connection with a consulting agreement | |
| - | | |
| 1,310,875 | |
| |
| | | |
| | |
Net changes in operating assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other | |
| (980,554 | ) | |
| 662,984 | |
Operating lease liability | |
| (41,228 | ) | |
| (38,233 | ) |
Accounts payable | |
| 641,469 | | |
| (88,526 | ) |
Due to related parties | |
| (39 | ) | |
| (51 | ) |
Accrued expenses | |
| 359,123 | | |
| (91,559 | ) |
Net cash used in operating activities | |
| (5,394,713 | ) | |
| (4,178,539 | ) |
| |
| | | |
| | |
Cash Flows From Financing Activities | |
| | | |
| | |
Net proceeds from issuance of stock | |
| 6,282,430 | | |
| 6,352,077 | |
Shares withheld to pay taxes on stock-based compensation | |
| (11,932 | ) | |
| - | |
Settlement of stock award | |
| (8,561 | ) | |
| - | |
Payment of finance lease obligation | |
| (2,301 | ) | |
| - | |
Net cash provided by financing activities | |
| 6,259,636 | | |
| 6,352,077 | |
| |
| | | |
| | |
Net Increase in Cash | |
| 864,923 | | |
| 2,173,538 | |
Cash and Cash Equivalents – Beginning of Period | |
| 4,706,197 | | |
| 6,503,595 | |
Cash and Cash Equivalents – End of Period | |
$ | 5,571,120 | | |
$ | 8,677,133 | |
| |
| | | |
| | |
Non-Cash Financing Activities | |
| | | |
| | |
Issuance of 5,000 shares of common stock in connection with a licensing agreement which had previously been recorded as a due to licensor | |
$ | 189,000 | | |
$ | - | |
| |
| | | |
| | |
Right-of-use asset | |
$ | 11,804 | | |
$ | - | |
Financing lease liability | |
| (11,804 | ) | |
| - | |
Net | |
$ | - | | |
$ | - | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
Processa
Pharmaceuticals, Inc.
Notes
to Condensed Consolidated Financial Statements
(Unaudited)
Note
1 – Organization and Summary of Significant Accounting Policies
Organization
We
are a clinical-stage biopharmaceutical company focused on incorporating our Regulatory Science Approach into the development of our
Next Generation Chemotherapy (“NGC”) drugs to improve the safety and efficacy of cancer treatment. Our NGC drugs are modifications of
existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution in
the body, while maintaining the well-established existing mechanisms of killing the cancer cells. By modifying the
NGC drugs in this manner, we believe our three NGC treatments will provide improved safety-efficacy profiles when compared to their
currently marketed counterparts.
On
January 22, 2024, we filed a Certificate of Amendment to our Certificate of Incorporation, as amended with the Secretary of State of
Delaware that effected a 1-for-20 reverse stock split of our common stock, par value $0.0001 per share (the “Reverse Stock Split”).
Pursuant to the Certificate of Amendment, our issued common stock decreased from 24,706,474 shares to 1,291,000 shares and our outstanding
common stock decreased from 24,606,474 to 1,286,000. The Reverse Stock Split did not affect our authorized common stock of 100,000,000
shares or our common stock par value. All shares of common stock, including common stock underlying warrants, stock options, restricted
stock awards and restricted stock units, as well as exercise prices and per share information in these condensed consolidated financial
statements give retroactive effect to the Reverse Stock Split.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions of the
Securities and Exchange Commission (“SEC”) on Form 10-Q and Article 8 of Regulation S-X.
Accordingly,
they do not include all the information and disclosures required by U.S. GAAP for complete financial statements. All material intercompany
accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated
financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of our
financial position and of the results of operations and cash flows for the periods presented. These condensed consolidated financial
statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form
10-K for the year ended December 31, 2023, as filed with the SEC. The results of operations for the interim periods shown in this report
are not necessarily indicative of the results that may be expected for any other interim period or for the full year.
Liquidity
Our
condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the continuity of operations,
realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. We have incurred losses
since inception, are currently devoting substantially all of our efforts toward research and development of our NGC drug product candidates,
including conducting clinical trials and providing general and administrative support for these operations, and have an accumulated deficit
of $81.1 million
at June 30, 2024. During the six months ended June 30, 2024, we generated a net loss of $5.7 million
and used $5.4 million in net cash for operating activities from continuing operations. To
date, none of our drug candidates have been approved for sale, and therefore we have not generated any product revenue and do not expect
positive cash flow from operations in the foreseeable future.
We
have financed our operations primarily through public equity issuances, including an offering we closed on January 30, 2024, where we
sold 476,000 shares of our common stock, pre-funded warrants to purchase up to 1,079,555 shares of our common stock, and warrants for
the purchase of up to 1,555,555 shares of our common stock for net proceeds of $6.3 million, after deducting placement agent fees and
offering-related expenses. Simultaneously with the closing of the sale, the pre-funded warrants were exercised in exchange for 1,079,555
shares of our common stock.
In
May 2024, we filed with the SEC a registration statement on Form S-3 (Registration No. 333-279588) (the “Registration
Statement”), including a base prospectus relating to the offering of up to $50,000,000
in the aggregate of the securities identified in the base prospectus from time to time in one or more offerings; and a prospectus
supplement relating to the shares of our common stock that may be issued and sold under a sales agreement dated May 21, 2024 (the
“Sales Agreement”) between us and A.G.P./Alliance Global Partners (the “Sales Agent”), through which we may issue and
sell in a registered “at the market offering” shares of our common stock having an aggregate offering price of up to
$2.4
million (subject to adjustment) from time to time through or to our Sales Agent (the “ATM Offering”). We expect to use
net proceeds, if any, from the ATM Offering over time for continued research and development for our portfolio of drug candidates,
especially our oncology products, and working capital and general corporate purposes. The shares under the ATM Offering will be sold
and issued pursuant to the Registration Statement.
At
June 30, 2024, we had cash and cash equivalents totaling $5.6 million
which, based on our current business plans, we believe these funds will satisfy our operating
needs into late 2024, including the beginning of our Phase 2 trial of NGC-Cap in breast cancer. Our ability to execute our
longer-term operating plans, including future preclinical studies and clinical trials for our portfolio of drugs depend on our
ability to obtain additional funding from the sale of equity and/or debt securities, a strategic transaction or other funding
transactions. We will continue to be dependent
upon equity and/or debt financing until we are able to generate positive cash flows from our operations.
We
plan to raise additional funds in the future through a combination of public or private equity offerings, debt financings, collaborations,
strategic alliances, licensing arrangements and other marketing and distribution arrangements, but will only do so if the terms are acceptable
to us. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend our current or
planned future clinical trial plans, or research and development programs. This may also cause us to not meet obligations contained in
certain of our license agreements and put these assets at risk. To the extent that we raise additional capital through marketing and
distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish
valuable rights to our product candidates, future revenue streams, research programs or product candidates or to grant licenses on terms
that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of
our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely
affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting
or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures. There can be no
assurance that future funding will be available when needed.
Absent
additional funding, we believe that our cash and cash equivalents will not be sufficient to fund our operations for a period of one year
or more after the date that these condensed consolidated financial statements are available to be issued based on the timing and amount
of our projected net loss from continuing operations and cash to be used in operating activities during that period of time. As a result,
substantial doubt exists about our ability to continue as a going concern within one year after the date that these condensed consolidated
financial statements are available to be issued. The accompanying condensed consolidated financial statements do not include any adjustments
to reflect the possible future effects on the recoverability and classification of recorded assets, or the amounts and classification
of liabilities that might be different should we be unable to continue as a going concern based on the outcome of these uncertainties
described above.
Use
of Estimates
In
preparing our condensed consolidated financial statements and related disclosures in conformity with U.S. GAAP and pursuant to the rules
and regulations of the SEC, we make estimates and judgments that affect the amounts reported in the condensed consolidated financial
statements and accompanying notes. Estimates are used for, but not limited to preclinical and clinical trial expenses, stock-based compensation,
intangible assets, future milestone payments and income taxes. These estimates and assumptions are continuously evaluated and are based
on management’s experience and knowledge of the relevant facts and circumstances. While we believe the estimates to be reasonable,
actual results could differ materially from those estimates and could impact future results of operations and cash flows.
Income
Taxes
We
account for income taxes in accordance with ASC Topic 740, Income Taxes. Deferred income taxes are recorded for the expected tax
consequences of temporary differences between the basis of assets and liabilities for financial reporting purposes and amounts recognized
for income tax purposes. At June 30, 2024 and December 31, 2023, we recorded a valuation allowance equal to the full recorded amount
of our net deferred tax assets since it is more-likely-than-not that such benefits will not be realized. The valuation allowance is reviewed
quarterly and will be maintained until sufficient positive evidence exists to support its reversal.
Under
ACS 740-270 Income Taxes – Interim Reporting, we are required to project our annual federal and state effective income tax
rate and apply it to the year-to-date ordinary operating tax basis loss before income taxes. Based on the projection, no current income
tax benefit or expense is expected for 2024 and the foreseeable future since we expect to generate taxable net operating losses.
Concentration
of Credit Risk
Financial
instruments that potentially subject us to significant concentration of credit risk consist primarily of our cash and cash equivalents.
We utilize only well-established banks and financial institutions with high credit ratings. Balances on deposit are insured by the Federal
Deposit Insurance Corporation (“FDIC”) up to specified limits. Total cash held by our banks at June 30, 2024, exceeded FDIC limits.
Recent
Accounting Pronouncements
From
time to time, the Financial Accounting Standards Board (“FASB”) or other standard setting bodies issue new accounting pronouncements.
Updates to the FASB Accounting Standards Codification are communicated through issuance of an Accounting Standards Update (“ASU”).
We have implemented all new accounting pronouncements that are in effect and that may impact our condensed consolidated financial statements.
We have evaluated recently issued accounting pronouncements and determined that there is no material impact on our condensed consolidated
financial position or results of operations.
Note
2 – Stockholders’ Equity
Preferred
Stock
There
were no issued or outstanding shares of preferred stock at either June 30, 2024 or December 31, 2023.
Common
Stock
During
the six months ended June 30, 2024, we sold 476,000
shares of common
stock, pre-funded warrants to purchase up to 1,079,555
shares of common stock
in lieu of shares of common stock (the “Pre-Funded Warrants”), and warrants to purchase up to 1,555,555
shares of our common
stock (the “Common Warrants’) in a public offering (the “Offering”). The Common Warrants have an exercise price
of $4.50,
are immediately exercisable and expire on January
30, 2029. The shares
of common stock were offered at a combined public offering price of $4.50
per share and accompanying
Common Warrant and $4.4999
per Pre-Funded Warrant
and accompanying Common Warrant. The Pre-Funded Warrants had an exercise price of $0.0001
and were exercised in
full simultaneously with the closing of the Offering in exchange for 1,079,555
shares of our common
stock. Gross proceeds in connection with the Offering were $7.0
million. We received
$6.3
million in net proceeds
from the Offering, after deducting the fees of the placement agent and other offering-related expenses. We also issued to the placement
agent warrants to purchase 62,222
shares of common stock,
exercisable at $5.625
per share that expire
on February
1, 2027.
During
the six months ended June 30, 2024, we also issued: 5,000 shares of common stock to Elion Oncology, Inc. (“Elion”) in satisfaction
of the third milestone event under the license agreement; 10,000 shares of common stock to a consultant in accordance with their consulting
agreement; and 12,328 shares of common stock to certain employees and consultants, net of 5,015 shares of common stock withheld for income
taxes owed upon distribution of the shares.
Note
3 - Stock-based Compensation
On
June 19, 2019, our stockholders approved, and we adopted, the Processa Pharmaceuticals Inc. 2019 Omnibus Equity Incentive Plan (the “2019
Plan”). The 2019 Plan allows us, under the direction of our Board of Directors or a committee thereof, to make grants of stock
options, restricted and unrestricted stock and other stock-based awards to employees, including our executive officers, consultants and
directors. On June 28, 2024, our shareholders approved an increase of shares available under the 2019 Plan, which now provides for the
aggregate issuance of 800,000 shares of our common stock. At June 30, 2024, we have 503,129
shares available for future grants.
Stock
Compensation Expense
We
recorded stock-based compensation expense for the three and six months ended June 30, 2024 and 2023 as follows:
Schedule
of Stock-based Compensation Expense
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 45,583 | | |
$ | 102,678 | | |
$ | 76,704 | | |
$ | 209,526 | |
General and administrative | |
| 107,049 | | |
| 216,445 | | |
| 243,571 | | |
| 451,101 | |
Total | |
$ | 152,632 | | |
$ | 319,123 | | |
$ | 320,275 | | |
$ | 660,627 | |
Stock
Options
Stock
options to purchase 4,245
shares of common stock with a weighted-average exercise price of $336.00 expired during the six months ended June 30, 2024. At June
30, 2024, we had outstanding and exercisable options for the purchase of 2,747
shares with a weighted average exercise price of $409.09 and
a weighted average remaining contractual life of 4.2
years. At June 30, 2024, we did not have any unrecognized stock-based compensation expense related to our granted stock
options.
Restricted
Stock Awards
During
the six months ended June 30, 2024, we vested 1,250 Restricted Stock Awards (“RSAs”) with a weighted average grant-date fair
value of $9.26 per share. We had no RSAs outstanding at June 30, 2024.
Restricted
Stock Units
Activity
with respect to our Restricted Stock Units (“RSUs”) during the six months ended June 30, 2024 was as follows:
Schedule
of Restricted Stock Units (“RSUs”) Activity
| |
Number of shares | | |
Weighted- average grant-date fair value per share | |
Outstanding at January 1, 2024 | |
| 222,722 | | |
$ | 45.82 | |
Granted | |
| 39,202 | | |
| 2.24 | |
Forfeited | |
| (10,775 | ) | |
| 58.37 | |
Issued | |
| (12,328 | ) | |
| 99.86 | |
Outstanding at June 30, 2024 | |
| 238,821 | | |
| 35.31 | |
Vested and unissued | |
| 143,793 | | |
| 50.71 | |
| |
| | | |
| | |
Unvested at June 30, 2024 | |
| 95,028 | | |
$ | 12.00 | |
On
June 28, 2024, we granted RSUs for the future issuance of 39,202
shares of common stock
to our employees which vest accordingly: RSUs for the future issuance of 14,969 shares of common stock vest on January 1, 2025; RSUs
for the future issuance of 18,173
shares of common stock
vest over a three-year period upon meeting service requirements; RSUs for the future issuance of 3,030
shares of common stock
vested upon grant due to regaining Nasdaq compliance; and RSUs for the future issuance of 3,030
shares of common stock
vest upon dosing the first patient in our Phase 2 study in NGC-Cap.
At
June 30, 2024, unrecognized stock-based compensation expense of approximately $538,000 for
RSUs is expected to be fully recognized over a weighted average period of 1.7 years.
The unrecognized expense excludes approximately $420,000 of
expense related to certain grants of RSUs with performance milestones that are not probable of occurring at this time.
Holders
of our vested RSUs will be issued shares of our common stock upon meeting the distribution restrictions contained in their Restricted
Stock Unit Award Agreement. The distribution restrictions are different (longer) than the vesting schedule, imposing an additional restriction
on the holder. Unlike RSAs, while certain employees may hold fully vested RSUs, the individual does not hold any shares or have any rights
of a shareholder until the distribution restrictions are met. Upon distribution to the employee, each RSU converts into one share of
our common stock. The RSUs contain dividend equivalent rights.
Warrants
During
the six months ended June 30, 2024, we did not grant any warrants to purchase shares of our common stock other than warrants to purchase
1,617,777 shares of common stock as part of the Offering (see Note 2). Warrants to purchase 5,000 shares of our common stock expired
unexercised. We also repurchased a warrant issued to a consultant in 2023 for the purchase of 15,000 shares of our common stock in exchange
for a payment of $10,000.
At
June 30, 2024, we had outstanding stock purchase warrants for the purchase of an aggregate of 1,778,284 shares
with a weighted average exercise price of $6.17 and
a weighted average remaining contractual life of 4.3 years.
All the outstanding stock purchase warrants are exercisable as of June 30, 2024. We did not have any unrecognized stock-based
compensation expense related to our granted stock purchase warrants at June 30, 2024.
Note
4 – Net Loss per Share of Common Stock
Net
Loss Per Share
Basic
net loss per share is computed by dividing our net loss available to common shareholders by the weighted average number of shares of
common stock outstanding (which excludes unvested RSAs and includes vested RSUs) during the period. Diluted loss per share is computed
by dividing our net loss available to common shareholders by the diluted weighted average number of shares of common stock (which includes
the potentially dilutive effect of stock options, unvested RSAs, unvested RSUs and warrants) during the period. Since we experienced
a net loss for all periods presented, basic and diluted net loss per share are the same. As such, diluted loss per share for the three
and six months ended June 30, 2024 and 2023 excludes the impact of potentially dilutive common shares since those shares would have an
anti-dilutive effect on net loss per share.
The
computation of net loss per share for the three and six months ended June 30, 2024 and 2023 was as follows:
Schedule
of Net Loss Per Share Basic and Diluted
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Basic and diluted net loss per share: | |
| | | |
| | | |
| | | |
| | |
Net loss available to common stockholders | |
$ | (3,010,326 | ) | |
$ | (2,612,565 | ) | |
$ | (5,736,707 | ) | |
$ | (6,634,638 | ) |
Weighted average number of common shares-basic and diluted | |
| 2,983,283 | | |
| 1,346,808 | | |
| 2,724,903 | | |
| 1,243,475 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss per share | |
$ | (1.01 | ) | |
$ | (1.94 | ) | |
$ | (2.11 | ) | |
$ | (5.34 | ) |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Weighted-average number of common shares outstanding – basic and diluted | |
| 2,849,192 | | |
| 1,217,095 | | |
| 2,590,530 | | |
| 1,114,324 | |
Weighted-average number of vested RSUs– basic and diluted | |
| 134,091 | | |
| 129,713 | | |
| 134,373 | | |
| 129,151 | |
Weighted-average number of common shares-basic and diluted | |
| 2,983,283 | | |
| 1,346,808 | | |
| 2,724,903 | | |
| 1,243,475 | |
Our
diluted net loss per share for the three and six months ended June 30, 2024 and 2023 excluded 1,876,059 and 254,314 of potentially dilutive
common shares, respectively, related to outstanding stock options, warrants and unvested restricted stock since those shares would have
had an anti-dilutive effect on net loss per share during the periods then ended.
Note
5 – Leases
We
lease our office space under an operating lease agreement. This lease does not have significant rent escalation, concessions, leasehold
improvement incentives, or other build-out clauses. Further, the lease does not contain contingent rent provisions. Our office space
lease includes both lease (e.g., fixed payments including rent, taxes, and insurance costs) and non-lease components (e.g., common-area
or other maintenance costs), which are accounted for as a single lease component as we have elected the practical expedient to group
lease and non-lease components for all leases. We also lease office equipment under a financing lease. Our leases do not provide an implicit
rate and, as such, we have used our incremental borrowing rate of 8% in determining the present value of the lease payments based on
the information available at the lease commencement date.
Lease
costs included in our condensed consolidated statements of operations totaled approximately $23,000
and $24,000 for the three months
ending June 30, 2024 and 2023, respectively, and approximately $45,000
and $49,000 for the six months
ended June 30, 2024, and 2023, respectively. The weighted average remaining lease terms and discount rate for our leases were as
follows at June 30, 2024:
Schedule
of Weighted Average Remaining Lease Terms and Discount Rate for Operating and Financing Leases
Remaining lease term (years) for our facility lease | |
| 1.3 | |
Remaining lease term (years) for our equipment lease | |
| 1.6 | |
Weighted average discount rate for our facility and equipment leases | |
| 8.0 | % |
Annual
lease liabilities for the operating lease were as follows at June 30, 2024:
Schedule
of Annual Lease Liabilities for all Operating Leases
| |
| | |
2024 | |
$ | 45,797 | |
2025 | |
| 70,040 | |
Total lease payments | |
| 115,837 | |
Less: Interest | |
| (6,511 | ) |
Present value of lease liabilities | |
| 109,326 | |
Less: current maturities | |
| (87,495 | ) |
Non-current lease liability | |
$ | 21,831 | |
Annual
lease liabilities for the financing lease were as follows at June 30, 2024:
Schedule
of Annual Lease Liabilities for all Financing Leases
| |
| | |
2024 | |
$ | 3,232 | |
2025 | |
| 6,820 | |
2026 | |
| 488 | |
Total lease payments | |
| 10,540 | |
Less: Interest | |
| (1,037 | ) |
Present value of lease liabilities | |
| 9,503 | |
Less: current maturities | |
| (5,686 | ) |
Non-current lease liability | |
$ | 3,817 | |
Note
6 – Related Party Transactions
CorLyst,
LLC (“CorLyst”) reimburses us for shared costs related to payroll, health insurance and rent based on actual costs
incurred, which are recognized as a reduction of our general and administrative operating expenses being reimbursed in our condensed
consolidated statement of operations. We recorded approximately $27,000
and $34,000
of reimbursements during the three months ended June 30, 2024 and 2023, respectively, and approximately $50,000
and $64,000
for the six months ended June 30, 2024 and 2023, respectively. No
amounts were due from CorLyst at June 30, 2024 or 2023. Our President of Research and Development is the CEO of CorLyst, and CorLyst
is a shareholder.
Note
7 – Commitments and Contingencies
Purchase
Obligations
We
enter into contracts in the normal course of business with contract research organizations (“CROs”) and subcontractors to further develop
our products. The contracts are cancelable, with varying provisions regarding termination. If we terminated a cancelable contract with
a specific vendor, we would only be obligated for products or services that we received at the effective date of the termination and
any applicable cancellation fees. At June 30, 2024, we are contractually obligated to pay up to $14.3 million of future services under
the agreements with the CROs. Our actual contractual obligations will also vary depending on the progress and results of the remaining
clinical trials.
Note
8 – Subsequent Event
On
July 16, 2024, Russell Skibsted was appointed as our Chief Financial Officer (“CFO”). Mr. Skibsted has nearly 30 years of experience
in the pharmaceutical industry, including expertise in financial management, global business development, capital markets, investor
relations and operations. In connection with his employment, Mr. Skibsted will be paid an annual base salary of $400,000
and will be eligible for a $50,000
base salary increase upon a cumulative (one or multiple) financing of at least $15
million that he leads and substantially participates in. He is also eligible to participate in an executive bonus pool with a target
bonus of 35%
of his base compensation. In addition, the Compensation Committee awarded 28,000
RSUs to Mr. Skibsted, which vest accordingly: 14,000
RSUs vest on July 16, 2025; 7,000
RSUs vest upon Processa reaching a market capitalization (i.e. total value of Processa’s outstanding shares of stock at the
then current market price) of at least $30
million; and 7,000
RSUs vest upon a cumulative (one or multiple) financing of at least $15
million that he leads and substantially participates in. He will also be eligible for other benefits as described in his employment
agreement.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operation
Forward
Looking Statements
This
Quarterly Report on Form 10-Q contains “forward-looking statements” that reflect, when made, the Company’s expectations
or beliefs concerning future events that involve risks and uncertainties. Forward-looking statements frequently are identified by the
words “believe,” “anticipate,” “expect,” “estimate,” “intend,” “project,”
“will be,” “will continue,” “will likely result,” or other similar words and phrases. Similarly,
statements herein that describe the Company’s objectives, plans or goals also are forward-looking statements. Actual results could
differ materially from those projected, implied or anticipated by the Company’s forward-looking statements. Some of the factors
that could cause actual results to differ include: our limited operating history, limited cash and history of losses; our ability to
achieve profitability; our ability to obtain adequate financing to fund our business operations in the future; our ability to secure
required FDA or other governmental approvals for our product candidates and the breadth of the indication sought; the impact of competitive
or alternative products, technologies and pricing; whether we are successful in developing and commercializing our technology, including
through licensing; the adequacy of protections afforded to us and/or our licensors by the anticipated patents that we own or license
and the cost to us of maintaining, enforcing and defending those patents; our and our licensors’ ability to protect non-patented
intellectual property rights; our exposure to and ability to defend third-party claims and challenges to our and our licensors’
anticipated patents and other intellectual property rights; and our ability to continue as a going concern. For a discussion of these
and all other known risks and uncertainties that could cause actual results to differ from those contained in the forward-looking statements,
see “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which is available
on the SEC’s website at www.sec.gov. All forward-looking statements are qualified in their entirety by this cautionary statement,
and the Company undertakes no obligation to revise or update this Quarterly Report on Form 10-Q to reflect events or circumstances after
the date hereof.
For
purposes of this Management’s Discussion and Analysis of Financial Condition and Results of Operations, references to the “Company,”
“we,” “us” or “our” refer to the operations of Processa Pharmaceuticals, Inc. and its direct and
indirect subsidiaries for the periods described herein.
Overview
We
are a clinical-stage biopharmaceutical company focused on utilizing our Regulatory Science Approach, which includes the principles
associated with FDA’s Project Optimus Oncology initiative and the related FDA Draft Guidance, in the development of Next Generation
Chemotherapy (“NGC”) oncology drug products. Our mission is to provide better treatment options than those that presently
exist by extending a patient’s survival and/or improving a patient’s quality of life. This is achieved by improving upon
FDA-approved, widely used oncology drugs or the cancer-killing metabolites of these drugs by altering how they are metabolized and/or
distributed in the body, including how they are distributed to the actual cancer cells.
Our
Regulatory Science Approach was conceived in the early 1990s when the founders of Processa and other faculty at the University of Maryland
worked with the FDA to develop multiple FDA Guidance Documents.
Regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance
of all FDA-regulated products. Over the last 30 years, two of our founders, Dr. David Young and Dr. Sian Bigora, have expanded the original
regulatory science concept by adding focused pre-clinical and clinical studies to justify the benefit-risk assessment required for FDA
approval when designing the development programs of new drug products.
Our
Regulatory Science Approach identifies the scientific information that the FDA requires to determine whether the benefit outweighs the risk of
a drug in a specific population of patients and at a specific dosage regimen for a specific drug product. The studies are designed to
obtain the necessary scientific information to support the regulatory decision.
Recently,
the FDA has taken steps to define some of the regulatory science required for the FDA approval of oncology products. Through the FDA’s
Project Optimus Oncology Initiative and the related Draft Guidance on determining the “optimal” dosage regimen for an oncology
drug, the FDA has chosen to make the development of oncology drugs more science-based than in the past. Since the principles of the FDA’s
Project Optimus and the related Draft Guidance have been used by our Regulatory Science Approach in a number of non-oncology drugs in
the past, our experience with the principles of Project Optimus differentiates us from other biotechnology companies by focusing us not
only on the clinical science, but also on the equally important regulatory process. We believe utilizing our Regulatory Science Approach
provides us with three distinct advantages:
|
● |
greater
efficiencies (e.g., the right trial design and trial readouts); |
|
● |
greater
possibility of drug approval by the FDA or other regulatory authorities; and |
|
● |
greater
ability to evaluate the benefit-risk of a drug compared to existing therapy, which allows prescribers to provide better treatment
options for each patient. |
Our
strategic prioritization is to advance our pipeline
of NGC proprietary small molecule oncology drugs. The NGC products are new chemical entities that change the metabolism, distribution
and/or elimination of already FDA-approved cancer drugs, or their active metabolites, while maintaining the drug’s proven mechanism
of action in killing cancer cells. We believe our NGC treatments will provide improved safety-efficacy profiles when compared to their
currently marketed counterparts – capecitabine, gemcitabine, and irinotecan.
Our
Drug Pipeline
![](https://www.sec.gov/Archives/edgar/data/1533743/000149315224031622/form10-q_001.jpg)
Our
pipeline currently consists of NGC-Cap, NGC-Gem and NGC-Iri (also identified as PCS6422, PCS3117 and PCS11T, respectively) and two non-oncology
drugs (PCS12852 and PCS499). The non-oncology drugs are not included in the pipeline chart above, as we are exploring our options for
those drugs, which may include out-licensing or partnership opportunities. A summary of each drug is provided below.
Next
Generation Chemotherapy
Historically,
much of oncology drug development has searched for novel or different ways to treat cancer. Our approach is to take three current FDA-approved
cancer drugs, e.g. capecitabine, gemcitabine and irinotecan, and modify and improve how the human body metabolizes and/or distributes
these NGC treatments compared to their presently approved counterpart chemotherapy drugs while maintaining the cancer-killing mechanism
of action; thus, our reason for calling our drugs Next Generation Chemotherapy treatments. Part of the development includes
determining the optimal dosage regimen based on the dose-response relationship as described in the FDA’s Project Optimus Initiative
and Draft Optimal Dosage Regimen Oncology Guidance. To date, we have data that we believe suggests our NGC treatments are likely to have
a better safety-efficacy profile than the current widely used marketed counterpart drugs, not only potentially making the development
and approval process more efficient, but also clearly differentiating our NGC treatments from the existing treatment. We believe our
NGC treatments have the potential to extend the survival and/or quality of life for more patients diagnosed with cancer while decreasing
the number of patients who are required to dose-adjust or discontinue treatment because of side effects or lack of response.
Next
Generation Chemotherapy Pipeline
|
● |
Next
Generation Capecitabine (“NGC-Cap”) is a combination of PCS6422 and a lower dose of the FDA-approved cancer drug capecitabine. PCS6422
is an orally administered irreversible inhibitor of the enzyme dihydropyrimidine dehydrogenase (“DPD”). DPD metabolizes 5-Fluorouracil
(“5-FU”), the major metabolite of capecitabine and widely used itself as an intravenous chemotherapeutic agent in many types of cancer,
to multiple metabolites classified as catabolites. These catabolites do not have any cancer-killing properties but frequently cause
dose-limiting side effects that may require dose adjustments or discontinuation of therapy. |
|
|
|
|
|
Capecitabine, as presently prescribed and FDA-approved, forms the cancer drug 5-FU which is then further metabolized to anabolites
(which kill both cancer cells and normal duplicating cells) and catabolites (which cause side effects and have no cancer killing
properties). When capecitabine is given in combination with PCS6422 in NGC-Cap, PCS6422 significantly changes the metabolism of
5-FU, which results in a change in the distribution of 5-FU within the body. Due to this change in metabolism and the overall
metabolite profile of anabolites and catabolites, the side effect and efficacy profile of NGC-Cap has been found to be different
from capecitabine given without PCS6422. Since the potency of NGC-Cap is also greater than FDA-approved capecitabine based on the
5-FU systemic exposure per mg of capecitabine administered, the amount of capecitabine anabolites formed from 1 mg of capecitabine
administered in NGC-Cap will, therefore, be much greater than formed from the administration of 1 mg of existing
capecitabine. |
|
|
|
|
|
The
Phase 1B trial in patients with advanced refractory gastrointestinal tract tumors demonstrated that the irreversible inhibition
of DPD by PCS6422 could alter the metabolism, distribution and elimination of 5-FU, making NGC-Cap significantly (up to 50 times)
more potent than capecitabine alone and potentially leading to higher levels of anabolites which can kill replicating cancer and
normal cells. By administering NGC-Cap to cancer patients, the balance between anabolites and catabolites changes depending on the
dosage regimens of PCS6422 and capecitabine used, making the efficacy-safety profile of NGC-Cap different than that of FDA-approved
capecitabine and requiring further evaluation of the PCS6422 and capecitabine regimens to determine the optimal NGC-Cap regimens for
patients. |
|
|
In
order for NGC-Cap to provide a safer and more efficacious profile for cancer patients compared to existing chemotherapy, understanding
how the different regimens of PCS6422 and capecitabine may affect the systemic and tumor exposure to the anabolites, as well as the
systemic exposure to the catabolites, is required. This can be achieved by following the timeline of DPD irreversible inhibition
and the formation of new DPD using the plasma concentrations of 5-FU and its catabolites. |
|
|
|
|
|
In
an effort to better estimate the timeline of DPD inhibition and formation of new DPD, we modified the protocol for the Phase 1B
trial and began enrolling patients in the amended Phase 1B trial in April 2022. On November 1, 2022, we announced that data from the
Phase 1B trial identified multiple dosage regimens with potentially better safety and efficacy profiles than currently existing
chemotherapy regimens. Since 5-FU exposure is dependent on both the PCS6422 regimen and the capecitabine regimen, safe regimens were
identified as well as regimens that cause dose-limiting toxicities (“DLTs”). One of the early regimens in the Phase 1B
trial did cause DLTs in two patients, one of whom died. No other DLTs were noted in the study. The Phase 1B trial has now completed
enrollment and we are currently conducting trial close-out activities. We submitted a new IND for the treatment of advanced and
metastatic breast cancer and received IND clearance from the FDA on July 24, 2024. The Phase 2 trial is currently being initiated
and will be a global multicenter, open-label, adaptive design trial comparing two different doses of NGC-Cap to FDA-approved
monotherapy capecitabine in approximately 60 to 90 patients with advanced or metastatic breast cancer. The trial is designed to
evaluate the safety-efficacy profile of NGC-Cap versus monotherapy capecitabine, to determine the potential optimal dosage regimens
of NGC-Cap as required by the FDA Project Optimus Initiative. Our license agreement with Elion for NGC-Cap requires us to use
commercially reasonable efforts, at our sole cost and expense, to research, develop and commercialize products in one or more
countries, including meeting specific diligence milestones that include dosing a first patient with a product in a Phase 2 or 3
clinical trial on or before October 2, 2024. We expect the first patient to be dosed before the conclusion of the third quarter of
2024, ahead of the required diligence milestone. |
|
● |
NGC-Gem
is a cytidine analog similar to gemcitabine (Gemzar®), but different enough in chemical structure that some patients are more
likely to respond to PCS3117 than gemcitabine. In addition, we believe those patients inherently resistant or who acquire resistance
to gemcitabine are likely not to be resistant to NGC-Gem. The difference in response occurs because NGC-Gem is metabolized to its
active metabolite through a different enzyme system than gemcitabine. We continue to evaluate the potential use of NGC-Gem in patients
with pancreatic and other potential cancers and to evaluate ways to identify patients who are more likely to respond to NGC-Gem than
gemcitabine. We plan to meet with the FDA to discuss potential trial designs including implementation of the Project
Optimus initiative as part of the design. Similar to NGC-Cap, we will need to obtain additional funding before we can begin the Phase
2 trial for NGC-Gem. |
|
|
Our
license agreement with Ocuphire Pharma, Inc. (“Ocuphire”) for NGC-Gem requires us to use commercially reasonable efforts,
at our sole cost and expense to oversee such commercialization efforts, to research, develop and commercialize products in one or
more countries, including meeting specific diligence milestones that consist of: (i) dosing a patient in a clinical trial prior to
June 16, 2024; and (ii) dosing a patient in a pivotal clinical trial or in a clinical trial for a second indication of the drug prior
to June 16, 2026. We are currently in discussions with Ocuphire to extend these deadlines. |
|
|
|
|
● |
NGC-Iri
is an analog of SN38 (SN38 is the active metabolite of irinotecan) and should have an improved safety/efficacy profile in every type
of cancer that irinotecan is presently used. The manufacturing process and sites for drug substance and drug product are presently
being evaluated and IND-enabling toxicology studies will then be initiated. In addition, we are defining the potential paths to approval,
which include defining the targeted patient population and the type of cancer. In 2025, we plan to expand the preclinical analysis, including additional preclinical efficacy and toxicity studies;
evaluate manufacturing options for PCS11T; and conduct chemistry, manufacturing and control (CMC) activities and pre-IND enabling studies. |
We
are focused on drug products that improve the survival and/or quality of life for patients by improving the safety and/or efficacy of
the drug in a targeted patient population, while providing a more efficient and probable path to FDA approval and differentiating our
drugs from those on the market or are currently being developed.
Other
Drugs in Our Pipeline
In
2023, we completed our Phase 2A trial for PCS12852 in gastroparesis patients with positive results. Additionally, in February 2023, due
primarily to the inability to identify and enroll patients in our rare disease Phase 2 trial for PCS499 in ulcerative Necrobiosis Lipoidica, we decided to cease further enrollment in the PCS499 trial and terminated the trial. We did not experience any safety concerns
during the conduct of either the PCS12852 or PCS499 trial. We continue to evaluate options to monetize these non-core drug assets, which
may include out-licensing or partnering these assets with one or more third parties.
Recent
Developments
Reverse
Stock Split
On
January 22, 2024, we effected a 1-for-20 reverse stock split, reducing the number of our common shares issued on that date from 24,706,474
shares to 1,291,000 shares. There is no corresponding reduction in the number of authorized shares of common stock and no change in the
par value per share. All share and per share amounts and conversion and exercise prices presented herein have been adjusted retroactively
to reflect this change.
Public
Offering
On
January 30, 2024, we raised gross proceeds of $7.0 million (net proceeds of $6.3 million) from the sale of 476,000 shares of our common
stock, pre-funded warrants to purchase up to 1,079,555 shares of our common stock and warrants to purchase 1,555,555 shares of our common
stock in a public offering, as described in Note 2. Simultaneously with the closing of the sale, the pre-funded warrants were exercised
in exchange for 1,079,555 shares of our common stock. We are using the net proceeds from this financing for continued research and
development for NCG-Cap, and working capital and general corporate purposes.
ATM
Offering
In
May 2024, we filed with the SEC a registration statement on Form S-3 (Registration No. 333-279588) (the “Registration Statement”),
including a base prospectus relating to the offering of up to $50,000,000 in the aggregate of the securities identified in the base prospectus
from time to time in one or more offerings; and a prospectus supplement relating to the shares of our common stock that may be issued
and sold under a sales agreement dated May 21, 2024 (the “Sales Agreement”) between us and A.G.P./Alliance Global Partners
(the “Sales Agent”), through which we may issue and sell in a registered “at the market offering” shares of our
common stock having an aggregate offering price of up to $2.4 million (subject to adjustment) from time to time through or to our Sales
Agent (the “ATM Offering”). We expect to use net proceeds, if any, from the ATM Offering over time for continued research
and development for our portfolio of drug candidates, especially our oncology products, and working capital and general corporate purposes.
The shares under the ATM Offering will be sold and issued pursuant to the Registration Statement.
New Chief Financial
Officer
On July 16, 2024, Russell Skibsted
was appointed as our Chief Financial Officer (“CFO”). Mr. Skibsted has nearly 30 years of experience in the pharmaceutical industry, including
expertise in financial management, global business development, capital markets, investor relations and operations. In connection with
his employment, Mr. Skibsted will be paid an annual base salary of $400,000 and will be eligible for a $50,000 base salary increase upon
a cumulative (one or multiple) financing of at least $15 million that he leads and substantially participates in. He is also eligible
to participate in an executive bonus pool with a target bonus of 35% of his base compensation. In addition, the Compensation Committee
awarded 28,000 RSUs to Mr. Skibsted, which vest accordingly: 14,000 RSUs vest on July 16, 2025; 7,000 RSUs vest upon Processa reaching
a market capitalization (i.e. total value of Processa’s outstanding shares of stock at the then current market price) of at least
$30 million; and 7,000 RSUs vest upon a cumulative (one or multiple) financing of at least $15 million that he leads and substantially
participates in. He will also be eligible for other benefits as described in his employment agreement.
Results
of Operations
Comparison
of the three and six months ended June 30, 2024 and 2023
The
following table summarizes our net loss during the periods indicated:
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
Change | | |
2024 | | |
2023 | | |
Change | |
Operating Expenses | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Research and development expenses | |
$ | 1,730,444 | | |
$ | 1,688,164 | | |
$ | 42,280 | | |
$ | 3,269,555 | | |
$ | 3,342,509 | | |
$ | (72,954 | ) |
General and administrative expenses | |
| 1,351,580 | | |
| 1,026,301 | | |
| 325,279 | | |
| 2,622,067 | | |
| 3,477,490 | | |
| (855,423 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Operating Loss | |
| (3,082,024 | ) | |
| (2,714,465 | ) | |
| | | |
| (5,891,622 | ) | |
| (6,819,999 | ) | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Other Income (Expense), net | |
| 71,698 | | |
| 101,900 | | |
| (30,141 | ) | |
| 154,915 | | |
| 185,361 | | |
| (30,309 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net Operating Loss Before Income Tax Benefit | |
| (3,010,326 | ) | |
| (2,612,565 | ) | |
| | | |
| (5,736,707 | ) | |
| (6,634,638 | ) | |
| | |
Income Tax Benefit | |
| - | | |
| - | | |
| | | |
| - | | |
| - | | |
| | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net Loss | |
$ | (3,010,326 | ) | |
$ | (2,612,565 | ) | |
| | | |
$ | (5,736,707 | ) | |
$ | (6,634,638 | ) | |
| | |
Revenues
We
do not currently have any revenue under contract or any immediate sales prospects.
Research
and Development Expenses
Our
research and development costs are expensed as incurred. Research and development expenses include (i) program and testing related expenses
including external consulting and professional fees related to the product testing and our development activities and (ii) internal research
and development staff salaries and other payroll costs including stock-based compensation, payroll taxes and employee benefits.
Costs
for the three- and six-month periods for the periods ended June 30, 2024 and 2023 were as follows:
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development salaries and benefits | |
| 468,724 | | |
| 502,626 | | |
| 976,554 | | |
| 1,048,294 | |
Preclinical, clinical trial and other costs | |
| 1,261,720 | | |
| 1,185,538 | | |
| 2,293,001 | | |
| 2,294,215 | |
Total | |
$ | 1,730,444 | | |
$ | 1,688,164 | | |
$ | 3,269,555 | | |
$ | 3,342,509 | |
During
the three months ended June 30, 2024, our preclinical, clinical trial and other costs increased when compared to the same period in
2023. This was attributable to an increase of approximately $146,000 for ongoing testing and related expenses related to our Phase
1B trial for NGC-Cap and the IND/initiation of our Phase 2 trial for NGC-Cap and offset by a decrease in professional fees of
approximately $70,000, mostly attributable to a decrease in patent-related legal fees. During the same period in 2023, in addition
to clinical trial costs for NGC-Cap, we were incurring closing costs in our clinical trial for PCS12852 and PCS499. We also had an
approximately $23,000 increase in salaries and related costs during the three months ended June 30, 2024 when compared to the same
period in 2023 due to one-time bonuses and increased salary rates for the research and development team in 2024. This was offset by
a decrease in stock-based compensation of approximately $57,000 as we waited for shareholder approval to increase the number of
shares available under the 2019 Plan.
During
the six months ended June 30, 2024, we had increases in testing and related expenses of approximately $132,000, and in salaries and
related costs of approximately $61,000, when compared to the same period in 2023. These increases were offset by decreases in
professional fees of approximately $133,000 and in stock-based compensation of approximately $133,000. The reasons for the changes
between the six-month periods in 2024 and 2023 are the same as the reasons between the three-month periods in 2024 and
2023.
On
July 24, 2024 we received approval of our IND for our Phase 2 trial for NGC-Cap in breast cancer. As we begin this Phase 2 trial and complete
our Phase 1B clinical trial for NGC-Cap, we anticipate our research and development costs will increase. We will also continue incurring
nominal costs for NGC-Gem as we prepare to meet with the FDA to discuss potential study designs and for NGC-Iri should we decide to conduct
IND-enabling and toxicology studies.
The
funding necessary to bring a drug candidate to market is subject to numerous uncertainties. Once a drug candidate is identified, the
further development of that drug candidate may be halted or abandoned at any time due to a number of factors. These factors include,
but are not limited to, funding constraints, safety or a change in market demand. For each of our drug candidate programs, we periodically
assess the scientific progress and merits of the programs to determine if continued research and development is economically viable.
Some programs may be terminated due to the lack of scientific progress and lack of prospects for ultimate commercialization.
Our
clinical trial cost accruals are based on estimates of patient enrollment and related costs at clinical investigator sites, as well as
estimates for the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that conduct
and manage clinical trials on our behalf.
We
estimate preclinical and clinical trial expenses based on the services performed, pursuant to contracts with research institutions and
clinical research organizations that conduct and manage preclinical studies and clinical trials on our behalf. In accruing service fees,
we estimate the time period over which services will be performed and the level of patient enrollment and activity expended in each period.
If the actual timing of the performance of services or the level of effort varies from the estimate, we will adjust the accrual accordingly.
Payments made to third parties under these arrangements in advance of the receipt of the related services are recorded as prepaid expenses
and expensed when the services are rendered.
General
and Administrative Expenses
Our general and administrative expenses for the three months ended June
30, 2024 increased by approximately $325,000 to $1.4 million from $1.0 million for the three months ended June 30, 2023. This increase
was due primarily as a result of an approximately $308,000 increase in professional fees, mostly attributable to an increase of legal
fees; an approximately $115,000 increase in salaries and other payroll-related costs from increased salary rates, primarily paid to our
executive officers; and a net increase of approximately $17,000 in travel, office and other miscellaneous expenses. These increases were
offset by a decrease in employee stock-based compensation of approximately $123,000. We also received approximately $8,000 less in reimbursements
from CorLyst during the three months ended June 30, 2024 when compared to the same period in 2023.
During
the six months ended June 30, 2024, our general and administrative expenses decreased by approximately $855,000 to $2.6 million from
$3.5 million for the six months ended June 30, 2023. This was due primarily to a decrease in professional fees of approximately
$955,000 as a result of the non-recurring expense that was incurred during 2023 in connection with the stock purchase warrant
granted to the placement agent for our registered direct offering in February 2023; and a decrease in employee stock-based
compensation of approximately $247,000 as we waited for shareholder approval to increase the number of shares available under the
2019 Plan. These decreases were primarily offset by increases in salaries and other payroll-related expenses of approximately
$296,000 and in office and other related expenses of approximately $37,000. We also received approximately $14,000 less in
reimbursements from CorLyst during the six months ended June 30, 2024 when compared to the same period in 2023.
Other
Income, net
Other
income represents interest income of approximately $72,000 and $102,000 for the three months ended June 30, 2024 and 2023,
respectively, and approximately $155,000 and $185,000 for the six months ended June 30, 2024 and 2023, respectively.
Income
Tax Benefit
We
did not recognize any income tax benefit for the three or six months ended June 30, 2024 or 2023.
Cash
Flows
The
following table sets forth our sources and uses of cash and cash equivalents for the six months ended June 30, 2024 and 2023:
| |
Six months ended June 30, | |
| |
2024 | | |
2023 | |
Net cash (used in) provided by: | |
| | | |
| | |
Operating activities | |
$ | (5,394,713 | ) | |
$ | (4,178,539 | ) |
Financing activities | |
| 6,259,636 | | |
| 6,352,077 | |
Net increase in cash | |
$ | 864,923 | | |
$ | 2,173,538 | |
Net
cash used in operating activities
We
used net cash in our operating activities of $5,394,713 and $4,178,539 during the six months ended June 30, 2024 and 2023,
respectively. The increase in cash used in operating activities was primarily attributable to the prepayment of expenses paid to our CRO for our Phase 2 trial for NGC-Cap during the six months ended June 30, 2024.
As
we continue our development of NGC-Cap and evaluate the other NGC drugs in our portfolio, we anticipate our research and development
efforts and ongoing general and administrative costs will continue to generate negative cash flows from operating activities for the
foreseeable future. As we begin our Phase 2 clinical trial for NGC-Cap in the
second half of 2024, we anticipate our clinical trial costs will increase when compared to prior periods since our current
activities are related primarily to the completion of our Phase 1b trial for NGC-Cap.
Net
cash provided by financing activities
During
the six months ended June 30, 2024, we sold 476,000 shares of common stock, pre-funded warrants to purchase up to 1,079,555 shares of
common stock in lieu of shares of common stock, all of which were exercised into shares of our common stock, and warrants to purchase
up to 1,555,555 shares of our common stock pursuant to a public offering for net proceeds of $6.3 million. We
also used cash classified as financing activities of $12,000 to pay income taxes owed on stock-based compensation, $8,600 for the settlement
of a stock award and $2,300 for payments owed under a financing lease obligation.
During
the six months ended June 30, 2023, we raised net proceeds of $6.4 million from the sale of 421,611 shares of our common stock.
Liquidity
During
the six months ended June 30, 2024, we began initiation activities for our Phase
2 trial for NGC-Cap in breast cancer. At June 30, 2024, we had cash and cash equivalents totaling $5.6 million which, based on our current
business and drug development plans, we believe will satisfy our operating needs into late 2024. Absent additional funding, our current
cash and cash equivalents will not be sufficient to fund our planned operations for a period of one year or more after the date that
these condensed consolidated financial statements were available to be issued based on the timing and amount of our projected net loss
from continuing operations and the related amount of cash to be used in operating activities during that period of time. Our ability
to execute our longer-term operating plans, including future preclinical studies and clinical trials for our portfolio of drugs depend
on our ability to obtain additional funding from the sale of equity and/or debt securities, a strategic transaction or other funding
transactions.
We
have incurred losses since inception, currently devoting substantially all of our efforts toward research and development of our next
generation chemotherapy drug product candidates, including conducting clinical trials and providing general and administrative support
for these operations, and have an accumulated deficit of $81.1 million at June 30, 2024. During the six months ended June 30, 2024, we
generated a net loss of $5.7 million and used $5.4 million
in net cash for operating activities from continuing operations. To date, none of our drug candidates have been approved for sale, and
therefore we have not generated any product revenue and do not expect positive cash flow from operations in the foreseeable future.
We
have financed our operations primarily through public equity issuances, including an offering we closed on January 30, 2024 in which
we sold 476,000 shares of our common stock, pre-funded warrants to purchase up to 1,079,555 shares of our common stock, and warrants
for the purchase of up to 1,555,555 shares of our common stock for net proceeds of $6.3 million, after deducting placement agent fees
and offering-related expenses. Simultaneously with the
closing of the sale, the pre-funded warrants were exercised in exchange for 1,079,555 shares of
our common stock. We will continue to be dependent upon equity and/or debt financing until we are able to generate positive cash flows
from our operations.
Further, in May 2024, we filed with the SEC a registration statement on Form S-3 (Registration No. 333-279588) (the “Registration
Statement”), including a base prospectus relating to the offering of up to $50,000,000 in the aggregate of the securities identified
in the base prospectus from time to time in one or more offerings; and a prospectus supplement relating to the shares of our common stock
that may be issued and sold under a sales agreement dated May 21, 2024 (the “Sales Agreement”) between us and A.G.P./Alliance
Global Partners (the “Sales Agent”), through which we may issue and sell in a registered “at the market offering”
shares of our common stock having an aggregate offering price of up to $2.4 million (subject to adjustment) from time to time through
or to our Sales Agent (the “ATM Offering”). We expect to use net proceeds, if any, from the ATM Offering over time for continued
research and development for our portfolio of drug candidates, especially our oncology products, and working capital and general corporate
purposes. The shares under the ATM Offering will be sold and issued pursuant to the Registration Statement.
We
plan to raise additional funds in the future through a combination of public or private equity offerings, debt financings, collaborations,
strategic alliances, licensing arrangements and other marketing and distribution arrangements, but will only do so if the terms are acceptable
to us. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend our current or
planned future clinical trial plans, or research and development programs. This may also cause us to not meet obligations contained in
certain of our license agreements and put these assets at risk. To the extent that we raise additional capital through marketing and
distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish
valuable rights to our product candidates, future revenue streams, research programs or product candidates or to grant licenses on terms
that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of
our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely
affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting
or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures. There can be no
assurance that future funding will be available when needed.
Contractual
Obligations and Commitments
There
have been no significant changes to the contractual obligations reported in our Annual Report on Form 10-K for the fiscal year ended
December 31, 2023.
Off
Balance Sheet Arrangements
At
June 30, 2024, we did not have any off-balance sheet arrangements.
Critical
Accounting Policies and Use of Estimates
Our
discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed consolidated financial
statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make
estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosure of contingent
assets and liabilities.
We
believe that the estimates, assumptions and judgments involved in the accounting policies described in the “Management’s
Discussion and Analysis of Financial Condition and Results of Operations” section of our most recent Annual Report on Form 10-K
have the greatest potential impact on our financial statements, so we consider these to be our critical accounting policies. Actual results
could differ from the estimates we use in applying our critical accounting policies. We are not currently aware of any reasonably likely
events or circumstances that would result in materially different amounts being reported.
There
have been no changes in our critical accounting policies from those included in our most recent Annual Report on Form 10-K.
Recently
Issued Accounting Pronouncements
We
have evaluated recently issued accounting pronouncements and determined that there is no material impact on our financial position or
results of operations.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
Item
3 is not applicable to us as a smaller reporting company and has been omitted.
Item
4. Controls and Procedures
At
June 30, 2024, management, with the participation of the Chief Executive Officer and Chief
Financial Officer, conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures,
as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on the evaluation of its disclosure controls and procedures,
the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at June
30, 2024 to provide reasonable assurance that information required to be disclosed in our
reports under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s
rules and forms and (ii) accumulated and communicated to our management, as appropriate, to allow timely decisions regarding required
disclosure. In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures,
no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily
applies its judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting during the quarter ended June 30, 2024 that have materially affected,
or are reasonably likely to materially affect the Company’s internal control over financial reporting.
Part
II. Other Information
Item
1. Legal Proceedings
As
of the date of this report, to our knowledge, there are no legal proceedings or regulatory actions material to us to which we are a party,
or have been a party to, or of which any of our property is or was the subject matter of, and no such proceedings or actions are known
by us to be contemplated, except as provided below:
As
previously disclosed in our Current report on Form 10-Q for the period ended March 31, 2024, on May 7, 2024, the Company received
notification from Elion purporting to terminate the license agreement by and between the Company and Elion as a result of the
Company’s alleged breach thereof. The Company believes that Elion’s claims are without merit and disputes that the
license agreement has been validly terminated. On May 10, 2024, the Company filed a summons with notice for damages, declaratory and
injunctive relief against Elion in New York State Court. On June 14, 2024, Elion filed a demand for complaint. On July 5, 2024, the
Company filed a complaint seeking monetary damages, declaratory judgement and injunctive relief. The Company intends to enforce its rights under the license agreement and will pursue such other remedies as it determines
are appropriate.
Item
1A. Risk Factors
There
have been no material changes to our risk factors as described in Item 1A of our Annual Report on Form 10-K for the year ended December
31, 2023, other than the addition of the following risk factor:
Our
licenses are subject to termination by the licensor in certain circumstances.
Our
rights to practice the inventions claimed in the licensed patents and patent applications are subject to our licensors abiding by the
terms of those licenses and not terminating them. Our licenses may be terminated by the licensor if we are in material breach of certain
terms or conditions of the license agreement or in certain other circumstances. Our license agreements each include provisions that allow
the licensor to terminate the license if (i) we breach any payment obligation or other material provision under the agreement and fail
to cure the breach within a fixed time following written notice of termination; (ii) we or any of our affiliates, licensees or sublicensees
directly or indirectly challenge the validity, enforceability, or extension of any of the licensed patents; or (iii) we declare bankruptcy
or dissolve. The majority of license agreements require us to satisfy due diligence milestones that relate to the development of new
products containing the licensed drug or the agreement may be terminated by such counterparty. Our rights under these licenses are subject
to our continued compliance with the terms of the license, including the payment of royalties due under the licenses. Termination of
any of these licenses could prevent us from marketing some or all of our products. Because of the complexity of our products and the
patents we have licensed, determining the scope of the license and related royalty obligations can be difficult and can lead to disputes
between us and the licensor. An unfavorable resolution of such a dispute could lead to an increase in the royalties payable pursuant
to the license. If a licensor believed we were not paying the royalties due under the license or were otherwise not in compliance with
the terms of the license, the licensor might attempt to revoke the license. If such an attempt were successful, we might be barred from
producing and selling some or all of our products.
As
previously disclosed in our Current Report on Form 10-Q for the period ended March 31, 2024, on May 7, 2024, the Company received
notification from Elion purporting to terminate the license agreement by and between us and Elion as a result of the Company’s
alleged breach thereof. The Company believes that Elion’s claims are without merit and disputes that the license agreement has
been validly terminated. On May 10, 2024, the Company filed a summons with notice for damages, declaratory and injunctive relief
against Elion in New York State Court. On June 14, 2024, Elion filed a demand for complaint. On July 5, 2024, the Company filed a
complaint seeking monetary damages, declaratory judgement and injunctive relief. The Company intends to enforce its rights under the license agreement and will pursue such other remedies as it determines
are appropriate.
If
we are unsuccessful or are unable to enforce our rights under the license agreement, our business and results of operations may be adversely
affected.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
(a)
Recent Sale of Unregistered Securities
On
June 6, 2024, we issued 10,000 shares of common stock to Paramount Advisors, LLC in connection with a consulting agreement. The sale
of shares was exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”),
in reliance on Section 4(a)(2) of the Securities Act.
There were no other sales of unregistered securities during the three months ended
June 30, 2024.
(b)
Use of Proceeds from Public Offering of Common Stock
None.
(c)
Issuer Purchases of Equity Securities
We
did not repurchase any shares of our common stock during the six months ended June 30, 2024.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
During
the three months ended June 30, 2024, none of our directors or officers adopted
or terminated
a “Rule 10b5-1 trading arrangement” or a “non-Rule
10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
Item
6. Exhibits
*
Filed herewith.
# Indicates management contract or compensatory plan
or arrangement.
++
This certification is being furnished solely to accompany this Quarterly Report pursuant to 18 U.S.C. Section 1350 and are not being
filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into
any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing
herewith.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned thereunto duly authorized.
|
PROCESSA
PHARMACEUTICALS, INC. |
|
|
|
|
By: |
/s/
George Ng |
|
|
George
Ng |
|
|
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
Dated:
August 13, 2024 |
|
|
|
|
By: |
/s/
Russell Skibsted |
|
|
Russell
Skibsted |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and Accounting Officer) |
|
|
Dated:
August 13, 2024 |
Exhibit
31.1
CERTIFICATION
I,
George Ng, Chief Executive Officer of PROCESSA PHARMACEUTICALS, INC. certify that:
1.
I have reviewed this quarterly report on Form 10-Q of PROCESSA PHARMACEUTICALS, INC. for the six months ended June 30, 2024;
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 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 at, and for, the periods presented in this report;
4.
I am 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 Rules13a-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, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b.
Designed such internal 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 financial statements
for external purposes in accordance 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, at 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.
5.
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 registrant’s board of directors (or persons performing 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.
|
By: |
/s/
George Ng |
|
|
George
Ng |
|
|
Chief
Executive Officer
(Principal
Executive Officer) |
|
Date: |
August
13, 2024 |
Exhibit
31.2
CERTIFICATION
I,
Russell Skibsted, Chief Financial Officer of PROCESSA PHARMACEUTICALS, INC. certify that:
1.
I have reviewed this quarterly report on Form 10-Q of PROCESSA PHARMACEUTICALS, INC. for the six months ended June 30, 2024;
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 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 at, and for, the periods presented in this report;
4.
I am 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 Rules13a-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, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared;
b.
Designed such internal 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 financial statements
for external purposes in accordance 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, at 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.
5.
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 registrant’s board of directors (or persons performing 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.
|
By: |
/s/
Russell Skibsted |
|
|
Russell
Skibsted |
|
|
Chief
Financial Officer
(Principal
Financial and Accounting Officer) |
|
Date: |
August
13, 2024 |
Exhibit
32.1
Written
Statement of the Chief Executive Officer and Chief Financial Officer Pursuant to 18 U.S.C. §1350
Solely
for the purposes of complying with 18 U.S.C. §1350, I, the undersigned Chief Executive Officer of Processa Pharmaceuticals, Inc.
(the “Company”), hereby certify, to the best of my knowledge, that the quarterly report on Form 10-Q of the Company for the
quarter ended June 30, 2024 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 and that the information contained in the Report fairly presents, in all material respects, the financial
condition and results of operations of the Company.
This
certification is being furnished solely to accompany this Report pursuant to 18 U.S.C. 1350 and is not being filed for purposes of Section
18 of the Securities Exchange Act of 1934 and is not to be incorporated by reference into any filing of the registrant, whether made
before or after the date hereof, regardless of any general incorporation language in such filing.
|
By: |
/s/
George Ng |
|
|
George
Ng |
|
|
Chief
Executive Officer
(Principal
Executive Officer) |
|
Date: |
August
13, 2024 |
Solely
for the purposes of complying with 18 U.S.C. §1350, I, the undersigned Chief Financial Officer of Processa Pharmaceuticals, Inc.
(the “Company”), hereby certify, to the best of my knowledge, that the quarterly report on Form 10-Q of the Company for the
quarter ended June 30, 2024 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the
Securities Exchange Act of 1934 and that the information contained in the Report fairly presents, in all material respects, the financial
condition and results of operations of the Company.
This
certification is being furnished solely to accompany this Report pursuant to 18 U.S.C. 1350 and is not being filed for purposes of Section
18 of the Securities Exchange Act of 1934 and is not to be incorporated by reference into any filing of the registrant, whether made
before or after the date hereof, regardless of any general incorporation language in such filing.
|
By: |
/s/
Russell Skibsted |
|
|
Russell
Skibsted |
|
|
Chief
Financial Officer
(Principal
Financial and Accounting Officer) |
|
Date: |
August
13, 2024 |
v3.24.2.u1
Cover - shares
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Current Assets |
|
|
Cash and cash equivalents |
$ 5,571,120
|
$ 4,706,197
|
Prepaid expenses and other |
1,906,854
|
926,300
|
Total Current Assets |
7,477,974
|
5,632,497
|
Property and Equipment, net |
2,276
|
2,554
|
Other Assets |
|
|
Lease right-of-use assets, net of accumulated amortization |
115,191
|
146,057
|
Security deposit |
5,535
|
5,535
|
Total Other Assets |
120,726
|
151,592
|
Total Assets |
7,600,976
|
5,786,643
|
Current Liabilities |
|
|
Current maturities of lease liabilities |
93,181
|
83,649
|
Accounts payable |
953,086
|
311,617
|
Due to licensor |
|
189,000
|
Due to related parties |
|
39
|
Accrued expenses |
505,397
|
146,274
|
Total Current Liabilities |
1,551,664
|
730,579
|
Non-current Liabilities |
|
|
Non-current lease liabilities |
25,648
|
66,905
|
Total Liabilities |
1,577,312
|
797,484
|
Commitments and Contingencies |
|
|
Stockholders’ Equity |
|
|
Common stock, par value $0.0001, 100,000,000 shares authorized: 2,873,883 issued and 2,868,883 outstanding at June 30, 2024; and 1,291,000 issued and 1,286,000 outstanding at December 31, 2023 |
287
|
129
|
Additional paid-in capital |
87,429,165
|
80,658,111
|
Treasury stock at cost — 5,000 shares at June 30, 2024 and December 31, 2023 |
(300,000)
|
(300,000)
|
Accumulated deficit |
(81,105,788)
|
(75,369,081)
|
Total Stockholders’ Equity |
6,023,664
|
4,989,159
|
Total Liabilities and Stockholders’ Equity |
$ 7,600,976
|
$ 5,786,643
|
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Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
Common stock, shares issued |
2,873,883
|
1,291,000
|
Common stock, shares outstanding |
2,868,883
|
1,286,000
|
Treasury stock shares |
5,000
|
5,000
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Operating Expenses |
|
|
|
|
Research and development expenses |
$ 1,730,444
|
$ 1,688,164
|
$ 3,269,555
|
$ 3,342,509
|
General and administrative expenses |
1,351,580
|
1,026,301
|
2,622,067
|
3,477,490
|
Operating Loss |
(3,082,024)
|
(2,714,465)
|
(5,891,622)
|
(6,819,999)
|
Other Income (Expense), net |
71,698
|
101,900
|
154,915
|
185,361
|
Net Operating Loss Before Income Tax Benefit |
(3,010,326)
|
(2,612,565)
|
(5,736,707)
|
(6,634,638)
|
Income Tax Benefit |
|
|
|
|
Net Loss |
$ (3,010,326)
|
$ (2,612,565)
|
$ (5,736,707)
|
$ (6,634,638)
|
Net Loss per Common Share - Basic |
$ (1.01)
|
$ (1.94)
|
$ (2.11)
|
$ (5.34)
|
Net Loss per Common Share - Diluted |
$ (1.01)
|
$ (1.94)
|
$ (2.11)
|
$ (5.34)
|
Weighted Average Common Shares Used to Compute Net Loss Applicable to Common Shares - Basic |
2,983,283
|
1,346,808
|
2,724,903
|
1,243,475
|
Weighted Average Common Shares Used to Compute Net Loss Applicable to Common Shares - Diluted |
2,983,283
|
1,346,808
|
2,724,903
|
1,243,475
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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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] |
Treasury Stock, Common [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 80
|
$ 72,018,222
|
$ (300,000)
|
$ (64,247,561)
|
$ 7,470,741
|
Balance. shares at Dec. 31, 2022 |
806,774
|
|
(5,000)
|
|
|
Stock-based compensation |
$ 1
|
341,503
|
|
|
341,504
|
Stock-based compensation, shares |
3,195
|
|
|
|
|
Shares issued in connection with capital raise, net of transaction costs |
$ 42
|
6,352,035
|
|
|
6,352,077
|
Shares issued in connection with capital raise, net of transaction costs, shares |
421,611
|
|
|
|
|
Net loss |
|
|
|
(4,022,073)
|
(4,022,073)
|
Balance at Mar. 31, 2023 |
$ 123
|
78,711,760
|
$ (300,000)
|
(68,269,634)
|
10,142,249
|
Balance. shares at Mar. 31, 2023 |
1,231,580
|
|
(5,000)
|
|
|
Balance at Dec. 31, 2022 |
$ 80
|
72,018,222
|
$ (300,000)
|
(64,247,561)
|
7,470,741
|
Balance. shares at Dec. 31, 2022 |
806,774
|
|
(5,000)
|
|
|
Net loss |
|
|
|
|
(6,634,638)
|
Balance at Jun. 30, 2023 |
$ 123
|
80,341,758
|
$ (300,000)
|
(70,882,199)
|
9,159,682
|
Balance. shares at Jun. 30, 2023 |
1,231,580
|
|
(5,000)
|
|
|
Balance at Mar. 31, 2023 |
$ 123
|
78,711,760
|
$ (300,000)
|
(68,269,634)
|
10,142,249
|
Balance. shares at Mar. 31, 2023 |
1,231,580
|
|
(5,000)
|
|
|
Stock-based compensation |
|
319,123
|
|
|
319,123
|
Net loss |
|
|
|
(2,612,565)
|
(2,612,565)
|
Warrants issued in connection with a consulting agreement |
|
1,310,875
|
|
|
1,310,875
|
Balance at Jun. 30, 2023 |
$ 123
|
80,341,758
|
$ (300,000)
|
(70,882,199)
|
9,159,682
|
Balance. shares at Jun. 30, 2023 |
1,231,580
|
|
(5,000)
|
|
|
Balance at Dec. 31, 2023 |
$ 129
|
80,658,111
|
$ (300,000)
|
(75,369,081)
|
4,989,159
|
Balance. shares at Dec. 31, 2023 |
1,291,000
|
|
(5,000)
|
|
|
Stock-based compensation |
$ 1
|
167,642
|
|
|
167,643
|
Stock-based compensation, shares |
13,176
|
|
|
|
|
Shares issued in connection with capital raise, net of transaction costs |
$ 156
|
6,282,274
|
|
|
6,282,430
|
Shares issued in connection with capital raise, net of transaction costs, shares |
1,555,555
|
|
|
|
|
Net loss |
|
|
|
(2,726,381)
|
(2,726,381)
|
Shares issued in connection with license agreement |
$ 1
|
188,999
|
|
|
189,000
|
Shares issued in connection with license agreement, shares |
5,000
|
|
|
|
|
Settlement of stock award |
|
(8,561)
|
|
|
(8,561)
|
Shares withheld to pay income taxes on stock-based compensation |
$ (1)
|
(9,923)
|
|
|
(9,924)
|
Shares withheld to pay income taxes on stock-based compensation, shares |
(3,750)
|
|
|
|
|
Balance at Mar. 31, 2024 |
$ 286
|
87,278,542
|
$ (300,000)
|
(78,095,462)
|
8,883,366
|
Balance. shares at Mar. 31, 2024 |
2,860,981
|
|
(5,000)
|
|
|
Balance at Dec. 31, 2023 |
$ 129
|
80,658,111
|
$ (300,000)
|
(75,369,081)
|
4,989,159
|
Balance. shares at Dec. 31, 2023 |
1,291,000
|
|
(5,000)
|
|
|
Net loss |
|
|
|
|
(5,736,707)
|
Balance at Jun. 30, 2024 |
$ 287
|
87,429,165
|
$ (300,000)
|
(81,105,788)
|
6,023,664
|
Balance. shares at Jun. 30, 2024 |
2,873,883
|
|
(5,000)
|
|
|
Balance at Mar. 31, 2024 |
$ 286
|
87,278,542
|
$ (300,000)
|
(78,095,462)
|
8,883,366
|
Balance. shares at Mar. 31, 2024 |
2,860,981
|
|
(5,000)
|
|
|
Stock-based compensation |
$ 1
|
152,631
|
|
|
152,632
|
Stock-based compensation, shares |
14,167
|
|
|
|
|
Net loss |
|
|
|
(3,010,326)
|
(3,010,326)
|
Shares withheld to pay income taxes on stock-based compensation |
|
(2,008)
|
|
|
(2,008)
|
Shares withheld to pay income taxes on stock-based compensation, shares |
(1,265)
|
|
|
|
|
Balance at Jun. 30, 2024 |
$ 287
|
$ 87,429,165
|
$ (300,000)
|
$ (81,105,788)
|
$ 6,023,664
|
Balance. shares at Jun. 30, 2024 |
2,873,883
|
|
(5,000)
|
|
|
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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 |
$ (5,736,707)
|
$ (6,634,638)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation |
278
|
|
Non-cash lease expense for right-of-use assets |
42,670
|
39,982
|
Stock-based compensation |
320,275
|
660,627
|
Warrant issued to purchase 158,007 shares of common stock in connection with a consulting agreement |
|
1,310,875
|
Net changes in operating assets and liabilities: |
|
|
Prepaid expenses and other |
(980,554)
|
662,984
|
Operating lease liability |
(41,228)
|
(38,233)
|
Accounts payable |
641,469
|
(88,526)
|
Due to related parties |
(39)
|
(51)
|
Accrued expenses |
359,123
|
(91,559)
|
Net cash used in operating activities |
(5,394,713)
|
(4,178,539)
|
Cash Flows From Financing Activities |
|
|
Net proceeds from issuance of stock |
6,282,430
|
6,352,077
|
Shares withheld to pay taxes on stock-based compensation |
(11,932)
|
|
Settlement of stock award |
(8,561)
|
|
Payment of finance lease obligation |
(2,301)
|
|
Net cash provided by financing activities |
6,259,636
|
6,352,077
|
Net Increase in Cash |
864,923
|
2,173,538
|
Cash and Cash Equivalents – Beginning of Period |
4,706,197
|
6,503,595
|
Cash and Cash Equivalents – End of Period |
5,571,120
|
8,677,133
|
Non-Cash Financing Activities |
|
|
Issuance of 5,000 shares of common stock in connection with a licensing agreement which had previously been recorded as a due to licensor |
189,000
|
|
Right-of-use asset |
11,804
|
|
Financing lease liability |
(11,804)
|
|
Net |
|
|
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v3.24.2.u1
Pay vs Performance Disclosure - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Pay vs Performance Disclosure [Table] |
|
|
|
|
|
|
Net Income (Loss) |
$ (3,010,326)
|
$ (2,726,381)
|
$ (2,612,565)
|
$ (4,022,073)
|
$ (5,736,707)
|
$ (6,634,638)
|
X |
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v3.24.2.u1
Organization and Summary of Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Organization and Summary of Significant Accounting Policies |
Note
1 – Organization and Summary of Significant Accounting Policies
Organization
We
are a clinical-stage biopharmaceutical company focused on incorporating our Regulatory Science Approach into the development of our
Next Generation Chemotherapy (“NGC”) drugs to improve the safety and efficacy of cancer treatment. Our NGC drugs are modifications of
existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution in
the body, while maintaining the well-established existing mechanisms of killing the cancer cells. By modifying the
NGC drugs in this manner, we believe our three NGC treatments will provide improved safety-efficacy profiles when compared to their
currently marketed counterparts.
On
January 22, 2024, we filed a Certificate of Amendment to our Certificate of Incorporation, as amended with the Secretary of State of
Delaware that effected a 1-for-20 reverse stock split of our common stock, par value $0.0001 per share (the “Reverse Stock Split”).
Pursuant to the Certificate of Amendment, our issued common stock decreased from 24,706,474 shares to 1,291,000 shares and our outstanding
common stock decreased from 24,606,474 to 1,286,000. The Reverse Stock Split did not affect our authorized common stock of 100,000,000
shares or our common stock par value. All shares of common stock, including common stock underlying warrants, stock options, restricted
stock awards and restricted stock units, as well as exercise prices and per share information in these condensed consolidated financial
statements give retroactive effect to the Reverse Stock Split.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions of the
Securities and Exchange Commission (“SEC”) on Form 10-Q and Article 8 of Regulation S-X.
Accordingly,
they do not include all the information and disclosures required by U.S. GAAP for complete financial statements. All material intercompany
accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated
financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of our
financial position and of the results of operations and cash flows for the periods presented. These condensed consolidated financial
statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form
10-K for the year ended December 31, 2023, as filed with the SEC. The results of operations for the interim periods shown in this report
are not necessarily indicative of the results that may be expected for any other interim period or for the full year.
Liquidity
Our
condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the continuity of operations,
realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. We have incurred losses
since inception, are currently devoting substantially all of our efforts toward research and development of our NGC drug product candidates,
including conducting clinical trials and providing general and administrative support for these operations, and have an accumulated deficit
of $81.1 million
at June 30, 2024. During the six months ended June 30, 2024, we generated a net loss of $5.7 million
and used $5.4 million in net cash for operating activities from continuing operations. To
date, none of our drug candidates have been approved for sale, and therefore we have not generated any product revenue and do not expect
positive cash flow from operations in the foreseeable future.
We
have financed our operations primarily through public equity issuances, including an offering we closed on January 30, 2024, where we
sold 476,000 shares of our common stock, pre-funded warrants to purchase up to 1,079,555 shares of our common stock, and warrants for
the purchase of up to 1,555,555 shares of our common stock for net proceeds of $6.3 million, after deducting placement agent fees and
offering-related expenses. Simultaneously with the closing of the sale, the pre-funded warrants were exercised in exchange for 1,079,555
shares of our common stock.
In
May 2024, we filed with the SEC a registration statement on Form S-3 (Registration No. 333-279588) (the “Registration
Statement”), including a base prospectus relating to the offering of up to $50,000,000
in the aggregate of the securities identified in the base prospectus from time to time in one or more offerings; and a prospectus
supplement relating to the shares of our common stock that may be issued and sold under a sales agreement dated May 21, 2024 (the
“Sales Agreement”) between us and A.G.P./Alliance Global Partners (the “Sales Agent”), through which we may issue and
sell in a registered “at the market offering” shares of our common stock having an aggregate offering price of up to
$2.4
million (subject to adjustment) from time to time through or to our Sales Agent (the “ATM Offering”). We expect to use
net proceeds, if any, from the ATM Offering over time for continued research and development for our portfolio of drug candidates,
especially our oncology products, and working capital and general corporate purposes. The shares under the ATM Offering will be sold
and issued pursuant to the Registration Statement.
At
June 30, 2024, we had cash and cash equivalents totaling $5.6 million
which, based on our current business plans, we believe these funds will satisfy our operating
needs into late 2024, including the beginning of our Phase 2 trial of NGC-Cap in breast cancer. Our ability to execute our
longer-term operating plans, including future preclinical studies and clinical trials for our portfolio of drugs depend on our
ability to obtain additional funding from the sale of equity and/or debt securities, a strategic transaction or other funding
transactions. We will continue to be dependent
upon equity and/or debt financing until we are able to generate positive cash flows from our operations.
We
plan to raise additional funds in the future through a combination of public or private equity offerings, debt financings, collaborations,
strategic alliances, licensing arrangements and other marketing and distribution arrangements, but will only do so if the terms are acceptable
to us. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend our current or
planned future clinical trial plans, or research and development programs. This may also cause us to not meet obligations contained in
certain of our license agreements and put these assets at risk. To the extent that we raise additional capital through marketing and
distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish
valuable rights to our product candidates, future revenue streams, research programs or product candidates or to grant licenses on terms
that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of
our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely
affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting
or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures. There can be no
assurance that future funding will be available when needed.
Absent
additional funding, we believe that our cash and cash equivalents will not be sufficient to fund our operations for a period of one year
or more after the date that these condensed consolidated financial statements are available to be issued based on the timing and amount
of our projected net loss from continuing operations and cash to be used in operating activities during that period of time. As a result,
substantial doubt exists about our ability to continue as a going concern within one year after the date that these condensed consolidated
financial statements are available to be issued. The accompanying condensed consolidated financial statements do not include any adjustments
to reflect the possible future effects on the recoverability and classification of recorded assets, or the amounts and classification
of liabilities that might be different should we be unable to continue as a going concern based on the outcome of these uncertainties
described above.
Use
of Estimates
In
preparing our condensed consolidated financial statements and related disclosures in conformity with U.S. GAAP and pursuant to the rules
and regulations of the SEC, we make estimates and judgments that affect the amounts reported in the condensed consolidated financial
statements and accompanying notes. Estimates are used for, but not limited to preclinical and clinical trial expenses, stock-based compensation,
intangible assets, future milestone payments and income taxes. These estimates and assumptions are continuously evaluated and are based
on management’s experience and knowledge of the relevant facts and circumstances. While we believe the estimates to be reasonable,
actual results could differ materially from those estimates and could impact future results of operations and cash flows.
Income
Taxes
We
account for income taxes in accordance with ASC Topic 740, Income Taxes. Deferred income taxes are recorded for the expected tax
consequences of temporary differences between the basis of assets and liabilities for financial reporting purposes and amounts recognized
for income tax purposes. At June 30, 2024 and December 31, 2023, we recorded a valuation allowance equal to the full recorded amount
of our net deferred tax assets since it is more-likely-than-not that such benefits will not be realized. The valuation allowance is reviewed
quarterly and will be maintained until sufficient positive evidence exists to support its reversal.
Under
ACS 740-270 Income Taxes – Interim Reporting, we are required to project our annual federal and state effective income tax
rate and apply it to the year-to-date ordinary operating tax basis loss before income taxes. Based on the projection, no current income
tax benefit or expense is expected for 2024 and the foreseeable future since we expect to generate taxable net operating losses.
Concentration
of Credit Risk
Financial
instruments that potentially subject us to significant concentration of credit risk consist primarily of our cash and cash equivalents.
We utilize only well-established banks and financial institutions with high credit ratings. Balances on deposit are insured by the Federal
Deposit Insurance Corporation (“FDIC”) up to specified limits. Total cash held by our banks at June 30, 2024, exceeded FDIC limits.
Recent
Accounting Pronouncements
From
time to time, the Financial Accounting Standards Board (“FASB”) or other standard setting bodies issue new accounting pronouncements.
Updates to the FASB Accounting Standards Codification are communicated through issuance of an Accounting Standards Update (“ASU”).
We have implemented all new accounting pronouncements that are in effect and that may impact our condensed consolidated financial statements.
We have evaluated recently issued accounting pronouncements and determined that there is no material impact on our condensed consolidated
financial position or results of operations.
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v3.24.2.u1
Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
Stockholders’ Equity |
Note
2 – Stockholders’ Equity
Preferred
Stock
There
were no issued or outstanding shares of preferred stock at either June 30, 2024 or December 31, 2023.
Common
Stock
During
the six months ended June 30, 2024, we sold 476,000
shares of common
stock, pre-funded warrants to purchase up to 1,079,555
shares of common stock
in lieu of shares of common stock (the “Pre-Funded Warrants”), and warrants to purchase up to 1,555,555
shares of our common
stock (the “Common Warrants’) in a public offering (the “Offering”). The Common Warrants have an exercise price
of $4.50,
are immediately exercisable and expire on January
30, 2029. The shares
of common stock were offered at a combined public offering price of $4.50
per share and accompanying
Common Warrant and $4.4999
per Pre-Funded Warrant
and accompanying Common Warrant. The Pre-Funded Warrants had an exercise price of $0.0001
and were exercised in
full simultaneously with the closing of the Offering in exchange for 1,079,555
shares of our common
stock. Gross proceeds in connection with the Offering were $7.0
million. We received
$6.3
million in net proceeds
from the Offering, after deducting the fees of the placement agent and other offering-related expenses. We also issued to the placement
agent warrants to purchase 62,222
shares of common stock,
exercisable at $5.625
per share that expire
on February
1, 2027.
During
the six months ended June 30, 2024, we also issued: 5,000 shares of common stock to Elion Oncology, Inc. (“Elion”) in satisfaction
of the third milestone event under the license agreement; 10,000 shares of common stock to a consultant in accordance with their consulting
agreement; and 12,328 shares of common stock to certain employees and consultants, net of 5,015 shares of common stock withheld for income
taxes owed upon distribution of the shares.
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- DefinitionThe entire disclosure for equity.
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v3.24.2.u1
Stock-based Compensation
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Stock-based Compensation |
Note
3 - Stock-based Compensation
On
June 19, 2019, our stockholders approved, and we adopted, the Processa Pharmaceuticals Inc. 2019 Omnibus Equity Incentive Plan (the “2019
Plan”). The 2019 Plan allows us, under the direction of our Board of Directors or a committee thereof, to make grants of stock
options, restricted and unrestricted stock and other stock-based awards to employees, including our executive officers, consultants and
directors. On June 28, 2024, our shareholders approved an increase of shares available under the 2019 Plan, which now provides for the
aggregate issuance of 800,000 shares of our common stock. At June 30, 2024, we have 503,129
shares available for future grants.
Stock
Compensation Expense
We
recorded stock-based compensation expense for the three and six months ended June 30, 2024 and 2023 as follows:
Schedule
of Stock-based Compensation Expense
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 45,583 | | |
$ | 102,678 | | |
$ | 76,704 | | |
$ | 209,526 | |
General and administrative | |
| 107,049 | | |
| 216,445 | | |
| 243,571 | | |
| 451,101 | |
Total | |
$ | 152,632 | | |
$ | 319,123 | | |
$ | 320,275 | | |
$ | 660,627 | |
Stock
Options
Stock
options to purchase 4,245
shares of common stock with a weighted-average exercise price of $336.00 expired during the six months ended June 30, 2024. At June
30, 2024, we had outstanding and exercisable options for the purchase of 2,747
shares with a weighted average exercise price of $409.09 and
a weighted average remaining contractual life of 4.2
years. At June 30, 2024, we did not have any unrecognized stock-based compensation expense related to our granted stock
options.
Restricted
Stock Awards
During
the six months ended June 30, 2024, we vested 1,250 Restricted Stock Awards (“RSAs”) with a weighted average grant-date fair
value of $9.26 per share. We had no RSAs outstanding at June 30, 2024.
Restricted
Stock Units
Activity
with respect to our Restricted Stock Units (“RSUs”) during the six months ended June 30, 2024 was as follows:
Schedule
of Restricted Stock Units (“RSUs”) Activity
| |
Number of shares | | |
Weighted- average grant-date fair value per share | |
Outstanding at January 1, 2024 | |
| 222,722 | | |
$ | 45.82 | |
Granted | |
| 39,202 | | |
| 2.24 | |
Forfeited | |
| (10,775 | ) | |
| 58.37 | |
Issued | |
| (12,328 | ) | |
| 99.86 | |
Outstanding at June 30, 2024 | |
| 238,821 | | |
| 35.31 | |
Vested and unissued | |
| 143,793 | | |
| 50.71 | |
| |
| | | |
| | |
Unvested at June 30, 2024 | |
| 95,028 | | |
$ | 12.00 | |
On
June 28, 2024, we granted RSUs for the future issuance of 39,202
shares of common stock
to our employees which vest accordingly: RSUs for the future issuance of 14,969 shares of common stock vest on January 1, 2025; RSUs
for the future issuance of 18,173
shares of common stock
vest over a three-year period upon meeting service requirements; RSUs for the future issuance of 3,030
shares of common stock
vested upon grant due to regaining Nasdaq compliance; and RSUs for the future issuance of 3,030
shares of common stock
vest upon dosing the first patient in our Phase 2 study in NGC-Cap.
At
June 30, 2024, unrecognized stock-based compensation expense of approximately $538,000 for
RSUs is expected to be fully recognized over a weighted average period of 1.7 years.
The unrecognized expense excludes approximately $420,000 of
expense related to certain grants of RSUs with performance milestones that are not probable of occurring at this time.
Holders
of our vested RSUs will be issued shares of our common stock upon meeting the distribution restrictions contained in their Restricted
Stock Unit Award Agreement. The distribution restrictions are different (longer) than the vesting schedule, imposing an additional restriction
on the holder. Unlike RSAs, while certain employees may hold fully vested RSUs, the individual does not hold any shares or have any rights
of a shareholder until the distribution restrictions are met. Upon distribution to the employee, each RSU converts into one share of
our common stock. The RSUs contain dividend equivalent rights.
Warrants
During
the six months ended June 30, 2024, we did not grant any warrants to purchase shares of our common stock other than warrants to purchase
1,617,777 shares of common stock as part of the Offering (see Note 2). Warrants to purchase 5,000 shares of our common stock expired
unexercised. We also repurchased a warrant issued to a consultant in 2023 for the purchase of 15,000 shares of our common stock in exchange
for a payment of $10,000.
At
June 30, 2024, we had outstanding stock purchase warrants for the purchase of an aggregate of 1,778,284 shares
with a weighted average exercise price of $6.17 and
a weighted average remaining contractual life of 4.3 years.
All the outstanding stock purchase warrants are exercisable as of June 30, 2024. We did not have any unrecognized stock-based
compensation expense related to our granted stock purchase warrants at June 30, 2024.
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Net Loss per Share of Common Stock
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
Net Loss per Share of Common Stock |
Note
4 – Net Loss per Share of Common Stock
Net
Loss Per Share
Basic
net loss per share is computed by dividing our net loss available to common shareholders by the weighted average number of shares of
common stock outstanding (which excludes unvested RSAs and includes vested RSUs) during the period. Diluted loss per share is computed
by dividing our net loss available to common shareholders by the diluted weighted average number of shares of common stock (which includes
the potentially dilutive effect of stock options, unvested RSAs, unvested RSUs and warrants) during the period. Since we experienced
a net loss for all periods presented, basic and diluted net loss per share are the same. As such, diluted loss per share for the three
and six months ended June 30, 2024 and 2023 excludes the impact of potentially dilutive common shares since those shares would have an
anti-dilutive effect on net loss per share.
The
computation of net loss per share for the three and six months ended June 30, 2024 and 2023 was as follows:
Schedule
of Net Loss Per Share Basic and Diluted
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Basic and diluted net loss per share: | |
| | | |
| | | |
| | | |
| | |
Net loss available to common stockholders | |
$ | (3,010,326 | ) | |
$ | (2,612,565 | ) | |
$ | (5,736,707 | ) | |
$ | (6,634,638 | ) |
Weighted average number of common shares-basic and diluted | |
| 2,983,283 | | |
| 1,346,808 | | |
| 2,724,903 | | |
| 1,243,475 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss per share | |
$ | (1.01 | ) | |
$ | (1.94 | ) | |
$ | (2.11 | ) | |
$ | (5.34 | ) |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Weighted-average number of common shares outstanding – basic and diluted | |
| 2,849,192 | | |
| 1,217,095 | | |
| 2,590,530 | | |
| 1,114,324 | |
Weighted-average number of vested RSUs– basic and diluted | |
| 134,091 | | |
| 129,713 | | |
| 134,373 | | |
| 129,151 | |
Weighted-average number of common shares-basic and diluted | |
| 2,983,283 | | |
| 1,346,808 | | |
| 2,724,903 | | |
| 1,243,475 | |
Our
diluted net loss per share for the three and six months ended June 30, 2024 and 2023 excluded 1,876,059 and 254,314 of potentially dilutive
common shares, respectively, related to outstanding stock options, warrants and unvested restricted stock since those shares would have
had an anti-dilutive effect on net loss per share during the periods then ended.
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v3.24.2.u1
Leases
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
Leases |
Note
5 – Leases
We
lease our office space under an operating lease agreement. This lease does not have significant rent escalation, concessions, leasehold
improvement incentives, or other build-out clauses. Further, the lease does not contain contingent rent provisions. Our office space
lease includes both lease (e.g., fixed payments including rent, taxes, and insurance costs) and non-lease components (e.g., common-area
or other maintenance costs), which are accounted for as a single lease component as we have elected the practical expedient to group
lease and non-lease components for all leases. We also lease office equipment under a financing lease. Our leases do not provide an implicit
rate and, as such, we have used our incremental borrowing rate of 8% in determining the present value of the lease payments based on
the information available at the lease commencement date.
Lease
costs included in our condensed consolidated statements of operations totaled approximately $23,000
and $24,000 for the three months
ending June 30, 2024 and 2023, respectively, and approximately $45,000
and $49,000 for the six months
ended June 30, 2024, and 2023, respectively. The weighted average remaining lease terms and discount rate for our leases were as
follows at June 30, 2024:
Schedule
of Weighted Average Remaining Lease Terms and Discount Rate for Operating and Financing Leases
Remaining lease term (years) for our facility lease | |
| 1.3 | |
Remaining lease term (years) for our equipment lease | |
| 1.6 | |
Weighted average discount rate for our facility and equipment leases | |
| 8.0 | % |
Annual
lease liabilities for the operating lease were as follows at June 30, 2024:
Schedule
of Annual Lease Liabilities for all Operating Leases
| |
| | |
2024 | |
$ | 45,797 | |
2025 | |
| 70,040 | |
Total lease payments | |
| 115,837 | |
Less: Interest | |
| (6,511 | ) |
Present value of lease liabilities | |
| 109,326 | |
Less: current maturities | |
| (87,495 | ) |
Non-current lease liability | |
$ | 21,831 | |
Annual
lease liabilities for the financing lease were as follows at June 30, 2024:
Schedule
of Annual Lease Liabilities for all Financing Leases
| |
| | |
2024 | |
$ | 3,232 | |
2025 | |
| 6,820 | |
2026 | |
| 488 | |
Total lease payments | |
| 10,540 | |
Less: Interest | |
| (1,037 | ) |
Present value of lease liabilities | |
| 9,503 | |
Less: current maturities | |
| (5,686 | ) |
Non-current lease liability | |
$ | 3,817 | |
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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
6 – Related Party Transactions
CorLyst,
LLC (“CorLyst”) reimburses us for shared costs related to payroll, health insurance and rent based on actual costs
incurred, which are recognized as a reduction of our general and administrative operating expenses being reimbursed in our condensed
consolidated statement of operations. We recorded approximately $27,000
and $34,000
of reimbursements during the three months ended June 30, 2024 and 2023, respectively, and approximately $50,000
and $64,000
for the six months ended June 30, 2024 and 2023, respectively. No
amounts were due from CorLyst at June 30, 2024 or 2023. Our President of Research and Development is the CEO of CorLyst, and CorLyst
is a shareholder.
|
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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
7 – Commitments and Contingencies
Purchase
Obligations
We
enter into contracts in the normal course of business with contract research organizations (“CROs”) and subcontractors to further develop
our products. The contracts are cancelable, with varying provisions regarding termination. If we terminated a cancelable contract with
a specific vendor, we would only be obligated for products or services that we received at the effective date of the termination and
any applicable cancellation fees. At June 30, 2024, we are contractually obligated to pay up to $14.3 million of future services under
the agreements with the CROs. Our actual contractual obligations will also vary depending on the progress and results of the remaining
clinical trials.
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v3.24.2.u1
Subsequent Event
|
6 Months Ended |
Jun. 30, 2024 |
Subsequent Events [Abstract] |
|
Subsequent Event |
Note
8 – Subsequent Event
On
July 16, 2024, Russell Skibsted was appointed as our Chief Financial Officer (“CFO”). Mr. Skibsted has nearly 30 years of experience
in the pharmaceutical industry, including expertise in financial management, global business development, capital markets, investor
relations and operations. In connection with his employment, Mr. Skibsted will be paid an annual base salary of $400,000
and will be eligible for a $50,000
base salary increase upon a cumulative (one or multiple) financing of at least $15
million that he leads and substantially participates in. He is also eligible to participate in an executive bonus pool with a target
bonus of 35%
of his base compensation. In addition, the Compensation Committee awarded 28,000
RSUs to Mr. Skibsted, which vest accordingly: 14,000
RSUs vest on July 16, 2025; 7,000
RSUs vest upon Processa reaching a market capitalization (i.e. total value of Processa’s outstanding shares of stock at the
then current market price) of at least $30
million; and 7,000
RSUs vest upon a cumulative (one or multiple) financing of at least $15
million that he leads and substantially participates in. He will also be eligible for other benefits as described in his employment
agreement.
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v3.24.2.u1
Organization and Summary of Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Organization |
Organization
We
are a clinical-stage biopharmaceutical company focused on incorporating our Regulatory Science Approach into the development of our
Next Generation Chemotherapy (“NGC”) drugs to improve the safety and efficacy of cancer treatment. Our NGC drugs are modifications of
existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution in
the body, while maintaining the well-established existing mechanisms of killing the cancer cells. By modifying the
NGC drugs in this manner, we believe our three NGC treatments will provide improved safety-efficacy profiles when compared to their
currently marketed counterparts.
On
January 22, 2024, we filed a Certificate of Amendment to our Certificate of Incorporation, as amended with the Secretary of State of
Delaware that effected a 1-for-20 reverse stock split of our common stock, par value $0.0001 per share (the “Reverse Stock Split”).
Pursuant to the Certificate of Amendment, our issued common stock decreased from 24,706,474 shares to 1,291,000 shares and our outstanding
common stock decreased from 24,606,474 to 1,286,000. The Reverse Stock Split did not affect our authorized common stock of 100,000,000
shares or our common stock par value. All shares of common stock, including common stock underlying warrants, stock options, restricted
stock awards and restricted stock units, as well as exercise prices and per share information in these condensed consolidated financial
statements give retroactive effect to the Reverse Stock Split.
|
Basis of Presentation |
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally
accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions of the
Securities and Exchange Commission (“SEC”) on Form 10-Q and Article 8 of Regulation S-X.
Accordingly,
they do not include all the information and disclosures required by U.S. GAAP for complete financial statements. All material intercompany
accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying unaudited condensed consolidated
financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of our
financial position and of the results of operations and cash flows for the periods presented. These condensed consolidated financial
statements should be read in conjunction with the audited financial statements and notes thereto included in our Annual Report on Form
10-K for the year ended December 31, 2023, as filed with the SEC. The results of operations for the interim periods shown in this report
are not necessarily indicative of the results that may be expected for any other interim period or for the full year.
|
Liquidity |
Liquidity
Our
condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the continuity of operations,
realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. We have incurred losses
since inception, are currently devoting substantially all of our efforts toward research and development of our NGC drug product candidates,
including conducting clinical trials and providing general and administrative support for these operations, and have an accumulated deficit
of $81.1 million
at June 30, 2024. During the six months ended June 30, 2024, we generated a net loss of $5.7 million
and used $5.4 million in net cash for operating activities from continuing operations. To
date, none of our drug candidates have been approved for sale, and therefore we have not generated any product revenue and do not expect
positive cash flow from operations in the foreseeable future.
We
have financed our operations primarily through public equity issuances, including an offering we closed on January 30, 2024, where we
sold 476,000 shares of our common stock, pre-funded warrants to purchase up to 1,079,555 shares of our common stock, and warrants for
the purchase of up to 1,555,555 shares of our common stock for net proceeds of $6.3 million, after deducting placement agent fees and
offering-related expenses. Simultaneously with the closing of the sale, the pre-funded warrants were exercised in exchange for 1,079,555
shares of our common stock.
In
May 2024, we filed with the SEC a registration statement on Form S-3 (Registration No. 333-279588) (the “Registration
Statement”), including a base prospectus relating to the offering of up to $50,000,000
in the aggregate of the securities identified in the base prospectus from time to time in one or more offerings; and a prospectus
supplement relating to the shares of our common stock that may be issued and sold under a sales agreement dated May 21, 2024 (the
“Sales Agreement”) between us and A.G.P./Alliance Global Partners (the “Sales Agent”), through which we may issue and
sell in a registered “at the market offering” shares of our common stock having an aggregate offering price of up to
$2.4
million (subject to adjustment) from time to time through or to our Sales Agent (the “ATM Offering”). We expect to use
net proceeds, if any, from the ATM Offering over time for continued research and development for our portfolio of drug candidates,
especially our oncology products, and working capital and general corporate purposes. The shares under the ATM Offering will be sold
and issued pursuant to the Registration Statement.
At
June 30, 2024, we had cash and cash equivalents totaling $5.6 million
which, based on our current business plans, we believe these funds will satisfy our operating
needs into late 2024, including the beginning of our Phase 2 trial of NGC-Cap in breast cancer. Our ability to execute our
longer-term operating plans, including future preclinical studies and clinical trials for our portfolio of drugs depend on our
ability to obtain additional funding from the sale of equity and/or debt securities, a strategic transaction or other funding
transactions. We will continue to be dependent
upon equity and/or debt financing until we are able to generate positive cash flows from our operations.
We
plan to raise additional funds in the future through a combination of public or private equity offerings, debt financings, collaborations,
strategic alliances, licensing arrangements and other marketing and distribution arrangements, but will only do so if the terms are acceptable
to us. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of, or suspend our current or
planned future clinical trial plans, or research and development programs. This may also cause us to not meet obligations contained in
certain of our license agreements and put these assets at risk. To the extent that we raise additional capital through marketing and
distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish
valuable rights to our product candidates, future revenue streams, research programs or product candidates or to grant licenses on terms
that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of
our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely
affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting
or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures. There can be no
assurance that future funding will be available when needed.
Absent
additional funding, we believe that our cash and cash equivalents will not be sufficient to fund our operations for a period of one year
or more after the date that these condensed consolidated financial statements are available to be issued based on the timing and amount
of our projected net loss from continuing operations and cash to be used in operating activities during that period of time. As a result,
substantial doubt exists about our ability to continue as a going concern within one year after the date that these condensed consolidated
financial statements are available to be issued. The accompanying condensed consolidated financial statements do not include any adjustments
to reflect the possible future effects on the recoverability and classification of recorded assets, or the amounts and classification
of liabilities that might be different should we be unable to continue as a going concern based on the outcome of these uncertainties
described above.
|
Use of Estimates |
Use
of Estimates
In
preparing our condensed consolidated financial statements and related disclosures in conformity with U.S. GAAP and pursuant to the rules
and regulations of the SEC, we make estimates and judgments that affect the amounts reported in the condensed consolidated financial
statements and accompanying notes. Estimates are used for, but not limited to preclinical and clinical trial expenses, stock-based compensation,
intangible assets, future milestone payments and income taxes. These estimates and assumptions are continuously evaluated and are based
on management’s experience and knowledge of the relevant facts and circumstances. While we believe the estimates to be reasonable,
actual results could differ materially from those estimates and could impact future results of operations and cash flows.
|
Income Taxes |
Income
Taxes
We
account for income taxes in accordance with ASC Topic 740, Income Taxes. Deferred income taxes are recorded for the expected tax
consequences of temporary differences between the basis of assets and liabilities for financial reporting purposes and amounts recognized
for income tax purposes. At June 30, 2024 and December 31, 2023, we recorded a valuation allowance equal to the full recorded amount
of our net deferred tax assets since it is more-likely-than-not that such benefits will not be realized. The valuation allowance is reviewed
quarterly and will be maintained until sufficient positive evidence exists to support its reversal.
Under
ACS 740-270 Income Taxes – Interim Reporting, we are required to project our annual federal and state effective income tax
rate and apply it to the year-to-date ordinary operating tax basis loss before income taxes. Based on the projection, no current income
tax benefit or expense is expected for 2024 and the foreseeable future since we expect to generate taxable net operating losses.
|
Concentration of Credit Risk |
Concentration
of Credit Risk
Financial
instruments that potentially subject us to significant concentration of credit risk consist primarily of our cash and cash equivalents.
We utilize only well-established banks and financial institutions with high credit ratings. Balances on deposit are insured by the Federal
Deposit Insurance Corporation (“FDIC”) up to specified limits. Total cash held by our banks at June 30, 2024, exceeded FDIC limits.
|
Recent Accounting Pronouncements |
Recent
Accounting Pronouncements
From
time to time, the Financial Accounting Standards Board (“FASB”) or other standard setting bodies issue new accounting pronouncements.
Updates to the FASB Accounting Standards Codification are communicated through issuance of an Accounting Standards Update (“ASU”).
We have implemented all new accounting pronouncements that are in effect and that may impact our condensed consolidated financial statements.
We have evaluated recently issued accounting pronouncements and determined that there is no material impact on our condensed consolidated
financial position or results of operations.
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v3.24.2.u1
Stock-based Compensation (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Stock-based Compensation Expense |
We
recorded stock-based compensation expense for the three and six months ended June 30, 2024 and 2023 as follows:
Schedule
of Stock-based Compensation Expense
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 45,583 | | |
$ | 102,678 | | |
$ | 76,704 | | |
$ | 209,526 | |
General and administrative | |
| 107,049 | | |
| 216,445 | | |
| 243,571 | | |
| 451,101 | |
Total | |
$ | 152,632 | | |
$ | 319,123 | | |
$ | 320,275 | | |
$ | 660,627 | |
|
Schedule of Restricted Stock Units (“RSUs”) Activity |
Activity
with respect to our Restricted Stock Units (“RSUs”) during the six months ended June 30, 2024 was as follows:
Schedule
of Restricted Stock Units (“RSUs”) Activity
| |
Number of shares | | |
Weighted- average grant-date fair value per share | |
Outstanding at January 1, 2024 | |
| 222,722 | | |
$ | 45.82 | |
Granted | |
| 39,202 | | |
| 2.24 | |
Forfeited | |
| (10,775 | ) | |
| 58.37 | |
Issued | |
| (12,328 | ) | |
| 99.86 | |
Outstanding at June 30, 2024 | |
| 238,821 | | |
| 35.31 | |
Vested and unissued | |
| 143,793 | | |
| 50.71 | |
| |
| | | |
| | |
Unvested at June 30, 2024 | |
| 95,028 | | |
$ | 12.00 | |
|
X |
- DefinitionTabular disclosure of activity for award under share-based payment arrangement. Includes, but is not limited to, outstanding award at beginning and end of year, granted, exercised, forfeited, and weighted-average grant date fair value.
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v3.24.2.u1
Net Loss per Share of Common Stock (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
Schedule of Net Loss Per Share Basic and Diluted |
The
computation of net loss per share for the three and six months ended June 30, 2024 and 2023 was as follows:
Schedule
of Net Loss Per Share Basic and Diluted
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Basic and diluted net loss per share: | |
| | | |
| | | |
| | | |
| | |
Net loss available to common stockholders | |
$ | (3,010,326 | ) | |
$ | (2,612,565 | ) | |
$ | (5,736,707 | ) | |
$ | (6,634,638 | ) |
Weighted average number of common shares-basic and diluted | |
| 2,983,283 | | |
| 1,346,808 | | |
| 2,724,903 | | |
| 1,243,475 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss per share | |
$ | (1.01 | ) | |
$ | (1.94 | ) | |
$ | (2.11 | ) | |
$ | (5.34 | ) |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Weighted-average number of common shares outstanding – basic and diluted | |
| 2,849,192 | | |
| 1,217,095 | | |
| 2,590,530 | | |
| 1,114,324 | |
Weighted-average number of vested RSUs– basic and diluted | |
| 134,091 | | |
| 129,713 | | |
| 134,373 | | |
| 129,151 | |
Weighted-average number of common shares-basic and diluted | |
| 2,983,283 | | |
| 1,346,808 | | |
| 2,724,903 | | |
| 1,243,475 | |
|
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v3.24.2.u1
Leases (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
Schedule of Weighted Average Remaining Lease Terms and Discount Rate for Operating and Financing Leases |
Schedule
of Weighted Average Remaining Lease Terms and Discount Rate for Operating and Financing Leases
Remaining lease term (years) for our facility lease | |
| 1.3 | |
Remaining lease term (years) for our equipment lease | |
| 1.6 | |
Weighted average discount rate for our facility and equipment leases | |
| 8.0 | % |
|
Schedule of Annual Lease Liabilities for all Operating Leases |
Annual
lease liabilities for the operating lease were as follows at June 30, 2024:
Schedule
of Annual Lease Liabilities for all Operating Leases
| |
| | |
2024 | |
$ | 45,797 | |
2025 | |
| 70,040 | |
Total lease payments | |
| 115,837 | |
Less: Interest | |
| (6,511 | ) |
Present value of lease liabilities | |
| 109,326 | |
Less: current maturities | |
| (87,495 | ) |
Non-current lease liability | |
$ | 21,831 | |
|
Schedule of Annual Lease Liabilities for all Financing Leases |
Annual
lease liabilities for the financing lease were as follows at June 30, 2024:
Schedule
of Annual Lease Liabilities for all Financing Leases
| |
| | |
2024 | |
$ | 3,232 | |
2025 | |
| 6,820 | |
2026 | |
| 488 | |
Total lease payments | |
| 10,540 | |
Less: Interest | |
| (1,037 | ) |
Present value of lease liabilities | |
| 9,503 | |
Less: current maturities | |
| (5,686 | ) |
Non-current lease liability | |
$ | 3,817 | |
|
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v3.24.2.u1
Organization and Summary of Significant Accounting Policies (Details Narrative) - USD ($)
|
|
|
|
|
3 Months Ended |
6 Months Ended |
|
|
May 31, 2024 |
May 21, 2024 |
Jan. 30, 2024 |
Jan. 22, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jan. 21, 2024 |
Dec. 31, 2023 |
OrganizationLineItems [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Reverse stock split |
|
|
|
1-for-20 reverse stock split
|
|
|
|
|
|
|
|
|
Common stock, par value |
|
|
|
$ 0.0001
|
$ 0.0001
|
|
|
|
$ 0.0001
|
|
|
$ 0.0001
|
Common stock shares issued |
|
|
|
1,291,000
|
2,873,883
|
|
|
|
2,873,883
|
|
24,706,474
|
1,291,000
|
Common stock shares outstanding |
|
|
|
1,286,000
|
2,868,883
|
|
|
|
2,868,883
|
|
24,606,474
|
1,286,000
|
Common stock shares authorized |
|
|
|
100,000,000
|
100,000,000
|
|
|
|
100,000,000
|
|
|
100,000,000
|
Accumulated deficit |
|
|
|
|
$ 81,105,788
|
|
|
|
$ 81,105,788
|
|
|
$ 75,369,081
|
Net loss |
|
|
|
|
3,010,326
|
$ 2,726,381
|
$ 2,612,565
|
$ 4,022,073
|
5,736,707
|
$ 6,634,638
|
|
|
Net cash for operating activities from continuing operations |
|
|
|
|
|
|
|
|
5,394,713
|
4,178,539
|
|
|
Net proceeds |
|
|
$ 6,300,000
|
|
|
|
|
|
6,282,430
|
$ 6,352,077
|
|
|
Shares issued initial offering |
$ 50,000,000
|
|
|
|
|
$ 6,282,430
|
|
$ 6,352,077
|
|
|
|
|
Cash and cash equivalents |
|
|
|
|
$ 5,571,120
|
|
|
|
$ 5,571,120
|
|
|
$ 4,706,197
|
Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
OrganizationLineItems [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares sold |
|
|
476,000
|
|
|
|
|
|
476,000
|
|
|
|
Net proceeds |
|
|
|
|
|
|
|
|
$ 6,300,000
|
|
|
|
Purchase Agreement [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
OrganizationLineItems [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase shares |
|
|
1,555,555
|
|
1,555,555
|
|
|
|
1,555,555
|
|
|
|
Purchase Agreement [Member] | Pre-Funded Warrants [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
OrganizationLineItems [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Warrants to purchase shares |
|
|
1,079,555
|
|
1,079,555
|
|
|
|
1,079,555
|
|
|
|
Warrant exercised |
|
|
1,079,555
|
|
1,079,555
|
|
|
|
1,079,555
|
|
|
|
Sales Agreement [Member] | Alliance Global Partners [Member] | Maximum [Member] | ATM Offering [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
OrganizationLineItems [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Maximum value to be sold at the market offering |
|
$ 2,400,000
|
|
|
|
|
|
|
|
|
|
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v3.24.2.u1
Stockholders’ Equity (Details Narrative) - USD ($)
|
|
6 Months Ended |
|
Jan. 30, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Class of Stock [Line Items] |
|
|
|
|
Preferred stock, shares issued |
|
0
|
|
0
|
Preferred stock, shares outstanding |
|
0
|
|
0
|
Proceeds from Issuance of Common Stock |
$ 6,300,000
|
$ 6,282,430
|
$ 6,352,077
|
|
Stock withheld for income taxes |
|
5,015
|
|
|
Employees and Consultants [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Shares issued |
|
12,328
|
|
|
Purchase Agreement [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Shares issued |
476,000
|
476,000
|
|
|
Gross proceeds from issuance of common stock |
|
$ 7,000,000.0
|
|
|
Proceeds from Issuance of Common Stock |
|
$ 6,300,000
|
|
|
Purchase Agreement [Member] | Placement Agent [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Class of Warrant or Right, Exercise Price of Warrants or Rights |
|
$ 5.625
|
|
|
Class of Warrant or Right, Outstanding |
|
62,222
|
|
|
Warrants and Rights Outstanding, Maturity Date |
|
Feb. 01, 2027
|
|
|
Purchase Agreement [Member] | Warrant [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Class of Warrant or Right, Number of Securities Called by Warrants or Rights |
1,555,555
|
1,555,555
|
|
|
Class of Warrant or Right, Exercise Price of Warrants or Rights |
|
$ 4.50
|
|
|
Warrants exercisable and maturity date |
|
Jan. 30, 2029
|
|
|
Purchase Agreement [Member] | Pre-Funded Warrants [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Class of Warrant or Right, Number of Securities Called by Warrants or Rights |
1,079,555
|
1,079,555
|
|
|
Class of Warrant or Right, Exercise Price of Warrants or Rights |
|
$ 0.0001
|
|
|
Shares Issued, Price Per Share |
|
$ 4.4999
|
|
|
[custom:StockIssuedDuringPeriodSharesWarrantExercised-0] |
1,079,555
|
1,079,555
|
|
|
License Agreement [Member] | Elion Oncology, Inc. [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Shares issued |
|
5,000
|
|
|
Consulting Agreement [Member] | Consultant [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Shares issued |
|
10,000
|
|
|
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v3.24.2.u1
Schedule of Stock-based Compensation Expense (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total |
$ 152,632
|
$ 319,123
|
$ 320,275
|
$ 660,627
|
Research and Development Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total |
45,583
|
102,678
|
76,704
|
209,526
|
General and Administrative Expense [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
Total |
$ 107,049
|
$ 216,445
|
$ 243,571
|
$ 451,101
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Schedule of Restricted Stock Units (“RSUs”) Activity (Details) - Restricted Stock Units (RSUs) [Member]
|
6 Months Ended |
Jun. 30, 2024
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of shares, Beginning balance | shares |
222,722
|
Weighted-average grant-date fair value per share, Beginning balance | $ / shares |
$ 45.82
|
Number of shares, granted | shares |
39,202
|
Weighted-average grant-date fair value per share, granted | $ / shares |
$ 2.24
|
Number of shares, forfeited | shares |
(10,775)
|
Weighted-average grant-date fair value per share, forfeited | $ / shares |
$ 58.37
|
Number of shares, issued | shares |
(12,328)
|
Weighted-average grant-date fair value per share, shares issued | $ / shares |
$ 99.86
|
Number of shares, ending balance | shares |
238,821
|
Weighted-average grant-date fair value per share, ending balance | $ / shares |
$ 35.31
|
Number of shares, vested and unissued | shares |
143,793
|
Weighted-average grant-date fair value per share, vested and unissued | $ / shares |
$ 50.71
|
Number of shares, unvested | shares |
95,028
|
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$ 12.00
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v3.24.2.u1
Stock-based Compensation (Details Narrative) - USD ($)
|
|
6 Months Ended |
|
Jun. 28, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Payments for settlement of stock awards |
|
$ 8,561
|
|
|
Warrant [Member] | Offering [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Warrants to purchase shares |
|
1,617,777
|
|
|
Consulting Agreement [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Warrants, expired |
|
5,000
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Forfeitures |
|
15,000
|
|
|
Payments for settlement of stock awards |
|
$ 10,000
|
|
|
Share-Based Payment Arrangement, Option [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Options, forfeited |
|
4,245
|
|
|
Options, forfeited weighted average exercise price |
|
$ 336.00
|
|
|
Options exercisable, shares |
|
2,747
|
|
|
Options exercisable weighted average exercise price |
|
$ 409.09
|
|
|
Exercisable weighted average remaining contractual term |
|
4 years 2 months 12 days
|
|
|
Restricted Stock [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Number of shares, vested |
|
1,250
|
|
|
Weighted-average grant-date fair value per share, shares vested |
|
$ 9.26
|
|
|
Number of shares, outstanding |
|
0
|
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Number of shares, outstanding |
|
238,821
|
|
222,722
|
Number of shares, granted |
|
39,202
|
|
|
Unrecognized share based compensation expense |
|
$ 538,000
|
|
|
Weighted average period for recognition |
|
1 year 8 months 12 days
|
|
|
Unrecognized share based compensation expense. |
|
$ 420,000
|
|
|
Restricted Stock Units (RSUs) [Member] | Employees [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Number of shares, granted |
39,202
|
|
|
|
Service Based RSUs [Member] | 3-Year Vesting [Member] | Employees [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Number of shares, granted |
18,173
|
|
|
|
Service Based RSUs [Member] | Employees [Member] | January 1, 2025 Vesting [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Number of shares, granted |
14,969
|
|
|
|
First Performance Based RSUs [Member] | Employees [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Number of shares, granted |
3,030
|
|
|
|
Second Performance Based RSUs [Member] | Employees [Member] | Next Generation Capecitabine - Cap [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Number of shares, granted |
3,030
|
|
|
|
Warrant [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Warrants to purchase shares |
|
1,778,284
|
|
|
Weighted average exercise price |
|
$ 6.17
|
|
|
Weighted average remaining contractual life |
|
4 years 3 months 18 days
|
|
|
2019 Plan [Member] |
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Maximum equity available for issuance |
800,000
|
|
|
|
Shares available for future grants |
|
503,129
|
|
|
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v3.24.2.u1
Schedule of Net Loss Per Share Basic and Diluted (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] |
|
|
|
|
Net loss available to common stockholders |
$ (3,010,326)
|
$ (2,612,565)
|
$ (5,736,707)
|
$ (6,634,638)
|
Weighted average number of common shares-basic |
2,983,283
|
1,346,808
|
2,724,903
|
1,243,475
|
Weighted average number of common shares-diluted |
2,983,283
|
1,346,808
|
2,724,903
|
1,243,475
|
Basic net loss per share |
$ (1.01)
|
$ (1.94)
|
$ (2.11)
|
$ (5.34)
|
Diluted net loss per share |
$ (1.01)
|
$ (1.94)
|
$ (2.11)
|
$ (5.34)
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] |
|
|
|
|
Weighted average number of common shares-basic |
134,091
|
129,713
|
134,373
|
129,151
|
Weighted average number of common shares-diluted |
134,091
|
129,713
|
134,373
|
129,151
|
Common Stock [Member] |
|
|
|
|
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] |
|
|
|
|
Weighted average number of common shares-basic |
2,849,192
|
1,217,095
|
2,590,530
|
1,114,324
|
Weighted average number of common shares-diluted |
2,849,192
|
1,217,095
|
2,590,530
|
1,114,324
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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Net Loss per Share of Common Stock (Details Narrative) - shares
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3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Earnings Per Share [Abstract] |
|
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Antidilutive securities excluded from computation of earnings per share, amount |
1,876,059
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Subsequent Event (Details Narrative) - USD ($)
|
|
6 Months Ended |
Jul. 16, 2024 |
Jun. 30, 2024 |
Restricted Stock Units (RSUs) [Member] |
|
|
Subsequent Event [Line Items] |
|
|
Number of shares, granted |
|
39,202
|
Subsequent Event [Member] |
|
|
Subsequent Event [Line Items] |
|
|
Annual base salary |
$ 400,000
|
|
Potential base salary increase |
50,000
|
|
Potential base salary increase financing minimum |
$ 15,000,000
|
|
Executive bonus percentage |
35.00%
|
|
Subsequent Event [Member] | Restricted Stock Units (RSUs) [Member] |
|
|
Subsequent Event [Line Items] |
|
|
Number of shares, granted |
28,000
|
|
Subsequent Event [Member] | Service Based RSU [Member] |
|
|
Subsequent Event [Line Items] |
|
|
Number of shares, granted |
14,000
|
|
Subsequent Event [Member] | First Performance Based RSUs [Member] |
|
|
Subsequent Event [Line Items] |
|
|
Number of shares, granted |
7,000
|
|
Market capitalization |
$ 30,000,000
|
|
Subsequent Event [Member] | Second Performance Based RSUs [Member] |
|
|
Subsequent Event [Line Items] |
|
|
Number of shares, granted |
7,000
|
|
Performance vesting criteria |
$ 15,000,000
|
|
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Processa Pharmaceuticals (NASDAQ:PCSA)
Gráfica de Acción Histórica
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Processa Pharmaceuticals (NASDAQ:PCSA)
Gráfica de Acción Histórica
De Sep 2023 a Sep 2024