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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 September 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 000-15327
LadRx
Corporation
(Exact
name of registrant as specified in its charter)
Delaware |
58-1642740 |
(State
or other jurisdiction of
incorporation or organization) |
(I.R.S.
Employer
Identification No.) |
11726
San Vicente Blvd., Suite 650
Los
Angeles, CA |
90049 |
(Address
of principal executive offices) |
(Zip
Code) |
(310)
826-5648
(Registrant’s
telephone number, including area code)
N/A
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
None |
|
None |
|
None |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐ |
Accelerated
filer ☐ |
Non-accelerated
filer ☒ |
Smaller
reporting company ☒ |
Emerging
growth company ☐ |
|
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Number
of shares of common stock of LadRx Corporation, $0.001 par value, outstanding as of November 14, 2024: 495,092 shares.
LADRX
CORPORATION
FORM
10-Q
TABLE
OF CONTENTS
Forward
Looking Statements
All
statements in this Quarterly Report on Form 10Q (this “Quarterly Report”), including statements in this section, other than
statements of historical fact are forward-looking statements, including statements of our current views with respect to the recent developments
regarding our business strategy, business plan and research and development activities, our future financial results, and other future
events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology industry, in
general. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,”
“expects,” “plans,” “anticipates,” “estimates,” “potential” or “could”
or the negative thereof or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements
contained herein are reasonable, there can be no assurance that such expectations or any of the forward-looking statements will prove
to be correct, and actual results could differ materially from those projected or assumed in the forward-looking statements.
All
forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual
results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to,
the factors discussed in this section and under the caption “Risk Factors” in our Annual Report on Form 10-K for the year
ended December 31, 2023 (the “2023 Annual Report”), which should be reviewed carefully. If one or more of these or other
risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what
we anticipate. Please consider our forward-looking statements in light of those risks as you read this Quarterly Report. We undertake
no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments
or otherwise.
Note
Regarding Company References
References
throughout this Quarterly Report, the “Company”, “LadRx”, “we”, “us”, and “our”,
except where the context requires otherwise, refer to LadRx Corporation.
PART
I — FINANCIAL INFORMATION
Item
1. — Condensed Financial Statements
LADRX
CORPORATION
CONDENSED BALANCE SHEETS
| |
September 30, 2024 | | |
December 31, 2023 | |
| |
(Unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 57,256 | | |
$ | 2,070,075 | |
Prepaid expenses and other current assets | |
| 13,557 | | |
| 191,783 | |
Total current assets | |
| 70,813 | | |
| 2,261,858 | |
Equipment and furnishings, net | |
| 2,086 | | |
| 6,711 | |
Other assets | |
| 1,475 | | |
| 7,703 | |
Operating lease right-of-use asset | |
| — | | |
| 31,610 | |
Total assets | |
$ | 74,374 | | |
$ | 2,307,882 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 795,680 | | |
$ | 1,202,689 | |
Accrued expenses and other current liabilities | |
| 1,033,158 | | |
| 964,233 | |
Current portion of operating lease liabilities | |
| — | | |
| 33,606 | |
Total current liabilities | |
| 1,828,838 | | |
| 2,200,528 | |
| |
| | | |
| | |
Commitments and contingencies | |
| - | | |
| - | |
| |
| | | |
| | |
Stockholders’ equity (deficit): | |
| | | |
| | |
Preferred Stock, $0.01 par value, 833,333 shares authorized, including 50,000 shares of Series B Junior Participating Preferred Stock; no shares issued and outstanding | |
| — | | |
| — | |
Common stock, $0.001 par value, 62,393,940 shares authorized 495,092 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively | |
| 495 | | |
| 495 | |
Additional paid-in capital | |
| 488,671,864 | | |
| 488,612,890 | |
Accumulated deficit | |
| (490,426,823 | ) | |
| (488,506,031 | ) |
Total stockholders’ equity (deficit) | |
| (1,754,464 | ) | |
| 107,354 | |
Total liabilities and stockholders’ equity (deficit) | |
$ | 74,374 | | |
$ | 2,307,882 | |
The
accompanying notes are an integral part of these condensed financial statements.
LADRX
CORPORATION
CONDENSED
STATEMENTS OF OPERATIONS
(Unaudited)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended September 30, | | |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenue: | |
| | | |
| | | |
| | | |
| | |
Licensing revenue | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 4,463 | | |
| 14,625 | | |
| 628,543 | | |
| 14,625 | |
General and administrative | |
| 823,250 | | |
| 825,688 | | |
| 2,325,636 | | |
| 2,926,892 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (827,713 | ) | |
| (840,313 | ) | |
| (2,954,179 | ) | |
| (2,941,517 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income: | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 3,173 | | |
| 24,307 | | |
| 33,386 | | |
| 31,405 | |
Sale of royalty and milestone rights, net of transaction costs | |
| — | | |
| — | | |
| 1,000,000 | | |
| 4,167,219 | |
Other | |
| — | | |
| 17 | | |
| — | | |
| 1,372 | |
| |
| | | |
| | | |
| | | |
| | |
Net income (loss) | |
$ | (824,540 | ) | |
$ | (815,989 | ) | |
$ | (1,920,793 | ) | |
$ | 1,258,479 | |
| |
| | | |
| | | |
| | | |
| | |
Dividends paid on preferred shares | |
| — | | |
| — | | |
| — | | |
| (68,809 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net income (loss) attributable to common stockholders | |
$ | (824,540 | ) | |
$ | (815,989 | ) | |
$ | (1,920,793 | ) | |
$ | 1,189,670 | |
| |
| | | |
| | | |
| | | |
| | |
Total basic and diluted income (loss) per share | |
$ | (1.67 | ) | |
$ | (1.65 | ) | |
$ | (3.88 | ) | |
$ | 2.59 | |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted weighted-average shares outstanding | |
| 495,092 | | |
| 495,092 | | |
| 495,092 | | |
| 486,101 | |
The
accompanying notes are an integral part of these condensed financial statements
LADRX
CORPORATION
CONDENSED
STATEMENTS OF CASH FLOWS
(Unaudited)
| |
2024 | | |
2023 | |
| |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | |
Cash flows from operating activities: | |
| | | |
| | |
Net income (loss) from operations | |
$ | (1,920,793 | ) | |
$ | 1,258,479 | |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 4,625 | | |
| 8,876 | |
Stock-based compensation expense | |
| 58,974 | | |
| — | |
Changes in assets and liabilities: | |
| | | |
| | |
Prepaid expenses and other current assets | |
| 178,226 | | |
| 592,511 | |
Other assets | |
| 6,228 | | |
| — | |
Amortization of operating lease right-of-use asset | |
| 31,610 | | |
| 138,236 | |
Accounts payable | |
| (407,009 | ) | |
| 11,079 | |
Operating lease liabilities | |
| (33,605 | ) | |
| (146,078 | ) |
Accrued expenses and other current liabilities | |
| 68,925 | | |
| 14,124 | |
Net cash provided by (used in) operating activities | |
| (2,012,819 | ) | |
| 1,877,227 | |
| |
| | | |
| | |
Cash flows from financing activities | |
| | | |
| | |
Preferred stock dividend | |
| — | | |
| (68,809 | ) |
Purchase of preferred investment option | |
| — | | |
| (250,000 | ) |
Net cash used in financing activities | |
| | | |
| (318,809 | ) |
| |
| | | |
| | |
Net increase (decrease) in cash and cash equivalents | |
| (2,012,819 | ) | |
| 1,558,418 | |
Cash and cash equivalents at beginning of period | |
| 2,070,075 | | |
| 1,374,992 | |
Cash and cash equivalents at end of period | |
$ | 57,256 | | |
$ | 2,933,410 | |
| |
| | | |
| | |
Supplemental disclosure of Cash Flow Information: | |
| | | |
| | |
| |
| | | |
| | |
Conversion of Series C 10% Convertible Preferred Stock to Common Stock | |
$ | — | | |
$ | 1,343,684 | |
The
accompanying notes are an integral part of these condensed financial statements
LADRX
CORPORATION
CONDENSED
STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(Unaudited)
For the Nine Month
Period Ended September 30, 2024
| |
Series B Preferred Shares Issued | | |
Common Shares Issued | | |
Common Stock Amount | | |
Additional Paid-in Capital | | |
Accumulated Deficit | | |
Total | |
Balance at January 1, 2024 | |
| — | | - |
| 495,092 | | |
$ | 495 | | |
$ | 488,612,890 | | |
$ | (488,506,031 | ) | |
$ | 107,354 | |
Stock compensation on vested options | |
| | | |
| | | |
| | | |
| 51,119 | | |
| | | |
| 51,119 | |
Net income | |
| - | | - |
| - | | |
| - | | |
| - | | |
| 186,735 | | |
| 186,735 | |
Balance at March 31, 2024 | |
| — | | - |
| 495,092 | | |
$ | 495 | | |
$ | 488,664,009 | | |
$ | (488,319,296 | ) | |
$ | 345,208 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock compensation on vested options | |
| | | |
| | | |
| | | |
| 3,928 | | |
| | | |
| 3,928 | |
Net loss | |
| - | | - |
| - | | |
| - | | |
| - | | |
| (1,282,987 | ) | |
| (1,282,987 | ) |
Balance at June 30, 2024 | |
| - | | - |
| 495,092 | | |
$ | 495 | | |
$ | 488,667,937 | | |
$ | (489,602,283 | ) | |
| (933,851 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock compensation on vested options | |
| | | |
| | | |
| | | |
| 3,927 | | |
| | | |
| 3,927 | |
Net loss | |
| - | | - |
| - | | |
| - | | |
| - | | |
| (824,540 | ) | |
| (824,540 | ) |
Balance at September 30, 2024 | |
| - | | - |
| 495,092 | | |
$ | 495 | | |
$ | 488,671,864 | | |
$ | (490,426,823 | ) | |
$ | (1,754,464 | ) |
For
the Nine Month Period Ended September 30, 2023
| |
Series B Preferred Shares Issued | | |
Common Shares Issued | | |
Common Stock Amount | | |
Additional Paid-in Capital | | |
Accumulated Deficit | | |
Total | |
Balance at January 1, 2023 | |
| — | | - |
| 450,374 | | |
$ | 450 | | |
$ | 487,519,251 | | |
$ | (488,837,665 | ) | |
$ | (1,317,964 | ) |
1 for 100 reverse stock split fractional shares | |
| | | |
| 13,191 | | |
| 13 | | |
| (13 | ) | |
| | | |
| — | |
Conversion of Series C Convertible Preferred Stock | |
| | | |
| 15,250 | | |
| 15 | | |
| 655,139 | | |
| | | |
| 655,154 | |
Preferred dividend | |
| | | |
| | | |
| | | |
| | | |
| (68,809 | ) | |
| (68,809 | ) |
Issuance of common stock | |
| | | |
| 250 | | |
| 1 | | |
| (1 | ) | |
| | | |
| — | |
Net loss | |
| | | - |
| | | |
| | | |
| | | |
| (1,074,498 | ) | |
| (1,074,498 | ) |
Balance at March 31, 2023 | |
| — | | - |
| 479,065 | | |
$ | 479 | | |
$ | 488,174,376 | | |
($ | 489,980,972 | ) | |
$ | (1,806,117 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Conversion of Series C Convertible Preferred Stock | |
| | | |
| 16,027 | | |
| 16 | | |
| 688,514 | | |
| | | |
| 688,530 | |
Payment to redeem investment option | |
| | | |
| | | |
| | | |
| (250,000 | ) | |
| | | |
| (250,000 | ) |
Net income | |
| | | - |
| - | | |
| - | | |
| - | | |
| 3,148,966 | | |
| 3,148,966 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at June 30, 2023 | |
| — | | - |
| 495,092 | | |
$ | 495 | | |
$ | 488,612,890 | | |
$ | (486,832,006 | ) | |
$ | 1,781,379 | |
Balance | |
| — | | - |
| 495,092 | | |
$ | 495 | | |
$ | 488,612,890 | | |
$ | (486,832,006 | ) | |
$ | 1,781,379 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net loss | |
| - | | - |
| - | | |
| - | | |
| - | | |
| (815,989 | | |
| (815,989 | ) |
Net income (loss) | |
| - | | - |
| - | | |
| - | | |
| - | | |
| (815,989 | | |
| (815,989 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at September 30, 2023 | |
| — | | - |
| 495,092 | | |
$ | 495 | | |
$ | 488,612,890 | | |
$ | (487,647,995 | ) | |
$ | 965,390 | |
Balance | |
| — | | - |
| 495,092 | | |
$ | 495 | | |
$ | 488,612,890 | | |
$ | (487,647,995 | ) | |
$ | 965,390 | |
LADRX
CORPORATION
NOTES
TO CONDENSED FINANCIAL STATEMENTS
For
the Three Months and Nine-Months Periods Ended September 30, 2024 and 2023
(Unaudited)
1. Basis of Presentation and Significant Accounting Policies
Basis
of Presentation
The
accompanying condensed financial statements of Ladrx Corporation (the “Company”) at September 30, 2024, and for the
three-month and nine-month periods ended September 30, 2024 and 2023, respectively, are unaudited, but include all adjustments,
consisting of normal recurring entries, that management believes to be necessary for a fair presentation of the periods presented.
Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2023 were
derived from our audited financial statements as of that date.
The
financial statements included herein have been prepared by us pursuant to the rules and regulations of the Securities and Exchange Commission
(“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with
accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to such rules and regulations.
The financial statements should be read in conjunction with our audited financial statements contained in the 2023 Annual Report.
Going
Concern
The
Company’s condensed financial statements have been presented on the basis that it will continue as a going concern, which contemplates
the realization of assets and satisfaction of liabilities in the normal course of business. During the nine-month period ended September
30, 2024, the Company incurred a net loss of $1.9 million and had total stockholders’ deficit as of September 30, 2024 of $1.8
million. The Company has no recurring revenue, and we are likely to continue to incur losses unless and until we conclude a successful
strategic partnership or financing for our LADR™ technology. As a result, management has concluded that there is substantial doubt
about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued.
In addition, the Company’s independent registered public accounting firm, in its audit report on the Company’s consolidated
financial statements for the year ended December 31, 2023, expressed substantial doubt about the Company’s ability to continue
as a going concern. The Company’s financial statements do not include any adjustments that might result from the outcome of this
uncertainty.
At
September 30, 2024, we had cash and cash equivalents and short-term investments of approximately $0.1 million. The Company expects to
receive a $1 million milestone payment upon the first commercial sale of arimoclomol from Xoma in the fourth quarter of 2024. This is
predicated upon the recent announcement in September 2024 by Zevra that arimoclomol was approved by the Food and Drug Administration
and that Zevra expects to initiate its lauch activities for MIPLYFFA (arimoclomol) in the fourth quarter of 2024. The continuation
of the Company as a going concern is dependent upon its ability to obtain necessary debt or equity financing to continue operations until
it begins generating positive cash flow. No assurance can be given that any future financing will be available or, if available, that
it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, it may contain
undue restrictions on our operations, in the case of debt financing or cause substantial dilution for our stockholders, in case of equity
financing.
2023 Reverse Stock Split
The
Company effected a 1-for-100 reverse stock split (the “Reverse Stock Split”) of its issued and outstanding shares of
common stock on May 17, 2023, pursuant to which every 100 shares of the Company’s issued and outstanding shares of common stock
were converted into one share of common stock without any change in the par value per share. Any
fraction of a share of common stock that would otherwise have resulted from the Reverse Stock Split was rounded up to the nearest whole
share. All share and per share amounts in this Quarterly Report and the accompanying financial statements and the notes thereto
have been adjusted to reflect the Reverse Stock Split as if it had occurred at the beginning of the earliest period presented.
Use
of Estimates
Preparation
of the Company’s condensed financial statements in conformance with U.S. GAAP requires the Company’s management to make estimates
and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets
and liabilities in the Company’s condensed financial statements and accompanying notes. The significant estimates in the Company’s
condensed financial statements relate to the valuation of equity awards, recoverability of deferred tax assets, and estimated useful
lives of fixed assets, The Company bases estimates and assumptions on historical experience, when available, and on various factors that
it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis, and its
actual results may differ from estimates made under different assumptions or conditions.
Fair
Value Measurements
The
Company measures the fair value of financial instruments using a fair value hierarchy that prioritizes the inputs to valuation techniques
used to measure fair value into three broad levels:
Level
1—Inputs used to measure fair value are unadjusted quoted prices that are available in active markets for the identical assets
or liabilities as of the reporting date.
Level
2— Other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement
date.
Level
3—Unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment
are used to measure fair value. These values are generally determined using pricing models for which the assumptions utilize management’s
estimates of market participant assumptions. The determination of fair value for Level 3 investments and other financial instruments
involves the most management judgment and subjectivity.
The
carrying amounts of financial assets and liabilities, such as cash, other current assets, accounts payable, and accrued expenses, approximate
their fair values because of the short maturity of these instruments.
Research
and Development Expenses
Research
and development expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs
to acquire technologies, including licenses and drugs, that are utilized in research and development and that have no alternative future
use are expensed when incurred. Technology developed for use in its products is expensed as incurred until technological feasibility
has been established.
Stock
Compensation
The
Company accounts for share-based awards to employees and non-employee directors and consultants in accordance with the provisions of
ASC 718, Compensation—Stock Compensation., and under the recently issued guidance following FASB’s pronouncement,
ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. Under
ASC 718, and applicable updates adopted, share-based awards are valued at fair value on the date of grant and that fair value is recognized
over the requisite service, or vesting, period. The Company values its equity awards using the Black-Scholes option pricing model, and
accounts for forfeitures when they occur. Recognition of compensation expense for non-employees is in the same period and manner
as if the Company had paid cash for the services.
Basic
and Diluted Net Income (Loss) Per Common Share
Basic
and diluted net loss per common share is computed based on the weighted-average number of common shares outstanding for the period. Diluted
net income (loss) per share is computed by dividing the net income (loss) applicable to common stockholders by the weighted average number
of common shares outstanding plus the number of additional common shares that would have been outstanding if all dilutive potential common
shares had been issued using the treasury stock method. Potential common shares are excluded from computation when their effect is antidilutive.
Common share equivalents that could potentially dilute net loss per share in the future, and which were excluded from the computation
of diluted loss per share, were as follows:
Schedule of Shares Excluded from Computation of Diluted Loss Per Share
| |
2024 | | |
2023 | |
| |
As of September 30, | |
| |
2024 | | |
2023 | |
Options to acquire common stock | |
| 69,000 | | |
| 15,647 | |
Warrants to acquire common stock | |
| — | | |
| 42 | |
Shares excluded from computation
of diluted loss per share | |
| 69,000 | | |
| 15,689 | |
Recently
Issued Accounting Pronouncements
Recent
authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants,
and the SEC did not, or are not expected to, have a material impact on the Company’s condensed financial statements and related
disclosures.
2. Financing Under Securities Purchase Agreement
On
July 13, 2021, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a single institutional
investor (the “Investor”) for aggregate gross proceeds of $10 million and net proceeds of approximately $9.2 million. The
transaction closed on July 16, 2021. Under the Purchase Agreement, the Company sold and issued (i) 20,000 shares of its common stock
at a purchase price of $88.00 per share for total gross proceeds of approximately $1.76 million in a registered direct offering (the
“Registered Direct Offering”) and (ii) 8,240 shares of Series C 10.00% Convertible Preferred Stock (the “Series C Preferred
Stock”) at a purchase price of $1,000 per share, for aggregate gross proceeds of approximately $8.24 million, in a concurrent private
placement (the “Private Placement” and, together with the Registered Direct Offering, the “July 2021 Offerings”).
The shares of the Series C Preferred Stock were convertible, upon shareholder approval as described below, into an aggregate of up to
93,637 shares of common stock at a conversion price of $88.00 per share. Holders of the Series C Preferred Stock were entitled to receive,
cumulative dividends at the rate per share (as a percentage of the stated value per share) of 10.00% per annum, payable quarterly on
January 1, April 1, July 1 and October 1, beginning on the first such date after the date of issuance. The terms of the Series C Preferred
Stock included beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99%
of the Company’s outstanding shares of common stock. LadRx also issued to the Investor an unregistered Preferred Investment Option
(“PIO”) that prior to redemption and cancelation of the PIO on June 29, 2023 (as described herein) allowed for the purchase
of up to 113,637 shares of common stock for additional gross proceeds of approximately $10 million if the PIO was exercised in full.
The exercise price for the PIO was $88.00 per share. The PIO had a term equal to five and one-half years commencing upon the Company
increasing its authorized common stock following shareholder approval.
In
2022, the Company paid the following dividends: on January 1, 2022, $206,000, on April 1, 2022, $202,567, on July 1, 2022, $84,005 and
on October 1, 2022, $68,809 for a total of $561,381. On January 3, 2023, the Company paid a dividend of $68,809.
At
December 31, 2022, the Company had 2,752 shares of Series C Preferred Stock outstanding. On January 31, 2023, the Investor converted
a further 1,342 shares of Series C Preferred Stock for 15,250 shares of common stock and on May 8, 2023, the Investor converted its remaining
shares of Series C Preferred Shares for 16,027 shares of common stock. As of September 30, 2024 and December 31, 2023, there were no
shares of Series C Preferred Stock issued and outstanding.
3. XOMA
Royalty
Purchase Agreement with XOMA
On
June 21, 2023, the Company, entered into (i) a Royalty Purchase Agreement (the “Royalty Agreement”) with XOMA (US) LLC (“XOMA”),
for the sale, transfer, assignment and conveyance of the Company’s right, title and interest in and to certain royalty payments
and milestone payments with respect to aldoxorubicin, and (ii) an Assignment and Assumption Agreement (the “Assignment Agreement”)
with XOMA for the sale, transfer, assignment and conveyance of the Company’s right, title and interest in the Asset Purchase Agreement
(the “2011 Arimoclomol Agreement”) between the Company and Orphazyme ApS (“Orphazyme”), dated as of May 13, 2011,
and assigned to Zevra Denmark A/S (“Zevra Denmark”), effective as of June 1, 2022, which includes certain royalty and milestone
payments with respect to arimoclomol. The combined aggregate purchase price paid to the Company for the sale, transfer, assignment and
conveyance of the Company’s right, title and interest in and to aldoxorubicin and arimoclomol was $5 million, less certain transaction
fees and expenses.
The
Royalty Agreement and the Assignment Agreement also provided for up to an additional $6 million based on regulatory and commercial milestones
related to the development of arimoclomol and aldoxorubicin by their respective sponsors, Zevra, Inc. and Immunity Bio. The $6 million
in potential post-closing payments was comprised of $1 million upon acceptance by the FDA of the arimoclomol New Drug Application (“NDA”),
$1 million upon first commercial sale of arimoclomol, and $4 million upon FDA approval of aldoxorubicin. All royalty and milestone payments
made to XOMA were net of the existing licensing and milestone obligations owed by LadRx related to arimoclomol and aldoxorubicin.
Pursuant
to the Royalty Agreement, the Company agreed to sell, transfer, assign and convey to XOMA, among other payments, all royalty payments
and regulatory and commercial milestone payments payable to the Company pursuant to the worldwide license agreement (the “License
Agreement”), dated July 27, 2017, by and between the Company and ImmunityBio, Inc (“ImmunityBio”). The Royalty Agreement
also provides for the sharing of certain rights with XOMA to bring any action, demand, proceeding or claim as related to receiving such
payments.
Management
determined that the Royalty Agreement is not considered to be with a customer, and it does not fall within the scope of ASC 606. Instead,
the Royalty Agreement represents an in-substance sale of non-financial assets and, therefore, should be accounted for within the scope
of ASC 610-20.
First
Amendment to Royalty Purchase Agreement
On
June 3, 2024, in consideration for the termination of the License Agreement pursuant to the Termination Agreement (as defined below),
the Company and XOMA entered into the First Amendment to the Royalty Agreement (the “First Amendment”).
Pursuant
to the First Amendment, if the Company decides to commercialize aldoxorubicin itself, prior to the first commercial sale of aldoxorubicin,
the Company and XOMA shall enter into a synthetic royalty purchase agreement, pursuant to which the Company shall agree to make quarterly
royalty payments to XOMA equal to the amount of all aggregate net sales of aldoxorubicin during each calendar quarter multiplied by 1.5%.
If the Company decides not to commercialize aldoxorubicin itself and instead licenses aldoxorubicin to a third party, upon entry of such
a new license agreement, XOMA shall be entitled to receive (i) royalty payments with respect to net sales of aldoxorubicin payable to
the Company multiplied by 7.5% and (ii) milestone payments of 7.5% of any milestone payable to the Company pursuant to the License Agreement.
The First Amendment contains customary covenants and other provisions customary for transactions of this nature.
Mutual
Termination and Release Agreement
On
June 3, 2024, pursuant to a Mutual Termination and Release Agreement (the “Termination Agreement”), the Company, NantCell,
Inc., a Delaware corporation (“NantCell, Inc.,” and together with ImmunityBio “NantCell”), and its parent company,
ImmunityBio, and XOMA agreed to a mutual termination of the License Agreement, effective as of the same date (the “Effective Date”).
Neither the Company nor NantCell will have any continuing obligations to each other than as described in the Termination Agreement. Additionally,
except that during the 30 day period following the Effective Date (the “Discussion Period”), the Company and NantCell shall
engage in good faith discussions regarding the terms of an agreement pursuant to which the Company would have the right to purchase the
inventory of aldoxorubicin (including, without limitation, active pharmaceutical ingredient, WPI and finished dose, the “Inventory”)
and all other materials necessary for the research, development and commercialization, among others, worldwide as of the Effective Date,
at the Company’s expense. Subsequently, the Company and NantCell have agreed that the disposition of the Inventory shall be at
NantCell’s sole discretion.
The
Termination Agreement additionally provides for the release of the Company and NantCell from claims, demands and liabilities, among others,
and customary representations and warranties, covenants, and other provisions customary for transactions of this nature.
Assignment
and Assumption Agreement with XOMA
On
June 21, 2023, the Company entered into the Assignment Agreement with XOMA, pursuant to which, among others, the Company agreed to sell,
transfer and assign to XOMA the Company’s right, title and interest in the arimoclomol pursuant to the 2011 Arimoclomol Agreement,
including the right to receive certain milestone, royalty and other payments from Zevra Denmark.
Pursuant
to the Assignment Agreement, the Company is entitled to receive (i) a one-time payment of $1 million upon acceptance of a re-submission
of an NDA to the FDA for arimoclomol, and (ii) a one-time payment of $1 million upon the first invoiced sale in certain territories of
a pharmaceutical product derived from arimoclomol as an active pharmaceutical ingredient, subject to the receipt of the applicable regulatory
approval required to sell such a product in such countries. In January 2024, Zevra announced the FDA had accepted the NDA for arimoclomol
and the Company received the one-time payment of $1 million in February 2024 recognized such net proceeds of $1.0 million as other income
in the statement of operations for the period ended March 31, 2024
4. Stock Based Compensation
The
Company has the 2008 Stock Incentive Plan (the “2008 Plan”) under which 50,000 shares of common stock are reserved for issuance.
As of September 30, 2024, there were approximately 10,500 shares subject to outstanding stock options and approximately 8,000 shares
outstanding related to restricted stock grants issued from the 2008 Plan. This plan expired on November 20, 2018 and thus no further
shares are available for future grant under this plan.
In
November 2019, the Company adopted the 2019 Stock Incentive Plan (the “2019 Plan”) under which 54,000 shares of common stock
are reserved for issuance. As of September 30, 2024, there were 3,500 shares subject to outstanding stock options and 250 shares outstanding
related to restricted stock grants from the 2019 Plan. This Plan expires on November 14, 2029.
On
September 7, 2023, the Board approved the first amendment (the “Plan Amendment”) to the 2019 Plan, effective as of the same
date. The Plan Amendment amends the 2019 Plan to (i) reflect the Company’s recent name change from CytRx Corporation to LadRx Corporation,
and (ii) increase the aggregate number of shares of common stock that may be issued under the 2019 Plan, as set forth in Section 4(a)
of the 2019 Plan, by an additional 75,000 shares of common stock. On September 7, 2023, the Board additionally approved and set January
16, 2024, as the grant date for certain stock options to purchase shares of common stock to certain directors and officers of the Company,
which such options to purchase up to a total of 55,000 shares of common stock were granted to employees and directors. Fifty percent
of these options were immediately vested, and the remaining balance will vest in equal installments on a monthly basis over three years.
There were no options issued in the period ended September 30, 2023.
The
fair value of the stock options at the date of grant was estimated using the Black-Scholes option-pricing model, based on the following
assumptions:
Schedule of Fair Value of Stock Options at the Date of Grant
| |
2024 | | |
2023 | |
Risk-free interest rate | |
| 3.88 | % | |
| 2.42 | % |
Expected volatility | |
| 147 | % | |
| 92 | % |
Expected lives (years) | |
| 6 | | |
| 6 | |
Expected dividend yield | |
| 0.00 | % | |
| 0.00 | % |
The
Company’s computation of expected volatility is based on the historical daily volatility of its publicly traded stock. For option
grants issued during the nine-months ended September 30, 2024, the Company used a calculated volatility for each grant. The Company lacks
adequate information about the exercise behavior at this time and has determined the expected term assumption under the simplified method
provided for under ASC 718, which averages the contractual term of the Company’s options of ten years with the average vesting
term of three years for an average of six years. In 2024, the Company used the average term of six years. The dividend yield assumption
of zero is based upon the fact the Company has never paid cash dividends on common stock and presently has no intention of paying cash
dividends. The risk-free interest rate used for each grant is equal to the U.S. Treasury rates in effect at the time of the grant for
instruments with a similar expected life. The Company accounts for forfeitures as they occur. No amounts relating to stock-based compensation
have been capitalized. No amounts relating to employee stock-based compensation have been capitalized.
During
the nine months ended September 30, 2024 and September 30, 2023, no options were exercised.
Presented
below is our stock option activity:
Schedule of Stock Options Activity
| |
Nine-Months Ended September 30, 2024 | |
| |
Number of Options (Employees) | | |
Number of Options (Non-Employees) | | |
Total Number of Options | | |
Weighted-Average Exercise Price | |
Outstanding at January 1, 2024 | |
| 10,350 | | |
| 3,650 | | |
| 14,000 | | |
$ | 501.70 | |
Issued | |
| 55,000 | | |
| — | | |
| 55,000 | | |
| 1.83 | |
Exercised, forfeited or expired | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding at September 30, 2024 | |
| 65,350 | | |
| 3,650 | | |
| 69,000 | | |
$ | 103.24 | |
Exercisable at September 30, 2024 | |
| 43,971 | | |
| 3,650 | | |
| 47,621 | | |
$ | 148.75 | |
The
following table summarizes significant ranges of outstanding stock options under the 2008 Plan and the 2019 Plan at September 30, 2024:
Schedule of Ranges of Outstanding Stock Options
Range
of
Exercise Prices | |
Number
of Options | | |
Weighted-Average
Remaining
Contractual
Life (years) | | |
Weighted-Average
Exercise Price | | |
Number
of
Options
Exercisable | | |
Weighted-Average
Remaining
Contractual
Life (years) | | |
Weighted-Average
Exercise Price | |
$1.83 - $25.99 | |
| 55,000 | | |
| 9.30 | | |
$ | 1.83 | | |
| 33,624 | | |
| 9.30 | | |
$ | 1.83 | |
$26.00 –$100.00 | |
| 3,500 | | |
| 5.20 | | |
$ | 26.00 | | |
| 3,500 | | |
| 5.20 | | |
$ | 26.00 | |
$100.01 – $300.00 | |
| 6,066 | | |
| 2.96 | | |
$ | 195.29 | | |
| 6,066 | | |
| 2.96 | | |
$ | 195.29 | |
$300.01 –$4,146.00 | |
| 4,434 | | |
| 0.86 | | |
$ | 1,296.92 | | |
| 4,431 | | |
| 0.86 | | |
$ | 1,296.92 | |
| |
| 69,000 | | |
| 7.99 | | |
$ | 103.24 | | |
| 47,621 | | |
| 7.99 | | |
$ | 148.75 | |
The
Company recorded $58,974 of stock compensation costs in the period ended September 30, 2024 and no costs in the period ended September
30, 2023. At September 30, 2024, there was $35,350 of unrecognized compensation expense related to unvested stock options.
There
was no aggregate intrinsic value of the outstanding options as of September 30, 2024.
At
December 31, 2023, the Company had warrants to purchase up to 42 shares of common stock outstanding at a weighted average exercise price
of $1,044.00 per share, which expired in 2024, and as such, the Company had no outstanding warrants at September 30, 2024.
5. Commitments and Contingencies
Commitments
Aldoxorubicin
The
Company has an agreement (the “Vergell Agreement”) with Vergell Medical (formerly with KTB Tumorforschungs GmbH) (“Vergell”)
for the exclusive license of patent rights held by Vergell for the worldwide development and commercialization of aldoxorubicin. Under
the agreement, we had to make payments to Vergell upon meeting certain clinical and regulatory milestones up to and including the product’s
second final marketing approval. However, those payments are no longer required since the intellectual property acquired under the Vergell
Agreement has now expired. The Company accrued $316,000 that we believe is owed prior to the expiry of the intellectual property. This
amount was outstanding both for the nine-month periods ended September 30, 2024 and September 30, 2023 and is included in accrued expenses
and other current liabilities on the condensed balance sheet.
As
discussed in Note 3, pursuant to the First Amendment to the Royalty Agreement, the Company and XOMA have amended the Royalty Agreement
to provide XOMA with a low single-digit synthetic royalty on aldoxorubicin and a mid-single digit percentage of any economics derived
by LadRx from future out-license agreements related to aldoxorubicin.
Arimoclomol
The
agreement relating to our worldwide rights to arimoclomol provides for our payment of up to an aggregate of $3.65 million upon receipt
of milestone payments from Orphayzme A/S. On May 31, 2022, Orphazyme announced that it had completed the sale of substantially all of
its assets and business activities for cash consideration of $12.8 million and assumption of liabilities estimated to equal approximately
$5.2 million to KemPharm (the “KemPharm Transaction”). KemPharm is a specialty biopharmaceutical company focused on the discovery
and development of novel treatments for rare central nervous system (“CNS”) diseases. As part of the KemPharm Transaction,
all of Orphazyme’s obligations to LadRx under the 2011 Arimoclomol Agreement, including with regard to milestone payments and royalties
on sales, were assumed by KemPharm. KemPharm re-branded to Zevra Therapeutics, Inc. in February 2023.
As
disclosed in Note 3, Assignment Agreement with XOMA, pursuant to the Assignment Agreement, although all the liabilities and obligations
related to arimoclomol remain the responsibility of the Company, XOMA will direct an escrow agent appointed by them to pay on behalf
of LadRx up to an aggregate of $3.25 million reflected in the preceding paragraph, as well as all future obligations related to Steven
A. Kriegsman, pursuant to the Amended and Restated Employment Agreement, as amended by and between the Company and Mr. Kriegsman, dated
March 26, 2019.
Innovive
Under
the merger agreement by which the Company acquired Innovive, the Company agreed to pay the former Innovive stockholders a total of up
to approximately $18.3 million of future earnout merger consideration, subject to our achievement of specified net sales under the Innovive
license agreements. As of September 30, 2024, there are no longer any further obligations due under this agreement, since the licensed
intellectual property rights have expired.
Contingencies
We
apply the disclosure provisions of ASC 460, Guarantees (“ASC 460”) to its agreements that contain guarantees or indemnities
by the Company. We provide (i) indemnifications of varying scope and size to certain investors and other parties for certain losses suffered
or incurred by the indemnified party in connection with various types of third-party claims; and (ii) indemnifications of varying scope
and size to officers and directors against third party claims arising from the services they provide to the Company.
The
Company is occasionally involved in legal proceedings and other matters arising from the normal course of business. On November 30, 2022,
Jerald Hammann (“Hammann”) filed a complaint (the “Complaint”) against the Company, Mr. Caloz, and Mr. Kriegsman
(together, “Defendants”) in the Court of Chancery of the State of Delaware, alleging various violations of a Cooperation
Agreement, dated August 21, 2020, by and between the Company and Hammann. The Complaint alleges breaches of a provision limiting the
Board’s ability to effect discretionary compensation and a non-disparagement provision. The Complaint further alleges a breach
of a purported implied obligation that the Company disclose various internal records to Hammann. Defendants moved to dismiss the Complaint
in its entirety. As a result, the Court subsequently dismissed the claims against Mr. Caloz and Mr. Kriegsman and also dismissed one
of the claims against the Company. The Company intends to litigate vigorously against Hammann’s claims.
The
Company evaluates developments in legal proceedings and other matters on a quarterly basis. The Company records accruals for loss contingencies
to the extent that the Company concludes that it is probable that a liability has been incurred and the amount of the related loss can
be reasonably estimated.
Item
2. — Management’s Discussion and Analysis of Financial Condition and Results of Operations
Overview
LadRx
Corporation (“LadRx,” the “Company,” “we,” “us,” or “our”) is a biopharmaceutical
research and development company specializing in oncology. The Company’s focus is on the discovery, research and clinical development
of novel anti-cancer drug candidates that employ novel technologies that target chemotherapeutic drugs to solid tumors and reduce off-target
toxicities. During 2017, LadRx’s discovery laboratory in Freiburg, Germany, synthesized and tested over 75 rationally designed
drug conjugates with highly potent anti-cancer payloads, culminating in the creation of two distinct classes of compounds. Four lead
candidates (LADR-7 through LADR-10) were selected based on in vitro and animal studies in several different cancer models, stability,
and manufacturing feasibility. In addition, a novel companion diagnostic, ACDx™, was developed to identify patients with cancer
who are most likely to benefit from treatment with these drug candidates.
On
June 1, 2018, LadRx launched Centurion BioPharma Corporation (“Centurion”), a wholly-owned subsidiary, and transferred into
Centurion all of its assets, liabilities and personnel associated with the laboratory operations in Freiburg, Germany. In connection
with said transfer, the Company and Centurion entered into a Management Services Agreement whereby the Company agreed to render advisory,
consulting, financial and administrative services to Centurion, for which Centurion shall reimburse the Company for the cost of such
services plus a 5% service charge. On December 21, 2018, LadRx announced that Centurion had concluded the pre-clinical phase of development
for its four LADRTM (Linker Activated Drug Release) drug candidates, and of its albumin companion diagnostic (ACDx™).
As a result of completing this work, operations taking place at the pre-clinical laboratory in Freiburg, Germany were no longer needed
and the lab was closed at the end of January 2019.
On
March 9, 2022, Centurion merged with and into LadRx, with LadRx absorbing all of Centurion’s assets and continuing after the merger
as the surviving entity (the “Merger”). The Merger was implemented through an agreement and plan of merger pursuant to Section
253 of the General Corporation Law of the State of Delaware and did not require approval from either our or Centurion’s stockholders.
The Certificate of Ownership merging Centurion into LadRx was filed with the Secretary of State of Delaware on March 9, 2022.
Effective
September 26, 2022, we changed our name from CytRx Corporation to LadRx Corporation pursuant to a Certificate of Amendment to our Certificate
of Incorporation filed with the Secretary of State of Delaware. In accordance with the General Corporation Law of the State of Delaware
(the “DGCL”), our board of directors approved the name change and the Certificate of Amendment. Pursuant to Section 242(b)(1)
of the DGCL, stockholder approval was not required for the name change or the Certificate of Amendment.
2023
Reverse Stock Split
The
Company effected a 1-for-100 reverse stock split (the “Reverse Stock Split”) of its issued and outstanding shares of common
stock on May 17, 2023, pursuant to which every 100 shares of the Company’s issued and outstanding shares of common stock were converted
into one share of common stock without any change in the par value per share. Any fraction of a share of common stock that would otherwise
have resulted from the Reverse Stock Split was rounded up to the nearest whole share. All share and per share amounts in this Quarterly
Report on Form 10-Q and the accompanying financial statements and notes thereto have been adjusted to reflect the Reverse Stock Split
as if it had occurred at the beginning of the earliest period presented.
Corporate
Information
We
are a Delaware corporation, incorporated in 1985. Our corporate offices are located at 11726 San Vicente Boulevard, Suite 650, Los Angeles,
California 90049, and our telephone number is (310) 826-5648. Our web site is located at http://www.ladrxcorp.com. We do not incorporate
by reference into this Quarterly Report on Form 10-Q the information on, or accessible through, our website, and you should not consider
it as part of this report.
LADR
Drug Discovery Platform
We
believe that the LADR™ technology offers the opportunity for multiple pipeline drugs. The Company’s LADR™ technology
platform consists of an organic backbone that is attached to a chemotoxic agent. The purpose of the LADR™ backbone is to first
target and deliver the chemotoxic agent to the tumor environment, and then to release the chemotoxic agent within the tumor. By delivering,
concentrating, and releasing the chemotoxic agent within the tumor, one expects to reduce the off-target side-effects of the chemotherapeutic,
which in turn allows for several-fold higher dosing of the chemotherapeutic to the patient. Being small organic molecules, the Company
expects LADR-based drugs to offer the benefits of targeting the tumor without the complexity, side effects, and expense inherent in macromolecules
such as antibodies and nanoparticles.
The
Company’s LADR-based drugs use circulating albumin as the binding target and as the trojan horse to deliver the LADR™ drugs
to the tumor. Albumin is the most abundant protein in plasma and accumulates inside tumors due to the aberrant vascular structure that
exists within solid tumors. Tumors use albumin as a nutritional source and for transport of signaling and other molecules that are important
to the maintenance and growth of the tumor, which makes albumin an excellent target for drugs that are intended for solid tumors.
The
first LADR-based drug is aldoxorubicin. Aldoxorubicin consists of the widely used chemotoxin doxorubicin attached to a LADR backbone
that targets the drug to the tumor, and releases the active drug once inside the tumor. Aldoxorubicin has been administered to hundreds
of patients in clinical trials in soft tissue sarcoma and glioblastoma. As expected for a LADR-based drug, aldoxorubicin is typically
dosed at a level that provides 3-4 times the amount of doxorubicin that can be safely delivered to a patient. In a large Phase II study
in advanced soft tissue sarcomas, aldoxorubicin met its primary endpoint in extending progression-free survival (PFS). This Phase II
study also resulted in preliminary data suggestive of aldoxorubicin having an improved cardiotoxicity profile relative to doxorubicin,
one of the major issues with the use of doxorubicin. This preliminary data suggesting a possible advantage in cardiotoxicity offered
by aldoxorubicin over doxorubicin was also shown in a subsequent Phase III trial in soft tissue sarcoma. The primary PFS endpoint was
not met in this Phase III trial, in which 2/3 of the patients in the aldoxorubicin group were known to have already progressed after
treatment with doxorubicin, making efficacy results difficult to interpret in this Phase III trial. It is the opinion of the Company
that additional Phase II and Phase III studies with aldoxorubicin are warranted.
The
Company’s efforts at furthering LADR™ development are focused on two classes of ultra-high potency albumin-binding drugs.
These LADR-based drugs, LADR7, 8, 9, and 10, combine the proprietary LADR™ backbone with novel derivatives of the auristatin and
maytansinoid drug classes. Auristatin and maytansinoid are highly potent chemotoxins, and require targeting to the tumor for safe administration
to humans, as is the case for the U.S. Food and Drug Administration (“FDA”)-approved drugs Adcetris (auristatin antibody-drug-conjugate
manufactured by Seagen, Inc.) and Kadcyla (maytansine antibody-drug-conjugate manufactured by Genentech, Inc.). We believe that LADR-based
drugs offer the benefits of tumor targeting without the disadvantages of antibodies and other macromolecules, which include expense,
complexity, and negative side effects. Additionally, albumin is a very well-characterized drug target, which we believe will reduce clinical
and regulatory costs and risks.
The
Company’s postulated mechanism of action for LADR-based drugs is as follows:
|
● |
after administration, the linker portion of the drug conjugate
forms a rapid and specific covalent bond to the cysteine-34 position of circulating albumin; |
|
|
|
|
● |
circulating albumin preferentially accumulates in tumors due
to a mechanism called “Enhanced Permeability and Retention”, which results in lower exposure to the drug in noncancerous
tissues of the heart, liver, and other organs; |
|
|
|
|
● |
once localized at the tumor, the acid-sensitive linker of the
LADR™ backbone is cleaved due to the specific conditions within the tumor and in the tumor microenvironment; and |
|
|
|
|
● |
free active drug is then released within the tumor, causing
tumor cell death. |
The
first-generation LADR-based drug is called Aldoxorubicin. Aldoxorubicin is the well-known drug doxorubicin attached to the first generation
LADR™ backbone (LADRs 7-10 employ a next generation LADR™ backbone). Aldoxorubicin has been administered to over 600 human
subjects in human clinical trials and has proven the concept of LADR™ in that several-fold more doxorubicin can be safely administered
to patients when the doxorubicin is attached to LADR™ than when administered as native doxorubicin.
The
next generation LADR™ drugs are termed LADR7, 8, 9, and 10. A great deal of Investigational New Drug (“IND”) enabling
work has already been accomplished on LADR7-10, including in-silico modeling, in-vitro efficacy testing in several different cancer models,
in-vivo dosing, safety, and efficacy testing in several different cancer models in animals. We have also developed and proven manufacturability,
an important step prior to beginning human clinical trials.
The
IND-enabling work that remains prior to applying to a regulatory agencyfor first-in-human studies for LADR 7-10 is limited due to the
extensive experimentation already completed. In the case of LADR 7, a manufacturing run under Good Manufacturing Practices (GMP) has
been completed.
The
final toxicology studies required for the IND for LADR 7 have been completed, and all that remains prior to initiating first-in-human
Phase I studies of LADR-7 are packaging of LADR-7 into clinical trial containers, and notification of relevant regulatory bodies. We
expect these activities to require 6 months once funding has been secured. If the Company fails to meet regulatory agencies’ requirements
for initiating first-in-human studies, the first-patient dosing could be substantially delayed.
Because
the LADR™ backbone in future products would be the same as the LADR™ backbone in current product candidates, (i.e. the chemotoxin
can be changed without changing the LADR™ backbone), management anticipates that future product candidates beyond LADR7-10 may
enjoy abbreviated pre-clinical pathways to first-in-human. Such abbreviated pathways would be subject to FDA review and agreement.
The
Company’s novel companion diagnostic, ACDx™ (albumin companion diagnostic) was developed to identify patients with cancer
who are most likely to benefit from treatment with the four LADR™ lead assets. We have not yet determined whether the use of a
companion diagnostic will be necessary or helpful, and plan to continue to investigate this question in parallel to the pre-clinical
and clinical development of LADRs 7-10.
The
LADR™ backbone and drugs that employ LADR™ are protected by domestic and international patents, and additional patents are
pending.
Business
Strategy for LADR™ Platform
With
the non-dilutive financing concluded with XOMA (as defined below) in June 2023, the Company is focused on the work necessary to receive
approval to initiate human clinical trials of LADR7 in the United States or another regulatory jurisdiction. The Company completed the
production of approximately 100 grams of LADR7 under GMP, which is sufficient to carry out final toxicology studies, and to conduct Phase
IA studies in human subjects.
The
Company has also completed the Good Laboratory Practices (“GLP”) toxicology program that is expected to form the foundation
of the regulatory applications necessary to initiate human clinical studies of LADR7. Management expects to apply for first-in-human
approval with the FDA or an international equivalent within 6 months of receiving additional funding.
Management
will continue to explore in parallel both partnered and non-partnered funding and development strategies for LADR™ with a goal
of obtaining the least costly capital possible to enable value inflection milestones.
Partnering
of Aldoxorubicin
On
July 27, 2017, the Company entered into an exclusive worldwide license agreement (the “License Agreement”) with ImmunityBio,
Inc. (formerly known as NantCell, Inc. (“NantCell, Inc.”), and which merged with NantKwest Inc. in March 2021 (“ImmunityBio”
and together with NantCell, Inc., “NantCell”)), granting to ImmunityBio the exclusive rights to develop, manufacture and
commercialize aldoxorubicin in all indications. As a result, we are no longer directly working on the development of aldoxorubicin. As
part of the License Agreement, ImmunityBio made a strategic investment of $13 million in LadRx’s common stock at $660.00 per share
(adjusted to reflect the 2017 reverse stock split), a premium of 92% to the market price on that date. The Company also issued ImmunityBio
a warrant to purchase up to 5,000 shares of common stock at $660.00 per share, which such warrant expired on January 26, 2019.
ImmunityBio
conducted an open-label, randomized, Phase 2 study of a combination of immunotherapy, aldoxorubicin, and standard-of-care chemotherapy
versus standard-of-care chemotherapy alone for the treatment of locally advanced or metastatic pancreatic cancer in patients who have
had 1 or 2 lines of treatment (Cohorts A and B) or 3 or greater lines of treatment (Cohort C). In June 2022, Immunity Bio presented data
at the American Society of Clinical Oncology meeting showing that patients receiving combination immunotherapy with aldoxorubicin plus
standard-of-care chemotherapy experienced overall survival of 5.8 months, compared to 3 months for historical control patients that had
received only the standard-of-care chemotherapy (n=78, 95% confidence interval of 4 to 6.9 months). Immunity Bio submitted the results
of the Phase 2 study to the FDA for registration. The FDA denied the request, and asked for a very large clinical trial with cohorts
for each of the combination therapies alone, and in permutative combination with the other combination therapies. Immunity Bio chose
not to proceed with the FDA’s recommended trial, and aldoxorubicin has been returned to LadRx (see below “Mutual Termination
and Release Agreement”).
Aldoxorubicin
has received Orphan Drug Designation (ODD) by the FDA for the treatment of soft tissue sarcoma (“STS”). ODD provides several
benefits including seven years of market exclusivity after approval, certain R&D related tax credits, and protocol assistance by
the FDA. European regulators granted aldoxorubicin Orphan designation for STS which confers ten years of market exclusivity among other
benefits.
Mutual
Termination and Release Agreement
On
June 3, 2024 (the “Effective Date”), we entered into a Mutual Termination and Release Agreement (the “Termination Agreement”)
with NantCell and its parent company, ImmunityBio and XOMA (as defined below). Pursuant to the Termination Agreement, the License Agreement
will terminate automatically on the Effective Date, and neither the Company nor NantCell will have any continuing obligations to each
other than as described in the Termination Agreement. Additionally, except that during the 30 day period following the Effective Date
(the “Discussion Period”), the Company and NantCell shall engage in good faith discussions regarding the terms of an agreement
pursuant to which the Company would have the right to purchase the inventory of aldoxorubicin (including, without limitation, active
pharmaceutical ingredient, WPI and finished dose, the “Inventory”) and all other materials necessary for the research, development
and commercialization, among others, worldwide as of the Effective Date, at the Company’s expense. Subsequently, the Company and
NantCell have agreed the disposition of the Inventory shall be at NantCell’s sole discretion.
The
Termination Agreement additionally provides for the release of the Company and NantCell from claims, demands and liabilities, among others,
and customary representations and warranties, covenants, and other provisions customary for transactions of this nature.
Royalty
Purchase Agreement with XOMA
On
June 21, 2023, the Company, entered into (i) a Royalty Purchase Agreement (the “Royalty Agreement”) with XOMA (US) LLC (“XOMA”),
for the sale, transfer, assignment and conveyance of the Company’s right, title and interest in and to certain royalty payments
and milestone payments with respect to aldoxorubicin, and (ii) an Assignment and Assumption Agreement (the “Assignment Agreement”)
with XOMA for the sale, transfer, assignment and conveyance of the Company’s right, title and interest in the 2011 Arimoclomol
Agreement (as defined herein) between the Company and Orphazyme ApS (“Orphazyme”), dated as of May 13, 2011, and assigned
to Zevra Denmark A/S (“Zevra”), effective as of June 1, 2022, which includes certain royalty and milestone payments with
respect to arimoclomol. The combined aggregate purchase price paid to the Company for the sale, transfer, assignment and conveyance of
the Company’s right, title and interest in and to aldoxorubicin and arimoclomol was $5 million, less certain transaction fees and
expenses.
The
Royalty Agreement and the Assignment Agreement also provide for up to an additional $6 million based on regulatory and commercial milestones
related to the development of arimoclomol and aldoxorubicin by their respective sponsors, Zevra, Inc. and Immunity Bio. The $6 million
in potential post-closing payments is comprised of $1 million upon acceptance by the FDA of the arimoclomol New Drug Application (“NDA”),
$1 million upon first commercial sale of arimoclomol, and $4 million upon FDA approval of aldoxorubicin. All royalty and milestone payments
made to XOMA will be net of the existing licensing and milestone obligations owed by LadRx related to arimoclomol and aldoxorubicin.
In January 2024, the Company recognized the $1 million milestone relating to the acceptance by the FDA of the arimoclomol NDA.
Pursuant
to the Royalty Agreement, the Company agreed to sell, transfer, assign and convey to XOMA, among other payments, all royalty payments
and regulatory and commercial milestone payments payable to the Company pursuant to the worldwide license agreement, dated July 27, 2017,
by and between the Company and Immunity Bio. The Royalty Agreement also provides for the sharing of certain rights with XOMA to bring
any action, demand, proceeding or claim as related to receiving such payments.
First
Amendment to Royalty Purchase Agreement
On
June 3, 2024, in consideration for the termination of the License Agreement pursuant to the Termination Agreement, the Company and XOMA
entered into the First Amendment to the Royalty Agreement (the “First Amendment”). Pursuant to the First Amendment, if the
Company decides to commercialize aldoxorubicin itself, prior to the first commercial sale of aldoxorubicin, the Company and XOMA shall
enter into a synthetic royalty purchase agreement, pursuant to which the Company shall agree to make quarterly royalty payments to XOMA
equal to the amount of all aggregate net sales of aldoxorubicin during each calendar quarter multiplied by 1.5%. If the Company decides
not to commercialize aldoxorubicin itself and instead licenses aldoxorubicin to a third party, upon entry of such a new license agreement,
XOMA shall be entitled to receive (i) royalty payments with respect to net sales of aldoxorubicin payable to the Company multiplied by
7.5% and (ii) milestone payments of 7.5% of any milestone payable to the Company pursuant to the License Agreement. The First Amendment
contains customary covenants and other provisions customary for transactions of this nature.
Transfer
of Rights to Molecular Chaperone Assets
On
May 13, 2011, pursuant to the Asset Purchase Agreement by and between the Company and Orphazyme A/S (“Orphazyme”, formerly
Orphazyme ApS), LadRx sold the rights to arimoclomol and iroxanadine, based on molecular chaperone regulation technology, in exchange
for a one-time, upfront payment and the right to receive up to a total of $120 million in milestone payments upon the achievement of
certain pre-specified regulatory and business milestones, as well as royalty payments based on a specified percentage of any net sales
of products derived from arimoclomol (the “2011 Arimoclomol Agreement”). Orphazyme transferred its rights and obligations
under the 2011 Arimoclomol Agreement to KemPharm Denmark A/S (“KemPharm”), a wholly owned subsidiary of KemPharm Inc., in
May 2022.
In
May 2021, Orphazyme announced that the pivotal phase 3 clinical trial for arimoclomol in Amyotrophic Lateral Sclerosis did not meet its
primary and secondary endpoints, reducing the maximum amount that LadRx currently has the right to receive under the 2011 Arimoclomol
Agreement to approximately $100 million. Orphazyme also tested arimoclomol in Niemann-Pick disease Type C (“NPC”) and Gaucher
disease, and following a Phase II/III trial submitted to the FDA a New Drug Application for the treatment of NPC with arimoclomol. On
June 18, 2021, Orphazyme announced it had received a complete response letter (the “Complete Response Letter”) from the FDA
indicating the need for additional data. In late October 2021, Orphazyme announced it held a Type A meeting with the FDA, at which the
FDA recommended that Orphazyme submit additional data, information and analyses to address certain topics in the Complete Response Letter
and engage in further interactions with the FDA to identify a pathway to resubmission. The FDA concurred with Orphazyme’s proposal
to remove the cognition domain from the NPC Clinical Severity Scale (“NPCCSS”) endpoint, with the result that the primary
endpoint is permitted to be recalculated using the 4- domain NPCCSS, subject to the submission of additional requested information which
Orphazyme had publicly indicated that it intended to provide. To bolster the confirmatory evidence already submitted, the FDA affirmed
that it would require additional in vivo or pharmacodynamic (PD)/pharmacokinetic (PK) data.
Orphazyme
had also submitted a Marketing Authorization Application (“MAA”) with the European Medicines Agency (the “EMA”).
In February 2022, Orphazyme announced that although they had received positive feedback from the Committee for Medicinal Products for
Human Use (“CHMP”) of the EMA, they were notified by the CHMP of a negative trend vote on the MAA for arimoclomol for NPC
following an oral explanation.
On
May 31, 2022, Orphazyme announced that it had completed the sale of substantially all of its assets and business activities for cash
consideration of $12.8 million and assumption of liabilities estimated to equal approximately $5.2 million to KemPharm (the “KemPharm
Transaction”). KemPharm is a specialty biopharmaceutical company focused on the discovery and development of novel treatments for
rare CNS diseases. As part of the KemPharm Transaction, all of Orphazyme’s obligations to LadRx under the 2011 Arimoclomol Agreement,
including with regard to milestone payments and royalties on sales, were assumed by KemPharm. KemPharm is expected to continue the early
access programs with arimoclomol, and to continue to pursue the potential approval of arimoclomol as a treatment option for NPC. KemPharm
re-branded to Zevra Therapeutics, Inc. (“Zevra”) in February 2023. In January 2024, the FDA accepted Zevra’s NDA for
arimoclomol and in September, the FDA approved arimoclomol as an orally-delivered treatment for NPC. In September 2024, Zevra additionally
announced that MIPLYFFA™ (arimoclomol) will be commercially available in the United States towards the end of 2024. Shortly thereafter,
we expect to receive a $1 million milestone payment pursuant to the terms of the Assignment Agreement.
Assignment
and Assumption Agreement with XOMA
On
June 21, 2023, the Company entered into the Assignment Agreement with XOMA, pursuant to which, among others, the Company agreed to sell,
transfer and assign to XOMA the Company’s right, title and interest in the arimoclomol pursuant to the 2011 Arimoclomol Agreement,
including the right to receive certain milestone, royalty and other payments from Zevra.
Pursuant
to the Assignment Agreement, the Company is entitled to receive (i) a one-time payment of $1 million upon acceptance of a re-submission
of a NDA to the FDA for arimoclomol, which the Company received in February 2024, and (ii) a one-time payment of $1 million upon the
first invoiced sale in certain territories of a pharmaceutical product derived from arimoclomol as an active pharmaceutical ingredient,
subject to the receipt of the applicable regulatory approval required to sell such a product in such countries.
Critical
Accounting Policies and Estimates
Management’s
discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared
in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requires management
to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure
of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition,
impairment of long-lived assets, including finite-lived intangible assets, research and development expenses and clinical trial expenses
and stock-based compensation expense.
We
base our estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances,
the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent
from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.
Our
significant accounting policies are summarized in Note 2 to our audited financial statements contained in the 2023 Annual Report.
We
believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our
financial statements.
Stock-Based
Compensation
The
Company accounts for share-based awards to employees and nonemployees directors and consultants in accordance with the provisions of
ASC 718, Compensation—Stock Compensation., and under the recently issued guidance following FASB’s pronouncement,
ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. Under
ASC 718, and applicable updates adopted, share-based awards are valued at fair value on the date of grant and that fair value is recognized
over the requisite service, or vesting, period. The Company values its equity awards using the Black-Scholes option pricing model, and
accounts for forfeitures when they occur.
Known
Trends, Events, and Uncertainties
The
Company does not believe that inflation has had a material effect on its operations to date, other than the impact of inflation on the
general economy. However, there is a risk that the Company’s operating costs could become subject to inflationary pressures in
the future, which would have the effect of increasing the Company’s operating costs, and which would put additional stress on the
Company’s working capital resources.
Additionally,
the consequences of the ongoing conflict between Russia and Ukraine, and the ongoing conflict between Israel and Hamas, including related
sanctions and countermeasures, are difficult to predict, and could adversely impact geopolitical and macroeconomic conditions, the global
economy, and contribute to increased market volatility, which may in turn adversely affect our business and operations. Furthermore,
other than as discussed in this Quarterly Report, we have no committed source of financing and may not be able to raise money as and
when we need it to continue our operations. If we cannot raise funds as and when we need them, we may be required to severely curtail,
or even to cease, our operations. Other than as discussed above and elsewhere in this report, we are not aware of any trends, events
or uncertainties that are likely to have a material effect on our financial condition.
Liquidity
and Capital Resources
Going
Concern
The
Company’s condensed financial statements have been presented on the basis that it will continue as a going concern,
which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. During the nine-month
period ended September 30, 2024, the Company incurred a net loss of $1.9 million and had total stockholders’ deficit as of
September 30, 2024 of $1.8 million. The Company has no recurring revenue, and we are likely to continue to incur losses unless and
until we conclude a successful strategic partnership or financing for our LADR™ technology. As a result, management has
concluded that there is substantial doubt about the Company’s ability to continue as a going concern within one year after the
date that the financial statements are issued. In addition, the Company’s independent registered public accounting firm, in
its audit report on the Company’s consolidated financial statements for the year ended December 31, 2023, expressed
substantial doubt about the Company’s ability to continue as a going concern. The Company’s financial statements do not
include any adjustments that might result from the outcome of this uncertainty.
At
September 30, 2024, we had cash and cash equivalents and short-term investments of approximately $0.1 million. The Company expects
to receive a $1 million milestone payment upon the first commercial sale of arimoclomol from Xoma in the fourth quarter of 2024.
This is predicated upon the recent announcement in September 2024 by Zevra that arimoclomol was approved by the Food and Drug
Administration and that Zevra expects to initiate its lauch activities for MIPLYFFA (arimoclomol) in the fourth quarter of 2024.
The continuation of the Company as a going concern is dependent upon its ability to obtain necessary debt or equity financing to
continue operations until it begins generating positive cash flow. No assurance can be given that any future financing will be
available or, if available, that it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain
additional financing, it may contain undue restrictions on our operations, in the case of debt financing or cause substantial
dilution for our stockholders, in case of equity financing.
Net
cash used in operating activities for the nine months ended September 30, 2024 was $2.0 million, which was primarily the result of the
sale of royalty and milestone rights, net of transaction costs of $1.0 million less a net loss from operations $2.9 million, and $0.1
million in net cash outflows associated with changes in assets and liabilities.
Net
cash provided by operating activities for the nine months ended September 30, 2023 was $1.9 million, which was primarily the result of
the sale of royalty and milestone rights, net of transaction costs of $4.2 million less a net loss from operations of $2.9 million, and
$0.6 million in net cash inflows associated with changes in assets and liabilities.
There
were no investing activities in either of the nine-month periods ended September 30, 2024 and 2023, and we do not expect any significant
capital spending during the next 12 months.
There
were no financing activities in the nine-month period ended September 30, 2024, whereas we purchase the preferred investment option for
$250,000 and paid dividends on the shares of Series C 10.00% Convertible Preferred Stock of $0.1 million in the nine-month period ended
September 30, 2023.
We
continue to evaluate potential future sources of capital, as we do not currently have commitments from any third parties to provide us
with additional capital and we may not be able to obtain future financing on favorable terms, or at all. The results of our technology
licensing efforts and the actual proceeds of any fund-raising activities will determine our ongoing ability to operate as a going concern.
Our ability to obtain future financings through joint ventures, product licensing arrangements, royalty sales, equity financings, grants
or otherwise is subject to market conditions and our ability to identify parties that are willing and able to enter into such arrangements
on terms that are satisfactory to us. Depending upon the outcome of our fundraising efforts, the accompanying financial information may
not necessarily be indicative of our future financial condition. Failure to obtain adequate financing would adversely affect our ability
to operate as a going concern.
We
do not have any off-balance sheet arrangements.
There
can be no assurance that we will be able to generate revenues from our product candidates and become profitable. Even if we become profitable,
we may not be able to sustain that profitability.
Results
of Operations
We
recorded a net loss of approximately $0.8 million and $1.9 million for the three-month and nine-month periods ended September 30, 2024,
respectively, as compared to a net income (loss) of approximately $(0.8) million and $1.2 million for the three-month and nine-month
periods ended September 30, 2023, respectively.
We
recognized no licensing revenue in the nine-month periods ended September 30, 2024 and 2023. We will no longer be entitled to future
licensing revenues from our current licensing agreements, since we transferred the royalty and milestone rights associated with arimoclomol
and aldoxorubicin to XOMA, pursuant to the Royalty Agreement, as amended, and the Assignment Agreement for net proceeds of approximately
$4.2 million, along with $6 million in potential post-closing payments, based on achievement of certain future milestones. For the nine-month
period ended September 30, 2023, we recognized those net proceeds of $4.2 million as Other Income on our statement of operations, and
for the nine-month period ended September 30, 2024, we recognized a $1.0 million post-closing as Other Income on our statement of operations.
General
and Administrative Expenses
| |
Three-Month
Period Ended September 30, | | |
Nine-Month
Period Ended September
30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
(In thousands) | | |
(In thousands) | |
General and administrative expenses | |
$ | 818 | | |
$ | 823 | | |
$ | 2,262 | | |
$ | 2,918 | |
Amortization of stock awards | |
| 4 | | |
| — | | |
| 59 | | |
| — | |
Depreciation and amortization | |
| 1 | | |
| 3 | | |
| 5 | | |
| 9 | |
| |
$ | 823 | | |
$ | 826 | | |
$ | 2,326 | | |
$ | 2,927 | |
General
and administrative expenses include all administrative salaries and general corporate expenses, including legal expenses. Our general
and administrative expenses, excluding stock expense, non-cash expenses and depreciation and amortization, were $0.8 million and $2.3
million for the three and nine-month periods ended September 30, 2024, respectively, and $0.8 million and $2.9 million, respectively,
for the same periods in 2023. Our general and administrative expenses in the comparative periods excluding amortization of stock awards,
non-cash expenses and depreciation and amortization, decreased primarily due to a decrease in professional fees, insurance costs and
salaries, offset by an increase in franchise taxes.
Research
and Development
Research
expenses are incurred by us in the discovery of new information that will assist us in the development of LADR-7. We incurred $14,000
of these expenses for both the three and nine-month periods ended September 30, 2023, whereas for the three and nine-month period ended
September 30, 2024, we incurred $4,400 and $629,000 respectively in research and development expenses.
Interest
Income
Interest
income was approximately $3,000 and $33,000 for the three-month and nine-month periods ended September 30, 2024, respectively, as compared
to $24,000 and $31,000, respectively, for the same periods in 2023.
Item
3. — Quantitative and Qualitative Disclosures About Market Risk
Our
exposure to market risk is limited primarily to interest income sensitivity, which is affected by changes in the general level of U.S.
interest rates, particularly because a significant portion of our investments are in short-term debt securities issued by the U.S. government
and institutional money market funds. The primary objective of our investment activities is to preserve principal. Due to the nature
of our short-term investments, we believe that we are not subject to any material market risk exposure. We do not have any speculative
or hedging derivative financial instruments or foreign currency instruments. If interest rates had varied by 10% in the three-month period
ended September 30, 2024, it would not have had a material effect on our results of operations or cash flows for that period.
Item
4. — Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and our Chief Financial Officer, performed an evaluation of the effectiveness
of the design and operation of our disclosure controls and procedures (as defined in Securities Exchange Act Rule 13a-15(e)) as of the
end of the quarterly period covered by this Quarterly Report on Form 10-Q. Based on that evaluation, our Chief Executive Officer and
our Chief Financial Officer concluded that our disclosure controls and procedures were effective to ensure that information required
to be disclosed by us in reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized
and reported within the time periods specified in the rules and forms of the SEC.
Our
disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives as specified above. Management
does not expect, however, that our disclosure controls and procedures will prevent or detect all errors and fraud. Any control system,
no matter how well designed and operated, is based upon certain assumptions and can provide only reasonable, not absolute, assurance
that its objectives will be met. Further, no evaluation of controls can provide absolute assurance that misstatements due to error or
fraud will not occur or that all control issues and instances of fraud, if any, within the Company have been detected.
Changes
in Controls over Financial Reporting
There
was no change in our internal control over financial reporting that occurred during the quarter ended September 30, 2024 that materially
affected, or is reasonably likely to materially affect, our internal control over financial reporting. We continually seek to assure
that all of our controls and procedures are adequate and effective. Any failure to implement and maintain improvements in the controls
over our financial reporting could cause us to fail to meet our reporting obligations under the SEC’s rules and regulations. Any
failure to improve our internal controls to address the weaknesses we have identified could also cause investors to lose confidence in
our reported financial information, which could have a negative impact on the trading price of our common stock.
PART
II — OTHER INFORMATION
Item
1. — Legal Proceedings
None.
Item
1A. — Risk Factors
The
following description of risk factors includes any material changes to risk factors associated with our business, financial condition
and results of operations previously disclosed in “Item 1A. Risk Factors” of the Annual Report on Form 10-K for the year
ended December 31, 2023, and filed with the SEC on April 16, 2024. Our business, financial condition and operating results can be affected
by a number of factors, whether currently known or unknown, including but not limited to those described below, any one or more of which
could, directly or indirectly, cause our actual financial condition and operating results to vary materially from past, or from anticipated
future, financial condition and operating results. Any of these factors, in whole or in part, could materially and adversely affect our
business, financial condition, operating results, and stock price.
The
following discussion of risk factors contains forward-looking statements. These risk factors may be important to understanding other
statements in this Form 10-Q. The following information should be read in conjunction with the condensed consolidated financial statements
and related notes in Part I, Item 1, “Financial Statements” and Part I, Item 2, “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” of this Form 10-Q.
Because
we have no source of significant recurring revenue, we must depend on capital raising to sustain our operations, and our ability to raise
capital may be severely limited.
Developing
products and conducting clinical trials require substantial amounts of capital. We need to raise additional capital to fund our general
and administrative expenses and, if we determine to develop products based on our LADR™ technology platform, we will need to raise
additional capital to fund development of product candidates, prepare, file, prosecute, maintain, enforce and defend patent and other
proprietary rights, and develop and implement sales, marketing and distribution capabilities. However, capital raising has been significantly
challenging.
At
September 30, 2024, we had cash and cash equivalents and short-term investments of approximately $0.1 million. Our continuation as a
going concern is dependent upon our ability to obtain necessary debt or equity financing to continue operations until we begin generating
positive cash flow. No assurance can be given that any future financing will be available or, if available, that it will be on terms
that are satisfactory to us. Even if we are able to obtain additional financing, it may contain undue restrictions on our operations,
in the case of debt financing or cause substantial dilution for our stockholders, in case of equity financing. Additionally, pursuant
to the Assignment Agreement, we expect to receive a $1 million milestone royalty payment upon the first commercial sale of MIPLYFFA (arimoclomol)
by Zevra. The commercial launch of MIPLYFFA is expected in the fourth quarter of 2024. There is no assurance that we will receive this
milestone royalty payment in a timely manner, or that such milestone royalty payment is sufficient to meet our anticipated cash requirements.
This in turn may have a material adverse effect on our business, operating results and prospects.
If
we raise additional funds by issuing equity securities, dilution to stockholders may result and new investors could have rights superior
to current equity holders. In addition, debt financing, if available, may include restrictive covenants. If adequate funds are not available
to us, we may have to liquidate some or all of our assets or delay or reduce the scope of or eliminate some portion or all of our development
programs. We also may have to license to other companies our product candidates or technologies that we would prefer to develop and commercialize
ourselves.
Item
2. — Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item
3. — Defaults Upon Senior Securities
None.
Item
4. — Mine Safety Disclosure
Not
applicable.
Item
5. — Other Information
None.
Item
6. — Exhibits
The
exhibits listed in the accompanying Index to Exhibits are filed or furnished as part of this Quarterly Report on Form 10-Q and incorporated
herein by reference.
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.
|
LadRx
Corporation |
|
|
|
Date:
November 14, 2024 |
By:
|
/s/
JOHN Y. CALOZ |
|
|
John
Y. Caloz |
|
|
Chief
Financial Officer |
INDEX
TO EXHIBITS
*
Filed herewith.
**
Furnished herewith.
Exhibit
31.1
CERTIFICATIONS
I,
Stephen Snowdy, Chief Executive Officer of LadRx Corporation, certify that:
1. I
have reviewed this quarterly report on Form 10-Q of LadRx Corporation;
2. Based
on my knowledge, this quarterly 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 quarterly report;
3. Based
on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this
quarterly report;
4. The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its subsidiaries, is made known to us by others within those entities,
particularly during the period in which this quarterly 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, as of the end of the period covered by this report based on such evaluation;
and
(d) Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):
(a) All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
November 14, 2024 |
By:
|
/s/
STEPHEN SNOWDY |
|
|
Stephen
Snowdy |
|
|
Chief
Executive Officer |
Exhibit
31.2
CERTIFICATIONS
I,
John Y. Caloz, Chief Financial Officer of LadRx Corporation, certify that:
1. I
have reviewed this quarterly report on Form 10-Q of LadRx Corporation;
2. Based
on my knowledge, this quarterly 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 quarterly 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 as of, and for, the periods presented in this quarterly
report;
4. The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act
Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its subsidiaries, is made known to us by others within those entities,
particularly during the period in which this quarterly 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, as of the end of the period covered by this report based on such evaluation;
and
(d) Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions):
(a) All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting.
Date:
November 14, 2024 |
By:
|
/s/
JOHN Y. CALOZ |
|
|
John
Y. Caloz |
|
|
Chief
Financial Officer |
Exhibit
32.1
Certification
of Chief Executive Officer
Pursuant
to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned Chief Executive Officer of LadRx
Corporation (the “Company”) hereby certifies that to his knowledge:
(i) the
accompanying Quarterly Report on Form 10-Q of the Company for the period ended September 30, 2024 as filed with the Securities and Exchange
Commission on the date hereof (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable,
of the Securities Exchange Act of 1934, as amended; and
(ii) the
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the
Company as of and for the periods covered in the Report.
Date:
November 14, 2024 |
By:
|
/s/
STEPHEN SNOWDY |
|
|
Stephen
Snowdy |
|
|
Chief
Executive Officer |
A
signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 (Section 906), or other document
authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written
statement required by Section 906, has been provided to LadRx Corporation and will be retained by LadRx Corporation and furnished to
the Securities and Exchange Commission or its staff upon request.
The
foregoing certification is being furnished to the Securities and Exchange Commission as an Exhibit to the Form 10-Q and shall not be
considered filed as part of the Form 10-Q.
Exhibit
32.2
Certification
of Chief Financial Officer
Pursuant
to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned Chief Financial Officer of LadRx
Corporation (the “Company”) hereby certifies that to his knowledge:
(i) the
accompanying Quarterly Report on Form 10-Q of the Company for the period ended September 30, 2024 as filed with the Securities and Exchange
Commission on the date hereof (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable,
of the Securities Exchange Act of 1934, as amended; and
(ii) the
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the
Company as of and for the periods covered in the Report.
Date:
November 14, 2024 |
By:
|
/s/
JOHN Y. CALOZ |
|
|
John
Y. Caloz |
|
|
Chief
Financial Officer |
A
signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 (Section 906), or other document
authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written
statement required by Section 906, has been provided to LadRx Corporation and will be retained by LadRx Corporation and furnished to
the Securities and Exchange Commission or its staff upon request.
The
foregoing certification is being furnished to the Securities and Exchange Commission as an Exhibit to the Form 10-Q and shall not be
considered filed as part of the Form 10-Q.
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v3.24.3
Condensed Balance Sheets - USD ($)
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 57,256
|
$ 2,070,075
|
Prepaid expenses and other current assets |
13,557
|
191,783
|
Total current assets |
70,813
|
2,261,858
|
Equipment and furnishings, net |
2,086
|
6,711
|
Other assets |
1,475
|
7,703
|
Operating lease right-of-use asset |
|
31,610
|
Total assets |
74,374
|
2,307,882
|
Current liabilities: |
|
|
Accounts payable |
795,680
|
1,202,689
|
Accrued expenses and other current liabilities |
1,033,158
|
964,233
|
Current portion of operating lease liabilities |
|
33,606
|
Total current liabilities |
1,828,838
|
2,200,528
|
Commitments and contingencies |
|
|
Stockholders’ equity (deficit): |
|
|
Preferred Stock, $0.01 par value, 833,333 shares authorized, including 50,000 shares of Series B Junior Participating Preferred Stock; no shares issued and outstanding |
|
|
Common stock, $0.001 par value, 62,393,940 shares authorized 495,092 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively |
495
|
495
|
Additional paid-in capital |
488,671,864
|
488,612,890
|
Accumulated deficit |
(490,426,823)
|
(488,506,031)
|
Total stockholders’ equity (deficit) |
(1,754,464)
|
107,354
|
Total liabilities and stockholders’ equity (deficit) |
$ 74,374
|
$ 2,307,882
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v3.24.3
Condensed Balance Sheets (Parenthetical) - $ / shares
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Preferred stock, par value |
$ 0.01
|
$ 0.01
|
Preferred stock, shares authorized |
833,333
|
833,333
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
62,393,940
|
62,393,940
|
Common stock, shares issued |
495,092
|
495,092
|
Common stock, shares outstanding |
495,092
|
495,092
|
Series B Junior Participating Preferred Stock [Member] |
|
|
Preferred stock, shares authorized |
50,000
|
50,000
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.3
Condensed Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Revenue: |
|
|
|
|
Licensing revenue |
|
|
|
|
Expenses: |
|
|
|
|
Research and development |
4,463
|
14,625
|
628,543
|
14,625
|
General and administrative |
823,250
|
825,688
|
2,325,636
|
2,926,892
|
Loss from operations |
(827,713)
|
(840,313)
|
(2,954,179)
|
(2,941,517)
|
Other income: |
|
|
|
|
Interest income |
3,173
|
24,307
|
33,386
|
31,405
|
Sale of royalty and milestone rights, net of transaction costs |
|
|
1,000,000
|
4,167,219
|
Other |
|
17
|
|
1,372
|
Net income (loss) |
(824,540)
|
(815,989)
|
(1,920,793)
|
1,258,479
|
Dividends paid on preferred shares |
|
|
|
(68,809)
|
Net income (loss) attributable to common stockholders |
$ (824,540)
|
$ (815,989)
|
$ (1,920,793)
|
$ 1,189,670
|
Total basic income (loss) per share |
$ (1.67)
|
$ (1.65)
|
$ (3.88)
|
$ 2.59
|
Total diluted income (loss) per share |
$ (1.67)
|
$ (1.65)
|
$ (3.88)
|
$ 2.59
|
Basic weighted-average shares outstanding |
495,092
|
495,092
|
495,092
|
486,101
|
Diluted weighted-average shares outstanding |
495,092
|
495,092
|
495,092
|
486,101
|
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v3.24.3
Condensed Statements of Cash Flows (Unaudited) - USD ($)
|
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Cash flows from operating activities: |
|
|
Net income (loss) from operations |
$ (1,920,793)
|
$ 1,258,479
|
Adjustments to reconcile net income (loss) to net cash used in operating activities: |
|
|
Depreciation and amortization |
4,625
|
8,876
|
Stock-based compensation expense |
58,974
|
|
Changes in assets and liabilities: |
|
|
Prepaid expenses and other current assets |
178,226
|
592,511
|
Other assets |
6,228
|
|
Amortization of operating lease right-of-use asset |
31,610
|
138,236
|
Accounts payable |
(407,009)
|
11,079
|
Operating lease liabilities |
(33,605)
|
(146,078)
|
Accrued expenses and other current liabilities |
68,925
|
14,124
|
Net cash provided by (used in) operating activities |
(2,012,819)
|
1,877,227
|
Cash flows from financing activities |
|
|
Preferred stock dividend |
|
(68,809)
|
Purchase of preferred investment option |
|
(250,000)
|
Net cash used in financing activities |
|
(318,809)
|
Net increase (decrease) in cash and cash equivalents |
(2,012,819)
|
1,558,418
|
Cash and cash equivalents at beginning of period |
2,070,075
|
1,374,992
|
Cash and cash equivalents at end of period |
57,256
|
2,933,410
|
Supplemental disclosure of Cash Flow Information: |
|
|
Conversion of Series C 10% Convertible Preferred Stock to Common Stock |
|
$ 1,343,684
|
X |
- DefinitionIncrease decrease in amortization of right of use asset.
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v3.24.3
Condensed Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($)
|
Preferred Stock [Member]
Series B Preferred Stock [Member]
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
|
$ 450
|
$ 487,519,251
|
$ (488,837,665)
|
$ (1,317,964)
|
Balance, shares at Dec. 31, 2022 |
|
450,374
|
|
|
|
Net income (loss) |
|
|
|
(1,074,498)
|
(1,074,498)
|
1 for 100 reverse stock split fractional shares |
|
$ 13
|
(13)
|
|
|
1 for 100 reverse stock split fractional shares, shares |
|
13,191
|
|
|
|
Conversion of Series C Convertible Preferred Stock |
|
$ 15
|
655,139
|
|
655,154
|
Conversion of Series C Convertible Preferred Stock, shares |
|
15,250
|
|
|
|
Preferred dividend |
|
|
|
(68,809)
|
(68,809)
|
Issuance of common stock |
|
$ 1
|
(1)
|
|
|
Issuance of common stock, shares |
|
250
|
|
|
|
Balance at Mar. 31, 2023 |
|
$ 479
|
488,174,376
|
489,980,972
|
(1,806,117)
|
Balance, shares at Mar. 31, 2023 |
|
479,065
|
|
|
|
Balance at Dec. 31, 2022 |
|
$ 450
|
487,519,251
|
(488,837,665)
|
(1,317,964)
|
Balance, shares at Dec. 31, 2022 |
|
450,374
|
|
|
|
Net income (loss) |
|
|
|
|
1,258,479
|
Balance at Sep. 30, 2023 |
|
$ 495
|
488,612,890
|
(487,647,995)
|
965,390
|
Balance, shares at Sep. 30, 2023 |
|
495,092
|
|
|
|
Balance at Mar. 31, 2023 |
|
$ 479
|
488,174,376
|
489,980,972
|
(1,806,117)
|
Balance, shares at Mar. 31, 2023 |
|
479,065
|
|
|
|
Net income (loss) |
|
|
|
3,148,966
|
3,148,966
|
Conversion of Series C Convertible Preferred Stock |
|
$ 16
|
688,514
|
|
688,530
|
Conversion of Series C Convertible Preferred Stock, shares |
|
16,027
|
|
|
|
Payment to redeem investment option |
|
|
(250,000)
|
|
(250,000)
|
Balance at Jun. 30, 2023 |
|
$ 495
|
488,612,890
|
(486,832,006)
|
1,781,379
|
Balance, shares at Jun. 30, 2023 |
|
495,092
|
|
|
|
Net income (loss) |
|
|
|
(815,989)
|
(815,989)
|
Balance at Sep. 30, 2023 |
|
$ 495
|
488,612,890
|
(487,647,995)
|
965,390
|
Balance, shares at Sep. 30, 2023 |
|
495,092
|
|
|
|
Balance at Dec. 31, 2023 |
|
$ 495
|
488,612,890
|
(488,506,031)
|
107,354
|
Balance, shares at Dec. 31, 2023 |
|
495,092
|
|
|
|
Stock compensation on vested options |
|
|
51,119
|
|
51,119
|
Net income (loss) |
|
|
|
186,735
|
186,735
|
Balance at Mar. 31, 2024 |
|
$ 495
|
488,664,009
|
(488,319,296)
|
345,208
|
Balance, shares at Mar. 31, 2024 |
|
495,092
|
|
|
|
Balance at Dec. 31, 2023 |
|
$ 495
|
488,612,890
|
(488,506,031)
|
107,354
|
Balance, shares at Dec. 31, 2023 |
|
495,092
|
|
|
|
Net income (loss) |
|
|
|
|
(1,920,793)
|
Balance at Sep. 30, 2024 |
|
$ 495
|
488,671,864
|
(490,426,823)
|
(1,754,464)
|
Balance, shares at Sep. 30, 2024 |
|
495,092
|
|
|
|
Balance at Mar. 31, 2024 |
|
$ 495
|
488,664,009
|
(488,319,296)
|
345,208
|
Balance, shares at Mar. 31, 2024 |
|
495,092
|
|
|
|
Stock compensation on vested options |
|
|
3,928
|
|
3,928
|
Net income (loss) |
|
|
|
(1,282,987)
|
(1,282,987)
|
Balance at Jun. 30, 2024 |
|
$ 495
|
488,667,937
|
(489,602,283)
|
(933,851)
|
Balance, shares at Jun. 30, 2024 |
|
495,092
|
|
|
|
Stock compensation on vested options |
|
|
3,927
|
|
3,927
|
Net income (loss) |
|
|
|
(824,540)
|
(824,540)
|
Balance at Sep. 30, 2024 |
|
$ 495
|
$ 488,671,864
|
$ (490,426,823)
|
$ (1,754,464)
|
Balance, shares at Sep. 30, 2024 |
|
495,092
|
|
|
|
X |
- DefinitionAdjustments to additional paid in payment to redeem investment option.
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v3.24.3
Basis of Presentation and Significant Accounting Policies
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation and Significant Accounting Policies |
1. Basis of Presentation and Significant Accounting Policies
Basis
of Presentation
The
accompanying condensed financial statements of Ladrx Corporation (the “Company”) at September 30, 2024, and for the
three-month and nine-month periods ended September 30, 2024 and 2023, respectively, are unaudited, but include all adjustments,
consisting of normal recurring entries, that management believes to be necessary for a fair presentation of the periods presented.
Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2023 were
derived from our audited financial statements as of that date.
The
financial statements included herein have been prepared by us pursuant to the rules and regulations of the Securities and Exchange Commission
(“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with
accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to such rules and regulations.
The financial statements should be read in conjunction with our audited financial statements contained in the 2023 Annual Report.
Going
Concern
The
Company’s condensed financial statements have been presented on the basis that it will continue as a going concern, which contemplates
the realization of assets and satisfaction of liabilities in the normal course of business. During the nine-month period ended September
30, 2024, the Company incurred a net loss of $1.9 million and had total stockholders’ deficit as of September 30, 2024 of $1.8
million. The Company has no recurring revenue, and we are likely to continue to incur losses unless and until we conclude a successful
strategic partnership or financing for our LADR™ technology. As a result, management has concluded that there is substantial doubt
about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued.
In addition, the Company’s independent registered public accounting firm, in its audit report on the Company’s consolidated
financial statements for the year ended December 31, 2023, expressed substantial doubt about the Company’s ability to continue
as a going concern. The Company’s financial statements do not include any adjustments that might result from the outcome of this
uncertainty.
At
September 30, 2024, we had cash and cash equivalents and short-term investments of approximately $0.1 million. The Company expects to
receive a $1 million milestone payment upon the first commercial sale of arimoclomol from Xoma in the fourth quarter of 2024. This is
predicated upon the recent announcement in September 2024 by Zevra that arimoclomol was approved by the Food and Drug Administration
and that Zevra expects to initiate its lauch activities for MIPLYFFA (arimoclomol) in the fourth quarter of 2024. The continuation
of the Company as a going concern is dependent upon its ability to obtain necessary debt or equity financing to continue operations until
it begins generating positive cash flow. No assurance can be given that any future financing will be available or, if available, that
it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, it may contain
undue restrictions on our operations, in the case of debt financing or cause substantial dilution for our stockholders, in case of equity
financing.
2023 Reverse Stock Split
The
Company effected a 1-for-100 reverse stock split (the “Reverse Stock Split”) of its issued and outstanding shares of
common stock on May 17, 2023, pursuant to which every 100 shares of the Company’s issued and outstanding shares of common stock
were converted into one share of common stock without any change in the par value per share. Any
fraction of a share of common stock that would otherwise have resulted from the Reverse Stock Split was rounded up to the nearest whole
share. All share and per share amounts in this Quarterly Report and the accompanying financial statements and the notes thereto
have been adjusted to reflect the Reverse Stock Split as if it had occurred at the beginning of the earliest period presented.
Use
of Estimates
Preparation
of the Company’s condensed financial statements in conformance with U.S. GAAP requires the Company’s management to make estimates
and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets
and liabilities in the Company’s condensed financial statements and accompanying notes. The significant estimates in the Company’s
condensed financial statements relate to the valuation of equity awards, recoverability of deferred tax assets, and estimated useful
lives of fixed assets, The Company bases estimates and assumptions on historical experience, when available, and on various factors that
it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis, and its
actual results may differ from estimates made under different assumptions or conditions.
Fair
Value Measurements
The
Company measures the fair value of financial instruments using a fair value hierarchy that prioritizes the inputs to valuation techniques
used to measure fair value into three broad levels:
Level
1—Inputs used to measure fair value are unadjusted quoted prices that are available in active markets for the identical assets
or liabilities as of the reporting date.
Level
2— Other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement
date.
Level
3—Unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment
are used to measure fair value. These values are generally determined using pricing models for which the assumptions utilize management’s
estimates of market participant assumptions. The determination of fair value for Level 3 investments and other financial instruments
involves the most management judgment and subjectivity.
The
carrying amounts of financial assets and liabilities, such as cash, other current assets, accounts payable, and accrued expenses, approximate
their fair values because of the short maturity of these instruments.
Research
and Development Expenses
Research
and development expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs
to acquire technologies, including licenses and drugs, that are utilized in research and development and that have no alternative future
use are expensed when incurred. Technology developed for use in its products is expensed as incurred until technological feasibility
has been established.
Stock
Compensation
The
Company accounts for share-based awards to employees and non-employee directors and consultants in accordance with the provisions of
ASC 718, Compensation—Stock Compensation., and under the recently issued guidance following FASB’s pronouncement,
ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. Under
ASC 718, and applicable updates adopted, share-based awards are valued at fair value on the date of grant and that fair value is recognized
over the requisite service, or vesting, period. The Company values its equity awards using the Black-Scholes option pricing model, and
accounts for forfeitures when they occur. Recognition of compensation expense for non-employees is in the same period and manner
as if the Company had paid cash for the services.
Basic
and Diluted Net Income (Loss) Per Common Share
Basic
and diluted net loss per common share is computed based on the weighted-average number of common shares outstanding for the period. Diluted
net income (loss) per share is computed by dividing the net income (loss) applicable to common stockholders by the weighted average number
of common shares outstanding plus the number of additional common shares that would have been outstanding if all dilutive potential common
shares had been issued using the treasury stock method. Potential common shares are excluded from computation when their effect is antidilutive.
Common share equivalents that could potentially dilute net loss per share in the future, and which were excluded from the computation
of diluted loss per share, were as follows:
Schedule of Shares Excluded from Computation of Diluted Loss Per Share
| |
2024 | | |
2023 | |
| |
As of September 30, | |
| |
2024 | | |
2023 | |
Options to acquire common stock | |
| 69,000 | | |
| 15,647 | |
Warrants to acquire common stock | |
| — | | |
| 42 | |
Shares excluded from computation
of diluted loss per share | |
| 69,000 | | |
| 15,689 | |
Recently
Issued Accounting Pronouncements
Recent
authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants,
and the SEC did not, or are not expected to, have a material impact on the Company’s condensed financial statements and related
disclosures.
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v3.24.3
Financing Under Securities Purchase Agreement
|
9 Months Ended |
Sep. 30, 2024 |
Equity Method Investments and Joint Ventures [Abstract] |
|
Financing Under Securities Purchase Agreement |
2. Financing Under Securities Purchase Agreement
On
July 13, 2021, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a single institutional
investor (the “Investor”) for aggregate gross proceeds of $10 million and net proceeds of approximately $9.2 million. The
transaction closed on July 16, 2021. Under the Purchase Agreement, the Company sold and issued (i) 20,000 shares of its common stock
at a purchase price of $88.00 per share for total gross proceeds of approximately $1.76 million in a registered direct offering (the
“Registered Direct Offering”) and (ii) 8,240 shares of Series C 10.00% Convertible Preferred Stock (the “Series C Preferred
Stock”) at a purchase price of $1,000 per share, for aggregate gross proceeds of approximately $8.24 million, in a concurrent private
placement (the “Private Placement” and, together with the Registered Direct Offering, the “July 2021 Offerings”).
The shares of the Series C Preferred Stock were convertible, upon shareholder approval as described below, into an aggregate of up to
93,637 shares of common stock at a conversion price of $88.00 per share. Holders of the Series C Preferred Stock were entitled to receive,
cumulative dividends at the rate per share (as a percentage of the stated value per share) of 10.00% per annum, payable quarterly on
January 1, April 1, July 1 and October 1, beginning on the first such date after the date of issuance. The terms of the Series C Preferred
Stock included beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99%
of the Company’s outstanding shares of common stock. LadRx also issued to the Investor an unregistered Preferred Investment Option
(“PIO”) that prior to redemption and cancelation of the PIO on June 29, 2023 (as described herein) allowed for the purchase
of up to 113,637 shares of common stock for additional gross proceeds of approximately $10 million if the PIO was exercised in full.
The exercise price for the PIO was $88.00 per share. The PIO had a term equal to five and one-half years commencing upon the Company
increasing its authorized common stock following shareholder approval.
In
2022, the Company paid the following dividends: on January 1, 2022, $206,000, on April 1, 2022, $202,567, on July 1, 2022, $84,005 and
on October 1, 2022, $68,809 for a total of $561,381. On January 3, 2023, the Company paid a dividend of $68,809.
At
December 31, 2022, the Company had 2,752 shares of Series C Preferred Stock outstanding. On January 31, 2023, the Investor converted
a further 1,342 shares of Series C Preferred Stock for 15,250 shares of common stock and on May 8, 2023, the Investor converted its remaining
shares of Series C Preferred Shares for 16,027 shares of common stock. As of September 30, 2024 and December 31, 2023, there were no
shares of Series C Preferred Stock issued and outstanding.
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v3.24.3
XOMA
|
9 Months Ended |
Sep. 30, 2024 |
Xoma |
|
XOMA |
3. XOMA
Royalty
Purchase Agreement with XOMA
On
June 21, 2023, the Company, entered into (i) a Royalty Purchase Agreement (the “Royalty Agreement”) with XOMA (US) LLC (“XOMA”),
for the sale, transfer, assignment and conveyance of the Company’s right, title and interest in and to certain royalty payments
and milestone payments with respect to aldoxorubicin, and (ii) an Assignment and Assumption Agreement (the “Assignment Agreement”)
with XOMA for the sale, transfer, assignment and conveyance of the Company’s right, title and interest in the Asset Purchase Agreement
(the “2011 Arimoclomol Agreement”) between the Company and Orphazyme ApS (“Orphazyme”), dated as of May 13, 2011,
and assigned to Zevra Denmark A/S (“Zevra Denmark”), effective as of June 1, 2022, which includes certain royalty and milestone
payments with respect to arimoclomol. The combined aggregate purchase price paid to the Company for the sale, transfer, assignment and
conveyance of the Company’s right, title and interest in and to aldoxorubicin and arimoclomol was $5 million, less certain transaction
fees and expenses.
The
Royalty Agreement and the Assignment Agreement also provided for up to an additional $6 million based on regulatory and commercial milestones
related to the development of arimoclomol and aldoxorubicin by their respective sponsors, Zevra, Inc. and Immunity Bio. The $6 million
in potential post-closing payments was comprised of $1 million upon acceptance by the FDA of the arimoclomol New Drug Application (“NDA”),
$1 million upon first commercial sale of arimoclomol, and $4 million upon FDA approval of aldoxorubicin. All royalty and milestone payments
made to XOMA were net of the existing licensing and milestone obligations owed by LadRx related to arimoclomol and aldoxorubicin.
Pursuant
to the Royalty Agreement, the Company agreed to sell, transfer, assign and convey to XOMA, among other payments, all royalty payments
and regulatory and commercial milestone payments payable to the Company pursuant to the worldwide license agreement (the “License
Agreement”), dated July 27, 2017, by and between the Company and ImmunityBio, Inc (“ImmunityBio”). The Royalty Agreement
also provides for the sharing of certain rights with XOMA to bring any action, demand, proceeding or claim as related to receiving such
payments.
Management
determined that the Royalty Agreement is not considered to be with a customer, and it does not fall within the scope of ASC 606. Instead,
the Royalty Agreement represents an in-substance sale of non-financial assets and, therefore, should be accounted for within the scope
of ASC 610-20.
First
Amendment to Royalty Purchase Agreement
On
June 3, 2024, in consideration for the termination of the License Agreement pursuant to the Termination Agreement (as defined below),
the Company and XOMA entered into the First Amendment to the Royalty Agreement (the “First Amendment”).
Pursuant
to the First Amendment, if the Company decides to commercialize aldoxorubicin itself, prior to the first commercial sale of aldoxorubicin,
the Company and XOMA shall enter into a synthetic royalty purchase agreement, pursuant to which the Company shall agree to make quarterly
royalty payments to XOMA equal to the amount of all aggregate net sales of aldoxorubicin during each calendar quarter multiplied by 1.5%.
If the Company decides not to commercialize aldoxorubicin itself and instead licenses aldoxorubicin to a third party, upon entry of such
a new license agreement, XOMA shall be entitled to receive (i) royalty payments with respect to net sales of aldoxorubicin payable to
the Company multiplied by 7.5% and (ii) milestone payments of 7.5% of any milestone payable to the Company pursuant to the License Agreement.
The First Amendment contains customary covenants and other provisions customary for transactions of this nature.
Mutual
Termination and Release Agreement
On
June 3, 2024, pursuant to a Mutual Termination and Release Agreement (the “Termination Agreement”), the Company, NantCell,
Inc., a Delaware corporation (“NantCell, Inc.,” and together with ImmunityBio “NantCell”), and its parent company,
ImmunityBio, and XOMA agreed to a mutual termination of the License Agreement, effective as of the same date (the “Effective Date”).
Neither the Company nor NantCell will have any continuing obligations to each other than as described in the Termination Agreement. Additionally,
except that during the 30 day period following the Effective Date (the “Discussion Period”), the Company and NantCell shall
engage in good faith discussions regarding the terms of an agreement pursuant to which the Company would have the right to purchase the
inventory of aldoxorubicin (including, without limitation, active pharmaceutical ingredient, WPI and finished dose, the “Inventory”)
and all other materials necessary for the research, development and commercialization, among others, worldwide as of the Effective Date,
at the Company’s expense. Subsequently, the Company and NantCell have agreed that the disposition of the Inventory shall be at
NantCell’s sole discretion.
The
Termination Agreement additionally provides for the release of the Company and NantCell from claims, demands and liabilities, among others,
and customary representations and warranties, covenants, and other provisions customary for transactions of this nature.
Assignment
and Assumption Agreement with XOMA
On
June 21, 2023, the Company entered into the Assignment Agreement with XOMA, pursuant to which, among others, the Company agreed to sell,
transfer and assign to XOMA the Company’s right, title and interest in the arimoclomol pursuant to the 2011 Arimoclomol Agreement,
including the right to receive certain milestone, royalty and other payments from Zevra Denmark.
Pursuant
to the Assignment Agreement, the Company is entitled to receive (i) a one-time payment of $1 million upon acceptance of a re-submission
of an NDA to the FDA for arimoclomol, and (ii) a one-time payment of $1 million upon the first invoiced sale in certain territories of
a pharmaceutical product derived from arimoclomol as an active pharmaceutical ingredient, subject to the receipt of the applicable regulatory
approval required to sell such a product in such countries. In January 2024, Zevra announced the FDA had accepted the NDA for arimoclomol
and the Company received the one-time payment of $1 million in February 2024 recognized such net proceeds of $1.0 million as other income
in the statement of operations for the period ended March 31, 2024
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v3.24.3
Stock Based Compensation
|
9 Months Ended |
Sep. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Stock Based Compensation |
4. Stock Based Compensation
The
Company has the 2008 Stock Incentive Plan (the “2008 Plan”) under which 50,000 shares of common stock are reserved for issuance.
As of September 30, 2024, there were approximately 10,500 shares subject to outstanding stock options and approximately 8,000 shares
outstanding related to restricted stock grants issued from the 2008 Plan. This plan expired on November 20, 2018 and thus no further
shares are available for future grant under this plan.
In
November 2019, the Company adopted the 2019 Stock Incentive Plan (the “2019 Plan”) under which 54,000 shares of common stock
are reserved for issuance. As of September 30, 2024, there were 3,500 shares subject to outstanding stock options and 250 shares outstanding
related to restricted stock grants from the 2019 Plan. This Plan expires on November 14, 2029.
On
September 7, 2023, the Board approved the first amendment (the “Plan Amendment”) to the 2019 Plan, effective as of the same
date. The Plan Amendment amends the 2019 Plan to (i) reflect the Company’s recent name change from CytRx Corporation to LadRx Corporation,
and (ii) increase the aggregate number of shares of common stock that may be issued under the 2019 Plan, as set forth in Section 4(a)
of the 2019 Plan, by an additional 75,000 shares of common stock. On September 7, 2023, the Board additionally approved and set January
16, 2024, as the grant date for certain stock options to purchase shares of common stock to certain directors and officers of the Company,
which such options to purchase up to a total of 55,000 shares of common stock were granted to employees and directors. Fifty percent
of these options were immediately vested, and the remaining balance will vest in equal installments on a monthly basis over three years.
There were no options issued in the period ended September 30, 2023.
The
fair value of the stock options at the date of grant was estimated using the Black-Scholes option-pricing model, based on the following
assumptions:
Schedule of Fair Value of Stock Options at the Date of Grant
| |
2024 | | |
2023 | |
Risk-free interest rate | |
| 3.88 | % | |
| 2.42 | % |
Expected volatility | |
| 147 | % | |
| 92 | % |
Expected lives (years) | |
| 6 | | |
| 6 | |
Expected dividend yield | |
| 0.00 | % | |
| 0.00 | % |
The
Company’s computation of expected volatility is based on the historical daily volatility of its publicly traded stock. For option
grants issued during the nine-months ended September 30, 2024, the Company used a calculated volatility for each grant. The Company lacks
adequate information about the exercise behavior at this time and has determined the expected term assumption under the simplified method
provided for under ASC 718, which averages the contractual term of the Company’s options of ten years with the average vesting
term of three years for an average of six years. In 2024, the Company used the average term of six years. The dividend yield assumption
of zero is based upon the fact the Company has never paid cash dividends on common stock and presently has no intention of paying cash
dividends. The risk-free interest rate used for each grant is equal to the U.S. Treasury rates in effect at the time of the grant for
instruments with a similar expected life. The Company accounts for forfeitures as they occur. No amounts relating to stock-based compensation
have been capitalized. No amounts relating to employee stock-based compensation have been capitalized.
During
the nine months ended September 30, 2024 and September 30, 2023, no options were exercised.
Presented
below is our stock option activity:
Schedule of Stock Options Activity
| |
Nine-Months Ended September 30, 2024 | |
| |
Number of Options (Employees) | | |
Number of Options (Non-Employees) | | |
Total Number of Options | | |
Weighted-Average Exercise Price | |
Outstanding at January 1, 2024 | |
| 10,350 | | |
| 3,650 | | |
| 14,000 | | |
$ | 501.70 | |
Issued | |
| 55,000 | | |
| — | | |
| 55,000 | | |
| 1.83 | |
Exercised, forfeited or expired | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding at September 30, 2024 | |
| 65,350 | | |
| 3,650 | | |
| 69,000 | | |
$ | 103.24 | |
Exercisable at September 30, 2024 | |
| 43,971 | | |
| 3,650 | | |
| 47,621 | | |
$ | 148.75 | |
The
following table summarizes significant ranges of outstanding stock options under the 2008 Plan and the 2019 Plan at September 30, 2024:
Schedule of Ranges of Outstanding Stock Options
Range
of
Exercise Prices | |
Number
of Options | | |
Weighted-Average
Remaining
Contractual
Life (years) | | |
Weighted-Average
Exercise Price | | |
Number
of
Options
Exercisable | | |
Weighted-Average
Remaining
Contractual
Life (years) | | |
Weighted-Average
Exercise Price | |
$1.83 - $25.99 | |
| 55,000 | | |
| 9.30 | | |
$ | 1.83 | | |
| 33,624 | | |
| 9.30 | | |
$ | 1.83 | |
$26.00 –$100.00 | |
| 3,500 | | |
| 5.20 | | |
$ | 26.00 | | |
| 3,500 | | |
| 5.20 | | |
$ | 26.00 | |
$100.01 – $300.00 | |
| 6,066 | | |
| 2.96 | | |
$ | 195.29 | | |
| 6,066 | | |
| 2.96 | | |
$ | 195.29 | |
$300.01 –$4,146.00 | |
| 4,434 | | |
| 0.86 | | |
$ | 1,296.92 | | |
| 4,431 | | |
| 0.86 | | |
$ | 1,296.92 | |
| |
| 69,000 | | |
| 7.99 | | |
$ | 103.24 | | |
| 47,621 | | |
| 7.99 | | |
$ | 148.75 | |
The
Company recorded $58,974 of stock compensation costs in the period ended September 30, 2024 and no costs in the period ended September
30, 2023. At September 30, 2024, there was $35,350 of unrecognized compensation expense related to unvested stock options.
There
was no aggregate intrinsic value of the outstanding options as of September 30, 2024.
At
December 31, 2023, the Company had warrants to purchase up to 42 shares of common stock outstanding at a weighted average exercise price
of $1,044.00 per share, which expired in 2024, and as such, the Company had no outstanding warrants at September 30, 2024.
|
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v3.24.3
Commitments and Contingencies
|
9 Months Ended |
Sep. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
5. Commitments and Contingencies
Commitments
Aldoxorubicin
The
Company has an agreement (the “Vergell Agreement”) with Vergell Medical (formerly with KTB Tumorforschungs GmbH) (“Vergell”)
for the exclusive license of patent rights held by Vergell for the worldwide development and commercialization of aldoxorubicin. Under
the agreement, we had to make payments to Vergell upon meeting certain clinical and regulatory milestones up to and including the product’s
second final marketing approval. However, those payments are no longer required since the intellectual property acquired under the Vergell
Agreement has now expired. The Company accrued $316,000 that we believe is owed prior to the expiry of the intellectual property. This
amount was outstanding both for the nine-month periods ended September 30, 2024 and September 30, 2023 and is included in accrued expenses
and other current liabilities on the condensed balance sheet.
As
discussed in Note 3, pursuant to the First Amendment to the Royalty Agreement, the Company and XOMA have amended the Royalty Agreement
to provide XOMA with a low single-digit synthetic royalty on aldoxorubicin and a mid-single digit percentage of any economics derived
by LadRx from future out-license agreements related to aldoxorubicin.
Arimoclomol
The
agreement relating to our worldwide rights to arimoclomol provides for our payment of up to an aggregate of $3.65 million upon receipt
of milestone payments from Orphayzme A/S. On May 31, 2022, Orphazyme announced that it had completed the sale of substantially all of
its assets and business activities for cash consideration of $12.8 million and assumption of liabilities estimated to equal approximately
$5.2 million to KemPharm (the “KemPharm Transaction”). KemPharm is a specialty biopharmaceutical company focused on the discovery
and development of novel treatments for rare central nervous system (“CNS”) diseases. As part of the KemPharm Transaction,
all of Orphazyme’s obligations to LadRx under the 2011 Arimoclomol Agreement, including with regard to milestone payments and royalties
on sales, were assumed by KemPharm. KemPharm re-branded to Zevra Therapeutics, Inc. in February 2023.
As
disclosed in Note 3, Assignment Agreement with XOMA, pursuant to the Assignment Agreement, although all the liabilities and obligations
related to arimoclomol remain the responsibility of the Company, XOMA will direct an escrow agent appointed by them to pay on behalf
of LadRx up to an aggregate of $3.25 million reflected in the preceding paragraph, as well as all future obligations related to Steven
A. Kriegsman, pursuant to the Amended and Restated Employment Agreement, as amended by and between the Company and Mr. Kriegsman, dated
March 26, 2019.
Innovive
Under
the merger agreement by which the Company acquired Innovive, the Company agreed to pay the former Innovive stockholders a total of up
to approximately $18.3 million of future earnout merger consideration, subject to our achievement of specified net sales under the Innovive
license agreements. As of September 30, 2024, there are no longer any further obligations due under this agreement, since the licensed
intellectual property rights have expired.
Contingencies
We
apply the disclosure provisions of ASC 460, Guarantees (“ASC 460”) to its agreements that contain guarantees or indemnities
by the Company. We provide (i) indemnifications of varying scope and size to certain investors and other parties for certain losses suffered
or incurred by the indemnified party in connection with various types of third-party claims; and (ii) indemnifications of varying scope
and size to officers and directors against third party claims arising from the services they provide to the Company.
The
Company is occasionally involved in legal proceedings and other matters arising from the normal course of business. On November 30, 2022,
Jerald Hammann (“Hammann”) filed a complaint (the “Complaint”) against the Company, Mr. Caloz, and Mr. Kriegsman
(together, “Defendants”) in the Court of Chancery of the State of Delaware, alleging various violations of a Cooperation
Agreement, dated August 21, 2020, by and between the Company and Hammann. The Complaint alleges breaches of a provision limiting the
Board’s ability to effect discretionary compensation and a non-disparagement provision. The Complaint further alleges a breach
of a purported implied obligation that the Company disclose various internal records to Hammann. Defendants moved to dismiss the Complaint
in its entirety. As a result, the Court subsequently dismissed the claims against Mr. Caloz and Mr. Kriegsman and also dismissed one
of the claims against the Company. The Company intends to litigate vigorously against Hammann’s claims.
The
Company evaluates developments in legal proceedings and other matters on a quarterly basis. The Company records accruals for loss contingencies
to the extent that the Company concludes that it is probable that a liability has been incurred and the amount of the related loss can
be reasonably estimated.
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v3.24.3
Basis of Presentation and Significant Accounting Policies (Policies)
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis
of Presentation
The
accompanying condensed financial statements of Ladrx Corporation (the “Company”) at September 30, 2024, and for the
three-month and nine-month periods ended September 30, 2024 and 2023, respectively, are unaudited, but include all adjustments,
consisting of normal recurring entries, that management believes to be necessary for a fair presentation of the periods presented.
Interim results are not necessarily indicative of results for a full year. Balance sheet amounts as of December 31, 2023 were
derived from our audited financial statements as of that date.
The
financial statements included herein have been prepared by us pursuant to the rules and regulations of the Securities and Exchange Commission
(“SEC”). Certain information and footnote disclosures normally included in financial statements prepared in accordance with
accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to such rules and regulations.
The financial statements should be read in conjunction with our audited financial statements contained in the 2023 Annual Report.
|
Going Concern |
Going
Concern
The
Company’s condensed financial statements have been presented on the basis that it will continue as a going concern, which contemplates
the realization of assets and satisfaction of liabilities in the normal course of business. During the nine-month period ended September
30, 2024, the Company incurred a net loss of $1.9 million and had total stockholders’ deficit as of September 30, 2024 of $1.8
million. The Company has no recurring revenue, and we are likely to continue to incur losses unless and until we conclude a successful
strategic partnership or financing for our LADR™ technology. As a result, management has concluded that there is substantial doubt
about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued.
In addition, the Company’s independent registered public accounting firm, in its audit report on the Company’s consolidated
financial statements for the year ended December 31, 2023, expressed substantial doubt about the Company’s ability to continue
as a going concern. The Company’s financial statements do not include any adjustments that might result from the outcome of this
uncertainty.
At
September 30, 2024, we had cash and cash equivalents and short-term investments of approximately $0.1 million. The Company expects to
receive a $1 million milestone payment upon the first commercial sale of arimoclomol from Xoma in the fourth quarter of 2024. This is
predicated upon the recent announcement in September 2024 by Zevra that arimoclomol was approved by the Food and Drug Administration
and that Zevra expects to initiate its lauch activities for MIPLYFFA (arimoclomol) in the fourth quarter of 2024. The continuation
of the Company as a going concern is dependent upon its ability to obtain necessary debt or equity financing to continue operations until
it begins generating positive cash flow. No assurance can be given that any future financing will be available or, if available, that
it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing, it may contain
undue restrictions on our operations, in the case of debt financing or cause substantial dilution for our stockholders, in case of equity
financing.
|
2023 Reverse Stock Split |
2023 Reverse Stock Split
The
Company effected a 1-for-100 reverse stock split (the “Reverse Stock Split”) of its issued and outstanding shares of
common stock on May 17, 2023, pursuant to which every 100 shares of the Company’s issued and outstanding shares of common stock
were converted into one share of common stock without any change in the par value per share. Any
fraction of a share of common stock that would otherwise have resulted from the Reverse Stock Split was rounded up to the nearest whole
share. All share and per share amounts in this Quarterly Report and the accompanying financial statements and the notes thereto
have been adjusted to reflect the Reverse Stock Split as if it had occurred at the beginning of the earliest period presented.
|
Use of Estimates |
Use
of Estimates
Preparation
of the Company’s condensed financial statements in conformance with U.S. GAAP requires the Company’s management to make estimates
and assumptions that impact the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets
and liabilities in the Company’s condensed financial statements and accompanying notes. The significant estimates in the Company’s
condensed financial statements relate to the valuation of equity awards, recoverability of deferred tax assets, and estimated useful
lives of fixed assets, The Company bases estimates and assumptions on historical experience, when available, and on various factors that
it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis, and its
actual results may differ from estimates made under different assumptions or conditions.
|
Fair Value Measurements |
Fair
Value Measurements
The
Company measures the fair value of financial instruments using a fair value hierarchy that prioritizes the inputs to valuation techniques
used to measure fair value into three broad levels:
Level
1—Inputs used to measure fair value are unadjusted quoted prices that are available in active markets for the identical assets
or liabilities as of the reporting date.
Level
2— Other significant observable inputs for the assets or liabilities through corroboration with market data at the measurement
date.
Level
3—Unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment
are used to measure fair value. These values are generally determined using pricing models for which the assumptions utilize management’s
estimates of market participant assumptions. The determination of fair value for Level 3 investments and other financial instruments
involves the most management judgment and subjectivity.
The
carrying amounts of financial assets and liabilities, such as cash, other current assets, accounts payable, and accrued expenses, approximate
their fair values because of the short maturity of these instruments.
|
Research and Development Expenses |
Research
and Development Expenses
Research
and development expenses consist of costs incurred for direct and overhead-related research expenses and are expensed as incurred. Costs
to acquire technologies, including licenses and drugs, that are utilized in research and development and that have no alternative future
use are expensed when incurred. Technology developed for use in its products is expensed as incurred until technological feasibility
has been established.
|
Stock Compensation |
Stock
Compensation
The
Company accounts for share-based awards to employees and non-employee directors and consultants in accordance with the provisions of
ASC 718, Compensation—Stock Compensation., and under the recently issued guidance following FASB’s pronouncement,
ASU 2018-07, Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting. Under
ASC 718, and applicable updates adopted, share-based awards are valued at fair value on the date of grant and that fair value is recognized
over the requisite service, or vesting, period. The Company values its equity awards using the Black-Scholes option pricing model, and
accounts for forfeitures when they occur. Recognition of compensation expense for non-employees is in the same period and manner
as if the Company had paid cash for the services.
|
Basic and Diluted Net Income (Loss) Per Common Share |
Basic
and Diluted Net Income (Loss) Per Common Share
Basic
and diluted net loss per common share is computed based on the weighted-average number of common shares outstanding for the period. Diluted
net income (loss) per share is computed by dividing the net income (loss) applicable to common stockholders by the weighted average number
of common shares outstanding plus the number of additional common shares that would have been outstanding if all dilutive potential common
shares had been issued using the treasury stock method. Potential common shares are excluded from computation when their effect is antidilutive.
Common share equivalents that could potentially dilute net loss per share in the future, and which were excluded from the computation
of diluted loss per share, were as follows:
Schedule of Shares Excluded from Computation of Diluted Loss Per Share
| |
2024 | | |
2023 | |
| |
As of September 30, | |
| |
2024 | | |
2023 | |
Options to acquire common stock | |
| 69,000 | | |
| 15,647 | |
Warrants to acquire common stock | |
| — | | |
| 42 | |
Shares excluded from computation
of diluted loss per share | |
| 69,000 | | |
| 15,689 | |
|
Recently Issued Accounting Pronouncements |
Recently
Issued Accounting Pronouncements
Recent
authoritative guidance issued by the FASB (including technical corrections to the ASC), the American Institute of Certified Public Accountants,
and the SEC did not, or are not expected to, have a material impact on the Company’s condensed financial statements and related
disclosures.
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X |
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v3.24.3
Stock Based Compensation (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Fair Value of Stock Options at the Date of Grant |
The
fair value of the stock options at the date of grant was estimated using the Black-Scholes option-pricing model, based on the following
assumptions:
Schedule of Fair Value of Stock Options at the Date of Grant
| |
2024 | | |
2023 | |
Risk-free interest rate | |
| 3.88 | % | |
| 2.42 | % |
Expected volatility | |
| 147 | % | |
| 92 | % |
Expected lives (years) | |
| 6 | | |
| 6 | |
Expected dividend yield | |
| 0.00 | % | |
| 0.00 | % |
|
Schedule of Stock Options Activity |
Presented
below is our stock option activity:
Schedule of Stock Options Activity
| |
Nine-Months Ended September 30, 2024 | |
| |
Number of Options (Employees) | | |
Number of Options (Non-Employees) | | |
Total Number of Options | | |
Weighted-Average Exercise Price | |
Outstanding at January 1, 2024 | |
| 10,350 | | |
| 3,650 | | |
| 14,000 | | |
$ | 501.70 | |
Issued | |
| 55,000 | | |
| — | | |
| 55,000 | | |
| 1.83 | |
Exercised, forfeited or expired | |
| — | | |
| — | | |
| — | | |
| — | |
Outstanding at September 30, 2024 | |
| 65,350 | | |
| 3,650 | | |
| 69,000 | | |
$ | 103.24 | |
Exercisable at September 30, 2024 | |
| 43,971 | | |
| 3,650 | | |
| 47,621 | | |
$ | 148.75 | |
|
Schedule of Ranges of Outstanding Stock Options |
The
following table summarizes significant ranges of outstanding stock options under the 2008 Plan and the 2019 Plan at September 30, 2024:
Schedule of Ranges of Outstanding Stock Options
Range
of
Exercise Prices | |
Number
of Options | | |
Weighted-Average
Remaining
Contractual
Life (years) | | |
Weighted-Average
Exercise Price | | |
Number
of
Options
Exercisable | | |
Weighted-Average
Remaining
Contractual
Life (years) | | |
Weighted-Average
Exercise Price | |
$1.83 - $25.99 | |
| 55,000 | | |
| 9.30 | | |
$ | 1.83 | | |
| 33,624 | | |
| 9.30 | | |
$ | 1.83 | |
$26.00 –$100.00 | |
| 3,500 | | |
| 5.20 | | |
$ | 26.00 | | |
| 3,500 | | |
| 5.20 | | |
$ | 26.00 | |
$100.01 – $300.00 | |
| 6,066 | | |
| 2.96 | | |
$ | 195.29 | | |
| 6,066 | | |
| 2.96 | | |
$ | 195.29 | |
$300.01 –$4,146.00 | |
| 4,434 | | |
| 0.86 | | |
$ | 1,296.92 | | |
| 4,431 | | |
| 0.86 | | |
$ | 1,296.92 | |
| |
| 69,000 | | |
| 7.99 | | |
$ | 103.24 | | |
| 47,621 | | |
| 7.99 | | |
$ | 148.75 | |
|
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v3.24.3
Basis of Presentation and Significant Accounting Policies (Details Narrative) - USD ($)
|
|
3 Months Ended |
9 Months Ended |
|
|
|
May 17, 2023 |
Sep. 30, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Jun. 21, 2023 |
Dec. 31, 2022 |
Accounting Policies [Abstract] |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ 824,540
|
$ 1,282,987
|
$ (186,735)
|
$ 815,989
|
$ (3,148,966)
|
$ 1,074,498
|
$ 1,920,793
|
$ (1,258,479)
|
|
|
|
Stockholders' deficit |
|
(1,754,464)
|
$ (933,851)
|
$ 345,208
|
$ 965,390
|
$ 1,781,379
|
$ (1,806,117)
|
(1,754,464)
|
$ 965,390
|
$ 107,354
|
|
$ (1,317,964)
|
Cash and cash equivalents and short-term investments |
|
100,000
|
|
|
|
|
|
100,000
|
|
|
|
|
Milestone payment, amount |
|
$ 1,000,000
|
|
|
|
|
|
$ 1,000,000
|
|
|
$ 6,000,000
|
|
Reverse stock split |
1-for-100 reverse stock split
|
|
|
|
|
|
1 for 100 reverse stock split
|
|
|
|
|
|
X |
- DefinitionAmount of milestone payment payable.
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v3.24.3
Financing Under Securities Purchase Agreement (Details Narrative) - USD ($)
|
|
|
|
|
|
|
|
|
|
12 Months Ended |
|
|
Jun. 29, 2023 |
May 08, 2023 |
Jan. 31, 2023 |
Jan. 03, 2023 |
Oct. 01, 2022 |
Jul. 01, 2022 |
Apr. 01, 2022 |
Jan. 01, 2022 |
Jul. 13, 2021 |
Dec. 31, 2022 |
Sep. 30, 2024 |
Dec. 31, 2023 |
Preferred stock, shares outstanding |
|
|
|
|
|
|
|
|
|
|
0
|
0
|
Preferred stock, shares issued |
|
|
|
|
|
|
|
|
|
|
0
|
0
|
Series C 10% Convertible Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares outstanding |
|
|
|
|
|
|
|
|
|
2,752
|
|
|
Investor [Member] | Series C 10% Convertible Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares outstanding |
|
|
|
|
|
|
|
|
|
|
0
|
0
|
Number of shares converted |
|
16,027
|
1,342
|
|
|
|
|
|
|
|
|
|
Number of shares issued upon conversion |
|
15,250
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, shares issued |
|
|
|
|
|
|
|
|
|
|
0
|
0
|
Securities Purchase Agreement [Member] | Investor [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Gross proceeds from issuance of equity |
|
|
|
|
|
|
|
|
$ 10,000,000
|
|
|
|
Net proceeds from issuance of equity |
|
|
|
|
|
|
|
|
$ 9,200,000
|
|
|
|
Securities Purchase Agreement [Member] | Investor [Member] | Preferred Investment Option [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Option to purchase common stock |
113,637
|
|
|
|
|
|
|
|
|
|
|
|
Option indexed to issuers equity shares value |
$ 10,000,000
|
|
|
|
|
|
|
|
|
|
|
|
Option exercisable price |
$ 88.00
|
|
|
|
|
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] | Investor [Member] | Series C 10% Convertible Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares, new issues |
|
|
|
|
|
|
|
|
8,240
|
|
|
|
Purchase price per share |
|
|
|
|
|
|
|
|
$ 1,000
|
|
|
|
Preferred stock dividend rate percentage |
|
|
|
|
|
|
|
|
10.00%
|
|
|
|
Proceeds from issuance of private placement |
|
|
|
|
|
|
|
|
$ 8,240,000
|
|
|
|
Preferred stock convertible shares issuable |
|
|
|
|
|
|
|
|
93,637
|
|
|
|
Preferred stock, conversion price |
|
|
|
|
|
|
|
|
$ 88.00
|
|
|
|
Preferred stock, contract terms |
|
|
|
|
|
|
|
|
The terms of the Series C Preferred
Stock included beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99%
of the Company’s outstanding shares of common stock
|
|
|
|
Dividends paid |
|
|
|
$ 68,809
|
$ 68,809
|
$ 84,005
|
$ 202,567
|
$ 206,000
|
|
$ 561,381
|
|
|
Securities Purchase Agreement [Member] | Investor [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period, shares, new issues |
|
|
|
|
|
|
|
|
20,000
|
|
|
|
Purchase price per share |
|
|
|
|
|
|
|
|
$ 88.00
|
|
|
|
Proceeds from issuance of common stock |
|
|
|
|
|
|
|
|
$ 1,760,000
|
|
|
|
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v3.24.3
XOMA (Details Narrative) - USD ($)
|
Jun. 03, 2024 |
Jun. 21, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Milestone payment, amount |
|
$ 6,000,000
|
$ 1,000,000
|
|
Payments for royalities |
|
$ 6,000,000
|
|
|
XOMA [Member] |
|
|
|
|
Royalty purchase agreement, description |
Pursuant
to the First Amendment, if the Company decides to commercialize aldoxorubicin itself, prior to the first commercial sale of aldoxorubicin,
the Company and XOMA shall enter into a synthetic royalty purchase agreement, pursuant to which the Company shall agree to make quarterly
royalty payments to XOMA equal to the amount of all aggregate net sales of aldoxorubicin during each calendar quarter multiplied by 1.5%.
If the Company decides not to commercialize aldoxorubicin itself and instead licenses aldoxorubicin to a third party, upon entry of such
a new license agreement, XOMA shall be entitled to receive (i) royalty payments with respect to net sales of aldoxorubicin payable to
the Company multiplied by 7.5% and (ii) milestone payments of 7.5% of any milestone payable to the Company pursuant to the License Agreement
|
|
|
|
Assignment and assumption agreement description |
|
Pursuant
to the Assignment Agreement, the Company is entitled to receive (i) a one-time payment of $1 million upon acceptance of a re-submission
of an NDA to the FDA for arimoclomol, and (ii) a one-time payment of $1 million upon the first invoiced sale in certain territories of
a pharmaceutical product derived from arimoclomol as an active pharmaceutical ingredient, subject to the receipt of the applicable regulatory
approval required to sell such a product in such countries. In January 2024, Zevra announced the FDA had accepted the NDA for arimoclomol
and the Company received the one-time payment of $1 million in February 2024 recognized such net proceeds of $1.0 million as other income
in the statement of operations for the period ended March 31, 2024
|
|
|
Royalty Purchase Agreement [Member] |
|
|
|
|
Payments for royalities |
|
$ 1,000,000
|
|
|
Aldoxorubicin and Arimoclomol [Member] |
|
|
|
|
Legal fees |
|
5,000,000
|
|
|
Arimoclomol [Member] |
|
|
|
|
Milestone payment, amount |
|
|
3,650,000
|
|
Commercial sale, amount |
|
1,000,000
|
|
|
Aldoxorubicin [Member] |
|
|
|
|
Milestone payment, amount |
|
|
$ 316,000
|
$ 316,000
|
Commercial sale, amount |
|
$ 4,000,000
|
|
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v3.24.3
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v3.24.3
Schedule of Stock Options Activity (Details)
|
9 Months Ended |
Sep. 30, 2024
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Total Number of Option, Outstanding at beginning |
14,000
|
Weighted Average Exercise Price Options, Outstanding Beginning | $ / shares |
$ 501.70
|
Total Number of Option, Issued |
55,000
|
Weighted Average Exercise Price Options, Issued | $ / shares |
$ 1.83
|
Total Number of Option, Exercised, forfeited or expired |
|
Weighted Average Exercise Price Options, Exercised, forfeited or expired | $ / shares |
|
Total Number of Option, Outstanding at ending |
69,000
|
Weighted Average Exercise Price Options, Outstanding ending | $ / shares |
$ 103.24
|
Total Number of Option, Exercisable at ending |
47,621
|
Weighted Average Exercise Price Options, Exercisable at ending | $ / shares |
$ 148.75
|
Share-Based Payment Arrangement, Employee [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Total Number of Option, Outstanding at beginning |
10,350
|
Total Number of Option, Issued |
55,000
|
Total Number of Option, Exercised, forfeited or expired |
|
Total Number of Option, Outstanding at ending |
65,350
|
Total Number of Option, Exercisable at ending |
43,971
|
Share-Based Payment Arrangement, Nonemployee [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Total Number of Option, Outstanding at beginning |
3,650
|
Total Number of Option, Issued |
|
Total Number of Option, Exercised, forfeited or expired |
|
Total Number of Option, Outstanding at ending |
3,650
|
Total Number of Option, Exercisable at ending |
3,650
|
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v3.24.3
Schedule of Ranges of Outstanding Stock Options (Details) - Share-Based Payment Arrangement, Option [Member]
|
9 Months Ended |
Sep. 30, 2024
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of Options, Outstanding | shares |
69,000
|
Weighted-Average Remaining Contractual Life (years), Outstanding |
7 years 11 months 26 days
|
Weighted-Average Exercise Price, Outstanding |
$ 103.24
|
Number of Options Exercisable | shares |
47,621
|
Weighted-Average Remaining Contractual Life (years), Exercisable |
7 years 11 months 26 days
|
Weighted-Average Exercise Price, Exercisable |
$ 148.75
|
Exercise Price Range One [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Range of Exercise Prices, Lower Range |
1.83
|
Range of Exercise Prices, Upper Range |
$ 25.99
|
Number of Options, Outstanding | shares |
55,000
|
Weighted-Average Remaining Contractual Life (years), Outstanding |
9 years 3 months 18 days
|
Weighted-Average Exercise Price, Outstanding |
$ 1.83
|
Number of Options Exercisable | shares |
33,624
|
Weighted-Average Remaining Contractual Life (years), Exercisable |
9 years 3 months 18 days
|
Weighted-Average Exercise Price, Exercisable |
$ 1.83
|
Exercise Price Range Two [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Range of Exercise Prices, Lower Range |
26.00
|
Range of Exercise Prices, Upper Range |
$ 100.00
|
Number of Options, Outstanding | shares |
3,500
|
Weighted-Average Remaining Contractual Life (years), Outstanding |
5 years 2 months 12 days
|
Weighted-Average Exercise Price, Outstanding |
$ 26.00
|
Number of Options Exercisable | shares |
3,500
|
Weighted-Average Remaining Contractual Life (years), Exercisable |
5 years 2 months 12 days
|
Weighted-Average Exercise Price, Exercisable |
$ 26.00
|
Exercise Price Range Three [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Range of Exercise Prices, Lower Range |
100.01
|
Range of Exercise Prices, Upper Range |
$ 300.00
|
Number of Options, Outstanding | shares |
6,066
|
Weighted-Average Remaining Contractual Life (years), Outstanding |
2 years 11 months 15 days
|
Weighted-Average Exercise Price, Outstanding |
$ 195.29
|
Number of Options Exercisable | shares |
6,066
|
Weighted-Average Remaining Contractual Life (years), Exercisable |
2 years 11 months 15 days
|
Weighted-Average Exercise Price, Exercisable |
$ 195.29
|
Exercise Price Range Four [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Range of Exercise Prices, Lower Range |
300.01
|
Range of Exercise Prices, Upper Range |
$ 4,146.00
|
Number of Options, Outstanding | shares |
4,434
|
Weighted-Average Remaining Contractual Life (years), Outstanding |
10 months 9 days
|
Weighted-Average Exercise Price, Outstanding |
$ 1,296.92
|
Number of Options Exercisable | shares |
4,431
|
Weighted-Average Remaining Contractual Life (years), Exercisable |
10 months 9 days
|
Weighted-Average Exercise Price, Exercisable |
$ 1,296.92
|
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v3.24.3
Stock Based Compensation (Details Narrative) - USD ($)
|
|
9 Months Ended |
|
|
Sep. 07, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Nov. 30, 2019 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Outstanding stock options |
|
69,000
|
|
14,000
|
|
Stock granted |
55,000
|
|
0
|
|
|
Vesting percentage |
50.00%
|
|
|
|
|
Vesting period |
3 years
|
|
|
|
|
Contractual term of options |
|
10 years
|
|
|
|
Vesting description |
|
average vesting
term of three years for an average of six years
|
|
|
|
Stock options exercised |
|
|
|
|
|
Stock compensation costs |
|
$ 58,974
|
$ 0
|
|
|
Unrecognized compensation expense |
|
35,350
|
|
|
|
Options outstanding and vested intrinsic value |
|
$ 0
|
|
|
|
Warrants to purchase common stock |
|
|
|
42
|
|
Weighted average exercise price |
|
|
|
$ 1,044.00
|
|
Outstanding warrants |
|
0
|
|
|
|
2008 Stock Incentive Plan [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Common stock reserved for issuance |
|
50,000
|
|
|
|
Outstanding stock options |
|
10,500
|
|
|
|
Plan expiration date |
|
Nov. 20, 2018
|
|
|
|
2008 Stock Incentive Plan [Member] | Restricted Stock [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Shares outstanding |
|
8,000
|
|
|
|
2019 Stock Incentive Plan [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Common stock reserved for issuance |
|
|
|
|
54,000
|
Outstanding stock options |
|
3,500
|
|
|
|
Plan expiration date |
|
Nov. 14, 2029
|
|
|
|
2019 Stock Incentive Plan [Member] | Restricted Stock [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Shares outstanding |
|
250
|
|
|
|
2019 Stock Incentive Plan Amendment [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Increase in common stock available for issuance |
75,000
|
|
|
|
|
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v3.24.3
Commitments and Contingencies (Details Narrative) - USD ($)
|
May 31, 2022 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Jun. 21, 2023 |
Product Liability Contingency [Line Items] |
|
|
|
|
Milestone payment, amount |
|
$ 1,000,000
|
|
$ 6,000,000
|
Kem Pharm [Member] | Orphayzme [Member] |
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
Cash consideration from sale of assets and business |
$ 12,800,000
|
|
|
|
Liabilities assumed |
$ 5,200,000
|
|
|
|
Aldoxorubicin [Member] |
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
Milestone payment, amount |
|
316,000
|
$ 316,000
|
|
Arimoclomol [Member] |
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
Milestone payment, amount |
|
3,650,000
|
|
|
Arimoclomol [Member] | XOMA Agreement [Member] |
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
Milestone payment, amount |
|
3,250,000
|
|
|
Innovive [Member] |
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
Future earnout merger consideration |
|
$ 18,300,000
|
|
|
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LadRx (QB) (USOTC:LADX)
Gráfica de Acción Histórica
De Oct 2024 a Nov 2024
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