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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

 

    Page
PART I. — FINANCIAL INFORMATION 4
Item 1. Condensed Financial Statements (unaudited) 4
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 14
Item 3. Quantitative and Qualitative Disclosures About Market Risk 21
Item 4. Controls and Procedures 21
   
PART II. — OTHER INFORMATION 22
Item 1. Legal Proceedings 22
Item 1A. Risk Factors 22
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 22
Item 3. Defaults Upon Senior Securities 22
Item 4. Mine Safety Disclosures 22
Item 5. Other Information 22
Item 6. Exhibits 22
   
SIGNATURES 23
 
INDEX TO EXHIBITS 24

 

2
 

 

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.

 

3
 

 

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.

 

4
 

 

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

 

5
 

 

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

 

6
 

 

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 
                               
Net loss   - -  -    -    -    (815,989    (815,989)
                               
Balance at September 30, 2023    -  495,092   $495   $488,612,890   $(487,647,995)  $965,390 

 

7
 

 

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.

 

8
 

 

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:

  

   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.

 

9
 

 

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.

 

10
 

 

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.

 

11
 

 

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:

  

   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:

  

   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:

  

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.

 

12
 

 

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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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.

 

14
 

 

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.

 

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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 LADRPlatform

 

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”).

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

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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.

 

22
 

 

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

 

23
 

 

INDEX TO EXHIBITS

 

Exhibit Number   Description
31.1*   Certification of Chief Executive Officer pursuant to Rule 13A-14(a) or 15D-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*   Certification of Chief Financial Officer pursuant to Rule 13A-14(a) or 15D-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**   Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2**   Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS*   Inline XBRL Instance Document
101.SCH*   Inline XBRL Schema Document
101.CAL*   Inline XBRL Calculation Linkbase Document
101.DEF*   Inline XBRL Definition Linkbase Document
101.LAB*   Inline XBRL Label Linkbase Document
101.PRE*   Inline XBRL Presentation Linkbase Document
104*   Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

* Filed herewith.

** Furnished herewith.

 

24

 

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.

 

 

v3.24.3
Cover - $ / shares
9 Months Ended
Sep. 30, 2024
Nov. 14, 2024
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Sep. 30, 2024  
Document Fiscal Period Focus Q3  
Document Fiscal Year Focus 2024  
Current Fiscal Year End Date --12-31  
Entity File Number 000-15327  
Entity Registrant Name LadRx Corporation  
Entity Central Index Key 0000799698  
Entity Tax Identification Number 58-1642740  
Entity Incorporation, State or Country Code DE  
Entity Address, Address Line One 11726 San Vicente Blvd.  
Entity Address, Address Line Two Suite 650  
Entity Address, City or Town Los Angeles  
Entity Address, State or Province CA  
Entity Address, Postal Zip Code 90049  
City Area Code (310)  
Local Phone Number 826-5648  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   495,092
Entity Listing, Par Value Per Share $ 0.001  
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
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
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
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
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      
v3.24.3
Condensed Statements of Stockholders' Equity (Deficit) (Unaudited) (Parenthetical)
3 Months Ended
May 17, 2023
Mar. 31, 2023
Statement of Stockholders' Equity [Abstract]    
Reverse stock split 1-for-100 reverse stock split 1 for 100 reverse stock split
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:

  

   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.

 

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.

 

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

 

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:

  

   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:

  

   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:

  

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.

 

 

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.

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:

  

   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.

v3.24.3
Basis of Presentation and Significant Accounting Policies (Tables)
9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
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 
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:

  

   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:

  

   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:

  

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   $148.75 
v3.24.3
Schedule of Shares Excluded from Computation of Diluted Loss Per Share (Details) - shares
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Shares excluded from computation of diluted loss per share 69,000 15,689
Share-Based Payment Arrangement, Option [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Shares excluded from computation of diluted loss per share 69,000 15,647
Warrant [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Shares excluded from computation of diluted loss per share 42
v3.24.3
Basis of Presentation and Significant Accounting Policies (Details Narrative) - USD ($)
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          
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      
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    
v3.24.3
Schedule of Fair Value of Stock Options at the Date of Grant (Details)
9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Share-Based Payment Arrangement [Abstract]    
Risk-free interest rate 3.88% 2.42%
Expected volatility 147.00% 92.00%
Expected lives (years) 6 years 6 years
Expected dividend yield 0.00% 0.00%
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
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
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        
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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