Form 10-Q - Quarterly report [Sections 13 or 15(d)]

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-Q

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

	For the quarterly period ended March 31, 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
Common Stock, $0.001 par value per share	LADX	OTC Markets
Series B Junior Participating Preferred Stock Purchase Rights

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. Yes ☐ No ☐

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 May 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	20
Item 4.	Controls and Procedures	20

PART II. — OTHER INFORMATION		21
Item 1.	Legal Proceedings	21
Item 1A	Risk Factors	21
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	21
Item 3.	Defaults Upon Senior Securities	21
Item 4.	Mine Safety Disclosure	21
Item 5.	Other Information	21
Item 6.	Exhibits	21

SIGNATURES		22

INDEX TO EXHIBITS		23

Forward Looking Statements

All statements in this Quarterly Report on Form 10-Q (this “Qaurterly Report”), including statements in this section, other than statements of historical fact are forward-looking statements, including statements of our current views with respect to the recent developments regarding our business strategy, business plan and research and development activities, our future financial results, and other future events. These statements include forward-looking statements both with respect to us, specifically, and the biotechnology industry, in general. In some cases, forward-looking statements can be identified by the use of terminology such as “may,” “will,” “expects,” “plans,” “anticipates,” “estimates,” “potential” or “could” or the negative thereof or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements contained herein are reasonable, there can be no assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual results could differ materially from those projected or assumed in the forward-looking statements.

All forward-looking statements involve inherent risks and uncertainties, and there are or will be important factors that could cause actual results to differ materially from those indicated in these statements. We believe that these factors include, but are not limited to, the factors discussed in this section and under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Annual Report”), which should be reviewed carefully. If one or more of these or other risks or uncertainties materialize, or if our underlying assumptions prove to be incorrect, actual results may vary materially from what we anticipate. Please consider our forward-looking statements in light of those risks as you read this Quarterly Report. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise.

Note Regarding Company References

References throughout this Quarterly Report, the “Company”, “LadRx”, “we”, “us”, and “our”, except where the context requires otherwise, refer to LadRx Corporation.

PART I — FINANCIAL INFORMATION

Item 1. — Condensed Financial Statements

LADRX CORPORATION

CONDENSED BALANCE SHEETS

	March 31, 2024			December 31, 2023
	(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	2,064,191		$	2,070,075
Prepaid expenses and other current assets		150,958			191,783
Total current assets		2,215,149			2,261,858
Equipment and furnishings, net		4,650			6,711
Other assets		1,475			7,703
Operating lease right-of-use assets		—			31,610
Total assets	$	2,221,274		$	2,307,882
LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:
Accounts payable	$	892,192		$	1,202,689
Accrued expenses and other current liabilities		983,874			964,233
Current portion of operating lease liabilities		—			33,606
Total current liabilities		1,876,066			2,200,528

Commitments and contingencies		-			-

Stockholders’ equity:
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 March 31, 2024 and December 31, 2023, respectively		495			495
Additional paid-in capital		488,664,009			488,612,890
Accumulated deficit		(488,319,296	)		(488,506,031	)
Total stockholders’ equity		345,208			107,354
Total liabilities and stockholders’ equity	$	2,221,274		$	2,307,882

The accompanying notes are an integral part of these condensed financial statements.

LADRX CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(Unaudited)


	Three Months Ended March 31,
	2024			2023
Revenue:
Licensing revenue	$	—		$	—

Expenses:
Research and development		30,296			—
General and administrative		801,601			1,080,039

Loss from operations		(831,897	)		(1,080,039	)

Other income:
Interest income		18,632			4,267
Royalty and milestone rights		1,000,000			—
Other income, net		—			1,274

Net income (loss)	$	186,735		$	(1,074,498	)

Dividends paid on preferred shares		—			(68,809	)

Net income (loss) attributable to common stockholders	$	186,735		$	(1,143,307	)

Total basic and diluted income (loss) per share	$	0.38		$	(0.03	)

Basic and diluted weighted-average shares outstanding		495,092			460,790

The accompanying notes are an integral part of these condensed financial statements

LADRX CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

(Unaudited)


	Three Months Ended March 31,
	2024			2023
Cash flows from operating activities:
Net income (loss)	$	186,735		$	(1,074,498	)
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Depreciation and amortization		2,060			2,958
Stock-based compensation expense		51,119			—
Changes in assets and liabilities:
Prepaid expenses and other current assets		40,825			199,102
Other assets		6,228			—
Right-of-use asset		31,610			45,654
Accounts payable		(310,497	)		150,347
Decrease in lease liabilities		(33,605	)		(47,529	)
Accrued expenses and other current liabilities		19,641			24,156
Net cash used in operating activities		(5,884	)		(699,810	)

Cash flows from financing activities
Preferred stock dividend		—			(68,809	)

Net cash used in financing activities		—			(68,809	)

Net decrease in cash and cash equivalents		(5,884	)		(768,619	)
Cash and cash equivalents at beginning of period		2,070,075			1,374,992
Cash and cash equivalents at end of period	$	2,064,191		$	606,373

Supplemental disclosure of Cash Flow Information:

Conversion of Series C Preferred Stock to Common Stock	$	—		$	2,011,351

The accompanying notes are an integral part of these condensed financial statements

LADRX CORPORATION

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

(Unaudited)

For the Three-Month Period Ended March 31, 2024

	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
Issuance of stock options for compensation						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

For the Three-Month Period Ended March 31, 2023

	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	)
Balance		450,374	$	450	$	487,519,251		$	(488,837,665	)	$	(1,317,964	)
1-100 reverse split fractional shares		13,191		13		(13	)
Preferred dividend									(68,809	)		(68,809	)
Conversion of Series C Convertible Preferred Stock		15,250		15		655,139			—			655,154
Issuance of common stock		250		1		(1	)
Net loss		-		-		-			(1,074,498	)		(1,074,498	)
Net income (loss)									(1,074,498	)		(1,074,498	)

Balance at March 31, 2023		479,065	$	479	$	488,174,376		$	(489,980,972	)	$	(1,806,117	)
Balance		479,065	$	479	$	488,174,376		$	(489,980,972	)	$	(1,806,117	)

The accompanying notes are an integral part of these condensed financial statements

LADRX CORPORATION

NOTES TO CONDENSED FINANCIAL STATEMENTS

For the Three-Months Period Ended March 31, 2024 and 2023
(Unaudited)

1. Basis of Presentation and Significant Accounting Policies

Basis of Presentation

The accompanying condensed financial statements at March 31, 2024 and for the three-month periods ended March 31, 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.

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 have been adjusted to reflect the Reverse Stock Split as if it had occurred at the beginning of the earliest period presented.

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 three-month period ended March 31, 2024, although we realized a net income of $0.2 million, we had a loss from operations of $0.8 million, and incurred a net loss from operations of $3.8 million for the year ended December 31, 2023, and had total stockholders’ equity as of March 31, 2024 of $0.3 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. The Company’s financial statements do not include any adjustments that might result from the outcome of this uncertainty. The Company’s independent registered public accounting firm, in its report on the Company’s consolidated financial statements for the year ended December 31, 2023, has also expressed doubt about the Company’s ability to continue as a going concern.

At March 31, 2024, we had cash and cash equivalents of approximately $2.1 million. We believe we have sufficient cash to fund operations into the summer 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.

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.

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.

Basic and Diluted Net Income (Loss) Per Common Share

Basic and diluted net income (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 the 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 March 31,
	2024		2023

Options to acquire common stock		68,997		17,651
Warrants to acquire common stock		—		42
Series C Convertible Preferred Stock		—		160,228
Preferred Investment Option		—		1,136,364
		68,997		1,314,285

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 consolidated financial statements and related disclosures.

2. Financing Under Securities Purchase Agreement

On July 13, 2021, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a single institutional investor (the “Investor”) for aggregate gross proceeds of $10 million and net proceeds of approximately $9.2 million. The transaction closed on July 16, 2021. Under the Purchase Agreement, the Company sold and issued (i) 20,000 shares of its common stock at a purchase price of $88.00 per share for total gross proceeds of approximately $1.76 million in a registered direct offering (the “Registered Direct Offering”) and (ii) 8,240 shares of Series C 10.00% Convertible Preferred Stock (the “Series C Preferred Stock”) at a purchase price of $1,000 per share, for aggregate gross proceeds of approximately $8.24 million, in a concurrent private placement (the “Private Placement” and, together with the Registered Direct Offering, the “July 2021 Offerings”). The shares of the Series C Preferred Stock were convertible, upon shareholder approval as described below, into an aggregate of up to 93,637 shares of common stock at a conversion price of $88.00 per share. Holders of the Series C Preferred Stock were entitled to receive, cumulative dividends at the rate per share (as a percentage of the stated value per share) of 10.00% per annum, payable quarterly on January 1, April 1, July 1 and October 1, beginning on the first such date after the date of issuance. The terms of the Series C Preferred Stock included beneficial ownership limitations that preclude conversion that would result in the Investor owning in excess of 9.99% of the Company’s outstanding shares of common stock. LadRx also issued to the Investor an unregistered Preferred Investment Option (“PIO”) that prior to redemption and cancelation of the PIO on June 29, 2023 (as described herein) allowed for the purchase of up to 113,637 shares of common stock for additional gross proceeds of approximately $10 million if the PIO was exercised in full. The exercise price for the PIO was $88.00 per share. The PIO had a term equal to five and one-half years commencing upon the Company increasing its authorized common stock following shareholder approval.

In 2022, the Company paid the following dividends: on January 1, 2022, $206,000, on April 1, 2022, $202,567, on July 1, 2022, $84,005 and on October 1, 2022, $68,809 for a total of $561,381. On January 3, 2023, the Company paid a dividend of $68,809.

At December 31, 2022, the Company had 2,752 shares of Series C Preferred Stock outstanding. On January 31, 2023, the Investor converted a further 1,342 shares of Series C Preferred Stock for 15,250 shares of common stock and on May 8, 2023, the Investor converted its remaining shares of Series C Preferred Shares for 16,027 shares of common stock. As of March 31, 2024 and December 31, 2023, there were no shares of Series C Preferred Stock issued and outstanding.

3. 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 March 31, 2024, there were 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 March 31, 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 March 31, 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		3.52	%		2.42	%
Expected volatility		134	%		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 years ended December 31, 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 three months ended March 31, 2024 and March 31, 2023, no options were exercised.

Presented below is our stock option activity:

Schedule of Stock Options Activity

	Three-Months Ended March 31, 2024
	Number of Options (Employees)		Number of Options (Non-Employees)		Total Number of Options		Weighted-Average Exercise Price
Outstanding at January 1, 2024		10,347		3,650		13,997	$	501.70
Issued		55,000		—		55,000		1.83
Exercised, forfeited or expired		—		—		—		—
Outstanding at March 31, 2024		65,647		3,650		68,997	$	103.24
Exercisable at March 31, 2024		39,391		3,650		43,041	$	164.39

The following table summarizes significant ranges of outstanding stock options under the 2008 Plan and the 2019 Plan at March 31, 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		9.80	$	1.83		29,044		9.80	$	1.83
	$26.00 –$100.00		3,500		5.70	$	26.00		3,500		5.70	$	26.00
	$100.01 – $300.00		6,066		3.46	$	195.29		6,066		3.46	$	195.29
	$300.01 –$4,146.00		4,431		1.36	$	1,296.92		4,431		1.36	$	1,296.92
			68,997		8.49	$	103.24		43,041		8.49	$	164.39

The Company recorded $51,119 of stock compensation costs in the period ended March 31, 2024 and no costs in the period ended March 31, 2023. At March 31, 2024, there was $43,206 of unrecognized compensation expense related to unvested stock options.

The aggregate intrinsic value of the outstanding options and options vested as of March 31, 2024 was approximately $32,000.

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 March 31, 2024.

4. 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 provides 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.

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, Inc.. 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 nonfinancial assets, and, therefore, should be accounted for within the scope of ASC 610-20.

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

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 expired. We accrued $316,000 that we believe was owed prior to the expiry of the intellectual property. This amount was outstanding at March 31, 2024 and December 31, 2023.

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 discussed in Note 6, 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 Pharmaceuticals, Inc. (“Innovive”), we 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 March 31, 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.

We have directors’ and officers’ liability insurance, which will be utilized, after the deductible, in the defense of any matter involving our directors or officers.

The Company evaluates developments in legal proceedings and other matters on a quarterly basis. If an unfavorable outcome becomes probable and reasonably estimable, we could incur charges that could have a material adverse impact on our financial condition and results of operations for the period in which the outcome becomes probable and reasonably estimable.

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, the Company’s discovery laboratory in Freiburg, Germany synthesized and tested over 75 rationally designed drug candidates 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, and based on 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, the Company 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 LADR™ (Linker Activated Drug Release) drug candidates, and for its 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 (this “Quarterly Report”) 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 www.ladrxcorp.com. We do not incorporate by reference into this Quarterly Report the information on, or accessible through, our website, and you should not consider it as part of this report.

LADR Drug Discovery Platform

LADR-based drugs are targeted therapeutics that offer the benefit of targeting, without some of the drawbacks that come with large molecules, such as antibodies. 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, thus LADR-based drugs are not limited in their use to targets that are specific to the cancer being treated. Albumin is the most abundant protein in human and accumulates inside tumors due to the aberrant vascular structure and draining system 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). The drug also proved the value of LADR targeting in that it showed far less cardiotoxicity, one of the major issues with the use of doxorubicin. This 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, but the cardiac safety of aldoxorubicin versus doxorubicin was demonstrated in a subgroup of leiomyosarcoma and liposarcoma patients. Preliminary clinical data has also been obtained in glioblastoma, Kaposi Sarcoma, and small cell lung cancer. Aldoxorubicin is currently licensed to Immunity Bio (see below).

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 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. Aldoxorubicin has been licensed to ImmunityBio.

The next generation LADR™ drugs are termed LADR7, 8, 9, and 10. A great deal of Investigational New Drug (“IND”) enabling work has already been accomplished on LADR7-10, including in-silico modeling, in-vitro efficacy testing in several different cancer models, in-vivo dosing, safety, and efficacy testing in several different cancer models in animals. We have also developed and proven manufacturability, an important step prior to beginning human clinical trials.

The IND-enabling work that remains prior to applying to the FDA for first-in-human studies for LADR 7-10 is limited due to the extensive experimentation already completed. For example, in the case of LADR 7, a manufacturing run under Good Manufacturing Practices (GMP) has been completed and the GMP LADR 7 currently in hand is sufficient to carry out final toxicology studies, and to initiate Phase IA studies in human subjects.

The final toxicology studies required for the IND for LADR 7 are underway and we expect the toxicology studies to be completed and the IND application for LADR 7 to be filed with the FDA by the end of the third quarter of 2024 or the beginning of the fourth quarter of 2024. Absent a clinical hold from the FDA, this timeline should allow the Company to be ready for first-patient dosing with LADR 7 by the end of 2024 (the period for the FDA review of an IND application is 30 days). If the Company encounters difficulties with the toxicology program or fails to meet the FDA’s requirements for the IND application, the first-patient dosing could be substantially delayed.

Because the LADR™ backbone in future products would be the same as the LADR™ backbone in current product candidates, (i.e. the chemotoxin can be changed without changing the LADR™ backbone), management anticipates that future product candidates beyond LADR7-10 may enjoy abbreviated pre-clinical pathways to first-in-human. Such abbreviated pathways would be subject to FDA review and agreement.

The Company’s novel companion diagnostic, ACDx™ (albumin companion diagnostic) was developed to identify patients with cancer who are most likely to benefit from treatment with the four LADR™ lead assets. We have not yet determined whether the use of a companion diagnostic will be necessary or helpful, and plan to continue to investigate this question in parallel to the pre-clinical and clinical development of LADRs 7-10.

The LADR™ backbone and drugs that employ LADR™ are protected by domestic and international patents, and additional patents are pending.

Business Strategy for LADR™ Platform

With the non-dilutive financing concluded with XOMA (as defined below) in June 2023, the Company is now focused on preparing the work necessary to file an IND application with the FDA for LADR7. For example, the Company recently completed the production of approximately 100 grams of LADR7 under GMP, which is sufficient to carry out final toxicology studies, and to initiate Phase IA studies in human subjects.

The Company has also initiated the Good Laboratory Practices (“GLP”) toxicology program that is expected to form the foundation of the IND application for LADR 7 to the FDA. Management expects the toxicology studies to be completed and the IND application for LADR 7 to be filed with the FDA by the end of the third quarter of 2024 or the beginning of the fourth quarter of 2024. Absent a clinical hold from the FDA, this timeline should allow the Company to be ready for first-patient dosing with LADR 7 by the end of 2024 (the period for the FDA review of an IND application is 30 days). If the Company encounters difficulties with the toxicology program or fails to meet the FDA’s requirements for the IND, the first-patient dosing could be substantially delayed.

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 with ImmunityBio, Inc. ( the “2017 License Agreement”) (formerly known as NantCell, Inc., and which merged with NantKwest Inc. in March 2021 (“ImmunityBio”)), 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 2017 License Agreement, ImmunityBio made a strategic investment of $13 million in LadRx’s common stock at $660.00 per share (adjusted to reflect our reverse stock splits), a premium of 92% to the market price on that date. The Company also issued a warrant to ImmunityBio 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). An additional 25 patients in the experimental group remain in the study. As of the date of this Quarterly Report, there have been no treatment-related deaths, and serious adverse events have been uncommon (6%).

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.

Royalty Purchase Agreement with XOMA

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.

Transfer of Rights to Molecular Chaperone Assets (Orphazyme)

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 NDA 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 resubmitted the NDA for arimoclomol in 2023, and in January 2024, the FDA accepted KenPharm’s NDA. KenPharm is also identifying a regulatory path forward with the EMA. KemPharm re-branded to Zevra Therapeutics, Inc. in February 2023.

Assignment and Assumption Agreement with XOMA

Pursuant to the Assignment Agreement, the Company is entitled to receive (i) a one-time payment of $1 million upon acceptance of a re-submission of a NDA to the FDA for arimoclomol, which the Company received in February 2024, and (ii) a one-time payment of $1 million upon the first invoiced sale in certain territories of a pharmaceutical product derived from arimoclomol as an active pharmaceutical ingredient, subject to the receipt of the applicable regulatory approval required to sell such a product in such countries.

Critical Accounting Policies and Estimates

Management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. 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 our 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 three-month period ended March 31, 2024, although we realized a net income of $0.2 million, we had a loss from operations of $0.8 million, and incurred a net loss from operations of $3.8 million for the year ended December 31, 2023, and had total stockholders’ equity as of March 31, 2024 of $0.3 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. The Company’s financial statements do not include any adjustments that might result from the outcome of this uncertainty The Company’s independent registered public accounting firm, in its report on the Company’s consolidated financial statements for the year ended December 31, 2023, has also expressed substantial doubt about the Company’s ability to continue as a going concern.

Net cash used in operating activities for the three months ended March 31, 2023 was $0.7 million, which was primarily the result of a net loss from operations of $1.1 million, and a net neutral in net cash outflows associated with changes in assets and liabilities. The net cash outflows associated with changes in assets and liabilities were primarily due to a decrease of $0.2 million of prepaid expenses and other current assets and an increase $0.2 million of accounts payable.

There were no investing activities in either of the three-month periods ended March 31, 2024 and 2023, and we do not expect any significant capital spending during the next 12 months.

There were no financing activities in the three-month period ended March 31, 2024, whereas we paid dividends on the shares of Series C 10.00% Convertible Preferred Stock of $0.1 million in the three-month period ended March 31, 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 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 from operations of approximately $0.8 million for the three-month period ended March 31, 2024, as compared to a net loss of approximately $1.1 million for the three-month period ended March 31, 2023.

During the three-month periods ended March 31, 2024 and 2023, we recognized no service revenue and earned an immaterial amount of license fees and grant revenue. 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 and the Assignment Agreement for net proceeds of approximately $4.2 million, along with an aggregate of $6 million in potential post-closing payments, based on achievement of certain future milestones. We received a gross payment of $1 million milestone from this agreement in the period ended March 31, 2024, which we recognized as Other Income on our statement of operations.

General and Administrative Expenses

	Three-Month Period Ended March 31,
	2024		2023
	(In thousands)
General and administrative expenses	$	749	$	1,077
Amortization of stock awards		51		—
Depreciation and amortization		2		3
	$	802	$	1,080

General and administrative expenses include all administrative salaries and general corporate expenses, including legal expenses. Our general and administrative expenses, excluding stock expenses, non-cash expenses and depreciation and amortization, were $0.7 million for the three-month period ended March 31, 2024, and $1.1 million for the same period 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 and insurance costs, offset by an increase in franchise taxes.

Depreciation and Amortization

Depreciation expense reflects the depreciation of our equipment and furnishings.

Interest Income

Interest income was approximately $18,600 for the three-month period ended March 31, 2024, as compared to $4,300 for the same period 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 March 31, 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, as amended, 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 March 31, 2024 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. We continually seek to assure that all of our controls and procedures are adequate and effective. Any failure to implement and maintain improvements in the controls over our financial reporting could cause us to fail to meet our reporting obligations under the SEC’s rules and regulations. Any failure to improve our internal controls to address the weaknesses we have identified could also cause investors to lose confidence in our reported financial information, which could have a negative impact on the trading price of our common stock.

PART II — OTHER INFORMATION

Item 1. — Legal Proceedings

None.

Item 1A. — Risk Factors

You should carefully consider and evaluate the information in this Quarterly Report and the risk factors set forth under the caption “Item 1A. Risk Factors” in our 2023 Annual Report, which was filed with the SEC on March 27, 2024. The risk factors associated with our business have not materially changed compared to the risk factors disclosed in the 2023 Annual Report.

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 as part of this Quarterly Report on Form 10-Q and incorporated herein by reference.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	LadRx Corporation

Date: May 15, 2024	By:	/s/ JOHN Y. CALOZ
		John Y. Caloz
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

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.

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 periods 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 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 Rules713a-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 periods 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: May 15, 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;

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:

(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: May 15, 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 officer of LadRx Corporation (the “Company”) hereby certifies based on his knowledge that:

(i) the accompanying Quarterly Report on Form 10-Q of the Company for the period ended March 31, 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: May 15, 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

Date: May 15, 2024	By:	/s/ JOHN Y. CALOZ
		John Y. Caloz
		Chief Financial Officer

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.

Cover - shares	3 Months Ended
Cover - shares	Mar. 31, 2024	May 14, 2024
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Mar. 31, 2024
Document Fiscal Period Focus	Q1
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
Common Stock, $0.001 par value per share
Title of 12(b) Security	Common Stock, $0.001 par value per share
Trading Symbol	LADX
Series B Junior Participating Preferred Stock Purchase Rights
Title of 12(b) Security	Series B Junior Participating Preferred Stock Purchase Rights

Condensed Balance Sheets - USD ($)	Mar. 31, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 2,064,191	$ 2,070,075
Prepaid expenses and other current assets	150,958	191,783
Total current assets	2,215,149	2,261,858
Equipment and furnishings, net	4,650	6,711
Other assets	1,475	7,703
Operating lease right-of-use assets		31,610
Total assets	2,221,274	2,307,882
Current liabilities:
Accounts payable	892,192	1,202,689
Accrued expenses and other current liabilities	983,874	964,233
Current portion of operating lease liabilities		33,606
Total current liabilities	1,876,066	2,200,528
Commitments and contingencies
Stockholders’ equity:
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 March 31, 2024 and December 31, 2023, respectively	495	495
Additional paid-in capital	488,664,009	488,612,890
Accumulated deficit	(488,319,296)	(488,506,031)
Total stockholders’ equity	345,208	107,354
Total liabilities and stockholders’ equity	$ 2,221,274	$ 2,307,882

Condensed Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 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

Condensed Statements of Operations (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Revenue:
Licensing revenue
Expenses:
Research and development	30,296
General and administrative	801,601	1,080,039
Loss from operations	(831,897)	(1,080,039)
Other income:
Interest income	18,632	4,267
Royalty and milestone rights	1,000,000
Other income, net		1,274
Net income (loss)	186,735	(1,074,498)
Dividends paid on preferred shares		(68,809)
Net income (loss) attributable to common stockholders	$ 186,735	$ (1,143,307)
Total basic income (loss) per share	$ 0.38	$ (0.03)
Total diluted income (loss) per share	$ 0.38	$ (0.03)
Basic weighted-average shares outstanding	495,092	460,790
Diluted weighted-average shares outstanding	495,092	460,790

Condensed Statements of Cash Flows (Unaudited) - USD ($)	3 Months Ended		12 Months Ended
	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023
Cash flows from operating activities:
Net income (loss)	$ 186,735	$ (1,074,498)	$ (3,800,000)
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Depreciation and amortization	2,060	2,958
Stock-based compensation expense	51,119
Changes in assets and liabilities:
Prepaid expenses and other current assets	40,825	199,102
Other assets	6,228
Right-of-use asset	31,610	45,654
Accounts payable	(310,497)	150,347
Decrease in lease liabilities	(33,605)	(47,529)
Accrued expenses and other current liabilities	19,641	24,156
Net cash used in operating activities	(5,884)	(699,810)
Cash flows from financing activities
Preferred stock dividend		(68,809)
Net cash used in financing activities		(68,809)
Net decrease in cash and cash equivalents	(5,884)	(768,619)
Cash and cash equivalents at beginning of period	2,070,075	1,374,992	1,374,992
Cash and cash equivalents at end of period	2,064,191	606,373	$ 2,070,075
Supplemental disclosure of Cash Flow Information:
Conversion of Series C Preferred Stock to Common Stock		$ 2,011,351

Condensed Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($)	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)
1-100 reverse split fractional shares	$ 13	(13)
1-100 reverse split fractional shares, shares	13,191
Preferred dividend			(68,809)	(68,809)
Conversion of Series C Convertible Preferred Stock	$ 15	655,139		655,154
Conversion of Series C Convertible Preferred Stock, shares	15,250
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)				(3,800,000)
Balance at Dec. 31, 2023	$ 495	488,612,890	(488,506,031)	107,354
Balance , shares at Dec. 31, 2023	495,092
Issuance of stock options for compensation		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

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	1-100 reverse split

Basis of Presentation and Significant Accounting Policies

3 Months Ended

Mar. 31, 2024

Accounting Policies [Abstract]

Basis of Presentation and Significant Accounting Policies

1. Basis of Presentation and Significant Accounting Policies

Basis of Presentation

Reverse Stock Split

Going Concern

Use of Estimates

Stock Compensation

Basic and Diluted Net Income (Loss) Per Common Share

	2024		2023
	As of March 31,
	2024		2023

Options to acquire common stock		68,997		17,651
Warrants to acquire common stock		—		42
Series C Convertible Preferred Stock		—		160,228
Preferred Investment Option		—		1,136,364
		68,997		1,314,285

Recently Issued Accounting Pronouncements

Financing Under Securities Purchase Agreement

3 Months Ended

Mar. 31, 2024

Equity Method Investments and Joint Ventures [Abstract]

Financing Under Securities Purchase Agreement

2. Financing Under Securities Purchase Agreement

Stock Based Compensation

3 Months Ended

Mar. 31, 2024

Share-Based Payment Arrangement [Abstract]

Stock Based Compensation

3. Stock Based Compensation

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		3.52	%		2.42	%
Expected volatility		134	%		92	%
Expected lives (years)		6			6
Expected dividend yield		0.00	%		0.00	%

During the three months ended March 31, 2024 and March 31, 2023, no options were exercised.

Presented below is our stock option activity:

Schedule of Stock Options Activity

	Three-Months Ended March 31, 2024
	Number of Options (Employees)		Number of Options (Non-Employees)		Total Number of Options		Weighted-Average Exercise Price
Outstanding at January 1, 2024		10,347		3,650		13,997	$	501.70
Issued		55,000		—		55,000		1.83
Exercised, forfeited or expired		—		—		—		—
Outstanding at March 31, 2024		65,647		3,650		68,997	$	103.24
Exercisable at March 31, 2024		39,391		3,650		43,041	$	164.39

The following table summarizes significant ranges of outstanding stock options under the 2008 Plan and the 2019 Plan at March 31, 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		9.80	$	1.83		29,044		9.80	$	1.83
	$26.00 –$100.00		3,500		5.70	$	26.00		3,500		5.70	$	26.00
	$100.01 – $300.00		6,066		3.46	$	195.29		6,066		3.46	$	195.29
	$300.01 –$4,146.00		4,431		1.36	$	1,296.92		4,431		1.36	$	1,296.92
			68,997		8.49	$	103.24		43,041		8.49	$	164.39

The aggregate intrinsic value of the outstanding options and options vested as of March 31, 2024 was approximately $32,000.

Xoma

3 Months Ended

Mar. 31, 2024

Xoma

Xoma

4. Xoma

Royalty Purchase Agreement with XOMA

Assignment and Assumption Agreement with XOMA

Commitments and Contingencies

3 Months Ended

Mar. 31, 2024

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

5. Commitments and Contingencies

Commitments

Aldoxorubicin

Arimoclomol

Innovive

Contingencies

We have directors’ and officers’ liability insurance, which will be utilized, after the deductible, in the defense of any matter involving our directors or officers.

Basis of Presentation and Significant Accounting Policies (Policies)

3 Months Ended

Mar. 31, 2024

Accounting Policies [Abstract]

Basis of Presentation

Basis of Presentation

Reverse Stock Split

Reverse Stock Split

Going Concern

Going Concern

Use of Estimates

Use of Estimates

Stock Compensation

Stock Compensation

Basic and Diluted Net Income (Loss) Per Common Share

Basic and Diluted Net Income (Loss) Per Common Share

	2024		2023
	As of March 31,
	2024		2023

Options to acquire common stock		68,997		17,651
Warrants to acquire common stock		—		42
Series C Convertible Preferred Stock		—		160,228
Preferred Investment Option		—		1,136,364
		68,997		1,314,285

Recently Issued Accounting Pronouncements

Recently Issued Accounting Pronouncements

Basis of Presentation and Significant Accounting Policies (Tables)

3 Months Ended

Mar. 31, 2024

Accounting Policies [Abstract]

Schedule of Share Excluded From Computation of Diluted Loss Per Share

	2024		2023
	As of March 31,
	2024		2023

Options to acquire common stock		68,997		17,651
Warrants to acquire common stock		—		42
Series C Convertible Preferred Stock		—		160,228
Preferred Investment Option		—		1,136,364
		68,997		1,314,285

Stock Based Compensation (Tables)

3 Months Ended

Mar. 31, 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		3.52	%		2.42	%
Expected volatility		134	%		92	%
Expected lives (years)		6			6
Expected dividend yield		0.00	%		0.00	%

Schedule of Stock Options Activity

Presented below is our stock option activity:

Schedule of Stock Options Activity

	Three-Months Ended March 31, 2024
	Number of Options (Employees)		Number of Options (Non-Employees)		Total Number of Options		Weighted-Average Exercise Price
Outstanding at January 1, 2024		10,347		3,650		13,997	$	501.70
Issued		55,000		—		55,000		1.83
Exercised, forfeited or expired		—		—		—		—
Outstanding at March 31, 2024		65,647		3,650		68,997	$	103.24
Exercisable at March 31, 2024		39,391		3,650		43,041	$	164.39

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 March 31, 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		9.80	$	1.83		29,044		9.80	$	1.83
	$26.00 –$100.00		3,500		5.70	$	26.00		3,500		5.70	$	26.00
	$100.01 – $300.00		6,066		3.46	$	195.29		6,066		3.46	$	195.29
	$300.01 –$4,146.00		4,431		1.36	$	1,296.92		4,431		1.36	$	1,296.92
			68,997		8.49	$	103.24		43,041		8.49	$	164.39

Schedule of Share Excluded From Computation of Diluted Loss Per Share (Details) - shares	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Share excluded from computation of diluted loss per shares	68,997	1,314,285
Series C 10% Convertible Preferred Stock [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Share excluded from computation of diluted loss per shares		160,228
Share-Based Payment Arrangement, Option [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Share excluded from computation of diluted loss per shares	68,997	17,651
Warrant [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Share excluded from computation of diluted loss per shares		42
Preferred Investment Option [Member]
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Share excluded from computation of diluted loss per shares		1,136,364

Basis of Presentation and Significant Accounting Policies (Details Narrative) - USD ($)		3 Months Ended		12 Months Ended
	May 17, 2023	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023	Dec. 31, 2022
Accounting Policies [Abstract]
Reverse stock split	1-for-100 reverse stock split		1-100 reverse split
Net income (loss)		$ 186,735	$ (1,074,498)	$ (3,800,000)
Operating income loss		831,897	1,080,039
Stockholders equity		345,208	$ (1,806,117)	107,354	$ (1,317,964)
Cash and cash equivalents		$ 2,064,191		$ 2,070,075

Financing Under Securities Purchase Agreement (Details Narrative) - USD ($)									12 Months Ended
	Jun. 29, 2023	Oct. 01, 2022	Jul. 01, 2022	Apr. 01, 2022	Jan. 03, 2022	Jan. 01, 2022	Jul. 16, 2021	Jul. 13, 2021	Dec. 31, 2023	Mar. 31, 2024	May 08, 2023	Jan. 31, 2023	Dec. 31, 2022
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Dividend paid					$ 68,809
Preferred stock, shares issued									0	0
Preferred stock, shares outstanding									0	0
Series C 10% Convertible Preferred Stock [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Preferred stock dividend rate percentage							10.00%
Investor [Member] \| Series C 10% Convertible Preferred Stock [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Shares issued upon conversion											16,027		2,752
Number of shares converted											15,250	1,342
Preferred stock, shares issued									0	0
Preferred stock, shares outstanding									0	0
Securities Purchase Agreement [Member] \| Investor [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Gross proceeds from issuance of equity								$ 10,000,000
Net proceeds from issuance of equity								$ 9,200,000
Stock issued during period, shares, new issues								20,000
Purchase price per share								$ 88.00
Proceeds from issuance of common stock								$ 1,760,000
Securities Purchase Agreement [Member] \| Investor [Member] \| Preferred Investment Option [Member]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
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]
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
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
Shares issued upon conversion								93,637
Preferred stock, convertible, 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
Dividend paid		$ 68,809	$ 84,005	$ 202,567		$ 206,000
Dividends total									$ 561,381

Schedule of Fair Value of Stock Options at the Date of Grant (Details)	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Share-Based Payment Arrangement [Abstract]
Risk-free interest rate	3.52%	2.42%
Expected volatility	134.00%	92.00%
Expected lives (years)	6 years	6 years
Expected dividend yield	0.00%	0.00%

Schedule of Stock Options Activity (Details)	3 Months Ended
Schedule of Stock Options Activity (Details)	Mar. 31, 2024 $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total Number of Option, Outstanding at beginning	13,997
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	68,997
Weighted Average Exercise Price Options, Outstanding ending \| $ / shares	$ 103.24
Total Number of Option, Exercisable at ending	43,041
Weighted Average Exercise Price Options, Exercisable at ending \| $ / shares	$ 164.39
Share-Based Payment Arrangement, Employee [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Total Number of Option, Outstanding at beginning	10,347
Total Number of Option, Issued	55,000
Total Number of Option, Exercised, forfeited or expired
Total Number of Option, Outstanding at ending	65,647
Total Number of Option, Exercisable at ending	39,391
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

Schedule of Ranges of Outstanding Stock Options (Details) - Share-Based Payment Arrangement, Option [Member]	3 Months Ended
	Mar. 31, 2024 $ / shares shares
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of Options Outstanding \| shares	68,997
Weighted-Average Remaining Contractual Life (years)	8 years 5 months 26 days
Weighted-Average Exercise Price	$ 103.24
Number of Options Exercisable \| shares	43,041
Weighted-Average Remaining Contractual Life (years)	8 years 5 months 26 days
Weighted-Average Exercise Price	$ 164.39
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)	9 years 9 months 18 days
Weighted-Average Exercise Price	$ 1.83
Number of Options Exercisable \| shares	29,044
Weighted-Average Remaining Contractual Life (years)	9 years 9 months 18 days
Weighted-Average Exercise Price	$ 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)	5 years 8 months 12 days
Weighted-Average Exercise Price	$ 26.00
Number of Options Exercisable \| shares	3,500
Weighted-Average Remaining Contractual Life (years)	5 years 8 months 12 days
Weighted-Average Exercise Price	$ 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)	3 years 5 months 15 days
Weighted-Average Exercise Price	$ 195.29
Number of Options Exercisable \| shares	6,066
Weighted-Average Remaining Contractual Life (years)	3 years 5 months 15 days
Weighted-Average Exercise Price	$ 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	4,431
Weighted-Average Remaining Contractual Life (years)	1 year 4 months 9 days
Weighted-Average Exercise Price	$ 1,296.92
Number of Options Exercisable \| shares	4,431
Weighted-Average Remaining Contractual Life (years)	1 year 4 months 9 days
Weighted-Average Exercise Price	$ 1,296.92

Stock Based Compensation (Details Narrative) - USD ($)		3 Months Ended
Stock Based Compensation (Details Narrative) - USD ($)	Sep. 07, 2023	Mar. 31, 2024	Mar. 31, 2023	Dec. 31, 2023	Nov. 30, 2019
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Outstanding stock options		68,997		13,997
Stock granted	55,000		0
Vesting percentage	50.00%
Vesting period	3 years
Stock options exercised
Stock compensation costs		$ 51,119	$ 0
Unrecognized compensation expense		43,206
Options vested intrinsic value		$ 32,000
Class of Warrant or Right, Outstanding		0		42
Class of Warrant or Right, Exercise Price of Warrants or Rights				$ 1,044.00
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
Common stock issued, shares	75,000
2019 Stock Incentive Plan [Member] \| Restricted Stock [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Shares outstanding		250

Xoma (Details Narrative) - USD ($) $ in Thousands	Jun. 21, 2023	Mar. 31, 2024
Milestone payment, amount	$ 6,000
Payments for royalities	$ 6,000
XOMA [Member]
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
Aldrorubicin And Arimoclomol [Member]
Legal fees	5,000
Arimoclomol [Member]
Milestone payment, amount		$ 3,650
Commercial sale, amount	1,000
Aldoxorubicin [Member]
Commercial sale, amount	$ 4,000

Commitments and Contingencies (Details Narrative) - USD ($)	May 31, 2022	Mar. 31, 2024	Jun. 21, 2023
Product Liability Contingency [Line Items]
Milestone payment, amount			$ 6,000,000
Kem Pharm [Member]
Product Liability Contingency [Line Items]
Cash consideration from sale of assets	$ 12,800,000
Liabilities assumed	$ 5,200,000
Aldoxorubicin [Member] \| Maximum [Member]
Product Liability Contingency [Line Items]
Milestone payment, amount		$ 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