MBRX Moleculin Biotech Inc

PART 1 FINANCIAL INFORMATION

 

Item 1. Financial Statements

Moleculin Biotech, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except for share and per share data)

(Unaudited)

 

 

 

See accompanying notes to condensed consolidated financial statements.

 

 

Moleculin Biotech, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

(Unaudited)

 

 

See accompanying notes to condensed consolidated financial statements.

 

 

Moleculin Biotech, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)

 

  

 

See accompanying notes to condensed consolidated financial statements.

 

 

Moleculin Biotech, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands, except for shares)

(Unaudited)

 

 

 

See accompanying notes to condensed consolidated financial statements.

 

 

Moleculin Biotech, Inc.

Notes to the Condensed Consolidated Financial Statements

(Unaudited)

 

1. Nature of Business 

 

The terms “MBI” or “the Company”, “we”, “our” and “us” are used herein to refer to Moleculin Biotech, Inc. MBI is a clinical-stage pharmaceutical company, organized as a Delaware corporation in July 2015, with clinical programs for hard-to-treat cancers and viruses. The Company has three core technologies, each of which have had one or more drugs successfully complete a Phase 1 clinical trial, based substantially on discoveries made at and licensed from MD Anderson Cancer Center (MD Anderson) in Houston, Texas. In July 2024 the Company’s lead program Annamycin completed a Phase 2 trial and has held it End-of-Phase 1/2 meeting with the Food and Drug Administration in the US and in August 2024 announced the preparations for a Phase 3 trial. The Company has two wholly owned subsidiaries, Moleculin Australia Pty. Ltd., which was set up to perform certain preclinical development and Moleculin Amsterdam B.V., which acts as its legal representative for clinical trials in Europe. The Company utilizes its own internal resources and funds to conduct some of these trials and also has trials being conducted via physician-sponsored trials. The physician-sponsored trials utilize primarily external funds, such as grant funds, which are not presented in these financial statements. The Company does not have manufacturing facilities, and all manufacturing activities are contracted out to third parties. Additionally, the Company does not have a sales organization. The Company’s overall strategy is to seek potential outlicensing or outsourcing opportunities with development/commercialization strategic partners who are better suited for the marketing, sales and distribution of its drugs, if approved.

 

In 2019, the Company sublicensed its technologies to Animal Life Sciences, Inc. (ALI), to enable research and commercialization for non-human use and share development data. As part of this agreement, ALI issued to the Company a 10% equity interest in ALI. 

 

On May 5, 2023, the Company received a letter from the Nasdaq Capital Market (Nasdaq) notifying the Company that for the prior 30 consecutive business days the bid price for the Company's common stock had closed below the minimum $1.00 per share requirement for continued inclusion on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2) (Bid Price Rule). The deficiency letter did not result in the immediate delisting of the Company's common stock from the Nasdaq. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial period of 180 calendar days, until  November 1, 2023, to regain compliance with the Bid Price Rule. On November 2, 2023, the Company received a 180-calendar day extension, until  April 29, 2024, from the Nasdaq to regain compliance with Bid Price Rule. On March 5, 2024, the Board of Directors approved a reverse 1-for-15 reverse stock split effective 11:59 P.M. (Eastern time) on March 21, 2024, with trading to commence on a split-adjusted basis on March 22, 2024. On April 8, 2024, the Company received a letter from Nasdaq notifying the Company that it had regained compliance with Bid Price Rule 5550(a)(2) as a result of the closing bid price of the Company's common stock being at $1.00 per share or greater for the 10 consecutive business days from March 22, 2024 through April 5, 2024. Accordingly, the Company is in compliance with the Bid Price Rule and Nasdaq considers the matter closed.

2. Basis of presentation, principles of consolidation, and significant accounting policies and liquidity 

 

Reverse Stock Split - On March 22, 2024, the Company completed a reverse stock split of all the issued and outstanding shares of the Company's common stock at a ratio of 1 to 15. The accompanying consolidated financial statements and notes to the consolidated financial statements gives retroactive effect to the reverse stock split for all periods presented. Certain amounts previously reported include rounding up of fractional shares as a result of the reverse stock split.

 

Basis of Presentation – Condensed Consolidated Financial Information - The accompanying condensed consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP) for financial information, and in accordance with the rules and regulations of the U.S. Securities and Exchange Commission (SEC) with respect to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The condensed consolidated financial statements furnished reflect all normal adjustments, which are, in the opinion of management, necessary for a fair statement of results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. These condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company as of  December 31, 2023 and for the year then ended, including the notes thereto contained in the Form 10-K filed with the SEC on March 22, 2024.

 

Principles of Consolidation - The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP. The Company views its operations and manages its business in one operating segment. All material long-lived assets of the Company reside in the U.S.

 

Significant Accounting Policies - The Company's significant accounting policies are described in Note 2, Basis of Presentation, principles of consolidation and significant accounting policies, to the consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023. There have been no material changes to the significant accounting policies during the nine months ended September 30, 2024.

 

Use of Estimates - The preparation of these condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of financial statements. Estimates are used in the following areas, among others: fair value estimates on intangible assets, warrants, and stock-based compensation expense, as well as accrued expenses and taxes. 

 

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Intangible Assets – Intangible assets with finite lives are amortized using the straight-line method over their estimated period of benefit. Acquired intangible assets identified as in-process research and development (IPR&D) assets, are considered indefinite lived until the completion or abandonment of the associated research and development efforts. If the associated research and development effort is abandoned, the related IPR&D assets will be written-off and the Company will record a noncash impairment loss on its statements of operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. Intangible assets are tested for impairment on an annual basis, which was completed as of September 30, 2024, and between annual tests if indicators of potential impairment exist, using a fair-value-based approach. The Company evaluates the recoverability of intangible assets periodically and take into account events or circumstances that warrant revised estimates of useful lives or that indicate that impairment exists. No impairments of intangible assets have been identified during any of the periods presented.

 

Going Concern and Liquidity - These condensed consolidated financial statements have been prepared on a going concern basis, which assumes the Company will continue to realize its assets and discharge its liabilities in the normal course of business. The continuation of the Company as a going concern is dependent upon the ability of the Company to obtain necessary equity financing to continue operations and the attainment of profitable operations. As of  September 30, 2024, the Company had an accumulated deficit of $151.5 million since inception and had not yet generated any revenues from operations. Additionally, management anticipates that its cash on hand of $9.4 million as of September 30, 2024 is not sufficient to fund its planned operations for a period of at least one year from when these consolidated financial statements are issued. These factors raise substantial doubt regarding the Company's ability to continue as a going concern. These unaudited condensed consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company intends to seek additional funding through one or more of the following: a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements and delay planned cash outlays or a combination thereof. There can be no assurance that such events or a combination thereof can be achieved.

 

 In March 2022, the Company received a subpoena from the SEC requesting information and documents, including materials related to certain individuals (none of which are the Company's officers or directors) and entities, and materials related to the development of and statements regarding the Company's drug candidate for the treatment of COVID-19. The Company has received, and expects to continue to receive, periodic further requests from the SEC staff with respect to this matter. The Company is not aware of the specific nature of the underlying investigation by the SEC, and to the extent that this investigation relates to prior public disclosures that it has made, the Company believes in the accuracy and adequacy of such prior disclosures. The correspondence from the SEC transmitting the subpoena to the Company states that the SEC is trying to determine whether there have been any violations of federal securities laws, but that its investigation does not mean that the SEC has concluded that anyone has violated the law or that the SEC has a negative opinion of any person, entity, or security. The Company cannot predict when this matter will be resolved or what, if any, action the SEC may take following the conclusion of the investigation. The company expensed approximately $0.1 million and $0.4 million in related general and administrative fees and expenses for the three months ended  September 30, 2024 and 2023, respectively, and $0.2 million and $1.4 million for the nine months ended  September 30, 2024 and 2023, respectively. The Company is in the process of filing a claim with its insurance carriers related to this loss which may cover a portion of the related expenses but not all. The claim is currently under review by the insurance company. The claim has not yet been approved nor has a reimbursement amount been determined which, if any, would be limited by the applicable retention as defined under the policy. Accordingly, the Company has not recorded any provision for insurance reimbursement. The Company expects to record the insurance reimbursement at the time that the amount to be reimbursed is determined and approved by the insurance carrier. Any insurance reimbursement receivable will be recorded at an amount not to exceed the recorded loss and only if the terms of the legally enforceable insurance contracts support that the insurance recovery will not be disputed and is deemed collectible, or if recovery of the loss is probable.

 

Cash and Cash Equivalents - Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. The Company maintains cash accounts principally at one financial institution in the U.S., which at times, may exceed the Federal Deposit Insurance Corporation’s limit. The Company has not experienced any losses from cash balances in excess of the insurance limit. The Company’s management does not believe the Company is exposed to significant credit risk at this time due to the financial condition of the financial institution where its cash is held. 

 

Fair Value of Financial Instruments - The Company's financial instruments consist primarily of non-trade receivables, accounts payable, accrued expenses and its warrant liability. The carrying amount of non-trade receivables, accounts payable, and accrued expenses approximates their fair value because of the short-term maturity of such.

 

The Company has categorized its assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy in accordance with U.S. GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3).

 

Assets and liabilities recorded in the condensed consolidated balance sheets at fair value are categorized based on a hierarchy of inputs as follows:

 

Level 1 – Unadjusted quoted prices in active markets of identical assets or liabilities.

Level 2 – Quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.

Level 3 – Unobservable inputs for the asset or liability.

 

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The Company’s financial assets and liabilities recorded at fair value on a recurring basis include the fair value of warrant liability discussed in Note 4.

 

The following table provides the financial liabilities reported at fair value and measured on a recurring basis at September 30, 2024 and December 31, 2023 (table in thousands): 

 

Description		Fair Value				Level 1				Level 2				Level 3
Fair value of warrant liability as of September 30, 2024:		$	9,932			$	—			$	—			$	9,932
Fair value of warrant liability as of December 31, 2023:		$	4,855			$	—			$	—			$	4,855

 

The table below of Level 3 liabilities (table in thousands) begins with the valuation as of the beginning of the third quarter and then is adjusted for changes in fair value that occurred during the third quarter. The ending balance of the Level 3 financial instrument presented above represents the Company's best estimates and may not be substantiated by comparison to independent markets and, in many cases, could not be realized in immediate settlement of the instruments. 

 

Three Months Ended September 30, 2024		Warrant Liability Long-Term
Balance, June 30, 2024		$	1,704
Issuances of warrants			6,111
Warrant amendment			389
Change in fair value - net			1,728
Balance, September 30, 2024		$	9,932

 

The table below of Level 3 liabilities (table in thousands) begins with the valuation as of December 31, 2023 and then is adjusted for changes in fair value that occurred during the nine months ended  September 30, 2024. The ending balance of the Level 3 financial instrument presented above represents the Company's best estimates and may not be substantiated by comparison to independent markets and, in many cases, could not be realized in immediate settlement of the instruments. 

 

Nine Months Ended September 30, 2024		Warrant Liability Long-Term
Balance, December 31, 2023		$	4,855
Issuances of warrants			6,111
Warrant amendment			389
Change in fair value - net			(1,423	)
Balance, September 30, 2024		$	9,932

 

Loss Per Common Share - Basic net loss per common share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding during the period. For purposes of this calculation, options to purchase common stock, restricted stock units subject to vesting and warrants to purchase common stock are considered to be common stock equivalents. Diluted net loss per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, the weighted-average number of common shares outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive. For the three months ended September 30, 2024 and 2023, approximately 4.8 million and 0.6 million, respectively, of potentially dilutive shares were excluded from the computation of diluted earnings per share due to their anti-dilutive effect. For the nine months ended September 30, 2024 and 2023, approximately 2.7 million and 0.5 million, respectively, of potentially dilutive shares were excluded from the computation of diluted earnings per share due to their anti-dilutive effect.

 

Subsequent Events - The Company’s management reviewed all material events through the date of these unaudited condensed consolidated financial statements. 

 

Recent Accounting Pronouncements - In November 2024, FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires disclosure in the notes to the financial statements of specified information about certain costs and expenses. The amendments are effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the new guidance to determine the impact it may have on its consolidated financial statements and related disclosures, but expects additional disclosures upon adoption. There are no other recently issued accounting standards updates that are currently expected to have a material impact on the Company. 

 

3. Accrued expenses and other current liabilities

 

Accrued expenses and other current liabilities consist of the following components (in thousands):

 

		September 30, 2024				December 31, 2023
Accrued payroll and bonuses		$	1,512			$	765
Accrued research and development			894				2,845
Accrued legal, regulatory, professional and other			431				547
Operating lease liability - current			116				100
Accrued liabilities due to related party			90				60
Total accrued expenses and other current liabilities		$	3,043			$	4,317

 

Additionally, accounts payable includes $20,000 and $67,000 as of September 30, 2024 and December 31, 2023, respectively, for related party payables.

 

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4. Warrants and Equity

 

2024 Warrant and Stock Issuances

 

In August 2024, the Company entered into a securities purchase agreement with an institutional investor for the sale by the Company of 283,000 shares of common stock, and 2,183,368 pre-funded warrants to purchase shares of common stock, series A warrants to purchase up to 2,466,368 shares of common stock, series B warrants to purchase up to 2,466,368 shares of common stock, and placement agent warrants. The combined purchase price for the securities was $2.23 per share of common stock (or pre-funded warrant in lieu thereof). Each pre-funded warrant is exercisable for one share of common stock at an exercise price of $0.001 per share. The pre-funded warrants are exercisable immediately and may be exercised at any time until all of the pre-funded warrants are exercised in full, subject to the beneficial ownership limitation. Each common warrant has an exercise price of $2.23 per share and will be exercisable beginning on the effective date of shareholder approval. The series A warrants expire on the earlier of (i) two years from the initial exercise date, or (ii) 60 days from the Company's public announcement that it has achieved the series A milestone event. The series B warrants expire on the earlier of (i) five years from the initial exercise date, or (ii) six months from the Company's public announcement that it has achieved the series B milestone event. The series A milestone event means the Company releases interim data for the first subject group from the MIRACLE trial whereby the complete remission rate for either dose of the Company's study drug is greater than placebo; and series B milestone event means the Company releases final topline data from the MIRACLE trial and documented a statistically significant improvement in the primary efficacy endpoint. In addition, in August 2024, the Company entered into a warrant amendment agreement, pursuant to which the Company agreed that effective upon closing of the offering, and subject to shareholder approval, to amend 895,834 existing warrants originally issued on December 26, 2023 at an exercise price of $9.60 per share and a termination date of February 14, 2029, so that the amended warrants would have a reduced exercise price of $2.23 per share and would expire five years from the date of shareholder approval. The Company calculated the valuation of the warrant amendment immediately prior to the offering, as well as the valuation of the warrant amendment with the repriced terms, and a 50% probability of obtaining shareholder approval. The loss on modification of the warrants of $0.4 million was recorded as a loss on issuance of warrant liabilities in the three and nine months ended September 30, 2024. The Company also considered a 50% probability of obtaining shareholder approval in the valuation for the August 2024 warrants in the three and nine months ended September 30, 2024. In October 2024, the Company’s shareholders approved the issuance of both the August 2024 warrants, as well as the warrant amendment.

 

The Company received gross proceeds of $5.5 million, before deducting the placement agent's fees and other offering expenses payable by the Company. Proceeds of offerings are allocated between common shares and warrants first by allocating to the warrants classified as a liability based on their fair value and then allocating the residual to the equity instruments, which would include pre-funded warrants. As the fair value of the liability classified warrants in the August 2024 offering exceeded the total proceeds, no consideration was allocated to the Common Shares or Pre-Funded Warrants. The full proceeds of the August 2024 offering were recorded to warrant liabilities, with an initial liability of $6.1 million, and a loss on initial recognition of $0.8 million. Transaction costs related to the offering were correspondingly fully allocated to warrant liabilities, and $1.0 million in related transaction costs were expensed during the three and nine months ended September 30, 2024. 

 

Lincoln Park Equity Line

 

The Company did not utilize the 2021 Lincoln Park purchase agreement during the nine months ended September 30, 2024. The 2021 Lincoln Park Agreement terminated in June 2024. 

 

Other Components of Equity 

 

In March 2024, the Company issued 6,834 shares of common stock to consultants in exchange for services to be provided. In addition, during the nine months ended September 30, 2024, the Company issued 20,485 shares of common stock related to the vesting of restricted stock units.

 

Liability Classified Warrants

 

The Company uses the Black-Scholes option pricing model (BSM) to determine the fair value of its warrants at the date of issue and outstanding at each reporting date. The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds linearly interpolated to obtain a maturity period commensurate with the term of the warrants. Estimated volatility is a measure of the amount by which the Company's stock price is expected to fluctuate each year during the expected life of the warrants. Only the volatility of the Company's own stock is used in the Black-Scholes option pricing model. Certain assumptions, including the expected term, are subjective and require judgment to develop. As a result, if factors or expected outcomes change and we use significantly different assumptions or estimates, our warrant liability could be materially different.

 

The assumptions used in determining the fair value of the Company's outstanding liability classified warrants are as follows:

 

		September 30, 2024			December 31, 2023
Risk-free interest rate		3.6% to 4.5%			3.8% to 5.4%
Volatility		78.7% to 111.5%			79.5% to 108.7%
Expected life (years)		0.4 to 5.0			0.3 to 5.0
Dividend yield		—%			—%

 

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A summary of the Company's liability classified warrant activity during the nine months ended September 30, 2024 and related information follows: 

 

		Number of Shares				Range of Warrant Exercise								Weighted Average				Weighted Average Remaining Contractual
		Under Warrant				Price per Share								Exercise Price				Life (Years)
Balance at January 1, 2024			1,082,895			$	9.60			$	157.50			$	24.32				5.1
Granted			5,056,054			$	2.23			$	2.79			$	2.24				2.9
Expired warrants			(75,909	)		$	99.00			$	99.00			$	99.00				—
Balance at September 30, 2024			6,063,040			$	2.23			$	94.50			$	12.90				3.1
Exercisable at September 30, 2024			1,006,986			$	2.23			$	94.50			$	8.75				4.1

 

For a summary of the changes in fair value associated with the Company's warrant liability for the nine months ended September 30, 2024, see Note 2 - Basis of presentation, principles of consolidation and significant accounting policies - Fair Value of Financial Instruments.

 

Equity Classified Warrants

 

In March 2024, the Company granted equity-classified warrants to purchase up to 3,334 shares of Company common stock with a ten-year term and an exercise price of $9.15. The warrants vest annually over four years while services are being performed.

 

At September 30, 2024, the Company had 2,089,105 equity classified warrants outstanding (including the remaining August 2024 pre-funded warrants) and 2,066,894 warrants were exercisable. At  December 31, 2023, the Company had 289,276 equity classified warrants outstanding and 266,350 warrants were exercisable.

 

5. Stock Based Compensation

 

The 2015 Stock Plan provides for the grant of stock options, stock awards, stock unit awards, and stock appreciation rights to employees, non-employee directors and consultants. In May 2023 and 2022, the 2015 Stock Plan (the Plan) was amended to authorize an additional 116,667 shares and 133,334 shares, respectively, such that 366,667 total shares may be issued under the Plan. As of September 30, 2024, there were 2,853 shares remaining to be issued under the 2015 Stock Plan. In October 2024, the Company's shareholders approved the 2024 Stock Plan, which authorizes a total of 1,000,000 shares of common stock, which will replace the 2015 Stock Plan. 

 

Stock-based compensation expense for the three and nine months ended September 30, 2024 and 2023, respectively, is as follows (table in thousands): 

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2024				2023				2024				2023
General and administrative		$	259			$	346			$	980			$	1,094
Research and development			94				147				319				411
Total stock-based compensation expense		$	353			$	493			$	1,299			$	1,505

 

The Company recorded stock compensation expense for the equity classified warrants relating to non-employee consulting agreements of $26,000 and $50,000 for the three months ended  September 30, 2024 and 2023, respectively, and $94,000 and $142,000 for the nine months ended September 30, 2024 and 2023 , respectively, which are included in the table above. At  September 30, 2024, there was $283,000 of unrecognized stock compensation expense related to the Company's equity classified warrants.

 

In October and November 2024, the Company granted 545,000 stock options, 267,500 shares of restricted stock units, 73,334 shares of performance based restricted stock units, and 36,000 in warrants to employees and contractors. These stock options have an exercise price ranging from $2.45 to $2.54 and vest over a one-to-four year period from the grant date on a straight-line basis over the requisite service period. The restricted stock units vest annually in four equal installments. 

 

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6. Income Taxes  

 

Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.

 

The Company does not expect to pay any significant federal, state, or foreign income taxes in 2024 as a result of the losses recorded during the three and nine months ended September 30, 2024 and the additional losses expected for the remainder of 2024 and cumulative net operating loss carryforwards. Accounting standards require the consideration of a valuation allowance for deferred tax assets if it is “more likely than not” that some component or all of the benefits of deferred tax assets will not be realized. As a result, as of September 30, 2024 and  December 31, 2023 the Company maintained a full valuation allowance for all deferred tax assets.

 

The Company recorded no income tax provision for the three and nine months ended September 30, 2024 and 2023, respectively. The effective tax rate for the nine months ended September 30, 2024 and 2023 is nil. The income tax rates vary from the federal and state statutory rates primarily due to the change in fair value of the stock warrants, Internal Revenue Code Section 162(m) limitations and ISO activity, as well as the valuation allowances on the Company’s deferred tax assets. The Company estimates its annual effective tax rate at the end of each quarterly period. Jurisdictions with a projected loss for the year where no tax benefit can be recognized due to the valuation allowance could result in a higher or lower effective tax rate during a particular quarter depending on the mix and timing of actual earnings versus annual projections. 

 

7. Commitments and Contingencies 

 

In addition to the commitments and contingencies described elsewhere in these notes, see below for a discussion of the Company's commitments and contingencies as of September 30, 2024.

 

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Lease Obligations Payable

 

The following summarizes quantitative information about the Company's operating leases for the three and nine months ended September 30, 2024 and 2023, respectively (table in thousands):

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2024				2023				2024				2023
Lease cost:
Operating lease cost		$	37			$	34			$	112			$	99
Variable lease cost			7				5				17				19
Total		$	44			$	39			$	129			$	118

 

In September 2023, the Company executed an amendment to extend the corporate office lease until August 31, 2029, with an option to renew. The Company is required to remit base monthly rent of approximately $4,700 which will increase at an average approximate rate of 2% each year. The Company is also required to pay additional rent in the form of its pro-rata share of certain specified operating expenses of the building. 

 

In June 2022, the Company extended the lab lease until September 30, 2027, with no further right or option to renew. The Company recorded approximately $12,000 in sublease income from a related party for the three months ended September 30, 2024 and 2023, and $37,000 for the nine months ended September 30, 2024 and 2023. Sublease income is recorded as other income, net on the Company's condensed consolidated statement of operations and comprehensive loss. Operating cash flows from operating leases was $39,000 and $34,000 for the three months ended  September 30, 2024 and 2023, respectively, and $107,000 and $109,000 for the nine months ended September 30, 2024 and 2023, respectively.

 

Licenses 

 

MD Anderson - Total expenses related to the Company's license agreements with MD Anderson were $63,000 and $64,000 for the three months ended September 30, 2024 and 2023, respectively, and $180,000 and $193,000 for the nine months ended September 30, 2024 and 2023, respectively.

 

HPI - The Company has two agreements with a related party, Houston Pharmaceuticals, Inc. (HPI) with total expenses of $59,000 for each of the three months ended September 30, 2024 and 2023, respectively, and $176,000 for the nine months ended September 30, 2024 and 2023, respectively.

 

Sponsored Research Agreements - The expenses recognized under the agreements were $767,000 and $221,000 for the three months ended September 30, 2024 and 2023, respectively, and $1,300,000 and $552,000 for the nine months ended September 30, 2024 and 2023, respectively.

 

8. Subsequent Events 

 

In addition to the subsequent events discussed elsewhere in these notes, no other subsequent events were noted as occurring after September 30, 2024.

 

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 

 

This Form 10-Q, including the Management’s Discussion and Analysis of Financial Condition and Results of Operations, contains certain forward-looking statements. Historical results may not indicate future performance. Our forward-looking statements reflect our current views about future events, are based on assumptions and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those contemplated by these statements.

 

Forward-looking statements include, but are not limited to, statements about: 

 

	•	Our ability to continue our relationship with MD Anderson, including, but not limited to, our ability to maintain current licenses and license future intellectual property resulting from our sponsored research agreements with MD Anderson;
	•	The success or the lack thereof, including the ability to recruit subjects on a timely basis, for a variety of reasons, of our clinical trials through all phases of clinical development;
	•	Our ability to satisfy any requirements imposed by the US Food & Drug Administration (FDA) (or its foreign equivalents) as a condition of our clinical trials proceeding or beginning as planned;
	•	World-wide events including the wars in Ukraine and in the Middle East, the COVID-19 pandemic, and the general supply chain shortages effects on our clinical trials, clinical drug candidate supplies, preclinical activities and our ability to raise future financing;

•

Our ability to obtain additional funding to commence or continue our clinical trials, fund operations and develop our product candidates;

•

The need to obtain and retain regulatory approval of our drug candidates, both in the United States and in Europe, and in countries deemed necessary for future trials;

•

Our ability to complete our clinical trials in a timely fashion in line with our stated milestones and within our expected budget and resources;

	•	Our ability to maintain compliance with the continued listing requirements of the Nasdaq Capital Market;
	•	Our ability to source our drug products at reasonable prices;
	•	Compliance with obligations under intellectual property licenses with third parties;

•

Any delays in regulatory review and approval of drug candidates in clinical development;

	•	Potential efficacy of our drug candidates;
	•	Our ability to commercialize our drug candidates;

•

Market acceptance of our drug candidates;

•

Competition from existing therapies or new therapies that may emerge;

•

Potential product liability claims;

•

Our dependency on third-party manufacturers to successfully, and timely, supply or manufacture our drug candidates for our preclinical work and our clinical trials;

•

Our ability to establish or maintain collaborations, licensing or other arrangements;

•

Our ability and third parties’ abilities to protect intellectual property rights;

•

Our ability to adequately support future growth; and

•

Our ability to attract and retain key personnel to manage our business effectively.

 

We undertake no obligation to publicly update or revise any forward-looking statements, including any changes that might result from any facts, events, or circumstances after the date hereof that may bear upon forward-looking statements. Furthermore, we cannot guarantee future results, events, levels of activity, performance, or achievements.

 

Our Business

 

We are a Phase 3 clinical stage pharmaceutical company with a portfolio of technologies for hard-to-treat cancers and viruses. We have three core technologies, each of which have had one or more drugs successfully complete a Phase 1 clinical trial, based substantially on discoveries made at and licensed from the University of Texas MD Anderson Cancer Center (MD Anderson) in Houston, Texas. Three of our six drug candidates have shown human activity in clinical trials and are currently or have been in Phase 1B/2 or Phase 2 clinical trials. Since our inception, our drugs have completed, are currently in, or have been permitted to proceed in, fourteen clinical trials. Annamycin is our lead molecule and we have recently concluded one Phase 1B/2 clinical trial for treating Acute Myeloid Leukemia (AML) and are embarking on a Phase 3 clinical trial for the treatment of AML, which we believe will be pivotal. Annamycin is also in two Phase 1B/2 clinical trials for treating Soft Tissue Sarcoma metastasized to the lungs (STS lung metastases, STS lung mets, or Advanced STS).

 

One of our core management beliefs is that anthracyclines represent the most important treatment for AML and Advanced STS, and we believe Annamycin may, for the first time ever, allow a majority of these patients to benefit from this treatment, mainly due to its lack of cardiotoxicity (which is found in currently prescribed anthracyclines) and its ability to avoid multidrug resistance mechanisms. This belief, coupled with our limited resources, leads us to currently focus mainly on the development of Annamycin. We intend to advance our other drug candidates via investigator led studies – both clinically and preclinically.

 

Our Core Technologies

 

Our core technologies consist of the following programs:

 

a) Annamycin or L-Annamycin is a “next generation” anthracycline (one of the most widely used classes of chemotherapy), designed to be different than currently approved anthracyclines, which are limited in utility because of cardiotoxicity risks and their susceptibility to multidrug resistance mechanisms. Annamycin was designed to avoid multidrug resistance and to be non-cardiotoxic and, with intensive cardiac monitoring, has shown no cardiotoxicity in subjects treated in our four Annamycin clinical trials to date. Furthermore, we have demonstrated safe dosing significantly beyond the dose limitations imposed by regulatory authorities upon commonly prescribed anthracyclines due to their inherent cardiotoxicity. Annamycin has demonstrated efficacy in two of its Phase 1B/2 trials in subjects with AML and Advanced STS. We believe that Annamycin has potential to fill an unmet need as a second line therapy (2nd line or 2L) in AML and potentially as first line therapy in Advanced STS.

 

 

As part of our Annamycin clinical trials, we have engaged an independent expert to assess cardiotoxicity associated with chemotherapy at the Cleveland Clinic (Expert or Independent Expert). The data made available to the Expert include left ventricular ejection fraction (LVEF) as determined by echocardiograms, and ECHO strain imaging, as well as serum Troponin levels (a biochemical marker of acute heart damage). “ECHO strain imaging” is a method in echocardiography (medical ultrasound) for measuring regional or global deformation (contraction or beating) of the myocardium (heart muscle). By strain rate imaging, the simultaneous function of different regions can be displayed and measured. Cardiac health biomarkers such as blood Troponin levels are considered an indicator of potential long-term heart damage. The Expert has issued and will continue to issue periodic reports as additional data are provided to him in batches of subject data. Such data include some data which are preliminary and subject to change. In our discussions regarding the lack of Annamycin's cardiotoxicity, we rely on the Expert's assessment.

 

Annamycin benefits from a promising advancement in lipid enabled drug delivery developed in collaboration with and exclusively licensed from MD Anderson. The unique patented lipid composition allows us to combine a new concept in chemotherapeutic agents within a lipid structure that helps target the delivery of the payload and reduce the potential for toxicity. In the case of Annamycin, our unique use of lipid technology enables improved tissue/organ distribution, and as demonstrated in multiple clinical trials, dramatically reduced toxicity, including cardiotoxicity. Annamycin has composition of matter patent protection through 2040.

 

b) Our WP1066 Portfolio includes WP1066, WP1193 and WP1220, three of several Immune/Transcription Modulators in the portfolio designed to inhibit p-STAT3 (phosphorylated signal transducer and activator of transcription) among other transcription factors associated with tumor activity. These also stimulate a natural immune response to tumors by inhibiting the errant activity of Regulatory T-Cells (TRegs). WP1066, in oral formulation, has been in two clinical trials for central nervous system (CNS) tumors, including compassionate use cases, in pediatric subjects. WP1066 and WP1193 are being tested in preclinical programs in intravenous (IV) formulations. WP1066 and WP1220 have been in clinical trials in a topical formulation. WP1066 and WP1220 have both independently successfully completed Phase 1 clinical trials and have demonstrated efficacy in their varied indications.

 

c) Our WP1122 Portfolio contains compounds (including WP1122, WP1096, and WP1097) designed to exploit the potential uses of inhibitors of glycolysis such as 2-deoxy-D-glucose (2-DG). We believe such compounds may provide an opportunity to cut off the energy supply of tumors by taking advantage of their high degree of dependence on glucose in comparison to healthy cells, as well as viruses that also depend upon glycolysis and glycosylation to infect and replicate. WP1122 has completed a Phase 1 clinical study in normal volunteers, successfully establishing a Recommended Phase 2 Dose or RP2D.

 

Recent Business Developments 

 

Below are recent business developments.

 

Annamycin 

 

Phase 3 MIRACLE Trial

 

We are in the process of evaluating and visiting potential sites for our Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML) with Annamycin in combination with Cytarabine (also known as “Ara-C” and for which the combination of Annamycin and Ara-C is referred to as “AnnAraC”). This Phase 3 “MIRACLE” trial (derived from (M)olecul(i)n (R)/(r) AML (A)nnAraC (Cl)inical (E)valuation) will be a global trial.

 

We plan to focus on sites in the North America, Europe, Eastern Europe, Western Asia, and MENA (Middle East and Africa) for the initial Part A of MIRACLE. Our initial target will be approximately 45 sites. We expect that this will enable the enrollment of approximately 45 subjects by the third quarter of 2025 and approximately 90 subjects by the second half of 2026. The data may also be unblinded after the initial 45 subjects and, as currently planned, the data will be unblinded after approximately 90 subjects complete their efficacy analyses. We believe that we will have the data for approximately the first 90 subjects by the second half of 2026. The trial is designed to enable the review of interim analyses for safety and efficacy upon reaching these enrollment milestones.

 

We held a conference call on August 6, 2024, along with Dr. Michael Andreeff, a member of our Science Advisory Board, to discuss the results of our most recent meeting with the FDA and the plans for the MIRACLE trial. That meeting, the MIRACLE trial and the current data from the MB-106 trial are discussed further below.

 

On August 1, 2024, we announced the discussion in and our resulting plans from our End of Phase 1B/2 (EOP1B/2) meeting held in late June with the FDA supporting the advancement of Annamycin in combination with Cytarabine (AnnAraC to a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This Phase 3 “MIRACLE” trial will be a global study, including sites in the US and consistent with the FDA’s recommendations, the adaptive Phase 3 trial is expected to rely solely on CR (complete remission) at day 35 (+/- 14 days) as the primary endpoint versus the control arm. We plan to utilize a double-blind, placebo-controlled design, where the control arm is high dose cytarabine (HiDAC) plus placebo. The MIRACLE trial will focus on AnnAraC as a 2^nd line treatment for R/R AML subjects, with a subsequent trial to be focused on AnnAraC as a 3^rd line treatment for R/R AML.

 

Based on our discussions with the FDA, we intend to amend our current investigational new drug application or IND to allow dosing above the lifetime maximum allowable dose (LTMAD) for currently prescribed anthracyclines in this trial in the US. The MIRACLE study, subject to appropriate future filings with and potential additional feedback from the FDA, their foreign equivalents and/or institutional review boards (IRBs), is expected to initially utilize an adaptive design whereby the first 90 subjects will be randomized to receive HiDAC combined with either placebo, 190 mg/m² of Annamycin, or 230 mg/m² of Annamycin with such doses recommended by the FDA based on their review of our safety and efficacy data. At that point, the trial data will be unblinded to select the optimum dose for Annamycin. For the second half of the trial, approximately 240 subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin. The selection of the optimum dose by the independent Data Monitoring Committee will be based on the overall balance of efficacy, safety, and pharmacokinetics, consistent with the FDA’s new Project Optimus initiative.

 

 

We believe the FDA wants to see the durability of response (DoR) and overall survival (OS) as secondary endpoints. In addition, we believe the FDA wants to see data for subjects beyond 2^nd line and, accordingly, our plan includes a follow-on MIRACLE2 trial in 3^rd line subjects starting once the optimum dose is established in the MIRACLE trial.

 

We have established plans for the following milestones with regard to the MIRACLE trial:

 

●

2024 2H – Begin contracting with MIRACLE trial sites

●

2025 Q1 – First subject treated in MIRACLE trial

	●	2025 Q4 – Recruitment and interim data (n=~45)
	●	2H 2026 – Interim efficacy and safety data (n=~90) unblinded and Optimum Dose set for MIRACLE trial

●

2027 – Begin enrollment of 3rd line subjects in MIRACLE2

●

2027 – Enrollment ends in 2nd line subjects

●

2028 – Primary endpoint efficacy data for 2nd line subjects in MIRACLE

●

2028 2H – Begin submission of a new drug application (NDA) the treatment of R/R AML for accelerated approval on primary endpoint of CR from MIRACLE

 

 

Clinical Trial for the Treatment of AML in Combination with Cytarabine (MB-106)

 

 

Table 1

Line of Therapy	All Lines (Range 1st-7th)	1st Line	2nd Line	2nd and 3rd Line
Subjects Evaluable To Date	22	4	10	14
Subjects Evaluable Not Dosed Per Protocol	2	0	1	1
Median Age - Years (Range)	67.5 (19-78)	56.5 (19-69)	71 (53-78)	69.5 (53-78)
Complete Remission (CR)	8 (36%)	2 (50%)	5 (50%)	6 (43%)
Complete Remission Composite (CRc)	9 (41%)	2 (50%)	6 (60%)	7 (50%)
Partial Response (PR)	2	0	1	2
CRc Relapsed To Date	5	1	4	4
BMT To Date	4	1	2	3
See Note 1 below

 

Note 1 for Table 1: Data from MB-106 is for Intent To Treat (ITT) subjects; is as of October 24, 2024; and, is preliminary and subject to change. Median Durability of all CRc's is ~8 months and climbing.

 

On May 7, 2024, our management held a Key Opinion Leader conference call with Dr. Martin Tallman and Dr. Michael Andreeff. Management made a presentation of the data above and discussion ensued with Drs Tallman and Andreeff on the significance of this data. Both Drs. Tallman and Andreeff are members of our Science Advisory Board.

 

The call included a discussion of the results to date for MB-106. We believe that the Phase 1B/2 trial has been successful in establishing safety and efficacy of Annamycin in combination with Cytarabine (AnnAraC) for the treatment of AML, and in providing sufficient data to support a Phase 3 registration-directed clinical trial (MB-108) to further provide data for efficacy which we intend to use to support an eventual application for New Drug Approval (NDA).

 

Preliminary Safety, Efficacy and Durability Data

 

The preliminary data for MB-106 demonstrate a CR rate of 36% and a CRc rate of 41% for all subjects (N=22), regardless of the number of prior treatments, up to 6 prior treatments. Segmenting the MB-106 subject population for 2^nd line subjects (N=10) yields a CR rate of 50% and CRc rate of 60%. Further segmenting for 2^nd and 3^rd line subjects (N=14) yields a CR rate of 43% and a CRc rate of 50%. We believe the results demonstrated by AnnAraC in 2^nd line subjects substantially exceeds the performance reported by any drug currently approved for use in 2^nd line AML.

 

Median durability of remission (DoR) for the 9 CRcs is approximately 8 months and developing. The DoR is being measured from the initiation of treatment to relapse or death.

 

Cardiovascular safety of Annamycin is thoroughly monitored as independent assessments are made by an independent expert cardio-oncologist from Cleveland Clinic. As of April 1, 2024, data from 84 subjects across five trials (AML & STS, internal and externally funded trials) have been reviewed. Of note, most of these subjects have received greater than the lifetime cumulative anthracycline dose above 550 mg/m2 associated with increased risk of cardiomyopathy. Some subjects have received four times this amount following Annamycin administration(s). No signal of cardiotoxicity has been identified.

 

Annamycin as Monotherapy for the Treatment of Soft Tissue Sarcoma Lung Metastases

 

Additionally, we expect to release in the near future the topline data from the MB-107 trial with Annamycin for the monotherapy treatment of soft tissue sarcoma lung metastases. This Phase 1B/2 clinical trial in the US is for subjects with STS lung metastases after first-line therapy for their disease. The trial began in the first half of 2021. The Phase 1B was concluded in July 2022. On September 21, 2023, we announced the completion of enrollment in the Phase 2 portion of our U.S. Phase 1B/2 clinical trial evaluating Annamycin as monotherapy for the treatment of soft tissue sarcoma lung metastases. Subjects who had stable disease at the time of study discontinuation will continue to be followed for progression free response and overall survival. The study database is locked and the clinical study report is being written and should be completed in early 2025 and will be released in detail at that time. The total number of intent to treat subjects in the trial is 36.

 

 

U.S Patents for Annamycin 

 

On April 9, 2024, the United States Patent and Trademark Office (USPTO) issued U.S. Patent number 11,951,118 titled, “Preparation of Preliposomal Annamycin Lyophilizate” (the ‘118 patent’) to Moleculin and The University of Texas System Board of Regents. Additionally on May 14, 2024, the USPTO issued an additional patent (U.S. Patent number 11,980,634) titled “Method of Reconstituting Liposomal Annamycin” (the ‘634 patent’). We have global, exclusive licenses to both patents.

 

The ‘118 patent provides claims to compositions that contain Annamycin, and the ‘634 patent, as issued, provides claims to liposomal Annamycin suspension compositions, both with a base patent term extending until June 2040, subject to extension to account for time required to fulfill regulatory requirements for FDA approval. Moleculin’s novel candidate for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets) uses a unique lipid-based delivery technology. In addition to the issued ‘118 and expected ‘634 U.S. patents, we have additional patent applications pending in major jurisdictions worldwide. 

 

EMA issues ODD to Annamycin for the treatment of AML

 

We announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to Annamycin for the treatment of AML. Combined with the Orphan Drug Designation we have in the US and with the new composition of matter and formulation patents just awarded by the US Patent and Trademark Office with coverage through 2040, we believe the commercial exclusivity of Annamycin is now well protected.

 

The EMA grants orphan drug designation to drugs and biologics intended for the treatment, diagnosis or prevention of rare, life-threatening or chronically debilitating diseases or conditions that affect fewer than five in 10,000 people in the European Union. Orphan designation potentially allows companies certain benefits, including reduced regulatory fees, clinical protocol assistance, research grants and up to 10 years of potential market exclusivity in the European Union if approved. 

 

Presentation at the International Association for the Study of Lung Cancer 2024 World Conference on Lung Cancer

 

On September 23, 2024, we announced positive in vivo efficacy data of Annamycin in orthotopic and experimental lung metastatic models of sarcoma at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer. Treatment with Annamycin resulted in statistically significant inhibition of tumor growth and extension of survival in orthotopic lung cancer models and continues to be 100% non-cardiotoxic. The poster titled “Annamycin: Opening New Doors for Organotropic Targeting of Primary and Metastatic Lung Cancer,” authored by Waldemar Priebe, PhD (Founder, Founding Scientist, and Chair of Scientific Advisory Board for Moleculin) and coworkers was presented at the IASLC 2024 World Conference on Lung Cancer. The presented poster outlined results from the efficacy assessment studies of Annamycin, Moleculin’s next-generation anthracycline in orthotopic models of lung cancer and sarcoma lung metastasis models in comparison with doxorubicin (a commonly prescribed anthracycline.

 

Key Highlights of the Data Presented:

	•	Annamycin demonstrated high uptake and retention in lung parenchyma of mice and rats.
	•	The therapeutic effects of doxorubicin (DOX) are diminished due to low lung DOX uptake as demonstrated in the tested in vivo models. In contrast, Annamycin exhibits consistent efficacy in vivo in orthotopic and experimental lung metastatic models of sarcoma, breast, and colon cancer. This correlated with high Annamycin concentration in lungs, which exceeded DOX levels by 10- to 30-fold.
	•	Preclinical tests clearly demonstrate a better cardiac safety profile of Annamycin when compared to DOX and no cardiotoxicity of Annamycin in the in vivo models. No cardiotoxicity of Annamycin has been noted in ongoing clinical studies.
	•	The observed organotropic properties of Annamycin, its efficacy in vivo, and its promising safety profile warrant further translational studies to evaluate Annamycin in patients with primary or metastatic lung cancers, as a single agent and in combination with currently used therapeutics.

AACR Presentation of Data Demonstrating High Anti-Cancer Activity of Annamycin and Non-Cardiotoxic Properties

 

Preclinical data regarding the Company’s next-generation anthracycline, Annamycin, was presented at the American Association for Cancer Research (AACR) Annual Meeting, which took place April 5-10, 2024 in San Diego, CA. The poster titled, Non-cardiotoxic Properties of Annamycin, a Clinically Evaluated Anthracycline and Potent Topoisomerase 2β Poison, was presented in the “Late-Breaking Research: Experimental and Molecular Therapeutics 2” session held on Monday, April 8^th. The presented poster outlined results from the assessment and comparison of the potency of doxorubicin (a commonly prescribed anthracycline) and Annamycin, Moleculin’s next-generation anthracycline, against topoisomerase II-alpha and II-beta and determine their impact on physiology of human cardiomyocytes demonstrating no pathologic changes in mice hearts following chronic in vivo exposure.

 

WP1066

 

We announced on September 9, 2024, the beginning of enrollment and treatment of patients in an investigator-initiated Phase 2 study evaluating WP1066 in combination with radiation therapy for the treatment of adults with glioblastoma (NU 21C06). The study is being conducted under Northwestern University’s investigative New Drug application (IND) which cross references our own IND, which received clearance from the U.S. Food and Drug Administration (FDA) in April 2022. This trial is funded by the National Institutes of Health (NIH) and BrainUp®, a non-profit organization dedicated to bringing awareness to brain cancer. The NU 21C06 trial is a Phase 2, open-label, multi-arm trial of radiation therapy in combination with WP1066 in newly diagnosed IDH (isocitrate dehydrogenase) wild-type, MGMT-unmethylated glioblastoma patients. The primary outcome measure for the study is progression-free survival and secondary outcome measures include tumor microenvironment analysis. Four subjects have been treated as of November 1, 2024.

 

Regarding an intravenous formula for WP1066, we are pursuing a new patent that is co-owned by us and MD Anderson. We are in discussions regarding licensing or an option to license the MD Anderson rights to the new formulation.

 

 

WP1122

 

With the data generated from the MB-301 clinical trial setting an RP2D for WP1122 and additional sponsored research, we continue to explore avenues of external funding for further development of this portfolio. For this study, we submitted the final clinical study report in late October 2023.

 

General Business

 

Science Advisory Board Appointment

 

We announced on November 4, 2024, the appointment of Daniel D. Von Hoff, M.D., F.A.C.P., FASCO, FAACR to our Annamycin Scientific Advisory Board. Dr. Von Hoff currently serves as the Distinguished Professor at the Translational Genomics Research Institute (TGen) in Phoenix, Arizona and City of Hope.

 

August Issuance of Equity

 

On August 19, 2024, we announced the closing of our previously announced public offering of 283,000 shares of common stock and 2,183,368 pre-funded warrants to purchase shares of common stock, Series A warrants to purchase up to 2,466,368 shares of common stock and Series B warrants to purchase up to 2,466,368 shares of common stock, at a combined public offering price of $2.23 per share (or per common stock equivalent in lieu thereof) and accompanying warrants. The Series A warrants have an exercise price of $2.23, are exercisable immediately upon shareholder approval (which was received in October 2024) and will expire upon the earlier of (i) the 2 year anniversary of the date of stockholder approval or (ii) the 60^th day following the date we release interim data for the first subject group from the MIRACLE trial whereby the complete remission rate for either doses of the Company’s study drug is greater than placebo. The Series B warrants have an exercise price of $2.23, are exercisable immediately upon shareholder approval (which was received in October 2024) and will expire upon the earlier of (i) the 5 year anniversary of the date of stockholder approval or (ii) the 6 month anniversary following the date we release final topline data from the MIRACLE trial and documented a statistically significant improvement in the primary efficacy endpoint. Pursuant to Nasdaq Listing Rule 5635(d), the exercise of the Series A warrants and Series B warrants were subject to shareholder approval, which was received.

 

The gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses payable by us, were approximately $5.5 million and we would receive up to an additional approximately $11.0 million in gross proceeds if the warrants are fully exercised for cash. We are using the net proceeds from this offering to advance Annamycin and our other two drug portfolios through clinical development, advance the remainder of our existing portfolio through preclinical studies and into INDs or their equivalent, sponsor research at MD Anderson and HPI, and for working capital.

 

 

Results of Operations

 

The following table sets forth, for the periods indicated, data derived from our statement of operations (table in thousands) and such changes in the periods are discussed below in approximate amounts:

 

Moleculin Biotech, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2024				2023				2024				2023
Revenues		$	—			$	—			$	—			$	—
Operating expenses:
Research and development			4,932				3,280				13,274				12,855
General and administrative			2,172				2,635				6,629				7,765
Depreciation and amortization			31				32				95				92
Total operating expenses			7,135				5,947				19,998				20,712
Loss from operations			(7,135	)			(5,947	)			(19,998	)			(20,712	)
Other income (loss):
(Loss) gain from change in fair value of warrant liability			(1,728	)			1				1,423				76
Transaction costs allocated to warrant liabilities			(993	)			—				(993	)			—
Loss on issuance of warrant liabilities			(847	)			—				(847	)			—
Other income, net			9				13				31				30
Interest income, net			102				324				503				1,106
Net loss		$	(10,592	)		$	(5,609	)		$	(19,881	)		$	(19,500	)

  

Three Months Ended September 30, 2024 Compared to Three Months Ended September 30, 2023

 

Research and Development Expense. Research and development (R&D) expense was $4.9 million and $3.3 million for the three months ended September 30, 2024 and 2023, respectively. The increase of $1.6 million is mainly related to costs incurred for clinical trials (clinical research organization and drug production) and sponsored research costs.

 

General and Administrative Expense. General and administrative expense was $2.2 million and $2.6 million for the three months ended September 30, 2024 and 2023, respectively. The decrease of $0.4 million is mainly related to a decrease in regulatory and legal fees.

 

(Loss) Gain from Change in Fair Value of Warrant Liability. We recorded a net loss of $1.7 million in the third quarter of 2024 as compared to a net gain of $0.001 million in the third quarter of 2023, for the change in fair value on revaluation of our warrant liability associated with our warrants issued in conjunction with certain of our previous stock offerings. We are required to revalue our liability-classified warrants at the time of each warrant exercise, if applicable, and at the end of each reporting period and reflect in the statement of operations a gain or loss from the change in fair value of the warrant in the period in which the change occurred. We calculated the fair value of the warrants outstanding using the Black-Scholes model. A gain results principally from a decline in our share price during the period and a loss results principally from an increase in our share price.

 

Transaction costs allocated to warrant liabilities and Loss on issuance of warrant liabilities. Proceeds of offerings are allocated between common shares and warrants first by allocating to the warrants classified as a liability based on their fair value and then allocating the residual to the equity instruments, which would include pre-funded warrants. As the fair value of the liability classified warrants in the August 2024 offering exceeded the total proceeds, no consideration was allocated to the Common Shares or Pre-Funded Warrants. The full proceeds of the August 2024 offering were recorded to warrant liabilities, with an initial liability of $6.1 million, and a loss on initial recognition of $0.8 million. The loss on modification of certain warrants of $0.4 million was also recorded as a loss on issuance of warrant liabilities in the three months ended September 30, 2024. Transaction costs related to the offering were correspondingly fully allocated to warrant liabilities, and $1.0 million in related transaction costs were expensed during the three and nine months ended September 30, 2024.

 

Interest income, net. Interest income, net decreased by approximately $0.2 million for the comparable quarterly periods due to a decreasing cash balance and decreasing interest rates during the past year.

 

Nine Months Ended September 30, 2024 Compared to Nine Months Ended September 30, 2023

 

Research and Development Expense. Research and development (R&D) expense was $13.3 million and $12.9 million for the nine months ended September 30, 2024 and 2023, respectively. The increase of $0.4 million is mainly related to costs incurred for clinical trials (clinical research organization and drug production) and sponsored research costs. These increases were offset by a $1.5 million decrease mainly related to the WPD sublicense termination in 2023, which enabled the reacquisition of our intellectual property rights in certain territories including parts of the European Union.

 

General and Administrative Expense. General and administrative expense was $6.6 million and $7.8 million for the nine months ended September 30, 2024 and 2023, respectively. The decrease of $1.2 million is mainly related to a decrease in regulatory and legal fees.

 

Gain from Change in Fair Value of Warrant Liability. We recorded a net gain of $1.4 million in the nine months ended 2024 as compared to a net gain of $0.1 million in the nine months ended 2023, for the change in fair value on revaluation of our warrant liability associated with our warrants issued in conjunction with certain of our previous stock offerings. We are required to revalue our liability-classified warrants at the time of each warrant exercise, if applicable, and at the end of each reporting period and reflect in the statement of operations a gain or loss from the change in fair value of the warrant in the period in which the change occurred. We calculated the fair value of the warrants outstanding using the Black-Scholes model. A gain results principally from a decline in our share price during the period and a loss results principally from an increase in our share price.

 

 

Transaction costs allocated to warrant liabilities and Loss on issuance of warrant liabilities. Proceeds of offerings are allocated between common shares and warrants first by allocating to the warrants classified as a liability based on their fair value and then allocating the residual to the equity instruments, which would include pre-funded warrants. As the fair value of the liability classified warrants in the August 2024 offering exceeded the total proceeds, no consideration was allocated to the Common Shares or Pre-Funded Warrants. The full proceeds of the August 2024 offering were recorded to warrant liabilities, with an initial liability of $6.1 million, and a loss on initial recognition of $0.8 million. The loss on modification of certain warrants of $0.4 million was also recorded as a loss on issuance of warrant liabilities in the nine months ended September 30, 2024. Transaction costs related to the offering were correspondingly fully allocated to warrant liabilities, and $1.0 million in related transaction costs were expensed during the three and nine months ended September 30, 2024.

 

Interest income, net. Interest income, net decreased by approximately $0.6 million for the comparable quarterly periods due to a decreasing cash balance and decreasing interest rates during the past year.

 

Liquidity and Capital Resources

 

The following table sets forth our primary sources and uses of cash for the period indicated (table in thousands): 

 

		Nine Months Ended September 30,
		2024				2023
Net cash used in operating activities		$	(18,779	)		$	(18,694	)
Net cash used in investing activities			(13	)			(43	)
Net cash provided by financing activities			4,634				186
Effect of exchange rate changes on cash and cash equivalents			13				(15	)
Net decrease in cash and cash equivalents		$	(14,145	)		$	(18,566	)

 

As of September 30, 2024, there was $0.4 million of cash on hand in a bank account in Australia and we know of no related limitations impacting our liquidity in Australia.

 

Cash used in operating activities

 

Cash used in operations was $18.8 million for the nine months ended September 30, 2024. This $0.1 million increase over the prior year period of $18.7 million was primarily due to the timing of costs incurred and associated payments for drug production and clinical trial expenses. 

 

Cash provided by financing activities 

 

On August 19, 2024, we announced the closing of our previously announced public offering of 283,000 shares of common stock and 2,183,368 pre-funded warrants to purchase shares of common stock, Series A warrants to purchase up to 2,466,368 shares of common stock and Series B warrants to purchase up to 2,466,368 shares of common stock, at a combined public offering price of $2.23 per share (or per pre-funded warrant in lieu thereof) and accompanying warrants. We received gross proceeds of $5.5 million, before deducting the placement agent's fees and other offering expenses.

 

We believe that our cash on hand and cash equivalents as of September 30, 2024, is sufficient to fund our planned operations into the first quarter of 2025. This takes into account cash outlays for preparations for clinical trials beyond the current active trials. The continuation of our Company as a going concern is dependent upon our ability to obtain necessary financing to continue operations and the attainment of profitable operations. We must seek additional funding of approximately $15 million to support MIRACLE and our operations into the third quarter of 2025 through a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements and delay planned cash outlays or a combination thereof to continue our operations in the near term. We cannot provide assurance that such events or a combination thereof can be achieved.

 

 

Critical Accounting Policies and Significant Judgments and Estimates

 

There have been no material changes to our critical accounting policies and use of estimates from those disclosed in our Form 10-K for the year ended December 31, 2023. For a discussion of our critical accounting policies and use of estimates, refer to Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Significant Estimates in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2023.

 

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS

 

Not applicable as we are a smaller reporting company.

 

ITEM 4. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures designed to ensure that material information required to be disclosed in our filings under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that material information is accumulated and communicated to our management, including our Chief Executive Officer (CEO), who is our principal executive officer, and Chief Financial Officer (CFO), who is our principal financial and accounting officer, as appropriate, to allow timely decisions regarding required disclosures. Our CEO and CFO have evaluated these disclosure controls and procedures as of the end of the period covered by this quarterly report on Form 10-Q and have determined that such disclosure controls and procedures were effective as of September 30, 2024.

 

Changes in Internal Control Over Financial Reporting

 

There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15-d-15(f) under the Exchange Act) during the three months ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting. 

 

PART II – OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

None.

 

ITEM 1A. RISK FACTORS

 

For information regarding factors that could affect our results of operations, financial condition and liquidity, refer to the section entitled “Risk Factors” in Part I, Item 1A in our annual report on Form 10-K for the year ended December 31, 2023. Except as updated below, there have been no material changes from the risk factors previously disclosed in our annual report on Form 10-K for the year ended December 31, 2023, and in Item II, Item 1A in our prior quarterly reports on Form 10-Q filed during this fiscal year, as filed with the SEC.

 

We will require significant additional funding to complete the MIRACLE trial, which may not be available to us on acceptable terms, or at all, and, if not so available, may require us to delay, limit, reduce or cease our operations.

 

We have used and we intend to use our current cash resources and the proceeds from any possible future offerings, to, among other uses, advance our portfolio through preclinical studies and into INDs or their equivalent, and sponsoring research at MD Anderson and HPI. Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive. We estimate supporting of MIRACLE and our operations into the third quarter of 2025 will require additional funds beyond our current cash as of September 30, 2024, of approximately $15 million. As such, based on our current cash, in order to fund our operations, including MIRACLE, we will need to raise significant financing for which we have no commitments. If the FDA or its EU equivalent requires that we perform additional nonclinical studies or clinical trials, our expenses would further increase beyond what we currently expect and the anticipated timing of any potential approval of Annamycin would likely be delayed. Further, there can be no assurance that the costs we will need to incur to obtain regulatory approval of Annamycin will not increase.

 

Recently enacted legislation, future legislation and healthcare reform measures may increase the difficulty and cost for us to obtain marketing approval for and commercialize Annamycin and any future product candidates and may affect the prices we may set.

 

At the federal level, in July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. In addition, the Inflation Reduction Act (IRA), among other things, (1) directs HHS to negotiate the price of certain high-cost, single-source drugs and biologics covered under Medicare and (2) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. These provisions will take effect progressively starting in fiscal year 2023, although the Medicare drug price negotiation program is currently subject to legal challenges. HHS has and will continue to issue and update guidance as these programs are implemented. It is currently unclear how the IRA will be implemented but is likely to have a significant impact on the pharmaceutical industry. Under the IRA, certain categories of drugs are excluded from price negotiations, including drugs that receive orphan drug designation as the only FDA-approved indication. While we have obtained orphan drug designation for Annamycin, if we seek additional indications, or fail to maintain our orphan drug status, we may become subject to the price negotiation process. This could reduce the ultimate price that we receive for Annamycin, which could negatively affect our business, results of operations, financial conditions, and prospects. Further, in response to the Biden administration’s October 2022 executive order, on February 14, 2023, HHS released a report outlining three new models for testing by the Center for Medicare and Medicaid Innovation which will be evaluated on their ability to lower the cost of drugs, promote accessibility, and improve quality of care. It is unclear whether the models will be utilized in any health reform measures in the future.

 

 

At the state level, individual states in the United States have also increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, results of operations, financial condition, and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs.

 

In June 2024, the U.S. Supreme Court reversed its longstanding approach under the Chevron doctrine, which provided for judicial deference to regulatory agencies, including the FDA. As a result of this decision, we cannot be sure whether there will be increased challenges to existing agency regulations or how lower courts will apply the decision in the context of other regulatory schemes without more specific guidance from the U.S. Supreme Court. For example, this decision may result in more companies bringing lawsuits against the FDA to challenge longstanding decisions and policies of the FDA, which could undermine the FDA’s authority, lead to uncertainties in the industry, and disrupt the FDA’s normal operations, which could impact the timely review of any regulatory filings or applications we submit to the FDA.

 

We cannot predict the likelihood, nature, or extent of health reform initiatives that may arise from future legislation or administrative action. We expect that the Affordable Care Act and other healthcare reform measures, including those that may be adopted in the future may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from third-party payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize Annamycin, if approved.

 

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. 

 

During the period covered by this Quarterly Report, none of the Company’s directors or executive officers has adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (each as defined in Item 408 of Regulation S-K under the Securities Exchange Act of 1934, as amended).

 

On November 4, 2024, the Compensation Committee of the Board of Directors took the following actions in connection with the executive compensation for the 2023/2024 compensation year ( June 1, 2023 to May 31, 2024) with its named executive officers (Walter Klemp, President and Chief Executive Officer; Jonathan P. Foster, Executive Vice President and Chief Financial Officer; and Dr. Donald Picker, Chief Scientific Officer): (i) cash bonuses in the aggregate amount of $735,000 were granted based on the full achievement of the goals and objectives for the compensation year, however the payment of the bonuses was accrued and will be paid the earlier of a) 364 days or b) approval by the CEO after consultation with the Board of Directors; and (ii) the Compensation Committee agreed that the accrued bonuses will earn interest at a rate of 8% per annum.

 

On November 4, 2024, the Compensation Committee and the Board of Directors agreed to issue each non-employee director a 10-year option to purchase 10,000 shares of our common stock, under our shareholder approved stock plan, with vesting through the end of April 2025 and an exercise price equal the closing price of our common stock on the date of the approval.

 

21

---

Table of Contents

 

ITEM 6. EXHIBITS 

 

Exhibit No.						Description
1.1						Engagement Agreement between Moleculin Biotech, Inc. and H.C. Wainwright & Co., LLC dated June 8, 2024 (incorporated by reference to Exhibit 1.1 of the Form S-1/A filed August 15, 2024)
4.1						Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.9 of the Form S-1/A filed August 15, 2024)
4.2						Form of Series A Common Warrant (incorporated by reference to Exhibit 4.10 of the Form S-1/A filed August 15, 2024)
4.3						Form of Series B Common Warrant (incorporated by reference to Exhibit 4.11 of the Form S-1/A filed August 15, 2024)
4.4						Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.12 of the Form S-1/A filed August 15, 2024)
10.1						Form of Securities Purchase Agreement incorporated by reference to Exhibit 10.32 of the Form S-1/A filed August 15, 2024)
10.2						Form of Warrant Amendment Agreement (incorporated by reference to Exhibit 10.2 of the 8-K filed August 16, 2024)
31.1*						Certification of Principal Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002
31.2*						Certification of Principal Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002
32.1*+						Certification of Principal Executive Officer Pursuant to Section 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2*+						Certification of Principal Accounting and Financial Officer Pursuant to Section 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 (the Instance Document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)
101.SCH*						Inline XBRL Taxonomy Extension Schema Document
101.CAL*						Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*						Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*						Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*						Inline XBRL Taxonomy Extension Presentation Linkbase Document
104						Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

* Filed herewith.

+ The certifications on Exhibit 32 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such certifications will not be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.

 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) 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.

 

			MOLECULIN BIOTECH, INC.
Date: November 8, 2024			By:			/s/ Walter V. Klemp
						Walter V. Klemp,
						Chief Executive Officer and Chairman (Principal Executive Officer)
Date: November 8, 2024			By:			/s/ Jonathan P. Foster
						Jonathan P. Foster,
						Executive Vice President & Chief Financial Officer (Principal Financial and Accounting Officer)

 

 

 

Exhibit 31.1

 

OFFICER’S CERTIFICATION PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Walter V. Klemp, certify that:

 

1.	I have reviewed this Quarterly Report on Form 10-Q of Moleculin Biotech, Inc.;

 

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made not misleading with respect to the period covered by this report;

 

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a.

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b.

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c.

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d.

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.	The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

a.

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

b.

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

 

November 8, 2024

 

By: /s/ Walter V. Klemp

Walter V. Klemp

Chief Executive Officer

(Principal Executive Officer)

 

 

Exhibit 31.2

 

OFFICER’S CERTIFICATION PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Jonathan P. Foster, certify that:

 

1.	I have reviewed this Quarterly Report on Form 10-Q of Moleculin Biotech, Inc.;

 

2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made not misleading with respect to the period covered by this report;

 

3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

a.

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b.

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c.

Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d.

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.	The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

a.

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

b.

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

November 8, 2024

 

By: /s/ Jonathan P. Foster

Jonathan P. Foster

Executive Vice President and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)

 

 

Exhibit 32.1

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 of Moleculin Biotech, Inc. (the “Company”) as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Walter V. Klemp, Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

•

The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C 78m or 78o(d)); and

 

•

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

Date: November 8, 2024

  

By: /s/ Walter V. Klemp

Walter V. Klemp

Chief Executive Officer

(Principal Executive Officer)

  

A signed original of this written statement required by Section 906 has been provided to Moleculin Biotech, Inc. and will be retained by Moleculin Biotech, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

 

 

Exhibit 32.2

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 of Moleculin Biotech, Inc. (the “Company”) as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Jonathan P. Foster, Chief Financial Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

•

The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934 (15 U.S.C 78m or 78o(d)); and

 

•

The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

 

Date: November 8, 2024

  

By: /s/ Jonathan P. Foster

Jonathan P. Foster

Executive Vice President and Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)

   

A signed original of this written statement required by Section 906 has been provided to Moleculin Biotech, Inc. and will be retained by Moleculin Biotech, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.

 

v3.24.3

Document And Entity Information - shares	9 Months Ended
	Sep. 30, 2024	Nov. 01, 2024
Document Information [Line Items]
Entity Central Index Key	0001659617
Entity Registrant Name	Moleculin Biotech, Inc.
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Period Focus	Q3
Document Fiscal Year Focus	2024
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2024
Document Transition Report	false
Entity File Number	001-37758
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	47-4671997
Entity Address, Address Line One	5300 Memorial Drive, Suite 950
Entity Address, City or Town	Houston
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	77007
City Area Code	713
Local Phone Number	300-5160
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Small Business	true
Entity Filer Category	Non-accelerated Filer
Entity Emerging Growth Company	false
Entity Shell Company	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	MBRX
Security Exchange Name	NASDAQ
Entity Common Stock, Shares Outstanding		3,001,895

v3.24.3

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 9,405	$ 23,550
Prepaid expenses and other current assets	2,201	2,723
Total current assets	11,606	26,273
Furniture and equipment, net	190	272
Intangible assets	11,148	11,148
Operating lease right-of-use asset	450	524
Total assets	23,394	38,217
Liabilities, Current [Abstract]
Accounts payable	2,550	2,498
Accrued expenses and other current liabilities	3,043	4,317
Total current liabilities	5,593	6,815
Operating lease liability - long-term, net of current portion	390	474
Warrant liability - long-term	9,932	4,855
Total liabilities	15,915	12,144
Commitments and contingencies (Note 7)
Stockholders' equity
Preferred stock, $0.001 par value; 5,000,000 shares authorized, no shares issued or outstanding	0	0
Common stock, $0.001 par value; 100,000,000 shares authorized; 3,001,895 and 2,227,516 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	3	33
Additional paid-in capital	158,957	157,653
Accumulated other comprehensive income (loss)	4	(9)
Accumulated deficit	(151,485)	(131,604)
Total stockholders’ equity	7,479	26,073
Total liabilities and stockholders’ equity	$ 23,394	$ 38,217

v3.24.3

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares	Sep. 30, 2024	Dec. 31, 2023
Preferred stock, par value (in dollars per share)	$ 0.001	$ 0.001
Preferred stock, shares authorized (in shares)	5,000,000	5,000,000
Preferred stock, shares issued (in shares)	0	0
Preferred stock, shares outstanding (in shares)	0	0
Common stock, par or stated value per share (in dollars per share)	$ 0.001	$ 0.001
Common stock, shares authorized (in shares)	100,000,000	100,000,000
Common stock, shares issued (in shares)	3,001,895	2,227,516
Common stock, shares outstanding (in shares)	3,001,895	2,227,516

v3.24.3

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Revenues	$ 0	$ 0	$ 0	$ 0
Operating expenses:
Research and development	4,932	3,280	13,274	12,855
General and administrative	2,172	2,635	6,629	7,765
Depreciation and amortization	31	32	95	92
Total operating expenses	7,135	5,947	19,998	20,712
Loss from operations	(7,135)	(5,947)	(19,998)	(20,712)
Other income (loss):
(Loss) gain from change in fair value of warrant liability	(1,728)	1	1,423	76
Transaction costs allocated to warrant liabilities	(993)	0	(993)	0
Loss on issuance of warrant liabilities	(847)	0	(847)	0
Other income, net	9	13	31	30
Interest income, net	102	324	503	1,106
Net loss	$ (10,592)	$ (5,609)	$ (19,881)	$ (19,500)
Net loss per common share - basic and diluted (in dollars per share)	$ (2.85)	$ (2.82)	$ (6.83)	$ (9.94)
Weighted average common shares outstanding, basic and diluted (in shares)	3,714,278	1,987,283	2,910,842	1,961,327
Net loss	$ (10,592)	$ (5,609)	$ (19,881)	$ (19,500)
Other comprehensive income (loss):
Foreign currency translation	14	(10)	13	(15)
Comprehensive loss	$ (10,578)	$ (5,619)	$ (19,868)	$ (19,515)

v3.24.3

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities:
Net loss	$ (10,592)	$ (5,609)	$ (19,881)	$ (19,500)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	31	32	95	92
Stock-based compensation			1,299	1,505
License rights expense settled in stock			0	772
Change in fair value of warrant liability	1,728	(1)	(1,423)	(76)
Loss on issuance of warrant liabilities	847	0	847	0
Operating lease, net			106	105
Transaction costs allocated to warrant liabilities			993	0
Changes in operating assets and liabilities:
Prepaid expenses and other current assets			522	(573)
Accounts payable			52	(87)
Accrued expenses and other current liabilities			(1,389)	(932)
Net cash used in operating activities			(18,779)	(18,694)
Cash flows from investing activities:
Purchase of fixed assets			(13)	(43)
Net cash used in investing activities			(13)	(43)
Cash flows from financing activities:
Payment of tax liability for vested restricted stock units			(26)	(25)
Proceeds from sale of common stock, pre-funded and common warrants, net of issuance costs			4,660	211
Net cash provided by financing activities			4,634	186
Effect of exchange rate changes on cash and cash equivalents			13	(15)
Net decrease in cash and cash equivalents			(14,145)	(18,566)
Cash and cash equivalents, - beginning of period			23,550	43,145
Cash and cash equivalents, - end of period	$ 9,405	$ 24,579	9,405	24,579
Non-cash investing and financing activities:
Transaction costs related to the sale of common stock, pre-funded and common warrants			156	0
Transaction costs included in accounts payable and accrued liabilities			$ 42	$ 0

v3.24.3

Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands	Common Stock [Member]	Additional Paid-in Capital [Member]	Retained Earnings [Member]	AOCI Attributable to Parent [Member]	Total
Balance (in shares) at Dec. 31, 2022	1,908,522
Balance at Dec. 31, 2022	$ 29	$ 153,985	$ (101,835)	$ 12	$ 52,191
Issuance of common stock in connection with Consulting Agreements (in shares)	10,026
Issuance of common stock in connection with Consulting Agreements	$ 0	141	0	0	141
Stock-based compensation	0	499	0	0	499
Net loss	0	0	(7,915)	0	(7,915)
Cumulative translation adjustment	$ 0	0	0	(4)	(4)
Balance (in shares) at Mar. 31, 2023	1,973,356
Balance at Mar. 31, 2023	$ 30	155,396	(109,750)	8	45,684
Common stock issued for license rights (in shares)	54,808
Common stock issued for license rights	$ 1	771	0	0	772
Balance (in shares) at Dec. 31, 2022	1,908,522
Balance at Dec. 31, 2022	$ 29	153,985	(101,835)	12	52,191
Net loss					(19,500)
Cumulative translation adjustment					(15)
Balance (in shares) at Sep. 30, 2023	1,987,366
Balance at Sep. 30, 2023	$ 30	156,446	(121,335)	(3)	35,138
Balance (in shares) at Mar. 31, 2023	1,973,356
Balance at Mar. 31, 2023	$ 30	155,396	(109,750)	8	45,684
Issuance of common stock in connection with Consulting Agreements (in shares)	5,013
Issuance of common stock in connection with Consulting Agreements		69			69
Stock-based compensation	0	513	0	0	513
Net loss	0	0	(5,976)	0	(5,976)
Cumulative translation adjustment	$ 0	0	0	(1)	(1)
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability) (in shares)	7,588
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability)	$ 0	(21)	0	0	(21)
Balance (in shares) at Jun. 30, 2023	1,985,957
Balance at Jun. 30, 2023	$ 30	155,957	(115,726)	7	40,268
Stock-based compensation	0	493	0	0	493
Net loss	0	0	(5,609)	0	(5,609)
Cumulative translation adjustment	$ 0	0	0	(10)	(10)
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability) (in shares)	1,409
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability)	$ 0	(4)	0	0	(4)
Balance (in shares) at Sep. 30, 2023	1,987,366
Balance at Sep. 30, 2023	$ 30	156,446	(121,335)	(3)	35,138
Balance (in shares) at Dec. 31, 2023	2,227,516
Balance at Dec. 31, 2023	$ 33	157,653	(131,604)	(9)	26,073
Issuance of common stock in connection with Consulting Agreements (in shares)	6,834
Issuance of common stock in connection with Consulting Agreements	$ 0	37	0	0	37
Reverse stock split (in shares)	77,186
Reverse stock split	$ (31)	31	0	0	0
Stock-based compensation	0	456	0	0	456
Net loss	0	0	(4,970)	0	(4,970)
Cumulative translation adjustment	$ 0	0	0	(9)	(9)
Balance (in shares) at Mar. 31, 2024	2,311,536
Balance at Mar. 31, 2024	$ 2	158,177	(136,574)	(18)	21,587
Balance (in shares) at Dec. 31, 2023	2,227,516
Balance at Dec. 31, 2023	$ 33	157,653	(131,604)	(9)	26,073
Net loss					(19,881)
Cumulative translation adjustment					$ 13
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability) (in shares)					20,485
Balance (in shares) at Sep. 30, 2024	3,001,895
Balance at Sep. 30, 2024	$ 3	158,957	(151,485)	4	$ 7,479
Balance (in shares) at Mar. 31, 2024	2,311,536
Balance at Mar. 31, 2024	$ 2	158,177	(136,574)	(18)	21,587
Stock-based compensation	0	453	0	0	453
Net loss	0	0	(4,319)	0	(4,319)
Cumulative translation adjustment	$ 0	0	0	8	8
Warrants exercised (in shares)	229,506
Warrants exercised	$ 1	0	0	0	1
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability) (in shares)	19,743
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability)	$ 0	(25)	0	0	(25)
Balance (in shares) at Jun. 30, 2024	2,560,785
Balance at Jun. 30, 2024	$ 3	158,605	(140,893)	(10)	17,705
Issuance of common stock in connection with Consulting Agreements (in shares)	283,000
Stock-based compensation	$ 0	353	0	0	353
Net loss	0	0	(10,592)	0	(10,592)
Cumulative translation adjustment	$ 0	0	0	14	14
Warrants exercised (in shares)	157,368
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability) (in shares)	742
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability)	$ 0	(1)	0	0	(1)
Balance (in shares) at Sep. 30, 2024	3,001,895
Balance at Sep. 30, 2024	$ 3	$ 158,957	$ (151,485)	$ 4	$ 7,479

v3.24.3

Note 1 - Nature of Business	9 Months Ended
	Sep. 30, 2024
Notes to Financial Statements
Nature of Operations [Text Block]	1. Nature of Business    The terms “MBI” or “the Company”, “we”, “our” and “us” are used herein to refer to Moleculin Biotech, Inc. MBI is a clinical-stage pharmaceutical company, organized as a Delaware corporation in July 2015, with clinical programs for hard-to-treat cancers and viruses. The Company has three core technologies, each of which have had one or more drugs successfully complete a Phase 1 clinical trial, based substantially on discoveries made at and licensed from MD Anderson Cancer Center (MD Anderson) in Houston, Texas. In July 2024 the Company’s lead program Annamycin completed a Phase 2 trial and has held it End-of-Phase 1/2 meeting with the Food and Drug Administration in the US and in August 2024 announced the preparations for a Phase 3 trial. The Company has two wholly owned subsidiaries, Moleculin Australia Pty. Ltd., which was set up to perform certain preclinical development and Moleculin Amsterdam B.V., which acts as its legal representative for clinical trials in Europe. The Company utilizes its own internal resources and funds to conduct some of these trials and also has trials being conducted via physician-sponsored trials. The physician-sponsored trials utilize primarily external funds, such as grant funds, which are not presented in these financial statements. The Company does not have manufacturing facilities, and all manufacturing activities are contracted out to third parties. Additionally, the Company does not have a sales organization. The Company’s overall strategy is to seek potential outlicensing or outsourcing opportunities with development/commercialization strategic partners who are better suited for the marketing, sales and distribution of its drugs, if approved.   In 2019, the Company sublicensed its technologies to Animal Life Sciences, Inc. (ALI), to enable research and commercialization for non-human use and share development data. As part of this agreement, ALI issued to the Company a 10% equity interest in ALI.    On May 5, 2023, the Company received a letter from the Nasdaq Capital Market (Nasdaq) notifying the Company that for the prior 30 consecutive business days the bid price for the Company's common stock had closed below the minimum $1.00 per share requirement for continued inclusion on Nasdaq pursuant to Nasdaq Listing Rule 5550(a)(2) (Bid Price Rule). The deficiency letter did not result in the immediate delisting of the Company's common stock from the Nasdaq. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial period of 180 calendar days, until  November 1, 2023, to regain compliance with the Bid Price Rule. On November 2, 2023, the Company received a 180-calendar day extension, until  April 29, 2024, from the Nasdaq to regain compliance with Bid Price Rule. On March 5, 2024, the Board of Directors approved a reverse 1-for-15 reverse stock split effective 11:59 P.M. (Eastern time) on March 21, 2024, with trading to commence on a split-adjusted basis on March 22, 2024. On April 8, 2024, the Company received a letter from Nasdaq notifying the Company that it had regained compliance with Bid Price Rule 5550(a)(2) as a result of the closing bid price of the Company's common stock being at $1.00 per share or greater for the 10 consecutive business days from March 22, 2024 through April 5, 2024. Accordingly, the Company is in compliance with the Bid Price Rule and Nasdaq considers the matter closed.

v3.24.3

Note 2 - Basis of Presentation, Principles of Consolidation, and Significant Accounting Policies and Liquidity	9 Months Ended
	Sep. 30, 2024
Notes to Financial Statements
Significant Accounting Policies [Text Block]	2. Basis of presentation, principles of consolidation, and significant accounting policies and liquidity    Reverse Stock Split - On March 22, 2024, the Company completed a reverse stock split of all the issued and outstanding shares of the Company's common stock at a ratio of 1 to 15. The accompanying consolidated financial statements and notes to the consolidated financial statements gives retroactive effect to the reverse stock split for all periods presented. Certain amounts previously reported include rounding up of fractional shares as a result of the reverse stock split.   Basis of Presentation – Condensed Consolidated Financial Information - The accompanying condensed consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP) for financial information, and in accordance with the rules and regulations of the U.S. Securities and Exchange Commission (SEC) with respect to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The condensed consolidated financial statements furnished reflect all normal adjustments, which are, in the opinion of management, necessary for a fair statement of results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. These condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company as of  December 31, 2023 and for the year then ended, including the notes thereto contained in the Form 10-K filed with the SEC on March 22, 2024.   Principles of Consolidation - The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP. The Company views its operations and manages its business in one operating segment. All material long-lived assets of the Company reside in the U.S.   Significant Accounting Policies - The Company's significant accounting policies are described in Note 2, Basis of Presentation, principles of consolidation and significant accounting policies, to the consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023. There have been no material changes to the significant accounting policies during the nine months ended September 30, 2024.   Use of Estimates - The preparation of these condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of financial statements. Estimates are used in the following areas, among others: fair value estimates on intangible assets, warrants, and stock-based compensation expense, as well as accrued expenses and taxes.    Intangible Assets – Intangible assets with finite lives are amortized using the straight-line method over their estimated period of benefit. Acquired intangible assets identified as in-process research and development (IPR&D) assets, are considered indefinite lived until the completion or abandonment of the associated research and development efforts. If the associated research and development effort is abandoned, the related IPR&D assets will be written-off and the Company will record a noncash impairment loss on its statements of operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. Intangible assets are tested for impairment on an annual basis, which was completed as of September 30, 2024, and between annual tests if indicators of potential impairment exist, using a fair-value-based approach. The Company evaluates the recoverability of intangible assets periodically and take into account events or circumstances that warrant revised estimates of useful lives or that indicate that impairment exists. No impairments of intangible assets have been identified during any of the periods presented.   Going Concern and Liquidity - These condensed consolidated financial statements have been prepared on a going concern basis, which assumes the Company will continue to realize its assets and discharge its liabilities in the normal course of business. The continuation of the Company as a going concern is dependent upon the ability of the Company to obtain necessary equity financing to continue operations and the attainment of profitable operations. As of  September 30, 2024, the Company had an accumulated deficit of $151.5 million since inception and had not yet generated any revenues from operations. Additionally, management anticipates that its cash on hand of $9.4 million as of September 30, 2024 is not sufficient to fund its planned operations for a period of at least one year from when these consolidated financial statements are issued. These factors raise substantial doubt regarding the Company's ability to continue as a going concern. These unaudited condensed consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company intends to seek additional funding through one or more of the following: a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements and delay planned cash outlays or a combination thereof. There can be no assurance that such events or a combination thereof can be achieved.    In March 2022, the Company received a subpoena from the SEC requesting information and documents, including materials related to certain individuals (none of which are the Company's officers or directors) and entities, and materials related to the development of and statements regarding the Company's drug candidate for the treatment of COVID-19. The Company has received, and expects to continue to receive, periodic further requests from the SEC staff with respect to this matter. The Company is not aware of the specific nature of the underlying investigation by the SEC, and to the extent that this investigation relates to prior public disclosures that it has made, the Company believes in the accuracy and adequacy of such prior disclosures. The correspondence from the SEC transmitting the subpoena to the Company states that the SEC is trying to determine whether there have been any violations of federal securities laws, but that its investigation does not mean that the SEC has concluded that anyone has violated the law or that the SEC has a negative opinion of any person, entity, or security. The Company cannot predict when this matter will be resolved or what, if any, action the SEC may take following the conclusion of the investigation. The company expensed approximately $0.1 million and $0.4 million in related general and administrative fees and expenses for the three months ended  September 30, 2024 and 2023, respectively, and $0.2 million and $1.4 million for the nine months ended  September 30, 2024 and 2023, respectively. The Company is in the process of filing a claim with its insurance carriers related to this loss which may cover a portion of the related expenses but not all. The claim is currently under review by the insurance company. The claim has not yet been approved nor has a reimbursement amount been determined which, if any, would be limited by the applicable retention as defined under the policy. Accordingly, the Company has not recorded any provision for insurance reimbursement. The Company expects to record the insurance reimbursement at the time that the amount to be reimbursed is determined and approved by the insurance carrier. Any insurance reimbursement receivable will be recorded at an amount not to exceed the recorded loss and only if the terms of the legally enforceable insurance contracts support that the insurance recovery will not be disputed and is deemed collectible, or if recovery of the loss is probable.   Cash and Cash Equivalents - Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. The Company maintains cash accounts principally at one financial institution in the U.S., which at times, may exceed the Federal Deposit Insurance Corporation’s limit. The Company has not experienced any losses from cash balances in excess of the insurance limit. The Company’s management does not believe the Company is exposed to significant credit risk at this time due to the financial condition of the financial institution where its cash is held.    Fair Value of Financial Instruments - The Company's financial instruments consist primarily of non-trade receivables, accounts payable, accrued expenses and its warrant liability. The carrying amount of non-trade receivables, accounts payable, and accrued expenses approximates their fair value because of the short-term maturity of such.   The Company has categorized its assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy in accordance with U.S. GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3).   Assets and liabilities recorded in the condensed consolidated balance sheets at fair value are categorized based on a hierarchy of inputs as follows:   Level 1 – Unadjusted quoted prices in active markets of identical assets or liabilities. Level 2 – Quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 – Unobservable inputs for the asset or liability.   The Company’s financial assets and liabilities recorded at fair value on a recurring basis include the fair value of warrant liability discussed in Note 4.   The following table provides the financial liabilities reported at fair value and measured on a recurring basis at September 30, 2024 and December 31, 2023 (table in thousands):    Description   Fair Value     Level 1     Level 2     Level 3   Fair value of warrant liability as of September 30, 2024:   $ 9,932     $ —     $ —     $ 9,932   Fair value of warrant liability as of December 31, 2023:   $ 4,855     $ —     $ —     $ 4,855     The table below of Level 3 liabilities (table in thousands) begins with the valuation as of the beginning of the third quarter and then is adjusted for changes in fair value that occurred during the third quarter. The ending balance of the Level 3 financial instrument presented above represents the Company's best estimates and may not be substantiated by comparison to independent markets and, in many cases, could not be realized in immediate settlement of the instruments.    Three Months Ended September 30, 2024   Warrant Liability Long-Term   Balance, June 30, 2024   $ 1,704   Issuances of warrants     6,111   Warrant amendment     389   Change in fair value - net     1,728   Balance, September 30, 2024   $ 9,932     The table below of Level 3 liabilities (table in thousands) begins with the valuation as of December 31, 2023 and then is adjusted for changes in fair value that occurred during the nine months ended  September 30, 2024. The ending balance of the Level 3 financial instrument presented above represents the Company's best estimates and may not be substantiated by comparison to independent markets and, in many cases, could not be realized in immediate settlement of the instruments.    Nine Months Ended September 30, 2024   Warrant Liability Long-Term   Balance, December 31, 2023   $ 4,855   Issuances of warrants     6,111   Warrant amendment     389   Change in fair value - net     (1,423 ) Balance, September 30, 2024   $ 9,932     Loss Per Common Share - Basic net loss per common share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding during the period. For purposes of this calculation, options to purchase common stock, restricted stock units subject to vesting and warrants to purchase common stock are considered to be common stock equivalents. Diluted net loss per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, the weighted-average number of common shares outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive. For the three months ended September 30, 2024 and 2023, approximately 4.8 million and 0.6 million, respectively, of potentially dilutive shares were excluded from the computation of diluted earnings per share due to their anti-dilutive effect. For the nine months ended September 30, 2024 and 2023, approximately 2.7 million and 0.5 million, respectively, of potentially dilutive shares were excluded from the computation of diluted earnings per share due to their anti-dilutive effect.   Subsequent Events - The Company’s management reviewed all material events through the date of these unaudited condensed consolidated financial statements.    Recent Accounting Pronouncements - In November 2024, FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires disclosure in the notes to the financial statements of specified information about certain costs and expenses. The amendments are effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the new guidance to determine the impact it may have on its consolidated financial statements and related disclosures, but expects additional disclosures upon adoption. There are no other recently issued accounting standards updates that are currently expected to have a material impact on the Company.

v3.24.3

Note 3 - Accrued Expenses and Other Current Liabilities	9 Months Ended
	Sep. 30, 2024
Notes to Financial Statements
Accounts Payable, Accrued Liabilities, and Other Liabilities Disclosure, Current [Text Block]	3. Accrued expenses and other current liabilities   Accrued expenses and other current liabilities consist of the following components (in thousands):       September 30, 2024     December 31, 2023   Accrued payroll and bonuses   $ 1,512     $ 765   Accrued research and development     894       2,845   Accrued legal, regulatory, professional and other     431       547   Operating lease liability - current     116       100   Accrued liabilities due to related party     90       60   Total accrued expenses and other current liabilities   $ 3,043     $ 4,317     Additionally, accounts payable includes $20,000 and $67,000 as of September 30, 2024 and December 31, 2023, respectively, for related party payables.

v3.24.3

Note 4 - Warrants and Equity	9 Months Ended
	Sep. 30, 2024
Notes to Financial Statements
Warrants and Equity [Text Block]	4. Warrants and Equity   2024 Warrant and Stock Issuances   In August 2024, the Company entered into a securities purchase agreement with an institutional investor for the sale by the Company of 283,000 shares of common stock, and 2,183,368 pre-funded warrants to purchase shares of common stock, series A warrants to purchase up to 2,466,368 shares of common stock, series B warrants to purchase up to 2,466,368 shares of common stock, and placement agent warrants. The combined purchase price for the securities was $2.23 per share of common stock (or pre-funded warrant in lieu thereof). Each pre-funded warrant is exercisable for one share of common stock at an exercise price of $0.001 per share. The pre-funded warrants are exercisable immediately and may be exercised at any time until all of the pre-funded warrants are exercised in full, subject to the beneficial ownership limitation. Each common warrant has an exercise price of $2.23 per share and will be exercisable beginning on the effective date of shareholder approval. The series A warrants expire on the earlier of (i) two years from the initial exercise date, or (ii) 60 days from the Company's public announcement that it has achieved the series A milestone event. The series B warrants expire on the earlier of (i) five years from the initial exercise date, or (ii) six months from the Company's public announcement that it has achieved the series B milestone event. The series A milestone event means the Company releases interim data for the first subject group from the MIRACLE trial whereby the complete remission rate for either dose of the Company's study drug is greater than placebo; and series B milestone event means the Company releases final topline data from the MIRACLE trial and documented a statistically significant improvement in the primary efficacy endpoint. In addition, in August 2024, the Company entered into a warrant amendment agreement, pursuant to which the Company agreed that effective upon closing of the offering, and subject to shareholder approval, to amend 895,834 existing warrants originally issued on December 26, 2023 at an exercise price of $9.60 per share and a termination date of February 14, 2029, so that the amended warrants would have a reduced exercise price of $2.23 per share and would expire five years from the date of shareholder approval. The Company calculated the valuation of the warrant amendment immediately prior to the offering, as well as the valuation of the warrant amendment with the repriced terms, and a 50% probability of obtaining shareholder approval. The loss on modification of the warrants of $0.4 million was recorded as a loss on issuance of warrant liabilities in the three and nine months ended September 30, 2024. The Company also considered a 50% probability of obtaining shareholder approval in the valuation for the August 2024 warrants in the three and nine months ended September 30, 2024. In October 2024, the Company’s shareholders approved the issuance of both the August 2024 warrants, as well as the warrant amendment.   The Company received gross proceeds of $5.5 million, before deducting the placement agent's fees and other offering expenses payable by the Company. Proceeds of offerings are allocated between common shares and warrants first by allocating to the warrants classified as a liability based on their fair value and then allocating the residual to the equity instruments, which would include pre-funded warrants. As the fair value of the liability classified warrants in the August 2024 offering exceeded the total proceeds, no consideration was allocated to the Common Shares or Pre-Funded Warrants. The full proceeds of the August 2024 offering were recorded to warrant liabilities, with an initial liability of $6.1 million, and a loss on initial recognition of $0.8 million. Transaction costs related to the offering were correspondingly fully allocated to warrant liabilities, and $1.0 million in related transaction costs were expensed during the three and nine months ended September 30, 2024.    Lincoln Park Equity Line   The Company did not utilize the 2021 Lincoln Park purchase agreement during the nine months ended September 30, 2024. The 2021 Lincoln Park Agreement terminated in June 2024.    Other Components of Equity    In March 2024, the Company issued 6,834 shares of common stock to consultants in exchange for services to be provided. In addition, during the nine months ended September 30, 2024, the Company issued 20,485 shares of common stock related to the vesting of restricted stock units.   Liability Classified Warrants   The Company uses the Black-Scholes option pricing model (BSM) to determine the fair value of its warrants at the date of issue and outstanding at each reporting date. The risk-free interest rate assumption is based upon observed interest rates on zero coupon U.S. Treasury bonds linearly interpolated to obtain a maturity period commensurate with the term of the warrants. Estimated volatility is a measure of the amount by which the Company's stock price is expected to fluctuate each year during the expected life of the warrants. Only the volatility of the Company's own stock is used in the Black-Scholes option pricing model. Certain assumptions, including the expected term, are subjective and require judgment to develop. As a result, if factors or expected outcomes change and we use significantly different assumptions or estimates, our warrant liability could be materially different.   The assumptions used in determining the fair value of the Company's outstanding liability classified warrants are as follows:       September 30, 2024     December 31, 2023   Risk-free interest rate   3.6% to 4.5%     3.8% to 5.4%   Volatility   78.7% to 111.5%     79.5% to 108.7%   Expected life (years)   0.4 to 5.0     0.3 to 5.0   Dividend yield   —%     —%     A summary of the Company's liability classified warrant activity during the nine months ended September 30, 2024 and related information follows:        Number of Shares     Range of Warrant Exercise     Weighted Average     Weighted Average Remaining Contractual       Under Warrant     Price per Share     Exercise Price     Life (Years)   Balance at January 1, 2024     1,082,895     $ 9.60     $ 157.50     $ 24.32       5.1   Granted     5,056,054     $ 2.23     $ 2.79     $ 2.24       2.9   Expired warrants     (75,909 )   $ 99.00     $ 99.00     $ 99.00       —   Balance at September 30, 2024     6,063,040     $ 2.23     $ 94.50     $ 12.90       3.1   Exercisable at September 30, 2024     1,006,986     $ 2.23     $ 94.50     $ 8.75       4.1     For a summary of the changes in fair value associated with the Company's warrant liability for the nine months ended September 30, 2024, see Note 2 - Basis of presentation, principles of consolidation and significant accounting policies - Fair Value of Financial Instruments.   Equity Classified Warrants   In March 2024, the Company granted equity-classified warrants to purchase up to 3,334 shares of Company common stock with a ten-year term and an exercise price of $9.15. The warrants vest annually over four years while services are being performed.   At September 30, 2024, the Company had 2,089,105 equity classified warrants outstanding (including the remaining August 2024 pre-funded warrants) and 2,066,894 warrants were exercisable. At  December 31, 2023, the Company had 289,276 equity classified warrants outstanding and 266,350 warrants were exercisable.

v3.24.3

Note 5 - Stock Based Compensation	9 Months Ended
	Sep. 30, 2024
Notes to Financial Statements
Share-Based Payment Arrangement [Text Block]	5. Stock Based Compensation   The 2015 Stock Plan provides for the grant of stock options, stock awards, stock unit awards, and stock appreciation rights to employees, non-employee directors and consultants. In May 2023 and 2022, the 2015 Stock Plan (the Plan) was amended to authorize an additional 116,667 shares and 133,334 shares, respectively, such that 366,667 total shares may be issued under the Plan. As of September 30, 2024, there were 2,853 shares remaining to be issued under the 2015 Stock Plan. In October 2024, the Company's shareholders approved the 2024 Stock Plan, which authorizes a total of 1,000,000 shares of common stock, which will replace the 2015 Stock Plan.    Stock-based compensation expense for the three and nine months ended September 30, 2024 and 2023, respectively, is as follows (table in thousands):        Three Months Ended September 30,     Nine Months Ended September 30,       2024     2023     2024     2023   General and administrative   $ 259     $ 346     $ 980     $ 1,094   Research and development     94       147       319       411   Total stock-based compensation expense   $ 353     $ 493     $ 1,299     $ 1,505     The Company recorded stock compensation expense for the equity classified warrants relating to non-employee consulting agreements of $26,000 and $50,000 for the three months ended  September 30, 2024 and 2023, respectively, and $94,000 and $142,000 for the nine months ended September 30, 2024 and 2023 , respectively, which are included in the table above. At  September 30, 2024, there was $283,000 of unrecognized stock compensation expense related to the Company's equity classified warrants.   In October and November 2024, the Company granted 545,000 stock options, 267,500 shares of restricted stock units, 73,334 shares of performance based restricted stock units, and 36,000 in warrants to employees and contractors. These stock options have an exercise price ranging from $2.45 to $2.54 and vest over a one-to-four year period from the grant date on a straight-line basis over the requisite service period. The restricted stock units vest annually in four equal installments.

v3.24.3

Note 6 - Income Taxes	9 Months Ended
	Sep. 30, 2024
Notes to Financial Statements
Income Tax Disclosure [Text Block]	6. Income Taxes     Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.   The Company does not expect to pay any significant federal, state, or foreign income taxes in 2024 as a result of the losses recorded during the three and nine months ended September 30, 2024 and the additional losses expected for the remainder of 2024 and cumulative net operating loss carryforwards. Accounting standards require the consideration of a valuation allowance for deferred tax assets if it is “more likely than not” that some component or all of the benefits of deferred tax assets will not be realized. As a result, as of September 30, 2024 and  December 31, 2023 the Company maintained a full valuation allowance for all deferred tax assets.   The Company recorded no income tax provision for the three and nine months ended September 30, 2024 and 2023, respectively. The effective tax rate for the nine months ended September 30, 2024 and 2023 is nil. The income tax rates vary from the federal and state statutory rates primarily due to the change in fair value of the stock warrants, Internal Revenue Code Section 162(m) limitations and ISO activity, as well as the valuation allowances on the Company’s deferred tax assets. The Company estimates its annual effective tax rate at the end of each quarterly period. Jurisdictions with a projected loss for the year where no tax benefit can be recognized due to the valuation allowance could result in a higher or lower effective tax rate during a particular quarter depending on the mix and timing of actual earnings versus annual projections.

v3.24.3

Note 7 - Commitments and Contingencies	9 Months Ended
	Sep. 30, 2024
Notes to Financial Statements
Commitments and Contingencies Disclosure [Text Block]	7. Commitments and Contingencies    In addition to the commitments and contingencies described elsewhere in these notes, see below for a discussion of the Company's commitments and contingencies as of September 30, 2024.   Lease Obligations Payable   The following summarizes quantitative information about the Company's operating leases for the three and nine months ended September 30, 2024 and 2023, respectively (table in thousands):       Three Months Ended September 30,     Nine Months Ended September 30,       2024     2023     2024     2023   Lease cost:                                 Operating lease cost   $ 37     $ 34     $ 112     $ 99   Variable lease cost     7       5       17       19   Total   $ 44     $ 39     $ 129     $ 118     In September 2023, the Company executed an amendment to extend the corporate office lease until August 31, 2029, with an option to renew. The Company is required to remit base monthly rent of approximately $4,700 which will increase at an average approximate rate of 2% each year. The Company is also required to pay additional rent in the form of its pro-rata share of certain specified operating expenses of the building.    In June 2022, the Company extended the lab lease until September 30, 2027, with no further right or option to renew. The Company recorded approximately $12,000 in sublease income from a related party for the three months ended September 30, 2024 and 2023, and $37,000 for the nine months ended September 30, 2024 and 2023. Sublease income is recorded as other income, net on the Company's condensed consolidated statement of operations and comprehensive loss. Operating cash flows from operating leases was $39,000 and $34,000 for the three months ended  September 30, 2024 and 2023, respectively, and $107,000 and $109,000 for the nine months ended September 30, 2024 and 2023, respectively.   Licenses    MD Anderson - Total expenses related to the Company's license agreements with MD Anderson were $63,000 and $64,000 for the three months ended September 30, 2024 and 2023, respectively, and $180,000 and $193,000 for the nine months ended September 30, 2024 and 2023, respectively.   HPI - The Company has two agreements with a related party, Houston Pharmaceuticals, Inc. (HPI) with total expenses of $59,000 for each of the three months ended September 30, 2024 and 2023, respectively, and $176,000 for the nine months ended September 30, 2024 and 2023, respectively.   Sponsored Research Agreements - The expenses recognized under the agreements were $767,000 and $221,000 for the three months ended September 30, 2024 and 2023, respectively, and $1,300,000 and $552,000 for the nine months ended September 30, 2024 and 2023, respectively.

v3.24.3

Note 8 - Subsequent events	9 Months Ended
	Sep. 30, 2024
Notes to Financial Statements
Subsequent Events [Text Block]	8. Subsequent Events    In addition to the subsequent events discussed elsewhere in these notes, no other subsequent events were noted as occurring after September 30, 2024.

v3.24.3

Insider Trading Arrangements	3 Months Ended	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2024
Insider Trading Arr Line Items
Material Terms of Trading Arrangement [Text Block]		ITEM 5. OTHER INFORMATION.    During the period covered by this Quarterly Report, none of the Company’s directors or executive officers has adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (each as defined in Item 408 of Regulation S-K under the Securities Exchange Act of 1934, as amended).   On November 4, 2024, the Compensation Committee of the Board of Directors took the following actions in connection with the executive compensation for the 2023/2024 compensation year ( June 1, 2023 to May 31, 2024) with its named executive officers (Walter Klemp, President and Chief Executive Officer; Jonathan P. Foster, Executive Vice President and Chief Financial Officer; and Dr. Donald Picker, Chief Scientific Officer): (i) cash bonuses in the aggregate amount of $735,000 were granted based on the full achievement of the goals and objectives for the compensation year, however the payment of the bonuses was accrued and will be paid the earlier of a) 364 days or b) approval by the CEO after consultation with the Board of Directors; and (ii) the Compensation Committee agreed that the accrued bonuses will earn interest at a rate of 8% per annum.   On November 4, 2024, the Compensation Committee and the Board of Directors agreed to issue each non-employee director a 10-year option to purchase 10,000 shares of our common stock, under our shareholder approved stock plan, with vesting through the end of April 2025 and an exercise price equal the closing price of our common stock on the date of the approval.
Rule 10b5-1 Arrangement Adopted [Flag]	false
Non-Rule 10b5-1 Arrangement Adopted [Flag]	false
Rule 10b5-1 Arrangement Terminated [Flag]	false
Non-Rule 10b5-1 Arrangement Terminated [Flag]	false

v3.24.3

Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2024
Accounting Policies [Abstract]
Reverse Stock Split [Policy Text Block]	Reverse Stock Split - On March 22, 2024, the Company completed a reverse stock split of all the issued and outstanding shares of the Company's common stock at a ratio of 1 to 15. The accompanying consolidated financial statements and notes to the consolidated financial statements gives retroactive effect to the reverse stock split for all periods presented. Certain amounts previously reported include rounding up of fractional shares as a result of the reverse stock split.
Basis of Accounting, Policy [Policy Text Block]	Basis of Presentation – Condensed Consolidated Financial Information - The accompanying condensed consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP) for financial information, and in accordance with the rules and regulations of the U.S. Securities and Exchange Commission (SEC) with respect to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The condensed consolidated financial statements furnished reflect all normal adjustments, which are, in the opinion of management, necessary for a fair statement of results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. These condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company as of  December 31, 2023 and for the year then ended, including the notes thereto contained in the Form 10-K filed with the SEC on March 22, 2024.
Consolidation, Policy [Policy Text Block]	Principles of Consolidation - The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP. The Company views its operations and manages its business in one operating segment. All material long-lived assets of the Company reside in the U.S.
Significant Accounting Policies [Policy Text Block]	Significant Accounting Policies - The Company's significant accounting policies are described in Note 2, Basis of Presentation, principles of consolidation and significant accounting policies, to the consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023. There have been no material changes to the significant accounting policies during the nine months ended September 30, 2024.
Use of Estimates, Policy [Policy Text Block]	Use of Estimates - The preparation of these condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of financial statements. Estimates are used in the following areas, among others: fair value estimates on intangible assets, warrants, and stock-based compensation expense, as well as accrued expenses and taxes.
Goodwill and Intangible Assets, Intangible Assets, Policy [Policy Text Block]	Intangible Assets – Intangible assets with finite lives are amortized using the straight-line method over their estimated period of benefit. Acquired intangible assets identified as in-process research and development (IPR&D) assets, are considered indefinite lived until the completion or abandonment of the associated research and development efforts. If the associated research and development effort is abandoned, the related IPR&D assets will be written-off and the Company will record a noncash impairment loss on its statements of operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. Intangible assets are tested for impairment on an annual basis, which was completed as of September 30, 2024, and between annual tests if indicators of potential impairment exist, using a fair-value-based approach. The Company evaluates the recoverability of intangible assets periodically and take into account events or circumstances that warrant revised estimates of useful lives or that indicate that impairment exists. No impairments of intangible assets have been identified during any of the periods presented.
Going Concern Policy [Policy Text Block]	Going Concern and Liquidity - These condensed consolidated financial statements have been prepared on a going concern basis, which assumes the Company will continue to realize its assets and discharge its liabilities in the normal course of business. The continuation of the Company as a going concern is dependent upon the ability of the Company to obtain necessary equity financing to continue operations and the attainment of profitable operations. As of  September 30, 2024, the Company had an accumulated deficit of $151.5 million since inception and had not yet generated any revenues from operations. Additionally, management anticipates that its cash on hand of $9.4 million as of September 30, 2024 is not sufficient to fund its planned operations for a period of at least one year from when these consolidated financial statements are issued. These factors raise substantial doubt regarding the Company's ability to continue as a going concern. These unaudited condensed consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company intends to seek additional funding through one or more of the following: a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements and delay planned cash outlays or a combination thereof. There can be no assurance that such events or a combination thereof can be achieved.    In March 2022, the Company received a subpoena from the SEC requesting information and documents, including materials related to certain individuals (none of which are the Company's officers or directors) and entities, and materials related to the development of and statements regarding the Company's drug candidate for the treatment of COVID-19. The Company has received, and expects to continue to receive, periodic further requests from the SEC staff with respect to this matter. The Company is not aware of the specific nature of the underlying investigation by the SEC, and to the extent that this investigation relates to prior public disclosures that it has made, the Company believes in the accuracy and adequacy of such prior disclosures. The correspondence from the SEC transmitting the subpoena to the Company states that the SEC is trying to determine whether there have been any violations of federal securities laws, but that its investigation does not mean that the SEC has concluded that anyone has violated the law or that the SEC has a negative opinion of any person, entity, or security. The Company cannot predict when this matter will be resolved or what, if any, action the SEC may take following the conclusion of the investigation. The company expensed approximately $0.1 million and $0.4 million in related general and administrative fees and expenses for the three months ended  September 30, 2024 and 2023, respectively, and $0.2 million and $1.4 million for the nine months ended  September 30, 2024 and 2023, respectively. The Company is in the process of filing a claim with its insurance carriers related to this loss which may cover a portion of the related expenses but not all. The claim is currently under review by the insurance company. The claim has not yet been approved nor has a reimbursement amount been determined which, if any, would be limited by the applicable retention as defined under the policy. Accordingly, the Company has not recorded any provision for insurance reimbursement. The Company expects to record the insurance reimbursement at the time that the amount to be reimbursed is determined and approved by the insurance carrier. Any insurance reimbursement receivable will be recorded at an amount not to exceed the recorded loss and only if the terms of the legally enforceable insurance contracts support that the insurance recovery will not be disputed and is deemed collectible, or if recovery of the loss is probable.
Cash and Cash Equivalents, Policy [Policy Text Block]	Cash and Cash Equivalents - Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents. The Company maintains cash accounts principally at one financial institution in the U.S., which at times, may exceed the Federal Deposit Insurance Corporation’s limit. The Company has not experienced any losses from cash balances in excess of the insurance limit. The Company’s management does not believe the Company is exposed to significant credit risk at this time due to the financial condition of the financial institution where its cash is held.
Fair Value of Financial Instruments, Policy [Policy Text Block]	Fair Value of Financial Instruments - The Company's financial instruments consist primarily of non-trade receivables, accounts payable, accrued expenses and its warrant liability. The carrying amount of non-trade receivables, accounts payable, and accrued expenses approximates their fair value because of the short-term maturity of such.   The Company has categorized its assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy in accordance with U.S. GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. The fair value hierarchy gives the highest priority to quoted prices in active markets for identical assets and liabilities (Level 1) and lowest priority to unobservable inputs (Level 3).   Assets and liabilities recorded in the condensed consolidated balance sheets at fair value are categorized based on a hierarchy of inputs as follows:   Level 1 – Unadjusted quoted prices in active markets of identical assets or liabilities. Level 2 – Quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument. Level 3 – Unobservable inputs for the asset or liability.   The Company’s financial assets and liabilities recorded at fair value on a recurring basis include the fair value of warrant liability discussed in Note 4.   The following table provides the financial liabilities reported at fair value and measured on a recurring basis at September 30, 2024 and December 31, 2023 (table in thousands):    Description   Fair Value     Level 1     Level 2     Level 3   Fair value of warrant liability as of September 30, 2024:   $ 9,932     $ —     $ —     $ 9,932   Fair value of warrant liability as of December 31, 2023:   $ 4,855     $ —     $ —     $ 4,855     The table below of Level 3 liabilities (table in thousands) begins with the valuation as of the beginning of the third quarter and then is adjusted for changes in fair value that occurred during the third quarter. The ending balance of the Level 3 financial instrument presented above represents the Company's best estimates and may not be substantiated by comparison to independent markets and, in many cases, could not be realized in immediate settlement of the instruments.    Three Months Ended September 30, 2024   Warrant Liability Long-Term   Balance, June 30, 2024   $ 1,704   Issuances of warrants     6,111   Warrant amendment     389   Change in fair value - net     1,728   Balance, September 30, 2024   $ 9,932     The table below of Level 3 liabilities (table in thousands) begins with the valuation as of December 31, 2023 and then is adjusted for changes in fair value that occurred during the nine months ended  September 30, 2024. The ending balance of the Level 3 financial instrument presented above represents the Company's best estimates and may not be substantiated by comparison to independent markets and, in many cases, could not be realized in immediate settlement of the instruments.    Nine Months Ended September 30, 2024   Warrant Liability Long-Term   Balance, December 31, 2023   $ 4,855   Issuances of warrants     6,111   Warrant amendment     389   Change in fair value - net     (1,423 ) Balance, September 30, 2024   $ 9,932
Earnings Per Share, Policy [Policy Text Block]	Loss Per Common Share - Basic net loss per common share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding during the period. For purposes of this calculation, options to purchase common stock, restricted stock units subject to vesting and warrants to purchase common stock are considered to be common stock equivalents. Diluted net loss per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, the weighted-average number of common shares outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive. For the three months ended September 30, 2024 and 2023, approximately 4.8 million and 0.6 million, respectively, of potentially dilutive shares were excluded from the computation of diluted earnings per share due to their anti-dilutive effect. For the nine months ended September 30, 2024 and 2023, approximately 2.7 million and 0.5 million, respectively, of potentially dilutive shares were excluded from the computation of diluted earnings per share due to their anti-dilutive effect.
Subsequent Events, Policy [Policy Text Block]	Subsequent Events - The Company’s management reviewed all material events through the date of these unaudited condensed consolidated financial statements.
New Accounting Pronouncements, Policy [Policy Text Block]	Recent Accounting Pronouncements - In November 2024, FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires disclosure in the notes to the financial statements of specified information about certain costs and expenses. The amendments are effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the new guidance to determine the impact it may have on its consolidated financial statements and related disclosures, but expects additional disclosures upon adoption. There are no other recently issued accounting standards updates that are currently expected to have a material impact on the Company.

v3.24.3

Note 2 - Basis of Presentation, Principles of Consolidation, and Significant Accounting Policies and Liquidity (Tables)	9 Months Ended
	Sep. 30, 2024
Notes Tables
Fair Value Measurements, Recurring and Nonrecurring [Table Text Block]	Description   Fair Value     Level 1     Level 2     Level 3   Fair value of warrant liability as of September 30, 2024:   $ 9,932     $ —     $ —     $ 9,932   Fair value of warrant liability as of December 31, 2023:   $ 4,855     $ —     $ —     $ 4,855   Three Months Ended September 30, 2024   Warrant Liability Long-Term   Balance, June 30, 2024   $ 1,704   Issuances of warrants     6,111   Warrant amendment     389   Change in fair value - net     1,728   Balance, September 30, 2024   $ 9,932   Nine Months Ended September 30, 2024   Warrant Liability Long-Term   Balance, December 31, 2023   $ 4,855   Issuances of warrants     6,111   Warrant amendment     389   Change in fair value - net     (1,423 ) Balance, September 30, 2024   $ 9,932

v3.24.3

Note 3 - Accrued Expenses and Other Current Liabilities (Tables)	9 Months Ended
	Sep. 30, 2024
Notes Tables
Schedule of Accrued Liabilities [Table Text Block]	September 30, 2024     December 31, 2023   Accrued payroll and bonuses   $ 1,512     $ 765   Accrued research and development     894       2,845   Accrued legal, regulatory, professional and other     431       547   Operating lease liability - current     116       100   Accrued liabilities due to related party     90       60   Total accrued expenses and other current liabilities   $ 3,043     $ 4,317

v3.24.3

Note 4 - Warrants and Equity (Tables)	9 Months Ended
	Sep. 30, 2024
Notes Tables
Schedule of Warrants or Rights, Assumptions Used [Table Text Block]	September 30, 2024     December 31, 2023   Risk-free interest rate   3.6% to 4.5%     3.8% to 5.4%   Volatility   78.7% to 111.5%     79.5% to 108.7%   Expected life (years)   0.4 to 5.0     0.3 to 5.0   Dividend yield   —%     —%
Schedule of Warrant Activity [Table Text Block]	Number of Shares     Range of Warrant Exercise     Weighted Average     Weighted Average Remaining Contractual       Under Warrant     Price per Share     Exercise Price     Life (Years)   Balance at January 1, 2024     1,082,895     $ 9.60     $ 157.50     $ 24.32       5.1   Granted     5,056,054     $ 2.23     $ 2.79     $ 2.24       2.9   Expired warrants     (75,909 )   $ 99.00     $ 99.00     $ 99.00       —   Balance at September 30, 2024     6,063,040     $ 2.23     $ 94.50     $ 12.90       3.1   Exercisable at September 30, 2024     1,006,986     $ 2.23     $ 94.50     $ 8.75       4.1

v3.24.3

Note 5 - Stock Based Compensation (Tables)	9 Months Ended
	Sep. 30, 2024
Notes Tables
Share-based Payment Arrangement, Expensed, Amount [Table Text Block]	Three Months Ended September 30,     Nine Months Ended September 30,       2024     2023     2024     2023   General and administrative   $ 259     $ 346     $ 980     $ 1,094   Research and development     94       147       319       411   Total stock-based compensation expense   $ 353     $ 493     $ 1,299     $ 1,505

v3.24.3

Note 7 - Commitments and Contingencies (Tables)	9 Months Ended
	Sep. 30, 2024
Notes Tables
Lease, Cost [Table Text Block]	Three Months Ended September 30,     Nine Months Ended September 30,       2024     2023     2024     2023   Lease cost:                                 Operating lease cost   $ 37     $ 34     $ 112     $ 99   Variable lease cost     7       5       17       19   Total   $ 44     $ 39     $ 129     $ 118

v3.24.3

Note 1 - Nature of Business (Details Textual)			6 Months Ended
	Mar. 22, 2024	Mar. 21, 2024	Apr. 29, 2024	Sep. 30, 2024	May 05, 2023 $ / shares
Number of Core Drug Technologies				3
NASDAQ Compliance, Minimum Closing Bid Price Per Share (in dollars per share)					$ 1
NASDAQ Compliance, Extension Period (Day)			180 days
Reverse Stock Split [Member]
Stockholders' Equity Note, Stock Split, Conversion Ratio	15	15
Animal Life Sciences, Inc [Member]
Equity Method Investment, Ownership Percentage				10.00%

v3.24.3

Note 2 - Basis of Presentation, Principles of Consolidation, and Significant Accounting Policies and Liquidity (Details Textual) $ in Thousands, shares in Millions			3 Months Ended		9 Months Ended		12 Months Ended
	Mar. 22, 2024	Mar. 21, 2024	Sep. 30, 2024 USD ($) shares	Sep. 30, 2023 USD ($) shares	Sep. 30, 2024 USD ($) shares	Sep. 30, 2023 USD ($) shares	Dec. 31, 2022	Dec. 31, 2023 USD ($)
Number of Operating Segments							1
Retained Earnings (Accumulated Deficit)			$ (151,485)		$ (151,485)			$ (131,604)
Cash			$ 9,400		$ 9,400
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in shares) | shares			4.8	0.6	2.7	0.5
General and Administrative Expense [Member]
Legal Fees			$ 100	$ 400	$ 200	$ 1,400
Reverse Stock Split [Member]
Stockholders' Equity Note, Stock Split, Conversion Ratio	15	15

v3.24.3

Note 2 - Basis of Presentation, Principles of Consolidation, and Significant Accounting Policies and Liquidity - Schedule of Fair Value Measurements, Recurring and Nonrecurring (Details) - USD ($) $ in Thousands	3 Months Ended	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2024	Dec. 31, 2023
Warrant Liability Long Term [Member]
Balance	$ 1,704	$ 4,855
Issuances of warrants	6,111	6,111
Warrant amendment	389	389
Change in fair value - net	1,728	(1,423)
Balance	9,932	9,932
Fair Value, Recurring [Member] | Warrant Liability [Member]
Fair value of warrant liability	9,932	9,932	$ 4,855
Fair Value, Recurring [Member] | Warrant Liability [Member] | Fair Value, Inputs, Level 1 [Member]
Fair value of warrant liability	0	0	0
Fair Value, Recurring [Member] | Warrant Liability [Member] | Fair Value, Inputs, Level 2 [Member]
Fair value of warrant liability	0	0	0
Fair Value, Recurring [Member] | Warrant Liability [Member] | Fair Value, Inputs, Level 3 [Member]
Fair value of warrant liability	$ 9,932	$ 9,932	$ 4,855

v3.24.3

Note 3 - Accrued Expenses and Other Current Liabilities (Details Textual) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Accounts Payable, Current	$ 2,550,000	$ 2,498,000
Related Party [Member]
Accounts Payable, Current	$ 20,000	$ 67,000

v3.24.3

Note 3 - Accrued Expenses and Other Current Liabilities - Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Accrued payroll and bonuses	$ 1,512	$ 765
Accrued research and development	894	2,845
Accrued legal, regulatory, professional and other	431	547
Operating lease liability - current	116	100
Accrued Liabilities, Current	3,043	4,317
Related Party [Member]
Accrued Liabilities, Current	$ 90	$ 60

v3.24.3

Note 3 - Accrued Expenses and Other Current Liabilities - Accrued Expenses and Other Current Liabilities (Details) (Parentheticals) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Liabilities, Current [Abstract]
Accrued Liabilities, Current	$ 3,043	$ 4,317

v3.24.3

Note 4 - Warrants and Equity (Details Textual) - USD ($) $ / shares in Units, $ in Thousands		1 Months Ended		3 Months Ended		9 Months Ended
	Mar. 31, 2024	Aug. 31, 2024	Mar. 31, 2024	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Oct. 31, 2024	Dec. 31, 2023	Dec. 26, 2023
Proceeds from Issuance or Sale of Equity						$ 4,660	$ 211
Loss On Issuance of Warrant Liabilities				$ (847)	$ 0	(847)	0
Warrant Liabilities, Transaction Costs				993	$ (0)	$ 993	$ (0)
Stock Issued During Period, Shares, Issued for Services (in shares)			6,834
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures (in shares)						20,485
Warrant Liability [Member]
Derivative Liability		$ 6,100
Pre-funded Warrants in 2024 Agreement [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)		2,183,368
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)		$ 0.001
Series A Warrants in 2024 Agreement [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)		2,466,368
Series B Warrants in 2024 Agreement [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)		2,466,368
Common Warrants in 2024 Agreement [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)		2.23
Common Warrants Issued In Connection With The 2023 Securities Purchase Agreement[Member]
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)										$ 9.6
Common Warrants Issued In Connection With The 2023 Securities Purchase Agreement[Member] | Subsequent Event [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)								895,834
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)								$ 2.23
Warrants and Rights Outstanding, Term (Year)								5 years
Securities Purchase Agreement 2024 [Member]
Loss On Issuance of Warrant Liabilities		$ 800
Warrant Liabilities, Transaction Costs				$ 1,000		$ 1,000
Equity Classified Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)	3,334		3,334
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)	$ 9.15		$ 9.15
Warrants and Rights Outstanding, Term (Year)	10 years		10 years
Class of Warrant or Right, Vesting Period (Year)	4 years
Class of Warrant or Right, Outstanding (in shares)				2,089,105		2,089,105			289,276
Class of Warrant or Right, Vested and Exercisable (in shares)				2,066,894		2,066,894			266,350
Common Stock in 2024 Agreement [Member]
Stock Issued During Period, Shares, New Issues (in shares)		283,000
Securities Purchase Agreement 2024 [Member]
Equity Issued, Purchase Price Per Share (in dollars per share)		$ 2.23
Proceeds from Issuance or Sale of Equity		$ 5,500

v3.24.3

Note 4 - Warrants - Assumptions Used (Details)	Sep. 30, 2024	Dec. 31, 2023
Minimum [Member] | Measurement Input, Risk Free Interest Rate [Member]
Warrants, assumptions	0.036	0.038
Minimum [Member] | Measurement Input, Price Volatility [Member]
Warrants, assumptions	0.787	0.795
Minimum [Member] | Measurement Input, Expected Term [Member]
Warrants, assumptions	0.4	0.3
Maximum [Member] | Measurement Input, Risk Free Interest Rate [Member]
Warrants, assumptions	0.045	0.054
Maximum [Member] | Measurement Input, Price Volatility [Member]
Warrants, assumptions	1.115	1.087
Maximum [Member] | Measurement Input, Expected Term [Member]
Warrants, assumptions	5	5

v3.24.3

Note 4 - Warrants - Warrant Activity (Details) - Liability Classified Warrants [Member] - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2024	Dec. 31, 2023
Balance (in shares)	1,082,895
Balance, weighted average remaining contractual life (Year)	3 years 1 month 6 days	5 years 1 month 6 days
Granted (in shares)	5,056,054
Granted (Year)	2 years 10 months 24 days
Expired warrants (in shares)	(75,909)
Balance (in shares)	6,063,040	1,082,895
Exercisable (in shares)	1,006,986
Exercisable, weighted average remaining contractual life (Year)	4 years 1 month 6 days
Minimum [Member]
Balance, warrant exercise price (in dollars per share)	$ 9.6
Granted (in dollars per share)	2.23
Expired warrants (in dollars per share)	99
Balance, warrant exercise price (in dollars per share)	2.23	$ 9.6
Exercisable, warrant exercise price (in dollars per share)	2.23
Maximum [Member]
Balance, warrant exercise price (in dollars per share)	157.5
Granted (in dollars per share)	2.79
Expired warrants (in dollars per share)	99
Balance, warrant exercise price (in dollars per share)	94.5	157.5
Exercisable, warrant exercise price (in dollars per share)	94.5
Weighted Average [Member]
Balance, warrant exercise price (in dollars per share)	24.32
Granted (in dollars per share)	2.24
Expired warrants (in dollars per share)	99
Balance, warrant exercise price (in dollars per share)	12.9	$ 24.32
Exercisable, warrant exercise price (in dollars per share)	$ 8.75

v3.24.3

Note 5 - Stock Based Compensation (Details Textual)			1 Months Ended		3 Months Ended		9 Months Ended
	May 31, 2023 shares	May 31, 2022 shares	Nov. 30, 2024 $ / shares shares	Oct. 31, 2024 $ / shares shares	Sep. 30, 2024 USD ($) shares	Sep. 30, 2023 USD ($)	Sep. 30, 2024 USD ($) shares	Sep. 30, 2023 USD ($)
Share-Based Payment Arrangement, Expense | $					$ 353,000	$ 493,000	$ 1,299,000	$ 1,505,000
Equity Classified Warrants [Member]
Share-Based Payment Arrangement, Expense | $					26,000	$ 50,000	94,000	$ 142,000
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $					$ 283,000		$ 283,000
Subsequent Event [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Number (in shares)				545,000
Subsequent Event [Member] | Restricted Stock Units (RSUs) [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period (in shares)			267,500
Share Based Compensation Arrangement by Share Based Payment Award, Number of Installment Periods			4
Subsequent Event [Member] | Restricted Stock Units (RSUs) [Member] | Maximum [Member]
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) | $ / shares			$ 2.54
Subsequent Event [Member] | Performance-based Restricted Stock Units [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period (in shares)			73,334
Subsequent Event [Member] | Warrants [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period (in shares)			36,000
Subsequent Event [Member] | Share-Based Payment Arrangement, Option [Member] | Minimum [Member]
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) | $ / shares				$ 2.45
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year)			1 year
Subsequent Event [Member] | Share-Based Payment Arrangement, Option [Member] | Maximum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year)			4 years
The 2015 Stock Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Additional Shares Authorized (in shares)	116,667	133,334
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares)	366,667
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares)					2,853		2,853
The 2024 Stock Plan [Member] | Subsequent Event [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares)				1,000,000

v3.24.3

Note 5 - Equity - Stock based Compensation (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Share-Based Payment Arrangement, Expense	$ 353	$ 493	$ 1,299	$ 1,505
General and Administrative Expense [Member]
Share-Based Payment Arrangement, Expense	259	346	980	1,094
Research and Development Expense [Member]
Share-Based Payment Arrangement, Expense	$ 94	$ 147	$ 319	$ 411

v3.24.3

Note 6 - Income Taxes (Details Textual) - USD ($) Pure in Thousands, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Income Tax Expense (Benefit)	$ 0	$ 0	$ 0	$ 0
Effective Income Tax Rate Reconciliation, Percent			0.00%	0.00%

v3.24.3

Note 7 - Commitments and Contingencies (Details Textual) - USD ($)	1 Months Ended	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Operating Lease, Monthly Rent Payment	$ 4,700		$ 4,700		$ 4,700
Operating Lease, Rent Expense, Annual Increase In Rent, Percent	2.00%
Sublease Income		$ 12,000	12,000	$ 37,000	37,000
Operating Lease, Payments		39,000	34,000	107,000	109,000
License Agreements Expense		767,000	221,000	1,300,000	552,000
Houston Pharmaceuticals, Inc [Member]
Related Party Transaction, Amounts of Transaction		59,000	59,000	176,000	176,000
MD Anderson [Member]
License Agreements Expense		$ 63,000	$ 64,000	$ 180,000	$ 193,000

v3.24.3

Note 7 - Commitments and Contingencies - Lease Cost (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Operating lease cost	$ 37	$ 34	$ 112	$ 99
Variable lease cost	7	5	17	19
Total	$ 44	$ 39	$ 129	$ 118

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