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 Phase 2 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 The University of Texas System on behalf of the MD Anderson Cancer Center (MD Anderson) in Houston, Texas. 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 out-licensing or outsourcing opportunities with development/commercialization strategic partners who are better suited for the marketing, sales and distribution of its drugs, if approved.

 

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) (the "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. In addition, the Company was required to notify Nasdaq of its intent to cure the minimum bid price deficiency, which  may include, if necessary, implementing a reverse stock split. 

 

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. The Company will continue to monitor the closing bid price of its common stock and plans to pursue available options to regain compliance with the Bid Price Rule, including potentially the Company’s Board of Directors authorizing a reverse stock split, as discussed further below. If the Company authorizes a reverse stock split, it will plan to effectuate the split no later than ten business days prior to the end of the extension in order to timely regain compliance. If, at any time before April 29, 2024, the bid price for the Company's common stock closes at $1.00 or more for a minimum of 10 consecutive business days, the Nasdaq Staff will provide written notification to the Company that it complies with the Bid Price Rule, unless the Staff exercises its discretion to extend this 10 day period pursuant to Nasdaq Listing Rule 5810(c)(3)(G).

 

On October 3, 2023, the Company held a Special Meeting of Stockholders (the "Special Meeting"). The Company's stockholders granted the Board of Directors the authority to effect an amendment to the Company’s amended and restated certificate of incorporation to effect a reverse stock split of the outstanding shares of the Company’s common stock, at a reverse stock split ratio of between 1-for-5 and 1-for-20 as determined by the Board in its sole discretion, prior to the one-year anniversary of the Special Meeting. The Board of Directors has taken no action with regard to this matter.

 

If the Company does not regain compliance with the Bid Price Rule by April 29, 2024, the Nasdaq Staff will provide written notification to the Company that its common stock  may be delisted. The Company would then be entitled to appeal the Nasdaq Staff’s determination to a NASDAQ Listing Qualifications Panel and request a hearing. There can be no assurance that, if the Company does appeal a delisting determination by the Nasdaq Staff to the NASDAQ Listing Qualifications Panel, that such appeal would be successful. There can be no assurance that the Company will be able to regain compliance with the Bid Price Rule. 

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

 

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, 2022 and for the year then ended, including the notes thereto contained in the Form 10-K filed with the SEC on March 22, 2023.

 

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.

 

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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, 2022. There have been no material changes to the significant accounting policies during the nine months ended September 30, 2023.

 

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. 

 

Going Concern - 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, 2023, the Company had an accumulated deficit of $121.3 million since inception and had not yet generated any revenues from operations. Additionally, management anticipates that its cash on hand of $24.6 million as of September 30, 2023 is sufficient to fund its planned operations into but not beyond the near term. 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  may seek additional funding 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. Management cannot be certain 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 $0.4 million and $1.1 million in related general and administrative fees and expenses for the three months ended  September 30, 2023 and 2022, respectively, and $1.4 million and $1.9 million for the nine months ended September 30, 2023 and 2022, 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. 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. 

 

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.

 

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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 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, 2023 and December 31, 2022 (table in thousands): 

 

Description		Fair Value				Level 1				Level 2				Level 3
Fair value of warrant liability as of September 30, 2023:		$	1			$	—			$	—			$	1
Fair value of warrant liability as of December 31, 2022:		$	77			$	—			$	—			$	77

 

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, 2023		Warrant Liability Long-Term
Balance, June 30, 2023		$	2
Change in fair value - net			(1	)
Balance, September 30, 2023		$	1

 

The table below of Level 3 liabilities (table in thousands) begins with the valuation as of  December 31, 2022 and then is adjusted for changes in fair value that occurred during the nine months ended September 30, 2023. 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, 2023		Warrant Liability Long-Term
Balance, December 31, 2022		$	77
Change in fair value - net			(76	)
Balance, September 30, 2023		$	1

 

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, 2023 and 2022, approximately 8.5 million and 6.0 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, 2023 and 2022, approximately 7.0 million and 5.2 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. See Note 8 - Subsequent Events. 

 

Recent Accounting Pronouncements - There are no recently issued accounting standards updates that are currently expected to have a material impact on the Company. 

 

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3. Accrued expenses and other current liabilities

 

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

 

		September 30, 2023				December 31, 2022
Accrued research and development		$	735			$	1,337
Accrued legal, regulatory, professional and other			549				437
Accrued payroll and bonuses			443				748
Operating lease liability - current			88				116
Accrued liabilities due to related party			65				86
Total accrued expenses and other current liabilities		$	1,880			$	2,724

 

Additionally, accounts payable includes $64,000 as of September 30, 2023 and December 31, 2022, respectively, for related party payables.

4. Warrants

 

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. 

 

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

 

		September 30, 2023			December 31, 2022
Risk-free interest rate		5.1% to 5.6%			4.2% to 4.8%
Volatility		69.1% to 89.8%			63.1% to 76.3%
Expected life (years)		0.2 to 1.9			0.1 to 2.6
Dividend yield		—%			—%

 

A summary of the Company's liability classified warrant activity during the nine months ended September 30, 2023 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, 2023			2,656,296			$	6.30			$	16.80			$	9.49				1.7
Expired warrants			(384,415	)		$	13.92			$	16.80			$	16.22				—
Balance at September 30, 2023			2,271,881			$	6.30			$	12.12			$	8.26				1.1
Exercisable at September 30, 2023			2,271,881			$	6.30			$	12.12			$	8.26				1.1

 

For a summary of the changes in fair value associated with the Company's warrant liability for the nine months ended September 30, 2023, see Note 2 - Basis of presentation, principles of consolidation and significant accounting policies - Fair Value of Financial Instruments.

 

Equity Classified Warrants

 

In August 2023, the Company granted equity-classified warrants to purchase up to 100,000 shares of Company common stock with a five-year term and an exercise price of $0.62. The warrants vest based on performance of certain services. As of September 30, 2023, no related vesting criteria were met.

 

In June 2023, the Company granted equity-classified warrants to purchase 150,000 shares of common stock with a ten-year term and an exercise price of $0.60 vesting annually over four years while services are being performed. 

 

At September 30, 2023, the Company had 896,501 equity classified warrants outstanding and 424,084 warrants were exercisable. At  December 31, 2022, the Company had 646,501 equity classified warrants outstanding and 400,859 warrants were exercisable.

 

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The Company recorded stock compensation expense for the non-employee consulting agreements of $50,000 and $232,000 for the three months ended  September 30, 2023 and 2022, respectively, and $142,000 and $398,000 for the nine months ended September 30, 2023 and 2022, respectively. At  September 30, 2023, there was $446,000 of unrecognized stock compensation expense related to the Company's equity classified warrants.

5. Equity 

 

Lincoln Park Equity Line

 

During the nine months ended September 30, 2023, pursuant to the 2021 Lincoln Park purchase agreement, the Company issued to Lincoln Park 225,568 shares of common stock for gross proceeds of $0.2 million. The 2021 Lincoln Park Agreement, which has $19.8 million available as of September 30, 2023, terminates in June 2024.

 

Other Components of Equity 

 

In March 2023, the Company and WPD Pharmaceuticals (WPD) agreed to terminate the WPD Agreement (defined below). Pursuant to the termination, the Company agreed to pay WPD (or its designees) $700,000 in cash and shares of its common stock valued at $800,000. In  March 2023, the Company issued 822,115 shares of common stock to WPD (or its designee) as part of satisfying this commitment. See Note 7 - Commitments and Contingencies. In addition, during the nine months ended September 30, 2023, the Company issued 134,933 shares of common stock related to the vesting of restricted stock units.

 

Stock-Based Compensation and Outstanding Awards

 

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 1,750,000 shares and 2,000,000 shares, respectively, such that 5,500,000 total shares may be issued under the Plan. As of September 30, 2023, there were 27,752 shares remaining to be issued under the 2015 Stock Plan. 

 

Stock-based compensation expense for the three and nine months ended September 30, 2023 and 2022, respectively, is as follows (table in thousands): 

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2023				2022				2023				2022
General and administrative		$	346			$	378			$	1,094			$	1,089
Research and development			147				321				411				651
Total stock-based compensation expense		$	493			$	699			$	1,505			$	1,740

 

During the nine months ended September 30, 2023, the Company granted 1,496,000 stock options with a weighted average fair value of $0.49 per share and 979,376 shares of restricted stock units with a weighted average fair value of $0.60 per share. These stock options have a weighted average exercise price of $0.60 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. 

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 2023 as a result of the losses recorded during the three and nine months ended September 30, 2023 and the additional losses expected for the remainder of 2023 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, 2023 and  December 31, 2022 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, 2023 and 2022, respectively. The effective tax rate for the nine months ended September 30, 2023 and 2022 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.

 

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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, 2023.

 

Lease Obligations Payable

 

The following summarizes quantitative information about the Company's operating leases for the three and nine months ended September 30, 2023 and 2022, respectively (table in thousands):

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2023				2022				2023				2022
Lease cost:
Operating lease cost		$	34			$	33			$	99			$	91
Variable lease cost			5				7				19				22
Total		$	39			$	40			$	118			$	113

 

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, 2023 and 2022, respectively, and $37,000 and $32,000 for the nine months ended September 30, 2023 and 2022, respectively. 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 $34,000 and $21,000 for the three months ended  September 30, 2023 and 2022, respectively, and $109,000 and $91,000 for the nine months ended September 30, 2023 and 2022, respectively.

 

Licenses 

 

MD Anderson - Total expenses related to the Company's license agreements with MD Anderson were $64,000 and $56,000 for the three months ended September 30, 2023 and 2022, respectively, and $193,000 and $189,000 for the nine months ended September 30, 2023 and 2022, 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, 2023 and 2022, respectively, and $176,000 for the nine months ended September 30, 2023 and 2022, respectively.

 

Sponsored Research Agreements - In October 2023, the Company entered into an amendment to the Sponsored Research Agreement with MD Anderson for total payments of $0.8 million to support the continuation of the project through December 31, 2025. In addition, the Company also has Sponsored Research Agreements with other universities, one in the US and one in Europe. The expenses recognized under the agreements were $221,000 and $315,000 for the three months ended September 30, 2023 and 2022, respectively, and $552,000 and $815,000 for the nine months ended September 30, 2023 and 2022, respectively.

 

License Terminations 

 

The Company was party to a sublicense agreement with WPD, pursuant to which it sublicensed to WPD certain intellectual property rights, including rights to Annamycin, its WP1122 portfolio, and its WP1066 portfolio (as amended, the “WPD Agreement”). WPD is affiliated with Dr. Waldemar Priebe, the Company's founder. In March 2023, the Company and WPD agreed to terminate the WPD Agreement and agreed to pay WPD (or its designee) $700,000 in cash and shares of its common stock valued at $800,000. In  March 2023, the Company issued 822,115 shares of common stock to WPD's designee as part of satisfying this commitment. With the termination of the WPD Agreement, the Company now has acquired the rights in certain territories previously sub-licensed to WPD to all of its licensed intellectual property, other than the rights related to non-human animals. Additionally, the Company acquired the in-process research and development that WPD has created during the term of the agreement.

 

In February 2022, the Company and Exploration Invest Pte Ltd. (Exploration) entered into a license termination agreement pursuant to which the Company agreed to pay Exploration $400,000 to terminate certain License Agreements and extend confidentiality requirements until the 10-year anniversary of the license termination agreement. Total expenses, reflected in research and development expenses, related to the Company's license terminations were $1.5 million and $0.4 million for the three and nine months ended September 30, 2023 and 2022, 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, 2023.

 

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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 Israel, 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 and within our expected budget and resources;

	•	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 clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs 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 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 in Phase 1B/2 or Phase 2 clinical trials. Since our inception, our drugs have completed, are currently in, or have received approval to proceed in eleven clinical trials.

 

Our Core Technologies

 

Our core technologies consist of the following:

 

a) Annamycin or L-Annamycin is a “next generation” anthracycline (one of the most common forms 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 has shown no cardiotoxicity in subjects treated in clinical trials to date. Furthermore, we have demonstrated safe dosing beyond the dose limitations imposed by regulatory authorities upon currently prescribed anthracyclines due to their inherent cardiotoxicity;

 

b) our WP1066 Portfolio, which includes WP1066 and WP1220, two of several Immune/Transcription Modulators in the portfolio designed to inhibit p-STAT3 (phosphorylated signal transducer and activator of transcription 3) among other transcription factors associated with tumor activity, while also stimulating a natural immune response to tumors by inhibiting the errant activity of Regulatory T-Cells (TRegs); and

 

c) our WP1122 Portfolio, which 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), which we believe may provide an opportunity to cut off the fuel supply of tumors by taking advantage of their high level of dependence on glucose in comparison to healthy cells, as well as viruses that depend upon glycolysis and glycosylation to infect and replicate.

 

In discussions regarding Annamycin’s lack of cardiotoxicity, we rely on our expert's assessment of certain clinical trial subject data including LVEF, ECHO strain analyses, and cardiac biomarkers – troponins I & T and our pre-clinical and clinical data, some of which are preliminary and subject to change.

 

 

Our Focus 

 

We are focused on internally funded development of:

 

1) Annamycin for the treatment of Soft Tissue Sarcoma metastasized to the lungs (STS lung metastases or STS lung mets)

 

2) Annamycin in combination with Cytarabine (also known as Ara-C, the combination with Annamycin is referred to as AnnAraC) for the treatment of Acute Myeloid Leukemia (R/R AML or AML).

 

3) A better formulation for delivery of WP1066 to further support current and possibly future externally funded oncology clinical trials. 

 

We have also recently established a Recommended Phase 2 Dose (RP2D) for WP1122 to potentially enable future externally funded oncology and virology trials. Beyond this, we support development of our core technologies through several externally funded clinical trials and primarily externally funded non-clinical research, with the potential for further studies in the future.

 

Our Clinical Trials

 

In the US and Europe, since our inception, we or independent investigators have approval to begin, are currently conducting or have completed eleven internally or externally funded clinical trials for four of our drug candidates – Annamycin, WP1066, WP1220, and WP1122. All clinical trials are or were in the Phase 1 or 2 stage. During 2021, we had four active clinical trials evaluating either Annamycin or WP1066 in the US and Europe. This increased to six active or recently completed trials in 2022 involving Annamycin, WP1066, and WP1122. Starting in 2021 through 2023, there have been seven "right-to-try" (or their foreign equivalent) uses of Annamycin and WP1066. Three of the six clinical trials active in 2022 were internally funded trials of Annamycin and one was an internally funded Phase 1 clinical trial for WP1122 establishing an RP2D.

 

Moving into 2023 with our internally funded trials focused on Annamycin, we were actively recruiting in two Phase 1B/2 stage clinical trials and have concluded one Phase 1 trial. We have recently concluded recruitment and treatment in one of the Phase 1B/2 trials but are still monitoring progression free survival and overall survival. This now leaves only one Phase 1B/2 clinical trial active with regard to recruiting and treatment. Both of these Phase 1B/2 clinical trials are open label, so we periodically announce safety and efficacy data.

 

In February 2023, the externally funded Phase 1 clinical trial with WP1066 for the treatment of pediatric brain tumors concluded. We expect up to two externally funded Phase 1B/2 clinical trials for WP1066 in the treatment of GBM and other brain tumors in the first half of 2024. One more pediatric clinical trial may occur later subject to the results of the other two possible clinical trials.

 

During 2022 and 2023, we or independent investigators filed applications, began recruiting or are currently recruiting for six internally or externally funded clinical trials in the US and Europe.

 

	•	Annamycin - A clinical trial application (CTA) in Poland for a Phase 1B/2 trial of Annamycin in combination with Cytarabine (the combination of which is referred to as AnnAraC) for the treatment of AML (MB-106) was allowed in 2022. This trial was later approved to expand into Italy in 2022 and dosing subjects began there in March 2023. With preclinical data in mice demonstrating a 68% improvement in activity in AML with AnnAraC as compared to Annamycin alone and having concluded our single agent trials of Annamycin in AML showing 80% activity in the highest dosing cohort, we are now focusing our efforts in AML exclusively on this combination trial. This trial is currently recruiting and treating subjects via 9 clinical sites throughout Poland and Italy.
	•	Annamycin - We are currently in a Phase 1B/2 clinical trial (MB-107) using Annamycin for the treatment of soft tissue sarcoma lung metastasese (STS lung mets). This multicenter trial is being conducted in five clinical sites throughout the US. We have concluded recruitment and treatment but are still monitoring progression free survival and overall survival.
	•	Annamycin - An investigator sponsored trial (externally funded) was initiated in Poland in 2022 to study an alternative dosing regimen for Annamycin in the treatment of STS lung mets. This trial began administering drug to subjects in late 2022 and is currently recruiting and treating subjects.
	•	WP1066 - In 2022, an investigational new drug (IND) application we filed in the US for a Phase 1 clinical trial studying WP1066 for treating glioblastoma multiforme (GBM) in adults went into effect. We anticipate that clinics associated with academic institutions or other health care systems may utilize this IND to begin their own externally funded trials with WP1066. Consistent with our strategy of leveraging external funding for many of our clinical trials, we intend to capitalize on external funding opportunities for investigator-initiated clinical trials in adult cancer patients in late 2023 or in 2024. We supplied drug product to an externally funded pediatric brain tumor trial with WP1066 up to its conclusion in February 2023.
	•	WP1122 - Our Phase 1a clinical trial of WP1122 in the United Kingdom for the treatment of COVID-19 (MB-301) began recruiting in 2022, and we completed the trial in late 2022, establishing an RP2D. We completed this trial, and we have issued a clinical study report (CSR). The RP2D established in this trial may possibly aid in future externally funded trials for the treatment of certain viruses and cancers as we look for investigator led studies.
	•	WP1122 - In 2022, we filed an IND with the FDA that then went into effect, allowing us to proceed with a clinical trial using WP1122 for the treatment of GBM. This may lead to an investigator-initiated trial (IIT) in oncology. Additionally, an investigator independently filed a CTA in Brazil in 2022 to study WP1122 for the treatment of moderate to severe COVID-19 (Clinicaltrials.gov ID: NCT NCT05365321). We do not expect this externally funded COVID-19 trial to be conducted.

 

Additionally, we are in discussions with research institutions in the US and Asia regarding possible externally funded trials or programs involving WP1066.

 

 

Recent Business Developments 

 

Below are recent business developments.

 

Annamycin 

 

New Positive Independent Report of No Cardiotoxicity in Annamycin

 

In September 2023, we received a new independent assessment for the absence of cardiotoxicity in subjects treated with Annamycin. We now have independent assessments covering 62 subjects that have been treated with Annamycin in four different clinical trials in the U.S. and Europe with no evidence of cardiotoxicity. 50 of all 66 subjects treated to date (which includes the 62 subjects independently assessed) were treated above the FDA’s lifetime maximum anthracycline limit of 550 mg/m², with 1 subject having been treated with 3420 mg/m² (or roughly six times the FDA approved lifetime anthracycline exposure) of standard anthracyclines and Annamycin with no evidence of cardiotoxicity.

 

Data from all subjects in our completed and all evaluable subjects in our ongoing clinical trials (a total of 62 subjects as of the most recent report) were made available to an expert in chemotherapy who is affiliated with a leading research institute in assessing chemotherapy-related cardiotoxicity. After review of this data, the independent expert, in their most recent report, concluded that there was no evidence of cardiotoxicity.

 

The data made available included left ventricular ejection fraction (LVEF) as determined by echocardiograms, ECHO strain imaging, and Troponin levels. “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.

 

MB-106 Annamycin in Combination with Cytarabine for the Treatment of AML (“5+3 Therapy”)

 

On May 2, 2023, we announced successful completion of the first cohort in our Phase 1B portion of our Phase 1B/2 clinical trial using Annamycin in combination with Cytarabine for the treatment of AML (MB-106). This study is utilizing a “5+3” regimen where Annamycin is administered with three days of infusion along with the five days of infusion of Cytarabine. This combination strategy is similar to the familiar “7+3” induction therapy that is considered to be a standard of care in AML, where seven days of Cytarabine infusions are paired with three days of an approved anthracycline (typically, daunorubicin). In the first cohort 3 subjects were treated, all of whom were relapsed from multiple prior therapies. Annamycin was dosed at 190 mg/m², along with Cytarabine at 2.0 g/m²/day for five days (total dose of 10g/m²). We, at the recommendation of the safety review committee, deemed the first cohort dose as safe and opened the second cohort with the Annamycin dose being increased to 230 mg/m². 

 

The median number of prior therapies for these 3 subjects in the first cohort was five (range of one to ten). 1 subject, who was 78 years of age at the time of the study initiation and enrolled after a single prior multi-year therapy, achieved a CR that has continued to be durable at approximately eight months. This subject has received a second course of treatment at the direction of the treating physician and as allowed per the protocol. The other 2 subjects were shown to have disease progression.

 

On August 7, 2023, we successfully completed the second cohort at 230 mg/m² of Annamycin in this combination study. 4 subjects were treated in this cohort, 1 is believed to be relapsed from one or more prior therapies and 3 are believed to be refractory from up to three prior therapies. 1 subject was replaced due to a Serious Adverse Event (SAE) experienced on Day 1 of dosing. The SAE was determined to be unrelated to Annamycin and definitively related to Cytarabine. We, at the recommendation of the safety review committee, deemed the second cohort dose as safe and opened recruitment, including for both first line therapy and for subjects who are refractory to or relapsed after induction therapy, to the Phase 2 portion of the trial. The median number of prior therapies for the 3 evaluable subjects in the second cohort was two (range of one to three) and the median age was 67. 1 subject, who was 64 years of age at the time of enrollment into the study with one prior therapy, was preliminarily recorded as a complete response with an incomplete recovery of the bone marrow or CRi per the protocol. This has since been deemed a CR (complete response), which has shown to be durable for approximately three months, which has allowed this subject to proceed to a bone marrow transplant. The other 2 subjects were shown to have disease progression. Durability of CRs is confirmed by repeat bone marrow aspirates (BMA's). 

 

The total CRs in the Phase 1B portion of this combination trial represent 33% (n=6). Notably, these CRs are considered durable. The median age of these subjects was 66.

 

On October 2, 2023, we announced the initial subjects had been treated in the Phase 2 portion of MB-106. The data below are as reported by the investigation sites as of November 9, 2023.

 

We have recruited, treated, and evaluated 3 subjects in the Phase 2 portion of the trial. 1 subject has been evaluated and determined to be a CR. We will assess durability in the near future. Another subject in the Phase 2 portion died from a stroke (deemed not be related to Annamycin) prior to being re-biopsied to determine disease status. The third has undergone a re-biopsy which shows zero blasts in the marrow and that data is now being assessed by the investigator. This latest subject is not included in the chart below. The median age of the first two subjects is 69 years (range of 69 to 70) and the median number of prior therapies for these subjects is three (both are three). Other subjects in the Phase 2 portion of the trial are in the process of screening and treatment. We intend to treat up to 21 subjects in this Phase 2 portion of the trial. We may recruit an additional 3 subjects depending on recruitment. At our rate of recruitment plus the addition of another three sites for the trial, we expect to complete recruitment by early 2024.

 

The total CR response rate in both Phases to date in MB-106 is 38% (n=8), and although sufficient time has not passed to assess durability for the latest of these CRs, the 2 earliest CRs have now shown durability. The median baseline bone marrow assessments for the 3 CRs was 74.2 (range of 20 to 80). CRc is used to denote composite complete responses including CRs and CRis.

 

 

Below in Table 1 is a summary of the above responses in MB-106 and in the concluded MB-105 monotherapy trial on AML.

 

Table 1 – Summary of Annamycin Responses in AML Studies
Study	Study MB-105 Monotherapy – Last Cohort at 240 mg/m2 (RP2D)	Study MB-106 Combination Therapy – Phase 1B (Annamycin at 190-230 mg/m2)	Study MB-106 Combination Therapy – Phase 2 To Date (Annamycin at 230 mg/m2)	Study MB-106 Combination Therapy – Phase 1B/2 To Date (Annamycin at 190-230 mg/m2)
Therapy	Annamycin – Single Agent	Ara-C + Annamycin “5+3+	Ara-C + Annamycin “5+3+	Ara-C + Annamycin “5+3+
Subjects To date	5	6	2	8
CRs	0	2	1	3
CRis	3	0	0	0
Total Response(s) or CRcs	3	2	1	3
Complete Response (CR) Rate	0%	33%	50%	38%
Overall Response (CRc) Rate	60%	33%	50%	38%
Median Prior Therapies (Months of Therapy))	6 (N/A)	2.5 (9)	3 (6)	3 (9)
Median Age - Years (Range)	65 (62-73)	66 (32-78)	69 (69-70)	68 (32-78)
Durability of CRs	Not followed	Approximately 8 and 3 months, respectively, to date for the 2 CRs	Not Available at This Time	See Data to Left
N/A - (Not available)	For subjects receiving a full course of Annamycin

 

All data presented above from the MB-106 trial are preliminary and subject to change.

 

MB-107 Annamycin Monotherapy for the Treatment of STS Lung Mets

 

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 (MB107). Subjects who had stable disease at the time of study discontinuation will continue to be followed for progression free response and overall survival. All subjects had pulmonary metastasis from soft tissue sarcoma and at least one prior therapy. There was no limit on how many prior therapies a subject could have prior to entering this study. Most subjects were heavily treated with other therapies prior to entering our trial with our treatment representing the fourth median therapy for all subjects in the Phase 1B and Phase 2 portion of the trial (range of two to twelve). As of November 6, 2023, as reported by the investigation sites, most subjects in Phase 2 are alive so overall survival data are not available at this time. Below in Table 2 is a summary of progression free survival for evaluable subjects, as discussed further below, by groupings and median overall survival for all subjects evaluable in Phase 1B:

 

Table 2	MB-107 Summary as of November 9, 2023
Progression Free Survival Months (mos)	All Subjects	Phase 1B All Subjects	Phase 2 All Subjects	All Subjects Treated at < 330 mg/m2	All Subjects with 2 or Fewer Prior Therapies (< 2PT)	All Subjects < 330 mg/m2  & < 2PT
1 mos or >	100%	100%	100%	100%	100%	100%
2 mos or >	59%	67%	53%	61%	83%	78%
3 mos or >	25%	27%	24%	30%	42%	56%
4 mos or >	16%	13%	18%	22%	25%	33%
5 mos or >	9%	7%	12%	13%	8%	11%
6 mos or >	6%	0%	12%	9%	8%	11%
n =	32	15	17	17	12	9
Median mos	2.2	2.6	2.0	2.1	2.7	3.4
Median Prior Therapies (Range)	3 (1-11)	3 (1-9)	3 (1-11)	3 (1-11)	2 (1-2)	2 (1-2)
Median O/S mos	N/A	11.3	N/A	N/A	N/A	N/A
Overall survival (OS); Not available for Phase 2 subjects at this time, as data continues to develop (N/A)

 

In the Phase 1B portion of the trial subjects were treated from 210 mg/m² to 390 mg/m². In the Phase 2 portion of the trial, an exploratory RP2D of 360 mg/m²  was initiated for the first 3 subjects and a final RP2D of 330 mg/m² was determined and 14 subjects were treated.

 

 

Including the 3 subjects treated at the same dose in the Phase 1B portion of this trial, this equates to 17 total subjects measurable for efficacy at the 330 mg/m² dose level. Including all measurable subjects at all dose levels in the Phase 1B portion of the trial, 32 subjects were treated with at least one cycle in this study and 27 received at least two cycles of treatment. For the Phase 2 subjects, the median time to entering the MB107 trial from the time of initial diagnosis is estimated to be approximately 20 months, and these subjects have been mostly heavily treated previously for STS lung mets prior to entering our study.

 

Once all data are collected, we plan a more in-depth presentation of the topline data for this study in 2024. The above information in Table 2 was shared with our investigators in a meeting held during the Connective Tissue Oncology Society Annual Meeting (CTOS) in Dublin, Ireland in early November 2023. Based on the data as shown in Table 2 above, we believe the following observations are in order:

 

●

Very few trials for subjects with such advanced (median = 20 months from initial diagnosis; all with lung metastases in MB-107) disease progression have been published, making comparisons to historical performance difficult.

●

With this in mind, median OS for subjects in the Phase 1B portion of this study is currently at 11 months, which we believe is notable.

●

Overall median Progression Free Survival (PFS) for the trial is 2.2 months (range 1.2 to 6.9 months) with 7 subjects discontinuing early due to thrombocytopenia. 5 of these subjects negatively impacted this median PFS, which we believe was exacerbated by the extreme advanced stage of the patients and their being weakened by prior therapies.

●

Median PFS improved to 3.4 months for lower doses of Annamycin (≤330 mg/m2) versus the maximum dose used in the trial and for subjects who had fewer prior therapies (<2).

●

These data suggest to us that Annamycin may be best positioned as a first line alternative to the current standard of care with an anthracycline and where the combination of high patient response rate, significant improvement in OS and the absence of cardiotoxicity may improve patient outcomes.

 

All data presented above from the MB-107 trial are preliminary and subject to change. 

 

WP1066

 

We continue discussions with two US academic institutions and another foreign academic institution for externally funded trials for the use of WP1066 for the treatment of glioblastomas and/or pediatric brain tumors. We expect to finalize agreements with Northwestern University and FDA filings in the second half of this year (Clinicaltrials.gov ID: NCT05879250). We do not expect the pediatric study to begin until an adult brain tumor trial commences and generates additional data.

 

Regarding an intravenous formula for WP1066, we continue to work towards and we believe we will be able to announce progress regarding an IV formulation near the end of 2023 or in early 2024.

 

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 have submitted the final clinical study report in late October 2023.

 

 

Other Trials and Publications 

 

Presented Poster at the 2023 Connective Tissue Oncology Society (CTOS) Annual Meeting

 

We presented preliminary efficacy findings from the Phase 2 portion of our ongoing MB-107 in an abstract titled, “A Phase 1b/2 Study of Liposomal Annamycin (ANN) in Subjects with Previously Treated Soft-Tissue Sarcomas (STS) with Pulmonary Metastases,” was presented by Brian Andrew Van Tine, MD, PhD, Professor of Medicine, Washington University School of Medicine in a poster presentation at the 2023 CTOS Annual Meeting held November 1-4, 2023 in Dublin, Ireland.

 

Externally Funded Annamycin Trial 

 

A Phase 1B/2 investigator sponsored trial (externally funded) was initiated in Poland in 2022 to study an alternative dosing regimen for Annamycin in the treatment of STS lung mets. This trial has enrolled and begun treatment with subjects in the Phase 1B portion of the study. There will be 3 subjects per cohort with the first cohort treating subjects with 35 mg/m² of Annamycin per week (3 weeks on and 1 week off per cycle). After two cycles the subjects will receive their end of cycle 2 scan. At the end of two cycles both subjects treated to date demonstrated progressive disease. Preclinical data demonstrated a benefit to weekly dosing of Annamycin versus traditional chemotherapy dosing of every three weeks. We expect a detailed update on this trial in early 2024.

 

Publication of Data from Successful European Phase 1 Trial Evaluating Annamycin as Single Agent Treatment of Relapsed or Refractory AML

 

On July 13, 2023, we announced the publication of data from our completed MB-105 European Phase 1 clinical trial assessing the safety and efficacy of Annamycin as a single agent for the treatment of adults with relapsed or refractory AML. The manuscript titled, “Results of a Phase 1 Study of Liposomal Annamycin for the Treatment of Relapsed or Refractory AML Patients After Induction Therapy,” was published in the peer-reviewed British Journal of Cancer Research.

 

AACR Annamycin Presentation

 

We announced in April 2023 a presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023 of positive pharmacokinetics and tissue-organ distribution data demonstrating high antitumor activity of Annamycin in preclinical cancer models, such data was based on research sponsored by us. In this research, Annamycin demonstrated increased penetration and accumulation in the liver, which correlated with high antitumor activity in HEPA 1-6 hepatocellular carcinoma and CT26 colon cancer liver metastasis models. This poster was presented at the AACR Annual Meeting 2023, which took place April 14-19, 2023, at the Orange County Convention Center in Orlando, FL. The poster titled, Exploration of Annamycin Organotropism to Target Primary and Metastatic Liver Cancers was presented by Rafal Zielinski, Ph.D., Department of Experimental Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center as part of the Experimental and Molecular Therapeutic Session: “Novel Antitumor Agents, PI3K/AKT Inhibitors, Proteasome Inhibitors, and Topoisomerases.” The poster outlined results from the analysis of the pharmacokinetics of two formulations of Annamycin, liposome formulated drug product (L-ANN) and free Annamycin (ANN), in the liver in comparison with doxorubicin (DOX) and to determine its tumoricidal potential in a hepatocellular carcinoma (HCC) model in situ and in experimental models of liver metastasis.

 

During the June 2023 meeting of the IV World Congress of Polish Physicians in Olsztyn, Poland. Dr. Waldemar Priebe, Chair of our Science Advisory Board was invited to lecture. He presented the above referenced AACR presentation “Discovery and Development of Novel Organotropic Anticancer Therapies”.

 

Licensing

 

WPD Licensing Agreement

 

Since February 2019, we were party to a sublicense agreement with WPD Pharmaceuticals (WPD), pursuant to which we sublicensed to WPD certain intellectual property rights, including rights to Annamycin, our WP1122 portfolio, and our WP1066 portfolio (as amended, the “WPD Agreement”). WPD is affiliated with Dr. Waldemar Priebe, our founder. In March 2023, we and WPD agreed to terminate the WPD Agreement. Pursuant to the termination, we agreed to pay WPD (or its designee) $700,000 in cash and shares of our common stock valued at $800,000. In March 2023, we issued 822,115 shares of common stock to WPD's designee as part of the satisfaction of this commitment. With the termination of the WPD Agreement, we now have acquired the rights in certain territories previously sub-licensed to WPD to all of our licensed intellectual property, other than the rights related to non-human animals. Additionally, we acquired the in-process research and development that WPD has created during the term of the agreement. As part of this Agreement, WPD assigned their rights and duties to us for the Phase 1B/2 investigator sponsored trial (externally funded) initiated in Poland in 2022 to study an alternative dosing regimen for Annamycin in the treatment of STS lung mets. The approximate value of the grant supporting this investigator sponsored trial is $1.5 million. 

 

 

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,
		2023				2022				2023				2022
Revenues		$	—			$	—			$	—			$	—
Operating expenses:
Research and development			3,280				5,965				12,855				14,790
General and administrative			2,635				3,087				7,765				8,704
Depreciation and amortization			32				32				92				98
Total operating expenses			5,947				9,084				20,712				23,592
Loss from operations			(5,947	)			(9,084	)			(20,712	)			(23,592	)
Other income:
Gain from change in fair value of warrant liability			1				421				76				1,184
Other income, net			13				19				30				39
Interest income, net			324				33				1,106				114
Net loss		$	(5,609	)		$	(8,611	)		$	(19,500	)		$	(22,255	)

  

Three Months Ended September 30, 2023 Compared to Three Months Ended September 30, 2022

 

Research and Development Expense. Research and development (R&D) expense was $3.3 million and $6.0 million for the three months ended September 30, 2023 and 2022, respectively. The decrease of $2.7 million is mainly related to the timing of costs incurred for clinical trials and timing of sponsored research payments.

 

General and Administrative Expense. General and administrative expense was $2.6 million and $3.1 million for the three months ended September 30, 2023 and 2022, respectively. The decrease of $0.5 million is mainly related to a decrease in regulatory and legal services, and consulting & advisory fees.

 

Gain from Change in Fair Value of Warrant Liability. We recorded a net gain of $0.001 million in the third quarter of 2023 as compared to a net gain of $0.4 million in the third quarter of 2022, 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.

 

Interest income, net. Interest income, net increased by approximately $0.3 million for the comparable quarterly periods due to rising interest rates during the past year.

 

Nine Months Ended September 30, 2023 Compared to Nine Months Ended September 30, 2022

 

Research and Development Expense. Research and development (R&D) expense was $12.9 million and $14.8 million for the nine months ended September 30, 2023 and 2022, respectively. The decrease of $1.9 million is mainly related to the timing of costs incurred for clinical trials and timing of sponsored research payments. These decreases were slightly offset by the WPD sublicense termination, 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 $7.8 million and $8.7 million for the nine months ended September 30, 2023 and 2022, respectively. The decrease of $0.9 million is mainly related to a decrease in regulatory and legal services, and consulting & advisory fees.

 

Gain from Change in Fair Value of Warrant Liability. We recorded a net gain of $0.08 million in the nine months ended September 30, 2023 as compared to a net gain of $1.2 million in the nine months ended September 30, 2022, 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.

 

 

Interest income, net. Interest income, net increased by approximately $1.0 million for the comparable quarterly periods due to rising 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,
		2023				2022
Net cash used in operating activities		$	(18,694	)		$	(20,383	)
Net cash used in investing activities			(43	)			(67	)
Net cash provided by (used in) provided by financing activities			186				(23	)
Effect of exchange rate changes on cash and cash equivalents			(15	)			(38	)
Net decrease in cash and cash equivalents		$	(18,566	)		$	(20,511	)

 

As of September 30, 2023, there was $0.3 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 $18.7 million for the nine months ended September 30, 2023. This $1.7 million decrease over the prior year period of $20.4 million was primarily due to an overall decrease in expenses, as well as license rights settled in stock. 

 

Cash provided by financing activities 

 

During the nine months ended September 30, 2023, utilizing the Lincoln Park Equity Line, we issued 225,568 shares of common stock (including commitment shares), at an average price of $0.94 per share, resulting in gross proceeds of $0.2 million. 

 

We believe that our existing cash and cash equivalents as of September 30, 2023 will be sufficient to fund our planned operations, which include our current Phase 1B/2 clinical programs and preparations for future clinical trials, into the third quarter of 2024, without the issuance of additional equity for cash. The continuation of our Company as a going concern is dependent upon our ability to obtain necessary equity financing to continue operations and the attainment of profitable operations. We may seek additional funding 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. We cannot be certain that such events or a combination thereof can be achieved. 

 

In March 2022, we received a subpoena from the SEC requesting information and documents, including materials related to certain individuals (none of which are our officers or directors) and entities, and materials related to the development of and statements regarding our drug candidate for the treatment of COVID-19. We have received, and expect to continue to receive, periodic further requests from the SEC staff with respect to this matter. We are 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 we have made, we believe in the accuracy and adequacy of such prior disclosures. The correspondence from the SEC transmitting the subpoena to us 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. We cannot predict when this matter will be resolved or what, if any, action the SEC may take following the conclusion of the investigation. We expensed approximately $0.4 million and $1.1 million in related general and administrative fees and expenses for the three months ended September 30, 2023 and 2022, respectively, and $1.4 million and $1.9 million for the nine months ended September 30, 2023 and 2022, respectively. 

 

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, 2022. 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, 2022.

 

 

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, 2023.

 

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, 2023 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, 2022, and in Part II, Item 1A in our prior quarterly reports on Form 10-Q filed during this fiscal year. 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, 2022, and in Part II, Item 1A in our prior quarterly reports on Form 10-Q filed during this fiscal year, as filed with the SEC.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS 

 

During the nine months ended September 30, 2023, the Company issued warrants to purchase 150,000 shares of common stock with an exercise price of $0.60 per share to two entities providing consulting services, which warrants will vest annually over four years while services are being performed, and 100,000 shares of common stock with an exercise price of $0.62 to an entity providing consulting services, which warrants will vest based on performance of certain services. The foregoing securities were issued pursuant to Section4(a)(2) of the Securities Act.

 

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).

 

 

ITEM 6. EXHIBITS 

 

Exhibit No.						Description
10.1*						First Amendment to Commercial Lease Agreement for 5300 Memorial
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 13, 2023			By:			/s/ Walter V. Klemp
						Walter V. Klemp,
						Chief Executive Officer and Chairman (Principal Executive Officer)
Date: November 13, 2023			By:			/s/ Jonathan P. Foster
						Jonathan P. Foster,
						Executive Vice President & Chief Financial Officer (Principal Financial and Accounting Officer)

 

 

Exhibit 10.1

 

 

FIRST AMENDMENT TO

COMMERCIAL LEASE AGREEMENT

 

This First Amendment to Commercial Lease Agreement ("First Amendment") is made by and between IPX MEMORIAL DRIVE INVESTORS, LLC, a Delaware limited liability company ("Landlord") and MOLECULIN BIOTECH, INC., a Delaware corporation (“Tenant”), on this 6^th day of September, 2023 (the “Effective Date”).

 

WHEREAS, Landlord and Tenant entered into that certain Commercial Lease Agreement dated March 22, 2018 (the "Lease") whereby Landlord leases to Tenant certain office space consisting of approximately 2,333 rentable square feet of space commonly known as Suite 950 (the "Premises") located on the ninth (9^th) floor of that certain office building located at 5300 Memorial Drive, Houston, Texas (the "Building");

 

WHEREAS, Landlord and Tenant desire to amend the Lease to evidence their agreement to (i) extend the Term of the Lease and (ii) make certain other amendments to the Lease, all as more particularly set forth in this First Amendment.

 

NOW THEREFORE, for and in consideration of the mutual promises contained herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Landlord and Tenant hereby agree as follows:

 

AGREEMENTS

 

1.     Recitals. The above recitals are incorporated herein for all purposes.

 

2.   Extension Term. The Term of the Lease expires on February 29, 2024. The term of the Lease is hereby extended for a term (the "Extension Term") commencing on September 1, 2023 (the "Extension Commencement Date") and expiring on August 31, 2029. All references to "Term" in the Lease shall also refer to the Extension Term, except as may be otherwise set forth herein. Tenant shall continue to have the Renewal Option as set forth in Section 53 of the Lease, provided that such renewal term shall commence at the end of the Extension Term as set forth herein and references to the "Term" in Section 53 shall mean and include the initial term of the Lease as extended by the Extension Term herein. The Right of First Refusal as set forth in Extension 54 of the Lease shall remain in effect during the Extension Term in accordance with the terms set forth therein.

 

3.    Base Rent. Tenant shall continue to pay to Landlord monthly Base Rent for the Premises as set forth in the Lease until the Extension Commencement Date. Thereafter, from and after the Extension Commencement Date and during the Extension Term of the Lease, Tenant shall pay to Landlord monthly Base Rent for the Premises as follows:

 

Period	Annual Base Rent PRSF	Monthly Base Rent
9/1/2023 - 2/29/2024*	$24.00	$4,666.00
3/1/2024 - 8/31/2024	$24.00	$4,666.00
9/1/2024 - 8/31/2025	$24.50	$4,763.21
9/1/2025 - 8/31/2026	$25.00	$4,860.42
9/1/2026 - 8/31/2027	$25.50	$4,957.63
9/1/2027 - 8/31/2028	$26.00	$5,054.83
9/1/2028 - 8/31/2029	$26.50	$5,152.04

* So long as Tenant is not in default beyond any applicable cure periods under the terms and conditions of this Lease as of the date any Rent would otherwise be due and owing, Tenant shall be entitled to a full credit of Base Rent and Additional Rent for the period from September 1, 2023 through February 29, 2024 (the "Abatement Period") (for a total estimated credit of $44,781.94). Said credit shall be used solely to offset Base Rent and Additional Rent during the Abatement Period and in no circumstances shall Tenant be paid any amounts pursuant thereto. Tenant shall continue to be responsible for the payment of all of its other monetary obligations under this Lease during the Abatement Period. In the event Tenant is in default (after any applicable grace or cure periods) under the terms and conditions of this Lease on the day any installment of Rent would have been due hereunder but for the aforesaid abatement of Base Rent and Additional Rent during the Abatement Period, then, in such event, the rent abatements as set forth above, shall no longer be in effect and Tenant shall be obligated, during the period of such uncured default, to pay the full installments of Base Rent in the amount set forth in the above Base Rent Schedule and Additional Rent. In the event of a default by Tenant under the terms of this Lease that results in early termination of this Lease, Landlord shall be entitled to the recovery of the full Base Rent and Additional Rent abated hereunder. In no event shall Tenant be entitled to any extension of any Abatement Period because of any payment of Base Rent or Additional Rent made due to defaults.

 

 

4.     Additional Rent. Tenant shall continue to pay its Pro-rata Share of Operating Expenses and Taxes for the Premises as set forth in the Lease. The Operating Expenses cap on Controllable Operating Expenses as set forth in Section 7(c) of the Lease shall continue to apply during the Extension Term.

 

5.    Leasehold Improvements. Landlord shall have no obligation to make any improvements or alterations to the Premises and Tenant accepts the Premises on an "AS-IS", "WITH ALL FAULTS" condition, and "WITHOUT WARRANTY, EXPRESS OR IMPLIED" during the Extension Term, except that Landlord shall, at Landlord's expense, (i) repair the water line from the dishwasher by installing a filter for the water line and a replaceable filter for the dishwasher to serve both hot and cold water, (ii) install a new like kind stainless steel dishwasher within the Premises, (iii) repair the lock to the sliding patio door, (iv) replace the broken mini blinds, and (v) install vertical blinds on sliding glass door (collectively, the "TI Work"). Landlord shall use commercially reasonable efforts to substantially complete the TI Work within one hundred twenty (120) days following the Effective Date of this First Amendment (the "Target Date"). Tenant shall cooperate with Landlord in allowing Landlord to complete the TI Work and by keeping the area clear of clutter so that the work may be performed.

 

6.    Parking. Section l(o) of the Lease shall be modified to provide that reserved parking charges for two (2) reserved spaces will be abated for the Extension Term of the Lease.

 

7.    Brokerage. Landlord and Tenant each warrant to the other that is has not dealt with any broker, finder or similar agent in connection with this transaction except for ICO Commercial, representing Tenant ("Tenant's Broker") and Jones Lang LaSalle Brokerage, Inc, representing Landlord ("Landlord's Broker"; together with Tenant's Broker, the "Brokers"). Landlord agrees to pay the Brokers a commission pursuant to the terms of a separate agreement between Landlord and Brokers. Tenant and Landlord shall each indemnify the other against all costs, expenses, attorneys' fees, and other liability for commissions or other compensation claimed by any broker or agent claiming the same by, through, or under the indemnifying party, except the Brokers.

 

8.     Estoppel. Tenant represents and warrants that, as of the Effective Date of this First Amendment, Landlord is not in default under the Lease and no events have occurred which, with the giving of notice or the passage of time, would become a default by Landlord under the Lease. Tenant acknowledges that Landlord is relying on the foregoing representation in entering into this First Amendment.

 

9.     Miscellaneous.

 

a.    It is mutually agreed that all covenants, conditions and agreements set forth in the Lease (as hereby amended) shall remain binding upon the parties and inure to the benefit of the parties hereto and their respective successors and assigns.

 

b.    Except as modified hereby, all other terms and conditions of the Lease shall remain unchanged and in full force and effect and are hereby ratified and confirmed by the parties hereto. Any inconsistencies or conflicts between the terms and provisions of the Lease and the terms and provisions of this First Amendment shall be resolved in favor of the terms and provisions of this First Amendment.

 

c.    Except as otherwise expressly provided herein, all defined terms shall have the meanings ascribed to them in the Lease.

 

d.    This First Amendment shall not be modified except in writing and signed by both parties hereto.

 

e.    This First Amendment may be executed in two or more counterparts, each of which will be deemed an original, which together will constitute one in the same agreement.

 

f.    This First Amendment shall be governed and construed in accordance with the laws of the State of Texas.

 

[SIGNATURE PAGE(S) TO FOLLOW]

 

 

[SIGNATURE PAGE FOR FIRST AMENDMENT TO COMMERCIAL LEASE AGREEMENT]

 

 

 

IN WITNESS WHEREOF, the parties have executed this First Amendment to be effective as of the date first set forth above.

 

 

 

LANDLORD:   IPX MEMORIAL DRIVE INVESTORS, LLC, a Delaware limited liability company   By: /s/ Gregory K. Chapin Name: Gregory K. Chapin Title: Vice President       TENANT:   MOLECULIN BIOTECH, INC., a Delaware corporation   By: /s/ Jonathan P. Foster 09/01/23 Name: Jonathan P. Foster, CPA, CGMA Title: EVP and CFO

 

 

 

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 13, 2023

 

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 13, 2023

 

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, 2023 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 13, 2023

  

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, 2023 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 13, 2023

  

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.

 

v3.23.3

Document And Entity Information - shares	9 Months Ended
	Sep. 30, 2023	Nov. 01, 2023
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	2023
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2023
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		29,810,443

v3.23.3

Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 24,579	$ 43,145
Prepaid expenses and other current assets	3,024	2,451
Total current assets	27,603	45,596
Furniture and equipment, net	225	275
Intangible assets	11,148	11,148
Operating lease right-of-use asset	547	403
Total assets	39,523	57,422
Current liabilities:
Accounts payable	2,008	2,095
Accrued expenses and other current liabilities	1,880	2,724
Total current liabilities	3,888	4,819
Operating lease liability - long-term, net of current portion	496	335
Warrant liability - long-term	1	77
Total liabilities	4,385	5,231
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; 29,810,443 and 28,627,827 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively	30	29
Additional paid-in capital	156,446	153,985
Accumulated other comprehensive income (loss)	(3)	12
Accumulated deficit	(121,335)	(101,835)
Total stockholders’ equity	35,138	52,191
Total liabilities and stockholders’ equity	$ 39,523	$ 57,422

v3.23.3

Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares	Sep. 30, 2023	Dec. 31, 2022
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)	29,810,443	28,627,827
Common stock, shares outstanding (in shares)	29,810,443	28,627,827

v3.23.3

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Revenues	$ 0	$ 0	$ 0	$ 0
Operating expenses:
Research and development	3,280	5,965	12,855	14,790
General and administrative	2,635	3,087	7,765	8,704
Depreciation and amortization	32	32	92	98
Total operating expenses	5,947	9,084	20,712	23,592
Loss from operations	(5,947)	(9,084)	(20,712)	(23,592)
Other income:
Gain from change in fair value of warrant liability	1	421	76	1,184
Other income, net	13	19	30	39
Interest income, net	324	33	1,106	114
Net loss	$ (5,609)	$ (8,611)	$ (19,500)	$ (22,255)
Net loss per common share - basic and diluted (in dollars per share)	$ (0.19)	$ (0.3)	$ (0.66)	$ (0.78)
Weighted average common shares outstanding, basic and diluted (in shares)	29,809,236	28,627,610	29,419,904	28,596,501
Net loss	$ (5,609)	$ (8,611)	$ (19,500)	$ (22,255)
Other comprehensive loss:
Foreign currency translation	(10)	(19)	(15)	(38)
Comprehensive loss	$ (5,619)	$ (8,630)	$ (19,515)	$ (22,293)

v3.23.3

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Cash flows from operating activities:
Net loss	$ (5,609)	$ (8,611)	$ (19,500)	$ (22,255)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	32	32	92	98
Stock-based compensation			1,505	1,740
License rights expense settled in stock			772	0
Change in fair value of warrant liability	(1)	(421)	(76)	(1,184)
Operating lease, net			105	96
Changes in operating assets and liabilities:
Prepaid expenses and other current assets			(573)	(1,507)
Accounts payable			(87)	2,204
Accrued expenses and other current liabilities			(932)	425
Net cash used in operating activities			(18,694)	(20,383)
Cash flows from investing activities:
Purchase of fixed assets			(43)	(67)
Net cash used in investing activities			(43)	(67)
Cash flows from financing activities:
Payment of tax liability for vested restricted stock units			(25)	(23)
Proceeds from sale of common stock, net of issuance costs			211	0
Net cash provided by (used in) provided by financing activities			186	(23)
Effect of exchange rate changes on cash and cash equivalents			(15)	(38)
Net decrease in cash and cash equivalents			(18,566)	(20,511)
Cash and cash equivalents, - beginning of period			43,145	70,903
Cash and cash equivalents, - end of period	$ 24,579	$ 50,392	$ 24,579	$ 50,392

v3.23.3

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, 2021	28,578,338
Balance at Dec. 31, 2021	$ 29	$ 151,733	$ (72,810)	$ 41	$ 78,993
Stock-based compensation	0	527	0	0	527
Net loss	0	0	(6,867)	0	(6,867)
Cumulative translation adjustment	0	0	0	12	12
Balance at Mar. 31, 2022	$ 29	152,260	(79,677)	53	72,665
Balance (in shares) at Mar. 31, 2022	28,578,338
Balance (in shares) at Dec. 31, 2021	28,578,338
Balance at Dec. 31, 2021	$ 29	151,733	(72,810)	41	78,993
Net loss					(22,255)
Cumulative translation adjustment					(38)
Balance at Sep. 30, 2022	$ 29	153,450	(95,065)	3	58,417
Balance (in shares) at Sep. 30, 2022	28,627,827
Balance (in shares) at Mar. 31, 2022	28,578,338
Balance at Mar. 31, 2022	$ 29	152,260	(79,677)	53	72,665
Stock-based compensation	0	514	0	0	514
Net loss	0	0	(6,777)	0	(6,777)
Cumulative translation adjustment	$ 0	0	0	(31)	(31)
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability) (in shares)	28,368
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability)	$ 0	(12)	0	0	(12)
Balance at Jun. 30, 2022	$ 29	152,762	(86,454)	22	66,359
Balance (in shares) at Jun. 30, 2022	28,606,706
Stock-based compensation	$ 0	699	0	0	699
Net loss	0	0	(8,611)	0	(8,611)
Cumulative translation adjustment	$ 0	0	0	(19)	(19)
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability) (in shares)	21,121
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability)	$ 0	(11)	0	0	(11)
Balance at Sep. 30, 2022	$ 29	153,450	(95,065)	3	58,417
Balance (in shares) at Sep. 30, 2022	28,627,827
Balance (in shares) at Dec. 31, 2022	28,627,827
Balance at Dec. 31, 2022	$ 29	153,985	(101,835)	12	52,191
Issuance of common stock with equity purchase agreement (in shares)	150,381
Issuance of common stock with equity purchase agreement	$ 0	141	0	0	141
Common stock issued for license rights (in shares)	822,115
Common stock issued for license rights	$ 1	771	0	0	772
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 at Mar. 31, 2023	$ 30	155,396	(109,750)	8	45,684
Balance (in shares) at Mar. 31, 2023	29,600,323
Balance (in shares) at Dec. 31, 2022	28,627,827
Balance at Dec. 31, 2022	$ 29	153,985	(101,835)	12	52,191
Net loss					(19,500)
Cumulative translation adjustment					$ (15)
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability) (in shares)					134,933
Balance at Sep. 30, 2023	$ 30	156,446	(121,335)	(3)	$ 35,138
Balance (in shares) at Sep. 30, 2023	29,810,443
Balance (in shares) at Mar. 31, 2023	29,600,323
Balance at Mar. 31, 2023	$ 30	155,396	(109,750)	8	45,684
Issuance of common stock with equity purchase agreement (in shares)	75,187
Issuance of common stock with equity purchase agreement	$ 0	69	0	0	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)	113,812
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability)	$ 0	(21)	0	0	(21)
Balance at Jun. 30, 2023	$ 30	155,957	(115,726)	7	40,268
Balance (in shares) at Jun. 30, 2023	29,789,322
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)	21,121
Common stock issued upon vesting of restricted stock units (net of shares withheld for payment of tax liability)	$ 0	(4)	0	0	(4)
Balance at Sep. 30, 2023	$ 30	$ 156,446	$ (121,335)	$ (3)	$ 35,138
Balance (in shares) at Sep. 30, 2023	29,810,443

v3.23.3

Note 1 - Nature of Business	9 Months Ended
	Sep. 30, 2023
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 Phase 2 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 The University of Texas System on behalf of the MD Anderson Cancer Center (MD Anderson) in Houston, Texas. 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 out-licensing or outsourcing opportunities with development/commercialization strategic partners who are better suited for the marketing, sales and distribution of its drugs, if approved.   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) (the "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. In addition, the Company was required to notify Nasdaq of its intent to cure the minimum bid price deficiency, which  may include, if necessary, implementing a reverse stock split.    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. The Company will continue to monitor the closing bid price of its common stock and plans to pursue available options to regain compliance with the Bid Price Rule, including potentially the Company’s Board of Directors authorizing a reverse stock split, as discussed further below. If the Company authorizes a reverse stock split, it will plan to effectuate the split no later than ten business days prior to the end of the extension in order to timely regain compliance. If, at any time before April 29, 2024, the bid price for the Company's common stock closes at $1.00 or more for a minimum of 10 consecutive business days, the Nasdaq Staff will provide written notification to the Company that it complies with the Bid Price Rule, unless the Staff exercises its discretion to extend this 10 day period pursuant to Nasdaq Listing Rule 5810(c)(3)(G).   On October 3, 2023, the Company held a Special Meeting of Stockholders (the "Special Meeting"). The Company's stockholders granted the Board of Directors the authority to effect an amendment to the Company’s amended and restated certificate of incorporation to effect a reverse stock split of the outstanding shares of the Company’s common stock, at a reverse stock split ratio of between 1-for-5 and 1-for-20 as determined by the Board in its sole discretion, prior to the one-year anniversary of the Special Meeting. The Board of Directors has taken no action with regard to this matter.   If the Company does not regain compliance with the Bid Price Rule by April 29, 2024, the Nasdaq Staff will provide written notification to the Company that its common stock  may be delisted. The Company would then be entitled to appeal the Nasdaq Staff’s determination to a NASDAQ Listing Qualifications Panel and request a hearing. There can be no assurance that, if the Company does appeal a delisting determination by the Nasdaq Staff to the NASDAQ Listing Qualifications Panel, that such appeal would be successful. There can be no assurance that the Company will be able to regain compliance with the Bid Price Rule.

v3.23.3

Note 2 - Basis of Presentation, Principles of Consolidation, Significant Accounting Policies and Liquidity	9 Months Ended
	Sep. 30, 2023
Notes to Financial Statements
Significant Accounting Policies [Text Block]	2. Basis of presentation, principles of consolidation, and significant accounting policies and liquidity    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, 2022 and for the year then ended, including the notes thereto contained in the Form 10-K filed with the SEC on March 22, 2023.   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, 2022. There have been no material changes to the significant accounting policies during the nine months ended September 30, 2023.   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.    Going Concern - 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, 2023, the Company had an accumulated deficit of $121.3 million since inception and had not yet generated any revenues from operations. Additionally, management anticipates that its cash on hand of $24.6 million as of September 30, 2023 is sufficient to fund its planned operations into but not beyond the near term. 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  may seek additional funding 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. Management cannot be certain 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 $0.4 million and $1.1 million in related general and administrative fees and expenses for the three months ended  September 30, 2023 and 2022, respectively, and $1.4 million and $1.9 million for the nine months ended September 30, 2023 and 2022, 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. 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.    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 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, 2023 and December 31, 2022 (table in thousands):    Description   Fair Value     Level 1     Level 2     Level 3   Fair value of warrant liability as of September 30, 2023:   $ 1     $ —     $ —     $ 1   Fair value of warrant liability as of December 31, 2022:   $ 77     $ —     $ —     $ 77     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, 2023   Warrant Liability Long-Term   Balance, June 30, 2023   $ 2   Change in fair value - net     (1 ) Balance, September 30, 2023   $ 1     The table below of Level 3 liabilities (table in thousands) begins with the valuation as of  December 31, 2022 and then is adjusted for changes in fair value that occurred during the nine months ended September 30, 2023. 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, 2023   Warrant Liability Long-Term   Balance, December 31, 2022   $ 77   Change in fair value - net     (76 ) Balance, September 30, 2023   $ 1     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, 2023 and 2022, approximately 8.5 million and 6.0 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, 2023 and 2022, approximately 7.0 million and 5.2 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. See Note 8 - Subsequent Events.    Recent Accounting Pronouncements - There are no recently issued accounting standards updates that are currently expected to have a material impact on the Company.

v3.23.3

Note 3 - Accrued Expenses and Other Current Liabilities	9 Months Ended
	Sep. 30, 2023
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, 2023     December 31, 2022   Accrued research and development   $ 735     $ 1,337   Accrued legal, regulatory, professional and other     549       437   Accrued payroll and bonuses     443       748   Operating lease liability - current     88       116   Accrued liabilities due to related party     65       86   Total accrued expenses and other current liabilities   $ 1,880     $ 2,724     Additionally, accounts payable includes $64,000 as of September 30, 2023 and December 31, 2022, respectively, for related party payables.

v3.23.3

Note 4 - Warrants	9 Months Ended
	Sep. 30, 2023
Notes to Financial Statements
Warrants Disclosure [Text Block]	4. Warrants   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.    The assumptions used in determining the fair value of the Company's outstanding liability classified warrants are as follows:       September 30, 2023     December 31, 2022   Risk-free interest rate   5.1% to 5.6%     4.2% to 4.8%   Volatility   69.1% to 89.8%     63.1% to 76.3%   Expected life (years)   0.2 to 1.9     0.1 to 2.6   Dividend yield   —%     —%     A summary of the Company's liability classified warrant activity during the nine months ended September 30, 2023 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, 2023     2,656,296     $ 6.30     $ 16.80     $ 9.49       1.7   Expired warrants     (384,415 )   $ 13.92     $ 16.80     $ 16.22       —   Balance at September 30, 2023     2,271,881     $ 6.30     $ 12.12     $ 8.26       1.1   Exercisable at September 30, 2023     2,271,881     $ 6.30     $ 12.12     $ 8.26       1.1     For a summary of the changes in fair value associated with the Company's warrant liability for the nine months ended September 30, 2023, see Note 2 - Basis of presentation, principles of consolidation and significant accounting policies - Fair Value of Financial Instruments.   Equity Classified Warrants   In August 2023, the Company granted equity-classified warrants to purchase up to 100,000 shares of Company common stock with a five-year term and an exercise price of $0.62. The warrants vest based on performance of certain services. As of September 30, 2023, no related vesting criteria were met.   In June 2023, the Company granted equity-classified warrants to purchase 150,000 shares of common stock with a ten-year term and an exercise price of $0.60 vesting annually over four years while services are being performed.    At September 30, 2023, the Company had 896,501 equity classified warrants outstanding and 424,084 warrants were exercisable. At  December 31, 2022, the Company had 646,501 equity classified warrants outstanding and 400,859 warrants were exercisable.   The Company recorded stock compensation expense for the non-employee consulting agreements of $50,000 and $232,000 for the three months ended  September 30, 2023 and 2022, respectively, and $142,000 and $398,000 for the nine months ended September 30, 2023 and 2022, respectively. At  September 30, 2023, there was $446,000 of unrecognized stock compensation expense related to the Company's equity classified warrants.

v3.23.3

Note 5 - Equity	9 Months Ended
	Sep. 30, 2023
Notes to Financial Statements
Equity [Text Block]	5. Equity    Lincoln Park Equity Line   During the nine months ended September 30, 2023, pursuant to the 2021 Lincoln Park purchase agreement, the Company issued to Lincoln Park 225,568 shares of common stock for gross proceeds of $0.2 million. The 2021 Lincoln Park Agreement, which has $19.8 million available as of September 30, 2023, terminates in June 2024.   Other Components of Equity    In March 2023, the Company and WPD Pharmaceuticals (WPD) agreed to terminate the WPD Agreement (defined below). Pursuant to the termination, the Company agreed to pay WPD (or its designees) $700,000 in cash and shares of its common stock valued at $800,000. In  March 2023, the Company issued 822,115 shares of common stock to WPD (or its designee) as part of satisfying this commitment. See Note 7 - Commitments and Contingencies. In addition, during the nine months ended September 30, 2023, the Company issued 134,933 shares of common stock related to the vesting of restricted stock units.   Stock-Based Compensation and Outstanding Awards   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 1,750,000 shares and 2,000,000 shares, respectively, such that 5,500,000 total shares may be issued under the Plan. As of September 30, 2023, there were 27,752 shares remaining to be issued under the 2015 Stock Plan.    Stock-based compensation expense for the three and nine months ended September 30, 2023 and 2022, respectively, is as follows (table in thousands):        Three Months Ended September 30,     Nine Months Ended September 30,       2023     2022     2023     2022   General and administrative   $ 346     $ 378     $ 1,094     $ 1,089   Research and development     147       321       411       651   Total stock-based compensation expense   $ 493     $ 699     $ 1,505     $ 1,740     During the nine months ended September 30, 2023, the Company granted 1,496,000 stock options with a weighted average fair value of $0.49 per share and 979,376 shares of restricted stock units with a weighted average fair value of $0.60 per share. These stock options have a weighted average exercise price of $0.60 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.

v3.23.3

Note 6 - Income Taxes	9 Months Ended
	Sep. 30, 2023
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 2023 as a result of the losses recorded during the three and nine months ended September 30, 2023 and the additional losses expected for the remainder of 2023 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, 2023 and  December 31, 2022 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, 2023 and 2022, respectively. The effective tax rate for the nine months ended September 30, 2023 and 2022 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.

v3.23.3

Note 7 - Commitments and Contingencies	9 Months Ended
	Sep. 30, 2023
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, 2023.   Lease Obligations Payable   The following summarizes quantitative information about the Company's operating leases for the three and nine months ended September 30, 2023 and 2022, respectively (table in thousands):       Three Months Ended September 30,     Nine Months Ended September 30,       2023     2022     2023     2022   Lease cost:                                 Operating lease cost   $ 34     $ 33     $ 99     $ 91   Variable lease cost     5       7       19       22   Total   $ 39     $ 40     $ 118     $ 113     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, 2023 and 2022, respectively, and $37,000 and $32,000 for the nine months ended September 30, 2023 and 2022, respectively. 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 $34,000 and $21,000 for the three months ended  September 30, 2023 and 2022, respectively, and $109,000 and $91,000 for the nine months ended September 30, 2023 and 2022, respectively.   Licenses    MD Anderson - Total expenses related to the Company's license agreements with MD Anderson were $64,000 and $56,000 for the three months ended September 30, 2023 and 2022, respectively, and $193,000 and $189,000 for the nine months ended September 30, 2023 and 2022, 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, 2023 and 2022, respectively, and $176,000 for the nine months ended September 30, 2023 and 2022, respectively.   Sponsored Research Agreements - In October 2023, the Company entered into an amendment to the Sponsored Research Agreement with MD Anderson for total payments of $0.8 million to support the continuation of the project through December 31, 2025. In addition, the Company also has Sponsored Research Agreements with other universities, one in the US and one in Europe. The expenses recognized under the agreements were $221,000 and $315,000 for the three months ended September 30, 2023 and 2022, respectively, and $552,000 and $815,000 for the nine months ended September 30, 2023 and 2022, respectively.   License Terminations    The Company was party to a sublicense agreement with WPD, pursuant to which it sublicensed to WPD certain intellectual property rights, including rights to Annamycin, its WP1122 portfolio, and its WP1066 portfolio (as amended, the “WPD Agreement”). WPD is affiliated with Dr. Waldemar Priebe, the Company's founder. In March 2023, the Company and WPD agreed to terminate the WPD Agreement and agreed to pay WPD (or its designee) $700,000 in cash and shares of its common stock valued at $800,000. In  March 2023, the Company issued 822,115 shares of common stock to WPD's designee as part of satisfying this commitment. With the termination of the WPD Agreement, the Company now has acquired the rights in certain territories previously sub-licensed to WPD to all of its licensed intellectual property, other than the rights related to non-human animals. Additionally, the Company acquired the in-process research and development that WPD has created during the term of the agreement.   In February 2022, the Company and Exploration Invest Pte Ltd. (Exploration) entered into a license termination agreement pursuant to which the Company agreed to pay Exploration $400,000 to terminate certain License Agreements and extend confidentiality requirements until the 10-year anniversary of the license termination agreement. Total expenses, reflected in research and development expenses, related to the Company's license terminations were $1.5 million and $0.4 million for the three and nine months ended September 30, 2023 and 2022, respectively.

v3.23.3

Note 8 - Subsequent Events	9 Months Ended
	Sep. 30, 2023
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, 2023.

v3.23.3

Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 30, 2023
Accounting Policies [Abstract]
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, 2022 and for the year then ended, including the notes thereto contained in the Form 10-K filed with the SEC on March 22, 2023.
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, 2022. There have been no material changes to the significant accounting policies during the nine months ended September 30, 2023.
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.
Going Concern Policy [Policy Text Block]	Going Concern - 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, 2023, the Company had an accumulated deficit of $121.3 million since inception and had not yet generated any revenues from operations. Additionally, management anticipates that its cash on hand of $24.6 million as of September 30, 2023 is sufficient to fund its planned operations into but not beyond the near term. 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  may seek additional funding 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. Management cannot be certain 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 $0.4 million and $1.1 million in related general and administrative fees and expenses for the three months ended  September 30, 2023 and 2022, respectively, and $1.4 million and $1.9 million for the nine months ended September 30, 2023 and 2022, 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. 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.
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 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, 2023 and December 31, 2022 (table in thousands):    Description   Fair Value     Level 1     Level 2     Level 3   Fair value of warrant liability as of September 30, 2023:   $ 1     $ —     $ —     $ 1   Fair value of warrant liability as of December 31, 2022:   $ 77     $ —     $ —     $ 77     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, 2023   Warrant Liability Long-Term   Balance, June 30, 2023   $ 2   Change in fair value - net     (1 ) Balance, September 30, 2023   $ 1     The table below of Level 3 liabilities (table in thousands) begins with the valuation as of  December 31, 2022 and then is adjusted for changes in fair value that occurred during the nine months ended September 30, 2023. 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, 2023   Warrant Liability Long-Term   Balance, December 31, 2022   $ 77   Change in fair value - net     (76 ) Balance, September 30, 2023   $ 1
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, 2023 and 2022, approximately 8.5 million and 6.0 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, 2023 and 2022, approximately 7.0 million and 5.2 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. See Note 8 - Subsequent Events.
New Accounting Pronouncements, Policy [Policy Text Block]	Recent Accounting Pronouncements - There are no recently issued accounting standards updates that are currently expected to have a material impact on the Company.

v3.23.3

Note 2 - Basis of Presentation, Principles of Consolidation, Significant Accounting Policies and Liquidity (Tables)	9 Months Ended
	Sep. 30, 2023
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, 2023:   $ 1     $ —     $ —     $ 1   Fair value of warrant liability as of December 31, 2022:   $ 77     $ —     $ —     $ 77   Three Months Ended September 30, 2023   Warrant Liability Long-Term   Balance, June 30, 2023   $ 2   Change in fair value - net     (1 ) Balance, September 30, 2023   $ 1   Nine Months Ended September 30, 2023   Warrant Liability Long-Term   Balance, December 31, 2022   $ 77   Change in fair value - net     (76 ) Balance, September 30, 2023   $ 1

v3.23.3

Note 3 - Accrued Expenses and Other Current Liabilities (Tables)	9 Months Ended
	Sep. 30, 2023
Notes Tables
Schedule of Accrued Liabilities [Table Text Block]	September 30, 2023     December 31, 2022   Accrued research and development   $ 735     $ 1,337   Accrued legal, regulatory, professional and other     549       437   Accrued payroll and bonuses     443       748   Operating lease liability - current     88       116   Accrued liabilities due to related party     65       86   Total accrued expenses and other current liabilities   $ 1,880     $ 2,724

v3.23.3

Note 4 - Warrants (Tables)	9 Months Ended
	Sep. 30, 2023
Notes Tables
Schedule of Warrants or Rights, Assumptions Used [Table Text Block]	September 30, 2023     December 31, 2022   Risk-free interest rate   5.1% to 5.6%     4.2% to 4.8%   Volatility   69.1% to 89.8%     63.1% to 76.3%   Expected life (years)   0.2 to 1.9     0.1 to 2.6   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, 2023     2,656,296     $ 6.30     $ 16.80     $ 9.49       1.7   Expired warrants     (384,415 )   $ 13.92     $ 16.80     $ 16.22       —   Balance at September 30, 2023     2,271,881     $ 6.30     $ 12.12     $ 8.26       1.1   Exercisable at September 30, 2023     2,271,881     $ 6.30     $ 12.12     $ 8.26       1.1

v3.23.3

Note 5 - Equity (Tables)	9 Months Ended
	Sep. 30, 2023
Notes Tables
Share-based Payment Arrangement, Expensed, Amount [Table Text Block]	Three Months Ended September 30,     Nine Months Ended September 30,       2023     2022     2023     2022   General and administrative   $ 346     $ 378     $ 1,094     $ 1,089   Research and development     147       321       411       651   Total stock-based compensation expense   $ 493     $ 699     $ 1,505     $ 1,740

v3.23.3

Note 7 - Commitments and Contingencies (Tables)	9 Months Ended
	Sep. 30, 2023
Notes Tables
Lease, Cost [Table Text Block]	Three Months Ended September 30,     Nine Months Ended September 30,       2023     2022     2023     2022   Lease cost:                                 Operating lease cost   $ 34     $ 33     $ 99     $ 91   Variable lease cost     5       7       19       22   Total   $ 39     $ 40     $ 118     $ 113

v3.23.3

Note 1 - Nature of Business (Details Textual)	Oct. 03, 2023	May 05, 2023 $ / shares	Jun. 30, 2023
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
Subsequent Event [Member] | Reverse Stock Split [Member] | Minimum [Member]
Stockholders' Equity Note, Stock Split, Conversion Ratio	5
Subsequent Event [Member] | Reverse Stock Split [Member] | Maximum [Member]
Stockholders' Equity Note, Stock Split, Conversion Ratio	20

v3.23.3

Note 2 - Basis of Presentation, Principles of Consolidation, Significant Accounting Policies and Liquidity (Details Textual) $ in Thousands, shares in Millions	3 Months Ended		9 Months Ended
	Sep. 30, 2023 USD ($) shares	Sep. 30, 2022 USD ($) shares	Sep. 30, 2023 USD ($) shares	Sep. 30, 2022 USD ($) shares	Dec. 31, 2022 USD ($)
Number of Operating Segments			1
Retained Earnings (Accumulated Deficit)	$ (121,335)		$ (121,335)		$ (101,835)
Cash and Cash Equivalents, at Carrying Value	$ 24,579		$ 24,579		$ 43,145
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in shares) | shares	8.5	6.0	7.0	5.2
General and Administrative Expense [Member]
Legal Fees	$ 400	$ 1,100	$ 1,400	$ 1,900

v3.23.3

Note 2 - Basis of Presentation, Principles of Consolidation, 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, 2023	Sep. 30, 2023	Dec. 31, 2022
Warrant Liability Long Term [Member]
Balance	$ 2	$ 77
Change in fair value - net	(1)	(76)
Balance	1	1
Fair Value, Recurring [Member] | Warrant Liability [Member]
Fair value of warrant liability	1	1	$ 77
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	$ 1	$ 1	$ 77

v3.23.3

Note 3 - Accrued Expenses and Other Current Liabilities (Details Textual) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Accounts Payable, Current	$ 2,008,000	$ 2,095,000
Related Party [Member]
Accounts Payable, Current	$ 64,000	$ 64,000

v3.23.3

Note 3 - Accrued Expenses and Other Current Liabilities - Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Accrued research and development	$ 735	$ 1,337
Accrued legal, regulatory, professional and other	549	437
Accrued payroll and bonuses	443	748
Operating lease liability - current	88	116
Total accrued expenses and other current liabilities	1,880	2,724
Related Party [Member]
Total accrued expenses and other current liabilities	$ 65	$ 86

v3.23.3

Note 4 - Warrants (Details Textual) - USD ($)	1 Months Ended	3 Months Ended		9 Months Ended
	Jun. 30, 2023	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Aug. 31, 2023	Dec. 31, 2022
Share-Based Payment Arrangement, Expense		$ 493,000	$ 699,000	$ 1,505,000	$ 1,740,000
Equity Classified Warrants [Member]
Class of Warrant or Right, Number of Securities Called by Warrants or Rights (in shares)	150,000					100,000
Warrants and Rights Outstanding, Term (Year)	10 years					5 years
Class of Warrant or Right, Exercise Price of Warrants or Rights (in dollars per share)	$ 0.6					$ 0.62
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year)	4 years
Class of Warrant or Right, Outstanding (in shares)		896,501		896,501			646,501
Class of Warrant or Right, Vested and Exercisable (in shares)		424,084		424,084			400,859
Share-Based Payment Arrangement, Expense		$ 50,000	$ 232,000	$ 142,000	$ 398,000
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount		$ 446,000		$ 446,000

v3.23.3

Note 4 - Warrants - Assumptions Used (Details)	Sep. 30, 2023	Dec. 31, 2022
Minimum [Member] | Measurement Input, Risk Free Interest Rate [Member]
Warrants, assumptions	0.051	0.042
Minimum [Member] | Measurement Input, Price Volatility [Member]
Warrants, assumptions	0.691	0.631
Minimum [Member] | Measurement Input, Expected Term [Member]
Warrants, assumptions	0.2	0.1
Maximum [Member] | Measurement Input, Risk Free Interest Rate [Member]
Warrants, assumptions	0.056	0.048
Maximum [Member] | Measurement Input, Price Volatility [Member]
Warrants, assumptions	0.898	0.763
Maximum [Member] | Measurement Input, Expected Term [Member]
Warrants, assumptions	1.9	2.6

v3.23.3

Note 4 - Warrants - Warrant Activity (Details) - Liability Classified Warrants [Member] - $ / shares	9 Months Ended	12 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Balance (in shares)	2,656,296
Balance, weighted average remaining contractual life (Year)	1 year 1 month 6 days	1 year 8 months 12 days
Expired warrants (in shares)	(384,415)
Balance (in shares)	2,271,881	2,656,296
Exercisable (in shares)	2,271,881
Exercisable, weighted average remaining contractual life (Year)	1 year 1 month 6 days
Minimum [Member]
Balance, warrant exercise price (in dollars per share)	$ 6.3
Expired warrants (in dollars per share)	13.92
Balance, warrant exercise price (in dollars per share)	6.3	$ 6.3
Exercisable, warrant exercise price (in dollars per share)	6.3
Maximum [Member]
Balance, warrant exercise price (in dollars per share)	16.8
Expired warrants (in dollars per share)	16.8
Balance, warrant exercise price (in dollars per share)	12.12	16.8
Exercisable, warrant exercise price (in dollars per share)	12.12
Weighted Average [Member]
Balance, warrant exercise price (in dollars per share)	9.49
Expired warrants (in dollars per share)	16.22
Balance, warrant exercise price (in dollars per share)	8.26	$ 9.49
Exercisable, warrant exercise price (in dollars per share)	$ 8.26

v3.23.3

Note 5 - Equity (Details Textual)	1 Months Ended			3 Months Ended		9 Months Ended
	May 31, 2023 shares	Mar. 31, 2023 USD ($) shares	May 31, 2022 shares	Jun. 30, 2023 USD ($)	Mar. 31, 2023 USD ($) shares	Sep. 30, 2023 USD ($) $ / shares shares	Sep. 30, 2022 USD ($)
Proceeds from Issuance of Common Stock | $						$ 211,000	$ 0
Stock Issued During Period, Value, New Issues | $				$ 69,000	$ 141,000
Stock Issued During Period, Shares, Restricted Stock Award, Net of Forfeitures (in shares)						134,933
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Gross (in shares)						1,496,000
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares						$ 0.49
Share-Based Compensation Arrangements by Share-Based Payment Award, Options, Grants in Period, Weighted Average Exercise Price (in dollars per share) | $ / shares						$ 0.6
Maximum [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year)						4 years
Restricted Stock Units (RSUs) [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period (in shares)						979,376
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) | $ / shares						$ 0.6
Share Based Compensation Arrangement by Share Based Payment Award, Number of Installment Periods						4
The 2015 Stock Plan [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Additional Shares Authorized (in shares)	1,750,000		2,000,000
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Authorized (in shares)						5,500,000
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant (in shares)						27,752
WPD Pharmaceuticals [Member] | License Termination [Member]
Stock Issued During Period, Shares, New Issues (in shares)		822,115			822,115
Payment, Related to Termination Clause | $					$ 700,000
Stock Issued During Period, Value, New Issues | $		$ 800,000			$ 800,000
Lincoln Park Transaction [Member]
Stock Issued During Period, Shares, New Issues (in shares)						225,568
Proceeds from Issuance of Common Stock | $						$ 200,000
Purchase Agreement, Common Stock, Available Amount | $						$ 19,800,000

v3.23.3

Note 5 - Equity - Stock based Compensation (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Share-Based Payment Arrangement, Expense	$ 493	$ 699	$ 1,505	$ 1,740
General and Administrative Expense [Member]
Share-Based Payment Arrangement, Expense	346	378	1,094	1,089
Research and Development Expense [Member]
Share-Based Payment Arrangement, Expense	$ 147	$ 321	$ 411	$ 651

v3.23.3

Note 6 - Income Taxes (Details Textual) - USD ($) Pure in Thousands, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Income Tax Expense (Benefit)	$ 0	$ 0	$ 0
Effective Income Tax Rate Reconciliation, Percent			0.00%	0.00%

v3.23.3

Note 7 - Commitments and Contingencies (Details Textual) - USD ($)	1 Months Ended				3 Months Ended				9 Months Ended
	Oct. 30, 2023	Sep. 30, 2023	Mar. 31, 2023	Feb. 28, 2022	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
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	$ 32,000
Operating Lease, Payments					34,000			21,000	109,000	91,000
License Agreements Expense					221,000			315,000	552,000	815,000
Stock Issued During Period, Value, New Issues						$ 69,000	$ 141,000
Houston Pharmaceuticals, Inc [Member]
Related Party Transaction, Amounts of Transaction					59,000			59,000	176,000	176,000
MD Anderson [Member]
License Agreements Expense					64,000			56,000	193,000	189,000
MD Anderson [Member] | Subsequent Event [Member]
Payments For Research And Development Agreement	$ 800,000
WPD Pharmaceuticals [Member] | License Termination [Member]
Payments for Termination of Commitment			$ 700,000
Stock Issued During Period, Value, New Issues			$ 800,000				$ 800,000
Stock Issued During Period, Shares, New Issues (in shares)			822,115				822,115
Exploration Invest Pte Ltd. (Exploration) [Member]
Payments for Termination of Commitment				$ 400,000
License Terminations Expense					$ 1,500,000			$ 400,000	$ 1,500,000	$ 400,000

v3.23.3

Note 7 - Commitments and Contingencies - Lease Cost (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Operating lease cost	$ 34	$ 33	$ 99	$ 91
Variable lease cost	5	7	19	22
Total	$ 39	$ 40	$ 118	$ 113

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