ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion should be read in conjunction with the Financial Statements and Notes thereto included in this Form 10-K. The forward-looking statements included in this discussion and elsewhere in this Form 10-K involve risks and uncertainties, including those set forth under “Cautionary Statement About Forward-Looking Statements.” Actual results and experience could differ materially from the anticipated results and other expectations expressed in our forward-looking statements as a result of a number of factors, including but not limited to those discussed in this Item and in Item 1A - “Risk Factors.”

Our Business Summary

We are a late-stage pharmaceutical development company currently evaluating Annamycin, also known as L-Annamycin and by its generic name “naxtarubicin”, which we believe is a “next-generation” anthracycline and, with it, are conducting a pivotal Phase 3 trial in combination with cytarabine for the treatment of subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML). We call this the “MIRACLE” trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation). A blinded preliminary data readout has already been released for the MIRACLE trial, and we expect to have an interim unblinding of data in mid-2026 and an additional unblinding in the second half of 2026, thereby concluding Part A of the two-part trial. We believe such early visibility for a pivotal registration-enabling trial is unique in that stakeholders will receive preliminary safety and efficacy data long before the conclusion of the trial.

We have two additional portfolios of technologies for hard-to-treat cancers and viruses with clinical and preclinical research funded by investigators at academic institutions. One of these portfolios has an ongoing investigator-initiated trial, another one planned and additional active preclinical testing. Since our inception, drug candidates from each of the three core portfolios are in active planning for, have approval to begin, are currently in or have successfully completed eighteen clinical trials.

Each of our three core technologies is based substantially on discoveries made at, made in conjunction with, and/or licensed from the University of Texas MD Anderson Cancer Center (MD Anderson) in Houston, Texas. For each of the core technologies, one or more drug candidates have successfully completed a Phase 1 or greater clinical trial. Three of our drug candidates have shown human activity in clinical trials and are currently or have been in Phase 1B/2, Phase 2, Phase 2B/3 clinical trials. One of those drug candidates is Annamycin, which is currently in the MIRACLE trial.

We believe Annamycin is the first of its kind DNA binding agent, a “next-generation” anthracycline. Whereas first- and second-generation anthracyclines are currently used to treat approximately half of all cancers, they carry with them the burden of dangerous cardiotoxicity and efficacy limitations associated with multidrug resistance mechanisms and poor tissue/organ distribution. Later generation anthracyclines are comprised mainly of attempts to reduce cardiotoxicity or enhance anticancer activity but we believe have failed to deliver the necessary safety and efficacy profiles to win approval or gain market acceptance. Annamycin is an entirely new chemical entity integrating a new molecular structure intended to enhance its ability to selectively kill cancer cells and reduce toxic side effects. Annamycin possesses a unique and innovative multilamellar lipid-based delivery system designed to improve bioavailability and to increase therapeutic window. The result is a next-generation anthracycline that we believe effectively addresses critical problems associated with currently used anthracyclines. It is our lead drug candidate, and we have concluded a Phase 1B/2 clinical trial for treating AML and are now conducting a Phase 3 clinical trial for R/R AML, which we believe will be registration enabling. We have also sponsored two Phase 1B/2 clinical trials of Annamycin for treating Soft Tissue Sarcoma metastasized to the lungs (STS lung metastases, STS lung mets, or Advanced STS), the results of which we believe supports the initiation of a pivotal approval trial in this additional indication.

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We believe that our lead drug candidate Annamycin has:

One of our core management beliefs is that anthracyclines represent one of the most important treatments available for AML and Advanced STS, as well as many other cancers, and we believe Annamycin may, for the first time ever, allow a majority of these patients to benefit from Annamycin’s improved safety and efficacy by allowing increased dosing (and even maintenance dosing), improved tolerability and allowing access for patients who otherwise would not be eligible for an anthracycline (including the elderly and those with impaired cardiac function). We believe that such benefits will be disruptive to the competitive landscape for these markets. This belief, coupled with our limited resources, leads us to currently focus mainly on the development of Annamycin. We seek to advance our other drug candidates via investigator led studies, both clinically and preclinically, and as available resources will allow.

Core Technologies and Focus

Our core technologies consist of the following programs:

a) Annamycin is what we believe to be a “next-generation” anthracycline (one of the most widely used classes of chemotherapy), designed to be different than currently approved anthracyclines, which are limited in utility because of cardiotoxicity risks, tolerability, their susceptibility to multidrug resistance mechanisms and a lack of efficacy in certain tumor models.

b) Our WP1066 Portfolio includes WP1066, WP1193 and WP1220, three of several Immune/Transcription Modulators in the portfolio designed to inhibit p-STAT3 (phosphorylated signal transducer and activator of transcription) among other transcription factors associated with tumor activity. These also stimulate a natural immune response to tumors by inhibiting the errant activity of Regulatory T-Cells (TRegs).

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

Our Current Clinical Trial Focus

We are focused on Annamycin and WP1066 program’s internally and externally funded (“internally” and “externally” funded trials are defined in the Funding Strategy section below) development of our core technologies as follows:

1. Annamycin:

We have established a Recommended Phase 2 Dose for WP1122 to potentially enable future externally funded oncology and virology trials. Beyond this, we support development of our core technologies through sponsored (internally funded) non-clinical research at MD Anderson.

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Moleculin Biotech, Inc.

Results of Operations for the Year Ended December 31, 2025 as Compared to the Year Ended December 31, 2024

The following table is data derived from the Consolidated Statement of Operations (in thousands) and the discussions that follow are in approximate amounts:

Year ended December 31,

Revenue $ — $ —

Operating expenses:

Depreciation and amortization 90 126

Other income:

Gain from change in fair value of warrant liabilities 24,441 —

Loss on issuance of warrant liabilities (30,962 ) —

Transaction costs allocated to warrant liabilities (1,407 ) —

Loss on extinguishment of warrant liabilities (614 ) —

Other (expense) income, net (20 ) 43

Research and Development Expense

Research and development (R&D) expense was $15.9 million and $17.7 million for the years ended December 31, 2025 and 2024, respectively. The decrease in R&D of $1.8 million is primarily attributable to a reduction in sponsored research activities during the current year compared to the prior year.

General and Administrative Expense

General and administrative (G&A) expense was $9.1 million and $8.8 million for the years ended December 31, 2025 and 2024, respectively. The increase in G&A of $0.3 million was primarily attributable to higher regulatory and legal services, as well as increased consulting and investor relations expenses.

Gain from Change in Fair Value of Warrant Liabilities, Loss on Issuance of Warrant Liabilities and Loss on Extinguishment of Warrant Liabilities

During the year ended December 31, 2025, we recognized a non-cash gain of $24.4 million related to the change in fair value of our warrant liabilities, a non-cash loss of $31.0 million associated with the issuance of warrant liabilities in connection with our equity offerings, and a $0.6 million non-cash loss related to the extinguishment of warrant liabilities that were reclassified to equity. Certain of our warrants are classified as liabilities and are remeasured at fair value upon issuance and at each reporting date, as well as upon modification or inducement. Changes in the fair value of these instruments are recognized in the consolidated statements of operations in the period in which they occur. The fair value of these warrant liabilities is estimated using a Monte Carlo simulation model, which incorporates significant assumptions including expected volatility, expected term, risk-free interest rate, and the contractual terms of the warrants, including path-dependent features. Because the valuation is sensitive to changes in our stock price and other inputs, the resulting gains or losses can be significant and may fluctuate materially from period to period. In general, decreases in our stock price during a reporting period result in non-cash gains, while increases in our stock price result in non-cash losses related to the remeasurement of warrant liabilities.

Transaction Costs Allocated to Warrant Liabilities

During the year ended December 31, 2025, we recognized $1.4 million of transaction costs associated with the issuance of Series E and Series F warrant liabilities in June and August 2025, respectively.

Interest Income, Net

Interest income, net decreased by approximately $0.4 million for the year ended December 31, 2025 from the comparable period in 2024 due to a decreasing cash balance during the past year.

Net Loss

Net loss for the year ended December 31, 2025 was $33.6 million, compared to a net loss of $26.0 million for the prior year. The current-year net loss includes a $31.0 million non-cash loss related to the issuance of warrant liabilities, a $24.4 million non-cash gain from the change in the fair value of warrant liabilities, and a $0.6 million non-cash loss on the extinguishment of warrant liabilities that were reclassified to equity.

Liquidity and Capital Resources

As of December 31, 2025, we had cash and cash equivalents of $8.9 million and prepaid expenses and other current assets of $0.8 million. We also had $3.5 million of accounts payable and $3.3 million of accrued expenses and other current liabilities. A significant portion of the accounts payable and accrued expenses were due to work performed in relation to our preclinical activities and our clinical trials. For the years ended December 31, 2025 and 2024, we used approximately $22.7 million and $23.9 million of cash in operating activities, respectively, which represents cash outlays for research and development and general and administrative expenses in such periods. The slightly decreased cash outflows in 2025 was primarily due to timing of payments for sponsored research and other expenses. For the year ended December 31, 2025, there were $27.3 million in net proceeds from financing activities. In 2024, there were $4.6 million in net proceeds from financing activities. Cash used in investing activities for the years ended December 31, 2025 and 2024 was approximately $0 and $13,000, respectively.

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We believe that our cash resources as of December 31, 2025, along with $8.3 million in gross proceeds received via our financing activities in the first quarter of 2026 (see Recent Stock Offerings below) will be sufficient to fund our planned operations into the third quarter of 2026, without the issuance of additional equity for cash. This takes into account cash outlays for preparations for clinical trials beyond the current active trials. The continuation of our Company as a going concern is dependent upon our ability to obtain necessary financing to continue operations and the attainment of profitable operations. We 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 provide assurance that such events or a combination thereof can be achieved.

Recent Stock Offerings

We have historically funded our operations through a combination of at-the-market equity sales, public offerings, and warrant exercises, including warrant exercise inducement transactions, and we expect to continue to rely on these sources of capital to support our operations.

On February 19, 2026, we entered into warrant inducement agreements with certain holders of our existing equity-classified Series E and Series F warrants. Pursuant to these agreements, the holders exercised warrants to purchase an aggregate of 2,122,652 shares of our common stock at an exercise price of $3.90 per share, resulting in gross proceeds of approximately $8.3 million. In consideration for such exercises, we issued new Series H warrants to purchase up to 6,367,956 shares of common stock. The Series H warrants are exercisable upon shareholder approval, have a term of five years from such approval, and an exercise price of $2.3976 per share. The Series H warrants contain customary anti-dilution adjustments and beneficial ownership limitations. We have agreed to file a resale registration statement covering the shares of common stock issuable upon exercise of the Series H warrants on or before March 31, 2026, and to use commercially reasonable efforts to cause such registration statement to be declared effective by April 30, 2026. Due to the completion of this transaction, the exercise price of our outstanding Series E warrants was adjusted to $3.00 per share, the exercise price of our outstanding Series F warrants was adjusted to $2.75 per share, and the exercise price of our outstanding Series G and Series H warrants was adjusted to $2.3976 per share.

On December 23, 2025, we increased the maximum aggregate gross sales price of our common stock that may be offered, issued and sold under our at the market equity offering agreement (the “2025 ATM Agreement”) with Roth Capital Partners, LLC (“Roth”), which we initially entered into in July 2025, from $6.5 million to $8.2 million. Pursuant to the terms of the 2025 ATM Agreement, we may offer and sell shares of our common stock having an aggregate offering price of up to $8.2 million from time to time through or to Roth, acting as sales agent or principal. Roth may sell shares of our common stock in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices. We pay Roth a commission equal to 3.0% of the gross proceeds from any shares of common stock sold under the 2025 ATM Agreement. During the fourth quarter of 2025, we sold 1,130,420 shares of common stock pursuant to the 2025 ATM Agreement for gross proceeds of approximately $1.1 million.

On December 21, 2025, we entered into separate warrant amendment agreements (collectively, the “Warrant Amendment”) with the holders of our Series E, Series F, and Series G warrants (each as defined below, and collectively, the “Warrants”). Pursuant to the Warrant Amendment, the exercise prices of the Warrants were reduced to $3.90 per share (which was subsequently adjusted as described above). In addition, the Series E and Series F warrants were amended to eliminate certain price adjustment provisions and to revise the definition of “Black-Scholes Value". The revised definition of Black-Scholes Value modified the expected volatility input used in the Black-Scholes option pricing model by eliminating the use of 30-day and 365-day historical volatility measures and limiting the volatility input to the greater of (i) 100-day historical volatility, as obtained from Bloomberg, or (ii) 100%. All other inputs to the Black-Scholes model, including the risk-free interest rate, underlying stock price, expected term, and cost of borrow, remained unchanged. As a result of the Warrant Amendment, we determined that the Series E and Series F warrants qualified for equity classification prospectively under applicable accounting guidance. Accordingly, upon the effectiveness of the Warrant Amendment, the Series E and Series F warrants were reclassified from liability to equity. In connection with the reclassification, we remeasured the Series E and Series F warrant liabilities to fair value immediately prior to reclassification, resulting in the recognition of a $21.5 million gain in the consolidated statement of operations. We then reclassified approximately $16.0 million of Series E and Series F warrant liabilities to additional paid-in capital. In addition, we recorded a loss on extinguishment of warrant liabilities of $0.6 million and a warrant-related deemed dividend of $0.1 million, which was recorded within additional paid-in capital and recognized as a reduction to income available to common stockholders. See Note 5 of our consolidated financial statements in Item 8 in this Annual Report on Form 10-K for further discussion. If exercised in full, the Warrants could result in gross proceeds to us of up to approximately $29.4 million.

On December 9, 2025, we entered into warrant exercise inducement agreements with holders of certain outstanding Series C, Series D and Series F warrants, pursuant to which such holders agreed to exercise warrants to purchase an aggregate of 1,044,329 shares of our common stock at reduced or existing exercise prices in exchange for the issuance of Series G warrants to purchase up to 2,610,823 shares of common stock, representing 250% of the shares underlying the exercised warrants, with a five-year exercise term. We received gross proceeds of approximately $6.8 million from the warrant exercises. Pursuant to ASC 815, and in accordance with our accounting policy, we determined that Series G warrants met the criteria for equity classification as of their issuance date. Additionally, we utilized our ATM on this date and sold 86,475 shares for gross proceeds of $0.6 million.

In August 2025, we entered into a warrant exercise inducement offer letter with holders of certain existing warrants pursuant to which the holders agreed to exercise Series E warrants to purchase up to 648,649 shares of common stock with an exercise price of $9.25 per share in exchange for our issuing new Series F warrants to purchase 2,594,595 shares of our common stock. Each Series F warrant had an exercise price of $13.75 per share (which was subsequently adjusted as described above) and is exercisable as of the date of issuance to October 16, 2030. We received gross proceeds of $6.0 million. In addition, during August and September 2025, 119,848 shares of Series E warrants were exercised for $1.1 million. Upon issuance the Series F warrants were initially classified as liability warrants. Pursuant to the Warrant Amendment described above, the Series F warrants were equity-classified as of December 21, 2025. In total, we received gross proceeds of $7.1 million.

In June 2025, we completed a public offering for the sale of 398,881 shares of common stock, and 244,319 pre-funded warrants to purchase shares of common stock, and Series E warrants to purchase up to 1,929,600 shares of common stock. The combined purchase price for the securities was $9.25 per share of common stock (or pre-funded warrant in lieu thereof). Each Series E warrant expires five years from the initial exercise date, or August 18, 2030. We received gross proceeds of $5.9 million.

On February 25, 2025, we entered into a securities purchase agreement with an institutional investor for the sale of 46,000 shares of common stock, and 84,841 pre-funded warrants to purchase shares of common stock, and Series D warrants to purchase up to 261,722 shares of common stock. The combined purchase price for the securities was $26.75 per share of common stock (or pre-funded warrant in lieu thereof). Each pre-funded warrant was exercisable for one share of common stock at an exercise price of $0.025 per share. All pre-funded warrants were exercised in June 2025. The Series D warrants expire five years from the initial exercise date, or August 18, 2030. We received gross proceeds of $3.5 million.

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On February 13, 2025, we entered into a warrant exercise inducement offer letter with a holder of certain existing warrants to receive new warrants to purchase up to a number of shares of common stock equal to 200% of the number of warrant shares issued pursuant to the exercise of such existing warrants to purchase up to 233,143 shares of common stock pursuant to which the warrant holder agreed to exercise for cash their existing warrants at a reduced exercise price of $25.00 in exchange for our agreement to issue the inducement warrants to purchase up to 466,286 shares of our common stock. Each inducement warrant is exercisable as of the date of issuance and may be exercised for a period of five years from the date of issuance. We received gross proceeds of $5.8 million.

On August 19, 2024, we completed a public offering of 11,320 shares of common stock and 87,355 pre-funded warrants to purchase shares of common stock, Series A warrants to purchase up to 98,655 shares of common stock and Series B warrants to purchase up to 98,655 shares of common stock, at a combined public offering price of $55.75 per share (or per pre-funded warrant in lieu thereof) and accompanying warrants. We received gross proceeds of $5.5 million, before deducting the placement agent's fees and other offering expenses.

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

For the Year Ended December 31,

Net cash used in operating activities $ (22,735 ) $ (23,862 )

Net cash used in investing activities — (13 )

Net cash provided by financing activities 27,284 4,635

Effect of exchange rate changes on cash and cash equivalents 51 (32 )

Net change in cash and cash equivalents $ 4,600 $ (19,272 )

Cash used in operating activities

Net cash used in operating activities was $22.7 million for the year ended December 31, 2025 compared to $23.9 million for the year ended December 31, 2024. This slight decrease in use of cash for operations was mainly due to timing of payments related to sponsored research and other expenses.

Cash used in investing activities

Net cash used in investing activities was de minimis for the years ended December 31, 2025 and December 31, 2024, respectively.

Cash provided by financing activities

Net cash provided by financing activities was $27.3 million for the year ended December 31, 2025, During 2025, we generated cash from financing activities primarily through at-the-market equity sales, public offerings, and warrant exercises, including warrant exercise inducement transactions. In the aggregate, these activities generated $27.3 million in net proceeds, including $1.0 million from at-the-market equity sales during the fourth quarter of 2025, $24.8 million from the issuance of common stock as a result of warrant inducement, pre-funded warrants, and common warrants, and $1.5 million from warrant exercises. Net cash provided by financing activities was $4.6 million for the year ended December 31, 2024, consisting of proceeds from the August 2024 stock offering.

Contractual Obligations

Our contractual obligations and commitments relate primarily to our operating leases and license, sponsored research, consulting, and laboratory access agreements with various research and development centers for the development and commercialization of our drug candidates targeting acute myeloid leukemia and certain hard to treat cancers. See Note 8 to our consolidated financial statements in Item 8 of this Annual Report on Form 10-K for further discussion.

Off-Balance Sheet Transactions

As of December 31, 2025, we did not have any off-balance sheet arrangements.

Recent Accounting Pronouncements

We have implemented all new accounting pronouncements that are in effect and may impact our financial statements and we do not believe that there are any other new accounting pronouncements that have been issued that might have a material impact on our financial position or results of operations.Refer to Note 2 of our consolidated financial statements in Item 8 in this Annual Report on Form 10-K for additional discussion.

Critical Accounting Policies and Significant Judgments and Estimates

The accompanying consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (US GAAP) for financial information, and in accordance with the rules and regulations of the SEC.

We believe that the following accounting policies are the most critical to aid in fully understanding and evaluating our reported financial results, and they require our most difficult, subjective or complex judgments, resulting from the need to make estimates about the effect of matters that are inherently uncertain.

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Research and Development Costs

We record accrued expenses for estimated costs of our research and development activities conducted by third-party service providers, which include the conduct of pre-clinical and clinical trials and preparation for clinical trials and contract manufacturing activities. We record the estimated costs of research and development activities based upon the estimated amount of services provided but not yet invoiced, and we include these costs in accrued liabilities in the balance sheets and within research and development expense in the statement of operations. These costs are a significant component of our research and development expenses. We record accrued expenses for these costs based on the estimated amount of work completed and in accordance with agreements established with these third parties.

We estimate the amount of work completed through discussions with internal personnel and external service providers as to the progress or stage of completion of the services and the agreed-upon fee to be paid for such services. We make significant judgments and estimates in determining the accrued balance in each reporting period. As actual costs become known, we adjust our accrued estimates. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed may vary from our estimates and could result in us reporting amounts that are too high or too low in any particular period. Our accrued expenses are dependent, in part, upon the receipt of timely and accurate reporting from clinical research organizations and other third-party service providers. To date, there have been no material differences from our accrued expenses to actual expenses.

Impairment of Long-Lived Assets

We evaluate the recoverability of our property and equipment and amortizable intangible assets for possible impairment whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable or at a minimum annually during the third quarter of the year. Recoverability of these assets is measured by a comparison of the carrying amounts to the future undiscounted cash flows the assets are expected to generate. If such review indicates that the carrying amount of property and equipment and amortizable intangible assets is not recoverable, the carrying amount of such asset is reduced to fair value.

Acquired in-process research and development (IPR&D) assets are considered indefinite lived until the completion or abandonment of the associated research and development efforts. We evaluate the recoverability of our IPR&D assets for possible impairment annually during the fourth quarter or whenever events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of IPR&D assets is measured by a comparison of the carrying amounts its fair value. If such review indicates that the carrying amount of IPR&D assets is not recoverable, the carrying amount of such asset is reduced to fair value.

Components of our Results of Operations, Net Loss and Financial Condition

Operating expenses

We classify our operating expenses into three categories: research and development, general and administrative and depreciation.

Research and development. Research and development expenses consist primarily of:

• costs related to compliance with drug development regulatory requirements.

We recognize all research and development costs as they are incurred. Pre-clinical costs, contract manufacturing and other development costs incurred by third parties are expensed as the contracted work is performed.

We expect our research and development expenses to increase in the future as we advance our product candidates into and through clinical trials and pursue regulatory approval of our product candidates in the United States and Europe. The process of conducting the necessary clinical research to obtain regulatory approval is costly and time-consuming. The actual probability of success for our product candidates may be affected by a variety of factors including: the quality of our product candidates, early clinical data, investment in our clinical program, competition, manufacturing capability and commercial viability. We may never succeed in achieving regulatory approval for any of our product candidates. As a result of the uncertainties discussed above, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent, if any, we will generate revenue from the commercialization and sale of our product candidates.

General and administrative

General and administrative expense consists of personnel related costs, which include salaries, as well as the costs of professional services, such as accounting and legal, facilities, information technology and other administrative expenses. We expect our general and administrative expense to increase due to the anticipated growth of our business and related infrastructure as well as accounting, insurance, investor relations and other costs associated with being a public company.

Depreciation and Amortization.

Depreciation and amortization expense consists of depreciation on our property and equipment. We depreciate our assets over their estimated useful life. We estimate leasehold improvements to have an estimated useful life over the term of the lease or the estimated useful life, whichever is shorter; computer equipment to have a 2-year life; software to have a 3-year life, machinery and equipment to have a 2 to 5 year life and furniture and office equipment to have a 2 to 7 year life.

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Accounting for warrants

When the Company enters into arrangements pursuant to which warrants are issued, modified, or amended, we evaluate the terms of the warrants to determine the appropriate accounting and classification in accordance with FASB Accounting Standards Codification (“ASC”) Topic 480, Distinguishing Liabilities from Equity (“ASC 480”), ASC Topic 505, Equity (“ASC 505”), ASC Topic 815, Derivatives and Hedging (“ASC 815”), and ASC Topic 718, Compensation—Stock Compensation (“ASC 718”).

Warrants that meet the criteria for liability classification under ASC 480, or that do not meet the criteria for equity classification under ASC 815 due to exercise contingencies, settlement provisions, or other contractual terms, are accounted for as derivative liabilities. These warrants are measured at fair value in accordance with ASC 820, Fair Value Measurement, with changes in fair value recognized in earnings, and are presented as warrant liabilities on the Company’s consolidated balance sheets. Warrants that meet the criteria for equity classification are recorded in stockholders’ equity.

During the year ended December 31, 2025, we changed our accounting policy related to the classification of certain outstanding warrants. Prior to the change in accounting policy, our policy was to account for warrants with a certain contingent settlement provision as liability warrants, initially measuring them at fair value on the date of issuance. The warrants were previously remeasured at fair value at the end of each reporting period, with the related liability reflected on our balance sheet. The changes in fair value during each previous reporting period were recognized as a gain (loss) from change in fair value of warrant liability in our consolidated statement of operations. We changed our policy and warrants that contain this certain contingent settlement provision are now accounted for as equity under ASC 815-40-15-7C through 15-7F and ASC 505. We concluded that accounting for our warrants as equity instruments is preferable under ASC 250, as equity classification better reflects the economic substance of the arrangement and enhances the clarity and consistency of our financial reporting. As a result of this change in accounting policy, all warrants issued prior to 2025, and certain warrants issued in 2025, that were previously accounted for as liability awards due to the certain contingent settlement provision now meet the equity classification criteria under ASC 815-40 and are classified as equity instruments. The effects of the change in accounting policy from warrant liabilities to equity have been retrospectively applied to all periods presented in these consolidated financial statements. See Note 2 and Note 5 of our consolidated financial statements in Item 8 in this Annual Report on Form 10-K for further discussion.

As a result of the change in accounting policy, we adjusted accumulated deficit, and additional paid-in capital to reverse previously recorded mark-to-market fair value changes of the liability-classified warrants.

Valuation of Warrant Liabilities

The fair value of the warrant liabilities is estimated using a Monte Carlo simulation model. This model is utilized due to certain features of the warrants, including path-dependent or market-based provisions, which cannot be appropriately valued using simpler option pricing models. The valuation model incorporates assumptions related to:

• the market price of our common stock at the measurement date;

• the contractual term of the warrants;

• expected volatility of our common stock;

• risk-free interest rates; and

• expected dividend yield.

The risk-free interest rate is based on observed interest rates of zero-coupon U.S. Treasury instruments with maturities corresponding to the expected term of the warrants. Expected volatility represents the amount by which our stock price is expected to fluctuate over the expected life of the warrants.

Changes in the fair value of warrant liabilities are recorded as other income or expense in the consolidated statements of operations.

Allocation of Warrant Proceeds

For equity offerings during 2025 that included both common stock, equity-classified warrants, and warrants classified as liabilities, we allocated the proceeds first to the warrants based on their fair value at issuance, with the residual proceeds allocated to the equity instruments, including common stock and pre-funded warrants.

Stock-based compensation

Stock based compensation transactions are recognized as compensation expense in the statement of operations based on their fair values on the date of the grant, with the compensation expense recognized over the period in which a grantee is required to provide service in exchange for the award. We estimate the fair value of options granted using the Black-Scholes option valuation model (BSM), and the fair value of restricted stock units using the closing price of our common stock as reported on the date of grant. The Black-Scholes estimate uses assumptions regarding a number of inputs that require us to make significant estimates and judgments. Beginning in 2020, only the volatility of our stock was used in the BSM as we now have sufficient historic data in our stock price.

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Income taxes

We account for income taxes using ASC 740, Income Taxes. ASC 740 is an asset and liability approach that requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in our financial statements or tax returns. In estimating future tax consequences, ASC 740 generally considers all expected future events other than enactments of and changes in the tax law or rates. The measurement of deferred tax assets is reduced, if necessary, by the amount of any tax benefits that, based on available evidence, are not expected to be realized. Valuation allowances are provided if, considering available evidence, it is more likely than not that the deferred tax assets will not be realized. ASC 740 clarifies the criteria that must be met prior to recognition of the financial statement benefit of a position taken in a tax return. ASC 740 provides a benefit recognition model with a two-step approach consisting of “more-likely-than-not” recognition criteria, and a measurement attribute that measures a given tax position as the largest amount of tax benefit that is greater than 50% likely of being realized upon ultimate settlement. ASC 740 also requires the recognition of liabilities created by differences between tax positions taken in a tax return and amounts recognized in the financial statements.

Recent accounting pronouncements

See Note 2 of our consolidated financial statements in Item 8 in this Annual Report on Form 10-K for discussion regarding recent accounting pronouncements.

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide information required under this item.

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

The financial statements required by this item are set forth beginning in Item 15 of this report and are incorporated herein by reference.

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

There have been no disagreements with our independent registered public accountants on accounting or financial disclosure matters during our two most recent fiscal years.

ITEM 9A. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Our management has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act), as of the end of the period covered by this Form 10-K. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission's rules and forms and that such information is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding disclosure.

Management concluded that our disclosure controls and procedures were effective as of December 31, 2025.

Attestation Report of the Registered Public Accounting Firm

Our independent registered public accounting firm will not be required to formally attest to the effectiveness of our internal controls over financial reporting for as long as we are a "non-accelerated filer."

Management's Report on Internal Control Over Financial Reporting

Our principal executive officer and our principal accounting and financial officer, are responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Exchange Act Rule 13a-15(f). Management conducted an assessment of the effectiveness of our internal control over financial reporting as of December 31, 2025. In making this assessment, management used the criteria described in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Our management concluded that our internal control over financial reporting was effective as of December 31, 2025.

Changes in Internal Control Over Financial Reporting

There was no change in the Company’s internal control over financial reporting identified in connection with the evaluation required by Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the year ended December 31, 2025, that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

ITEM 9B. OTHER INFORMATION.

Our certificate of incorporation provides that the Court of Chancery of the State of Delaware shall be the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our directors or officers to us or our stockholders, (iii) any action asserting a claim against us arising pursuant to any provision of the Delaware General Corporation Law, or our certificate of incorporation or the bylaws, and (iv) any action asserting a claim against us governed by the internal affairs doctrine. This provision would not apply to suits brought to enforce a duty or liability created by the Exchange Act or Securities Act.

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This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits against us and our directors, officers and employees. Alternatively, a court could find these provisions of our certificate of incorporation to be inapplicable or unenforceable in respect of one or more of the specified types of actions or proceedings, which may require us to incur additional costs associated with resolving such matters in other jurisdictions, which could adversely affect our business and financial condition.

During the three months ended December 31, 2025, no director or officer of the Company adopted or terminated a "Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.

Not applicable.

PART III

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

The information required by this item is incorporated by reference to our proxy statement for the 2026 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission within 120 days of the fiscal year ended December 31, 2025 and is incorporated into this Annual Report on Form 10-K by reference.

Our Board of Directors has adopted a written Code of Business Conduct and Ethics applicable to all officers, directors and employees, which is available on our website (www.moleculin.com) under “Governance Documents” within the “Corporate Governance” section. We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding amendment to, or waiver from, a provision of this Code and by posting such information on the website address and location specified above.

ITEM 11. EXECUTIVE COMPENSATION

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES

PART IV

ITEM 15. EXHIBITS AND FINANCIAL STATEMENTS

a. Documents filed as part of this Report

1. Financial Statements

The financial statements and notes thereto which are attached hereto have been included by reference into Item 8 of this part of the annual report on Form 10-K. See the Index to Financial Statements on page below.

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2. Financial Statement Schedules

All schedules are omitted because they are inapplicable or not required or the required information is shown in the financial statements or notes thereto.

3. Exhibits

EXHIBIT INDEX

Exhibit Number Description

4.1 Description of Registrant's Securities

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23.1* Consent of Grant Thornton, LLP

101.INS * Inline XBRL Instance 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

* Filed herewith.

** Denotes a management contract or compensatory plan or arrangement.

ITEM 16. FORM 10-K SUMMARY

None.

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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.

By: /s/ Walter V. Klemp

Walter V. Klemp,

Chief Executive Officer and Chairman

Date: March 18, 2026

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons on behalf of the Registrant in the capacities and on the dates indicated.

Signature Title Date

/s/ Walter V. Klemp Chief Executive Officer and Chairman March 18, 2026

Walter V. Klemp (Principal Executive Officer)

/s/ Jonathan P. Foster Executive Vice President and March 18, 2026

Jonathan P. Foster Chief Financial Officer

(Principal Financial and Accounting Officer)

/s/ Robert George Director March 18, 2026

Robert George

/s/ Michael Cannon Director March 18, 2026

Michael Cannon

/s/ John Climaco Director March 18, 2026

John Climaco

/s/ Elizabeth Cermak Director March 18, 2026

Elizabeth Cermak

/s/ Joy Yan Director March 18, 2026

Joy Yan

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Moleculin Biotech, Inc.

Index to Consolidated Financial Statements

PAGE

Report of Independent Registered Public Accounting Firm (PCAOB ID Number 248) 68

Consolidated Balance Sheets as of December 31, 2025 and 2024 69

Notes to Consolidated Financial Statements 73

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

Board of Directors and Stockholders

Moleculin Biotech, Inc.

Opinion on the financial statements

We have audited the accompanying consolidated balance sheets of Moleculin Biotech, Inc. (a Delaware corporation) and subsidiaries (the “Company”) as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive loss, stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.

Going concern

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company has incurred an accumulated deficit of $206.0 million since inception and has not generated any revenue from operations. These conditions, along with other matters as set forth in Note 2, raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Change in accounting principle

As discussed in Note 2 to the consolidated financial statements, during the year ended December 31, 2025 the Company changed its accounting policy related to the classification of certain outstanding warrants. The Company retrospectively applied this change by reclassifying certain warrants from liability to equity in the consolidated financial statements for all periods presented.

Basis for opinion

These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

Critical audit matter

The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

Change in Accounting Policy Related to the Classification of Warrants

As described further in Note 2 to the consolidated financial statements, during the year ended December 31, 2025, the Company changed its accounting policy for the classification of certain outstanding warrants. Management concluded that the warrants met the criteria for equity classification under the applicable accounting guidance and, as a result, reclassified the warrants from liability to equity.

The principal consideration for our determination that the change in accounting policy related to the classification of warrants is a critical audit matter is that it involved especially challenging and complex auditor judgement. In particular, the evaluation required significant judgment in assessing management's interpretation and application of the accounting guidance governing the classification of freestanding financial instruments, including the assessment of contractual terms and settlement provisions.

Our audit procedures related to the change in accounting policy for the classification of warrants included the following, among others: (1) we evaluated management's accounting policy memorandum and assessed whether the revised classification of the warrants as equity was appropriate under the applicable accounting guidance, including consideration of relevant interpretive guidance and prevailing practice; (2) we read and analyzed the warrant agreements and related amendments to evaluate contractual provisions affecting classification, including settlement terms, adjustment features, and contingencies; (3) we involved professionals with specialized accounting expertise to assist in evaluating management's conclusions regarding the appropriate classification of the warrants; and (4) we tested the accuracy and completeness of the retrospective adjustments recorded to reclassify the warrants from liability to equity, including recalculation of prior-period balances and the elimination of previously recognized fair value changes.

/s/ GRANT THORNTON LLP

We have served as the Company’s auditor since 2017.

Fort Lauderdale, Florida

March 18, 2026

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Moleculin Biotech, Inc.

Consolidated Balance Sheets

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

December 31,

Assets

Current Assets:

Cash and cash equivalents $ 8,878 $ 4,278

Prepaid expenses and other current assets 808 916

Furniture and equipment, net 78 159

Other non-current assets 900 —

Operating lease right-of-use asset 314 424

Liabilities and Stockholders' Equity

Current Liabilities:

Accrued expenses and other current liabilities 3,346 3,329

Operating lease liability - long-term, net of current portion 222 358

Warrant liability 44 —

Commitments and contingencies (Note 8)

Stockholders' Equity:

Accumulated other comprehensive income (loss) 10 (41 )

Total liabilities and stockholders' equity $ 22,126 $ 16,925

See accompanying notes to these consolidated financial statements.

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Moleculin Biotech, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

Year Ended December 31,

Revenue $ — $ —

Operating expenses:

Depreciation and amortization 90 126

Other income:

Gain from change in fair value of warrant liabilities 24,441 —

Loss on issuance of warrant liabilities (30,962 ) —

Transaction costs allocated to warrant liabilities (1,407 ) —

Loss on extinguishment of warrant liabilities (614 ) —

Other (expense) income, net (20 ) 43

Warrant deemed dividend (104 ) —

Net loss available to common stockholders $ (33,664 ) $ (26,048 )

Net loss per common share - basic and diluted $ (28.42 ) $ (189.14 )

Weighted average common shares outstanding, basic and diluted 1,184,569 137,720

Comprehensive loss:

Other comprehensive loss:

Foreign currency translation 51 (32 )

See accompanying notes to these consolidated financial statements.

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Moleculin Biotech, Inc.

Consolidated Statements of Cash Flows

(in thousands)

Year Ended December 31,

Cash flows from operating activities:

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization 90 126

Change in fair value of warrant liabilities (24,441 ) —

Loss on issuance of warrant liabilities 30,962 —

Transaction costs allocated to warrant liabilities 1,407 —

Loss on extinguishment of warrant liabilities 614 —

Operating lease, net (26 ) 103

Changes in operating assets and liabilities:

Prepaid expenses and other assets (792 ) 1,807

Accrued expenses and other liabilities 17 (1,108 )

Net cash used in operating activities (22,735 ) (23,862 )

Cash flows from investing activities:

Purchase of fixed assets — (13 )

Net cash used in investing activities — (13 )

Cash flows from financing activities:

Proceeds from exercise of warrants 1,527 1

Payment of tax liability for vested restricted stock units (8 ) (26 )

Net cash provided by financing activities 27,284 4,635

Effect of exchange rate changes on cash and cash equivalents 51 (32 )

Net increase (decrease) in cash and cash equivalents 4,600 (19,272 )

Cash and cash equivalents, at beginning of year 4,278 23,550

Cash and cash equivalents, at end of year $ 8,878 $ 4,278

Supplemental disclosures of cash flow information:

Non-cash investing and financing activities:

Offering costs included in accounts payable and accrued liabilities $ 138 $ —

Deemed dividend in connection with warrant amendment $ 104 $ —

See accompanying notes to these consolidated financial statements.

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Moleculin Biotech, Inc.

Consolidated Statements of Stockholders’ Equity

(in thousands except for shares and per unit)

Common Stock

Warrants exercised 30,555 — — — — —

Reverse stock split 3,087 — — — — —

Stock based compensation — — 1,689 — — 1,689

Cumulative translation adjustment — — — — (32 ) (32 )

Reverse stock split (292 ) — — — — —

Warrant deemed dividend — — 104 — — 104

Deemed dividend in connection with warrant amendment — — (104 ) — — (104 )

Stock based compensation — — 1,664 — — 1,664

Cumulative translation adjustment — — — — 51 51

See accompanying notes to these consolidated financial statements.

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Moleculin Biotech, Inc.

Notes to the Consolidated Financial Statements

1. Nature of Business

The terms “MBI” or “the Company”, “we”, “our” and “us” are used herein to refer to Moleculin Biotech, Inc. MBI is a clinical-stage pharmaceutical company, organized as a Delaware corporation in July 2015. MBI is a late-stage pharmaceutical development company currently conducting a pivotal Phase 2B/3 trial evaluating Annamycin, also known by its non-proprietary name "naxtarubicin", in combination with cytarabine for the treatment of subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML). The Company has two additional portfolios of technologies for hard-to-treat cancers and viruses with clinical and preclinical research funded primarily by investigators at academic institutions.

Each of its three core technologies is based substantially on discoveries at, or in conjunction with and with rights originating from the University of Texas MD Anderson Cancer Center (MD Anderson) in Houston, Texas, and features one or more drugs that have successfully completed a Phase 1 clinical trial. Three of its drug candidates have shown human activity in clinical trials and are currently or have been in Phase 1B/2 or Phase 2 clinical trials. Since MBI’s inception, its drugs have completed, are in planning, are currently in, or have been permitted to proceed in, eighteen clinical trials. Annamycin, in a unique multilamellar lipid formulation, is the Company’s lead molecule, and in 2024 MBI has concluded treatment in several Phase 1B/2 clinical trials for treating AML and in March 2025 began treating subjects in its Phase 2B/3 clinical trial for the treatment of R/R AML. The latter is the main focus the Company’s management and resources. Annamycin was in two closed or concluded Phase 1B/2 clinical trials for treating Soft Tissue Sarcoma metastasized to the lungs (STS lung metastases, STS lung mets, or Advanced STS), with one physician-sponsored. The Company announced in 2025 a physician-sponsored trial for Annamycin for the treatment of pancreatic cancer intended to begin in the second half of 2026. Additionally, there is another phase 1B/2 clinical trial that is physician sponsored which is investigating using WP1066 in combination with radiation for the treatment of glioblastoma, a form of brain cancer, with another similar trial planned within the next year for pediatric brain tumors.

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.

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

On May 23, 2025, the Company received a letter from Nasdaq Stock Market LLC notifying the Company that it was not in compliance with Nasdaq Listing Rule 5550(b)(1) (the “Equity Rule”), which requires a minimum of $2.5 million in stockholders’ equity. The letter also noted that the Company did not meet the alternative compliance standards of market value of listed securities or net income from continuing operations under the Equity Rule. The notification had no immediate effect on the listing of the Company’s common stock on the Nasdaq Capital Market, and the Company was provided 45 calendar days to submit a plan to regain compliance. The Company’s compliance plan was subsequently accepted, and the Nasdaq staff granted an extension of up to 180 calendar days, through November 19, 2025, to demonstrate compliance.

On June 27, 2025, the Company received an additional deficiency letter from the staff of Nasdaq indicating that, for the previous 30 consecutive business days, the closing bid price of the Company’s common stock had been below the minimum $1.00 per share requirement for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).

On November 20, 2025, the Company received a delisting determination letter from Nasdaq stating that the Company had not regained compliance with the Equity Rule within the permitted timeframe. The Company subsequently requested a hearing before a Nasdaq hearing panel (the “Panel”) to appeal the delisting determination.

On December 15, 2025, the Company received a letter from Nasdaq confirming that the Company had regained compliance with the Bid Price Rule because the closing bid price of the Company’s common stock was $1.00 per share or greater for the 10 consecutive business days from December 1, 2025 through December 12, 2025. Accordingly, this matter was closed.

On January 6, 2026, Nasdaq informed the Panel that the Company had regained compliance with the Equity Rule and that the Company was in compliance with all applicable continued listing standards. As a result, the hearing before the Panel was cancelled.

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

Reverse Stock Split - On December 1, 2025, pursuant to authority granted by our stockholders, the Company effected a 1-for-25 reverse stock split of our common stock and the filing of an amendment to our amended and restated certificate of incorporation to effectuate the reverse stock split. The amendment provides that, every twenty-five shares of our issued and outstanding common stock will automatically be combined into one issued and outstanding share of common stock, without any change in par value per share, which will remain at $0.001. The accompanying consolidated financial statements and notes to the consolidated financial statements give retroactive effect to the reverse stock split for all periods presented. Certain amounts in the financial statements, the notes thereto, and elsewhere in the Form 10-K may be slightly different than previously reported due to rounding up of fractional shares as a result of the reverse stock split.

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Change in Accounting Policy – During the year ended December 31, 2025, the Company changed its accounting policy related to the classification of certain outstanding warrants. Prior to the change in accounting policy, the Company's policy was to account for warrants with a certain contingent settlement provision as liability warrants, initially measuring them at fair value on the date of issuance. The warrants were previously remeasured at fair value at the end of each reporting period, with the related liability reflected on the Company's balance sheet. The changes in fair value during each previous reporting period were recognized as a gain (loss) from change in fair value of warrant liability in the Company's condensed consolidated statement of operations. The Company changed its policy and warrants that contain this certain contingent settlement provision are now accounted for as equity under ASC 815-40-15-7C through 15-7F and ASC 505. The Company concluded that accounting for its warrants as equity instruments is preferable under ASC 250, as equity classification better reflects the economic substance of the arrangement and enhances the clarity and consistency of the Company's financial reporting. As a result of this change in accounting policy, all warrants issued prior to 2025, and certain warrants issued in 2025, that were previously accounted for as liability awards due to the certain contingent settlement provision now meet the equity classification criteria under ASC 815-40 and are classified as equity instruments. The effects of the change in accounting policy from warrant liabilities to equity have been retrospectively applied to all periods presented in these consolidated financial statements. Subsequent to the change in accounting policy, certain warrants will continue to be classified as liabilities, as these instruments contain features other than the certain contingent settlement provision that previously resulted in liability classification, which preclude equity classification under applicable accounting guidance. See also Note 5 - Warrants and Equity.

As a result of the change in accounting policy, the Company adjusted accumulated deficit, and additional paid-in capital to reverse previously recorded mark-to-market fair value changes of the liability-classified warrants. Accumulated deficit as of January 1, 2024, changed from $131.6 million, as reported under the liability classification, to $146.4 million under the equity classification.

The following financial statement line items were impacted by the change in accounting policy, as shown in the table below (in thousands, except for net loss per common share):

As Reported As Adjusted Effect of

Under Old Policy Under New Policy Change

Consolidated Balance Sheets

Total liabilities and stockholders' equity $ 16,925 $ 16,925 $ -

Year Ended

As Reported As Adjusted Effect of

Under Old Policy Under New Policy Change

Consolidated Statement of Operations

Gain from change in fair value of warrant liability $ 6,125 $ — $ 6,125

Transaction costs allocated to warrant liabilities (993 ) — (993 )

Loss on issuance of warrant liabilities (847 ) — (847 )

Net loss per common share - basic and diluted (158.02 ) (189.14 ) 31.12

Year Ended

As Reported As Adjusted Effect of

Under Old Policy Under New Policy Change

Consolidated Statement of Cash Flows

Adjustments to reconcile net loss to net cash used in operating activities

Change in fair value of warrant liability (6,125 ) — (6,125 )

Loss on issuance of warrant liabilities 847 — 847

Transaction costs allocated to warrant liabilities 993 — 993

Net cash used in operating activities $ (23,862 ) $ (23,862 ) $ —

Basis of Presentation - The accompanying consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the United States of America (US GAAP), and in accordance with the rules and regulations of the United States Securities and Exchange Commission (the SEC).

Principles of consolidation - The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. All material long-lived assets of the Company reside in the United States. In accordance with FASB ASC Topic 280, Segment Reporting, the Company views its operations and manages its business as one segment. As a result, the financial information disclosed herein represents all of the material financial information related to its principal operating segment.

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Segment Information - Management has determined that the Company operates in one reportable segment, which is the development and commercialization of drug products. The Company's chief operating decision maker (CODM) is its Chief Executive Officer and Chairman, who reviews financial information presented on a consolidated basis. The CODM primarily uses consolidated net loss, which is also reported on the Consolidated Statements of Operations and Comprehensive Loss as net loss, to assess financial performance and allocate resources. These financial metrics are used by the CODM to make key operating decisions, such as the assessment of segment performance and allocation of resources. The significant expense categories within net loss from operations that the CODM regularly reviews are research and development expenses, general and administrative expenses, and depreciation and amortization. The significant expense categories and subcategories are reported on the Consolidated Statements of Operations and Comprehensive Loss. Other expenses included in the Company’s net loss include change in fair value of warrant liabilities, other income (expense), interest income, net, and any additional non-operating expenses that are reported on the Consolidated Statements of Operations and Comprehensive Loss.

Use of Estimates - The preparation of these 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 and Liquidity - These 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 financing to continue operations and the attainment of profitable operations. As of December 31, 2025, the Company had an accumulated deficit of$206.0million since inception and had not yet generated any revenues from operations. Additionally, management anticipates that its cash on hand of$8.9 million as of December 31, 2025, along with $8.3 million in gross proceeds via our financing activities during the first quarter of 2026, is not sufficient to fund its planned operations for a period of at least one year from when these consolidated financial statements are issued. These factors raise substantial doubt regarding the Company's ability to continue as a going concern. These consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern. The Company intends to seek additional funding through one or more of the following: a combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements and delay planned cash outlays or a combination thereof. There can be no assurance that such events or a combination thereof can be achieved.

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 US, which at times, may exceed the Federal Deposit Insurance Corporation's limit of $250,000. The Company considers all highly liquid accounts with original maturities of three months or less to be cash equivalents. 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.

Prepaid Expenses and Other Current Assets - Prepaid expenses and other current assets consist of the following (in thousands):

December 31,

Vendor prepayments and deposits 278 331

Prepaid sponsored research 11 11

Non-trade receivables 7 20

Total prepaid expenses and other current assets $ 808 $ 916

Furniture and equipment - Furniture and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line depreciation method as follows:

Years

Computer equipment 2

Software 3

Machinery and equipment 2 to 5

Furniture and office equipment 2 to 7

Depreciation expense was $0.1 million for each of the years ended December 31, 2025 and 2024. Accumulated depreciation was $1.1 million and $1.0 million as of December 31, 2025 and 2024, respectively.

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

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Other non-current assets - In May 2025, the Company provided a $0.9 million deposit in connection with the MB-108 clinical trial, a Phase 2B/3 pivotal study evaluating treatment for relapsed or refractory acute myeloid leukemia in the second-line setting. This deposit is expected to be held as a prepayment through the anticipated completion of the study in 2029 and, accordingly, has been classified as a non-current asset.

Operating Lease Right-of-Use Asset - The Company determines if an arrangement is a lease at contract inception or during modifications or renewal of an existing lease. Operating lease assets represent the Company's right to use an underlying asset for the lease term and operating lease liabilities represent the Company's obligation to make lease payments arising from the lease. Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. The lease payments used to determine the Company's operating lease assets may include lease incentives, stated rent increases and escalation clauses linked to rates of inflation when determinable and are recognized in the Company's operating lease assets in the Company's consolidated balance sheet. The Company has elected the practical expedient and does not separate lease components from nonlease components for its leases. The Company's operating leases are reflected in operating lease right-of-use asset (ROU), accrued expenses and other current liabilities, and operating lease liability - long-term in the Company's consolidated balance sheets. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. Short-term leases, defined as leases that have a lease term of 12 months or less at the commencement date, are excluded from this treatment and are recognized on a straight-line basis over the term of the lease. Refer to Note 8 - Commitments and Contingencies - Lease Obligations Payable for additional information related to the Company’s operating leases.

Sublicense Arrangement - The Company has a sublicense arrangement which consists of an investment in ALI in which it does not have the ability to exercise significant influence over its operating and financial activities. Management evaluates this investment for possible impairment quarterly.

Fair Value of Financial instruments -The Company’s financial instruments consist primarily of non-trade receivables, accounts payable, accrued expenses, and a warrant liability. The carrying amounts of non-trade receivables, accounts payable, and accrued expenses approximate their fair values due to the short-term maturities of these instruments. The Company’s financial assets and liabilities measured at fair value on a recurring basis include the fair value of its warrant liability, which is discussed further in Note 5.

The Company has categorized its assets and liabilities that are valued at fair value on a recurring basis into three-level fair value hierarchy in accordance with US 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 following table provides the financial assets and liabilities reported at fair value and measured on a recurring basis at December 31, 2025 and 2024 (in thousands):

Fair value of warrant liability:

December 31, 2024 $ — $ — $ — $ —

The following table provides a summary of changes in fair value associated with the Level 3 liabilities for the years ended December 31, 2025 and 2024 (in thousands):

Warrant Liability Long-Term

Issuances of warrants —

Change in fair value - net —

Issuances of warrants 46,737

Change in fair value - net (24,441 )

Loss on extinguishment of warrant liabilities 614

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The table above presents a rollforward of the Company’s Level 3 liabilities, beginning with the fair value as of December 31, 2023 and reflecting changes in fair value and other activity during the years ended December 31, 2025 and 2024. The ending balance of these Level 3 financial instruments represents management’s estimate of fair value at the respective reporting date. Because these instruments are not actively traded, their valuations are based on significant unobservable inputs and are not derived from observable market prices. Accordingly, the estimated values may differ from amounts that could be realized in an immediate settlement.

The Company estimates the fair value of its outstanding warrant liabilities using a Monte Carlo simulation model, as the warrants provide holders with the right, but not the obligation, to purchase the Company’s common stock at a contractual exercise price. This valuation technique incorporates significant unobservable inputs, including the Company’s stock price, expected volatility, the risk-free interest rate, and the expected term at each measurement date. Accordingly, the warrant liabilities are classified within Level 3 of the fair value hierarchy.

The valuation of these instruments is inherently subjective and involves the use of significant estimates and assumptions. Changes in these inputs, including those resulting from factors outside of the Company’s control, such as market conditions or a potential change in control, could result in significant fluctuations in the estimated fair value of the warrant liabilities. Such changes may result in material non-cash gains or losses recognized in the Company’s statements of operations in future periods.

Income Taxes - The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of reported 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 must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized.

The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740-10 which prescribes a recognition threshold and measurement attribute for financial statement disclosure of tax positions taken, or expected to be taken, on its tax return. The Company evaluates and records any uncertain tax positions based on the amount that management deems is more likely than not to be sustained upon examination and ultimate settlement with the tax authorities in the tax jurisdictions in which it operates.

Translation of Foreign Currencies - The functional currency for the Company's foreign subsidiaries is the local currency. For the Company's non-US subsidiaries that transact in a functional currency other than the US dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date. Income and expense items are translated at the average foreign currency rates for the period. Adjustments resulting from the translation of the financial statements of the Company's foreign operations into US dollars are excluded from the determination of net income and are recorded in accumulated other comprehensive income, a separate component of equity.

Stock-based Compensation - Stock-based compensation expense includes the estimated fair value of equity awards vested or expected to vest during the reporting period. The Company accounts for its stock-based compensation awards in accordance with FASB ASC Topic 718, Compensation—Stock Compensation (ASC 718). ASC 718 requires all stock-based payments to employees, including grants of employee stock options, restricted stock units, modifications to existing stock options, and equity classified warrants to be recognized in the consolidated statements of operations based on their grant date fair values. The grant-date fair value of stock options is estimated using the Black-Scholes option pricing model. The grant-date fair value of restricted stock awards is determined based on the closing price of the Company’s common stock on the date of grant (or, if the grant date is not a business day, the closing price on the preceding business day). The grant-date fair value of equity-classified warrants is estimated using a Monte Carlo simulation model, which incorporates significant assumptions, including expected volatility, expected term, risk-free interest rate, and the contractual terms of the warrants, including potential path-dependent features. The awards are subject to service vesting conditions. Compensation expense related to stock-based awards with service-based vesting conditions is recognized on a straight-line basis over the requisite service period of the award, which is generally the vesting period, based on the grant-date fair value of the award. The Company recognizes forfeitures as they occur. Compensation expense related to stock-based awards with performance-based vesting conditions is recognized based on the grant-date fair value of the award when it is probable that the performance condition will be achieved and is adjusted for changes in the probability of achievement until the performance condition is satisfied

Net Loss Available to Common Stockholders- 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 were considered to be common stock equivalents. Shares of the Company's common stock underlying pre-funded warrants are included in the calculation of basic and diluted earnings per share. 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 years ended December 31, 2025, and 2024, approximately 2.6 million and 0.4 million (taking into account the reverse stock splits we have completed) of potentially dilutive shares were excluded from the computation of diluted loss per share due to their antidilutive effect.

Research and Development Costs - Research and development costs are expensed as incurred. These costs consist primarily of salaries and benefits of research and development personnel, costs related to research activities, preclinical studies, clinical trials, drug manufacturing and allocated overhead and facility-related expenses.

Subsequent Events - The Company’s management reviewed all material events through the date these consolidated financial statements were issued for subsequent event disclosure consideration as described in Note 9 and elsewhere in other notes to the financial statements.

Recent Accounting Pronouncements

In December 2025, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements. The ASU clarifies the applicability of interim reporting guidance, the form and content of interim financial statements, and the related disclosure requirements. The amendments are intended to improve the organization and consistency of interim reporting guidance and do not change the fundamental nature of interim reporting or expand or reduce existing disclosure requirements. The ASU is effective for interim reporting periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact of adopting this guidance; however, the Company does not expect the adoption of this standard to have a material impact on its consolidated financial statements.

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In November 2024 and January 2025, FASB issued ASU 2024-03 and ASU 2025-01, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires disclosure in the notes to the financial statements of specified information about certain costs and expenses. The amendments to the standards are effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the new guidance to determine the impact it may have on its consolidated financial statements and related disclosures, but expects additional disclosures upon adoption.

In December 2023, the FASB issued Accounting Standards Update, or ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 improves the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the effective tax rate reconciliation and income taxes paid disaggregated by jurisdiction. It also includes certain other amendments to improve the effectiveness of income tax disclosures. This guidance is effective for the annual periods beginning after the year ended December 31, 2024. The Company adopted ASU 2023-09 as of January 1, 2025, and it has included the necessary disclosures in this Annual Report on Form 10-K.

There are no other effective pronouncements, or pronouncements issued but not yet effective, which if adopted, would have a material effect on the accompanying financial statements.

3. Intangible Assets

In conjunction with its acquisition of Moleculin, LLC in 2016, the Company recognized an intangible asset for acquired in-process research and development (IPR&D) related to the acquired WP1066 portfolio. As the Company's WP1066 portfolio is currently in development, the Company’s IPR&D intangible asset will not be amortized until development is complete. If the associated research and development effort is abandoned, the Company’s IPR&D intangible asset will be written-off and the Company will record a noncash impairment loss on its statements of operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. IPR&D was $11.1million as of December 31, 2025 and 2024, respectively.

4. Accrued expenses and other current liabilities

Accrued expenses and other current liabilities at December 31, 2025 and 2024 consist of the following components (in thousands):

December 31,

Accrued payroll and bonuses $ 1,821 $ 1,817

Accrued research and development 1,117 988

Accrued legal, regulatory, professional and other 271 404

Operating lease liability - current 137 120

Total accrued expenses and other current liabilities $ 3,346 $ 3,329

5. Warrants and Equity

Warrant and Stock Issuances

On December 21, 2025, the Company entered into separate warrant amendment agreements (collectively, the “Warrant Amendment”) with the holders of its Series E, Series F, and Series G warrants (each as defined below, and collectively, the “Warrants”). Pursuant to the Warrant Amendment, the exercise prices of the Warrants were reduced to $3.90 per share (which were subsequently further adjusted as described in Note 9 below). In addition, the Series E and Series F warrants were amended to eliminate certain price adjustment provisions and to revise the definition of “Black-Scholes Value". The revised definition of Black-Scholes Value modified the expected volatility input used in the Black-Scholes option pricing model by eliminating the use of 30-day and 365-day historical volatility measures and limiting the volatility input to the greater of (i) 100-day historical volatility, as obtained from Bloomberg, or (ii) 100%. All other inputs to the Black-Scholes model, including the risk-free interest rate, underlying stock price, expected term, and cost of borrowing, remained unchanged. As a result of the Warrant Amendment, the Company determined that the Series E and Series F warrants qualified for equity classification prospectively under applicable accounting guidance. Accordingly, upon the effectiveness of the Warrant Amendment, the Series E and Series F warrants were reclassified from liability to equity. In connection with the reclassification, the Company remeasured the Series E and Series F warrant liabilities to fair value immediately prior to reclassification, resulting in the recognition of a $24.4 million gain in the consolidated statement of operations. The Company then reclassified approximately $16.0 million of Series E and Series F warrant liabilities to additional paid-in capital. In addition, the Company recorded a loss on extinguishment of warrant liabilities of $0.6 million and a warrant-related deemed dividend of $0.1 million, which was recorded within additional paid-in capital and recognized as a reduction to income available to common stockholders.

On December 9, 2025, the Company entered into warrant exercise inducement agreements with holders of certain outstanding Series C, Series D and Series F warrants, pursuant to which such holders agreed to exercise warrants to purchase an aggregate of 1,044,329 shares of the Company’s common stock at reduced or existing exercise prices in exchange for the issuance of Series G warrants to purchase up to 2,610,823 shares of common stock, representing 250% of the shares underlying the exercised warrants, with a five-year exercise term. The Company received gross proceeds of approximately $6.8 million from the warrant exercises. Pursuant to ASC 815, and in accordance with the Company’s accounting policy, the Company determined that Series G warrants met the criteria for equity classification as of their issuance date.

In August 2025, the Company entered into a warrant exercise inducement offer letter with holders of certain existing warrants pursuant to which the holders agreed to exercise Series E warrants to purchase up to 648,649 shares of common stock with an exercise price of $9.25 per share in exchange for the Company issuing new Series F warrants to purchase 2,594,595 shares of the Company's common stock. Each Series F warrant had an exercise price of $13.75 per share and is exercisable as of the date of issuance to October 16, 2030. The Company received gross proceeds of $6.0 million. In addition, during August and September 2025, 119,848 shares of Series E warrants were exercised for $1.1 million. Upon issuance the Series F warrants were initially classified as liability warrants. Pursuant to the Warrant Amendment described above, the Series F warrants were equity-classified as of December 21, 2025.

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In June 2025, the Company closed a public offering of (i) 398,881 shares of the Company’s common stock; (ii) pre-funded warrants to purchase up to an aggregate of 244,319 shares of common stock; and (iii) Series E warrants to initially purchase up to an aggregate of 1,929,600 shares of common stock (of which Series E warrants to purchase 649,649 shares of common stock were exercised as described in the above paragraph). The combined purchase price for the securities was $9.25 per share of common stock (or pre-funded warrant in lieu thereof). Each pre-funded warrant was exercisable for one share of common stock at an exercise price of $0.025 per share. All of the pre-funded warrants were exercised during the three months ended June 30, 2025. Each Series E warrant had an initial exercise price of $9.25 per share (which was subsequently adjusted as described in Note 9 below) and became exercisable beginning on the effective date of stockholder approval on August 18, 2025, at the Company's Annual Meeting. The Company also received approval at the Annual Meeting to increase its authorized shares of common stock to 500,000,000, such that it can issue all shares of common stock required under the Series E warrants upon any future adjustments to the exercise price of the Series E warrants. The Series E warrants provide that if, while the Series E warrants are outstanding, the Company sells any common stock and/or common stock equivalents other than in connection with certain exempt issuances (as defined in the Series E warrant agreement), at a purchase price per share less than the exercise price of the Series E warrants in effect immediately prior to such sale, then immediately after such sale the exercise price of the Series E warrants then in effect will be reduced to an amount equal to such new issuance price, and, the number of shares issuable upon exercise of the Series E warrants will be proportionately adjusted such that the aggregate price will remain unchanged, subject to the floor price of $3.00 (Down Round Feature). The Series E warrants expire on August 18, 2030. As of November 10, 2025, the Company had received gross proceeds of $7.5 million and may receive up to an additional approximately $10.3 million in gross proceeds if the Series E warrants are fully exercised for cash. Proceeds of offerings are allocated between common shares and Series E warrants first by allocating to the Series E warrants classified as a liability based on their fair value and then allocating the residual to the equity instruments, which would include pre-funded warrants. The fair value of the Series E warrants was $16.3 million on the issuance date. Because the fair value of the liability classified warrants issued in the June 2025 offering exceeded the total proceeds, no consideration was allocated to the common stock or pre-funded warrants. The full proceeds from the June 2025 offering were recorded as warrant liabilities, and the Company recognized a $10.4 million loss on the issuance of the Series E warrants. The Company also incurred $1.2 million in transaction costs related to the June 2025 public offering. Pursuant to the Warrant Amendment, 2,628,175 of the Company’s 2,642,420 outstanding Series E warrants were reclassified from warrant liabilities to equity as of December 21, 2025.

In February 2025, the Company entered into a securities purchase agreement with an institutional investor for the sale by the Company of 46,000 shares of common stock, and 84,841 pre-funded warrants to purchase shares of common stock, and Series D warrants to purchase up to 261,722 shares of common stock. The combined purchase price for the securities was $26.75 per share of common stock (or pre-funded warrant in lieu thereof). Each pre-funded warrant was exercisable for one share of common stock at an exercise price of $0.025 per share. All of the pre-funded warrants were exercised during the three months ended March 31, 2025. Each Series D warrant will expire five years from the initial exercise date. The Company received gross proceeds of $3.5 million. Based on the change in accounting policy as noted in Note 2, these Series D warrants are classified within equity for all periods presented within these consolidated financial statements.

In February 2025, the Company entered into a warrant exercise inducement offer letter with a holder of certain existing warrants to receive new warrants to purchase up to a number of shares of common stock equal to 200% of the number of warrant shares issued pursuant to the exercise of such existing warrants to purchase up to 233,143 shares of common stock pursuant to which the holder agreed to exercise for cash their existing warrants at a reduced exercise price of $25.00 in exchange for the Company's agreement to issue the inducement warrants to purchase up to 466,286 shares (Series C warrants) of the Company's common stock. Each Series C warrant had an exercise price of $18.75 and was exercisable as of the date of issuance and may be exercised for a period of five years. The Company received gross proceeds of $5.8 million. Total gross proceeds received in the two February 2025 transactions were $9.3 million. Based on the change in accounting policy as noted in Note 2, these Series C warrants are classified within equity for all periods presented within these consolidated financial statements.

Other Components of Equity and Share Issuances

During the years ended December 31, 2025 and 2024, the Company issued 2,351 and 273 shares of common stock, respectively, to consultants for services provided and 796 and 819 shares, respectively, upon the vesting of restricted stock units (“RSUs”). In February 2026, the Company issued 1,997 shares of common stock upon the vesting of RSUs that vested during the fourth quarter of 2025.

Preferred Stock

The Company's certificate of incorporation authorizes the Company to issue these shares in one or more series, to determine the designations and the powers, preferences and relative, participating, optional or other special rights and the qualifications, limitations and restrictions thereof, including the dividend rights, conversion or exchange rights, voting rights (including the number of votes per share), redemption rights and terms, liquidation preferences, sinking fund provisions and the number of shares constituting the series. No preferred stock was issued or outstanding as of December 31, 2025.

At Market Issuance Sales Agreement (ATM)

On December 31, 2025, the Company increased the maximum aggregate gross sales price of the Company’s common stock that may be offered, issued and sold under a certain At Market Offering Agreement (2025 ATM Agreement) with Roth Capital Partners, LLC (Roth), which the Company initially entered into in July 2025, from $6.5 million to $8.2 million. Pursuant to the terms of the 2025 ATM Agreement, the Company may offer and sell shares of its common stock having an aggregate offering price of up to $8.2 million from time to time through or to Roth, acting as sales agent or principal. Roth may sell shares of the Company’s common stock in negotiated transactions at market prices prevailing at the time of sale or at prices related to such prevailing market prices, and either party may terminate the 2025 ATM Agreement upon two business days’ notice.

The Company has agreed to pay Roth a commission equal to 3.0% of the gross proceeds from any shares of common stock sold under the 2025 ATM Agreement, in addition to reimbursing certain expenses. The 2025 ATM Agreement will terminate upon the sale of shares having an aggregate offering price equal to the maximum amount authorized under the agreement. During the fourth quarter of 2025, the Company sold 1,130,420 shares of common stock pursuant to the 2025 ATM Agreement for gross proceeds of approximately $1.1 million.

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Warrant Background

Upon its issuance of warrants to purchase shares of common stock, the Company evaluates the terms of the warrant issue to determine the appropriate accounting and classification of the warrant issue pursuant to FASB ASC Topic 480, Distinguishing Liabilities from Equity, FASB ASC Topic 505, Equity, FASB ASC 815, Derivatives and Hedging, and ASC 718, Compensation - Stock Compensation. Warrants that meet the criteria for liability classification under ASC 480, or that do not meet the criteria for equity classification under ASC 815 due to exercise contingencies, settlement provisions, or other contractual terms, are accounted for as derivative liabilities.

Liability classified warrants are measured at fair value on the date of issuance and remeasured at fair value at each reporting date in accordance with FASB ASC 820, Fair Value Measurement (ASC 820), and are presented as warrant liabilities on the Company’s consolidated balance sheet. Changes in the fair value of warrant liabilities are recognized as gains or losses from changes in fair value of warrant liabilities in the Company’s consolidated statement of operations.

Equity-classified warrants issued to non-employees in exchange for services are accounted for in accordance with ASC 718, which requires stock-based compensation to be recognized in the consolidated statements of operations based on the warrants’ grant-date fair value. For further information, see Note 2, Basis of Presentation, Principles of Consolidation and Significant Accounting Policies—Stock-Based Compensation.

At December 31, 2025 and 2024, the Company has the following warrants outstanding:

Liability Classified Warrants (1)

Equity Classified Warrants

(1) If the Company subdivides (by any stock split, stock dividend, recapitalization or otherwise) its outstanding shares of its common stock into a smaller number of shares, the warrant exercise price is proportionately reduced and the number of shares under outstanding warrants is proportionately increased. Additionally, if the Company combines (by combination, reverse stock split or otherwise) its outstanding shares of common stock into a smaller number of shares, the warrant exercise price is proportionately increased and the number of shares under outstanding warrants is proportionately decreased.

Liability Classified Warrants

The Company applies a Monte Carlo simulation model to appropriately reflect the impact of the Down Round Feature to the Series E Warrants. The risk-free interest rate assumption is based upon observed interest rates on zero coupon US 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.

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The assumptions used in determining the fair value of the Company’s outstanding liability classified warrants as of December 31, 2025 are as follows:

Risk-free interest rate 3.63%

Expected life (years) 4.6

Dividend yield —%

During the year ended December 31, 2025, the exercise price and number of shares underlying certain warrants were adjusted pursuant to the anti-dilution provisions of the warrant agreements. These adjustments were triggered by the Company’s reverse stock split and the issuance of common stock and common stock equivalents at prices below the then-current exercise prices of such warrants. In the aggregate, these adjustments increased the number of shares underlying the affected warrants by 1,528,326 shares. The resulting changes are reflected in the warrant activity rollforward below.

Number of Shares Weighted Average Weighted Average Remaining Contractual

Under Warrant Exercise Price Life (Years)

Balance at January 1, 2025 — $ — -

For a summary of the changes in fair value associated with the Company's warrant liability for the years ended December 31, 2025 and 2024, see Note 2. Basis of presentation, principles of consolidation and significant accounting policies – Fair Value of Financial Instruments.

Equity Classified Warrants

A summary of the Company's equity classified warrant activity during the year ended December 31, 2025 and related information follows:

Number of Shares Weighted Average Weighted Average Remaining Contractual

Under Warrant Exercise Price Life (Years)

The Company’s equity awards granted during the year ended December 31, 2025 primarily consisted of Series C and Series D warrants granted during the quarter ended March 31, 2025, Series G warrants issued in connection with the Company’s warrant exercise inducement in December 2025, and Series E and Series F warrants that were reclassified to equity upon execution of the Warrant Amendment in December 2025. Equity awards exercised during the year ended December 31, 2025 primarily consisted of the exercise of Series A, B, C, D, E and F warrants.

In September 2025, the Company granted equity classified warrants to purchase up to 14,000 shares of the Company’s common stock with a ten year term and an exercise price of $10.75 per share. These warrants vest annually over four years, subject to continued service. In July 2025, the Company issued 8,000 equity-classified warrants to a consultant, of which 4,000 vested immediately and 4,000 vest upon the execution of a letter of intent or the closing of a licensing transaction with a value of $10.0 million or more. In January 2025, the Company granted equity classified warrants to two consultants to purchase up to 2,000 shares of common stock each, with a ten-year term and an exercise price of $41.00 per share. Of these warrants, 2,000 vest upon the performance of specified services and the remaining 2,000 vest annually over four years.

In October 2024, the Company issued equity classified warrants to consultants to purchase up to 1,440 shares of common stock. Of these warrants, 1,200 vest annually over four years, 200 vest monthly over three years, and 40 vested immediately upon issuance. In March 2024, the Company granted equity classified warrants to purchase up to 133 shares of common stock with a ten year term and an exercise price of $228.75 per share. These warrants vest annually over four years, subject to continued service.

6. Stock Based Compensation

Stock Plan, Stock-based Compensation and Outstanding Awards

In October 2024, the Company’s Board of Directors approved the Moleculin Biotech, Inc. 2024 Equity Incentive Plan (the “2024 Stock Plan”), which replaced the Company’s 2015 Stock Plan. The 2024 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 of the Company.

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All share and per share amounts presented herein reflect the effect of the Company’s 1-for-25 reverse stock split completed on December 1, 2025.

As initially approved, 40,000 shares of the Company’s common stock were reserved for issuance under the 2024 Stock Plan. In August 2025, the Company’s stockholders approved an amendment to the 2024 Stock Plan to increase the number of shares authorized for issuance from 40,000 shares to 280,000 shares of the Company’s common stock. As of December 31, 2025, there were 22,105 shares available for future issuance under the 2024 Stock Plan.

Stock-based compensation expense for the years ended December 31, 2025 and 2024 is as follows (in thousands):

Year Ended December 31,

General and administrative $ 1,181 $ 1,310

Research and development 483 416

Total stock-based compensation $ 1,664 $ 1,726

Each of the Company’s stock-based compensation arrangements are discussed below.

Stock Options

Stock option awards are generally granted with an exercise price equal to the market price of the Company’s stock at the date of grant. Stock option awards generally have a 10-year contractual term and vest over a 4-year period for employees and over a 1 to 3-year period for directors from the grant date on a straight-line basis over the requisite service period. The grant-date fair value of stock options is determined using the Black-Scholes option-pricing model (BSM). Additionally, the Company’s stock options provide for full vesting of unvested outstanding options, in the event of a change of control of the Company.

The fair value of each stock option is estimated on the date of grant using the BSM model that uses the assumptions noted below. The expected term of the stock option awards was computed using the plain vanilla method as prescribed by the Securities and Exchange Commission Staff Accounting Bulletin 107 because the Company does not have sufficient data regarding employee exercise behavior to estimate the expected term. Beginning in 2020, the Company used the volatility of its own stock in the BSM as it now has sufficient historic data in its stock price. The risk-free rate for periods within the contractual life of the option is based on the US Treasury yield curve in effect at the time of grant.

The fair value of the option grants has been estimated, with the following weighted-average assumptions:

Year Ended December 31,

Risk-free interest rate 3.8 % 4.0% to 4.5%

Expected life (years) 6.25 5.1 to 6.3

Expected dividend yield — % — %

Stock option activity for the year ended December 31, 2025 is as follows:

Options granted during 2025 and 2024 have an aggregated grant date fair value of $1.5 million and $1.1 million, respectively, that was calculated using the Black-Scholes option-pricing model. At December 31, 2025, total compensation cost not yet recognized was $2.5 million and the weighted average period over which this amount is expected to be recognized is 3.9 years. The aggregate fair value of options vested was $1.1 million and $1.2 million in the years ended December 31, 2025 and 2024, respectively.

The Company recorded stock compensation expense for the non-employee consulting agreements of $88,000 and $120,000 for the years ended December 31, 2025 and 2024, respectively. At December 31, 2025, there was $8,000 of unrecognized stock compensation expense related to the Company's equity-classified warrants.

Restricted Stock Units

Restricted stock units (RSU) are granted with a grant date fair value determined using the closing price of the Company's common stock on the grant date. Restricted stock units vest annually in four equal installments. Additionally, the Company's restricted stock unit agreements provide for full vesting of the restricted stock award in the event of a change of control of the Company.

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RSU activity for the year ended December 31, 2025 is as follows:

Granted — $ — -

As of December 31, 2025, total compensation cost for RSUs not yet recognized was $0.7 million and the weighted average period over which this amount is expected to be recognized is 2.6 years.

Performance-Based Restricted Stock Units

Performance-based restricted stock units (PSU) are granted primarily to our executive officers and only vest when specific conditions are met based on pre-established performance goals for the Company. PSUs are expensed only when meeting those conditions are deemed probable.

PSU activity for the year ended December 31, 2025 is as follows:

As of December 31, 2025, total compensation cost for PSUs not yet recognized was $1.7 million. The weighted average remaining contract term for these awards is 9.9 years.

In November 2025, the Company granted 62,000 PSUs to executive officers. Each PSU vests in equal tranches upon the achievement of specified clinical and operational milestones related to the Company’s MIRACLE clinical trial, including patient enrollment thresholds, achievement of defined clinical data outcomes, and advancement to subsequent study phases. Vesting of each tranche is subject to certification by the Company’s board of directors or its compensation committee. Stock-based compensation expense for these performance-based awards is recognized when achievement of the applicable performance conditions is considered probable, based on management’s best estimates, which incorporate the inherent risks and uncertainties associated with achieving the underlying milestones. As of the issuance date and through December 31, 2025, none of the performance conditions were considered probable; accordingly, no compensation expense was recognized for these performance-based vesting awards.

In December 2023, the Company granted 2,935 PSUs to executive officers. Each PSU will vest upon the first of the following to occur: (a) a licensing transaction with a valuation, at the time, in excess of $150 million, which valuation shall be determined by the Board; (b) the filing of a new drug application; or (c) upon a Change in Control (as defined in the Plan), in each case subject to the respective executive officer's continued service with the Company as of each such vesting date. Recognition of stock-based compensation expense associated with these performance-based stock options commences when the performance condition is considered probable of achievement, using management’s best estimates, which consider the inherent risk and uncertainty regarding the future outcomes of the milestones. As of the date of issuance and through December 31, 2025, none of the performance goals were deemed probable, and as a result, no expense was recognized for these performance-based vesting awards.

7. Income Taxes

The provision for income taxes consists of the following components (in thousands):

Year Ended December 31,

Current expense (benefit):

Federal $ — $ —

State — —

Foreign — —

Current income tax benefit — —

Deferred expense (benefit):

Federal — —

State — —

Foreign — —

Deferred income tax expense — —

Total $ — $ —

Table of Contents

The following summarizes activity related to the Company’s valuation allowance (in thousands):

Year Ended December 31,

Valuation allowance at beginning of period $ 38,637 $ 32,308

Change charged to expense (income) 5,032 6,329

Release of valuation allowance — —

Valuation allowance at end of period $ 43,669 $ 38,637

The domestic and foreign components of the Company's loss before tax provision for the years ended December 31, 2025 and 2024, were as follows (in thousands):

Year Ended December 31,

The following summarizes the Company’s cash taxes paid by jurisdiction (in thousands):

Year Ended December 31,

Federal $ — $ —

State — —

Foreign — —

Total taxes paid $ — $ —

A reconciliation of the income tax benefit computed using the federal statutory income tax rate to the Company’s effective income tax rate is as follows (in thousands):

Year Ended December 31,

Amount Percent Amount Percent

Federal tax (benefit) at statutory rate $ (7,034 ) 21.0 % $ (5,431 ) 21.0 %

State and local income Taxes — - (34 ) -

Foreign tax effects — - — -

Change in tax laws and rates — - — -

Effects of cross-border tax laws — - — -

Federal tax credits — - — -

Nontaxable or nondeductible items

Other permanent differences 74 - 60 (0.2 )

Total tax (expense) benefit $ — - % $ — (0.0 )%

The principal components of the Company’s deferred tax assets and liabilities consist of the following (in thousands):

Year Ended December 31,

Deferred tax assets:

Federal net operating loss carryforwards 15,972 12,965

State tax loss carryforwards 270 560

Foreign net operating loss carryforwards 290 332

Net deferred tax assets $ 68 $ 92

Deferred tax liabilities:

ROU Asset $ (68 ) $ (92 )

MBRX US Equity

MBRX · 10-K · period ended 2025-12-31

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

ITEM 9A. CONTROLS AND PROCEDURES

ITEM 9B. OTHER INFORMATION.

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

ITEM 11. EXECUTIVE COMPENSATION

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES

ITEM 15. EXHIBITS AND FINANCIAL STATEMENTS

ITEM 16. FORM 10-K SUMMARY

MBRX US Equity☆

MBRX · 10-K · period ended 2025-12-31

ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

ITEM 9A. CONTROLS AND PROCEDURES

ITEM 9B. OTHER INFORMATION.

ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

ITEM 11. EXECUTIVE COMPENSATION

ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES

ITEM 15. EXHIBITS AND FINANCIAL STATEMENTS

ITEM 16. FORM 10-K SUMMARY

MBRX US Equity