Moleculin Biotech, Inc. 10-K

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. 54 Table of Contents We believe that our lead drug candidate Annamycin has: ● The following advantages over early-generation anthracyclines which in their totality support Annamycin’s classification as a “next-generation” anthracycline: 1) demonstrated across five clinical trials to be non-cardiotoxic (n=90) with some patients being safely dosed at five times the typical lifetime maximum allowable anthracycline dose, (which potentially enables repeated dosing, consolidation and even use as a maintenance therapy); 2) exhibits no vesicant activity as well as greater tolerability, making it safer to handle and administer and easier on patients; 3) shown in preclinical models to circumvent multidrug resistance by avoiding MDR1 mechanisms and also to avoid cross-resistance with some of the most commonly used drugs for the treatment of AML (as well as many other cancers), including currently approved early-generation anthracyclines, cytarabine and venetoclax and, 4) exhibited in preclinical models substantially improved tissue/organ distribution; ● Demonstrated a complete remission (CR) rate of 50% and a composite complete remission (CRc) rate of 60% in combination with Cytarabine for the treatment of R/R AML as second line therapy (n=10). On an all comer’s basis (no limit on prior lines of therapy), the population of subjects who achieved a CR (n=8) demonstrated durability of approximately 13 months with median overall survival of 15 months and developing at the time of analysis, with 4 of 8 subjects (50%) censored; ● Shown promising blinded safety and efficacy data for the first 30 subjects treated in the MIRACLE trial as we head towards the planned interim unblinding of data for the first 45 subjects treated with efficacy data in Part A of the MIRACLE trial in mid-2026; ● Shown encouraging activity in a total of five different clinical trials (most of which are now complete), funded both internally and externally (through investigator-initiated trials); specifically including relapsed and refractory AML with complete remission rates significantly above currently approved second line therapies and STS lung mets with overall survival as a median seventh line therapy comparable to overall survival seen with approved first line monotherapies; and ● Obtained composition of matter patent protection through 2040 with the potential to extend as far as 2045 as well as Orphan Drug and Fast Track designation. 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: a. Internally funded – In combination with Cytarabine (also known as Ara-C, the combination with Annamycin of which is referred to as AnnAraC) for the treatment of R/R AML, and b. Externally funded – Advancing beyond our initial Phase 1B/2 internally funded trial for the treatment of STS metastasized to the lungs. c. Externally funded – Based on sponsored research, we intend to begin in 2026 a Phase 1B/2 clinical trial with Annamycin as a monotherapy treating 3 rd line pancreatic cancer. d. Internally funded – MB-109 utilizing AnnAraC for R/R AML as 3 rd line therapy in adults is planned for 2027. e. Externally funded – MB-110 utilizing AnnAraC for R/R AML as 2 nd line therapy in pediatrics is planned for 2027. We are researching potential sites for a grant funded trial. 2. WP1066: a. Externally funded - An improved formulation for delivery intravenously (IV) of a molecule from the WP1066 portfolio to possibly further support future externally funded oncology clinical trials. Such a formulation requires additional preclinical work prior to a clinical trial. b. Externally funded - Phase 1B/2 trial for WP1066 oral formulation in combination with radiation treating glioblastoma (GBM) both in adults and pediatrics. An adult clinical trial is in process and a pediatric trial is in the planning stage. 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. 55 Table of Contents 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, 2025 2024 Revenue $ — $ — Operating expenses: Research and development 15,891 17,729 General and administrative 9,122 8,786 Depreciation and amortization 90 126 Total operating expense 25,103 26,641 Loss from operations (25,103 ) (26,641 ) 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 Interest income, net 105 550 Net loss $ (33,560 ) $ (26,048 ) 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. 56 Table of Contents 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. 57 Table of Contents 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, 2025 2024 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 w as de minimis f or 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 . 58 Table of Contents 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 incurred to conduct research, such as the discovery and development of our product candidates; • costs related to production of clinical supplies, including fees paid to contract manufacturers and drug manufacturing costs; • fees paid to clinical consultants, clinical trial sites and vendors, including clinical research organizations, in preparation for clinical trials and our IND and Orphan Drug applications with the FDA; and • 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. 59 Table of Contents 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. 60 Table of Contents 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.