SEC Form 10-Q filed by Moleculin Biotech Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
or
For the transition period from to
Commission File Number:
| MOLECULIN BIOTECH, INC. | |||||||||||||
| (Exact name of registrant as specified in its charter) | |||||||||||||
| | 2834 | | |||||||||||
| (State or Other Jurisdiction of Incorporation or Organization) | (Primary Standard Industrial Classification Code Number) | (IRS Employer Identification Number) | |||||||||||
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| (Address of principal executive offices) | (Zip Code) | |||||||
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Registration S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.:
| Large accelerated filer ☐ | Smaller reporting company | |||||||
| | Emerging growth company | |||||||
| Accelerated filer ☐ | ||||||||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.): Yes
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol (s) | Name of each exchange on which registered | ||||||
| | | The |
The registrant had
Form 10-Q
Table of Contents
| Page |
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| Item 1. |
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| Condensed Consolidated Balance Sheets as of March 31, 2026 and December 31, 2025 |
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| Condensed Consolidated Statements of Cash Flows for the Three Months ended March 31, 2026 and 2025 |
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| Item 2. |
Management's Discussion and Analysis of Financial Condition and Results of Operations |
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| Item 3. |
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| Item 4. |
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| Item 1. |
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| Item 1A. |
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| Item 2. |
Unregistered sales of Equity Securities and Uses of Proceeds |
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| Item 3. |
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| Item 4. |
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| Item 5. |
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| Item 6. |
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Condensed Consolidated Balance Sheets
(in thousands, except for share and per share data)
(Unaudited)
| March 31, | December 31, | |||||||
| 2026 | 2025 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Intangible assets | ||||||||
| Other non-current assets | ||||||||
| Operating lease right-of-use asset | ||||||||
| Furniture and equipment, net | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses and other current liabilities | ||||||||
| Total current liabilities | ||||||||
| Operating lease liability - long-term, net of current portion | ||||||||
| Warrant liability | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 7) | ||||||||
| Stockholders' equity | ||||||||
| Preferred stock, $ par value; shares authorized, shares issued or outstanding | ||||||||
| Common stock, $ par value; shares authorized; and shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated other comprehensive income (loss) | ( | ) | ||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
See accompanying notes to these condensed consolidated financial statements.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(Unaudited)
| Three Months Ended March 31, |
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| 2026 |
2025 |
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| Revenues |
$ | $ | ||||||
| Operating expenses: |
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| Research and development |
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| General and administrative |
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| Depreciation and amortization |
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| Total operating expenses |
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| Loss from operations |
( |
) | ( |
) | ||||
| Other income (loss): |
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| Gain from change in fair value of warrant liability |
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| Transaction costs allocated to warrant liabilities |
( |
) | ||||||
| Loss on issuance of warrant liabilities |
( |
) | ||||||
| Other income, net |
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| Interest income, net |
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| Net loss |
$ | ( |
) | $ | ( |
) | ||
| Warrant deemed dividend |
( |
) | ||||||
| Net loss available to common stockholders |
$ | ( |
) | $ | ( |
) | ||
| Net loss per common share - basic and diluted |
$ | ( |
) | $ | ( |
) | ||
| Weighted average common shares outstanding, basic and diluted |
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| Net loss |
$ | ( |
) | $ | ( |
) | ||
| Other comprehensive income (loss): |
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| Foreign currency translation |
( |
) | ||||||
| Comprehensive loss |
$ | ( |
) | $ | ( |
) | ||
See accompanying notes to these condensed consolidated financial statements.
Condensed Consolidated Statements of Cash Flows
(in thousands)
| Three Months Ended March 31, |
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| 2026 |
2025 |
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| Cash flows from operating activities: |
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| Net loss |
$ | ( |
) | $ | ( |
) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: |
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| Depreciation and amortization |
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| Stock-based compensation |
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| Change in fair value of warrant liability |
( |
) | ||||||
| Loss on issuance of warrant liabilities |
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| Operating lease, net |
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| Transaction costs allocated to warrant liabilities |
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| Changes in operating assets and liabilities: |
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| Prepaid expenses and other assets |
( |
) | ||||||
| Accounts payable |
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| Accrued expenses and other current liabilities |
( |
) | ||||||
| Net cash used in operating activities |
( |
) | ( |
) | ||||
| Cash flows from investing activities: |
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| Net cash used in investing activities |
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| Cash flows from financing activities: |
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| Proceeds from sale of common stock, pre-funded and common warrants and warrant inducement, net of issuance and transaction costs |
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| Proceeds from exercise of warrants |
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| Net cash provided by financing activities |
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| Effect of exchange rate changes on cash and cash equivalents |
( |
) | ||||||
| Net increase in cash and cash equivalents |
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| Cash and cash equivalents - beginning of period |
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| Cash and cash equivalents - end of period |
$ | $ | ||||||
| Non-cash investing and financing activities: |
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| Equity warrants issued in relation to liability classified warrant inducements |
$ | $ | ||||||
| Reclassification of warrant liabilities to equity upon contractual reset of exercise price |
$ | $ | ||||||
| Deemed dividend in connection with warrant amendment |
$ | $ | ||||||
| Offering costs included in accounts payable and accrued liabilities |
$ | $ | ||||||
| Transaction costs related to the sale of common stock, pre-funded and common warrants, and warrant inducements |
$ | $ | ||||||
See accompanying notes to these condensed consolidated financial statements.
Condensed Consolidated Statements of Stockholders’ Equity
(in thousands, except for shares)
(Unaudited)
| Three Months Ended March 31, 2026 |
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| Common stock - shares |
Common stock - Par Value Amount |
Additional Paid-In Capital |
Accumulated Deficit |
Accumulated Other Comprehensive Income (Loss) |
Total |
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| Balance, December 31, 2025 |
$ | $ | $ | ( |
) | $ | $ | |||||||||||||||||
| Warrant inducement and exercise of common stock warrants |
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| Issuance of common stock in connection with Consulting Agreements |
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| Issuance of common stock under at-the-market equity program, net of transaction costs |
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| Warrants exercised |
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| Common stock issued upon vesting of restricted stock units (net of taxes) |
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| Reclassification of warrant liabilities to equity upon contractual reset of exercise price |
— | |||||||||||||||||||||||
| Warrant deemed dividend |
— | |||||||||||||||||||||||
| Deemed dividend in connection with warrant amendment |
— | ( |
) | ( |
) | |||||||||||||||||||
| Stock-based compensation |
— | |||||||||||||||||||||||
| Consolidated net loss |
— | ( |
) | ( |
) | |||||||||||||||||||
| Cumulative translation adjustment |
— | ( |
) | ( |
) | |||||||||||||||||||
| Balance, March 31, 2026 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||
| Three Months Ended March 31, 2025 |
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| Common stock - shares |
Common stock - Par Value Amount |
Additional Paid-In Capital |
Accumulated Deficit |
Accumulated Other Comprehensive Income (Loss) |
Total |
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| Balance, December 31, 2024 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||
| Warrant inducement and exercise of repriced common stock warrants at $1.00 per share |
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| Warrants exercised |
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| Issued for cash - sale of common stock, pre-funded and common warrants |
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| Stock-based compensation |
— | |||||||||||||||||||||||
| Consolidated net loss |
— | ( |
) | ( |
) | |||||||||||||||||||
| Equity warrants issued |
— | |||||||||||||||||||||||
| Cumulative translation adjustment |
— | |||||||||||||||||||||||
| Balance, March 31, 2025 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | |||||||||||||||
See accompanying notes to these condensed consolidated financial statements.
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
1. Nature of Business
The terms “MBI” or “the Company”, “we”, “our” and “us” are used herein to refer to Moleculin Biotech, Inc. MBI is a clinical-stage pharmaceutical company, organized as a Delaware corporation in July 2015. 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. In June 2018, we formed Moleculin Australia Pty. Ltd., a wholly owned subsidiary to oversee pre-clinical development in Australia. In April 2026, the board of directors of both MBI and the Australian subsidiary approved the closing of this subsidiary to reduce corporate overhead costs. With the MIRACLE trial focused in the US, Europe, and, possibly, the Middle East future activities are not anticipated to include Australia.
Each of its 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, has completed several clinical trials in AML and soft tissue sarcoma 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 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 and there is another pediatric brain tumor trial also in the planning states for late 2026.
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
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
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 $
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 $
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 and liquidity
Reverse Stock Split - On December 1, 2025, pursuant to authority granted by our stockholders, the Company effected a 1-for-
Basis of Presentation – Condensed Consolidated Financial Information - The accompanying condensed consolidated financial statements and related notes have been prepared in accordance with accounting principles generally accepted in the US (US GAAP) for financial information, and in accordance with the rules and regulations of the US Securities and Exchange Commission (SEC) with respect to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by US GAAP for complete financial statements. The condensed consolidated financial statements furnished reflect all normal adjustments, which are, in the opinion of management, necessary for a fair statement of results for the interim periods presented. Interim results are not necessarily indicative of the results for the full year. These condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company as of December 31, 2025, and for the year then ended, including the notes thereto contained in the Form 10-K filed with the SEC on March 18, 2026.
Principles of Consolidation - The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. The Company views its operations and manages its business in
Segment Information - Management has determined that the Company operates in 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 and general and administrative expenses. 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.
Significant Accounting Policies - The Company's significant accounting policies are described in Note 2, Basis of Presentation, principles of consolidation and significant accounting policies, to the consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2025. There have been no material changes to the significant accounting policies during the three months ended March 31, 2026, except as discussed further below under Changes in Accounting Policy.
Use of Estimates - The preparation of these condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of financial statements. Estimates are used in the following areas, among others: fair value estimates on intangible assets, warrants, and stock-based compensation expense, as well as accrued expenses and taxes.
Going Concern and Liquidity - These condensed consolidated financial statements have been prepared on a going concern basis, which assumes the Company will continue to realize its assets and discharge its liabilities in the normal course of business. The continuation of the Company as a going concern is dependent upon the ability of the Company to obtain necessary financing to continue operations and the attainment of profitable operations. As of March 31, 2026, the Company had an accumulated deficit of $
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. 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.
Intangible Assets – Intangible assets with finite lives are amortized using the straight-line method over their estimated period of benefit. Acquired intangible assets identified as in-process research and development (IPR&D) assets, are considered indefinite lived until the completion or abandonment of the associated research and development efforts. If the associated research and development effort is abandoned, the related IPR&D assets will be written-off and the Company will record a noncash impairment loss on its statements of operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. Intangible assets are tested for impairment on an annual basis, which was completed as of September 30, 2025, 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.
Prepaid Expenses and Other Current Assets - Prepaid expenses and other current assets consist of the following (in thousands):
| March 31, 2026 | December 31, 2025 | |||||||
| Prepaid insurance | $ | $ | ||||||
| Vendor prepayments and deposits | ||||||||
| Prepaid sponsored research | ||||||||
| Non-trade receivables | ||||||||
| Total prepaid expenses and other current assets | $ | $ | ||||||
Other Non-Current Assets - The Company provided a cash deposit on the MB-108 trial that is expected to be held as a prepayment until the end of the study in 2029.
Fair Value of Financial Instruments - The Company's financial instruments consist primarily of non-trade receivables, accounts payable, accrued expenses and its warrant liability. The carrying amount of non-trade receivables, accounts payable, and accrued expenses approximates their fair value because of the short-term maturity of such.
The Company has categorized its assets and liabilities that are valued at fair value on a recurring basis into a three-level fair value hierarchy in accordance with 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 condensed consolidated balance sheets at fair value are categorized based on a hierarchy of inputs as follows:
Level 1 – Unadjusted quoted prices in active markets of identical assets or liabilities.
Level 2 – Quoted prices for similar assets or liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.
Level 3 – Unobservable inputs for the asset or liability.
The Company’s financial assets and liabilities recorded at fair value on a recurring basis include the fair value of warrant liability discussed in Note 4.
The following table provides the financial liabilities reported at fair value and measured on a recurring basis at March 31, 2026 and December 31, 2025 (table in thousands):
| Description | Fair Value | Level 1 | Level 2 | Level 3 | ||||||||||||
| Fair value of warrant liability as of March 31, 2026: | $ | $ | $ | $ | ||||||||||||
| Fair value of warrant liability as of December 31, 2025: | $ | $ | $ | $ | ||||||||||||
The table below of Level 3 liabilities (table in thousands) begins with the valuation as of the beginning of the first quarter and then is adjusted for changes in fair value that occurred during the first quarter. The ending balance of the Level 3 financial instrument presented above represents the Company's best estimates and may not be substantiated by comparison to independent markets and, in many cases, could not be realized in immediate settlement of the instruments.
| Three Months Ended March 31, 2026 | Warrant Liability Long-Term | |||
| Balance, December 31, 2025 | $ | |||
| Warrants issued | ||||
| Warrants exercised | ( | ) | ||
| Warrants reclassification | ( | ) | ||
| Change in fair value - net | ( | ) | ||
| Balance, March 31, 2026 | $ | |||
Loss Per Common Share - Basic net loss per common share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding during the period. For purposes of this calculation, options to purchase common stock, restricted stock units subject to vesting and warrants to purchase common stock are considered to be common stock equivalents. Diluted net loss per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, the weighted-average number of common shares outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive. For the three months ended March 31, 2026 and 2025, approximately
Subsequent Events - The Company’s management reviewed all material events through the date of these unaudited condensed consolidated financial statements. See Note 8. Subsequent Events included in these unaudited condensed financial statements.
Recent Accounting Pronouncements - In December 2025, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2025-12, Codification Improvements, which clarifies various topics in the Accounting Standards Codification to improve consistency and address technical corrections. Key improvements include (clarifying the calculation of diluted earnings per share (EPS) when a loss from continuing operations exists. The amendments in this update are effective for the Company beginning January 1, 2027, with early adoption permitted. Currently, the Company is assessing the potential impact of this guidance on its condensed consolidated financial statement disclosures.
In December 2025, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements. This standard clarifies current interim reporting requirements on topic 270 and introduces a disclosure principle requiring entities to disclose events since the end of the last annual reporting period that have a material impact on the entity. This standard will be effective for fiscal years beginning after December 15, 2027, with the option to apply it retrospectively. Early adoption is allowed. Currently, the Company is assessing. the potential impact of this guidance on its condensed consolidated financial statement disclosures.
In November 2024 and January 2025, FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires disclosure in the notes to the financial statements of specified information about certain costs and expenses. The amendments are effective for fiscal years beginning after December 15, 2026, and for interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any or all prior periods presented in the financial statements. The Company is currently evaluating the new guidance to determine the impact it may have on its consolidated financial statements and related disclosures but expects additional disclosures upon adoption.
There are no other effective pronouncements, or pronouncements issued but not yet effective, if adopted, that would have a material effect on the accompanying financial statements.
Change in Accounting Policy - During the quarter ended September 30, 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 has changed its policy and warrants that contain this certain contingent settlement provision will now be accounted 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 will now meet the equity classification criteria under ASC 815-40 and will be 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 condensed consolidated financial statements. Certain warrants issued in 2025 will continue to be classified as a liability as these warrants contain features other than the contingent settlement provision that cause liability classification. See also Note 4 - 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. Warrants classified as liability warrants were adjusted retrospectively from January 2017 to June 2025, and the beginning balances have been adjusted for the policy change to equity warrant classifications. Accumulated deficit as of January 1, 2024, changed from $
The following financial statement line items were impacted by the change in accounting policy, as shown in the tables below (in thousands, except per common share data):
| Three Months Ended | ||||||||||||
| March 31, 2025 | ||||||||||||
| As Reported | As Adjusted | Effect of | ||||||||||
| Under Old Policy | Under New Policy | Change | ||||||||||
| Condensed Consolidated Statement of Operations | ||||||||||||
| Gain (loss) from change in fair value of warrant liability | $ | $ | $ | ( | ) | |||||||
| Transaction costs allocated to warrant liabilities | ( | ) | ||||||||||
| Loss on issuance of warrant liabilities | ( | ) | ||||||||||
| Net loss | ( | ) | ( | ) | ||||||||
| Net loss per common share - basic and diluted | ( | ) | ( | ) | ||||||||
| Other comprehensive income (loss) | ( | ) | ( | ) | ||||||||
The change in accounting policy did not have a material effect on the statement of cashflows for any current or prior period presented.
3. Accrued expenses and other current liabilities
Accrued expenses and other current liabilities consist of the following components (in thousands):
| March 31, 2026 | December 31, 2025 | |||||||
| Payroll and bonuses | $ | $ | ||||||
| Research and development | ||||||||
| Legal, regulatory, professional and other | ||||||||
| Operating lease liability - current | ||||||||
| Total accrued expenses and other current liabilities | $ | $ | ||||||
4. Warrants and Equity
Warrant and Stock Issuances
On February 19, 2026, the Company entered into warrant inducement agreements with certain holders of our existing equity-classified Series E and Series F warrants. Pursuant to the agreements, the holders exercised warrants to purchase an aggregate of
Warrants
The Company uses the Monte Carlo simulation model to reflect the impact of the down round feature to the warrants and also uses a Black-Scholes option pricing model (BSM) to determine the fair value of its liability warrants at the at each reporting date, the date of issue and any other measurement date during the quarter. 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.
Liability Classified Warrants
The assumptions used in determining the fair value of the Company's outstanding liability classified warrants are as follows:
| March 31, 2026 | December 31, 2025 | |||||
| Risk-free interest rate | % | % | ||||
| Volatility | % | % | ||||
| Expected life (years) | ||||||
| Dividend yield | % | % |
A summary of the Company's liability classified warrant activity during the three months ended March 31, 2026 and related information follows:
| Number of Shares | Range of Warrant Exercise | Weighted Average | Weighted Average Remaining Contractual | |||||||||||||||||
| Under Warrant | Price per Share | Exercise Price | Life (Years) | |||||||||||||||||
| Balance at January 1, 2026 | $ | $ | $ | |||||||||||||||||
| Granted | $ | $ | $ | |||||||||||||||||
| Adjustment for VWAP | $ | $ | $ | |||||||||||||||||
| Exercised | ( | ) | $ | $ | $ | |||||||||||||||
| Reclassed to equity warrants | ( | ) | $ | $ | $ | |||||||||||||||
| Balance at March 31, 2026 | $ | $ | $ | |||||||||||||||||
| Exercisable at March 31, 2026 | $ | $ | $ | |||||||||||||||||
For a summary of the changes in fair value and the impact of changes in accounting policy associated with the Company's warrant liability for the three months ended March 31, 2026, see Note 2 - Basis of presentation, principles of consolidation and significant accounting policies.
Equity Classified Warrants
A summary of the Company's equity classified warrant activity during the three months ended March 31, 2026 and related information follows:
| Number of Shares | Range of Warrant Exercise | |||||||||||
| Under Warrant | Price per Share | |||||||||||
| Balance at January 1, 2026 | 7,588,026 | $ | 2.75 | $ | 1,361.25 | |||||||
| Granted and/or reclassed from liability warrants | 6,367,956 | $ | 2.40 | $ | 2.40 | |||||||
| Adjustment for VWAP | 593,085 | $ | 3.00 | $ | 3.00 | |||||||
| Exercised | (2,122,652 | ) | $ | 3.90 | $ | 3.90 | ||||||
| Balance at March 31, 2026 | 12,426,415 | $ | 2.40 | $ | 1,361.25 | |||||||
| Exercisable at March 31, 2026 | 12,378,597 | $ | 2.40 | $ | 1,361.25 | |||||||
At Market Issuance Sales Agreement (ATM)
On December 23, 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 $
The Company paid Roth a commission equal to
During May of 2026, the Company sold an additional
5. Stock-Based Compensation
Stock-based compensation expense for the three months ended March 31, 2026 and 2025, respectively, is as follows (table in thousands):
| Three Months Ended March 31, | ||||||||
| 2026 | 2025 | |||||||
| General and administrative | $ | $ | ||||||
| Research and development | ||||||||
| Total stock-based compensation expense | $ | $ | ||||||
The Company recorded stock compensation expense for the equity classified warrants relating to non-employee consulting agreements of $
On May 6, 2026, the Company entered into a consulting agreement with an entity to provide clinical services pursuant to which it issued the consultant a -year warrant to purchase
6. Income Taxes
Deferred income tax assets and liabilities are determined based upon differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.
The Company does not expect to pay any significant federal, state, or foreign income taxes in 2026 as a result of the losses recorded during the three months ended March 31, 2026 and the additional losses expected for the remainder of 2026 and cumulative net operating loss carryforwards. Accounting standards require the consideration of a valuation allowance for deferred tax assets if it is “more likely than not” that some component or all of the benefits of deferred tax assets will not be realized. As a result, as of March 31, 2026 and December 31, 2025, the Company maintained a full valuation allowance for all deferred tax assets.
The Company recorded
On July 4, 2025, the United States enacted tax reform legislation through the One Big Beautiful Bill Act, which changes existing US tax laws, including extending or making permanent certain provisions of the Tax Cuts and Jobs Act, repealing certain clean energy initiatives, in addition to other changes. The Company continues to evaluate the impact the new legislation will have on the consolidated financial statements, but the Company does not anticipate a significant impact due to the Company’s valuation allowance position.
7. Commitments and Contingencies
In addition to the commitments and contingencies described elsewhere in these notes, see below for a discussion of the Company's commitments and contingencies as of March 31, 2026.
Lease Obligations Payable
The following summarizes quantitative information about the Company's operating leases for the three months ended March 31, 2026 and 2025, respectively (table in thousands):
| Three Months Ended March 31, | ||||||||
| Lease cost: | 2026 | 2025 | ||||||
| Operating lease cost | $ | $ | ||||||
| Variable lease cost | ||||||||
| Total | $ | $ | ||||||
The Company executed an amendment to extend the corporate office lease until August 31, 2029, with an option to renew. The Company is required to remit base monthly rent of approximately $
The Company has an extended lab lease until September 30, 2027, with no further right or option to renew. The Company recorded approximately $
Licenses
MD Anderson - Total expenses related to the Company's license agreements with MD Anderson were $
Sponsored Research Agreements - The expenses recognized under the agreements were $
8. Subsequent Events
Other than the subsequent events discussed elsewhere in these notes, no other subsequent events were noted as occurring after March 31, 2026.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This Form 10-Q, including the Management’s Discussion and Analysis of Financial Condition and Results of Operations, contains certain forward-looking statements. Historical results may not indicate future performance. Our forward-looking statements reflect our current views about future events, are based on assumptions and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those contemplated by these statements.
Forward-looking statements include, but are not limited to, statements about:
| • | Our ability to continue our relationship with the University of Texas MD Anderson Cancer Center (MD Anderson), including, but not limited to, our ability to maintain current licenses and license future intellectual property resulting from our sponsored research agreements with MD Anderson; | |
| • | The success or the lack thereof, including the ability to recruit subjects and onboard new clinical trial sites on a timely basis, for a variety of reasons, of our clinical trials through all phases of clinical development; | |
| • | Our ability to satisfy any requirements imposed by the United States (US) Food & Drug Administration (FDA) (or its foreign equivalents) as a condition of our clinical trials proceeding or beginning as planned; | |
| • |
World-wide events including geopolitical conflicts, public health emergencies, and global supply chain disruptions that may affect our clinical trials, clinical drug candidate supplies, preclinical activities and our ability to raise future financing; |
| • |
Our ability to obtain additional funding to commence or continue our clinical trials, fund operations and develop our product candidates; |
| • |
The need to obtain and retain regulatory approval of our drug candidates, both in the US and in Europe, and in countries deemed necessary for future trials; |
| • |
Our ability to complete our clinical trials in a timely fashion in line with our stated milestones and within our expected budget and resources; |
| • | Our ability to maintain compliance with the continued listing requirements of the Nasdaq Capital Market; | |
| • | Our ability to source our drug products at reasonable prices; |
| • |
Compliance with obligations under intellectual property licenses with third parties; |
| • |
Any delays in regulatory review and approval of drug candidates in clinical development; |
| • | Potential efficacy of our drug candidates; | |
| • |
Our ability to commercialize our drug candidates; |
| • |
Market acceptance of our drug candidates; |
| • |
Competition from existing therapies or new therapies that may emerge; |
| • |
Potential product liability claims; |
| • |
Our dependency on third-party manufacturers to successfully, and timely, supply or manufacture our drug candidates for our preclinical work and our clinical trials; |
| • |
Our ability to establish or maintain collaborations, licensing or other arrangements; |
| • |
Our ability and third parties’ abilities to protect intellectual property rights; |
| • |
Our ability to adequately support future growth; and |
| • |
Our ability to attract and retain key personnel to manage our business effectively. |
We undertake no obligation to publicly update or revise any forward-looking statements, including any changes that might result from any facts, events, or circumstances after the date hereof that may bear upon forward-looking statements. Furthermore, we cannot guarantee future results, events, levels of activity, performance, or achievements.
Our Business
We are a 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 a first-in-class, next-generation anthracycline and DNA-binding agent designed to overcome key limitations associated with currently approved anthracyclines. 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 further clinical development beyond Phase 1 and further evaluation of Annamycin’s therapeutic potential in this indication.
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 prescribed 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 in Part A of the MIRACLE trial in mid-2026; | |
| • | Shown encouraging activity in a total of five different clinical trials, which are now complete with clinical study reports for internally funded trials, 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 | |
| • | 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. |
A core management belief 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 leads us to focus our available resources 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 the development of Annamycin and WP1066 through internally and externally funded programs (“internally” and “externally” are defined in the Funding Strategy section below) 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, the aforementioned MIRACLE trial, 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 3rd line pancreatic cancer. | |
| d. | Internally funded – MB-109 utilizing AnnAraC for R/R AML as 3rd line therapy in adults is planned for 2027. | |
| e. | Externally funded – MB-110 utilizing AnnAraC for R/R AML as 2nd 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.
On March 23, 2026, we announced that the 45th subject was enrolled in the MIRACLE trial, a milestone triggering the final phase of preparation for the trial’s highly anticipated interim 45 subject data unblinding, which remains on track for mid-2026.
Scientific Presentations of Preclinical Data
Abstract on Cardiac Safety of Annamycin at EHA
On May 12, 2026, we announced the publication of an abstract at the European Hematology Association (EHA) 2026 Congress highlighting the cardiac safety profile of Annamycin (or as known in scientific journals "L-Annamycin"). The abstract titled, "Cardiac Safety of L-Annamycin Across High Cumulative Anthracycline Exposure: Implications for Relapsed/Refractory AML," highlighted pooled cardiac safety findings from five completed clinical trials evaluating Annamycin in heavily pretreated patients, including those with substantial prior anthracycline exposure. Importantly, the analysis demonstrated no clinically significant treatment-related cardiotoxicity across cumulative anthracycline-equivalent doses that exceeded conventional lifetime exposure limits associated with traditional anthracyclines.
The independent cardiac review, conducted by a cardio-oncology laboratory at the Cleveland Clinic, analyzed comprehensive cardiac monitoring data from 90 patients treated with Annamycin. Among 78 patients with source-data verified pre- and post-treatment ejection fraction assessments, no patients met criteria for clinically significant left ventricular dysfunction. Mean ejection fraction remained stable, and no association was observed between cumulative dose and cardiac function decline. Additional analyses of serial ECG's, troponins, and global longitudinal strain assessments similarly demonstrated no evidence of drug-induced cardiotoxicity.
Data Presented at AACR 2026 Annamycin Extends Survival in Metastatic Pancreatic Cancer Preclinical Models
On April 23, 2026, we announced the presentation of new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting 2026 highlighting the potential of our lead drug candidate, Annamycin, in pancreatic cancer. Access the poster here. The data demonstrate that liposomal Annamycin (L-ANN or naxtarubicin), a novel, non-cardiotoxic anthracycline, produced significant tumor growth inhibition across multiple pancreatic ductal adenocarcinoma (PDAC) models, including orthotopic human PDAC and syngeneic systems, with strong statistical significance (p < 0.001). These findings were accompanied by a meaningful survival benefit in a metastatic model, where treatment extended median survival by more than 60% compared to control (29 days versus 18 days; p = 0.0003), underscoring the potential clinical relevance of L-ANN in aggressive disease settings. Pharmacokinetic analyses further demonstrated enhanced tumor penetration and retention of Annamycin compared to doxorubicin, with significantly higher accumulation observed in pancreatic tissue and tumors (p<0.0001). These data provide a mechanistic basis for the observed anti-tumor activity and highlight a key differentiating feature of Annamycin relative to traditional anthracyclines, which have historically shown limited efficacy in pancreatic cancer. In addition to its direct cytotoxic effects, L-ANN was shown to induce immune activation within the tumor microenvironment, including increased infiltration of CD8+ cytotoxic T cells and CD4+ helper T cells. These findings suggest the potential for Annamycin to convert immunologically “cold” pancreatic tumors into more responsive phenotypes, supporting its evaluation both as a monotherapy and in combination with other drugs, including immune checkpoint and KRAS inhibitors.
Consistent with prior studies, Annamycin also demonstrated a favorable safety profile, including the absence of cardiotoxicity, a well-documented limitation of conventional anthracyclines such as doxorubicin. This differentiated safety profile may enable broader therapeutic use and synergistic combination strategies.
Abstract Accepted for Poster Presentation at the 2026 ASCO Annual Meeting
On April 21, 2026, we announced that an abstract highlighting data on our lead drug candidate, Annamycin, was accepted for poster presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, Illinois. The abstract, titled “Cardiac safety of L-annamycin at high cumulative anthracycline exposure: Pooled analysis,” will be presented in a poster session focused on Symptom Science and Palliative Care. The abstract presents a pooled analysis evaluating the cardiac safety profile of annamycin in patients with high cumulative exposure to anthracyclines, an important consideration given the known risk of cardiotoxicity associated with this class of chemotherapeutic agents.
Other Corporate
Closing Australian Subsidiary
In June 2018, we formed Moleculin Australia Pty. Ltd., a wholly owned subsidiary to oversee pre-clinical development in Australia. In April 2026, we began the process of closing this subsidiary to reduce corporate overhead costs. Both the board of directors of Moleculin and the subsidiary approved the closing of the subsidiary. The subsidiary did not have any employees or conduct a separate line of business. With the MIRACLE trial focused in the US, Europe, and, possibly, the Middle East future activities are not anticipated to include Australia.
Patents for Annamycin Globally
We announced on May 8, 2026, an advancement in our intellectual property portfolio with the issuance of a Hong Kong patent covering our proprietary method of reconstituting liposomal Annamycin. The newly granted patent (No. 40073244), titled “Method of Reconstituting Liposomal Annamycin,” extends protection through June 25, 2040, further reinforcing Moleculin’s long-term global exclusivity strategy. The invention is jointly owned with The University of Texas System.
Business transactions
In May 2026, we sold 354,757 shares under the 2025 ATM Agreement for net proceeds of approximately $0.8 million where the lowest price sold was $2.01 per share which reset the Series G and H warrants from $2.40 to $2.01 per share.
In May 2026, we entered into a consulting agreement to provide clinical services pursuant to which it issued the consultant a five-year warrant to purchase 100,000 shares of common stock at an exercise price of $2.48 per shares vesting in twelve equal installments over a one-year period.
Results of Operations
The following table sets forth, for the periods indicated, data derived from our condensed consolidated statement of operations (table in thousands) and such changes in the periods are discussed below in approximate amounts:
Moleculin Biotech, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
| Three Months Ended March 31, |
||||||||
| 2026 |
2025 |
|||||||
| Revenues |
$ | — | $ | — | ||||
| Operating expenses: |
||||||||
| Research and development |
5,378 | 3,435 | ||||||
| General and administrative |
2,488 | 2,477 | ||||||
| Depreciation and amortization |
8 | 31 | ||||||
| Total operating expenses |
7,874 | 5,943 | ||||||
| Loss from operations |
(7,874 | ) | (5,943 | ) | ||||
| Other income (loss): |
||||||||
| Gain from change in fair value of warrant liability |
10,770 | — | ||||||
| Transaction costs allocated to warrant liabilities |
(693 | ) | — | |||||
| Loss on issuance of warrant liabilities |
(15,158 | ) | — | |||||
| Other income, net |
76 | 9 | ||||||
| Interest income, net |
34 | 30 | ||||||
| Net loss |
$ | (12,845 | ) | $ | (5,904 | ) | ||
Three Months Ended March 31, 2026 Compared to Three Months Ended March 31, 2025
Research and Development Expense. Research and development (R&D) expense was $5.4 million and $3.4 million for the three months ended March 31, 2026 and 2025, respectively. The increase of $2.0 million is mainly related to the MIRACLE clinical trials in Europe of $1.4 million and additional nonclinical studies of $0.3 million plus other research costs during the current quarter as compared to the prior year quarter.
Gain from Change in Fair Value of Warrant Liability. We recorded a net gain of $10.8 million in the first quarter of 2026 due to the change in fair value of the Series H warrant liability after the February 2026 inducement. Changes in fair value are reflected in the statement of operations as a gain or loss from the change in fair value of the warrant in the period in which the change occurred. A gain results principally from a decline in our share price during the period and a loss will result principally from an increase in our share price.
Transaction costs allocated to warrant liabilities and Loss on issuance of warrant liabilities. Proceeds of offerings are allocated between common shares and warrants first by allocating to the warrants classified as a liability based on their fair value and then allocating the residual to the equity instruments. Transaction costs on the Series H warrants in February 2026 amounted to $0.7 million. The loss on issuance of the warrant liabilities for the Series H warrants was $15.2 million as compared to no loss for the prior quarterly period in 2025.
Liquidity and Capital Resources
The following table sets forth our primary sources and uses of cash for the period indicated (table in thousands):
| Three Months Ended March 31, |
||||||||
| 2026 |
2025 |
|||||||
| Net cash used in operating activities |
$ | (6,111 | ) | $ | (4,564 | ) | ||
| Net cash provided by financing activities |
7,612 | 7,999 | ||||||
| Effect of exchange rate changes on cash and cash equivalents |
(62 | ) | 3 | |||||
| Net increase in cash and cash equivalents |
$ | 1,439 | $ | 3,438 | ||||
Cash used in operating activities
Cash used in operations was $6.1 million for the three months ended March 31, 2026. This $1.5 million increase over the prior year period of $4.6 million was primarily due to the timing of costs incurred and associated payments for clinical trial expenses and drug production and other testing related expenses.
Cash provided by financing activities
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 the 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 aggregate 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 have a five-year term and an exercise price of $2.3976 per share. The warrants contain customary anti-dilution adjustments and beneficial ownership limitations and became exercisable upon stockholder approval in April 2026. As a result of the completion of this transaction, the exercise price of our outstanding Series E warrants was adjusted to $3.00 per share, and the number of shares underlying the remaining outstanding Series E warrants increased, in each case pursuant to the anti-dilution provisions contained in such warrants. In addition, 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 warrants was adjusted to $2.3976 per share. We recorded a deemed dividend of $1.8 million resulting from the downward adjustment to the exercise price of certain warrants and the increase in the number of shares underlying certain outstanding warrants, in each case triggered by the anti-dilution provisions contained in the original warrant agreements. The deemed dividend was recorded within additional paid-in capital and recognized as a reduction to income available to common stockholders.
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 first quarter of 2026, we sold 3,785 shares of common stock pursuant to the 2025 ATM Agreement for gross proceeds of approximately $18,000.
We believe that our cash on hand and cash equivalents as of March 31, 2026, plus the $0.8 million raised subsequent to the quarter via issuance of common stock under its ATM, is sufficient to fund our planned operations into the third quarter of 2026. This takes into account cash outlays for preparations for clinical trials beyond the current active trials. The continuation of our Company as a going concern is dependent upon our ability to obtain necessary financing to continue operations and the attainment of profitable operations. We must seek additional funds of approximately $25 million, to support MIRACLE and our operations into the first quarter of 2027 through the combination of equity offerings, debt financings, government or other third-party funding, commercialization, marketing and distribution arrangements, other collaborations, strategic alliances and licensing arrangements and delay planned cash outlays or a combination thereof to continue our operations in near term. We cannot provide assurance that such events or a combination thereof can be achieved.
There have been no material changes to our critical accounting policies and use of estimates from those disclosed in our Form 10-K for the year ended December 31, 2025, refer to Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Significant Estimates in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2025.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS
Not applicable as we are a smaller reporting company.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures designed to ensure that material information required to be disclosed in our filings under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that material information is accumulated and communicated to our management, including our Chief Executive Officer (CEO), who is our principal executive officer, and Chief Financial Officer (CFO), who is our principal financial and accounting officer, as appropriate, to allow timely decisions regarding required disclosures. Our CEO and CFO have evaluated these disclosure controls and procedures as of the end of the period covered by this quarterly report on Form 10-Q and have determined that such disclosure controls and procedures were effective as of March 31, 2026.
Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15-d-15(f) under the Exchange Act) during the three months ended March 31, 2026, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
None.
For information regarding factors that could affect our results of operations, financial condition and liquidity, refer to the section entitled “Risk Factors” in Part I, Item 1A in our annual report on Form 10-K for the year ended December 31, 2025. Except as set forth below, there have been no material changes from the risk factors previously disclosed in our annual report on Form 10-K for the year ended December 31, 2025, as filed with the SEC.
We are subject to Nasdaq's continued listing requirements. We have in the recent past failed to satisfy one or more of the requirements, and if we fail to satisfy one or more of the requirements in the future, we may be delisted from Nasdaq.
Our common stock is listed on Nasdaq, and we are therefore subject to its continued listing requirements, including requirements with respect to the market value of publicly held shares, market value of listed shares, minimum bid price per share, and minimum stockholder’s equity, among others, and requirements relating to board and committee independence. If we fail to satisfy one or more of the requirements, we may be delisted from Nasdaq.
During 2025, we received notices that we were not in compliance with Nasdaq Listing Rule 5550(b)(1) (the “Equity Rule”), which requires that we maintain a minimum of $2.5 million in stockholders’ equity, and Nasdaq Listing Rule 5550(a)(2), which related to the bid price for our common stock being below the minimum $1.00 per share (the “Bid Price Rule”).
On December 15, 2025, we received a letter from Nasdaq confirming that we 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. On January 6, 2026, we received notice that we had regained compliance with the Equity Rule and that the Company was in compliance with all applicable continued listing standards.
Although we are currently in compliance with all Nasdaq continued listing standards, there is no assurance that we will be able to maintain such compliance in the future. Delisting from Nasdaq would adversely affect our ability to raise additional financing through the public or private sale of equity securities, may significantly affect the ability of investors to trade our securities and may negatively affect the value and liquidity of our common stock. Delisting also could have other negative results, including the potential loss of employee confidence, the loss of institutional investors and general investors that will consider investing in our common stock, a reduction in the number of market makers in our common stock, a reduction in the availability of information concerning the trading prices and volume of our common stock, a reduction in the number of broker-dealers willing to execute trades in shares of our common stock or interest in business development opportunities. Further, we would likely become a “penny stock”, which would make trading of our common stock more difficult.
We will require additional financing in the near term, which financing may result in the reduction of the exercise price of certain of our warrants.
Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive. We will require substantial additional future capital in order to complete clinical development and commercialize Annamycin.
Our Series G warrants and Series H warrants, which combined represent the potential issuance of 8,978,779 shares of common stock, provide that if, while such warrants are outstanding, we sell any common stock and/or common stock equivalents other than in connection with certain exempt issuances, at a purchase price per share less than the exercise price of the warrants in effect immediately prior to such sale, then immediately after such sale the exercise price of the Series G warrants and/or Series H warrants then in effect will be reduced to an amount equal to the new issuance price, subject to floor prices of $1.326 and $0.962, respectively.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Other than as previously disclosed in our Current Report on Form 8-K on February 20, 2026, we did not sell any unregistered equity securities during the fiscal quarter ended March 31, 2026.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURE
Not applicable.
During the period covered by this Quarterly Report, of the Company’s directors or executive officers has adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (each as defined in Item 408 of Regulation S-K under the Securities Exchange Act of 1934, as amended).
On May 6, 2026, we agreed to issue warrants to purchase 100,000 shares of common stock with an exercise price of $2.48 per share to an entity providing consulting services, which warrants will vest in 12 equal monthly installments over one year, subject to the entity's continued provision of consulting services to the Company. The warrant was issued pursuant to the exemption from the registration requirements of the Securities Act of 1933 available under Section 4(a)(2) thereunder.
* Filed herewith.
+ The certifications on Exhibit 32 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such certifications will not be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| MOLECULIN BIOTECH, INC. |
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| Date: May 14, 2026 |
By: |
/s/ Walter V. Klemp |
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| Walter V. Klemp, |
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| Chief Executive Officer and Chairman (Principal Executive Officer) |
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| Date: May 14, 2026 | By: |
/s/ Jonathan P. Foster |
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| Jonathan P. Foster, |
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| Executive Vice President & Chief Financial Officer (Principal Financial and Accounting Officer) |
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