Moleculin Biotech: $7.29M cash, going-concern warning
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Moleculin Biotech, Inc. (MBRX) reported a third-quarter net loss of $6.493 million on zero revenue, versus a $25.399 million loss a year earlier. For nine months, net loss was $26.973 million versus $49.112 million, while operating loss widened to $22.046 million from $17.570 million. Research and development expense rose to $15.317 million from $10.774 million; the 2026 net loss included a $10.798 million warrant fair-value gain and a $15.158 million loss on warrant issuance.
Cash was $7.287 million at September 30, 2026; operating activities used $21.738 million over nine months. Management said this cash was insufficient for planned operations for at least one year from when the statements were issued, raising substantial doubt about the company’s ability to continue as a going concern. The August public offering generated approximately $9.3 million gross; nine-month ATM sales generated $1.6 million gross, and the ATM’s maximum aggregate offering price was raised to $19.7 million.
MIRACLE Part A enrollment closed with 90 subjects; a comprehensive data readout is expected in the first quarter of 2027. Nasdaq granted a listing exception subject to bid-price compliance through November 16, 2026 and compliance with all Nasdaq listing rules through March 15, 2027.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointReported nine-month net loss narrowed to $26.973 million from $49.112 million.
Negative
- Major point. Forward-looking: it has not happened yet and may not happen.Management: $7.287 million cash insufficient for planned operations for at least a year.
- Moderate pointNine-month operating loss widened to $22.046 million from $17.570 million.
- Moderate pointNine-month operating cash use rose to $21.738 million from $17.369 million.
Filing Explained
Post-quarter awards create potential new shares; ATM sales already issued 16,175 shares, while the Series I warrant repricing is not itself an exercise.
This unaudited quarterly report says Moleculin completed a 1-for-20 reverse split on
After quarter-end, stockholders approved expanding the 2024 Stock Plan to 207,095 shares, including 193,095 beyond the prior 14,000 authorization; on October 15, the company issued 10-year options covering 107,625 shares at an exercise price of
After September 30, the company sold 16,175 shares under its at-the-market agreement for gross proceeds of
Key Figures
Key Terms
substantial doubt financial
going concern financial
pre-funded warrants financial
anti-dilution provisions financial
at-the-market equity program financial
composite complete remission (CRc) medical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were MBRX’s third-quarter 2026 results?
How much cash did MBRX have, and what did management say about its runway?
When will MBRX report the MIRACLE trial’s Part A data?
What did MBRX’s August 2026 public offering include?
AI-generated analysis. How Rhea-AI works. Not financial advice.
Table of Contents
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) | |||||||||||
| | ||||||||
| | | |||||||
| (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 Regulation 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
Moleculin Biotech, Inc.
Form 10-Q
Table of Contents
| Page |
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| PART I – FINANCIAL INFORMATION |
3 |
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| Item 1. |
Financial Statements (Unaudited) |
3 |
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| Condensed Consolidated Balance Sheets as of September 30, 2026 and December 31, 2025 |
3 |
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| Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three and Nine Months ended September 30, 2026 and 2025 |
4 |
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| Condensed Consolidated Statements of Cash Flows for the Nine Months ended September 30, 2026 and 2025 |
5 |
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| Condensed Consolidated Statements of Stockholders' Equity for the Three and Nine Months Ended September 30, 2026 and 2025 |
6 |
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| Notes to Condensed Consolidated Financial Statements |
7 |
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| Item 2. |
Management's Discussion and Analysis of Financial Condition and Results of Operations |
13 |
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| Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
20 |
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| Item 4. |
Controls and Procedures |
20 |
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| PART II – OTHER INFORMATION |
21 |
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| Item 1. |
Legal Proceedings |
21 |
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| Item 1A. |
Risk Factors |
21 |
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| Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
21 |
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| Item 3. |
Defaults Upon Senior Securities |
21 |
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| Item 4. |
Mine Safety Disclosures |
21 |
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| Item 5. |
Other Information |
21 |
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| Item 6. |
Exhibits |
22 |
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| Signatures |
23 |
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
Moleculin Biotech, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except for share and per share data)
(Unaudited)
| September 30, | 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 September 30, 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.
Moleculin Biotech, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Revenues | $ | $ | $ | $ | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Depreciation and amortization | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (loss): | ||||||||||||||||
| Gain from change in fair value of warrant liability | ||||||||||||||||
| Transaction costs allocated to equity and liability warrant issuances | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Loss on issuance of warrant liabilities | ( | ) | ( | ) | ( | ) | ||||||||||
| Other income, net | ||||||||||||||||
| Interest income, net | ||||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Warrant deemed dividends | ( | ) | ( | ) | ||||||||||||
| Net loss available to common stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per common share - basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted average common shares outstanding, basic and diluted | ||||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Foreign currency translation | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Comprehensive loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
See accompanying notes to these condensed consolidated financial statements.
Moleculin Biotech, Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
| Nine Months Ended September 30, | ||||||||
| 2026 | 2025 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Stock-based compensation | ||||||||
| Change in fair value of warrant liability | ( | ) | ( | ) | ||||
| Loss on issuance of warrant liabilities | ||||||||
| Operating lease, net | ( | ) | ||||||
| Transaction costs allocated to equity and liability warrant issuances | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Prepaid expenses and other assets | ( | ) | ( | ) | ||||
| Accounts payable | ||||||||
| Accrued expenses and other current liabilities | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Net cash used in investing activities | ||||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from sale of common stock, pre-funded and common warrants and warrant inducement, net of issuance and transaction costs | ||||||||
| Proceeds from exercise of warrants | ||||||||
| Proceeds from issuance of common stock under at-the-market equity program, net of transaction costs | ||||||||
| Net cash provided by financing activities | ||||||||
| Effect of exchange rate changes on cash and cash equivalents | ( | ) | ( | ) | ||||
| Net increase (decrease) in cash and cash equivalents | ( | ) | ||||||
| Cash and cash equivalents - beginning of period | ||||||||
| Cash and cash equivalents - end of period | $ | $ | ||||||
| Non-cash investing and financing activities: | ||||||||
| Equity warrants issued in relation to liability classified warrant inducements | $ | $ | ||||||
| Reclassification of warrant liabilities to equity upon contractual reset of exercise price | $ | $ | ||||||
| Deemed dividends in connection with warrant amendments | $ | $ | ||||||
| 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.
Moleculin Biotech, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(in thousands, except for shares)
(Unaudited)
| Nine Months Ended September 30, 2026 | ||||||||||||||||||||||||
| Common stock - shares | Common stock - Par Value Amount | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total Stockholders' Equity | |||||||||||||||||||
| Balance, December 31, 2025 | $ | $ | $ | ( | ) | $ | $ | |||||||||||||||||
| Warrant inducement and exercise of common stock warrants | ||||||||||||||||||||||||
| Issuance of common stock in connection with Consulting Agreements | ||||||||||||||||||||||||
| Issuance of common stock under at-the-market equity program, net of transaction costs | ||||||||||||||||||||||||
| Warrants exercised | ||||||||||||||||||||||||
| Common stock issued upon vesting of restricted stock units (net of taxes) | ||||||||||||||||||||||||
| 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 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||
| Warrants exercised | ||||||||||||||||||||||||
| Issuance of common stock under at-the-market equity program, net of transaction costs | ||||||||||||||||||||||||
| Issuance of common stock in connection with Consulting Agreements | ||||||||||||||||||||||||
| Warrant deemed dividends | — | |||||||||||||||||||||||
| Deemed dividend in connection with warrant amendments | — | ( | ) | ( | ) | |||||||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||||||
| Consolidated net loss | — | ( | ) | ( | ) | |||||||||||||||||||
| Cumulative translation adjustment | — | ( | ) | ( | ) | |||||||||||||||||||
| Balance, June 30, 2026 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||
| Proceeds from sale of common stock, pre-funded and common warrants and warrant inducement, net of issuance and transaction costs | ||||||||||||||||||||||||
| Warrants exercised | ||||||||||||||||||||||||
| Issuance of common stock under at-the-market equity program, net of transaction costs | ||||||||||||||||||||||||
| Common stock issued upon vesting of restricted stock units (net of taxes) | ||||||||||||||||||||||||
| Issuance of common stock in connection with a consulting agreement | ||||||||||||||||||||||||
| Warrant deemed dividends | — | |||||||||||||||||||||||
| Deemed dividends in connection with warrant amendments | — | ( | ) | ( | ) | |||||||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||||||
| Consolidated net loss | — | ( | ) | ( | ) | |||||||||||||||||||
| Cumulative translation adjustment | — | ( | ) | ( | ) | |||||||||||||||||||
| Balance, September 30, 2026 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||
| Nine Months Ended September 30, 2025 | ||||||||||||||||||||||||
| Common stock - shares | Common stock - Par Value Amount | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total Stockholders' Equity/(Deficit) | |||||||||||||||||||
| Balance, December 31, 2024 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||
| Warrant inducement and exercise of repriced common stock warrants at $ per share | ||||||||||||||||||||||||
| Warrants exercised | ||||||||||||||||||||||||
| Issued for cash - sale of common stock, pre-funded and common warrants | ||||||||||||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||||||
| Consolidated net loss | — | ( | ) | ( | ) | |||||||||||||||||||
| Equity warrants issued | — | |||||||||||||||||||||||
| Cumulative translation adjustment | — | |||||||||||||||||||||||
| Balance, March 31, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||
| Common stock issued upon vesting of restricted stock units (net of taxes) | ||||||||||||||||||||||||
| Warrants exercised | ||||||||||||||||||||||||
| Issued for cash - sale of common stock, pre-funded and common warrants | ||||||||||||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||||||
| Consolidated net loss | — | ( | ) | ( | ) | |||||||||||||||||||
| Cumulative translation adjustment | — | |||||||||||||||||||||||
| Balance, June 30, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||
| Issued for cash - sale of common stock, pre-funded and common warrants | ||||||||||||||||||||||||
| Common stock issued upon vesting of restricted stock units (net of taxes) | ||||||||||||||||||||||||
| Issuance of common stock in connection with a consulting agreement | ||||||||||||||||||||||||
| Warrants exercised | ||||||||||||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||||||
| Consolidated net loss | — | ( | ) | ( | ) | |||||||||||||||||||
| Cumulative translation adjustment | — | ( | ) | ( | ) | |||||||||||||||||||
| Balance, September 30, 2025 | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||
See accompanying notes to these condensed consolidated financial statements.
Moleculin Biotech, Inc.
Notes to the Condensed Consolidated Financial Statements
(Unaudited)
1. Nature of Business
The terms “MBI” or “the Company”, “we”, “our” and “us” are used herein to refer to Moleculin Biotech, Inc. MBI is a clinical-stage pharmaceutical company, organized as a Delaware corporation in July 2015. MBI is currently conducting a pivotal Phase 2/3 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). This trial is called MB-108 or MIRACLE. 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 2/3 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 drug candidate, has completed several clinical trials in AML and soft tissue sarcoma and in March 2025 began treating subjects in its Phase 2/3 clinical trial for the treatment of R/R AML with an interim readout planned for the first quarter of 2027. The latter is the main focus of 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), one of which was physician-sponsored. The Company plans to support a physician-sponsored trial for Annamycin for the treatment of pancreatic cancer intended to begin in the first half of 2027. 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.
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 September 15, 2026, the Company received a letter from the Nasdaq Stock Market LLC (Nasdaq), which notified the Company that for the last 30 consecutive business days the bid price for the Company’s common stock had closed below the minimum $1.00 per share requirement for continued inclusion on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). The deficiency letter did not result in the immediate delisting of the Company’s common stock from the Nasdaq Capital Market. Ordinarily, a company that fails to meet the Bid Price Rule would be afforded a 180-calendar day compliance period pursuant to Nasdaq Listing Rule 5810(c)(3)(A) to regain compliance. However, pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(iv), the Nasdaq Listing Qualifications Staff (the "Staff") determined that the Company was not eligible for any compliance period specified in Nasdaq Listing Rule 5810(c)(3)(A), because the Company effected a reverse stock split in the prior one-year period. As previously disclosed, the Company effected a 1-for-25 reverse stock split of its common stock on December 1, 2025. The Company made a timely request for a hearing before the Nasdaq Hearings Panel (the “Panel”), which hearing occurred on October 27, 2026. On November 12, 2026, the Company received notice that the Panel had granted the Company an exception to the Nasdaq Listing Rules, provided that it maintains compliance with the Bid Price Rule until November 16, 2026 and it maintains compliance with all Nasdaq Listing Rules through March 15, 2027. There can be no assurance that the Company will be able to maintain compliance with the Bid Price Rule or all other applicable requirements for continued listing on The Nasdaq Capital Market.
2. Basis of presentation, principles of consolidation, and significant accounting policies and liquidity
Reverse Stock Split - On October 20, 2026, 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 in these financial statements. Other items 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 and liquidity, 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 and nine months ended September 30, 2026.
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 September 30, 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 - 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 most recently completed as of September 30, 2026, 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):
| September 30, 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 MIRACLE 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 these instruments.
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 September 30, 2026 and December 31, 2025 (table in thousands):
| Description | Fair Value | Level 1 | Level 2 | Level 3 | ||||||||||||
| Fair value of warrant liability as of September 30, 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 third quarter and then is adjusted for changes in fair value that occurred during the third quarter. The ending balance of the Level 3 financial instrument presented above represents the Company's best estimates and may not be substantiated by comparison to independent markets and, in many cases, could not be realized in immediate settlement of the instruments.
| Three Months Ended September 30, 2026 | Warrant Liability Long-Term | |||
| Balance, June 30, 2026 | $ | |||
| Change in fair value - net | ( | ) | ||
| Balance, September 30, 2026 | $ | |||
The table below of Level 3 liabilities (table in thousands) begins with the valuation as of December 31, 2025 and then is adjusted for changes in fair value that occurred during the nine months ended September 30, 2026. The ending balance of the Level 3 financial instrument presented above represents the Company's best estimates and may not be substantiated by comparison to independent markets and, in many cases, could not be realized in immediate settlement of the instruments.
| Nine Months Ended September 30, 2026 | Warrant Liability Long-Term | |||
| Balance, December 31, 2025 | $ | |||
| Warrants issued | ||||
| Warrants exercised | ( | ) | ||
| Warrants reclassification | ( | ) | ||
| Change in fair value - net | ( | ) | ||
| Balance, September 30, 2026 | $ | |||
Loss Per Common Share - Basic net loss per common share is computed by dividing net loss available to common stockholders by the weighted-average number of common shares outstanding during the period. For purposes of this calculation, options to purchase common stock, restricted stock units subject to vesting and warrants to purchase common stock are considered to be common stock equivalents. Diluted net loss per common share is determined using the weighted-average number of common shares outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, the weighted-average number of common shares outstanding excludes common stock equivalents, because their inclusion would be anti-dilutive. For the three months ended September 30, 2026 and 2025, approximately
Subsequent Events - The Company’s management reviewed all material events through the date these unaudited condensed consolidated financial statements were issued. See Note 8. Subsequent Events included in these unaudited condensed consolidated 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 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.
3. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consist of the following components (in thousands):
| September 30, 2026 | December 31, 2025 | |||||||
| Payroll and bonuses | $ | $ | ||||||
| Research and development | ||||||||
| Legal, regulatory, professional and other | ||||||||
|
| ||||||||
| Total accrued expenses and other current liabilities | $ | $ | ||||||
4. Warrants and Equity
Warrant and Stock Issuances
On August 3, 2026, the Company completed a public offering of (i)
During June of 2026, Series H warrants were exercised for the issuance of
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
During the nine months ended September 30, 2026, the Company recorded deemed dividends 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 dividends were recorded to additional paid-in capital and recognized as a reduction to income available to common stockholders.
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 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:
| September 30, 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 nine months ended September 30, 2026 and related information follows (includes adjustment for volume-weighted average price or VWAP):
| 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 September 30, 2026 | $ | $ | $ | |||||||||||||||||
| Exercisable at September 30, 2026 | $ | $ | $ | |||||||||||||||||
Equity Classified Warrants
A summary of the Company's equity classified warrant activity during the nine months ended September 30, 2026 and related information follows:
| Number of Shares | Range of Warrant Exercise | |||||||||||
| Under Warrant | Price per Share | |||||||||||
| Balance at January 1, 2026 | $ | $ | ||||||||||
| Granted | $ | $ | ||||||||||
| Adjustment for VWAP | $ | $ | ||||||||||
| Exercised | ( | ) | $ | $ | ||||||||
| Reclassed from liability warrants | $ | $ | ||||||||||
| Expired warrants | ( | ) | $ | $ | ||||||||
| Balance at September 30, 2026 | $ | $ | ||||||||||
| Exercisable at September 30, 2026 | $ | $ | ||||||||||
At The Market Issuance Sales Agreement (ATM)
On August 21, 2026, 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 The Market Offering Agreement (2025 ATM Agreement) with Roth Capital Partners, LLC (Roth), which the Company initially entered into in July 2025, from $
The Company pays Roth a commission equal to
5. Stock-Based Compensation
Stock-based compensation expense for the three and nine months ended September 30, 2026 and 2025, respectively, is as follows (table in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2026 | 2025 | 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 $
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 and nine months ended September 30, 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 September 30, 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 new legislation did not have a material impact on the Company 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 September 30, 2026.
Lease Obligations Payable
The following summarizes quantitative information about the Company's operating leases for the three and nine months ended September 30, 2026 and 2025, respectively (table in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| Lease cost: | 2026 | 2025 | 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
On October 9, 2026, stockholders approved an amendment to the Company’s 2024 Stock Plan to increase the number of shares of common stock that may be issued to
The Compensation Committee of our board of directors approved on October 15, 2026, and we issued, in connection with our 2026/2027 compensation year, to our employees and advisors, -year options to purchase an aggregate of
Subsequent to September 30, 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 obtain additional funding to commence or continue our clinical trials, fund operations and develop our product candidates; | |
| • | 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 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; | |
| • | 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; |
| • |
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 regain and then 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
Moleculin is 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 2/3 trial in combination with cytarabine for the treatment of subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML). AnnAraC is the combination of Annamycin and cytarabine.
We call this the “MIRACLE” trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation). We released interim unblinded data on June 30, 2026, for the first 45 subjects of Part A of MIRACLE where the Annamycin arms demonstrated a complete remission (CR) rate at least three times greater than the control arm’s CR rate. The unblinding of Part A’s full 90 subjects (including the first 45 subjects already released) is expected in the first quarter of 2027, thereby concluding Part A of the two-part trial. Since results from Part A will be combined with Part B to determine the trial outcome, this means that preliminary primary endpoint results for approximately 20% of the total trial will be disclosed with the completion of Part A. 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 clinical trial (IIT) and another one has an IIT planned with 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 clinical trials. These clinical trials range from Phase 1B/2, Phase 2, to Phase 2/3. 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 consist 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 2/3 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 support 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 Multi-Drug Resistant-1 or 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 positive clinical activity in our MB-106 trial with a 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-comers 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 (the median OS was still immature/not reached), with 4 of 8 subjects (50%) censored; | |
| • | Exhibited positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the Company's pivotal Phase 2/3 MIRACLE trial, analyzed on a full intent-to-treat basis with no patient exclusions with both Annamycin treatment arms demonstrating favorable efficacy trends compared with the control arm in patients with relapsed or refractory acute myeloid leukemia (R/R AML). The interim analysis in a difficult to treat population (increased age and prior venetoclax therapies included) demonstrated an efficacy advantage for both Annamycin treatment arms, 190 mg/m² plus high-dose cytarabine or HiDAC and 230 mg/m² plus HiDAC, over the HiDAC control arm. CR reached 43% and 36% in the respective Annamycin cohorts, compared with 12% for control, while CRc reached 50% and 57%, respectively, versus 29% for the control arm; | |
| • | Shown encouraging activity in a total of five different clinical 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 (funded by the Company) and externally funded (funded by investigator grants) programs:
| 1. | Annamycin: |
| a. | Internally funded – In combination of cytarabine (also known as Ara-C, the combination with Annamycin with cytarabine 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 2027 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 2028. | |
| e. | Externally funded – MB-110 utilizing AnnAraC for R/R AML as 2nd line therapy in pediatrics is planned for late 2028. 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. |
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.
Recruitment Update: On September 29, 2026, we announced that we have completed and closed enrollment in Part A of our pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in combination with cytarabine (AnnAraC) for the treatment of adults with relapsed or refractory acute myeloid leukemia (R/R AML), with 90 subjects enrolled. With Part A enrollment closed, we remain on track for our planned comprehensive data readout of Part A in the first quarter of 2027.
We believe the rapid pace of enrollment underscores the significant unmet need in R/R AML as well as strong engagement from investigators and clinical sites participating in MIRACLE. We expect the expanded Part A dataset to provide important insight into the potential efficacy of AnnAraC across subjects who have relapsed from or are refractory to different first-line (1L) AML treatment approaches, including subjects previously treated with intensive 7+3 chemotherapy and those previously treated with venetoclax-based regimens. Such treatment approaches associated with 1L patient populations are commonly, while not universally, deemed as “fit” and “unfit”, respectively.
We estimate that Part A will end with approximately a 50/50 split between “fit” and “unfit” subjects, compared to a roughly 70/30 split, respectively, in the first 45 subjects in Part A. While we are mindful that this shift in composition to more “unfit” subjects represents a more challenging environment for achieving treatment responses, it should provide valuable insight into Annamycin’s ability to fill critical unmet needs.
Blinded data update (n=62): On July 31, 2026, we announced updated preliminary blinded results from Part A of our MIRACLE trial. With 62 subjects evaluable to date in Part A, the preliminary blinded CR rate was 24% and the CRc rate was 37%. Of those 62 subjects, 30, or 48%, had previously received a venetoclax-based regimen. Among that subgroup, the preliminary blinded CR and CRc rates were 23% and 37%, respectively, essentially identical to the evaluable population as a whole. Because this analysis remains blinded, it includes subjects randomized to the control arm and is therefore expected to be lower than the unblinded Annamycin-arm results reported at the June 2026 interim analysis, stated below. The two sets of response rates – blinded data versus unblinded data - are not directly comparable.
Across three successive blinded analyses, at 30, 45 and 62 evaluable subjects, the blinded CRc has remained within a narrow band of approximately 37% to 40%+, while the proportion of subjects entering the trial after failure of a first-line venetoclax-based regimen has risen from 31.1% in the n=45 population to 48% in the latest blinded data readout. The Company recruited the 90th subject in September 2026 and completed treating subjects in October 2026, with unblinding of the comprehensive Part A data anticipated in the first quarter of 2027.
Unblinded data update (n=45): On June 30, 2026, we announced positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the Company's pivotal Phase 2/3 MIRACLE trial, analyzed on a full intent-to-treat basis with no patient exclusions. Both Annamycin treatment arms demonstrated favorable efficacy trends compared with the control arm in patients with relapsed or refractory acute myeloid leukemia (R/R AML). The interim analysis demonstrated a clear efficacy advantage for both Annamycin treatment arms, 190 mg/m² plus HiDAC and 230 mg/m² plus HiDAC, over the HiDAC control arm. CR reached 43% and 36% in the respective Annamycin cohorts, compared with 12% for control, while CRc reached 50% and 57%, respectively, versus 29% for the control arm. The n=45 population contained 75.6% over 60 years of age, 55.6% 7 days of cytarabine plus 3 days of an anthracycline (7+3) and 31.1% venetoclax regimens for first line (1L) therapies. Importantly, the remission rates for all three arms, including the control arm, reflect outcomes measured after only a single cycle of therapy, as specified by the MIRACLE protocol. The most commonly cited historical benchmarks in this setting, including the MIRROS and CLASSIC I studies, as well as Moleculin’s own MB-106 study, permitted multiple cycles of treatment. The Company therefore expected absolute remission rates for both the control and Annamycin arms in this single-cycle interim analysis to be lower than those reported in such multi-cycle datasets and believes the most meaningful comparison is the performance of the Annamycin arms relative to the concurrent, randomized control arm evaluated on the same single-cycle basis. As of the cutoff date for the unblinded data, there continued to be no evidence of drug related cardiotoxicity.
Blinded data update (n=45): On May 13, 2026, we reported that preliminary blinded efficacy data for the first 45 subjects treated continue to approximate previously disclosed results, including a composite complete remission rate (CRc) exceeding 40% and a complete remission (CR) rate of approximately 30%. These results compare favorably to historical CR rates from two major independent trials of approximately 17–18% observed with cytarabine alone in similar patient populations. Cytarabine monotherapy is considered a standard of care for second line treatment of AML.
Recruitment Update March 2026: 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 remained on track for mid-2026.
Market Research
On June 5, 2026, we announced results from an independent market landscape assessment evaluating Annamycin in relapsed/refractory acute myeloid leukemia (R/R AML). The research demonstrated strong physician interest in Annamycin, with oncologists reporting an average likelihood-to-prescribe score of 6 out of 7. Physicians cited Annamycin's reported complete remission rates, measurable residual disease (MRD)-negative responses, potential to bridge patients to bone marrow transplant, biomarker-agnostic applicability and lack of cardiotoxicity as key factors supporting potential adoption.
The study included perspectives from academic and community hematologist-oncologists, medical oncologists and pediatric AML specialists. Respondents consistently identified significant unmet need in R/R AML, particularly for patients without actionable mutations and those who relapse or progress following venetoclax-based therapy. Separately, interviews with hospital administrators and insurers revealed that payers view Annamycin as a potentially meaningful value proposition, driven by its efficacy and safety profile and applicability to a broad patient population.
Scientific/Regulatory
Peer-Reviewed Cardiac Safety Analysis of Annamycin
On September 28, 2026, we announced the publication of a peer-reviewed analysis of the cardiac safety of Annamycin in Frontiers in Cardiovascular Medicine. The publication, titled “Cardiac safety of L-Annamycin: a pooled analysis of five clinical trials,” reports cardiac safety findings from 90 patients treated across five clinical trials in acute myeloid leukemia (AML) and metastatic soft tissue sarcoma (STS).
The analysis was independently evaluated by a cardio-oncology laboratory at Cleveland Clinic and found no clinical or subclinical evidence of treatment-related cardiotoxicity, including at cumulative Annamycin exposures exceeding traditional lifetime limits for conventional anthracyclines.
Annamycin Turns “Cold” Pancreatic Tumors “Hot” in New Preclinical Data Presented at American Association for Cancer Research (AACR) Conference
On September 25, 2026, we announced new preclinical data indicating that the antitumor activity of our lead drug candidate, Annamycin, in pancreatic cancer is partially mediated by CD8+ T cell cytotoxicity. The findings were presented at the AACR Conference on Pancreatic Cancer: New Frontiers in Biology and Therapeutic Development, held September 25–28, 2026 in San Diego, California.
In preclinical models of pancreatic cancer, Annamycin’s antitumor activity appears to depend in part on CD8+ T cells, the immune system’s primary tumor-killing cells. The finding suggests Annamycin may do more than kill cancer cells directly; it may also expose tumors that are typically considered immunologically “cold” to immune attack, effectively turning the tumors “hot.”
Pancreatic cancer is among the most treatment-resistant solid tumors, and its characteristically “cold” immune microenvironment is believed to be one reason checkpoint inhibitors have shown limited single-agent activity in the disease. Preclinical evidence that Annamycin’s activity is partly immune-mediated points to a potential basis for combination approaches and complements the immune-modulating mechanism of the Company’s WP1066 program.
Mexican Patent
On September 23, 2026, we announced that the Mexican Patent Office has granted Patent No. 436849, further strengthening our global intellectual property portfolio protecting our proprietary lung-targeted liposomal Annamycin technology. The newly issued patent supports Moleculin's strategy of building a robust worldwide intellectual property estate around Annamycin, our next-generation anthracycline currently being evaluated in the pivotal MIRACLE trial for relapsed or refractory acute myeloid leukemia (AML), while also reinforcing the platform's broader potential across additional oncology indications.
Poster on Cardiac Safety of Annamycin at ASCO
On May 29, 2026, new data were presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting further reinforcing the differentiated cardiac safety profile of our lead drug candidate, Annamycin (also known as “L-Annamycin” or “naxtarubicin”). The poster presentation, titled “Cardiac safety of L-annamycin at high cumulative anthracycline exposure: Pooled analysis,” highlighted findings from a pooled analysis across five completed clinical trials evaluating Annamycin in patients with acute myeloid leukemia (AML) and soft tissue sarcoma. The analysis demonstrated no detectable cardiotoxicity despite cumulative exposure levels that substantially exceeded traditional lifetime anthracycline dose limitations.
The pooled analysis included 90 patients treated with Annamycin across five completed clinical trials, with source-verified paired pre- and post-treatment left ventricular ejection fraction (LVEF) assessments available for 78 patients. Patients received a median cumulative Annamycin dose of 660 mg/m², with exposure ranging from 210 mg/m² to 2,970 mg/m² – levels that, in many cases, substantially exceeded conventional anthracycline lifetime dose thresholds.
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 electrocardiogram or ECGs, 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 AACR Annual Meeting 2026 highlighting the potential of our lead drug candidate, Annamycin, in pancreatic cancer. 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, which was held May 29 – June 2, 2026, in Chicago, Illinois. The abstract, titled “Cardiac safety of L-annamycin at high cumulative anthracycline exposure: Pooled analysis,” was presented in a poster session focused on Symptom Science and Palliative Care. The abstract presented 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
Reverse Stock Split October 2026
On October 20, 2026, pursuant to authority granted by our stockholders, the Company effected a 1-for-20 reverse stock split of our common stock and the filing of an amendment to our amended and restated certificate of incorporation to effectuate the reverse stock split. The amendment provided that every twenty shares of our issued and outstanding common stock be automatically combined into one issued and outstanding share of common stock, without any change in par value per share, which remained at $0.001. The accompanying consolidated financial statements and notes to the consolidated financial statements give retroactive effect to the reverse stock split for all periods presented. Certain amounts in the financial statements, the notes thereto, and elsewhere in the Form 10-Q may be slightly different than previously reported due to the elimination of fractional shares as a result of the reverse stock split.
Financing in August 2026
On August 3, 2026, we completed a public offering of (i) 618,834 shares of common stock, or pre-funded warrants in lieu thereof, and (ii) Series I Warrants to purchase up to 1,856,502 shares of common stock. The combined public offering price was $15.00 per share of common stock (or pre-funded warrant in lieu thereof) and accompanying warrant. Each pre-funded warrant is exercisable into one share of common stock at an exercise price of $0.02 per share and expires when exercised in full. The Series I Warrants are exercisable into one share of common stock at an exercise price of $15.00 per share and expire on the five-year anniversary of the closing date. The Series I Warrants contain anti-dilution provisions that reduce the exercise price (subject to a floor price of $4.20) in the event we issue common stock or common stock equivalents at a price below the then-current exercise price, other than in connection with certain exempt issuances. In connection with the offering, we agreed not to issue any shares of common stock or securities convertible into common stock for 45 days after the closing date, subject to certain exceptions, and agreed not to effect any variable rate transaction for 180 days after the closing date. We received gross proceeds of approximately $9.3 million in the offering, before deducting placement agent fees and other offering expenses. We paid total placement agent fees and other offering expenses of approximately $0.8 million. Due to the pricing of the offering, and certain provisions, the exercise price of our outstanding Series G warrants was adjusted to $26.52 per share, and the exercise price of our outstanding Series H warrants was adjusted to $19.24 per share. We issued 554,417 common shares, and pre-funded warrants for 64,417 shares, which were exercised shortly after the offering.
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.
Other
In May 2026, we sold 17,738 shares under the 2025 ATM Agreement for net proceeds of approximately $0.8 million where the lowest price sold was $40.20 per share which reset the Series G and H warrants' exercise price from $47.95 to $40.20 per share. These warrants were reset on August 3, 2026 to $26.52 and $19.24, respectively.
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 September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2026 |
2025 |
2026 |
2025 |
|||||||||||||
| Revenues |
$ | — | $ | — | $ | — | $ | — | ||||||||
| Operating expenses: |
||||||||||||||||
| Research and development |
4,488 | 3,738 | 15,317 | 10,774 | ||||||||||||
| General and administrative |
2,114 | 2,147 | 6,705 | 6,715 | ||||||||||||
| Depreciation and amortization |
8 | 21 | 24 | 81 | ||||||||||||
| Total operating expenses |
6,610 | 5,906 | 22,046 | 17,570 | ||||||||||||
| Loss from operations |
(6,610 | ) | (5,906 | ) | (22,046 | ) | (17,570 | ) | ||||||||
| Other income (loss): |
||||||||||||||||
| Gain from change in fair value of warrant liability |
35 | 1,591 | 10,798 | 1,031 | ||||||||||||
| Transaction costs allocated to warrant liabilities |
(12 | ) | (530 | ) | (707 | ) | (1,737 | ) | ||||||||
| Loss on issuance of warrant liabilities |
— | (20,609 | ) | (15,158 | ) | (30,962 | ) | |||||||||
| Other income, net |
36 | 16 | 125 | 30 | ||||||||||||
| Interest income, net |
58 | 39 | 15 | 96 | ||||||||||||
| Net loss |
$ | (6,493 | ) | $ | (25,399 | ) | $ | (26,973 | ) | $ | (49,112 | ) | ||||
Three Months Ended September 30, 2026 Compared to Three Months Ended September 30, 2025
Research and Development Expense. Research and development (R&D) expense was $4.5 million and $3.7 million for the three months ended September 30, 2026 and 2025, respectively. The increase of $0.8 million is mainly related to the MIRACLE clinical trial.
Gain from Change in Fair Value of Warrant Liability. We recorded a net gain of $35 thousand in the third quarter of 2026 as compared to a gain of $1.6 million in the third quarter of 2025, for the change in fair value on revaluation of our warrant liability associated with our warrants issued in conjunction with certain of our previous stock offerings. 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 Offerings and Warrant Issuance. Proceeds of equity offerings are allocated between common shares and additional paid-in capital while transaction costs are allocated to additional paid-in capital. During the three months ended September 30, 2026, $1.0 million in transaction costs were allocated to additional paid-in capital for the Series I warrants. Proceeds from liability 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. During the three months ended September 30, 2025, $0.5 million in transaction costs were expensed on the Series F warrants in August 2025. During the three months ended September 30, 2025, the loss on issuance of the warrant liabilities for the Series F warrants was $20.6 million.
Nine Months Ended September 30, 2026 Compared to Nine Months Ended September 30, 2025
Research and Development Expense. Research and development (R&D) expense was $15.3 million and $10.8 million for the nine months ended September 30, 2026 and 2025, respectively. The increase of $4.5 million is primarily related to the MIRACLE clinical trial of $3.1 million, additional nonclinical studies of $0.9 million and other research costs of $0.4 million during the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025.
Gain from Change in Fair Value of Warrant Liability. We recorded a gain of $10.8 million in the nine months ended September 30, 2026 as compared to a gain of $1.0 million in the nine months ended September 30, 2025, for the change in fair value on revaluation of our warrant liability associated with our warrants issued in conjunction with certain of our previous stock offerings. 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 Offerings and Warrant Issuance. Proceeds of equity offerings are allocated between common shares and additional paid-in capital while transaction costs are allocated to additional paid-in capital. During the nine months ended September 30, 2026, $1.0 million in transaction costs were allocated to additional paid-in capital for the Series I warrants and $0.7 million was expensed for the issuance of Series G and H warrants. Proceeds from liability 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. During the nine months ended September 30, 2025, $1.7 million in transaction costs were expensed on the Series E and F warrants. The loss on issuance of the warrant liabilities for the Series H warrants was $15.2 million as compared to a loss of $31.0 million for the Series E and F warrants.
Liquidity and Capital Resources
The following table sets forth our primary sources and uses of cash for the period indicated (table in thousands):
| Nine Months Ended September 30, |
||||||||
| 2026 |
2025 |
|||||||
| Net cash used in operating activities |
$ | (21,738 | ) | $ | (17,369 | ) | ||
| Net cash provided by financing activities |
20,250 | 19,797 | ||||||
| Effect of exchange rate changes on cash and cash equivalents |
(103 | ) | (3 | ) | ||||
| Net increase (decrease) in cash and cash equivalents |
$ | (1,591 | ) | $ | 2,425 | |||
Cash used in operating activities
Cash used in operations was $21.7 million for the nine months ended September 30, 2026. This $4.3 million increase over the prior year period of $17.4 million was primarily due to the timing of costs incurred and associated payments for clinical trial expenses and drug production for the MIRACLE Phase 2/3 trial and other testing related expenses.
Cash provided by financing activities
On August 21, 2026, we increased the maximum aggregate gross sales price of our common stock that may be offered, issued and sold under a certain At The Market Offering Agreement (2025 ATM Agreement) with Roth Capital Partners, LLC (Roth), which we initially entered into in July 2025, from $8.2 million to $19.7 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 $19.7 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, and either party may terminate the 2025 ATM Agreement upon two business days’ notice.
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, in addition to reimbursing certain expenses. During the three and nine months ended September 30, 2026, the Company sold 69,969 shares and 87,897 shares, respectively, of common stock pursuant to the 2025 ATM Agreement for gross proceeds of approximately $0.8 million and $1.6 million, respectively.
On August 3, 2026, we completed a public offering of (i) 618,834 shares of common stock, or pre-funded warrants in lieu thereof, and (ii) Series I Warrants to purchase up to 1,856,502 shares of common stock. The combined public offering price was $15.00 per share of common stock (or pre-funded warrant in lieu thereof) and accompanying warrant. Each pre-funded warrant is exercisable into one share of common stock at an exercise price of $0.02 per share and expires when exercised in full. The Series I Warrants are exercisable into one share of common stock at an exercise price of $15.00 per share and expire on the five-year anniversary of the closing date. The Series I Warrants contain anti-dilution provisions that reduce the exercise price (subject to a floor price of $4.20) in the event we issue common stock or common stock equivalents at a price below the then-current exercise price, other than in connection with certain exempt issuances. In connection with the offering, we agreed not to issue any shares of common stock or securities convertible into common stock for 45 days after the closing date, subject to certain exceptions, and agreed not to effect any variable rate transaction for 180 days after the closing date. We received gross proceeds of approximately $9.3 million in the offering, before deducting placement agent fees and other offering expenses. We paid total placement agent fees and other offering expenses of approximately $0.8 million. Due to the pricing of the offering, and certain provisions, the exercise price of our outstanding Series G warrants was adjusted to $26.52 per share, and the exercise price of our outstanding Series H warrants was adjusted to $19.24 per share. We issued 554,417 common shares, and pre-funded warrants for 64,417 shares, which were exercised shortly after the offering.
During June of 2026, warrants were exercised for the issuance of 69,825 shares at $40.20 per share for proceeds of approximately $2.8 million.
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 106,133 shares of our common stock at an exercise price of $78.00 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 318,401 shares of common stock. The Series H warrants have a five-year term and an initial exercise price of $47.952 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 $60.00 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 $55.00 per share, and the exercise price of our outstanding Series G warrants was adjusted to $47.952 per share. In connection with the August 2026 offering, the exercise price of the outstanding Series G warrants was further adjusted to $26.52 per share, and the exercise price of the outstanding Series H warrants was adjusted to $19.24 per share.
We believe that our cash and cash equivalents as of September 30, 2026, and including the capital raised subsequent to the quarter, are sufficient to fund our planned operations into the first quarter of 2027. 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 $7.0 million to support MIRACLE and our operations into the second 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 the 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 RISK
Not applicable as we are a smaller reporting company.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures designed to ensure that material information required to be disclosed in our filings under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that material information is accumulated and communicated to our management, including our Chief Executive Officer (CEO), who is our principal executive officer, and Chief Financial Officer (CFO), who is our principal financial and accounting officer, as appropriate, to allow timely decisions regarding required disclosures. Our CEO and CFO have evaluated these disclosure controls and procedures as of the end of the period covered by this quarterly report on Form 10-Q and have determined that such disclosure controls and procedures were effective as of September 30, 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 15d-15(f) under the Exchange Act) during the three months ended September 30, 2026, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II – OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 1A. RISK FACTORS
For information regarding factors that could affect our results of operations, financial condition and liquidity, refer to the section entitled “Risk Factors” in Part I, Item 1A in our annual report on Form 10-K for the year ended December 31, 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.
If we fail to maintain compliance with Nasdaq’s continued listing requirements, our common stock will be delisted from Nasdaq which could have a material adverse effect on our financial condition and could make it more difficult for stockholders to sell their shares.
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 stockholders' 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.
On September 15, 2026, we received a letter from Nasdaq notifying us that for the last 30 consecutive business days the bid price for our common stock had closed below the minimum $1.00 per share requirement for continued inclusion on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). In accordance with Nasdaq rules, we would normally be provided with a grace period of 180 calendar days to regain compliance with the Bid Price Rule. However, because we completed a reverse stock split on December 1, 2025, which is within the prior one-year period, the Nasdaq Staff determined that we were not eligible for any compliance period. We made a timely request for a hearing before the Nasdaq Hearings Panel (the “Panel”), which hearing occurred on October 27, 2026. On November 12, 2026, the Company received notice that the Panel had granted the Company an exception to the Nasdaq Listing Rules, provided that it maintains compliance with the Bid Price Rule until November 16, 2026 and it maintains compliance with all Nasdaq Listing Rules through March 15, 2027. If we fail to maintain such compliance, we will be subject to immediate delisting. There can be no assurance that we will be able to maintain compliance with the Bid Price Rule or all other applicable requirements for continued listing on the Nasdaq Capital Market through March 15, 2027 or thereafter.
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.
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. The Series I warrants that we issued in the August 2026 Offering provide that if, while the Series I 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 Series I warrants in effect immediately prior to such sale, then immediately after such sale the exercise price of the Series I warrants then in effect will be reduced to an amount equal to the new issuance price, subject to a floor price of $4.20 per share. Since the issuance of the Series I warrants we have completed issuances pursuant to our ATM Agreement that have reduced the exercise price of the Series I warrants to $8.22, and we expect to make additional issuances pursuant to our ATM Agreement in the future, which may further reduce the exercise price of the Series I warrants.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
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 September 15, 2026, we received a letter from Nasdaq notifying us that for the last 30 consecutive business days the bid price for our common stock had closed below the minimum $1.00 per share requirement for continued inclusion on the Nasdaq Capital Market pursuant to the Bid Price Rule. In accordance with Nasdaq rules, we would normally be provided with a grace period of 180 calendar days to regain compliance with the Bid Price Rule. However, because we completed a reverse stock split on December 1, 2025, which is within the prior one-year period, the Nasdaq Staff determined that we were not eligible for any compliance period. We made a timely request for a hearing before the Nasdaq Hearings Panel (the “Panel”), which hearing occurred on October 27, 2026. On November 12, 2026, the Company received notice that the Panel had granted the Company an exception to the Nasdaq Listing Rules, provided that it maintains compliance with the Bid Price Rule until November 16, 2026 and it maintains compliance with all Nasdaq Listing Rules through March 15, 2027.
ITEM 6. EXHIBITS
| Exhibit No. |
Description |
|
| 3.1 |
Amended and Restated Certificate of Incorporation of Moleculin Biotech, Inc. (incorporated by reference to exhibit 3.1 of the Form S-1/A filed March 21, 2016) |
|
| 3.2 |
Certificate of Amendment of the Amended and Restated Certificate of Incorporation of Moleculin Biotech, Inc. (incorporated by reference to Exhibit 3.1 of the Form 8-K filed May 24, 2019) |
|
| 3.3 |
Certificate of Amendment of the Amended and Restated Certificate of Incorporation of Moleculin Biotech, Inc. (incorporated by reference to Exhibit 3.1 of the Form 8-K filed January 29, 2021) |
|
| 3.4 |
Certificate of Amendment of the Amended and Restated Certificate of Incorporation of Moleculin Biotech, Inc. (incorporated by reference to Exhibit 3.1 of the Form 8-K filed March 19, 2024) |
|
| 3.5 |
Certificate of Amendment to Amended and Restated Certificate of Incorporation of Moleculin Biotech, Inc., dated August 21, 2025 (incorporated by reference to Exhibit 3.1 of the Form 8-K filed August 27, 2025) |
|
| 3.6 | Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Moleculin Biotech, Inc., filed with the Secretary of State of the State of Delaware. (incorporated by reference to Exhibit 3.1 of the Form 8-K filed November 28, 2025) | |
| 3.7 | Amended and Restated Bylaws of Moleculin Biotech, Inc. (incorporated by reference to exhibit 3.1 of the Form 8-K filed December 17, 2021) | |
| 3.8 | Certificate of Amendment to Amended and Restated Certificate of Incorporation of Moleculin Biotech, Inc., dated October 15, 2026 (incorporated by reference to Exhibit 3.1 of the Form 8-K filed October 20, 2026) | |
| 4.1 |
Form of Series I Common Stock Purchase Warrant used in August 2026 offering (incorporated by reference to exhibit 4.1 of the Form 8-K filed August 3, 2026) | |
| 4.2 | Form of Pre-Funded Warrant used in August 2026 offering (incorporated by reference to exhibit 4.2 of the Form 8-K filed August 3, 2026) | |
| 10.1 |
Placement Agency Agreement dated July 31, 2026, by and between Moleculin Biotech, Inc. and Roth Capital Partners, LLC (incorporated by reference to exhibit 1.1 of the Form 8-K filed August 3, 2026) | |
| 10.2 | Form of Securities Purchase Agreement used in August 2026 offering (incorporated by reference to exhibit 10.1 of the Form 8-K filed August 3, 2026) | |
| 10.3 | Moleculin Biotech, Inc. 2024 Stock Plan (as amended and restated) (incorporated by reference to exhibit 10.1 of the Form 8-K filed October 9, 2026) | |
| 31.1* |
Certification of Principal Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
| 31.2* |
Certification of Principal Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002 |
|
| 32.1*+ |
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
| 32.2*+ |
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
| 101.INS* |
Inline XBRL Instance Document (the Instance Document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) |
|
| 101.SCH* |
Inline XBRL Taxonomy Extension Schema Document |
|
| 101.CAL* |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
|
| 101.DEF* |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
|
| 101.LAB* |
Inline XBRL Taxonomy Extension Label Linkbase Document |
|
| 101.PRE* |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
|
| 104 |
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
* Filed herewith.
+ The certifications on Exhibit 32 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such certifications will not be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| MOLECULIN BIOTECH, INC. |
||||||||
| Date: November 13, 2026 |
By: |
/s/ Walter V. Klemp |
||||||
| Walter V. Klemp, |
||||||||
| Chief Executive Officer and Chairman (Principal Executive Officer) |
||||||||
| Date: November 13, 2026 | By: |
/s/ Jonathan P. Foster |
||||||
| Jonathan P. Foster, |
||||||||
| Executive Vice President & Chief Financial Officer (Principal Financial and Accounting Officer) |
||||||||