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Moleculin Biotech’s quarterly report shows a clinical-stage company investing heavily in its lead cancer drug while facing meaningful funding pressure. For the quarter ended March 31, 2026, it reported no revenue and a net loss of $12.8 million, wider than $5.9 million a year earlier, driven largely by higher research and development spending of $5.4 million as the pivotal Phase 2B/3 MIRACLE trial for Annamycin advances.
Cash and cash equivalents were $10.3 million with total assets of $23.4 million, and management states this cash is not sufficient to fund operations for at least one year, raising substantial doubt about the company’s ability to continue as a going concern. A February 2026 warrant inducement brought in gross proceeds of about $8.3 million and created new Series H warrants, while at-the-market share sales added smaller amounts of capital.
The company believes its cash plus approximately $0.8 million raised after quarter-end will fund operations into the third quarter of 2026 and estimates it needs roughly $25 million of additional financing to support the MIRACLE trial and operations into the first quarter of 2027. Operationally, Moleculin progressed MIRACLE enrollment, highlighted blinded efficacy rates it views as favorable versus historical cytarabine data, closed its Australian subsidiary to cut overhead, and extended Annamycin patent protection in Hong Kong through 2040.
Moleculin Biotech reported encouraging preliminary blinded results from its pivotal Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in relapsed or refractory acute myeloid leukemia. Among the first 45 subjects, the complete remission rate approximates 30%, with a composite complete remission rate exceeding 40%.
The company notes these blinded response rates compare favorably to historical cytarabine monotherapy complete remission rates of about 17–18% in similar second-line AML populations. As of May 1, 56 of the planned 90 Part A subjects had been recruited, and the first 45-subject unblinding is expected before June 30, 2026.
Moleculin Biotech, Inc. furnished an update on its lead drug Annamycin, highlighting new cardiac safety data in relapsed/refractory acute myeloid leukemia (R/R AML). An abstract accepted for the European Hematology Association 2026 Congress reports an independent Cleveland Clinic review of pooled results from five completed trials.
The analysis covered 90 Annamycin-treated subjects and found no clinically significant treatment-related cardiotoxicity even at cumulative anthracycline-equivalent doses beyond conventional lifetime limits. Among 78 patients with verified pre- and post-treatment ejection fraction measurements, none met criteria for clinically significant left ventricular dysfunction and mean ejection fraction remained stable, with no link between cumulative dose and cardiac decline. Management believes this supports Annamycin’s potential as a differentiated anthracycline for heavily pretreated R/R AML patients, while noting that further data, long-term follow-up, and significant additional financing will be needed to advance clinical trials.
Moleculin Biotech, Inc. filed a current report to highlight a new Hong Kong patent covering its proprietary method of reconstituting liposomal Annamycin, its lead oncology candidate. The patent, titled “Method of Reconstituting Liposomal Annamycin” (No. 40073244), extends protection through June 25, 2040 and is jointly owned with The University of Texas System.
The company views this as an additional layer of global intellectual property protection for Annamycin ahead of an expected Phase 3 clinical data release later this quarter. Moleculin notes broader Annamycin patent coverage across regions including the United States, Europe and multiple Asian markets, supporting its long-term commercialization strategy in relapsed or refractory acute myeloid leukemia and soft tissue sarcoma lung metastases.
Moleculin Biotech, Inc. reported new preclinical data showing its lead drug candidate Annamycin extended median survival by more than 60% in a metastatic pancreatic cancer model, from 18 to 29 days. Liposomal Annamycin produced significant tumor growth inhibition across multiple pancreatic ductal adenocarcinoma models with strong statistical significance (p<0.001).
The drug showed much higher accumulation in pancreatic tissue and tumors than doxorubicin (p<0.0001), suggesting a mechanistic basis for its activity, and induced increased CD8+ and CD4+ T-cell infiltration, indicating potential to turn “cold” tumors more immune-responsive. Annamycin continued to demonstrate absence of cardiotoxicity and is also being evaluated in the pivotal Phase 2B/3 MIRACLE trial in relapsed or refractory acute myeloid leukemia.
Moleculin Biotech, Inc. reported results of a Special Meeting of Stockholders. As of the February 20, 2026 record date, there were 4,933,110 shares of common stock outstanding, with 2,382,989 shares represented at the meeting, constituting a quorum.
Stockholders approved a Nasdaq-related proposal authorizing the issuance of up to 6,367,956 shares of common stock upon exercise of certain warrants issued on February 20, 2026. The vote was 854,036 for, 211,394 against, and 7,489 abstentions, with 1,310,070 broker non-votes.
Stockholders did not approve an amendment to change the company’s name to Moleculin Inc., as this proposal required a majority of all outstanding shares to vote in favor. An adjournment proposal to allow additional proxy solicitation, if needed, was approved.
Moleculin Biotech, Inc. filed Amendment No. 1 to its Annual Report for the year ended December 31, 2025 to add Part III information on directors, executive compensation, ownership and auditor matters. The amendment does not change prior financial statements.
The company reports aggregate market value of voting equity held by non‑affiliates of $8.8 million and had 5,336,350 common shares outstanding as of March 11, 2026. Executive pay for the CEO, CFO and Chief Scientific Officer combines base salary, performance‑based cash bonuses, stock options and performance‑based restricted stock units tied to MIRACLE trial milestones, with some bonuses accrued and earning 8% annual interest until paid.
Moleculin Biotech, Inc. is registering up to 6,367,956 shares of common stock for resale, consisting of shares issuable upon exercise of inducement warrants with an exercise price of $2.3976 per share.
The shares are being registered for the benefit of the selling stockholders and the company will not receive proceeds from resale; the company would receive proceeds only if the warrants are exercised for cash, which at full cash exercise at the initial exercise price would yield gross proceeds of $15.3M. The registration covers shares issuable upon exercise subject to holder-level Beneficial Ownership Limitations of 4.99% or 9.99% (holder election). Shares outstanding were 5,336,350 as of March 11, 2026.
Moleculin Biotech, Inc. filed a prospectus to register up to 6,367,956 shares of its common stock for resale by selling stockholders. The registered shares are issuable upon exercise of newly issued warrants (the “Warrants”) from a February 2026 warrant inducement offer.
Shares outstanding were 5,336,350 as of March 11, 2026. The Warrants have an exercise price of $2.3976 per share, will be exercisable following shareholder approval of the issuance of the Inducement Warrant Shares, and include a Beneficial Ownership Limitation (holders may elect either 4.99% or 9.99%). The company will only receive cash proceeds if holders elect cash exercise; full cash exercise of all underlying warrants at the initial exercise price would result in gross proceeds of $15.3 million.