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Moleculin Biotech, Inc. filings document regulatory disclosures for a Delaware clinical-stage pharmaceutical company focused on drug development and commercialization. Recent Form 8-K reports cover Regulation FD releases, investor presentations, financial results, clinical and preclinical updates for Annamycin, and intellectual-property matters involving liposomal Annamycin.
The filing record also includes capital-structure and governance disclosures tied to warrant exercise inducement arrangements, warrant-related share issuance, and stockholder voting matters. Definitive proxy materials and voting results describe special-meeting proposals, including Nasdaq-related approval for warrant shares and charter-related governance items, while exhibit filings attach press releases, presentation materials, and other public-company disclosures.
Moleculin Biotech filed an 8-K to highlight new clinical data on its lead drug candidate Annamycin presented at the 2026 ASCO meeting. A pooled analysis of 90 patients with acute myeloid leukemia and soft tissue sarcoma found no detectable cardiotoxicity, even at cumulative doses far above traditional anthracycline limits.
The analysis used paired left ventricular ejection fraction assessments in 78 patients and was independently reviewed by Cleveland Clinic cardiology specialists. Moleculin views these safety data as strengthening support for its pivotal Phase 2b/3 MIRACLE trial of AnnAraC (Annamycin plus cytarabine) in relapsed or refractory AML, with unblinding of the first 45 patients expected in June 2026.
Moleculin Biotech, Inc. furnished a new investor presentation as part of a current report. The company is using this May 2026 corporate presentation, attached as Exhibit 99.1, for its website and investor communications. The material is provided under a Regulation FD disclosure item and is expressly treated as “furnished,” not “filed,” which means it is not automatically incorporated into other Securities Act or Exchange Act filings unless specifically referenced later.
Moleculin Biotech, Inc. furnished a press release announcing that pooled cardiac safety data for its lead drug candidate Annamycin were accepted for poster presentation at the 2026 ASCO Annual Meeting. The pooled analysis covered 90 patients with acute myeloid leukemia and soft tissue sarcoma treated across five completed clinical trials.
The abstract reports a median cumulative L-Annamycin dose of 660 mg/m2, with most patients receiving doses above conventional lifetime anthracycline limits, yet showing no statistically significant change in left ventricular ejection fraction from baseline to final assessment and no evidence of drug-induced cardiotoxicity on independent review. Previously reported Phase 1b/2 data in relapsed or refractory AML showed a 50% complete remission rate, 60% composite complete remission rate, and median overall survival of 12.39 months, supporting the company’s ongoing pivotal Phase 2b/3 MIRACLE trial of Annamycin plus cytarabine.
Moleculin Biotech reported first quarter 2026 results and highlighted progress in its pivotal MIRACLE trial for relapsed or refractory acute myeloid leukemia. Early blinded data show a 40% composite complete remission rate in this difficult-to-treat population. The first interim unblinding is expected in June 2026 after enrollment of 45 subjects, with the 90th subject targeted for Q3 2026.
For the quarter ended March 31, 2026, Moleculin had no revenue and reported research and development expenses of $5.4 million, up from $3.4 million a year earlier, mainly due to MIRACLE trial costs. General and administrative expenses were stable at about $2.5 million. The company recorded a net loss of $12.8 million versus $5.9 million in 2025, influenced by warrant-related fair value charges and a warrant deemed dividend, bringing net loss available to common stockholders to $14.6 million, or $3.54 per share.
Cash and cash equivalents were $10.3 million as of March 31, 2026. Management believes existing cash, together with recent financing proceeds, will fund planned operations into the third quarter of 2026, and notes that significant additional financing will be required to conduct the described clinical trials.
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.