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Moleculin Biotech reported that it entered into an agreement with Atlantic Health System to begin an investigator-initiated Phase 1B/2 single-arm study of Annamycin for third-line treatment of advanced pancreatic cancer. This design allows a clinical site to lead the study while evaluating Annamycin in a heavily pretreated setting.
The announcement was furnished under Item 7.01, with the related press release included as Exhibit 99.1. Because it is furnished rather than filed, it is intended for informational purposes. No financial terms or clinical timelines are included in the disclosure.
Moleculin Biotech, Inc. (MBRX) reported stockholder voting results from its Special Meeting. Holders approved the Nasdaq Proposal authorizing the issuance of up to 64,864,864 shares upon exercise of certain warrants issued on August 28, 2025. The proposal passed with 4,937,555 votes for, 1,479,087 against, and 142,257 abstentions, with 8,178,900 broker non-votes.
Stockholders did not approve changing the company name to Moleculin Inc., which required a majority of outstanding shares. The name proposal received 11,258,199 for, 843,364 against, and 2,636,236 abstentions. An adjournment proposal was approved with 5,589,386 for, 806,047 against, and 163,466 abstentions. As of August 28, 2025, there were 36,739,360 shares outstanding; 14,737,799 shares were present or represented by proxy, constituting a quorum.
Moleculin Biotech announced updates to its pivotal Phase 2B/3 trial ("MIRACLE") evaluating Annamycin combined with cytarabine ("AnnAraC") for adults with relapsed or refractory acute myeloid leukemia (R/R AML). The company reported active site status and recruitment updates for the multi-center, randomized, double-blind, placebo-controlled, adaptive-design study. The MIRACLE trial is described as a global approval trial with sites in the U.S., Europe and the Middle East. A press release providing these trial updates is attached to the report as Exhibit 99.1 and is furnished with the filing.
Moleculin Biotech, Inc. filed a Current Report on Form 8-K disclosing that on September 8, 2025 the company posted and is using an Investor Presentation dated September 2025 as its corporate presentation and furnished that presentation as Exhibit 99.1. The filing states the furnished presentation is not being "filed" under the Exchange Act and will not be incorporated by reference into future filings unless expressly identified. The report identifies the registrant, principal executive office address in Houston, Texas, trading symbol MBRX on NASDAQ, and includes the Exhibit list and Inline XBRL cover page reference.
Moleculin Biotech announced the start of EU enrollment in its pivotal Phase 2B/3 trial of Annamycin combined with cytarabine (AnnAraC) for adults with relapsed or refractory acute myeloid leukemia (R/R AML). The company reported that the first two subjects in the European Union have been enrolled and one subject has been treated, marking initiation of EU participation in a multi-center, randomized, double-blind, placebo-controlled, adaptive-design study.
The press release is attached as an exhibit to the company's report and is being furnished rather than filed. The disclosure focuses on clinical development progress—specifically geographic expansion of patient enrollment in a late-stage trial evaluating Annamycin plus Ara-C for R/R AML.
Moleculin Biotech, Inc. reported two corporate actions in this Current Report. Stockholders approved and the company filed a Certificate Amendment to increase authorized common shares from 100,000,000 to 500,000,000, which became effective upon filing with the Delaware Secretary of State on August 21, 2025. The company also furnished a press release dated August 27, 2025 announcing completion of its Phase 1B/2 (MB-106) clinical trial evaluating Annamycin combined with Cytarabine (referred to as AnnAraC) for treatment of subjects with acute myeloid leukemia (AML). The Certificate Amendment and the press release are attached as exhibits.
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