Moleculin Biotech, Inc. (MBRX) SEC Filings

Moleculin Biotech, Inc. furnished a new corporate presentation as Exhibit 99.1. The company states this presentation is being used for its corporate presentation and is also posted on its website. The material is provided under Item 7.01 and is furnished, not filed, under the Exchange Act.

Moleculin Biotech reported a 2025 net loss of $33.6M, with research and development expenses of $15.9M and general and administrative plus depreciation and amortization expenses of $9.2M. Cash and cash equivalents were $8.9M as of December 31, 2025, and management expects existing cash plus $8.3M of first‑quarter 2026 financing proceeds to fund operations into the third quarter of 2026.

The company highlighted rapid progress in its pivotal global MIRACLE trial of Annamycin plus cytarabine (AnnAraC) for relapsed or refractory AML. Blinded preliminary data from the first 30 subjects showed a composite complete remission rate of 40%, including 30% complete remission and 10% CRh, across six countries, despite roughly 35% of subjects having prior venetoclax exposure and other high‑risk features. An initial 45‑patient interim unblinding is planned for mid‑2026 as part of the adaptive Phase 2B/3 design.

Moleculin Biotech, Inc. is a late-stage pharmaceutical development company focused on oncology, led by its anthracycline candidate Annamycin. The drug is in the global Phase 2B/3 MIRACLE trial for relapsed/refractory acute myeloid leukemia, with interim data unblindings planned for mid-2026 and the second half of 2026.

Across multiple AML and soft tissue sarcoma lung metastases studies, Annamycin has shown human activity and, in over 90 treated subjects, independent experts have reported no evidence of cardiotoxicity, even above traditional lifetime anthracycline dose limits. The program holds Orphan Drug and Fast Track designations in AML and soft tissue sarcoma.

The company also advances two additional technology portfolios: WP1066, a STAT3-focused immune/transcription modulator platform with externally funded brain tumor trials and encouraging early pediatric data, and WP1122, a glycolysis/glycosylation inhibitor platform with a completed Phase 1a study and a Recommended Phase 2 Dose established.

Moleculin Biotech, Inc. has called a special stockholder meeting on April 15, 2026 to vote on three key items. The main proposal seeks approval, under Nasdaq Listing Rule 5635(d), to allow the exercise of warrants for up to 6,367,956 new common shares at an initial exercise price of $2.3976 per share, which could raise about $15.3 million if fully exercised for cash and would significantly dilute current holders relative to the 4,933,110 shares outstanding as of February 20, 2026. Stockholders will also vote on changing the company’s name to Moleculin Inc. and on authorizing adjournment of the meeting, if needed, to gather additional proxies in favor of the two main proposals.

Moleculin Biotech, Inc. is asking shareholders to approve three proposals at a Special Meeting on April 15, 2026. The primary item seeks shareholder approval to permit up to 6,367,956 shares of common stock to be issued upon exercise of Series H warrants issued February 20, 2026; those Warrants will only become exercisable upon shareholder approval.

The proxy also asks shareholders to approve a corporate name change to Moleculin Inc. and to authorize adjournment of the meeting if additional solicitation of proxies is needed. Shares outstanding were 4,933,110 as of February 20, 2026, and the company states that full cash exercise of the Warrants at the initial exercise price would yield $15.3 million.

Moleculin Biotech entered into warrant exercise inducement agreements with holders of existing warrants to buy up to 2,122,652 shares at $3.90 per share. The company expects aggregate gross proceeds of up to approximately $8.3 million from these exercises before fees.

In return, Moleculin will issue new Series H Inducement Warrants to purchase up to 6,367,956 shares, equal to 300% of the exercised shares. These warrants will have a five-year term and an exercise price per share equal to the lesser of $3.90 and the lowest volume-weighted average price over the five trading days after the public announcement, subject to shareholder approval. The warrants include price-adjustment features with a floor of $0.962, beneficial ownership limits of 4.99% or 9.99%, and cashless exercise under certain conditions.

Moleculin Biotech, Inc. filed a current report to make investors aware that it is using an updated corporate presentation. The company states that this presentation is posted on its website and is included as Exhibit 99.1.

The company clarifies that the information in this presentation is being furnished under a disclosure item and is not considered "filed" under securities laws, unless a future document specifically incorporates it by reference. This distinction affects how the information is treated for legal and liability purposes.

Moleculin Biotech updated progress on its pivotal Phase 2B/3 MIRACLE trial of Annamycin plus cytarabine in second-line relapsed/refractory AML. As of February 10, 2026, 35 subjects have been treated, with another 11 in screening or identified, targeting 45 subjects for the first data unblinding.

In the first 30 treated subjects with blinded efficacy data, the company reports a preliminary composite complete remission (CRc) rate of 40%, made up of 30% complete remission (CR) and 10% CR with partial hematologic recovery (CRh). Moleculin highlights that roughly 35% of treated subjects had failed prior venetoclax regimens and that current blinded CR rates are described as 67% higher than historical cytarabine-alone HiDAC trials at about 17–18% CR.

The company continues to report an absence of cardiotoxicity for Annamycin based on safety data from 90 prior trial subjects and expects to reach 45 treated MIRACLE subjects in the first quarter of 2026, with unblinding of the first 45 subjects’ efficacy data anticipated in late second quarter 2026, followed by additional unblindings as Part A of the trial completes.

Moleculin Biotech reported that the Japan Patent Office issued a notice of allowance for Patent Application No. 2021-577862, titled “METHOD OF RECONSTITUTING LIPOSOMAL ANNAMYCIN.” A patent from this application is expected to be granted in Japan in the coming months.

The allowed claims cover proprietary methods for reconstituting and preparing liposomal Annamycin from a preliposomal lyophilizate under controlled temperature conditions, targeting precise concentrations for intravenous use and consistent dosing and stability. This Japanese protection complements existing U.S. and European patent coverage for Annamycin.

Annamycin, also known as naxtarubicin, is Moleculin’s lead anthracycline drug candidate in Phase 3 development for relapsed or refractory acute myeloid leukemia, with Fast Track Status and multiple Orphan Drug Designations in the U.S. and Europe.