Moleculin Biotec Stock Price, News & Analysis

Moleculin (NASDAQ: MBRX) announced on January 13, 2026 that an independent expert reviewed cardiac data for 90 subjects treated with Annamycin and found no evidence of cardiotoxicity. The assessment covers data from five clinical trials in acute myeloid leukemia (AML) and soft tissue sarcoma (STS) across the US and EU, including serial 12-lead ECGs, transthoracic echocardiography with centralized global longitudinal strain (GLS) analysis, and central-lab troponin I/T measurements. The company reported that 65 of 90 subjects exceeded the FDA lifetime anthracycline limit of 550 mg/m2, with one subject exceeding 6500 mg/m2. Moleculin said the results support Annamycin's safety profile and its development as a next-generation anthracycline.

Moleculin (Nasdaq: MBRX) outlined 2026–2028 clinical milestones for its anthracycline Annamycin and STAT3 inhibitor WP1066. The pivotal Phase 2B/3 MIRACLE trial for relapsed/refractory AML has expanded to nine countries with >46 sites selected and ~20 sites contracted, and is on track to treat the 45th Part A subject in Q1 2026 with an unblinding shortly thereafter and a second unblinding in Q3 2026. Part A targets 90 subjects; Part B will add 222 subjects. Institutional/externally funded trials include a 2026 Atlantic Health pancreatic trial and investigator‑initiated WP1066 trials at Northwestern and Emory. Primary MIRACLE efficacy data and a rolling NDA are targeted in 2028.

Moleculin (Nasdaq: MBRX) announced positive Phase 1 results for WP1066 in pediatric recurrent malignant brain tumors on Dec 17, 2025. The Emory physician‑sponsored trial at Aflac/Children’s Healthcare of Atlanta treated 10 children (plus 3 compassionate‑use cases) to identify a maximum feasible dose given twice daily for 14 days.

Key findings: no significant toxicity, determination of a maximum feasible dose, suppression of STAT3 with demonstrable anti‑tumor immune responses, and a partial response in a diffuse intrinsic pontine glioma (DIPG) patient. Results were published in Journal of Clinical Investigation Insight. Trial identifier: NCT04334863.

Moleculin (Nasdaq: MBRX) announced agreements for immediate exercise of existing warrants to purchase an aggregate of 1,044,329 shares of common stock (727,969 shares issued Feb 2025 at $6.63; 316,360 shares issued Aug 2025 at $6.3219).

The aggregate gross proceeds are expected to be approximately $6.5 million before advisory fees. In exchange, the company will issue new unregistered warrants exercisable for up to 2,610,823 shares at $6.63 per share, exercisable upon shareholder approval for a term of five years. Transaction expected to close on or about Dec 11, 2025, subject to customary closing conditions. Roth Capital Partners and Maxim Group are financial advisors.

Moleculin (Nasdaq: MBRX) reported that 78% of the target subjects for the first planned interim unblinding of its pivotal Phase 2B/3 MIRACLE trial have consented, up from 60% in November, with consented subjects now across seven countries. The company expects to complete treatment of the first 45 subjects in Q1 2026 and to finish Part A (up to 90 patients) in the first half of 2026. Annamycin (naxtarubicin) holds FDA Fast Track and Orphan Drug designations and composition-of-matter patent protection through 2040 (potential extension to 2045). Enrollment and blinded activity are reported as within expected ranges.

Moleculin (Nasdaq: MBRX) entered a research and material transfer agreement dated December 8, 2025 with CIC biomaGUNE to support investigator-initiated preclinical studies of Annamycin in glioblastoma multiforme (GBM).

The collaboration will evaluate intra-arterial delivery of liposomal Annamycin (L-Annamycin) and Free-Annamycin versus Doxil and Free-doxorubicin in mouse GBM models. Moleculin will supply Annamycin and CIC biomaGUNE will conduct the planned studies under Principal Investigator Jesús Ruiz-Cabello.

Annamycin holds FDA Fast Track status and multiple Orphan Drug designations (FDA and EMA) and has shown prior clinical activity in AML and soft tissue sarcomas per the announcement.

Moleculin (NASDAQ: MBRX) announced that Walter Klemp, Chairman and CEO, will participate in the Virtual Investor Closing Bell Series on Tuesday, December 2, 2025 at 4:00 PM ET.

Mr. Klemp will provide a corporate overview and business outlook, followed by a live Q&A. A live video webcast will be available on the Events page under Investors at moleculin.com. A replay will be posted two hours after the live event and remain accessible for 90 days.

Moleculin (Nasdaq: MBRX) filed an amendment to its certificate of incorporation to effect a 1-for-25 reverse stock split of its common stock, effective 12:01 am ET on December 1, 2025. The company said shares will open for trading on Nasdaq on December 1, 2025 on a post-split basis under the existing ticker MBRX but with a new CUSIP 60855D 408. Every 25 pre-split shares will be consolidated into one share, with no change to the $0.001 par value. Fractional shares will not be issued; holders entitled to fractions will receive a cash payment in lieu. Outstanding shares are expected to fall from approximately 51.7 million to approximately 2.1 million, while authorized shares remain 500 million.

Moleculin (Nasdaq: MBRX) reported that 60% of the target subjects for the first planned interim unblinding of its pivotal Phase 2B/3 MIRACLE trial have consented, toward a 45-subject early-unblinding target. The company expects to complete treatment of the first 45 subjects in Q1 2026 with initial unblinded efficacy and safety data thereafter, and a second unblinding expected in H1 2026.

The MIRACLE design combines Part A (2B) and Part B (3) for primary efficacy assessment; the first unblinding will include 30 subjects receiving Annamycin plus HiDAC and 15 subjects receiving HiDAC plus placebo. Annamycin holds FDA Fast Track status, Orphan Drug designations (FDA and EMA), and composition-of-matter patent protection through 2040 with potential extension to 2045.