HOUSTON, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced it has entered into agreements with certain holders of its existing warrants for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 727,969 shares of common stock of the Company originally issued in February 2025 at an ex ...

Continues to drive enrollment with increase to 78% now consentedBlinded response activity tracking within expected range Consented subjects now across seven countries supporting the expansion of the MIRACLE trial HOUSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today provided an update on enrollment from its November report with an increase to 78% of the target number of subjects for the first planned interim unblinding of data having consent ...

Investigator-Initiated Preclinical studies at CIC biomaGUNE aimed at combatting Glioblastoma Multiforme Research will evaluate effects of intra-arterial delivery of Annamycin HOUSTON, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, today announced it has entered into a research and material transfer agreement with CIC ...

Core Insights - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses [4] - The company will host a live video webcast featuring CEO Walter Klemp on December 2, 2025, to provide a corporate overview and business outlook [1][2] Company Overview - Moleculin Biotech is advancing a pipeline of therapeutic candidates, with its lead program Annamycin targeting relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases [4] - Annamycin is designed to avoid multidrug resistance mechanisms and lacks the cardiotoxicity associated with current anthracyclines [4] Clinical Trials - The company has initiated the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML [5] - Following a successful Phase 1B/2 study, the company believes it has de-risked the development pathway for Annamycin's potential approval [5] Additional Developments - Moleculin is also developing WP1066, an immune/transcription modulator targeting brain tumors and other cancers, and a portfolio of antimetabolites including WP1122 for treating pathogenic viruses [6]

Core Viewpoint - Moleculin Biotech, Inc. announced a 1-for-25 reverse stock split of its common stock, effective December 1, 2025, to consolidate shares and potentially enhance stock performance [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will consolidate every 25 shares into one share, maintaining the nominal par value of $0.001 per share [2]. - The number of outstanding shares will decrease from approximately 51.7 million to about 2.1 million, while the authorized shares will remain at 500 million [3]. Group 2: Company Overview - Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company focused on developing therapies for hard-to-treat tumors and viruses [4]. - The lead program, Annamycin, is designed to treat relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases [4]. Group 3: Clinical Trials and Pipeline - The company has initiated the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for AML treatment [5]. - Moleculin is also developing WP1066, an immune/transcription modulator targeting various cancers, and has a portfolio of antimetabolites, including WP1122 for treating pathogenic viruses [6].

Core Insights - Moleculin Biotech, Inc. is progressing with its pivotal Phase 2B/3 "MIRACLE" study of Annamycin for treating adult patients with relapsed or refractory acute myeloid leukemia (AML), with 60% of the target enrollment completed as of November 4, 2025 [1][2][4] - The company expects to complete treatment for the first 45 subjects by Q1 2026, with initial unblinded data anticipated shortly thereafter [1][4][5] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for AML treatment, and it is designed to avoid common cardiotoxicity associated with existing anthracyclines [7][9] Enrollment and Study Progress - The MIRACLE study is a global, multi-center, randomized, double-blind, placebo-controlled trial, combining data from its Phase 2B and Phase 3 portions to measure primary efficacy endpoints [3][10] - The first unblinding will involve 30 subjects treated with Annamycin in combination with HiDAC and 15 subjects treated with HiDAC plus placebo [3] - Recruitment is ongoing, with subjects enrolled from five countries, although some European sites are experiencing bed shortages affecting enrollment [5][2] Future Expectations - The company anticipates a second unblinding in the first half of 2026, following the initial unblinding of data [4] - The accelerated timeline for recruitment is attributed to positive feedback from potential investigators [4] - Annamycin is positioned as a potentially safer and more effective treatment option for AML, addressing a significant gap in current therapies [2][4]

Core Insights - Moleculin Biotech, Inc. has entered into a research agreement with the University of North Carolina at Chapel Hill to conduct preclinical studies on Annamycin for pancreatic cancer treatment [1][2][3] - Annamycin is being evaluated for its ability to enhance tumor delivery compared to existing treatments like Doxil and Free-doxorubicin [2] - The company aims to leverage Annamycin's high affinity for the pancreas and its correlation with poor survival rates in pancreatic cancer patients to expand its clinical applications [3] Company Overview - Moleculin Biotech is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat cancers and viral infections [1][6] - Annamycin is a next-generation anthracycline designed to avoid multidrug resistance and cardiotoxicity associated with traditional anthracyclines [6][8] - The company is currently conducting a pivotal Phase 2B/3 trial named MIRACLE, evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML) [4][8] Research and Development - The preclinical research at UNC will assess the effectiveness of Annamycin in conjunction with novel agents to improve treatment outcomes for pancreatic cancer [1][2] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for treating relapsed or refractory AML and soft tissue sarcoma lung metastases [3][6] - The company is also developing WP1066, an immune/transcription modulator targeting various cancers, including pancreatic cancer [9]

Core Viewpoint - Moleculin Biotech, Inc. is advancing its lead program Annamycin, a non-cardiotoxic anthracycline, through a pivotal Phase 3 trial for treating relapsed or refractory acute myeloid leukemia (AML) [1][4] Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat cancers and viral infections [1][3] - The company’s lead candidate, Annamycin, is designed to avoid multidrug resistance mechanisms and lacks the cardiotoxicity associated with current anthracyclines [3] Clinical Trials - The ongoing MIRACLE trial is a Phase 2B/3, multi-center, randomized, double-blind, placebo-controlled study evaluating Annamycin in combination with cytarabine for adult patients with R/R AML [1][4] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for R/R AML and STS lung metastases, as well as Orphan Drug Designation from the EMA [2] Upcoming Presentation - Dr. Paul Waymack, Senior Chief Medical Officer, will present details of the MIRACLE trial at the 14th Annual Acute Leukemia Meeting on October 30, 2025 [1]

Core Insights - Moleculin Biotech, Inc. has been granted an Australian patent for preliposomal Annamycin lyophilizates, enhancing its global intellectual property portfolio with a base patent term extending until June 2040 [1][2] - Annamycin is being developed as a non-cardiotoxic anthracycline for treating acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases, with potential applications for various other cancers [2][4] - The company has initiated the MIRACLE trial, a Phase 3 study evaluating Annamycin in combination with cytarabine for relapsed or refractory AML, following a successful Phase 1B/2 study [5] Patent and Intellectual Property - The newly granted Australian patent covers preliposomal Annamycin with improved stability and high purity, contributing to the company's competitive position in oncology [1][2] - The patent family includes expected Canadian patents and previously issued U.S. and European patents, with additional applications pending in major jurisdictions worldwide [2] Drug Development and Clinical Trials - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML and STS lung metastases, as well as Orphan Drug Designation from the EMA [3] - The MIRACLE trial aims to evaluate the efficacy of Annamycin in combination with cytarabine, which is expected to de-risk the development pathway towards potential approval [5] Additional Pipeline Candidates - The company is also developing WP1066, an immune/transcription modulator targeting various cancers, and WP1122, an antimetabolite for treating pathogenic viruses and certain cancer indications [6]

Core Insights - Moleculin Biotech, Inc. is collaborating with Atlantic Health to conduct a Phase 1B/2 study of Annamycin for third-line treatment of advanced pancreatic cancer, addressing a significant unmet medical need in this high-mortality disease [1][3][2] Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat cancers and viral infections, with Annamycin as its lead program [11] - Annamycin is a next-generation anthracycline designed to avoid multidrug resistance and cardiotoxicity, currently in development for relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases [11][4] Study Details - The Phase 1B/2 study will evaluate Annamycin's efficacy in advanced pancreatic cancer, with an estimated cost of approximately $1 million for the trial from 2026 to 2030 [3][1] - Atlantic Health will conduct the study, while Moleculin will supply Annamycin and manage the Investigational New Drug Application (IND) with the FDA [3][1] Preclinical Data - Recent preclinical studies suggest that Annamycin targets critical factors in pancreatic cancer, showing a high level of activity against the disease and associated liver metastases [2][3] - The upregulation of topoisomerase II, the primary target of Annamycin, correlates with poor survival in pancreatic cancer patients, validating the target's relevance [3][2] Industry Context - Pancreatic cancer is the cancer with the highest mortality rate globally and has limited treatment options, particularly in the third-line setting where no approved standard of care exists [2][3] - The collaboration aims to drive innovation in pancreatic cancer treatment, addressing a significant gap in available therapies for patients who have progressed beyond first- and second-line treatments [3][2]