Core Viewpoint - Moleculin Biotech, Inc. has announced a public offering of 16,080,000 shares of common stock and Series E warrants, priced at $0.37 per share, aiming to raise approximately $5.9 million to advance its drug development pipeline [1][2]. Group 1: Offering Details - The public offering includes 16,080,000 shares of common stock and Series E warrants to purchase up to 48,240,000 shares, with a combined offering price of $0.37 per share [1]. - The offering is expected to close on or about June 23, 2025, subject to customary closing conditions [2]. - Gross proceeds from the offering are anticipated to be approximately $5.9 million before deducting fees and expenses [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to advance the development of Annamycin and two other drug portfolios through clinical development [2]. - Funds will also support preclinical studies and research sponsorship, as well as working capital needs [2]. Group 3: Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing therapies for hard-to-treat tumors and viruses, with its lead program Annamycin targeting relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma [6][7]. - The company is conducting the MIRACLE trial, a pivotal Phase 3 study evaluating Annamycin in combination with cytarabine for AML treatment [7]. - Additionally, Moleculin is developing WP1066, an immune/transcription modulator for various cancers, and a portfolio of antimetabolites including WP1122 for treating pathogenic viruses [8].

Core Viewpoint - Moleculin Biotech is advancing Annamycin, a drug designed to eliminate cardiotoxicity associated with anthracyclines, which are used to treat approximately 60% of children with cancer [1][2] Group 1: Pediatric Study and FDA Interaction - The FDA has recommended including patients as young as 6 months in the pediatric clinical study of Annamycin, which is a younger age than initially proposed by Moleculin [1][2] - The pediatric study will evaluate Annamycin in combination with Cytarabine as a second-line therapy for pediatric patients with relapsed/refractory acute myeloid leukemia (R/R AML) [1][2] - Moleculin plans to submit an updated Initial Pediatric Study Plan (iPSP) to the FDA later this quarter, with the pediatric clinical study expected to start in the second half of 2027 [3] Group 2: Clinical Trials and Data - The ongoing Phase 3 MIRACLE trial is evaluating Annamycin in combination with Cytarabine for adult patients with R/R AML, with initial data readout anticipated in the second half of 2025 [1][4] - An independent review of study data has shown no cardiotoxicity in 84 adult patients treated with Annamycin, reinforcing its potential for pediatric use [2][6] - The FDA has granted Annamycin Fast Track Status and Orphan Drug Designation for treating R/R AML and soft tissue sarcoma [4] Group 3: Company Overview and Pipeline - Moleculin Biotech is a late-stage pharmaceutical company focused on developing therapies for hard-to-treat cancers and viral infections [5] - Annamycin, also known as naxtarubicin, is designed to avoid multidrug resistance mechanisms and eliminate cardiotoxicity common with existing anthracyclines [5][6] - The company is also developing other therapeutic candidates, including WP1066 for various cancers and WP1122 for pathogenic viruses [8]

Globally recognized Oncology Key Opinion Leader, Brian Andrew Van Tine, MD, PhD, discusses the positive topline results from the U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of Soft Tissue Sarcoma Lung Metastases (MB-107) Watch the “What This Means" segment here HOUSTON, June 11, 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 ...

Access the on-demand webcast here HOUSTON, June 05, 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 viruses, today announced the release of its Soft Tissue Sarcoma (STS) Lung Mets KOL Webcast discussing the final data from its U.S. Phase 1B/2 clinical trial evaluating Annamycin as monotherapy for the treatment of soft tissue sarcoma lung metastase ...

Core Viewpoint - Moleculin Biotech, Inc. reported positive topline efficacy results from its Phase 1B/2 clinical trial of Annamycin for treating soft tissue sarcoma lung metastases, indicating significant potential for this treatment option in a challenging cancer market [1][3]. Company Summary - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat cancers and viruses, with Annamycin as its lead program [13]. - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for both relapsed or refractory acute myeloid leukemia and soft tissue sarcoma [5]. - The company is also advancing other therapeutic candidates, including WP1066 and WP1122, targeting various cancers and pathogenic viruses [16]. Clinical Trial Results - The MB-107 trial demonstrated a Clinical Benefit Rate (CBR) of 59.4%, with 18 subjects showing stable disease and 1 subject achieving a partial response [6]. - Median Progression Free Survival (PFS) was approximately 4 months, and Overall Survival (OS) was around 20 months for optimized dose subjects [6]. - In Phase 2, subjects with fewer prior therapies (≤2) showed improved OS of 19.9 months and PFS of 127 days, indicating better outcomes with Annamycin [6]. Market Opportunity - The soft tissue sarcoma market is projected to grow to $2.6 billion by 2030, with approximately 13,500 new cases expected annually [1][10]. - The current market for soft tissue sarcoma was valued at $1.58 billion in 2024, with a compound annual growth rate (CAGR) of 8.43% anticipated [10]. Study Design - The MB-107 trial was a multi-center, open-label, single-arm study assessing the safety and efficacy of Annamycin as a monotherapy for STS lung metastases [2][11]. - Treatment involved intravenous infusion of Annamycin over 2 hours, followed by a 20-day rest period, with safety monitoring conducted at each cycle [11][12].

Enrollment and dosing underway in Phase 3 clinical trial (the “MIRACLE” trial) evaluating Annamycin (naxtarubicin) for the treatment of R/R AML Regulatory and site selection progress to date supports interim data readout expected in the second half of 2025 Recently received European Medicines Agency (EMA) approval adds nine additional countries to the Company’s ongoing MIRACLE trial; Authorization granted in all EU countries requested Company to host conference call and webcast today, May 14th at 8:30 AM E ...

Core Viewpoint - Moleculin Biotech, Inc. has received two additional U.S. patents for Annamycin, enhancing its intellectual property portfolio and exclusivity for this novel drug candidate targeting hard-to-treat cancers and viruses [1][3]. Patent and Intellectual Property - The U.S. Patent and Trademark Office granted U.S. patent number 12,257,261 for the preparation of preliposomal Annamycin lyophilizate and U.S. patent 12,257,262 for the method of reconstituting liposomal Annamycin, both extending the patent term until June 2040 [1]. - With these new patents, the total number of U.S. patents related to Annamycin has increased to four, in addition to European patents granted [3]. Drug Development and Clinical Trials - Annamycin is being developed as a treatment for acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases (STS lung mets), with potential applications for other cancer types based on preclinical studies [2][4]. - The company is conducting the pivotal, adaptive Phase 3 MIRACLE trial evaluating Annamycin in combination with cytarabine for relapsed or refractory AML, with initial data expected in the second half of 2025 [3][5]. Regulatory Status - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML and STS lung mets, as well as Orphan Drug Designation from the European Medicines Agency [3]. Company Overview - Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company focused on developing therapeutic candidates for hard-to-treat tumors and viruses, with Annamycin as its lead program designed to avoid cardiotoxicity associated with current anthracyclines [4].

Core Viewpoint - Annamycin is a next-generation anthracycline that shows potential for synergistic effects with various FDA-approved anticancer therapies, indicating opportunities for expanded clinical applications in treating both hematological malignancies and solid tumors [1][2][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, with Annamycin as its lead program [6][7] - The company is advancing its pipeline through pivotal clinical trials, including the MIRACLE trial for relapsed or refractory acute myeloid leukemia (AML) [8] Research Findings - Recent studies presented at the AACR Annual Meeting 2025 demonstrate that Annamycin can work effectively in combination with various FDA-approved drugs, both in vitro and in vivo [1][4] - The research aims to identify new clinical applications for Annamycin, particularly in combination therapies for treatment-resistant cancers [4][5] Clinical Trials - The company is initiating the MIRACLE trial, which evaluates Annamycin in combination with cytarabine for AML treatment, following a successful Phase 1B/2 study [8] - Annamycin has shown high activity against drug-resistant cell lines in previous experiments, suggesting its potential effectiveness in challenging cancer cases [3][4] Future Development - The company is exploring additional indications for Annamycin, including pancreatic cancer and soft tissue sarcomas, as part of its strategy to expand the drug's market potential [2][4]

HOUSTON, April 17, 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 viruses, today announced that an abstract regarding the Company's next-generation anthracycline, Annamycin, has been selected for poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25-30, 2025, at the McCormick Place Co ...

Moleculin Biotech, Inc. (NASDAQ:MBRX) Q4 2024 Earnings Conference Call March 24, 2025 8:30 AM ET Company Participants Walter Klemp - Chairman and CEO John Paul Waymack - Senior CMO Jonathan Foster - EVP and CFO Conference Call Participants Jonathan Aschoff - Roth Capital Partners Jason McCarthy - Maxim Group Vernon Bernardino - H.C. Wainwright Operator Hello, and welcome to the Moleculin Biotech Fourth Quarter and Full Year 2024 Update Conference Call and Webcast. A question-and-answer session will follow t ...