Atlantic Health, a leading provider of health care based in New Jersey, to conduct the investigator-initiated Phase 1B/2 study Preclinical studies indicate Annamycin targets key factors in pancreatic cancer HOUSTON, Oct. 23, 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 is working with Atlantic Health on an ...

Core Viewpoint - Moleculin Biotech, Inc. has received a notice of allowance for a Canadian patent related to its drug candidate Annamycin, which is being developed for the treatment of hard-to-treat cancers, particularly acute myeloid leukemia and soft tissue sarcoma lung metastases [1][2][3] Group 1: Patent and Intellectual Property - The Canadian patent application covers methods for producing a preliposomal Annamycin lyophilizate with improved stability and high purity, with a base patent term extending until June 2040 [2] - The company is actively building its global intellectual property portfolio for Annamycin, which includes patents in the U.S., Europe, and other major jurisdictions [3] Group 2: Drug Development and Clinical Trials - Annamycin is positioned to be the first non-cardiotoxic anthracycline approved for use, with Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML and STS lung metastases [3][4] - The company has initiated the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory AML, following a successful Phase 1B/2 study [5] Group 3: Additional Pipeline and Research - In addition to Annamycin, the company is developing WP1066, an immune/transcription modulator targeting various cancers, and WP1122 for potential treatment of pathogenic viruses and certain cancer indications [6]

Core Viewpoint - Moleculin Biotech, Inc. has announced agreements for the immediate exercise of existing warrants, which will generate approximately $6.0 million in gross proceeds for the company [1][3]. Group 1: Financial Transactions - The company has entered into agreements for the immediate exercise of warrants to purchase up to 16,216,216 shares of common stock at an exercise price of $0.37 per share [1]. - Roth Capital Partners is acting as the financial advisor for this transaction [2]. - In exchange for the immediate exercise of the warrants, the company will issue new unregistered warrants for up to 64,864,864 shares at an exercise price of $0.55 per share, subject to shareholder approval [2]. Group 2: Use of Proceeds - The net proceeds from the offering are intended for working capital and general corporate purposes [3]. Group 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 [6]. - The lead program, Annamycin, is designed to treat relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases [6][7]. - The company has initiated the MIRACLE trial, evaluating Annamycin in combination with cytarabine for AML treatment [7]. - Additionally, the company is developing WP1066, an immune/transcription modulator targeting various cancers, and WP1122 for potential treatment of pathogenic viruses [8].

Core Insights - The clinical trial results for Annamycin in combination with Cytarabine (AnnAraC) show significant improvements in overall survival (OS) for patients with relapsed acute myeloid leukemia (AML), exceeding industry expectations by over 30% [2][4] - The median OS for subjects achieving complete remission (CR) is reported at 15 months, while the median OS for the intent-to-treat (ITT) population is 9 months [5][3] - The company is progressing with the pivotal MIRACLE Phase 3 trial and anticipates the final clinical study report (CSR) for the MB-106 trial to be published in early Q1 2026 [1][6] Clinical Trial Results - A total of 22 subjects were enrolled in the MB-106 trial, with 8 subjects (36%) achieving complete remission [3][5] - The median OS for the 2nd line efficacy evaluable population is 12 months [5] - The durability of CR for the 8 subjects ranged from 2 to 22 months, with a median of 10 months [3] Safety and Tolerability - No clinically significant signs of cardiotoxicity were observed in any subjects, which is a critical aspect of Annamycin's profile [7][4] - The combination treatment was well tolerated, with myelosuppression and infections being the main adverse events [7] Future Developments - The company aims to recruit the first 45 patients for the MIRACLE trial by the end of the year, with safety and efficacy data expected to be unblinded thereafter [6] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory AML, indicating its potential significance in addressing unmet medical needs [8][11]

Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses [3] - The company's lead program, 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 (STS) lung metastases [3] Clinical Trials - The company has initiated the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for treating relapsed or refractory AML [4] - Following a successful Phase 1B/2 study (MB-106) and FDA input, the company believes it has de-risked the development pathway for Annamycin's potential approval for AML [4] Additional Drug Development - Moleculin is also developing WP1066, an Immune/Transcription Modulator targeting brain tumors and pancreatic cancers by inhibiting oncogenic transcription factors and stimulating immune response [5] - The company is working on a portfolio of antimetabolites, including WP1122, aimed at treating pathogenic viruses and certain cancer indications [5] Upcoming Events - Moleculin will present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech on August 20, 2025, at 2:00 PM ET, with CEO Walter Klemp as the presenter [1]

Core Insights - Moleculin Biotech, Inc. announced promising preclinical data for its lead drug candidate, Annamycin, showing significant efficacy against various liver cancers, including hepatocellular carcinoma, colorectal liver metastases, and pancreatic ductal adenocarcinoma liver metastases [1][4][5] - Annamycin is currently in late-stage clinical development for the treatment of acute myeloid leukemia (AML) in combination with cytarabine, with preliminary data expected in the second half of 2025 [1][7] 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 being a next-generation anthracycline designed to avoid multidrug resistance and cardiotoxicity [6][8] - The company is also developing WP1066, an immune/transcription modulator targeting brain tumors and other cancers, along with a portfolio of antimetabolites for potential treatment of pathogenic viruses and certain cancer indications [8] Preclinical Findings - Annamycin demonstrated targeted accumulation in organs, particularly the liver, spleen, lungs, and pancreas, leading to higher concentrations compared to doxorubicin, which is critical for treating liver-localized tumors [5] - In orthotopic hepatocellular carcinoma models, Annamycin showed excellent anti-tumor activity, significantly reducing tumor progression and improving survival rates [5] - The drug also exhibited significant efficacy in inhibiting metastatic growth in colorectal liver metastasis models and showed promising results in managing advanced pancreatic cancer with liver involvement [5] Safety Profile - Annamycin has a favorable safety profile, showing low or no cardiotoxicity, which is a significant advantage over traditional anthracyclines like doxorubicin, often limited by dose-dependent cardiac side effects [5]

Core Viewpoint - Moleculin Biotech, Inc. has received a Notice of Intent to Grant for a European patent that will enhance its market position for Annamycin, a potential first non-cardiotoxic anthracycline, aimed at treating hard-to-treat tumors and viruses [2][3][4] Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses, with its lead program being Annamycin [5] - Annamycin is designed to avoid multidrug resistance and lacks the cardiotoxicity associated with current anthracyclines, currently in development for relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases [5] Patent and Development - The new European patent will cover methods for creating a preliposomal Annamycin lyophilizate with improved stability and high purity, with a base patent term extending until 2040 [3][4] - 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 [4] Clinical Trials - The company has initiated the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory AML, following a successful Phase 1B/2 study [6] - The development pathway for Annamycin is considered substantially de-risked with input from the FDA [6] Additional Developments - Moleculin is also developing WP1066, an immune/transcription modulator targeting various cancers, and a portfolio of antimetabolites including WP1122 for potential treatment of pathogenic viruses and certain cancer indications [7]

Core Insights - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses [1][3] - The company's lead program, 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 (STS) lung metastases [3][4] - The MIRACLE Trial (MB-108) is a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML, with a successful Phase 1B/2 study providing confidence in the development pathway [4] Company Overview - Moleculin Biotech, Inc. is advancing a pipeline of therapeutic candidates, including WP1066, an immune/transcription modulator targeting brain tumors and pancreatic cancers, and a portfolio of antimetabolites like WP1122 for treating pathogenic viruses and certain cancers [5] Recent Developments - Walter Klemp, the company's Founder, President, CEO, and Chairman, participated in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference, sharing insights into his dedication to the company and its programs [2]

Core Viewpoint - Moleculin Biotech, Inc. has appointed Adriano Treve as a Strategic Advisor for partnerships, leveraging his extensive experience in global healthcare to enhance the company's strategic positioning and partnership opportunities as it advances its clinical trials [1][3][5]. 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]. - The company's lead program, Annamycin, is designed to avoid multidrug resistance and cardiotoxicity associated with current anthracyclines, targeting relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma [10][11]. Key Developments - The Phase 2B/3 MIRACLE trial for Annamycin in combination with cytarabine is ongoing, with the first unblinding of data for 45 patients expected in the second half of 2025 and a second unblinding anticipated in the first half of 2026 [4][8]. - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for treating relapsed or refractory AML, as well as similar designations from the EMA [9]. Strategic Partnerships - Mr. Treve's appointment is expected to enhance Moleculin's ability to secure partnerships that could optimize the value of Annamycin, which has the potential to significantly impact the global oncology drug market [5][6]. - The company is experiencing increased interest from potential strategic partners as it approaches key milestones in its clinical trials [6]. Clinical Trial Details - The MIRACLE trial is a pivotal, adaptive design Phase 3 study evaluating Annamycin in combination with cytarabine for adult patients with relapsed or refractory AML, conducted across multiple sites in the US, Europe, and the Middle East [11]. - The trial follows a successful Phase 1B/2 study, which has de-risked the development pathway towards potential approval for Annamycin [11].

Core Points - The Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia has approved the Clinical Trial Application (CTA) for the pivotal Phase 2B/3 MIRACLE trial of Annamycin in combination with cytarabine for treating adult patients with relapsed or refractory acute myeloid leukemia (AML) [2][3] - The European Medicines Agency (EMA) has also granted approval for the trial, enhancing its profile and recruitment efforts [3][5] - Enrollment in Part A of the MIRACLE trial has reached seven subjects treated, with one additional subject in screening, and the company plans to expand to over 30 clinical sites by the end of the year [3][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 [11][12] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for treating relapsed or refractory AML, as well as similar designations from the EMA [8][11] - The MIRACLE trial is designed to combine data from the Phase 2B and Phase 3 portions to measure the primary efficacy endpoint, utilizing an adaptive design [3][12] Trial Details - The MIRACLE trial will randomize the first 75 to 90 subjects to receive high-dose cytarabine combined with either placebo or two different doses of Annamycin [3][6] - The first unblinding of preliminary efficacy data is expected in the second half of 2025, with a second unblinding anticipated in the first half of 2026 [4][6] - Approximately 220 additional subjects will be randomized in Part B of the trial to receive either high-dose cytarabine plus placebo or the optimum dose of Annamycin [6] Recruitment and Collaboration - The company expects to add 16 additional clinical sites in Europe and the US by the end of August, building to over 30 sites for Part A of the trial [3][4] - The recruitment success is attributed to the capabilities of clinical sites, particularly the ARENSIA Exploratory Medicine's research clinic in Kyiv, Ukraine [3][9]