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]

HOUSTON, Oct. 29, 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 that the Australian Patent Office (IP Australia) has granted Patent No. 2024203598 titled, “PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE,” with claims covering certain preliposomal Annamycin lyophilizates with improved stability and high purit ...

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]

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. (MBRX) has been upgraded to a Zacks Rank 2 (Buy), indicating an upward trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to institutional investors adjusting their valuations, resulting in stock price movements due to large transactions [4]. Company Performance and Outlook - The upgrade for Moleculin Biotech suggests an improvement in the company's underlying business, which could lead to higher stock prices as investors respond positively [5]. - Over the past three months, the Zacks Consensus Estimate for Moleculin Biotech has increased by 47.2%, indicating a positive trend in earnings expectations [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a "Strong Buy" or "Buy" rating, indicating superior earnings estimate revisions [9][10]. - The upgrade of Moleculin Biotech to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Core Insights - Moleculin Biotech, Inc. is advancing its pivotal Phase 2B/3 clinical trial, named MIRACLE, for Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia (AML) [1][10] - The company aims to recruit a total of 45 patients by Q4 2025 for initial data unblinding, with 13 subjects already recruited as of September 2025 [1][2][4] Recruitment and Trial Progress - The company has expanded its recruitment sites to include countries such as Georgia, Italy, Lithuania, Poland, Romania, Spain, and the US, with a goal of treating, enrolling, or screening 20 subjects by the end of September [1][4] - The recruitment strategy is on track, with expectations to increase active sites to over 30 by year-end, facilitating the recruitment of an additional 30 to 45 subjects for the trial [2][4] Trial Design and Data Insights - The MIRACLE trial employs an adaptive design, allowing for preliminary unblinding of efficacy data at 45 subjects, with a focus on complete remission (CR) rates [3][6] - The first unblinding is expected to provide insights into the efficacy and safety of Annamycin in combination with high-dose cytarabine, with a second unblinding anticipated in the first half of 2026 [3][4] Regulatory and Development Status - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for treating relapsed or refractory AML, along with patent protection extending to 2040, potentially to 2045 [8][9] - The company is required to present results from nonclinical GLP studies to the EMA before initiating Part B of the trial, which will involve approximately 220 additional subjects [5][6]

Core Insights - Moleculin Biotech, Inc. has initiated the pivotal Phase 2B/3 MIRACLE trial for Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia (R/R AML) [1][10] - The trial aims to recruit 45 subjects by the end of 2025 for initial data unblinding, with the first two subjects already enrolled in Spain [2][3] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for R/R AML and soft tissue sarcoma [7] Trial Details - The MIRACLE trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Annamycin combined with cytarabine [1][10] - The trial will consist of two parts: Part A will involve 75 to 90 subjects, while Part B will randomize approximately 220 additional subjects [5][10] - 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 [3][6] Regulatory and Design Aspects - The trial is subject to future filings with the FDA and EMA, with the EMA requiring nonclinical GLP study results before initiating Part B [4][10] - The adaptive design allows for the unblinding of data at 45 subjects, focusing on Complete Remission (CR) and safety/tolerability across three treatment arms [3][5] Company Overview - Moleculin Biotech is a late-stage pharmaceutical company focused on developing therapies for hard-to-treat cancers and viral infections [9] - The lead program, Annamycin, is designed to avoid multidrug resistance and cardiotoxicity associated with traditional anthracyclines [9][10] - The company is also developing additional therapeutic candidates, including WP1066 and WP1122, targeting various cancers and viral infections [11]

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]