Core Viewpoint - Moleculin Biotech, Inc. is set to report its financial results for the year ended December 31, 2024, on March 21, 2025, with a conference call scheduled for March 24, 2025, to discuss these results [1][2] Company Overview - 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 aimed at overcoming multidrug resistance and reducing cardiotoxicity associated with current treatments [3] Clinical Trials and Development - The company is initiating the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML) [4] - Following a successful Phase 1B/2 study, the company believes it has de-risked the development pathway for Annamycin's potential approval for AML treatment [4] - Additionally, the company is developing WP1066, an immune/transcription modulator targeting various cancers, and a portfolio of antimetabolites, including WP1122 for treating pathogenic viruses and certain cancer indications [5]

Core Insights - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focusing on drug candidates for hard-to-treat tumors and viruses [1][3] - The company participated in the Virtual Investor "Top 5 for '25" On-Demand Conference, where CEO Walter Klemp highlighted five reasons for investment interest in Moleculin [2] Company Overview - Moleculin 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 [3] - Annamycin is designed to avoid multidrug resistance and eliminate cardiotoxicity associated with current anthracyclines [3] Clinical Trials - The company is initiating the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for AML treatment [4] - Following a successful Phase 1B/2 study, the company believes it has de-risked the development pathway for Annamycin's potential approval [4] Additional Developments - Moleculin is also developing WP1066, an Immune/Transcription Modulator targeting brain tumors and pancreatic cancers [5] - The company is working on a portfolio of antimetabolites, including WP1122 for treating pathogenic viruses and certain cancer indications [5]

Core Insights - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses [3] - The company will participate in the 37th Annual ROTH Conference on March 18, 2025, with a live webcast of the fireside chat available [1][2] Company Overview - Moleculin Biotech, Inc. 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 [3] - Annamycin is designed to avoid multidrug resistance and eliminate cardiotoxicity associated with current anthracyclines [3] Clinical Trials - The company is initiating the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML [4] - Following a successful Phase 1B/2 study, the company believes it has de-risked the development pathway for Annamycin towards potential approval [4] Additional Developments - Moleculin is also developing WP1066, an immune/transcription modulator targeting brain tumors and pancreatic cancers [5] - The company is working on a portfolio of antimetabolites, including WP1122, for potential treatment of pathogenic viruses and certain cancer indications [5]

Core Insights - Moleculin Biotech, Inc. has received a Notice of Intent to Grant for a European patent for its drug candidate Annamycin, which is aimed at treating certain cancers and is expected to enhance global exclusivity [1][2][3] - The company anticipates an initial data readout from the phase 3 MIRACLE trial in the second half of 2025, which evaluates Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML) [1][3] Patent and Market Expansion - The new patent will cover methods for making liposomal Annamycin suspension and its compositions for cancer treatment, with a base patent term extending until June 2040, potentially longer due to regulatory approval processes [2] - Annamycin is positioned to be the first non-cardiotoxic anthracycline approved for use, with ongoing studies suggesting its potential for treating various cancer types [2] Clinical Development - The MIRACLE trial (MB-108) is a pivotal phase 3 study that follows a successful phase 1B/2 study, indicating a de-risked development pathway for Annamycin's approval for AML treatment [3] - The company is also developing WP1066, an immune/transcription modulator targeting brain tumors and other cancers, along with a portfolio of antimetabolites for treating pathogenic viruses and certain cancer indications [4]

Core Insights - Moleculin Biotech, Inc. has announced that its abstract has been accepted for poster presentation at the Acute Leukemias XIX International Symposium, scheduled for March 16-19, 2025, in Munich, Germany [1][2]. Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses. Its lead program, Annamycin, is a next-generation anthracycline aimed at overcoming multidrug resistance and reducing cardiotoxicity associated with traditional anthracyclines [3]. - The company is currently advancing a pipeline that includes Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases [3]. Clinical Trials - The company is initiating the MIRACLE Trial (MB-108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory AML. This follows a successful Phase 1B/2 study, which has provided confidence in the development pathway towards potential approval [4]. - The trial design is adaptive, and the company is preparing for future regulatory filings with the FDA and other international regulatory bodies [4]. Additional Developments - Moleculin is also developing WP1066, an immune/transcription modulator targeting various cancers, including brain tumors and pancreatic cancer. Additionally, the company is working on a portfolio of antimetabolites, including WP1122, aimed at treating pathogenic viruses and certain cancer indications [5].

Core Viewpoint - Moleculin Biotech, Inc. has announced a securities purchase agreement for a registered direct offering and concurrent private placement, aiming to raise approximately $3.5 million for working capital and corporate purposes [1][2]. Group 1: Offering Details - The company will sell 3,271,029 shares of common stock (or pre-funded warrants) at a price of $1.07 per share, along with warrants to purchase up to 6,542,058 additional shares [1]. - The warrants will have an exercise price of $1.07 per share, exercisable upon shareholder approval, and will expire five years from the initial exercise date [1]. - Roth Capital Partners is acting as the exclusive placement agent for the offering, which is expected to close on or about February 26, 2025 [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for working capital and general corporate purposes [2]. 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 avoid multidrug resistance and cardiotoxicity, currently in development for relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases [6][7]. - The company is initiating the MIRACLE trial, a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for AML treatment [7]. Group 4: 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 [8].

Core Insights - Moleculin Biotech, Inc. (MBRX) stock has experienced a significant surge, increasing by 426% to $2.21 with a trading volume of 64.85 million shares compared to an average of 157.048K shares [1][7]. Company Developments - The company received FDA feedback on its IND amendment, allowing a reduction in the size of its Phase 3 pivotal trial for Annamycin in combination with Cytarabine for refractory/relapsed Acute Myeloid Leukemia patients [2][3]. - The FDA's guidance recommended an alteration to the statistical plan, enabling a 10% reduction in the size of Part B of the trial, facilitating quicker site openings in the US, Europe, and the Middle East [3]. - The MIRACLE Phase 3 study employs an adaptive design, with the first 75 to 90 subjects randomized to receive high-dose cytarabine combined with either placebo or two different doses of Annamycin [4]. - The amended protocol allows for early unblinding of preliminary primary efficacy data and safety/tolerability results at 45 subjects, with expectations for the first unblinding in the second half of 2025 and the second in the first half of 2026 [5]. Trial Details - For Part B of the trial, approximately 220 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin [6]. - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory acute myeloid leukemia and soft tissue sarcoma, as well as Orphan Drug Designation from the European Medicines Agency for the same conditions [6].

Core Viewpoint - Moleculin Biotech, Inc. has announced agreements for the immediate exercise of existing warrants, allowing the purchase of up to 5,828,570 shares at a reduced price of $1.00 per share, expected to generate approximately $5.8 million in gross proceeds [1][3] Group 1: Financial Transactions - The company will issue new unregistered warrants for the immediate exercise of existing warrants, allowing the purchase of up to 11,657,140 shares at an exercise price of $0.75 per share, with a term of five years [2] - The transaction is expected to close on or about February 14, 2025, pending customary closing conditions [3] Group 2: Use of Proceeds - The net proceeds from the offering will be utilized 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 avoid multidrug resistance and cardiotoxicity, currently in development for relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma (STS) lung metastases [6][7] - The company is initiating the MIRACLE Trial (MB-108) to evaluate Annamycin in combination with cytarabine for treating relapsed or refractory AML [7] Group 4: 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 potential treatment of pathogenic viruses and certain cancer indications [8]

Core Viewpoint - Moleculin Biotech is advancing its pivotal Phase 3 clinical trial, named the "MIRACLE" trial, for Annamycin in combination with Cytarabine for treating relapsed or refractory acute myeloid leukemia (R/R AML), with the first subject expected to be treated in Q1 2025 [1][8]. Company Developments - The FDA has provided feedback that allows Moleculin to reduce the size of Part B of the trial by approximately 10%, while major aspects of the trial remain unchanged [2]. - The trial will be global, with sites in the US, Europe, and the Middle East, facilitating an accelerated timeline for new drug approval [2][3]. - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for R/R AML and soft tissue sarcoma, as well as Orphan Drug Designation from the European Medicines Agency [5]. Trial Design and Expectations - The MIRACLE trial will utilize an adaptive design, with the first 75 to 90 subjects randomized to receive high dose cytarabine combined with either placebo or two different doses of Annamycin [3][4]. - Preliminary primary efficacy data will be unblinded at 45 subjects, with the first unblinding expected in the second half of 2025 and a second unblinding in the first half of 2026 [3]. - Part B of the trial will involve approximately 220 additional subjects randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin [4]. Product Overview - Annamycin is a next-generation anthracycline designed to avoid multidrug resistance mechanisms and eliminate cardiotoxicity associated with current anthracyclines, targeting R/R AML and soft tissue sarcoma [7][8].

First of many site approvals, including sites in the US, Europe and the Middle East, expected throughout Q1-Q3 2025 Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025 Recently amended protocol accelerates unblinding of preliminary primary efficacy data (CR) and safety/tolerability of the three arms at first 45 subjects, expected in the second half of 2025 HOUSTON, Feb. 11, 2025 /PRNewswire/ -- Moleculin Biotech, ...