Core Insights - Moleculin Biotech, Inc. has launched a new platform called CEO Corner to enhance communication with investors and stakeholders, providing deeper insights into corporate developments and clinical progress [1][2] 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 [5] - The 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 [5] 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 [6] - Following a successful Phase 1B/2 study, the company believes it has de-risked the development pathway for Annamycin towards potential approval for AML treatment [6] Additional Pipeline Developments - Moleculin is also developing WP1066, an immune/transcription modulator targeting brain tumors and pancreatic cancers, and has a portfolio of antimetabolites including WP1122 for treating pathogenic viruses and certain cancer indications [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 [3] - The lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance and cardiotoxicity associated with current treatments [3] - Annamycin is 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 [4] Additional Pipeline - Moleculin is also developing WP1066, an Immune/Transcription Modulator targeting brain tumors and pancreatic cancers by inhibiting oncogenic transcription factors [5] - The pipeline includes antimetabolites like WP1122, aimed at treating pathogenic viruses and certain cancer indications [5] Upcoming Events - The company will participate in the Corporate Connect Webinar Series hosted by Webull Financial on February 10-11, 2026, with a presentation by Walter Klemp, the Founder, President, CEO, and Chairman [1]

Core Viewpoint - Annamycin, a next-generation anthracycline, shows no evidence of cardiotoxicity in 90 subjects across five clinical trials, indicating its potential as a safer treatment option for various cancers [1][3]. Group 1: Clinical Trial Results - An independent assessment confirmed the absence of cardiotoxicity in subjects treated with Annamycin, with data reviewed from 90 subjects [1]. - The trials involved treating acute myeloid leukemia (AML) and soft tissue sarcoma (STS) with Annamycin as a monotherapy and in combination with cytarabine [1]. - Notably, 65 out of 90 subjects received doses exceeding the FDA's lifetime maximum of 550 mg/m², with one subject receiving over 6500 mg/m² [3]. Group 2: Safety and Efficacy Data - The assessment included data from serial 12-lead ECGs, echocardiography, and cardiac biomarker measurements, which are critical for evaluating potential heart damage [2]. - Annamycin is designed to avoid multidrug resistance mechanisms and lacks the cardiotoxicity associated with current anthracyclines [4]. Group 3: Future Development and Market Potential - The company has initiated the MIRACLE trial, a pivotal Phase 3 study evaluating Annamycin in combination with cytarabine for relapsed or refractory AML [5][6]. - The company believes that Annamycin could become the first non-cardiotoxic anthracycline, addressing a significant unmet medical need in cancer treatment [3]. - The potential market opportunity for Annamycin is substantial, given the high incidence of cardiotoxicity in existing cancer treatments [3].

Core Insights - The company has reported an increase in enrollment for the MIRACLE trial, reaching 78% of the target number of subjects for the first interim unblinding, up from 60% in November [1][2] - The trial aims to evaluate Annamycin in combination with cytarabine for treating adult patients with relapsed or refractory acute myeloid leukemia (AML) [1][9] - The first unblinding is expected to occur in the first quarter of 2026, with a target of 45 subjects [1][4] Enrollment and Trial Progress - As of December 3, 2025, the company has consented subjects from seven countries, indicating a diverse patient population [4] - The company anticipates completing treatment of the first 45 subjects by the first quarter of 2026 and aims to finish Part A of the trial with up to 90 patients in the first half of 2026 [4][2] - The trial design allows for unblinding of preliminary efficacy data at 45 subjects, with a focus on complete remission as a primary endpoint [3] Annamycin's Potential and Designation - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for treating relapsed or refractory AML, as well as Orphan Drug Designation from the EMA [6][7] - The drug is designed to avoid multidrug resistance mechanisms and lacks the cardiotoxicity associated with current anthracyclines [8] - The company believes Annamycin could provide a safer and more effective treatment option for AML patients [2]

Core Viewpoint - Moleculin Biotech, Inc. has entered into a research agreement with CIC biomaGUNE to evaluate Annamycin for treating glioblastoma multiforme, a challenging brain cancer with significant unmet medical needs [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 [2][6]. - The company's lead program, Annamycin, is a next-generation anthracycline designed to avoid multidrug resistance and cardiotoxicity associated with existing treatments [6]. Research Agreement Details - Under the agreement, Moleculin will supply Annamycin, and CIC biomaGUNE will conduct preclinical studies comparing the effects of intra-arterial delivery of liposomal Annamycin and Free-Annamycin against Doxil and Free-doxorubicin in mouse models [3][4]. - The research aims to explore Annamycin's potential to address drug delivery challenges and resistance in central nervous system tumors [4]. Glioblastoma Multiforme Insights - Glioblastoma is the most aggressive primary brain tumor, accounting for 54% of all gliomas and 16% of all primary brain tumors, with a median survival of only 15 months [4]. - The average annual age-adjusted incidence rate of glioblastoma in the U.S. is 3.19 per 100,000 persons, and survival rates have not significantly improved in the last three decades [4]. Annamycin's Regulatory Status - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for treating relapsed or refractory acute myeloid leukemia (AML) and soft tissue sarcoma lung metastases [5]. - The drug also holds Orphan Drug Designation from the EMA for the same indications [5]. Clinical Trials - The company has initiated the MIRACLE trial, a Phase 3 study evaluating Annamycin in combination with cytarabine for relapsed or refractory AML [7]. - Following a successful Phase 1B/2 study, the company believes it has reduced risks associated with the development pathway for Annamycin's approval [7].

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]