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 - Moleculin Biotech, Inc. is advancing its drug candidates Annamycin and WP1066, targeting hard-to-treat tumors and viruses, with significant milestones expected in 2026 [2][3][11] Annamycin Development - Annamycin is set for pivotal Phase 2B/3 MIRACLE trial data readouts in Q1 2026, focusing on second line acute myeloid leukemia (AML) and initiating a trial for pancreatic cancer [3][4] - The MIRACLE trial has expanded to nine countries, with over 46 sites selected and 20 contracted, aiming to treat 45 subjects in Part A by Q1 2026 [3][4] - Annamycin is anticipated to be the first non-cardiotoxic anthracycline, addressing a significant market opportunity as current treatments often lead to heart damage [3][4] Expected Milestones for Annamycin - Q1 2026: Update on non-cardiotoxicity review and unblinding of data for the first 45 subjects [4] - 1H 2026: Recruitment of the 90th subject for the MIRACLE trial [4] - 2027: Begin recruitment for third line AML subjects and pediatric AML clinical study [4] WP1066 Development - WP1066 is designed to stimulate immune response against tumors by inhibiting regulatory T cells and oncogenic transcription factors [5][14] - Ongoing Phase 2 trial for WP1066 in combination with radiation for glioblastoma (GBM) is being conducted at Northwestern University [6][8] - Emory University is conducting a Phase 1 trial with positive results, leading to plans for a follow-on trial [7][8] Expected Milestones for WP1066 - Q1 2026: Continuation of Phase 2 GBM trial at Northwestern [11] - 2H 2026: Initiation of Phase 2 pediatric trial for brain tumors at Emory [11] - 2H 2026: Preclinical data on WP1066 intravenous formulation [11]

Emory University physician-sponsored clinical trial conducted at the Aflac Cancer and Blood Disorders Center at Children’s Healthcare of AtlantaResults demonstrated WP1066 induces anti-tumor immune responses and were recently published in the Journal of Clinical Investigation Insight WP1066 found to be safe and effective, warranting a Phase 2 trial HOUSTON, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced positive results from the Emor ...

Core Viewpoint - Moleculin Biotech, Inc. has announced agreements for the immediate exercise of existing warrants, which will generate approximately $6.5 million in gross proceeds for the company [1][4]. Group 1: Financial Transactions - The company has entered into agreements for the immediate exercise of warrants to purchase up to 727,969 shares at an exercise price of $6.63 per share and 316,360 shares at an exercise price of $6.3219 per share [1]. - In exchange for the immediate exercise of these warrants, the company will issue new unregistered warrants for an aggregate of up to 2,610,823 shares at an exercise price of $6.63 per share, exercisable upon shareholder approval for a term of five years [3]. - The transaction is expected to close on or about December 11, 2025, subject to customary closing conditions, with net proceeds intended for working capital and general corporate purposes [4]. Group 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][7]. - The company's 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 [7]. - The company has initiated the MIRACLE Trial, a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML, following a successful Phase 1B/2 study [8]. Group 3: Pipeline and Development - Moleculin is also developing WP1066, an immune/transcription modulator targeting brain tumors and other cancers, along with a portfolio of antimetabolites including WP1122 for potential treatment of pathogenic viruses and certain cancer indications [9].

Continues to drive enrollment with increase to 78% now consentedBlinded response activity tracking within expected range Consented subjects now across seven countries supporting the expansion of the MIRACLE trial HOUSTON, Dec. 09, 2025 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today provided an update on enrollment from its November report with an increase to 78% of the target number of subjects for the first planned interim unblinding of data having consent ...

Investigator-Initiated Preclinical studies at CIC biomaGUNE aimed at combatting Glioblastoma Multiforme Research will evaluate effects of intra-arterial delivery of Annamycin HOUSTON, Dec. 08, 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 has entered into a research and material transfer agreement with CIC ...

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].

Clinical Trials and Drug Development - The company is conducting a pivotal Phase 3 trial for Annamycin in combination with Cytarabine for the treatment of relapsed/refractory acute myeloid leukemia (AML), with an interim unblinding expected after recruiting the first 45 subjects[85]. - As of November 4, 2025, 60% of the targeted 45 subjects have consented to participate in the MIRACLE trial, with treatment of the last subject expected in Q1 2026[98]. - Annamycin has been administered to 84 subjects across five clinical trials with no evidence of cardiotoxicity, including subjects treated above the FDA's lifetime maximum anthracycline limit of 550 mg/m2[93]. - The company has a total of fourteen clinical trials, with ongoing studies for Annamycin and other drug candidates, including a Phase 2B/3 trial for AML and a Phase 1B/2 trial for soft tissue sarcoma[96]. - The MIRACLE trial is designed as an adaptive study with a lead-in Part A to determine the optimum dose of Annamycin, followed by Part B for further evaluation[97]. - The company has received ten communications from the FDA regarding the MIRACLE trial, focusing on safety and monitoring, with no significant changes to the trial design or dosing of Annamycin[101]. - Annamycin is designed to be non-cardiotoxic and has shown no cardiotoxicity in clinical trials, which is a significant advantage over currently prescribed anthracyclines[89]. - The MIRACLE trial protocol was amended to allow dosing above the lifetime maximum allowable dose for anthracyclines, with FDA feedback reducing the size of Part B of the Phase 3 trial to 222 subjects, a 10% reduction[102]. - The European Medicines Agency approved the Clinical Trial Application for the MIRACLE trial in nine EU countries, contingent on presenting results of nonclinical GLP studies before initiating Part B[104]. - In the Phase 1B/2 clinical trial of AnnAraC for AML, 36% of subjects achieved complete remission, with a median durability of 10 months for those in remission[106]. - The FDA approved a single pediatric study plan for Annamycin in combination with Cytarabine for children with relapsed/refractory AML, expected to commence in the second half of 2027[108]. - The MB-107 trial for Annamycin in STS Lung Mets showed a median overall survival of 13.5 months, compared to 8-12 months for standard treatments[110]. - Annamycin is being evaluated for pancreatic cancer in a grant-funded research project at UNC, with a Phase 1B/2 study planned to start in 2026[113][115]. Financial Performance - Research and development (R&D) expenses decreased to $3.7 million in Q3 2025 from $4.9 million in Q3 2024, a reduction of approximately 24.5%[134]. - General and administrative expenses slightly decreased to $2.1 million in Q3 2025 from $2.2 million in Q3 2024, a decrease of about 4.6%[135]. - The net loss for Q3 2025 was $25.4 million, compared to a net loss of $7.0 million in Q3 2024, indicating a significant increase in losses[133]. - The company recorded a net gain of $1.6 million from the change in fair value of warrant liability in Q3 2025, compared to no gain in Q3 2024[136]. - Cash used in operating activities was $17.4 million for the nine months ended September 30, 2025, a decrease of $1.4 million from $18.8 million in the prior year[145]. - The company raised gross proceeds of $6.0 million from the exercise of Series E warrants in August 2025[146]. - The company reported a net increase in cash and cash equivalents of $2.4 million for the nine months ended September 30, 2025, compared to a decrease of $14.1 million in the prior year[144]. - The company must seek additional funds of approximately $7 million to support operations into the second quarter of 2026[152]. Intellectual Property and Collaborations - The Australian Patent Office granted a patent for preliposomal Annamycin lyophilizate, extending the patent term until June 2040[122]. - The World Health Organization approved "naxtarubicin" as the international non-proprietary name for Annamycin, facilitating its recognition in clinical documents[125]. - The US Patent and Trademark Office granted two additional patents covering methods of making liposomal Annamycin, extending the patent term until June 2040[127]. - The company received a Notice of Intent to Grant for a European patent for "Method of Reconstituting Liposomal Annamycin," enhancing global exclusivity with a base patent term extending until June 2040[128]. - The company has additional patent applications related to Annamycin pending in major jurisdictions worldwide[128]. - The company has established collaborations with the University of Texas MD Anderson Cancer Center for research and development of its drug candidates[84]. Regulatory and Compliance - The company received a subpoena from the SEC in March 2022 regarding information related to its COVID-19 drug candidate, with expenses of approximately $0.1 million and $0.2 million for the three and nine months ended September 30, 2024, respectively[153]. - There have been no material changes to the company's critical accounting policies and estimates from those disclosed in the Form 10-K for the year ended December 31, 2024[154]. - The company is classified as a smaller reporting company, and thus, quantitative and qualitative disclosures about market risks are not applicable[156]. Strategic Focus and Growth - The company plans to expand treated indications with Annamycin in 2026, indicating a focus on growth and market expansion[86]. - The company aims to attract and retain key personnel to effectively manage its business and support future growth[84].

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]