HOUSTON, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced it has entered into agreements with certain holders of its existing warrants for the immediate exercise of certain outstanding warrants to purchase up to an aggregate of 2,122,652 shares of common stock of the Company at an exercise price of $3.90 per share. The issuance or resale of the shares of common stock issuable upon exercise of the outstanding warrants has been registere ...

Preliminary blinded CR rate showed 67% improvement over historical cytarabine response Roughly 35% of the subjects treated to date represent ventoclax regimen failuresFirst 45 subjects treated on track for Q1 2026 milestone with unblinding thereafter; treated 35 subjects to date with another 11 identified Continued absence of cardiotoxicity and high efficacy expected to position Annamycin as a “significant advancement” in AML treatment HOUSTON, Feb. 18, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nas ...

Core Viewpoint - Moleculin Biotech, Inc. has received a notice of allowance for a patent in Japan related to the preparation of liposomal Annamycin, which is expected to enhance its intellectual property position and support the development of its non-cardiotoxic therapy for acute myeloid leukemia [1][2][3] Group 1: Patent and Intellectual Property - The Japan Patent Office has allowed claims for a patent application covering methods for reconstituting liposomal Annamycin, ensuring consistent dosing and stability for intravenous administration [2] - This patent allowance complements existing U.S. and European patent protections, with additional applications pending in major jurisdictions worldwide [2][3] Group 2: Product Development and Clinical Trials - Annamycin, also known as naxtarubicin, is being developed for the treatment of relapsed or refractory acute myeloid leukemia (AML) and is positioned to be the first non-cardiotoxic anthracycline approved for clinical use [2][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 [5] - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML, as well as Orphan Drug Designation from the EMA [3][5] Group 3: Company Overview - Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company focused on developing therapies for hard-to-treat tumors and viruses, with Annamycin as its lead program [4][6] - The company is also developing WP1066, an immune/transcription modulator targeting various cancers, and has a portfolio of antimetabolites for potential treatment of pathogenic viruses and certain cancer indications [6]

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 - 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]

Core Insights - Moleculin Biotech, Inc. announced positive results from a Phase 1 clinical trial of WP1066, demonstrating its safety and efficacy in treating pediatric brain tumors, particularly aggressive forms resistant to chemotherapy [2][4][5] Group 1: Clinical Trial Results - The Phase 1 trial involved 10 children treated with WP1066 twice daily for 14 days, with no significant toxicity observed and a maximum feasible dose established [5] - Encouraging signs of activity were noted, including partial tumor response in a patient with diffuse intrinsic pontine glioma (DIPG) and observable anti-tumor immune changes [4][5] - The study was the first to evaluate WP1066 in children, addressing a critical need for new treatment options for high-grade gliomas, which have a poor prognosis [6] Group 2: Mechanism of Action - WP1066 is designed to stimulate the immune response against tumors by inhibiting regulatory T cells and key oncogenic transcription factors such as p-STAT3, c-Myc, and HIF-1α [3][11] - The drug's ability to suppress STAT3 expression and demonstrate anti-tumor immune responses is a significant finding for its potential as a treatment [5][7] Group 3: Future Development - The results from the Phase 1 trial will serve as the foundation for a proposed Phase 2 trial to further evaluate WP1066's efficacy [8] - Moleculin is also advancing other therapeutic candidates, including Annamycin, which targets relapsed or refractory acute myeloid leukemia and soft tissue sarcoma [9][10]

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].

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]