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 ...

HOUSTON, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that the Japan Patent Office (JPO) has issued a notice of allowance for Patent Application No. 2021-577862 titled, “METHOD OF RECONSTITUTING LIPOSOMAL ANNAMYCIN.” A patent from the application is expected to be issued in the coming months. The allowed claims cover proprietary methods for reconstituting and preparing liposomal Annamycin from a preliposomal lyophilizate under cont ...

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]

Summary of Moleculin Biotech Conference Call Company Overview - **Company Name**: Moleculin Biotech (NasdaqCM: MBRX) - **Industry**: Pharmaceutical, specifically focused on cancer treatment - **Stage**: Phase 3 clinical stage with a focus on therapeutic candidates for hard-to-treat tumors and viruses - **Key Product**: Annamycin, a next-generation anthracycline Core Points and Arguments - **Management Experience**: The management team has a combined experience of over 200 years in drug development, with 7 FDA approvals and 14 clinical trials conducted at Moleculin alone [4][5] - **Investment Confidence**: Management has invested approximately $1 million of their own money into Moleculin stock, indicating confidence in the company's future [5] - **Technological Portfolio**: Moleculin has three distinct technologies, all discovered at MD Anderson Cancer Center, with Annamycin being the lead technology [5][6] - **Annamycin's Unique Profile**: - Designed to be non-cardiotoxic, avoiding the 65% chance of permanent heart damage associated with traditional anthracyclines [7] - Demonstrated no evidence of cardiotoxicity in over 100 patients treated, even at high doses [7] - More potent than existing anthracyclines and has fewer severe side effects [7] - **Patent Protection**: Annamycin has composition and matter patent protection through 2040, with potential extensions, and has orphan drug and fast-track status [8] - **Focus on Acute Myeloid Leukemia (AML)**: - Approximately 60% of AML patients are treated with anthracyclines, and Annamycin is positioned to provide a better option for those who cannot tolerate existing treatments [9][10] - Phase 2 trial results showed a 50% complete remission rate in second-line patients, significantly outperforming existing therapies [10][11] Important Developments - **MIRACLE Trial**: - Designed for accelerated approval of Annamycin, with two parts focusing on optimizing dosing and assessing safety and efficacy [12][13] - Early unblinding of data will provide visibility on success likelihood within the first half of the year [14] - Recruitment in Europe is steady, with expectations to reach the first 45 patients soon [15] - **Clinical Trial Results**: - The MB107 trial for Soft Tissue Sarcoma lung metastases showed an overall survival of 13.5 months in heavily pre-treated patients [16] - Annamycin's potential revenue is estimated to be ten times greater than just AML alone due to its applicability across various cancers [16] Market Position and Future Outlook - **Strategic Partnerships**: The company is actively seeking partnerships with big pharma for Annamycin's development, leveraging the expertise of a new strategic advisor from Roche [17] - **Market Cap Potential**: Moleculin is positioned for a market cap breakout, with a strong patent position and promising clinical data [17][18] - **Competitive Landscape**: Annamycin is highlighted as having more near-term visibility and upside potential compared to other Phase 3 assets in the market [18] Additional Insights - **Real-World Impact of Non-Cardiotoxicity**: Clinicians are increasingly recognizing the importance of Annamycin's non-cardiotoxic profile, especially for patients with limited treatment options [20][21] - **Focus on Pediatric AML**: Annamycin could significantly impact pediatric AML patients, who currently have few acceptable treatment options [22] - **Success Metrics for Upcoming Trials**: The primary endpoint for the MIRACLE trial is complete remission after a single cycle, with expectations based on historical data suggesting a 50% complete remission rate [24][25] This summary encapsulates the key points discussed during the conference call, highlighting Moleculin Biotech's strategic direction, product potential, and market positioning.

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]