Moleculin Biotech, Inc.

Data presented at the AACR Conference on Pancreatic Cancer indicate Annamycin’s antitumor activity is partially mediated by CD8+ T cells, supporting a potential immune-mediated mechanism alongside its direct cytotoxic activity HOUSTON, Sept. 25, 2026 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc. (Nasdaq: MBRX) (“Moleculin” or the “Company”) today announced new preclinical data indicating that the antitumor activity of its lead drug candidate, Annamycin (naxtarubicin), in pancreatic cancer is partially mediated by CD8+ T cell cytotoxicity. The findings are being presented at the AACR Conference on Pancreatic Cancer: New Frontiers in Biology and Therapeutic Development, held September 25-28, 2026 in San Diego, California. In preclinical models of pancreatic cancer, Annamycin’s antitumor activity appears to depend in part on CD8+ T cells, the immune system’s primary tumor-killing cells. The finding suggests Annamycin may do more than kill cancer cells directly; it may also expose tumors that are typically considered immunologically “cold” to immune attack. Pancreatic cancer is among the most treatment-resistant solid tumors, and its characteristically “cold” immune microenvironment is one reason checkpoint inhibitors have shown limited single-agent activity in the disease. Preclinical evidence that Annamycin’s activity is partly immune-mediated points to a potential basis for combination approaches, and complements the immune-modulating mechanism […] The post Annamycin Turns “Cold” Pancreatic Tumors “Hot” in New Preclinical Data Presented at AACR appeared first on Moleculin.

Strengthens Global Intellectual Property Estate for Annamycin’s Proprietary Liposomal Formulation Designed to Target Lung Metastases While Supporting Long-Term Commercial Opportunity HOUSTON, Sept. 23, 2026 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that the Mexican Patent Office has granted Patent No. 436849, further strengthening the Company’s global intellectual property portfolio protecting its proprietary lung-targeted liposomal Annamycin technology. The newly issued patent supports Moleculin’s strategy of building a robust worldwide intellectual property estate around Annamycin, the Company’s highly efficacious and well tolerated anthracycline currently being evaluated in the pivotal MIRACLE trial for relapsed or refractory acute myeloid leukemia (AML), while also reinforcing the platform’s broader potential across additional oncology indications. Unlike conventional anthracyclines, Annamycin was specifically engineered to avoid multidrug resistance mechanisms while demonstrating the ability to penetrate tissues that are traditionally difficult to treat, including the lungs. The patented liposomal formulation is designed to enhance delivery of Annamycin to pulmonary tumors and metastatic disease, potentially expanding future development opportunities beyond hematologic malignancies. “This newly granted Mexican patent represents another important milestone in strengthening the global intellectual property foundation supporting our Annamycin platform,” said Walter Klemp, Chairman and Chief Executive Officer of Moleculin. “As we […] The post Moleculin Biotech Secures Mexican Patent Protecting Lung-Targeted Liposomal Annamycin Through 2040 appeared first on Moleculin.

Presentations examine where Annamycin concentrates in the body, how it targets topoisomerase II, and its antitumor activity in pancreatic cancer HOUSTON, Sept. 14, 2026 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc. (Nasdaq: MBRX) (“Moleculin” or the “Company”) today announced that new data on its lead drug candidate, Annamycin (naxtarubicin), will be presented at three scientific venues in September 2026, including the American Association for Cancer Research (AACR) Conference on Pancreatic Cancer: New Frontiers in Biology and Therapeutic Development. The three presentations address distinct questions about Annamycin: where it concentrates in the body, how it kills cancer cells, and whether it can also enlist the immune system to do so. Together they inform the Company’s development of Annamycin in hard-to-treat cancers. Title: “Antitumor activity of ANNAMYCIN, a highly effective lipophilic DNA-binding drug: Impact of its organotropism”Author/Presenter: Waldemar Priebe, PhD, UT MD Anderson Cancer CenterCongress: XIII Congress of the Polish Medical DiasporaDates: September 9-12, 2026Location: Wroclaw, Poland Annamycin’s lipophilic structure drives it to concentrate in specific tissues rather than distribute uniformly. Dr. Priebe’s presentation examines how that distribution relates to the antitumor activity observed across preclinical models, and what it may mean for treating tumors in those tissues. Title: “Organotropism-guided exploration of anticancer […] The post Moleculin to Showcase New Annamycin Data at AACR Conference on Pancreatic Cancer and Two European Scientific Meetings appeared first on Moleculin.

Access the video webcast here HOUSTON, Sept. 11, 2026 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that its pre-recorded presentation from the H.C. Wainwright 28th Annual Global Investment Conference is now available for on-demand viewing here. The presentation, featuring Walter Klemp, Chairman and Chief Executive Officer of Moleculin, provides an overview of the Company as well as recent corporate and clinical developments. The on-demand presentation is available for viewing beginning today, September 11, 2026, at 7:00 a.m. ET, and can be accessed through the Events page on the Investors section of the Company’s website (moleculin.com). Management will be available on-site at the conference being held September 14-16, 2026, in New York, NY to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin (also known as naxtarubicin), is a highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to […] The post Moleculin Presentation from H.C. Wainwright Conference Now Available On-Demand appeared first on Moleculin.

– Video webcast now available here HOUSTON, Aug. 27, 2026 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that it participated in the Virtual Investor “Why Now” on-demand conference. During the presentation, Walter Klemp, Chairman and Chief Executive Officer of Moleculin, highlighted the Company’s clinical progress and long-term opportunity, discussing encouraging interim results from the pivotal Phase 2/3 MIRACLE trial evaluating Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML). The presentation also emphasized Annamycin’s differentiated clinical profile, continued enrollment progress, expanding commercial opportunity, and the upcoming 90-patient interim analysis as a key value-driving catalyst supporting the Company’s path toward potential registration. The video webcast is now accessible for on-demand viewing here. JTC Team and Virtual Investor Co. are paid consultants to Moleculin Biotech, Inc. JTC Team and Virtual Investor Co. are investor relations and corporate communications firms. Any content included in this release shall not be construed as an offer to purchase securities of Moleculin Biotech, Inc. Interested parties are responsible for conducting their own due diligence and are encouraged to review the Company’s website and the SEC website for the latest information and filings on the Company. About Moleculin […] The post Moleculin CEO, Walter Klemp, Participates in the Virtual Investor “Why Now” On-Demand Conference appeared first on Moleculin.

Positive interim MIRACLE data showed complete remission rates three times higher than control in relapsed/refractory AML MIRACLE trial advancing toward planned 90-patient enrollment milestone in September 2026 with the unblinded efficacy readout in December 2026 to February 2027 timeframe MIRACLE trial Part B initiation expected in the first half of 2027 following optimal dose selection Cash position, including $9.3 million raised after quarter-end, expected to fund operations into the first quarter of 2027 Absence of cardiotoxicity continues in the MIRACLE trial HOUSTON, Aug. 14, 2026 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today reported financial results for the second quarter ended June 30, 2026, and highlighted continued progress in its pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in relapsed or refractory acute myeloid leukemia (AML). Moleculin continues to advance the pivotal Phase 2/3 MIRACLE trial following positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A, which showed complete remission rates at least three times greater than the control arm. Enrollment remains on track to reach the 90-patient milestone in September with the data readout in the December 2026 to February 2027 timeframe. These data are expected to support selection of […] The post Moleculin Biotech Reports Second Quarter 2026 Financial Results and Highlights Continued Advancement of Pivotal MIRACLE Trial appeared first on Moleculin.

HOUSTON, July 31, 2026 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced the pricing of a best-efforts public offering of an aggregate of 12,376,667 shares of common stock (or pre-funded warrants in lieu thereof), and warrants (the “Common Warrants”) to purchase up to 37,130,001 shares of common stock at a combined public offering price of $0.75 per share of common stock (or pre-funded warrant in lieu thereof) and associated warrants. The Common Warrants will be immediately exercisable at an exercise price of $0.75 per share and will expire five years following the initial exercise date. The offering is expected to close on or about August 3, 2026, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds of the offering to advance Annamycin through clinical development and for working capital. Roth Capital Partners is acting as exclusive placement agent for the offering. Maxim Group LLC is acting as financial advisor to the Company. The securities described above are being offered by the Company pursuant to a registration statement on Form S-1 (File No. 333-297776) originally filed July 29, 2026 with the Securities and Exchange Commission (“SEC”) and declared effective […] The post Moleculin Announces Pricing of $9.3 Million Public Offering appeared first on Moleculin.

Prior venetoclax failure – a setting in which published salvage remission rates are approximately 13% and median survival approximately 2.4 months – shows no adverse impact on blinded composite remission rates as MIRACLE approaches the end of Part A Preliminary blinded CR of 24% and CRc of 37% (n=62), with essentially identical rates among the 30 patients who had failed first-line venetoclax: CR of 23% and CRc of 37% (3X the published salvage remission rates following first-line venetoclax failure of approximately 13%) Enrollment reaches 74 of 90 patients, with final Part A treatment expected in September 2026 and comprehensive unblinded Part A results on track for the planned December 2026-February 2027 timeframe No evidence of cardiotoxicity continues to differentiate Annamycin from conventional anthracyclines HOUSTON, July 31, 2026 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced updated preliminary blinded results from Part A of its pivotal Phase 2/3 MIRACLE trial (MB-108) of Annamycin in combination with cytarabine (AnnAraC) for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML). With 62 subjects evaluable to date, the preliminary blinded complete remission (CR) rate is 24% and the composite complete remission (CRc) rate is 37%. Of […] The post Moleculin’s MIRACLE R/R AML Trial Reports Positive Interim Data with 37% Blinded CRc in Venetoclax-Failed Patients appeared first on Moleculin.

Access the segment here HOUSTON, July 06, 2026 (GLOBE NEWSWIRE) — Moleculin Biotech, Inc., (Nasdaq: MBRX) (“Moleculin” or the “Company”), today announced that Walter Klemp, Chairman and Chief Executive Officer of Moleculin, participated in a Virtual Investor “What This Means” segment. For the segment, Chairman and CEO Wally Klemp discusses the positive preliminary unblinded efficacy results from the first 45 patients enrolled in Part A of the pivotal Phase 2/3 MIRACLE trial evaluating Annamycin in relapsed or refractory acute myeloid leukemia (R/R AML). During the conversation, Mr. Klemp provides his perspective on the significance of the early efficacy trends observed across both Annamycin treatment arms, summarizes the key data, and discusses the commercial opportunity, including insights from the Company’s recent market research assessing the potential addressable market for Annamycin if approved. The segment is now available for on-demand viewing here. About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a Phase 3 clinical stage pharmaceutical company advancing a pipeline of therapeutic candidates addressing hard-to-treat tumors and viruses. The Company’s lead program, Annamycin (also known as naxtarubicin), is a highly efficacious and well tolerated anthracycline designed to avoid multidrug resistance mechanisms and to lack the cardiotoxicity common with currently prescribed anthracyclines. Annamycin […] The post Moleculin CEO, Walter Klemp, Highlights Positive Preliminary MIRACLE Trial Results in Virtual Investor “What This Means” Segment appeared first on Moleculin.