Moleculin Biotech, Inc. (MBRX)

HOUSTON, Sept. 25, 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 that the Canadian Intellectual Property Office (CIPO) has issued a notice of allowance for Patent Application No. 3,142,510 titled, “PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE.” A patent from the application is expected to be issued in the coming months.

Moleculin Biotech (MBRX) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Spain site opens with two R/R AML subjects enrolled; One treated On track to recruit 45 subjects in 4Q25 for initial data unblinding HOUSTON, Sept. 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 that it has enrolled the first two subjects, and treated one, in the European Union (EU) in its pivotal Phase 2B/3, multi-center, randomized, double-blind, placebo-controlled, adaptive design study of Annamycin in combination with cytarabine (also known as “Ara-C” and for which the combination of Annamycin and Ara-C is referred to as “AnnAraC”) for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML).

HOUSTON, Aug. 28, 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 tumors and viruses, 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 16,216,216 shares of common stock of the Company originally issued in June 2025 at an exercise price of $0.37 per share. The shares of common stock issuable upon exercise of the outstanding warrants are registered pursuant to an effective registration statement on Form S-1 (File No. 333-287727). The aggregate gross proceeds from the exercise of the existing warrants is expected to total approximately $6.0 million, before deducting financial advisory fees.

– Live video webcast on Wednesday, August 20 th at 2:00 PM ET HOUSTON, Aug. 14, 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 tumors and viruses, today announced that it will present at the Webull Financial Corporate Connect Webinar Series: Biotech/MedTech being held virtually August 19-21, 2025. Details of the presentation are as follows: Date and Time: Wednesday, August 20, 2025 at 2:00 PM ET Presenter: Walter Klemp, Founder, President, CEO and Chairman of Moleculin Registration Link: HERE About Webull Financial Webull Financial is a leading online brokerage platform committed to empowering self-directed investors with innovative tools and cutting-edge technology.

- Continues recruitment and opens US and EU sites for the Phase 2B/3 MIRACLE trial - 20+ additional clinical sites in Europe and the US expected to begin recruitment by the end of Q3

Presented data highlights the potential of Annamycin for treating broad range of human cancers, including high-need oncology indications

– New patent enhances market position in Europe HOUSTON, July 30, 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 tumors and viruses, today announced it has received a Notice of Intent to Grant for the European patent application titled, “PREPARATION OF PRELIPOSOMAL ANNAMYCIN LYOPHILIZATE.“ Such grant should solidify the Company's European Union exclusivity of Annamycin, also known by its non-proprietary name of naxtarubicin, with the potential to become the first non-cardiotoxic anthracycline.

– Video webcast now available on-demand  HOUSTON, July 22, 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 tumors and viruses, today announced that Walter Klemp, Founder, President, CEO and Chairman of Moleculin, participated in the Virtual Investor “What's Your Story” Summer Spotlight On-Demand Conference. As part of the segment, Mr.

40+ year career at Roche founded on dedication to bringing new innovative medicines to patients and making them accessible

Secured approval from the Regulation Agency for Medical and Pharmaceutical Activities (RAMPA) in Georgia for Phase 2B/3 MIRACLE trial

HOUSTON, June 20, 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 tumors and viruses, today announced the pricing of a public offering consisting of 16,080,000 shares of common stock (or pre-funded warrants in lieu thereof) and Series E warrants to purchase up to 48,240,000 shares of its common stock, at a combined public offering price per share of common stock (or per pre-funded warrant in lieu thereof) and accompanying Series E warrants of $0.37. The Series E warrants will have an exercise price of $0.37 per share, are exercisable upon stockholder approval, and will expire five years following the initial exercise date.

Watch the “What This Means" segment here

Annamycin aims to eliminate cardiotoxicity associated with anthracyclines used to treat about 60% of all children with cancer  FDA recommends inclusion of patients as young as 6 months – younger than Moleculin had proposed – to be allowed in the pediatric clinical study Enrollment and dosing are ongoing in pivotal, adaptive design Phase 3 MIRACLE trial of Annamycin in adult patients with R/R AML; Initial data readout is on track for the second half of 2025 HOUSTON, June 18, 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 received a written response from the Office of Oncologic Diseases - Pediatric Oncology, of the U.S. Food and Drug Administration (FDA) regarding the Company's Initial Pediatric Study Plan (iPSP), which was submitted after a June 2024 end-of-phase 1/2 meeting. The FDA has agreed to a single pediatric approval study in which Annamycin (also known as naxtarubicin) in combination with Cytarabine (also known as “Ara-C” and for which the combination of Annamycin and Ara-C is referred to as “AnnAraC”) will be evaluated as second line therapy in pediatric patients with relapsed/refractory acute myeloid leukemia (R/R AML), a form of cancer.

Globally recognized Oncology Key Opinion Leader, Brian Andrew Van Tine, MD, PhD, discusses the positive topline results from the U.S. Phase 1B/2 clinical trial evaluating Annamycin for the treatment of Soft Tissue Sarcoma Lung Metastases (MB-107)