Moleculin Biotech (MBRX) News & Sentiment

Live webcast fireside chat on Tuesday, March 18 th at 11:00 AM PT HOUSTON , March 10, 2025 /PRNewswire/ -- 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 Walter Klemp, Chairman and Chief Executive Officer of Moleculin will participate in a fireside chat on Tuesday, March 18, 2025 at 11:00 AM PT at the 37th Annual ROTH Conference being held in Dana Point, CA. In addition to the presentation, management will be available to participate in one-on-one in-person meetings with qualified members of the investor community who are registered to attend the conference.

HOUSTON , March 3, 2025 /PRNewswire/ -- 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 its abstract has been accepted for poster presentation at the Acute Leukemias XIX (ISALXIX) International Symposium being held March 16-19, 2025 in Munich, Germany. Details for the poster presentation are as follows: Abstract: P002 Session: Clinical Studies in AML and ALL Title: Liposomal Annamycin in Combination with Cytarabine for Treatment of Acute Myeloid Leukemia (AML) Presenting Author: Cristina Papayannidis, MD, PhD, Adjunct professor, Department of Medical and Surgical Sciences, University of Bologna, Bologna Italy For more information about the ISALXIX International Symposium, visit the event website.

HOUSTON , Feb. 13, 2025 /PRNewswire/ -- 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 5,828,570 shares of common stock of the Company originally issued in December 2023 and August 2024 all at a reduced exercise price of $1.00 per share. The shares of common stock issuable upon exercise of the outstanding warrants are registered pursuant to effective registration statements on Form S-1 (File No.

Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025 HOUSTON , Feb. 13, 2025 /PRNewswire/ -- 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 U.S. Food and Drug Administration ("FDA") feedback and guidance on its IND amendment that has allowed a reduction in the size of its Phase 3 pivotal trial protocol evaluating 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 AML patients who are refractory to or relapsed after induction therapy (R/R AML) (MB-108). This Phase 3 "MIRACLE" trial (derived from M olecul i n R /R AML A nnAraC Cl inical E valuation) will be a global trial, including sites in the US, Europe and the Middle East.

First of many site approvals, including sites in the US, Europe and the Middle East, expected throughout Q1-Q3 2025 Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025 Recently amended protocol accelerates unblinding of preliminary primary efficacy data (CR) and safety/tolerability of the three arms at first 45 subjects, expected in the second half of 2025 HOUSTON , Feb. 11, 2025 /PRNewswire/ -- 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  first country regulatory approval in Europe to begin recruiting for its Phase 3 pivotal trial protocol evaluating 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 AML patients who are refractory to or relapsed after induction therapy (R/R AML) (MB-108). In Ukraine the final necessary regulatory approvals from the Ministry of Health were received last week.

– Received US Institutional Review Board (IRB) approval for pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) and engaged leading contract research organization (CRO); On track to begin dosing of Annamycin in combination with cytarabine for the treatment of R/R AML in Q1 2025 – Expected timelines for recruitment updates and preliminary readouts of MIRACLE trial accelerated to 2H 2025 (n=45); 1H 2026 (n=~75-90) with potential for accelerated NDA process beginning as early as 2027 – Continued growing body of data with recently announced new preliminary clinical results demonstrating Annamycin plus Ara-C achieved 60% CR/CRi in subjects who were relapsed from or refractory to Venetoclax regimens; more than 4 times greater than published historical rates HOUSTON , Jan. 8, 2025 /PRNewswire/ -- 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 provided a business outlook and outlined expected upcoming milestones. "We have positioned Moleculin to achieve value-driving milestones through the next several years, starting with the imminent beginning of enrollment for MIRACLE and the first interim read-out from that study later this year.

Abstract published as part of the American Society of Hematology (ASH) Annual Meeting Study shows Annamycin effectively targets both Cytarabine (Ara-C) and Venetoclax resistant acute myeloid leukemia (AML) cell lines from heavily pretreated relapsed/refractory primary AML patients in vitro Lack of apparent cardiotoxicity, improved organotropism, synergy with Ara-C, and possible immune-memory reinforcing properties appear to contribute to the favorable performance of Annamycin in clinical settings Such preclinical data appear to correlate with preliminary clinical data showing Annamycin in combination with Ara-C achieving a 60% CRc rate in subjects who relapsed from or were refractory to Venetoclax as a first line therapy HOUSTON , Dec. 11, 2024 /PRNewswire/ -- 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 online publication of its abstract titled, " Annamycin, a non-cardiotoxic anthracycline, demonstrates unique organotropism and activity against Ara-C and Venetoclax resistant AML ," as part of the ASH Annual Meeting held December 7-10, 2024, in San Diego, CA. For the preclinical study, subsets of parental, cytarabine (Ara-C)-resistant, and Venetoclax (VEN)-resistant AML cell lines were treated with Annamycin at 0-3000 nM in vitro, alone, or ± VEN (1-1000 nM) and ± Ara-C (1-3000 nM).

Preclinical data accepted for online publication at ASH Annual Meeting reveal significant activity of Annamycin in Venetoclax resistant AML model New preliminary clinical results show Annamycin plus Ara-C achieved 60% CR/CRi in subjects who were relapsed from or refractory to Venetoclax regimens; more than 4 times greater than published historical rates Annamycin demonstrates an even greater potential than previously reported to address a significant AML patient population for which treatment options are extremely limited New data from MB-106 trial show median overall survival of 11.6 months in subjects receiving AnnAraC as 2nd line therapy HOUSTON , Nov. 18, 2024 /PRNewswire/ -- 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 new findings supporting the ability of Annamycin to overcome resistance to Venetoclax in acute myeloid leukemia ("AML").  This includes data from preclinical in vitro studies recently accepted for online publication at the upcoming American Society of Hematology ("ASH") Annual Meeting, and correlates with efficacy demonstrated by recent preliminary clinical data in subjects who were relapsed from or refractory to first line Venetoclax regimens and were then treated with Annamycin in combination with Ara-C ("AnnAraC").

Amended protocol accelerates unblinding of preliminary primary efficacy data (CR) and safety/tolerability of the three arms at first 45 subjects Company remains on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025 Company releases Virtual Investor "What This Means" segment discussing the amended protocol; Available here HOUSTON , Nov. 14, 2024 /PRNewswire/ -- 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 amended the clinical trial protocol with the U.S. Food and Drug Administration ("FDA") for its Phase 3 pivotal trial protocol evaluating 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 AML patients who are refractory to or relapsed after induction therapy (R/R AML) (MB-108). This Phase 3 "MIRACLE" trial (derived from M olecul i n R /R AML A nnAraC Cl inical E valuation) will be a global trial, including sites in the US.