Moleculin Biotech (MBRX) Company Overview

– 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.

Company on track for first subject treated in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) in the first quarter of 2025 Trial designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML HOUSTON , Nov. 12, 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 received Institutional Review Board (IRB) approval 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.

Moleculin Biotech, Inc. (NASDAQ:MBRX ) Q3 2024 Earnings Conference Call November 11, 2024 8:30 AM ET Company Participants Jenene Thomas - IR Walter Klemp - Chairman and CEO John Paul Waymack - Senior CMO Jonathan Foster - EVP and CFO Conference Call Participants Jonathan Aschoff - Roth MKM Jason McCarthy - Maxim Group Vernon Bernardino - H.C. Wainwright Operator Greetings, and welcome to the Moleculin Biotech Quarterly Update Conference Call and Webcast.

- On track to start dosing in pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of R/R AML in Q1 2025 - Median durability of CRc in MB-106 Annamycin+ Cytarabine AML clinical trial continues to climb - now past 8 months  - Recent virtual AML KOL event underscores how Annamycin could significantly change the AML treatment landscape; Replay available here   - Company to host conference call and webcast today, Monday, November 11 th at 8:30 AM ET HOUSTON , Nov. 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 reported its financial results for the quarter ended September 30, 2024. As previously announced, the Company will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET on Monday, November 11, 2024 (details below).

Strong preclinical evidence of Annamycin's potential for treating pancreatic cancer presented at AACR expands collaboration HOUSTON , Nov. 4, 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 appointment of Daniel D. Von Hoff, M.D.

HOUSTON , Oct. 4, 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 its participation at two upcoming investor conferences. Details of the upcoming presentations are as follows: 3rd Annual ROTH Healthcare Opportunities Conference Format: Panel - Innovative Therapies for Liquid Tumors The panel will cover the drugs in development by the presenting companies and where they fit competitively for the initial indication as well as for potential subsequent indications, and upcoming data readouts.