Abstract published as part of the American Society of Hematology (ASH) Annual MeetingStudy 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 vitroLack 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 settingsSuch preclini ...

Preclinical data accepted for online publication at ASH Annual Meeting reveal significant activity of Annamycin in Venetoclax resistant AML modelNew 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 ext ...

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 hereHOUSTON, Nov. 14, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a l ...

Core Viewpoint - Moleculin Biotech, Inc. is advancing its pivotal Phase 3 clinical trial, named the "MIRACLE" trial, for Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia (AML), with the first subject expected to be treated in Q1 2025 [1][2]. Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses, with Annamycin as its lead program targeting relapsed or refractory AML and soft tissue sarcoma [4][5]. Clinical Trial Details - The MIRACLE trial has received Institutional Review Board (IRB) approval and will include global sites, with an initial adaptive design involving 75 to 90 subjects randomized to receive high-dose cytarabine combined with either placebo or two different doses of Annamycin [1][2]. - The trial will consist of two parts: Part A will determine the optimum dose of Annamycin, while Part B will randomize approximately 240 additional subjects to receive either high-dose cytarabine plus placebo or the optimum dose of Annamycin [2][5]. Regulatory Status - 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 European Medicines Agency (EMA) [3]. Future Development - The company is also developing WP1066, an immune/transcription modulator targeting various cancers, and WP1122, an antimetabolite for potential treatment of pathogenic viruses and certain cancer indications [6].

Exhibit 99.1 Moleculin Reports Third Quarter 2024 Financial Results and Provides Corporate Update - 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 ...

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. At this time, all participants are in listen only mode ...

- 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 web ...

Table of Contents Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol (s) Name of each exchange on which registered Common Stock, par value $0.001 per share MBRX The NASDAQ Stock Market LLC UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...

HOUSTON, Nov. 5, 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 that it will report its financial results for the quarter ended September 30, 2024, on Friday, November 8, 2024. Moleculin management will host a conference call and live audio webcast to discuss the operational and financial results at 8:30 AM ET on Monday, Novem ...

Strong preclinical evidence of Annamycin's potential for treating pancreatic cancer presented at AACR expands collaborationHOUSTON, 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., F.A.C.P., FASCO, FAACR to its Annamycin Scientific Advisory Board.Walter Klemp, Chairman and Chief E ...