Clinical Development Update - The company has received US Institutional Review Board (IRB) approval for the pivotal, adaptive Phase 3 clinical trial (MIRACLE trial) and engaged a leading contract research organization (CRO) [1] - The MIRACLE trial is on track to begin dosing of Annamycin in combination with cytarabine for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML) in Q1 2025 [1] - Expected timelines for recruitment updates and preliminary readouts of the MIRACLE trial have been accelerated to 2H 2025 (n=45) and 1H 2026 (n=~75-90) with potential for an accelerated NDA process beginning as early as 2027 [1] - Annamycin plus Ara-C achieved a 60% CR/CRi rate in subjects who were relapsed from or refractory to Venetoclax regimens, more than 4 times greater than published historical rates [1] - The MIRACLE trial will be global, including sites in the US, Europe, and the Middle East [3] - The trial utilizes an adaptive design with the first 75 to 90 subjects randomized in Part A to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin [4] - The amended protocol allows for unblinding of preliminary primary efficacy data (CR) and safety/tolerability at 45 subjects, with the first unblinding expected in 2H 2025 and the second in 1H 2026 [4] - Part B of the trial will randomize approximately 244 additional subjects to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin [5] Annamycin Performance and Potential - Annamycin has demonstrated a 50% CR rate and a 60% CRc rate for second-line subjects in the Phase 1B/2 study (n=10) [12] - Median durability was ~8 months and increasing, with median overall survival of 9.1 months for 0-6 prior lines of therapies (n=22) and 11.6 months for second-line subjects (n=10) [12] - Annamycin has shown strong efficacy even where prior venetoclax combination therapy has failed [12] - The company believes Annamycin is a potential game-changing asset for the treatment of AML, with significant value creation potential [2] - Annamycin has outperformed the response rates seen in billion-dollar assets in the AML space [2] - The drug has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of R/R AML and soft tissue sarcoma, as well as Orphan Drug Designation from the EMA for R/R AML [9] Expected Milestones - 1Q 2025: First subject enrolled and treated in the MIRACLE trial [12] - 2H 2025: Data readout (n=45) unblinded efficacy/safety review [12] - 1H 2026: Interim efficacy and safety data (n=~75-90) unblinded and optimum dose set for the MIRACLE trial [12] - 2027: Begin enrollment of third-line subjects in MIRACLE2 and end enrollment of second-line subjects [12] - 2028: Primary efficacy data for second-line subjects in MIRACLE and begin submission of a Rolling New Drug Application (NDA) for accelerated approval [12] Other Development Programs - The company completed enrollment in the Phase 2 portion of its U.S. Phase 1B/2 clinical trial evaluating Annamycin as monotherapy for the treatment of soft tissue sarcoma lung metastases [8] - The clinical study report for the soft tissue sarcoma trial is expected to be completed in early 2025 [8] - The company is also developing WP1066, an Immune/Transcription Modulator targeting brain tumors, pancreatic and other cancers, and a portfolio of antimetabolites including WP1122 for the potential treatment of pathogenic viruses and certain cancer indications [15]

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 ...

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 AMLHOUSTON, 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, t ...

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 ...