Wally Klemp, CEO of Moleculin, discusses the Company's recent update on the Phase 2 clinical trial of STAT3 inhibitor in combination with radiation for the treatment of glioblastoma Watch the "What This Means" video here HOUSTON, Sept. 16, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company), a Phase 3 clinical-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced that Walter Klemp, Chairman an ...

– Investigator-initiated Phase 2 study is being conducted at Northwestern University in cooperation with Moleculin – Funding for study provided by NIH and BrainUp® – Trial combines WP1066 and radiation, which demonstrated both significant therapeutic response and immune memory in glioblastoma animal models HOUSTON, Sept. 9, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company), a Phase 3 clinical-stage pharmaceutical company with a broad portfolio of drug candidates targ ...

- Positive outcome from End of Phase 1B/2 Meeting with FDA - Company proceeding with a 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 - Webcast replay of the Company's recent MIRACLE trial update available here HOUSTON, Aug. 14, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a Phase 3 clinical stage pharmaceutical company with a bro ...

Based on an encouraging discussion in the End of Phase 1B/2 Meeting with FDA the Company plans to: Proceed with a pivotal, adaptive Phase 3 clinical trial (the "MIRACLE" trial) designed for possible accelerated approval of Annamycin in combination with cytarabine for the treatment of relapsed or refractory AML; Run such future studies globally and in the US above the lifetime maximum allowable anthracycline dose; and Provide the FDA with additional data supporting the selection of the optimal dosing level v ...

Company Overview - Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses [6] - The company's lead program, Annamycin, is a next-generation anthracycline aimed at avoiding multidrug resistance and cardiotoxicity associated with current treatments [6] Clinical Trials and Results - The company has completed its End of Phase 2 (EOP2) meeting with the FDA regarding the Phase 1B/2 clinical trial of Annamycin in combination with Cytarabine for treating acute myeloid leukemia (AML) [8] - In the ongoing MB-106 clinical trial, 22 subjects have been enrolled, with 20 completing efficacy evaluations; 9 subjects (45%) achieved a composite complete remission (CRc) [12] - Among the 10 subjects treated with AnnAraC in the second-line setting, 5 achieved a complete remission (CR) [1] Drug Development Pipeline - The company is also developing WP1066, an Immune/Transcription Modulator targeting brain tumors and other cancers [2] - Moleculin is working on a portfolio of antimetabolites, including WP1122, for potential treatment of viruses and certain cancer indications [2] Regulatory Status - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for relapsed or refractory AML, as well as Orphan Drug Designation from the European Medicines Agency [9]

– Current median durability of response (mDOR) of CRc's = 6 months and increasing (n=9) – Recruitment increased to 22 subjects and CRc's in all subjects evaluable for efficacy (n=20) was 45% – Data presented at European Hematology Association (EHA) 2024 Hybrid Congress and Company KOL Meeting in Madrid Preliminary Results Across All Lines of TreatmentPreliminary Results Across All Lines of Treatment Median Durability of ResponseMedian Durability of Response Response by Genotype and Mutations Response by Gen ...

As part of the event, Walter Klemp, Chairman and Chief Executive Officer of Moleculin, will provide an "elevator pitch" and outline the Company's upcoming milestones. Additionally, investors and interested parties will have the opportunity to submit questions live during the event. Participating companies will answer as many questions as possible in the time allowed. Live video webcast on Tuesday, June 18th at 3:00 PM ET A live video webcast of the event will be available on the Events page under the Invest ...

A live video webcast of the event will be available on the Events page under the Investors section of the Company's website (moleculin.com). A webcast replay will be available two hours following the live event and will be accessible for 90 days. Investor Contact: About Moleculin Biotech, Inc. Moleculin Biotech, Inc. is a clinical stage pharmaceutical company with a growing pipeline, including Phase 2 clinical programs, for hard-to-treat tumors and viruses. The Company's lead program, Annamycin is a next- g ...

HOUSTON, May 16, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical 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 EHA2024 Hybrid Congress being held June 13-16, 2024 in Madrid, Spain and virtually. Details for the poster presentation are as follows: For more information about the Company, please visit www.mole ...

– Investigator-Initiated Phase 2 study is being conducted at Northwestern University in cooperation with Moleculin – Trial combines WP1066 and radiation, which demonstrated both significant therapeutic response and immune "memory" in glioblastoma animal models HOUSTON, May 15, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company), a clinical-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard- to-treat tumors and viruses, today announced ...