Business
Moleculin Reports Second Quarter 2024 Financial Results and Provides Corporate Update
- 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
About this update from Moleculin Biotech, Inc.
[{"type":"text","content":"- Positive outcome from End of Phase 1B/2 Meeting with FDA\n- 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\n- Webcast replay of the Company's recent MIRACLE trial update available here\nHOUSTON, Aug. 14, 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 reported its financial results for the quarter ended June 30, 2024.\n\n \n \n \n \n \n \n\n \n\"I am extremely pleased with our recent clinical and regulatory achievements. Of particular note, the recent positive outcome from our end of phase 1B/2 clinical trial (EOP1B/2) meeting with the US Food and Drug Administration (FDA) combined with the encouraging Annamycin data demonstrated to date, positions us well for the next phase of development for our AML program,\" commented Walter Klemp, Chairman and Chief Executive Officer of Moleculin. \"We are grateful to the FDA for their constructive feedback and I would like to congratulate our entire clinical team for their operational excellence in driving Annamycin forward as a potential treatment for relapsed or refractory acute myeloid leukemia (R/R AML) patients. We believe we are truly on the cusp of unlocking high-value potential for all stakeholders, and most importantly addressing a significant unmet need for R/R AML patients.\"\nRecent Highlights \nHosted webcast presentation to discuss the Company's previously announced plans for its MIRACLE Phase 3 pivotal trial;Completed EOP1B/2 meeting with FDA and planning for pivotal, adaptive Phase 3 clinical trial of Annamycin in combination with cytarabine for the treatment of R/R AML;Reported additional positive efficacy findings from the Company's Phase 1B/2 (MB-106) clinical trial 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 subjects with acute myeloid leukemia (AML);Announced abstract has been accepted for poster presentation at the EHA2024 Hybrid Congress being held in Madrid, Spain and virtually; andRecruitm...