- 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 ...

Company Overview - Moleculin Biotech, Inc. is a late-stage pharmaceutical company focused on developing drug candidates for hard-to-treat tumors and viruses [3] - The company's lead program, Annamycin, is a next-generation anthracycline aimed at avoiding multidrug resistance and reducing cardiotoxicity associated with current treatments [3] Financial Results Announcement - Moleculin will report its financial results for the quarter ended September 30, 2024, on November 8, 2024 [1] - A conference call and live audio webcast will be held on November 11, 2024, at 8:30 AM ET to discuss these results [1][2] Clinical Trials and Development - The company is initiating the MIRACLE Trial (MB108), a pivotal Phase 3 trial evaluating Annamycin in combination with cytarabine for relapsed or refractory acute myeloid leukemia (AML) [4] - Following a successful Phase 1B/2 study, Moleculin believes it has reduced the risks associated with the development pathway for Annamycin's approval [4] Additional Drug Development - Moleculin is also developing WP1066, an immune/transcription modulator targeting brain tumors and pancreatic cancers [5] - The company is working on a portfolio of antimetabolites, including WP1122, for potential treatment of pathogenic viruses and certain cancer indications [5]

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 ...

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-totreat 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 ...

Data recently presented at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer Treatment with Annamycin results in statistically significant inhibition of tumor growth and extension of survival in orthotopic lung cancer models Annamycin continues to be 100% non-cardiotoxic HOUSTON, Sept. 23, 2024 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug can ...

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 ...

Core Insights - Moleculin Biotech, Inc. has received positive feedback from the FDA regarding its End of Phase 1B/2 meeting, allowing the company to proceed with the pivotal Phase 3 clinical trial (MIRACLE trial) for Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia (R/R AML) [1][3] Clinical Development - The MIRACLE trial will be a global study, including sites in the US, and aims to evaluate Annamycin combined with cytarabine for R/R AML patients [3] - Recent data from the Phase 1B/2 trial showed that 41% of subjects achieved a composite complete remission (CRc), with 36% achieving complete remission (CR) [3] - The trial design includes an adaptive approach where the first 75 subjects will be randomized to receive different doses of Annamycin, followed by an unblinding to select the optimum dose for the remaining subjects [3] Financial Results - For Q2 2024, the company reported R&D expenses of $4.1 million, up from $3.9 million in Q2 2023, primarily due to increased sponsored research costs [4] - General and administrative expenses decreased to $2.1 million from $2.5 million year-over-year, attributed to lower regulatory and legal fees [4] - As of June 30, 2024, the company had cash and cash equivalents of $10.8 million, which is expected to fund operations into Q4 2024, with plans to raise an additional $12 million through equity issuance [4] Upcoming Milestones - Key milestones for the Annamycin AML development program include beginning site contracting for the MIRACLE trial in 2H 2024 and treating the first subject in Q1 2025 [3] - Interim data is expected to be unblinded in mid-2026, with a new drug application submission anticipated in 2H 2028 for accelerated approval based on primary endpoint of CR [3] Company Overview - Moleculin Biotech, Inc. is focused on developing therapeutic candidates for hard-to-treat tumors and viruses, with Annamycin as its lead program targeting R/R AML and soft tissue sarcoma [5] - The company is also developing WP1066, an immune/transcription modulator for various cancers, and a portfolio of antimetabolites for potential viral treatments [5]

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]