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 ...

As filed with the Securities and Exchange Commission on July 30, 2024. (Name, address, including zip code, and telephone number, including area code, of agent for service) Copies to: Registration No. 333-280951 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) | Delaware | 2834 | 47-4671997 | | --- | --- | --- | | (State or o ...

As filed with the Securities and Exchange Commission on July 22, 2024. FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Moleculin Biotech, Inc. (Exact name of registrant as specified in its charter) | Delaware | 2834 | 47-4671997 | | --- | --- | --- | | (State or other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or organization) | Classification Code Number) | Identification Number) | | | 5300 Memorial Drive, Suite 950 | | | | Houston, Texas 77007 | | ...

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 ...