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 ...

Table of Contents As filed with the Securities and Exchange Commission on August 15, 2024. Registration No. 333-280951 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 3 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 other jurisdiction of | (Primary Standard Industrial | (I.R.S. Employer | | incorporation or ...

As filed with the Securities and Exchange Commission on August 14, 2024. | 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 | | | | (713) 300-5160 | | Registration No. 333-280951 (Address, including zip code, and telephone number, including area code, of registrant's pr ...

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 | | ...