Moleculin Hosted Webcast on MIRACLE Phase 3 Trial Plans

On August 6, 2024, Moleculin hosted a corporate update webcast at 8:30 AM ET and discussed its plans to advance Annamycin combined with Cytarabine (Ara-C) into a Phase 3 pivotal trial, named the MIRACLE trial (Moleculin R/R AML AnnAraC Clinical Evaluation). This trial aims to treat AML patients who have not responded to or have relapsed following initial therapy. 

Moleculin Biotech, Inc., a pharmaceutical company at the Phase 3 clinical trial stage, is making strides in the treatment of hard-to-treat tumors and viruses. The company has a broad portfolio of drug candidates, including its flagship program, Annamycin, which is designed to bypass multidrug resistance and eliminate cardiotoxicity commonly associated with current anthracyclines. Annamycin is being developed for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML) and lung metastases from soft tissue sarcoma (STS).

Participants and investors can access the webcast by dialing (877) 407-0832 for domestic calls or (201) 689-8433 for international calls, or by visiting the Events page of the Investors section on the Moleculin website. The live audio webcast will be archived for 90 days.

Moleculin's lead program, Annamycin, has shown promise in a successful Phase 1B/2 study (MB-106) and is now progressing towards a Phase 3 trial with the potential for approval based on input from the FDA. The MIRACLE trial will evaluate the combination of Annamycin and Cytarabine, collectively called AnnAraC, for treating R/R AML. This global trial includes sites in the US and is subject to further regulatory filings and feedback.

In addition to Annamycin, Moleculin is developing WP1066, an Immune/Transcription Modulator that inhibits p-STAT3 and other oncogenic transcription factors while stimulating the immune response. WP1066 targets brain tumors, pancreatic cancer, and other malignancies. The company is also working on a portfolio of antimetabolites, including WP1122, aimed at treating viruses and specific cancers.

Moleculin Biotech, Inc. is dedicated to advancing its pipeline of therapeutic candidates to address challenging tumors and viral infections. The ongoing development efforts and upcoming Phase 3 MIRACLE trial underscore the company's commitment to making significant strides in cancer treatment and improving patient outcomes.

By continuing to focus on innovative treatments and leveraging insights from clinical studies, Moleculin aims to address the unmet needs of patients with hard-to-treat conditions. The upcoming webcast will provide valuable insights into the company's progress and future directions, offering stakeholders an opportunity to stay informed about the latest advancements in their clinical programs.

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