Strategic Partnership Initiative: Moleculin Welcomes Adriano Treve

Moleculin Biotech Strengthens Partnerships with New Appointment

With over 40 years of experience in the pharmaceutical industry, Adriano Treve is set to enhance Moleculin's strategic initiatives.

HOUSTON – Moleculin Biotech, Inc. (Nasdaq: MBRX), a company dedicated to developing innovative therapies for challenging cancers and viral infections, has announced the engagement of Adriano Treve as a Strategic Advisor. This appointment aims to accelerate the company’s efforts in forming strategic partnerships crucial for optimizing its promising therapies.

Adriano Treve's Extensive Experience in Healthcare

Mr. Treve boasts more than four decades at Roche, where he displayed exceptional leadership across various global healthcare markets. His robust background includes pivotal roles managing U.S. supply chains and leading operations in diverse regions like Portugal, Brazil, Turkey, and Eastern Europe. His experience is expected to significantly benefit Moleculin as the Company pursues crucial alliances during a critical phase of its clinical trials.

Relevant Clinical Developments and Impending Milestones

As Moleculin approaches the unblinding of data from its Phase 2B/3 MIRACLE trial evaluating Annamycin in treating acute myeloid leukemia (AML), Mr. Treve's insights are anticipated to be pivotal. His expertise aligns with the Company's efforts to leverage this data to secure fruitful partnerships.

Walter Klemp, Chairman and CEO, expressed enthusiasm for Mr. Treve's appointment, stating, “His extensive industry experience will be instrumental in solidifying alliances that maximize the potential value of our therapies like Annamycin, which we believe can profoundly impact the oncology drug market.

Advancements in Clinical Trials for Annamycin

Moleculin is actively progressing with its MIRACLE trial, an adaptive design study evaluating the efficacy of Annamycin in combination with cytarabine for adults suffering from refractory or relapsed AML. This multi-center clinical trial spans across the US, Europe, and the Middle East, and is an essential step towards exploring Annamycin’s therapeutic potential.

Expected Timeline for Clinical Milestones

The Company projects that the initial unblinding of data involving 45 patients will occur by the second half of 2025, followed by an additional data release in early 2026. These timelines are part of a broader strategy to foster collaborations and expedite the development of Annamycin for AML and other indications.

The Future of Moleculin Biotech and Emerging Opportunities

According to Mr. Klemp, the visibility of the timeline for data dissemination has significantly intensified interest from various strategic partners. He emphasized, “Mr. Treve’s breadth of experience, alongside our existing advisors, is expected to amplify our strategic partnership opportunities as we venture into 2026.”

Moleculin's leading candidate, Annamycin, has garnered Fast Track Status and Orphan Drug Designation from the FDA, reflecting its potential for treating relapsed or refractory acute myeloid leukemia and soft tissue sarcoma. This recognition illustrates the urgent need for innovative treatments in areas of high unmet medical need.

Furthermore, Moleculin continues to diversify its pipeline with WP1066, intended for treating a range of cancers, including brain tumors and pancreatic cancers. This immune/transcription modulator represents another facet of Moleculin’s commitment to addressing critical healthcare challenges.

About Moleculin Biotech, Inc.

Moleculin Biotech, Inc. is at the forefront of developing a range of therapeutic options for challenging tumors and viral infections. The Company’s innovative approach focuses on Annamycin and its application in oncology, showcasing its potential to reshape treatment paradigms for difficult-to-treat conditions.

The engagement of Adriano Treve aligns with the company’s goal of creating impactful partnerships that can enhance its capabilities and accelerate drug development. Through strategic collaborations, Moleculin aims to forge a path that not only propels the company forward but also addresses significant patient needs within the healthcare sector.

Frequently Asked Questions

Who is Adriano Treve and what is his role at Moleculin Biotech?

Adriano Treve is a seasoned professional with over 40 years at Roche, now appointed as a Strategic Advisor at Moleculin to facilitate partnerships.

What is the MIRACLE trial and its significance?

The MIRACLE trial is a pivotal clinical study for Annamycin aimed at treating acute myeloid leukemia, vital for demonstrating the drug’s efficacy.

How does Moleculin Biotech plan to utilize its partnerships?

Moleculin aims to leverage partnerships to optimize the development and market potential of Annamycin and other therapies.

What are Annamycin's designations from the FDA?

Annamycin has received Fast Track Status and Orphan Drug Designation for relapsed or refractory AML, highlighting its therapeutic significance.

What other therapies is Moleculin Biotech developing?

Moleculin is developing WP1066 and a portfolio of antimetabolites targeting various cancers and viral infections.

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