Dr. Mark Williams reports

MARVEL BIOSCIENCES SIGNS LETTER OF INTENT WITH NOVATECH FOR PHASE 1 TRIAL OF MB-204 AND PROVIDES CORPORATE UPDATE

Marvel Biosciences Corp. has signed a letter of intent with Novatech, widely recognized as the premier Asia-Pacific (APAC) full-service clinical CRO (contract research organization) for small to mid-sized biotech and pharmaceutical companies.

The signing of the LOI (letter of intent) marks an important development milestone for Marvel as MB-204 advances from preclinical development toward first-in-human clinical evaluation. The planned phase 1 program is designed to establish the initial safety, tolerability and pharmacokinetic profile of MB-204 in humans, while generating clinical data to inform subsequent development. This transition is supported by encouraging preclinical findings, with MB-204 demonstrating immediate, robust and durable effects, including measurable carry-over effects following cessation of treatment, across multiple mouse models relevant to neurodevelopmental disorders, including Oprm1, Rett and Fragile X models. Together, these findings provide a scientific rationale for advancing MB-204 into clinical development and establishing its initial human safety and pharmacokinetic profile.

"We are pleased to begin moving forward into a phase I trial for MB-204 in partnership with Novatech following the recent closing of our private placement and signing of a letter of intent," said Marvel's chief executive officer, Rod Matheson.

"Novatech provides end-to-end clinical trial management, site selection, regulatory and ethics submissions, biostatistics, data management, and medical writing. They have an early phase clinical focus including first-in-human and proof-of-concept studies. The trial will be conducted in Australia which offers a streamlined and favourable regulatory environment as well as a generous 43-per-cent tax credit. We look forward to updating the market on our single ascending dose and multiple ascending dose studies as we progress. This marks Marvel's transition from a preclinical to clinical phase company."

Corporate update:

• The phase I single ascending dose (SAD) study is expected to begin in Q4 of 2026. The SAD study is designed to test the safety, tolerability and pharmacokinetics (PK) of MB-204, as well as include a potential biomarker and several cognitive end points. The data from the SAD will inform the design of the subsequent multiple ascending dose (MAD) study.
• Marvel has previously developed a novel liquid-based formulation of MB-204 for its phase 1 trial SAD study which improved the drug's PK in preclinical studies and may facilitate administration in patient populations where swallowing solid dosage forms may present challenges. The work was conducted with a grant from the National Research Council of Canada.
• The company is currently preparing manuscripts for scientific publication and will provide a future update on conference participation.
• In collaboration with the iBrain Inserm Lab, Marvel is planning an upcoming experiment to test the efficacy of MB-204 against Yamo Pharmaceuticals' L1-79 (repurposed racemic N-methyl Tyrosine) in a mouse model of autism. L1-79 recently demonstrated efficacy in a phase 2 study.

About Marvel Biosciences Corp.

Marvel Biosciences Corp. and its wholly-owned subsidiary, Marvel Biotechnology Inc., is a Calgary-based pharmaceutical development biotechnology company entering phase 1 clinical stage. The company is developing MB-204, a novel fluorinated derivative of the approved anti-Parkinson's drug Istradefylline, the only clinically approved adenosine A2a antagonist. A significant and growing body of scientific evidence suggests drugs that block the adenosine A2a receptor, such as MB-204, could be useful in treating other neurological diseases such as autism, depression and Alzheimer's Disease. The company is actively investigating its potential in addressing other neurodevelopmental disorders, such as Rett Syndrome and Fragile X Syndrome, to expand its therapeutic reach.

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