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Marvel Biosciences Corp
Symbol MRVL
Shares Issued 63,143,790
Close 2026-10-16 C$ 0.10
Market Cap C$ 6,314,379
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Marvel Biosciences picks CMAX for MB-204 phase 1 trial

2026-10-19 11:54 ET - News Release

Mr. Roderick Matheson reports

MARVEL BIOSCIENCES ADVANCES MB-204 TOWARD FIRST-IN HUMAN TESTING, SELECTS CMAX AS PHASE I CLINICAL TRIAL SITE

Marvel Biosciences Corp. has selected CMAX as the phase I clinical site to test its lead drug candidate MB-204, an important step in the company's preparations to advance its lead patented drug candidate toward first-in-human clinical evaluation.

CMAX Clinical Research is an independent clinical research facility, based in Adelaide, Australia. CMAX has been established as a phase I unit since December, 1993, making it the longest-running in Australia and, since establishment, has consistently maintained world class standards with a total commitment to providing excellence and quality in all areas of clinical service. CMAX is also one of Australia's most modern phase I clinical facilities, adjacent to Adelaide's Biomed city. The facility offers 78-bed capacity for in-house stays and conducts greater than 40 studies per year. The CMAX site specializes in phase I -- FTIH, SAD/MAD, first time in patients, BA/BE, PK/PD and proof-of-concept studies. CMAX has conducted greater than 600 studies since the unit was established.

Marvel's preparations for clinical development are supported by a growing body of preclinical research evaluating MB-204 across multiple genetically distinct models of neurodevelopmental disorders. The company has reported behavioural and cognitive improvements in mouse models associated with Rett syndrome (Mecp2), Fragile X syndrome (Fmr1) and autism spectrum disorder (Oprm1), alongside preliminary findings from a Shank3 mouse model associated with Phelan-McDermid syndrome. In its August, 2026, Fragile X study, Marvel reported statistically significant improvements in recognition memory at both tested doses and persistent effects on selected end points following treatment cessation (refer to press release dated Aug. 5, 2026). Preliminary Shank findings also indicated improvements across multiple behavioural measures, although final statistical analyses and additional endpoints remained pending at the time of that announcement (refer to press release dated Oct. 8, 2026).

"We are pleased to be working with CMAX and Novotech as our clinical partners for the phase I trial of MB-204," commented Dr. Mark Williams, chief science officer of Marvel Biosciences. "We look forward to navigating the ethics approval and regulatory process with both groups to start clinical testing."

The selection of CMAX represents an important operational step in Marvel's preparations to advance MB-204 toward first-in-human clinical evaluation. As previously disclosed, the company is planning a phase I program beginning with a single ascending dose (SAD) study designed to evaluate the candidate's initial safety, tolerability and pharmacokinetic profile in humans. The planned study is also expected to assess potential biomarkers and selected cognitive endpoints, with findings intended to inform the design of a subsequent multiple ascending dose (MAD) study. Initiation of the trial remains subject to applicable regulatory and ethics approvals and completion of the necessary clinical preparations.

About Marvel Biosciences Corp.

Marvel Biosciences, 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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