Marvel Biosciences Signs LOI With Novotech CRO for Phase 1 First-in-Human Trial of MB-204 in Australia

• Marvel Biosciences Corp. (TSXV: MRVL; OTCQB: MBCOF), a Calgary-based drug discovery company developing novel therapeutics for autism spectrum disorder and related neurodevelopmental disorders, has signed a Letter of Intent with Novatech — widely recognized as the premier Asia-Pacific full-service CRO for small to mid-sized biotech companies — to conduct the Phase 1 first-in-human trial of MB-204, its novel fluorinated adenosine A2a antagonist.

• Novotech will provide end-to-end clinical trial management including site selection, regulatory and ethics submissions, biostatistics, data management, and medical writing for the planned Phase 1 SAD and MAD studies in Australia — which offers a streamlined regulatory environment and a 43.5% R&D tax credit — with the SAD study expected to begin in Q4 2026.

Marvel Biosciences Corp. (TSXV: MRVL; OTCQB: MBCOF), a Calgary, Alberta-based pharmaceutical development company transitioning into the clinical stage, announced on October 6, 2026, that it has signed a Letter of Intent with Novotech, widely recognized as the premier Asia-Pacific full-service CRO for small to mid-sized biotech and pharmaceutical companies. The LOI covers Novatech’s engagement to conduct the Phase 1 clinical trial of MB-204 — Marvel’s novel fluorinated derivative of Istradefylline, the only clinically approved adenosine A2a antagonist — marking Marvel’s formal transition from a preclinical-stage to a clinical-stage company.

The planned Phase 1 program is designed as a two-part study. The first component, a single ascending dose study expected to initiate in Q4 2026, will evaluate the safety, tolerability, and pharmacokinetics of MB-204, and may incorporate a biomarker component and several cognitive endpoints. Data from the SAD study will inform the design of a subsequent multiple ascending dose study. The trial will be conducted in Australia — selected for its streamlined and favourable regulatory environment and a 43.5% R&D tax credit on qualifying expenditures — with Novatech providing the full range of CRO services including site selection and management, regulatory and ethics submissions, biostatistics, data management, and medical writing.

MB-204 is a novel adenosine A2a receptor antagonist developed for the treatment of autism spectrum disorder, Rett Syndrome, and Fragile X Syndrome. The compound has demonstrated 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. A novel liquid-based formulation of MB-204 developed for the SAD study with grant support from the National Research Council of Canada has demonstrated improved pharmacokinetics in preclinical studies and may also facilitate administration in patient populations where swallowing solid dosage forms presents challenges. A significant and growing body of scientific evidence supports the therapeutic potential of A2a antagonism across ASD, depression, and Alzheimer’s Disease — broadening the program’s potential commercial and scientific scope beyond its primary neurodevelopmental indication.

For the CRO sector, the engagement reflects Novotech’s established positioning as the preferred first-in-human CRO partner for early-stage biotech companies seeking to leverage Australia’s regulatory and financial advantages for Phase 1 programs. Australia’s Therapeutic Goods Administration provides one of the most efficient regulatory frameworks globally for first-in-human study initiation, and Novatech’s end-to-end management model — combining site network access, regulatory expertise, biostatistics, and data management under a single CRO relationship — reduces the operational complexity that can otherwise overwhelm small, capital-constrained sponsors managing their first clinical program.

“Novotech 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% tax credit. This marks Marvel’s transition from a pre-clinical to clinical phase company.”

Rod Matheson, Chief Executive Officer, Marvel Biosciences Corp.