Avata Biosciences Signs Co-Development and Licensing Agreement with Oceanus Bio for Exclusive Rights in Japan and Asia (Excluding China and India) for Novel Adult and Pediatric Oral Cannabidiol Therapies for Development in Epilepsy and Schizophrenia

• Agreement includes $95m in co-development contributions and milestones, and additionally double-digit royalty payments to Avata
• AVAT-021 is a solid dose cannabidiol for clinical development in adult patients with treatment resistant epilepsy and schizophrenia
• AVAT-022 is a water-soluble CBD powder in development for pediatric patients

LONDON & MELBOURNE, Australia & PHOENIX--(BUSINESS WIRE)--Avata Biosciences Holdings Ltd (‘Avata’), a pioneering biopharmaceutical company specializing in neuroscience drug discovery and clinical development, today announced it has signed a co-development and licensing agreement with Oceanus Bio, Inc. for the exclusive rights to AVAT-021 and AVAT-022 in Japan and Asia, except in China and India. The agreement comprises $95m in co-development contributions, regulatory and sales milestone payments to Avata. A further double-digit royalty on sales is agreed for the term of the agreement.

Oceanus Bio, Inc. is a clinical-stage pharmaceutical company founded by Kazunari Tsunaba and built upon proven leadership experience from Novartis Japan and Aculys Japan. With a mission to accelerate access to breakthrough therapies in Asia, Oceanus brings deep CNS expertise and a track record of successful drug development and commercialization in Japan.

"We are thrilled to enter into this co-development and licensing agreement with Oceanus Bio to advance our patient-friendly, solid dose investigational CBD medicine in Japan and Asia," said Rupert Haynes, Chief Executive Officer of Avata Biosciences. "The epilepsy community has long sought a solid dose CBD medicine. While many have attempted to deliver a solid dose form, achieving the high therapeutic levels needed has proven challenging for developers. The ability to pack more than 200mg of CBD into size 0 capsules represents a significant technological innovation. This agreement and funding will accelerate clinical development, enable build out of our scalable manufacturing in the US, and open a broader opportunity to support many more patients with neurological diseases."

Avata has achieved positive Phase 1 data demonstrating the tolerability and bioavailability of its lead oral asset, AVAT-021, in comparison to Epidiolex®. The trial met all pharmacokinetic objectives, marking a significant milestone in the development of the portfolio. The company is also developing AVAT-022, a water-soluble powder, as an alternative route of administration for children and others who find capsules difficult to swallow.

“We are excited to partner with Avata to advance the development of AVAT-021 and AVAT-022 in Japan and Asian countries. At Oceanus, we are committed to bridging global innovation with regional patient needs by accelerating access to transformative therapies. This collaboration represents a key step in fulfilling our mission to improve outcomes for patients with neurological and psychiatric disorders in Asia,” said Kazunari Tsunaba, CEO of Oceanus Bio.

In the U.S., Avata plans to file an Investigational New Drug application in 2H 2025 and utilize the Food and Drug Administration 505(b)(2) expedited regulatory pathway, with a view to making a solid dose CBD prescription medicine commercially available for U.S. patients in the shortest possible timeframe. Oceanus will lead regulatory engagement and clinical development in Japan and Asian regions in close collaboration with Avata.

About Avata Biosciences

Avata Biosciences Ltd is a privately held biopharmaceutical company with a mission to improve the lives of patients living with neurological disease. The Company’s lead asset has successfully completed its first Phase 1 study and is advancing to the next stage of clinical development in 2025. With a leadership team comprised of neuroscience and cannabinoid medicine veterans, Avata is utilizing the experience gained in cannabinoid drug development to bring new prescription medicines to patients suffering from serious diseases. For more information, visit AvataBio.com.

About Oceanus Bio

Oceanus Bio, Inc. is a private, clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics in neurology and psychiatry. With deep experience in CNS drug development and a proven track record in bringing treatments to market in Japan and across Asia, Oceanus aims to accelerate patient access to transformative therapies through global partnerships.
Contacts

Mike Beyer
[email protected]
Tel: +1-312-961-2502

Lisa Stone, MBA
Avata Biosciences, Inc.
Investor Relations
[email protected]
Tel: +1-917-843-0223