RegCell – a biotechnology company developing first-in-class therapies for autoimmune diseases and transplantation with its epigenetic reprogramming platform utilizing the natural biology of regulatory T-cells (Tregs) – announced the closing of an oversubscribed seed round and its transition to a U.S.-based company.
The $8.5 million seed funding round was co-led by The University of Tokyo Edge Capital Partners (UTEC) and Fast Track Initiative (FTI), with participation from Celadon Partners, Mitsubishi UFJ Capital, Osaka University Venture Capital (OUVC), and Kyoto University Innovation Capital (Kyoto i-Cap).
RegCell was also awarded up to $37.3 million in non-dilutive funding (¥5.6 Billion) from Japan’s Agency for Medical Research and Development (AMED). This funding will support the development of RegCell’s epigenetic reprogramming platform through clinical proof-of-concept and further validate RegCell’s technology and Japan’s commitment to innovation.
This additional funding will support RegCell’s plans to initiate a first-in-human trial in 2025 targeting an antigen-specific autoimmune indication. And AMED’s support will fund IND-enabling studies, GMP optimization, and establishing clinical proof-of-concept in the US.
The strategic U.S. corporate restructuring transitions RegCell to a U.S.-based corporation, broadening access to international talent, capital, and partnerships, enhancing R&D capabilities, and expanding business development outreach to global partners. And RegCell will continue to operate its core scientific operations to access world-class scientific capabilities in Japan while leveraging its U.S. footprint to access regulatory and commercialization expertise that tends to be scarce in the emerging Japanese biotech ecosystem.
KEY QUOTES:
“This funding accelerates RegCell’s mission of developing potentially curative treatments for autoimmune diseases and transplantation and provides a very efficient path to clinical proof of concept.”
– RegCell’s scientific founder Professor Shimon Sakaguchi – whose pioneering research led to the discovery of regulatory T cells (Tregs) and their essential function in maintaining immunological self-tolerance
“This funding, combined with our ambitious corporate restructuring, represents a crucial milestone in RegCell’s evolution as it propels us forward in our mission to bring groundbreaking immunology therapies to the forefront of global healthcare. This financial support and U.S.-based restructuring are not just strategic steps; they are forces that will drive both our clinical development and business success in the years ahead.”
– Dr. Michael McCullar, CEO of RegCell
“I am truly delighted that the innovative Treg cell therapy, developed by Prof. Sakaguchi, is progressing towards transformative clinical milestones with the support of Japan’s AMED, a team of seasoned drug development experts—primarily from the U.S.—and new investors committed to our shared vision for RegCell. This therapy has the potential to bring relief to countless patients suffering from immune diseases worldwide. I sincerely hope it reaches clinical practice in the most appropriate and widespread manner as soon as possible.”
– Dr. Atsushi Usami, Partner and Board Director at UTEC and RegCell
“Regulatory T-cells play a critical role in maintaining immune tolerance, yet translating their biology into effective therapies has been challenging. RegCell’s differentiated approach has the potential to address a broad range of autoimmune diseases and beyond. We are excited to support this breakthrough Japanese science developed by Prof. Sakaguchi and his team and help bring its impact to the U.S. and global markets.”
– Dr. Koji Yasuda, Principal at Fast Track Initiative, who will join the RegCell Board
