Funding includes $8.5M from an oversubscribed seed financing with up to $37.3M in non-dilutive investment from The Japan Agency for Medical Research and Development (AMED), underscoring Japan’s commitment to breakthrough therapies

Funding will advance RegCell’s first-in-class epigenetic regulatory T-cell reprogramming platform to first-in-human clinical trials in 2025

Strategic move to a U.S.-based entity will accelerate clinical development, global partnerships, and commercialization opportunities for company founded by pioneering immunologist

EMERYVILLE, Calif., March 18, 2025 /PRNewswire/ — RegCell, Inc., a biotechnology company developing first-in-class therapies for autoimmune diseases and transplantation with its epigenetic reprogramming platform leveraging the natural biology of regulatory T-cells (Tregs), today announced the closing of an oversubscribed seed round and its transition to a U.S.-based company.

The $8.5 million seed financing 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).

In addition, RegCell was 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 validates RegCell’s technology and Japan’s commitment to innovation.

This additional capital will support RegCell’s plans to initiate a first-in-human trial in 2025 targeting an antigen-specific autoimmune indication. AMED’s support will fund IND-enabling studies, GMP optimization, and establishing clinical proof-of-concept in the US.

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, stated, “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.”

Furthermore, 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. 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.

“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,” said Dr. Michael McCullar, CEO of RegCell. “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.”

On behalf of existing investors, Dr. Atsushi Usami, Partner and Board Director at UTEC and RegCell, shared the following statement “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. Koji Yasuda, Principal at Fast Track Initiative, will join the RegCell Board and added the following statement: “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.”

About RegCell 

RegCell is a global biotechnology company pioneering cell therapies for autoimmune diseases and transplantation. With newly established U.S. headquarters and deep roots in Japan’s renowned scientific community, RegCell is founded on the pioneering discoveries of Co-Founder Professor Shimon Sakaguchi, a leader in regulatory T-cell (T-reg) biology.

RegCell has developed a proprietary, best-in-class platform to generate stable, epigenetically reprogrammed, antigen-specific Tregs designed to restore immune tolerance. Current autoimmune treatments rely on immunosuppression, leading to persistent adverse events and the need for life-long therapy. RegCell’s platform overcomes key barriers that have hindered the development of autoimmune cell therapies by addressing unknown or multiple pathogenic antigens. Unlike genetic modification approaches, RegCell’s epigenetic reprogramming technology simplifies manufacturing, enhances safety, and enables scalable production, bringing the promise of transformative cell therapies to a broad spectrum of autoimmune patients, including those with diseases driven by undefined autoantigens.

Driven by a vision to redefine self-tolerance, RegCell is committed to delivering safe, life-changing cell therapies that can restore immune tolerance, reverse autoimmune disorders, and overcome challenges in transplantation.  

For more information, visit http://www.regcellbio.com/

About AMED 

The Japan Agency for Medical Research and Development (AMED), established in 2015, is a government agency dedicated to accelerating medical innovation and strengthening Japan’s global competitiveness in healthcare. AMED supports integrated research and development across the medical spectrum, from basic science to clinical applications, to translate cutting-edge discoveries into real-world treatments. As part of this mission, AMED launched the V-ECO (Strengthening Program for Pharmaceutical Startup Ecosystem) grant to foster the growth of Japan’s biotech sector. This program provides substantial non-dilutive funding to startups developing innovative therapies, contingent upon investment from pre-certified venture capital firms. By supporting early-stage pharmaceutical development, including non-clinical and clinical studies, V-ECO aims to accelerate breakthrough medical innovations and position Japan as a leader in biotech entrepreneurship.

Media Contact:
Ignacio Guerrero-Ros, Ph.D.
Russo Partners LLC
ignacio.guerrero-ros@russopartnersllc.com  

Investor Contact:
James Ahlers
RegCell, Inc.
james.ahlers@regcellbio.com

SOURCE RegCell, Inc.

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