Japanese-founded RegCell secures $45.8M in funding and completes U.S. headquarters transition

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)

RegCell, 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), has closed an oversubscribed seed round and is transitioning 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.

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.