March 18, 2025 

Fast Track Initiative (FTI) has co-led a 45.8M USD funding round for RegCell, Inc. (Headquarters: Emeryville, CA; CEO: Michael McCullar), a biotechnology company developing regulatory T cell (Treg) therapy for autoimmune diseases. The financing includes 8.5M USD in equity and 37.3M USD in non-dilutive grants from the Japan Agency for Medical Research and Development (AMED). Koji Yasuda, Principal at FTI, has joined RegCell’s Board of Directors as an external board member.

RegCell is founded on the basis of the discoveries of Professor Shimon Sakaguchi, a world-renowned immunologist and leading authority in Treg biology. The company’s proprietary platform epigenetically reprograms patient-derived T cells into stable, functional Tregs that restore immune tolerance. Its pipeline includes rare single-antigen derived dermatological autoimmune disease, and autoimmune liver disease. 

With this funding, RegCell will advance human clinical trials and relocate its headquarters to the United States to accelerate clinical development, expand global partnerships, and prepare for commercialization.

FTI will support RegCell’s global growth by providing strategic guidance across management, research and development, and business expansion. By leveraging its deep expertise in building impactful life-sciences therapeutics companies and cross-border investment and support.

 

 

About RegCell, Inc.

RegCell, Inc. is a biotechnology company developing regulatory T cell (Treg) therapy to restore immune tolerance (immune cell balance) to treat autoimmune diseases. Founded on the  discoveries of Dr. Shimon Sakaguchi, the company’s platform epigenetically reprograms T cells into disease-modifying Tregs. Headquartered in San Francisco, CA, with R&D operations in Japan, RegCell is advancing toward gloabl clinical trials and commercial partnerships.

For more information, visit www.regcellbio.com

 

About Fast Track Initiative:

Established in 2004, Fast Track Initiative, Inc. (FTI) is a life science venture capital firm focusing its investments on early-stage startups with a strong focus on biotech and therapeutics. FTI has a strict mission to make a ground-breaking impact on the quality of our life and human wellness through investments across a broad range of areas in the life science community including therapeutics, diagnostics, digital health, healthcare services, and more. The company provides valuable, hands-on support to its 30+ portfolio companies through business and R&D strategy, partnering, investor syndication, and more, including access to its network of professionals in Japan.

Visit https://us.fasttrackinitiative.com for more details, or follow us on LinkedIn: https://www.linkedin.com/company/fast-track-initiative/

 

Media Coverage:

Endpoint News: https://endpts.com/japans-regcell-raises-45-8m-for-treg-cell-therapies-will-move-to-us/

BioWorld: https://www.bioworld.com/articles/718368-japans-regcell-launches-in-us-with-458m-to-advance-treg-platform?v=preview

 

Media Contact:

For press inquiries or investor inquiries, please email:  message.us@fasttrackinitiative.com