- $44 Million Series A led by Playground Global, with participation from new and existing investors
- Second AMED grant adds ¥3.4 billion (~$22 million)
- Combined financing will enable IND submission and advance RegCell’s next-generation epigenetic reprogramming platform into a second autoimmune indication through Phase 2 as proof of concept
EMERYVILLE, Calif.--(BUSINESS WIRE)--RegCell, Inc., a biotechnology company developing first-in-class therapies to restore immune tolerance, today announced the closing of a fully subscribed Series A financing and a second non-dilutive grant from Japan’s Agency for Medical Research and Development (AMED), totaling $66 million. The funding will advance RegCell’s epigenetic reprogramming platform, built on Nobel Laureate and RegCell co-founder Professor Shimon Sakaguchi’s discovery of regulatory T cells (Tregs), into clinical-stage development across multiple autoimmune indications.
“For decades, my research has centered on the question of how the immune system governs itself,” says Dr. Sakaguchi, whose pioneering research led to the discovery of Tregs’ essential function in maintaining immune tolerance. “To see this platform carry that discovery toward patients is deeply meaningful to me after all these years.”
Unlike conventional immunosuppressants, which have remained the standard of care for autoimmune diseases for decades, RegCell’s platform distinguishes disease-causing immune cells from healthy ones. Rather than broadly dampening immune function and leaving patients vulnerable to serious infections, cardiac toxicity, and secondary malignancies, RegCell’s approach converts pathogenic T cells into stable, epigenetically reprogrammed, disease-relevant Tregs that restore immune tolerance at the source.
Existing autoimmune therapies work by broadly suppressing the immune system with actions ranging from blocking cytokines to impeding trafficking to depleting immune cells. RegCell’s platform is designed to instead restore immune tolerance through a durable, targeted mechanism upstream of conventional approaches, converting the specific T cells driving disease into regulatory T cells that can restore immune tolerance while preserving normal immune function.
“We believe that patients need better options than what current autoimmune therapies provide,” said Michael V. McCullar, Ph.D., MBA, President and CEO of RegCell. “With this financing and AMED’s continued support, we intend to rapidly advance our epigenetic reprogramming platform into the clinic, establish proof of concept in patients, and expand its potential across autoimmune disease.”
Led by Playground Global, the $44 million Series A financing was joined by other new investors including Global Brain, Mitsui Chemicals, LG Technology Ventures, Alumni Ventures, and Medical Incubator Japan, and was supported by existing investors including Fast Track Initiative, The University of Tokyo Edge Capital Partners (UTEC), Osaka University Venture Capital, and Kyoto iCAP. As part of this financing, Jory Bell, General Partner at Playground Global, will join RegCell’s Board of Directors.
“RegCell is pursuing something genuinely novel in autoimmune disease: instead of chasing a single target, the company’s approach reprograms a patient’s own auto-reactive T cells to reset the immune system on its own terms,” said Jory Bell, General Partner at Playground Global, and RegCell Board Member. “The company has the potential to move beyond symptom management toward something closer to a cure for conditions like myasthenia gravis, rheumatoid arthritis and ulcerative colitis.”
In addition to the Series A financing, RegCell was awarded an additional approximately $22 million in non-dilutive funding (¥3.4 billion) from AMED. This funding will accelerate the second generation of RegCell’s epigenetic reprogramming platform to convert pathogenic T cells into lineage-stable antigen-specific Tregs, as well as the strategic expansion of RegCell’s clinical pipeline through an additional Phase 2 proof-of-concept study.
This milestone marks RegCell’s second AMED award, bringing AMED’s total commitment of non-dilutive capital for RegCell to approximately $59.3 million (¥9.0 billion). RegCell was first awarded approximately $37.3 million (¥5.6 billion) in non-dilutive capital from AMED in 2024 to develop the first generation of its epigenetic reprogramming platform through clinical proof-of-concept in autoimmune liver diseases.
“Our conviction is that restoring immune tolerance through Treg biology could meaningfully change how autoimmune disease is treated. We look forward to building alongside Playground and RegCell’s team as it moves toward the clinic,” said Koji Yasuda, Principal at Fast Track Initiative and Board Director at RegCell.
“RegCell’s platform has the potential to redefine the treatment of autoimmune disease by restoring immune tolerance at its source rather than broadly suppressing the immune system,” said Azusa Shiohara, Principal at UTEC and Board Director at RegCell. “UTEC has supported RegCell since its early days in Japan and through the relocation of its headquarters to the U.S. Built on Prof. Sakaguchi’s Nobel Prize-winning science, RegCell and its world-class team are well positioned to bring this approach to patients worldwide.”
About RegCell
RegCell is a global biotechnology company pioneering therapy for autoimmune diseases. Their proprietary immune tolerance platform is based on the Nobel Prize-winning research of Co-Founder Professor Shimon Sakaguchi and is built to generate stable, epigenetically reprogrammed, antigen-specific Tregs designed to restore immune tolerance. Current autoimmune treatments broadly suppress the immune system, generally don’t distinguish disease-causing immune cells from healthy ones, and don’t target the underlying cause. By addressing unknown or multiple pathogenic antigens, RegCell’s platform overcomes these limitations. Because RegCell’s approach requires no gene engineering, it enables simplified manufacturing, enhanced safety, and greater scalability across a broad spectrum of patients. Driven by a vision to redefine self-tolerance, RegCell is committed to delivering safe, life-changing therapies for autoimmune disease.
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.
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