Talaris Therapeutics, a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, today announced the closing of a $100 million Series A financing. The Series A funding will be used to advance the company's proprietary, one-time, allogeneic cell therapy, FCR001, into later-stage clinical development in multiple immune-related indications. The financing was led by Blackstone Life Sciences, with participation from Longitude Capital and Qiming Venture Partners USA.

Talaris, formerly Regenerex, will leverage this funding to conduct a Phase 3 registration trial of FCR001 in living donor kidney transplant (LDKT) recipients, as well as additional Phase 2 studies in other high-need indications, following the company's promising Phase 2 data also announced today. In the Phase 2 trial, 70 percent of LDKT patients who received FCR001 were able to safely and durably discontinue immunosuppressive therapy. The company will also expand its in-house cell processing capabilities to support these development programs as well as early commercial launch needs.

"Talaris' cell therapy technology has great promise for post-transplant care, with the potential to replace lifelong immunosuppressants with a single, durable treatment," said Nicholas Galakatos, Head of Blackstone Life Sciences. "Talaris' focus on disease modifying therapies, its readiness to initiate a pivotal study executed by an experienced management team, and the product's potential to improve the lives of many patients, all align well with the Blackstone Life Sciences investment strategy."

Mr. Requadt, Talaris' new CEO, is an experienced biotech leader and life sciences investor with nearly 20 years of industry experience. Prior to joining Talaris, he was part of the investment team of Clarus Funds (now Blackstone Life Sciences) for 13 years, having most recently served as Managing Director. He remains a Venture Partner with Blackstone Life Sciences. Previously, he was Director, Business Development at Transform Pharmaceuticals until its acquisition by Johnson & Johnson. He started his career as a mergers & acquisitions lawyer at Davis Polk & Wardwell.

"Inducing durable, drug-free immune tolerance to a transplanted organ has been a long-standing aspiration in the transplant field," said CEO Scott Requadt. "With this substantial financing, Talaris is well positioned to rapidly advance this important therapy into a registration study for LDKT and through additional proof-of-concept clinical trials. The opportunity to change the course of the post-transplant outlook for patients is tremendously exciting, and I am thrilled to join Talaris at this pivotal time in the company's journey toward this goal."

The company also today announced the founding Board of Directors of Talaris, comprised of:

Independent Chairman, Francois Nader, M.D., previously CEO of NPS Pharmaceuticals, Inc.;
Independent Director, Geoff MacKay, CEO of AVROBIO, Inc.;
Scott Requadt, newly appointed CEO of Talaris;
Nicholas Galakatos, Ph.D., Head of Blackstone Life Sciences;
Sandip Agarwala, Managing Director of Longitude Capital;
Mark McDade, Managing Partner at Qiming Venture Partners USA; and
Suzanne Ildstad, M.D., Founder and Chief Scientific Officer of Talaris.

Dr. Ildstad, a transplant surgeon by training, developed the FCR001 platform while at the Institute for Cellular Therapeutics at the University of Louisville. She has devoted over 30 years of her career to researching and developing approaches to induce immune tolerance in organ transplant recipients and to enable safer allogeneic stem cell transplant procedures between mismatched donor-recipient pairs.

"Safely and reproducibly inducing or restoring immune tolerance via a one-time administration of FCR001 could eventually become a new standard of care both in organ transplant and in certain types of severe auto-immune or immune-mediated disorders," said Dr. Francois Nader, Chairman of Talaris. "This financing will enable the company to explore the therapy's potential to benefit patients across a number of areas of significant unmet medical need."

Talaris has also added four key members to its senior leadership team:

Chief Medical Officer Nancy Krieger, M.D., a transplant surgeon by training, has over 15 years of diverse global development experience in the pharmaceutical industry. Dr. Krieger previously served as the clinical lead at Novartis for the FCR001 program, and earlier in her career was a clinical lead at Bristol-Myers Squibb for the development of transplant drug belatacept.

SVP of Technical Operations Carlos Yuraszeck joins Talaris from Celgene, where he led Quality, Clinical Production and Supply teams within the company's cell therapy division. He brings to the company over 25 years of experience in manufacturing and quality systems spanning cell therapy, biologics and small molecules.

VP of Human Resources Rick Purdy has more than 25 years of HR experience, most recently as Chief Human Resources Officer at ResCare Corporation. His earlier career spans several other leading companies such as General Electric and Aetna.

Head of New Product Planning Eric Gornstein joins Talaris from Radius Health, where he led commercial insights and analytics efforts. He has over 20 years of experience in market analytics and commercial planning.

About FCR001

FCR001 is an investigational, allogeneic cell therapy developed by Talaris to induce or restore patients' immune tolerance. FCR001 builds on over 30 years of research by the company's founder, Dr. Suzanne Ildstad, into the means by which durable immune tolerance can be induced in a patient who receives a transplanted organ or can be restored in patients with certain immune-mediated or blood disorders. It was patented and incubated at the University of Louisville. The lead indication for FCR001 is to induce durable immune tolerance in living donor kidney transplant recipients. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

About Talaris Therapeutics
Talaris Therapeutics, Inc., formerly Regenerex, is a late-clinical stage biotechnology company that is developing transformative cell therapies with the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients as well as induce durable remissions in patients with severe auto-immune and immune-mediated disorders. Talaris was founded on technology discovered and developed by Dr. Suzanne Ildstad and operates its own cell processing facility in Louisville, KY. Talaris is backed by leading life sciences investors Blackstone Life Sciences, Longitude Capital and Qiming Venture Partners USA and maintains corporate offices in Boston, MA and Louisville, KY.