Talaris Therapeutics, Inc. Announces $100M Series A Financing to Advance Its Novel, Allogeneic Cell Therapy Through Late-Stage Clinical Development

– Financing will support Phase 3 trial of FCR001 for living donor
kidney transplant patients and additional Phase 2 studies in high-need
indications

– Formerly Regenerex, the company’s new name reflects its patient-
and impact-driven mission of inducing and restoring immune tolerance

– Names Scott Requadt Chief Executive Officer and additional members
of leadership team and Board of Directors

BOSTON & LOUISVILLE, Ky.–(BUSINESS WIRE)–Talaris
Therapeutics, Inc., 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.
www.TalarisTx.com.

Contacts

Lisa Raffensperger
Ten Bridge Communications
[email protected]
(617)
903-8783