Talaris’s lead candidate, FCR001, is a facilitated allogeneic hematopoietic stem cell transplantation product made by a proprietary process that optimizes key immune and stem cell subsets. FCR001 is being evaluated in an open-label Phase 3 study enrolling 120 first-time kidney transplant patients receiving organs from living donors, with the therapy administered one day after transplant and an update expected in Q4. The company describes FCR001 as a "pipeline in a product," and is also pursuing Phase 2 studies of a delayed-tolerance approach in patients who have already received kidney transplants and a separate Phase 2 study in scleroderma, both planned to begin in the second half of the year. Talaris is conducting preclinical research to assess whether similar donor cells can be procured from deceased donors to enable use in the far larger deceased-donor transplant population. The company was founded in 2002 (originally Regenerex) and previously partnered with Novartis from 2013–2016; through the end of last year it had raised $186.2 million, including a $115 million Series B announced last October. After its IPO proceeds allocation, Talaris says its cash should support operations at least until 2025. Talaris Therapeutics is a privately held, late-clinical-stage biotechnology company developing transformative cell therapies intended to induce durable immune tolerance across multiple indications. Its lead candidate, FCR001, is being evaluated in a pivotal Phase 3 trial in first-time living donor kidney transplant recipients and is now enrolling at U.S. sites. The company has laid the groundwork for two additional Phase 2 studies, including a planned trial in diffuse systemic sclerosis (SSc) and a future trial in individuals who previously received a living donor kidney transplant. Over the past 18 months Talaris reports dramatic progress, having expanded its team and bolstered wholly in-house cell processing capabilities. Talaris maintains corporate offices in Boston and a cell processing facility in Louisville, Ky. The recent financing will support advancement of its immune tolerance programs through key clinical milestones in organ transplant and autoimmune disease. Talaris Therapeutics develops a proprietary, one‑time allogeneic cell therapy, FCR001, intended to induce or restore durable immune tolerance in organ transplant recipients and certain immune‑mediated disorders. FCR001 was patented and incubated at the University of Louisville and has received Orphan Drug and RMAT designations from the FDA. In Phase 2, 70% of living donor kidney transplant (LDKT) patients who received FCR001 were able to safely and durably discontinue immunosuppressive therapy. The company will use the $100 million Series A financing to advance FCR001 into later‑stage clinical development, including a Phase 3 registration trial in LDKT and additional Phase 2 studies in other high‑need indications. Talaris also plans to expand its in‑house cell processing capabilities to support these development programs and early commercial launch needs. The company operates a cell processing facility in Louisville, KY and maintains corporate offices in Boston, MA and Louisville, KY.

Total raised

$365M

Funding rounds

3

Latest round

Equity

Latest activity

May 2021