Talaris Phase 3 Clinical Update

 Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders, today provided a clinical update on its ongoing Phase 3 FREEDOM-1 study in living donor kidney transplant (LDKT) recipients.

To date, Talaris has enrolled 22 donor-recipient pairs in the Phase 3 FREEDOM-1 study (NCT# 03995901) of FCR001. Seven patients have been successfully dosed at five different trial sites. All three patients who were dosed more than 12 months prior to the data cutoff date have been successfully weaned off all chronic anti-rejection drugs without evidence of rejection and with stable kidney function. All of these patients, including the first patient who is now 24 months post-transplant, continue to remain off all anti-rejection drugs. Furthermore, all patients treated with FCR001 at least three months prior to the data cutoff date have achieved and maintained T-cell chimerism levels >50% at each of the 3-, 6- and 12-month timepoints post-transplant. The safety profile observed was generally consistent with that expected in patients receiving a kidney transplant and an allo-HSCT. Three cases of low-grade acute graft-versus-host disease (aGvHD) were reported, all of which were treatment-responsive and have since resolved. One of these patients is more than 12 months post-transplant and has been successfully weaned off all anti-rejection drugs. As a result of an internal review triggered by the GvHD cases, Talaris has modified its mobilization protocol and added a second post-transplant dose of cyclophosphamide for GvHD prophylaxis. Trial enrollment continues.

Conference Call & Webcast Information
Talaris will host an investor webcast and conference call today at 8:00 a.m. ET to discuss its presentations at the American Transplant Congress (ATC) and provide a data update from its ongoing Phase 3 FREEDOM-1 study in living donor kidney transplant (LDKT) recipients. To access the conference call, the dial-in numbers are 1-855-605-1739 for domestic callers and 1-914-987-7955 for international callers. The conference ID number for the live call will be 6249115. A live webcast and replay of the conference call will also be available under "Events & Presentations" in the Investors section of the Company's website at www.talaristx.com.

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