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, presented new data characterizing the mechanisms of FCR001-induced immune tolerance in two oral presentations at the 2022 American Society of Nephrology (ASN) Annual Meeting.

The first presentation reported on transcriptional changes following successful tolerization with FCR001. Urinary cell mRNA profiling was conducted on 19 patients tolerized with FCR001 in the Company’s Phase 2 clinical trial and 159 control patients who received a living donor kidney transplant (LDKT) but were not treated with FCR001. The analysis identified a unique urinary cell mRNA signature that is consistent with immune quiescence as defined by the ratio of CTLA-4 to granzyme B mRNA, which is significantly higher in the FCR001 cohorts compared to the control cohorts. This signature may help identify FCR001 patients who could safely discontinue chronic immunosuppression.

In a second oral presentation, the Company reported data on the specific composition of patients’ peripheral blood mononuclear cells (PBMCs) following treatment with FCR001 in a small cohort of patients enrolled in the Company’s Phase 3 FREEDOM-1 trial. Longitudinal single-cell RNA sequencing was conducted on PBMCs from three patients treated with FCR001 and one patient in the standard of care control arm treated with immunosuppressants. The analysis found that immune reconstitution following FCR001 treatment was characterized by important changes in natural killer (NK) cell and B cell sub-populations, and that this immune activation preceded observation of clinical manifestations.

“We are pleased to present these new analyses that shed light on how FCR001 treatment may modulate the immune landscape to induce durable immune tolerance,” said Nancy Krieger, M.D., Chief Medical Officer of Talaris. “These important insights into the transcriptional response and immune cell behavior will inform our ongoing development of Facilitated Allo-HSCT Therapy across multiple therapeutic areas.”

About Talaris Therapeutics
Talaris Therapeutics, Inc. is 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. Talaris maintains corporate offices in Boston, MA, its cell processing facility in Louisville, KY, and additional research operations in Houston, TX.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Talaris Therapeutics, Inc.’s (“Talaris,” the “Company,” “we,” or “our”) strategy, business plans and focus; the progress and timing of the preclinical and clinical development of Talaris’ programs, including FCR001. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the timing and anticipated timing and results of its clinical trials; the risk that the results of Talaris’ clinical trials may not be predictive of future results in connection with future clinical trials; the Company’s ability to successfully demonstrate the safety and efficacy of its drug candidates. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Talaris’ views only as of today and should not be relied upon as representing our views as of any subsequent date. Talaris explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

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