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Talaris Therapeutics (TALS) announced the discontinuation of its FREEDOM-1 and FREEDOM-2 clinical trials for FCR001 due to slow enrollment and long timelines. The company is reallocating resources to continue its FREEDOM-3 Phase 2 trial evaluating FCR001 for scleroderma. In conjunction with a strategic review aimed at maximizing shareholder value, Talaris will reduce its workforce by one-third. As of December 31, 2022, Talaris reported approximately $181.3 million in cash and marketable securities.
The company emphasized its commitment to addressing significant medical needs despite the setbacks in its kidney transplant program.
Talaris Therapeutics (Nasdaq: TALS) announced that CEO Scott Requadt will participate in a fireside chat at the 5th Annual Evercore ISI HealthCONx Conference on November 29, 2022, at 4:20 PM ET. This virtual event will provide insights into Talaris's innovative cell therapy advancements aimed at enhancing solid organ transplantation and addressing severe immune and blood disorders. A live webcast will be accessible on Talaris's investor website, remaining archived for 30 days post-event.
Talaris Therapeutics reported updates on its Phase 3 FREEDOM-1 trial for FCR001 in living donor kidney transplant patients. The company presented findings at the 2022 ASN Annual Meeting, showcasing a new mRNA signature for monitoring patient health. Talaris ended Q3 2022 with $193.9 million in cash, down from $244 million in December 2021, while R&D expenses rose to $15 million, attributed to increased trial costs and staffing. The net loss widened to $19 million, or $0.46 per share, compared to $12.9 million, or $0.32 per share, in Q3 2021.
Talaris Therapeutics (TALS) presented new findings on FCR001 at the 2022 ASN Annual Meeting, showcasing its potential to induce immune tolerance in organ transplantation. The first study analyzed mRNA profiles from 19 patients showing significant immune quiescence compared to 159 controls. The second study focused on PBMC changes in patients from the Phase 3 FREEDOM-1 trial, revealing critical immune cell modifications post-treatment. These insights may guide the development of Facilitated Allo-HSCT Therapy across various therapeutic applications.
Talaris Therapeutics (Nasdaq: TALS) provided a status update on its Phase 3 FREEDOM-1 study for living donor kidney transplant recipients. Following a patient death, the Data Monitoring Committee (DMC) recommended continuing enrollment and dosing, citing protocol modifications implemented in June 2022 to mitigate risks of graft-vs-host disease (GvHD). The deceased patient, diagnosed with severe GvHD and serious infections, did not receive the updated treatment protocol. Other patients in the study showed resolution of symptoms. Talaris aims to improve outcomes for kidney transplant patients.
Talaris Therapeutics (Nasdaq: TALS) has announced data presentations at the American Society of Nephrology (ASN) Annual Meeting from November 3-6, 2022. They will discuss findings related to patients' peripheral blood mononuclear cells post-treatment with FCR001 during the Phase 3 FREEDOM-1 trial for living donor kidney transplants. Key presentations include:
- Title: Immune cell transcriptome in living-donor kidney transplant patients tolerized with allo-HSCT cell therapy
Forward-looking statements highlight expectations around clinical trials and potential outcomes.
