Welcome to our dedicated page for Talaris Therapeutics news (Ticker: tals), a resource for investors and traders seeking the latest updates and insights on Talaris Therapeutics stock.
Talaris Therapeutics, Inc. (Nasdaq: TALS) is a late-clinical stage biotechnology company based in Boston, MA, and Louisville, KY. Specializing in the development of transformative cell therapies, Talaris aims to alleviate the burden of chronic immunosuppression in organ transplant recipients and to induce durable remissions in patients with severe autoimmune and immune-mediated disorders. Founded on pioneering technology discovered by Dr. Suzanne Ildstad, Talaris operates its own cell processing facility in Louisville.
Recent Developments: Talaris recently announced the results of a special stockholder meeting held on October 17, 2023, where stockholders approved the issuance of shares to the stockholders of Tourmaline Bio, Inc. as part of a merger agreement. This merger, expected to close around October 19, 2023, will result in Tourmaline surviving as a direct wholly-owned subsidiary of Talaris. Post-merger, the combined company plans to operate under the name Tourmaline Bio, Inc., trading on Nasdaq under the new ticker symbol “TRML”.
In conjunction with the merger, Talaris will effect a 1-for-10 reverse stock split, reducing outstanding shares from approximately 42.8 million to about 4.28 million. Stockholders will receive cash payments for fractional shares. The reverse stock split will uniformly impact all holders and does not alter percentage ownership interests except for fractional shares.
Financial Condition & Partnerships: Talaris is supported by notable life sciences investors, including Blackstone Life Sciences, Longitude Capital, and Qiming Venture Partners USA. The merger with Tourmaline Bio will create a combined entity focusing on developing transformative medicines, with Tourmaline's lead program, TOUR006, targeting thyroid eye disease and atherosclerotic cardiovascular disease.
Talaris Therapeutics has initiated its Phase 2 FREEDOM-3 trial to assess the safety and efficacy of its investigational allogeneic cell therapy, FCR001, for treating severe diffuse cutaneous systemic sclerosis (dcSSc). This multicenter study aims to halt organ damage progression in patients by providing a one-time treatment with non-myeloablative conditioning. The University of Michigan is the first clinical site activated, with more sites expected in 2022. Positive outcomes could extend FCR001's applicability to other severe autoimmune diseases.
Talaris Therapeutics (TALS) announced significant advancements in its clinical trials for FCR001, focusing on kidney transplant patients. The company reported that all patients reaching the three-month post-transplant mark in the Phase 3 FREEDOM-1 trial achieved sustained chimerism, indicating potential for long-term immunosuppression withdrawal. Additionally, Talaris initiated the Phase 2 FREEDOM-2 trial to explore delayed tolerance induction. Financially, Talaris ended Q3 2021 with $254.7 million in cash but recorded a net loss of $12.9 million, an increase from the previous year.
Talaris Therapeutics (Nasdaq: TALS) announced participation in key investor conferences aimed at showcasing its innovative therapies for solid organ transplantation and severe autoimmune diseases. Key events include the Virtual Guggenheim 3rd Annual Neuro/Immunology Conference on Nov 15-16, 2021, the Stifel 2021 Virtual Healthcare Conference on Nov 15, 2021, at 11:20 a.m. ET, and the Evercore ISI 4th Annual HealthCONx Virtual Conference with a fireside chat on Dec 1, 2021, at 4:20 p.m. ET. Live webcasts will be available on the Talaris website.
Talaris Therapeutics (TALS) reported promising initial findings from its Phase 3 FREEDOM-1 study, focusing on kidney transplant recipients. Two patients treated with FCR001, over 12 months post-transplant, successfully weaned off chronic immunosuppression (IS) with stable kidney function. All patients who received FCR001 at least three months prior achieved >50% T-cell chimerism, a key indicator of potential long-term tolerance to the donated kidney. The safety profile remains consistent with earlier studies, indicating potential for a transformative approach in kidney transplantation.
Talaris Therapeutics has launched the Phase 2 FREEDOM-2 trial to assess the safety and efficacy of its investigational allogeneic cell therapy, FCR001, aimed at inducing immune tolerance in living donor kidney transplant recipients. The trial has commenced at Northwestern University, with potential for additional sites in 2022. This study may pave the way for alternatives to long-term immunosuppression, which is currently standard for transplant recipients. FCR001 has received Orphan Drug Designation and RMAT designation from the FDA, indicating its potential therapeutic value.
Talaris Therapeutics, Inc. (Nasdaq: TALS) announced key data presentations at the upcoming American Society of Nephrology (ASN) Kidney Week 2021, scheduled for November 4-7, 2021. The company will provide the first clinical update on its Phase 3 FREEDOM-1 study, focusing on living donor kidney transplant recipients. Additionally, a poster will present long-term follow-up data from a Phase 2 study, featuring urinary cell mRNA profiling results. An investor conference call will be held on November 4, 2021, at 8:00 a.m. ET to discuss these updates.
Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-stage cell therapy company, announced its participation in upcoming investor conferences. The company will host a fireside chat at the Morgan Stanley Virtual 19th Annual Global Healthcare Conference on September 13, 2021, at 5:00 PM ET. Additionally, Talaris will participate in the SVB Leerink CybeRx Series on September 22-23, 2021. A live webcast of the Morgan Stanley event will be available on its website and archived for 90 days.
Talaris focuses on innovative cell therapies for organ transplantation and severe autoimmune diseases.
Talaris Therapeutics (TALS) has reported its financial results for Q2 2021 and provided updates on its clinical trials. The company is on track to deliver the initial clinical update for the FREEDOM-1 trial later this year and will initiate the FREEDOM-2 and FREEDOM-3 trials in Q4 2021. As of June 30, 2021, Talaris held $266.2 million in cash, marking a significant increase from $149.5 million at year-end 2020. Despite increased R&D and G&A expenses, the net loss widened to $11.4 million compared to $4.7 million in Q2 2020.
Talaris Therapeutics (Nasdaq: TALS) reported its Q1 2021 financial results, highlighting its focus on advancing the FCR001 therapy for solid organ transplantation and severe autoimmune diseases. The company ended the quarter with $140.1 million in cash and equivalents. A significant milestone was the completion of an IPO in May 2021, raising approximately $150 million. R&D expenses increased to $6.5 million due to expanded clinical trials and personnel. Talaris incurred a net loss of $9.3 million, compared to $4.8 million in Q1 2020, as it prepares for multiple upcoming clinical trials and progress in its innovative therapies.
Talaris Therapeutics (TALS) announced significant presentations at the American Transplant Congress from June 4-9, 2021. Key highlights include data from the Phase 2 study of FCR001, emphasizing peripheral blood chimerism's role as a biomarker for transplantation tolerance. Results show a predictive correlation between chimerism levels and the ability to withdraw immunosuppression within one year. In a trial with 37 kidney transplant recipients, 26 achieved durable chimerism, maintaining rejection-free status for up to 12 years. The company will also host invited sessions and poster presentations.
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