TALS Talaris Therapeutics Inc.

9.04
-0.34  -4%
Previous Close 9.38
Open 9.19
52 Week Low 9.26
52 Week High 19.82
Market Cap $373,845,973
Shares 41,354,643
Float 25,204,170
Enterprise Value $129,507,972
Volume 65,125
Av. Daily Volume 128,191
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Upcoming Catalysts

Drug Stage Catalyst Date
FCR001 - (FREEDOM-1)
Transplanted Organ Rejection
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
FCR001 - (FREEDOM-2)
Delayed tolerance kidney transplant
Phase 2
Phase 2
Phase 2 trial initiated. In delayed tolerance induction patients noted, November 12, 2021.
FCR001 - (FREEDOM-3)
Scleroderma
Phase 2
Phase 2
Phase 2 trial initiated November 30, 2021.

Latest News

  1. BOSTON and LOUISVILLE, Ky., Jan. 06, 2022 (GLOBE NEWSWIRE) -- 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 announced that Scott Requadt, Chief Executive Officer of Talaris, will present at the virtual 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 2:15 PM ET.

    A live webcast of the presentation will be available on the investors section of the Talaris website at www.talaristx.com. After the live webcast, the event will remain archived on the Talaris website for 30 days.

    About Talaris Therapeutics
    Talaris Therapeutics…

    BOSTON and LOUISVILLE, Ky., Jan. 06, 2022 (GLOBE NEWSWIRE) -- 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 announced that Scott Requadt, Chief Executive Officer of Talaris, will present at the virtual 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 2:15 PM ET.

    A live webcast of the presentation will be available on the investors section of the Talaris website at www.talaristx.com. After the live webcast, the event will remain archived on the Talaris website for 30 days.

    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.

    Media Contact

    Marin Bergman

    Ten Bridge Communications



    (818) 516-2746

    Investor Contact

    Chris Brinzey

    ICR Westwicke



    (339) 970-2843



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  2. BOSTON and LOUISVILLE, Ky., Jan. 04, 2022 (GLOBE NEWSWIRE) -- 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 announced that Scott Requadt, Chief Executive Officer of Talaris, will present at the H.C. Wainwright BioConnect 2022 Virtual Conference being held January 10-13, 2022.

    A webcast of the pre-recorded presentation will be made available the morning of the conference starting at 7:00 AM ET on Monday, January 10th, and can be accessed by visiting the investors section of the Talaris website at www.talaristx.com. After the live webcast, the event will…

    BOSTON and LOUISVILLE, Ky., Jan. 04, 2022 (GLOBE NEWSWIRE) -- 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 announced that Scott Requadt, Chief Executive Officer of Talaris, will present at the H.C. Wainwright BioConnect 2022 Virtual Conference being held January 10-13, 2022.

    A webcast of the pre-recorded presentation will be made available the morning of the conference starting at 7:00 AM ET on Monday, January 10th, and can be accessed by visiting the investors section of the Talaris website at www.talaristx.com. After the live webcast, the event will remain archived on the Talaris website for 90 days.

    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.

    Media Contact

    Lisa Raffensperger

    Ten Bridge Communications



    (617) 903-8783

    Investor Contact

    Chris Brinzey

    Westwicke, an ICR Company



    (339) 970-2843



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  3. BOSTON and LOUISVILLE, Ky., Dec. 20, 2021 (GLOBE NEWSWIRE) -- 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, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders, today announced that the company has been added to the NASDAQ Biotechnology Index (NASDAQ:NBI), active prior to market open today.

    The NASDAQ Biotechnology Index, launched in 1993, is designed to track the performance of a set of securities listed on the NASDAQ Stock Market® (NASDAQ®) that are classified according to the Industry Classification Benchmark as biotechnology or pharmaceutical…

    BOSTON and LOUISVILLE, Ky., Dec. 20, 2021 (GLOBE NEWSWIRE) -- 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, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders, today announced that the company has been added to the NASDAQ Biotechnology Index (NASDAQ:NBI), active prior to market open today.

    The NASDAQ Biotechnology Index, launched in 1993, is designed to track the performance of a set of securities listed on the NASDAQ Stock Market® (NASDAQ®) that are classified according to the Industry Classification Benchmark as biotechnology or pharmaceutical companies. The NASDAQ Biotechnology Index is calculated under a modified capitalization-weighted methodology and ranked on a semi-annual basis.

    The NASDAQ Biotechnology Index is the basis for the iShares NASDAQ Biotechnology Index Fund. All securities in the NASDAQ Biotechnology Index are listed on the NASDAQ Global Market or the NASDAQ Global Select Market and meet minimum market value and share volume requirements among other criteria.

    More information about the NASDAQ Biotechnology Index can be found at nasdaqomx.com.

    About Talaris Therapeutics

    Talaris Therapeutics, Inc. is a late-clinical stage biopharmaceutical company developing investigational, one-time, allogeneic cell therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic 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 and the continued expansion of applications of Facilitated Allo-HSCT Therapy to other areas of high patient need. 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 September 30, 2021, 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.

    Media Contact

    Marin Bergman

    Ten Bridge Communications



    (818) 516-2746

    Investor Contact

    Chris Brinzey

    ICR Westwicke



    (339) 970-2843



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  4. BOSTON and LOUISVILLE, Ky., Dec. 14, 2021 (GLOBE NEWSWIRE) -- Talaris Therapeutics, Inc., (NASDAQ:TALS), a late-clinical stage cell therapy company, today presented a new analysis of HLA mismatching between donors and recipients participating in the Company's Phase 2 trial in living donor kidney transplant (LDKT). High-resolution allele typing at six loci found that FCR001 induced durable immune tolerance in highly mismatched related and unrelated recipients. The findings were shared in an oral presentation by Joseph R. Leventhal, M.D., Ph.D., Fowler McCormick Professor of Surgery at Northwestern University Feinberg School of Medicine and principal investigator for the Phase 2 study, at the American Society of Hematology (ASH) Annual Meeting…

    BOSTON and LOUISVILLE, Ky., Dec. 14, 2021 (GLOBE NEWSWIRE) -- Talaris Therapeutics, Inc., (NASDAQ:TALS), a late-clinical stage cell therapy company, today presented a new analysis of HLA mismatching between donors and recipients participating in the Company's Phase 2 trial in living donor kidney transplant (LDKT). High-resolution allele typing at six loci found that FCR001 induced durable immune tolerance in highly mismatched related and unrelated recipients. The findings were shared in an oral presentation by Joseph R. Leventhal, M.D., Ph.D., Fowler McCormick Professor of Surgery at Northwestern University Feinberg School of Medicine and principal investigator for the Phase 2 study, at the American Society of Hematology (ASH) Annual Meeting.

    The new analysis is based on DNA samples collected in Talaris' Phase 2 trial of FCR001 in living donor kidney transplant recipients. The focus of the analysis was to evaluate the degree of donor/recipient HLA mismatching using high-resolution allele typing at HLA-A, -B, -C, -DRB1, -DQB1 and -DPB1, and to understand its correlation with the ability to establish durable chimerism in this patient sample.

    Samples from 29 of the 37 donor/recipient pairs were evaluated across all 12 of the relevant HLA alleles; three other donor/recipient pairs were evaluated across 10 alleles as the samples did not have sufficient DNA to test for locus DPB1. In the former group, 21 of 29 donor/recipient pairs had 6/12 or more mismatching; in the latter group, two of the three pairs had 5/10 or more mismatching. Despite this high degree of mismatch, durable chimerism induced by FCR001 allowed for full withdrawal of immunosuppression (IS) in 25 of these 32 subjects, with time off IS ranging from 3.5 to 11 years. Twelve of these 25 pairs were unrelated with ≥ 8 HLA mismatches, and the majority of treated patients showed >95% donor whole blood/T cell chimerism. As previously reported, there was limited incidence of GvHD, being two cases, both in the setting of a female donor to unrelated male recipient. An exclusion criterion for this donor-recipient pairing was added to the Phase 2 trial.

    "We're pleased to share this new, more detailed examination of the HLA mismatching among patients in our Phase 2 trial, indicating that FCR001 induced durable immune tolerance across very high levels of mismatch," said Nancy Krieger, M.D., Chief Medical Officer of Talaris. "These insights are highly valuable as we progress our ongoing Phase 3 registrational study in LDKT, FREEDOM-1, and as we continue to expand the applications of Facilitated Allo-HSCT Therapy to other areas of high patient need."

    About Talaris Therapeutics

    Talaris Therapeutics, Inc. is a late-clinical stage biopharmaceutical company developing investigational, one-time, allogeneic cell therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic 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 and the continued expansion of applications of Facilitated Allo-HSCT Therapy to other areas of high patient need. 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 September 30, 2021, 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.

    Media Contact

    Lisa Raffensperger

    Ten Bridge Communications



    (617) 903-8783

    Investor Contact

    Chris Brinzey

    ICR Westwicke



    (339) 970-2843 



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  5. BOSTON and LOUISVILLE, Ky., Nov. 30, 2021 (GLOBE NEWSWIRE) -- 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, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders, today announced the initiation of the company's Phase 2 FREEDOM-3 trial in diffuse cutaneous systemic sclerosis (dcSSc), a severe form of the rare autoimmune disease scleroderma. This trial will explore the safety of the company's investigational allogeneic cell therapy, FCR001, delivered with non-myeloablative conditioning, in these patients, as well as its potential to halt the progression…

    BOSTON and LOUISVILLE, Ky., Nov. 30, 2021 (GLOBE NEWSWIRE) -- 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, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders, today announced the initiation of the company's Phase 2 FREEDOM-3 trial in diffuse cutaneous systemic sclerosis (dcSSc), a severe form of the rare autoimmune disease scleroderma. This trial will explore the safety of the company's investigational allogeneic cell therapy, FCR001, delivered with non-myeloablative conditioning, in these patients, as well as its potential to halt the progression of organ damage or induce clinical remission in individuals with dcSSc. The University of Michigan is the first FREEDOM-3 clinical site to be activated and has now begun screening for eligible patients. Additional sites are expected to be activated in 2022.

    "Currently there are no approved, disease-modifying therapies for dcSSc. While there is encouraging data that suggests that patients with dcSSc could benefit from autologous hematopoietic stem cell transplant (HSCT), the myeloablative conditioning generally associated with those treatment protocols poses considerable safety risks, and disease recurrence has been observed. Unlike autologous HSCT, which infuses the patient's own cells and requires full myeloablative conditioning to optimize efficacy, our investigational therapy, FCR001, is administered with non-myeloablative conditioning and involves the use of cells from a healthy donor with no genetic predisposition for scleroderma," said Nancy Krieger, M.D., Chief Medical Officer at Talaris. "Positive proof-of-concept data in this trial could support the potential applicability of FCR001 to other severe, systemic autoimmune diseases."

    FREEDOM-3 (NCT# NCT05098145) is a multicenter, open-label study evaluating the efficacy, safety and tolerability of FCR001, the company's investigational allogeneic cell therapy, in adults with rapidly progressive dcSSc at risk for organ failure. It consists of a one-time treatment administered with non-myeloablative conditioning, after which patients are followed for five years, with a primary analysis on a variety of safety and exploratory efficacy endpoints performed at 24 months.

    "Having observed firsthand the promise of autologous stem cell therapy in dcSSc patients, I look forward to exploring the potential of FCR001 to benefit these patients without the need for full myeloablative conditioning," said Dinesh Khanna, M.D., M.Sc., Director of the Scleroderma Program and Professor of Medicine at the University of Michigan Medical School and one of the study's principal investigators. "I am delighted that the University of Michigan is the first activated site to participate in this important study."

    "Scientists and healthcare professionals have long been looking for a way to restore self-tolerance in patients suffering from severe autoimmune diseases," said Keith Sullivan, M.D., James B. Wyngaarden Professor of Medicine at Duke University Medical School. "I am excited that FCR001 will be explored as a potential disease-modifying and perhaps corrective therapeutic option for patients with severe scleroderma."

    About FCR001

    FCR001 is an investigational, allogeneic cell therapy developed by Talaris Therapeutics to induce or restore patients' immune tolerance. FCR001 builds on over 30 years of research by the company's founder, Dr. Suzanne Ildstad, into the means by which durable immune tolerance can be induced in a patient who receives a transplanted organ or can be restored in patients with certain immune-mediated or blood disorders. FCR001 has received both Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration. A Phase 3 trial of FCR001 in living donor kidney transplant recipients, FREEDOM-1, is now enrolling patients; more information can be found at: http://freedom1study.com/

    About Scleroderma and Diffuse Cutaneous Systemic Sclerosis

    Scleroderma is a rare, chronic autoimmune disease that is potentially fatal. The condition involves progressive scarring, or fibrosis, of the body's connective tissues, which affects the skin and vital internal organs, especially the lungs, kidneys, gut and heart, resulting in organ dysfunction. Scleroderma can be classified as either localized or systemic with systemic scleroderma (SSc) being further identified as either limited cutaneous or diffuse cutaneous based on the degree of skin impacted. Patients with the diffuse cutaneous subtype of SSc generally have more rapid skin and internal organ decline and worse outcomes than the limited cutaneous subtype.

    About Talaris Therapeutics

    Talaris Therapeutics, Inc. is a late-clinical stage biopharmaceutical company developing investigational, one-time, allogeneic cell therapies with the potential to transform the standard of care in solid organ transplantation, certain severe autoimmune diseases, and certain severe non-malignant blood, immune and metabolic disorders. Talaris maintains corporate offices in Boston, MA, and its cell processing facility in Louisville, KY.

    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 September 30, 2021, 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.

    Media Contact

    Marin Bergman

    Ten Bridge Communications



    (818) 516-2746

    Investor Contact

    Chris Brinzey

    ICR Westwicke



    (339) 970-2843



    Primary Logo

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