Acute cellular graft rejection

Record Number of 65 Abstracts Showcasing CareDx Innovation Including Data Showing Clinical Utility of AlloSure Kidney to Guide Immunosuppression Management Experts Review Advancements in Artificial Intelligence and Molecular Diagnostics During CareDx Symposium BRISBANE, Calif.--(BUSINESS WIRE)-- CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced a leading presence at the 2023 American Transplant Congress (ATC) with 65 scientific presentations. CareDx will also be hosting a satellite symposium1 and sponsoring the Women’s Networking Event. The ATC meeting takes place June 3-7 in San Diego, California. "We are proud to showcase our leadership with our highest-ever number of abstracts at the 2023 Transplant Congress with data that not only validates the performance of AlloSure® and AlloMap® but also demonstrates their clinical utility in the surveillance and management of patients,” said Reg Seeto, CEO and President of CareDx. “We're also excited to have assembled a world-class panel of experts to describe the latest innovations in transplantation including the additive clinical value of incorporating our molecular biomarkers into artificial intelligence tools to drive earlier insights regarding a patient’s risk of rejection for more personalized, preventative care.” Noteworthy Presentations AlloSure Kidney AlloSure donor-derived cell-free DNA (dd-cfDNA) and blood gene expression profiling used to guide immunosuppression minimization in patients on belatacept maintenance (B204). AlloSure used for immunologic surveillance of calcineurin inhibitor (CNI) intolerant patients and to guide transition to belatacept therapy (C145). Tissue gene expression and AlloSure Kidney used to guide treatment in patients presenting with T-Cell Mediated Rejection (TCMR) (oral abstract #73). Multinational multi-center validation of a predictive model showing the clinical value of adding AlloSure Kidney to assess patient risk of clinical and subclinical rejection (oral abstract #91). AlloSure dd-cfDNA provides less invasive monitoring for allograft function and survival. A combination of AlloSure, serum creatinine and biopsy can improve early detection of subclinical rejection and predict graft failure (C127). HeartCare (AlloSure and AlloMap) One-year outcomes of patients on rejection surveillance protocol utilizing dd-cfDNA resulted in patients receiving significantly fewer biopsies and fewer treated rejection episodes, and had no difference in survival compared to patients on biopsy surveillance (oral abstract #30). Additionally, by using AlloSure dd-cfDNA, a heart transplant center was able to perform only one surveillance biopsy per patient without an increase in morbidity or mortality (BLB017). Greater elevations of AlloSure Heart and AlloMap Heart were associated with higher grades of biopsy confirmed Acute Cellular Rejection (ACR) (oral abstract #31). AlloSure Lung Abstracts AlloSure Lung dd-cfDNA and plasma inflammatory markers can predict CLAD risk equivalent to or better than an invasive biopsy (oral abstract #33). For a complete list of abstracts by title and presentation date and time, please follow this link. Satellite Symposium1 Leading experts will discuss the latest advancements in kidney and heart transplantation during a symposium hosted by CareDx titled, “An Evolving Standard of Care: Artificial Intelligence and Molecular Diagnostics”. It will be held on Monday, June 5, from 12:15 to 1:15pm PT. Speakers include: Jonathan Bromberg, MD, PhD, Professor of Surgery, University of Maryland Giselle Guerra, MD, Medical Director, Transplant Services, Kidney Transplant Program, Miami Transplant Institute Gaurav Gupta, MD, Interim-Chair, Division of Nephrology, Medical Director, Kidney Transplant Program, Virginia Commonwealth University Health Jeffrey Teuteberg, MD, Professor of Medicine, Section Chief of Heart Failure, Cardiac Transplantation, and Mechanical Circulatory Support, Stanford University “I’ve been a long-standing proponent of using non-invasive molecular diagnostics such as dd-cfDNA for surveillance to help overcome the inherent limitations of functional parameters and tissue biopsies in detecting early signs of rejection and for immunosuppression management,” said Giselle Guerra, MD, Medical Director, Transplant Services, Kidney Transplant Program, Miami Transplant Institute. “I look forward to sharing findings from my clinical practice on utilizing dd-cfDNA to make more personalized immunosuppression treatment decisions based on a patient’s risk stratification.” About CareDx – The Transplant Company CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit: . Forward Looking Statements This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that may be achieved with AlloSure, AlloMap and HeartCare, as well as CareDx’s leading participation at the 2023 ATC meeting (the “ATC Participation”) and its hosting of a satellite symposium to discuss the latest advancements in kidney and heart transplantation (the “Symposium”). These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of AlloSure, AlloMap, HeartCare, its ATC Participation or its hosting of the Symposium; general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed by CareDx with the SEC on February 27, 2023, the quarterly report on Form 10-Q for the quarter ended March 31, 2023 filed by CareDx with the SEC on May 10, 2023, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements. References This symposium is not part of the ATC official educational program, and the sessions and content are not endorsed by ATC. View source version on businesswire.com: Contacts CareDx, Inc. Media Relations Anna Czene 818-731-2203 aczene@caredx.com Investor Relations Greg Chodaczek investor@caredx.com Source: CareDx, Inc. View this news release online at:

BRISBANE, Calif.--( BUSINESS WIRE )--CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced the issuance of a new position statement by the American Society of Transplant Surgeons (ASTS) supporting the use of CareDx’s AlloSure® Kidney for organ transplant surveillance, and AlloSure Heart and AlloMap® Heart. Specifically, the new position statement, “ASTS Statement on donor-derived cell-free DNA (dd-cf-DNA)”: Supports consideration of donor-derived cell-free DNA (dd-cfDNA), as in AlloSure Kidney, for surveillance in kidney transplant recipients to exclude subclinical antibody mediated rejection (ABMR). Recommends dd-cfDNA (AlloSure Kidney) for use in kidney transplant recipients experiencing acute allograft dysfunction to exclude rejection, particularly ABMR. Recommends that dd-cfDNA (AlloSure Heart) may be utilized to rule out subclinical rejection in heart transplant recipients. Recommends peripheral blood gene expression profiling (GEP), as in AlloMap Heart, as a non-invasive diagnostic tool to rule out acute cellular rejection in stable, low-risk, adult heart transplant recipients who are over 55 days status post heart transplantation. “We applaud ASTS for their leadership in issuing a position statement on the use of dd-cfDNA for routine monitoring of allograft health in kidney, and additionally the use of dd-cfDNA and peripheral blood gene expression profiling in heart,” said Reg Seeto, CEO and President of CareDx. To read the position statement, go here . About CareDx – The Transplant Company CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com . Forward Looking Statements This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the ASTS position statement and the potential benefits and results that may be achieved with CareDx’s non-invasive testing services, AlloSure and AlloMap. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of its testing services; general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed by CareDx with the SEC on February 27, 2023 and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

Enrollment and dosing continue in the Phase 3 FREEDOM-1 trial of FCR001 in living donor kidney transplant (LDKT) patients Two presentations at the 2022 American Society of Nephrology (ASN) Annual Meeting Strong cash balance with expected runway through 2024 BOSTON and LOUISVILLE, Ky., Nov. 10, 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 reported financial results for the three- and nine-month periods ended September 30, 2022 and provided an update on its business. “Patient safety remains our top priority and we continue to maintain rigorous oversight of patients participating in our clinical trials,” stated Scott Requadt, Chief Executive Officer of Talaris. “Our Scientific Advisory Board and the FREEDOM-1 Data Monitoring Committee (DMC) have endorsed modifications to the FREEDOM-1 protocol that were triggered by the higher incidence of graft-versus-host disease (GvHD) that was reported in June 2022. Our investigators continue to remain committed to our programs and we continue to enroll patients in our FCR001 clinical studies.” Corporate & Pipeline Highlights Presented data on FCR001 at the 2022 American Society of Nephrology (ASN) Annual Meeting. In November, the Company presented data on mRNA transcriptional changes following successful tolerization with FCR001. This urinary cell mRNA signature may help identify patients who could safely discontinue chronic immunosuppression. In addition, the Company reported data on the immune landscape 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. The analysis found unique patterns of immune cell types, cell states, and transcriptional activity that may underlie FCR001’s mechanisms of inducing immune tolerance.Expanded management team with the addition of Senior Vice President of Clinical Operations. In October, the Company added a key executive to the Talaris clinical team. Courtney Wells brings over 20 years of clinical operations experience at several biotech companies including AveXis, Avadel Pharmaceuticals, and mostly recently at Jaguar Gene Therapy. Ms. Wells will oversee clinical operations including patient recruitment and trial management. Three clinical trials continue enrollment. Talaris continues to study its investigational product FCR001 in three clinical trials including FREEDOM-1, a Phase 3 clinical trial in LDKT patients, FREEDOM-2, a Phase 2 clinical trial in LDKT delayed tolerance induction, and FREEDOM-3, a Phase 2 clinical trial evaluating the safety and efficacy of FCR001 in adults with a severe form of scleroderma, a systemic autoimmune disease.FREEDOM-1 is a randomized, controlled, open-label, multi-center Phase 3 registrational trial of FCR001 in 120 adult LDKT recipients in the United States. The primary endpoint of FREEDOM-1 is the proportion of kidney transplant recipients treated with FCR001 who are free from chronic immunosuppression, without biopsy-proven acute rejection (BPAR), at month 24 post-transplant. The Company is enrolling and dosing patients in this trial. On October 20, 2022, the Company reported the death of a patient in the FREEDOM-1 clinical trial. In light of modifications to the study protocol that were already implemented in June 2022 to mitigate the risk of GvHD, the FREEDOM-1 DMC recommended the study may continue without further modifications. Third Quarter Financial Results Cash, Cash Equivalents and Marketable Securities: Talaris finished the third quarter of 2022 with $193.9 million in cash, cash equivalents, and marketable securities compared with $244.0 million as of December 31, 2021. R&D Expenses: Research and development expenses increased to $15.0 million in the third quarter of 2022, up from $9.2 million in the third quarter of 2021. The increase in research and development expenses was primarily due to an increase in employee headcount necessary to support the growth of the Company’s research and development efforts, increased clinical trials costs for increased enrollment and additional site activations, increased patient advocacy and recruitment efforts, and increases in facilities and other expenses. G&A Expenses: General and administrative expenses totaled $4.8 million in the third quarter of 2022, up from $3.9 million in the third quarter of 2021, primarily due to an increase in employee headcount and increased professional fees.Net Loss: The Company reported a net loss of $19.0 million, or $0.46 per share, in the third quarter of 2022, compared with a net loss of $12.9 million, or $0.32 per share, in the third quarter of 2021. About Talaris TherapeuticsTalaris 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, a GMP cell processing facility in Louisville, KY, and research and development laboratories 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 rate of enrollment for its clinical trials; expectations regarding the timing and data from the planned clinical update of FREEDOM-1, FREEDOM-2 or FREEDOM-3, including potential safety, tolerability and therapeutics effects; expectations around the anticipated contribution of the members of Talaris’ board of directors and executives to its operations and progress; and expectations regarding Talaris’ growth as a company and use of capital, expenses and other financial results during the third quarter ended on September 30, 2022 and in the future as well as Talaris’ expected cash runway through 2024. 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 impact of COVID-19 on countries or regions in which the Company has operations or does business, as well as on the timing and anticipated timing and results of its clinical trials, strategy and future operations, including the expected timing and results from FREEDOM-1; the risk that the results of Talaris’ clinical trials, including the early data from the FREEDOM-1 study, may not be predictive of future results in connection with future clinical trials; the Company’s expectations regarding future safety and efficacy following the implementation of a protocol amendment in FREEDOM-1 and the Company’s ability to successfully demonstrate the safety and efficacy of its drug candidates more generally; the timing and outcome of Talaris’ planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. 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, 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. TALARIS THERAPEUTICS, INC (TALS) Statements of Operations (Unaudited, in thousands, except share and per share amounts) Three Months Ended September 30, 2022 2021 Operating expenses Research and development $14,981 $9,183 General and administrative 4,842 3,874 Total operating expenses 19,823 13,057 Loss from operations (19,823) (13,057) Interest and other income (expense), net 812 116 Net loss $(19,011) $(12,941) Net loss per common share, basic and diluted $(0.46) $(0.32) Weighted average number of common shares outstanding used in computation of net loss per common share, basic and diluted 41,375,537 40,669,412 Balance Sheets Selected Financial Data (Unaudited, in thousands) As of September 30, As of December 31, 2022 2021 Cash, cash equivalents and marketable securities $193,869 $243,971 Working capital 188,959 238,527 Total assets 206,544 251,422 Other liabilities 2,509 626 Total liabilities 11,677 8,613 Total stockholders' equity 194,867 242,809 Media ContactLisa RaffenspergerTen Bridge Communicationslisa@tenbridgecommunications.com(617) 903-8783 Investor ContactChris BrinzeyICR Westwickechris.brinzey@westwicke.com(339) 970-2843