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Tempus Announces the Clinical Launch of its Immune Profile Score Algorithmic Test

TEM

IPS test validation study data will be unveiled at the 2024 SITC Annual Meeting

Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced the clinical launch of its Immune Profile Score (IPS) algorithmic test. IPS, which is now available for clinicians to order, is a multimodal biomarker that can be used as a prognostic indicator for adult patients with stage IV and metastatic pan-solid tumors who are already considered candidates for immune checkpoint inhibitor (ICI)-based therapy. Tempus is presenting the results of its validation study at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting, which demonstrated that IPS-High patients in the study were more likely to have an overall survival benefit while receiving ICI-based therapy than IPS-Low patients in the study (HR 0.45).

Tempus validated IPS in a retrospective study involving 1,600 metastatic and/or stage IV adult patients with 19 different solid tumor types from the company’s real-world de-identified database. The study also demonstrated that IPS has prognostic utility that is independent of tumor mutational burden (TMB), PD-L1 immunohistochemistry (IHC), and microsatellite instability (MSI) status in the study cohort. Tempus’ IPS is a laboratory developed test that assesses a combination of immunotherapy-related biomarkers from DNA and RNA test results to calculate a score from 0-100 and a classification of either IPS-Low or IPS-High. IPS is a unique biomarker that, in addition to being used in clinical practice, is available for life science research to help facilitate the expansion of indications for ICI therapies in order to enhance patient selection and treatment outcomes.

"This is Tempus’ first time leveraging a multimodal algorithm in the immunotherapy space, and we look forward to providing clinicians the ability to use our IPS test to garner data-driven insights that can inform important treatment decisions," said Ezra Cohen, MD, Chief Medical Officer of Oncology at Tempus. "We are excited to introduce this innovative test to clinicians, empowering them with the ability to make more informed choices for their patients while simultaneously moving the field forward in meaningful ways."

"This study demonstrates that IPS scoring is beneficial in that it can identify patients, independent of standard biomarkers, who may have better overall survival with ICI therapy," said Sandip Patel, MD, Professor at UC San Diego Health. "IPS scoring can inform tumor-intrinsic sensitivity to immune checkpoint blockade beyond PD-L1 IHC and TMB, and help manage patients on immunotherapy utilizing data already collected as part of DNA and RNA sequencing."

The IPS test is now available as an add-on option for clinicians ordering Tempus’ xT (DNA) and xR (RNA) assays. For more information on the validation study, visit tempus.com/publications.

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding the potential impact and uses of IPS and other tests. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.

You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed with the Securities and Exchange Commission (“SEC”) as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.