Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, today announced results from a new study demonstrating that its algorithmic test, Immune Profile Score (IPS), more accurately predicts outcomes for patients receiving immune checkpoint inhibitors (ICIs) than conventional biomarkers, including tumor mutational burden (TMB) and microsatellite instability (MSI), and PD-L1.

IPS is a multimodal biomarker that combines known and novel clinical and immune-related biomarkers from DNA and RNA analysis to predict a patient’s response to ICI-based therapy. The new clinical validation results demonstrate that IPS consistently outperforms conventional biomarkers, highlighting its potential to change the way physicians can identify patients most likely to benefit from immunotherapy. In four independent validation cohorts of pan-cancer metastatic solid organ cancer patients, IPS was shown to be a more accurate predictor of ICI outcomes (HR=0.45) than TMB, MSS, and PD-L1, demonstrating prognostic utility that is independent of those conventional biomarkers.

IPS identified 13% of patients with microsatellite stable colorectal cancer who demonstrated strong real-world overall survival with ICI treatment (HR=0.2), indicating that ICI immunotherapy may be a viable option for a key patient population that might have been overlooked with conventional biomarkers alone. Beyond colorectal cancer, the study’s findings highlight how IPS could expand treatment options for patients with rare cancers. IPS classified 17% of patients with rare metastatic solid tumors as "IPS-High," despite these patients not falling within a cancer-specific FDA-approved ICI label. The significant difference in median real-world overall survival in “IPS High” versus "IPS-Low" patients (HR=0.26) shows that ICI could be a relevant and potentially life-saving option for patients that might otherwise be missed.

"This study builds on previous findings showing that IPS scoring can identify patients who may have better overall survival with ICI therapy. These results are a significant step forward in the personalization of cancer care, particularly for patients that might be missed by conventional biomarkers," said Halla Nimeiri, MD, Chief Development Officer at Tempus. "By leveraging a multimodal algorithm, our IPS test provides a more accurate and comprehensive view than traditional, independent biomarkers, empowering physicians to make more confident treatment decisions for their patients while simultaneously moving the field forward in meaningful ways."

The test is available as an add-on for clinicians ordering Tempus’ xT (DNA) and xR (RNA) assays, helping to manage patients on immunotherapy by utilizing data already collected as part of a patient’s standard sequencing.

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 benefits of the IPS test in research and clinical care. 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-K for the fiscal year ended December 31, 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.

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