Natera Announces New Signatera™ MRD Data at 2023 AACR Annual Meeting

Includes long-term follow-up data (>5 years) in patients with muscle-invasive bladder cancer and additional studies in colorectal, gastroesophageal and hepatocellular carcinoma

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced new data on its Signatera molecular residual disease (MRD) test being presented at the annual meeting of the American Association for Cancer Research (AACR) taking place April 14 – 19, 2023.

Natera and its collaborators will present findings from five studies on Signatera in esophago-gastric adenocarcinoma, muscle-invasive bladder cancer (MIBC), colorectal cancer (CRC) and hepatocellular carcinoma (HCC). Highlights include:

• ctDNA prediction of tumor response and recurrence in patients with esophago-gastric carcinoma receiving FLOT + immunotherapy (avelumab) pre- and post-surgery

• ctDNA prediction of tumor response and recurrence in patients with MIBC, with and without neoadjuvant therapy, with long term follow-up (median 68 months) after radical cystectomy

• Genomic profiling of >13,000 patients with early (≤50 years old) vs late (≥60 years old) onset CRC

• Potential of ctDNA to guide imaging-based surveillance strategies in patients after surgery for peritoneal metastases from CRC

• ctDNA as a pharmacodynamic and predictive biomarker in patients with resectable HCC treated with immunotherapy (cemiplimab) pre- and post-surgery

“We are pleased to share additional Signatera data at this year’s AACR annual meeting that continues to highlight the important role of personalized MRD testing in assessing treatment response and predicting relapse across a broad range of indications,” said Minetta Liu, M.D., chief medical officer of oncology at Natera. “These data presentations underscore Natera’s commitment to generating novel insights on MRD testing and genomic testing to help advance cancer care.”

The full list of Signatera poster presentations at AACR is below.

Abstract #2178 | April 17, 9:00 AM - 12:30 PM

Presenter: Thomas U. Marron, M.D., Ph.D. - Icahn School of Medicine at Mount Sinai

Circulating tumor DNA (ctDNA) correlates closely with tumor necrosis and relapse-free survival (RFS) in hepatocellular carcinoma (HCC) patients treated with perioperative cemiplimab

Abstract #5600 | April 18, 1:30 - 5:00 PM

Presenter: Sia Viborg Lindskrog - Aarhus University Hospital

Utility of circulating tumor DNA and transcriptomic profiling in predicting outcome in muscle invasive bladder cancer patients

Abstract #5591 | April 18, 1:30 - 5:00 PM

Presenter: Marco Gerlinger, M.D., FRCP - Barts Cancer Institute & St Bartholomew's Hospital

Circulating tumor DNA for recurrence prediction and efficacy analysis in the ICONIC trial of peri-operative FLOT and avelumab (PD-L1) in localized esophago-gastric adenocarcinoma

Abstract #5604 | April 18, 1:30 - 5:00 PM

Presenter: Kevin Chang, M.S. - University of Iowa

Circulating tumor DNA for predicting peritoneal only disease recurrence in colon cancer

Abstract #6696 | April 19, 9:00 AM - 12:30 PM

Presenter: Eric Lander, M.D. - Vanderbilt University Medical Center

Genomic alterations associated with early-onset and late-onset colorectal cancer

The AACR abstracts are available here.

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted three Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions.

About Natera

Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 100 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

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