Natera Inc Stock Price, News & Analysis

Natera (NASDAQ: NTRA) announced the publication of its clinical validation study on the Fetal RhD noninvasive prenatal test (NIPT) in Obstetrics & Gynecology. This study, the largest of its kind in the U.S., demonstrated high performance metrics with 100% sensitivity and 99.3% specificity. The study involved 655 RhD-negative pregnant patients, confirming fetal RhD status via newborn serology. Key results included 356/356 fetuses correctly identified as RhD positive and 295/297 as RhD negative. The test also showed a positive predictive value of 99.4% and a negative predictive value of >99.9%. The study emphasized the test's potential to assist in the prevention and management of RhD alloimmunization, especially amid RhIg shortages. The NGS-based test can identify RHD pseudogene and hybrid variants common in non-European ancestries. Experts highlight the test's potential to transform care for RhD-negative pregnant patients, aligning with ACOG's guidance on cfDNA screening for fetal RhD testing.

Natera announced that its Prospera Lung test has received Medicare coverage from CMS's MolDX Program for single lung transplant (SLT) recipients in surveillance settings. SLT patients represent ~20% of U.S. lung transplants and face higher risks of rejection and biopsy complications. The test's performance was validated in the SLAM study, showing an AUC-ROC of 0.85 in distinguishing rejection, infection, and CLAD from stable patients, with 77.8% sensitivity, 84.6% specificity, and 96.8% NPV. Prospera Lung is now used by over half of U.S. lung transplant centers.

Natera (NASDAQ: NTRA) announced its upcoming presentation of new SignateraTM data at the San Antonio Breast Cancer Symposium (SABCS), December 10-13. The company will present six abstracts, including significant findings from the ZEST clinical trial, which showed improved disease-free survival with niraparib treatment in ctDNA-positive breast cancer patients (11.4 months vs 5.4 months for placebo).

Key highlights include a clinical genomics study revealing 44% of Signatera-positive patients had targetable genomic alterations, with 34.5% showing PIK3CA mutations. Additionally, four abstracts will present patient-reported outcomes indicating that ctDNA testing provides valuable treatment planning information without increasing patient anxiety.

A federal court jury unanimously ruled in favor of Guardant Health in its lawsuit against Natera for false advertising and unfair competition. The jury awarded $292.5 million to Guardant Health, including $175.5 million in punitive damages, making it one of the largest false advertising verdicts in history. The case, filed in May 2021, centered on Natera's deliberate campaign to mislead cancer clinicians about Guardant Reveal™, a tissue-free minimal residual disease test for early-stage colorectal cancer. The jury rejected all of Natera's counterclaims.

Natera has responded to a jury decision favoring Guardant Health in a false advertising case from 2021. The litigation involved mutual claims regarding statements about Guardant's Reveal test. Natera disagrees with the verdict and plans to appeal. The company emphasizes that the case focused solely on comparative advertisements from 2021 and does not affect their Signatera test, which has become the leading MRD test in the U.S., supported by over 100 peer-reviewed publications.

Natera co-founder and executive chairman Matthew Rabinowitz has been named 2024 R&D Leader of the Year by R&D World. The organization recognized his pioneering work in genetic testing and precision medicine, particularly highlighting the development of transformational products including: Panorama™ for prenatal screening, Signatera™ for cancer recurrence detection, and Prospera™ for transplant rejection risk assessment. Dr. Rabinowitz, who served as CEO from 2005 to 2019, has authored numerous publications in prestigious journals and holds multiple patents in the field.

Natera has achieved a significant milestone with over 100 peer-reviewed publications on Signatera, its personalized molecular residual disease (MRD) test. The studies, published in prestigious journals like Nature and Journal of Clinical Oncology, demonstrate excellent clinical performance and utility. Signatera, the most widely used MRD test in the U.S., has served more than 200,000 cancer patients. The company continues to expand its research pipeline with several phase III randomized clinical trials across various cancer types.

Natera (NASDAQ: NTRA) reported Q3 2024 financial results, highlighting a 63.9% revenue increase to $439.8 million compared to Q3 2023. Product revenues surged by 64.4%. The company achieved a gross margin of 61.8%, up from 45.1% in the prior year. Natera processed approximately 775,800 tests, a 23.9% increase, and performed around 137,100 oncology tests, a 54.4% rise. The company reported a positive cash flow of $34.5 million and raised its annual guidance to $1.61-$1.64 billion in total revenue, 58%-61% gross margin, and $50-$75 million in net cash inflow.

Natera reported a net loss of $31.6 million ($0.26 per diluted share), an improvement from a $109.0 million net loss ($0.95 per diluted share) in Q3 2023. Total operating expenses increased by 34% to $311.1 million. The company held $922.3 million in cash and equivalents as of September 30, 2024, with total debt at $367.0 million. All convertible senior notes were redeemed or converted on October 11, 2024.

Natera (NASDAQ: NTRA) announced the completion of a study using Signatera from the CALGB (Alliance)/SWOG 80702 randomized, phase III clinical trial. This study evaluated the benefit of adding celecoxib to standard postoperative treatment FOLFOX in stage III colorectal cancer (CRC) patients. The analysis included 1,011 patients with post-surgical plasma samples, focusing on Signatera’s ability to identify a subgroup of patients who may benefit from celecoxib addition. Primary and secondary endpoints were disease-free survival (DFS) and overall survival (OS), respectively. Although celecoxib addition did not significantly improve DFS, NSAIDs like celecoxib have shown promise in benefiting certain CRC subpopulations. Results will be presented at the ASCO GI symposium in January 2024.