Natera Inc - NTRA STOCK NEWS

Natera (NASDAQ: NTRA) has initiated the HEROES clinical trial, enrolling its first patients to study the potential discontinuation of anti-HER2 targeted therapy in metastatic HER2+ breast cancer patients. The phase II trial, supported by the French Ministry of Health and sponsored by Unicancer, will involve approximately 170 patients across 35 French sites.

The study focuses on patients with HER2+ breast cancer, which affects 15-20% of breast tumors. Using Natera's Signatera™ testing, the trial will monitor patients who discontinue anti-HER2 maintenance therapy, with the primary endpoint being 1-year progression-free survival in Signatera-negative patients.

Key protocol elements include baseline testing of patients who have been on standard-of-care anti-HER2 therapy for two or more years. Signatera-negative patients will stop treatment and undergo regular monitoring, while Signatera-positive patients will continue maintenance therapy. Treatment will resume if radiological progression is confirmed or if a patient becomes Signatera-positive.

Natera (NASDAQ: NTRA) has secured a new patent (No. 12,203,142) from the U.S. Patent and Trademark Office, strengthening its intellectual property portfolio in tumor-informed molecular residual disease (MRD) testing. The patent specifically covers methods for testing single nucleotide variants in circulating-tumor DNA (ctDNA) using whole exome and whole genome sequencing.

The patent details various target enrichment techniques in plasma, including multiplex polymerase chain reaction PCR and capture by hybridization. This addition expands Natera's extensive intellectual property estate, which now includes over 110 patents in cell-free DNA analysis for oncology testing, with 23 patents obtained in 2024 alone.

Natera (NASDAQ: NTRA) reported strong financial results for Q4 and full year 2024. The company achieved total revenues of $476.1M in Q4 2024, up 53.0% from Q4 2023, with product revenues growing 53.9%. Full-year 2024 revenues reached $1.70B, a 56.7% increase from 2023.

Q4 2024 highlights include improved gross margin of 62.9% (vs 51.4% in Q4 2023), processing of 792,800 tests (26.5% increase), and positive cash flow of $45.7M. Notably, oncology tests grew 54.7% to 150,800 in Q4. The company's net loss decreased to $53.8M in Q4 2024 ($0.41 per share) from $78.0M in Q4 2023.

For 2025, Natera projects revenue between $1.87B-$1.95B, with expected gross margins of 60-64%. The company held $968.3M in cash and investments as of December 31, 2024.

Natera (NASDAQ: NTRA) announced that its Signatera test has received Medicare coverage for patients with non-small cell lung cancer (NSCLC) in the surveillance setting. This coverage applies to stage I-III NSCLC patients with resectable or unresectable disease, expanding upon existing Medicare coverage for immunotherapy monitoring.

Lung cancer is the leading cause of cancer death in the U.S., representing about 1 in 5 cancer deaths. By 2025, it's projected to have 226,650 new cases and 124,730 deaths. Despite treatment advances, the 5-year survival rate remains low at 28%.

Current surveillance tools have limitations including sensitivity issues and interpretation difficulties with CT scans. Signatera's performance for NSCLC surveillance was validated in three peer-reviewed studies showing 93-100% sensitivity to extracranial recurrence, 96-100% specificity, and detection up to one year before imaging (median: 5 months).

Signatera is also Medicare-covered for monitoring in colorectal, bladder, breast, and ovarian cancers.

Natera (NASDAQ: NTRA), a leading provider of cell-free DNA and genetic testing services, has announced its upcoming fourth quarter and full year 2024 financial results release. The company will disclose its results after market close on February 27, 2025, followed by a conference call and webcast at 1:30 p.m. PT (4:30 p.m. ET).

Interested parties can access the conference call through domestic (1-888-770-7321) or international (1-929-201-7101) dial-in numbers using Conference ID 7684785. A webcast will be available at the provided link, with a replay accessible later at investor.natera.com.

Natera (NASDAQ: NTRA) announced significant updates to the National Comprehensive Cancer Network (NCCN) Guidelines regarding circulating tumor DNA (ctDNA) testing. The NCCN has now included ctDNA as a high risk factor for recurrence in colon and rectal cancer guidelines, marking the first formal recognition of ctDNA's prognostic value.

For Merkel Cell Carcinoma (MCC), the guidelines now positively recommend ctDNA monitoring for surveillance, suggesting tests every 3 months. This recommendation cites Natera's Signatera study data, which showed 95% detection at enrollment and 20x higher recurrence risk in persistently positive patients.

MCC, affecting approximately 3,000 patients annually (mostly elderly), has a 40% recurrence rate within 5 years. The inclusion of ctDNA testing in these guidelines represents a significant step toward more personalized cancer care.

Natera (NASDAQ: NTRA) has secured national commercial coverage for its cfDNA Fetal RhD noninvasive prenatal test from one of the largest U.S. payors. The coverage, effective January 2025, will be available when pregnancies are at risk for alloimmunization, when paternal antigen typing is unavailable or heterozygous, and if amniocentesis is declined or not recommended.

The test, which can be performed as early as nine weeks into pregnancy, determines fetal RhD status from maternal blood samples. This is particularly significant as up to 15% of pregnant patients are RhD-negative. When a mother is RhD-negative and the fetus is RhD-positive, there's a risk of antibody development leading to hemolytic disease of the fetus and newborn.

The test is part of Natera's women's health product suite, which includes Panorama, the most ordered NIPT in the United States.

Natera (NTRA) announced significant results from two clinical trials in colorectal cancer (CRC). The Phase III CALGB/SWOG 80702 study, involving ~1,000 patients, demonstrated that Signatera-positive patients treated with both chemotherapy and celecoxib showed a 40% improvement in overall survival compared to chemotherapy alone.

Key findings revealed that adding celecoxib to standard chemotherapy significantly improved disease-free survival (DFS) in Signatera-positive patients, with a three-year DFS of 44.1% versus 26.6%. The study also confirmed Signatera's effectiveness in predicting recurrence.

Additionally, the ALTAIR clinical trial, studying 243 Signatera-positive patients, showed promising results for stage IV CRC patients treated with Trifluridine/Tipiracil (FTD/TPI). These patients demonstrated a median DFS of 9.76 months compared to 3.96 months in the placebo group, marking a significant advancement in personalized medicine for CRC treatment.

Natera Inc (NASDAQ: NTRA) announced multiple studies to be presented at the 2025 ASCO GI Symposium in San Francisco. Key highlights include data from the BESPOKE CRC study, the largest prospective MRD study in the U.S., which demonstrated Signatera's effectiveness as a prognostic and predictive biomarker in colorectal cancer patients.

The study showed that Signatera-positive patients had significantly inferior outcomes in both stage II (HR=10.4) and stage III patients (HR=10.1). The 24-month disease-free survival rates were 91.7% for Signatera-negative and 41.4% for Signatera-positive patients.

Additionally, Natera will present initial results from their novel tissue-free MRD detection test, showing high sensitivity and specificity, and early cancer detection data with 95% sensitivity and 91% specificity in colorectal cancer detection. The symposium will feature multiple presentations, including a late-breaking oral presentation on the CALGB/SWOG 80702 study.