On November 3, 2025 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the third quarter and nine months ended Sept. 30, 2025.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We delivered a strong third quarter, generating $83 million in revenue and 26,841 in total test report volume," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "These strong results are a testament to the workforce culture we have built at Castle and our unwavering commitment to improving patient care.
"Our momentum this quarter reflects the strength of our core dermatologic and gastrointestinal testing franchises, with DecisionDx-Melanoma and TissueCypher each surpassing 10,000 test reports for the first time in a single quarter, significant milestones that underscore the expanding adoption of our core tests. Based on our strong execution, we are raising our full-year 2025 total revenue guidance to $327-335 million from the previously provided range of $310-320 million.
"Additionally, with the launch of AdvanceAD-Tx, our new test designed to guide systemic treatment decision making in patients with moderate-to-severe atopic dermatitis, we are thrilled to provide an additional innovative, first-in-class, proprietary test addressing a significant unmet need in clinical dermatology."
Third Quarter Ended Sept. 30, 2025, Financial and Operational Highlights
•Revenues were $83.0 million, compared to $85.8 million in the third quarter of 2024. Affecting third quarter 2025 revenue was the Novitas local coverage determination (LCD), Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as the discontinuation of IDgenetix in May 2025.
•Delivered 26,841 total test reports in the third quarter of 2025, compared to 26,010 in the same period of 2024. Affecting third quarter 2025 test report volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as the discontinuation of IDgenetix in May 2025:
◦DecisionDx-Melanoma test reports delivered in the quarter were 10,459, compared to 9,367 in the third quarter of 2024.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 10,609, compared to 6,073 in the third quarter of 2024.
◦DecisionDx-SCC test reports delivered in the quarter were 4,186, compared to 4,195 in the third quarter of 2024. Affecting third quarter test report volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025.
◦MyPath Melanoma test reports delivered in the quarter were 1,151, compared to 933 in the third quarter of 2024.
◦DecisionDx-UM test reports delivered in the quarter were 436, compared to 397 in the third quarter of 2024.
•Gross margin was 75%, and Adjusted Gross Margin was 77%, compared to 79% and 82%, respectively, for the same periods in 2024.
•Net cash provided by operations was $22.6 million, compared to $23.3 million for the same period in 2024.
•Net loss, which includes non-cash stock-based compensation expense of $12.1 million, was $0.5 million, compared to net income of $2.3 million for the same period in 2024.
•Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.02, compared to net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.08, for the same period in 2024.
•Adjusted EBITDA was $9.2 million, compared to $21.6 million for the same period in 2024.
Nine Months Ended Sept. 30, 2025, Financial and Operational Highlights
•Revenues were $257.2 million, compared to $245.8 million during the same period in 2024. Affecting nine months ended September 30, 2025 revenue was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as the discontinuation of IDgenetix in May 2025.
•Delivered 77,817 total test reports in the nine months ended September 30, 2025, compared to 72,000 in the same period of 2024. Affecting nine months ended September 30, 2025 test report volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as the discontinuation of IDgenetix in May 2025:
◦DecisionDx-Melanoma test reports delivered in the nine months ended September 30, 2025, were 29,061, compared to 27,336 for the same period in 2024.
◦TissueCypher Barrett’s Esophagus test reports delivered in the nine months ended September 30, 2025, were 27,211, compared to 14,284 for the same period in 2024.
◦DecisionDx-SCC test reports delivered in the nine months ended September 30, 2025, were 13,323, compared to 12,049 for the same period in 2024. Affecting nine months ended September 30, 2025 test report volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025.
◦MyPath Melanoma test reports delivered in the nine months ended September 30, 2025, were 3,243, compared to 3,030 for the same period in 2024.
◦IDgenetix test reports delivered in the nine months ended September 30, 2025, were 3,605, compared to 14,026 for the same period in 2024. The Company discontinued its IDgenetix test offering effective May 2025.
◦DecisionDx-UM test reports delivered in the nine months ended September 30, 2025, were 1,374, compared to 1,275 for the same period in 2024.
•Gross margin for the nine months ended September 30, 2025, was 67%, and Adjusted Gross Margin was 80%, compared to 79% and 82%, respectively, for the same period in 2024.
•Net cash provided by operations was $37.4 million, compared to $40.5 million for the same period in 2024.
•Net loss, which includes non-cash stock-based compensation expense of $34.5 million, was $21.8 million, compared to net income of $8.7 million for the same period in 2024.
•Net loss per share, Basic and Diluted, was $0.76 and Adjusted Net Loss per Share, Basic and Diluted, was $0.06, compared to net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.31 and $0.30, respectively, for the same period in 2024.
•Adjusted EBITDA was $32.5 million, compared to $53.7 million for the same period in 2024.
Cash, Cash Equivalents and Marketable Investment Securities
As of Sept. 30, 2025, the Company’s cash, cash equivalents and marketable investment securities totaled $287.5 million.
2025 Outlook
Castle Biosciences is raising its guidance for anticipated total revenue in 2025. The Company now anticipates generating between $327-335 million in total revenue in 2025, compared to the previously provided guidance of between $310-320 million.
Third Quarter and Recent Accomplishments and Highlights
Dermatology- Skin Cancer
•DecisionDx-Melanoma: The Company presented new data demonstrating DecisionDx-Melanoma stratifies risk across histological subtypes at the 25th Annual Fall Clinical Dermatology Conference, which was held Oct. 23–26, 2025, in Las Vegas, Nevada. Specifically, cutaneous melanoma (CM) subtypes, such as superficial spreading and nodular melanoma, vary in how often they occur and in their outcomes. Even among patients with the same subtype, differences in tumor biology can lead to very different prognoses. In a real-world cohort of 13,560 patients with stage I–III CM from Castle’s ongoing collaboration with the National Cancer Institute’s Surveillance, Epidemiology and End Results (NCI’s SEER) Program Registries, DecisionDx-Melanoma stratified melanoma-specific survival (MSS) across different tumor subtypes. For example, five-year MSS in nodular melanoma was 98.5% for patients with Class 1A (lowest risk) test results versus 82.3% for patients with Class 2B (highest risk) test results; similar stratification was observed across superficial spreading, lentigo maligna and unspecified subtypes. These results suggest that DecisionDx-Melanoma provides clarity in overall risk beyond histology, supporting more informed treatment planning and potentially improved outcomes. See the Company’s news release from October 24, 2025, for more information.
•DecisionDx-SCC: Two new studies were published supporting the clinical utility of DecisionDx-SCC in patients with high-risk cutaneous squamous cell carcinoma (SCC). The first study represented a new validation milestone, establishing DecisionDx-SCC as a significant predictor of local recurrence (LR) in patients classified as high-risk by National Comprehensive Cancer Network (NCCN) guidelines, thereby adding a third utility to the test’s existing capabilities. The test has now been validated to predict individual risk of metastasis, benefit from adjuvant radiation therapy (ART) and risk of LR, providing comprehensive results to support tailored post-surgical management and treatment pathway recommendations for patients with SCC. The second publication shared results from a clinical impact study, affirming the impact of the test’s results in guiding these recommendations, specifically the use of ART and surveillance imaging, by providing actionable decision points based on individual patient risk. See the Company’s news release from August 25, 2025, for more information.
Gastroenterology
•The Company announced new data demonstrating the personalized risk stratification provided by its TissueCypher Barrett’s Esophagus (BE) test at the American Foregut Society’s (AFS) 2025 Annual Meeting. Specifically, this study evaluated TissueCypher’s ability to stratify risk in 85 patients diagnosed with non-dysplastic Barrett’s esophagus (NDBE) who received test results from four surgical practices. Patients with NDBE are generally considered to have the lowest risk of cancer progression, and current guidelines recommend surveillance every three to five years. However, while 85% of patients in the study received low-risk TissueCypher results, 15% were classified as intermediate- or high-risk by the TissueCypher test, indicating a significantly higher likelihood of progressing to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) than their pathology results suggested. Patients with intermediate-risk scores had a median five-year progression probability of 9%, and those with high-risk scores had a 16% probability. Both groups exceeded the 8.5% five-year risk of progression associated with expert-confirmed low-grade dysplasia (LGD) based on population estimates, which is the threshold at which guidelines recommend escalating to endoscopic eradication therapy (EET) or more frequent surveillance every six to twelve months. These findings show that TissueCypher can deliver clinically meaningful risk insights that can help physicians better tailor care for patients with BE. Notably, patients in the study with intermediate- and high-risk scores had similar or greater predicted progression risk than patients diagnosed with LGD, despite having a NDBE diagnosis. By identifying low-risk patients whose care can follow guideline-based surveillance intervals and intermediate- and high-risk patients who may benefit from earlier intervention, TissueCypher can potentially support more precise, risk-aligned management aimed at preventing disease progression. See the Company’s news release from September 9, 2025, for more information.
Dermatology- Atopic Dermatitis
•AdvanceAD-Tx: The Company announced the launch of AdvanceAD-Tx, a gene expression profile (GEP) test designed to guide systemic treatment decision making in patients ages 12 and older with moderate-to-severe atopic dermatitis (AD). This innovative 487-GEP test is designed to identify patients with a Janus kinase (JAK) inhibitor responder profile who are more likely to achieve an Eczema Area and Severity Index improvement of 90% (EASI-90), more quickly and with reduction of flares and itch by three months, when treated with a JAK inhibitor than those treated with a T helper type 2 (Th2)-targeted therapy. See the Company’s news release from November 3, 2025, for more information.
Corporate
•The Company announced that its founder, president and chief executive officer Derek Maetzold was named CEO of the Year by The CEO Magazine. The Executive of the Year Awards program recognizes senior executives driving measurable impact, innovation and inspiration. See the Company’s news release from October 1, 2025, for more information.
•The Company announced it was recognized as a Greater Pittsburgh Top Workplace by The Pittsburgh Post-Gazette. The designation is based exclusively on anonymous employee feedback gathered through a third-party survey. The confidential survey measures several aspects of workplace culture designed to be indicative of employee satisfaction and engagement, including feeling respected and supported, enabled to grow and empowered to execute. Castle was among just 89 companies honored with a Greater Pittsburgh Top Workplaces award in 2025. See the Company’s news release from September 23, 2025, for more information.
•The Company announced it was included in the inaugural 2025 America’s Greatest Companies list, published by Newsweek. The ranking honors 650 U.S. companies demonstrating strong performance across four key pillars: financial strength, workforce dedication, innovation, and commitment to environmental sustainability and corporate ethics. Evaluations were based on company reviews, filings with the U.S. Securities and Exchange Commission (SEC) and Patent and Trademark Office (USPTO), and third-party data sources to provide an objective measure of corporate performance. See the Company’s news release from September 17, 2025, for more information.
Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Monday, November 3, 2025, at 4:30 p.m. Eastern time to discuss its third quarter 2025 results and provide a corporate update.
A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until November 24, 2025.
To access the live conference call via phone, please dial 833-470-1428 from the United States, or global dial-in numbers are available here: View Source, at least 10 minutes prior to the start of the call, using the conference ID 735311.
There will be a brief Question & Answer session following management commentary.
(Press release, Castle Biosciences, NOV 3, 2025, View Source [SID1234659246])