Castle Biosciences Stock Price, News & Analysis

Castle Biosciences (CSTL) has published significant results from their DECIDE study regarding their DecisionDx-Melanoma test in melanoma patients. The study demonstrates the test's ability to accurately identify patients with less than 5% risk of sentinel lymph node (SLN) positivity who can safely avoid sentinel lymph node biopsy (SLNB) surgery.

Key findings show that DecisionDx-Melanoma influenced 85% of SLNB decisions. In patients with low-risk test results (Class 1A), none who underwent SLNB had positive nodes (0/35 patients). Notably, all patients with Class 1A results remained recurrence-free after two years of median follow-up, regardless of whether they underwent SLNB.

The study validates the test's alignment with National Comprehensive Cancer Network guidelines, which recommend avoiding SLNB when SLN positivity risk is below 5%. This helps reduce unnecessary surgical procedures, complications, and associated costs while focusing surgical interventions on higher-risk patients.

Castle Biosciences (CSTL) will present new data at the 11th World Congress of Melanoma and 21st EADO Congress in Athens, Greece (April 3-5, 2025), highlighting the clinical value of their DecisionDx-Melanoma test.

Two key studies will be presented: The first demonstrates the test's ability to stratify survival rates in stage IIB-IIC cutaneous melanoma patients, while the second shows its capability to identify early-stage patients at higher risk of central nervous system metastasis.

Key findings include:

• The test effectively stratified melanoma-specific and overall survival in stage IIB-IIC patients
• Patients with Class 2B (high risk) results showed significantly higher death risk
• DecisionDx-Melanoma was the only significant predictor of CNS metastasis in multivariable analyses

Dr. Brent Moody of Heritage Medical Associates emphasized that the test provides valuable biological insights complementing traditional staging, potentially improving melanoma outcomes through personalized care.

Castle Biosciences (CSTL) will present new validation data for its skin cancer tests at the NCCN 2025 Annual Conference. The company's DecisionDx-SCC test, earning a top-five abstract recognition, demonstrated enhanced risk stratification in a large cohort of 1,412 high-risk squamous cell carcinoma patients.

The study showed that combining DecisionDx-SCC with BWH staging significantly improved metastatic risk prediction within NCCN risk groups. Class 1 results indicated a nearly two-fold decrease in metastatic risk, while Class 2B showed more than a five-fold increase in risk for lower-stage NCCN High-Risk patients.

Additionally, new data for DecisionDx-Melanoma, tested in 6,892 patients with early-stage cutaneous melanoma, demonstrated the test's ability to predict mortality risk beyond traditional AJCC8 staging criteria. The study validated the test's effectiveness in identifying high-risk patients who might benefit from enhanced surveillance.

Castle Biosciences (CSTL) will present new data on its skin cancer diagnostic tests at the 2025 AAD Annual Meeting in Orlando. The company will showcase two significant studies:

1. A validation study of DecisionDx-SCC test involving 515 high-risk SCC patients, which demonstrated significant predictive ability for metastatic risk (p < 0.001).

2. An expanded analysis of DecisionDx-Melanoma test through collaboration with SEER Program Registries, encompassing nearly 10,000 patients. The study showed the test's ability to independently predict risk and its association with improved survival rates compared to untested patients.

Castle Biosciences (CSTL) reported strong financial results for 2024, with revenue reaching $332.1 million, a 51% increase from 2023. The company delivered 96,071 total test reports, up 36% year-over-year. Key highlights include:

- Net income of $18.2 million in 2024, compared to a net loss of $57.5 million in 2023
- Year-end cash position of $293 million, a $50 million increase from 2023
- Gross margin of 79% for 2024
- Adjusted EBITDA of $75 million, compared to -$4.4 million in 2023

The company saw significant growth across its test portfolio, with TissueCypher Barrett's Esophagus test reports increasing 130% and dermatologic tests up 17%. For 2025, Castle Biosciences anticipates generating between $280-295 million in total revenue.

Castle Biosciences (Nasdaq: CSTL), a healthcare company specializing in innovative diagnostic tests, has announced its upcoming participation in two major investor conferences in March 2025. The company's executive management will present at the Leerink Partners Global Healthcare Conference on March 10 at 1:40 p.m. Eastern time, and the KeyBanc Capital Markets Healthcare Forum (virtual) on March 18 at 11:15 a.m. Eastern time.

Both presentations will be accessible via live audio webcasts through Castle Biosciences' investor relations website, with replay options available after the events conclude.

Castle Biosciences (Nasdaq: CSTL) will present research data on its dermatologic gene expression profile (GEP) tests at the 2025 Winter Clinical Dermatology Conference in Hawaii. The company will showcase three posters focusing on different tests:

1. DecisionDx-Melanoma: Research on i31-SLNB's ability to identify melanoma patients with low risk of SLN positivity

2. DecisionDx-SCC: Study on using 40-GEP test to identify high-risk immunosuppressed patients with cutaneous squamous cell carcinoma

3. MyPath Melanoma: Research on enabling access to prognostic GEP testing for invasive melanoma

The posters will be displayed in the Queen's Ballroom 5-6 throughout the conference, with additional information available at Castle's exhibit hall booth.

Castle Biosciences (CSTL) has announced it will release its fourth quarter and full-year 2024 financial results after market close on Thursday, February 27, 2025. The company will host a conference call and webcast at 4:30 p.m. Eastern time to discuss the results.

Investors can access the live webcast through the company's Investor Relations page or directly via the provided link. For those joining by phone, the U.S. dial-in number is 1-833-470-1428 with access code 944585. International dial-in numbers are available through a separate link. A Q&A session will follow management's presentation, and a webcast replay will be available after the call.

Castle Biosciences (CSTL) will present data on its dermatologic portfolio at Maui Derm Hawaii 2025, with its DecisionDx-SCC poster selected as a top five finalist for the Akamai Award. The study, involving 1,408 patients with cutaneous squamous cell carcinoma (SCC), demonstrates improved risk stratification when combining test results with BWH staging.

The DecisionDx-SCC test showed significant metastasis prediction capabilities with three-year metastasis-free survival rates of 92.3% for Class 1, 81.3% for Class 2A, and 57.8% for Class 2B. Additional studies showed DecisionDx-Melanoma reduced unnecessary SLNB procedures by 25%, while MyPath Melanoma research revealed 24% diagnostic discordance among dermatopathologists for difficult-to-diagnose melanocytic lesions.