Castle Biosciences (CSTL) Piper Sandler 36th Annual Healthcare Conference summary

Business strategy and innovation

• Focuses on addressing significant clinical unmet needs with proprietary, first-in-class diagnostic tests to improve patient outcomes.

• Emphasizes continuous investment in evidence generation to drive clinician adoption and payer reimbursement.

• Commercial strategy centers on three pillars, with dermatology products as the largest revenue and volume drivers.

Product portfolio and clinical impact

• DecisionDx-Melanoma and DecisionDx-SCC tests guide risk stratification and treatment decisions for melanoma and high-risk squamous cell carcinoma.

• DecisionDx-Melanoma informs sentinel lymph node biopsy decisions and recurrence risk, addressing 130,000 U.S. patients annually.

• DecisionDx-SCC targets 200,000 high-risk SCC patients, re-stratifying risk and predicting response to adjuvant radiation therapy.

• MyPath Melanoma aids in differentiating ambiguous pigmented lesions, reducing overdiagnosis.

• TissueCypher, acquired in 2022, addresses Barrett's esophagus, identifying high-risk patients for intervention among 415,000 annual endoscopies.

Evidence generation and clinical validation

• Over 54 peer-reviewed publications support the consistent performance of DecisionDx-Melanoma.

• Recent prospective study confirmed low-risk patients had only 1.6% sentinel lymph node positivity and 99.5% three-year recurrence-free survival.

• Six new publications in 2024 for DecisionDx-SCC, including large independent cohort studies demonstrating the test's ability to identify patients who benefit from or can avoid adjuvant radiation therapy.

• Arron and Ruiz studies are the largest published on ART effectiveness in SCC, supporting clinical and reimbursement discussions.