Castle Biosciences Announces Pipeline Initiative to Develop Genomic Test Targeting Systemic Therapy Response in Patients with Psoriasis, Atopic Dermatitis and Related Conditions

Castle Biosciences has designed, developed and validated multiple genomic tests, including three dermatologic genomic tests, all of which are currently commercially available. These tests are designed to provide information for clinicians and patients to make personalized treatment decisions along the patient care continuum, including pre-diagnosis and following diagnosis, based on the biology of each patient’s disease. With the Company’s pipeline test for psoriasis, atopic dermatitis and related conditions, Castle expands its dermatology focus from cancer to include inflammatory skin disease. This pipeline initiative is expected to produce a genomic test that predicts systemic therapy response to guide therapy selection in patients with moderate to severe psoriasis, atopic dermatitis and related conditions.

“We are in an industry-leading position, as the only diagnostic company with a suite of dermatologic gene expression profile tests,” said Derek Maetzold, president and chief executive officer of Castle Biosciences. “We have demonstrated our ability to successfully develop, validate and bring to market clinically actionable, innovative tests. We start by identifying dermatologic diseases with high unmet clinical need. We then use the gene expression profile of an individual patient’s biology in an effort to develop gene expression profile tests designed to assist clinicians and their patients by better informing treatment to optimize health outcomes and reduce health care costs.

“We are excited to expand our pipeline beyond cancer to other dermatologic diseases that significantly impact patients’ lives and have unanswered clinical questions. We are working with several leading experts in inflammatory skin diseases to develop a test that can predict a patient’s response to therapy for patients with moderate to severe psoriasis, atopic dermatitis and related conditions. Our goal is to shift systemic therapy selection such that the appropriate therapy is selected the first time. This goal is clinically and economically important, as the burden of cost for today’s therapies are front loaded, and a significant amount is incurred within the first three months of treatment. If our test is able to guide therapy selection, based on the patient’s own disease biology, we believe we can help direct therapy selection decisions to start patients on potentially the most effective treatment sooner, while reducing the likelihood of a patient discontinuing or switching therapies, possibly resulting in a better utilization of healthcare resources.

“Based upon our development and validation timelines, we believe that we can launch this pipeline test by the end of 2025, utilizing our well-established dermatologic sales channels, adding approximately $1.9 billion to our current estimated U.S. total addressable market.”

Castle has initiated a 4,800 patient, prospective, multi-center clinical study to develop and validate this pipeline test. We expect to recruit approximately 50 participating centers from across the U.S.

About Psoriasis, Atopic Dermatitis and Related Conditions

Inflammatory skin disease accounts for a significant number of patient visits to both primary care and dermatology clinics across the U.S. every year. Psoriasis and atopic dermatitis are among the most common inflammatory skin conditions, and patient quality of life is severely impacted by these chronic diseases. Fortunately, systemic medications developed over the past 15 years have demonstrated a significant improvement in patients’ lives. In the U.S. alone, there are about 18 million patients diagnosed with psoriasis and atopic dermatitis, and approximately 450,000 patients annually are eligible for these systemic therapies. While there are now many effective treatments options available for those with moderate to severe disease, current clinical practice relies on a trial-and-error approach for therapy selection. To answer this unmet clinical need, Castle Biosciences is developing a gene expression profile test to predict response to systemic therapies for patients with moderate to severe psoriasis, atopic dermatitis and other related diseases. Personalized guidance for therapy selection and anticipated efficacy has the potential to improve patient health outcomes by enabling clinicians to select the best medication for their patients’ specific skin disease.

About Castle Biosciences

Castle Biosciences (Nasdaq: CSTL) is a commercial-stage dermatologic diagnostics company focused on providing physicians and their patients with personalized, clinically actionable genomic information to make more accurate treatment decisions. The Company currently offers tests for patients with cutaneous melanoma (DecisionDx®-Melanoma, DecisionDx®-CMSeq), cutaneous squamous cell carcinoma (DecisionDx®-SCC), suspicious pigmented lesions (DecisionDx® DiffDx™-Melanoma) and uveal melanoma (DecisionDx®-UM, DecisionDx®-PRAME and DecisionDx®-UMSeq). For more information about Castle’s gene expression profile tests, visit www.CastleTestInfo.com. Castle also has active research and development programs for tests in other dermatologic diseases with high clinical need, including its test in development to predict systemic therapy response in patients with moderate to severe psoriasis, atopic dermatitis and related conditions. Castle Biosciences is based in Friendswood, Texas (Houston), and has laboratory operations in Phoenix, Arizona. For more information, visit www.CastleBiosciences.com.

DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, DecisionDx DiffDx-Melanoma, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc.

Forward-Looking Statements

The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning the potential success of our pipeline initiative; potential improvements in patient treatment, optimized health outcomes and reduced healthcare costs attributable to any test developed by our pipeline initiative; anticipated timing for launch of our pipeline test; and the potential increase in our estimated U.S. total addressable market. The words “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation, changes in need and market opportunity for any tests developed through this pipeline initiative may impact our estimated total U.S. market opportunity, delays in clinical studies may delay our ability to launch our pipeline test, our pipeline test may not be as effective as anticipated, the effects of the COVID-19 pandemic on our business and our efforts to address its impact on our business, changes in the competitive landscape and introduction of competitive products, subsequent study results and findings that contradict earlier study results and findings, the level and availability of reimbursement for our products, our ability to manage our anticipated growth and the risks set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law.

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