7/30/2026

speaker
Operator
Conference Operator

Good afternoon and welcome to the CASEL Biosciences second quarter 2026 conference call. As a reminder, today's call is being recorded. We will begin today's call with opening remarks and introductions, followed by a question and answer session. I would like to turn the call over to Camilla Zuckero, Vice President, Investor Relations and Corporate Affairs. Please go ahead.

speaker
Camilla Zuckero
Vice President, Investor Relations and Corporate Affairs

Thank you, operator. Good afternoon, everyone. Welcome to CASEL Biosciences' second quarter 2026 results conference call. Joining me today are CASEL's founder, president, and chief executive officer, Derek Maetzold, and chief financial officer, Frank Stokes. Information recorded on this call speaks only as of today, July 30, 2026. Therefore, if you are listening to the replay or reading the transcript of this call, any time-sensitive information may no longer be accurate. A recording of today's call will be available on the Investor Relations page of the company's website for approximately three weeks following the conclusion of the call. Before we begin, I would like to remind you that some of the statements made today will contain forward-looking statements, including statements about expected addressable markets, statements containing projections regarding future events or our future financial or operational results and performance, including our anticipated 2026 total revenue and the impact of our investments in growth initiatives including our ability to achieve long-term growth and drive stockholder value. Forward-looking statements are based upon current expectations and involve inherent risks and uncertainties and there can be no assurances that the results contemplated in these statements will be realized. A number of factors and risks could cause actual results to differ materially from those contained in these forward-looking statements. Please refer to the risk factors in our most recent SEC filings for more information. These forward-looking statements speak only as of today, and we assume no obligation to update or revise these forward-looking statements as circumstances change. In addition, some of the information discussed today includes non-GAAP financial measures such as adjusted revenue, adjusted gross margin, and adjusted EBITDA that have not been calculated in accordance with U.S. GAAP. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of our earnings release issued earlier today, which has been posted on the investor relations page of the company's website. I will now turn the call over to Derek.

speaker
Derek Maetzold
Founder, President, and Chief Executive Officer

Thank you, Camilla, and good afternoon, everyone. What a great quarter. Our team across all areas at Castle did a phenomenal job in executing on our growth plans and pulling it through the business. including revenue on the top line in evidence development and clinical research. Thanks to the efforts by our team and the clinical value that our clinicians see in the actionability of our tests, we delivered revenue of $103.5 million, 20% growth compared to the second quarter of 2025. Furthermore, if we exclude decision DXSCC and IDGenX revenue for both 2026 and 2025, Our revenue growth for the second quarter of 2026 was 40% compared to the second quarter of 2025. Test report volume for our core revenue drivers grew 32% compared to the second quarter of 2025. Our strong second quarter results reflect the continued execution of our growth strategy, and we remain focused on investing thoughtfully in the future growth of CASEL. We continue to invest in commercial resources to drive adoption of our tests, generate the clinical evidence needed to support reimbursement and expanded option, advance pipeline opportunities across our dermatology and gastroenterology offerings, and add the laboratory capacity, technology, and personnel needed to support future growth. Supported by our robust balance sheet, we believe these investments position us to capitalize on the opportunities across our current portfolio and pipeline while maintaining a disciplined approach to capital allocation. We believe we will continue this positive momentum in the second half of 2026, and our strong second quarter performance gives us the confidence to raise our 2026 total revenue guidance to $365 to $375 million compared to the previously provided guidance of $345 to $355 million. Now, I will walk you through the business highlights in the second quarter, and then Frank will provide additional financial highlights before we turn to your questions. Let's start with our four revenue drivers for 2026, DecisionDx Melanoma and TissueCypher. For DecisionDx Melanoma, we delivered 10,280 test reports in the second quarter, representing 3% growth compared to the second quarter of 2025. We are on track to meet our expectations of mid to high single-digit volume growth for the full year 2026 over 2025. DecisionDX melanoma test volume also increased approximately 3% in the second quarter of 2026 compared with the first quarter of 2026, representing moderate sequential growth, though below the sequential increase we typically see based upon historical seasonality. We believe this moderate sequential growth was due in part to our commercial team adapting its customer engagement model to support three products within the same customer call. This is a deliberate investment in the growth of our business. DecisionDx Melanoma remains the established foundation of our dermatological commercial portfolio, while the additional products DecisionDx SCC and Advanced ADTX expand the value we can provide the same customer base and support growth over the medium and long term. Additionally, we continue to generate a substantial body of evidence to support the clinical performance and use of our DecisionDx Melanoma test. In fact, during the second quarter, we were pleased to announce the publication of a prospective multicenter study demonstrating decision DX melanoma outperforming the Melanoma Institute of Australia Nomogram, or MIA, in identifying patients at low and high risk of sentinel lymph node biopsy positivity. Importantly, patients predicted to be low risk by decision DX melanoma, that is, they were predicted to have a sentinel lymph node positivity rate of less than 5%, at an actual observed sentinel lymphoma positivity rate of just 2.6%, well below the National Comprehensive Cancer Network, or NCCM, 5% threshold used to consider avoiding a sentinel lymphoma biopsy surgical procedure. These findings further demonstrate the value of integrating tumor biology with clinical pathologic factors to improve risk assessment, support more informed Risk-Aligned Care, and Help Identify Patients Who May Safely Forego the Sentinel-Liftoid Biopsy Surgical Procedure. Now, let's turn to our tissue cipher test. During the quarter, we delivered 14,988 tissue cipher test reports, representing 63% growth compared to the second quarter of 2025. Based upon trends for the first half of the year, we believe our 2026 test report volume for tissue cycle will trend toward 50% to 52% growth compared to 2025. Now, let's move on to our advanced ADTX test. During the second quarter, we delivered more than 1,000 orders. Given the test ability to guide systemic treatment selection for patients ages 12 and up with moderate to severe atopic dermatitis, We were particularly pleased that the ADVANCED-AD-TX test was recently recognized with the Genomics Innovation Award in the 10th Annual MedTech Breakthrough Awards Program. In addition, we were encouraged by a new independent real-world clinical utility study for ADVANCED-AD-TX presented in June at the Revolutionizing Atopic Dermatitis meeting. In this multicenter study, only 54.3%, or just over half, of patients receiving baseline systemic therapy were initially on pathway concordant treatment. However, following testing with our advanced AD test, 97.8% of patients were initiated on molecularly concordant systemic therapy. The impact of advanced AD TX on assisting clinicians and patients with making molecularly aligned therapy decisions overlaps the market research we conducted in the summer and fall of 2025. That is, clinicians are searching for tools, in this case, our advanced ADTX test, to assist them in making more informed, better therapy selections that align with an individual patient's underlying disease biology. And with that, I will now turn the call over to Frank.

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