Caris Life Sciences (NASDAQ:CAI) executives said the company is expanding its commercial reach, product pipeline and biopharma partnerships as it looks to build on recent revenue growth following its IPO last June.
Speaking at an investor conference, a Caris executive identified by Chief Scientific Officer Milan Radovich as Brian said the company sees “more remarkable” market opportunities for its precision oncology platform than at any point since its founding in 2008. He said Caris is annualizing at more than 200,000 molecular profiles and reaches more than 6,100 oncologists in the U.S.
Caris has built its platform around whole exome and whole transcriptome sequencing, covering 23,000 genes for each patient profile, the executive said. He added that the company has accumulated more than 1 million genomic profiles, most of which are now matched with clinical outcomes.
Executives Highlight Market Opportunity in Molecular Profiling
The Caris executive said molecular profiling has become the standard of care, but adoption remains uneven. He said the therapy selection market is only about 35% penetrated, while newer applications such as minimal residual disease, or MRD, remain in early stages.
He said cancer centers are increasingly moving toward institution-wide precision oncology programs rather than leaving profiling decisions solely to individual oncologists. Caris supports that effort through a commercial organization that works with cancer center leadership, individual oncologists and a team of about 50 Ph.D.-level medical science liaisons focused on molecular medicine.
The company also pointed to its Precision Oncology Alliance, which now includes 100 sites after adding UC San Francisco. The executive said the alliance represents about 4,000 of the roughly 10,000 medical oncologists in the U.S. and gives academic partners access to Caris’ data for research collaborations.
Technology Platform Includes Tissue, Blood and AI Tools
Radovich said Caris standardized on whole exome and whole transcriptome sequencing in 2019 and has “the only FDA-approved whole exome and transcriptome” assay on the market. He said the FDA approval includes eight companion diagnostic indications across 20 therapies.
Radovich said the breadth of the platform allows Caris to identify therapy options, clinical trial eligibility and complex biomarkers without needing to redevelop panels when new biomarkers emerge. He said Caris has an evidence team that monitors literature, abstracts and guidelines, and when a new drug is approved, the company reviews prior patient results and notifies physicians if their patients are positive for the relevant biomarker.
He also discussed Caris Assure, the company’s blood-based whole exome and transcriptome product, which is currently launched for therapy selection and is being developed for monitoring and MRD applications. Radovich said Caris sequences both plasma and the white blood cell layer to distinguish tumor-derived mutations from clonal hematopoiesis, or CHIP, which can otherwise interfere with liquid biopsy interpretation.
Radovich highlighted GPSai, an artificial intelligence algorithm used to determine tissue of origin. He said it was designed for cancers of unknown primary and is also helping identify cases where the diagnosis differs from the pathology report.
Pipeline Includes Early Detection, Hematology and Digital Pathology
Caris executives outlined several recent and planned product initiatives:
- Caris Detect: Radovich said the company is applying a whole genome approach to early cancer detection. In the Achieve 1 study, a roughly 3,000-patient case-control cohort, he said the test demonstrated 60.3% sensitivity for stage one and two cancers while maintaining high specificity.
- Caris ChromoSeq: The company recently launched a whole genome assay for therapy selection in hematological cancers, including AML, MDS and MPN. Radovich said the test was originally developed at Washington University and later licensed and improved by Caris.
- MI Clarity: Radovich described the product as a digital pathology AI algorithm for breast cancer recurrence prediction and a digital pathology alternative to Oncotype and MammaPrint.
- MRD: Caris is developing both tumor-naive and tumor-informed MRD solutions.
Radovich also discussed Caris’ biopharma business, which includes molecular profiling for clinical trials and banked tissue, strategic data partnerships and Caris Discovery, a division focused on identifying novel drug targets. He cited a December partnership with Genentech as the largest pharma deal in Caris’ history, focused on identifying novel drug targets in refractory tumors. He said the agreement includes an upfront payment and milestones, though he did not provide financial terms.
CFO Points to Revenue Growth and Profitability
Chief Financial Officer Luke Power said Caris reported a strong first quarter, with revenue up 79% year over year. He said molecular profiling was the primary driver, with both blood and tissue growing above 80%.
Power said volume grew 15% year over year, while average selling price rose 61%. He said Caris has been free cash flow positive for the past four quarters and is using that cash flow to reinvest in the business, including early detection, MRD, MI Clarity and ChromoSeq.
Power said Caris Assure volume grew 58% in the quarter, albeit from a smaller base. He also said the molecular profiling sales team is expected to increase by 25% to 30%, with similar expansion planned for the pharma team. Caris ended the first quarter with 270 commercial team members and is moving toward 300, he said.
Power said the company’s gross margin profile benefits from its broad sequencing approach and expected improvements in sequencing costs over time. He said molecular profiling average selling price for tissue was just under $4,100 in the first quarter, while Caris Assure was just under $2,421.
He also said Caris has made progress in payer contracting, with MI Cancer Seek reaching more than 225 million covered lives within one year. Power said the company is now applying that approach to Caris Assure.
Caris reaffirmed its full-year guidance, Power said, adding that the guidance does not include potential revenue contributions from MI Clarity, ChromoSeq or the planned launch of Caris Detect.
About Caris Life Sciences (NASDAQ:CAI)
Caris Life Sciences (NASDAQ: CAI) is a molecular science company focused on advancing precision medicine in oncology. The company develops and delivers comprehensive molecular profiling services designed to identify actionable biomarkers across DNA, RNA and protein modalities. Its clinical services are intended to support oncologists in treatment decision-making by matching patients to targeted therapies, immunotherapies and relevant clinical trials based on tumor biology.
Caris provides laboratory-based diagnostic testing and related interpretive reports, combining high-throughput sequencing and other molecular technologies with bioinformatic analysis.
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