Tuesday, June 10, 2025

Caris Files for IPO at $5B: Documentation Links; Key Quotations and Metrics

Caris Life Sciences has filed for an IPO, with a planned value of $424M, at a valuation per share of $16-18.  According to one summary, this yields a market cap of $4.8-5.3B.

See coverage at MedTechDive here:

https://www.medtechdive.com/news/Caris-Life-Sciences-files-424M-IPO/750341/

See also Axios here and Reuters here.

See the June 9 press release here:

https://www.carislifesciences.com/about/news-and-media/caris-life-sciences-announces-launch-of-initial-public-offering/

See the SEC Preliminary Prospectus (dated June 9) here:

https://www.sec.gov/Archives/edgar/data/2019410/000110465925057593/tm2415719-16_s1a.htm

For me the PDF of the web document tallies 364 pages.

Recall that Caris won FDA approval for its paraffin comprehensive genomic profiling test in November 2024; the assay includes a full transcriptome and whole exome sequencing.  Here.  See the extensive FDA documentation for the test (P240010) here.

##

Caris states it has:

  • Profiled 849,000 cases
  • Measured 38 billion biomarkers
  • Built 51 petabytes of genomic data
  • Utilized 220 AI tools
  • Digitized 4.4M slides
  • Now assesses 23,000 genes per order (RNA, WES)
  • 5,500 regularly ordering oncologists (> 4/yr)
  • 270 commercial sales force
  • 96 members of the Caris Precision Oncology Alliance
  • 200+  patents
  • 1700+ employees
  • 31% CAGR (case volume) 2019-2024.. Revenue CAGR 28%.


Caris opens its summary by stating:

  • We are a leading, patient-centric, next-generation AI TechBio company and precision medicinepioneer. We develop and commercialize innovative solutions to transform healthcare through the use of comprehensive molecular information and artificial intelligence/machine learning algorithms at scale. 
  • Our entire portfolio of precision medicine solutions is designed to benefit patients, with an initial focus on oncology, and serves the clinical, academic, and biopharma markets.

###

Caris states that its current MolDx pricing for LBx therapy selection (Caris Assure) is $3649.   By my tally, the word "MOLDX" occurs 37 times in the prospectus.

Topics like LCDs, NCDs (p. 40), crosswalk/gapfill, and PLA coding are discussed.  They note (page 217) that AMA issued a PLA code for MI Cancer Seek of 0211U which is priced by CMS at $8455.  

They add, "We have obtained Medicare coverage for MI Cancer Seek for CPT code 0211 under the NGS NCD" and that "we began to market MI Cancer Seek in the first quarter as the WES WTS NGS component of MI Profile."  

MI Profile

See the web page hereMI Profile is the full package and includes DNA, RNA, proteins (IHC).  When ordering MI Profile, Caris will perform MI Cancer Seek CDx.  But, if the sample does not qualify for the FDA CDx test, then they will run the comparable LDT, MI Tumor Seek Hybrid.

MI Profile will also run IHC on 25+ markers, CISH, pyrosequencing for MGMT methylation (for glioma), and AI signatures, which include Caris GPSai for CUP (cancer of unknown type) and Caris FOLFIRSTai for CRC cases.

Gapfill

Separately, they describe that AMA issued PLA code 0485U for liquid biopsy Caris Assure for therapy selection, which is being priced by "the gapfill method."  As released in April for public comment, the proposed national gapfill price is $3649 for 0485U.  See my April 2025 article on the gapfill process here.

Risks

As to risks, among other statements Caris remarks,
  • Third-party payers are increasingly attempting to contain healthcare costs by limiting both coverage of certain diagnostic tests and the amounts that they will pay for such tests. Payers may also create conditions for coverage or may contract with third-party vendors to manage laboratory benefits, in both cases creating administrative hurdles for ordering physicians and patients that may make our services more difficult to sell.....
  • Obtaining approvals from third-party payers to cover our existing and new solutions and establishing adequate coding recognition and reimbursement levels is an unpredictable, challenging, time-consuming, and costly process, and we may not always be successful. 
AI Corner (Not Guaranteed)

I gave Chat GPT the 364-page prospectus and asked the AI to read and summary Caris' AI strategy.  

I have not read the full prospectus, so I can't vouch for the summary, and I copy it below "as is" and "if of interest" only.

Based on the S-1 filing, Caris Life Sciences' AI strategy is a core pillar of its business model, deeply integrated into its clinical services, research tools, and pharmaceutical partnerships. Their approach can be described as a data-driven precision oncology platform, where AI and machine learning (ML) are used to unlock insights from complex multi-omic and clinical datasets at scale.


1. AI Strategy Overview

Caris has created a vertically integrated platform that generates, aggregates, and analyzes whole exome sequencing (WES), whole transcriptome sequencing (WTS), and matched clinical data. Their AI strategy focuses on:

  • Automating the interpretation of molecular profiles

  • Predicting therapeutic response

  • Identifying novel biomarkers

  • Supporting clinical decision-making and trial enrollment


2. Key AI Products

Caris offers several AI-driven tools that exemplify their strategic priorities:

  • DETECT: A proprietary dataset of over 1.6 million molecular profiles linked with detailed clinical outcomes. This forms the training and validation foundation for their AI models.

  • CODEai: A cloud-based analytics engine that allows pharma partners to explore the DETECT dataset using natural language processing and AI. It supports hypothesis generation, biomarker validation, and trial site selection.

  • Caris Molecular Artificial Intelligence (MAI™): A suite of AI-based predictive algorithms trained on WES/WTS and outcomes data. These models aim to:

    • Predict patient benefit from specific therapies (e.g., checkpoint inhibitors, EGFR inhibitors)

    • Classify cancer subtypes based on transcriptomic signatures

    • Forecast prognosis and therapy resistance

  • Biosimilarity AI Models: These include models that predict which therapy classes (not just individual drugs) a tumor is most similar to in terms of molecular response, which is useful when direct evidence is limited.


3. AI Infrastructure

Caris has made significant investments in AI infrastructure, including:

  • A dedicated bioinformatics and AI team of ~140 employees

  • A cloud-native architecture optimized for high-throughput computation

  • Integration of deep learning and natural language processing (NLP) models for data extraction, annotation, and hypothesis testing


4. Strategic Use Cases

Caris deploys its AI for both clinical and biopharma-facing applications:

  • In the clinic, MAI algorithms provide oncologists with therapy prediction scores and help interpret complex molecular data.

  • In biopharma, AI is used for:

    • Patient stratification and trial matching

    • Novel target identification

    • Biomarker-driven drug development support

They highlight AI as a tool to reduce time and cost in drug development and increase R&D efficiency for their pharma clients.


5. Differentiation

Unlike some peers that rely primarily on static gene panels, Caris emphasizes multi-omic breadth (DNA, RNA, protein) and AI-enhanced interpretation. This gives them a competitive edge in producing actionable insights from complex biology.


Summary

Caris’s AI strategy is tightly woven into its clinical, research, and business operations. By linking comprehensive WES/WTS data with real-world clinical outcomes—and applying robust AI/ML analytics—Caris positions itself not only as a test provider but as a molecular intelligence company that bridges diagnostics, therapeutics, and data science. This strategy underpins their goal of becoming a market leader in precision oncology and biomarker-driven drug development.

Reminder: AI summary offered "as is" and "for interest only."