Cerenome, Inc. filed a Current Report on Form 8-K dated October 2, 2026, announcing the incorporation of an updated corporate presentation as Exhibit 99.1. The filing, dated September 30, 2026, details the company’s integrated approach to central nervous system (CNS) oncology, focusing on diagnostics and therapeutics.
The presentation outlines the company’s business model, which integrates three areas: diagnostics, therapeutics, and AI/data analytics. The diagnostic segment is led by the CNSide platform, which analyzes cerebrospinal fluid (CSF) to detect, quantify, and characterize CNS cancer. The company highlights that CNSide offers a comprehensive clinical report based on a single CSF specimen, utilizing Tumor Cell Enumeration (TCE) to identify leptomeningeal (LM) metastasis and molecular profiling to guide therapy selection.
The filing includes epidemiological data regarding CNS metastases in the United States. It estimates that 2 million Americans are at risk for developing CNS metastatic disease, with approximately 190,000 brain metastases and 110,000 leptomeningeal metastasis cases diagnosed annually. The company projects a total addressable market for diagnostics in this space of approximately $10 billion.
Regarding financial and operational milestones, Cerenome anticipates growth in its annualized test run rate. The company noted that a Vice President of Commercial Sales was hired in Q3 2026, with the sales team deploying in Q4 2026. Billing and collections are expected to begin in the second half of 2026. The presentation also discusses reimbursement strategies, noting that a Medicare rate is effective January 2027 and coverage from Novitas is underway.
In the therapeutic pipeline, the company referenced REYOBIQ, which is expected to have multiple Phase 2 data readouts over the next 12 months. The filing also includes a forward-looking statement section detailing potential risks, including the early stage of product candidates, liquidity and capital resources, and the ability to raise additional cash.
