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Cerenome — Third Quarter 2026 Earnings Summary

  • Financial Performance:

    • Total revenue for the quarter ended September 30, 2026, was $0.7 million, consisting entirely of net diagnostic revenue, compared to $0 in the same period of the prior year.
    • Gross billings at list prices were approximately $1.55 million; net diagnostic revenue recognized was $0.7 million after estimated payer adjustments and price concessions.
    • Cost of revenue was $0.9 million, compared to $0 in the prior year period.
    • Research and development expense was $2.1 million, down from $2.4 million a year earlier.
    • Selling, general and administrative expense was $5.2 million, up from $3.4 million a year earlier.
    • Operating loss was $7.5 million, compared to $4.5 million a year earlier.
    • Net loss was $8.7 million, or $1.14 per share, compared to $4.4 million, or $1.03 per share, a year earlier.
    • Cash, cash equivalents, and investments totaled $4.9 million as of September 30, 2026, down from $8.6 million as of June 30, 2026.
    • The Company announced closing a senior secured financing facility up to $20 million with royalty-based repayments in September.
    • The Company raised $3.8 million under the Equity Distribution Agreement subsequent to the end of the quarter.
    • Accounts receivable, net was $722,000 as of September 30, 2026, compared to $0 as of December 31, 2025.
    • Convertible notes totaled $3,851,000 as of September 30, 2026, compared to $0 as of December 31, 2025.
    • Total stockholders' deficit was $(923,000) as of September 30, 2026, compared to a surplus of $3,996,000 as of December 31, 2025.
  • Guidance and Future Outlook:

    • The Company is on track for Medicare reimbursement in the first half of 2027.
    • The Company is separately pursuing a coverage determination from Novitas Solutions.
    • Topline data is expected from the ReSPECT-GBM and ReSPECT-LM trials in mid-2027.
    • The Company plans to hold an End-of-Phase 2 meeting with the FDA following the ReSPECT-GBM topline readout.
    • Future plans include expanding CNSide adoption across cancer centers, building out the field sales team, and enhancing the testing menu.
  • Business Segments and Product Lines:

    • CNSide® CSF Assay Platform:
      • Contracted coverage expanded through agreements with Medical Mutual, Health Care Service Corporation, and Blue Cross Blue Shield of Michigan.
      • Secured in-network agreements with Florida Blue and Aetna; the Aetna agreement effective November 1 is the first national CNSide payer agreement to include both tumor cell enumeration and molecular profiling.
      • The aggregate contracted footprint represents approximately 190 million covered lives.
      • CNSide CSF Molecular Profile tests were launched for solid tumors and hematologic malignancies, available to order beginning October 12.
      • Entered into a collaboration with Genomic Testing Cooperative to add DNA and RNA profiling to CNSide.
      • XiFin selected for revenue cycle management and clearinghouse services.
      • Samantha Fowlkes appointed as Vice President and Head of Commercial Sales for CNSide Diagnostics.
    • REYOBIQ® Development:
      • Enrollment completed in the Phase 2 ReSPECT-GBM study in recurrent glioblastoma in October.
      • Interim Phase 1 ReSPECT-LM (multi-dose) findings presented at the Society of Neuro Oncology Annual meeting in November; the first 10 patients treated with repeated intraventricular doses showed no dose-limiting toxicities or treatment discontinuations due to adverse events.
      • Dose escalation is ongoing in the ReSPECT-LM study to identify a recommended multiple-dose regimen.
      • Preclinical data presented at the Rivkin Ovarian Cancer Research Symposium showed REYOBIQ positively impacts the tumor environment and enhances antitumor activity when combined with anti-PD-1 checkpoint blockade.
      • Pharmacokinetic, dosimetry, and safety observations from the ReSPECT-LM program were presented at the SNO/ASCO CNS Metastases Conference in August.
    • Corporate:
      • Plus Therapeutics rebranded as Cerenome, and common stock began trading on Nasdaq under the symbol CNSY on August 3.
      • Ron Andrews appointed as Chief Business Officer in November.
  • Market and Competitive Landscape:

    • Approximately 80% of U.S. private payers are now contracted, representing approximately 190 million covered lives.
    • The Aetna agreement provides physicians an in-network option for both tumor cell enumeration and molecular profiling.
    • Updated NCCN CNS Cancers Guidelines recognize a role for CSF analysis in the assessment of leptomeningeal metastases (LM).
    • Leptomeningeal metastases affect approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources.
  • Risks and Challenges:

    • Forward-looking statements regarding clinical trials, expected operations, and 2027 milestones are subject to risks including uncertainties in trial results and timing.
    • Risks include the ability to maintain Nasdaq listing, liquidity position, ability to raise additional cash, and outcomes of partnering/licensing efforts.
    • Challenges include regulatory requirements, market conditions, product performance, and manufacturing, production, and distribution capabilities for radiotherapeutics.
    • Success of CNSide CSF Assay revenue and corporate profitability expectations depend on support reimbursements and payments.
  • Management Commentary and Tone:

    • Marc H. Hedrick, M.D., President and CEO, described the recognition of the first quarter of CNSide diagnostic revenue and commercial payments beginning in October as a "tremendous landmark."
    • Management noted the payer universe continues to expand and the commercial team is focused on helping more cancer centers use the test in patient care.
    • Management highlighted material advancement in key therapeutic programs through trial enrollment completion and interim data reporting.
  • Other Key Points:

    • The Company rebranded from Plus Therapeutics to Cerenome in August 2026.
    • REYOBIQ is being evaluated in three clinical trials: ReSPECT-GBM (supported by an NCI award), ReSPECT-LM (funded by a $17.6 million CPRIT grant), and ReSPECT-PBC (supported by a $3 million Department of Defense grant).
    • The Company raised $3.8 million under the Equity Distribution Agreement subsequent to the quarter-end.
    • The Company announced a senior secured financing facility up to $20 million with royalty-based repayments in September.
    • CNSide Diagnostics, LLC is a wholly owned subsidiary developing proprietary laboratory-developed tests.
Company
CERENOME INC
Sector
Healthcare
Industry
Biotechnology