Cerenome Inc.
11/13/2026 | Press release | Distributed by Public on 11/13/2026 15:52
Cerenome Reports Third Quarter 2026 Financial Results and Business Highlights Featuring REYOBIQ ReSPECT- LM Data and CNSide Commercial and Reimbursement Progress (Form 8-K)
Cerenome Reports Third Quarter 2026 Financial Results and Business Highlights Featuring REYOBIQ ReSPECT- LM Data and CNSide Commercial and Reimbursement Progress
HOUSTON, November 13, 2026 - Cerenome, Inc. (Nasdaq: CNSY) ("Cerenome" or the "Company"), a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted radiopharmaceuticals, and artificial intelligence, announces financial results for the third quarter ended September 30, 2026, and provides an overview of recent business progress.
"Recognition of our first quarter of CNSide® diagnostic revenue and commercial payments beginning in October is a tremendous landmark," said Marc H. Hedrick, M.D., Cerenome's President and Chief Executive Officer. "Furthermore, our payer universe continues to expand with now about 80% of U.S. private payers representing approximately 190 million covered lives. Most recently, with Aetna coverage, it gives physicians an in-network option for both tumor cell enumeration and molecular profiling. In parallel, our growing commercial team is focused on helping more cancer centers use our test in patient care. In therapeutics, we materially advanced our two key programs by completing enrollment in our Phase 2 trial in adults with recurrent glioblastoma, opening up higher dose cohorts in the repeat dosing of REYOBIQ™ in patients with leptomeningeal metastases and reporting interim data in that trial."
Q3 2026 AND RECENT HIGHLIGHTS
Corporate
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During the quarter, Plus Therapeutics rebranded as Cerenome, and on August 3 its common stock began trading on Nasdaq under the symbol CNSY. The new name and brand reflect the Company's focus on integrating CNS diagnostics, therapeutics, and data.
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In November, Ron Andrews was appointed as Chief Business Officer to advance CNSide commercial adoption and strategic partnerships. Mr. Andrews continues to serve on the Company's Board of Directors.
CNSide® CSF Assay Platform
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The company submitted billing claims for approximately $1.55 million in gross billings at list prices and recognized $0.7 million in net diagnostic revenue in the quarter after estimated payer adjustments and price concessions.
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Contracted coverage was expanded through agreements with Medical Mutual, Health Care Service Corporation and Blue Cross Blue Shield of Michigan.
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Secured in-network agreements were also made 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 Company's aggregate contracted footprint now represents approximately 190 million covered lives.
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The company entered into a collaboration with Genomic Testing Cooperative to add DNA and RNA profiling to CNSide. In July, the Company also highlighted updated NCCN CNS Cancers Guidelines recognizing a role for CSF analysis in the assessment of LM.
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XiFin was selected for revenue cycle management and clearinghouse services, and Samantha Fowlkes was appointed as Vice President and Head of Commercial Sales for CNSide Diagnostics.
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The Company is on track for Medicare reimbursement in 1st half of 2027 and is separately pursuing a coverage determination from Novitas Solutions.
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CNSide CSF Molecular Profile tests were launched for solid tumors and hematologic malignancies. The test was available to order beginning October 12, providing DNA and RNA profiling from cerebrospinal fluid (CSF). CNSide can be ordered independently or alongside tumor cell enumeration.
REYOBIQ™ Development
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The company presented interim Phase 1 ReSPECT-LM (multi-dose) findings at the Society of Neuro Oncology Annual meeting in November. The first 10 patients have been treated with repeated intraventricular doses of
REYOBIQ, with no dose-limiting toxicities or treatment discontinuations due to adverse events reported. This highlights the potential for REYOBIQ to safely administer higher dose of tumor-destroying radiation (compared to single-dose study). Dose escalation is ongoing to identify a recommended multiple-dose regimen for a follow-on randomized study.
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Also, enrollment was completed in the Phase 2 ReSPECT-GBM study in recurrent glioblastoma in October. Cerenome expects topline data in mid-2027 following additional patient follow-up, and plans to hold an End-of-Phase 2 meeting with the FDA thereafter.
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Investigators reported preclinical data at the Rivkin Ovarian Cancer Research Symposium in October showing the active agent in REYOBIQ was associated with a new mechanism of action, namely positively impacting the tumor environment. The net effect described by investigators was administering REYOBIQ along with anti-PD-1 checkpoint blockade enhanced antitumor activity in these preclinical studies, opening up the possibility of novel combination therapies.
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Investigators presented pharmacokinetic, dosimetry, and safety observations from the ReSPECT-LM program at the SNO/ASCO CNS Metastases Conference in August. A separate presentation examined the potential health economic impact of earlier detection of leptomeningeal metastases (LM) using CNSide.
THIRD QUARTER 2026 FINANCIAL RESULTS
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Cash, cash equivalents and investments totaled $4.9 million as of September 30, 2026, compared with $8.6 million as of June 30, 2026. In September, the Company announced closing a senior secured financing facility up to $20 million with royalty-based repayments. In addition, the Company raised $3.8M under the Equity Distribution Agreement subsequent to the end of the quarter.
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Total revenue was $0.7 million, consisting entirely of net diagnostic revenue.
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Cost of revenue was $0.9 million. Research and development expense was $2.1 million, compared with $2.4 million a year earlier. Selling, general and administrative expense was $5.2 million, compared with $3.4 million a year earlier.
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Operating loss was $7.5 million, compared with $4.5 million a year earlier. Net loss was $8.7 million, or $1.14 per share, compared with $4.4 million, or $1.03 per share, a year earlier.
ANTICIPATED MILESTONES AND OUTLOOK FOR 2027
CNSide Commercial Rollout
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Expand CNSide adoption across cancer centers, build-out the field sales team, enhance the testing menu and build on existing payer collection experience across the CNSide test menu.
REYOBIQ Clinical Program
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Continue dose escalation in LM Multi-dose study and follow patients in ReSPECT-GBM for the anticipated mid-2027 topline readouts from both trials.
Conference Call and Webcast
Cerenome will host a conference call and webcast Monday, November 16, 2026, at 8:30 a.m. Eastern Time to discuss third quarter results and provide a business update.
Webcast and Conference Call
Date/Time: Monday, November 16, 2026 at 8:30 AM ET
Webcast: https://event.choruscall.com/mediaframe/webcast.html?webcastid=vTAb1pUs
Dial-in: U.S.: 833-862-0853 International: 412-317-6789
Please dial in 15 minutes before the start time.
Following the live call, a replay will be available on the Company's website under the 'For Investors' section. The webcast will be available on the Company's website for 90 days following the live call.
About Leptomeningeal metastases (LM)
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with
breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.
About REYOBIQ™ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high-dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off-target risks and improve outcomes for CNS cancer patients versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials, respectively. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). The Company's ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense's Peer Reviewed Cancer Research Program.
About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Cerenome, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases.
About Cerenome
Cerenome (Nasdaq: CNSY) is a CNS oncology company advancing an integrated platform that combines precision diagnostics, targeted therapeutics, and artificial intelligence to improve outcomes for patients with central nervous system cancers. The CNSide® CSF diagnostics platform combines cellular and molecular testing to support the detection, characterization, and longitudinal assessment of cancers involving the CNS.
Its lead therapeutic platform, REYOBIQ™ (rhenium Re186 obisbemeda), is being evaluated in clinical trials for leptomeningeal metastases, recurrent glioblastoma, and pediatric brain cancers. The data & artificial intelligence platform is designed to integrate diagnostic, molecular, imaging, and clinical data into actionable insights that support precision oncology and therapeutic innovation.
By integrating commercial diagnostics, targeted therapeutics, proprietary longitudinal data, and artificial intelligence within a single organization, Cerenome is building a differentiated CNS oncology platform designed to improve patient care while creating long-term shareholder value. For more information, visit https://www.cerenome.com.
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