Cerenome Completes Enrollment in Phase 2 ReSPECT-GBM Trial of REYOBIQ™ in Recurrent Glioblastoma

Topline data expected in mid-2027

Previously reported interim Phase 2 data showed a 63% improvement in median overall
survival versus standard of care in recurrent glioblastoma (13 months vs. 8 months)

HOUSTON, Oct. 29, 2026 (GLOBE NEWSWIRE) -- Cerenome, Inc. (Nasdaq: CNSY) (“Cerenome” or the “Company”), a CNS oncology company integrating diagnostics, therapeutics, and artificial intelligence, today announced that it has completed enrollment in the Phase 2 ReSPECT-GBM (NCT01906385) study. This multicenter, open-label trial is evaluating a single administration of REYOBIQ™ (rhenium Re186 obisbemeda), the Company's lead investigational radiotherapeutic, in adults with recurrent glioblastoma (GBM). The Phase 2 portion was designed to enroll 34 patients. Following a statistical review, the Company closed enrollment with 32 patients treated at the recommended Phase 2 dose, which it determined is sufficient to support the planned final statistical analysis with minimal effect on statistical power. The Company expects to report topline data in mid-2027 (to allow for appropriate patient follow-up and data maturity) and subsequently hold an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss next steps for the program.

In ReSPECT-GBM, REYOBIQ bypasses the blood-brain barrier by direct infusion into the tumor through convection-enhanced delivery (CED) catheters. This approach is designed to deliver a high, targeted radiation dose to the tumor while keeping exposure to the rest of the brain and body low. Patients in Phase 2 receive the recommended Phase 2 dose of 22.3 mCi in 8.8 mL, which was selected in the Phase 1 dose-escalation study.

"Completing enrollment in ReSPECT-GBM brings us an important step closer to understanding REYOBIQ’s potential in recurrent glioblastoma. We are very grateful to the patients, their families, and the investigators and study teams at each of our clinical sites," said Eric J. Daniels, M.D., MBA, Cerenome’s Chief Development Officer. "The Phase 1 and interim Phase 2 data reported so far show a consistent safety picture and response pattern: when REYOBIQ reaches the tumor at therapeutic doses, survival reliably exceeds controls in company sponsored, demographically matched synthetic controls. With enrollment complete, our focus moves to patient follow-up and final analysis. We look forward to reporting topline results in mid-2027 and discussing them with regulatory authorities."

"Patients with recurrent glioblastoma have very few treatment options, and median survival has held around eight months, despite multiple therapeutic approaches," said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine at Mays Cancer Center at UT Health San Antonio, and lead investigator of ReSPECT-GBM. "In Phase 1, patients whose tumors received 100 Gy or more lived a median of 17 months. That finding gave us a clear delivery goal for Phase 2. Getting REYOBIQ to the tumor at therapeutic doses has been the focus of this trial, and the final Phase 2 data will show how well that approach holds up in a larger group of patients."

Previously Reported ReSPECT-GBM Data

Phase 1 (published in Nature Communications, 2025)

• Median overall survival was 17.0 months (95% CI 8.0–35.0) in patients whose tumors received 100 Gy or more (n=12). It was 6.0 months (95% CI 1.0–11.0) in patients whose tumors received less than 100 Gy (n=9).
• Survival improved as the absorbed dose and the share of tumor covered by the drug increased. Each 100 Gy increase in absorbed dose was associated with a 35.7% lower risk of death (HR 0.643; p=0.003).
• Six patients in the Phase 1 dose cohort received 22.3 mCi in 8.8 mL, the dose selected for Phase 2.
  

Phase 2 (interim data)

• Median overall survival was 13 months in the first 15 patients treated, compared with approximately 8 months historically reported for bevacizumab monotherapy. Median progression-free survival was 11 months, compared with approximately 4 months for standard of care (Society for Neuro-Oncology Annual Meeting, November 2023).
• The average absorbed dose to the tumor was 300 Gy. Of the Phase 2 patients evaluated at that time, 88.9% met the key CED delivery targets linked to longer survival in Phase 1: an absorbed tumor dose above 100 Gy and radiation coverage of more than 70% of the tumor (Congress of Neurological Surgeons Annual Meeting, 2024).

Safety (Phase 1 and Phase 2 combined)

• Most treatment-related adverse events were Grade 1 or 2. The most common were lymphopenia (7.9%), cognitive disorder (7.0%) and headache (7.0%). There were no treatment-related deaths and no study discontinuations due to serious adverse reactions (WFNOS/SNO Annual Meeting, November 2025).
  

About ReSPECT-GBM

ReSPECT-GBM (NCT01906385) is a prospective, multicenter, open-label Phase 1/2 trial of REYOBIQ given by convection-enhanced delivery to adults with recurrent glioblastoma after standard surgery, radiation and/or chemotherapy. The Phase 2 portion is evaluating safety and efficacy, including overall survival, at the recommended Phase 2 dose in patients with tumors of about 20 mL or less. Including six patients treated at the same dose level during Phase 1 dose escalation, a total of 38 patients in ReSPECT-GBM have received REYOBIQ at the recommended Phase 2 dose of 22.3 mCi in 8.8 mL. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health.

About REYOBIQ™ (rhenium Re186 obisbemeda)

REYOBIQ is an investigational injectable radiotherapeutic in which the radioisotope rhenium-186 is held inside a nanoliposome. It is designed to deliver targeted, high-dose beta radiation directly to central nervous system (CNS) tumors while keeping radiation exposure to healthy tissue low. Rhenium-186 also emits gamma energy, which allows imaging of where the drug goes in real time. REYOBIQ is being evaluated for the treatment of leptomeningeal metastases, recurrent glioblastoma and pediatric brain cancers in the ReSPECT-LM, ReSPECT-GBM and ReSPECT-PBC clinical trials. Results from the multicenter Phase 1 ReSPECT-GBM trial were published in Nature Communications in 2025 (Brenner AJ, et al. Nat Commun. 2025;16:2079). REYOBIQ is investigational and has not been approved by the FDA or any other regulatory authority for any use.

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 Company's CNSide® Diagnostics platform supports the detection, molecular characterization, and longitudinal monitoring of CNS cancers through cerebrospinal fluid-based testing. 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.

Forward-Looking Statements

This press release contains statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "expect," "potential," "may," "could," "look forward," "planning" and similar expressions or the negatives thereof. These statements include, without limitation, statements about the timing of topline data from the ReSPECT-GBM Phase 2 trial; the timing and outcome of an End-of-Phase 2 meeting with the FDA; whether final Phase 2 results will be consistent with previously reported Phase 1 or interim Phase 2 data; the potential safety and efficacy of REYOBIQ in recurrent glioblastoma; and the Company's clinical development and regulatory plans for REYOBIQ. Interim results may not predict final results, and comparisons with historical controls have inherent limitations. These statements are based on assumptions and assessments made by management in light of their experience, their view of historical trends, current conditions, expected future developments and other factors they believe are appropriate. Actual results could differ materially because of risks and uncertainties, including those described under "Risk Factors" in the Company's filings with the U.S. Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement, except as required by law.

Investor Contact
CORE IR
IR@cerenome.com