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

Final analysis will use 32 treated patients rather than the planned 34, with topline results expected in mid-2027.

Rhea-AI Summary

Cerenome (CNSY) completed enrollment in its Phase 2 ReSPECT-GBM trial evaluating REYOBIQ in adults with recurrent glioblastoma, a brain cancer. Enrollment closed with 32 patients treated at the recommended dose, versus 34 planned. Following statistical review, the company determined this was sufficient for final analysis with minimal effect on statistical power. Cerenome expects topline data in mid-2027, followed by an FDA meeting to discuss next steps.

The multicenter, open-label trial evaluates a single administration delivered directly into the tumor. Previously reported interim results in the first 15 patients showed median overall survival of 13 months, versus approximately 8 months historically reported for bevacizumab alone. Across Phase 1 and Phase 2, most treatment-related adverse events were Grade 1 or 2; there were no treatment-related deaths or discontinuations due to serious adverse reactions.

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0 major · 3 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointPhase 2 enrollment completed with 32 patients treated at the recommended dose.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Topline data expected in mid-2027, with Cerenome planning a subsequent FDA End-of-Phase 2 meeting.
• Moderate pointInterim median overall survival was 13 months in the first 15 patients versus approximately 8 months historically for bevacizumab monotherapy.
• Moderate pointInterim median progression-free survival was 11 months versus approximately 4 months for standard of care.
• Minor point88.9% of Phase 2 patients evaluated met delivery targets: tumor dose above 100 Gy and coverage exceeding 70%.

3 minor points

• Minor pointPhase 1 median survival was 17.0 months at tumor doses ≥100 Gy versus 6.0 months below 100 Gy.
• Minor pointEach 100 Gy increase in absorbed dose was associated with 35.7% lower death risk in Phase 1.
• Minor pointNo treatment-related deaths or discontinuations due to serious adverse reactions occurred across Phase 1 and Phase 2.

Negative

• Moderate pointInterim survival comparisons used historical benchmarks, rather than a concurrent randomized control group in this open-label trial.
• Minor pointEnrollment closed below the planned 34 patients; Cerenome judged 32 sufficient, with minimal effect on statistical power.
• Minor pointTreatment-related adverse events included lymphopenia (7.9%), cognitive disorder (7.0%) and headache (7.0%) across both phases.

Key Figures

Patients treated: 32 patients Planned enrollment: 34 patients Topline data timing: Mid-2027 +3 more

Patients treated

32 patients

Phase 2 enrollment closed; treated at the recommended Phase 2 dose

Planned enrollment

34 patients

Phase 2 portion design

Topline data timing

Mid-2027

Company expectation for ReSPECT-GBM

Median overall survival

13 months vs. approximately 8 months

Previously reported interim Phase 2 data; first 15 patients vs. historical bevacizumab monotherapy

Median progression-free survival

11 months vs. approximately 4 months

Previously reported interim Phase 2 data vs. standard of care

Recommended Phase 2 dose

22.3 mCi in 8.8 mL

Single administration; dose selected in the Phase 1 dose-escalation study

Key Terms

overall survival, progression-free survival, convection-enhanced delivery, open-label, +1 more

5 terms

overall survival medical

"Previously reported interim Phase 2 data showed a 63% improvement in median overall survival"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

progression-free survival medical

"Median progression-free survival was 11 months"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

convection-enhanced delivery medical

"through convection-enhanced delivery (CED) catheters"

Convection-enhanced delivery is a medical technique that uses a gentle, controlled push of fluid to carry a drug directly into a specific part of the brain or spinal cord, producing wider and more uniform distribution than simple injection. For investors, it matters because the method can increase a therapy’s effectiveness and reduce side effects by concentrating medicine where it’s needed, which can materially affect clinical trial results, regulatory chances and commercial value.

open-label medical

"This multicenter, open-label trial is evaluating a single administration"

Open-label describes a situation where everyone involved in a study or process knows the full details, such as who is receiving a treatment or intervention. For investors, understanding whether a project or product is open-label helps gauge the level of transparency and potential biases, influencing trust and decision-making. It’s like knowing whether a test or experiment is conducted openly or behind closed doors.

dose-escalation medical

"which was selected in the Phase 1 dose-escalation study"

Dose-escalation is the part of an early-stage clinical trial where researchers gradually increase a drug’s dose in small groups of participants to find the safest and most effective amount. Think of it like turning up the volume slowly to find the sweet spot: investors watch these results closely because they reveal safety risks, potential effectiveness, and how quickly a drug can move to later trials or approval, all of which affect the development timeline and commercial prospects.

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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

FAQ

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When does Cerenome expect results from the Phase 2 REYOBIQ trial?

Cerenome expects topline ReSPECT-GBM data in mid-2027, allowing for patient follow-up and data maturity. The company subsequently plans an End-of-Phase 2 meeting with the FDA to discuss the program's next steps.

What did Cerenome's interim Phase 2 REYOBIQ results show?

The first 15 patients had median overall survival of 13 months, compared with approximately 8 months historically reported for bevacizumab monotherapy. Median progression-free survival, the time before disease progression or death, was 11 months versus approximately 4 months for standard of care.

How is REYOBIQ administered in Cerenome's Phase 2 ReSPECT-GBM trial?

Patients receive a single administration of 22.3 mCi in 8.8 mL, infused directly into the tumor through convection-enhanced delivery catheters. This bypasses the blood-brain barrier. The dose was selected in Phase 1, where six patients in the dose cohort received it.

How many patients supported Cerenome's Phase 1 REYOBIQ survival comparison by tumor radiation dose?

The Phase 1 comparison included 12 patients whose tumors received at least 100 Gy and nine patients receiving less than 100 Gy. Median overall survival was 17.0 months, with a 95% confidence interval of 8.0–35.0 months, versus 6.0 months, with a 95% confidence interval of 1.0–11.0 months.