Company on track to achieve value-driving milestones before year-end

HOUSTON, TX / ACCESSWIRE / October 11, 2023 / CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced it has achieved enrollment of 229 of the expected 243 patients in the ongoing potentially pivotal study evaluating Berubicin for the treatment of recurrent GBM, an aggressive and incurable form of brain cancer. The Company has opened 46 clinical trial sites across the U.S., Italy, France, Spain, and Switzerland.

John Climaco, CEO of CNS Pharmaceuticals commented, "The momentum in patient enrollment for this important study has frankly exceeded even our own high expectations. Recall that each patient who joins our study does so after their disease has recurred following the failure of standard of care treatment; an excruciating and deeply challenging moment in their life and their battle against glioblastoma. The confidence and trust these patients and their physician teams are demonstrating in our work is truly gratifying. With the sustained rapid pace of enrollment we've experienced here and in Europe, we are clearly on track to achieve complete enrollment of our study before year end. Perhaps even more importantly, we also expect to report results from the interim analysis later this quarter, with data derived from the robust sample set we have desired from the beginning as we seek to conclusively demonstrate Berubicin's potential. As we continue to drive this study forward, we remain hopeful in our effort to address this devastating disease and potentially offering an effective treatment in GBM that is safe and well tolerated."

As previously announced, CNS Pharmaceuticals has reached the criteria required by the study protocol to conduct a pre-planned, non-binding futility analysis, which an independent Data Safety Monitoring Board (DSMB) will review to determine whether to recommend continuing the study as planned or modifying the study based on Berubicin showing potential value as a second-line treatment for patients with glioblastoma. CNS Pharmaceuticals previously reported that the Company would conduct this analysis after at least 50% of the patients in the population to be analyzed for the interim analysis (30-50% of the total number of patients for this trial) had reached the primary efficacy endpoint, as provided for in the study protocol. The DSMB will review the number of deaths in each arm to ensure that the overall survival of patients receiving Berubicin shows at least a statistically significant comparability to those receiving Lomustine. Additional analyses will include comparisons of secondary endpoints, including progression-free survival (PFS), response rates, and safety assessments.

Upcoming Expected Milestones

• Report topline results of interim analysis expected in Q4 2023. Enrollment will continue during the interim analysis.
• Complete enrollment in Q4 2023.

For more information about this trial, visit clinicaltrials.gov and reference identifier NCT04762069.

The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the agency for guidance on expediting the development and review process. Additionally, the Company has received Orphan Drug Designation from the FDA, which may provide seven years of marketing exclusivity upon approval of an NDA.

About Berubicin

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc. Berubicin, was developed by Dr. Waldemar Priebe, Professor of Medicinal Chemistry at The University of Texas MD Anderson Cancer Center.