CNS Pharmaceuticals' (NASDAQ:CNSP) Ongoing Potentially Pivotal Study of Berubicin for the Treatment of Glioblastoma Multiforme (GBM) Continues Rapid Pace of Enrollment with 229 Patients Enrolled to Date

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CNS Pharmaceuticals achieves enrollment of 229 patients in pivotal study for brain cancer treatment

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• CNS Pharmaceuticals has achieved enrollment of 229 patients in the ongoing potentially pivotal study evaluating Berubicin for the treatment of recurrent GBM, an aggressive form of brain cancer. The enrollment has exceeded expectations and the company is on track to complete enrollment before year-end. Interim analysis results expected later this quarter.

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• None.

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.

About CNS Pharmaceuticals, Inc.

CNS Pharmaceuticals is a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's lead drug candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.

For more information, please visit www.CNSPharma.com, and connect with the Company on Twitter, Facebook, and LinkedIn.

Forward Looking Statements

Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the Company's completion of enrollment of the study and the timing of the interim analysis each to occur before year end, the ability to continue to open additional clinical trial sites on a timely basis, and whether the FDA will recognize the Company's primary endpoint as a basis for approval. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

CONTACTS:

Investor Relations Contact
JTC Team, LLC
Jenene Thomas
833-475-8247
CNSP@jtcir.com

SOURCE: CNS Pharmaceuticals, Inc.

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FAQ

What is CNS Pharmaceuticals working on?

CNS Pharmaceuticals is working on the development of novel treatments for primary and metastatic cancers in the brain and central nervous system.

What is the ongoing study evaluating?

The ongoing study is evaluating Berubicin for the treatment of recurrent GBM, an aggressive form of brain cancer.

How many patients have been enrolled in the study?

229 patients have been enrolled in the study.

When is the expected completion of enrollment?

The company expects to complete enrollment before year-end.

When will the interim analysis results be reported?

The interim analysis results are expected to be reported later this quarter.