CNS Pharmaceuticals (NASDAQ: CNSP) Presents Updated Safety Data from Ongoing Potentially Pivotal Study Evaluating Berubicin in Advance of the Pre-Planned Interim Analysis of Efficacy

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CNS Pharmaceuticals, Inc. (CNSP) presented updated safety data on Berubicin, its novel anthracycline being evaluated for the treatment of Glioblastoma Multiforme (GBM) at the Society of NeuroOncology (SNO) 28th Annual Meeting. The topline result from the preplanned interim futility analysis is expected in December 2023. The data showed the comparability of patient demographics and safety data for each therapeutic modality in treating recurrent GBM.

Data presented at the Society of NeuroOncology (SNO) 28^th Annual Meeting

Berubicin currently being evaluated in an ongoing potentially pivotal study for the treatment of Glioblastoma Multiforme (GBM)

Topline result from preplanned interim futility analysis on track for December 2023

HOUSTON, TX / ACCESSWIRE / November 22, 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 the presentation of updated safety data from the ongoing potentially pivotal study evaluating Berubicin, the Company's novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier, in a poster presentation at the SNO 28^th Annual Meeting, held November 15-19, 2023 in Vancouver, Canada.

Sandra Silberman, MD, PhD, Chief Medical Officer of CNS Pharmaceuticals presented the poster, which was titled, "A randomized, controlled trial of Berubicin vs. Lomustine after first-line therapy for glioblastoma multiforme (GBM): Interim Results." The poster is now available on the Company's website. The data presented at the SNO Annual Meeting show the comparability of the patient demographics in the two arms of the study, and of the safety data for each therapeutic modality in treating recurrent GBM.

"We continue to be encouraged by the preliminary safety data from Berubicin, and are committed to moving this program forward," said Dr. Silberman. "The preclinical and phase 1 clinical results give us reason to hope that Berubicin will ultimately be shown to provide a much needed clinical benefit for GBM patients, and we remain on track to report the results of our interim analysis of efficacy data in December," commented Dr. Silberman.

Summary of Updated Safety Results from the Potentially Pivotal Study:

• Patient demographics are comparable between each arm, including age, gender, race, body surface area (BSA), andKarnofsky Performance Status Scale (KPS). In addition, patients with unmethylated MGMT comprise approximately 40% of each arm, allowing for comparison irrespective of the molecular profile that might influence the efficacy of the therapy administered. Although more patients withdrew from the study in the Lomustine arm than the Berubicin arm, there are too few patients to reach any conclusion about whether this will affect the outcome.
• All reported adverse events for both arms are shown for all grades and grades 3-5. These were similar, including the more severe events in the higher grades. The adverse events occurring in more than 10% of patients and/or that were considered treatment-related, are shown for all grades as well as grades 3-5, and overall were relatively similar in the Berubicin and Lomustine arms. In terms of myelosuppression (lymphocyte, neutrophil/white blood cell count or red blood cell [anemia] reductions), there is no significant difference between the therapeutic arms, although thrombocytopenia (platelet count decrease) appears to be slightly greater with Lomustine for all grades of severity as well as grades 3-5.

The primary endpoint of the study is Overall Survival (OS), a rigorous endpoint the FDA has recognized as the basis for approval of oncology drugs when a statistically significant improvement can be shown relative to a randomized control arm.

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 or not to recommend continuing the study. 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. The Company expects to release the conclusion of the DSMB before year end.

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, among other things, 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 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 did CNS Pharmaceuticals present at the SNO 28th Annual Meeting?

CNS Pharmaceuticals presented updated safety data on Berubicin, its novel anthracycline, being evaluated for the treatment of Glioblastoma Multiforme (GBM).

When is the topline result from the preplanned interim futility analysis expected?

The topline result from the preplanned interim futility analysis is expected in December 2023.

What did the data show at the SNO Annual Meeting?

The data showed the comparability of patient demographics and safety data for each therapeutic modality in treating recurrent GBM.

Who presented the poster at the SNO 28th Annual Meeting?

Sandra Silberman, MD, PhD, Chief Medical Officer of CNS Pharmaceuticals, presented the poster.

What is the title of the poster presented at the SNO 28th Annual Meeting?

The title of the poster presented at the SNO 28th Annual Meeting was 'A randomized, controlled trial of Berubicin vs. Lomustine after first-line therapy for glioblastoma multiforme (GBM): Interim Results.'

What is the molecular profile that might influence the efficacy of the therapy administered?

The molecular profile that might influence the efficacy of the therapy administered is the MGMT status, with approximately 40% of patients having unmethylated MGMT in each arm of the study.