CNS Pharmaceuticals Announces Preliminary Results from Ongoing Potentially Pivotal Trial Evaluating Berubicin for the Treatment of Recurrent Glioblastoma Multiforme (GBM)

Data recently presented at the Society for Neuro-Oncology (SNO) 27^th Annual Meeting

Preliminary results showcase updated patient population profile and safety

Continued progress toward planned interim analysis when 30-50% of subjects are evaluable at 6 months after enrollment on the study, expected mid-year 2023

HOUSTON, Dec. 8, 2022 /PRNewswire/ -- 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 preliminary results from its ongoing potentially pivotal trial evaluating Berubicin for the treatment of recurrent glioblastoma multiforme (GBM).

“Although data are still early, we are pleased with these results in terms of recruiting a balanced patient population to compare Berubicin to Lomustine in the treatment of GBM, which may highlight Berubicin’s potential to provide a better therapeutic option for patients after first-line therapy for their disease. We remain steadfast in our efforts to drive patient enrollment across the U.S. and Europe and are making significant progress toward our planned interim analysis, which we expect to occur in mid-2023. Our team remains dedicated to moving this important program forward and to providing patients, families and physicians with a much needed treatment opportunity for this devastating disease,” commented John Climaco, CEO of CNS Pharmaceuticals.

“Berubicin continues to demonstrate its ability to be an innovative treatment in GBM as a safe and potentially effective therapy. These preliminary findings bolster our conviction in Berubicin as we continue to advance this study forward. Based on the results we’ve seen preclinically and in the clinic thus far, we remain confident in Berubicin’s potential to provide a consequential and much needed clinical benefit for GBM patients. We are making excellent progress with patient recruitment worldwide and, because we have currently described a balanced randomized population, we look forward to providing a meaningful comparison between Berubicin and what has been considered a standard of care for second line therapy (Lomustine),” added Sandra Silberman, MD, PhD, Chief Medical Officer of CNS Pharmaceuticals.

The preliminary results showed that the enrolled patients have comparable demographics, including age, gender, race, BSA and KPS and, in addition, the unmethylated MGMT population, which was approximately 40% in both arms. The percentage of patients that are currently continuing on study or having withdrawn is also comparable between arms. All grades of adverse events occurring in more than 5% of patients, as well as Grade 3-5 events, were also similar in the Berubicin and Lomustine arms.

As of the data cutoff of October 17, 2022, 49 patients were enrolled in this potentially pivotal trial with 35 subjects on Berubicin and 14 subjects on Lomustine, reflective of the Company’s 2:1 randomization schema. This study is evaluating the efficacy of this novel drug in terms of overall survival (OS), with the goal of providing the first approved therapeutic option for patients after first-line therapy. A pre-planned, non-binding futility analysis of OS will be performed after approximately 30 to 50% of all planned patients are enrolled in the study. These patients will be evaluated at 6 months after enrollment in the study, which we expect mid-year 2023. This review will include additional evaluation of safety as well as secondary efficacy endpoints related to the efficacy of Berubicin. Enrollment will not be paused during this interim analysis.

The data were recently presented by Dr. Silberman at the Society of Neuro-Oncology’s 27^th Annual Meeting in a poster titled, “A Randomized, Controlled Trial of Berubicin, a Doxorubicin Analog That Effectively Crosses the Blood-Brain Barrier (BBB), After First-Line Therapy for Glioblastoma Multiforme (GBM): Preliminary Results¹.”

The Company can now report that subsequent to Dr. Silberman’s presentation at the Society of Neuro-Oncology’s 27th Annual Meeting, enrollment has increased to 67 patients in this potentially pivotal study. “It is a remarkable testament to both the design of our study and the magnitude of the unmet clinical need in this terrible disease that our study is enrolling at this rapid pace. We are extremely grateful to our patients, our investigators and to our investors who are all facilitating this potentially game-changing clinical program,” said John Climaco, Chairman and CEO of CNS Pharmaceuticals, Inc.

For more information about the ongoing potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.

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. The FDA has granted CNS Pharmaceuticals Fast Track Designation and Orphan Drug Designation for Berubicin.

CNS Pharmaceuticals 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.

Additionally, the Company is advancing the development of its WP1244 drug technology portfolio, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. CNS Pharmaceuticals is evaluating the use of the WP1244 portfolio in the treatment of brain cancers, pancreatic, ovarian, and lymphomas.

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

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 include, without limitation, the Company’s ability to drive patient enrollment across the U.S. and Europe and the timing of the planned interim analysis to occur in mid-2023. 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.

¹ https://doi.org/10.1093/neuonc/noac209.317

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