Potentially pivotal GBM study evaluating lead program, Berubicin, enrollment completed; Topline data expected in the first half of 2025

Recent strategic in-license of TPI 287 is highly synergistic with the ongoing potentially pivotal Berubicin program and demonstrates further commitment to changing the treatment paradigm in GBM

Company plans to engage the U.S. FDA to seek guidance on advancing TPI 287 into a potential registration study for recurrent GBM

Company committed to addressing the most aggressive type of brain cancer with an average survival of only 14 to 16 months after diagnosis and no cure

HOUSTON, TX / ACCESSWIRE / August 15, 2024 / 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 reported its financial results for the second quarter 2024 ended June 30, 2024.

"It has been an important year for CNS Pharmaceuticals with completion of enrollment in our Berubicin trial, and more recently, our in-licensing of a highly synergistic asset for development, TPI 287. As we look to the remainder of the year, we are executing on the path towards our planned topline results for our Berubicin trial, which we expect in the first half of next year and engaging the U.S. FDA to seek guidance on advancing TPI 287 into a potential registration study for recurrent GBM. We are poised for a catalytic 2025 with some value-driving milestones expected across our pipeline. Our mission and vision remain firm; bring a meaningful treatment option to GBM patients and practitioners, as well as value to all stakeholders," commented John Climaco, Chief Executive Officer of CNS Pharmaceuticals.

Clinical Development Progress
Berubicin: Innovative, first-in-class anthracycline that appears to cross the blood brain barrier and kill tumor cells currently being evaluated in a potentially pivotal trial is a multicenter, open-label, randomized and controlled study in adult patients with recurrent glioblastoma multiforme (WHO Grade IV) after failure of standard first-line therapy.

As previously announced in April 2024, the Company completed enrollment with 252 patients in its global potentially pivotal study evaluating Berubicin for the treatment of GBM. In December 2023 the Company announced the successful completion of its pre-planned interim futility analysis and received a recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the study without modification. CNS Pharmaceuticals expects to report topline results from its potentially pivotal study of Berubicin in the first half of 2025.

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

TPI-287: Late stage, novel blood brain barrier permeable abeotaxane for treatment of brain malignancies.

In July 2024, the Company entered into an exclusive license agreement with Cortice Biosciences, Inc. for drug candidate, TPI 287, which has been awarded Orphan designation and studied in over 350 patients to date, including clinical trials as monotherapy and in combination with bevacizumab demonstrating encouraging clinical efficacy and safety profile at target therapeutic doses.

In clinical trials, TPI 287 has been administered as monotherapy as well as in combination with bevacizumab for the treatment of recurrent glioblastoma, neuroblastoma, medulloblastoma, refractory prostate cancer and in tauopathy disease (dementia caused by aggregation of abnormal tau proteins in the brain). Like other taxanes, TPI 287 inhibits cancer cell growth by disrupting microtubule dynamics which are required for cell division. However, unlike all other known taxanes, TPI 287 is not a substrate for a wide spectrum of efflux pumps that constitute the blood-brain barrier (BBB), including PgP, which may allow TPI 287 to reach the brain in high concentrations.

CNS Pharmaceuticals plans to engage the U.S. FDA and obtain feedback on the design of a study focused on the registration of TPI 287 in recurrent GBM, with the goal of initiating the study in 2025.

Summary of Financial Results for the Second Quarter 2024
The net loss for the three months ended June 30, 2024 was approximately $2.5 million compared to approximately $4.0 million for the comparable period in 2023. The change in net loss is attributable to a decrease in research organization ("CRO") expenses related to continued progress with the Company's clinical trial of Berubicin, as well as decreases in legal and professional fees and other expenses.

The Company reported research and development expenses of $1.1 million for the three months ended June 30, 2024 compared to approximately $2.8 million for the comparable period in 2023. The decrease in research and development expenses during the period was mainly attributed to the timing of CRO expenses related to continued progress with the Company's clinical trial.

General and administrative expense was approximately $1.4 million for the three months ended June 30, 2024 compared to approximately $1.2 million for the comparable period in 2023. The increase in general and administrative expense was mainly attributable to increases of approximately $333,000 in legal and professional expenses, which were offset by decreases of approximately $65,000 in marketing and advertising expenses and $35,000 in insurance expense.

As of June 30, 2024, the Company had cash of approximately $1.5 million. Between June 30, 2024 and August 14, 2024, the Company has raised total gross proceeds of approximately $12.4 million of financing, and has sufficient cash to fund its operations through the first quarter of 2025. The Company expects to be able to release final topline data from its potentially pivotal trial of Berubicin in the first half of 2025.

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 , and connect with the Company on X, 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 include, without limitation, the timing of the topline results from the Company's potentially pivotal study of Berubicin in the first half of 2025. 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 market and other conditions and 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, except as required by law.

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

SOURCE: CNS Pharmaceuticals, Inc.