Primary analysis data in potentially pivotal GBM study with lead program, Berubicin, on track for the first half of 2025

Company strengthens cash position to extend runway to fund operations beyond data readout of Berubicin potentially pivotal GBM study

Quarter marked by pipeline expansion with in-license of TPI 287, a late stage novel potential blood brain barrier permeable abeotaxane for treatment of brain malignancies

HOUSTON, TX / ACCESSWIRE / November 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 third quarter 2024 ended September 30, 2024.

"Our team has made nothing short of transformational advancements throughout 2024. Fundamentally, the Company has never been stronger, and we believe we are poised to unlock value for all stakeholders in the near term," commented John Climaco, Chief Executive Officer of CNS Pharmaceuticals. "We have a strong cash position, expanded our pipeline in complete alignment with our mission and importantly, believe we are closer than ever to potentially bringing Berubicin, our targeted chemotherapy drug candidate, to market as a meaningful treatment option to GBM patients and practitioners."

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 of efficacy and safety and received a recommendation from the independent Data Safety Monitoring Board (DSMB) to continue the study without modification.

CNS Pharmaceuticals expects to report primary analysis data 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 potentially 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 was previously awarded Orphan Drug Designation and studied in over 350 patients to date, including clinical trials as monotherapy and in combination with bevacizumab showing encouraging clinical efficacy and safety profile at target therapeutic doses.

CNS Pharmaceuticals plans to engage the FDA and obtain feedback on the design of a study focused on the registration of TPI 287 in recurrent GBM.

Summary of Financial Results for the Third Quarter 2024

The net loss for the three months ended September 30, 2024 was approximately $5.6 million compared to approximately $4.5 million for the comparable period in 2023.

The Company reported research and development expenses of $4.2 million for the three months ended September 30, 2024 compared to approximately $3.4 million for the comparable period in 2023.

General and administrative expense was approximately $1.4 million for the three months ended September 30, 2024 compared to approximately $1.1 million for the comparable period in 2023.

As of September 30, 2024, the Company had cash of approximately $7.0 million. Subsequent to the quarter end, the Company closed a $3.0 million registered direct offering of common stock priced at the market under Nasdaq rules, as well as completing $1.6 million of offerings via the Company's at-the-market facility. Based on management's planned activities and current expectations, cash on hand is sufficient to fund our operations through the second quarter 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.

The Company's second drug candidate, TPI 287, is an abeotaxane which stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. Similar to Berubicin, TPI 287 has shown the potential to cross the blood-brain barrier and treat CNS tumors. TPI 287 has been well tolerated in over 350 patients to date, including in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of recurrent neuroblastoma and medulloblastoma, as well as refractory prostate cancer and melanoma, and in tauopathy disease, which can result in dementia.

For more information, please visit www.CNSPharma.com, 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 release of the primary analysis data for the potentially pivotal study of Berubicin, the timing of the commencement of the registration study for TPI 287, and the Company's cash runway. 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
908.824.0775
CNSP@jtcir.com

SOURCE: CNS Pharmaceuticals, Inc.