Strong cash position of $12.1 million expected to fund operations into the second half of 2026
Driving lead program, TPI 287, towards Phase 2 study for treatment of glioblastoma multiforme (GBM)
HOUSTON, TX / ACCESS Newswire / August 15, 2025 / 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 ended June 30, 2025 and provided a corporate update.
"Every decision we make is grounded in our science and driven by a sense of urgency and responsibility to the patients and families counting on us for better outcomes. We are making excellent progress in our development strategy for TPI 287, working rapidly toward commencing a Phase 2 study for the treatment of GBM in the first half of 2026. Looking ahead, we are continuing to leverage our operational experience and global infrastructure to support TPI 287 while working to get our trial up and running and begin dosing patients with this exciting drug candidate," commented John Climaco, CEO of CNS Pharmaceuticals.
TPI 287: Late Stage, Novel Blood Brain Barrier Permeable Abeotaxane for Treatment of Brain Malignancies
TPI 287 is an abeotaxane and has the same mechanism of action as other taxanes, e.g. paclitaxel (Taxol®) and docetaxel, in which it stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. While most taxanes are substrates for multi-drug resistant transporters, which maintain the blood brain barrier (BBB), TPI 287's clinical data suggest it has the potential to cross the BBB and treat CNS tumors. In a Phase 1 trial treating glioblastoma patients with TPI 287 in combination with bevacizumab (Avastin®), the efficacy data included 3 Complete Responses and 9 Partial Responses out of 23 patients evaluable.
As previously announced, TPI 287 was granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of gliomas, pediatric neuroblastoma, and progressive supranuclear palsy.
CNS Pharmaceuticals plans to engage the FDA on the design of a study potentially focused on the registration of TPI 287 in recurrent GBM in 2025.
Summary of Financial Results for the Second Quarter 2025
The net loss for the three months ended June 30, 2025 was approximately $2.4 million compared to approximately $2.5 million for the comparable period in 2024. The change in net loss is largely attributable to declining trial costs on the Berubicin trial.
The Company reported research and development expenses of $1.2 million for the three months ended June 30, 2025 compared to approximately $1.1 million for the comparable period in 2024. The increase in research and development expenses during the period were mainly attributed to declining trial costs on the Berubicin trial offset by expenditures preparing for a TPI 287 trial including drug manufacturing.
General and administrative expense was approximately $1.2 million for the three months ended June 30, 2025 compared to approximately $1.4 million for the comparable period in 2024. The decrease in general and administrative expense is attributable to decreases of approximately $36,000 in legal and professional expenses, $19,000 in travel expenses, $195,000 in stock-based compensation, which were offset by increases of approximately $51,000 in compensation expense and $29,000 in insurance expense.
As of June 30, 2025, the Company had cash of approximately $12.1 million. The Company believes that the cash on hand as of June 30, 2025 is sufficient to fund planned operations into the second half of 2026.
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 drug candidate TPI 287 is an abeotaxane, which stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. The initial clinical efficacy data suggest TPI 287 has the potential to cross the blood-brain barrier and treat CNS tumors. TPI 287 also has been tested in over 350 patients in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of a range of diseases or conditions, including recurrent glioblastoma, recurrent neuroblastoma and medulloblastoma, advanced malignancies, advanced unresectable pancreatic cancer, metastatic melanoma, and breast cancer metastatic to the brain. To date TPI 287 appears have both an excellent safety profile and high tolerability among patients.
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 in this release include, without limitation, the timing of the start of a trial of TPI 287and 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.
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/cns-pharmaceuticals-reports-second-quarter-2025-financial-results-and-1061372
