CNS Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Corporate Update

Cash expected to fund operations into the second half of 2026

Advancing development strategy for lead program TPI 287 to commence Phase 2 study around year end 2025 for treatment of glioblastoma multiforme (GBM)

HOUSTON, TX / ACCESS Newswire / May 16, 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 first quarter ended March 31, 2025 and provided a corporate update.

"Our company remains focused as tightly as ever on neuro-oncology drug development. We are off to a very rapid start on our lead program, TPI 287, for the treatment of GBM. With the encouraging published body of data established and anticipation of productive discussions with FDA, we remain confident in our ability to drive this program towards the start of our Phase 2 study around year end 2025. Importantly, we have further solidified our financial security with a cash runway into the second half of 2026 which we believe will fund the Company and our operational execution through much of the next planned study of TPI 287," commented John Climaco, CEO of CNS Pharmaceuticals.

TPI 287 Update

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.

The Company recently announced the successful transfer of the previously granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for TPI 287 from Cortice Biosciences, Inc. The granted Orphan Drug Designations for TPI 287 include use as treatments of gliomas, pediatric neuroblastoma, and progressive supranuclear palsy.

CNS Pharmaceuticals plans to engage the FDA and obtain feedback 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 First Quarter 2025