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
The net loss for the three months ended March 31, 2025 was approximately $4.3 million compared to approximately $3.5 million for the comparable period in 2024. The change in net loss is largely attributable to the costs of data clean-up, preparation and analysis for the topline primary data release on the Berubicin trial.
The Company reported research and development expenses of $3.2 million for the three months ended March 31, 2025 compared to approximately $2.5 million for the comparable period in 2024. The increase in research and development expenses during the period were mainly attributed to the costs of data clean-up, preparation and analysis for the topline primary data release on the Berubicin trial.
General and administrative expense was approximately $1.09 million for the three months ended March 31, 2025 compared to approximately $1.11 million for the comparable period in 2024. The decrease in general and administrative expense was mainly attributable to increases of approximately $76,000 in legal and professional expenses, $54,000 in compensation expense, $80,000 in travel expenses, and $13,000 in other expenses, which were offset by decreases of approximately $120,000 in stock-based compensation, $103,000 in marketing, advertising expenses and $19,000 in insurance expense.
As of March 31, 2025, the Company had cash of approximately $13.1 million. Subsequent to the end of the quarter, in May 2025, the Company completed a public offering with a single healthcare focused institutional investor for gross proceeds of approximately $5 million, before deducting placement agent fees and other estimated offering expenses. The Company believes that the cash on hand as of March 31, 2025 in addition to the $5 million public offering, 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, progressive neoplastic disease, 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.
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 287, the timing of the release of further analysis data on Berubicin's performance 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.
