Cash expected to fund operations into the second half of 2026
Company focused on advancing next-generation anti-cancer therapies derived from well-established drug classes, now engineered to cross the blood-brain barrier, potentially enhancing efficacy for patients
Lead program, TPI 287, progressing toward Phase 2 study for treatment of glioblastoma multiforme (GBM), one of the most aggressive types of brain cancer, with a median survival of only around 15 months from the time of diagnosis
HOUSTON, TX / ACCESS Newswire / November 17, 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 third quarter ended September 30, 2025 and provided a corporate update.
"As we head into the final quarter of the year, our mission remains centered on delivering meaningful developments for patients battling brain and CNS cancers. We continue to build momentum with our lead product candidate TPI 287 and work towards important, catalytic milestones. With Phase 1 data indicating potential blood-brain barrier penetration and tumor responses, we are aggressively advancing towards our Phase 2 study in GBM. We believe TPI 287 has the potential to be a meaningful new option for patients with brain tumors. Leveraging our established clinical data and team of experts, we are positioned to drive this program forward while creating value for our stakeholders. In the months ahead, we aim to concentrate on initiating the next chapter of TPI 287's development and delivering on our commitment to execute with urgency and precision," 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 suggests 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 evaluable patients. These results are from an early-stage trial and may not be indicative of results in larger, controlled studies.
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 early 2026.
Summary of Financial Results for the Third Quarter 2025
The net loss for the three months ended September 30, 2025 was approximately $3.3 million compared to approximately $5.6 million for the comparable period in 2024.
The Company reported research and development expenses of $2.2 million for the three months ended September 30, 2025 compared to approximately $4.2 million for the comparable period in 2024.
General and administrative expense was approximately $1.1 million for the three months ended September 30, 2025 compared to approximately $1.4 million for the comparable period in 2024.
As of September 30, 2025, the Company had cash of approximately $9.9 million. While trial costs are difficult to estimate and the Company does not yet have firm estimates as the trial design for the upcoming trial of TPI 287 is not yet fixed, the Company believes that it has sufficient working capital to fund 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 to 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 287 and FDA engagement on the clinical trial for TPI 287, statements regarding potential of TPI 287 to treat brain tumors, and statements regarding 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.
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