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

Rhea-AI Summary

CNS Pharmaceuticals (NASDAQ:CNSP) reported Q3 2025 results and a corporate update on November 17, 2025. Key financials: net loss $3.3M vs $5.6M year-ago, R&D $2.2M vs $4.2M, G&A $1.1M vs $1.4M, and cash $9.9M as of September 30, 2025. Management says cash is expected to fund operations into the second half of 2026. Lead program TPI 287 — an abeotaxane engineered for blood-brain barrier penetration — showed Phase 1 activity in GBM with 3 complete responses and 9 partial responses among 23 evaluable patients. The company plans FDA engagement on a potential Phase 2/registration study in early 2026.

Positive

• Phase 1 efficacy: 3 CR and 9 PR of 23 evaluable GBM patients
• Cash position of $9.9M as of September 30, 2025
• Reduced net loss to $3.3M from $5.6M year-ago

Negative

• Cash runway limited to into H2 2026, financing risk thereafter
• Trial design for TPI 287 not fixed; no firm cost estimates

Insights

Senior Biotech Analyst

CNS reports cash runway into second half of 2026, reduced quarterly loss, and plans FDA engagement to advance TPI 287 toward a Phase 2 GBM study.

TPI 287 is described as an abeotaxane with the taxane mechanism; Phase 1 combination data showed 3 Complete Responses and 9 Partial Responses among 23 evaluable glioblastoma patients. The company plans to seek FDA feedback on a potential registration study in recurrent GBM in early 2026. Financially, the net loss narrowed to $3.3 million for Q3 2025 from $5.6 million in Q3 2024, with R&D spending at $2.2 million and G&A at $1.1 million.

The business mechanism is clear: advance a BBB‑permeable cytotoxic agent toward a registration pathway while conserving cash. The reported Phase 1 responses are clinically meaningful signals, but they come from a small, uncontrolled cohort and the company explicitly notes those early results may not predict larger trials. Cash of $9.9 million is stated as sufficient into second half of 2026, making near‑term financing or clear trial cost estimates key dependencies.

Key risks include the limited size and uncontrolled nature of the Phase 1 dataset and the absence of a fixed trial design or firm cost estimates. Watch for FDA feedback in or after early 2026, formal Phase 2 trial design details, and any financing actions once trial parameters and budgets are set. Time horizon: milestones and runway decisions are primarily near‑term, within the next 6–12 months.

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.

View the original press release on ACCESS Newswire

FAQ

What did CNS Pharmaceuticals (CNSP) report for Q3 2025 net loss?

CNSP reported a $3.3 million net loss for the three months ended September 30, 2025.

How much cash did CNSP have at September 30, 2025 and how long will it last?

CNSP had $9.9 million cash and expects it to fund operations into the second half of 2026.

What Phase 1 results did TPI 287 show in glioblastoma (GBM)?

In a Phase 1 trial of TPI 287 plus bevacizumab, there were 3 complete responses and 9 partial responses among 23 evaluable patients.

When will CNSP engage the FDA about a potential TPI 287 registration study?

CNSP plans to engage the FDA and seek feedback on trial design in early 2026.

What were CNSP's R&D and G&A expenses in Q3 2025?

R&D was $2.2 million and G&A was $1.1 million for the three months ended September 30, 2025.