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

Rhea-AI Summary

CNS Pharmaceuticals (NASDAQ:CNSP) has reported its Q2 2025 financial results and provided updates on its drug development programs. The company maintains a strong cash position of $12.1 million, expected to sustain operations into H2 2026.

The company's lead program, TPI 287, an abeotaxane designed to cross the blood-brain barrier, showed promising results in Phase 1 trials for glioblastoma multiforme (GBM), achieving 3 Complete Responses and 9 Partial Responses out of 23 evaluable patients when combined with bevacizumab. CNS plans to initiate a Phase 2 study in H1 2026 and engage with FDA on study design in 2025.

For Q2 2025, CNS reported a net loss of $2.4 million, slightly improved from $2.5 million in Q2 2024, with R&D expenses of $1.2 million and reduced G&A expenses of $1.2 million.

Positive

• Strong cash position of $12.1 million sufficient to fund operations into H2 2026
• Promising Phase 1 trial results for TPI 287 with 12 out of 23 patients showing complete or partial responses
• FDA Orphan Drug Designation granted for TPI 287 in multiple indications
• Reduced net loss compared to previous year ($2.4M vs $2.5M)
• Decreased G&A expenses from $1.4M to $1.2M year-over-year

Negative

• Increased R&D expenses from $1.1M to $1.2M year-over-year
• Phase 2 study not expected to commence until first half of 2026
• Continued operating losses with $2.4M net loss in Q2 2025

Insights

Biotechnology Financial Analyst

CNS Pharmaceuticals reports stable financial position with $12.1M cash runway while advancing TPI 287 for glioblastoma toward Phase 2 in 2026.

CNS Pharmaceuticals has reported Q2 2025 results showing a $12.1 million cash position that should fund operations into the second half of 2026. The company's quarterly net loss was $2.4 million, slightly improved from the $2.5 million loss in the same period of 2024. This financial stability provides a solid runway for their development programs.

The company's lead candidate, TPI 287, is positioned as a differentiated asset in the challenging glioblastoma multiforme (GBM) space. As an abeotaxane, TPI 287 shares the mechanism of action of established taxanes like paclitaxel, but critically, appears capable of crossing the blood-brain barrier - a significant hurdle in treating central nervous system malignancies. Early clinical signals are encouraging, with the Phase 1 combination trial with bevacizumab yielding 3 Complete Responses and 9 Partial Responses among 23 evaluable patients - a response rate of approximately 52%.

The company has already secured Orphan Drug Designation for TPI 287 across multiple indications (gliomas, pediatric neuroblastoma, and progressive supranuclear palsy), which provides development incentives including tax credits and potential market exclusivity. Management plans to engage with the FDA on a potential registrational study design for recurrent GBM in 2025, with the Phase 2 study expected to commence in the first half of 2026.

The slight increase in R&D expenses to $1.2 million reflects the strategic pivot from their Berubicin program to manufacturing and preparation activities for the upcoming TPI 287 trials. Meanwhile, G&A expenses decreased to $1.2 million, down from $1.4 million in the comparable quarter, primarily due to reduced legal, professional, and stock-based compensation expenses.

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

FAQ

What were CNS Pharmaceuticals' (CNSP) Q2 2025 financial results?

CNS Pharmaceuticals reported a net loss of $2.4 million, R&D expenses of $1.2 million, and G&A expenses of $1.2 million. The company has $12.1 million in cash, sufficient to fund operations into H2 2026.

What are the Phase 1 trial results for CNSP's TPI 287 in glioblastoma?

In Phase 1 trials, TPI 287 combined with bevacizumab showed 3 Complete Responses and 9 Partial Responses out of 23 evaluable patients with glioblastoma.

When will CNS Pharmaceuticals begin Phase 2 trials for TPI 287?

CNS Pharmaceuticals plans to begin Phase 2 trials for TPI 287 in the first half of 2026, with FDA engagement on study design planned for 2025.

What regulatory designations has TPI 287 received from the FDA?

TPI 287 has received Orphan Drug Designation from the FDA for the treatment of gliomas, pediatric neuroblastoma, and progressive supranuclear palsy.

How long can CNS Pharmaceuticals fund its operations with current cash?

With its cash position of $12.1 million as of June 30, 2025, CNS Pharmaceuticals expects to fund operations into the second half of 2026.