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

Rhea-AI Summary

CNS Pharmaceuticals (NASDAQ:CNSP) reported its Q1 2025 financial results and provided updates on its lead program TPI 287. The company reported a net loss of $4.3 million, up from $3.5 million in Q1 2024, with R&D expenses increasing to $3.2 million. CNS ended Q1 with $13.1 million in cash and subsequently raised an additional $5 million through a public offering in May 2025, extending their cash runway into H2 2026. The company's lead drug candidate, TPI 287, an abeotaxane for treating glioblastoma multiforme (GBM), showed promising Phase 1 results with 3 Complete Responses and 9 Partial Responses out of 23 evaluable patients when combined with bevacizumab. CNS plans to commence a Phase 2 study around year-end 2025 and will engage with FDA for study design feedback. The company successfully transferred Orphan Drug Designations from Cortice Biosciences for TPI 287 in treating gliomas, pediatric neuroblastoma, and progressive supranuclear palsy.

Positive

• Successful Phase 1 trial results showing 12 responses out of 23 patients for TPI 287
• Secured $5 million in additional funding through public offering
• Extended cash runway into second half of 2026
• Successfully transferred Orphan Drug Designations for multiple indications

Negative

• Increased net loss to $4.3 million in Q1 2025 from $3.5 million in Q1 2024
• R&D expenses increased to $3.2 million from $2.5 million year-over-year

Insights

Biotechnology Analyst

CNS Pharmaceuticals advances TPI 287 for glioblastoma with promising early data, extending cash runway to 2026 through recent $5M offering.

CNS Pharmaceuticals is making strategic progress with its lead candidate TPI 287 for glioblastoma multiforme (GBM), an aggressive brain cancer with limited treatment options. The company has successfully transferred Orphan Drug Designations from Cortice Biosciences, which provides regulatory advantages and market exclusivity if approved.

The most compelling aspect of TPI 287 is its preliminary efficacy from a Phase 1 trial where the drug combined with bevacizumab (Avastin) demonstrated 3 Complete Responses and 9 Partial Responses among 23 evaluable patients - a response rate of approximately 52%, which is noteworthy for this difficult-to-treat indication. As an abeotaxane, TPI 287 works similarly to established taxanes like paclitaxel, but crucially appears capable of crossing the blood-brain barrier, a significant advantage for treating CNS tumors.

Financially, the company reported a net loss of $4.3 million for Q1 2025, up from $3.5 million in the comparable period, primarily due to data preparation costs for their Berubicin trial. R&D expenses increased to $3.2 million from $2.5 million, while G&A expenses slightly decreased to $1.09 million.

The company's cash position of $13.1 million at quarter-end, supplemented by a $5 million public offering completed in May 2025, provides runway into the second half of 2026. This should fund their planned Phase 2 study of TPI 287 scheduled to begin around year-end 2025, following anticipated FDA discussions on study design potentially aimed at registration for recurrent GBM.

While the company continues to develop its programs, investors should note the increasing net loss and the focus shift from Berubicin to TPI 287 as their lead program, suggesting a strategic reprioritization of their pipeline.

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.

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, 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.

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 CNSP's Q1 2025 financial results?

CNS Pharmaceuticals reported a net loss of $4.3 million, with R&D expenses of $3.2 million and cash position of $13.1 million as of March 31, 2025.

What are the Phase 1 trial results for TPI 287 in glioblastoma patients?

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

How long will CNSP's current cash runway last?

With $13.1 million cash on hand plus $5 million from a recent public offering, CNS Pharmaceuticals expects to fund operations into the second half of 2026.

What are the Orphan Drug Designations for CNSP's TPI 287?

TPI 287 has Orphan Drug Designations for treatments of gliomas, pediatric neuroblastoma, and progressive supranuclear palsy.

When will CNSP start Phase 2 trials for TPI 287?

CNS Pharmaceuticals plans to commence Phase 2 study for TPI 287 in glioblastoma multiforme around year-end 2025.