Company has one year of cash to fund operations
Company advancing plans to develop TPI 287, a novel, late stage abeotaxane that is potentially blood brain barrier permeable with published clinical efficacy data in glioblastoma multiforme (GBM) for treatment of brain malignancies
HOUSTON, TX / ACCESS Newswire / April 1, 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 full year ended December 31, 2024 and outlined recent corporate and clinical development highlights.
"Oncology drug development can be complex and challenging, but the GBM patients who live with this devastating condition in the shadow of a significant unmet medical need keep us motivated and determined to succeed. Although our recently announced findings from the primary analysis of our Berubicin study did not meet its primary target, it provided valuable insight and proof in a large dataset that Berubicin is safe, well-tolerated and has activity against GBM, attributes that few compounds have ever shown in the last 30 years. As a result, the coming months will be spent in part making preparations to discuss the future of this program with regulatory authorities. Simultaneously we have seamlessly pivoted our scientific, CMC and clinical operations toward the development of TPI 287 to promptly bring this program back to the clinic. Importantly for both efforts, we are in a fundamentally secure position as a company, with a year of cash to focus our resources on the advancement of our entire pipeline," commented John Climaco, CEO of CNS Pharmaceuticals. "Looking ahead, we strongly believe in the potential of TPI 287 to be an important candidate for the treatment of GBM. The published body of data are highly compelling, and we look forward to productive discussions with FDA to best advance its development in the near term."
Clinical Programs Update
TPI 287
In July 2024, the Company entered into an exclusive license agreement with Cortice Biosciences, Inc. for drug candidate TPI 287, which was previously awarded Orphan Drug Designation and studied in over 350 patients to date, including clinical trials as monotherapy and in combination with bevacizumab showing an encouraging clinical efficacy and safety profile at target therapeutic doses.
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.
Berubicin
The Company recently reported results from the primary analysis of Berubicin in second line treatment of glioblastoma multiforme (GBM). The trial compared Berubicin to Lomustine, a current standard of care in GBM. The analysis did not demonstrate statistically significant superiority in overall survival, the primary endpoint. However, although the trial was not powered to determine non-inferiority, the data appear comparable in clinically important endpoints, including overall survival (OS) and progression free survival (PFS), in all patients treated with Berubicin, including those with the most unfavorable tumor markers. Additionally, patients experienced no cardiotoxicity, a risk that curtails the use of other anthracyclines, and the safety profile continues to be favorable in this patient population. Further, the aggregate data facilitate multiple additional clinical analyses for informed hypothesis generation for the Berubicin program as well as for TPI 287 and other future pipeline opportunities.
This study of Berubicin is a multicenter, open-label, randomized controlled study in adult patients with recurrent GBM (WHO Grade IV - IDH Wild-Type), comparing Berubicin to Lomustine, an accepted treatment for second line therapy in this disease. The study has included 252 patients across North America and Europe, randomizing Berubicin to Lomustine 2:1. Continuation of patients on treatment and their follow-up for overall survival is proceeding. Further data will be included in a future analysis.
For more information about the Berubicin clinical trial, visit clinicaltrials.gov and reference identifier NCT04762069.
Summary of Financial Results for the Full Year 2024
The net loss for the year ended December 31, 2024 was approximately $14.9 million compared to approximately $18.9 million for the comparable period in 2023. The change in net loss is primarily attributable to decreased research and development costs.
The Company reported research and development expenses of $9.3 million for the year ended December 31, 2024 compared to approximately $14.1 million for the comparable period in 2024. The decrease in research and development expenses during the period was mainly attributed to a decline in clinical research organization (CRO) expenses and patient treatment costs related to continued progress with our clinical trial for Berubicin.
General and administrative expenses were approximately $5.6 million for the year ended December 31, 2024 compared to approximately $4.8 million for the comparable period in 2023. The increase in general and administrative expense was mainly attributable to increase of approximately $756,000 in professional expenses and $440,000 in employee compensation. These changes were offset by decrease of approximately $104,000 in stock-based compensation, $49,000 in insurance expenses, advertising and marketing of $119,000 and other general and administrative expenses of $52,000.
As of December 31, 2024, the Company had cash of approximately $6.5 million. Subsequent to December 31, 2024, the Company has sold 1,530,985 shares of common stock for net proceeds of approximately $9.9 million. Management anticipates that its cash on hand as of December 31, 2024 combined with capital raised subsequent to year-end is sufficient to fund operations into the first quarter 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 Berubicin is the first anthracycline to appear to cross the blood-brain barrier. Berubicin is the subject of the Company's late-stage, fully-enrolled, global clinical trial for the treatment of glioblastoma multiforme (GBM), an aggressive and currently incurable form of brain cancer. Results of the primary analysis for the study did not demonstrate statistically significant superiority in overall survival, the primary endpoint. However, although the trial was not powered to determine non-inferiority, the data appear comparable in clinically important endpoints in all patients, including those with the most unfavorable tumor markers.
The Company's drug candidate TPI 287 is an abeotaxane which stabilizes microtubules and inhibits cell division, causing apoptosis and cell death. TPI 287 has shown the potential to cross the blood-brain barrier and treat CNS tumors. TPI 287 has been well tolerated in over 350 patients to date, including in clinical trials as a monotherapy and in combination with bevacizumab for the treatment of recurrent glioblastoma, recurrent neuroblastoma and medulloblastoma, advanced malignancies, progressive neoplastic disease, advanced unresectable pancreatic cancer, metastatic melanoma as well as breast cancer metastatic to the brain.
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.
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