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CNS Pharmaceuticals Inc. (CNSP-8.00%) has submitted its 10-K filing for the fiscal year ended December 31, 2024.
The filing details the company's focus on developing anti-cancer drug candidates, specifically TPI 287 and Berubicin, for treating brain and central nervous system tumors. CNS Pharmaceuticals is working under license agreements with Cortice Biosciences, Inc. and Reata Pharmaceuticals, Inc.
The company highlighted that Berubicin has been granted Orphan Drug Designation by the FDA for the treatment of malignant gliomas, which may enable market exclusivity for seven years upon approval.
CNS Pharmaceuticals reported a net loss of approximately $14.9 million for the year ended December 31, 2024, compared to a net loss of approximately $18.9 million in 2023. The decrease in net loss was primarily due to reduced research and development expenses.
The company does not have manufacturing facilities and outsources all manufacturing activities to third parties. CNS Pharmaceuticals also does not have a sales organization.
CNS Pharmaceuticals has entered into various agreements, including a Collaboration and Asset Purchase Agreement with Reata Pharmaceuticals and an Exclusive License Agreement with Cortice Biosciences, Inc., to secure intellectual property rights for its drug candidates.
The company raised approximately $23 million in net proceeds from the issuance of common stock during the year ended December 31, 2024. These funds are intended to support the ongoing development of its drug candidates.
CNS Pharmaceuticals acknowledges the need for substantial additional capital to continue its clinical development and commercialization activities. The company estimates it has sufficient capital to operate into the first quarter of 2026.
The company is exploring potential paths forward for Berubicin following a clinical trial that did not demonstrate a statistically significant difference in overall survival compared to Lomustine, a current standard of care.
CNS Pharmaceuticals' management has identified material weaknesses in its internal controls over financial reporting, primarily due to a lack of segregation of duties and limited access to timely data from third-party contract research organizations.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the CNS Pharmaceuticals Inc. annual 10-K report dated March 31, 2025. To report an error, please email earnings@qz.com.