HOUSTON - CNS Pharmaceuticals, Inc. (NASDAQ:CNSP), a biopharmaceutical company focused on brain and central nervous system cancers, has acquired an exclusive license for TPI 287, a drug candidate for glioblastoma multiforme (GBM), from Cortice Biosciences, Inc.
The agreement, which includes an upfront payment in shares and potential future milestones, aims to advance TPI 287 toward a registration study for recurrent GBM in the United States, Canada, Mexico, and Japan.
TPI 287, a microtubule inhibitor that may penetrate the blood-brain barrier, has been studied in over 350 patients. In a Phase 1 study combined with bevacizumab for recurrent GBM, TPI 287 showed a 60% objective response rate and a 96% disease control rate. Progression-free survival was 5.5 months, and overall survival was 13.4 months, favorable when compared to bevacizumab monotherapy or combination with chemotherapy.
CNS Pharmaceuticals plans to engage with the U.S. FDA for guidance on a study design for TPI 287, with hopes to initiate a study in 2025.
John Climaco, CEO of CNS Pharmaceuticals, expressed that the in-licensing of TPI 287 represents a strategic step in complementing their Berubicin program, and leverages the company's clinical infrastructure and relationships within the Neuro-Oncology community.
The company recently completed enrollment in a potentially pivotal study of Berubicin for GBM treatment, with top-line results expected in the first half of 2025. Berubicin is the first anthracycline believed to cross the blood-brain barrier, and is currently one of the largest GBM studies underway.
Dr. Samuel A. Goldlust, former investigator in the Berubicin study and principal investigator of TPI 287 studies, noted the encouraging data and the need for diverse therapeutic approaches for GBM.
This news is based on a press release statement from CNS Pharmaceuticals.
In other recent news, CNS Pharmaceuticals has made significant strides in its financial operations. The Houston-based biopharmaceutical company recently entered into a sales agreement with A.G.P./Alliance Global Partners (NYSE:GLP), allowing a potential stock sale of up to $5.2 million.
This move is part of an "at the market" equity offering under the company's existing "shelf" registration. Concurrently, CNS Pharmaceuticals also initiated a 1-for-50 reverse stock split to elevate the company's per-share trading price, a strategy designed to meet NASDAQ's minimum price requirement.
CNS Pharmaceuticals has been granted several extensions to demonstrate compliance with the Listing Rule 5550(b), with the most recent extension given until August 12, 2024. The company's strategy includes a waiver agreement with an investor from its February 1, 2024 offering, which will adjust the exercise price of certain warrants as of August 1, 2024.
Amid these financial maneuvers, CNS Pharmaceuticals continues to focus on its main drug candidate, Berubicin, which is under development for various serious brain and central nervous system cancers. These are the latest updates in the company's ongoing efforts to maintain its NASDAQ listing and navigate the financial challenges in the pharmaceutical industry.
InvestingPro Insights
In light of CNS Pharmaceuticals' recent strategic licensing agreement for TPI 287, investors are closely monitoring the company's financial health and stock performance. According to real-time data from InvestingPro, CNS Pharmaceuticals has a market capitalization of $2.98 million. The company's stock is currently trading near its 52-week low, at $1.04 per share, which is only 0.76% of its 52-week high. This reflects a significant decline, with a one-year price total return of -99.03%, underscoring the high-risk nature of investing in biopharmaceutical companies focused on drug development.
InvestingPro Tips reveal that CNS Pharmaceuticals holds more cash than debt on its balance sheet, which may offer some solace to investors concerned about the company's financial stability. However, the company is quickly burning through cash, and analysts do not expect CNS Pharmaceuticals to be profitable this year. With a negative P/E ratio of -0.01 and an adjusted P/E ratio for the last twelve months as of Q1 2024 at -0.17, the company's earnings outlook is currently under pressure.
For investors considering CNS Pharmaceuticals as a potential investment, the company's high price volatility and weak gross profit margins are important factors to consider. Additionally, the company's short-term obligations exceed its liquid assets, which could pose challenges in maintaining operational momentum. For a more comprehensive analysis and additional metrics, investors can explore the full list of 17 InvestingPro Tips available at https://www.investing.com/pro/CNSP. Remember to use coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.