CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) Advances Drug Candidate to Fight Aggressive Brain Cancer Amid Difficult Era for Market

• CNS Pharmaceuticals is a U.S.-based drug innovator developing novel chemotherapy agents capable of taking the fight against cancerous tumors across the blood-brain barrier to directly attack cancerous growths of the central nervous system 
• The company’s lead candidate is an anthracycline named Berubicin, which has previously shown promise among glioblastoma (“GBM”) patients in a safety study — particularly for one who remains cancer-free more than 15 years later
• CNS is enrolling patients in the United States, Italy, France, Spain, and Switzerland, for the global Phase 2 clinical trial to measure Berubicin’s potential to match or exceed the effectiveness of Lomustine, a standard-of-care chemotherapy agent used to treat GBM
• Berubicin has achieved fast track and orphan drug status from the FDA, opening priority regulatory pathways for the drug if it continues to demonstrate successes through the trial process

Glioblastoma (“GBM”) is a brain cancer that has no cure at the present time and few treatment options for patients. It is the most aggressive primary brain tumor, affecting approximately 13,000 newly diagnosed patients each year in the United States with an average survival time of less than a year after diagnosis. 

While the median age of diagnosis is 64 years and it is most common in men, recent news reports have drawn attention to its diagnosis in a 10-year-old Scottish girl (https://ibn.fm/Rn1lF) and a 39-year-old American teacher (https://ibn.fm/C8plY).

CNS Pharmaceuticals (NASDAQ: CNSP) is working within a competitive worldwide field of biopharmaceuticals to develop a therapy for treating GBM. The company’s lead drug candidate is a novel anthracycline named Berubicin that has set itself apart from other potential therapies because of its apparent ability to cross the blood-brain barrier with central nervous system uptake. 

CNS Pharmaceuticals is conducting a potentially pivotal global Phase 2 clinical trial to measure Berubicin’s potential to match or exceed the effectiveness of Lomustine, a standard-of-care chemotherapy agent used in the treatment of GBM patients as the tumor progresses (https://ibn.fm/zNvGr). Patients are being enrolled at 19 sites thus far, with 42 more anticipated across the United States, Italy, France, Spain and Switzerland now that European regulatory approvals have been granted.

The U.S. Food and Drug Administration (“FDA”) has granted “fast-track” and “orphan drug” status to Berubicin, demonstrating the value of CNS’s initial successes in opening regulatory pathways for the drug’s market priority if it can continue to show success in its trial stage. 

Berubicin generated excitement after its initial development by another company more than 15 years ago resulted in a positive finding among patients with recurrent primary brain tumors. The safety study ended with several patients demonstrating clinical benefits (a 44 percent rate) and one of them showing a cancer-free response and ongoing cancer-free survival up to the most recent evaluation during the current COVID pandemic (https://ibn.fm/ExK7y).

It’s a difficult time for biopharmaceuticals — a severe market downturn amid inflationary pressures has challenged companies’ efforts to finance their operations. Walmart’s announcement that its profits would be affected (https://ibn.fm/wYpEw) was just one of the dark clouds appearing ahead of the latest move by the Federal Reserve in late July to use interest rates to combat inflation. Financial analysts at Evaluate Vantage e-magazine reported that out of the more than 600 drug developers they track with a market cap of $250 million or more, only a fifth ended June with their share prices up on the year (https://ibn.fm/NdSf8).

CNS recently announced its own measures to maintain its financial strength amid the tough market pressures as stockholders met July 27 for their annual voting, and CEO John Climaco recorded a video message to personally explain the company’s strategy in regard to the potentially “controversial” vote to authorize a reverse stock split to be used as a tool if the board finds it necessary. 

“We simply cannot allow the company to be at the mercy of those market headwinds,” Climaco said in promoting the company’s market strategy (https://ibn.fm/hZy4y). “Our trial is going beautifully; the work of the last four years. We can see the interim analysis point just over the horizon next year. And we just feel as a board, and myself as the chairman, very passionately that we must have these tools in place to adapt to market conditions should they be needed.”

CNS is also in the process of developing an anthracycline-based drug candidate labeled WP1244 that is believed to be 500 times more potent than chemotherapy agent daunorubicin in stopping tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity, according to the company. 

For more information, visit the company’s website at www.CNSPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to CNSP are available in the company’s newsroom at https://ibn.fm/CNSP

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