• CNS Pharmaceuticals is focused on advancing its clinical development for the Berubicin drug candidate in order to bring meaningful treatment to GBM patients
• GBM, which has a low survival rate, has limited treatment options when it progresses after first-line therapy
• The company is looking to find a solution with Berubicin and is currently evaluating this drug candidate in a potentially pivotal global study
• CNS’s ongoing R&D efforts are boosted by its strong cash position; in its Q2 2022 report, the company announced it had cash of about $9.0 million and working capital of $10.5 million

CNS Pharmaceuticals (NASDAQ: CNSP), an oncology drug development company specializing in developing anti-cancer drugs for the treatment of primary and metastatic brain and central nervous system (“CNS”) cancer, started 2022 on a high, closing an $11.5 million private placement whose net proceeds the company intended to deploy toward funding its clinical trials and preclinical programs as well as other research and development (“R&D”) activities and general corporate purposes. The additional funding not only boosted the company’s R&D efforts but also enhanced its cash position, as reflected in its subsequent financial reports (https://ibn.fm/GK93f).

In its report for the three months ended June 30, 2022 (“Q2 2022”), CNS Pharmaceuticals had cash and cash equivalents of about $9.0 million and working capital of $10.5 million (https://ibn.fm/UiG9a). And although the figure represented a drop from about $12.4 million and $13.7 million, respectively, recorded in the period ended March 31, 2022 (“Q1 2022”) (https://ibn.fm/ycZXd), the company spent 46% more on R&D in Q2 2022 than in Q1 2022. (Its R&D expenditure in Q2 2022 was $2.2 million.) CNS Pharmaceuticals expects its cash on hand and proceeds from the placement to fund its operations into Q1 2023.

The first half of fiscal 2022 saw the company make a number of clinical and operational advancements in its pursuit of treatment for Glioblastoma Multiforme (“GBM”), according to CNS Pharmaceuticals CEO John Climaco. The company’s focus and priorities, Climaco emphasized, are firmly anchored in the advancement of its clinical development for its drug candidate Berubicin with the aim of bringing meaningful treatment to GBM patients. And as he separately told attendees at the recently held H.C. Wainwright 24th Annual Global Investment Conference, this focus is driven by a significant unmet clinical need, especially given that recurrent GBM does not have “an approved therapy anywhere in the world” (https://ibn.fm/ciFue).

For GBM patients, this unmet need causes anguish that often culminates in death. A 2021 study, for instance, notes, “Once tumors progress after first-line therapy, treatment options are limited, and the management of recurrent GBM remains a challenge” (https://ibn.fm/4ZfEE). Another, a 2015 study, underlines that recurrence is, unfortunately, inevitable, with its management unclear and case-dependent (https://ibn.fm/DRKYF). These characteristics have meant that GBM remains one of the most aggressive primary brain tumors, with a grim prognosis.

Data from the American Cancer Organization shows that GBM has the least 5-year relative survival rate of the various common adult brain and spinal cord tumors in the list. For example, among 20- to 44-year-old patients, the survival rate stands at 22%. This figure drops to 9% among adults aged between 45 and 54 and 6% among those between 55 and 64. In comparison, anaplastic astrocytoma, the condition with the second lowest survival rate in the list, has higher survival rates of 58%, 29%, and 15%, respectively, across the three age categories (https://ibn.fm/IR0ko).

The condition’s aggressiveness is further concretized by the fact that over 10,000 patients succumb to GBM annually in the United States, where 13,000 people are diagnosed with GBM every year the average length of survival for GBM patients is estimated to be only eight months. (https://ibn.fm/hUVew).

With the survival rate and mortality statistics for GBM remaining virtually unchanged for decades, according to the National Brain Tumor Society, CNS Pharmaceuticals is working hard to find a solution. The company is relying on Berubicin, a novel anthracycline whose mechanism of action is inhibiting the topoisomerase II enzyme that causes cell replication and is abundantly found in tumor cells. CNS Pharmaceuticals has observed that the drug, which appears, based on limited clinical data, to cross the blood-brain barrier, is selectively absorbed in cancerous cells and tissue in the brain.

The Berubicin drug candidate solves a problem that has long dogged cancer research for years. Although anthracyclines have existed for the past six decades, they could not cross the blood-brain barrier. CNS Pharmaceutical’s drug candidate, therefore, is the first anthracycline to appear to cross this critical barrier. The company is currently undertaking a potentially pivotal global study evaluating the efficacy and safety of Berubicin compared with Lomustine administered after first-line therapy for the treatment of recurrent GBM.

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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