• Company expects reporting on interim analysis for the first 18 patients of a Phase 2 multicenter clinical trial of Berubicin in adult GBM patients during the first half of 2022
• One patient from the first Berubicin trial has survived cancer-free for 14 years, while two patients saw tumor reduction of up to 80 percent
• CNS Pharmaceuticals reported a net loss of $3.6 million, attributed to increased personnel, activity preparing for clinical trials, drug manufacturing, and labor for the Phase 2 study
• The global brain tumor therapeutics market is expected to grow at a CAGR during 2020-2025, resulting in forecasted market size of $1.6 billion by 2025

CNS Pharmaceuticals (NASDAQ: CNSP), a developer of novel treatments for primary and metastatic cancers of the brain and central nervous system, recently reported the summary of financial results for the first quarter of 2021. For the period ending March 2021, CNS reported research and development expenses in excess of $2.2 million, compared to $0.6 million for the same period in 2020 (https://ibn.fm/6GRIf). The expenses incurred are due to the drug manufacturing and labor related to the preparation for the Phase 2 study. An approximate total of $1.4 million was spent on general and administrative expenses, which is in line with the $1.3 million spent during the same period in 2020. 

The company reported that the three months ending March 2021 resulted in a net loss of approximately $3.6 million compared to the approximately $2.0 million for the comparable period in 2020. CNS attributes the net loss to increased personnel and activity associated with preparing for the company’s clinical trials in 2020. 

Berubicin, CNS’s lead drug candidate, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier based on limited clinical data. The company is currently developing Berubicin to be used to treat several serious brain and central nervous system oncological indications and plans to commence patient enrollment in a potentially pivotal study to evaluate the efficacy of Berubicin for adult Glioblastoma Multiforme (“GBM”) in the second quarter.

Additionally, the company’s sublicensee partner in Poland, WPD Pharmaceuticals, will initiate a Phase 2 multicenter clinical trial of Berubicin in adult GBM patients in the second half of 2021, and is expected to report an interim analysis of the first 18 patients during the first half of 2022.WPD Pharmaceuticals is also scheduled to launch the first-ever Phase 1 pediatric trial for Berubicin, sometime during H2 2021.

The first clinical trials of Berubicin were completed in 2006 by Reata Pharmaceuticals Inc. Since then, one of the original patients from the trial has survived 14 years cancer-free, while two additional participants saw tumor reduction of up to 80 percent.

At this time, the Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to Berubicin, providing CNS seven years of marketing exclusivity upon approval of an NDA. CNS intends to file for additional patents on Berubicin to further secure intellectual property.

CNS CEO John Climaco underlined that 2021 is poised to be an exciting year for the company. “Throughout the first quarter, we have made continued development and regulatory progress on all fronts. We are committed to driving our novel treatments forward as expeditiously as possible with the primary focus on our Berubicin program to improve patient outcomes for GBM,” Climaco said.

Despite the progress being made in surgical procedures and other therapies, effective treatments for brain tumors are limited by the lack of specific therapies for the brain. A significant amount of these setbacks has to do with the inability to cross the blood-brain barrier. Berubicin is the first to be able to accomplish this task, enabling CNS Pharmaceuticals to secure a unique position on the expanding brain tumor therapeutics market. The global brain tumor therapeutics sector was valued at $1.1 billion in 2019, and is expected to grow at a CAGR of 10%, reaching a total of $1.6 billion by 2025 (https://ibn.fm/9DYsF). 

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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