WPD and CNS Pharmaceuticals Announce Positive Opinion of the Polish Central Ethics Committee for the WPD-201 Study and Central IRB Study Level Approval for the CNS-201 Study - Seite 2

“We are pleased for WPD to achieve this key milestone and are encouraged by their continued execution in furthering the development of Berubicin,” commented John Climaco, CEO of CNS Pharmaceuticals. “Importantly, we believe WPD’s Ethics Committee approval of the WPD-201 Clinical Trial Protocol coupled with our recent IND approval and Central IRB Study Level approval, position us one step closer to collaboratively initiating three clinical trials for Berubicin during 2021. We look forward to continuing our trial preparations, as well as WPD’s planned submissions to the Polish Competent Authority.”

Following the sublicense agreement, WPD was subsequently awarded a reimbursement grant for further development of Berubicin that was valued at $6 million upon the date of the grant from the Polish National Center for Research and Development under Smart Growth Operational Program 2014-2020 co-financed by the European Union. WPD plans to initiate both a multicenter Berubicin Phase 2 adult GBM trial in the first half of 2021 and a multicenter pediatric malignant glioma Phase 1 clinical trial in 2021. Roughly 60% of the program budget is expected to be funded by the reimbursement grant.

CNS Pharmaceuticals has received approval to proceed with their previously submitted Investigational New Drug (IND), from the U.S. Food and Drug Administration (FDA) for Berubicin in the treatment of GBM. The Company plans to initiate its Phase 2 trial evaluating the efficacy and safety of Berubicin in the treatment of adults with GBM who have failed first-line therapy in the first quarter of 2021. The Company has also received Central IRB study level approval for the U.S. portion of the adult GBM study.

About Berubicin

Berubicin is an anthracycline, a class of drugs among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to damage the DNA of targeted cancer cells by interfering with the action of the topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin was developed at the MD Anderson Cancer Center (MDACC), the world's largest cancer research facility. Berubicin appeared to demonstrate one Durable Complete Response in a Phase I human clinical trial conducted by a prior developer.