CNS Pharmaceutical Inc. (NASDAQ: CNSP) announced its business update, including the recent launch of a pivotal study of its flagship program assessing Berubicin in adult Glioblastoma Multiforme (FB) treatment and expects to commence dosing in Q3 2021.
Berubicin receives Fast Track Designation
The company received Fast track Designation for Berubicin from the FDA for recurrent GBM treatment. With the designation, the company will have frequent meetings with the FDA to accelerate the review and development process of Berubicin. The company had previously announced that the FDA had granted it an Orphan Drug designation which could offer marketing exclusivity for up to seven years once the FDA approves the NDA
CNS Pharmaceuticals CEO John Climaco said, “In the last 60 days alone we have achieved fundamental clinical, regulatory and corporate milestones that together demonstrate CNS’ operational, strategic and financial strengths. We are continuously de-risking our Berubicin clinical program by driving development of this truly novel treatment forward as expeditiously as possible. In a mere 18 months from our IPO our laser focus on this program created a potentially pivotal study now open for enrollment with patient dosing expected to commence at any time. With the addition of our recent Fast Track Designation for GBM, we believe we are poised to execute on our milestones ahead and bring a meaningful treatment to patients who suffer from this devasting and heretofore incurable disease.”
CNS Pharmaceuticals bolsters balance sheet with $4.7 million ATM transaction
During the quarter, the company strengthened its balance sheet by securing $4.7 million from ATM transition at $2.32 this expending its cash runway up to the second quarter of 2022. Climaco said that the ATM transaction bolsters the company’s runway and offers funding to help the company advance important clinical programs.