On July 1, 2021 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, reported a business update (Press release, CNS Pharmaceuticals, JUL 1, 2021, View Source [SID1234584558]).

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Recent Highlights

Secured an additional $4.7 million in gross proceeds from ATM at average price of $2.32; extending the Company’s cash runway to Q2 2022;
Granted Fast Track Designation from the U.S. Food and Drug Administration (FDA) for lead investigational drug candidate, Berubicin, for the treatment of patients with recurrent GBM; and
Commenced enrollment in potentially pivotal study evaluating the efficacy and safety of Berubicin in the treatment of recurrent GBM.
"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," commented John Climaco, CEO of CNS Pharmaceuticals. "Additionally, the $4.7 million of ATM transactions significantly bolsters our cash runway and provides funding to advance our important clinical programs for several quarters to come. We are passionate about driving Berubicin’s development forward, creating value in the near- and long-term, and most importantly making a positive impact on patients lives."

Clinical Programs Update

Berubicin – Novel anthracycline

CNS’ lead product candidate, Berubicin, is a novel anthracycline and the first anthracycline to appear to cross the blood-brain barrier. Berubicin is currently in development for the treatment of a number of serious brain and CNS oncology indications. The Company recently announced the commencement of its potentially pivotal study evaluating the efficacy of Berubicin in the treatment of adult GBM, one of the most aggressive types of brain cancer. Patient dosing is expected to commence in the third quarter of 2021.

The FDA recently granted CNS Pharmaceuticals Fast Track Designation for Berubicin which enables more frequent interactions with the FDA to expedite the development and review process. As previously announced, the Company also received Orphan Drug Designation from the FDA which may provide seven years of marketing exclusivity upon approval of an NDA.

For more information about the potentially pivotal Berubicin trial, visit clinicaltrials.gov and reference identifier NCT04762069.