CNS Pharmaceuticals Continues to Execute on Corporate, Clinical and Regulatory Strategies to Drive Berubicin Towards Commercialization for the Treatment of GBM

Rhea-AI Summary

CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) announced significant advancements on July 1, 2021, including the securing of $4.7 million through an ATM offering at an average price of $2.32, extending its cash runway to Q2 2022. The company received Fast Track Designation from the FDA for its lead drug candidate, Berubicin, aimed at treating recurrent glioblastoma multiforme (GBM). Enrollment has begun in a pivotal study aimed at evaluating Berubicin's efficacy and safety, with patient dosing expected to start in Q3 2021, marking key milestones in CNS's clinical and regulatory strategy.

Positive

• Secured $4.7 million in gross proceeds from ATM offering, extending cash runway to Q2 2022.
• Received Fast Track Designation from the FDA for Berubicin, facilitating expedited development.
• Commenced enrollment for a pivotal study evaluating Berubicin's efficacy in treating recurrent GBM.

Negative

• None.

HOUSTON, July 1, 2021 /PRNewswire/ -- 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, today provided a business update.

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.

About CNS Pharmaceuticals, Inc.

CNS Pharmaceuticals a clinical-stage pharmaceutical company developing a pipeline of anti-cancer drug candidates for the treatment of primary and metastatic cancers of the brain and central nervous system. The Company's lead drug 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 including glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer.

Additionally, the Company is advancing the development of its WP1244 drug technology, which utilizes anthracycline and distamycin-based scaffolds to create small molecule agents and is believed to be 500x more potent than daunorubicin in inhibiting tumor cell proliferation. Preclinical studies of WP1244 demonstrated high uptake in the brain with antitumor activity. CNS Pharmaceuticals is evaluating the use of WP1244 in the treatment of brain cancers, pancreatic, ovarian, and lymphomas.

For more information, please visit www.CNSPharma.com, and connect with the Company on Twitter, Facebook, and LinkedIn.

Forward-Looking Statements

Some of the statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, the ability of the Company's cash runway to extend until Q2 2022 and the timing of patient dosing to commence. These statements relate to future events, future expectations, plans and prospects. Although CNS believes the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. CNS has attempted to identify forward-looking statements by terminology including ''believes,'' ''estimates,'' ''anticipates,'' ''expects,'' ''plans,'' ''projects,'' ''intends,'' ''potential,'' ''may,'' ''could,'' ''might,'' ''will,'' ''should,'' ''approximately'' or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including those discussed under Item 1A. "Risk Factors" in CNS's most recently filed Form 10-K filed with the Securities and Exchange Commission ("SEC") and updated from time to time in its Form 10-Q filings and in its other public filings with the SEC. Any forward-looking statements contained in this press release speak only as of its date. CNS undertakes no obligation to update any forward-looking statements contained in this press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 

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SOURCE CNS Pharmaceuticals, Inc.

FAQ

What is CNS Pharmaceuticals' latest funding update?

CNS Pharmaceuticals secured $4.7 million in gross proceeds from an ATM offering.

Has CNS Pharmaceuticals received any FDA designations?

Yes, CNS Pharmaceuticals received Fast Track Designation for its lead drug candidate, Berubicin.

What is the focus of the pivotal study initiated by CNS Pharmaceuticals?

The pivotal study aims to evaluate the efficacy and safety of Berubicin for recurrent glioblastoma multiforme (GBM).

When is patient dosing expected to commence for the Berubicin study?

Patient dosing for the Berubicin study is expected to commence in the third quarter of 2021.