- In a video message to shareholders, CEO John Climaco detailed the operational and clinical progress made by lead drug candidate Berubicin despite market volatility and share price fluctuations
- CNS is currently enrolling patients into a potentially pivotal global drug trial of Berubicin for recurrent glioblastoma multiforme
- Interim analysis of the trial is currently expected as early as the first quarter of 2023, once 30-50% of trial patients have been on the study for six months
CNS Pharmaceuticals (NASDAQ: CNSP), a clinical-stage biotech company specializing in developing novel treatments for primary and metastatic cancers of the brain and central nervous system, has released a video to its shareholders that reiterates the operational and clinical progress of its lead drug candidate, Berubicin. The video features CNS CEO John Climaco and addresses the recent share price activity (https://ibn.fm/Z40Gw).
“The divergence that exists between our operational strength and share price is top of mind for myself and the whole team at CNS Pharmaceuticals. As a shareholder of CNS Pharma, I share in the frustrations as it pertains to the share price and fluctuation in the market – both of which are things out of our control,” Climaco said in his video message. “However, as the CEO, what I do have control over is executing on the day-to-day operations, which I want to reiterate and emphasize have simply never been stronger.”
Climaco went on to detail the company’s operational strengths, including the fact that it continues to enroll patients in its potentially pivotal global study of Berubicin in the treatment of adult glioblastoma multiforme (“GBM”). “We have the leading minds in the field around the world working on this trial with us, and we have encouraging ongoing dialogue with the FDA to ensure that our potentially pivotal trial continues to represent the state-of-the-art in the field,” he said.
The CNS CEO also underlined that his company remains committed to continuing to execute its operational excellence to drive recognition in the market of Berubicin and its immense potential for patients – the key driver for ultimately generating shareholder value and tremendous hope for GBM patients worldwide. “We put our heads down every day and continue to charge forward in our mission to change the game in glioblastoma via Berubicin,” Climaco added.
The video comes days after the company released its full-year 2021 financial results and corporate update, highlighting key milestones during the previous year, including (https://ibn.fm/Lb1r3):
- May 2021 – Beginning of patient enrollment for a potentially pivotal global study evaluating the efficacy of Berubicin for adult recurring GBM
- June 2021 – Granting of Fast Track Designation by the FDA for recurrent GBM treatment with Berubicin
- September 2021 – First patients from potentially pivotal study dosed with Berubicin
- December 2021 – Approval from “swissethics,” the umbrella organization of the Ethics Committee (“EC”) in Switzerland, for the potentially pivotal study of Berubicin for treatment of recurrent GBM to proceed in Switzerland
- January 2022 – Announcement of $11.5 million private placement, priced at the market under NASDAQ rules
CNS plans to expand the potentially pivotal study of Berubicin in recurrent GBM into additional countries and complete the enrollment needed for the interim analysis of the study within the year. The interim analysis of the trial will occur when 30-50% of the total expected patients have been on the study for at least six months, which is anticipated during the first half of 2023.
Berubicin is a novel anthracycline and the first that appears to cross the blood-brain barrier. It is currently in development for the treatment of a number of serious brain and oncology indications. The first trial of the drug was initiated by Reata Pharmaceuticals over 16 years ago. It resulted in one patient surviving cancer-free, and two others reporting a reduction in tumor size of up to 80%.
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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