- CNS Pharmaceuticals is a biopharmaceutical company that focuses on developing novel treatments for primary and metastatic cancers in the brain and central nervous system
- The company is currently evaluating the efficacy of Berubicin, a novel anthracycline that appears to cross the blood-brain barrier, in a potentially pivotal Phase 2 trial involving patients with recurrent glioblastoma multiforme (“GBM”)
- CEO John Climaco recently participated in the Virtual Investor “Ask the CEO” Event in which he provided an update on recent key events and plans for the future in addition to allaying the investors’ concerns regarding the recent reverse stock split
- CNS Pharmaceuticals also announced the pricing of a public offering that closed December 5; the company intends to use the net proceeds of the offering for its ongoing trial, R&D, and working capital
CNS Pharmaceuticals (NASDAQ: CNSP) CEO John Climaco recently participated in the Virtual Investor “Ask the CEO” Event held December 6. As part of the virtual event, Climaco discussed his and the company’s background, provided an update on recent key events and plans for the 2023 calendar year, and assuaged investors’ concerns regarding the recent reverse stock split. Lastly, Climaco also fielded questions from the investment community (https://ibn.fm/bEl2S).
A clinical-stage biopharmaceutical company focused on developing novel treatments for primary and metastatic cancers in the brain and central nervous system, CNS Pharmaceuticals is presently enrolling patients in a potentially pivotal Phase 2 trial to evaluate the efficacy of Berubicin, its flagship drug candidate for the treatment of glioblastoma multiforme (“GBM”) and potentially other forms of cancer. So far, according to Climaco, the enrollment is approaching 70 patients against a target of 243 patients, a remarkable achievement since it began about 14 months earlier.
“Patients are a lifeblood of a trial like this,” Climaco explained. “Our target is recurring and refractory GBM patients, and sadly in this deadly cancer, almost everyone will recur. And when they do, they do not have any approved treatment option anywhere in the world…. We’ve now offered those patients a chance at a chemotherapy that we believe can have efficacy and change the outcome of this disease.”
GBM is an aggressive brain tumor with an average overall survival rate of only 10-12 months. “Most patients experience recurrence or progression of their disease within 12 months after frontline therapy and face a dismal outcome with no effective therapy,” a 2019 study explains (https://ibn.fm/q6snr). This lack of effective therapy is partly because conventional anthracyclines cannot cross the blood-brain barrier. But Berubicin changes this narrative as it is the first anthracycline with the demonstrated ability to cross this barrier and kill brain tumor cells otherwise unreachable by other therapies. “In other words,” the company’s website underlines, “Berubicin may become an effective treatment against glioblastoma, the most aggressive type of brain cancer.”
To prove this hypothesis and demonstrate the drug candidate’s efficacy, CNS Pharmaceuticals set out to undertake an elaborate potentially pivotal Phase 2 trial designed in close collaboration with the US Food and Drug Administration (“FDA”). The trial aims to establish whether Berubicin extends overall survival, the primary endpoint of the trial and, as Climaco explained, “the only endpoint the FDA recognizes as the approvable endpoint.”
The trial’s design encompasses a built-in interim analysis that will commence when the company enrolls 30-50% of the targeted figure and will last for six months. “When that [six-month period elapses], we will examine that data, and we will look to see if those patients are living longer than they are in the control arm. And if they are, and we believe they will, the study will continue. Our firmest hope is the data will be so conclusive that we may have the opportunity to discuss an accelerated approval with the FDA,” Climaco continued.
CNS Pharmaceuticals expects to release the data from this interim analysis, potentially in mid-2023. The company believes that Berubicin, an anthracycline, has a real shot at changing the game in GBM in a way no one else has been able to do before. At the same time, the company believes Berubicin could be used to treat multiple other cancers, with Climaco describing the drug candidate as a “sledgehammer in oncologists’ toolkit.”
Moreover, Climaco explained the reasons behind the company’s move to undertake a 1-for-30 reverse split of its common stock, which was announced November 28 (https://ibn.fm/wTksP). The split freed up shares, allowing the company to announce a $6 million public offering that closed December 5 (https://ibn.fm/2Ikp9).
As part of this latest capital raise, CNS announced the pricing of a public offering of an aggregate of 1,889,764 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 1,889,764 shares of common stock at a combined offering price of $3.175 per share. The warrants were immediately exercisable at an exercise price of $3.03 per share and will expire five years after the initial exercise date. In addition, CNS also announced amendments to certain existing warrants.
CNS Pharmaceuticals intends to use the net proceeds of the offering for its Phase 2 clinical trial, other research and development initiatives, and working capital. Following this most recent capital raise, the company is fully funded until late Q3 into early Q4 2023.
A recording of the Virtual Investor “Ask the CEO” Event is available for 90 days post-event via https://ibn.fm/7aFjv.
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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