Public drug and device companies may want to think twice before eagerly jumping on the COVID-19 bandwagon with announcements overselling their efforts to develop or repurpose products to treat patients infected with the coronavirus.
The SEC imposed 14-day trading suspensions, which started Thursday, on two developmental-stage drug companies, due in part to the “accuracy and adequacy” of COVID claims in press releases. Trading for Signpath Pharma Inc. (US OTC:SGTH) and Bioxytran Inc. (OTCMKTS:BIXT) will be suspended until 11:59 p.m. April 29, 2020. While Signpath’s shares are at zero, Bioxytran closed trading Tuesday at 25 cents.
In suspending Newton, Mass.-based Bioxytran, the SEC said questions had been raised about information the company provided in press releases, blog posts and a podcast between Feb. 5 and March 25, 2020, about its ability to develop a drug to mitigate or treat COVID-19.
The commission also had concerns about possible manipulative trading of Bioxytran’s stock, including certain transactions between Jan. 21 and Feb. 28, 2020.
Bioxytran issued a press release Feb. 5 touting the potential of its lead candidate, BXT-25, to treat end-stage COVID-19 patients with acute respiratory distress syndrome (ARDS) and announcing its intention to explore partnering with international drug companies.
“This could be a major advancement in the treatment of end-stage patients infected with the Wuhan coronavirus. … We believe that potential partners will recognize that we have an immediate solution to treat acute patients with BXT-25,” Bioxytran CEO David Platt said in the press release.
The company also said it had the opportunity to upgrade MDX Life Sciences Inc.’s MDX Viewer to enable remote monitoring of oxygen consumption of the organs after a drug is taken. “This is such a fundamental concept that we feel confident that we will be successful partnering for the ARDS due to the Wuhan coronavirus indication,” Platt said.
Last month, Bioxytran issued two more press releases about its COVID-19 efforts. It reported March 24 that it had reached what could add up to a $4.5 million exclusive global licensing deal with Platt to develop and commercialize a galectin inhibitor that could potentially treat the coronavirus.
“Our rationale for a viral entry inhibitor is based on extensive scientific evidence. We believe that our drug candidate can eliminate COVID-19,” Platt said in the release.
A week later, Bioxytran announced that it had posted a slide deck about BXT-10, a galectin inhibitor being developed to take on the coronavirus. The slide deck claimed a galectin inhibitor was the “ideal drug” for COVID-19, because it has prophylactic properties that could “stop the viral expansion dead in its tracks,” could reduce the viral load of people who are infected and could stop the trafficking of suppressor cells designed to silence the immune response.
In announcing the slide deck, Platt said, “With the proper funding, the company could be in human trials shortly.”
Since shares of Signpath have been at zero, the trading suspension could be a moot point for the Sandy, Utah-based company. The temporary suspension is due to questions and concerns regarding the accuracy and adequacy of publicly available information about the company, including a claim Signpath made March 17, 2020, about its development of a COVID-19 treatment, the SEC said. The commission also cited a lack of current financial information about the company in the marketplace.
Last month, Signpath reported it was exploring ways to expedite opportunities for utilizing Lipocurc (liposomal curcumin) in clinical settings to treat patients with COVID-19 or other viral diseases that can trigger a cytokine storm. The intravenous formulation initially was being developed as a cancer treatment.