An endgame could be coming into focus for CytoDyn.
The Vancouver biotechnology firm intends to file with the U.S. Food and Drug Administration to take its HIV treatment to market, after spending roughly $150 million to development the treatment over the last six years.
Although regulatory approval — or denial — could take six more months, CEO Nader Pourhassan is optimistic. He said the treatment, a self-injectable antibody called PRO 140, has undergone eight clinical trials since 2000.
“It’s a pretty good indication that we have something very major here,” he said. CytoDyn purchased the treatment in 2012 from its original developer, Progenics Pharmaceuticals Inc.
If approved, CytoDyn could begin hiring teams to market and sell PRO 140, which would be used in conjunction with other treatments. Pourhassan acknowledged it’s possible that larger pharmaceutical companies could make an offer to buy CytoDyn and its property outright.
“If someone comes and offers us what we think we’re worth, we’re done,” he said. “But if we don’t get the offer we want or any offer at all, which is possible, then we’ll take it to market ourselves. We have the capability to do that.”
Regulatory filings show CytoDyn is making changes to prepare. On June 26, it announced raising an extra $5 million from a private institutional investor. Then, last week, two members of its board of directors stepped down.
Pourhassan told The Columbian Wednesday that at least one of those board seats could be filled by Dr. Richard Pestell, a well-known oncologist and academic, who has a company CytoDyn now hopes to acquire.
“We want to have more visibility. It’s very important to be visible and be able to tell the scientific community, investment community, what we have,” he said. “Without that we wouldn’t be able to be successful to get to the finish line.”
CytoDyn is a publicly traded company sold over the counter on the OTCQB Venture Market. Traded as CYDY, shares closed trading Wednesday at $0.60, up 5 cents.
Correction: A previous version of this article stated CytoDyn had already filed for federal approval to take its HIV treatment to market. Rather, the firm announced its intentions to file.