PORTLAND, Ore. (KOIN) — A biotech company in Vancouver, Washington expects to release its trial data for severe to critically ill coronavirus patients as soon as next week, pending discussions with federal and international regulators. The company — and investors — are betting big on its potential on multiple fronts, and the stock price has taken a wild ride in the last year from .81 cents to a high of $10.01 and everywhere in between as bets were made on whether the drug would prove to be a viable treatment.
CytoDyn’s leronlimab (which has the tentative trade name Vyrologix) was originally intended for HIV treatment, but has shown promise with countless other diseases, according to CEO Nader Pourhassan.
“We have some very fantastic product in our hand and we are very determined,” Pourhassan said.
Leronlimab is a monoclonal antibody directed against CCR5, supposedly inhibiting viral entry and protecting healthy T cells from infection.
The U.S. Food and Drug Administration has not given it market approval yet, but Pourhassan makes leronlimab sound like a miracle cure.
In addition to HIV treatment and prevention, leronlimab has been in a trial for 22 different cancers, is almost done with a Phase 2 trial for Nonalcoholic steatohepatitis (NASH), has implications in multiple sclerosis, Parkinson’s and more, according to Pourhassan.
Most recently, the company saw it as a potential treatment for COVID-19.
It’s now in the final stages of a Phase 2b/3 randomized, double-blind, placebo-controlled study into its safety and efficacy in patients with severe or critical COVID-19 symptoms. Nearly 400 patients at numerous hospitals — including OHSU and Good Samaritan Hospital Corvallis — participated.
Last year, CytoDyn requested an Emergency Use Authorization (EUA) from the FDA for COVID-19 treatment. If the FDA approves the EUA, Pourhassan said the company will have to ramp up production. Currently, they have about 1.3 million vials of product, he said, and would need to request more from Samsung Biologics, which manufactures leronlimab.
They’re also currently enrolling for an exploratory trial on coronavirus longhaulers.
Cytodyn’s stock, meanwhile, has fluctuated wildly, especially in the past few weeks as questions about the trial data trickled out. Passionate investors, like Battle Ground resident Matt Elerding, aren’t overly concerned. To the contrary, when the stock went down to the low $4 range last week, he bought more shares.
“I think that those who have been invested for a while understand that it is a slow and methodical process,” he said. “You do have the people who jump in you know, four months ago and now are like, ‘Am I a millionaire yet?'”
Pourhassan doesn’t show any doubts either. KOIN 6 News asked him if he stood by earlier statements that the stock value could hit the triple digits. He said yes, adding that each one of the numerous clinical trials could result in hundreds of billions of dollars in revenue if they’re approved.
“I’m being very conservative when I said three digit,” Pourhassan said.
As an over-the-counter (OTC) stock, CytoDyn is susceptible to “short attacks,” Elerding said, similar to the GameStop saga. CytoDyn enthusiasts and skeptics trade barbs in article comment sections and platforms like Reddit. As part of the former group, Elerding has no tolerance for what he views as misinformation and rumors being spread online in an effort to drive down prices.
“I’m a little turned off and disgusted by that approach, the fact that you can just go onto a social media platform and spread lies and deceit to basically make yourself money,” he said. “Especially when we’re dealing with a drug that has the potential to save human life.”
Elerding is quick to disclaim that he’s not a financial expert, and hasn’t invested more in CytoDyn than he’d be comfortable losing, since biotech companies can be very risky. If he went all in, he’d have to face the wrath of both his financial advisor and his wife.
“I’ve always always always seen this CytoDyn investment as kind of one of those little fun little side things,” he said. “If it happens, you know, great. And if it doesn’t, eh. It makes for a good story.”