CytoDyn announces Phase 3 trial data, plans to answer investor questions


Leronlimab underwent a Phase 3 trial for patients with severe to critical COVID-19

FILE – Health officials test novel coronavirus samples. (NEXSTAR)

PORTLAND, Ore. (KOIN) — CytoDyn stock tumbled to $2.90 Monday when the markets opened, its lowest price in months. The shift comes after the Vancouver, Washington biotech company announced select results from the Phase 3 trial of it’s drug leronlimab for the treatment of patients with severe to critical coronavirus, and ahead of its live webcast for investors.

CytoDyn announced the trial results Friday after the markets had closed — its stock price was $4.05 at the time.

According to the company, there was a 24% reduction in mortality for patients on leronlimab versus the placebo. The average hospital stay length was reduced by six days, according to a press release.

Nearly 400 patients at numerous hospitals — including OHSU and Good Samaritan Hospital Corvallis — participated in the trial.

After communications with regulators including the U.S. Food and Drug Administration and Health Canada, CytoDyn said it will conduct another study of 140 patients in the critically ill population to try to gain approval in the United States. The primary endpoint for the study will be defined as length of hospital stay, according to CytoDyn.

Meanwhile, the company has started the process to submit an Interim Order with Health Canada, which could allow it to sell leronlimab in the country while additional patients are enrolled in further studies, CytoDyn said Monday.

Leronlimab (which has the tentative trade name Vyrologix) was originally intended for HIV treatment, but has shown promise with countless other diseases, including numerous types of cancers, nonalcoholic steatohepatitis (NASH), Parkinson’s, and multiple sclerosis, according to CytoDyn CEO Nader Pourhassan.

Pourhassan spoke with KOIN 6 News last week, and doubled down on his previous statement that the over-the-counter stock could eventually hit triple digits.

CytoDyn plans to host a webcast Monday afternoon to discuss the COVID-19 data and address questions from analysts and investors. The webcast is at 1 p.m. PST and can be accessed at this link. A recording of the webcast can be viewed after it ends, CytoDyn said.

Questions can be submitted via email to prior to the webcast.

CytoDyn also said it will release the CD12 clinical trial data via a Form 8-K, filed with the Securities and Exchange Commission, after the webcast.

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