CD12 interim moet vandaag of morgen binnenkomen...Het enige patroon dat ik bij dit bedrijf tot nog toe heb kunnen ontdekken is dat Nader vooraf juicht en dat het dan toch tegenvalt...
CytoDyn: COVID-19 High Anxiety
Oct. 15, 2020 7:44 AM ET|
CytoDyn's prospects as a potential lead therapeutic for mild-to-moderate COVID-19 are looking much diminished.
CytoDyn is facing a key catalyst within days as regards mortality in its severe/critical COVID-19 trial.
CytoDyn's rush to assure adequate supplies of leronlimab, a molecule which has yet to be approved anywhere for anything, presents jumbo challenges.
I took on a role as chronicler of the tales of CytoDyn (OTCQB:CYDY) with enthusiasm over recent months. I wrote articles, participated in comment streams, purchased and sold shares (on the long side only) and generally edified myself as I hibernated in COVID-19 induced isolation.
After a longish period as a strong CytoDyn skeptic, I had moved from a bearish view to a neutral stance and then cautious optimism. In the first bullish article, "CytoDyn's COVID-19 Game Changer", I tried to draw a nuanced portrait of CytoDyn's risks compared to its prospects.
Such article featured a bullet point that "CytoDyn's leronlimab is shaping up as a prime contender to be a preferred COVID-19 therapeutic". I would be hard pressed to make that statement today. This article reviews recent developments that have diminished CytoDyn's prospects.
Early shareholder optimism around leronlimab in treatment of mild-to-moderate COVID-19 is fading
CytoDyn was early in advancing its leronlimab as a COVID-19 therapy. Its EIND program success was highly suggestive that leronlimab would prove out as effective in treating COVID-19. More importantly, CytoDyn mapped out a phase 2 clinical trial ("CD10") for mild-to-moderate patients and a phase 2/3 trial ("CD12") for severe/critical patients.
CD10 was a trial designed for 75 patients, although 86 were actually treated. It required 14 days of weekly treatments with 700 mg leronlimab or placebo with study participants randomized 2:1. The primary outcome measure was:
CytoDyn's CEO Nader Pourhassan (hereafter "NP") encouraged shareholders to expect quick readouts of the data from CD10. As it turned out, CytoDyn began reporting driblets in various press releases. In what has become a tedious stylistic trope, the headlines for the releases have been overblown with the content often unremarkable.
This was particularly true of CytoDyn's first such release in the early hours of 7/21/20, subsequently corrected a few hours later, as discussed in "CytoDyn's COVID-19 Trial Tribulations". The bottom line is that CD10 missed its primary endpoint.
In a subsequent 8/11/20 press release, CytoDyn announced that CD10 achieved statistically significant results in a key secondary outcome measure, National Early Warning Score 2 scale (NEWS2). In its 8/12/20 conference call CytoDyn announced that it had applied to the FDA for an emergency use authorization [EUA] based on the "fantastic" NEWS2 news.
As far as I have been able to tell, this was the situation that shareholders thought was applicable until NP's 9/23/20 interview with Dr. Been. In this interview NP explains that CytoDyn ran the idea of applying for an EUA by the FDA but elected not to when it became clear that it was unlikely to succeed.
Leronlimab in treatment of severe/critical COVID-19 presents a catalyst expected in days
As for CD12, it is a bigger phase 2b/3 trial with a longer treatment period. Full enrollment requires 390 patients, although as a phase 2b/3 trial there will be a preliminary read out when half of the participants have been treated. The treatment is the same as CD10 but extended to include weekly doses of 700 mg leronlimab or placebo for 28 days, randomized 2:1.
The action for CytoDyn at the current point is all about CD12. During CytoDyn's 8/12/20 conference call, NP advised that 175 patients had been enrolled, just 20 less than the 195 required for the interim analysis. By 9/23/20 NP advised during his Dr. Been interview that enrollment stood at ~215. He rightly noted the criticality of completing the trial avowing an intent to do so by the close of 2020 with data submitted to the FDA.
Moving on to CytoDyn's 9/30/20 shareholder's conference, CytoDyn issued the following slide relevant to CD12 (discussed 24:05-25:20/1:16:01). During the discussion on CD12, NP emphasized how information already known from the EIND and from the safety look following 100 patients treated derisked the situation. He posited that the interim analysis presents the potential first time a COVID-19 trial hits a primary endpoint of mortality.