Here is my opinion, BL's copy of the article since

Here is my opinion, BL's copy of the article since I can't access it, and BL's opinion last.

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The drug is an injectable antibody, making it less convenient and more expensive than standard HIV pills.

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I agree about the money being an issue. I don't agree about injectable once a week. My daughter takes a once a month at home b12 injection for her low b12 levels. A daily pill in another option, but once a month injectable is more convenient.

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Biotech penny stocks are ignored by most investors and therefore struggle to raise the money necessary to develop drugs. CytoDyn is no exception. The company’s shares trade on an over-the-counter exchange and it’s perennially short of cash.

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I agree here.

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. Selzentry was approved in 2007 but generated just $150 million in 2018 sales for GlaxoSmithKline. The FDA approved Trogarzo one year ago; sales were $4.25 million in the last reported quarter ending Nov. 30, 2018, according to Theratechnologies, the drug maker that markets the treatment.

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I don't see a way to compare Maraviroc and IZ with leronlimab mono. Maraviroc can have serious side-effects and was given in combo; IZ is given with IV. Leronlimab with mono is much more attractive. The comparison is not valid here.

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The company started the FDA submission process but it won’t be complete until additional leronlimab safety data are collected. When that happens seems to be a moving target.

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The moving target is valid, it has been moving. This 700mg safety data will be the last curve ball from the fda in my opinion.

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? Leronlimab peak HIV sales potential of $11 billion? That figure would make it the most commercially successful HIV drug of all time. Please, that’s just not credible,

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I disagree. Monotherapy approval would a first ever breakthrough in HIV, attracting a lot of people to switch from daily pills, sometimes toxic, to once a week injectable with a great safety profile. I could see especially those on maraviroc switching quickly as they already know their type is ccr5. If it is approved for mono, leronlimab could very well be the most commercially successful HIV drug of all time. I'm not even sure af is aware of mono, as it was not mentioned. I guess this is better than his last review of 'total scam' Maybe each time his review will improve until he joins the movement around the time we get good cancer data.



Article

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CytoDyn claims to be developing a new drug for HIV that will fundamentally change the way the disease is treated, deliver billions of dollars in revenue, and end the HIV market dominance of Gilead Sciences. It’s an enticing investor pitch that’s often echoed across biotech investing message boards and DIY investing websites like Seeking Alpha.

Unfortunately, very little of this overly optimistic CytoDyn story is likely to ever come true. CytoDyn might secure FDA approval for its HIV drug, called leronlimab, or PRO 140. And the drug does treat HIV differently than most currently approved HIV drugs, although it’s a stretch to call it a medical breakthrough.

After that, the CytoDyn investor pitch veers off the road. Even if approved, leronlimab is a niche therapy that will be used by a tiny number of patients with HIV resistant to current medicines. The drug is an injectable antibody, making it less convenient and more expensive than standard HIV pills. Revenue might be measured in the tens of millions of dollars per year, if all goes right. Is Gilead worried about its HIV business collapsing from CytoDyn competition? No, hardly.

Related: Taking the measure of small-cap biotech: Fennec Pharma, Actinium Pharma
Leronlimab belongs to a class of HIV drugs called entry (or fusion) inhibitors. These drugs work by blocking the virus from entering healthy immune cells. That’s different from most HIV drugs, which act against the virus after it infects immune cells. Three entry/fusion inhibitors have reached the market, but none generates significant revenue because doctors reserve their use for the small number of patients with multidrug-resistant HIV. Selzentry was approved in 2007 but generated just $150 million in 2018 sales for GlaxoSmithKline. The FDA approved Trogarzo one year ago; sales were $4.25 million in the last reported quarter ending Nov. 30, 2018, according to Theratechnologies, the drug maker that markets the treatment.

Trogarzo is a good comparable for leronlimab. FDA approval was based on a small study of 40 heavily treatment-experienced HIV patients published in the New England Journal of Medicine. It’s also worth reading the accompanying editorial for the concerns raised about interpreting data from such a limited study.

CytoDyn’s registration study for leronlimab enrolled 52 HIV patients with multidrug resistance (although patients were not as sick as those in the Trogarzo study). Results were presented at a medical meeting in June 2018. You can download the poster here. There’s nothing in these leronlimab data that would worry Gilead. At best, CytoDyn’s drug is similar to Trogarzo, with the important caveat that FDA hasn’t vetted leronlimab. The company started the FDA submission process but it won’t be complete until additional leronlimab safety data are collected. When that happens seems to be a moving target.

Leronlimab is also being developed as an injectable maintenance therapy for HIV patients who might want a break from taking a single pill each day. But this idea is already being explored by GlaxoSmithKline with long-acting, injectable versions of its own HIV medicines.

Biotech penny stocks are ignored by most investors and therefore struggle to raise the money necessary to develop drugs. CytoDyn is no exception. The company’s shares trade on an over-the-counter exchange and it’s perennially short of cash. The balance sheet is a mess, bloated with convertible stock offerings and a mountain of warrants. At 51 cents per share, CytoDyn’s market value is just over $150 million. If you count dilution from convertible stock and warrants, the market value already approaches $350 million.

I understand and can even sympathize with CytoDyn’s predicament, but that doesn’t excuse the outlandish claims made in investor presentations. Leronlimab “revenue potential of greater than $480 million” in 2020? Leronlimab peak HIV sales potential of $11 billion? That figure would make it the most commercially successful HIV drug of all time. Please, that’s just not credible, which also explains why CytoDyn is a biotech penny stock.

About the Author

Adam Feuerstein
Senior Writer, Biotech

Adam is STAT’s national biotech columnist, reporting on the intersection of biotech and Wall Street.

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BL's opinion
Here is the relevant text, below.

Notes: (1) no mention of cancer
(2) no mention of GvHD
(3) no mention of monotherapy data

My conclusion: This is no different than a poorly researched SA, other than it is more well-written and researched with respect to combination therapy alone. Anyone that presents such an incomplete picture of CYDY either: (a) has an agenda; or (b) is not competent to do basic research. In any case, logic dictates that their opinion should be taken with a grain of salt. CYDY is absolutely still risky, for the reasons we are all so familiar with (cash, cancer unproven, time delays, etc.), and this article IS CORRECT to the extent it addresses CYDY's perennially cash-poor position. However, CYDY's potential is so much greater than this article addresses.