Cytodyn's Great Prospects

Cytodyn is a triple threat with one drug, leronlimab.  First, is its work on HIV over the past years.  Over 800 patients were tested, and since it blocks the CCR5 receptor which is HIV’s known point of entry, it works very well.  A BLA has been applied for in combination with a chemotherapy agent.   The next step will be to do whatever testing is required for leronlimab to be approved as a monotherapy.

It seems to have a wonderful safety profile.  None of the 800 patients died or had serious side effects.

Secondly, they tried it against cancer.  Triple negative breast cancer.  So far, 12 ladies have seen their CTC’s (circulating tumor cells) drop to zero with a once a week injection over three to six weeks.  It was this striking result that attracted me to the company.  Once again, it seems to be the CCR5 receptor that is at the center of all the mischief.  It was their early results with the drug in this breast cancer trial that attracted my attention, and the additional patients appear to confirm the early results.

Now the company has expanded its exploration to other cancers with expression of CCR5 with a basket trial against 22 different kinds of cancers to see if the effect against metastasis plays out in all of those cases.

Here is my piece on the cancer possibilities:

https://biotechintelligence.blogspot.com/2020/05/the-implications-of-cytodyns-basket.html

Thirdly, researcher Bruce Patterson, formerly of Stanford and Northwestern, felt that this same CCR5 receptor might have a role in the cytokine storms that killing people with the coronavirus.   After all, if it blocks CCR5 receptor, known to create cytokine and chemokine mischief, maybe it would work.  He made his case to the CEO Nader Pourhassan, and he and the board have followed him into this unknown territiory.  Apparently, it regulates over-responsive immune systems, and in addition, reduces the viral load.  So, they have been having pretty good luck against Covid, although in the serious cases there are usually other conditions which makes interpretation of results much more complicated. Here is a summary of that luck with serious and critical patients as of April 30, 2020:

https://www.cytodyn.com/newsroom/press-releases/detail/424/cytodyn-reports-strong-results-from-eind-covid-19-patients

There was a conference call yesterday, June 11, 2020, and you can listen to it here:

https://www.cytodyn.com/newsroom/press-releases/detail/438/drs-pourhassan-and-kelly-of-cytodyn-to-hold-conference

In that conference call, they announced that have fully completed the enrollment of the 75 patients in their double blind study of mild to moderate cases of their coronavirus trial.  As I understand it, they need to get a couple weeks of results for these last enrollees, so they will not report any findings until July.  At that time they will have interim results of their results with serious patients.  The FDA at that point will direct them about the need for further testing.  Pourhassan said that major drug companies are waiting to see these results  for possible partnering, and presumably, to make offers for the company.

Pourhassan also said that enough of the drug could be produced to sell $2.5 billion worth of the drug this year, and if it can produce 6 million vials next year, that could generate sales of $9 billion for 2021, which would be astounding for a company with no sales at present, and creates the need for partners for distribution.

Further studies are in the works.  There is interest in a 400 patient trial of leronlimab for alzheimer’s.  I heard talk of the blood brain barrier, but I do not understand the method of action here.  Presumably, cytokines and chemokines may be creating mischief in the brain.  Without further explanation, I would not make this my reason to buy CYDY.

But there are other reasons to buy.  Also announced was a Phase II trial for NASH (non-alcoholic steatohepatitis) three arm study of 90 patients.

https://www.cytodyn.com/newsroom/press-releases/detail/440/cytodyn-initiates-phase-2-clinical-trial-with-leronlimab

And trials are also in the planning stages for multiple sclerosis (MS), Graft versus Host disease (GvH), and the trials for breast cancer, and the basket trial for cancer, which is a test of how leronlimab works in cancers which express the CCR5 receptor, is continuing.

It was disheartening to this writer, after writing multiple articles, to learn that there were other CCR5 blockers in progress.  GlaxoSmithKline (GSK) is working on their compound aplaviroc, Schering-Plough is working on vicriviroc, and Pfizer is working on maraviroc, which has been approved by the FDA, and may be useful against the inflammatory response in strokes (and may which explain why leronlimab works against coagulation in coronavirus).   You can further your education by looking at these Wikipedia articles:

https://en.wikipedia.org/wiki/CCR5

https://en.wikipedia.org/wiki/CCR5_receptor_antagonist

My conclusion, as of now, is that leronlimab is the best of these CCR5 blockers.  Cytodyn’s results have been excellent.  They may generate very significant sales since there is no drug for coronavirus of even remotely close effectiveness.  Remdesivir did not show any effect on mortality, and so was kind of a disappointment.  But after the coronavirus crisis passes, Cytodyn’s leronlimab will generate revenues from HIV, and breast cancer, possibly other cancers, and possibly other conditions – NASH, GvH, multiple sclerosis, alzheimer’s, stroke and other conditions.  The stock price at $3 appears to be low, though there are so many shares (possibly as many as 700 million, fully-diluted) that the market cap is $1.5 billion.  The news from the trials, if good, could see the stock double to $6 in July.  If there are good results from the cancer trials, and sales start up, the train leaves the station, and there could be more remarkable, even quantum leap type of gains.