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CytoDyn's Lofty Promise

Mar. 03, 2020 8:00 AM ETCytoDyn Inc. (CYDY)494 Comments
Out of Ignorance profile picture
Out of Ignorance


  • CytoDyn bills Leronlimab as some kind of wonder drug.
  • Leronlimab's benign safety profile sets it far in advance of other therapies which attack dread diseases like HIV, cancers and autoimmune diseases.
  • CytoDyn's management has fallen into counterproductive practices that are holding the company back.
  • CytoDyn is definitely hot stuff; yet its finances present a significant ongoing challenge.

CytoDyn (OTCQB:CYDY) promotes its Leronlimab as some kind of wonder drug, a virtual pan-therapeutic. This article discusses such claims, while also cautioning investors to check it out carefully before jumping on the promotion. Due diligence is certainly necessary here. This article will describe the promise and point out concerns.

CytoDyn bills Leronlimab as some kind of wonder drug

Initially, CytoDyn acquired Leronlimab from Progenics (PGNX) because of its potential as a potent therapy to attack HIV. Serendipitously, CytoDyn has found its potential to attack a host of other diseases. In my most recent article on the company, "CytoDyn's Big Bang", I recounted how it was being evaluated in 26 different indications - 22 different cancers and four others.

In preparation for this article, I double-checked CytoDyn's latest (1/21/20) investor presentation. I noticed the following sub-panel to slide 13 which had previously escaped my notice:

Adding this to the mix of 26 possible indications notches a cool 36, making Leronlimab potentially one of the top dogs in all pharma, especially if it should pan out on even just a few.

That is the rub - can it pan out? CytoDyn bulls are convinced that "the science" underlying Leronlimab's favorable prognosis is solid. The company thumbnails the scientific rationale for such optimism as follows:

How Monoclonal Antibodies Came to Be

CytoDyn’s monoclonal antibody, Leronlimab (PRO 140), is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling. Leronlimab (PRO 140) has successfully completed nine Phase 1/2/3 clinical trials with over 800 patients, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients.

It is the italicized trifecta that makes Leronlimab so potentially exciting. Its advantages are further emphasized

This article was written by

Out of Ignorance profile picture
Writing under the pseudonym "out of ignorance", I very much regard investing as a learning process. Investing failures are tuition paid. Investing successes enter the trove of lessons learned. In my Seeking Alpha articles I share my experience from decades of investing and from ~5 years of focused research on a variety of stocks, in recent years with a primary emphasis on healthcare stocks. I greatly appreciate those who take the time to share their reactions to articles, particularly those who share relevant anecdotes and experiences.

Analyst’s Disclosure: I am/we are long CYDY. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

I may buy or sell shares in CytoDyn over the next 72 hours.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

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Comments (494)

What a concall. I'm thinking CYDY is one of the drugs approved and makes a huge impact on Covid19 treatment options. Anyone else walk away from the concall feeling like this is the game changer we need? That was very convincing and I'm all in.
He doesn't offer much info but Leronlimab dropped in the same discussion as Remdesivir and Hydroxychloroquine

New Executive Director Supply Chain PM position posted for Cytodyn in past 2 days, hmmmm....

Hopefully CYDY's current trials are continuing. Would like some feedback from management as to status of HIV mono, TNBC, Basket Trial as many/most pharmas are stopping their trials. Here's an article: www.marketwatch.com/...
I would say 50/50 at best. access to hospitals has been severely restricted. At least they have covid19 trial, some companies have put trials on hold without that indication.
@Life Sciences rookie - Going to be a real adventure running 2 Covid-19 trials in the chaos of a pandemic. Hope they get the # of sites they need (FDA said 10) that can meet the requirements for executing a trial.
Novant health has 15 hosptials, I know they are also running one out of UCLA through Dr. Otto Yang and then the NYC hospitals. thoughts?

Novant Health is an integrated network of physician clinics, outpatient facilities and hospitals that delivers a seamless and convenient healthcare experience to communities in Virginia, North and South Carolina, and Georgia. The Novant Health network cares for approximately 5 million patients annually at nearly 700 locations, including 15 hospitals and hundreds of outpatient facilities and physician clinics.

“COVID-19 is the most significant health threat of our generation,” said Dr. Eric Eskioglu, Executive Vice President and Chief Medical Officer for Novant Health. “We want to thank CytoDyn for partnering with us in this very important leronlimab clinical drug trial. With lives at risk, we are working together towards an effective treatment solution.”


Both NEW articles that are positive!👍
Shh...still accumulating :)
With NYC being the new epicenter, this news will be hard to ignore and I'm sure the buzz in the city for an effective treatment will surely follow as they are all very tuned into the subject at this point.

I smell a short squeeze, hopefully Chris stang gets a good lesson about the constant bad mouthing, just saying.
@Pdoubler you see this one?

RussianBearwithBalalaika profile picture
Wow! Cytodyn's "lofty promises" have been saving some real people in a real Brooklyn!
@RussianBearwithBalalaika Leronlimab is no Joke! BF will soon notice and wake up to smell the coffee. This in my opinion is going to get bought out next year after commercial revenue kicks in and BTD for multiple cancers. Only a matter of time now. This will hit $2 if they submit BLA in the coming week.👍🏼GL to you and all of us invested. Sit back and enjoy the ride💰
The Blue Baron profile picture
CYDY may turn out to be the Google of HealthCare. If Leronlimab proves successful in its next stage of treatments (assume 50 or so), it will touch the lips of Donald Trump and then the world will know and there will be no turning back. We might one day see $100 per share.
@The Blue Baron

Hahaha, I like the sound of $100.
Leronlimab Used in Seven Patients with Severe COVID-19 Demonstrated Promise with Two Intubated Patients in ICU, Removed from ICU and Extubated with Reduced Pulmonary Inflammation

Anybody heard any news of the formal start of the Phase 2 Covid-19 clinical trial? The IND treatments are helpful, but it will take formal trial to get approval.
Read that and it's great news! While i care mostly about the patients, I'm sure @Chris Stang will come in here and figure out a way to trash talk the company.

Care more about than the patients improving than your gains/losses chris, seriously.
SA Article on another Covid-19 option for comparison:
Gilead suspends access to remdesivir amid flood of requests
Mar. 23, 2020 7:22 AM ET|
Citing "overwhelming demand," Gilead Sciences (NASDAQ:GILD) has temporarily halted patient access to its experimental antiviral remdesivir, adding that it is transitioning its compassionate use program to expanded use programs as "rapidly as possible." It will make exceptions for severely ill pregnant women and children under the age of 18 with confirmed COVID-19 infections. Almost the entire investment world expects the FDA to conditionally approve the nucleotide prodrug for COVID-19, originally being developed for Ebola virus disease, any day.
24 Mar. 2020
I think it is very likely that remdesivir is approved, and if it proves effective in the current WHO trial or in IND usage, I hope that approval comes very soon. However, there are a couple issues with remdesivir.
1: it is administered intravenously which requires hospitalization.
2: as an antiviral medication it most likely will be most effective in the very early stages of the covid 19 disease process.
These two factors combined while not unsurpassable certainly complicate the delivery of this medication on a large scale and in a timely manner.

If leronlimab proves effective in the current trial, the fact that it is administered subcutaneously as well as in potentially later stages of the disease process would bode well for it also being a valuable medication in this setting.

Here's to hoping both medications, as well as many others, prove effective.
pro8 profile picture
and Gilead buys CYDY for $7 a share...
I would signup for that now..
Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn’s Leronlimab, Bringing the Total to Four Patients

Out of Ignorance profile picture
"Tantalus was a Greek mythological figure, most famous for his eternal punishment in Tartarus. He was also called Atys. He was made to stand in a pool of water beneath a fruit tree with low branches, with the fruit ever eluding his grasp, and the water always receding before he could take a drink." www.google.com/...
Tantalus has a lot in common with those counting on Leronlimab to save their health/portfolio...lets hope one of the tree's branches dips lower
The article reads:

"The treatment with leronlimab is intended to serve as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19)."

Since respiratory complications are typically associated with the more severe cases, I assume this means CYDY is targeting those in a late stage of infection.

Would anyone agree?

I'm assuming the patients they are treating are in severe condition when the secondary infection occurs (upper respiratory in mild cases vs. lower respiratory in severe) and ARDS. Possibly eventually moving to treat less severe cases once they can show good efficacy and safety profile

If they can less the ARDS cases then it's a big improvement and less impact on our healthcare system via ventilators needed and/or days on ventilator, freeing one up for someone else. ATHX (possibly MESO too) has ongoing trials for the ARDS patients prior to covid19 and they have shown to lessen impact of ARDS and the days a patient spends on ventilator.

maybe I'm off base, someone smarter than me chime in.
Hopefully this is it,put CytoDyn and Leronlimab on the Map!
U.S. Food and Drug Administration (FDA) Grants Emergency IND for Two Coronavirus Patients Treated in New York with CytoDyn’s Leronlimab
Out of Ignorance profile picture
I truly pray those patients get better, for their sake, CytoDyn's and the country.
The rubber meets the road for Leronlimab.
@Out of Ignorance

I completely agree.

Regardless of being short or long the stock, I shudder to think what it must be like having someone you know get infected.

My brother is in medical school and was just about to start his clinical rotations. It looks like those rotations were cancelled for the obvious reason that doctors must be free to focus their full efforts on the expected avalanche of infected.

I know he really wants to do his clinical rotation, but secretly I am glad he isn't going to any hospital in the near future, to the best of my knowledge.
I bet even if CYDY "cures" those two patients, when the next step is to administer to 50-70 patients, we'll see the floodgates of negative SA posts about "oh, now its extended, delayed" or "why wasn't it done first"... SMH
IglooGM profile picture
Potential concerns over the safety of remdesivir for treatment of Wuhan coronavirus
New CYDY press release -- FDA has instructed CYDY to change the COVID-19 clinical trial design to -- "75 planned patients in up to 10 centers in the United States. Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks." Demonstrates the need to get FDA approval for your trial design before you publicly announce it. There is also a correction on the TNBC trial result (patient #1) report from the prior press release. Link:

IglooGM profile picture
anyone can have access to this report? of course, there are many factors contribute to the profit of a drug, but I guess, due to the favorable safety profile of leronlimab compared to maraviroc, the profit from leronlimab won't be less than that of maraviroc.

@IglooGM -- Major factor is the size of the sales force promoting the therapy and getting HIV treaters to change their treatment behavior. Maraviroc has a large Viiv sales force, Leno will get support from a much smaller Vyera sales force (currently less than 15). The profit is driven by getting large scale treater adoption to put patients on Leno (requires a prescription) and the resulting revenue.
@IglooGM Using that as a metric would fail to take into account the far superior efficacy, the far superior safety profile and no resistance developed with leronlimab.
AOC profile picture
16 Mar. 2020
This is the age of eCommerce!

If you have a great drug, attend some of the healthcare conferences, advertise in some medical journals, mail out a few samples and engage the services of Cardinal Health ... jackpot ... your product (the Rx) would gain access into most of the major Hospitals.

CYDY just needs an approval of Leronlimab in one indication - TNBC, HIV ... etc.

Cheers and GLTA.
Great article and snapshot of where this company has been and where it is now. You dug up some history that brought back old memories. One subject that you are not entirely correct on is when NP started to make promises on completing the BLA filing.
Out of Ignorance profile picture
Thank you for reading and commenting.
..."One subject that you are not entirely correct on is when NP started to make promises on completing the BLA filing."
Can you expand on this?
It appears the investment community is not convinced of CYDY's Cov-19 market potential. INO is up nicely today and CYDY is down ~10%. The TNBC FDA response also appears to have been a negative. Live by the press release, die by the press release.
For persons who are holding CYDY, please see the video CytoDyn files investigational new drug application with FDA for coronavirus symptom treatment
Any news on completing the set up of their Cov-19 clinical trial? It was in negotiation at last report.
Out of Ignorance profile picture
This constant onslaught of videos is beyond irritating.
Some people who invest in CytoDyn can actually read and would prefer a concise written report to verbal bloviating...just an idea.
@Out of Ignorance -- Don't worry, I received three press releases on these topics too.
IglooGM profile picture
2 presentations about leronlimab at CROI 2020 Meeting:


i could not find the presentation, titled “CCR5 antibody blockade protects macaques from intrarectal SHIV acquisition,” from Dr. Jonah Sacha.
Interesting that the Italian clinician CROI presentation was analyzing what patient population would be susceptible to CCR-5 antagonists based on the type of HIV virus they carried. These researchers were doing clinical studies on CCR-5 antagonists. Their conclusion was CCR5-tropic virus was observed in 36%, 43%, 36% accordingly to Sanger, NGS and the phenotypic assay. If this is correct it suggests that a less than half of the HIV patients will be susceptible to a CCR5 antagonists. Am I correct that CYDY screened for CCR-5 tropic virus? Anyone want to respond to their conclusion??
Out of Ignorance profile picture
Going from a very shaky memory I believe you are correct on the screening. I thought the percentage was higher, but I erased all my research and don't have time to redo.
@ Life Sciences. I am continuing to add to my position at these low prices so I got your back.

It is truly remarkable that Cytodyn continues to out perform a down market with only a small number of employees. Speaks volumes to how this management team is managing shareholders interest. Best of luck to you
Out of Ignorance profile picture
L S r
I wouldn't bother to mention this except your screen name includes "rookie".
The fact that participant "7342341" in an open message board writes that that they have "got your back" is creepy at best.
I'm definitely a rookie on this website so please elaborate
Tumblebug profile picture
@7342341 - please explain to all of us how continuing to delay BLA filing for HIV indicates that management has our best interest in mind.
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