E CytoDyn's Update Provides A Clear Path Towards Approval With Up-Listing Potential Still In The Cards

Investors were poised to hit the sell button on CytoDyn Inc. (OTCMKTS: CYDY) after their investor conference call Wednesday. It played right into the hands of the shorts and gave them one more chance to sow confusion before an impending run-up happens on good data as severe to critical read-outs are disclosed. This latest conference call pretty much cemented a potential approval in Severe to Critical COVID-19 within a month. What disappointed momentum traders was the FDA’s guidance to hold off on the CD-10 Mild to Moderate COVID-19 Emergency Use Authorization (EUA) before having a look at the interim readout on the Severe to Critical patients in the CD-12 trial. Recently, biotech investors in CYDY seem to have forgotten that clinical trials normally take years. During the call, the CEO of Cytodyn, Dr. Pourhassan tried to interject a dose of realism that the first patient was dosed on March 31 which was only 6 months ago, but assured investors there should be an approval by the end of the year.

“We have a powerful drug called leronlimab. We believe it will change the history of treatment. . .We are going to be getting approval.No matter what. That's what we believe. Because we have the data.” - CEO Nader Pourhassan

Panel of Doctors and Researchers Stake Reputations - The Drug Works

The conference call started off with doctors giving a testimony about their experience with patients in the COVID-19 clinical trials. The doctors gave powerful case studies that highlighted a drug that, in their minds, worked really well. 

Dr. Harish Seethamraju

  • Submitted manuscript for the first 11 eIND’s
  • Lead Author in Manuscript for CD-10 almost complete

He talked about the selection of his patients and how they were not eligible for any trials. His hospital had many options but these patients were in such bad shape that “we thought were not going to be around in a day or two.”After administering leronlimab they turned around immediately and continued to recover. The things that surprised him was that patients recovered so quickly that they were able to take them off life support. He talked about end-organ recovery. He didn't think they would recover to the extent that they wouldn’t need life support anymore. He saw patients come off the ventilator and dialysis. 

“Stopping inflammation and promoting immunity to clear up the virus and Institute mechanisms that preserve end organs like without pulmonary fibrosis and or renal failure. These were my observations and I was very eager to try in phase 2 and phase 3.”

Dr. Otto Yang - Dr who oversaw the treatment of Samantha Mottet - the woman who on TV claimed leronlimab saved her life. 

  • Submitted for publication (30 patients eIND)

Dr. Nicholas Agresti - Internal medicine, Gastroenterology, Liver transplant doctor

  • Manuscript being reviewed for publication(4 patients with remarkable recoveries) 

The discussion revolved around 4 patients that were in a critical condition and all on mechanical ventilators and ended up having remarkable recoveries after being given leronlimab. Half of his patients (2) were on hemodialysis.  Most of his patients saw clinical improvement within 24 hours. His team thought that these patients had zero chance of survival. He said, “these people were expected to pass on.”They had received multiple treatments before trying leronlimab. In terms of cytokines he observed a decrease in IL-6 and CRP that was correlated to the dosing of leronlimab. Of the 2 patients on hemodialysis one was off by the time she was discharged and the other was on it intermittently until he recovered.    

“Our patients were critically ill. These patients were even before covid19 would be patient you would likely contact the family members and ask them to come in and pay their respects because that patient would pass on. Until we have clinical trial results from phase 3 we are cautiously optimistic. Given the fact that all 4 patients recovered and received multiple other treatments and did not improve until receiving leronlimab gives us promise.” 

Dr. Recknor’s comments were primarily related to the CD-10 trial. When he recruited patients it was actually a very diverse group so he learned a lot from it. Half the group ended up being mild. Enrollment didn’t exclude people who were sick a long time. Other studies frowned upon that and were looking to recruit people that had symptoms less than 10 days. He indicated that some patients in the study might have had COVID-19 four weeks before they were enrolled. He also noticed groups of patients that would just not get better due to adverse events. Dr. Recknor is coming onto the leronlimab’s team and provided huge contributions in terms of getting people enrolled in Cytodyn’s trials.   

“What I was extremely impressed by is that Leronlimab seems to work extremely well beyond the 10 day time period. Some of the patients might have had COVID diagnosis 4 weeks before enrollment in the study yet still included per the protocol.”

FDA and MHRA Emergency Use Authorization

The most germane news on the call was that both the FDA and the MHRA wanted to see interim data from the Severe to Critical (CD-12) patients before ruling on the Mild to Moderate. There was a clear sense that the door was still very open on the Mild to Moderate approval in the UK and closed with respect to the USA FDA. The MHRA echoed the FDA’s sentiment that Mild to Moderate patients are not really in danger and that a look forward to the severe to critical patients that would likely chart the pathway to approval. 

The MHRA however, took the discussions to a higher level than the FDA. They showed interest in the data from the 60 eIND’s. By complying with their request, early access seems like it's on the table. Early access would result in higher usage in the United Kingdom allowing the regulators to monitor results in country and get a better comfort level with using the drug. The company submitted its paperwork and is trying to get funding for the trial and patient recruiting assistance directly from the government. This would be part of the package called an Early Access to Medicines Scheme, or EAMS, which would be sponsored by the U.K.’s Department of Health and Social Care. Patients who are hospitalized with severe disease will be eligible to receive the drug. The arrangement is similar to the EUA that the U.S. Food and Drug Administration granted earlier this month and a similar one in Japan.

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Disclosure: I own shares in CYDY.

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Moon Kil Woong 1 week ago Author's comment

Here's an update.

www.cytodyn.com/.../cytodyn-receives-positive-dsmc-recommendation-after-interim

www.zerohedge.com/.../unrecognized-therapeutic-takes-dying-covid-19-table-30000-american-lives-hanging

Interim results were good. However they want the study finished. In reality this provides a clear path to approval with a positive finding half way through. It is sad so many are dying while we lollygag through approvals with a drug that has been proven to save some lives with an extremely high safety profile.

Moon Kil Woong 1 week ago Author's comment

Some new news I found that you may find interesting as we wait for CYDY results. The article writer says he expects the official release of interim results on Tuesday next week. The other article says the WHO found that Remdesivir after an 11k study was ineffective at helping patients recover any faster and has no effect on mortality either. They put it in the same ineffective designation as hydroxychloroquine, the HIV combination of lopinavir and ritonavir, and interferon.

www.msn.com/.../ar-BB1a4MeV

insiderfinancial.com/.../180558/

Moon Kil Woong 3 weeks ago Author's comment

Trump news is getting more people to look at Cytodyn today.

insiderfinancial.com/.../180495/

Wall Street Wiz 3 weeks ago Member's comment

Why?

Moon Kil Woong 3 weeks ago Author's comment

Trump is taking Remdesivir even though he's not on supplemental oxygen, REGN-COV2 an experimental antibody treatment from Regeneron, zinc, vitamin D, famotidine (acid reflux), melatonin (for sleep), and aspirin so far.

www.msn.com/.../ar-BB19EVNe?ocid=msedgntp

Wall Street Wiz 2 weeks ago Member's comment

But what does this drug have to do with Regeneron's drug?

Moon Kil Woong 2 weeks ago Author's comment

He took REGN-COV2 as well and supposedly invested in the company too.

Alpha Stockman 2 weeks ago Member's comment

See the article the author linked to. But the author, Moon Kil Woong, should write about it here as well.

Moon Kil Woong 2 weeks ago Author's comment

Here is a short on the controversy about Trump using premature babies to cure himself. He did invest in Regeneron. They do use premature baby tissue. This is an article that is a defense regarding Regeneron's drug.

They claim their product came from premature baby organ cells so it is not a stem cell. Furthermore, they claim their drug isn't a cell but was derived from premature baby organ cells so it's not a premature baby, They just grew or took it from a premature baby organ cell they manipulated and that doesn't count. It's your call if parts of a cell duplicated from a premature baby's organ is still using a part of a premature baby for a drug. this is why it takes time to manufacture it in quantity. Trump has been cited promoting this and calling it a "miracle".

heavy.com/...

Sadly, if Cytodyn is approved it will show that there are solutions that we don't need to use aborted fetus experiment parts in a Corona cure.

Andrew Armstrong 3 weeks ago Member's comment

Trump was on supplemental oxygen, the white house has since confirmed.

Moon Kil Woong 2 weeks ago Author's comment

Thanks you are correct although getting the truth is tough since they are forcing doctors to sign NDAs and Trump won't disclose details including information on exactly when he got infected.

Ketan Desai 1 month ago Contributor's comment

Scientific knowledge that Cytodyn pumpers dont know or deliberately obfuscate - neutrophils in COVID19 are determined by CCR8, and not CCR5. See article below. Leronlimab binds CCR5, not CCR8. Which is why other than Cytodyn, NOBODY IN THE SCIENTIFIC OR PHARMA COMMUNITY trusts cytodyn data.

Ketan Desai 1 month ago Contributor's comment
Moon Kil Woong 1 month ago Author's comment

One article doesn't make scientific fact. This is why there is a scientific procedure, not conjecture being studied. Your arguments saying things aren't worth studying because you found something that fits your conclusion is not worth studying because you found something that fits your conclusion is not scientific and undermines what the FDA is doing, authorizing and managing clinical studies to determine scientific fact.

And no, Cytodyn isn't the only one identifying this link to fight Covid. It so happens to be the first drug going through the FDA approval to help those with Covid.

https://pubmed.ncbi.nlm.nih.gov/32511656/

www.wired.com/.../why-does-covid-19-make-some-people-so-sick-ask-their-dna/

www.peakprosperity.com/.../any-populations-with-natural-genetic-resistance-to-covid-19/

magazine.jhsph.edu/.../clues-covid-19-severity-may-lie-our-genes

www.pharmacytimes.com/.../novel-drug-may-reduce-inflammation-in-critical-covid-19-patients

Ketan Desai 1 month ago Contributor's comment

What a poor response. You DID NOT SHOW A SINGLE PEER REVIEWED INDEPENDENT ARTICLE ON CCR5 AND COVID19. We are not talking about HIV but COVID19. Stay on topic, will you, and stop dissembling the truth?

Moon Kil Woong 1 month ago Author's comment

Your article is making the case that neutrophils determine the severity of COVID-19. Severity is clearly correlated to the comorbidities of COVID-19. To prove that point there has to be some linkage between the comorbidities and neutrophils. When they do the UMAP presentation they use a healthy person. If the goal of the article is talking about predicting severity is should have compared to a diabetes patient or a hypertension patient. It did not. The comparison to covid state in the article is just an observation of what the end result of the disease is. If we follow your logic then blocking neutrophils will cure the disease. That is not the case. It will would help but its not a panacea. Neutrophils are just one of many immune cells. Blocking CCR5 results in blocking the macrophages that are primarily responsible for the signaling cascade. It is a multi pronged approach. That’s what leronlimab does. Regarding peer review, I will take wired and others journalistic integrity over an article that in no way says CCR5 is no good and which you wrongly assume blocking neutrophils will cure the disease which it won't. You are free to look on google regarding CCR5 and Covid. There are a lot and papers that are downloadable. However, I don't link them because people don't wantto go to a ling that downloads a scholarly paper to read. If you want you can go to research square and look up: Disruption of the CCL5/RANTES-CCR5 Pathway Restores Immune Homeostasis and Reduces Plasma Viral Load in Critical COVID-19 to read a professional scolarly rticle if you think the tons of press articles on this are garbage along with the tons of doctors cited in them. https://insight.jci.org/articles/view/139834 www.ncbi.nlm.nih.gov/pmc/articles/PMC7277012/ www.ncbi.nlm.nih.gov/pmc/articles/PMC7406242/ air.unimi.it/.../...EAE6347C985.suir-unimi-prod-02 I will not due your homework anymore but posted what I did as a service to all those who want to know the truth about your incorrect allegation against the scientific nature of Covid. Don't bother the informed with outlandish accusations.

Ketan Desai 4 weeks ago Contributor's comment

What an ignorant and biased rant. Look at these reviews on the status of immune response to COVID19. These are by independent scientists who, unlike you or Cytodyn, have no conflict of interest. They are peer reviewed and are in world class journals Sciene, Lancet. CCR5 is not a pathway that anyone of repute espouses.

www.sciencedirect.com/.../S1074761320301837

science.sciencemag.org/content/369/6508/eabc8511

www.thelancet.com/.../fulltext#seccestitle60

Moon Kil Woong 4 weeks ago Author's comment

Here is yet another article for the readers if they want to know more about CCR5 since Desai continues to ignore data on the topic. www.medrxiv.org/.../2020.05.02.20084673v1.full.pdf

Ketan Desai 4 weeks ago Contributor's comment

Written by Cytodyn insiders!! What conflict of interest!! Zero credibilty!! LOL!!!!

Ketan Desai 1 month ago Contributor's comment

Not everyone against CYDY is a short. Some like me dislike lies and respond to restore clarity and science.

1. The drug works. In HIV, yes. In COVID19, no. It MISSED THE PRIMARY ENDPOINT

2. NASDAQ uplisting in process. Unlikely. IS NOT MEETING CRITERIA.

3. MHRA is positive on funding trials for EAMS patients in the U.K. MORE GOEBBLES DOUBLESPEAK.

4. NASH trial to start soon. That is a problem as the company is running out of money, and has no expertise in NASH. Most importantly, SCIENCE DOES NOT SUPPORT NASH.

5. Long Hauler Study to start soon. SEE 1 ABOVE. WON'T WORK.

6 At least 4 journal articles submitted for publication. YET NOTHING PUBLISHED.

7. Leronlimab crosses the blood-brain barrier. SO WHAT? NO SCIENCE TO SUPPORT ANY CNS INDICATION.

8. GILD bought a comparable drug platform with an inferior safety profile for $21 billion. BUT IMMUNOMEDICS DRUG WORKS, LMAB IS NOT AS GOOD. IF LMAB IS SO GOOD, WHY HAS NO PHARMA COMPANY APPROACHED IT? NO VC?

9. MANAGEMENT HAS NO DRUG DEVELOPMENT EXPERIENCE. ONLY EXPERIENCE IN BEATING WIVES AND SELLING FAKE INDIAN ARTIFACTS.

Adam Reynolds 1 month ago Member's comment

It's very hard to know who/what to believe about $CYDY. There seems to be so much conflicting info.

Moon Kil Woong 1 month ago Author's comment

Agreed, I suggest people do a bit of their own research on this. The price is low partially due to the big dissonance between the bulls and the bears. Then follow the science.

Ketan Desai 1 month ago Contributor's comment

Which is why you should do your own due diligence and not listen to pumpers.

Moon Kil Woong 1 month ago Author's comment

Yawn.

1. Look at phase II results. It exhibited traits that existing drugs don't address and met the safety profile it was meant to prove. Even so, with a small sample size as a phase II it almost met the primary endpoint which is not expected. Read FDA results. I agree that it may be suitable for HIV.

2-3. Nasdaq approval isn't off the table and the major concern is price volatility which may be moderated especially after an approval as will better funding options just like all pharmaceutical companies. That said, it has plenty of cash to operate currently and will make adjustments as they see fit.

4-5. NASH trials are suppose to determine NASH results as are other study results. The FDA has not cited any of their studies as deficient to prove their points.

6. It is funny you mention studies on this. There have been numerous pre-FDA study results by doctors which have been cited by bears as being indicative of its ability and not proof thus is why one does FDA studies which were used to get FDA studies authorized. Blaming the egg for not being a chicken is a rather dumb argument in my book. Here are some as you claim unpublished articles on the topic. You are welcome to google this subject yourself:

www.cytodyn.com/.../cytodyn-reports-strong-results-from-eind-covid-19-patients

www.targetedonc.com/.../leronlimab-shows-further-promise-for-covid-19-treatment-study-shows

apnews.com/.../5f340ac37ee044e098fd1a843cb46b08

http://www.bioquicknews.com/node/5315

www.biospace.com/article/clinical-catch-up-may-4-8/

7. This is just something that was disclosed recently and may be a sign it can help people who may suffer from Covid related brain hemorrhages. The science has yet to be studied in depth or proven one way or another. Thus its too early to call and is fine to announce.

8. Who are you to say one drug is better than another. This is what regulatory bodies are for. You are injecting opinion not science into the argument.

9. This is just spiteful bear ranting. It makes me wonder why I even bother responding to such comments. Write your own article and be judged on it by your peers.

Ketan Desai 1 month ago Contributor's comment

Then don't respond. You must have a guilty conscience.

Moon Kil Woong 1 month ago Author's comment

It is hilarious that you think responding to commenters on their own article is disingenuous. So you are saying not responding is showing what? That people can spout idiocracy without being corrected. If so, I'm sure you will say not responding is showing a guilty conscience too. If your logic is that anyone disagreeing with you is wrong it is more likely you are the one spouting falsehoods. I can equally say your mad posting on all boards spouting rumors and innuendo about Cytodyn shows both your bias and your position, not that it makes a difference. My readers aren't stupid.

Craig Newman 1 month ago Member's comment

Are you truly nothing more than a share holder and fan of this stock? Or has the company compensated you for these articles? It sounds like this CYDY has a lot of haters.

Moon Kil Woong 1 month ago Author's comment

I am a shareholder. My compensation will be when the stock skyrockets. And yes, there are a lot of haters and the company is small so they don't know how to make their information clear to small investors. That's why I write such articles. To me, it seems pretty clear that the FDA is moving forward on CYDY for Covid as laid out by the disclosures and the company meetings. Unfortunately, others have different opinions and still others muddle the waters with misleading disclosures and speculation. This is what short interest does when it has nothing of substance. To me, in most cases, it is just a matter of time before they get approval. Thanks to the shorts those who get it at this price won't have to wait long to make a lot of money. I've been on this board and Seeking Alpha for a long time. You can look me up if you want. I mostly comment.

Terrence Howard 1 month ago Member's comment

Chuckles 759 and Chump Punk, you'd probably enjoy this article.

Tom Callahan 1 month ago Member's comment

Good article, but my enthusiasm for $CYDY has really waned after reading some of Ketan Desai's comments.

William K. 1 month ago Member's comment

It seems like a very interesting tale here, with a case of "who do we believe" twisting things around a bit. Certainly a worthwhile article in its entirety!

Hopefully they are onto a real wonder-drug that can benefit a lot of folks.

I look at the FDA and especially that double-blind test, giving a few hundred what is believed to actually be a cure and then lying to another few hundred and giving them nothing that will be a benefit. I can appreciate the need to have unbiased data but at the same time it seems like they learned about compassion from the Nazis. Promising a cure and then delivering nothing, all in the name of some sacred statistical process certainly looks rather horribly cruel from where I stand.

Would I buy shares in the company? I think so, if it would push towards progress in this battle. Would I be doing it to make a profit? Not really. There are times that one should do good without making a profit. Although some will challenge me about it, I think that there is much more to life than gaining lots of wealth.

Silas Bitchly 1 month ago Member's comment

Thx Moon. The way I see it, longs have won. They have the simplest of tasks. Hold. Don't sell. Think of the SP in a couple years, not in the next couple months. And if you don't already have a position, now is not a bad time to start one. Investing, not trading.

Donald Kaplan 4 weeks ago Member's comment

Yes, the longs have won.

Moon Kil Woong 1 month ago Author's comment

I agree, it is best to have conviction that this company is onto something and keep track of its progress. So far the progress is not bad and hopefully the reward will come shortly, however, one should not be anxious. Still, I feel sorry for those who keep getting hammered short term by misleading information. Anyways, I am hopeful more progress will be displayed in the next month or so.