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CytoDyn: Q4 Is Crunch Time

Oct. 01, 2021 7:38 PM ETCytoDyn Inc. (CYDY)90 Comments


  • CytoDyn continues to match leronlimab up against COVID-19. The company recently started two clinical trials in Brazil where the pandemic endures.
  • If the Brazilian trials hit their endpoints, CytoDyn could file for EUAs in several countries. I expect these trials to produce better results than the U.S. trials.
  • The company is moving leronlimab forward in HIV, oncology, NASH, and COVID-19. It is this potential that keeps me involved in the ticker, but Q4 is crunch time.
  • I discuss a couple of downside risks and how I plan to manage my CYDY position as we head into Q4.

Man fighting Covid-19 Virus

peterschreiber.media/iStock via Getty Images

A lot has happened since my last CytoDyn (OTCQB:CYDY) article, including a nasty proxy fight and the start of Phase III COVID-19 trials in Brazil. What is more, the company just announced that they are hoping to

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Biologics profile picture

Biologics is a full-time healthcare investor who developed a passion for biotech and life saving therapies after working in the medical field for years. His trade focus is around innovative companies developing breakthrough therapies and/or pharmaceuticals with catalysts for potential acquisitions.

He is the leader of the investing group Compounding Healthcare. Features of the group include: Several model healthcare portfolios, a weekly newsletter, a daily watchlist, and chat for dialogue and questions. Learn more.

Analyst’s Disclosure: I/we have a beneficial long position in the shares of CYDY either through stock ownership, options, or other derivatives. 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.

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Comments (90)

Take a look at NP's Q4 list and look at how badly his success rate is? It is at best 50% assuming he delivers some of the items in his cc call this week. That's pretty miserable, The BLA looks questionable for Q1 '22 as he has even settled with Amarex so he can get the clinical trial data back. None of the follow up HIV projects were delivered.

You looking at $1.60-70 support and the stock is down barely holding onto $1.00 support. And that is just at the company is starting to dump 250,000,000 new shares on the market. They need about half just to cover the $120 million in short-term debt -- payables and vulture fund. Not look like a pretty 2022 with the massive dilution.
1GMD profile picture
@HyGro - Congrats, almost 5 thousand comments on CYDY alone.
Biologics profile picture
This is rediculous
Biologics profile picture
1st patient today? They better start expediting enrollment fast if they want to hit their timelines.
@Biologics -- And break the streak of never making a timeline? The fanboys have already declared it a slam dunk. More and more monthly burn of ~$10 million a month. Added to $65 million of payables and ~$55 million of vulture funded debt. Not a pretty picture. Just wait until they start dumping the 200,000,0000 new shares on the market (directly or indirectly through Fife).
A week old but I only just spotted:


"VANCOUVER, Washington, Oct. 07, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc....announced today the appointments of Christopher Recknor, M.D. as Senior Executive VP of Clinical Operations and Nitya Ray, Ph.D. as the Company’s Chief Operating Officer.

CytoDyn is realigning its management structure to optimize the BLA resubmission process and to advance clinical development potential. The team of Drs. Ray and Recknor will now hire additional professionals to complement Dr. Srinivasan, Executive Director of CMC Regulatory Affairs, who recently joined CytoDyn from Regeneron.

The Company’s central focus remains on completing the BLA resubmission. Dr. Recknor and his clinical development team will manage the clinical and nonclinical activities, while Dr. Ray and his team will manage regulatory submissions, as well as all CMC activities. Dr. Ray has over 30 years of experience in the biotech industry and was one of the original members of the leronlimab (PRO 140) product development team at Progenics.

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “Our CMC package for the BLA is a direct reflection of the tremendous expertise of Dr. Ray and his team. This restructure will help maintain focus on the BLA, while providing the ability to rapidly pursue other indications in a fast-track development program. Expanding the managerial role for Dr. Ray is wonderful news for us, as his performance in the past has been tremendous. Without his broad expertise, our company would not currently have in stock and ready for delivery over 1.2 million vials of commercial grade leronlimab.”

Even ignoring how they plan to PAY for TWO additional stroke/Alzheimers trials or to PAY to hire MORE "professionals," the line about "realigning its management structure to optimize the BLA resubmission" had me ROFLMAO!

It sort of NEGLECTS to explain HOW exactly "realigning" management will affect the BLA in ANY way whatsoever, but CLEARLY the implication is that the bLA is NO CLOSER to being finished than it was a YEAR and a HALF ago.
@CitronSource -- And now they are stuck with a vendor holding their clinical trial data hostage to get past due bill paid. That includes the ongoing HIV extension, HIV combo data, NASH (going trial), mTNBC, GvHD, etc. How long will it take to resolve that issue now that it is in litigation? Holds up mTNBC BTD filing, BLA, NASH trial reporting, etc... Another screw up.
I posted these origially under the 10-Q filing that SA published today, but since no one seems to be paying attention to that, here is some stuff gleaned from the "emerging growth" conference Q&A:

1) CD 16 has ZERO enrollment. CDC 17 has about 20. Some problem blocking CD 16, waiting for ANVISA to give approval. I don't remember which is which, but Recknor HAS said:

"With approximately 1,500 patients in total for both trials, we anticipate having adequate power in each trial to achieve a significant p-value for our endpoints and will be performing an interim analysis after 40% of the critically ill patients are enrolled.”

Pretty safe to infer that at the current rate of enrollment these trials will take a REAL LONG time.

2) New news to me, some problem with "particulates" in IVF in Brazil. Ray tried to explain but I simply can't understand the guy.

3) I may have misunderstood Nader but I swear he said that leronlimab in combination therapy is basically a waste of time financially, that the market is so small that it is barely worth pursuing. Monotherapy is actually the "main" objective.

4) from the 10-Q:

1) 6.5 million cash

2) Accounts PAYABLE -- 66 million

3) DEBT including interest -- 56 million

DESPITE this, Nader said in the conference that they got enough money to pay the bills! Go FIGURE!

Most INTERESTIN, for the FIRST time EVER I heard Nader mention "PIPE":

"Private investment in public equity (PIPE) is when an institutional or an accredited investor buys stock directly from a public company below market price."

Think maybe there's a HINT in there?

5) For the most part, Nader is simply too difficult to understand to try to quote him correctly. Nevertheless:

1) He REFUSES to reveal either the COST of or what they will CHARGE for leronlimab.

2) He REFUSES to explain the delay in the HIV BLA -- SAYS he's already answered this question many times.

3) Recknor made a RIDICULOUS claim that leronlimab crosses the blood brain barrier and even tries to claim 75% receptor occupancy. That's all pure BS.

4) Extended access to leronlimab is closed.

Nitya Ray MIGHT have said something interesting but his accent is so thick that I don't feel comfortable trying to interpret.
@CitronSource -- There has been no evidence on the pharmacodynamics of an IVF delivered LL. It they use the same 700 mg dose as the injectable, it hits the blood in much higher level when could cause unforeseen problems. Sure adds more risk to a trial.

He probably doesn't include the $12 million or so that Amarex says they are owed to release any of their data (like the mTNBC data for BTD, NASH that is still in process -- who's on top of that trial and the ongoing HIV trials). Then the $30 million due to Samsung from the P.O. unless it is identified as a payable -- this one means inventory could get held back as Samsung is holding all of it . Then those vulture fund boys going to look for a lot of discount stock for any debt payment. Going to start dipping into that 200,000 new share pretty fast -- dilution, dilution, dilution. Not anything positive for the share price in the current financial scenario,
@CitronSource So, was there anyone playing hand puppet for distraction while Nader was questioned ?
@HyGro -- Another issue has just showed up in the 10Q for last quarter: "The decrease in inventory during the three months ended August 31, 2021, was primarily related to the write down of expiring raw materials purchased for commercial production.."
Maybe I missed it, but where will they get financing? The obviously can't go to traditional sources since they have taken two loans out with toxic lender John Fife in the last year. Nobody would do that unless it were their only choice.
@Tyler Durden 42 -- Adding a board member who used to work at Paulson is not the answer. When you are insolvent and have debts approaching $100 million due in the near future. Then there is the SEC/DOJ investigations, shareholder lawsuits, etc. and an OTC penny stock with a stock promoting CEO.
@Tyler Durden 42 where will they get financing?
LOL , Have you check your wallet lately ?
@Soyunmoron -- They are doing small financings to keep the lights on. Converting discount warrants held by a Board member, then a discounted private stock placement to well-heeled investors. These have provided close to $7 million that covers about a month of operating expenses. They are going to have to partition the vulture debt and covert it to discounted shares Q4 to meet their payments. Dilution becomes the solution. We'll see what they come up with for the shareholder meeting.
I had waited for years for them to submit the BLA for HIV. I had wanted to bail after they make excuses after excuses adn kept shifting the date of submission. The pie in the sky GILD buyout fantasy never come to pass. I knew I have been had and wanted to get out many times but was amazed at how many suckers keeping this shzt afloat. finally my chance of getting out alive came early this year and I bailed with a big profit when it was around 10.

Years earlier I got my friend in below $1. He got taken in with all the stories pumped out by the company and is still holding. I feel sorry but he wont listen. I will never talk to him about another hot tip because some people know when to buy but not knowing when to sell ( for profit or to cut loss short ).

If I get pay $10 millions a year, I would tell you any story you may want to hear.
Keep on hoping thatht Brazilians are not aware of teh monoclonal antibodies already usefullly used in the US, and hope they also do not hear about Merak orally active molnupiravir.
The Blue Baron 3.0 profile picture
" In fact, CEO Nader Pourhassen recently revealed that the MHRA in England will consider giving leronlimab an EUA if the interim p-value is significant. In addition, the company has been in contact with Health Canada and the Philippines. Maybe… the U.S. FDA would consider the data to be adequate to run a similar trial in the U.S., which could vindicate the company's efforts to continue their COVID-19 programs."

Don't believe this lie from Nader. How many times has he lied for you to stop believing whatever he says?
@The Blue Baron 3.0 -- He's done several "going to" press releases of filing in UK and Canada and never did.

CCR5 mechanisms have already failed in NASH ( Tobira/Allergan)

NASH trials are now all adaptive design and require years of therapy and need proper clinical outcomes

I don’t know the future of this drug but the company needs to stop dangling NASH in front of investors- even if it works for NASH, that track will be many years away
@Fattyliverman -- Can hardly wait to see how they spin the data result for NASH. 50 sample, not much chance of success.
CTRL+P_QE.exe profile picture
@Fattyliverman furthermore NASH is a very heterogeneous condition and the P2 again is small, n of 50 or 60 I believe. Probably another failure of poor trial design if it doesn't hit its p value, all should be revealed soon.
Another article that seems oblivious to the many downsides for Cytodyn.
1. Brazil CoV Trials for FDA -- There are specific FDA guidelines for using a foreign trial for FDA applications: The most certain is file an FDA IND in advance with the protocol and FDA audit procedures -- that wasn't done by NP of he would have announced it. From the FDA here's what happens without an IND:
"Acceptance of Foreign Clinical Data FDA --Accepts Foreign Clinical data from studies not conducted under an IND if the following conditions are met:
I. Study was conducted in accordance with Good Clinical Practice (GCP)
II. FDA is able to validate the data from the study through an onsite inspection (From FDA Guidance presentation)
2. No mention of the SEC and DOJ investigations. They don't invest the time doing an investigation without have significant evidence already in hand. The specific events mentioned was the company's communications of the CD10 and CD12 trials -- manipulating data, spinning the reporting without clear report on the primary and secondary endpoints that they failed to meet and manipulated the p-values to claim significance. The FDA Statement provided a clear demonstration of their misrepresentation of the data and that got the SEC's attention about potential stock fraud. They saw enough to bring in the DOJ for criminal investigations. As NP has been a serial stock promoter using company paid, ghost written "investor articles" these is clear evidence of other stock fraud. In addition, both NP and Dr. K have had insider trades that appear on fact value to be pump and dumps -- promote the stock while management (or family) sells stock.
3. NASH Trial -- company presentation above says 60 participants but actual clinicaltrial.gov protocol only has 50. This is not powered to show significant results. Not looking like Phase 2 will be strong results with such a small sample.
4. Brazil Trials -- Using a new mode of delivery (infusion) is risky. This provides a much higher dose much quicker, may be good for efficacy but poses greater safety risk. This has no safety testing to date so adds risk to the trial and FDA comfort with this protocol.
5. mTNBC -- Where to start. It was a Phase 1 trial with 8, count them 8 patients that met the screener criteria. But another 22 compassionate use that may or may not meet any screener criteria were lumped in in their analysis. It was a dose escalation trial to determine appropriate dose for Phase 2 trials and did not have a control arm with a comparator (SoC). But instead the company spun it into something unrecognition to hype the stock (another potential stock fraud issue). They lumped all the trial and non-trial data together and got an experimental model to hype some triple digit percent outcome. Hunh?? PFS is the % of patients that responded to the drug -- less than 100%. The model they used is not validated or FDA accepted but somehow gives the naive retail investor some spectacular sounding outcome that isn't PFS -- one of the standard metrics for oncology trials. Talk about deceptive -- no control to show the effect of the chemo along and big hype of some unknown outcome through an unproven model. But it got a little stock pump that has since faded away. This is deception.
@HyGro FDA grants Priority Review to ViiV Healthcare’s New Drug Application for cabotegravir long-acting for prevention of HIV.

@Soyunmoron Not to mention molnupiravir from MRK so there goes the COVID pie in the sky.
Agni Research profile picture
@HyGro One more thing, if OTC Markets bothered to investigate the company, it would realize that CYDY falls under its "Caveat Emptor" designation since it is being investigated by both the SEC and DOJ. If a "Caveat Emptor" designation is slapped on the company it would put it on the gray sheets, which has severe consequences. For example, TD Ameritrade will restrict orders in Caveat Emptor designated OTC securities to liquidating trades only.

And here come the short d fools.
Agni Research profile picture
You failed to mention the risk that the outcomes from the SEC and DOJ investigations could be very adverse for the company. Plus no mention that the ludicrous executive compensation of $10M yearly for Pourhassan, $3.3M for Kelly, and $1M for various BOD members is unheard of for a pre-revenue OTC biotech penny stock.
@Agni Research The average compensation for biotech in the 600 m market cap range is about 1.10 million. Anat Cohen at CGEN for example, pulls down $1.3 millions and they have a monopoly on PVRIG in combo with other checkpoint inhibitors for cancer and reported great ORR result recently.
$10 M for Pourhassan must be a typo.
@Soyunmoron - Unfortunately (except for Pourhassan), $10 M is not a typo.
Agni Research profile picture
@Soyunmoron Its all in the company's 10K. Pourhassan's total comp for 2020 was $9M. For 2021 it is $10M.
Check out the Proxy Group Zoom for a deeper feel for the company https://youtu.be/5vJixEl4s-I . Great drug, needs competent management to develop it.
Interesting to note the 13D's have no funding plan in their proxy. Just allot of vague promises. CytoDyn plans to raise money via PIPE and ATM, per their proxy. Plus board nominees that are leaders in immunology, lung disease, and finance/capital requirements. Likely the 13D proxy will be confirmed to be invalid in court on Oct. 6, as it does not adhere to CytoDyn’s by-laws. We'll know next week.
@Thoughtful Investing It's a no from me. 13D will get wiped out
@Thoughtful Investing How much are you paid to say the same things on every message board: SA, Reddit, YMB? 13 D has no history of success, no clear business plan, and no clear way of financing. You are so short, it’s almost comical. 13 D and you (maybe one and the same) always come in with a copycat response every time CYDY has an announcement. No original thought. At least CYDY has trials going. There were many what one might politely call screwups early, and I am no big fan of NP, but 13 D has an evil, malevolent aura about them.
nellarl profile picture
Good that money is flowing in from the Philippines. A real shame if leronlimab works as 700,000 dead from covid-19 now in the US. The Brazil
trial has to be better than the US trial. A mystery why the US trial
went so badly. Hopefully the 4 dose with IV will give better results in Brazil.
Not a mystery. FDA rejected CytoDyn's requested four doses to 2. DSMC was MIA, and didn't adjust dosing, even though it was an adaptive trial, and didn't manage the ages of patients to be equivalent, resulting in more older sicker patients in the leronlimab arm. CytoDyn was blinded until results, and had no say in the patient distribution or dosing. When leronlimab is successful in Brazil, and people continue to live in Philippines, FDA gonna look very dull. They follow the money, not the science. The latest evidence is the championing of Merck's pill, which is a mutagenetic. Sad, really.
@geauxnow -- B.S. FDA has no reason to reject the 4 doses protocol -- they have seen the HIV trials with years of weekly use. What you fail to understand is the company has a press release that said the trial was going to do two doses from the beginning (14 mortality). They changed the primary endpoint to 28 days but not the dosing schedule. Show us any evidence the FDA changed the dosing -- they had no reason to, the company outlines the protocol, not FDA.

The average age of the CD12 patients was the same for both the test and control. The company didn't propose stratifying the sample by age group in the protocol. Cytodyn doesn't get the right to manipulate the p-value based on an age differences. That's not acceptable and was one of the reasons the FDA Statement occurred because the company manipulated the p-values to make it look better.

Merck's treatment -- you said: "which is a mutagenetic" Where's your evidence?
@HyGro FDA had no reason, yet they rejected 4 doses. Fact. I know you're just a paid poster, and don't really understand medicine or immunology, but their drug, in fact, is mutagenic. But you are entitled to your opinion however ludicrous it might be. Carry on.

Thomas Barnard profile picture
Highly risky since management never completes anything, but moves on to the next. They don't finish HIV, but move on the breast cancer. Breast cancer looks interesting, but never mind, they move on to Covid. The mild to moderate was too small (even in concept) to generate a significant P value, so why even bother? The severe to critical study didn't work out. But never mind, there is NASH and MS and stroke. Since I cannot rely on management, I'm out, but I'm watching from the sidelines, there still might be something to an effective CCR5 blocker.
Risky if you're a trader. Gold mine if you're an investor. Pretty happy. Holding for years.
SawyerTeam profile picture
@Thomas Barnard get back in if you are really a true investor
Kage Glantz profile picture
@Thomas Barnard Uninformed post. They began Covid a year and a half ago, and cancer even farther back. There's a reason to begin with as many indications as they possibly can simultaneously -- looking years down the road to patent expirations, so none of these blockbuster indications become targets of off-label generic use. The plain fact is that this molecule WORKS against cancer, Coivid, HIV and NASH. Others? We'll find out.
rickhaus profile picture
Great post. Thank you.
Wait now that Hygro, Citron Source and the bashers gang denigrate your plan and Cytodyn.
@rickhaus The shorts will definitely come out, matter of time. Morons.
@rickhaus -- Fun to watch the cult trying to get back at company critics. They have to be shorts, paid posters, etc. Couldn't possibly be that the facts about this company are truly that grim. Hate to see grifting of shareholders by convicted felon who just sucked out $10 million in 2020. He's making $10s of millions and shareholders have lost over $1,000,000,000+ in the last year. NPs laughing all the way to the bank. From auditors: not a "going concern" within 12 months. Hope you don't have too much of your life savings tied up in this stock.
The Blue Baron 3.0 profile picture
@Big John 09 You've been pumping this stock since it was $5. How'd that go for you?
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