CytoDyn at a Standstill? Hardly.

Alright, so tomorrow 4/15/24 at 10:00am EST, we have the continuation of NP & KK hearing, so look for those pertinent transcripts to follow. Now, we talked about that last week, and that post explains my take about the path that case is taking.

I think this is kind of monumental, because it definitively shows a pre-disposed prejudice against CytoDyn and it also vividly displays outright disdain that was then projected towards our current CEO physician in his prior humble request for an EUA in the midst of the then worldwide crisis. On multiple attempts, repeatedly, Dr. Lalezari makes his request to be heard, kindly, with respect, speaking doctor to doctor, in an attempt to make progress, headway towards solving the massive problem of the pandemic, given the evidence of the results, which was not hearsay, only to be flatly rejected and denied with no legitimate reason. This has created more curiosity for us as a whole and has given us a reason as to why NP walks.

Now, we may pinpoint more, and could explain in part, as to where we are and that is that the severity of destruction happens suddenly. I do give credence to the evidence presented by NP. I believe that there is more where that came from and more might be presented on Monday. In addition, unlike LeClosetRedditor, I do believe that the outcome of this SEC/DOJ case does have an impact on the Amarex Arbitration Settlement. I suspect that the outcome of the SEC/DOJ case will be a huge event, regardless of which way it goes. I'm believing that the SEC/DOJ will regret indicting NP. The results that this case produces shall be utilized by Sidley Austin in the quantification of the punitive and compensatory damages levied against Amarex and NSF. It is important to understand the magnitude of the total dollar amount that this might sum up to be. Does this explain why the company does nothing to bolster the share price at the moment? The question is, how does it get paid? Tyler Blok as well as SA need to work that out.

Let's see what the evidence reveals. Are the plaintiffs against NP as comfortable as Mazzy Star who feels she has the entire case already figured out and pre-decided? I think they are questioning their own facts in the matter.

Stagnant CytoDyn? At a Standstill? Through it all, CytoDyn continues working. Just last week, Mitch Cohen broke down the dam and water is allowed to flow again. All that is needed now is water, but the dam don't exist anymore. He broke down the $44 million debt into a structured payment that CytoDyn absolutely can achieve with Samsung's acceptance. Genius. Now, water may flow once again where prior, it was stopped at the dam. What Cohen did, allows CytoDyn to bust loose from this stagnant stance. This has given much credence to what CytoDyn/Lalezari/Cohen/Blok have been saying, even what Migliarese said as of late.

These are the last words that I have from Migliarese:

"00:44:31 Marta:

Thank you, Assuming the clinical holds lifting, how much money and on what time frame will the company need to raise to execute going forward? Dr. Jay Lalezari: Antonio, can you speak to that?

Antonio Migliarese:

Yeah, I think we're still in the process of evaluating next steps and where we're going to head. So I don't think we're in a position quite yet to answer that, but we're in the middle of the process of going through that and as I think Jay kind of alluded to earlier, we've kind of through this clinical hold process and the new group of consultants that we brought in in the May-June time frame did a great job of identifying this new potential HIV trial, which is quite interesting. And what I can say is that this proposed trial requires significantly less capital investment than the NASH trial that we've been... looking at doing within the NASH space. And I think some of the other things we've also been evaluating is, are some other what I'll call micro or less capital-intensive investments that we could make that could lead to some sort of near-term potential catalyst? So, for example, in the NASH space, as I just mentioned, a NASH clinical trial on humans is quite expensive. You're probably looking at the $100 million range. However, could we perform some sort of preclinical trial combination therapy with another drug, such as Madrigal or one of the other players out there that's further ahead than us in the game? And so, I think what we're getting at is identifying these preclinical studies, which are significantly cheaper in the $200,000 to $300,000 range could lead to some potential partnerships and credibility with some of the other larger pharmas, which could then help propel us within these other spaces with well-investing limited funds. So just saying that, I think help people understand as we've been going through this clinical hold process and the process that we're in the middle of right now is coming up with a judicious plan, which we think we can utilize the least amount of capital to create the greatest number of catalysts for the company, which we're very much in need of as we've been working through the hold."

CytoDyn is currently working towards the goals AM mentions here. Also, Tyler Blok hits on many of the company concerns here, and they are coming about as he has indicated. Why would we not think the remaining goals do not materialize just as he says they will?

"Marta:

Thank you. What is the status of a manufacturing partner and their relationship with Samsung?

Dr. Jacob Lalezari:

I'll just say that one of the things I've been working on is to make sure leronlimab has enough drug to do the study that we're proposing. It would be a good problem to launch this study, enroll it, and have enough positive outcomes that we need more drug. But that is not going to be. Antonio, do you want to speak to that?

00:35:25 Tyler Blok:

Then I can actually... Yeah, yeah, yeah. So, Hi Marta. Tyler here again, company counsel. Tyler Blok. I imagine this question somewhat came up due to the recent AK filing disclosure about the relationship with Samsung. So, the long and the short of it is we're in prolonged negotiations with Samsung. It represents a significant and substantial past due balance rate. It's a very large financial commitment if and when we're able to resolve it with Samsung. So, what we're evaluating in our approach to the Samsung relationship is we're considering a couple of variables, but one of which is that we do, in fact, currently hold enough leronlimab to complete the contemplated clinical trials in both the short and the long term short and mid-term that the company would have. So with that in mind, we are evaluating, okay, what's the perspective future manufacturing needs and which third parties make sense to work with. Because at the end of the day, we don't exclusively manufacture with Samsung and we have options in that regard. So, while we have a vested interest in resolving the situation with Samsung, we're going to do it if and when it makes sense for the company to reach a resolution with Samsung. And then as Jay alluded to earlier, in the short term, we do have enough leronlimab to complete the contemplated trial. So, while Samsung recently notified us that they intend to terminate the agreement in January, that is viewed, for the most part, as a negotiating tactic and really trying to get us to the table. So, we're working with their counsel. We intend to continue the negotiations. But for right now, we're not in a panic as it relates to Samsung.

Marta:

All right. Thank you. Can you discuss the status of your IP?

Tyler Blok:

Yeah, I can take this one. as well. So, the two most common questions that we get when people ask about IP, and I'm just going to assume this is what people would want to hear by way of an update, is what exactly started to expire by way of IP in 2023, and then generally they want an assurance that the company has some sort of plan, right, or an idea or is monitoring IP. So as to the first, in terms of what started to expire in 2023, the company is very cognizant of what expires and when. Needless to say, we are a pre-revenue biotech company developing a single molecule at this point, right, or some there are varieties of that molecule. So, we view that as our only asset and the most valuable asset, and we invest time, energy, and resources ensuring adequate protection. So, where the questions arise as to what expires is primarily related to our exposures, and I imagine our 10k. So, the underlying molecule of the leronlimab antibody itself started to expire in 2023. So that is the foundational leronlimab. You heard Jay speak earlier about how long he's been working with the antibody, right? There's IP tied to that. So, as the longer the random at itself has been out in, the IP can only last so long as to the underlying antibodies. Now, what the company does to build out the next levels of protection is we've gotten IP around the concentrated protein formulation and those don't start to expire until 2031. We've gotten levels of IP protection surrounding the use of leronlimab and the treatment of HIV. That won't start to expire until 2035. We have methods of action associated with cancer indications and methods of use associated with cancer indications and those don't start to expire in 2040. And then COVID-19, we have certain protections that again would start to expire in 2040. And then the most recently developed IP surrounding NASH would not even start to expire in 2043. So, our approach to that IP and what technically started to expire would allow people to use leronlimab antibody for research purposes. But the practical reality is we've built up adequate protections around the applications of leronlimab and HIV, COVID-19, NASH, and then there's also some certain methods of action. IP that would prevent anybody from substantially competing with us while using the wrong amount of antibodies.

The second part that we get and the question we get frequently about IP is, okay, what's the plan? So, something that we're currently excited about internally, and you would have seen disclosures about this, is the third-party generative AI company that we've been working with. In early 2023, we entered into a partnership directed towards developing a long-acting therapeutic*, and instead of me talking like an attorney, I'll actually hand it off to Jay here maybe to finish off this concept, but we're very excited about the prospects of a long-acting therapeutic and what it could mean to the marketability of leronlimab as a whole. So I'll stop, and I don't know, Jay, if you wanted to add anything about the long-acting molecule.*

00:40:38 Dr. Jacob Lalezari:

Well, what I try to paint a picture of is how leronlimab has been wandering in the HIV treatment landscape for two decades, trying to figure out where it fits in, and as a once-a-week therapy, I've had had conversations with Merck and Gilead and VIIV and they uniformly rejected a once a week sub-Q. A feeling that a once a week regimen needed to be all oral, but that once a month sub-Q was acceptable. So if we had or CytoDyn had a longer acting formulation, I think they immediately become competitive in the treatment landscape. Moreover, I think the whole world of PrEP, pre-exposure prophylaxis, with a once a month patient self-administered regimen would be very appealing. So I think having a once a month treatment opens up several doors which are not currently open to CytoDyn*.*

00:41:40 Marta:

Thank you. What is the status of the Amarex litigation?

Tyler Blok:

Oh, excuse me. It's Tyler again, counsel for the company. I'm sure everybody wanted to hear from the attorney as much as possible today, but I'll field this one as well. So, what people want to know... know about the Amarex arbitration, of course, is the timeline. And by way of pertinent dates that we have currently, and these have been disclosed, and then obviously happy to field some follow-up questions if there are any. But what we have is a final hearing date set, and that's set to commence on August 12, 2024. So what that means is both parties go present to an arbitrator their evidence, their cases. Sometimes that process can last one to two weeks. That process is starting in August, on August 12, 2024. After that hearing, that two-week hearing, perhaps maybe one week, an arbitrator typically has 30 days to issue an award. And what that award is, is that's the arbitrator's findings as that proceeding. So, of course, in this instance we anticipate getting a favorable award to us, and we would anticipate having that in hand should this matter go to a hearing sometime in September 2024. Some people ask, when would it be resolved, or when will it be settled? Well, the answer to that question is: it could happen anytime between now and the hearing*. Um, parties sometimes reach a settlement after one to two days of a hearing because one party really doesn't like how the proceeding went. The long and the short of it is, is that I think the most prudent approach, uh, that the company could take to this proceeding, and I speak from a position of I was in insurance defense litigation for the better part of the last decade. So, fortunately, this is what I did and I feel comfortable with, is insurance defense litigation, and specifically in arbitration. And* I'm working with Sidley Austin right now, and our approach to this case is to get very pointed discoveries, attempt to locate and identify insurance policies in play as to Amarex, and then get those insurance companies, get Amarex potentially in a room to mediate, um, from a position of power on behalf of CytoDyn, and see if they have an offer that makes sense to the company and then if they don't, then proceed to the arbitration and hold them accountable. Because again, we're working with Sidley Austin in this case. They've been familiar with the fact pattern. We've been reviewing and preparing our case for the better part of the last 12 to 18 months, and we feel very comfortable proceeding and getting the awards. going to hold them accountable if we have to.**"

Even My69z can vouch as well as here for what Tyler Blok has stated here regarding patents. Many things are going right for CytoDyn and CytoDyn leaders are saying it ahead of time. CytoDyn is fighting for the survival of its life, of leronlimab. NP is fighting the SEC and DOJ. He has some decent evidence working in his favor. The destruction of that dam revived CytoDyn's life, almost like CPR on a suffocating individual or an entity drowning in debt. More evidence comes from the coming trial with NP. Remember, he is in a fight for his life, and he is a fighter and makes no bones about it. There will be no question as to what went down because all will know who really want to know.

The magnitude of what happens here dwarfs the share price. Perrenialloser says it much better. How this unfolds is very much dependent upon how much CytoDyn is willing to negotiate and/or capitulate and how much NP is willing to give and how much KK flips on who pushed him into the act of sabotage. This is in the process of coming to a head. It is slowly working its way towards resolution. Then what? It all goes away?

How does this peace and security come about? Truce? Compromise? Pull back? Retreat? Why? The dam was broken down to partner. CytoDyn is not backing down. "we feel very comfortable proceeding and getting the awards. going to hold them accountable if we have to" from above.

The week and what happened with Mitch Cohen was absolutely necessary to allow CytoDyn to exit out of the stagnant standstill it has been in for years. CytoDyn couldn't do anything with that burden on its shoulders, couldn't go left, right, up or down. It was stuck. Now, the company is released from this beast of burden and will have more avenues to go down and more strength behind them to allow them to prove that what they said is going to happen in all the matters I discussed in this post. This makes it CytoDyn's turn. It is open for CytoDyn to make the next move. As I said before, Lalezari plays hardball and chess simultaneously.

CytoDyn is in a new position, and it is going to change things. I think the magnitude of what is coming might influence the decisions made by both parties on each side and a means to bring justice to the current arguments will preside. Then, after it all settles down, the hard work will have been done and gone. This ordeal which CytoDyn has gone through and still is, is a big deal to any company, and CytoDyn survived it, where many might not have. Unexplainable mysteries mark its history as to how it got through this quagmire, and how it will continue to get through will again probably be almost miraculous.

Thank you all for your kind comments and replies. So helpful.