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Consideration of the Consolidation and Convergence of Facts

Consolidating the facts. Convergence of evidence. Brings us to the point where I think we are. Very close. Too many indications which CytoDyn pursues are countered by G. In just about every direction CytoDyn is poised to go, G finds its way in front to be an obstacle. But one thing is for sure, CytoDyn remains unhindered, never backing away. From the very beginning until the day HIV is eradicated, it keeps fighting, adamant to complete its mission.

But, CytoDyn has multiple missions. HIV in its various forms of treatment, prevention, Cure via AAV or via LATCH. On the oncology front, there is ColoRectal Cancer, Triple Negative Breast Cancer, Breast Cancer in general, Brain metastasis of any etiology, Glioblastoma Multiforme, Prostrate Cancer, Pancreatic Cancer, Head and Neck Cancers, HepatoCellular Carcinoma and Renal Cell Carcinoma. Then there are a litany of inflammatory indications like Chronic Fatigue Syndrome, Long Hauler's following COVID 19, Alzheimer's Disease, reducing the aftereffects of Stroke, reducing the rate and quantity of fibrosis of any etiology. It goes on and on... The treatment of infectious disease also, mainly of viral origin, such as HIV or COVID-19 is a very viable path the company could certainly take.

This is the end direction which CytoDyn takes. Which one? There are so many end points, but each one is a viable direction. Many of these directions are blocked though. In general, CytoDyn itself is thwarted because of all the avenues it has to choose from. Many entities already know that leronlimab is a massive game changer, not just for the indication it is approved for, but rather in the entire spectrum of inflammatory disease. Leronlimab changes forever the way disease is treated and for this one reason, it is being vehemently thwarted today.

Am I missing something? CytoDyn has compelling data, compelling evidence that could bring an end to mTNBC. With all the recent silence following ESMO-BC Munich, I have to think talks are in progress with likely an ICI manufacturer in an effort to prove out this treatment in a Phase 3 trial that would give that ICI the indication to treat the remaining 85% of all mTNBC, not just the 15% it's currently indicated for.

In a short time, by October-November, 2025, leronlimab will have already treated 21 patients, 5 + 8 = 13 at 350mg and 8 at 700mg and it will be lucidly clear that the 700mg patients are safe, but that their CTCs are the ones that have an increased PD-L1. It quickly becomes even clearer that these patients soon require the additional treatment with an ICI and are then rolled into an arm of the study, (yet to be incorporated into the protocol) which assess the subsequent treatment with an ICI for those patients with increased PD-L1 on their CTCs. It becomes even clearer still that patients who were treated by such a protocol as this, in fact do have NED 1 year following initial treatment.

What else can we expect in the coming year? What about LATCH? What about GBM? What about Alzheimer's Disease? All are viable. All are either underway or about to be started. All are expected to be started, initiated, commenced inside of 2025. The GBM study is a murine study and that should even be resulted within 2025. These are 3rd party funded, sponsored and conducted, so they happen at the pace of the sponsor, but those sponsors said they would begin within 2025. So, we should be hearing soon about any one of them.

Within the leadership team at CytoDyn, there exists no opposition to any one plan of which I'm aware. Even the board, as far as I am aware, are all on board with CytoDyn's overall plan. United at the top and all are in favor of the pursuance of each and every indication as listed on the pipeline. There have been some changes along the way, to arrive at the current spectrum of focus, but that may also have been a concerted and united effort in getting to where we are here.

So, this is our finger on the pulse of what is happening. The center of it all right now is the transformation of Cold Tumors to Hot Tumors and then the subsequent treatment with an ICI. But, everything Jay has mentioned in past Press Releases can not just be ignored or swept away as chaff. They very well could be working on anyone of the lesser discussed indications. Part of the recent silence could be due to NDAs concerning any one of those.

However it turns out, what ever we learn next, it is clear that Lalezari continues his trek in all of these directions including HIV via 3rd party sponsorship towards Revealing Reservoir secrets, in the utilization of Endoplasmic Reticulum switches that enable the HIV-CURE through AAV and lastly, (2) Pilot Trials in LATCH slated to begin within 2025, which use Stem Cells and Bone Marrow transplants from HIV negative patients who do not have the CCR5 delta 32 gene malformation. In addition to that route, Lalezari and his team use this MSS mCRC clinical trial with probable addition of an arm that includes an ICI treatment for qualified patients. Breakthrough Designation also remains an option in both mTNBC and/or MSS mCRC.

Given the already proven results of the LATCH trial, Lalezari is almost assured success in that endeavor which is set to begin this year, and given the already observed transition of Cold Tumors to Hot, he is also just about guaranteed success in proving out that LL converts Cold Tumors to Hot, and in the added arm, he again is just about assured success when those Hot patients are subsequently treated with an ICI, have NED after a year of treatment, by July 2026.

In this year of 2025-26, at a minimum, Lalezari is confirming scientifically and clinically, these foundational truths. And as I said in the prior post, the MSS mCRC clinical trial is Open, meaning, the results are immediately available. In LATCH, since it is sponsored via (2) 3rd parties, those results are up to the individual sponsors to release, but I suspect, if they are curing patients of HIV via LATCH, then, we could be hearing about it sooner rather than later. We should hear though, when LATCH has begun at least when the 1st sponsor start up their Pilot trial. In all of these studies and trials, leronlimab's safety profile is ever strengthened.

In one year, the MSS mCRC clinical trial shows scientifically significant results with an ORR of over 33% and many of the patients in the arm treated with an ICI have NED. That means, no evidence of any tumor on MRI or CT. In one year following the start of the LATCH trial, those patients who received the Stem Cell Transplant remain alive with no evidence of HIV at all and have no need to continue taking any HAART or leronlimab. They are cured of HIV.

Where does it go from there? Question is, where does it go in between? Who else gets involved? Seems pretty likely we know who gets involved in Oncology as Cyrus already alluded to it 2 years ago when he discussed MD Anderson. Seems also that the GF is really keen about an HIV Cure and might want to strongly pursue something together with ViiV in regards to LATCH when this is proven out.

We've gone over this so many times. Seems just redundant now. So the focus is: all of it. Every indication. We don't know which one hits first. Many are vying for the lead. Any one can sprint to the forefront. Regardless, I see victory for each one despite G's opposition. We have already seen the most important outcomes already occur. We have clear understanding on how these should turn out. At any moment, the intervention we're all looking for could happen and that would take care of it all right there.

But all is coming down to one point. Pivoting from point A to point B. Point B is the transition to a partnership. We're orienting ourselves and preparing ourselves for that moment when that day comes. This seems to me to be the only viable exit from the past 5 years I've been documenting CytoDyn. I don't believe I've done this for nothing. I just don't believe that. I feel like there has been a purpose. So I stick with what I've said above.

CytoDyn has not relented, though, we think they may have. There have been tremendous gains in recent days not just in MSS mCRC and mTNBC, but all around. I want to know when to expect that partnership. All of us realize the need for such a partnership and how it can benefit both parties. I just don't know what G's reaction will be to that announcement.

Posted Jul 13, 2025, 1:57 PM UTC

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