So Where Do We Stand Now?

I appreciate that some questions are being asked. So in response, I'll write this.

So in It Takes 2, we discussed the increasing likelihood of partnering due to the unveiling of the new Synergistic MOA which results from the initial treatment with leronlimab followed by the subsequent treatment with a PD-1 blockade.

"It validates a mechanism (CCL5/CCR5 blockade → PD-L1 upregulation)"

Isn't is apparent, that as time moves along, more and more things are being revealed unto us as we get closer and closer to when that asteroid hits, or to when that boulder hits them square behind the knees in the hamstrings.

At this point, CytoDyn is firing on all cylinders. They are on track, even though MSS mCRC seems to have been delayed. Now, we know now why it was delayed, and that was to allow for the incorporation of the newly found MOA into that clinical trial. The answer is Yes, PD-L1 shall be monitored and the subsequent treatment with a PD-1 blockade shall be made an option to all patients in the upcoming clinical trial. In addition, comparisons shall be made between those following through with the subsequent treatment of the Physician chosen PD-1 Blockade against those who opted against subsequent PD-1 blocking treatment.

So then, given that CytoDyn is on track and the fact that the further along we go down that track, the more information is revealed unto us, then, is it possible to know exactly, at which time when we shall obtain that specific information for which we earnestly search? I believe the answer to that question is Yes.

CytoDyn is very fair. It moves to either force G to negotiate and compromise or ultimately to eliminate G's power and overcome their indications with CytoDyn's own treatments, yes, even at the risk of needing to relinquish an indication or two. But G never negotiates. So we know how this ends.

At ESMO 5/15/25 in Munich, what CytoDyn did was unprecedented. This was one of CytoDyn's biggest sudden movements ever experienced by the company. Completely different than what it has done in its past. A great accomplishment achieved by this Leadership Team. Absolutely huge what they've done. Again I preface, CytoDyn is very fair. They are not looking to start any wars, but it has an amazing solution and it is making it known. Essentially, it presented extremely convincing evidence that with the application of the treatments in succession, humanity has a very decent shot at the eradication of cancer and metastatic disease from the body. They made the announcement to the Big Pharmaceuticals that this is a very real possibility and that with the number of PD-1 blockers on the market, their ears should be wide open for hearing and mind duly focused and attentive. Yes, share price went up in anticipation, but it hardly reflects what was accomplished at ESMO due to the grandest of G's efforts.

Combining the two treatments leads to Peace and Safety. Leronlimab establishes the necessary Peace within the body while the PD-1 blockade makes the body Safe from any future uprising or resurgence of the Tumor. Similarly, CytoDyn actively looks for a Peacefully Partner in a Big Pharmaceutical, especially a Big Pharmaceutical whose PD-1 Blockade currently fails in the treatment of low CPS type Tumors, or Tumors which do not produce much PD-L1 at all. From the link above, Keytruda for example is currently only indicated in Tumors with CPS > 10. What if leronlimab could make it such that Keytruda would be indicated regardless of CPS? It can.

Regardless of CPS, initial treatment with leronlimab ramps up PD-L1 so much, that really any PD-L1 blockade could be successful. If Merck cares to have even a fighting shot at this vast market, it needs to consider first preparing all indicated patients first with a couple of months of leronlimab before administering their chaser Keytruda.

This newly uncovered MOA has nothing to do with G's sacituzumab govitecan MOA which is simply focused chemotherapy. That drug just goes about killing Tumor cells and hopefully not killing any other cells of the organs or tissues. Where as, CytoDyn's leronlimab and PD-1 blockade differ in that this mechanism is all about blocking the communication of the Immune System. In general, G's SG can not compete. We are talking 1 year OS vs CURE. This would destroy G's capabilities of even continuing let alone moving forward should our new MOA take hold.

"It shows real-world benefit in an extremely difficult-to-treat population

And it raises the question: Why aren't we fast-tracking or further accelerating trials based on this?"

But they care not to negotiate. They are not threatened by any of this. All they want is to do is propagate their treatments.

On the other hand, with these findings, Dr. Lalezari has delayed the MSS mCRC clinical trial in order to include the option of using a PD-1 blockade in an effort to Cure the patient of their ColoRectal Cancer. This certainly is in hopes of establishing an incredible unequivocal data base of Cancer Cures based on this new MOA. For that matter, how could anyone really compete with that? Cancer treatments for anyone not capitalizing on this Cure would basically dry up and dwindle down to diddly squat.

Plenty of upcoming initiatives that shall flaunt this new MOA. u/BuildGoodThings does an incredible job of organizing such events, so take a look at his calendars and look for events coming in the near future, for example, Conference Links May and July 2025. Yes, on 7/4/25, there shall be another ESMO event, but on GastoIntestinal Cancer, which includes ColoRectal Cancer. There shall be another conference discussing the mTNBC results on 7/7/25 where Richard Pestell will again present this same mTNBC topic but to the Cancer Congress in Vienna. We're going to have to wait to see how all this unfolds.

So, you know I've said many times in the past, that what we're looking for happens very quickly. Like in the blink of an eye. I've related it to an Asteroid hitting or to a boulder hitting them at the hamstrings. I see a Triumphant Victory, but one which comes at the last moment. I believe the movement and the maneuvering shall be very large at least relatively speaking, much of this work, potentially not even declared up to that point. I'm tending to think that there might even lie within that previously captured and hidden Amarex data, even more potential secrets yet to be unveiled. Maybe one shall be disclosed in the upcoming GI Conference.

The Basket Trial had a variety of Cancers and mCRC was a part of the Basket Trial. Many of the cancers also had metastases to the brain.

"27:15 Nader: Yeah, and BTD that we will be filing, Dr. Nitya Ray did a fantastic job on that. There were some patients with brain metastases. Dr. Ray, explain to us, for a breakthrough designation strategy, are we going to file for brain metastases and perhaps later on, if we do get BTD on the original submissions, maybe we want to ask for Basket Trial data, but tell us about the Basket Trial please.

27:60 Nitya Ray: The BTD application that is submitted is 28 patients from 3 different trials. And out of the 28, 6 had brain metastases. They are all mTNBC patients. So we have submitted all of the results, including all of the patients with brain metastases, now with the FDA and FDA is reviewing it and we are waiting for FDA to respond for BTD application and we expect to hear from them in about 2 weeks. 2-3 weeks. Our CTA application I believe was submitted on November 5. So by January 5, we should hear from FDA. and then we are going to discuss with FDA and see that forward with brain metastases. Now, these are not the only patients with brain metastases because these are mTNBC patients. But, we have other patients in the Basket Trial and not mTNBC, with brain metastases. And so we are very excited about what is happening with these patients. And so we are going to discuss this with the FDA and we do plan, after we receive the response from the FDA on the BTD application that is submitted, we are going to plan for perhaps another BTD just focusing on the brain metastases."

Were PD-1 blockers used in the Basket Trial in the ColoRectal Cancer Patients? We might very soon find out. We might find out that these patients also remain alive today when they should have died 3-4 years ago. We shall see. 7/7/25 is a repeat discussion of the mTNBC findings, but to yet another conference. Things should be panning out following that. Does the following image taken from the 12/7/22 R&D Update give a clue as to what we could expect regarding the CRC patients of the Basket Trial?

6 Patients of the Basket Trial were CRC Patients. How many remain Alive today? Why?

In addition to what this new MOA is doing to by giving Big Pharma the realization of, Big Pharma is also having to deal with the new administration. RFK Jr. and the head of the new FDA, the head of the new NIH, etc... Now, they have to deal with the fact that a Cancer Cure is very possible. They need to deal with new pricing restraints in that Big Pharma can not charge the US more than the lowest charged nation. They also need to deal with Patents on their PD-1 blockades expiring. Oh, what is a Big Pharma to do?

A Press Release comes disclosing plans which knocks their socks off. It outlines the collaboration agreement between CytoDyn and the Partner or Partners. It describes how the implementation of this agreement is peacefully achieved between the companies involved which thereby enables patients to find their own peace and safety far away from the threat of their metastatic disease returning which is a direct result due to the efficacy of the Synergy of the medications they are taking.

Who, I ask, is CytoDyn most synergistic with? I'd say GSK who owns a PD-1 inhibitor named Jemperli or dostarlimab used in the treatment of ColoRectal Cancer with a certain gene mutation. Well, would you think of that?

• The global colorectal cancer market was valued at $13.9 billion in 2024.
• Jemperli-Eligible Segment: If 5–10% of colorectal cancers are dMMR/MSI-H, then Jemperli is indicated for approximately 5–10% of the total colorectal cancer market.
• What if leronlimab makes Jemperli eligible for the entire MSS colorectal cancer market, which is about 85% of the overall colorectal cancer market?

All of this recent up-rise was in response to ESMO. Did CytoDyn act accordingly regarding ESMO? Certainly. Is ESMO the beginning or the end? Seriously, how can nothing actually materialize? Given the fact that Dr. Lalezari took the time out of our schedule and modified the upcoming MSS mCRC clinical trial to include the new MOA, it practically proves the point that the CRC patients in the Basket Trial who subsequently took a PD-1 blockade potentially could remain alive today. Therefore, if nothing materializes following ESMO, what happens when the MSS mCRC patients of the clinical trial go on to survive way beyond the expected OS? Is that when it slaps them clear across the face?

CytoDyn is expending its last dollars into this MSS mCRC clinical trial. At this point in its trajectory, it appears as their last ditch effort to get this drug across the finish line. Surely, they have proof positive from the Basket Trial leronlimab's efficacy against CRC. Roche is also on board and plays a huge part in this clinical trial.

"Bevacizumab, a VEGF inhibitor, originally made by Genentech as Avastin, is now owned by Roche. We are aware that although leronlimab primarily functions as a CCR5 blockade, it also functions to inhibit VEGF indirectly. CytoDyn is looking for Synergy in this combination trial. It is not looking for monotherapy.

So, we can clearly see by this recent Press Release, that CytoDyn [could] be in discussions with Genentech and/or Roche. The simple fact that these medications were mentioned in the PR and given the similarity of the proposed CytoDyn trial to last year's Trifluridine/Tipiracil Combined with Bevacizumab Receives FDA Approval in Metastatic CRC trial, it becomes rather clear that the companies are seeking an improvement over and above the SUNLIGHT linked trial performed last year. That medication combination currently competes with Regorafenib by Bayer in the treatment of mCRC. Certainly, Genentech/Roche are interested in the treatment of the MSS MicroSatellite Stable tumors, which are those cancer types which represent about 85% of the cancer tumors. With the addition of leronlimab, this vast slice of the oncology pie becomes available. Without leronlimab, they are limited to treating only 15% of the oncology pie which are the MSI MicroSatellite Instability tumors.

On May 16, 2024, in the May 2024 Letter to Shareholders, Dr. Lalezari made the decision to drop the Inflammation, Immune Activation trial as Priority #1 and to replace that with this proposed mCRC trial in combination with Trifluridine/Tipiracil and Bevacizumab. Please re-read the following posts which I had written immediately following Lalezari's change, but on this re-read, replace Merck and Keytruda with Genentech/Roche and bevacizumab/Avastin: Changing Gears and its Part 2 complement A Means To An End."

I do speak much more about Roche in that same post, ORR whose link is bolded above.

To me, it seems as if all this Cancer focus is coming together all around these cancer conferences which are somehow focused on our current indications of mTNBC and MSS mCRC. What's the possibility of that? Could this be a hint pointing to that day when the Asteroid hits, when they're hamstringed behind their knees? I think it tells us that we're pretty close and if we looked out into the night time sky through our telescopes, we could appreciate that asteroid approaching, bigger and bigger each night. And that's what I'm doing.

What is CytoDyn actually doing? Sounding the alarm. Putting the word out. Making known the molecule we own. And isn't that what we're doing as well? This news has got to hurt G. Come on G, admit it... It's gonna hurt. This is the way I'm seeing it unfold, but simplified. I think CytoDyn lets us know as much as they can without giving it all away at once. They're leaving it up to us to put together the pieces.

We're getting very close Folks. The next few weeks should reveal even more, especially with the uncovering of even more secrets previously hidden by Amarex. If G finally capitulates and yells loud enough, "OK, enough is enough, we want to have Peace, and they are willing to compromise, make amends, stop the shorting"... We all know G will never do any of this, so I won't go any further down that road. Instead, they fight until their brutal end, though they may want to pretend they're concerned, but only to delay and give them more time to double down.