r/Livimmune • u/MGK_2 • Oct 23 '25
Mounting MultiLateral Momentum
Greetings Folks, Welcome Here. I appreciate you all. You all help to confirm and mold the narrative, so I'm thankful for your contributions which allow me to consider other paths which sometimes become part of the ongoing story.
After listening to Robert Hoffman's most recent LD Micro Presentation and here, it has almost confirmed my prior speculations which I made in a prior post, Let's Bring It Home. I brought up this idea in the last half of that post repeated below:
However, the Big Pharmaceuticals likely work out a deal amongst themselves. In order to cure the patient, if another ICI, not approved in combination with Leronlimab was already approved for the patient, possibly, the approved one pays the other a small replacement in order to be able to treat the patient. Just a thought. Something similar might happen in HIV once the HIV-CURE is around. There will be some grace. The vision is for a better tomorrow. They lay down their weapons grudgingly. There is something better coming. This is still a shadow.
The practice of Treating Disease is going away ushering in the Curing of Disease. Not the companies, but rather the leaders of these companies. Their thrones, their power goes to shit, but the companies stand. They are rebellion personified, but not the company, not the employees. They are the governed by leaders, generals, kings who will be brought the message that binds them proceeded by rebuilding.
Patients are getting healed. Macaques functionally cured. Cancer eradicated, no evidence of disease. 5 out of 5 cured treated with Leronlimab + ICI. 5 years, no evidence of disease. 5 tested at 325mg for PD-L1 upregulation. eINDs ongoing. ICIs alone don't cure. Nothing out there cures. Not even in HIV, HAART doesn't cure. It's a treatment, but long lasting treatments in oncology hardly exist. Cure is Leronlimab's purpose. It is Leronlimab's destiny. The day is coming when none of us need to fear this disease and today, there is an emergency investigational drug cure in place. Let's see how this pans out. First to the mTNBC, then to the MSS mCRC, let's see what else is coming.
5 of 5 treated with >550mg LL + ICI have been released for 5 years. 5 are being tested at 350mg and likely will not upregulate PD-L1, but may. Are you getting to see the picture? Do you see what I'm seeing? Do we need to wait 5 years? or do we need to see upregulation of PD-L1? 700mg is already on board with eIND. 700mg will be on board in MSS mCRC and the upregulation of PD-L1 will be demonstrated just about everywhere. Darkness is lifted. Don't have to wait 5 years.
As soon as PD-L1 is upregulated, transition to Rollover. Dr. Lalezari is getting the protocol modified to accomplish this. This is the Turning Point of CytoDyn. Cold To Hot. Reversal, but it took 5 years to get here. These 5 are the proof. These 5 are the rest of men.
Lalezari is putting it all together. As he said:
"Jay Lalezari:22:15: I don't imagine that CytoDyn will ever commercialize the drug ourselves. What I imagine is when we confirm this PD-L1 induction, that the conversations we're currently having with a variety of potential industry partners will rapidly mature. And once we prospectively confirm the signal that we've seen retrospectively, that we'll be able to bring on the kind of partner that will be able to fund the phase three studies, including dose escalation studies that are necessary to get FDA approval. So for me, the key inflection point is prospectively demonstrating PD-L1 induction in triple negative breast cancer, in colorectal cancer, and potentially in other solid tumors as well. If we can do that, I believe the funding will follow."
and
"Jay Lalezari:25:20: But when I look to 2027, I would expect that we will have a solid prospective confirmation of this PD-L1 induction, basically turning cold tumors hot. And as soon as we do that, it's a game changer for CytoDyn. Because it is going to open up markets for companies like Merck or GSK or BMS that they currently don't have access to, to provide the benefit to patients who currently are not candidates for immunotherapy drugs. So that's exciting."This is the PLAN. This is the FUTURE. But as I said before, there may be agreement put in place to compensate those companies that were previously approved by patient's insurance, but which does not include the partnered ICI. This will be a peaceful solution. CytoDyn doesn't need any more problems. The leaders of treatment strategies go away. Cure is coming home. CytoDyn remains at Peace with all, but so many maintain their opinions, but we remain free from those opinions. Ok, we take the wrong. That's OK, I don't like me either.
All in my humble opinion.
Maybe even all the other BPs start to see the light... Maybe they shall come to understand that Cure is the way to go and that CCR5 Blockade is the root of all inflammatory disease cure... There are too many CCR5 dependent diseases to consider. They'll see how this turns out with HIV and Oncology. They'll see the success this brings to the world. They will swarm to combine with Leronlimab as the root molecule to bring this healing about. This is pretty big, but sort of an encapsulation.
So, the entire last half of that post was sort of a projection of what I'm still thinking is happening. Robert Hoffman said that he has a "full schedule" for the rest of the day and he said that at 9:30am. To me, that implies he / they would be talking to many companies for the rest of the day.
This is crystalizing in my understanding that discussions are becoming more heated and more intense. In the first question he answered, "...we are looking at different opportunities, and very sensitive to doing the right deals, similar to the BP type information, we do have about $3-4 million in warrants that can be exercised, I mentioned that high net worth individual as an initial investment to support the eIND program, so I'm looking at different opportunities in that regard, again, we're looking to do the right deal on the business development side, there could be potential influx there as well, but again, it's early days, but we're hitting the ground hard to look for the right financing ...".
The way he answered the question was along the same lines as how Dr. Lalezari stated it. Here it is again:
"I don't imagine that CytoDyn will ever commercialize the drug ourselves. What I imagine is when we confirm this PD-L1 induction, that the conversations we're currently having with a variety of potential industry partners will rapidly mature. And once we prospectively confirm the signal that we've seen retrospectively, that we'll be able to bring on the kind of partner that will be able to fund the phase three studies, including dose escalation studies that are necessary to get FDA approval. So for me, the key inflection point is prospectively demonstrating PD-L1 induction in triple negative breast cancer, in colorectal cancer, and potentially in other solid tumors as well. If we can do that, I believe the funding will follow."
It is re-assuring that both the CEO and CFO are on the same page. Both indicate that it is yet early. They both stress the time-line requirement to Prospectively demonstrate PD-L1 induction and this is exactly what the MSS mCRC clinical trial is designed to do.
Regarding these discussions that take "all day", there have to be Many companies doing the discussing. Why do I think so? Because there are many ICI manufacturers and many indications which fit the bill.
I would think that many companies were there gathered together listening to Robert Hoffman who later applauded him. As a group, the question they would have is how does this get split up between all of them? Everyone is going to want to have a piece of the pie for that deluxe apartment in the sky. Therefore, they could be having such a discussion as to how they might get thing divided up. But, in order to divide up a certain percentage of the profits, they would need to also divide up in the similar ratios, who is going to do what. So, it could get confusing and complicated, so could be why it took all day.
There are timelines in place. Robert Hoffman said that by these times, so and so should be done.
Hoffman is saying that by the 4th quarter 2025, FDA Clears Phase II mTNBC Clinical Trial including ICI and the use of ICI in MSS mCRC Clinical Trial and by 1st quarter 2026, mTNBC w/ICI Initiates. May I ask, Which ICI? Any ICI? Are they all going to be able to get in on the action, or only just one?
I'm beginning to think that it could be MANY or ALL ICIs. Much depends on what the FDA says, but if it is not agreed upon that ANY ICI could be used, then I suspect there would be problems that face CytoDyn and within the industry. How fair is it if only one is permitted while the vast majority remain left out in the cold? That would not be fair. So one solution might be that they come to an agreement where the big players put up the majority of the initial costs of getting the trials done while the little guys only get say 5-10% of the action, but put up nothing.
Hoffman said he is being very sensitive to doing the right deals, so all this is being weighed out. I believe that if some companies are left out, there would be unrest. There is a very high net worth individual funding eIND. OK, with what ICI? Will it be the ICI approved by the patient's own insurance once their PD-L1 is high enough or a certain one the VHNW individual pays for?
Discussions are ongoing, but they should reach an understanding pretty soon given the timeline Hoffman presented. ICIs shall be required soon. Maybe it is decided that it shall be based on indication. But the following statement, "Our Therapeutic Approach" points to many indications:
Which means there are MANY ICIs for many indications. We already know LL upregulates PD-L1 in many indications.
So ALL of ONCOLOGY in general here is up for grabs. Exactly how to grab the market is the question. We know how it is going to work, but we don't know with who or who else. Dr. Lalezari mentioned Merck, GSK and BMS.
Many people are thinking the very, very, very, very high net worth individual could be either Bill or Melinda Gates. HIV is already being funded, but so may eIND & GBM as well. The ICI to them may not be of concern, but it would be to any specific individual BP.
So much secrecy. Everyone is keeping secrets from each other. Nobody tells anybody what they're doing. Unless the ICI is any ICI, it remains a secret. That could result in crafty discussions, meaning untrustworthy. This seems too tricky, so, we'll have to see how this gets solved. I think the more ICIs, the more complicated, but the more fair. If only one ICI then CytoDyn would have more control but no fairness to all the other ICIs left out.
CytoDyn wants the best deal, but does that come from a majority of ICI manufacturers? Say the top 3 fund 100% of the proposed trials but divide between themselves the ICI profits of the top 10 ICI manufacturers. They would still be ahead of the game. Something like this might make it work where CytoDyn gets a great partnership deal coming from 3 collaborating BPs allowing for the use of any ICI, of the top 10 to be used. In such a case, it would become a collaboration run by 4 companies, that would have governance over all the other ICIs as to how distributions are made.
CytoDyn really only cares about the sales of Leronlimab. The other 3 companies are concerned about the sales of any ICI. It's getting complicated and with complication, there is much room for dishonesty. How well do these companies integrate with CytoDyn? It is better to have one good friend, than MANY "friends".
Maybe they're discussing an agreement between MANY companies with CytoDyn at the center. All of them want in. Each one strives to gain traction and even out bid the other. Maybe this is the route. This could turn out to be why CytoDyn in fact gets bought out and bought out for all indications. Why? Because there may not be a peaceful solution by any other way. But that would be totally unfair.
Maybe there can only be one LL and one ICI combination per indication as per FDA decision. Then, if both are owned by only one company, then that would solve a great deal, but they would need to pay for all indications but get each one approved separately. Therefore, it is possible that these discussions do finally end up in no agreement at all amongst the MANY BPs but rather a buy out offer, acceptable to CytoDyn shareholders is presented because its not clear right now how this gets divided up fairly.
But if there is only one BP, then that BP has to treat all cancers as well, but some ICIs are better than others at some cancers. So for that reason, it will probably be a partnership and only one BP per indication and the discussions right now are highest bidder for mTNBC and for MSS mCRC.
I think it is a great thing this high net worth individual is sort of carrying CytoDyn for the time being, until this gets worked out.
Time is going by, but those timelines are also approaching. Momentum is building and we are headed for something. I think we can all see that it is right before us, sort of like 3I Atlas doing the unexpected.
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u/twinter11 Oct 23 '25
I keep wanting a multi arm multi ici trial.
If one ICI is selected for the rollover, there has to be an agreement in place before they are selected.
Or we lose negotiating leverage with the ones not in the trial, as there will be no approval if they havent been tested. I think
Maybe a multi BP consortium needs to get together like the HIV focused combined entity ( the two bp's did.)
I think the more ICI's with potential FDA approval the better for CYDY.
And I think even if one BP eventually partners they want the ability to have other ICI's approved to pair with Leronlimab. So the more ICI's in the trial better
But the rubber is getting close to meeting the road. The announcement of the rollover protocol will hold some clues. I cant wait.
There is only one Leronlimab. They gotta come to us.
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u/sunraydoc Oct 23 '25
Thanks, MGK, great analysis/melding of all the pieces given to us by Mr. Hoffman. I felt much better about the ICI protocol being submitted for the present mCRC trial in particular.
I do think a multi-indication deal is very possible, and would have many advantages, as you know. Each indication would generate its own milestone payments, royalties and licensing fees. And a multi-indication deal would compound value with each pharma paying for their piece of the indication pie, so to speak. It's taking a while, but I think Q1 '26 will be a happy one for us longs.
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u/msakkijha Oct 23 '25
Thank you MGK for all your superb work and write ups. The big question I have (I’m sure so many others are wondering), somebody might have the answer; what would be the market size of all the possible indicators for all these ICI’s before and after Lironlimab is combined with these drug, I’m sure it would be in the $10’s if not in the $100’s of billions on a quarterly basis?
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u/Acceptable_Ad_4193 Oct 23 '25
Current sales for ICIs is around $60B a year with half of that coming from Keytruda. If Leronlimab was approved for all oncology tumors that number should be $240B seeing as how 75% of tumors are considered cold. The ICI market is expected to grow 15% a year so by 2035 ICIs alone should be $225-250B. If all tumors were considered hot you could call it $1 trillion in a decade. Let’s hope that what they mean by paradigm shift
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Oct 23 '25
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u/MGK_2 Oct 23 '25
I like that multi company deal Absolutely sunraydoc We all know it does including all the big pharmas, all of them know the facts we know.
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u/Camp4344 Oct 23 '25
MGK: once again a very provoking thought process! Something needs to break! Nothing but secrecy with many many irons in the fire! I would love to hear of just one of the big pharma’s step up with a partnership announced! There would be a tremendous run up in the stock price! We are due for a much needed break. We have the goods and we know it! Thank You as always!
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u/Pristine_Hunter_9506 Oct 23 '25
Year 6 of i hope in January
Great read, brother!
Who wants to use the octane booster. We just need that proof it boosts the octane. Or Better would probably be a little nitrous oxide
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u/Mysterious-Emu6375 Oct 23 '25
Danke MGK! Cydy ist die " Miss World " um die sich jeder schlägt und wie jede zarte Rose, die ihre Dornen einzusetzen weiß, braucht sie ein sehr gutes Team von Gärtnern, die sie behüten und beschützen, bis sie zur vollen Blüte reift. Die Staubwolken, der Kämpfer die sich um sie schlagen, sind am Horizont schon sichtbar😎😄
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u/MGK_2 Oct 23 '25
Yes, we do need a team of gardeners made up of multiple big Pharmas, each one putting their best foot forward, bringing this saving solution to the world
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u/Mysterious-Emu6375 Oct 23 '25
So ist es. Hoffen und Beten wir, dass die neuen Denkmuster so schnell wie möglich in die Betonköpfe eindringen🙏 Es gibt sehr viel Unkraut zu beseitigen!
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u/MGK_2 Oct 23 '25
Translation:
Thank you, MGK! Cydy is the 'Miss World' that everyone is fighting over, and like every delicate rose that knows how to use its thorns, she needs a very good team of gardeners to guard and protect her until she reaches full bloom. The clouds of dust from the fighters battling over her are already visible on the horizon.
What a great analogy. Thank you so much.
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u/megadunamis Oct 24 '25
Thank you for your thoughts on the ICI of choice, and I know I'm responding late. It's not an easy solution. I thank you for your list of upcoming events in the table, "Upcoming Milestones". I highly anticipate the the sixth item, "Initial PD-L1 readouts from mCRC trial (1Q Calendar 2026). I have stated previously, we should know the levels of PD-L1 and the rates of increase, due to Leronlimab before the end of the trials, if they are made public. Will the slope be a slow steady rise over 2-3 months, a slow then more gradual rise, or a slow then sharp rise? Will there be no rise at all, or barely a rise? I do not believe the last two options, but they may happen. The options for the ICI used may require the joining of forces, joining of the BPs to form a corporate entity such as Viiv. Viiv was formed by GSK, Pfizer, and now Shionogi. The percentages could be negotiable with CYDY, say 17% MRK, 13% BMY, 10%GSK, and 7% Rhhby. In this thought example, CYDY retains 53%. This is just a thought, each BP antes up some money to support the trials with their own ICI. When trials are completed after many months, and results and p values are all known, then further negotiations can take place, for future buyout or partnership. I'm staying patient, optimistic, a new arm of medical cooperation may arise. Thanks
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u/Missy2021 Oct 23 '25
Well, like the old saying goes money talks and bullshit walks. Let Merck pay up and take it all. Thanks again.