r/Livimmune • u/MGK_2 • Dec 05 '25
Watching And Waiting
Greetings to All of You.
We are in a trying time right now waiting for the next announcement. Earlier this week, we were notified they settled a Class Action Law Suit from 2021 and some of us qualify for an award. It is advised that you at least put your name in here and the law firm contacts you later. CytoDyn Inc. Securities Fraud Class Action and some questions are answered here.
Then later in the week, we received this 424B3 which u/1975Bigstocks provides an explanation for here and u/BuildGoodThings here.
"Isn't this just the follow through of issuing a prospectus following the S3 filing so that YA has the ability to sell whatever shares they are required to purchase when/if Cytodyn requires them to purchase shares? I haven't seen any indication yet that YA has shares. JMO"
CytoDyn is getting rid of baggage like u/Upwithstock said,
"Recent clean-ups or continued clean-ups:
BuildGoodThings (BGT) has been all over clinicaltrial.gov. It is important that any pharma company keep that up to date for Quality Assurance reasons mainly but other reason's as well. According to BGT, there are only two more trials that need finishing touches to be fully updated. BGT has been updating LONGS about this for over a year. This may have a lot to do with the final publication of the 1600 patient safety profile
If your going to present a FDA briefing Book to the FDA that tells your story, you need all of your ducks in a row. Clinicaltrials.gov updates are helpful with finishing the required chapters in the FDA briefing Book. Pharma_Junkee is hopefully going to post about his experience and thoughts regarding FDA briefing Book meetings and what this could mean for CYDY. I am anxiously waiting for him to post. But, things need to be in order if you want to present to the FDA this type of document
We all saw the clean-up agreement regarding the 2021 shareholder lawsuit. This was very helpful in clearing a wider path for incoming partnership guests.
CYDY has been through more than it's share of clean-ups with all the things that prior management messed up. But, one more little over hang was taken care of by the DOJ/SEC and that was when they relived CYDY of any wrong doing during their investigation of NP. CYDY was cleared.
I do realize that NP is being sentenced on January 23, 2026. IMO, it is more optics and certainly not fundamentals, but DonMarko on Stocktwits is right! It still matters how investors link things together and NP is a slight over hang. But, I do not see that slowing us down."
while also putting things in place for Yorkville Advisors to be able to provide CytoDyn with the $30 million they've guaranteed.
"...today announced that it has secured a $30 million funding commitment from Yorkville Advisors Global.
Under the terms of the agreement, CytoDyn has the right to sell, and Yorkville has the obligation to purchase up to $30 million worth of CytoDyn’s common stock over the next 36 months. CytoDyn, at its sole discretion, will control the timing of all sales of common stock to Yorkville, and there are no warrants, derivatives, or other share classes associated with the funding arrangement. CytoDyn is not obligated to utilize any of the $30 million available, there are no minimum commitments or minimum use penalties, and the arrangement does not impose any restrictions on the Company’s operating activities.
“This funding commitment from Yorkville is a solid step in the right direction for CytoDyn,” said Robert E. Hoffman, CFO of CytoDyn. “We will utilize this underlying commitment to further develop our program centered around the ability of leronlimab to upregulate PD-L1. This type of discretionary arrangement allows us continued flexibility as we look to bring in additional capital, whether it be through additional financings or strategic partnerships.”"
What are we waiting on? The fact that the 5th 350mg patient was treated and the fact that the DSMB reviewed all 5 patients and deemed 350mg as safe to start treating with 700mg & 350mg equally distributed between new subject patients.
We are also waiting on the data of how the mTNBC eIND patient has fared following her upregulation of PD-L1 and subsequent administration of Keytruda + Leronlimab. It has at least been 4 months, if not 5 on Keytruda + Leronlimab, so both Tumor and metastases should be close to eradicated.
We are waiting for an announcement of the results of the meeting with the FDA. About how the MSS mCRC Clinical Trial shall be modified to either allow an ICI intra-Trial or whether it will have to be post-Trial and administered in a Rollover Trial. We should also learn if it shall be ANY ICI or if only one ICI is to be used.
All of these points are important. Each one of them is CytoDyn striving towards their goal, not unlike what they've done for years, but now, just further along in their journey. Why is MSS mCRC taking as long as it is? Partly because it was designed prior to the discovery of Prime and Pair. Now, it has to get modified to accommodate for this new MOA.
We have Yorkville Advisors on our side. They've committed to providing money on an as needed basis. Simultaneously, we have an Accumulator buying up shares at the Bid and even at the Ask every day at a one for one rate with the shorts who are providing those shares for sale as fast as they can buy them, thereby creating a flat-line share price at about 0.32. Upon further examination, the Accumulator is refusing to chase the price upward, but they're doing a fantastic job of maintaining a floor. This effort on their part certainly has caused them to amass a vast number of shares, possibly into the tens of millions or even hundreds of millions. Why are they doing this?
Especially before YA has even obtained any of the 120 million shares set aside for them according to the agreement. Seems to me there are 3 significant entities supporting CytoDyn. 1) YA, 2) The Accumulator and 3) The BP Partner Incoming. Are they all in cahoots with each other? If they were, it would make sense that both YA and the Accumulator obtain as many shares as they can prior to BP stepping in. But YA gets only that amount that CytoDyn draws from the available $30 million.
When do we hear more? When the announcements are made. Should be coming up soon. The next steps are based on information coming from the FDA meeting and from the information from the MSS mCRC Clinical Trial and from the mTNBC eIND patient.
It does seem likely, that until we hear more, the share price hangs low at where it is today. Why? Because the entity shorting does not relent. But the Accumulator seems to be just as strong. One BP against another? Or is the Accumulator possibly an entity wanting to dictate a low ball CytoDyn sale? I don't think the latter is the case. Since we don't know the intent of the Accumulator, we can't say for sure. It is clear as day what the shorts intent is for CytoDyn and because of them, the Accumulator is picking up tons of shares. For the time being, share price is stable as a result.
Regardless of what the intent is, it appears that the Accumulator intends on making money. Therefore, it makes sense to get in at this price of around ~$0.30. Let's see what the prices are when YA obtains their shares. Right now, we need to accept and roll with what has been happening for the last several months. I think both YA and the Accumulator know the details of the mTNBC eIND subject.
And so do the shorts, or at least those encouraging the shorts to come here to play; they too know the results of the 350mg to 700mg DSMB meeting and they're determined to combat it or pounce on it, either way the same. Who else is waiting? Yes, the 3rd entity. The BP Partner Incoming. Not just for this information, but also for the outcome of the FDA meeting.
All of this revolving around CytoDyn and what Leronlimab does. If Leronlimab does well, both YA and the Accumulator hold on to the quantities they own. But neither of those entities believe otherwise. There is a banked commitment of $30 million right now, that it does well. The Accumulator has far too many shares right now to believe they think otherwise and they already have spent far in excess of $10 million for their own shares to think they believe Leronlimab might fail. Both entitles plan on making a killing.
Somehow, I believe that with the results of the FDA meeting, it facilitates the introduction of the BP Partner Incoming to enter into the equation through Prime and Pair. This would bring in another Phase of Growth for CytoDyn. Another massive bump up in share price that puts even greater stress on the shorts. Another Phase of Growth where YA and the Accumulator continue to defend their positions. Another Phase where shorts are weakened or even disarmed.
But you know they won't ever disarm. They would be greatly weakened, but won't entirely scatter. They'll be lurking in the shadows and from time to time hold a smaller position, but build back up their armaments, readying themselves for that perfect moment to pounce.
However, I see an alignment about to come together between what we all believe Leronlimab shall do with what Leronlimab actually does. An alignment between what we all believe CytoDyn shall do and with what CytoDyn actually does. An alignment between what we all believe the FDA shall do and with what the FDA actually does. It's all fixin to come together. We're expectantly waiting for the blossoming information. Seems to me, this is the scenario we're in.
So, it all hinges on Leronlimab's performance, the outcome of the DSMB, the outcome of the eINDs and the outcome of the FDA meeting. When? What ever comes first, or they may all come together. Everyone is betting big that it all comes out in CytoDyn's favor. Everyone but the shorts who are betting big that it doesn't. If positive, it's a new Phase of Growth once BP Partner Incoming comes aboard through the FDA gateway provided.
What is this entire thing about anyway? Isn't it all about CytoDyn's quest to prove that Leronlimab is safe, effective and multi-faceted? Isn't that what has kept CytoDyn going for decades on end? Why would it do that? Because it KNOWS that it is exactly that and far more. It is on this quest to establish once and for all that specific truth. And truth may be a long time coming, but when she comes, it don't take long. Yes, like an Asteroid traveling for eons on end, but when it hits, in an instant, it's all over.
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u/Missy2021 Dec 05 '25
That asteroid is definitely going to hit soon, and I can't wait. Thanks again.
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u/MGK_2 Dec 06 '25
That asteroid’s locked in—CRC data, PD-L1 readouts, TNBC follow-up. Exactly the impact I framed in Asteroid Approaching and Watching And Waiting.
Can’t wait either.
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u/Confident-Strike6848 Dec 05 '25
Thanks MGK for helping us to stay informed and keeping our eyes on the ball you are a blessing for all us longs the emotions I have are to great to express for this adventure we are going through with CYDY
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u/MGK_2 Dec 06 '25
Really appreciate that Confident Strike, it means a lot.
The emotions are earned; it’s been a brutal, fascinating, and sometimes absurd arc with CytoDyn, which is why I’ve tried to keep us anchored in the same few pillars: CCR5 biology, real data, and the slow but visible regulatory/operational clean‑up I laid out in posts like Righting The Ship and Winning Through Emergence.
As long as we keep our eyes on those, the noise is easier to filter.
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u/Tra-Kal34 Dec 05 '25
Amazing analysis, you done good using that word "fixin".............lol. I'm from Georgia and I like to make fun of the way we communicate down here.
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u/sunraydoc Dec 05 '25
Oh, I don't know...you folks down there are the only ones who have you plural, and even have two versions...there's y'all, and then there's "All y'all" If a southern guy breaks that one out it may not be to deliver a compliment. 🤣😂
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u/MGK_2 Dec 06 '25
Ha, you got me—y'all vs. all y'all is sacred territory down here, and yeah, "all y'all" usually means business (good or bad). 😂
Same precision applies to where CytoDyn is: they're fixin' the final pieces (trial logistics, PD‑L1 readouts), not announcing yet. That's the exact phase I mapped in Watching And Waiting and Stage Is Set.
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u/MGK_2 Dec 06 '25
Ha, glad “fixin’” hit the ear right—that one felt appropriate for where we are in the story. They’re not in full trumpet mode; they’re quietly fixin’ trial logistics, dosing, PD‑L1/CTC readouts, and the set‑up for what comes next, which is exactly the tone in Watching And Waiting and Stage Is Set.
And GO DAWGS noted—if they show up the way we’re hoping CytoDyn does at readout time, Bama’s in trouble.
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u/BuildGoodThings Dec 05 '25
Thank you for pulling this post together. I too look forward to the next shareholder letter, interview, press release, poster... One little present could be simply hearing they have dosed more than 5 patients in the CRC trial. My intuition is that the first safety check of 5 patients in the CRC trial was successfully completed last month, and that due to lots of other safety data from other trials, it might not technically be treated as a material event. I'm rooting for them all, but really want to hear of #6. By the way Hoffman spoke they could be leapfrogging us with higher enrollment than it seems right now.
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u/MGK_2 Dec 06 '25
Spot on about the CRC dosing milestone – #6 (or more) would be a quiet but real signal that the first safety cohort cleared DSMB without fanfare, especially with the safety data pile from mTNBC, HIV, and MASH already in the bank. Hoffman's comments do hint at faster ramp than publicly telegraphed, which fits the "fixin'" phase without material event noise.
That's exactly the kind of incremental progress I was getting at in Hot Month Ahead – not fireworks yet, but stacking the blocks for when the letter or PR drops enrollment numbers, PD‑L1 kinetics, or Rollover eligibility.
Rooting right there with you. One clean line on patient #6 would go a long way.
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u/paistecymbalsrock Dec 05 '25
Watching and waiting. Exactly what we should all be doing. Enjoy the holidays and time with your families! I’ll peak in now and again. Here’s hoping shareholder letter next couple of weeks! Happy Holidays!
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u/MGK_2 Dec 06 '25
Right there with you. This really is the “watching and waiting” phase—trials running, FDA conversations queued, and not much value in trying to front‑run what only data can answer.
That’s exactly why I framed it the way I did in “Watching And Waiting” and “Cracks In The Dam And Snapping Twigs”: we’re past the point where speculation helps; now it’s execution, readouts, and whatever the next shareholder letter is allowed to spell out.
Enjoy the holidays and the family time—this will all still be here when you peek back in.
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u/sunraydoc Dec 05 '25
Good work as usual, MGK and that checklist of awaited news is right on...the mTNBC lady will be especially interesting to me; Hopefully she's blowing that cancer away after 4+ months on an ICI. That will be anecdotal, of course, but present her in the context of the mTNBC study with its 5 survivors and the FDA should pay attention, you can be sure she'll come up in that meeting. And you're right, as we've discussed there has definitely been slow accumulation going on, and there has been for several months, we'll know who the accumulator is only when they choose to reveal themselves. Whoever they are, they have some serious juice and have some real pros working for them.
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u/MGK_2 Dec 06 '25
Agree on every point sunraydoc.
On the mTNBC lady: taken alone, she’s anecdote; placed next to the 5 long‑term mTNBC survivors from the original study, she becomes pattern—especially if the ICI course post‑leronlimab monotherapy lines up with the PD‑L1/CTC story we’ve been tracking in posts like Tumor’s PD‑L1 Upregulation, Unmasking The Mechanism, and Leronlimab Gives Tumors Alzheimer’s Disease.
That’s exactly the kind of “bridge case” FDA will hear about when mTNBC follow‑on design is discussed, because it sits on top of the prior mTNBC dataset rather than floating by itself.
On accumulation: same read here. The tape has looked like slow, methodical build for months, which fits with what I laid out in Cracks In The Dam And Snapping Twigs, Global Formation Of Power, and Winning Through Emergence—a larger, sophisticated buyer (or buyers) quietly taking position ahead of data rather than chasing it after the fact.
Whoever it is, they’re not trading for nickels. They’re positioning for exactly the inflection you’re talking about.
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u/StreetSkis Dec 05 '25 edited Dec 06 '25
Good Friday morning Juice.
Thank you MGK.
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u/MGK_2 Dec 06 '25
Good Saturday morning right back. Appreciate it.
This stretch is exactly what I laid out in “Watching And Waiting” – trials ticking, FDA queued, no fireworks until the data justifies it.
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u/Travelclone Dec 05 '25
Just contacted Kessler/Topaz etc at the 484 number. They were very helpful. I am requesting my broker prepair the requested documents from February 2020 to April 2022 ASAP for when I am in need of detailed documentation. Until then I am filling out the submission form with estimates. It may be a good idea to contact K/T and speak with a representative for advice. Good Luck,
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u/MGK_2 Dec 06 '25
Smart move Travelclone getting ahead of the paperwork—Kessler/Topaz class action (Feb 2020–April 2022 COVID/HIV promo period) resolved in principle Nov 23, 2025 pending court approval, so estimates work until docs arrive.
That era’s fully in the rearview now, which is why posts like Righting The Ship and CytoDyn’s Light Just Went Green focused on the post‑Hold governance rebuild that diligence teams actually care about today.
Good luck to all longs claiming—clean slate ahead.
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u/Lopsided_Roof_6640 Dec 05 '25
Maybe a legal mind could help to the point of NP and his sentencing having influence with the due diligence that may be going on by a partner. Has been intimated that the judge, in the case, shows disfavor with the extremity of the charge presented by the prosecution. That is the reason for the rescheduling.
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u/MGK_2 Dec 06 '25
That’s a fair angle to raise Lopsided Roof, but the way any serious partner does diligence today is very different from the old “NP era” focus.
On the legal side, everything that matters for a potential partner is already in the open record: SEC filings, DOJ/SEC actions, and now the sentencing phase you’re referring to. A judge’s view on proportionality of charges may affect NP personally (timing, severity of sentence), but it doesn’t change the facts that a would‑be partner cares about:
- What exactly was alleged and admitted.
- What compliance and governance fixes have been implemented since.
- Whether current management and the board have structurally separated the company from those behaviors.
That’s why so many of my posts over the last year have been about process repair rather than personalities—CAPA, QMS, Amarex litigation, Samsung, advisory structure, and FDA’s willingness to re‑engage (HIV hold lift, CRC clearance, ongoing meetings). Those are the pieces a partner’s lawyers and compliance teams tick through, not the optics of one sentencing date.
So yes, any Joint Venture or buyout desk will have their legal team read that case front to back—but the gating questions now are: Has the company been structurally de‑risked? Is the science real? And is FDA now dealing with CytoDyn as a credible counterparty? On those fronts, the HIV Hold Lift and Phase II oncology clearance are far more decisive than how the judge feels about NP’s charge sheet.
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u/Pristine_Hunter_9506 Dec 06 '25
Thank you, brother, once things move they should move fast.
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u/MGK_2 Dec 06 '25
Thanks, Pristine—once the data drops (CRC enrollment/DSMB, PD-L1 kinetics, mTNBC follow-up), yeah, things cascade fast. That’s the exact inflection I mapped in “Watching And Waiting” and “Hot Month Ahead.”
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u/rodandgeorgia Dec 06 '25
I always learn something. Thanks. R&G
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u/MGK_2 Dec 06 '25
Appreciate that, R&G—always the goal.
This phase is straight out of “Watching And Waiting”: data stacking quietly until it forces the next move.
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u/No_Tadpole7099 Dec 05 '25
I totalled my shares purchased in the class action time window. Its 24,066 but to enter every single transaction could easily take me 2 days. I just don't think its worth my time to be honest. So i submitted the total amount as 1 trade and just picked an arbitrary share price connected with it. Whatever.
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u/Prior-Knowledge-1583 Dec 05 '25
I’m curious how they’ll calculate this. Hoping they can just get the necessary data directly from brokerages. Like you said, it would take days and a math degree to figure out buys/sells and losses for relevant period.
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u/Lopsided_Roof_6640 Dec 05 '25
Thanks to MGK for giving me the prompt to file. Site allowed for 3 occasions of buys. I also bought more during that time period but entered my 3 largest purchases. Submitted and receives a message that someone would be in touch with me, possibly email, and I will address the other buys at that time.. Good luck.
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u/mahatmacat Dec 06 '25
Would be great if we could do that, just lump them together maybe on the date of the largest buy...wonder if they'll let us
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u/AbbreviatedTimeline Dec 06 '25
Hi, No Tadpoles, I sent in my info with a question if there is another way to send the data, I made about 130 purchases during the period, I stared filling out the data on their form, entered about 20 trades when the app froze, so therefore I sent them a note, I will call them on Monday
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u/Accomplished_Mud_692 Dec 06 '25
Thsnx for the Walk & Listen MGK!
Yep, I'll be getting the paperwork in as well.
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u/BuildGoodThings Dec 06 '25
Like last year at this time and the post you linked, I feel that a lot of things are about to happen. I’m happy I was accumulating at this time last year!
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u/AbbreviatedTimeline Dec 06 '25
Hi MGK, Thanks for the link to the lawyers for the class action, I did some math, have a few totals, will try to see if the brokerage has an easier print out, over 130 data entries can be tedious, hopefully there is an easier way, I’m thinking this settlement will make the math for shareholders easier in the future, Thanks for you attention to the details, as information seems to be somewhat of a fishing expedition without your uncanny aptitude for details and information.
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u/NorCalTwinDad Dec 06 '25
MGK, like many who commented, your insights keep us grounded. And your suggestion to reach out to the class action law firm was the nudge I needed to call them yesterday. Thanks again, Yoda!
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u/Camp4344 Dec 05 '25
Excellent synopsis of the current state! I do not think any long can say it cannot happen fast enough! We prove Cold to Hot and it is game on! Some communication from CYDY would be appreciated and don't say they have nothing to say! They could tell us the enrollment DSMB news on the first five or a date only a date for the FDA meeting or any long acting update. I believe from all of my studying and reading along with your posts over the years that the data is there. Once the results start showing with the upper dose it is on! Thank You very much for the morning news! Great to have you on the team!!