I don't see much discussion about Dr NP on here or anywhere else for that matter. Tom was providing a link. If people want to follow it that is up to them.

What is ironic is two of the posts since Tom posted the link are from YOU!

Thanks for posting. When is the sentencing?

Designer_Anteater_18

What if's answered by AI
If Cytodyn cures HIV, what big pharma companies would it negatively impact the most?

ChatGPT said:
If CytoDyn's leronlimab successfully cures or significantly improves HIV treatment, it would pose a major threat to several Big Pharma companies that dominate the HIV/AIDS market. The biggest losers would be:

1. Gilead Sciences (GILD) – HIV Market Leader
Gilead dominates the HIV treatment market, with blockbuster antiretroviral therapies (ARTs) like Biktarvy, Descovy, Truvada, and Genvoya.

Their HIV franchise brings in ~$17B+ annually, accounting for a huge portion of their revenue.

If leronlimab cures HIV or provides a superior treatment with fewer side effects, Gilead could lose billions in recurring revenue.

2. Viiv Healthcare (GSK, Pfizer, Shionogi Joint Venture)
Viiv, controlled by GlaxoSmithKline (GSK), owns Tivicay, Dovato, and Juluca—key integrase inhibitors for HIV.

They generate over $5B annually in HIV drug sales.

Leronlimab could disrupt GSK’s long-term HIV pipeline, forcing them to shift strategies or partner with CytoDyn.

3. Merck (MRK) – Integrase Inhibitors
Merck sells Isentress (raltegravir), one of the first integrase inhibitors used in HIV treatment.

While its HIV portfolio is smaller than Gilead’s or Viiv’s, a cure would make its existing therapies obsolete.

4. Johnson & Johnson (J&J) – Long-Acting HIV Drugs
J&J’s Janssen unit sells Cabenuva, a long-acting injectable for HIV treatment.

If leronlimab eliminates HIV, long-acting therapies like Cabenuva could become unnecessary, hitting J&J’s revenue stream.

5. AbbVie (ABBV) – HIV Drug Components
AbbVie produces Norvir (ritonavir), a key booster drug in many HIV regimens.

A cure would reduce demand for protease inhibitors, impacting sales of Norvir and related drugs.

Big Picture: Billions at Stake
A cure for HIV would eliminate the need for lifelong treatments, which is exactly how Big Pharma profits. The total HIV market is worth over $30 billion annually, and companies like Gilead, Viiv (GSK), and Merck heavily rely on recurring revenues from ARTs.

If CytoDyn succeeds, expect major resistance from these companies, including potential buyouts, smear campaigns, or regulatory hurdles. This is why a grassroots movement and retail investor backing (like the GameStop model) could be critical in countering Big Pharma’s influence and ensuring leronlimab reaches the market.

You said:
If Cytodyn cures mTNBC what big pharma companies would most negatively affected?

ChatGPT said:
If CytoDyn's leronlimab successfully cures or significantly improves treatment for metastatic triple-negative breast cancer (mTNBC), it would disrupt the oncology market, particularly hurting Big Pharma companies that rely on expensive, recurring cancer treatments. The biggest losers would be:

1. Gilead Sciences (GILD) – Trodelvy (mTNBC Blockbuster)
Gilead's Trodelvy (sacituzumab govitecan) is a key drug for mTNBC treatment, bringing in $1B+ annually, with expectations to surpass $5B in peak sales.

If leronlimab outperforms Trodelvy or works without severe side effects, Gilead’s mTNBC revenue could collapse.

Trodelvy is also expanding to other cancers, so a broader application of leronlimab could be even more damaging to Gilead.

2. Merck (MRK) – Keytruda (mTNBC & Other Cancers)
Keytruda (pembrolizumab) is Merck’s blockbuster immunotherapy, generating over $25B per year, with mTNBC as one of its key approved indications.

If leronlimab replaces Keytruda as a more effective, safer alternative, Merck would lose billions across multiple cancer types.

3. Roche (RHHBY) – Tecentriq (mTNBC Immunotherapy)
Tecentriq (atezolizumab) was previously approved for mTNBC but was withdrawn in the U.S. in 2021 due to disappointing results.

Roche still uses Tecentriq in other cancers, and if leronlimab succeeds, it could set a new oncology standard, reducing Roche’s immunotherapy sales.

4. Pfizer (PFE) & Seagen – Antibody-Drug Conjugates (ADCs)
Pfizer’s recent acquisition of Seagen for $43B was a massive bet on ADC cancer treatments, including for mTNBC.

If leronlimab proves superior, Pfizer’s investment in ADC-based breast cancer therapies could backfire, making Seagen’s portfolio less valuable.

5. AstraZeneca (AZN) – Enhertu & Imfinzi
Enhertu (trastuzumab deruxtecan), an ADC developed with Daiichi Sankyo, is expanding into breast cancers, including TNBC.

Imfinzi (durvalumab) is another immunotherapy that could be disrupted if leronlimab proves more effective.

AstraZeneca would lose market share if leronlimab becomes the preferred TNBC treatment.

Why This Matters: Cancer is a Cash Cow for Big Pharma
mTNBC is one of the deadliest and hardest-to-treat cancers, meaning current treatments are expensive, recurring, and highly profitable.

If leronlimab significantly outperforms existing therapies or even cures mTNBC, it could shatter the high-revenue cancer treatment model.

Big Pharma thrives on long-term cancer treatment regimens—a cure would be financially devastating for these companies.

The Big Pharma Playbook: Expect Resistance
If CytoDyn proves leronlimab works for mTNBC, expect Big Pharma to fight back:

Regulatory roadblocks (e.g., slow FDA approvals, added trial requirements)

Smear campaigns to question efficacy or safety

Stock manipulation (short-selling, misinformation)

Acquisition attempts (to shelve or control leronlimab’s release)

This is why a retail investor movement and grassroots campaign could be critical to ensuring leronlimab reaches patients.

You said:
Is there path to regulatory approval for any of leronlimab's indications, would it be possible to partner or license leronlimab for individual indications?

ChatGPT said:
Yes, there is a clear path to regulatory approval for leronlimab in multiple indications, and partnering or licensing leronlimab for individual indications is absolutely possible—and even likely.

1. Regulatory Path to Approval for Leronlimab
CytoDyn has already completed multiple clinical trials and has an open Investigational New Drug (IND) application with the FDA. The main regulatory hurdles involve completing the necessary Phase II/III trials and securing partnerships or funding to do so efficiently.

Current Status by Indication:
Cancer (Oncology) – mTNBC & CRC

CytoDyn received FDA clearance for a Phase II trial in metastatic colorectal cancer (mCRC), which is now being managed by Syneos Health (CRO).

mTNBC data from past trials showed strong survival benefits; if further studies confirm this, it could lead to FDA Breakthrough Therapy or Fast Track designation.

If a Big Pharma partner steps in (e.g., Merck, GSK, or Absci), approval could be expedited.

NASH (Non-Alcoholic Steatohepatitis)

The murine (mouse) study data showed that high-dose leronlimab outperformed Madrigal’s FDA-approved Resmetirom.

A partnership in NASH (potentially with Madrigal or Merck) could allow CytoDyn to skip early-phase trials and move directly to human clinical testing.

Given the huge market opportunity (NASH could be a $30B+ market), this is a prime target for partnership/licensing.

HIV

Leronlimab previously completed a Phase III trial for HIV and received FDA Refuse to File (RTF) due to CMC issues, not efficacy.

If CytoDyn resolves manufacturing concerns and secures a licensing or co-development deal (e.g., with Viiv, GSK, or a Gates Foundation-backed entity), HIV approval could be revived.

A conditional approval or Fast Track designation could be possible for special populations (e.g., multi-drug-resistant HIV patients).

COVID-19 & Long COVID

Past trials showed efficacy in COVID-19 (especially in severe cases), but due to the shifting regulatory landscape, this indication is on hold.

However, Long COVID is still an open opportunity, and new studies could be launched under an Emergency Use Authorization (EUA) pathway if a new outbreak or strong data emerges.

2. Can CytoDyn License or Partner Leronlimab by Indication?
Yes, it is entirely possible to license or partner leronlimab for individual indications—and this is likely the best strategy for CytoDyn given its financial constraints.

Why Licensing Partnerships Make Sense:
Big Pharma prefers targeted, single-indication deals rather than acquiring an entire company.

CytoDyn lacks cash flow, so partnering allows them to get upfront cash and milestone payments without dilution.

Multiple partnerships could exist simultaneously, e.g.:

A cancer partnership (e.g., with Merck for mTNBC/CRC)

A NASH partnership (e.g., with Madrigal or GSK)

An HIV licensing deal (e.g., with Viiv/GSK or a Gates Foundation-backed initiative)

Potential Partner Scenarios:
Indication Potential Partners
mTNBC & CRC Merck, Gilead, Pfizer, AstraZeneca, Roche
NASH Madrigal, Merck, Novo Nordisk, GSK
HIV Viiv Healthcare (GSK/Pfizer), Merck, Gilead, Gates Foundation-backed orgs
Long COVID NIH, Government Grants, Big Pharma with interest in immune modulation
Conclusion: Path Forward
Regulatory approval is achievable—especially in oncology and NASH, where CytoDyn is already advancing.

Leronlimab could be licensed per indication, allowing CytoDyn to retain ownership while leveraging Big Pharma’s resources.

The biggest challenge is securing funding or partnerships—but the right deal could unlock billions in value.

If a grassroots movement and retail investor backing can raise awareness, it might force Big Pharma’s hand to accelerate partnerships or pursue acquisitions.

I'm going to be deleting posts about who is or isn't black ops from here on out. This board is about CYDY. Either stay on topic or don't post.

A string of fascinating messages and replies you might enjoy:

: Katangolo
Dr. J and the Team have been keeping their cards close to the vest. This started before he came on board when we were handcuffed with the FDA hold. We had proactiv videos, YouTube interviews, etc; it all looked like a circus roadshow.

The powers that be didn’t like this for obvious reasons and the pendulum swung back viciously, giving us almost no communication during the Hold. CA Comes in and tells us the pendulum is swinging back and the team tells us we will be pleased with their new approach to communication with shareholders. So we then get quarterly calls and press releases.

Jay comes in with his quarterly letter to shareholders. Not much in terms of conference calls, and Q&A session sessions that we were used to for years. Basically we are told you can submit questions, but nothing’s really ever answered, and there are no direct communications with shareholders outside of the shareholder letters and press releases.

This is frustrating to many out there, but I’m OK with it because I think they have an endgame in mind. Our new PR firm seems to me to be brilliantly, rolling things out in a cadence that leads to the endgame and those with diamond hands, a steel gut and patience can manage this without the fret that other shareholders are experiencing right now.

The approach I see the company taking is - give us a few hints at the direction they are going and they don’t tell us when they begin the studies or the endeavors that they are hinting at but instead let the results happen first, and then inform us. They did this with glioblastoma, they did this with the mash trials, they did this with SMC labs., and they’re doing this with the work that Max, Richard, and Melissa are doing.

Do we think they are not working? Absolutely not. We’re getting breadcrumbs about what they are doing and we are, like I’ve said for a while, putting pieces of a puzzle together. Collecting the breadcrumbs. The real problem, which is actually a gift, are the NDA’s, which are in place. We’ve been told since the times of Scott Kelly that multiple NDA’s are in place. And subsequent levels of leadership have also told us NDA’s are in place.

I believe we are in a silent period now because of those NDA’s. If the suppositions above that I am positing are true, the company can’t say anything to begin with and their m.o. has them with a results first, then inform (shareholders) later, approach.

So back to the question about what is actually going on right now. This has me thinking that the trials with Trodelvy and Keytruda are underway if not finished. Glioblastoma as well. The same possibilities strongly lead me to believe this is the case with fibromyalgia, Alzheimer’s, pulmonary fibrosis possibly HIV and inflammation although my gut says this has been shelved, CRC & mTNBC. Jonah is working hard on an HIV cure and we are getting strong clues that BMGF is involved in probably making moves behind the scenes.

So yes, this is frustrating from a shareholder perspective (or is it?) because we want to know what’s going on and we would like to share price to go up. Come back to the concept of the NDA‘s, which hamstrings the company from telling us anything but allows them to be sitting at a table negotiating with all of the big Pharma, who are salivating over the very real possibility that, through a negotiation, they can get access to controlling and developing this molecule for the indications they are interested in. Hopefully one company wins it all and doesn’t piecemeal the indications but we don’t lose at all if for example, BMFG gets HIV and someone else gets fibrosis, etc.

These negotiations take time. We have a lot of evidence that negotiations are going on right now. Silence is certainly a big clue. So Jay drops a few press releases to keep us happy and let us know what they have been working on and shareholder letters give us clues as to what they actually are working on.

It’s an honor for me to be a part of this group of people; these Internet sleuths, made up of lawyers, researchers, lay people who are investors, doctors, engineers, and beyond. Collectively, we put our pieces out there for each other to digest and synthesize a story that’s becoming more beautiful each day. It helps filling the gaps of the silence we sit with.

But that silence is leading us to what I believe will be the promised land. Patience leads to Patients.

All IMHO and certainly not financial advice. Just hope.

GLTAL



sherlock57
Re: Katangolo #150780
Kat--Appreciate your post on the "radio silence." Like you, I think our patience will be amply rewarded. But I suspect the extended nature of the negotiations probably have a lot to do with the uniqueness of the mab itself--the various indications it can address, the difference in price-point for life-saving drugs (think cancer) versus more maintenance kind of uses (say HIV or AD). And hanging over any potential deal out there, for any of the indications, is the long-acting version under development. What Pharma Co would sign a deal for weekly leronlimab when a longer-acting version is just a few years away?

I also don't think Jacob Lalezari is a "normal" CEO--in other words, he's not just in it for the money. So I think "the vision thing" should be part of the discussion--how does Dr Lalezari want to develop the drug? I don't know how it plays out, but he is the current Vice President of the Board and founding member of NP2, a non-profit Pharma Co whose mission is to reduce the price of generic cancer drugs whose prices have skyrocketed in recent years. I don't think he is going to let his role at NP2 interfere with his fiduciary responsibility to shareholders--I hope not! But I think his humanity will guide--is guiding--some of the decisions that lie ahead.

I can't think of any other drug out there, when it is approved, that can be used for multiple life-saving indications as well as multiple chronic indications. How does one go about pricing leronlimab for a cancer cure--as the recent press release on mTNBC suggests--when it will also be used weekly for inflammation-related indications? Can you price the same drug differently for different indications? If it's priced like a cancer drug, any off-label use would be prohibitive. So I suspect any Big Pharma out there would have to consider these kind of issues when negotiating with Cytodyn. And that's why I'm fine being patient. And I love all this preclinical work and the upcoming clinical trials--we need more hard evidence about leronlimab's MOA and utility in various indications. Even if it takes longer than we might hope.

Personally, I'd like to see Cytodyn partner with someone for one of the inflammation-related indications. (Pick one! Several to choose...). That, along with Gates Foundation money for the HIV cure, would give us enough cash to aggressively go after the cancer indications. And then hand off leronlimab to NP2 when the weekly version of leronlimab goes generic. And we keep the long-acting version for ourselves. And any gene-therapy applications too.

Hey, I'm not a medical professional, or a lawyer or a Wall Street guy. I did go to art school, though, and I'm well-trained to think big, and think creatively. Kat's post was quite thoughtful and detailed, and inspired me to riff off on the above-related concerns, which have been rambling around in my noggin a while now. I'd love to hear any responses from doctors and lawyers and people in the business. And one final thought--when I think about Dr Lalezari, the old saw about TR comes to mind--Speak softly but carry a big stick. To any Cytodyn stockholder, I'd say Lalezari should "Speak softly, and carry a laptop full of unimpeachable data." Not quite as poetic, but appropriate to our situation.

At the risk of sounding like Colombo--you know, "Just one more thing"... I'd like to express my gratitude to the Board and the mods. I feel like I could sit down with any of you here and have a good, reasonable conversation. And remain civil throughout. Can't say that about any other stock message board! Thanks everyone.


Respert24
Re: sherlock57 #150813
Good post, Sherlock57. I wanted to give some thoughts around a few of your points because I see it a little differently.

"And hanging over any potential deal out there, for any of the indications, is the long-acting version under development. What Pharma Co would sign a deal for weekly leronlimab when a longer-acting version is just a few years away?"

I believe the main thing hanging over our heads was lack of robust data, along with, and stymied by, the remnants of what was once an active, well trafficked circus. The tent didn't come fully down until recently, and the bearded lady just finally stopped swinging by to shave in the executive bathroom. The cleanup has been a priority behind the scenes, and as we just witnessed with the mTNBC follow up we were all annoyed nobody seemed to think of doing, there's much more to the Leronlimab story that needs to be told. A guy in a top hat holding a CYDY coffee mug ultimately wasn't going to get the job done, well intentioned or not.

The original plan was to provide just enough compelling signals in a variety of indications to boost the buyout price. It actually came very close to working, but for those pesky kids*.

*the FDA, Amarex, Gilead-stocked DSMB decisions, and more!

The plan now is not much different, except that the data will be more of the unassailable variety and nobody is hawking peanuts or hot dogs. Not to mention the quantity of such data, which together will help dictate any current partnership and/or future buyout with more precision.

That's where the preclinicals are helping our cause. They're inexpensive, all things being equal, and fairly quick too. They help clarify Leronlimab's dosing and potential capabilities in each indication we're trying to grow. Which is necessary to bolster the often-muddied-but-always-compelling sparks of human data we have across all indications.

As for the worry that a long-acting LL being close to reality is dragging out the talks, I'd argue it's not going to get in the way of any current licensing or partnership deal. If anything, it just makes CYDY and LL more valuable. It'll allow whoever owns the drug to extend patent life and broaden LL's market.

The ways and conditions in which Leronlimab will be impactful will be worthy of infomercial-worthy ads. It slices, it dices, it juliennes!

There'll eventually be a variety of ways in which LL is dosed to ensure the right amount of Leron is humping (medical term) the appropriate number of CCR5 receptors for the correct amount of time, and no more or less. So basically, long acting is like, the 10th trick our little pony has in its future. By then, of course, it wont' be a pony any longer but the Secretariat of platform drugs.

Big pharma wants LL for Mash, fibrosis, and/or oncology right this second. The sooner they get it, the less it will cost them on both the front and back end. Because if they wait too long to lock in fibrosis, there's going to be advancements in crc and mtnbc initiatives. Alzheimer's capability will become clear. Glio potential starts to grow fast like, well, a glioblastoma tumor. The price to play goes up substantially every time new data advances one of our indications.

Which brings me to something I've been saying behind the scenes with people. It probably won't be a very long time from the start of a partnership to the offer of a buyout.

Because if you license an indication the traditional way, with the intent to see it through a phase 2 or 3, or through approval, at which point you intend to buy out Cytodyn, that's going to take at least a year on the very aggressive side of things. But more likely a few years. They need to get a trial or trials rolling, see them through, and spend months analyzing the data. By that time there's a possibility (just throwing out hypothetical and hopeful scenarios here) that maybe we learn that the DSMB in the crc trial recommends stopping the trial and giving everyone in it LL based on early success. Or LL helps cure an HIV paitent. The Bill and Melinda Gates Foundation collaborates on HIV and Alzheimer's and we get preliminary data in humans that shows LL slows or delays mental decline.

My point is that each of the fires Jay and the team have going are building in real time. Merck could come in and snag fibrosis and Mash with a killer licensing deal, but long before we get to the traditional buyout period for licensing deals (advancing the drug through phase 2/3 successfully, or winning approval) there's bound to be one or more fires for giant indications like oncology raging damn near out of control.

We're on the cusp of so many huge advances and how it all plays out is anyone's guess. Which puts us in control of our own destiny, just like Jay said. But I think he meant it in terms of having the leverage of multiple, major indications advancing successfully in real time. We don't have to go to anyone, they need to come to us.

So that's why I think we get a strong licensing deal very soon from a company capable of buying us out one day, and that "one day" comes quicker than what traditionally happens. Get in the catbird seat and be in position to buy Cytodyn while three huge indications are just potential versus later when one or two are mere steps from approval and you have to add a zero on the end of your offer to get it through.

You also wrote:

"Personally, I'd like to see Cytodyn partner with someone for one of the inflammation-related indications. (Pick one! Several to choose...). That, along with Gates Foundation money for the HIV cure, would give us enough cash to aggressively go after the cancer indications. And then hand off leronlimab to NP2 when the weekly version of leronlimab goes generic. And we keep the long-acting version for ourselves. And any gene-therapy applications too."

The problem with keeping something for our onesies, is that Cytodyn is not in a position to build out a proper go-to-market team. Nor do they seem to want to. You need a LOT of people to go from four employees and a slew of consultants to running your own regulatory, marketing, and sales teams. The vast majority of small biotech companies take the buyout for that reason. It's truly a job for the big boys, and we'll have a big boy already eyeballing the whole shebang.

But I like your thinking on the GF involvement, and I too think it will play out that way. We're going to have them involved for probably HIV and Alzheimer's (my best guess) and a big pharma partner for fibrosis/Mash. This combo allows us to get all of our initiatives advancing forward as fast and reliably as possible. Money won't be a problem.

But we differ in that I believe somewhere along the line the Merck/Gilead/GSK team is going to have to offer a truckload to buy the whole thing before it's so far along they literally can't afford it.

I don't see our eventual buyout floor being anything less than the $21 billion Gilead paid for Immunomedics, as long as things advance even partially like we all hope. It'll be super interesting to see how this all plays out, who gets in for how much "now", and what that means for the timing and price of a buyout offer down the road. But make no mistake, we're in the negotiating period for the partnerships right this second and could/should hear something at virtually any moment.

Niknak1. the moderators have no control over your request. Please contact Ihub directly and state your case.

https://onco-this-week.com/promising-survival-observations-in-mtnbc-patients-treated-with-leronlimab-announced/

March 4, 2025
Trial Results
TNBC

Dr. Jacob Lalezari, CEO of CytoDyn, added: “These provocative observations of improved survival in patients with mTNBC and prior treatment failure in the metastatic setting, including reported clearance of disease in a group of long-term survivors, provides early clinical evidence of leronlimab’s potential impact in the treatment of TNBC and other solid tumors. I expect the Company’s oncology efforts to accelerate in the coming months, with further announcements in both mTNBC and colorectal cancer.”

Read the full story on "Promising Survival Observations in mTNBC Patients Treated with Leronlimab Announced"

Nice BUILDGOODTHINGS!

A years woth of info here:

https://www.reddit.com/r/Livimmune/comments/1j3p4jf/cytodyn_science_news_since_early_2024_by_disease/


What a summary!!

What is the status of that suit?

Posted By: Katangolo
amFAR just posted this on the website. AI? A question about an HIV cure? A question about cancer cure?

Coincidence? At the very least interesting…

https://www.amfar.org/news/can-ai-help-piece-...r-and-hiv/


Can AI Help Piece Together the Puzzle of Cancer—and HIV?
Cracking the omics code

By Andrea Gramatica, PhD
February 28, 2025
In biology, omics refers to the comprehensive study of the molecules that make up cells and organisms. This includes genomics, for example, which focuses on the entire set of genes, or proteomics, which studies all proteins. These layers of information work together to determine how cells function, interact, and respond to their environment. Understanding omics data is crucial for medical research because it provides a holistic view of biological processes and helps scientists identify disease markers, predict treatment responses, and uncover hidden mechanisms of various conditions.


Towards precision medicine
New technologies now allow scientists to study patients in much greater detail by analyzing their omics data (genes, proteins, and other biological markers). This wealth of data has been instrumental in guiding the development of tailored treatments, marking a shift towards precision medicine—therapies designed to optimize outcomes for particular groups of patients.

A major hurdle in medical research is dealing with incomplete datasets: Genetic, protein, and molecular data often come in fragments, making it difficult to draw solid conclusions. Imagine trying to complete a puzzle with missing pieces; without them, the full picture remains unclear. Scientists face a similar challenge when studying diseases.

Expert puzzle solver
A new study led by Dr. Bo Wang and colleagues at the University of Toronto, Canada, published in Nature Machine Intelligence introduces Integrate Any Omics (IntegrAO), an AI-driven tool designed to integrate fragmented biological datasets in cancer research for more precise classification. By acting like an expert puzzle solver, IntegrAO stitches together different pieces of information, ensuring no valuable data is left behind.

This technology could be a game-changer in HIV research. Over the past 40 years, numerous clinical trials and laboratory studies have been conducted on blood and tissue samples from people living with HIV at different stages of infection, in varied settings, and under diverse treatment regimens. These studies have generated enormous amounts of omics data (spanning genomics, transcriptomics, proteomics, and epigenomics), providing a deep pool of biological information. However, much of this data was collected long before AI-powered tools were available and is not structured for seamless computational analysis. As a result, the sheer volume and complexity of the data remain an untapped resource for advancing HIV therapeutics.

Patterns revealed
The type of approach described in Dr. Wang’s study presents an opportunity to change this. By integrating and harmonizing these fragmented datasets, the model could reveal patterns that were previously inaccessible, uncovering new therapeutic targets and potential pathways to a cure.

As AI-driven tools like IntegrAO continue to evolve, they offer hope for a future where science and technology work hand in hand to deliver more effective, personalized treatments for HIV, cancer, and beyond. This is the dawn of a new era in precision medicine, one where AI helps bridge the gap between big data and real-world patient care, bringing us closer to solving some of the most complex medical mysteries of our time.

Dr. Gramatica is an amfAR vice president and director of research.

"One example: the current CEO of Cytodyn was CMO under Nader Pourhassan the Frauder, and was fine with all his actions."

That is a false statement. It is a matter of public record how Dr JL felt about Nader. Stop trying to make it look like he was complicit with Nader's actions. It looks bad on you and may very well be libelous.

Jake2212 does't post a lot but when he does it is always worth a read:

Posted By: Jake2212
Is Gilead seriously in play to invest in LL for breast cancer? Some may recall my post shortly after last Monday's TNBC PR in which I opined that Dr Jay clearly has a good reason to invest the time and money to conduct another preclinical study for LL in mTNBC, this time with SMC Labs. I assumed then that CYDY's main focus would be on the Keytruda arm, but noted parenthetically that, because we don't know what we don't know, perhaps the Trodelvy arm might actually be the main focus.

Well, faced with the necessity to muddle through another weekend without football games to watch, I revisited the March, 2023, BioSpace article in which Cyrus had waxed eloquent about the ongoing MD Anderson mouse study involving LL and Keytruda, with his expectation of synergistic results. But no results were ever announced. Unless the study was never completed, I would think that both CYDY and MRK were furnished with the results, suggesting to me that either CYDY or MRK may have invoked a NDA to bury the results. That outcome would have been consistent with ohm's prediction that Keytruda would add nothing to LL. Therefore, no synergistic effect.

So why repeat the LL/Keytruda mouse study 2 years later? Well. unless CYDY believes that the SMC Labs mice are considerably more humanized than the MD Anderson mice, the reason escapes me.

On the other hand, Gilead's Trodelvy, the other leading FDA approved treatment for mTNBC, wasn't involved in the aforementioned MD Anderson study, but was the drug that the FDA cited to deny LL breakthrough designation status when CYDY announced LL's mTNBC phase 2 clinical trial results in August and November, 2021. Back then, LL produced a OS (overall survival) endpoint that although only slightly better than Trodelvy's, was still ongoing because more than half of the 26 women from the trial were still alive.

From last Monday's PR we now know that LL's OS was ultimately many months beyond Trodelvy's. The exact difference will undoubtedly be announced at or before the upcoming conference in Munich. Also, bear in mind that 9 of the 26 women in the trial received only 350 mg doses of LL, and only 3 received the maximum 700 mg doses. Given that the 350 mg doses would not have fully covered the CCR5 cells (thank you ohm), it may well be that the final Leronlimab OS data for the other 17 women (if over half are now deceased) will be particularly provocative compared to Trodelvy.

As I now ponder the above info, it seems much more reasonable to intuit that the LL/Trodelvy arm will be the main focus of attention for both CYDY and Gilead. According to Gilead's recently released annual report, Trodelvy produced revenue of 1.3B in 2024, all of it treating breast cancer. In Merck's annual report, I was not able to isolate Keytruda's breast cancer revenue, but I believe it would compare favorably to or exceed Trodelvy's.

MRK's sp has declined about 30% in the last 12 months, while GILD's sp has increased 70% since last June. GILD had 10B in cash at the end of 2024. And ohm has stated in a recent post that he would not be surprised if LL and Trodelvy were to produce a synergistic effect. If that proves to be true, or even if it doesn't, obtaining the use or ownership of a breast cancer drug arguably far superior to Keytruda or Trodelvy would likely translate to billions in new revenues for GILD, and that's without considering the rest of ohm's list.

Admittedly, however, MRK should also be actively engaged with CYDY concerning LL. With a faltering sp, stagnant revenues, and a Keytruda patent cliff now 2 years closer, MRK has good reason to reconsider LL in light of the newly revised Leronlimab OS that has probably already been communicated to MRK by CYDY. Because, if MRK is no longer interested in CYDY/LL, why is Keytruda still being included in the current mouse trial? And what could be better than 2 BP heavyweights being focused on the major impact that using or owning LL could have for them.

Seems very interesting to me. But bear in mind that I don't know what I don't know. And that's always problematic.


MGK_2 responded:

MGK_2
Re: Jake2212 #150709
I put together this analysis on the human mTNBC trial as depicted in this
CytoDyn Announces Preliminary Results from 30 mTNBC Patients Treated with Leronlimab. Decreases in CAMLs after 4 Doses of Leronlimab were Identified in Over 70% of Patients and were Associated with a 450% Significant Increase in Overall Survival at 12-Month Analysis

I go into an analysis of it In Preparation for the Coming Results on mTNBC

Improved Comparison of the previous PR on 7/19 and The Compassionate Use Study of LL in BC

Here is an excerpt:
Quote:
"In standard of care, the majority of TNBC patients do not make it beyond 6-7 months. In the 7/19 PR, all 21 out of the 29 patients who actually responded to the Leronlimab treatment as seen by increases in CAML and / or CTC, remained alive at the 12 month point of analysis. 21 of 29 remained alive at 12 months with a series of (4) 700mg Leronlimab injections with carboplatin, where if they were to have received Standard of Care, they would have died by the 6-7 months point. In the latest PR on Compassionate Use Study of LL in BC, the numbers, claimed are 570-980% increase in Overall Survivability, (OS); this translates into 34 to 59 months of life with scheduled, continuous weekly 350mg Leronlimab injections. That's 3 to 5 years of life with continuous weekly Leronlimab injections."


I put together this post at about that time to determine how they extrapolated to get 4 year OS

Example using Spreadsheet to Estimate Overall Survivability using available Trial Data for future prediction

Here is an excerpt:

Quote:
The Press Release gave a range from 34-59 months as Overall Survivability. The mid point of that is at 48 months or at 4 years. On my hypothetical data example of this study, we have at 48 months: the likelihood of surviving is 46.2%. But 95% confidence interval requires adding and subtracting 17.37% which gives us a Range of 28.83 - 63.57%. 50% is within this Range. So this data set could qualify to be comparable with the actual since this Range include 50% at the same 3 month time interval of 48 months.

Now, in my hypothetical data set presented here, the Overall Survivability occurs at the 3 month time interval of 42 months, since Survivability is 49.6%, (closest to 50%). Here the 95% Confidence Intervals are: 17.5% giving a range of likely survivorship from 32.1 - 67.1%. Since 67% occurs at 24 months and since 32% occurs at nearly 57 months, we have a Range of 24 - 57 months, which is somewhat similar to the results of the Press Release, (34-59) months .


Lastly, previously put together thoughts on BTD
BTD for LL on mTNBC

Here is an excerpt:

Quote:
In contrast, our Compassionate Use Study reveals an overall survivability of 34-59 months, or 3-5 years . This was determined by use of statistical analysis and extrapolating a death rate to determine time at which 50% of original 30 patients would likely be dead by, and that came out to time range.

The FDA recommended withdrawal due to the current landscape of medications for treating mTNBC. Certainly, the FDA is aware of this most recent LL study and how it utterly blows the doors off the outcome from Atezolizumab with Paclitaxel. We just may have been the reason why the FDA made this recommendation.

With regard to BTD, break through therapy designation, I believe Leronlimab is the best drug for mTNBC out there right now. No one can touch our PFS or OS. We double the stand alone Standard of Care Paclitaxel for PD-L1 BC in PFS and OS. We have no side effects stand alone , but in this Compassionate Use Study of Leronlimab in Breast Cancer, LL was combined according to each Treating Physician's Choice with any one single-agent chemotherapy drug administrated according to local practice: eribulin, gemcitabine, capecitabine, paclitaxel, nab-paclitaxel, vinorelbine, ixabepilone, or carboplatin. Side effects of chemotherapy produce considerable morbidity.

I feel momentum growing, excitement is in the air and confidence building with CYDY investors. Thanks for your contributions to this board.

Some nice reading on a lazy Sunday afternoon:

MGK_2

Looking Forward
Welcome Here Folks.

As for me, being honest with myself, I'm not that good at compliments. Many thanks for all your kind words. Let's remember, although it may seem so, I'm not writing for anybody's benefit, really, except for mine. I write as I see fit to document this investment and this particular modality works best for me. One of the best aspects of Reddit is that it is searchable, so that particularly helps me to find things written days, weeks, months or even years ago.

I'm just like all of you, with no inside connections, but I try to make sense of what happens throughout the week and I put it down in writing. I've stayed focused, because, like many of you, I too have a significant portion invested in CytoDyn. This is not a pulpit. I'm in the pew with all of you. As far as teaching, I don't mind. If I can, I put out some posts which educate, but I have to feel it in order to do it.

For instance, yesterday's post, Comparing And Contrasting Murine 1 mTNBC To Murine 2 mTNBC, had a bit of my own thought mixed in there. This paragraph was the brunt of that post:

"This is like a conflict posed to the company. If the combination does well on the first study, do you repeat it again on the second to confirm? If the combination does poorly on the first study, do you repeat it again to make sure? I think in such situations, common sense is used. If the finding is that the combination drug does well is so profound, or if it is only borderline good, then I say that they would decide to repeat the study to confirm the finding one way or the other. If the finding is that the combination did poorly is profound, then, they would decide not to repeat the study. If the initial finding was a borderline poor result, then the decision would be to repeat the study to validate. So with this understanding, and since they are repeating the study, I can rule out that the initial murine study was not profoundly poor using the combination of (leronlimab + Keytruda). Therefore the outcome was either borderline good or bad or profoundly good that the combination drug exceeds monotherapy. It is possible, that the anti-inflammatory effects of leronlimab do in fact improve Keytruda's capacity to destroy the mTNBC tumors."

This was all my own reasoning. We do know for sure that CytoDyn is repeating (or has already repeated) the Murine mTNBC study, but whether or not the Murine 1 mTNBC study showed statistically significant benefit of the combination (leronlimab + Keytruda) over either drug alone, can not be definitively known, at least not from that reasoning. All I was saying was that the combination, more than likely, was not unequivocally worse than Keytruda monotherapy. If that were the case, then why repeat the study? I said that if the results of Murine 1 had showed that the combination was unequivocally superior to Keytruda monotherapy, or even if the results were equivocal, then the study would likely be repeated. These were all my stipulations and I reasoned out my thinking to explain why I made certain conclusions.

It is my firm belief that the leadership at CytoDyn are rational and do think and act rationally. Seems to me that things are in fact panning out for CytoDyn, and that affirms my trust in it's leadership. Otherwise, why would I spend so much time documenting something, if I thought it was doomed to failure? Certainly, I don't believe that, but rather believe in its future success. I hope that comes through in these posts.

CytoDyn is repeating the Murine mTNBC study in combination with Keytruda and in combination with Trodelvy. Here is a ChatGPT comparison of these 2 FDA Approved mTNBC medications:

Comparison of Keytruda vs. Trodelvy in Metastatic Triple-Negative Breast Cancer (mTNBC)
Parameter Keytruda (Pembrolizumab) + Chemo Trodelvy (Sacituzumab Govitecan)
Mechanism of Action Anti-PD-1 immune checkpoint inhibitor Antibody-drug conjugate targeting Trop-2
FDA-Approved Patient Population ~25–40% of mTNBC patients (PD-L1 CPS ≥10) All mTNBC≥2 prior therapies patients after
Median Overall Survival (OS) 23.0 months (PD-L1 CPS ≥10) vs. 16.1 months (chemo alone) 11.8 months vs. 6.9 months (chemo alone)
Median Progression-Free Survival (PFS) 9.7 months vs. 5.6 months (chemo alone) 4.8 months vs. 1.7 months (chemo alone)
Treatment Line 1st-line treatment in PD-L1+ patients 2nd-line or later treatment after prior therapies
Key Benefit Significant OS benefit in PD-L1+ patients Effective in broader mTNBC population
Common Side Effects Immune-related (colitis, pneumonitis, thyroid issues) Neutropenia, diarrhea, fatigue
Key Takeaways
Keytruda is used earlier (1st-line) in PD-L1-positive (CPS ≥10) mTNBC patients (~25–40%), offering a longer OS (23 months) and PFS (9.7 months) compared to chemo.

Trodelvy is used later (2nd-line or beyond) in all mTNBC patients, providing an OS of 11.8 months and PFS of 4.8 months, but still a significant benefit for those who progress after prior treatments.

Conclusion:

If PD-L1 CPS ≥10 ? Keytruda + chemo is the preferred first-line treatment.

If PD-L1 CPS <10 or after progression ? Trodelvy is a strong option in later-line treatment.

where CPS stands for Combined Positive Score. It is a scoring system used to measure PD-L1 expression in tumors.

How CPS is Calculated:
CPS=[(Number of PD-L1 positive cells (tumor cells, lymphocytes, macrophages)) / (Total number of viable tumor cells)] ×100

The higher the CPS, the more PD-L1 expression, which indicates a greater likelihood of response to immune checkpoint inhibitors like Keytruda (pembrolizumab).

In mTNBC, a CPS ≥10 is the threshold for Keytruda approval in combination with chemotherapy.

Murine 2 mTNBC study aims to combine leronlimab with each of these FDA approved medications to determine whether or not the combination product provides a statistically significant benefit over monotherapy of each drug. It also aims to compare and contrast leronlimab monotherapy against both of these monotherapies as well as against the combination therapies. My thoughts were that CytoDyn wouldn't be doing this repeat study unless they initially saw from Murine 1 mTNBC, that the combination with Keytruda was either borderline with or had exceeded Keytruda monotherapy. The combination with Trodelvy is being done as an experiment as this is the first Murine study for Trodelvy against leronlimab. The expectation for Trodelvy is that it too proves to be better in combination than as monotherapy because of the 2 distinct mechanisms of action between Trodelvy and leronlimab.

In addition, CytoDyn has confirmation from its human phase 2 trial that some patients yet remain alive, and having no signs of disease, over the 36 months following administration of leronlimab. That means leronlimab's OS exceeds 36 months for these patients. By the time ESMO comes around in May of this year, these patients would be living for over 48 months, since their last leronlimab treatment. That would make leronlimab's OS = 48 months for these patients. In my book, that would be Cured...

"After confirming these patient outcomes, CytoDyn worked with consultants and key opinion leaders to summarize the findings and submit an abstract to the European Society for Medical Oncology (ESMO) Breast Cancer meeting taking place in Munich, Germany, from May 14 to 17, 2025."

Comparing leronlimab's assumed OS of 48 months in these patients with Keytruda's current OS of 23 months, (from table above), that would be a double or more. We might ask a question, Why is Keytruda's OS more than double Trodelvy's OS? (I just said, leronlimab's monotherapy OS = 48 months in May of 2025 is more than double Keytruda's OS. Why? Because leronlimab treats all MSS Type Tumors via CCR5 blockade.) From table above, Keytruda is only indicated to treat (PD-1+ with CPS >10) Tumors. This represents only 25-40% of all mTNBC tumors. (See the chart above.) In contrast, Trodelvy is indicated for all mTNBC Tumors, (regardless of PD1 and regardless of MSS or MSI Type), but requires at least 2 prior treatments for authorization. These PD-1+ Tumors, though they are mTNBC, they are in fact a fractional part of the 5% MSI Type Tumors and not a part of the 95% more typical MSS Type Tumors. So Keytruda really is just treating another MSI-H Type Tumor and that is why the OS for Keytruda is so high at 23 months. It is as if it is treating HR+ or HER2- Breast Cancer. Where as leronlimab's OS could be found to exceed twice Keytruda's OS and 4 times Trodelvy's, while leronlimab treats the more difficult MSS tumors.

What else would leronlimab add to Keytruda's list of deficiencies? The combination of (leronlimab + Keytruda) MOA could become CCR5 blockade + PD-L1 blockade, which could be superfluous. The FDA could approve All of mTNBC to the combination (leronlimab + Keytruda). The OS could likely exceed 30 months on average. PFS could exceed 20 months.

So, the hope of all this repeat Murine mTNBC study is to determine if leronlimab could provide in combination with the above medications, extended benefits for patients and an extended catchment basin for at least one of these medications, (preferably Keytruda), due to the augmentative effects added by leronlimab.

Merck has a close eye, watching the outcome of this Murine 2 mTNBC study and who knows, this study could already be complete. An excerpt from Undeniable Indisputable And Unequivocal:

"Merck would love to have the 85% that Keytruda leaves on the table, wouldn't they? Look at what they've built with only the 15% their blockbuster treats. Now, with the thousands of tests and trials to expand the use of Keytruda, it becomes obvious that they are desperately seeking a way to treat all the rest."

Like for instance mCRC. But that could really bring in a counter offer from GSK with their Jemperli.

"Our protocol built on the published pre-clinical work of Dr. Dan Linder at the Cleveland Clinic, who demonstrated that leronlimab inhibited metastasis in a humanized Mouse model of colon cancer. As well as the unpublished, clinical observation that four of six patients with colon cancer in our prior basket trial, had either stable, or partially responsive disease up to 11 months after starting leronlimab."

Cyrus Arman describes the mCRC patients in the Basket Trial.

r/Livimmune - 4 of 6 with Stable Disease: No Progression of Disease with Leronlimab
4 of 6 with Stable Disease: No Progression of Disease with Leronlimab
"55:22: So, when we look again at their tumor growth through the spyre grams and through the waterfall plots, that we only had 6 patients here. But as you can see, all of them remain within the stable disease and many actually achieve partial responses over the course of the short study. And one of them actually had no measurable lesions on the PET scan at follow-up. And the remainder saw either stable disease or partial responses."

As you might already sense, as I have recently also realized, that CytoDyn is way ahead of their Press Releases and are doing things way before they even tell us anything about what they are doing. Probably has something to do with their new Press Release company, Gagnier Communications.

So if the Press Releases are behind and Merck with a watchful eye... Who owns those 250,000,000 Institutional Shares again? We know that Merck is absolutely keen about finding a way to extend their patent on Keytruda which is soon to go South in 2028 unless something soon is discovered. If the study is already done and Results are already Resulted, and if the combination (leronlimab + Keytruda) has statistically significant improvement over Keytruda monotherapy... who owns those shares??

As we already know, CytoDyn has much going on in the HIV front. The HIV Cure has taken center stage. With the Patenting of AAV technology and the recent discoveries of both Triple Therapy and LS Mutations which enable leronlimab to cross the placenta, Jonah Sacha is drawing ever so close to an HIV Cure. This has not been unnoticed by Bill Gates at the GF who recently awarded Jonah Sacha another $966,600 towards research on the HIV Reservoir. What happens when the GF actually makes an investment into a partnership which includes CytoDyn? Or is this where those 250 M Institutional Shares went?

We talked in the past about moving from Phase 2 to Phase 3 requiring an investment of some sort coming from Big Pharma, or maybe even from the GF. I think it was that Phase 1 to Phase 2 required the lifting of the clinical hold. Now, CytoDyn is in Phase 2, but to get to Phase 3, a large investment is required. If the 22% Institutional Ownership is in fact real, then we are already in Phase 3.

Seems to me, if u/Upwithstock is correct, then, by 60 days post 1/14/25, (the date when CytoDyn filed form 424B, which would be the date when the 13D entity would have declared to buy 5% of the company), which would be March 14, 2025, by 3/14/25, CytoDyn might officially be in Phase 3 when it could officially be declared by. From the discussion above, the entity could be the GF. It could be Merck. I've said over and over, I think it's GSK because of so many commonalities it shares with CytoDyn. We've spoken about Novo Nordisk too. Hell, it could be G because of both CytoDyn's proximity to the HIV Cure and even to the mTNBC Cure.

CytoDyn is unrelenting as far as the pressure it is applying to Big Pharma on so many fronts. Hell in HIV, CytoDyn is pushing Cure. In mTNBC, CytoDyn is pushing Cure. In Fibrosis, the removal of. A whole new world abides beyond the curtain in long acting leronlimab. And that curtain is about to open. It goes on an on. In addition, CytoDyn is gaining favor with some big players such as the Gates Fund. The Gates Fund is gaining the favor of the new DJT administration. I definitely see the favor of a GSK and a ViiV if they prove not to become partners, both still want an HIV Cure. I definitely see a Novo Nordisk or an Eli Lilly interested at least in a licensing deal or even Madrigal at some point wanting a licensing deal. Alzheimer's Disease is on the way and so is Chronic Fatigue Syndrome. Unrelenting and Unstoppable.

The only way CytoDyn stops is via Buy-Out. Otherwise, CytoDyn doesn't sleep. It goes back to war. It is done resting. It did that for 2 long years getting the hold lifted. We are in the game, and can not be knocked out, unless of course, a buying company buys and then shelves leronlimab. May it never be, but that is a possibility, unless of course, we vet/examine the buyer extensively. Since it is Dr. Lalezari's purpose to place this company in the hands of someone who absolutely gets leronlimab FDA approved, therefore, I leave this determination, as to who to sell to, in his hands.

If there is any inkling of proof that G is behind the short selling or behind the market makers or behind what Amarex did, then in no way should they be the buyers. In no way should they have over 5% control either, especially not at $0.15 / share. Or are these Institutional Shares reserved for purchase at a somewhat higher price? Even if they are bought at $1/share, I don't believe G's intentions or end game would be shared by Dr. Lalezari. Let's see what happens here. Intentions of the buyer are very important.

CytoDyn is not going to abandon its game because of a 22% interest which may not be aligned. But, I don't believe Dr. Lalezari would permit such an interest at 22% had it not been aligned with his overall game plan. CytoDyn has been on this same trajectory ever since Dr. Lalezari came on board and this is the trajectory we remain on. We are getting somewhere, and shall not be derailed.

Again, we need to wait and see. Time is approaching. 3/14/25? Don't really know, but sure does seem very close.

MGK_2

Comparing and Contrasting Murine 1 mTNBC to Murine 2 mTNBC
Just wanted to extrapolate a bit to compare and contrast the prior MD Anderson Cancer Center murine 1 study in metastatic Triple Negative Breast Cancer with the current murine 2 study in metastatic Triple Negative Breast Cancer. (mTNBC)

Here is the Time Line History:

In October 2021, This BioSpace copy of CytoDyn's Press Release CytoDyn Announces Study To Evaluate Potential Synergistic Effects Of Leronlimab With Immune Checkpoint Blockade ICB, lays out murine 1 mTNBC study. CytoDyn

"today announced a study for treating triple-negative breast cancer (TNBC) with leronlimab in a humanized TNBC xenograft model. This investigator-initiated study is being led by Jangsoon Lee, Ph.D., assistant professor of Breast Medical Oncology Research at The University of Texas MD Anderson Cancer Center*.*

The study is intended to determine the potential synergistic therapeutic efficacy of leronlimab in combination with immune checkpoint blockade (ICB) to attempt to raise the standard of care for breast cancer patients.
...
We are also very grateful to Dr. Scott Kelly for arranging for this study to be conducted by Dr. Jangsoon Lee, assistant professor of Breast Medical Oncology Research at The University of Texas MD Anderson Cancer Center*.”"*

This raised the question, "Which Immune Checkpoint Blockade (ICB) was being tested in combination with leronlimab?"

The following gives an idea of how much time would be necessary for the result. 6 weeks of mouse time is equivalent to 6 years of human life. Therefore, not even a few months would be necessary to determine the approximate effectiveness of an ICB combined with Leronlimab in the treatment of mTNBC. Let's say that leronlimab has an overall survivability (OS) of about 13 months and a progression free survival (PFS) of about 6 months for mTNBC. Let's triple that for HR+ and HER2- type breast cancers where OS = 36 months and PFS = 18 months. Therefore, if 6 mice weeks = 6 human years, then 3 mice weeks = 3 human years. So therefore, the results of the effectiveness of this combination of medications should not take long at all. If the combination medication was very effective, even allowing these mice to survive for just 4 weeks, or 5 weeks after being inoculated with the cancer tumors, then we can know that the combination is very effective in MSS tumor types. MSS being Microsatellite stable, which are a type of tumor which are very difficult to treat, but 85% of breast cancer is MSS. Keytruda alone is only indicated currently to treat MSI or Microsatellite Instability. But, Keytruda + leronlimab could become indicated to treat the MSS tumor population or about 2,000% more than what it currently treats in breast cancer alone. If it is found that leronlimab allows some of its mTNBC patients to remain alive for 4 years after treatment, they would be considered Cured. mTNBC patients usually don't live beyond 1 year following diagnosis. HR2+ and HER2- patients could live 3 years post diagnosis, but not mTNBC patients.

Now, the results of this study were never publicly released because the data was owned by MD Anderson. Scott Kelly originally set the trial up with MD Anderson in partnership with CytoDyn. The data was only disclosed to CytoDyn, but the hard data & Results were not given to CytoDyn. They were only shown the results. If they wanted the hard results to work with the data, they would need to purchase it from MD Anderson and that was not done because of costs. But they saw what they needed to see.

They wanted to determine whether there was any benefit to combining leronlimab with a check point inhibitor, PD-1 blockade, and they had a look at the data and got an answer, but never said one way or the other what they found.

Continuing on with the time line, 18 months after murine 1 mTNBC started, in March of 2023, in the BioSpace Article Embattled CytoDyn Sets New Course Towards NASH, Tough Tumors, Cyrus Arman related,

"Along with NASH, CytoDyn will focus primarily on oncology*. Here, the company* will target colorectal cancer and hormone receptor-positive, HER2-negative breast cancer.

These are both areas where checkpoint inhibitors have failed to show efficacy when added to a standard-of-care backbone, Arman said, adding that leronlimab has shown positive signals in both.

“From a mechanistic standpoint, we believe we could get a synergistic effect with a checkpoint inhibitor,” he said.

Leronlimab is currently being trialed in combination with Keytruda (pembrolizumab) in a breast cancer xenograft model in partnership with MD Anderson Cancer Center.

Arman said CytoDyn expects to observe an enhanced anti-tumor effect from the combination and identify immunological biomarkers.

In terms of future partnerships, Arman isn’t concerned that CytoDyn’s history will have a negative effect.

“I think that most companies are data-first,” he said. “If we come and we show the data that we have…I think they’ll see, here’s an organization that has transformed from what it used to be.”"

Cyrus let us know, that the Immune Checkpoint Inhibitor was with Merck's Keytruda, pembrolizumab. "Arman said CytoDyn expects to observe an enhanced anti-tumor effect from the combination and identify immunological biomarkers." But Cyrus said this 18 months after the study began. Does that make any sense? By that time, the study had already concluded. CytoDyn had already been shown the results. CytoDyn already knew whether or not there was an improvement over leronlimab monotherapy by combining leronlimab with Keytruda against mTNBC. Nevertheless, Cyrus made the statement and he was comfortable making this statement in the BioSpace Article 18 months after the study began. CytoDyn was comfortable because the outcome of the study was likely favorable towards the combo treatment over leronlimab monotherapy."

Yet another 18 months of mTNBC hiatus passes, and then in the September 2024 Letter To Shareholders, mTNBC is reintroduced:

"In addition to CRC, CytoDyn is investigating the role for leronlimab in two other oncology indications via strategic and low-cost research and development opportunities*, and in collaboration with several reputable institutions. I am pleased to announce that CytoDyn is working with a team of experts to resume the exploration of* Triple-Negative Breast Cancer (“TNBC”), including colleagues from the University of Hawaii Cancer Center, MD Anderson Cancer Center, and the Pennsylvania Cancer and Regenerative Medicine Research Center*. We will be working with this team in the coming months to design and conduct a preclinical TNBC study that will aim to confirm the mechanism of action of leronlimab in oncology and address the question of* potential synergies with both antibody-drug conjugates and immune checkpoint inhibitors*. The Company intends to use this preclinical study to form the basis for a potential partnership and better inform the design of a follow-up clinical study in patients with metastatic TNBC."*

Then, close to Thanksgiving time of 2024, CytoCyn Appoints Richard Pestell MD, PHD As Lead Consultant In Oncology.

"He is currently the President of the Pennsylvania Cancer and Regenerative Medicine Research Center*, a part of the Baruch S. Blumberg Institute in Doylestown, Pennsylvania. Prior to this role, he spent a decade at Thomas Jefferson University in Philadelphia, Pennsylvania, serving as Director of the Sidney Kimmel Cancer Center, Chairman of the Department of Cancer Biology and Executive Vice President. Dr. Pestell’s work has been published in over 600 publications, and his research has been credited with well over 95,000 citations. He previously served as Vice Chairman of the Board, and* Chief Medical Officer (CMO), spearheading the Company’s successful effort to obtain Fast Track Designation from the FDA for the use of leronlimab in combination with carboplatin for the treatment of patients with CCR5-positive metastatic triple-negative breast cancer. In addition, Dr. Pestell was instrumental in designing and initiating CytoDyn’s Phase 1b/2 clinical trial in that indication*."*

Lastly on the Timeline, most recently, on February 24, 2025, CytoDyn released CytoDyn Announces Promising Survival Observations In mTNBC Patients Treated With Leronlimab. This Press Release discusses the Phase 1b/2 clinical trial that Dr. Pestell initiated referenced just above. The resulted data of that clinical trial were delayed due to the actions of CytoDyn's CRO at the time, Amarex. Over the past few years, CytoDyn worked to obtain this data and has the results.

"...today announced encouraging survival outcomes among a group of patients with metastatic triple-negative breast cancer (“mTNBC”) treated with leronlimab.

... In addition, the Company confirmed that a small group of patients who failed treatment after developing metastatic disease survived more than 36 months after receiving leronlimab, are alive today, and currently identify as having no evidence of ongoing disease*.*

... Following the resolution of the Company’s dispute with its former CRO, CytoDyn obtained follow-up records from patients treated with leronlimab during the Company’s prior clinical trials in oncology. After confirming these patient outcomes*, CytoDyn worked with consultants and key opinion leaders to summarize the findings and submit an abstract to the* European Society for Medical Oncology (ESMO) Breast Cancer meeting taking place in Munich, Germany, from May 14 to 17, 2025*.*

“We are encouraged by the longer-term survival data to pursue this potentially paradigm-shifting therapeutic pathway for patients suffering from metastatic triple-negative breast cancer,” said Richard Pestell, MD, PhD, AO, the Company’s Lead Consultant in Preclinical and Clinical Oncology. “As a cancer therapeutic, leronlimab was well tolerated with remarkably infrequent treatment-related adverse events. These promising results suggest further studies with leronlimab are warranted to expand oncology treatment options and improve patient care.”

Dr. Jacob Lalezari, CEO of CytoDyn, added: “These provocative observations of improved survival in patients with mTNBC and prior treatment failure in the metastatic setting, including reported clearance of disease in a group of long-term survivors, provides early clinical evidence of leronlimab’s potential impact in the treatment of TNBC and other solid tumors*. I expect the Company’s oncology efforts to accelerate in the coming months, with* further announcements in both mTNBC and colorectal cancer*.”*

Based on these survival observations, the Company has initiated two pre-clinical studies in mTNBC that will evaluate possible treatment synergies between leronlimab, an antibody-drug complex treatment (sacituzumab govitecan), and an immune checkpoint inhibitor (pembrolizumab). The Company will also continue to perform follow-up testing on the group of mTNBC survivors who currently identify as having no evidence of ongoing disease."

So, this last paragraph is where we are at right now. End of the History Time Line. Discussion.

Everything written in this most recent February 2025 Press Release was also known in the September 2024, Letter To Shareholders. They are way ahead of what they announce. In September, 2024, CytoDyn knew they would be doing murine studies again in mTNBC.

"We will be working with this team in the coming months to design and conduct a preclinical TNBC study that will aim to confirm the mechanism of action of leronlimab in oncology and address the question of potential synergies with both antibody-drug conjugates and immune checkpoint inhibitors*. The Company intends to use this preclinical study to form the basis for a potential partnership and better inform the design of a follow-up clinical study in patients with metastatic TNBC.*"

They knew back in September, 2024, that they would be combining leronlimab with both Gilead's Trodolvy (sacituzumab govitecan) and Merck's Keytruda (pembrolizumab). February 2025 PR was just a delayed release of knowledge which they already had back in September of 2024. They needed the time in between for Pestell to come on board, and his team of experts to get organized to take a look at the prior MD Anderson murine 1 study which was set up by Scott Kelly, and extract out of it, the pertinent information which would be useful and design and initiate an appropriate combination murine 2 study in mTNBC that would use leronlimab in combination with both Keytruda and Trodelvy.

My main question is, "Why did they choose to include another combination of leronlimab + Keytruda?" Remember, Cyrus Arman hinted that the results were good?

“From a mechanistic standpoint, we believe we could get a synergistic effect with a checkpoint inhibitor,” he said.

Leronlimab is currently being trialed in combination with Keytruda (pembrolizumab) in a breast cancer xenograft model in partnership with MD Anderson Cancer Center.

Arman said CytoDyn expects to observe an enhanced anti-tumor effect from the combination and identify immunological biomarkers."

This is like a conflict posed to the company. If the combination does well on the first study, do you repeat it again on the second to confirm? If the combination does poorly on the first study, do you repeat it again to make sure? I think in such situations, common sense is used. If the finding is that the combination drug does well is so profound, or if it is only borderline good, then I say that they would decide to repeat the study to confirm the finding one way or the other. If the finding is that the combination did poorly is profound, then, they would decide not to repeat the study. If the initial finding was a borderline poor result, then the decision would be to repeat the study to validate. So with this understanding, and since they are repeating the study, I can rule out that the initial murine study was not profoundly poor using the combination of (leronlimab + Keytruda). Therefore the outcome was either borderline good or bad or profoundly good that the combination drug exceeds monotherapy. It is possible, that the anti-inflammatory effects of leronlimab do in fact improve Keytruda's capacity to destroy the mTNBC tumors.

Considering the above paragraph, it is my suspicion that CytoDyn has chosen to repeat the combination of (leronlimab + Keytruda) in the new murine 2 studies with Richard Pestell against mTNBC because the initial MD Anderson murine 1 study probably did show that the combination of these two drugs was better than leronlimab alone against both MSS mTNBC. I tend to believe that if the original MD Anderson murine 1 study did not show any improvement what-so-ever of the combination of (leronlimab + Keytruda) over leronlimab monotherapy, then they would not have decided to confirm their findings by including Keytruda, in this second up coming study. There was enough good in the initial murine 1 study to warrant a repeat and confirmation of those good findings. Why validate a profoundly poor result by making the same mistake twice? Rather, the decision to validate the good is profoundly better.

If this conjecture proves to be the outcome of the 2nd murine mTNBC study, then this combination of (leronlimab + Keytruda) would give Merck the indication to treat 100% of MSS mTNBCs. Merck already has Keytruda's right to treat MSI mTNBC tumors. Right now, Keytruda alone may treat MSI type tumors, but not MSS type tumors. That is only 15% of all mTNBC tumors. But, if this combination is proven to be more effective than leronlimab alone, then 100% of mTNBC tumors become treatable by the combination drug. Chances of Merck offer just went up greatly.

As for Gilead's Trodelvy, sacituzumab govitecan, the combination of this antibody-drug conjugate with leronlimab, would be the 1st time this combination is being studied, but could very well be better than leronlimab alone by simply considering the fact that each drug has its own distinct mechanism of action and the combination could prove to exceed the monotherapy of either. Leronlimab's anti-inflammatory effects could bolster Trodelvy's capacity to fight the disease and make its contribution much greater that without leronlimab. If this becomes the outcome of this combination study, the possibility of getting an offer from Gilead greatly increases. Because, then, CytoDyn would have virtually (2) Cures in Indications Gilead already is in, HIV and mTNBC.

When we get to European Society for Medical Oncology (ESMO) Breast Cancer meeting taking place in Munich, Germany, from May 14 to 17, 2025*.* , these patients will already have been Breast Cancer Free for 48 months, in other words 4 years without BC = Cured. The Company will also continue to perform follow-up testing on the group of mTNBC survivors who currently identify as having no evidence of ongoing disease.

The implications that what Richard Pestell & CytoDyn are doing in conducting this confirmatory combination murine 2 study in mTNBC are huge. You don't repeat a study when initially, it's a total failure. We already know it is not a failure from the human trial, because as stated in the latest Press Release, some patients are still alive nearly 4 years after taking leronlimab, when most would have already died at most 1 year after contracting the disease. Remember, don't confuse mTNBC and HR+ or HER2- cancers. CytoDyn is expanding on what they already know from prior human trials and prior murine studies. More specific knowledge shall be gained, such that the next human clinical trial in mTNBC leads to leronlimab's approval. What a journey Folks!

Maybe this will help. Price performance od CYDY:
5-day 3.33%
10-day 40.91%
1-month 19.23%
3-month 158.33%
6-month 138.46%
YTD 181.82%
1-year 93.75%

Wonder which entity will be the first to want to trial the fibrosis indication using LL? GSK? GILD? PFE? MRK?

https://www.smccro-lab.com/news/cytodyn-reports-significant-fibrosis-reversal-in-smc-lab-studies/

2025.02.28

CytoDyn Reports Significant Fibrosis Reversal in SMC Lab Studies
In a great collaboration with CytoDyn Inc., we are pleased to share promising preclinical results demonstrating the efficacy of leronlimab (a CCR5 antagonist) in liver disease models. Using our STAM (MASH-HCC) and CCl4-induced liver fibrosis models, leronlimab monotherapy successfully reversed liver fibrosis—an area with significant unmet medical need.



These findings suggest that leronlimab’s anti-fibrotic potential may extend beyond liver disease, with possible implications for other fibrotic conditions, such as those affecting the lungs and heart.
We look forward to its continued development and success.



For more details, please see the press release:

CytoDyn Announces Findings of Statistically Significant Fibrosis Reversal Across Studies with SMC Laboratories

Yeah they've been pretty guarded with LA LL details to date. We know the multiple new formulations are key to future plans. I look forward to getting an update along those lines.

I would expect something about the CRC trial before then.

Let's hear it.

There are a ton of members reading along.

All these 40 years of owning stocks, I never knew why stocks moved up and down. It all makes sense now that I know it is the difference between buy and sell orders. Wish I knew this decades ago.

https://www.clinicaltrialvanguard.com/news/leronlimab-shows-promise-in-mtnbc-patient-survival/

Leronlimab Shows Promise in mTNBC Patient Survival
ByJon Napitupulu February 25, 2025
CytoDyn Inc. announced encouraging survival outcomes in a group of patients with metastatic triple-negative breast cancer (mTNBC) treated with leronlimab, a CCR5 antagonist. Some patients who had failed prior treatments for metastatic disease survived beyond 36 months, are currently alive, and show no evidence of active disease. Following the resolution of a dispute with its former CRO, CytoDyn accessed follow-up records from patients previously treated with leronlimab in oncology trials. These findings have been summarized and submitted as an abstract to the European Society for Medical Oncology (ESMO) Breast Cancer meeting in May 2025.

This news is potentially impactful for both the oncology field and patients with mTNBC, a particularly aggressive and difficult-to-treat cancer. The observed survival rates, especially in patients who had exhausted other treatment options, suggest that leronlimab may offer a new therapeutic avenue. This is particularly noteworthy given the limited treatment options and generally poor prognosis associated with mTNBC. The apparent lack of significant adverse events associated with leronlimab further strengthens its potential as a viable treatment option.

CytoDyn is initiating two pre-clinical studies investigating potential synergistic effects of leronlimab in combination with sacituzumab govitecan (an antibody-drug conjugate) and pembrolizumab (an immune checkpoint inhibitor). The company is also continuing follow-up testing on the long-term survivors currently demonstrating no evidence of disease.

This development could mark a significant step forward in the treatment of mTNBC. The upcoming presentation at the ESMO Breast Cancer meeting will provide a valuable opportunity for peer review and discussion within the oncology community. The pre-clinical studies focusing on combination therapies hold promise for further enhancing treatment efficacy. The ongoing follow-up of long-term survivors will be crucial to further understanding the long-term effects and potential of leronlimab in mTNBC.

Source link: https://www.globenewswire.com/news-release/2025/02/24/3031147/19782/en/CytoDyn-Announces-Promising-Survival-Observations-in-mTNBC-Patients-Treated-with-Leronlimab.html

Fife is working with CYDY in a positive manner and has eased off the pedal considerably.

Scroll down below the messages and just above the big box labeled DISCLAIMER and you will find the info you are asking.

Tiny-Ad-8280

Breaking Down CytoDyn’s Latest Announcement (Feb 24, 2025)
???? Big News: CytoDyn just announced promising survival results for metastatic triple-negative breast cancer (mTNBC) patients treated with leronlimab. This is a major update, especially since some patients who previously failed treatment are still alive over 36 months later—with no evidence of disease.

This could be a major step forward for CytoDyn in oncology, and it’s being presented at a major cancer conference in May 2025. ????

???? Key Takeaways for Investors:
Survival Data Looks Strong

mTNBC typically has a very poor prognosis, but patients treated with leronlimab showed higher-than-expected survival rates at 12, 24, and 36 months.

Some patients who previously failed treatment are alive and disease-free after 3+ years.

Potential Paradigm Shift in Cancer Treatment

CytoDyn is working with top oncologists and consultants to publish this data.

Their abstract will be presented at the European Society for Medical Oncology (ESMO) Breast Cancer Meeting (Munich, May 14-17, 2025).

If the oncology community sees this as groundbreaking, it could attract partnerships and funding.

Expanding Cancer Research with New Trials

Two new pre-clinical studies are now underway, testing leronlimab with:

Sacituzumab govitecan (Trodelvy – a targeted antibody-drug for breast cancer).

Pembrolizumab (Keytruda – a major immune checkpoint inhibitor used in many cancers).

These combination therapies could open up new treatment options beyond TNBC.

CEO Confirms More Oncology News is Coming

Dr. Lalezari expects more announcements soon, including updates on colorectal cancer.

This suggests momentum is building for CytoDyn in oncology, which could drive interest from both investors and pharmaceutical companies.

???? What This Means for CytoDyn Investors
✅ Bullish Signals
Positive survival data ? Increases credibility in the oncology space.

Presentation at a major cancer conference ? More visibility and potential industry interest.

New pre-clinical studies ? Expanding into combination therapies, which could lead to more clinical trials.

CEO hinting at more cancer-related updates ? More catalysts coming.

⚠️ Risks & Unknowns
These are still observations, not from a formal ongoing clinical trial.

Need confirmation in larger studies before regulatory approvals.

No mention of partnerships or funding yet.

⏳ What’s Next?
May 2025: ESMO Breast Cancer Conference ? Expect detailed data.

More announcements coming on colorectal cancer and other solid tumors.

Potential partnerships? If results hold, CytoDyn could attract pharma interest for oncology collaborations.

???? Investor Takeaway
This announcement adds credibility to CytoDyn’s push into cancer treatments. If the survival data is strong, it could be a huge opportunity—but we need to see more trials and partnerships to confirm the real impact.

???? If you're holding, this could be a major catalyst leading up to the May conference. If they secure funding or a partnership, things could move quickly. Stay tuned.

Tiny-Ad-8280

I'm back for the turnaround! LFG. Here is a plain English version of the "HIV Cure using AAV"
CytoDyn’s New HIV Cure Patent: What Investors Need to Know
🚀 The Big Picture
CytoDyn just secured a patent for a new approach to curing HIV using gene therapy (AAV9-macLS) to deliver leronlimab. This means that instead of weekly injections, the body could continuously produce leronlimab, potentially leading to a functional cure for HIV.

If this works in humans, it could be a game-changer—a one-time or long-term treatment instead of daily HIV meds.

🧬 What’s in the Patent?
1️⃣ How It Works: Leronlimab + Gene Therapy
Instead of injecting leronlimab weekly, this approach uses an AAV gene therapy (AAV9-macLS) to make the body produce leronlimab on its own.

This ensures 100% CCR5 receptor occupancy, which blocks HIV from infecting new cells.

If successful, HIV would remain undetectable without daily antiretroviral therapy (ART).

2️⃣ Long-Term Viral Suppression in Animal Studies
Tested in primates (rhesus macaques) for nearly 2 years.

They measured:

How well leronlimab binds to immune cells (CCR5 receptor occupancy).

HIV viral load (was the virus staying suppressed?).

HIV hidden in reservoirs (spleen, lymph nodes, etc.).

Results suggest the virus stayed suppressed, which could mean long-term control or even elimination of HIV.

3️⃣ Why This Matters: A Step Toward an HIV Cure
HIV-AAV could replace daily pills with a long-term or permanent solution.

If it works in humans, this could be the closest thing to a real cure.

💰 What This Means for Investors
✅ Best-Case Scenario
Major funding or partnership (Gates Foundation, GSK/ViiV, NIH).

Human trials begin soon, accelerating the path to approval.

Stock sees a massive jump on real progress toward an HIV cure.

⚠️ Risks & Unknowns
Who will fund the trials? CytoDyn needs deep pockets to move forward.

Still early-stage—human trials are the real test.

Regulatory & scientific hurdles—they must prove safety & effectiveness in humans.

⏳ What’s Next?
Waiting for news on funding & trial plans.

Potential partnerships (GSK/ViiV, Gates, NIH) could speed things up.

If trials get greenlit, this could be a game-changer for CytoDyn and the HIV treatment market.

💡 Investor Takeaway
This patent locks in CytoDyn’s ownership of a potential HIV cure technology. If they secure funding and move to human trials, it could transform the company’s future. However, until a partnership or funding is secured, it remains a high-risk, high-reward opportunity.

Stay tuned for updates—the next few months could be critical. 🚀

Excellent response. I appreciate the education tidbits. I figured you were a finance guy and I'm not at all surprised you specialize in shorting. I can't imagine making my living doing that type of trading but to each his own. I shorted Taser once for about 2 hours after some terrible news about a Taser related death. Too much excitement for me although I certainly understand why people do it. I think you are clearly right with CYDY needing to show they can prove something to the FDA via a human trial.for an approval. They've plenty of positive signals but the proof needs to come from completed trials.

That isn't a prerequisite for an appreciating PPS though.

I have heard statisticians are like mice and those crazy monkeys. They lie and exaggerate. Sometimes.

Do you really have a degree in biostatistics? If so, congrats on being so.

In May, I believe CYDY plans on releasing the data from yesterday's news at a cancer conference. I'm hoping you'll let us know your thoughts once the info becomes public.

BuildGoodThings

And they told 2 friends, and so on
Three internationally known execs have recently posted on LinkedIn mentioning Cytodyn and/or its drug, Leronlimab.

Max Lataillade, Yuki Sakakibara, Richard Pestell

The people who liked, commented or shared these posts, include Pharma and Investment executives.

The word is spreading.

Keep 'em coming Yahsho. You got the CYDY haters fan club bothered. I wonder when that next PR is going to drop? Is it going to be the one about the CRC trial or the one naming a new partner? Or is it going to be the one with updated GBM info? Or perhaps the new hire I've been hearing about?

I was expecting a partnership announcement along that line with the recent study results on MASH. I guess negotiations take longer when there is that kind of money at stake. Especially with multiple indications being discussed.

https://www.allpennystocks.com/specialreportsus/3828/micro-cap-surging-on-company-developed-ccr5-antagonist-showing-promise-in-patients

Upwithstock

Gagnier Communication and the Cadence of PR's
Dear Longs,

What an EXCITING day! I have to admit it was hard to work today. I was totally distracted with the volatility of the SP. Nonetheless, hearing about the mTNBC results that had to be sorted through (no thanks to our former CRO's inability to perform moral tasks like following cancer patients). Thank God for Joe Mielding at CYDY and possibily the Syneos team for digging through the past data and finding these patients and following up. My God !! some patients still walking around alive with an average life span of only 6-7 months and here we are 36 months later with no trace of disease and still alive. AWESOME RESULTS!

I wanted o remind everyone, especially the newbies, that before anymore news hits the wire, CYDY should be trading at a minimum $3-$5 per share (that is conservative). Why?

I'll Quote Cytomight with a list of activities that we LONGS are well aware of. The below list represents unrealized potential. Almost any of those can translate to $3-$5 per share just by themselves.

.HIV PAPER OUT/SALVAGE THERAPY
.MASH Large trial confirming that LL beat Resmetiron & reverses fibrosis from any cause completed with a p value &<.01 and will now lead to Fully funded Pulm Fibrosis trial &possible cardiac
.Dr.Palmer announces results and unmet need
.Fully funded 2025.
. MAX IS TAKING LL GLOBAL WORKS FOR BMGF
.Gates meets with President TRUMP for HIV CURE warp speed.
.ART+bNAB+LL=HIV cure
.CRC trial starting to screen
.Inflammation trial will lead to proof of concept and numerous indications
.Glioblastoma redo combo
&pilot trial
.Alzheimer’s trial start Jan-AN funder may be BMGF
.Long acting partner with AI capabilities AN
.Berlin scientist just cured the 5th HIV patient requested LL
.CFS hold pending LH NIH grant
.Latch HIV cure trial funded by AMFAR
. mtnbc back in play major players Drs Pastel,Ueno,YAM
. LL CROSSES BBB &PLACENTA .FcRn mutation prolonged blocks CCr5 in fetus
.Engaged SYNEOS
.Transferred MNFR tech anonymous partner

We might be missing a few but let's just stay with Cytomight's list:

I mentioned in a post maybe a couple of months back how important it can be to keep a cadence of PR's coming out. CYDY after all hired Gagnier Communications

Who is Gagnier Communications (GC) is a strategic PR & IR agency, serving clients across North America, Europe and Asia. We are based in New York City.

The team has led numerous corporate positioning and investor relations programs and has been actively involved in numerous special situations in the United States, Canada, Europe, Australia and Asia.

From senior counsel through to implementation of full-scale communications and investor relations programs, GC has assisted clients in critical assignments covering high-profile positioning assignments, shareholder activism, mergers, acquisitions, restructurings, litigation and other complex situations.

I can say from experience that these folks know what they are doing and I believe they have moved things around to help set a cadence. Below is a list of PR's and dates from their first PR that they officially signed off on to today's PR:

CytoDyn Announces Promising Survival Observations in mTNBC Patients Treated with Leronlimab
Feb 24, 2025 8:30am EST

CytoDyn Announces Findings of Statistically Significant Fibrosis Reversal Across Studies with SMC Laboratories
Feb 06, 2025 8:30am EST

December 2024 Letter to Shareholders
Dec 17, 2024 8:30am EST

CytoDyn Appoints Richard Pestell, M.D., Ph.D. as Lead Consultant in Oncology
Nov 25, 2024 8:30am EST

CytoDyn Announces FDA Clearance of Its Phase II Oncology Trial
Nov 04, 2024 8:30am EST

CytoDyn Appoints Dr. Melissa Palmer, M.D., as Lead Consultant in Hepatology; Announces Follow-Up Inflammation Studies with SMC Laboratories
Oct 30, 2024 8:30am EDT

CytoDyn Appoints Dr. Max Lataillade as Senior Vice President and Head of Clinical Development
Oct 08, 2024 8:30am EDT

CytoDyn Announces Abstract that Highlights Leronlimab’s Potential in Mediating ART-Free Viral Control in Infant Rhesus Macaques
Oct 07, 2024 11:05am EDTCytoDyn Announces Promising Survival Observations in mTNBC Patients Treated with Leronlimab

You can not have a cadence where you set a metronome to it, but if you can average 14-24 calendar days between news events, that is how you drive more investors to check out what is happening. Great work Gagnier Communications!!! There is a lot more to news/announcements to come.

Cytomight's list is what we know is supposed to happen based on communication from CYDY. What else are we waiting on?

Major funding events: Possibilities:

NIH grants

Gates Foundation

Other non-profit funding like "amFar"

BP partnerships

M&A

We know that as of the last 10Q, CYDY was holding $21 million with another $2 million due from Ama-fraud. Total $23 million. CYDY spends approximately $1.4 M per month. By the end of February 2025 we have to subtract a minimum of $4.2 million from $23 m = $18.8 balance. Not sure how much more the two additional preclinical trials for mTNBC is going to cost but we have other additional costs that might increase the monthly spend to some number higher than $1.4 million.

My point being is there has been a lot of intriguing movement that has not been officially recognized by CYDY and I believe a BIG MATERIAL EVENT is close at hand.

Clues:

CYDY pulls out of the MASH conference scheduled for 1/9 thru 1/11/25. No word from CYDY, but prior word from CYDY in a a shareholder letter dated 12-17-24 that they had submitted to the MASH conference for "late-breaking designation". The MASH-TAG conference accepted the abstract and approved of it. Only for CYDY to pull out at the last minute. That has been the biggest clue that some BP is close to pulling the trigger on at least a partnership, maybe more.

Soon after the mysterious increase in the % institutional ownership on Schwab and Yahoo Finance. Reporting it at 18 percent, then changing it to 19% then 21% before reporting today's results at 18.76 %. I looked up on the SEC site about 13D filings and I reported in another post about the 13D - 60 days

What is the rule 13D 60 days?The non-SBS cash-settled derivative grants a right to acquire beneficial ownership: Under Rule 13d-3(d)(1) generally, a person is deemed a beneficial owner of an equity security if the person (i) has a right to acquire beneficial ownership of the equity security within 60 days or (ii) acquires the right to acquire ...Jan 30, 2024

The entity acquiring more than 5% of CYDY's shares has ten days to file it in their process of document filings, but not CYDY. They can wait until it is completed before filing. This might be filed by CYDY around March 14, 2025, because on 1-14-25 CYDY filed form 424B which is a prospectus to resell shares and convert warrants if warrant holders desired to exercise their warrants. Approximately 279 million shares were up for re-sale. It is February 24th today, and I have not heard a peep about the re-sale. I heard a rumor that the re-sales was closed in early Feb.

2A) It is my GUT feeling of 33 years in Medical Devices that a partnership is lurking and once the details of the deal are finalized then it will be announced.

3) All we have talked about for weeks is the Gates interview with Trump and the possibility of funding coming from Gates into our HIV program and possibly Alzheimer's. The $966 K to OHSU/Dr. Sacha may have been from Gates but I have not found proof of that. Nonetheless, we all feel strongly that Gates is interested in Leronlimab and in particular, Long Acting LL for HIV Cure. MGK is all over this with great write-ups on the THREE approaches to HIV-CURE. I recommend reading those but for our purposes here: some entity, probably GATES could be the institutional entity as well.

4) As has been pointed out before and worth bringing up here: Every forward step that CYDY takes can lead to a higher valuation. Each step that brings more definitive evidence means that whatever entity that wants to acquire CYDY is going to pay more the longer they wait. This is the balancing act of any negotiation. The delta between what value leadership at CYDY envisions and what amount of money the buying company is willing to pay. How big that delta is determines the length of negotiations.

In the end, with all CYTOMIGHT has listed and the potential pending MATERIAL EVENTS soon to be discovered, any stock price under $10 is a STEAL! This .35 cents is unbelievably low and everyone should know what they own!!

in a post in early Feb titled "My Valuation of CYDY" I concluded with:

My best comparable is Prometheus. I shared the Prometheus stats above. No doubt that LL, and Long Lasting LL has way more value and 3X to 4X over the $10.8 billion buyout price is what I think CYDY can fairly argue and negotiate. That 3X to 4X translates to: $32.4 Billion to $43.2 billion. which translates to $26.34 per share or $35.12 per share.

https://www.reddit.com/r/Livimmune/comments/1il6yt7/my_valuation_of_cydy/

I believe Gagnier Communications is going to roll out more news like today (especially around March 14th) and eventually reveal some serious material events.

This is my opinion and not investment advice.

You might be right given the past PR's but isn't that part of the idea that today's CYDY marketing plan is a bit more conservative than in the past. Maybe they want OHSU to take the lead. I don't know and frankly it is such a minor thing in the big picture. Maybe it isn't for lero related research at all. I get your point.

"Sunshine is the best disinfectant" agreed except things in public traded companies don't always allow for such in a timely manner because of contract negotiations, NDA's, having to wait on paper's to be published, conferences etc etc.

I don't think anyone here currently is lying about anything. We just have a different viewpoint on current events.

Good morning.

I am not going to argue about your points based on the companies overall history. Individually. there lot's of explanations and certainly CYDY of today is not the same company as yesteryear. The biggest mistake was hiring Amarex. Our current situation is nearly 100% a result of NP and KK's f'ing the company.

I'd say 90% of people believe the company will pull through but I bet the vast majority probably have some fear in the back of thier minds. For me, I question their ability to design trials properly and even interpret the outcome as far as lero's mechanism of action. I think they need a partner like GSK, PFE, VIIV etc. I do think Syneos is the real deal as far as CRO's go. CYDY needs money. The 18-19 million they have isn't gong to get them through this year with all these new trials.

"By the way, where is that Leronlimab grant PR? Hmm…" You know full well, CYDY can't mention this via a PR because the money went directly to to Dr Sacha's research center. That means nothing. We know full well, LL is being used as part of DrS's research in finding an HIV cure. I think it is fine to be excited about the grant and I hope it leads to more data helping sove this terrible disease.

What do you think is going on with the CRC study enrollment?

banned

Been a long shareholder since 2018. I sold a big chunk on the way to $10 but I'm still quite long. I do however call it like I see it. Good or bad. I get a lot of posts deleted on the orher board you mentioned earlier because I say things that rub against their 100% positive cult like doctrine.

I am not deleting your posts and I am the furthest thing from a short as there is. I get you are very enthusiastic, as are many, but that isn't going to save you from having a moderator or Ihub's mod squad or admin from removing your posts if you break the rules.

Ihub doesn't care whether someone is a long or short. Surprisingly, they don't really care if someone is lying about CYDY unless you can prove the disinformation is accurate. If you can prove someone is wrong use the report function.

Some posters create such a toxic environment in Ihub's perspective they eventually get banned. We've had good long and good short posters be banned because the can't behave themselves. Don't let that happen to you by repeating the request over and over to delete someon's posts.

I hope you will stick around and post often. I really enjoyed you initial post.

Please post about CYDY and not about other posters or else ihub may delete the post even if a board moderator lets it slide