u/Upwithstock

The Stock Tests Our Patience. CLOVER Tests Our Thesis.

Dear Longs,

I realize how tough it is to endure a stagnant stock price. Our expectations are lofty—and justifiably so. We want to break things, go outside and scream, and, in my case, pull out what little hair I have left on my head. Not much is left to pull!!

What helps me is the conventional path CYDY leadership has chosen to follow. First, you clean up your own house, and we all know how long that took. Then you establish a clear direction. In CYDY’s case, that means prospectively demonstrating that leronlimab works in solid tumors.

I get that we’ve had a few side roads with MASH and inflammation, but we are moving forward in the solid-tumor space. CYDY has improved its financial position by renegotiating obligations with Samsung and Fife and raising money that, according to leadership, should provide runway through August 2027.

They have also introduced LL and its mechanism of action to academic institutions, allowing us to keep other irons hot while moving CLOVER forward. Institutions such as Cornell, MD Anderson, and Mayo have been discussed in connection with this work, including Cornell’s Alzheimer’s trial and other efforts moving through institutional review. The patent portfolio continues to develop, and I believe parts of it could provide a meaningful moat.

But what gives me the most satisfaction—and CALMS my emotions—is the information we’ve received about CLOVER.

I want to make sure everyone understands why a reduction in ctDNA matters, even this early. I am certainly not the first to discuss it. MGK, Twinter, BGT, rogex2, Lab Monkey, Lopside Roof, my69z, and a host of others have dug deeply into this topic. Yet I still see confusion among longs about what these results do—and don’t—tell us.

The key takeaway is this: CLOVER’s reported two-week ctDNA decline is encouraging because published metastatic colorectal cancer research shows that early reductions can precede and correlate with later tumor response. Its importance will become clearer when those early blood-test changes are linked to sustained responses, scans, and survival in the same patients.

That is why I see the anticipated ESMO presentation on October 25, 2026, followed by ASCO-GI, as an opportunity to begin establishing a TREND LINE.

My understanding is that the ESMO presentation will focus on two-week biomarker data. We should be careful about assuming what scans or other results will be available. A molecular response can emerge before a change becomes measurable on imaging, which is part of what makes ctDNA interesting.

If we see encouraging changes after ONLY TWO WEEKS, that will be worth paying attention to. But we also need to keep our terminology straight: the roughly 30% tumor-shrinkage criterion used to define a partial response is different from the overall response rate, which measures the proportion of patients who respond. Neither should be casually assumed from an early ctDNA result. More importantly, molecular changes are unseen through a visual assessment of a scan. Whatever scan results that are reported after two weeks will be remarkable for only two weeks but I am not going to fret over ORR, Partial response or stable response until we get more mature data.

What I hope scientists at ESMO walk away asking is: “These early results are remarkable for only two weeks. What will longer follow-up look like in these same patients?” The results across the two dose groups could make that question even more interesting.

Based on the published ctDNA research, I am optimistic that more mature data will trend in the right direction. I hope the anticipated ASCO-GI presentation in January 2027 gives us substantially longer follow-up, potentially including 24-week results for some patients. The actual follow-up will depend on enrollment dates and the presentation’s data cutoff. BGT has offered a more detailed discussion of that timeline, but that level of detail is not the purpose of this post.

I am sharing why this process helps me stay grounded. Clean up the company. Establish a clear clinical direction. Fund the work. Generate data. Present it. Build on it.

That is the conventional playbook successful companies follow. In my view, CYDY is working through that playbook. It doesn’t guarantee success, but it gives us concrete progress to evaluate.

There are two things CYDY cannot control: how patients ultimately respond to LL and what the stock does from day to day.

Some days, it sure FEELS like somebody is “F”ing with this stock. But the market’s daily nonsense does not determine what LL does in a patient. That battle is being fought in the trenches against mCRC, and I remain highly confident in LL’s potential.

Another post I appreciated was from ibelieveinCYDY, discussing what it could mean if a patient improves enough to become a candidate for surgical resection. Becoming eligible for surgery could be an encouraging clinical development. How that patient’s outcomes are counted, however, depends on the study protocol and its prespecified analysis. But, from what Ibelievein cydy discovered; was very promising and favorabe to the CLOVER data.

I can’t remember exactly where we heard it—I think it was one of the Paulson presentations—but I recall Dr. JL saying that a patient was doing well enough to become a candidate for tumor resection. We don’t know how often that may have happened, and I don’t want to turn one reported example into a claim about the entire trial. Still, that is the kind of development that gets my attention.

These are patients facing very difficult disease. I believe CLOVER has the potential to produce results that compare favorably with SUNLIGHT. Personally, I hope we beat the pants off it. But comparing separate trials requires care, particularly when patient populations and prior treatments differ. The CLOVER data will have to make that case.And CLOVER HAS A VERY STRONG ARGUEMENT. Our Cohort of patients is SIGNIFICANTLY more challenging.

As we know, CLOVER is OPEN LABEL. That gives the investigators and company visibility into treatment assignments and accumulating results, although we should not assume how frequently leadership reviews the data. It also creates the possibility that potential partners could review more detailed information through appropriate confidential discussions, subject to applicable obligations.

Now, I am making a BIG assumption here, but I think it is worth explaining my thinking.

If the ongoing accumulating data are compelling, CYDY could have more mature information available for potential partners than the early results presented publicly at ESMO. I would hope leadership is arranging meetings with companies it has already spoken with.

Leadership has also described feedback from two Big Pharma companies along the lines of: “See how far leronlimab can go without an ICI.” If I have understood those comments correctly, that makes the developing CLOVER results particularly relevant to those conversations. Those two BP's I would think would be sitting in separate hotel suites anxiously awaiting an update on CLOVER.

The public presentation in Madrid may give us an early snapshot. What interests me a lot more is the possibility of private discussions about more mature interim results.

I would LOVE to be a fly on the wall in those meeting rooms.

To be clear, I don’t know whether those meetings are scheduled, what data might be shared, or whether any company is ready to act. That is my speculation. But if continued treatment produces stronger clinical outcomes alongside those early ctDNA reductions, I can certainly see why a potential partner would want a closer look.

Will there be enough evidence for a SMART Big Pharma company to make a move before the world sees more mature results at ASCO-GI in January 2027?

I FREAKING HOPE SO! Why would a BP want to let paradigm shifting CLOVER data become public at ASCO-GI and let other BPs to become competitive with the current discussions. NO WAY, would I want to bring in more competitors.

For now, I am watching the clinical progress and reminding myself why I invested. The stock price tests our patience. The data will test our thesis.

Take a BIG breath in, and let it out.

I believe we’re gonna be ALRIGHT!!

Have a GREAT WEEKEND!

reddit.com
u/Upwithstock — 6 days ago

My start-up companies First FDA Clearance to My Hopes for Leronlimab: A Toast to What’s Possible

Dear Longs,

I work for a medical device start-up, and we received word last night that our FDA submission received clearance. Needless to say, the champagne corks were popping!

We still have work to do before our public announcement, but I couldn’t help thinking about what it would feel like if leronlimab receives its first FDA approval.

Our device focuses on early detection of heart failure. Working on something that could help patients has made this milestone especially meaningful to me. It also reinforces why I became interested in CytoDyn: the possibility of supporting a treatment that could make a meaningful difference in people’s lives.

Almost every conversation I have with fellow investors eventually comes back to patients. Yes, we want our investment to succeed. But there is something powerful about hoping that financial success comes from helping people facing serious illnesses.

I often read arguments that pharmaceutical companies have more incentive to manage disease than to cure it. I tend to look for the good in people—and companies are made up of people. From my own experience, I know how much the people developing medical products care about the patients they hope to help. It does seem like the business model of Big Pharma is to create marginal imporvements and create a longer sustained treatment pathway.

I also believe there is a compelling business case for developing treatments that deliver substantially better outcomes. A drug that shortens treatment times and reduces the typical adverse event profile. A drug that proves useful across multiple diseases could create enormous value for patients and its developer.

That is why I am fully invested into leronlimab.

When I first invested nearly six years ago, I remember reading OHM20’s posts discussing the many diseases in which CCR5 might play a role (90 indications). Those posts opened my eyes to the breadth of the research possibilities. This message board and other sare constantly coming across publications of the CCR5 molecule being a primary driver of that disease state. This is part of the reson why Dr. JL recently stated that because of Leronlimab they will be re-writing chapters in the medical text books.

Of course, a biological connection is only a starting point. Each proposed use still needs evidence that blocking CCR5 with leronlimab safely improves patient outcomes. Keytruda did not happen overnight it took time to expand.

Today, CytoDyn is evaluating leronlimab in cancer settings, including metastatic colorectal cancer and triple-negative breast cancer. It remains investigational, but those programs give us concrete research to follow as the company works to establish what the drug can do. CytoDyn’s colorectal cancer update

For perspective, look at Keytruda.

Merck’s second-quarter 2026 report describes Keytruda as having more than 45 approved U.S. indications, spanning 19 tumor types and two tumor-agnostic indications. Keytruda and Keytruda Qlex generated approximately $31.7 billion in worldwide sales in 2025. That demonstrates the commercial potential of a medicine with multiple established uses. Merck’s indication count | 2025 sales results

I’m not predicting that leronlimab will match those numbers. What interests me is whether it could eventually earn approvals in multiple settings—and whether combinations with other cancer treatments could improve outcomes.

We all know that one question worth studying is whether leronlimab could help checkpoint inhibitors work better in certain patients. We already have retrospective anecdotal data that has given us a positive signal. CytoDyn has reported exploratory findings relevant to that possibility, but proving a clinical benefit will require further trials. That is a research opportunity I want to see pursued. CytoDyn’s research announcement

The recent AstraZeneca–Summit Therapeutics announcement offers an example of how a major pharmaceutical company can help fund combination development.

On September 28, AstraZeneca announced an agreement to invest $2 billion in Summit, alongside a clinical collaboration involving ivonescimab, which targets PD-1 and VEGF. The initial collaboration will evaluate ivonescimab with AstraZeneca’s sonesitatug vedotin in gastrointestinal cancers, with plans for a broader program involving additional cancer medicines. AstraZeneca’s announcement

That deal doesn’t establish what CytoDyn is worth or predict a partnership for leronlimab. It does show that major companies are willing to commit substantial capital to promising cancer combinations.

My hope is that CytoDyn produces the evidence needed to attract that kind of development support: funding, trial capacity, and expertise that could help move successful programs toward patients.

For now, the next clinical results matter far more than any prediction about dozens of future indications. The first approval would be a tremendous milestone. Any additional approvals would have to be earned through the evidence.

After experiencing the excitement of my company’s FDA clearance, I can tell you this: if leronlimab reaches that first approval, I’ll be ready to pop another cork.

And if it eventually proves useful across multiple diseases—HOLY MOLY, we might need that swimming pool of champagne!

Have a great weekend, Longs!

u/Upwithstock — 14 days ago

Total Share count! No new shares needed !

Dear Longs,

I haven’t posted in a while for two reasons. First, this community has been producing excellent research and thoughtful discussion. Often, I finish reading and feel there’s little for me to add. Second, work has been busy. Tonight’s last call ended at 9:00 p.m., and tomorrow’s first starts at 6:30 a.m. I’m grateful to enjoy what I do, but it hasn’t left much time to dig into filings.

Still, the September 28 DEF 14A caught my attention.

With the annual meeting scheduled for November 20, I had expected management to request another 500 million authorized shares above the existing 2.25 billion. That request is not on the proxy agenda, and I’m pleased to see it. It also raises a question: How much room does CYDY have left, and what might management be expecting? September 28 proxy

Before getting to the numbers, one passage stood out. In discussing executive bonuses, the compensation committee cited:

>“Significant development towards strategic partnerships and/or supply agreements with third-parties.”

That wording interests me, although progress toward an agreement is different from a signed deal.

The Natera collaboration may account for some of that progress. I don’t know the financial terms, so I wouldn’t assume CYDY receives the testing for free or at a discount. What I’m watching for is whether this language eventually translates into additional agreements that help fund or advance leronlimab.

My personal hope remains a meaningful partnership. I can imagine further clinical results and presentations helping those discussions, but any prediction about when a deal might happen is speculation.

Now, the share count.

CYDY reported 1,469,518,019 common shares outstanding as of September 24. Against 2.25 billion authorized shares, that leaves a gap of 780,481,981 shares. But that is not the same as having 780 million shares available for new fundraising. Existing commitments consume much of that capacity. Proxy, page 3

The complete reserve breakdown I found was dated May 31, 2026:

Category Shares, millions
Outstanding common shares 1,373.5
Warrants 306.4
Preferred stock and dividend conversions 42.5
Outstanding options and performance stock units 53.7
Future equity awards 6.1
Standby Equity Purchase Agreement 115.5
Legal settlement 49.0
Convertible notes 12.0
Total reserved 585.2
Unreserved and available 291.3

The annual report later gives 206.3 million available shares as of July 31. Those are historical snapshots, not September balances. 10-K, pages 42–43

Warrants are another substantial piece. The May balance was approximately 306.4 million. Adding the disclosed summer financing warrants suggests roughly 397 million before subsequent exercises, expirations or cancellations. That is an estimate, not a verified September total. 10-K

Separately, the September 25 S-3 covers 384,925,833 shares underlying outstanding warrants. That tells us what this registration covers; it does not necessarily establish the total number of warrants outstanding companywide. September 25 S-3

This is where the accounting gets frustrating. We have different dates, new issuances and different categories of commitments. We cannot simply subtract May’s reserves from September’s outstanding balance and call the result today’s available shares. Warrants are also already part of the reserve calculation, so they should not be subtracted twice.

For that reason, I’m not treating July’s 206 million available shares as a current fundraising budget. Multiplying that old balance by today’s stock price would overlook subsequent changes, financing discounts, fees and any additional warrants attached to a raise.

What interests me is management’s decision not to request more authorization at this meeting.

My bullish interpretation is that management may see a path through the next milestones using existing resources, potential warrant proceeds, a partnership or another source of funding. But the absence of a share-increase proposal does not prove that a material transaction is imminent. There could be other explanations, and a future authorization request remains possible.

I remain optimistic about CLOVER and leronlimab’s potential in a very difficult-to-treat patient population. I’m hoping the upcoming data strengthen the case for both further development and a meaningful partnership. Whether that leads to an FDA designation, an agreement or another next step remains to be seen.

For me, the data are still what matter most. That’s what I’ll be watching as we look toward Madrid.

Have a GREAT WEEK LONGS

reddit.com
u/Upwithstock — 17 days ago

Now until May 2027

Dear Longs,

The 10-K is out, and by now many shareholders have combed through it. To me, the most important development of the past few days is the PIPE financing through Paulson and the extension of our operational runway.

Using very rough, back-of-the-envelope math—considering the cash available before the raise, the new proceeds, and the current burn rate—I estimate that CytoDyn may have sufficient cash through approximately August 2027. That raises an important question: What is leadership’s strategy for using this runway?

We know about the scientific activity. Several clinical trials have been discussed, and Dr. Jay Lalezari has also mentioned a potential FDA submission. In public discussions, management has alluded to possible partnerships. From my perspective, matters may be coming to a head.

Several potentially important events could occur over the coming months:

  1. Shareholder update: We typically receive an investor letter or call around September or October. These communications serve several purposes, including updating shareholders on the company’s progress. I would like to request greater transparency and a high-level strategic roadmap covering the next 12 months and beyond. Plus, I am anticipating a request to authorize more shares. As a reminder, authorizing more shares in and of itself is not dilutive. It is when those shares are issued and registered for use is when they are dilutive. Nonetheless, prior to any partnership announcement, we have to continue operating like we are going at this alone.
  2. ESMO in Madrid: We may see an initial look at very early mCRC data, potentially including approximately two weeks of observations for all 66 patients. Hopefully, this is enough of a tease that gets people excited about January 2027.
  3. J.P. Morgan Healthcare Conference: This takes place in San Francisco in January. Could this be the year CytoDyn has something substantial to report, or will partnership discussions still be described as being in the “early stages”?
  4. ASCO GI: Shortly afterward, ASCO GI will be held in San Francisco from January 23–25. We have heard that this could be a much more meaningful data reveal. BGT has charted the expected timeline, and it appears to align with more mature data from the full cohort. Although this may not represent the complete final dataset, Dr. Lalezari has suggested that the clinical and scientific communities should be able to draw meaningful conclusions from it.

If the positive trends continue, this data could outshine SUNLIGHT—pun intended.

I would like management to address several strategic questions:

  1. Is the primary goal to secure an oncology partnership with a large pharmaceutical company?I get they have alluded to this; but are they also talking about LATCH/HIV?
  2. Which of the other proposed studies are management’s highest priorities, and which cannot realistically begin without a fully committed Big Pharma partner?
  3. If an oncology partnership is secured, does CytoDyn intend to expand into other indications such as HIV, stroke, or Alzheimer’s disease? How deeply can we start to go with other indications?
  4. Is the objective to structure an oncology partnership that provides enough funding to pursue additional indications independently?
  5. Is management seeking a partnership that supplies sufficient capital to make another PIPE financing unnecessary?

If CytoDyn is still in the early stages of partnership discussions in January 2027, I can think of no better source of leverage than outstanding prospective clinical data. Strong results could create significant competition among potential partners.

In my view, the ideal outcome would be to announce a partnership—and receive the associated funding—no later than April 2027. Why? Because ASCO, the world’s largest cancer conference, takes place in Chicago in May 2027.

If I were the prospective pharmaceutical partner, I would want that partnership finalized before ASCO. I would want my company’s flag at full mast, announcing that we had partnered on what could potentially become an important new oncology treatment.

By May, CytoDyn should be able to present the complete dataset from all 66 patients. The company may have an opportunity to present meaningful findings at ASCO GI in January, but ASCO Chicago could provide the larger stage. A strong presentation there could draw considerable interest from oncologists, investigators, and prospective collaborators.

Obviously, this is only my opinion, but it is the strategic timeline I would encourage management to pursue.

As most of you know, I try not to become consumed by daily stock-price movements. I focus instead on whether CytoDyn’s leadership is making the right strategic decisions. We cannot always see the tactics being employed behind the scenes, but scientifically, I believe the company is making sensible choices with its limited resources. Management must decide which programs it can fund now and which must wait.

When the mCRC data becomes public, my hope is that we will no longer see trading volume consistently below 2 million shares but ideally start to rise to a dialy volume of 10–15 million shares. And ideally, daily volume could eventually exceed 20 million shares on a sustained basis.

CytoDyn remains largely hidden from the broader investment community. Many of us have discussed the company with friends, family members, and colleagues. I have been surprised by how many people say the story sounds interesting but assume something must be wrong because supposedly a promising drug is associated with a stock trading near $0.20. They believe I must be missing something. Or something is a miss.

A genuine prospective oncology trial—and credible data from it—could begin to change that perception. Dr. Lalezari has said that the data will speak for itself.

Rather than watching every daily price movement, I will be waiting for the January data. That is what I believe could truly move the needle.

In the meantime, I believe this company has been overlooked and undervalued. HIV-MDR produced statistically significant results, leronlimab has demonstrated an encouraging safety profile, and there is a substantial amount of anecdotal and observational evidence suggesting that a prospective oncology trial and anecdotal COVID data could produce meaningful results.

My conclusion is simple: I believe the stock is “on sale,” and January 2027 could be when a much larger audience begins to understand the story.

God bless all the longs—and CytoDyn.

This is my personal opinion, not financial advice. Clinical outcomes, regulatory decisions, partnerships, financing needs, and future share prices remain uncertain.

reddit.com
u/Upwithstock — 1 month ago

Aloha from Hawaii

As I sit back and enjoy a Kona Coffee this morning and look at this awesome view. I couldn’t help but let my thoughts drift over to CYDY. Yes, it’s hard not to think of CYDY.
There are a ton of things happening and as usual I would recommend reading Cytomight’s posts where a list is provided.

I want to point out a couple of things that we should be aware of:

  1. The release of CLOVER data will be THEEEE most significant event in this company’s history! And as we heard Dr. JL state: there will be at least another chapter added to the medical text books about the CCR5 molecule
  2. May 31, 2026 was the end of CYDY’s 2026 FY. But September/October or even November is when we usually get some investor conference call or Investor letter. Part of the reasoning for this is the annual proxy vote comes up. The board members are voted on, compensation is voted on and authorization of more shares has been voted on.
    If I were a betting man and I am a betting man; I would hope Dr. JL shares CLOVER data before ESMO in Madrid. The more the merrier!!

But, back to our 10K for fiscal 2026:

CYDY’s FY2026 ended 5/31/26 but the good news is that the 10-K is not late. I checked the SEC rules and CytoDyn’s latest filings.
CytoDyn is classified as a non-accelerated filer (and smaller reporting company). Its February 28, 2026 10-Q confirms that status.
For a non-accelerated filer, the SEC gives the company 90 days to file its 10-K.
That puts the 10K due 8/29.
However, August 29 is a Saturday, and SEC rules move a weekend deadline to the next business day. Therefore, I calculate CytoDyn’s actual 10-K deadline as:
Monday 8/31/26

One thing I think will be particularly interesting in this 10-K: the Subsequent Events section. Because the report covers May 31 but will likely be filed in August, it can give us a window into important financing, trial, warrant/share issuance, debt, and other developments occurring after May 31 and before the filing. Given everything happening around CYDY right now, I will be looking at this section!!

It’s off to the beach and a catamaran cruise!
ALOHA 🍹🍹🍹🍹

u/Upwithstock — 2 months ago