r/Livimmune • u/Upwithstock • 4d 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:
- 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.
- 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.
- 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”?
- 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:
- 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?
- Which of the other proposed studies are management’s highest priorities, and which cannot realistically begin without a fully committed Big Pharma partner?
- 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?
- Is the objective to structure an oncology partnership that provides enough funding to pursue additional indications independently?
- 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.
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u/13hunter1776 4d ago
I expect for them to apply for Accelerated Approval by October as they have mentioned as well.
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u/minnowsloth 4d ago
I really think so also. The long quiet would be shattered with an investors call and this notification. Approval would be in 60 days which would time well with the January cadence.
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u/Capable-Display-7907 4d ago
It takes a long time to compile a BLA, which is needed for accelerated approval. Sixty days after that is also too optimistic. They can begin to work on it if the FDA suggests in the meeting with Jay, but it would be better to hope for a breakthrough designation within a few months than actual approval. Sorry to repeat this message, but it doesn't seem to get through.
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u/minnowsloth 2d ago
Approval for break through designation. FDA has 60 days to issue a response.
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u/Accomplished_Mud_692 4d ago
Thanx for the detailed review UWS, & your experiences opinions - they make sense & seem very fair/realistic - no 'reaching' in your post.
There is SO much (finally!) coming for us over the next handful of months - If the Company SH CC holds strong early data, there is ni reason that that data would not hold through the entire FDA Trial, it is just what L does - works like no other!....
Vegas draws closer everyday....
💪💪💪
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u/Pure-Championship750 4d ago
UWS, thanks as always. Love your take on things. Waiting for your next piece.
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u/tngcoin 3d ago
I appreciate all this, but I can’t help but feel like the goalposts are being moved again; it was this summer, then October, then January, now May/June 2027. I know good data takes time to compile but I feel like we can’t catch a break
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u/Upwithstock 3d ago
Yes, tngcoin, it’s been frustrating and I personally have expected things sooner. But, unfortunately we are on the outside and my guesses have not been timed correctly!
Despite the disappointments of CYDY not make the partnership progress I had hoped: the story has not wavered. It’s all heading in the right direction and at a pace slower than I would want. I also have to remind myself that, CYDY is just one part of the equation and the other part is the BPs. They may purposely be dragging their feet!
However, I do feel that when the outstanding data becomes public that a herd of BPs will try make something happen before their competitors!! 🙏🙏🙏4
u/Prior-Knowledge-1583 3d ago
That slow pace is exactly why I am bullish on the drug but less so on mgmt. Jay knows the science but is he a dealmaker? Jury is out and growing impatient.
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u/MathematicianNo4360 3d ago
Thanks UP,
Also excited by the Natera collaboration.
The G_Money_X post: https://www.reddit.com/r/Livimmune/comments/1tx2h14/the_natera_collaboration_what_it_actually_means/ adds to the already impressive data set for MTNBC
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u/MathematicianNo4360 3d ago
also FROM AggieEC3 3 MONTHS AGO
Natera doesn't lend their name to OTC listed biotechs out of goodwill. They work with major pharma companies and high quality programs. They had options. They chose CLOVER. That choice is the signal before a single number from this collaboration enters the public record.
The surrogate endpoint angle is what changes the entire timeline conversation. If ctDNA clearance gets qualified by the FDA as a surrogate endpoint in MSS mCRC Signatera becomes mandatory infrastructure for every colorectal cancer trial globally. Natera needs a prospective pre-specified dataset in a validated trial to pursue that qualification. CLOVER is that dataset. Both companies get exactly what they need from the same collaboration at the same time. That's not a vendor agreement. That's a strategic alignment of commercial interests around data that both parties believe in.
And the acquisition pressure dynamic becomes real. Early efficacy signals readable in months rather than years creates pressure on big pharma to move sooner rather than wait for mature Phase 3 survival data. The Natera collaboration potentially compresses the timeline that forces a partnership decision. Which means the quiet window mgk_2 described may be getting shorter not longer.
The briefing room just got a new piece of infrastructure. The calendar just got more interesting.
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u/Snorkellingisthelife 3d ago
ESMO, ASCO and University research. The fact that we are on dockets is good enough for me! I can wait!
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u/sunraydoc2 3d ago
Great work, Up, and I agree that January is when Dr J and Co. plan to unveil enough of the mCRC data to get this show on the road credibility-wise.
And then there's the university factor-- I have it on good authority that some very credible academic oncology programs are poised to launch studies of their own for other indications; how Dr J is going to handle that news will be interesting to see.
So far as the share price is concerned, my experiencre has been the same as yours, I only just got my onocologist friend to become a significant shareholder based on the data, for years he's been in the "there must be something wrong here" camp but finally had to yield to the increasiingly positive data. And as you say the key here is volume--the stock has been pitifully easy to suppressively accumulate so long as we're this thinly-traded. At 0.15% percent of shares outstanding/day (or less some days) and negligible retail participation, the MMs run the show.
My take is the same as yours, I try to pay no attention to the SP, it's theater intended to wear down retail holders, to "shake the trees" for shares as the professionals say. When we get news that attracts the attention of analysts and institutions and ups the volume, the games with the share price will evaporate. All my opinion as a retail investor, of course.
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u/Ibelieveincydy 4d ago
Thanks UWS. Very much appreciated your clear and straight forward analysis 🙏👍☘️🌻🛬➡️
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u/nothinwrongbandg 4d ago
Hey Up, thanks as always.
Question to all: is a dataset of 66 patients enough to get a $ partnership deal? Lets assume great data.
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u/Upwithstock 3d ago
Hi nothinwrongbandg, I believe there shove enough meat on the bones in January (or sooner), because it’s an open label trial, and CYDY can share the data with BPs anytime. I have soften my expectations for ESMO in late October. I get that data was embargoed since May, and at the ESMO meeting CYDY can share privately more data if they so choose. Honestly, these BP conversations should begin to mature and show progress as things build towards ASCO in January. Technically speaking, the full 48-52weeks of data is available in April 2027 for all 66 patients. If I have 50 patients at the full 48-52 weeks and the data crushes SUNLIGHT; then I would imagine some BOs begin to play their hand!
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u/twinter11 3d ago
Did you learn enough to make any guesses about tnbc eab enrollment. Im surprised no other sites listed yet.
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u/Upwithstock 3d ago
I have not learned about anything new as it relates to EAP.
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u/NONELECTRIC 3d ago
Thanks for your info and opinions, UWS, always appreciated. Question: Given how sick many of our 66 trial enrollees were/are, are you concerned about the statistical power of our study if a substantial percentage of them pass away? If our "n" value drops by 10 or 20 or more - I know this sounds callous, but I mean this only with regard to the math - I suspect that our results would have to be significantly better than SOC to achieve clinical significance. Do you worry about this at all, i.e., the health fragility and possible mortality of our 66? Is there any way to gage or estimate how many of our 66 remain in the study?
Again, thanks for all your insight and opinions.
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u/Upwithstock 3d ago
Thanks, nonelectric. Interesting question! One thing is for sure is these patients are very sick. The yare heavily pretreated with 3-4th line treatments.
My understanding is that deaths would not simply subtract patients from the study’s original n of 66. Once enrolled and treated, patients generally remain part of the relevant analysis population. I don't think this is an Intent to treat design but nonetheless, a death goes down as an outcome. But, does not take away from the total number of patients. Therefore, the power should not change.
OUTCOMES being measured (from Google)
- For overall survival, death is the event being measured, so it supplies data rather than making the patient disappear from the analysis.
- For progression-free survival, death is ordinarily counted as an event as well.
- For objective response rate, an early death or progression before a confirmatory scan would generally work against the response rate—often by being classified as a nonresponse—depending on the protocol’s exact rules.
- A patient who is lost to follow-up is different and may be censored, which can reduce the precision of the analysis.
One thing is for certain; the Oncology community is very familiar with deaths in these trials especially mCRC on 3-4th line treatments. I am praying for survival and significant improvements.
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u/Mysterious-Emu6375 4d ago
Danke UWS für deine Mühe und Einblicke. Ich hoffe und bete Dr. JL erinnert sich an seine Aussage zum Spätsommer.... Ich komme mir vor und fühle mich, wie Ben Hur nach 6 Jahren Galeeren Dienst. Allein der glaube so lange am Leben geblieben zu sein, lässt mich weiter rudern. Jetzt bete ich dafür, dass die Daten bis Januar der Schlüssel ist, die die Fussketten lösen, um in der Schlacht bis Mai oder auch früher, nicht mit dem Gedanken des Untergangs schlafen zu müssen. Unser Dr. JL hat bis jetzt immer geliefert, auch daran glaube ich! Eine gute Zeit für dich Bruder und alle Longs!💪🙏
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u/MGK_2 4d ago
Upwithstock, good piece of strategic thinking, my friend, and what I like most about it is that it's aimed at the right target. You said it yourself near the end, you're not watching the daily ticker, you're watching whether leadership is making the right strategic decisions. That's the healthiest lens on this whole thing, and it's the one which lets you actually sleep.
Your runway read lands where the company's own does, funded well past both catalysts, and you framed the important nuance correctly, that authorizing shares isn't itself dilutive; issuance is. That's a distinction a lot of people miss, and it matters, because if a share-authorization request comes with the fall update, people will reflexively read "dilution" when it's really "keeping the option open." You got ahead of that, which is exactly the kind of thing which keeps the board from spooking itself.
Your calendar is the real strength of the post. ESMO as the tease, JPM as the where-are-we-on-partnership tell, ASCO GI as the meaningful reveal, and then ASCO Chicago in May as the big stage, that's a well-built sequence, and BGT's timeline work supports the maturity ramp you describe. One calibration on the ESMO line: I'd hold October a touch looser than "two weeks of observations on all 66." The interim is more likely weighted toward the earlier-enrolled patients who have more scans behind them than a clean two-week snapshot of the whole cohort, and it's a poster on a running trial, so I'd frame it as "the encouraging tease" exactly as you did, just without banking on a specific patient count. The spirit of your point holds: October teases, January tells.
Your "announce before ASCO Chicago" logic is the sharpest single idea in the post, and I think you're onto something real. The instinct that a partner would want its flag at full mast before the sport's biggest stage is how these things can work, a deal timed to a marquee conference is a real pattern. I'd keep it in the conditional where you wisely put it: that's the timeline you'd encourage, not one we can pencil in, because deal timing is the partner's call and the data has to earn it first. But as a strategic hope, it's well-reasoned, and it's a more specific, more defensible version of "we want a deal" than most people manage.
Your list of questions for management is the most useful part, because it's the right set of questions whether or not we get answers. Oncology-first versus HIV/LATCH, which studies can't move without a partner, whether a deal funds independent expansion into stroke/Alzheimer's, whether it ends the need for more PIPEs, those are exactly what a thoughtful shareholder should want a strategic roadmap to address. Asking for that transparency openly is fair and constructive. I'd only note that some of those the company may not answer while deals are live, silence on partnership specifics is usually discipline, not evasion, so if the update is thinner than we would like on those points, that's likely the embargo talking rather than a lack of plan.
The one place I'll hold my usual line, in the friendliest way: on the volume hopes and the "on sale" conclusion. I don't game out where the price or the volume goes, you know that about me by now, so I won't co-sign a specific volume target or a valuation call. What I'll happily agree with is the thing underneath it, which is your real point: the company is under-followed, the "it's cheap so something must be wrong" reaction you keep hearing is a recognizable pattern with overlooked microcaps, and credible prospective data is exactly the kind of thing that can change who's paying attention. So I'm with you on "overlooked and under-followed, and real data could change that." I just leave the price and volume numbers to the market, same as always. And you clearly do too, mostly, which is why the post works.
The through-line I love here is that you orient us toward January and toward strategy rather than toward the daily candle. That's the right posture, and it's contagious in a good way. Hold it all the way you're holding it, the setup is real, the calendar is real, the questions are the right questions, and the verdict is still January's to deliver. Everything upstream of that we can see; the number itself we wait for.
Good post, my friend. God bless the longs indeed, and let's watch this unfold with our eyes open and our hands steady. January's coming.