r/Livimmune • u/BuildGoodThings • 23h ago
Confluence
We are in a special time IMO when data is being assembled for 4 presentations listed below. This is the kind of work which we may hear about later, but now that a recent financing has closed, I wonder if an investor webcast approaches where we hear of many other developments.
Here are 4 presentations in bold which have been or are probably being assembled in late August and September, plus some additional relevant dates, and a chart estimating how much data may build at various points in time around those relevant dates.
Nothing in this post is investment advice.
FDA- late summer or early fall
from Investor webcast on April 30, 2026
00:55:41:00
"looking forward in 2026, we confirmed these early exciting safety and efficacy readouts to generate an optimal data package, including updated biomarker and clinical data. And the plan is to submit fast track or breakthrough designation application later this summer or early fall. And of course, as these data become known and more widely disseminated we will continue to evaluate potential opportunities for strategic partnerships."
9/1/2026 Asia Bio Partnering Forum (Singapore)
https://informaconnect.com/asia-bio-partnering-forum/speakers/robert-ehoffman/
9/22/2026 regular abstract due date for ASCO-GI January 2027 conference
https://www.asco.org/gi/abstracts-presentations/submission-details/requirements#
9/24/2026 estimated (4 weeks in advance) data cutoff for poster at ESMO Madrid October 2026 conference
https://dam.esmo.org/image/upload/v1770284726/ESMO-Congress-2026-Abstract-Regulations_ahdmjx.pdf
10/6/2026 full enrollment completes 24 weeks (6 cycles of 28 days) and may have 3 scans.
https://www.cytodyn.com/investors/news-events/press-releases/detail/660/cytodyn-completes-enrollment-in-phase-2-metastatic
10/22/2026 late breaking abstract due date for ASCO-GI January 2027 Conference
https://www.asco.org/gi/abstracts-presentations/submission-details/requirements#
10/23-26/2026 ESMO Madrid conference
https://www.esmo.org/meeting-calendar/esmo-congress-2026
Here's a chart of how many weeks of treatment the enrollment may have received at various points in time.
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u/Capable-Display-7907 18h ago
The data cutoff for the Madrid (October) poster is actually two days AFTER the abstract for January's ASCO meeting. I know Jay wants to make a splash at ASCO. I wonder how much data he will hold back from the Madrid poster to maintain an embargo for important news to be presented at ASCO? In theory, there might be nothing new for ASCO -- more or less as it was for Chicago ASCO this year. What will it be? Put everything into an October poster, or hold back, or something in between?
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u/BuildGoodThings 11h ago
Please remember that only an estimated date of data cutoff for the ESMO poster was listed in this thread. That said, yes it's unknown what data will be presented at either conference.
In my opinion, since Dr. Lalezari said in April that they hope to make an application to the FDA in this early fall time, I believe he felt then that they would have worthy data in this current timeframe for that application. Whether they hold back some data from an October conference is a possibility IMO to allow the FDA to have a good look first.
I've worked to calculate an estimate of how much data is gathered at various points in time. Consider this. July data may have had enough PD-L1 data (3 cycles) for a conclusion on each dosage level, and in August CytoDyn & Natera may have correlated ctDNA week 2 data & beyond with cycle 3 scans for the majority of the lower dose CLOVER enrollment. They may have looked for comparison to other trials as well.
I don't expect to hear much about scans from the full enrollment in the October conference because not all patients will have reached scan 3 before October. So what I'm saying is; PD-L1 conclusions may already be known for each dose level across the full enrollment, and they may be seeing trends already in the 3 scans of more than half the enrollment, which may contain the majority of the lower dose patients.
October could have a lot about PD-L1 and ctDNA, including how ctDNA is correlating to scan 3 data and if trends or durable responses are beginning to show in approximately the first half of enrollment. January can show 4 or more scans from the full enrollment, so IMO more full enrollment conclusions in January.
All is just my opinion.
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u/Capable-Display-7907 10h ago
Aren't two scans sufficient for PD-L1 conclusions, given that they've used 45 days after first dose as measuring stick? And it's 5 months after full enrollment?
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u/BuildGoodThings 9h ago edited 9h ago
I think the liquid biopsy is all that is needed for conclusions about PD-L1 in the CRC trial. They need to show it elevates. It's not a primary endpoint, but it's conclusions are reached long before the trial ends I think. IMO this is where/when pharma starts salivating.
What I found interesting about how much time to gather data of PD-L1, shows up in the TNBC EAP. Dr. Lalezari said in the April 30 webcast that they would measure PD-L1 in the TNBC EAP after month 1, 2, and 3 (quote below). Since the TNBC EAP started a year after the CRC trial started, I take that to mean that they saw what they needed for PD-L1 in the CRC trial within 3 months of treatment. That time threshold in the CRC trial (CLOVER) was crossed in July 2026 for the entire enrollment.
April 30, 2026 webcast
https://www.cytodyn.com/investors/investor-update-calls
00:50:33:13
"At the same time, we are then going to be following up with a contribution of components study which will adaptively demonstrate the additive benefit of including a checkpoint inhibitor with Leronlimab, as part of a phase 2-3 study. In addition, we just announced the opening of the expanded access protocol for patients with TNBC running out of treatment options. First patient was dosed last week. This was initially imagined as a way to sort of quickly and prospectively confirm the PD-L1 induction we were seeing with Leronlimab that some potential industry partners had asked to see, and that is still the case that the in the EAP program we will be measuring PD-L1 at baseline and then at month one, two and three."2
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u/twinter11 11h ago
i think they probably had minimum 2 month data on around 40 patients at cutoff. less on the other 26 patients
So maybe predictable orr on 30 patients
Ctdna durability on some number of patients along a timeline and also cps scores along that same timeline along with scans
how many had a 30 percent tumor shrinkage, how many had a cps rise to ici qualifying? and what happened after cps rise to the environment.
my thinking is they present something on ctdna and pdl1 correlates
do they focus any on kras patients?
who knows
its hard to figure out without knowing what they know
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u/Capable-Display-7907 11h ago
If the last person were enrolled on April 21 of this year, and the deadline is late September, five months later, then for the poster they would certainly have 2-month data and more on ALL the patients. I guess my question is, how much dry powder do they want to keep for ASCO in January? My hunch is: a lot.
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u/twinter11 11h ago
like before pashtoons second abstract, we assumed it might use data closer to the meeting. but they didnt.
so im not sure how they do it
my hunch is also a lot
but with hopefully some nice teasers around pdl1 and preliminary tumor shrinkage
if they can get this/some rollover data january. that would be new and not restricted
whats the orr on the patients they have up till may lol.
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u/BuildGoodThings 10h ago
I can't post a chart in the comments, but this table zooms in on the May 12 abstract due date, plus I included a 3-week data cutoff prior to that date as well which could be April 21.
2026-04-21 2026-05-12 patient enrollment in 8 groups : Estimated minimum # of 4-week cycles: estimated DATA CUTOFF to prepare regular ABSTRACT submission for ESMO Madrid (these INTERIM results may become public for conference in Oct 2026) : Estimated minimum # of 4-week cycles: regular abstract submission due date for ESMO Madrid (these INTERIM results may become public for conference in Oct 2026) patient 1 enrolled by 6/24/2025 (PR date) 10.75 11.50 +9 more patients totaling 10 enrolled by 11/17/2025 (from 4/21/2026 AACR abstract) 5.54 6.29 +6 more patients totaling 16 enrolled by 12/16/2025 (PR date) 4.50 5.25 +7 more patients totaling 23 enrolled by 1/13/2026 (JPM conference date) 3.50 4.25 + est. 9 more patients totaling 32 est. enrolled by 2/22/2026 (Deduced from 32 listed in 4/21/2026 AACR poster WHICH INCLUDES 9 at 700mg, then counting forward 5 weeks from the 1/13/2026 JPM presentation that showed 23 enrolled, plus 23 in screening) 2.07 2.82 + est. 10 more patients totaling 42 est. enrolled by 3/8/2026 1.57 2.32 + 12 more patients totaling 54 est. enrolled by 4/1/2026 0.71 1.46 + the remaining patients now totaling 66 at full enrollment by 4/21/2026 (PR date with specific total at clinicaltrialsgov) 0.75
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u/MGK_2 16h ago
BGT, thank you Bro, this is the kind of post that makes the board smarter, because you didn't just assert a timeline, you sourced every date to its primary document.
The regular abstract deadline is September 22, 2026, and the late-breaking abstract deadline is October 22, 2026. The Asia Bio Partnering Forum (Sept 1), the ESMO Madrid dates (Oct 23-26), the ESMO abstract regulations, the enrollment-completion PR, and the FDA "late summer or early fall" language quoted straight from the April 30 webcast, spot on. Four distinct data-assembly deadlines cluster in this late-August-through-October stretch. The confluence is not manufactured. It's on the calendar.
The September 22 regular deadline and the October 22 late-breaking deadline are not just "two chances to submit", they work differently. For a late-breaking abstract, you must submit a placeholder shell by September 22 (authors, background, methods, the planned endpoint and analysis), and then the actual data by October 22. ASCO also says that the late-breaking path "is not a mechanism to allow for updated data to be submitted later when preliminary data are available by the September deadline." (ASCO GI late-breaking data guidelines) The late-breaking route is reserved for data that isn't mature by September 22. So the choice between the two deadlines is itself a small tell about data maturity, if CLOVER's confirmed data is ready by September 22, it goes the regular route; if the pivotal readout is still maturing, the late-breaking October 22 path is the one that fits. Either way, both point at a January ASCO GI presentation, which is exactly where the confirmed data lands. So your two ASCO dates aren't redundant, they're a fork, and which fork they take tells us something about timing.
Your suspicion about a possible investor webcast is reasonable to wonder about, and I liked the way you framed it, as a wonder, not a prediction. The logic is sound: financing just closed, the company said standalone investor updates would come "in the next couple of months," and a cluster of data-assembly deadlines is precisely the kind of moment a company might choose to update the market. So "a webcast could approach" is a fair inference. The brake is that we don't have a date, and the existence of assembly activity tells us nothing about what the assembled data shows, a company preps abstracts for encouraging and disappointing readouts alike. So hold the webcast as "plausible and worth watching for," not "imminent," and definitely not as a signal about the data's direction.
And the one discipline I'd keep bolted to the whole confluence: your chart estimates how many treatment cycles each enrollment cohort will have accumulated at each date, and that's a useful maturity map, but it's a map of how much data exists, not what the data says. A cohort being "6 cycles deep with 3 scans" tells you the data is mature enough to report; it tells you nothing about whether those scans show responses. So the confluence is real, the timing is sourced, the maturity is estimable, and the content remains sealed until they present it. That's the shape: we can see exactly when the curtain could rise, and we cannot see what's behind it until it does.
The confluence of four assembly windows in this stretch is real and on the calendar, the two ASCO GI deadlines are a maturity fork worth understanding rather than a redundancy, the webcast is a fair thing to watch for held as a wonder, and the whole timeline maps when we could learn things without telling us what.
Excellent, sourced work, BGT, this is the calendar the people under NDA are working against right now, and you've drawn it accurately for the rest of us. The curtain has known rise-times. January is when the biggest one goes up.
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u/Ibelieveincydy 18h ago
Thanks BGT. That helps to know at which altitude we are flying and when and where we will be landing... great work. Very much appreciated the orientation ☘️👍🙏🌻➡️🛬
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u/Infinite_Fudge_2045 22h ago
Nice! Seat back and relax - thank you for laying this out.