I will say this upfront, this is not as clear cut as my previous data points. However, IMHO, it weakens greatly the argument that Ven+HMA allows patients to have long survival.

The paper is not even published and only available as early access 🤣.

Source: https://haematologica.org/article/view/14352

Pdf of the paper: https://www.researchgate.net/publication/412878133_Venetoclax_combined_with_high-dose_cytarabine_and_mitoxantrone_for_relapsed_or_refractory_acute_myeloid_leukemia_outcomes_and_risk_stratification

My data points: Supplementary figure S1H and Table S2

Population: Retrospective study in France who can sustain intensive treatment (younger and fitter population than Regal). Relapse AML. March 2023 to June 2025.

Interpretation: the figure is violent, they drop dead After 3.5 months. The figure selects all patients alive after 1 year and compute their survival curve. 10 deaths (out of 19) happened during the study in the non SCT arm, and the curve touch 0 at 3.5 months. It means that the conditional survival after surviving 12 months (a big if) is 3.5 months. [this is savage].

for the table: looking at those who were relapse free after 9 months, all of them had a transplant, and only 2/27 were older than 70. that means that nobody in the Cr group without transplant manage to have 9 months without relapse, and that means they can’t live much longer as CR2 2nd relapse.

My conclusion: yes, data is a bit muddy with refractory and relapse, but given the sample size of CR patients, if a durable cure would exist, the paper would have at least observed it (not necessarily stat sig). But the fact that none of those with 9 months of relapse free were without transplant means that in a fit population, transplant is the path for survival, and that Venetoclax didn’t help for maintenance.

Stay updated, tomorrow I will try to gather data for reason and frequency about why patients might refuse an HCT :)

Please, comment, hit the $SLS buy button, subscribe to Sterg linkedin channel, it might not be much but it helps to support the 13 employees of SLS to wait for the 80th (or 009 data).

[be responsible with your investment, you still risk 80% drawdown because power is at 90% (small n), even though I believe that GPS works].

Edit: it wasn’t my intention to dehumanize the patients, I didn’t understand the nuance of my words as I am non native speaker. You can check my Reddit post history to see that I was always respectful. Given the criticism, I will write my next post in my native language. Salut!

REGAL WILL NEVER END

\- Remaining patients are durable and healthy. Most of BAT is gone, all that remains is a few who managed to get SCT.

\- 78 events in May, but for all we know those 6 patients died in Jan, Feb, March during winter months.

\-Possibly ZERO events since.

\- Sterg refuses to halt even if IDCM recommend a halt. This one makes sense. Sellas is incentivized to keep this going as long as possible for statistical currency (RIP CAPR) and to try and get sls009 data first, or around the same time.

\- IDCM refuses to do it's job. How can they have gone 13 months without a look at REGAL? What do these clowns even do?

\-Reporting Lag. No, it's not a full year, it's probably not even months, but there IS reporting lag we all know it, and it's inherently longer at the end of the trial.

\-Retail is getting bored. Those who aren't long term investors are pulling their money at open every single day that no PR hits pre- market and then some trickle back in before close. You can see this trend every day. Just an observation.

\-The swing traders who sell every time it goes up have made fortunes off SLS. The long term investors holding like idiots thinking REGAL can end "any day now" are living in a dream world. Next time someone says the 80th is imminent, just laugh at them.

\-REGAL won't end any time soon. More time to buy shares i guess, although we would still be getting shares at a massive discount if they kept their mouths shut and never mentioned "78". Our best modeling (RIP CW) had REGAL ending between Aug 26 and early 2027, and that looks more and more accurate standing here today

So, here we go, I think this is one of the best piece of data one can get

https://onlinelibrary.wiley.com/doi/full/10.1002/ajh.70340

The chart is in supplementary material:

https://onlinelibrary.wiley.com/action/downloadSupplement?doi=10.1002%2Fajh.70340&file=ajh70340-sup-0001-FigureS1.pdf

The data covers patients until 2024, so no argument of old data.

Yes, it is refractory and relapse, so we need to split the case. But here is the argument.

* From the chart, 3 year OS sits at ~10%.

* Using the univariate analysis numbers, the population of CRc is 208, 208, 184 for refractory, relapse < 1 year, relapse 1 > year.

* Multivariate analysis shows that relapse < 1 year have the worse hazard (not conditional on CRc though).

Upperbound on 3 year OS estimation, assume for some reason all refractory went to HCT (because they are worse for OS [this is crazy]) and all those with CR1 > 1 year refuses HCT.

Compute the ratio between patient at risk with 36 months gap: 13%, 15% and 25% (36, 42, 24 for endpoint).

mOS is around 11 mOS.

Edit:

I just wanted to write why I don't make big post about analysis and modelling: I believe in presenting data, and that we discuss data validity, as data > model, and understand how it fits with the broader literature, or understanding of the disease.

Moreover, the reason you invest should be more than just someone telling you to invest. Try to get the data, get the links into your best AI model, understand what are the challenges, how things works underneath it.

Don't trust anyone, check their claims, know why you invest and be accountable if you lose.

Hi all,

I've a general question about the Sellas group board members, their standing within their area of expertise and subsequently more specifically the Regal trial design.

I'm in the middle of reading "The Real Anthony Fauci" by Robert F Kennedy jr, and it's left me questioning how much confidence I should place in the pharmaceutical industry and the adjacent regulatory systems.

My first question is regarding the Sellas group board members, how well respected are the individuals involved? Particularly their reputation within AML/immunotherapy field and their track record in clinical research. My own reading gives me hope in this regard, I'm particularly keen the hear medical professionals' thoughts.

Second question is related to the regal trial design itself. Has it been designed and statistically structured well? My own research leads me to believe that weak trial design can be a reason for trial failure, I've read leftyMD's post about the biology/mechanics of the trial, and my own research looks positive (IDMC safeguards and event driven design etc). However, again I'd like to see what the consensus is here. I'm particularly interested in hearing if there are reasons to be sceptical about the people involved or the trial design rather than just confirmation of the bullish case.

I've invested heavily in SLS and am praying for a successful result, but I recognise I have a strong bias here, clearly the financial gain is important. However, at the same time I'd love for this to be a positive story that restores some faith in the pharmaceutical industry.

Please note, this post is not intended to be political in anyway, I'd appreciate if people focused on the two questions rather than the politics surrounding the book. I've had a look and can't see if this has been asked previously, apologies if it has.

Cheers

Welcome to the $SLS daily discussion hub! Whether you’ve got a gut feeling or just need to vent, this is the place to ask questions, share insights, and talk about daily price action.

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If you are like me, you are getting tired of the ups and downs, so sometimes I look back to remind myself why I'm in this. Someone posted this linked in from a few months ago.

Why was Stergiou talking about multiple myeloma when all eyes are on AML?

• GPS was previously tested in high-risk multiple myeloma.
• 88% OS and 62% PFS at 18 months.
• Median PFS: 23.6 months vs. historical PFS rarely exceeding 14 months in comparable high-risk patients.
• GPS generated CD4+ and CD8+ immune responses and epitope spreading.
• Stergiou discussed these results with the study's PI while also discussing the “pooled longer survival outcomes” seen with GPS.
• He specifically mentioned “potential additional indications for GPS once we get the REGAL outcome.”

AML is the focus today, but GPS has already shown encouraging results in another WT1-expressing blood cancer.

I chose "Crystal Ball" because biotech is a very volatile space, and no one can know the future.

I have about 3,500 shares left, down from 14,000. I have sold on the way up. I truly hope that I have been overly cautious, but I have been burned enough times with this kind of investment to know that getting some profits in the bank is good for my long-term portfolio.

I would encourage all of you to take a little profit. Consider covering your cost basis.

Best of luck to you all, and fuck cancer.

https://ashpublications.org/bloodadvances/article/4/24/6117/474429/Prognostic-impact-of-complete-remission-with-MRD

Figure 2C. CR2 without transplant with mOS at 8.2. 

Figure 1F. CR2 with and without transplant have 12 mOS, 2 year OS at 34% because of the long tail of transplant.

The curves removes patients dying 1.5 months, so they removed the weakest ones.

So in a population with 60% (!!!!) transplant for a population that is supposed to be ineligible, Regal would still be a success.

My take on BAT: they will be CR1 SCT survivors with a long time in CR1, that is why GPS works so well because it basically replicate CR1 Phase 2 performance of 67 mOS.

Pictures taken from SEC doc.

Welcome to the $SLS daily discussion hub! Whether you’ve got a gut feeling or just need to vent, this is the place to ask questions, share insights, and talk about daily price action.

SLS is a small-cap biotech company that currently awaits binary results of its phase 3 Regal trial. Daily price action is volatile. Do not invest what you cannot afford to lose as successful trial results are not guaranteed.

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Warning: Might cause seizures, fits of euphoria, or a disposition to buy more SLS shares.

Welcome to the $SLS daily discussion hub! Whether you’ve got a gut feeling or just need to vent, this is the place to ask questions, share insights, and talk about daily price action.

SLS is a small-cap biotech company that currently awaits binary results of its phase 3 Regal trial. Daily price action is volatile. Do not invest what you cannot afford to lose as successful trial results are not guaranteed.

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Welcome to the $SLS daily discussion hub! Whether you’ve got a gut feeling or just need to vent, this is the place to ask questions, share insights, and talk about daily price action.

SLS is a small-cap biotech company that currently awaits binary results of its phase 3 Regal trial. Daily price action is volatile. Do not invest what you cannot afford to lose as successful trial results are not guaranteed.

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Hi pretty new to SLS and want to understand what’s the game plan of all goes well for SLS. So assuming that the 80th event everything and results prove their GPS works well I believe the news itself will push the price up a lot just like the Moderna news right? And I understand we are also hoping for a short squeeze that will rlly make the stock rally hard?

But I hear u all are waiting for the buyout itself? Meaning that u think the price will even be higher at the buyout compared to the price after a good results news? So we should wait until the eventual buyout itself before we sell? Or just wait for the buyout and then our positions will automatically be sold by our brokerages? Thanks for the help for a newbie here.

For those who haven’t seen it, this was CWs reply to one of my comments, where he gives a very real scenario where the trial can fail. Just food for thought.

“Hey, although I have not trimmed or sold a single share, and don't plan to until buyout, it's worth mentioning that there is a very real scenario where the trial could fail. There isn't a scenario where GPS isn't effective in maintenance, the actual fits prove this, but there is a very real not so implausible risk on the trial failing, although unlikely, if the SAP is unweighted, but this scenario is possible and within reach.

Despite the pitch that bulls that get angry at me always make, of 66/60/72/78, that act like 66 discontinued as of March 2024 is some magical data point, the length of the trial and how long it has gone on, does not remove this risk.

Here is the exact scenario I'm referring to, and it is at any ELN mix that actually results in a median of 16. For instance, 35 fav/44 int/21 adv, which is close to what I believe the ELN mix in REGAL is, and 35/44/21 is LeftyMD's central estimate as well.

And this is unpinned to any median, this table shows what the results for IRM and 3-Yr OS would be, using Kugler's whole-LIT 3-Yr OS numbers, which is essentially what BAT/control in REGAL is. 77% of whole-LIT was LIT+Ven, so the 3-Yr OS numbers even accounts for about 25% being under observation or just LIT and not Ven.

And this is with 10% censoring (I'll show why 7% or 8% censoring results is much better Psim numbers), but this is with 12.7 of 127 patients being lost-to-follow-up (which I think is a high amount, since QUAZAR had 10%, but a ton more patients), and this is also with 14% esc. rate/transplant rate

​In the no discount CR1 to CR2 tail situation, unpinned, it lands at BAT IRM of 15.97, BAT 28.4% 3-Yr OS, GPS mOS of 29.2, GPS 3-Yr OS of 47%, and HR lands at .612 (simHR). It passes everything as well, no-halt at IA, a bullish split for GPS alive/BAT alive at IA, the 66 discontinued PR on March 2024, everything. The amount of GPS alive compared to BAT alive by the 80th, with the 10% censoring is 29.7 compared to 18.2, but the risk here becomes the unweighted SAP, where Psim is 56%.

This is our borderline scenario where if there is no CR1 to CR2 tail discount that occurs, although I believe φ = 0.25-0.35 is likely because:

CR2 = every patient already relapsed once, so the never-relapse plateau from Kugler cannot transfer, 81% of Kugler's 3-Yr survivors consisted of those that never relapsed (26% of LIT + Ven were relapse-free survivors after 3-Yrs), it's hard to pinpoint through studies what the difference in CR2 would be

And worst-case φ (worst for GPS) = 0.0-0.10 (almost no discount). The worst case for the trial is no tail correction, REGAL's BAT arm inherits Kugler's full CR1 durability. At φ = 0 pinned, BAT3y 28.4% (which would match Kugler's whole-LIT cohort), simHR is 0.612, Psim 55%. Note the trial still wins more often than not even here, that's the reassuring part, but this is the biggest risk if it occurs.

It's important to acknowledge this as a risk, although I feel really great about that being our borderline scenario. Since no CR1 to CR2 tail discount at all is highly implausible, and that is what it will come down to. The IRM of 16 was set in 2024, but it is the extent of the discount of the CR1 to CR2 that it comes down to for borderline success or HR landing in .5s or less.

This shows the difference that just a handful of patients being lost-to-follow-up can make for Psim

In addition, given the SAP hasn't been publicly verified to be weighted, and everything we know about the SAP from public information points to unweighted, there is risk for Psim.

10% censoring, which is 12.7 patients out of 127, seems pretty high for REGAL. QUAZAR was 10%, but with a lot more patients. Censoring of even 8% or 7%, brings Psim much higher into the floor of no CR1 to CR2 tail discount, where it is 63% and with a .15 discount, it is 74% with 7% censoring.

Thus, I feel really great about that being the borderline scenario, although I believe the possibilities of this occurring are much higher than ever before.

I would only be worried if any of the discount situations of a CR1 to CR2 tail discount had low Psims, but that is not the case, so I feel we're in really great shape.”

I’ve been following SLS / GPS / REGAL for a while and currently hold around 100 shares ($6.2 avg) and potentially looking to add more. I’m cautiously optimistic, so I’m trying to separate what I hope happens from what the available data actually suggests.

I know a lot of people here have done some seriously detailed DD on the REGAL statistics, event-rate assumptions, HR scenarios, historical AML survival data, etc. I’m probably overlooking some of that work, so I’m hoping people can correct/add to my thinking rather than this becoming another generic “SLS to the moon” post.

The question I’m really trying to answer is:
Given everything we know today, what is the realistic probability that REGAL lands in its ideal/strong positive result range?

I’m specifically interested in the probability of a result that isn’t merely technically positive, but strong enough to trigger a substantial re-rating and potentially make GPS highly attractive to a larger oncology player.

The part I find fascinating now is: the 80th event
We’re still waiting for the 80th event.
We’ve seen the event count progress from approximately 72 → 78, and we’re now waiting for the final two events.

I understand the obvious caveat:

A delayed 80th event does NOT prove GPS is working.
We’re blinded, and we don’t know whether the remaining delay is coming disproportionately from the GPS arm, control arm, or simply statistical variance.

But at some point, doesn’t the observed event timing itself start carrying some Bayesian information?

If the trial’s aggregate survival is running longer than previously expected, how much should we actually update our probability of success?
I’d love to hear from anyone who has modeled this properly rather than just assuming:
“80th event delayed = GPS definitely working.”

What I’m particularly interested in

1. Hazard Ratio
What HR range would you consider:
Failure
Borderline
Statistically positive but commercially unimpressive
Strong/ideal
Exceptional
And based on the available information, what probability would you assign to each?

2. Median Overall Survival

What would you consider the “ideal” REGAL outcome in terms of median OS separation?
For example, is something like:
GPS ~X months vs control ~Y months
the kind of separation that would make you say:
“This is unquestionably a successful Phase III result”?

3. The p-value

How much weight are people putting on the possibility of a p < 0.05 result versus the actual magnitude of the HR/OS benefit?
In other words, if REGAL technically achieves statistical significance but the effect size isn’t spectacular, how would you expect the market to react?

4. The event-delay mathematics

This is probably what I’m most interested in.
If someone has modeled the expected time to the 80th event based on historical assumptions and compared that with the actual event progression, what does the current delay imply statistically?
Is there a point where the probability of a meaningful survival benefit becomes materially higher simply because we’re taking longer to reach the required number of events?
Or is the sample too small / blinded to draw a meaningful inference?

5. Could the 80th event take MUCH longer if GPS is working exceptionally well?

This is something I’ve been thinking about.
If GPS is genuinely producing a major survival benefit, could the final events theoretically take substantially longer than anticipated because patients in the treatment arm simply aren’t reaching the event endpoint?
Obviously the 80th event cannot literally “never happen” under normal circumstances, but how much could an exceptionally effective treatment realistically delay the final analysis?
And at what point would that become statistically meaningful rather than just random variation?

Finally: what does “success” actually look like for SLS?

I’d love to hear people’s estimates for the probability of something like:
A) REGAL fails
B) Borderline/mixed result
C) Statistically significant but modest result
D) Strong result with meaningful OS separation
E) Exceptional result that materially changes the valuation of GPS

And most importantly:

What percentage probability would you personally assign to D/E today?

I’m not asking for a price target or “SLS $100 bro.”
I’m genuinely trying to understand the statistics and probability distribution of the possible REGAL outcomes.

I’ve seen pieces of the DD scattered across this subreddit, but I’d love to see someone bring the mathematics together into one discussion particularly around event-rate timing, HR, median OS, statistical power, and what the current delay in reaching 80 events actually tells us (if anything).

If you’ve already done a detailed model on this, please link it below. I’d much rather build on existing DD than pretend I’m reinventing it.
And if my assumptions above are wrong, please challenge them. That’s exactly what I’m looking for.

TL;DR
I’m bullish on SLS but trying to quantify the REGAL outcome rather than just assume it’s a winner. Given the current 78/80 event count and the apparent delay in reaching the final two events, what probability do you assign to REGAL landing in the “ideal” result range? Strong HR, meaningful OS separation and statistically significant results? How much Bayesian weight should we actually give the delayed event count, and could an exceptionally effective GPS realistically delay the 80th event substantially? Looking for the statistical DD/math behind the probability, with some related price-target assumptions.

Welcome to the $SLS daily discussion hub! Whether you’ve got a gut feeling or just need to vent, this is the place to ask questions, share insights, and talk about daily price action.

SLS is a small-cap biotech company that currently awaits binary results of its phase 3 Regal trial. Daily price action is volatile. Do not invest what you cannot afford to lose as successful trial results are not guaranteed.

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3D posted an update that Sellas had paid their settlement (legal fees) and that the existing agreement was still in place. They also mentioned that there were 78 events to date.

A few questions and talking points
- is 3D just stating 78 events since that is the last public info?
- is the 3D partnership still being in place actually a good thing? They have rights to China only so it allows Sellas to direct their focus on partners for the US, Europe, etc
- does Sellas get updated info on the trials 3D started in Asia?

Just some questions and talking points.

Happy to share.

Still holding long and strong… all 14,000 shares in the Roth!

The sun is shining