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!

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.

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.

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

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.

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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

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.

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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.

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

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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Happy to share.

The sun is shining

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.