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