r/sellaslifesciences

Moderna news for skin cancer vaccine. SLS is next.

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https://haematologica.org/article/view/11956

Figure 1B. CR2 non transplant survival curve with Ven+HMA. 9 months mOS, 1 year survival at 31%.

Jackpot everyone :)

The low risk group is composed of at least 31 CR2 patients (probably 33) because only 5 patients had TP53 mutation.

There was 36 CR/CRi patients, so in order for a CR patients to shift from low risk to intermediate risk, they would need both mutation conditions, which is possible only for 5 patients (piegonhole argument in mathematics).

Also the ELN mix is 70/30 (fav+int/adv).

Median time to response was 1 month.
It is not a perfect 1 to 1 with REGAL, but the filtering criteria for the population is correct: only consider CR2 with and without transplant.

I believe this is an extremely bullish datapoint.

Edit:

I wonder if someone could clear this: I don’t think line of treatment number is equal to CR number. You can have more than 2 line of treatments to reach CR2.

Brayer et al.

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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What’s your strategy if REGAL goes well? Are you planning on selling everything or take some profits and keep part of the position? Isn’t there a risk that everyone starts selling at the first big peak and the stock then drops hard? Wouldyou guys wait for a potential BO instead?

And then there is SLS009. If REGAL goes well and Sellas eventually gets bought out, how do you think about that if SLS009 is still developing and could potentially become a huge asset further down the line? Wouldn’t a BO potentially mean giving up the future upside from SLS009?

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 Weekly In Depth Discussion Thread.

This thread is for serious, substantive discussion about SELLAS Life Sciences.

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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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Hey,

I'm brand new to biotech investing, I'm a Civil Engineer by trade, so the terms and concepts are alien to me, however I've really enjoyed trying to get to grips with the excellent models and reasoning being posted/argued here.

I've a general question about biotech investing, Is this situation common whereby publicly available information (enrollment start date, milestone/event dates etc) allow such detailed and confident assessments to be made, or are we dealing with a rare situation?

For example, is it common for the event trajectories to be made public so investors can make these types of strong inferences about potential outcomes before the trial ends?

Here's hoping for a successful trial for all involved 🤞🙏

I have close to 1000 shares meant for swing trading, apart from the 1.6K shares long (2.6K is very much above my risk threshold).

This got me wondering what I can expect the pop to look like on the announcement of the 80th event.

Claude gave me this answer, of a similar Therapeutic company,

Celator Pharmaceuticals (CPXX) — CPX-351 (Vyxeos) Phase 3 trial in high-risk AML

which ended up eventually getting bought out .

I am simply copy pasting what I found, I have not done any background deep dive research into this.

The Analogy: Small-cap, oncology, OS-driven, strong Phase 2 data beforehand, and a public "we hit the event threshold" announcement that's cleanly separable from the topline reveal weeks later.

Setup: previously reported Phase II data had already shown a survival benefit with CPX-351 versus standard chemotherapy in patients with secondary AML, so — like SLS — this was a small biotech riding real, positive earlier-phase efficacy signal into a single binary Phase 3 survival trial.

Design: it's structurally identical to REGAL — a randomized, controlled Phase 3 study comparing CPX-351 to standard 7+3 chemotherapy as first-line therapy in high-risk AML, with overall survival as the primary endpoint, requiring a pre-specified number of deaths before analysis could run.

The trigger announcement: On February 16, 2016, Celator announced its Phase 3 trial had reached its pre-specified number of events required for the overall survival analysis, and that it expected to announce the OS results later that quarter — this is the exact "80th event" moment you're asking about. No data was unblinded yet; it was purely "we've hit the number, now the clock starts."

Stock reaction to that trigger (not the data): It was large. Shares jumped more than 30% on the news that Celator had reached the number of events required for analysis, trading around $1.80 in the days after. That's a dramatically bigger move than Esperion's ~6% — likely because Celator was a tiny, single-asset, pre-commercial company where this trial was effectively the entire investment thesis (much closer to SLS's situation than Esperion, which had two approved drugs cushioning the stock).

My own search: The stock was trading at $1.42 on Feb 5, 2016 and then dipped to $1.2 on Feb 11 2016. From there on, it peaked back up to $1.41 at the close of Feb 16, 2016. Then, the price mooned and shot up to a peak of $2.52 and closed at $2.37 on Feb 22, 2016. So, we can see a gain of approx 67% when comparing the price at closing of days Feb 11 & Feb 22, 2016.
The link for the price chart: https://www.investing.com/equities/celator-pharm-chart

The quiet period: ran almost exactly the length SLS has guided to. The trigger was announced Feb 16; the positive topline survival results were announced the night of Monday, March 14, 2016 — call it about 4 weeks, right in your 1–4 week range.

What happened next: the actual data was strongly positive — CPX-351 reduced the risk of death by 31% versus 7+3, with a statistically significant 3.6-month median OS improvement — and the stock kept running from there; Celator shares were up roughly 1,610% for the year by late June 2016, as Jazz Pharmaceuticals moved to acquire the company shortly after.

If there are any factual inaccuracies, or false equivalences or claims made, please feel free to dispute or argue. I am not a well-versed investor and this is just AI work, just to get an idea of what to expect for the 80th event announcement and thought I'd share here.

TLDR: I have swing shares of 1K and wanted to know by how much I can expect the stock price to increase when 80th event is announced. On a similar clinical trial that happened in 2016, when they announced the event trigger, the stock price increased nearly 67%.

So, I have seen almost nobody bring this up in discussion. I only saw it myself because CW brought it up on over on stocktwits, and even then it wasn't a post but rather, it was buried in a response to someone else's question.

I'm paraphrasing here but the general idea is that while SELLAS is informed within 24 hours of an event, the sites gathering those events are severely lagged. This is due to the protocol for how patients will be checked up on during the trial. GPS patients are checked as they receive their treatment (every 3 months), but BAT arm patients who (i think) are over 1 year into the trial are only checked in on once per year, so annually.

It may very well be that we are beyond 80 events and simply waiting for that annual (or 3 month) check in, which is likely a rolling calendar.

If BAT patient died in August, but they were checked in July, that means waiting 11 months to find out.

Now clearly they didn't expect the trial to go this long, but this seems like a huge problem with the protocol.

Not to mention, if GPS is working as intended, then we may have a strong set of cured patients who won't die any time soon. Therefore, the checking in more frequently will be of little use to ending the trial.

If only 5-8 BAT remain, we are not just waiting for two of them to die, but perhaps waiting 6 months or 8 months or 11 months just to find out after the fact.

Being only 3 months removed from the 78th event we are left with a durable group of patients (from both arms) and a protocol that will blind SELLAS from that event for anywhere from 3-11 months.

SELLAS refusal (seemingly) to end the trial and risk losing an ounce of statistical currency has put us in this position. And like, I kinda get it. They know 009 data is scheduled for Q4 and I'm sure internally they would like both shoes to drop at the same time.

Pragmatically speaking, this has me extremely worried about my 2027 LEAPS , which I thought after the 78th in May was a conservative investment. I have since watched their value erode and are now faced with the possibility of the 80th not even being announced by January (insane, I know). But that's the protocol and it's awful. And nobody is talking about it.

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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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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Hey everyone, pretty excited to share this as I feel like I had a lightbulb moment and now have a great sense of clarity on relationship between IRM/median OS, esc. rate, ELN mix, for what BAT 3-Yr OS has to land at (meaning required to without any other option) if IRM was XYZ, i.e. for instance, 16, meaning there is a joint relationship. This was a real light-bulb moment for me when I was reconciling 3-Yr OS numbers from Kugler's KM curves through pixel tracing.

If transplant rate in REGAL is 10% to 18%, and IRM is 16 for instance, then at that combo, BAT 3-Yr OS has to be 26.8% to 27%, there isn't another way around that (for context in Kugler, LIT+Ven 3-Yr OS was 32.5% and whole-LIT was 29.5%). I'll go over this in detail.

First if IRM is truly fixed at at a certain amount, for instance, 16 months, and the component shapes come from Kugler (median OS by ELN mix, 3-Yr OS by fav/int/adv, etc.), the mixture math mechanically forces 3-year OS. The two are connected in order for the actual median to end up at the fixed amount, whatever IRM that is, in this example/instance, 16.

And what you'll find as I walk through this, is even after CR1 to CR2 discounting of 3-Yr OS form Kugler to land at 16, BAT 3-Yr OS essentially has to be 27% to land an IRM of 16 to work when modeling/ran to the actual fits, after transplant rates are taken into account.

First, to begin, Kugler provides the ELN 2024 mix for the whole LIT cohort: 48% favorable / 28% intermediate / 24% adverse (n = 123/71/63 = 257, from the Fig 3B at-risk table in Kugler)

Venetoclax penetration in LIT is 77% (198/257) (I feel this is great that it lands at 77%, since 25% of REGAL based on the EU protol may be observation, so it is a great comparator)

I used two methods to arrive at the 3-Yr OS for LIT+Ven in Kugler. Explained simply, first is by using the published medians for fav/int/adv, and second, through pixel tracing on the KM curves/figures.

First is my LIT+Ven bucket set (41.9 fav/31.2 int/17.2 adv), from derived medians 27.3/19.1/11.6, is entirely a construction, a 1.09x uplift I applied to the published whole-LIT ELN medians. That gives 32.9% 3-year OS at the natural ELN mix against the 32.5% I traced off Figure 2B. The ELN shape within LIT+Ven is unverifiable from this paper, but the whole-LIT ELN 3-Yr from the two approaches is very close (32.5% and 32.9%).

Now, for the ELN mix, REGAL opened in early 2021, with the protocol written in 2018-2020. ELN 2024 did not exist. ELN 2022 was the contemporary standard, and the protocol may even reference the older ELN 2017 or a pure cytogenetic-risk scheme. Either way, the trial is almost certainly not using ELN 2024 for stratification or reporting. So anchoring REGAL's mix to ELN 2024 labels doesn't work.

Why this is important is because under ELN 2022, 20 fav/50 int/30 adv essentially with a .877 of Kugler's 3-Yr OS numbers for fav/int/adv for LIT, lands at an IRM of 16. But that is ELN 2022. Under ELN 2024, the amount of favorable would be higher, and 38% fav/ 27% int/ 35% adv with a .846 discount also lands at an IRM of 16.

So, even though the ELN 2022 numbers and ELN 2024 numbers/mixes are different, these both arrive at an IRM of 16.

This just context for how ELN 2022 vs ELN 2024 mix changes land at the same IRM, in this case 16, after applying a CR1 to CR2 discount, which are required to actually land at 16.

There are no assumptions here for the discount, it's just the discounts it has to be on Kugler's 3-Yr OS numbers (for fav/int/adv) to arrive at a BAT IRM of 16.

So now with that understand of where Kugler's 3-Yr OS comes from and the relationship between ELN mix and BAT IRM, I wanted to go over visually why ELN mix and BAT IRM have a direct relationship with 3-Yr OS.

First is the published medians for fav/int/adv in Kugler, and this is from the published results and also from pixel tracing, so you can see how close they are.

Curve	Traced Median	Published	Delta
LIT+Ven	16.9	16.6	0.3
LIT no-Ven	12.8	12.5	0.3
LIT favorable	25.3	25.1	0.2
LIT intermediate	17.4	17.5	0.1
LIT adverse	10.7	10.6	0.1
IT+Ven	30.8	30.3	0.5
IT adverse	18.7	19	0.3
IT favorable	NR	NR	N/A since Not Reached

And then for Kugler's 3-Yr OS Numbers:

Cohort	n	3-Yr OS (traced)	At risk at 36 mo
Overall	362	35.4%	-
LIT + Ven	198	32.50%	34/198
Whole LIT	257	29.5%	-
LIT without Ven	59	18.50%	7/59
IT (all)	105	49-51%	-

And Kugler's 3-Yr OS Numbers by ELN 2024 within LIT (traced):

ELN 2024 (LIT)	n	Traced 3-yr OS
Favorable	123	43.60%
Intermediate	71	28.90%
Adverse	63	4.10%

Now, that the Kugler published and traced data is clear for LIT + Ven and Whole LIT medians and 3-Yr OS, now we can look at what ELN mixes actually build up to 16.

For context on the logic, the model never computes the mixture median. The ELN buildup produces exactly one number, the 3-Yr OS. The model then imposes median = 16 and back-solves the Weibull shape k so a single curve passes through both. Which is two constraints, one free parameter.

Bucket set	Implied component medians (fav/int/adv)	Mixture median @ 38/27/35	vs IRM 16	Mixture 3-Yr OS	Solved k
Kugler whole-LIT	25.0 / 17.5 / 10.6	16.5	0.5	26.30%	0.81
whole-LIT x 0.9	22.2 / 16.0 / 10.0	15.2	-0.8	23.70%	0.903
whole-LIT x 0.8	19.7 / 14.7 / 9.4	13.9	-2.1	21.00%	1
Kugler LIT+Ven	27.3 / 19.1 / 11.6	18.1	2.1	30.40%	0.668
LIT+Ven x 0.9	23.7 / 17.2 / 10.8	16.3	0.3	27.30%	0.773
LIT+Ven x 0.8838	23.2 / 16.9 / 10.6	16	0	26.80%	0.79
LIT+Ven x 0.8	20.7 / 15.4 / 10.0	14.7	-1.3	24.30%	0.88
Traced empirical curves	25.2 / 17.3 / 10.7	14.2	-1.8	25.80%	-

You can see Kugler whole-LIT undiscounted gives 16.5, and LIT+Ven x 0.9 gives 16.3. Both within rounding of 16. And what lands exactly at 16, is a Kugler LIT+Ven discount of .8838.

The exact-16 IRM buckets are 37.03% 3-Yr OS fav / 27.57% 3-Yr OS int / 15.20% 3-Yr OS adv.

And when I show the full view of the actual fits, you will see that when transplant rate is anywhere from 10% to 18% (and single digits to 13% is likely), 3-Yr OS at that specific ELN mix has to be 26.8% in order to land exactly at a BAT IRM of 16.

Meaning they are connected. If transplant rate in BAT/control in REGAL is 10% to 18%, then 3-Yr OS has to be 27%, in order to arrive at IRM of 16.

So, with that understanding, it was important to look what the actual fits show at the likely ELN mix (38 fav, 27 int, 35 adv) using Kugler's 3-Yr OS numbers, discounted from CR1 to CR2 not just cause, but as required for IRM to land at 16, which results in a 3-Yr OS of 26.8%/27%, and what the results would be, because if BAT IRM is 16 in REGAL, that is what the results would be if transplant rate was 10% to 18%, it would be at a 27% 3-Yr OS.

And as I was looking at these, it honestly was one of the most reasonable/rational fits that covers every single question/objection I've ever had (and most others have had)

And here is what they are:

Exact-16 IRM solutions, Kugler LIT+Ven discounted, mix 38% fav / 27% int / 35% adv, IRM 16, May-2023 enrollment (t=27.65), 80th = Aug-11-2026, fitted to 60/72/78/80

Escape survivors on base Weibull shape

esc	disc	buckets (fav/int/adv)	pre-esc med	post-esc med	fav	BAT2y	BAT3y	BAT4y	BAT5y	k	cureC	psi	HR@IA	HR@80	Pana	simHR	Psim	Psnh	GPSd@IA	BATd@IA	GPSa@IA	BATa@IA	GPSa@80	BATa@80	RESID	GPSmOS	GPS3y	GPS4y	GPS5y	uncRAW	uncMOS	BAT3yS	HR80S	PsimS	PsimSd	Pnostop	PnsCons	PsimIW
10%	x0.827	34.64 / 25.79 / 14.22	15.1	16	38%	39%	27%	20%	14%	0.78	0.37	1.11	0.556	0.483	82%	0.463	82%	80%	23.6	35.2	39.4	27.8	31.6	15.4	1.14	40	52%	47%	44%	11.2	14	23%	0.369	97%	62%	50%	77%	63
14%	x0.800	33.53 / 24.97 / 13.77	14.6	16	38%	39%	27%	20%	14%	0.78	0.36	1.09	0.556	0.486	82%	0.467	81%	80%	23.7	35.2	39.3	27.8	31.5	15.4	1.15	40	52%	47%	44%	11.4	14.4	23%	0.371	97%	62%	50%	77%	62
18%	x0.772	32.33 / 24.07 / 13.27	14.2	16	38%	39%	27%	20%	15%	0.77	0.35	1.06	0.557	0.49	81%	0.471	81%	79%	23.7	35.2	39.3	27.8	31.3	15.6	1.15	39	51%	47%	43%	11.5	14.8	23%	0.373	97%	61%	50%	77%	62

https://preview.redd.it/cmi0gupa02jh1.png?width=1893&format=png&auto=webp&s=db30bd30ea96cd1fe490dcfb7e66263454fe2bb6

You can see the pre-esc (pre-transplant) IRM and post-transplant IRM, and what is interesting is how the pre-esc median is a discount to Kugler's whole-LIT mOS of 16.6 (which we don't know if any of those patients transplanted or not). But the IRM numbers between both are similar.

In addition, you can see the exact discount needed for the 3-Yr Kugler whole-LIT OS numbers for fav/int/adv, to arrive at exactly a BAT IRM of 16. I've done a ton of research on literature, and with REGAL's criteria and randomization uplift, a discount of just .772 to .827 is not unreasonable, that is actually right in line with a floor .8 I came to a conclusion to after a ton of research, so that was helpful to see.

And then this fit is also just spot on with no halt at IA, where it was a coin-flip, and the GPS mOS numbers are what you would expect from continuous dosing. They aren't outrageously high, but an mOS of 39/40 is in line with what you would expect, and the reason I say that, and I'll touch on why this is so bullish in a moment, the enrollment criteria/randomization lift/ELN mix is very close to CR1, just a slight discount essentially (if IRM is indeed 16), so given the patient population is close to CR1 newly diagnosed, with about a .2 discount, having GPS achieve CR1 like mOS numbers with a discount is not unusual as well.

And the GPS dead at IA is also completely reasonable, 23/24 dead, with 35 BAT dead at IA, which makes sense as BAT mOS was set in 2024.

And the 3-Yr OS of 51% is right in line with the HLA decomposition thesis I shared earlier this year.

Link: Why I Now Believe Cure-Fraction is around 50%, and not 62%-68%, and Why That Now Makes It Likely the 80th will Occur by Q3 2026
https://www.reddit.com/r/sellaslifesciences/comments/1sz9eu5/why_i_now_believe_curefraction_is_around_50_and/

In that post, there is a helpful comment thread between Remarkable-Big and I where the conclusion was the likely cure-fraction/3-Yr OS rate in REGAL, for GPS is likely 45% to 50%.

When I shared my first ever Part 1 DD for REGAL, I had capped it at 50%, based on previous GPS studies, but capping it just cause is not right. Nothing about GPS should be an input, it should fall out of the model. And then when I shared my HLA decomposition thesis, it also pointed to 45% to 50%, but I still could not figure out why the actual fits were showing a higher cure-fraction around 62% to 68%. But then after my learnings in the HLA decomposition thesis, when I modeled with multiple-buckets in GPS (3 buckets with the 3rd being extremely-long survivors), it ended up matching very closely with the 78th event update (off by 1 event). And then once I started to model with ELN mix, transplant rate taken into account, etc. and we finally got Kugler data shortly afterwards, it now aligns perfectly with all those previous conclusions and the HLA decomposition thesis as well.

At an IRM of 16, with BAT 3-Yr OS at 27% which is has to be with a transplant rate of 10% to 18%, uncured mOS is 14 to 14.8 (which makes perfect sense), the no halt at IA makes perfect sense, the GPS mOS of 39 to 40 makes perfect sense (not a super-"cure" but extremely long survival), and the 3-Yr OS of 51% makes perfect sense.

Another reddit user also shared their meeting notes with a hematologist that mentioned 3-Yr OS of 25% in CR2, and the 27% concurrently is very close.

P(sim) here is 82%, and HR at .463 to .471, which is incredible.

Now, why this high of an IRM/3-Yr OS for BAT (which is not really high at all, just the wrong expectations were set from older data), is really bullish for the CR1 indication/CR1 revenue, is because if GPS is achieving these results in patients where the population/cytogenetics are all fairly close (just a .8 discount) to CR1, newly diagnosed that didn't transplant, then it can likely achieve these same results or slightly better in CR1.

And we know from Kugler, whole-LIT mOS was 16.6 and all of Kugler was 19, and if GPS in REGAL is getting 39/40 mOS, then when the FDA is looking at this data, they will see it is clear as day that the results in almost the same population will be great in CR1.

I believe an IRM of 16 and 27% 3-Yr OS in REGAL (which have to go together if transplant rate is 10% to 18%) is our ceiling.

Dr. Tsirigotis said these exact words in his correspondence:

"Dear sir

Regarding the median survival of patients with AML in CR2:  

the range of median OS without transplant is really wide and depends on many factors, such as cytogenetics, molecular abnormalities, type of previous lines of therapy, etc

In a recent randomized trial i was involved the median OS of patients with AML in CR2 was 16 months, but many patients were on treatment with new agents and not with standard chemotherapy"

There is only one CR2 randomized trial that we know of, and that 16 likely represents the patients he oversees in REGAL. Kugler data is from MD Anderson (the top in the world), but the centers Dr. Tsirigotis oversees are world-class as well, ATTIKON, General University Hospital is a world-class center too.

Thus, it's either 16 IRM is the ceiling, or it comes in lower than 16 IRM, and 3-Yr OS would then not be 27% but would be lower, if transplant rate is 10% to 18%.

Hope this is insightful for everyone, this was a real lightbulb moment for me and I'm feeling really excited for topline results as it all clicks really well now. I'm glad I came across this just before topline, not for any reason specifically, but it is a suitable closing chapter in my REGAL modeling posts (this was unplanned by the way, I just discovered this as I was doing deep-dives into Kugler for 3-Yr OS and decided to test against the actual fits)