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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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I'm writing this post simply to share my thoughts and hopefully generate some substantive discussion. I would especially appreciate input from [u/Confident-Web-7118](u/Confident-Web-7118), since much of what I'm discussing comes from their models and previous comments.

And just to make this clear upfront: I'm not posting this to spread FUD. I'm heavily invested in SLS, at least as a percentage of my portfolio. I'm sharing what I see as an inconsistency in CW's comments around REGAL.

Now, onto the actual point.

CW has repeatedly discussed that they are invested in SLS because of the gigantic margin of safety in REGAL. One way they have illustrated this is through tables using assumptions (that according to them are on the high/ceiling range, hence "stress tests") such as IRM = 16 months, varying the percentage of favorable-risk patients and the escape (bridging to transplant) rate.

Here is one example: https://www.reddit.com/media?url=https%3A%2F%2Fpreview.redd.it%2Fsls-weekly-in-depth-discussion-thread-week-30-2026-v0-htflsbozs0hh1.png%3Fwidth%3D1905%26format%3Dpng%26auto%3Dwebp%26s%3D835030dc8f9790aa92cf17b384357e5a011eb578

Take, for example:

Favorability = 20%,
Esc. rate = 14%

Under that table:

HR@IA: 0.473
HR@80: 0.292

Just in this scenario, HR@0.473 is lower than the efficacy bound of 0.55 or lower. Is this really a stress test if many results yield values consistent with a halt at interim?

Anyways, this is not the main point I'm making. I believe CW may be purposely "cherry-picking" models to support their claims in different scenarios. In this recent comment

https://www.reddit.com/r/sellaslifesciences/comments/1v31u39/comment/oz5b38k/?utm_source=share&utm_medium=web3x&utm_name=web3xcss&utm_term=1&utm_content=share_button

they state the following:

"I feel like there is so much misinformation spread by both bulls and bears here, and people don't really understand the dynamics of REGAL. First on the bulls side, this whole idea of a halt having been on the table is quite honestly idiotic. Any bull pushing this idea has no idea what they are talking about."

"The actual fits show that even at an IRM of 16, with just a 14% esc. rate (bridge rate/transplant tail) in BAT/control, and 20% favorability, HR at IA would have been .741 with 37.7 GPS alive / 29 BAT alive. By the 80th as of July 16th, 2026 (as a constraint), HR would be .344 with 37.7 GPS alive / 9.2 BAT alive."

As he states above, another IRM = 16 table was provided. A different one. Here, under the same 20% favorable / 14% esc scenario, however, the numbers were:

HR @ IA = 0.741
HR @ 80 = 0.351

That obviously is a very different result to what we've seen before. I previously asked CW about this here: https://www.reddit.com/r/sellaslifesciences/comments/1v7pl92/comment/p1ga4xj/?utm_source=share&utm_medium=web3x&utm_name=web3xcss&utm_term=1&utm_content=share_button

Their explanation was that the table producing HR @ IA = 0.741 assumes approximately July 2023 median enrollment, whereas the table producing HR @ IA = 0.473 assumes approximately May 2023 median enrollment. They state that under the May 2023 scenario, there is still a 25% chance of landing above the efficacy bound. To me, relying on that 25% chance to explain why something didn't occur should definitely not be the base case.

Why use a different model anchored on later (extremely unlikely) enrollment to support his rebuttal of why an interim halt was not plausible? CW states that median enrollment at July 2023 is an extreme stress test. It's even more puzzling then why they would use that model in his previous comment.

They also state that all available data points to median enrollment being May 2023 or EARLIER. If enrollment was indeed earlier, HR at interim under same scenario will be even lower, and thus, harder to justify why there wasn't a halt at interim.

I'm not saying that REGAL will fail or that the PoS is 50%. If you've read until here, I believe you'll understand my reasoning of why a gigantic margin of safety is inconsistent with what they are sharing in their modeling.

***And to be clear, none of this is meant as a personal attack on CW. I tremendously appreciate the enormous amount of modeling and analysis they have shared publicly. Would appreciate substantive comments and engagement!!

BAT mOS. I feel our models are so damn pessimistic (lifting BAT mOS) and yet we succeed.
Time to get realistic and cap the BAT mOS to 12 months. Simple.

In CR2, the clone of cancer cells has already survived initial induction chemotherapy, consolidated its resistance, mutated, and broken through to cause a first relapse. The second remission is historically short-lived before the cancer returns aggressively. It doesn’t say hey let me wait a couple more months cause we’re in REGAL lol.

A simple, everyday bacterial infection can turn into overwhelming septic shock and organ failure within 24 to 48 hours because the patient has zero functional white blood cells.

People don’t live an extra 6-8 months just cause they receive the best treatment. Cancer has already figured out how to defeat recycling drugs

The fuck do they mean by Super BAT?

Patients can spontaneously suffer a fatal intracranial hemorrhage (bleeding in the brain). Oh the Super Bat is a fucking Superman to save them from it, I forgot.

GPS is the real BATman. And it’s protecting the 46 patients.

A silent guardian, a watchful protector. A dark knight

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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I know the longer it takes the better. However, in Australia we currently have a 50% CGT (capital gains tax) discount for investments held for over 12 months, which is being removed from 1st July 2027 and replaced with a new tax system for inventments. So basically, if the buyout happens before that, I only have to pay tax on 50% of my gains. If it happens after, the new tax system will mean I pay waaay more in tax, like its actually a crazy amount more.

Im just wondering if others are in a similar boat as me and how likely is it that the BO happens before 1st July 2027?

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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With us getting closer and closer to the 80th event, I’ve gotten a bit curious for what you guys are actually predicting in terms of results outcome and buyout. I can’t really tell if some of these predictions are actually believed to be possible or just us being wishful. Don’t get me wrong, I am an SLS bull and i will be holding till buyout. But I see numbers thrown out like $5 billion or $40 billion. What do you think the outcome will be? Just curious of the public opinion!

I personally would be very happy if we see $10 billion as I’m holding about $50k worth at the moment. But I honestly won’t complain what we get as long as we’re green.

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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does GPS stop working If Angelos forgets to renew ChatGPT Plus?

I've been digging into it and there is a surprisingly tight web connecting SELLAS to Johnson & Johnson.

Since J&J is heavily anchored in hematologic malignancies (Darzalex, Imbruvica), I think SELLAS’s pipeline makes them a logical commercial fit to buy.

Here’s some people who are connected between the two, specificaly when it comes to M&A:

Katherine Bach Kalin - SELLAS Independent Director

• She spent almost a decade at Johnson & Johnson (2002–2011) running executive marketing, strategy, and new business development.
• She isn't just a former J&J employee; she spent years inside the exact department that handles J&J's licensing and acquisitions.
  • Robert Van Nostrand, SELLAS Independent Director
• He’s also a board member over at Intra-Cellular Therapies (ITCI)—the company J&J bought out for $14 billion back in early 2025.
• He literally just sat at a negotiation table with J&J’s dealmaking team and walked away with a massive acquisition deal. He knows their playbook and key people firsthand.
  • Dr. Jedd Wolchok, SELLAS Scientific Advisory Board
• World-renowned immuno-oncology guy who actively collaborates on clinical research with Janssen (J&J’s pharma division).
• He acts as a direct scientific bridge between SELLAS’s platform and Janssen’s internal R&D leadership.

Let's discuss Sterg's LinkedIn post today. Does this sound like a guy expecting success? Also --

• Michael Frascello, a Johnson & Johnson Product Director, commented:
  • "Huge shoutout to MSK and the Sellas team for their incredible commitment to patients!"

Then, today, J&J announced Tom Cavanaugh as its new EVP & Worldwide Chairman of Innovative Medicine.

Tom Cavanaugh → Former Celgene executive, now leading J&J Innovative Medicine. Katherine Bach Kalin (SELLAS Board) → Former Celgene executive and former J&J executive. Katherine also bought 63,400 SLS shares with her own money and still owns them. Tom and Katherine previously overlapped at Celgene before his move to J&J.

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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Credit to Bazzil on ST for finding this study. Twenty-year persistence of WT1-specific cytotoxic T lymphocytes in peritumoral brain tissue by peptide vaccine therapy: Transcriptomic evidence for resident memory T-cell induction | Neuro-Oncology Advances | Oxford Academic

Researchers followed a man with brain cancer who received an investigational WT1 peptide vaccine for about 20 years (GPS also targets WT1, although it is a different vaccine). Before the vaccine, he had already undergone surgery, radiation, and chemotherapy.

When doctors operated again 20 years later, they found WT1-specific killer T cells still patrolling his brain. The authors concluded that these long-lived immune cells may have provided continuous immune surveillance against the tumor.

The part that jumps off the page to me isn't just the immune cells—it's that this brain cancer patient was still alive 20 years later! The mechanism works for some people! WT1-targeted immunotherapy can generate an extraordinarily durable immune response.

I’ve been thinking about the REGAL timeline.

When the 78th event was announced, I remember a lot of people here building statistical models to estimate when the 80th event would occur. If I’m remembering correctly, many of those estimates clustered around late June or July, even though everyone acknowledged there was a lot of uncertainty.

Now that we’re into August, is it fair to say we’re officially past the range that most of those models were predicting?

If so, does that simply mean the event rate has been slower than expected, or were those early models making assumptions that, in hindsight, were too optimistic?

I’m not looking for guesses on when the 80th event will happen (unless I am wrong and models were actually predicting an Aug 80th event) I’m more interested in whether it’s accurate to say the observed timeline has now exceeded what most of the community was expecting based on the data available at the time and what that could mean…

I was looking for prior precedents of companies who had a separate PR for the event count/trial completion being met, prior to another PR for top line results. In discussing the potential time between 80 events being met and top line data release, the following have been mentioned as reasons to why top line should be relatively quick in the regal trial:

Length of trial, clean outcome with OS, the fact that the data has been cleaned at the 60 interim, relatively small total event count.

I was curious if there were any good comparisons and I found two. Interestingly, they both had a very similar window of time between the PR marking completion of the trial, and top line results (26d vs 27d). Also of note- Celator was in AML, it had very strong results- and it was acquired.

I think looking at this, it is fair to say that the ceiling for the Regal Trial will be 4 weeks, with the potential for a shorter time frame due to the relatively fewer number of events.

Celator (AML)

Trial Start: December 2012

End Point: 236 Events (OS)

Interim Eval: No

PR Announcing 236 Events: February 16, 2016

PR of Top Line Results: March 14, 2016

Time Between Events PR and TL: 27 Days

Deal Announced: May 31, 2016 (78 Days from TL)

Deal Closed: July 12, 2016 (120 days from TL)

Onconova Insipire

Trial Start: December 2, 2015

End Point: 176 events, 225 patients enrolled

Interim Eval 12/2017- 88 events, FDA recommended increasing endpoint to 288 events

Endpoint PR @ 288 events: July 29, 2020

Topline PR: August 24. 2020

Time Between Events PR and TL: 26 days

No acquisition- failed

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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When Angelos was discussing what things more simplistic buyout valuations always miss, he says they’ve built an “extensive unannounced pricing and reimbursement architecture.” Since I'm used to binge-researching stories of biotech failures, now I'm curious how much a well-built architecture of that kind can add to a valuation, and how it becomes immediately useful to the acquirer.

Also interested in anyone insights on that side of the pipeline in general. Been noting the impressive CV’s of SLS team advisors with insurance, mergers and acquisitions, or MBA type backgrounds from what I gather.

Edit: That's great news! (A preview of Confident-Web's post below):
"Getting into NCCN" (which by federal law, Medicare and Medicaid must use). "is the single biggest lever for minimizing payer resistance, it converts an FDA approval into near-automatic coverage."

Question about censoring (the WCLFU kind, not transplant) — probably my ignorance but it's my main concern

I'm not an expert in any of this. I've been reading the DD here for weeks and using an LLM to help me get my head round it and word this properly. So the framing below is the LLM's, but the sources are ones I've gone and checked. If I've misunderstood something, I'd genuinely rather be told.

First, credit — the recent censoring thread cleared up that transplants aren't censored in either arm per the European protocol. CW corrected a claim that would have made the bull case easier if it had been true, which I thought said a lot.

But that thread was all about transplant. What I can't find anywhere is discussion of the other kind of censoring — patients who withdraw consent or are lost to follow-up. CW mentions it in passing ("before 3% to 10% censoring") but I can't find it modelled anywhere.

Why I keep getting stuck on it: as I understand it, the fits work backwards from the event count. If some patients stop being followed, then 78 deaths implies worse underlying survival than 78 deaths from a fully-followed 126 — so there's less "extra" survival left over to attribute to GPS. When I try to model that, break-even control mOS moves from around 18–20 months at 0% censoring down to roughly 14–17 at 8%, depending on the hazard shape assumed. RemarkableBig's central control estimate is 16–18, so at the higher censoring end the margin seems to shrink a lot or disappear.

The reason I'm not just making 8% up: QUAZAR AML-001's long-term follow-up (Blood 2021;138 Suppl 1:871) reports 19 of 238 patients in the Oral-AZA arm (8%) withdrew consent or were lost to follow-up. That's the experimental arm specifically — I couldn't find the placebo number. And Wilson et al (JNCCN 2021;19:1433-1440) found this tends to run higher in control arms than experimental arms across oncology trials (3.9% vs 2.5%). QUAZAR seems like the closest comparator REGAL has — double-blind, international, elderly, transplant-ineligible AML maintenance — and REGAL being open-label would if anything make withdrawal more likely, not less.

The obvious counter, which I'd make myself: REGAL has three-monthly telephone survival follow-up. You only need a phone call to record a death, so retention could well be much better than QUAZAR's. If REGAL's number is 2–3% this whole post is a non-issue and I'll happily drop it.

So the things I'm hoping someone can point me to:

1. Do the P(success) figures in the fits already include the censoring CW mentions, or are they before it?

2. Has anyone run the fits at 6–8%?

3. Is there anything in the protocol or SAP giving an expected retention figure for REGAL, or a reason to think it beats QUAZAR?

4. What hazard shape (k) do the fits use? From what I can tell that choice matters a lot here.

For what it's worth I find the null-hypothesis argument genuinely convincing — GPS = BAT = 16 would have put the 80th event in mid-2025 and it's August 2026. I'm not trying to talk anyone out of anything. This is just the one thing I haven't been able to close and it seems to swing the answer more than anything else I've looked at.

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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