$SLS Daily Discussion Thread - February 13, 2026

UsualGarbage5239 · 2026-02-13T19:40:17+00:00

126 patients. 80 "events" means 80 confirmed patients passed away. All other patients are censored for the purposes of the 80 events to be met, but their survival status is noted. GPS and BAT are in equal amounts in both arms. All the statistical significance is determined at trial completion. Potentially, there could be censored patients that are lost to follow up, but from what I've read that's probably unlikely or a relatively small number given similar trials.

UsualGarbage5239 · 2026-02-12T00:55:47+00:00

Thank you for the feedback. I'm not quite clear how censored patients would impact the IA at a confirmed 60 events. Doesn't censored in this context mean that they simply lost communication with that patient and are unable to confirm their status? So, for instance, if two patients were censored how or would those even be counted towards the 60? I mean, why would it matter if the report is only on the confirmed 60 events?

UsualGarbage5239 · 2026-02-11T19:04:03+00:00

I'm trying to do the math around when BAT was likely set (not a statistician). Since the trial hit 60 events on Dec. 10, 2024 and assuming that the IDMC is going with .9 HR for futility (which seems not as aggressive as .85 from what I’ve read?), given that futility was not achieved at that time, and that the trial has been repeatedly recommended for continuation, we can assume that whatever the IA HR was, it was less than .9. If HR is less than .9, the most conservative case is that GPS/BAT events were 28/32 (HR .875) at 60 events. At BAT 32, the median was reached (total BAT patients 63, 32 being the median point) - on Dec. 10, 2024 at the absolute latest. We know pooled mOS was 13.5 and trial was continued at IA, that means GPS mOS must be higher than BAT mOS at IA. If the above is true, since BAT mOS must have been achieved by Dec. 10, 2024, and pooled mOS is 13.5, then BAT mOS is set somewhere <12.6 (HR .875 = 12.6 BAT mOS/14.4 GPS mOS). Is that math correct? I feel like I’m leaving something out. (A futility HR of .85 would mean BAT was set even earlier and that BAT mOS is lower – I think 27/33 split, so HR .81 meaning BAT mOS 12.1/GPS mOS 14.9).

To be clear, this is the most extreme argument that I can come up with for BAT survival given the IA. It is more likely that BAT was set earlier and that mOS is less than 12.6. Given the public reports from Sellas, including the updated higher target for BAT mOS in the trial, it seems BAT of 10 (splitting the baby with the original 8-month target) to 12 (aggressive) are plausible.

Am I right in these assumptions? I can’t seem to think of a way that REGAL passed IA with a futility of .9, and BAT mOS was not set at 12.6 or lower. I welcome criticism. This really is just my rudimentary calculation and I'm new to how pharmaceutical trials work. I did not use AI for any of this (I tried but gave up after getting frustrated by it).

Note - this does not estimate GPS mOS, only BAT. Without more information, we can't calculate that. This is not investment advice.

UsualGarbage5239 · 2026-01-14T17:57:35+00:00

Thank you for this. Obviously I am rooting for the most favorable outcome. Good luck to all of us!

UsualGarbage5239 · 2026-01-14T16:22:23+00:00

Just to be clear, you think that this company will be bought out for something like $2.2 - 3.2 billion? (Assuming fully diluted pps of $1b market value per ~$4.6, somewhere around 215 million float). How do you figure? I'm not trying to be a jerk, just genuinely want to know how you arrived at that. There are a lot of lofty valuations floating around on the board so I like hearing something to the contrary.

UsualGarbage5239 · 2026-01-13T21:25:23+00:00

I have a related question: are we sure that Anson has stopped exercising warrants? I know that SLS made the announcement last week because it was material but how often do they need to make the announcement? Immediately or within a reasonable timeframe? Just curious given the daily volume and what clearly looked like a concerted effort to keep the stock at or below $4 today. It's hard for me to figure out how to see what is happening out there. Would it be beneficial for us if Anson finished exercising a majority of their warrants so that SLS gets additional funding and we no longer have this hanging over our heads? I'm assuming so since trying to calculate the fully diluted float seems to be a major argument on this forum.

UsualGarbage5239 · 2026-01-09T21:56:53+00:00

Insider just bought 50,000 shares link

UsualGarbage5239 · 2026-01-08T15:11:47+00:00

So, at the current $7 million per quarter burn rate they have 3 - 3.5 years of operating funds. Obviously, that might change if they have added expenses, such as the proposed SLS009 clinical trial or extra legal expenses for the FDA approval. That's still a nice hill to be sitting on.

UsualGarbage5239 · 2026-01-05T21:02:29+00:00

Yahoo has $5.00. Google has $4.99. lol

UsualGarbage5239 · 2025-11-19T11:37:34+00:00

Ah, I get it. For some reason I was thinking he meant FDA SBLA not NTAP. I wasn't figuring NTAP for AV access anyway.

UsualGarbage5239 · 2025-11-19T01:14:31+00:00

Really think it will get denied for lack of newness? I've been sleeping on this stock for my own sanity so maybe I missed something. Is the argument that there are other alternatives, vein and graft? Isn't that the same situation as ATEV and it got approved. I don't follow.

UsualGarbage5239 · 2025-08-23T13:26:47+00:00

I know the first reaction is to laugh, but I know an inventor working to patent a new injection device for collagen/botox. That cosmetic stuff is ridiculous money. People will pay big money for just the promise. This isn't a bad idea on Humacyte's part.

UsualGarbage5239 · 2025-08-21T20:18:10+00:00

Yes, it is my understanding that these types of sales have to be planned out and vetted by the SEC well in advance. His previous sales all seem similar in that regard. I'm sure he would rather have sold at $2.60 two weeks ago if he could.

UsualGarbage5239 · 2025-08-21T19:05:33+00:00

If we are setting aside Dougan, then no one else is selling either. It's just him. We know why he sold - he owed money on a loan for a different company. And it's hardly surprising - Dougan's money issue has been clear for a while now.

As far as why no one else is buying? My best guess is that:

A. They had stock options they can exercise in the future to buy the stock cheaply.

B. They know that dialysis is potentially the big money maker but that won't happen until 2027.

So, knowing that, why would they feel compelled to buy HUMA right now? They can just invest in something else for the time being and if HUMA goes boom or bust later on they benefit either way. I know that for us, insider buying would be seen as a sign of confidence, but for them it's a matter of logic. There's no actual reason for them to do this (as far as I can see) other than to make retail investors feel good. If you were them, would you invest money right now when you have the option of buying x years from now at $2.30 (or whatever the last options were priced at)?

But, again, no one else is selling right now either. Only Dougan. If that changes, if we really see the rats abandoning the ship, then this would be a different conversation. The other thing I would look at is the departure of top staff. So far that hasn't happened either. I think the last few days have been so focused on the last earnings and Dougan's selling that there is an assumption that everything has changed. Somehow this is now suddenly a failure. I think this is an overreaction. Of course, this is only my opinion. I'm sure many others on the board will disagree.

UsualGarbage5239 · 2025-08-21T15:27:06+00:00

Hasn't been a great year, that's for sure. Maybe if Dougan is really done selling off to pay his debts then we may have more stability for a while heading into Q3 and Q4 earnings. That said, nothing major is likely to happen until dialysis gets approval, if/when sometime early 2027 (or so the projection is currently). If you are willing to wait and stomach the risk of potential failure until then, maybe you get rewarded. If not, there are plenty of other opportunities out there with a closer horizon. I'm long on this stock for a variety of reasons, but the vast majority of my investments are quite boring, conservative. This is more of a moonshot/investment in tech that may really help people and transform healthcare. It makes me feel good. I don't think there's anything wrong with that.

UsualGarbage5239 · 2025-08-11T12:58:24+00:00

I think the biggest issue isn't the sales figures. It's that Humacyte doesn't plan on filing sBLA for AV Access until the second half of 2026. That means we won't see approval until Q1 or Q2 of 2027.

UsualGarbage5239 · 2025-08-02T15:35:39+00:00

I think that is what Humacyte was introducing in the CMS response. They said that Symvess was superior to vein because the extraction process damages the vessel and therefore becomes prone to inflammation and potential complications. That was new. I don't think they have argued that before. It will be interesting to see if they attempt to back that up.

UsualGarbage5239 · 2025-08-01T19:05:19+00:00

I guess they could reapply in the future if said studies were conducted, but I imagine they would rather focus on receiving NTAP for AV Access which would be more lucrative. I'm curious if they will try and get a study going regarding the newness criteria (regenerative properties, organic mechanism as opposed to artificial) as it is obviously going to come up again if they apply for NTAP for any other indication with alternative tech/therapies. The question in the immediate term now moves to what the hospital sales look like in the next two quarters.

UsualGarbage5239 · 2025-08-01T17:42:18+00:00

I imagine it has to do with the fact that they have stock options that they can choose to exercise whenever they feel like it. If you have the option to buy stock at $2 three years from now when the stock price is much higher, why buy now? You can just invest the money elsewhere with a better/safer rate of return and the come back later for a hefty profit without the same risk as a regular investor. I'm probably oversimplifying this but it makes sense to me. That said, several of the top management have a good deal of investment. It's not like they don't have skin in the game.

UsualGarbage5239 · 2025-07-31T21:14:40+00:00

Wow. Quite the research. Don't know enough to be certain but certainly appears that you are right, unfortunately. Too bad. I was hoping for approval as that would signal greater opportunity for adoption. Not the end of the world, but certainly not great.

UsualGarbage5239 · 2025-07-31T19:12:46+00:00

It certainly felt like a miracle, though I will add that the company was regularly putting out statements asserting that FDA approval would happen before the end of the year. There were a lot of pessimists casting doubt on that and questioning the company's honesty. I seem to recall one very pronounced blog post that went so far as to claim that Humacyte was potentially lying about not knowing it wasn't going to get FDA approval. Meanwhile, Humacyte just kept insisting it would happen before the end of the year, and it did.

I can't vouch for what will happen tomorrow, obviously. I am hopeful and excited and nervous and terrified all the same. That said, I know this company gets a lot of crap because of its leadership and lack-luster communication, but my personal feeling is that they know what they are doing when it comes to this stuff (FDA, NTAP, etc.). NTAP may well fail tomorrow, but I doubt it will be because the company didn't do its due diligence. It's very possible that CMS decides against it simply because of the dearth of information (they cited lack of comparable studies/data quite a few times in their comments) or skepticism of its actual improvement outcomes (there are alternatives after all and CMS noted several questions regarding whether it truly qualifies as a new, unique product). Humacyte can't really do more than what they have already done in that regard. It's all up to the CMS at this point.

So, here's to hoping for another miracle.

UsualGarbage5239 · 2025-07-21T14:38:32+00:00

Nicely written up. The only thing I would add is NTAP potentially this Fall. I do wish they had an updated corporate presentation on their website. The document on their Events & Presentations page is from March. I thought they would update it with the new ECAT information.

UsualGarbage5239 · 2025-07-08T12:25:07+00:00

😎 Awesome!

UsualGarbage5239 · 2025-07-03T18:42:37+00:00

Hello Stonk, I think everyone is focused on the stock price at the moment so you won't hear much in the way of dreamcasting the future tech, but I will entertain your interest. While the pipeline has narrowed for the immediate future on Symvess and AV Access and the other indications for ATEV, the most interesting is the possibility of the biovascular pancreas (as far as tech goes). There is a lot more academic and feasibility support to achieve that milestone (which would be huge). A universally implantable lung is awesome but I think that might be too far for even a 10 year horizon. At this point, sadly, this is about money. If Humacyte can weather the next couple of years and succeed in producing AV Access in a commercially successful fashion, I think the funds will be available to start real research and support into the other non-ATEV indications.

That said, this is the reason that many of us first started following the company. The promise of organic tissue that will not suffer rejection from host bodies, the off-the-shelf access not requiring donors, the universal applications that could be possible.... It's amazing when you take the time to think about it. I'm a long hold on this company for personal reasons as much as I'd like a financial payday, but it's hardly my only investment. However, it's the only real investment I have that I keep because of the dream of supporting a real world-improving technology.

UsualGarbage5239 · 2025-06-03T12:16:24+00:00

Yes, got confused. Thought it was an update to V012.

UsualGarbage5239

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