Member Info for Haywain

I had no idea - thankyou : https://snipboard.io/8oL7QK.jpg

It would be a very long post to describe what I know that you don't pumpky - I would have to break it into parts (1), (2) etc that would even beats Stu's record.

You seem very happy about that pumpky - personally i would not have used a laughing emoji at the end of a sentence that describes the sad loss of your best friend - but each to their own

Thats what you think/hope pumpky - I will not tell you why I know different - Would want to spoil the fun

Thats precisely the point - none of us have real-time access to P1/P2 outcomes, but FDA does. And they just approved a paediatric extension afeter only two adult patients - Something unprecedented in AML CAR-T trials. That isn't speculation - its a regulatory first. If there were serious adverse events or lack of efficacy, this extension simplu would not have happened. You dont have to know exactly how the patients are doing to see the direction of travel.

Speculation about failure at this point ignores both the clinical logic and strategic behaviour typical of pharma. Deals are often struck early when curative potential is visible, particularly in paediatric oncology where regulatory incentives and unmet need are highest and especially in r/r AML - In that context, the current chat narrative—focused on short-term fears and daily share price movements —fails to appreciate the asymmetric upside if ongoing patient data continues to confirm what early signals suggest. If this therapy truly induces complete responses without transplant, the rerating won’t be gradual IMO

Tiered funding from big pharma - every time : small amount up front with big milestone payments and commercial royalties

I agree - much rather it be big pharma than VC but VC is often the earliest to offer funding as they have a different risk tolerance to big pharma. Though in cell based therapies in rare paediatric disease - that tips the scale for big pharma and they become slightly more risk tolerant.

Who knew there were so many companies working on nasal antifectives

It’s been mentioned on here that they are talking to VCs etc

Destiny went private because it had no choice — no traction, no offers, and working in a small molecule antinfective for nasal decongestion. Hemogenyx, by contrast, is sitting on a potentially curative AML therapy, showing unusual regulatory acceleration, and is in ongoing discusions - Going private would be strategically regressive unless the company were in absolute crisis — which, based on all signs, it isn’t.

Now that I am in the bin I can freely answer Stu's questions: Essentially he is hanging his hat on previous trial performances which is an error in this case because the previous trials that he references did not target FLT3 so they are not relevant and its a good job they are not relevant because they were not successful. Nobody has successfully treated r/rAML with a CAR-T that targets not only the AML blasts themselves but the leukaemic precursors which Hemo- CAR-T does and that is one of the differentiators that gave me faith in the first place.

1. Has early efficacy and patient CR’s been relatively common in Car-T r/r AML trials to date ? Please attach any supporting multiple trial report papers to substantiate your view, all as i did .

Definitely not relatively common - some early CRs have been observed but most patients had AE's /Dose limiting toxicities and relapse - That have not been observed in Hemo CAR-T (to date)

2. What time period post treatment do you believe required to practicality demonstrates curative durability?

Wrong question again - question should be how long before big pharma notice a difference in trend when comparing Hemo -CAR-T performance against historical not FLT3 directed CAR-T treatments for r/r AML ? I assume that the fact that FDA have granted paediatric expansion which is a first for any CAR-T in AML after only 2 adult patients is not normal - I would notice things like this and flag it for further investigation.

3. What treated cohort size do you believe required to practically demonstrate curative durability?

Again not relevant - see response to question 2

Stu, There is no tragedy in being wrong. The tragedy is clinging onto wrongness as though it were a crown. You mistake cynicism for wisdom and now flail as truth advances without your permission. The trial you said would never being ...Began. The IND you mocked...was approved. The clinical hold you glorified... dissolved- The FDA you wielded as a hammer, now grant paediatric expansion and still you claim vindication?

This is no longer a debate - When reality contradicts a man and he does not yeild - he does not grow stronger: only more contorted as the 2 page chat CPT aided tripe that you post demonstrates. Your arguments no longer persuade : is more of the same sad sack perfomance and like all performaces they betray the anxiety of being unseen. Take heart : even a shadow has a shape , if only it learns to face the light.

farewell,

Haywain

Stu,

The irony of you lecturing anyone on credibility is, frankly, staggering. Let’s dismantle your latest revisionist narrative step by step.

1. “The company expected pediatric expansion in H1 2025…”

Yes, we all read the October 2024 RNS where the CRO projected pediatric expansion might occur in H1 2025 — but that was contingent, not guaranteed. The fact that the FDA formally approved the expansion mid-dose escalation (in a FIH trial, no less) is unprecedented in AML CAR-T.

You’re trying to retroactively pretend this was always baked in — it wasn’t. And if you’d like to name any other AML CAR-T that received pediatric clearance during dose escalation, please go ahead. Spoiler: there are none.

2. “Approval would only have been denied had there been a safety issue…”

That’s complete conjecture on your part. FDA does not grant protocol expansions like this just for being safe. They require compelling risk-benefit justification, especially in paediatric oncology. So either:

• You think the FDA is rubber-stamping unproven therapies into kids, or

• You’re ignoring that such an expansion implies meaningful early clinical benefit.

3. “No mention of extraordinary efficacy…”

Correct — Hemogenyx didn’t announce CMR in a press release. But no biotech in a FIH trial ever does, especially pre-publication. What we can infer is that FDA greenlighting pediatric expansion this early strongly implies they’ve seen enough efficacy to justify exposing children. That doesn’t happen by accident.

4. Your history of shifting narratives:

Let’s remind everyone:

• You said the IND wouldn’t be approved.

• Then the trial wouldn’t start.

• Then it would be unsafe.

• Then there’d be a clinical hold.

• Now that it’s cleared every single hurdle, your line is “it’s meaningless, they expected this.”

It’s clear the only thing predictable here is your refusal to admit when you’re wrong.

5. “Let the company do the talking…”

They have. The FDA approval is the company talking. You just don’t like what it’s saying.

⸻

If you want people to take your posts seriously, start owning the fact that every key prediction you’ve made has been wrong — and stop dressing up reactive damage control as rational foresight.

Have a good day 😉

– Haywain

Well Stu. by your own prior statements, we’ve already far exceeded the outcome you originally forecast. You said the trial would never start, that the FDA wouldn’t approve the IND, that it wouldn’t be safe and would result in a clinical hold. Then when none of that happened, you moved the goalposts again — claiming it wouldn’t be durable, and now, apparently, even if it is, it’s not worth anything. The truth is, every stage you’ve doubted has been proven wrong. Your overly negative and repetitive posting hasn’t just been pessimistic — it’s been consistently inaccurate. Maybe it’s time to acknowledge that the science is doing the talking, and so far, it’s speaking volumes

Stu some times I think you actually believe what you are saying.

Hindsight is a glorious thing but it the fullness of time you will be able to look back through my posts and see that I took you to school but you just didn’t listen - shame because you could have actually made some money. Do the right thing and turn that frown upside down would be my advice.

What you have learned is that it’s my birthday and I have better things to be doing to be honest - but if you insist - check back through my last hundred posts on the topic and you will find they are consistent in their logic - unlike you : the reason for that is because I know what I am talking about .

It’s an Interesting shift from ‘it categorically won’t work’ to ‘if it works, it’s not a big deal.’ If you’re already preparing the goalposts for CRs in P1 and P2, that says more about your expectations than mine. I’ll stick to my consistent logic: novel target, clean safety, and solid scientific rationale. If it delivers, it will deserve recognition — not rationalisation

Stu - I don’t know why you have such a hard on for me that you should wish to whisper me sweet nothings at the weekend : I am obviously living in your mind rent free- anyways I don’t suppose there is much point responding to this as it is obvious that you are desperate. I don’t like to kick a man when he is down- you now have the floor.