Member Info for Haywain

Mrs India, that is an interesting and well-articulated psycological frame work and it may well apply to many overhyped , sentiment driven stocks. But I would counter this when applied to hemogenyx and here is why:

My belive isnt emotional its evidence based. Hemo is not being propped up by tribalism or blind fatih. The optimisim is driven by unusually strong early clinical data including:

- 2 r/r AML patients treated with novel FLT3 targeting CAR-T

-No adverse events, no cytokine storms, no neurotoxicity

-Sustained remission now reaching 6M without a transplant - virtually unheard of

-FDA clearance for paediatric AML inclusion after two patients - a mile stone unprecedented for AML CAR-T.

So the critisim isnt being rejected - its just being weighed against real data. The community as you put it is not reacting emotionally to negativity. Its questioning the unfounded negativity especially when it ignores the biological plausibility of targeting FLT3, the raity of such early durability and the fact that FDA and by virtue of that major pharma are almost certainly paying attention.

Hemo isnt a lifestyle stock , its a clinical-stage biotech with tangible milestones. There is little room for "religous" attachment in a company priced at 6-8M with curative potential. If belief perservereance were really the issue the price would be irrationally high. Its the opposite- the market has irrationally underpriced the potential and that dissonance is what justifies engagement - not tribal delusion. What ewe have here is a data-supported conviction in a technology that might fundamentally shift how we treat FLT3+ AML - and if anything the frustration comes not from opposing views but from a market that refuses to price in the facts.

Dear Christ….

Work / Pleasure : all the same thing - I will do my best to get there irrespective.

Not necessarily RNS'ed- but it could be - And yes that would be significant if MD Anderson were to publish on this as it would be external validation direct from the clinical site - Who are world leaders in AML research. We may be early - Yes - but the clinical ramifications if Hemo-CAR-T does what it is designed to do are very significant.

It would be excellent yes - I am going to try and get there in person this year

Yes normally cryopreserved with a pre assigned / preagreed shelf-life 3M + through submission of data in the IND stability section 3.2.p.8.1 - 3.2.p.8.3 .

I don’t need to be the “hype man” FDA have taken on that role for me.

Further to that - the reason I know FDA think this is special because it’s the first time in history that FDA have green lighted a CAR-T for paediatric AML and second they did so after 2 adult patients : FDA simply do not take chances and do not set president based on limited weak data

FDA didn’t just “allow” Hemogenyx to expand to pediatrics—they did so because HG‑CT‑01 met or exceeded every threshold they would demand to justify that risk.

For the agency to make this decision after only 2 patients is a resounding vote of confidence that this therapy:

• Is safe,

• Is biologically rational,

• And is already demonstrating disease-modifying activity.

It signals to external observers especially pharma and investors that this is not a standard Phase 1. Something special is happening here.

you have been totally correct all the way through stu you are big and all knowing and i am small and slightly ******ed- i can admit it now : your superior intellect has correctly identified that we will need to test the batch post manufacturing change and because of that we are all doooomed. forget about anything else they have this is number one priority so we should all focus intently on it because it means delays and devastating finance decisions. if i were you i would increase my short - remortgage the house and go in big.

Pumpky if one of your best friends had died from this disease - I would have thought you would support cutting edge research that could be potentially curative in r/r AML rather than spending your time printing snide remarks followed by crying/laughing emojis - What are you offering to the world? What is the point of you?

So let me get this straight - I accuse you of being morally bankrupt (which you seem to be) - And the thing that is most important to you is that you get confirmation that a standard regulatory requirement of performing analytical comparability on materials manufactured after major process change will need to occur ? as the great TA DA - TOLD YOU SO moment ? : Is that really all you have got?

Stu, This kind of post is exactly what's wrong with the state of your discourse. Lets be real- you are not here to "explore timelines" or seek clarity, You're here to slyly cast doubt, sow fear, and insinuate negative outcomes based on fragments you present as fact. You lace your messages with just enough faux uncertainty ("if correct", "i read", "may explain") to maintain plausible deniability while actively steering the narrative to suit your agenda.

What I find morally bankrupt is doing this while a company is trialing a potentially curative treatment for one of the deadliest cancers known and one that is so far succeeding. You are showing zero regard for the team pushing this forward OR THE PATIENTS RELYING ON THIS. Its cheap, its transparent and frankly, its getting boring.

Ah I see - couldn't quite run the risk of actually binning me. Stu you are clearly rattled again - understandably so! But lets at least get a few things straight before you embarrass yourself further. First off, nobody said that a 2- patient submission to Ash would be statistically powered. Thats a strawman and you know it. ASH accepts early-phase data when it is clinically compelling not necessarily statistically final. Phase 1 trials, especially in ultr-high risk indications like r/r AML where early signals of efficacy and safety recorded is relevant to ASH to inform the field. That is the point of a medical congress: Scientific relevance (Oh I forgot you are incapable of understanding the scientific relevance) not final p-values. To your other point yes - City of Hopes FLT3 CAR-T (Zhao et.al) : their initial ASH poster in 2019 was based on 2 patients in Phase 1. One patient had grade 3 CRS the other cleared balsts temporariliy but relapsed.

you know what they didnt have?

-Durable Remission

-Safety

Rather than accuse others of BS, maybe spend some time reading actual precedent in the literature. Pr, betterstill, just day : "I didn't realsie 2-patient case reports with clinical impact often go to ASH and that safety/durability like this in AML is highly unusual" - You will sound a lot more informed.

Socialist - I would argue it is price sensitive information if MD Anderson do submit an abstract to ASH with respect to the performance of Hemo- CAR-T. There is a high bar for acceptance of these abstracts so to submit so early into a phase 1 study means that they have seen something significant and unusual in the patient response - it would be very significant

Stu’s running out of rope…

Clutching at straws while the clinical data quietly tears up his entire playbook.

Two patients infused.No CRS. No ICANS.No cytopenias.

No HSCT.No relapse.FDA greenlight for paediatric expansion — an unprecedented vote of confidence mid-Phase 1.

Meanwhile Stu’s stuck recycling decade-old Amgen failures like they somehow apply to a next-gen, selective, precision-engineered CAR-T that’s doing exactly what it was designed to do:

Target FLT3+ AML blasts while sparing healthy stem cells.

It must be tough…Watching his narrative of doom fall apart piece by piece, as real-world human data keeps quietly, clinically proving him wrong. The science has moved on. The regulators have moved on. Even the patients are moving on — literally, living longer than anyone expected.

But not Stu. He’s still here.

Clutching his straws, whispering ghost stories to an empty room.

Let’s be clear — the only reason my name has gained traction here is because I’ve consistently challenged your skewed, selective, and at times willfully misleading reinterpretation of historical events, most of which have nothing to do with Hemogenyx.

You repeatedly cite failed CAR-Ts, discontinued programs, or regulatory precedents from unrelated indications and use them to manufacture fear and poison the narrative around HEMO CAR-T ; a therapy now showing strong durability, safety, and regulatory endorsement.

What you call “infamy” is actually just resistance to misinformation. I’ve posted facts. You’ve posted spin.

And now that Hemogenyx appears to have achieved durable, transplant-free remission in two consecutive AML patients (a potential first ) your playbook of dragging in irrelevant historical analogies and misusing Phase 1 definitions is falling apart in real time.

You’re not defending science.

You’re defending a short position — poorly.

Apologies - I asked A.I to review and my last post was a brain fart - not British government- it’s a scheme put together by Wilson wolf and fresenious Kabi - but still positive

Great news - this will be the first of many such payments as G-Rex typically support all manufacturing and development activities - ie up to 50% of costs associated with manufacturing are now backed by uk government - not bad

Socialist - no the cost will be nowhere near that - they don’t have to do all of the dose escalations they might decide 1 or 2 dose cohorts is showing promising enough data to request FDA to move to phase 2/3 registrational trial that may have a paediatric and adult arm. officially and not saying Hemo will do this but one could decide that the first adult dose cohort is enough to request phase 2/3 ie we have already manufactured the first dose cohort so if that were the case then 3rd patient + 6M could be enough- every trial is different and comes with different costs associated with different products so I don’t know how A.I generated the 50M but I would suggest that is way off