Member Info for Haywain

Worth the wait : https://www.londonstockexchange.com/news-article/HEMO/third-patient-safety/17234377 :)

A.I can say what it likes about my enthusiasm but I have been saying the same thing from the conceptual stage of Hemo’s anti-FLT3 CAR-T : so far all predictions have been bourne out in reality - So I trust my judgement thanks, accepting that we are at an early stage.

I know this - and therefore pharma knows this too. Good luck all.

You’re missing the key biological distinction here – CD19 is just a lineage marker, which is why we see CD19-negative relapses after CAR-T. Leukaemic cells can switch off CD19 and carry on surviving. FLT3 is fundamentally different – it’s an oncogene and a driver of leukaemigenisis. These AML blasts are addicted to FLT3 signaling; down-regulating or losing FLT3 isn’t a viable escape route without severely compromising their ability to proliferate or even survive. That makes FLT3 a very high-value target, because antigen escape is far less likely compared with CD19.

On the data side, we have two patients now several months out – roughly 6.5 months and 4.5 months – both with no HSCT, no follow-up therapy, no relapses, and a clean safety profile. In r/r FLT3+ AML, where median remission durations are typically measured in weeks even with drugs like gilteritinib, this kind of durability is already highly encouraging. The FDA evidently agreed, since they approved paediatric dosing after reviewing just the first two adults – that’s not a routine decision and suggests they saw a strong and clean efficacy/safety signal.

Yes, pharma will want to be sure, but this is exactly when early strategic discussions happen – when the product looks safe, efficacious, and differentiated, but before the price becomes prohibitive. Hemogenyx is already in the sweet spot for interest, and every month of additional remission data only strengthens the case and pushes valuation pressure upward.

Thats funny that you were invested here a few years back - Don't remember seeing any of your posts Alde -Think i would have noticed the incessant ramblings - Or have you got a new moniker?

What a.i thinks : Yes — this almost certainly means Hemo has been screened and deemed “investment-ready” by at least one of the summit’s strategic partners (Saudi, India, or both). It’s unlikely they would be invited without some degree of prior conversation or at least a strong recommendation from an existing connection (e.g., MD Anderson, US political/industry contact, or a VC already looking at Hemo).

This is an excellent sign — it raises the probability that regional licensing or sovereign-backed growth capital is already being explored.

Very interesting pumpky - could be a blockbuster but speed to market slower than HG-CT-01 because of broad applicability in solid tumours - large phase 3 studies will be required - particularly like the fact it is a brain penetrant and impacts mitosis. I may buy a few when Hemo hits a billion dollar market cap

What a dodgy company that is trying to cure a paediatric cancer and has already been "fast tracked" by FDA by greenlighting paediatric trial after two adult patients dosed? That sort of dodgy company ? The first CAR-T to ever be green lighted by FDA in paediatric AML?

Yes but the difference between me and you - I presume ? I have worked for twenty years + for big pharma developing biologics for the treatment of ALL/ AML and other malignancies - the last 15 in regulatory affairs - I believe I am well positioned to understand the behaviour of DD teams. - what qualifies you?

The figures for the gilteritinib you have quoted- median overall survival 9,3M, 37% one year survival, and partial or complete responses are based on intent to treat data where a substantial proportion of patients went on to receive stem cell transplant in some cases with gilteritinib maintenance afterwards. In other words the survival signal for gilteritinib is already being propped up by the HSCT. By contrast HG-CT-01 is showing something quite different: how many of the gliteritinib patients would have relapsed by 7/4M? Practically all? Therefore the efficacy signal is stronger in HG-CT-01 - I can see it and I have used Bayesian statistics to model the probabilities - I can tell you HG-CT-01 already stacks up very favourably to the standard of care both from a safety and efficacy perspective - In fact if these sort of responses continue it will be considered a paradigm shift in the standard of care. I can see this - how long until big pharma see it too : I don't believe you have as long as you think to trade.

Why focus on one gilteritinib- why not compare a contrasts to all chemotherapeutic agents and inhibitors used as part of the standard of care ? None have curative potential - all are a bridge to bone marrow transplant and all of them have significant adverse reactions associated with their use in a significant proportion of patients.

To me the significance is that this decision is already looking past phase 1 to phase 2/3 and commercial - All happy with the trajectory that the phase 1 data already supports.

Simply put in my view the longer Hemo hang onto HG-CT-01 the higher the price tag up to a limit and depending on the clinical data - if we are seeing complete responses and dose escalation and paediatrics started, that is probably optimal timing - ie from now through to Q1 2026. If this is presented at Ash then expect bidding war IMO

Yes - I agree - could be as little as 6-9 patients before a phase 2-3

Both complementary and competition- therefore I would not buy one without the other …

Process Guy - yes it does CDX is a bispecific antibody binds two antigens (1) anti- CD3 (recruits CD8 T-cells) (2) anti-FLT3 - it’s the same anti-FLT3 binding domain as HG-Ct-1 therefore it is an off the shelf version of Hemo CAR-T - preclinical but derisked substantially by the Hg-CT-01 trial

To “the masses” 3 patients in a phase 1 may seem very early and tiny number. To people who know the field HG-CT-01 is doing something that isn’t seen/ hasn’t been seen before looks very much like a safe effective CAR-T in FLT3 +ve r/r aml. Though early it looks like the start of something that could rewrite the treatment landscape. And that’s why the market may start putting in those higher highs — because the people who really get it, get it. If you had been here a bit longer I have explained it many many times

What’s been done to Hemogenyx by the City is shameful. Naked shorting is illegal, yet I suspect it’s been allowed to run unchecked here. Institutions didn’t just withhold support – they bankrolled the company only to close out their own shorts, forcing desperate discounts by hammering the price down first and then renegotiating placings on their terms. Last March they pulled this trick with a 40% discount. That isn’t investing, it’s predatory abuse. And because of it, paediatric recruitment has been delayed and children were denied a shot at a potentially life-saving therapy. That’s the human cost of this market manipulation.

Now the irony is turning. The company no longer has to dance to their tune. Funding has been secured without them, data is progressing, and major catalysts are lining up. When the real news breaks, the shorts who thought they could control the story will be forced to buy back into genuine demand, not synthetic supply. The very tactics they used to strangle Hemogenyx will end up fuelling a violent re-rating. They tried to suffocate a life-saving treatment for their own profit – but in the end, the burn will be theirs.

Also sorry for your loss, but that was then - this is now : hope may turn into reality

Well mr Jinx - you could be right - although mechanistically if there isn’t any cancer there then they are in permanent remission - Remember that the leukaemic precursors (cause of relapse) also express FLT3