Member Info for Haywain

Mr Jinx- the short answer is that its a mix of science, logistics and regulation : Autologous CAR-Ts in general start with apheresis samples from the patient which isn't a neat little vial of stable cells - You are dealing with a large volume of patient leukocytes which need to be enriched, activated and transduced before they can be cryopreserved. So yes cryo is used later in the process but the very first step requires fresh viable cells - flying apheresis bags half way across the world is a recipe for degradation, variability and ultimately higher manufacturing failure rates. On the regulatory side I believe the pathway in Estonia is only available if manufacturing takes place in Estonia - That is how they justify funding - a US made product would not easily qualify under Estonian or EU frameworks.

Boom 🤣

Making money is an aside for me - I can assure you my primary focus is supporting a product that has curative potential : sure it would be nice to be rich but nicer to know that you have had a part (albeit a small one) in helping to save lives - All about where your moral compass lies: personally I value life over money - But apparently that means I am warped

Lucain, I think you will find that FDA have already ruled - They greenlighted paediatrics after 2 adult doses : this is a first for CAR-T in AML - the first CAR-T to ever have been allowed by FDA to be studied in paediatric AML. I think what you are probably referring to is the IRB approval which I understand is a rubber stamp given that FDA have already approved.

I presume your recent trades went badly - I can see that you have also failed in "notposting" ; I am here to support a company who are developing a potentially live saving product for an incurable cancer, including paediatric cancer - But we each of us have our own reasons to post.

agree some amount ****e all designed to shake the weak from their shares - my view is the hg-ct-1 has crossed the rubicon of clinical and regulatory proof of concept . the main risks now are executional rather that existential ie does it work at all? the answer is yes it does - and that is good enough for me.

Well you have only posted a few times jxf004 - so must have been mostly to tell long term holders not to respond to the mongs- Point taken : enjoy your beers; may have one myself !

It’s about the external validation - MD Anderson like what they are seeing , FDA agree, now an EU independent company that are Estonia’s leading cellular therapeutics company agree - one thing in common all have access to detailed information and they like what they see.

Boom - it’s quite the opposite in fact - it is because I do have a conscience that I continue to support Hemogenyx and in doing so also support thousands of patients with incurable cancer get access to potentially curative cutting edge cellular therapeutics such as HG-CT-1

I did - it appears HG-CT-1 is the flagship - it would also seem that we can assume that Celin and by virtue of that the Estonian Ministry of Health agree with FDAs decision to fast track - wonder why ?

Excellent news - European partners already- wow : wonder if this provides a route for US patients who could not gain access to the trial to receive treatement in Estonia? Or is this for Estonian/EU nationals to gain treatment through their respective reimbursement pathways? Either way amazing news for Hemo, patients and shareholders alike.

Well said Mickey

In other words you want 100% assurance that we have a blockbuster otherwise you will continue to be nervous : fair enough - just have to wait for the signals by RNS then - I am reading the tea leaves for you.

Aside from the required reporting of such events one thing worth remembering when thinking about P1 and P2 is that relapse risk in AML is very front-loaded. If a patient is going to relapse after achieving remission, it almost always happens in the first few weeks or months – because any surviving leukaemic progenitor cells will start repopulating the marrow very quickly. The fact that P1 is now more than six months post-HEMO-CAR-T and P2 is four months out with no relapse is hugely encouraging. Each extra month in remission actually makes it less likely that they will relapse, not more likely.

This is because CAR-T can generate memory T-cells that continue to patrol for any stray leukaemic cells. The longer a patient stays MRD-negative, the more evidence we have that either there are no leukaemic stem cells left or that the immune system is successfully keeping them in check. That’s why survival curves for CAR-T therapies flatten out over time – once you get past the early risk window you often see a “tail of the curve” where most patients stay in long-term remission and may effectively be cured.

So when you see P1 at 6+ months and P2 at 4+ months, it’s not just good news – it actually becomes increasingly powerful evidence that HEMO-CAR-T is doing more than just bridging to transplant. It’s showing the potential for durable, possibly curative remissions in FLT3+ r/r AML without HSCT.

In a nutshell Hulver - that is how it is designed : full proof of the pudding will be in the molecular level tests that no doubt MD A have done and in the longevity of remission - but all looking to be going as intended currently

You’re right that there hasn’t been a formal RNS explicitly stating “P1 and P2 did not receive HSCT” — but that’s actually by design. The clinical protocol for HG-CT-01 is not built as a bridging therapy to transplant like standard chemo + FLT3 inhibitors. The entire goal of HEMO-CAR-T is to provide a potentially curative, stand-alone treatment by eradicating leukaemic blasts and leukaemic progenitors without the need for HSCT rescue.

This is one of the key differentiators of HEMO-CAR-T versus “best in class” chemo + inhibitor regimens, which typically serve as a bridge to transplant. The fact that patients have remained in remission several months out without undergoing HSCT is exactly the outcome the trial is designed to test — durable MRD-negative remissions without transplant.

That’s why you won’t see it in an RNS; it will be reported formally as part of the Phase 1 readouts and/or conference data. But yes, if durability continues without HSCT, it’s a potentially paradigm-shifting result — it would mean HEMO-CAR-T is functioning as a definitive therapy, not just a bridge. If you have read my posts I explained this multiple times over the course of 5 years

Davie -b : read the RNS on the 15th Aug re P1 and P2

Single infusion pumpky- no follow up treatment

I would agree with the valation but I would also comment that cell therapy products tend not to follow small molecule risk adjusted 10% of future revenue models - typically 15-20% is applied. Second this is only factoring in FLT3 positive r/r AML - though up of 70% of all AML (conservatively) express FLT3. then you consider its potential applicability to BPDCN and ALL and possibly other indications. In my opinion if Hemo was listed on the Nasdaq we would be seeing a market cap in the multiple 100 M at this stage.

Well I don't know - but its looking very cure-y to me : good luck all