Member Info for Haywain

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Page 13 of the above report was interesting - BARDA approved grants to companies developing antivirals. Not insignificant sums of money!

Mickey - not that it should make any difference but I am still invested in hemo with more shares than I have ever had we will find out over the course of time whether I have invested wisely or not. Don't assume because I am not posting much that I have sold up: I have been extremely busy on working on my own programs which with any luck will be approved by FDA this year. I know the path that Hemo are on and I have travelled it several times myself albeit working for companies that have the resources to plough into early stage programs - Ultimately if the science is right (which I think it is) the money will come.

In my opinion they have done well on a small budget to get a product to the point of clinical studies starting. The sooner they get the clinical validation of their pre-clinical work the better and Hemo CAR-T will then be an extremely valuable asset. It is, however, very important that the trial is run in the right way and that we get the data that we need. So while I agree it is frustrating having to wait - I would rather that they get it right first time.

A little bit of patience for patients required here.

Wonder if Vlad was also at ASCO ?

I am still checking in here but not much to say at the moment - Looking forward to the next piece of positive news :)

Just notice of AGM later in June

Disagree - you can count me out of the doom & gloom club but just nothing to say at this juncture until the next RNS drops.

That is impossible to say - put it this way I wouldn't be surprised to get further updates from CBR it seems like they put a lot of work into developing an off the shelf solution to virus X last year by chosing an mRNA construct, stabilising it with nano- polymers and developing a aerosol mode of delivery. They could have decided to do this off their own bat but to me I link these sorts of requirements with DARPR. So I wouldn't be surprised if some sort of matched funding was announced to further develop CBR for government use. I don't expect to hear anything on CDX until we get clinical data back from CAR-T personally .

In fairness mr India irrespective of what the share price is, there is an intrinsic value to Hemogenyx's pipeline of products that can only be estimated by comparison to other companies developing similar products for similar indications. The one aspect that Hemo seem to have set against them is their ability to raise funds (at a reasonable price) which would factor into valuation because that is one thing they will need plenty of to continue with the clinical program. I have very little doubt over the science which I think is excellent and somewhat revolutionary. For me (as someone that is positive about Hemo's future) I am essentially betting that those funds will materialise due to the nature of the products being developed by Hemo whether that be in dilutive or non-dilutive form. The shorters are betting that they wont be able to access funds or if they do it will be dilutive and at an ever decreasing share price. Who will be right? I am hanging around to find out!

Clinical trials.gov is just a database listing all clinical trials currently ongoing in the US . I think it is a requirement for the sponsor to list the study as soon as the trial begins or immediately prior to the trial beginning in the US. The recruitment would be via the clinical trial centre that the study is conducted in and through various awareness campaigns with patient advocacy groups etc

You are correct in noting that Phase 1 trials are primarily designed to evaluate safety and tolerability, rather than efficacy. The emphasis on efficacy in my posts was driven by a common interest in the potential treatment outcomes, but this certainly should not overshadow the importance of safety data.

Regarding the typical CRS incident rate in CAR-T treatments it varies widely depending on the specific CAR-T construct and the patient population. Generally CRS occurs in approximately 50% to 90% of patients treated with some of the more common CAR-T therapies like those targeting CD19 in B-cell malignancies. Most cases are mild to moderate and manageable with standard treatment protocols including the administration of tocilizumab an IL-6 receptor antagonist approved specifically for severe CRS.

With regard to whether or not the trial would be stopped if the first patient where to react with severe CRS? I think it would depend. It is of course a possibility, however If the CRS was severe but could be managed effectively with standard protocols (as has been the case for some other approved CAR-T therapies) and measures could be taken to mitigate future risk the trial could continue with adjustments and would need to be discussed with FDA/ethics committee. I do have a tendency to focus on the positive because I am positive about Hemo's product candidates but in the interests of balance there a risk that the trial could fail because of safety reasons.

Here you go:

Venetoclax (Venclexta):

In combination with hypomethylating agents or low-dose cytarabine, venetoclax has shown overall response rates (ORR) ranging from 50% to 70% in newly diagnosed elderly patients unfit for intensive chemotherapy. In RR AML, the response rates might be lower, generally expected around 20%-30%, depending on the combination and patient specifics.

Gilteritinib (Xospata):

For patients with RR AML harboring FLT3 mutations, gilteritinib has demonstrated a composite complete remission rate (CRc, including complete remission with partial hematological recovery) of approximately 20%-30%.

Ivosidenib (Tibsovo):

In patients with an IDH1 mutation, ivosidenib has shown a CR+CRh (complete remission with partial hematologic recovery) rate of around 30% in clinical trials.

Enasidenib (Idhifa):

For RR AML patients with IDH2 mutations, enasidenib has shown a CR+CRh rate of approximately 20%-30%.

Gemtuzumab ozogamicin (Mylotarg):

Response rates for gemtuzumab ozogamicin can vary, with CR rates around 15%-20% in the setting of RR AML, depending on the specifics of the patient population and treatment regimen.

Decitabine and Cedazuridine (Inqovi):

As an oral formulation of a hypomethylating agent used in more accessible settings, the response rates are similar to intravenous decitabine, typically in the range of 15%-20% for CR in RR AML settings, but can vary based on combination therapies.

Sorry missed a bit - FDA do allow tweaks along the way depending on what those tweaks are if they are unforeseen tweaks that are beyond the parameters that have been defined in the IND then a discussion / supplement to IND may be required prior to proceeding.

Well in the case of RR AML where patients have limited options due to the aggressive nature of the disease and it’s resistance to standard treatments I would imagine even modest response rates are significant. I can’t put an exact value on it but for instance 20-30% of patients responding whether that be complete response or partial response would probably be considered promising enough to proceed to further trials: anything better than that is very promising. Because the are so many intra patient variabilities it is difficult to say whether or not you would be able to determine signs of efficacy in a single patient - but if you did see any sign of response in the first patient infused it would be significant. In RR AML where effective treatment options are desperately needed even small improvements in response rates can be clinically significant. Maybe to get an understanding of what constitutes success look at the clinical data from Ivosienib, Enasidenib, Gemtuzumab or Gilteritinib in terms of response rate - think Venetoclax is used off label too for RR AML.

Don't think it has much to do with prevail the number of patients tested they are just monitoring the trial and analysing the data - comes down to recruitment (how many patients are currently being treated for AML at the centre for clinical, how many go on to have RR AML and of those which meet the criteria of having FLT3 overexpression and of those how many sign the consent form to have a new CAR-T treatment. When you put it in this context you can see that it can take a while to get a study going considering AML will affect less than 1 in 10000 . About 75K living with AML in the states currently and about 20K new diagnosis per annum. Having said that the patients who do go on to have RRAML have very little treatment options left to them save perhaps bone marrow transplant which requires a donor with a matching human leukocyte antigen (which takes time - unless already available from databased donors) and a horrendous conditioning regimen which most older patients wouldn't survive anyway. So I think there is a very good chance that the trial will successfully recruit.

The irony is not lost on me that you talk about emotionally distancing oneself from investment decisions …. yet you are still posting about a share you sold two years ago.

CBR has absolutely unbelievable potential and CAR-T might be the cash cow to allow Hemo to realise some of that potential

No - not new : certain neurodegenerative disorders in scope - but i think only those that are related to accumulation aggregated misfolded proteins like beta ameyloid for example- might mean though that parkinson’s huntingtons, cruetzfelde-jacob and amyotrophic lateral sclerosis are in scope as i think they are also associated with accumulation of misfolded protein - the principal here is binding and immune cell clearance of the aberrant proteins i believe.

In truth I have no idea about the financial side - but if they have developed what I think they have then the financial side will take care of itself IMO. It is plausible that a deal could be done at any time but they will need to show efficacy before the big deals are struck - that is the gamble. A whiff of efficacy and this is worth many multiples of the current market cap whether that be 1 patient or 3 I dont know.