Member Info for Haywain

Pingu - you know what my views are : read my previous post.

In my view hemogenyx represents one of the most asymmetrically undervalued biotech opportunities in the industry today. With a team of less than 15 people they have achieved on a budget of circa $20million what other biotech companies have taken $100M's to achieve. An alignment of valuation to Hemo's peers for CAR-T alone disregarding the fact that they have an FDA approved GMP manufacturing facility and a pipeline laden with scientific breakthroughs would see a 10 fold re-rate with fair valuation being in the $100M's. I steer away from talking about the financial side of hemogenyx or commenting on the day to day movements in share price as this isn't where my skills lie but I appreciate that in order to raise funds to develop the remainder of their assets it would be a lot easier if their market cap in any way reflected their peers. I struggle with this site because instead of focusing on the potential of hemogenyx pipeline both for investors and patients alike which represent major scientific breakthroughs across the board we have somehow attracted short termist traders, shorters and absolute nut jobs. Well I suppose from a financial perspective I should thank them because the current market cap is unfathomably low as a result. Initiating phase 1 clincial trials opens doors to some more sophisticated investors and specialist oncology investment institutions my hope is Hemogenyx get the funding they and patients who might benefit from their brilliant science deserve.

We actually already know it works as demonstrated by chimeric mouse model. It’s whether the safety and efficacy profile that has already been demonstrated to effectively eradicate AML in the mouse model translates to humans. My guess is that it will based on the fact that this is not a standard humanised mouse but one specially developed by hemogenyx using human stem cellls to populate the immune system. Ie the mouse actually has human immune cells rather than being engrafted. In terms of predicting the human response their model is about as good as it gets. That is why MD Anderson sought Hemogenyx out (not the other way around) based on their preclinical data.

I provided what I could towards this fund raise and I am excited to hear about Hemo’s clinical progress in the coming days and weeks. This is when we get to see all of the excellent preclinical work that Hemo have put into developing Hemo CAR-T translate into meaningful treatments for AML patients which I believe it has every chance of doing.

Does this mean that we might get a few weeks where we can actually focus on what the company is trying to achieve - ie developing ground breaking treatments for relapsed refractory AML and peadiatric AML: diseases with devastatingly poor survival rates and limited treatment options instead of fixating on share price ? - I hope so. Financial debate is one thing but mocking or dissmissing the efforts of a biotech company developing treatments for critically ill children and adults reflects a staggering lack of perspective. If hemogenyx succeeds, it wont just be a financial win for investors it will be a life changing breakthrough for patients who have little hope. Maybe it is time for the conversation to shift to what really matters?

JRDC - its totally separate to the clinical trial time line as you can apply for it any time up to the BLA /NDA application - There are formal FDA review timelines for ODD - Its a separate department in the FDA - Office of Orphan Products development (OOPD) that independently verify & approve your application

The procedure itself it relatively straight forward and FDA can come back with an approval within a few weeks : officially it is 3 months they have to review the application

Yes there will waiver of FDA review fees which are a few million and faster review process -accelerated review - greater interactions and advice from FDA - and exclusivity after approval for I think 7 years that they cannot approve a similar drug for the same indication

Typically 28 days following first injection a bone marrow biopsy will be performed to assess for complete remission or measurable residual disease and assign the course of action for the patient. But as early as 7-14 days a reduction in AML blasts in the peripheral blood would be the first early sign of efficacy which would be confirmed by the bone marrow biopsy. We are weeks away from the medics running the trial getting an initial read on Hemo CAR-T with patient no 1 which is incredibly exciting. Best of luck all and especially to the prospective patients receiving this potentially curative treatment.

Agree that a deal is much more likely to be done (all being well with the data) early to mid phase 1 for CAR-T programs - and with the other points made by JHFH

If they find complete remission in the initial dose cohort - I would imagine (apart from there being a lot of excitement) that they may continue the escalation to better understand the dose response relationship and whether varying the dose impacts CAR-T persistence and or expansion and because of heterogeneity in the patient population there may be differences in effect at different doses - even if complete response is observed it provides a more rounded saftey profile for the study - but that is just my thought and I am not a oncologist clinician

Trial on clinical trials .gov - officially recruiting: https://clinicaltrials.gov/study/NCT06786533#participation-criteria

Still here - and still excited about the potential of Hemo's pipeline - Just not a lot to talk about at the moment as we wait for information about the CAR-T clinical study/US funding etc.

I am not sure when they would decide to implement it or even if the CAR-T program will still be theirs when this gets implemented but the fact that cutting edge 24hour manufacturing is being considered by a company developing their first CAR-T makes me think someone is thinking into the future of this being a commercial product. But to answer your question I would think that it would be implemented post phase 1 prior to phase 2 as it would likely represent a major manufacturing change and take some time to develop - they would need to do comparability testing and an IND amendment first before it could be implemented.

That isnt where I was going - I suggest you look at Kure.AI - they have had two phase 1 studies to date using their proprietary rapid CAR-T manufacturing process. UF-Kure19 (Anti-CD19 CAR-T) for non-hodgkin lymphoma and UF-KURE-BCMA (anti-BCMA) in relapsed or refractory Multiple Myeloma. Look at the papers that resulted from these two studies and you will notice two names of interest - Dr David Wald (founder of Kure A.I) and our own Dr Kohen Van Besien. Then ask yourself what companies do I know of that have commercial CAR-T's targeting BCMA and CD19? Hemo is certainly keeping very good company at the moment and the fact that Hemo CAR-T has been added to this prestigious company through their partnership with Kure - I find very interesting. The cast that surrounds Hemo is stellar and I am looking forward to some stellar results when the trial gets underway.

...my post was cut off - I will repost when I get a chance

Cost of manufacturing approximately halves with a 24 hour manufacturing process not that Hemo's cost of manufacturing is too high because Hemo is doing it in-house. But for the likes of big pharma with commercial CAR-t's on the market there is currently a race to reduce the manufacturing time

Moorscloud - I don't, however I imagine their inclusion criteria will be walking the tightrope of selecting a patient that is well enough to go through the treatment but that has measurable/quantifiable disease beyond a predefined threshold ie rrAML is indicated by >5% of immature leukemia cells (blasts) after treatment or relapse. So they will be looking for a patient that meets the above criteria + whatever else is predefined in the inclusion criteria.

What is weird though is that normally before a placing a crew of "AIMO's" appear prior to the placing to save us all from the impending doom and there is normally strange share price action in the lead up and immediately following any placing with all "AIMO's" leaving the chat until the next round of impending doom. That didn't happen this time (which is very odd) - have we moved on from the "AIMO's" or are there still a few stragglers left?

I cant imagine who the new poster is -

AIMO