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In memoriam:
https://www.youtube.com/watch?v=FKTG96-DeYw
Remember that there has also been, and is, a clock ticking on CBR too.
They only have until approx September this year before the patent becomes available to all and others can see what Hemo has been experimenting with - so I think particular scientists will have had to have been flat out on that too (whilst investors here have been focused on CAR-T and IND).
Vlad said in one of last year's interviews that CBR had the potential to move quickly (well that was a while ago now). We had the CBR update start of January, which seems to have been as a result of or in order to be discussing CBR's potential with interested parties/funding sources when he was attending conferences.
I don't expect them to want to concede any first mover advantage on CBR - the fountain's effervescing nicely.
Hue Quach joined HEMO August 2022 from Memorial Sloan Kettering Cancer Center Prasad Adusumilli Lab
See below for an insight in to the skills she brings including what seems to be a relatively recent particular focus on science to combat solid tumours as well as CAR-T therapies.
https://www.linkedin.com/in/hue-quach?original_referer=https%3A%2F%2Fwww.google.com
https://pubmed.ncbi.nlm.nih.gov/36448335/
https://pubmed.ncbi.nlm.nih.gov/33972125/
on the subject of grants - some interesting new regulations between BARDA and FDA mentioned in the below news item from January this year - given Hemo's decision to move to new labs and have them certified GMP compliant last year were they aware that these new regs were coming; they certainly seem to aiming to meet required funding criteria in all areas - fund raise, innovative platform tech for CBR and compliant lab facility.
https://www.raps.org/news-and-articles/news-articles/2023/1/budget-law-calls-for-barda-and-fda-to-establish-wa
Some things to take a closer look at in the numbers but - the very last paragraph of accounts 'subsequent events note' states:
"The Company has entered into a preliminary agreement with a service provider that it is anticipated will project manage and supervise the running of Phase I clinical trials for its HEMO-CAR-T cell therapy subject to negotiation of a Master Services Agreement."
Is that the new information disclosure?
HH
I just think that if they are expanding and new activities/collaborations are going to be happening then I'd be very happy to see an additional full-time executive board member, particularly one on the US side where the core business is developing. That would ease some of the pressure off Vlad, who seems to have to be driving this on his own; although I think more and more that the principal scientists are starting take leadership of the scientific developments side now.
We have (or I think we still have) a board observer in Dr Alan Walts but my interpretation is that some other investing or collaborating party insisted on his involvement at that time (I may be totally wrong there; and indeed can we be certain that he is still in situ). His LinkedIn page suggests that he is; but there is nothing to evidence it.
In any case all of the other board members either have significant other employment interests outside of Hemo; if Hemo is to stand alone then it needs appropriate corporate governance structure and this has to happen at some point - and I don't think that time should be far off. Perhaps the board believe they have sufficient cover for everything - certainly a matter for clarification at the AGM.i
I did predicted the need for bigger/better lab space - I think that this is a bit like that situation - it's time to grow!
Not mentioned by anyone yet, but I'm wondering whether the Annual Report will bring news of corporate governance enhancements or changes. The company has grown and we believe it is set to grow further.
Cyrox surmised:
"Strong floor and an open roof"
That sound like someone else that considers HEMO might be a fountain!
For those that need to trade some, do, but perhaps think about keeping a few in reserve so you can enjoy being part of this investment story, with its ups and downs, along with those of us forever in Group 1.
.....except that some of the board probably don't want a meeting on a Friday before a long bank holiday weekend!
Last year it took them all day (and beyond 5.30pm) to get them approved by auditors and then signed off by auditors for release. Given their locations board meeting would be UK pm.
Hopefully the Finance Office/Company Secretary has planned ahead this year.
Because this is the latest RNS statement information issued re: IND submission status:
https://hemogenyx.com/investors/investors/announcements/announcement/2023/hemo-car-t-analytical-release-tests-completed/
We should get a further update on any further progress with the Annual Report, hopefully out on or before Friday 28th April.
Hoping the following might help those seeking relevant research re HEMO CAR-T and safety considerations which have previously referenced in RNS:
Firstly HEMO CAR-T targets FLT3 ligand (CD135) - this is a different target (but other institutions are also working on it as a target).
The FLT3 cell-surface receptor tyrosine kinase (CD135) is expressed in a majority of both acute lymphoid leukemia (ALL) and myeloid leukemia (AML).
HEMO CAR-T is an autologous therapy so I think that means that GvHD is not an issue (as it would be with an allogenic therapy).
As regards safety in October 2020 Hemo issued the following RNS that referenced SAFE HEMO CAR-T:
https://hemogenyx.com/investors/investors/announcements/announcement/2020/car-t-cells-with-a-safety-switch-are-effective-against-aml-in-vitro/
Subsequently it was again reference in the Master Translational Agreement with UPenn, perhaps as a subsequent add on, since work with UPenn on HEMO CAR-T had already started by the time of the SAFE HEMO CAR-T RNS:
https://hemogenyx.com/investors/investors/announcements/announcement/2021/car-t-master-translational-agreement-with-penn/
In the following publication, Hemo referenced that they were currently testing the safety mechanism to help prevent cytokine release syndrome.
https://ashpublications.org/blood/article/136/Supplement%201/4/473807/Preclinical-Development-of-Anti-FLT3-CAR-T-Therapy
So it looks as though Hemo have already given considerable consideration to enhancing safety aspects of their CAR-T therapy in creating a mechanism that will help prevent cytokine storm; whether that is to the satisfaction of the FDA remains to be seen. Perhaps work has been continuing at UPenn on that aspect and maybe they are almost there with that too.
As a committed and hopefully very long-term shareholder I intend to be there; work commitments prevented me attending last year and prior year was online only.
Last year I too asked some questions by email but they were not referenced. The prior year most of the questions seemed to come from a single investor as Vlad kept quoting the same name and avoided (someone of importance to Vlad or another board member?). There were probably only 10 or so questions that year, and no mention of the Mint fiasco that had been terminated just a month earlier - even though that was clearly a matter of significant impact on shareholders.
Will this suffice so the board can move on?
From the 29th September RNS - the first of the Key Highlights at the very top - in fact it seems to be the very Key Highlight that you have referenced the first part of on multiple occasions; though neglecting to state it in full:
"Key Highlights
ยท In final stages of preparation for filing an Investigational New Drug ("IND") application to commence clinical trials for HEMO-CAR-T, following positive feedback from the US Federal Drug Administration"
It states "positive" rather than "detailed" - but arguably "positive" is more informative for shareholders as "detailed" would not infer either positive or negative in Hemo's progress towards IND submission.
"the rest of the board....."
IMO therein lies the problem - where were the 'rest of the board' with the due diligence review regarding Mint funding (or even the initial funding given the alleged criminality of some of them in the US); the CV's suggest a financier, a lawyer and chartered accountant as finance officer and company secretary. Mint fiasco, financial statements released after close of business on the final day just avoiding suspension last year. The evidence suggests that they are not spending the time or focus that is appropriate for corporate governance of a public company.
How they can get away with a website which is so out of date is another mystery. Where is the regulator?
Hoping others will be at the AGM to express these concerns face to face. Time also to research the Articles (which I think they changed relatively recently). There needs to be a proper corporate governance for the protection of shareholders.
Thanks for posting the details re: the grant awards.
Just one thing concerns me - that: "each Awardee will be appointed an Industry Mentor" - or words to that effect.
I can't believe that Vlad will want anyone else near CBR yet, nor a mentor - sharing and listening (I've not seen any evidence of that characteristic so far). I guess if awarded, he will just plough his own furrow regardless.
However the matched funding certainly ties in with recent fiund raise and is required for any amounts > $2m so perhaps he may have achieved an amount of funding, but less than the $4m that the company raised.
PK1, unfortunately I'm not of a science background - it's just that this subject has captured my scientific interest.
Based on the fact that:
- AML is very progressive (estimate 18 months to live after diagnosis) - witnessed;
- left untreated, leads to ever more frequent blood transfusions to try to delay its progression - every 4 to 6 weeks - also witnessed;
- the mouse trials showed results after just a number of days; and
- previous BBC press articles reporting the miraculous cures (although it was for ALL) of a couple of UK patients who having exhausted all other options had their T-cells sent to America for processing, and then following expansion, return and injection back into the patient, it was reported that the patient was clear of ALL within three to six weeks (I think) and in those cases reportedly continues to remain clear years later
So I think that with daily monitoring they will know how effective it is for each human trial patient within a matter of days/weeks from the patient receiving his/her initial Hemo CAR-T treatment - though the trial phase will presumably need to run its course in terms of numbers for validation (maybe that could take a year, but maybe less). I do not think that there will be a shortage of trial patients - and would hope that they are already being lined up.
And so, Vlad's version of Walter Mischel's Marshmallow Test is almost upon us:
If:
Marshmallow 1 = Hemo CAR-T
&
Marshmallow 2 = CBR
(or might it be the other way around; and with CDX still in play somewhere, who's to say that there isn't three marshmallows, or more, in Vlad's experiment).
Will you be patient enough (and brave enough) to wait?
and this subsequent comment from Vlad also referring to it.
https://twitter.com/vmsandler/status/1616491359086718976?cxt=HHwWgMDRjfOU9-4sAAAA