Member Info for Hulver

ThanksJHFH,

My interest in this field is from a close experience of AML. I don't have a biology or medical background so I find this complex field challenging to read up on and understand (though I try) and so I really appreciate your taking time to share your latest distilled thoughts and that all makes sense.

Assuming that CDX has the much wider applications than just AML, as we think it does due to its bone marrow conditioning properties that are relevant for treatment of other conditions, then I think the ability to manufacture in-house could result in significant acceleration and expansion of the CDX product candidate (and perhaps that's part of the plan). We are not sure when they will be operational at The Mink Building. I also consider that there might be an element of IP protection in their decision to keep the manufacturing in-house and the expansion to a new lab suggests significant confidence (and perhaps we are turning into the home straight).

With CAR-T, one has to consider that autologous is least open to ethical challenge or set-backs and the best way forward for HEMO. For anyone needing this treatment it only really makes sense to use their own T-cells rather than add further risk of rejection and the complications for patients that that could bring. Autologous seems to me to be the nature-safe constraint to work within. Then if HEMO truly has found a SAFE switch with which to control the patient's CAR-T once administered then this seems a potentially successful product candidate for AML. Whilst each patient will require their own processing I think I have read previously that this does not necessarily take that long, perhaps just several weeks based on BBC reports of a UK patient whose T-cells had been flown to America, processed and returned to UK for treatment, and that she was clear of the cancer within a few months (ALL I think), and that was someone that had exhausted all other treatments.

Now that the above products are getting closer to realisation, I would hope that Hu-PHEC is back on the agenda, or if it isn't as shareholders we should be informed why.

Not long ago I speculated that HEMO might need to be moving to bigger labs; now bearing in mind recent announcements the thought has crossed my mind as to whether their first expansion is going to involve anyone joining them from any of the global co's that they have been working with, particularly with regard to CDX.

For genuine investors it is a shame that there is so little information from the company though I understand that confidential developments need to be protected. With having a genuine interest in the success of these products it would be great to have an investor day where Vlad and the scientific team could share more about their work. Hopefully the next of the promised more frequent updates is not to far away.

Link now attached:

https://www.biocentury.com/article/632368/bispecifics-spring-ahead-at-this-year-s-ash-sitc

The following report on bi-specifics was written after the conferences end 2020 but I can't recall seeing it posted previously (apologies if it has).

In any case gives a good overview and also makes the statement that manufacturing of bi-specifics is much easier than manufacturing of CAR-T, which may indicate where (and why) Hemogenyx is going with expansion to the new Mink building lab and manufacturing functionality. Earlier in the year, following completion of the collaboration agreement with Eli Lilly, Vlad was very bullish on the quality of Hemo's bi-specific antibody.

Continuing to hold.

Someone though seems to be preying on the small investor. IG NT to buy for anything < 200,000 shares and only then at a premium price, basically NT for anything less than £4k. Are they trying to fill a larger buy order at 1.95p by suppressing the smaller buys?

Today's RNS provides a possible explanation for the apparent push-back of HEMO CAR-T clinical trials. On 3rd February it was announced that 'The Company intends to initiate PhaseI/IIa clinical studies by the end of 2021/beginning of 2022' whereas in last week's podcast with TMS Reach Vlad said that the expectation for commencement of CAR-T trials was now summer 2022. Such development is somewhat frustrating as shareholders are consistently being told 'this will accelerate the company's development of its pipeline products' - time for them to stop using that phrase I think.

However and more importantly the signing up to new premises and the specific mention of CAR-T in today's RNS inherently suggests that the work with Penn on HEMO CAR-T has been successful so far. I don't think they would be doing this if any problems had been encountered in the IND enabling studies being undertaken with Penn - it must be getting ready to go trials.

and potentially very rewarding!

I wonder whether we will learn significantly more regarding future financing plans (or the extent to which financing is needed) when/if we are updated regarding the Orgenesis Convertible Loans due for conversion or repayment by 7 November 2021:

(Extract taken from the Mint Prospectus):

"on 7 November 2018 the Group entered in to the Orgenesis Convertible Loan Facilities comprising two loans. The loan amounts were for not less than US$1,000,000 each with the proceeds of the loans to be used solely for (a) the development of the cell therapy technology and (b) for the development of the Company’s AHC humanised mouse models and their use for antibody development, in accordance with the plans of the associated collaboration agreements. The loans carry an interest rate of 2 per cent. and have a term of three years. Orgenesis has the option to convert both principal and accrued interest into equity in Hemogenyx-Cell SPRL (“Hemogenyx-Cell”) and Immugenyx respectively at any time prior to maturity. Under the Orgenesis Convertible Loan Facilities the lender has the right to convert the outstanding convertible loan amount into either: (i) shares in Hemogenyx-Cell at a price per share based on a pre-money valuation of $12,000,000 or shares in Immugenyx at a price per share based on a pre-money valuation of $8,000,000, respectively; or (ii) shares of Orgenesis’ common stock at a price per share equal to the weighted average trading price of Orgenesis’ common stock for the three trading days preceding conversion. The full amount of the facility was drawn down by the Group in February 2020

In addition, to the extent that Orgenesis does not elect to convert the outstanding convertible loan under the Orgenesis Convertible Loan Facilities, the Group will need to repay the principal of $2,000,000 plus accrued interest in November 2021".

As I understand it the Immugenyx loan was in respect of AHC mouse development and the Hemogenyx-SPRL loan in respect of Hu-Phec.

What are others thoughts here:

- have recent events been focussed on unravelling the development contributions or legal obligations of previous collaboration agreements with Orgs and Eli, to the satisfaction of both parties;

- are we possibly looking at joint venture(s) of either subsidiary with funding provided on CDX/Hu-Phec or even CAR-T;

- could there be another Global Co in the frame for CAR-T ?

In my view HEMO CAR-T seems to fit quite well with ORGS focus and POCare Platform model; Vlad was in Maryland earlier in the year.

I am not sure Janus would be entering into such a property lease unless HEMO could clearly demonstrate the future financing for it. Similarly with regard to agreements with parties for CAR-T manufacturing and the high level personnel engagements and collaborations.

Im my view there is a much bigger plan in play here.

Extract of RNS 3 February 2021 stated that:

"The Company intends to use approximately £6 million of the received funds to achieve clinical proof of concept for HEMO-CAR-T for the treatment of acute myeloid leukemia (AML), including:

- approximately £0.5 million on completing IND-enabling preclinical studies that are needed in order to file an IND application requesting authorization from the FDA or other applicable regulatory body to initiate clinical trials and administer HEMO-CAR-T to humans. The Company anticipates completing these studies by September 2021;

- approximately £0.5 million on filing an IND; and

- approximately £5 million on completing Phase I/IIa clinical studies aimed at achieving clinical proof of concept and advancing HEMO-CAR-T towards later stages of clinical trials including Phase II and Phase III. The Company intends to initiate Phase I/IIa clinical studies by the end of 2021/beginning of 2022."

Per the first part of the above, the IND-enabling studies should have been completed and so it is "due time" for a CAR-T update.

We have to (ignore today's SP movement) consider the bigger picture, and HEMO's goals and future growth.

HEMO has now achieved control of CDX from which (I believe) a fountain of remedies for a number of currently life constraining illnesses will flow. For me there is now a solid foundation from which to grow and expand - the stage is set.

Let the plays commence, and our scientists take centre stage.

Let's hope all the recent activity with regard to patents, mean conditions precedent have now been met and a positive announcement can be made.

Due time to give us a ping Vlad, one ping only - let us know you are still there and that everything is still on track.

When Vlad deals the next CDX RNS update let's hope we don't find ourselves in Room 17 with Hermann muttering "Three, Seven, Ace! Three, Seven, Queen!".

I remain committed that this is a great company to be invested in and that the past eight months have been just one short story, of challenge and struggle, in this unfolding epic.

Best wishes to all those who have remained strong throughout.

Some random finds:
It seems that Carina Sirochinsky who gave the ASH 2020 CDX Antibody presentation

https://www.youtube.com/watch?v=A7ROU8npL40

has moved on from Hemogenyx in July 2021. One could read a number of things into that.

https://www.linkedin.com/in/carina-sirochinsky-44016084?trk=public_profile_browsemap

The following May 2021 publication from Hemogenyx affiliated scientist Raymond Liang indicates a further aspect of ongoing research into the development of red blood cells that he has been involved in.

https://ashpublications.org/bloodadvances/article/5/10/2490/476006/Mitochondrial-localization-and-moderated-activity

Interesting article on Orgenesis and CAR-T:

https://www.precisiononcologynews.com/cancer/orgenesis-tackles-cell-therapy-costs-barriers-decentralized-model#.YRf42y3MxsM

"Still, these therapies are considered the future of cancer immunotherapy because some patients with advanced cancers known to have notoriously poor prognosis, such as relapsed and refractory lymphomas and leukemias, have gone into long-term remissions. With growing demand, manufacturers are facing a host of bottlenecks and shortages. For example, there is currently a major shortage of viral vectors, a critical engineering component of cell therapy manufacturing, since the supply chain lags well behind demand."

We should therefore expect that things will take time (but that should be the same for everyone in this sector); hopefully HEMO have the right product, financing in place and connections for their manufacturing to be a priority.

Bearing in mind Vlad's latest tweets:

https://twitter.com/vmsandler/status/1424766668279099395
https://twitter.com/vmsandler/status/1424657262350635009

this summary review of Malcolm Gladwell's David and Goliath provides further breadth and depth to this story, and some interesting analogies for HEMO investors:

https://scholarlykitchen.sspnet.org/2014/02/26/book-review-david-and-goliath-by-malcolm-gladwell/

There seems to have been another graduate scientist recruited? - Michael Haugbro from Muir Lab, Princeton:

https://muir.princeton.edu/people/alumni/
https://muir.princeton.edu/michael-haugbro/
https://muckrack.com/michael-haugbro

Things happening and Hemo growing.

A star looks down at me,
And says: “Here I and you
Stand each in our degree:
What do you mean to do,—

Mean to do?”

I say: “For all I know,
Wait, and let Time go by,
Till my change come.”—”Just so,”
The star says: “So mean I:—
So mean I.”

(Waiting Both by Thomas Hardy)

Tuan,

not sure where you get just two staff plus Vlad from (those numbers seem a bit outdated) - now you can see there are the four lab staff (other than Vlad who is holding the camera) shown in the video (including I think one of the new recruits) plus Ronen, Raymond and Michael (also new). Some of the scientists have been promoted to senior scientists recently and new scientists joining - I like to see the business growing in this way bringing in new skills and retaining experience and research knowledge; though I am aware that Sydney did not stay with them that long having only joined last year.

As well as product(s) update does anyone else think that Hemogenyx may be looking at a change/upgrade of lab/US location, given the new recruitment(s), Vlad's short video of the current lab (looks small in size) and the comments Vlad made on recent business trip? It is noted as an incubator - does there come a time when small start-ups have to move on?

It may not be necessary yet, but such a move might well be a step in the metamorphosis to where Hemogenyx wants to be.

per 13 January 2021 RNS:
"if GlobalCo does not exercise the Option, Hemogenyx Pharmaceuticals will have three months to exercise an option to license the GlobalCo's intellectual property necessary to exploit the CDX antibody on an exclusive worldwide basis, followed by six months to reach an exclusive licensing agreement."

per 14 April 2021 RNS:
"The Company has now received notice from GlobalCo that it will not exercise its option to license the Company's intellectual property. Accordingly, the Company has given notice to GlobalCo of its intention to exercise its own option to license GlobalCo's intellectual property on an exclusive, worldwide basis."

From the above shouldn't we be expecting a further update by 14 July as to whether Hemo has exercised its own option having only given its intention to do so on 14 April, or does anyone think that we started the six month agreement negotiation period and therefore finalisation of any agreement may take until 14 October?

As things stand I am expecting further CDX update in July, though in typical Hemo fashion I also expect will probably be vague and make use of the opportunity of dragging out anything concrete (including the naming of Globalco) for a further six months - but confirmation that Hemo had exercised its option would suggest there is agreement in principle with just the finer legalities still to be worked through.