Member Info for Hulver

I think it was in at least one of Vlad's interviews last year (possibly for TMS) that he said that he hoped that they might partner with one or two other hospitals (in addition to Penn) so that would seem a rational explanation for the late fund raise (if successful completion of the PQ runs was a requirement to start engagement discussions with those other hospitals which would broaden, and accelerate, the initial trial) and the extra time that it is taking and as I have previously noted it would not surprise me if there was some connection with University Hospitals and the Seidman Cancer Centre through Dr Koen van Besien.

Wouldn't the IND require to include details of who, when and where the trials would be undertaken?

I too consider that those details might still be being finalised to satisfaction of all parties - the terms agreed, responsibilities, timelines, written consents and confirmations etc before the IND can go in.

I also happened to be contemplating this earlier today and my line of investigations were drawing me (for no particular reason) towards BMS (whom I don't think have been considered on this board previously) as another possibility - offices NY and Washington. Recently cleared out some of their therapy trials.

'good quality products' - this published paper reported HEMO CAR-T quite favourably in comparison with their existing 'gold standard' CD-123 CAR-T (by UPenn).

https://www.sciencedirect.com/science/article/pii/S0006497121036673

It's approximately six months since the new lab/clean rooms were passed. Could this be half-yearly simulation testing (also required) to maintain that certification; that certification would be needed in order to proceed with clinical trials and therefore probably needed before IND submission/acceptance, important since Hemo are going to be producing HEMO CAR-T in their own lab! Does anyone with experience of the process requirements have any thoughts on this possibility?

"The net proceeds from the Placing will be used to facilitate progression of the Company's HEMO-CAR-T product candidate into clinical trials and to enable the Company to continue development of product candidates for the treatment of viral infections based on its Chimeric Bait Receptor ("CBR") platform."

so should we now expect that clinical trials will take place at a second institution as well as at UPenn (Vlad had previously alluded to that hope/possibility)? It seems a rational reason for additional upfront funding - especially as some of it is designated for CAR-T trials per the RNS.

Isn't this just normal process?
It would not be appropriate for Hemo to sign off on its own work.

Positives - at least, after just the minimum three PQ runs, Hemo are at this stage of being able to request the external certification!

Not sure that I fancy retirement.

But my hope is that my Hemo investment provides family security and plenty of additional funding that I can put to good use in sponsoring projects/opportunities for young people in the wider community, things that will keep me busy (and a new job) for as long as I can.

.......and hence the 'unexpected' placing.

So a shareholder (such as Cornell) would need to know the exact number of shares held for what I wonder......?

.........for completing a TR-1 (number of voting rights held are disclosed).

or perhaps a TR-1 was submitted and from it the discrepancy was discovered by the Nomad.

In Vlad's position you would want Cornell, whom he left in order to deliver Hemogenyx, and who supported him to do so to participate in Hemo's success, and did he not mention that he had reacquainted with former colleagues at JPM2023.

My earlier thought that the share adjustment could be to do with shares issued on incorporation would appear to have been proven incorrect following further research below.

In the 2017 audited year end accounts the Share Capital Note (Note 16) has a CLOSING position of 360,051,360 shares in issue.
In the 2018 audited year end accounts the Share Capital Note (Note 17) has an OPENING position of 360,051,358 shares in issue.

Per the 2017 Statement of Cashflows: at a placing in October 2017 a total of 4,437,075 shares were issued to pay off debt:
(i) the notes to the accounts refer to 4,008,504 shares being issued to Cornell University as 50% consideration (value £140,297) for the purchase of IP.
(ii) that leaves an additional undisclosed (as far as I can see) amount of 428,571 shares also issued in lieu of payment of a debt. At the placing price of 3.5p that equates to a £16,000 debt. I guess it is possible that this was for reimbursement of legal costs to Cornell for transaction (i), but it could be entirely unrelated.

In any case it seems that today's RNS is to correct this discrepancy between what was originally recorded as the shareholders shares and the number admitted to the listing and carried forward in the accounts since that date.

So that points to the discrepancy being found on / to do with the Cornell holding? Interesting.

Further thoughts:

This probably dates back to the formation of the company, when it (Silver Falcon) was formed as a shell. It is not unusual for just two shares (one each for two shareholders) to be issued on incorporation.

An extract from the post balance sheet event note of the first interim report shows:
"On 29 July 2015, the Company raised a further £24,999.99 through the issue of 2,499,999 Ordinary Share of £0.01 each to Catalyst Corporate Consultants Limited, a Company controlled by Peter Redmond. On the same date, Catalyst Corporate Consultants Limited also purchased 1 Ordinary Share of £0.01 each of the Company from Chesterfield Capital Limited, a Company controlled by Mr Geoffrey Dart, a Director of the Company."

There was also an issue of 4,999,999 shares on 13/11/2014, which presumably did something similar with another already issued share.

It therefore seems plausible that two shares issued on incorporation, whilst being transferred to new shareholders those shares may never have been admitted as shares on the exchange.

A tidying up exercise. So - What Is Next ?

Is one of those shareholders preparing to exit/transfer their holding ? PR perhaps? And they found this discrepancy - as they could not be transferred unless on the exchange ?

Is it not (partly) as a consequence of the following reported in December and I think also tweeted about at that time; was a Hemo competitor for AML treatment:

https://www.fiercebiotech.com/biotech/magenta-halts-high-dose-group-leukemia-trial-after-serious-adverse-events

Something for your Sunday.

Below is the link to the recording of the biodefense commission event that Vlad attended last September, and which adds weight to the theory that grants go together with the company's own raising of finance.

https://biodefensecommission.org/events/banding-together-partnerships-for-biodefense/

I would strongly recommend a listen to Panel 5 which is Dr Sandeep Patel of BARDA's DRIVe division and Labeeb Abboud of the Global Health Investment Corporation - that section is from 3:58:32 to 4:42:00.

This clearly highlights that their goal is to get finance to where it is needed, timely.

Dr Patel noted the strength of (preference for) products which have multiple applications when it comes to allocating financing (isn't that what Hemo has?). He also mentioned the array of businesses that they assist. Mr Abboud represents a not-for-profit organisation that CO-INVESTS alongside other investors.

BARDA articles are (or were) also referenced on the linked in pages of a couple of Hemo's staff.

For Tilly

https://www.youtube.com/watch?v=2H5uWRjFsGc

one of the sowers of the seeds of doubt's questions has been answered today, that risk has gone (at least for another while).

cheers all!

Sure seems to be ....

"Big locomotive right on time,
Big locomotive coming' down the line"

https://www.youtube.com/watch?v=rQGbsMHIOI0

Vlad's "got the mainline sewed up tight"

https://www.youtube.com/watch?v=5yJmBC7cMTM

"Let it be known there is a fountain
That was not made by the hands of men"

da da da da
da da da da da

Vlad retweeted a tweet today with a comment referencing 'next step CAR-T production in 12 - 24 hours' - fits in well with the two clips I posted this morning regarding the Wesley Center at the Seidman Cancer Center, so I've reposted them for you below:

https://twitter.com/vmsandler/status/1616491359086718976?cxt=HHwWgMDRjfOU9-4sAAAA

https://www.uhhospitals.org/for-clinicians/articles-and-news/articles/2022/10/expansion-of-wesley-center-for-immunotherapy-at-uh-seidman-cancer-center-officially-opens

https://www.youtube.com/watch?v=x18WQ5ymXRM

UH Researchers at the Seidman Cancer Center have developed a method of producing CAR-T cells in 12 - 24 hours and this 'Rapid' CAR-T was to be used for the first time in a Phase I trial that began in November last year. The Wesley Center at Seidman is where Dr Koen van Besien (HEMO's long term adviser and recently appointed medical director for clinical trials) is based (possibly in charge) – he comments in one of the clips - "we are in a unique position". A great connection to have and perhaps HEMO might be using them for part of the forthcoming HEMO CAR-T trial. He's also a shareholder!

From the appointment RNS:
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
"We are excited to welcome Dr Koen van Besien as Medical Director. Koen's rich experience and deep insight into the cutting-edge treatments of patients suffering from blood cancers will undoubtedly help to accelerate Hemogenyx Pharmaceuticals' product candidates, and specifically in the short term the transition into the clinic of HEMO-CAR-T, our lead product candidate."

Dr Koen Van Besien, Medical Director of Hemogenyx Pharmaceuticals, commented:
"I have been privileged to work with Hemogenyx since its founding. It is great to see their research efforts come to fruition and I am committed to helping bring their first product to the clinic."

Wouldn't it be a joy to be reading reports of patients who have been 'free and clear' of AML as a result of HEMO CAR-T.

We're getting closer!

Hopefully we will find out where the HEMO CAR-T trials will be conducted and I am hoping the potential additional one or two hospitals (that's additional to Penn) that have been referred too by Vlad might include University Hospitals The Wesley Centre at the Seidman Cancer Centre, where Dr Koen van Besien is currently appointed.

They have also been involved in the development of a process for producing CAR-T within a much reduced timescale, one to two days, and are reported to have begun initial testing of that process last November, with the aim of rolling it out to other forms of CAR-T in the future. Might HEMO benefit from that?

https://www.uhhospitals.org/for-clinicians/articles-and-news/articles/2022/10/expansion-of-wesley-center-for-immunotherapy-at-uh-seidman-cancer-center-officially-opens

https://www.youtube.com/watch?v=x18WQ5ymXRM

Is there likely to be much to do between PQ3 results and IND submission - or is it possible that the next RNS will say that following the completion of PQ3 an IND has been submitted? If it's only likely to be a matter of days is it worth them making two announcements - any thoughts?

Another one bites the dust:

https://www.reuters.com/business/healthcare-pharmaceuticals/jj-discontinue-hiv-vaccine-trial-2023-01-18/?taid=63c857f89dbb1600019b14bd&utm_campaign=trueAnthem:+Trending+Content&utm_medium=trueAnthem&utm_source=twitter

=> CBR needed for HIV