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Some gene therapy insights from Q&A with Carl June from UPenn

https://www.biopharmadive.com/news/carl-june-in-vivo-car-t-capstan-tmunity/633980/

Friday 29th September is the due date for the Interim Report. I hope the board meet to approve takes place on Thursday 28th (or earlier) so they are out at latest first thing on the Friday, rather than leave the approval until the last day (US time) and we end up with a late RNS on a Friday afternoon.

If things are going well I'd expect an update before then though. But it's an increasing probability that the Interim Results will be the next RNS, the development progress, testing and possible contract negotiations always seems to take longer than we would like.

Still, there's always the website update to look forward to - per PR (30/06) - "it's in hand"!! So far they seem only to have removed Andrew Wright.

It was good to hear the Chairman contribute to the discussion at this AGM.

Here's a final reminder from him:

'I think the scientific progress is really good and now the company is at a turning point but the scientific progress is now becoming focussed on the regulatory process to get it into the clinic so that's a very important step for a small biotech company, and I think it's important to remind you that many biotech companies do not reach this stage; they can do good science but they can't link, so I think Vladik and his team are to be congratulated on having successfully negotiated a very major transition to have delivered an IND to the FDA.'

I was just posting some extracts from the AGM, no reason other than to keep people informed (as I was too busy to do so to this extent at the time). There have however been some recent articles that reference further uses of Kymriah in combination with other products, so one would think HEMO CAR-T is in good hands.

Here's another quote, which expands on the positions of the BSL3 studies at the time of the AGM. I posted a bit on this last week, but this is more confirmation. I think it was in the context of the testing of the CBR for SARS-COVID-2 (rather than for any other virus).

'we are doing in vitro studies in BSL3 facility. We have to complete these in vitro studies first; and actually we are not doing them, the people who work in the BSL3 facility, that's completely disconnected from us, institution, they are doing these studies and when they report the results of these studies only then will we decide if it's worth going in vivo; meaning that if the results of in vitro studies are positive then we will try testing in vivo. If the results are negative or they are not conclusive then either we will repeat something or we will say that it does not work but at this point it is unclear when it's going to happen because science is unpredictable, and also as I just said it's being done by a third party.'

I am assuming that testing for some potential applications of CBR (eg measles) does not require a BSL3 facility and therefore could be progressing in parallel (or it might not be due to priorities).

It's strange that the January RNS, and subsequent April financial statements both referred to in vivo studies being carried out. Perhaps there is a iterative cycle of improvement and testing; or maybe the BSL3 facility people wished to conduct their own in vitro tests to their satisfaction first - and maybe once that was realised the placing was required to fund the extra work - a part of it was for continued development of CBR).

'Upenn gave us a new principal investigator so it's not going to be Saar Gill. I'm not going to tell you the name of this principal investigator except that this principal investigator is one of the people who actually participated in the development of Kymriah for Novartis.' - VS

"we will keep using money but we are ok for now" - VS

and

"we maintain 100% ownership of CAR-T we don't have a partner at this stage, and likewise CBR; that's not to say we are not looking at the possibility of bringing partners, it's not the appropriate time, it's not necessary; it's certainly not necessary at the moment with CBR we are moving ahead quite well and in due course we may need equity in the market, but we are not looking for equity in the market at the moment let's be clear; and we may bring in partners in the future but we don't have partners in in CAR-T or CBR. And as far as CDX is concerned there are some ongoing discussions but it's pointless to tell you, we can't until they resolve, they are confidential." - PR

At the AGM (30/06/23), Vlad gave the following update:

"We are actually developing CBR rapidly right now, and this is the second area of intense focus of the company after our CAR-T programme. So we have certain new results and and we're talking to the government of the United States regarding our CBR programme that could potentially be used for the purposes of biodefense.

It is too early to give a detailed update but the moment we can, we will update our shareholders of the most recent developments. The one thing I can say is that the portion of CBR that we are developing for the treatment of SARS-CoVid-2 is actually progressing well and as we speak we are doing in vitro studies at BSL3 facility that belongs to government organisation; trying to figure out if our approach is good enough to fight live infectious SARS-CoVid. So these experiments are ongoing and the moment we have results we will update our shareholders."

At the AGM he definitely seemed to say "in vitro" rather than "in vivo" - even though the January RNS and later Annual Report mentioned that "in vivo" tests had started at a BSL3 facility. Perhaps there is further work that can be done "in vitro" to refine this portion of CBR before further "in vivo" testing.

At the AGM he did not make reference to the anti-cancer portion of CBR, he seems to have gone quieter on that, though it was mentioned in the Annual Report that work was still progressing with respect to CBR's applicability to the treatment of certain cancers, so perhaps that development is just less advanced (farther off).

With little alternative, I'm sure AML patients within access range of the trial sites will be asking if they are eligible for the trial and if so pushing to get on it. It will be a case of how many and the breadth of locations are the trials being undertaking at - we know that Vlad is hoping to have more than just UPenn (but how many more)? This depends on the partner(s).

"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."

Dhub,

1.512 was the ask price at the start of this morning; the 1,250,000 trade is timed at 8:32 but was only posted an hour or so later. So pretty certain this was a buy (not mine unfortunately). There have been a few buys of this size over the past week or so. One poster mentioned picking up 3m. Once they're gone they're gone!

Let's not forget the seminal provisional patent application submitted for CBR Platform.

We were told about the submission by RNS on 16/03/22. It lasts for 12 months, after which Vlad (at that time) indicated that they would then switch it to an International patent; and shortly after that switch it would become publicly available for all to read (he suggested that would be around 18 months from the original application - March 22?). I think he indicated at the AGM that the patent would be publicly available around August time. He gave the impression that publication was not a concern - as things had moved on a lot since that.

That suggests to me: that CBR has been progressing, that work has started on the International patent, and that a CBR/patent update should not be far away.

Two days prior to the AGM it was noticed that HEMO's Company Secretary changed from Andrew Wright to Ben Harber. There was no mention of this at the AGM (in fact AW was in attendance), and there has been no announcement made since (presumably it doesn't need to be announced).

Andrew Wright, who was the holder of 4 million shares at an average of around 2.3p, was for a number of years also HEMO's Financial Controller.

https://uk.linkedin.com/in/wrightbyname?original_referer=https%3A%2F%2Fwww.google.com

Per AW's updated LinkedIn page he took up a new role with TPRM Product in June 2023 and seems to have ceased his other roles within Thomas Murray prior to that. He has also removed references to his positions of company secretary and CFO with HEMO.

Has he ceased his Financial Controller role with HEMO also? I am pretty sure he used to appear on the 'People' page of HEMO's website - he isn't any longer (maybe that's the promised website update!).

This raises other questions - who is current Financial Controller, is a new CFO appointment being sought/imminent as part of continuing growth or is Vlad taking the opportunity to make cost savings due to the delayed timetable?

HEMO's new company secretary, Ben Harber is based at Shakespeare Martineau LLP, who operate at HEMO's registered office address, so that seems appropriate. He has a CGI qualification and does not appear to have an accounting background for the Financial Controller role.

Are there any requirements with regard to Financial Controller or CFO of a UK listed company - eg qualifications and location? Do a majority of directors need to be resident in the UK?

I am not sure what to make of HEMO being included in DB's TMS list.

To me, it's not something to be proud of, it totally downplays what HEMO is about; and it casts doubt over TMS's authenticity.

How can you compare HEMO with a mining company?

How can you understand both?

Well obviously there's someone that purports to -- PR director of HEMO and URA - personally I cannot see how he has the skillsets required for either!

If he is in situ as a finaning expert - why hasn't he brought it? (Mint!, cheap placings! payments to finance arrangers).

Director designated for shareholder communication - so many of you complaining about lack or quality of communications.

Your call next year!

The AGM recorded just 16.4% of share in issue voting.

10.7% of those were directors and persons linked to the company (per the AGM Notice)

There's allegedly some very large shareholders on this board that must in aggregate represent greater than 5.7% of shares in issue - did you not vote? Why would you note vote?

The London Stock Exchange have updated their website recently.

It's most amusing to see that there is an error of a factor x100 in their trade value column, such that the trade value shown suggests that the HEMO share price translates to £1.40 rather than 1.4p. According to today's report there was a large trade of over £1m today rather than £11,000.

A Freudian slip? subliminal messaging? did JHFH hack the programming? or just a sign!

Mr I - to whinge or not to whinge - that is a matter for you to decide. Vlad doesn't have control over that, surely.

In attendance at the AGM (and a serious shareholder) the opportunity was afforded you to ask your questions then.

To buy or not to buy, is this a dip? - matter for me to decide - no fuss, thank you very much.

He's also the CFO, is he continuing in that role? - or is it time (soon) for a new full-time person with a position on the board?

Here's some news anyway:

Two days ago (just before our AGM) there was a change of company secretary:

Resigned: Andrew Wright (was the holder of 4million shares at an average of just of 2p, does he still hold them I wonder or has he been selling this week?)

Appointed: Ben Harber (of Shakespeare Martineau LLP, which is based at the company's registered office address)

Also noted from Companies House that the company has not yet filed its 2022 Financial Statements - due by today. Not sure why they wouldn't already have done that as they were approved at the end of April, or what the implications of not doing so would be.

A little irony in the thread title.

It would appear that AGM agenda items 3, 4 and 5 relating to the proposed re-appointment of PR, AS and VS respectively were added after the initial draft of the agenda as the references in Resolution 9 to Resolutions 5, 6(a) and 6(b) should be to Resolutions 8, 9(a) and 9(b). There's also reference to a non-existent Resolution 8.1.

I also noted that the Notice of AGM refers to the Company endeavouring to publish and maintain on its website in advance of the AGM a list of questions raised prior to the AGM by investors together with an appropriate summary of responses - nothing on the website yet.

SB

Appreciate your thoughts behind that post; and I would just like to add that in my opinion Dr Sandler is assembling a great team of exceptional highly skilled and compelled younger scientists (Michael, Elina, Ronen and now the computational biologist, Paula?) that I hope will become the backbone of HEMO for years to come. With a long term investment horizon for me this is about them coming through now and leading the science.

The seeds are sown, I believe that a fountain will flourish, hiccups (such as this) have to be expected along the way but these people have the character type that will find a way.

A summary of key points for me from yesterday's interview were:

- clinical holds are 'not uncommon'

- Vlad described it as a 'hiccup' - 'unlike the market we don't recoil when faced with a hiccup'

- they aim to fulfil the FDA's requests 'as expeditiously as possible so we can move ahead into clinical trials'

- they 'anticipate what's the real reason for the clinical hold and we are already working and moving towards the resolution of this main concern of the FDA'

- with regard the parties already in place for the clinical trial - 'there's no indication that they are going to lose anyone'

- impact on cash: it may lead to additional spend in order to get into clinical trials, which 'will change our cash position eventually'

- CBR is 'truly a novel treatment' and 'is poised to change the way we fight viral infections'

- moving forward with CBR 'on several fronts'

- CDX continues to be developed and attract interest from potential partners

- potential partnerships: 'I cannot talk about it right now; in due time when this partnerships... materialise we will obviously announce it' - possibly referring to CAR-T but equally could have been any or more than one of product candidates

- later, (again on the subject of partnerships) he said they are talking to several entities; 'I'm not sure who's going to be our partner, one or more than one, and then regarding which product candidate, but we will definitely succeed partnering and developing ..(you know).. and getting more resources'

- seemingly new company policy: 'only tweets that basically reflect regulatory news are being released'

- they have 'almost completed video interviews with different people inside the company that we are planning to release in the near future'

- companies that are developing cell therapies typically have a market cap 100x that of HEMO and also cash of 50-100x that of HEMO

- the future: 'very very optimistic about it'

TMS happy with title: "FDA questions no stumbling block for Hemogenyx Pharmaceuticals"

My thoughts:

So unlike larger companies HEMO's current 'nimbleness' remains a strength and should enable them to make decisions quickly that address whatever changes are needed in order to have the clinical hold lifted and to commence their first clinical trial. But the comment about 'getting more resources' towards the end seemed quite telling and I just wonder whether HEMO's small size and therefore limited availability of resources is one of the FDA's concerns. A partner's commitment might be something that would address that.

I'd also suggest that the videos that are being developed might be part of additional information released around the AGM at which point perhaps we will get a more complete update on all product candidates (noting that they should have had the FDA letter by then; though I hope it is with them much sooner). Were videos in 'antisipation' of going clinical?

Holding status: 'Poised' - ready for future progress of CAR-T, CDX and