Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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
Sorry, not intending to take words out or ignore context - my point is more why have the words "to the effect" been included in the RNS ?
Those three words could have been left out and it would still have made sense and construed a clinical hold; so were they deliberately included for a reason ? Perhaps there is a reason perhaps there is not - just my thoughts.
HH,
All good. A solid hold for me.
I get frustrated that things/risks that I see as being easily within HEMO's control are not kept on top of/mitigated.
I did think Friday was the deadline day for us last week (as I considered it the last day that FDA practically had to decide/notify if they were not yet comfortable for the trial to start yet). So it was not that much of a shock to me, but when there was no RNS at 7am I was beginning to hope we were there but knew we had until end of the US day before I could really start to consider that. As I am an investor here, even with that possible RNS outcome considered, I had no intention of selling even a small amount either to hedge the risk or to try and make an extra gain over the long term.
Thank you for the invitation to join the Twitter group but unfortunately I am not on any social media (out of choice) and have no intention of changing that status in the short term. So I will continue to share here any information that I come across which I think may be of interest to investors - and leave off posting when the board is subjected to a wave of inane posts. It's been an education!
If I decide to go to the AGM, I will make contact there.
From the AGM notice:
"Shareholders may access the AGM remotely, follow the business of the AGM, and subsequently view a shareholder update by Company management by webcast via a video conference call." - so looks like there will be a more complete presentation "shareholder update" on pipeline progress at the AGM.
Three directors (PR, AS, VS) are retiring by rotation - putting themselves forward for re-election. I'd like to have some justification as to why the board recommends the re-appointment of PR and AS. What do they bring in their role - financing has not gone well and been costly, and the other brings a significant conflict and could input as a significant shareholder? Any ideas how we get that justification - when imo it isn't apparent in the outcomes of the past few years?
Also, anyone any thoughts on why Resolution 10 - shortening the notice required for calling an EGM from 21 days to just 14 days - might have been included this time (and not previously or at the outset). This seems to just impose restriction on shareholders - any significant events requiring shareholder approval ought to be known well in advance that the normal notice could be given to allow due consideration. HEMO seems to have very few institutional shareholders - I could perhaps understand it if there were few shareholders such as a private VC company, but even then corporate would need time to consider transactions and unlikely to agree to this reduction. I have copied the wording of the resolution below - it requires a 75% majority (presumably of those votes cast at the meeting). The M&A's were amended not that long ago and this was change was missed - who's job?
"RESOLUTION 10 – NOTICE OF MEETINGS OTHER THAN ANNUAL GENERAL MEETINGS
The Directors wish to obtain the flexibility and benefit from the ability to call general meetings on 14 clear days’ notice and this Resolution, which is proposed as a special resolution, seeks authority from Shareholders for this flexibility. Such approval will not affect annual general meetings, which will continue to be held on at least 21 clear days’ notice. In the event that this authority is to be exercised, the Directors will ensure that it is not used as a matter of routine, but only where the flexibility is merited by the business of the meeting and is thought to be to the advantage of Shareholders as a whole. The Company intends to meet the requirements for a means of electronic voting to be made available to all Shareholders before calling a meeting on 14 clear days’ notice. The approval will be effective until the Company’s next annual general meeting, when it is intended that a similar resolution will be proposed."
Two things of interest today (a sunny Saturday) though:
1. I wonder who started that thread title and why ?
2. Vlad did not tweet yesterday's RNS (as he normally has done in recent times), why ?
We'll find out more next week (from Vlad).
Agree, all publicity is good publicity here.
Most people aren't aware of these advances in science such as CAR-T - even though they are reasonably proven now.
More long term investors however small - not for traders.
I'm inclined to think that because this hold is because it is cutting edge tech and a novel FLT-3 ligand targeted therapy, and therefore probably slightly different to what the FDA has had submitted in the CAR-T space previously, and that it was not necessarily unexpected by HEMO that the FDA would need more than thirty days to review their IND or that they would have questions on it. Hence the split of options and further deferred conditional options. In today's RNS, Vlad refers to the FDA's 'questions and concerns', which suggests to me that they want further explanation of the science, the controls surrounding it and possibly the capabilities of the service providers to be able to execute it safely etc.
When you consider what has gone in to preparing the IND submission and the prior IND experience that HEMO has brought in or engaged to undertake it - UPenn, WuXi, Quality Systems LLC (Randall Tlachac) and Stuart Tinch, Director of Quality I cannot see that there would be anything deficient in the application. My take is that this is about the FDA (and presumably this requires a high level sign-off within the FDA) having sufficient time to review, check and get comfortable with the novel therapy clinical trial HEMO (and its partners) will be undertaking. It may even be that further information is required on the logistics and/or associated partners and their capabilities.
Glad to see the AGM RNS issued today (suggests business as usual?).
It's clearly not that easy to achieve these milestones; I came across the below articles referencing other companies that have recently come up against difficulties and had to cut back in this arena.
https://www.biopharmadive.com/news/fate-century-tcr2-layoffs-cell-therapy-restructuring/639810/
It's interesting that the above reports bi-specific antibodies (eg CDX) as a serious alternative to CAR-T. So the development road may be longer than anticipated - however, unlike them, we should not that HEMO is expanding operations, with new lab facilities and increased staffing.
https://endpts.com/french-car-t-biotech-mnemo-therapeutics-shutters-us-operations/
Mnemo Therapeutics was the destination of HEMO's senior scientist Raymond Liang in 2021 (one of Vlad's 'dream team' who worked on CDX, and who may also have worked on HEMO CAR-T especially in its early stages). After Raymond left HEMO, Vlad reported that Raymond was made an offer that HEMO could not compete with. His employment with Mnemo ceased in March 23.
Dr Saar Gill was a co-founder of Carisma Therapeutics, listed on NASDAQ. Has the ticker CARM and per website proclaims to be the leader in engineering macrophages.
I started looking at it yesterday and am considering adding it to my HEMO investment to create a cell therapy basket of shares (in CARM's case CAR-M biotech is targeting solid tumours).
Carisma seems to have had a similar share price trajectory to HEMO - down 90% over past 5 years, down 50% past year, up 30% in the last month; current price $5.18 up 7% yesterday (and seemingly a further 7% after hours yesterday). Results from a couple of clinical trials due in H2 2023. To be researched further - though I don't find it as easy to find out information on US quoted companies.
For anyone wishing to do some research over the bank holiday weekend here's some detail on the science behind HEMO CAR-T and its most recent progressions towards IND and the UPenn expertise that has been involved:
2020 ASH publication (Hemogenyx):
https://ashpublications.org/blood/article/136/Supplement%201/4/473807/Preclinical-Development-of-Anti-FLT3-CAR-T-Therapy
2021 ASH publication (UPenn and Hemogenyx)
https://ashpublications.org/blood/article/138/Supplement%201/1703/480872/Anti-FLT3-CAR-T-Cells-in-Acute-Myeloid-Leukemia?searchresult=1
It is stated that the HEMO CAR-T based on FLT3 ligand compares favourably with the previous CD123 gold standard.
An extract from VM Sandler, Share Talk Podcast (8 March 2021):
“With UPenn and CAR-T we chose them because again they have unmatched expertise in developing of CAR-T type products because they were the first who developed a CAR-T that was the first to be approved by the FDA and EMA as a cell therapy of this type for the treatment of leukemias. So that was the first CAR-T ever approved, I think it was in 2015 and they developed it for Novartis and since then they run multiple dozens of clinical trials and they have a number of product candidates that are going through both pre-clinical IND-enabling and clinical trials inside UPenn, so it’s very difficult to find a better partner. And I would like to also point out that it wasn’t purely commercial arrangement, you know UPenn basically is bombarded by offers to collaborate simply because of their expertise. But they chose us because they looked at the data that we produced you know for our CAR-T, and they loved the idea, they loved the data and they said well let’s do it, and so we are now halfway through our sponsored research agreement basically the agreement where they verify and validate our product candidates and generate data that is necessary to file an IND. And we are talking right now, and we are going into the manufacturing phase together with them and with some certain external partners."
UPenn - Dr Saar Gill's impressive CV (mentor to Dr Sara Sleiman, lead presenter of the 2021 ASH paper)
http://icksh.org/data/cv/CV_Saar_I_Gill.pdf
It would be interesting to have heard some of the presentations that Dr Saar Gill has been giving surrounding the future prospects of CAR-T therapies for AML.
In 2022 Vlad was still indicating that UPenn would be involved in the HEMO CAR-T clinical trials - we have yet to find out if that is still going to be the case.
And (from Q1 2022) a reminder of the science and of what HEMO are aspiring to achieve; the author has links to Perelman who would possibly have knowledge of Hemo's link with UPenn and Saar Gill
https://www.healio.com/news/hematology-oncology/20220324/next-breakthrough-for-car-t-cells-may-come-in-acute-myeloid-leukemia
https://hemogenyx.com/investors/investors/announcements/announcement/2021/car-t-master-translational-agreement-with-penn/