Member Info for Hulver

Thanks for that insight, pretty significant if it is designated to Hemo - would appear to make it much more attractive to a potential sponsor - especially the period of exclusivity.

I wonder when we will here whether HG-CT-1 has been granted orphan drug status. Application was going to be made at the start of clinical trials (not sure what defines/defined start - seems a bit vague). And what benefit does getting that have, and when will any benefit be deived?

No, that's not correct either.

Hemo is actually doing much better than you thought.

Valley, tunnel, end - you'll see it soon.

Good news from the Prevail stable:

https://www.tipranks.com/news/the-fly/briacell-announces-resolution-of-lung-metastasis-in-patient-receiving-bria-ots

Does similar beckon for Hemo?

Thanks, having weighed up all those things too I have continued to hold, ever tighter and hopefully for along time yet.

It'd be great to have Hemo retain some control over CBR for another five years. Originally I thought an investment timeline of 2027/28 but now I'm thinking 2030 is not unreasonable to see what happens by then.

No intention to sell - so many things in the pipeline, though we haven't the same proof of CBR yet Vlad is confident (and I seem to recall that the scientist that came from Cellectis, but has since left, said that CBR was Hemo's best product). No recent changes in the key scientists is a positive.

So what does continue to hold institutional investors back?

Is it the performance of the corporate governance team, who have ever reducing skin in the game, significant conflicts and seem to be inadequate for the stage Hemo is now at? How did that Mint fiasco happen - what questions did teh non-executive directors ask, who did the due diligence and then allowed a deal to happen with what seems to have been a letterbox company in Bermuda. Separately, the Chair seems to have been fighting his own business legal wrangles for the past couple of years. Why have there been no replacements or new appointments to the board - perhaps it is being kept lean for a sale.

There's the previous close involvement of Vlad with Bauer and Auringer and the funding they provided to Hemo (as 'friends' of Vlad). Bauer has now pleaded guilty in the US (November 24) - could that now have implications for Hemo as they look to where the proceeds of Bauer's crimes went?

There's also the Russia nexus as they look to try and raise funding in the US. In the past companies with any Russia connection whatsoever, even after having relocated all operations to US, have found it difficult to raise monies or find buyers. In the current climate the situation can't be any better than it was in the early 2000s.

Hopefully the science will pull Hemo through, and then I think there are a few possibilities, which are not necessarily mutually exclusive:

(i) spin-off of CBR into a new venture with new investors taking a share in that entity and significant investors having seats on its board.

(ii) sale of HG-CT-1 (would eliminate need for capital raise) or new capital raise in Hemo, with significant investors taking a seat on the board

(iii) outright sale, the buyer takes the science and takes on the scientists - the non-execs are retired.

By the way - does anyone have any knowledge of who is behind the Prevail fund that invested in Hemo and has invested significant sums in several other companies - these are not small amounts, who are Prevail fund's investors, is it a front for a group of large pharma investors or companies?

Any thoughts?

Here's a reminder of what's going on in the background with Kure.ai Therapeutics (19th December 2024 RNS):

https://www.lse.co.uk/rns/HEMO/ultrafast-car-t-manufacturing-rssfbwlpviwxpnr.html

"Hemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical company developing innovative therapies for blood malignancies, and Kure.ai ("Kure"), a leader in ultrafast CAR-T manufacturing technology, are pleased to announce a strategic collaboration to advance the production of CAR-T cell therapies for acute myeloid leukemia (AML) and a subset of acute lymphoblastic leukemia (ALL).

This partnership aims to integrate Kure's ultrafast manufacturing (UM) technology with Hemogenyx Pharmaceuticals's proprietary CAR-T therapy, HG-CT-1 (formerly known as HEMO-CAR-T) to enable faster, more efficient production of CAR-T cells, significantly reducing manufacturing timelines while maintaining therapeutic potency.

Key Highlights of the Collaboration

1. Clinical Study: Hemogenyx Pharmaceuticals will initiate a clinical study to evaluate its CAR-T therapy for AML and KMT2A-rearranged ALL, utilizing Kure's UM process.

2. Process Development: Both parties will collaborate on developing a customized UM process for Hemogenyx Pharmaceutical's CAR-T therapy, optimizing its application in AML treatment.

3. Material and Expertise Sharing:Hemogenyx Pharmaceuticals will provide critical materials, including lentiviral vectors, and necessary technical know-how to facilitate process development.

4. In Vitro Testing:Hemogenyx Pharmaceuticals will conduct in vitro testing to assess the potency and vector copy number (VCN) of CAR-T cells manufactured using Kure's ultrafast platform.

5. Adaptation of Manufacturing Technology:Kure will adapt and refine its ultrafast CAR-T manufacturing process specifically to the Company's CAR-T therapy requirements.

6. Licensing Option: Upon successful completion of process development, Hemogenyx Pharmaceuticals will have the option to license Kure's UM technology for clinical trial production, with licensing terms to be negotiated."

And this is what they hope it may lead to (results published by Kure.ai in November at ASH 2024):

https://ashpublications.org/blood/article/144/Supplement%201/94/530351/Phase-I-Study-Results-of-UF-Kure19-a-CAR-T-Product

So Kure.ai (and notice that Hemo's Medical Adviser Koen van Besien is named on the paper) have already achieved it once with a CD19 CAR-T therapy, UF-KURE19.

It's easy to lose sight of these things when most people seem focussed on the share price but this is the way scientists expect to make CAR-T therapy, and hopefully HG-CT-1, more practicable and eventually a mainstream treatment.

There are also some advantageous side effects with ultrafast car-t manufacturing - cost savings, and they anticipate improved safety (or is it reduced risk).

HEMO are clearly planning ahead.

From the RNS 9th September:

FLT3 Assay Ready for Phase I Trials at MD Anderson

"Hemogenyx Pharmaceuticals plc (LSE: HEMO), a clinical-stage biopharmaceutical group focused on developing treatments for cancers and viral diseases, is pleased to announce the successful completion of the development of a clinical-grade assay ("Assay") designed to assess FLT3 protein expression in acute myeloid leukemia ("AML") cells.

FLT3 protein expression in AML cells is crucial for the accurate identification and recruitment of patients for the imminent Phase I clinical trials of the Company's HEMO-CAR-T product candidate. The trials are expected to commence shortly at MD Anderson Cancer Center ("MD Anderson"), one of the world's most respected centers devoted exclusively to cancer patient care, research, education and prevention. The Phase I clinical trials are planned to expand to the University of Pennsylvania Medical Center thereafter."

I understood this to mean that prior to treating/enrolling any patient, they would be testing the potential patients blood to ensure that the FLT3 was sufficiently expressed in that person's blood in order to optimise the chance of having a meaningful trial result from that patient.

To me that implies that all potential patients will have blood drawn pre-treatment to evaluate their appropriateness for the treatment - not sure how else they could do it, or why it was important to develop a FLT3 Assay test if they aren't using it.

...perhaps some people think the words 'clinical-grade' are meaningless too.

For the patient(s) that are selected, this represents a hope of freeing them of this affliction.

Proverbs 2 6

https://www.biblegateway.com/passage/?search=Proverbs%202%3A6&version=KJV

We've been short changed with this 2 and 6.

Someone was asking about the video of the mice.

On the Hemo website page, videos and presentations and select the youtube Investor Webinar dated 6 July 2022.

https://hemogenyx.com/videos/

I'd recommend a re-listen to the whole webinar, remind yourselves of the progress to get to this point; for just the mice they appear at 29:30 to 30:20; that was in respect of CDX, and just prior to that, at the end of the previous slide Vlad stated 50% cured of AML in CDX testing. CDX and HEMO CAR-T have same/similar target, but HEMO CAR-T was presumably the superior solution to take forward for AML (for whatever reasons, possibly non-scientific).

Will HG-CT-1 be the eradication tool referred to in this clip from December 24?

https://www.vjhemonc.com/video/x9blpowlbbo-improving-car-development-to-circumvent-the-challenges-presented-by-aml/

4th Feb - World Cancer Day !?!

Thankfully we have some very loyal top scientists working with him, is my view of it.

Possibly two (maybe three) years ago Vlad, against a backdrop of increasing waiting times for manufacturing facilities, talked about the future ability for Hemo to earn an income stream from servicing other companies that required GMP-compliant lab manufacturing facilities for there research activities. At the time he said that noone would Hemo as a manufacturing service provider until Hemo had proved their ability to manufacture a product that had achieved FDA approval. Hemo now have that in HG-CT-1 - they are also very close to a number of research companies who presumably need these facilities to accelerate their work. Hemo seem to have an experienced lab management team in place (in addition to the research scientists that we know about) to organise them. It would be interesting to know if there is already an income stream, as presumably these services are not cheap. Let's hope they are maximising potential without impacting their own research work.

Can it possibly be any more opaque than it has been?

Over a year ago Hemo had an arrangement with someone for testing CBR on a live virus in a government associated BSL-3 lab. No specific results disclosed yet, but we have been informed - 'once sufficient resources are provided, the Company anticipates moving new CBR-based product candidates into clinical trials'.

'are provided' - that seems very specific wording

You hear the noise of a plane overhead, and instinctively look in the direction of the sound for it, only to finally locate that it is much further on - so be Hemo!

Do we need action like BriaCell Therapeutics are taking in the US? There is a board member with legal background (there is also one with financing background!).

https://feeds.issuerdirect.com/news-release.html?newsid=4707519538439052

https://briacell.com/briacell-provides-update-on-alleged-illegal-trading-of-public-securities/

https://briacell.com/briacell-therapeutics-corp-announces-closing-of-plan-of-arrangement-spinning-out-briapro-therapeutics-corp-to-existing-shareholders/

https://www.globenewswire.com/news-release/2025/01/03/3004189/0/en/BriaCell-Announces-Proposed-Effective-Date-of-Share-Consolidation.html

There are several similarities with Hemo; Prevail is a common investor in both though the initial allegations at BriaCell appear to have come prior to Prevail's investment in BriaCell, but nevertheless the share prices of both have continued a downward spiral since Prevail's involvement, in spite of what appear to be the announcement of positive trial results; now being forced to consolidate 15 for 1 at end January to get its SP back above the minimum for listing; certain assets spun out into a private investment vehicle in 2023 after Prevail invested. Vlad talked about a spin out for CBR. Anything could happen here - and perhaps the most unexpected?

Vlad seems to be off to San Francisco for BioTech Showcase.

https://www.linkedin.com/posts/vladislavsandler_biotechshowcase-activity-7283574121592963072-wcRc

It seems to be well attended by investors

https://informaconnect.com/biotech-showcase/

Let's hope with new year they have new budgets and looking to invest.

The website needs to play catch up:

Registered office changed on 1 January - not yet updated on the website.

Also noted that per the RNS issued 20/01/2020.

"Peter Redmond, a Non-Executive Director of the Company, is subscribing for 555,556 ordinary shares in the Placing. Following completion of the Placing, Mr Redmond will be interested in 5,596,270 ordinary shares representing 1.4% of the enlarged share capital."

The 2023 Annual Report still shows Peter Redmond as owning 5,596,270 - the majority of which are (or at that time were) held through Catalyst Corporate Consultants Limited of which he is the sole shareholder. UK companies house show the current status of CCCL is "Active - Active proposal to strike off". The latest filing 14/02/2023 indicates that the compulsory strike off action has been suspended as an objection to the striking off has been received by the registrar.

Per the website, post-consolidation in December 2024, Peter Redmond is now shown as having an interest in 12,601 shares.

https://hemogenyx.com/investors/

However, if he had 5,596,270 old shares pre-consolidation as previously reported then he would have 13,990 new shares post consolidation.

It would appear that the 555,556 old shares that he acquired in January 2020 have been disposed of since the start of 2024 as that would account for the difference. A small amount in value but when did such disposal happen and shouldn't it have been reported in an RNS?

Or I suppose the website disclosure could be wrong - there will be confirmation in the audited report in April.

Is there a connection between the last two RNS's - appointment of Westend Corporate LLP as company secretary and the fund raise of £340k - one or more of the principals perhaps?

I presume there would be no connected party disclosure requirement for a company secretary and it's below the 3%.

For me, it's what the RNS didn't say that's most interesting today.

Remember CBR ?

VS wrote 6 December:

"The Company's first-class scientific team continues to make good progress with CBR and, once sufficient resources are provided, the Company anticipates moving new CBR-based product candidates into clinical trials, bringing them closer to addressing unmet medical needs."

Should we expect an announcement soon for funding specifically for CBR - non-dilutive funding perhaps?