Member Info for HereforHemo

There might be lots on trials ongoing especially in the United States and China but there are only a handful of CAR-T products approved in the States, and absolutely none that I’m aware of that are third generation like HG-CT-1. What does that mean in layman’s terms, it means Hemogenyx have the safest CAR-T, as demonstrated by all three patients having no adverse affects from the first cohort. It should also mean HG-CT-1 is more potent than any other CAR-T, which in turn should increase efficacy and ultimately the curative nature of it, as demonstrated already with the minimum dose showing ‘promising signs’.

What does that mean to shareholders? Well once proven, it’ll be an extremely valuable product within an extremely valuable company.

Others who are actually invested might disagree with your view as Sir Marc shares the Academic credit for inventing and developing anti-TNF therapy for rheumatoid arthritis, the first major use of monoclonal antibodies in a common disease. Centocor, Inc licensed Sir Marc’s key patent, and then developed Infliximab, ultimately branded as Remicade. Remicade was the main driver of the $4.9 billion acquisition of Centocor by Johnson and Johnson in 1999, and is still J&J’s best selling drug. Since 2012 Anti-TNF therapy has become the world’s largest drug class with sales in 2016 exceeding US$36 billion. Sir Marc was previously Chairman of the Company’s Scientific Advisory Board working closely with Vlad in product development and has a remarkably broad experience of discovering new medicines, having worked through all stages from developing new concepts of how diseases emerge, through testing ideas and early clinical development, leading clinical trials, approval, registration and commercial reality. The fact that as both the head of the Scientific Advisory Board and now as Chairman he decided to take his remuneration in shares is both a measure of the man and his confidence in the product candidates.

Some good valid points raised today but the bottom line is this. Hemogenyx has a treatment for r/r AML that sailed through the first cohort with hardly any, if any adverse effects whilst also showing promising signs of efficacy, even at the lowest dose.

Now we look towards what was outlined in the prospectus:

The Group’s intention is not to develop as a manufacturer of its products. It would insteadseek to bring them to the market through licensing, joint venture or sale to a larger, more established,pharmaceutical industry partner in order to benefit from the manufacturing, marketing and distribution channelsthat these companies can provide. A goal is the licensing of one or more if the Group’s therapies to partnersin return for potential upfront payments, research funding support and success milestone and royaltypayments.

Let’s wish Vlad the best of luck in his discussions.

Socialist I probably have different favourites as most would no doubt say the likes of Gilead or BMS. But that’s because I think there is a reason Hemogenyx have outsourced to Made Scientific and it has nothing to do with saving money. Why when you only intend to treat two patients a month would you go through a highly complex, costly and time consuming process to get a highly efficient, state of the art manufacturing process with scalability up to commercial levels? To me, no Major who has manufacturing facilities in the USA would use Made Scientifics facilities they’d use their own, so why would Hemogenyx have adopted this path? There’s only one logical answer in my opinion, the pharmaceutical companies Hemogenyx are taking to are outside of the USA and see tremendous value in Hemogenyx delivering them a turnkey tariff free solution. So potential candidates to me are from Ireland, the UK, India but most likely from China. Bearing in mind I think whoever gets HG-CT-1 will also want CDX, I believe it’s highly significant that CDX has already been granted patent approval in China, so if were to guess, it would be one of two companies in China and for those who have researched Hemogenyx they’ll know that one of them has already worked extensively with Hemogenyx on HG-CT-1.

Whilst they might do a JV and get hundreds of millions in working capital I see no scenario where they would sell HG-CT-1 for only $500m. Besides which, whoever took CAR-T would undoubtedly want CDX as well, in my opinion. So through simple economy of scale there’s only one outcome I envisage and that’s the outright sale of Hemogenyx, probably with CBR being spun out in advance.

So either a lucrative JV or outright sale for me.

The agreement was announced the first week of September:

Under the agreement, Hemogenyx Pharmaceuticals will leverage Made Scientific's specialized expertise in CAR-T cell therapy technology transfer and manufacturing at its GMP facilities in Newark and Princeton, NJ, which are equipped for both clinical and commercial supply of cell therapies. The collaboration is expected to accelerate Company's ongoing Phase I clinical trial of HG-CT-1 in adult patients and to support the potential inclusion of additional cohorts for pediatric r/r AML patients.

The Company has already made significant progress in the trial, with early clinical data supporting growing confidence in both safety and potential efficacy.

Vlad said well over a month ago now that the first manufacturing run had already been completed and I assume Made would have done maybe three runs back to back, so my take is that they’re done and just waiting for FDA approval. I could be wrong but I don’t think we’ll be waiting until March.

Mr mojo you are correct in your assessment.

Let’s be clear on exactly what they said:

‘The Company is of the opinion that the working capital available to the Group will be insufficient for its present

requirements, that is, for at least the next 12 months from the date of this document. Following Admission, the

Directors expect that the Group will have an aggregate funding shortfall of approximately £15.6 million to

enable it to complete the Phase I clinical trials of HG-CT-1 in both adult and pediatric patients over the period

to December 2028.

To address this anticipated funding shortfall, the Group will require additional working capital of approximately

£5.6 million by the end of January 2026 in order to continue its product development activities, with a primary

focus on HG-CT-1, to the end of 2026 and an additional £10 million during the period from 2027 to 2028. This

amount is expected to cover the ongoing development of the Group’s other product candidates within its

product portfolio, as well as general corporate overheads and operating expenses for the period from February

2026 to December 2028.

There can be no assurance that either the funding shortfall anticipated in February 2026 or the subsequent

financing requirements necessary to meet the Company’s objectives over the three-year period from 2026 to

2028 will be met in whole or in part. Furthermore, there can be no assurance that the Group will be able to

obtain such financing on terms acceptable to it, or at all.

In circumstances where insufficient funding were to be forthcoming to enable the Company to implement its

business plan through 2026, the Directors would use all endeavours to sell an interest in the development of

HG-CT-1, as well as its other product candidates. The Directors are reasonably confident that they would be

able to do so based on the data received to date in the Phase 1 trial of HG-CT-1 and discussions with a large

pharmaceutical company’.

Bear in mind this is from a legal document covering directors for any eventuality. Also, with warrants exercised at the end of last year they now have headroom until March. Furthermore with other warrants still to be exercised I’d estimate they’ll be looking for around £5m to take them through 2026 and my guess is it’ll come from a major pharmaceutical company.

Let’s be e-learning on exactly what they said:

‘The Company is of the opinion that the working capital available to the Group will be insufficient for its present

requirements, that is, for at least the next 12 months from the date of this document. Following Admission, the

Directors expect that the Group will have an aggregate funding shortfall of approximately £15.6 million to

enable it to complete the Phase I clinical trials of HG-CT-1 in both adult and pediatric patients over the period

to December 2028.

To address this anticipated funding shortfall, the Group will require additional working capital of approximately

£5.6 million by the end of January 2026 in order to continue its product development activities, with a primary

focus on HG-CT-1, to the end of 2026 and an additional £10 million during the period from 2027 to 2028. This

amount is expected to cover the ongoing development of the Group’s other product candidates within its

product portfolio, as well as general corporate overheads and operating expenses for the period from February

2026 to December 2028.

There can be no assurance that either the funding shortfall anticipated in February 2026 or the subsequent

financing requirements necessary to meet the Company’s objectives over the three-year period from 2026 to

2028 will be met in whole or in part. Furthermore, there can be no assurance that the Group will be able to

obtain such financing on terms acceptable to it, or at all.

In circumstances where insufficient funding were to be forthcoming to enable the Company to implement its

business plan through 2026, the Directors would use all endeavours to sell an interest in the development of

HG-CT-1, as well as its other product candidates. The Directors are reasonably confident that they would be

able to do so based on the data received to date in the Phase 1 trial of HG-CT-1 and discussions with a large

pharmaceutical company’.

Bear in mind this is from a legal document covering directors for any eventuality. Also, with warrants exercised at the end of last year they now have headroom until March. Furthermore with other warrants still to be exercised I’d estimate they’ll be looking for around £5m to take them through 2026 and my guess is it’ll come from a major pharmaceutical company.

Yes

So with a vastly reduced burn rate and around £200k of warrants that were issued doesn’t take them into March before funding is required then?

Obviously if it does then we can expect the technology transfer to Made to be completed and does escalation and pediatrics safety to be reported on before any license deal, JV or company buy out occurs.

But if you’re banking on a placing this week..well good luck with that.

With a focus on Cancer and viruses (disease X) they are definitely a candidate to aquire Hemogenyx, in my opinion.

https://www.fiercebiotech.com/biotech/jpm-lenacapavir-momentum-builds-gilead-eyes-new-deals-position-strength

Https://www.fiercebiotech.com/biotech/jpm26-day-3-gileads-cmo-talks-virus-strategy

Socialist I know Vlad had several meetings arranged so let’s hope he was one of them.

Hulver dear oh dear ‘look what Prevail have done with Briacell..I fear they do the same with HEMO’ Well personally I hope they do!

Firstly let’s address what’s happened with the $30m Briacell have recently raised, through a public offering by a broker called ThinkEquity. Link to Prevail..none, zero, never heard of them.

Now let’s look at what Prevail ACTUALLY did for Briacell. At a similar stage to Hemogenyx they provided funding of $4m at a 20% premium to the share price. That would be very nice, thanks for alerting holders to one avenue of funding.

If you’re going to spread crap because you’re short then at least try a little harder.

Although old this is well worth a watch as we await further information on safety and efficacy as at least it shows statistics from their humanised mice, which should be replicated in clinical trials, and certainly the first cohort of patients look like they have.

So although timescales have changed and manufacturing has been outsourced it still gives a great idea of the scope of their portfolio.

https://youtu.be/LFH95Zw8e6Y?si=vWbhAObVkrUs3R_O

Https://www.fiercepharma.com/pharma/fierce-pharmas-jpm26-tracker-day-2

Https://www.fiercepharma.com/pharma/fierce-pharmas-jpm26-tracker-day-1

If a patient had died we’d know about it as it would trigger a series of critical reviews from the Data Safety Monitoring Board to ascertain whether they had died because of HH-CT-1, the underlying disease or another factor and according to the FDA protocol investors would be notified.

As we haven’t heard anything it’s a logical assumption that all three are still alive which looks extremely promising that it’s a best in class treatment for r/r AML, further reinforced by a high net worth individual taking his investment to nearly 8% of the company.

HT From my limited knowledge and understanding I believe what they have on their website is highly significant as it looks like Hemogenyx believe that HG-CT-1 is potentially curative. I’m sure Haywain could clarify.

They also mention phase two timelines of 2026 which again not only exude confidence but strongly suggest this will be fast tracked by the FDA.

Hugely encouraging and exciting.