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Following on from Haywain’s excellent post, investors should also make themselves aware of the Moonshot program. The Moon Shots Program at the University of Texas MD Anderson Cancer Centre operates as a massive, infrastructure-heavy engine designed to drastically accelerate clinical trials and bring novel therapies to patients, such as HG-CT-1 for relapsed/refractory AML which means it is heavily impacted by the operational ecosystem created by the Moon Shots Program. 

The institutional framework of the Moon Shots Program directly impacts, supports, and shapes the Hemogenyx pediatric trials through several key mechanisms:

At the core of the Moon Shots Program are 10 specialised "implementation platforms." One of the most prominent is the Immunotherapy Platform.  This platform is designed to seamlessly run advanced immune profiling on blood and bone marrow samples taken from trial patients. For the pediatric arm of the HG-CT-1 trial, this infrastructure allows MD Anderson researchers to deeply analyze how a child's immune system interacts with the CAR-T cells. It helps investigators pinpoint precisely why a pediatric patient might respond excellently to the therapy or why they might experience resistance, allowing for real-time adaptations to the protocol as well as enhancing the probability of success.

The Moon Shots initiative heavily funded MD Anderson’s longitudinal big data systems, integrating full genomic, proteomic, and clinical tracking data.  MD Anderson's Moon Shot data infrastructure streamlines this screening process and allows clinical data from the adult cohort to be seamlessly cross-referenced with incoming pediatric data, ensuring that early efficacy signals are quickly recognized and capitalised on. Historically, pharmaceutical companies face steep disincentives when expanding early-phase trials into pediatric populations due to strict regulatory hurdles, smaller patient pools, and a high risk of toxicity. 

The national momentum of the federal Cancer Moonshot, combined with MD Anderson's internal Moon Shots institutional culture, actively shifts incentives toward prioritising pediatric hematologic oncology, which assisted in gaining speedy approval and also bodes well for fast track approval and the issuing of a Priority Review Voucher.

70% of all cancer drugs approved by the FDA in 2025 were tested at MD Anderson.

I think we’ve got the right partner.

Well MD Anderson have on their website they are enrolling pediatric patients now. Their Internal Review Board has already approved the treatment of pediatric patients as have the FDA. Also all trial data including the clinical government website clearly state the FDA protocol:

Pediatric Dosing:

Enrollment on any pediatric (≥12 and <18 years of age) cohort shall begin after the corresponding adult cohort has been safely completed.

Well the Data Management Safety Board, an independent group of experts passed the previous cohort but who knows you may be right, they may now all say no, let’s all wait for far more data instead.

We are finally entering a very news rich period as we know that pediatrics are going to run in parallel with the adult dose escalation cohort, and that two patients are going to be treated a month so the next cohort of three adult patients and the first three children should all have been treated by July or early August at latest.

When coupled with the Master Service Agreement for Cellin and the Estonian government, guaranteeing early revenues this should act like a coiled spring being released.

If and when Hemogenyx pass 14 and 28 day safety on both dose escalation and pediatrics with good signs of efficacy as we expect, we enter the final stretch and it becomes highly probable we just wait for the major pharmaceutical company to pounce. That’s how I see it playing out anyway. Anyway even with Vlads terms like slightly delayed, soon or imminently, major news really is imminent now and it’ll be ongoing from here.

HT as you can’t even read a simple RNS from the end of April:

“The Company is pleased to report that the necessary hardware and infrastructure for the manufacturing of HG-CT-1 in Estonia have now been established, Hemogenyx in collaboration with its Estonian partner Cellin Technologies OÜ, intends to commence the technology transfer process required for local manufacturing of HG-CT-1 imminently”

And I think you will find I can say whatever I like is true. Like I think you’re a total imbecile. Is that true or just in my own mind? Either way I don’t care.

HT my first point is a matter of fact. Vlad has stated the technology transfer to Cellin is imminent and it’s also a fact that you simply cannot start until a Master Service Agreement is in place which amongst other things will outline the commercial terms and therefore the revenue projections. You will not put trade secrets and your IP at risk without full commercial protection.

It’s also true that this technology transfer should be substantially quicker than the one to Made Scientific.

Zero Process Changes: That’s assuming there are no modifications made to the bioreactor scaling, closing mechanisms, or raw material brands already FDA approved from Made Scientific.

Estonia's streamlined Hospital Exemption framework will bypass full-scale European Medicines Agency (EMA) centralised market authorisation, moving the validated product straight into regional clinical use.Therefore only staff training and probably three test manufacturing runs need to be done to validate comparative output.

Now if you simply don’t believe Estonia will proceed, not only for Estonian patients but for the whole of Europe then I don’t think you have a handle on what is happening here.

The dose escalation announcement for the second cohort of adults to be treated with HG-CT-1 is now very close and with it the opportunity to not only prove it’s safe, but also the chance to prove complete remission and it’s curative potential. We also know that pediatrics will run in parallel so with it, the treatment of the first child gives Hemogenyx multiple opportunities to create additional value. Priority Review Vouchers worth hundreds of millions of dollars, fast track approval and an expansion of their target market.

With all hardware and infrastructure in place for Estonia and the technology transfer about to commence. BUT, you cannot start the technology transfer without a Master Service Agreement so expect an announcement on this very very soon.

"The company's internal and external focus is now on next generation CAR-T" and "cancers that are reoccurring after treatment"

Yet another major facing a patent cliff.

https://www.ft.com/content/ae053d2c-de07-47a8-92fa-3310b20eae19?syn-25a6b1a6=1

Vlad

The strategy and building blocks that Vlad has put in place have been very impressive in my opinion.

The timing of the last placing, the staff reductions and sub leasing the lab have all reduced the burn rate and given a financial runway that completely eliminates the need to accept any low ball offer that undervalues the company.

The technology transfer to Made Scientific being completed and FDA approved allows not only commercial grade scalable manufacturing, it is tariff free potentially saving a global pharmaceutical hundreds of millions of dollars and any suitors around $50m in set up costs with no delay in time to market.

With Estonia already having the hardware and infrastructure in place to manufacture HG-CT1 commercially, treating Estonian patients under the hospital exemption pathway and European ‘tourists’ who have exhausted all treatment options generating early revenue and perhaps more importantly compiling real world data, which both add additional value to Hemogenyx, there is a certainly a high bar for any suitors or partners to reach.

Having previous and current strategic partnerships with the University of Pennsylvania and MD Anderson, the two leaders of cancer treatment in the world followed by the successful treatment of the first cohort, passing safety with no DLT’s, whilst also showing encouraging signs of efficacy (even at the lowest dose) substantially de-risks both the upcoming dose escalation and initial pediatric treatment. The therapy is proven to be safe, with potentially even better efficacy and durability to be demonstrated as we know being a third generation product it’s a potent treatment. To any potential suitor passing safety on these next two patients could well be a true infection point turning HG-CT-1 from a ‘nice to have’ to a ‘must have’ product.

This is especially so in pediatrics where any success would not only increase the total addressable market but also increase the probability of FDA fast track approval and the award of a priority review voucher (PRV) which alone would be worth over three times the current Mcap of the whole company.

When you add the ‘off the shelf’ recently improved (better efficacy) CDX bi-specific antibody, jointly developed with Eli Lilly, which in itself is de-risked due to the scientific synergy with HG-CT1 Hemogenyx has the potential to dominate the multi billion dollar AML market, a market where virtually every major pharmaceutical company wants to be.

CAR-T as a product is valuable, CDX as a product is valuable but both together takes a product company into a platform company that immediately doubles the NPV of Hemogenyx.

Adding the jewel in the crown, the platform that is CBR, for the treatment of solid tumours and viral infections (disease X), you’ve suddenly created an oncology powerhouse.

Continued success would value Hemogenyx at what? License deals with $100-150m up front payments or acquisition from anywhere between $1.5bn to $2.5bn.

Exciting times

Micky keep calm my friend. There was a strategic reason for Hemogenyx to do a technology transfer and outsource manufacturing to Made Scientific that will become apparent in time. So whilst the delay in patient enrolment has been frustrating firstly it's now over and secondly it's been for good reasons that will ultimately add substantial value to the share price.

Tenantry you’re not understanding the trial.

It’s a 3x3 dose escalation trial meaning there are three cohorts each consisting of three patients.

The first who are infused are level 1, the next at level 2, the last at least 3, all defined by the FDA trial protocol.

There are no ‘half’ or ‘full’ doses.

It beggers belief to me that with the Made Scientific technology transfer announced as completed and FDA approved and enrolment underway weeks ago that certain individuals ask when the trial will resume, and with MD Anderson selecting the patients, Prevail doing the management and logistics and Made Scientific doing the manufacturing have such a lack of understanding in…well everything, criticise Vlad for not giving timescales.

It would be like having confirmation of all hardware and infrastructure being complete in Estonia and the technology transfer underway to Cellin Technologies and saying ‘it’s probably never going to happen’.

Some great posts this evening and although I’m no scientist, and I welcome Haywain or others with knowledge to correct me, but I feel it’s important to realise why Hemogenyx have achieved the results with the first cohort of patients they have.

CAR-T therapy has evolved and will continue to do so. My understanding is that all first generation products are no longer used in the clinic and that the only CAR-T products FDA approved , of which there are a handful are second generation therapies.

However, Hemogenyx’s HG-CT-1 is a third generation CAR-T therapy specifically designed to be safer than anything currently approved and one could say the first cohort has demonstrated that. It also is designed to be more potent than anything currently approved and again, early signs of efficacy with patient three showing no signs of AML even at the lowest dose is a good indication of that potency and efficacy.

I’m not saying that Hemogenyx will have the first third generation CAR-T FDA approved but it’s highly likely in my opinion they’ll have the first for r/r AML.

He’s just being a prat as always. Anyone that thinks making 40 odd percent in six months on a share turns him into Warren Buffett really needs psychiatric help, especially when posting his ‘expertise’ multiple times a day on a completely different board to the one he’s ’invested’ in.

A very strange but totally irrelevant individual.

Very happy indeed. What’s not to like:

First cohort passed safety with no DLTs and early efficacy in all patients with patient 3 showing no signs of AML.

Cash rich, Phase one fully funded.

FDA approved manufacturing outsourcing partner, scalable up to commercial levels.

Early revenue potential from Estonia and Europe with HG-CT-1 actually being commercial through exemption pathway.

Further reduction in burn rate through sublease of laboratory.

Progression of other product candidates in all probability through capital injection through partnerships.

Experienced scientist being employed to work on CBR with latest gene editing technology.

Imminent treatment of adult on escalated dose.

Imminent treatment of child on first dose in parallel.

All the above look very much like the building blocks to position Hemogenyx for acquisition.

Yoris yes I’m now 100% certain Estonia will now go ahead, initially treating Estonian patients then rapidly expanding to take in European ‘tourist’ patients that will pay for their treatment, as opposed to the Estonians who will have their treatment paid for them by the Estonian government under the exemption pathway.

To some the recent RNS may not have had a ‘wow’ factor. Probably the same people that picked up on one paragraph in the Prospectus saying Hemogenyx couldn’t possibly raise the funds and we’re doomed:

“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”

Well surprise, Hemogenyx has already raised MORE than is required for the whole of the year AND a a substantial premium of the current price and what’s more there’s an additional £3m of warrants that can be exercised at a further premium of £9.

So to me, knowing that the first dose escalation patient will be treated very soon and the first child in parallel AND with all hardware and infrastructure in place, Estonia is 100% certain to treat patients across Europe COMMERCIALLY generating early revenue, I for one did go WoW.

Socialist, another excellent post. When you couple it with a completed and FDA approved technology transfer that gives commercial scalability and allows the dose escalation and pediatrics patients to be treated, rapid data accumulation will now occur as both trials will run in parallel.

When you add the first cohort at the lowest dose achieved:

All three patients showed CAR-T cell expansion.

Reductions in "blast burden" in both peripheral blood and bone marrow.

The third patient treated, preliminary assessments indicated that the original AML cells were not detectable using standard testing methods shortly after treatment. 

Our understanding is that all three patients remain alive.

HG-CT-1 has been well-tolerated at the initial dose with no Dose-Limiting Toxicities (DLTs) reported.

No ICANS, a common side effect of CAR-T therapies, were observed.

So traders can mock my predictions. They can dismiss how curative HG-CT-1 will be, and how valuable. They can dismiss fast track funding and partnerships for CDX and or CBR, and they can dismiss the potential for an outright sale of Hemogenyx.

And they can obviously take joy over the current SP. What they cannot do is shake an investors belief of where the SP will get to this year.

We’ll see who laughs last and loudest.

The current licensing situation for CDX is that Hemogenyx holds an exclusive worldwide licence from Eli Lilly to the intellectual property (IP) required to develop and commercialise the antibody.Even though Hemogenyx has modified and enhanced CDX using Lonza’s technology, the fundamental legal relationship with Lilly remains unchanged.

Hemogenyx exercised its own option to in-licence Lilly’s IP after Lilly declined to exercise its option to lead the program. Bear in mind Hemogenyx developed the product and own it but we licensed Eli’s development work.

This means HEMO is now the lead developer and HEMO paid an upfront fee of $250,000 and is liable for milestone payments of up to $1 million through to Phase II trials.

Lilly is also entitled to tiered royalties on future sales and a percentage of any cash payments HEMO receives if they sub-licence CDX to a third-party. That’s important as I know that’s exactly what Vlad is negotiating with a major organisation to do.

The new version, developed with Lonza's technology, has demonstrated significantly enhanced efficacy in laboratory testing and theimprovements allow Hemogenyx to resume the path toward a Phase I clinical trial this year, so personally I expect an IND submission in the near future. Vlad has already stated that the improved product is specifically designed to attract new industry partners interested in fast-tracking co-development.

So, while Lilly "stepped aside" as the primary developer, they remain a financial beneficiary of the program's success through their existing licence agreement. Furthermore there recent strategic shift into the CAR-T arena make them a company more than likely to aquire HEMO after dose escalation safety is proven as this is when they’ve purchased other early stage phase one companies.

Although this is not a place for political opinion, this is arguably the only sensible thing Trump has done:

The FDA is actively implementing initiatives to entice early-stage drug manufacturing to the United States, driven by a desire to boost domestic supply and reduce reliance on foreign manufacturing and combat the threat of China. Key initiatives launched in 2026 include the FDA PreCheck program, which offers expedited regulatory review and closer communication for new, onshored manufacturing sites. In February 2026, this program provides selected manufacturers of "critical medications" with increased regulatory predictability during facility design, construction, and pre-production. It aims to reduce regulatory uncertainty, acting as a "carrot" for onshoring.Advanced Manufacturing Technologies (AMT) Designation: This program provides a pathway for accelerated adoption of advanced technologies like continuous manufacturing, AI and 3D printing, which can increase production efficiency in the US.Faster Regulatory Reviews:

The FDA has pledged to speed up reviews of drug applications that are made in the US, with some proposals promising fast-track, rapid reviews (in a few weeks) for projects that align with national priorities, like pediatriccancer treatment. The PreCheck program includes two-phase communication, involving pre-operational reviews and early feedback on Chemistry, Manufacturing, and Controls (CMC) sections of a drug application, allowing for faster, more predictable approvals.These initiatives are specifically designed to reduce the high-risk, expensive nature of facility investment for smaller pharmaceutical companies.

This month FDA officials proposed easing the transition into clinical testing for drugs made in the US and offering exclusivity periods for US-based generic manufacturers.These initiatives are driven by a May 2025 Executive Order focused on "Regulatory Relief to Promote Domestic Production of Critical Medicines".

This is exciting news for Hemogenyx being both developed and manufactured in the USA, in particular for the imminent start of the pediatric trial as cancer treatment for children is at the top of this administrations agenda. Fast tracking of HG-CT-1 could lead to tax incentives, grants and even priority review vouchers that can be used or sold on for on excess of ,$100m. We have already seen the FDA move very quickly to approve HG-CT-01 for pediatrics after seeing the initial data from just two patients and I think this is just the start.

Personally I can't wait for the next patients to be treated which I think should start next week. Passing safety on both dose escalation and the first child will be the most important milestone in Hemogenyx's history.

Tick tock.