Member Info for HereforHemo

Outlook for 2026 and beyond

With the tech transfer to Made Scientific complete and paediatric expansion cleared, the Company is entering what the Board believes will be the most clinically informative period in its history. In the near term, we expect to dose the first adult patient at the second dose level of HG-CT-1 and, in parallel, to commence paediatric recruitment at the starting dose.

Over the course of 2026 we anticipate that the trial will progress through further dose levels, that preliminary efficacy data from higher doses will begin to emerge, and that discussions under the Cellin letter of intent will mature into definitive agreements.

In parallel, the Company will continue to advance its CDX antibody platform and broader pipeline, which remain important sources of long-term value even as HG-CT-1 takes the centre of attention.

The most important point in this statement is also the simplest: Hemogenyx Pharmaceuticals enters 2026 with a clinical trial that is demonstrably active and successful to date and will move forward definitively in the coming months. There is much work ahead but the trajectory of 2025 is one that, in my view, justifies confidence in the strategy, in the team, and in the potential of HG-CT-1 to change the outlook for patients with relapsed and refractory AML.

Professor Sir Marc Feldmann, AC, FRS

The above reflects the conference of most investors, hence why some are overstretched and some perhaps overly defensive on what they see as an opportunity of a lifetime creating generational wealth. All is fundamentally based on the revised Hemogenyx development goal:

TO CURE PATIENTS SUFFERING FROM r/r AML

We believe in HG-CT-01 and its curative potential. We may of course be wrong, there is risk. BUT, if we are right and this indeed cures adults and children of a vicious deadly cancer, how much is that worth? One billion dollars, two billion? And with the CDX bi-specific antibody? And CBR?

Good luck everyone, especially those early patients who are putting their faith on a third generation early phase CAR-T trial from a small company we’ll always know as HEMO.

One thing of huge strategic significance that hasn’t been discussed is the inclusion on the presentation of Freedom To Operate (FTO).

Establishing Freedom to Operate is a major foundational milestone for HG-CT-1 as it acts as a protective shield that safeguards their clinical trial momentum.

The specific architecture and IP profile of HG-CT-1 highlight the high significance of its FTO status with the core differentiator being its custom, humanised antibody fragment that binds directly to FLT3.

FTO status confirms that Hemogenyx owns this unique binding sequence free and clear. Crucially, the construct is designed to bind to FLT3 without competing with the natural FLT3 ligand, which greatly enhances it clinical efficacy.

HG-CT-1 is classified as a third-generation CAR-T. While first- and second-generation constructs use only one signaling domain, third-generation therapies stack multiple costimulatory domains together to maximise T-cell activation and survival. Because Hemogenyx has established FTO, it has navigated the extensive "patent thicket" surrounding these intracellular engines. They can use this high-powered dual-signaling architecture without risking a multi-million-dollar lawsuit from larger oncology pioneers.

This legal safety net has already directly enabled Hemogenyx to execute critical strategic advancements such as the CDMO Tech Transfer to Made Scientific and the ongoing Tech Transfer to Cellin in Estonia.

Furthermore to have undertaken this rigorous work with patent legal professionals and to have secured 100% legal ownership and IP protection of the whole process is another major tick in the box in advance of any licensing deal or acquisition

No deaths have been reported with patient 3 showing no signs of AML.

Did anyone notice that following the first cohort of patients Hemogenyx have fundamentally changed their development goal of the trial from ‘treat’ (to manage symptoms and extend life expectancy) to:

TO CURE PATIENTS OF r/r AML

By shifting the language to "cure," Hemogenyx is saying that early data from cohort one, passing safety with initial signs of efficacy gives management confidence that HG-CT-1 has the biological mechanism required to eradicate the leukemia entirely!

Hemogenyx making this pivot is designed to do one thing, and that’s to attract big pharmaceutical companies who are looking for blockbusters, not marginal improvements. Pitching an asset as a potential cure for r/r AML commands a massively higher valuation during licensing or acquisition talks.

It also justifies the expanded trial into pediatric patients. When treating children with highly toxic relapsed leukemia, the ultimate medical justification is to provide a definitive cure, rather than subjecting them to continuous, cyclic "treatments." 

It also goes without saying that curative therapies (like single-dose HG-CT-2 are priced drastically higher than chronic treatments because they save the healthcare system millions of dollars in ongoing hospitalisations, bone marrow transplants, and continuous chemotherapy and as such are very valuable to the majors.

Obviously we have to pass the dose escalation and pediatrics safety to ascertain just how curative it is but in my mind I’m even more convinced Hemogenyx is on track for a billion dollar valuation.

Alde what you fail to realise with your unrelenting criticism of Hemo and your statements that other investments are far better is that AVCT is not one of them, and it’s particularly strange you are so vocal today with its share price crashing.

The fact is, despite your trading expertise and highly accurate reading of charts that if you had put all your money in Hemo today you’ll have made more. In fact if you invested 5 days ago, a month ago, six months ago or even a year ago, every timestamp has Hemogenyx outperforming them.

People will listen to you at their peril because all this is before we really start issuing transformative news, which I assure you starts in the very near future.

Now run along, there’s a good boy.

it’s a bit rich saying yeah but the share price was this, the reality is it isn’t and the boards options, and the recent placees and their warrants are all at a premium of today’s share price. so it’s a fact they all need and expect the share price to rise.

and there’s levels of derisking a product candidate. with prevail investing, the made scientific partnership ensuring quality, eliminating manufacturing bottlenecks and giving scalability to commercial levels, the rapid fda approval for pediatric patients, the md anderson irb approval for pediatrics, the dsmb approval for dose escalation, the irb approval for dose escalation, the passing of safety for cohort one with no dlts and early signs of efficacy, the endorsement of the estonian government and their health services to allow the commercial sale of hg-ct-1 with technology transfer underway and all hardware and infrastructure already in place.

dose escalation imminent. pediatrics in parallel.

everyone incentivised to ensure success, i’m happy with progress.

if people aren’t happy, what the **** are you doing here? go and invest somewhere else.

We’re all guilty of being emotional when we invest, myself included, but when we use logic we invariably come to far better conclusions.

So here’s the conclusion I have reached. Whether someone has multi million pound £8 options or multi million pounds in £9 warrants it’s irrelevant to me, because until such time as someone exercises them and buys them it has zero impact on my holdings and the reality is very very few individuals have millions sitting idle, with the irony being if I did I could buy them today far cheaper than they could with their ‘options’. And it’s worth bearing in mind all the individuals having these options or warrants are highly unlikely to purchase anything until the share price is many multiples of today’s share price, probably far in excess of my exit price.

So what we are actually complaining about is risk. We have to take a financial risk in advance whereas they can sit there and wait to see if profit accrues before buying. Well personally I can live with that as the bottom line is nobody makes anything unless we’re successful and if we are successful we all make a lot of money, and if they make more money or if anyone makes more than I do it really doesn’t bother me at all, because if I make what I want and expect I’ll be more than happy with that.

I have no objection of the award of options to senior management or staff for achievement, but it appears to me this has been done with a view to eliminate their past dilution, the irony being that the largest portion of that has been caused by their own poor judgment.

Let me give an example upon the Data Safety Management Board approval from 29th October:

'As a reward for the Hemogenyx team's outstanding contribution to the HG-CT-1 program and their dedication to advancing this groundbreaking therapy, the Company has granted a total of 6,000 Restricted Share Units ("RSUs") to key team members' Yet on no announcement these individuals have been awarded 60,000 options, which is strange at best.

And leaving aside the award today being excessive (Vlad being the exception), why would you award someone like Peter Redmond 300,000 options whilst only giving what some might say is the chief architect of HG-CT-1 Dr Koen van Besien only 60,000?

However my gripe is not the amount of options awarded its that they are not linked to any achievement or milestone. But at least the recent selling has an explanation. Certain individuals were party to this award and knew what was coming, allowing them to sell and now buy back at a far cheaper price and also have the sweetener of their warrants being extended way into the future.

So everyone is happy. Well not everyone but a select few individuals. But as these individuals have eluded to, nobody makes any money until the share price rises and that only happens upon success. So whilst the rest of us will make far less than previously thought we'll still make a handsome profit..eventually.

Again, as others have said, it's just the way of the world. If you don't like it then don't invest.

Haywain, I asked about going down an age group in the pediatrics trial after the first cohort and the answer was no they won’t.

It would actually require a separate IND application rather than just a protocol amendment.

Haywain, maybe you will articulate better than me but as I understand the value in pediatrics, aside from getting fast track approval and a lucrative Priority Review Voucher is that Hemogenyx are also expanding upon the total addressable market of HG-CT-1, which is why the pediatrics trial will not increase the dose level through the cohorts, they’ll reduce the age level as safety is proven.

Pumpky if course ‘if’ is an important word because if the FDA hadn’t approved pediatric treatment after data from just the first two patients, and if the MD Anderson Internal Review Board hadn’t rapidly given rapid pediatric approval, and if the independent Data Safety Management Board hadn’t passed HG-CT-1 for safety with no reported toxicities whilst confirming early signs of efficacy and patient three with no detectable signs of AML, and if Hemogenyx hadn’t spent approaching £1m ensuring HG-CT-1 was already commercially scalable and if the Estonian government and health authority wasn’t completely comfortable with the initial patient data they would not have allowed Hemogenyx the hospital exemption to not only treat their patients but also charge for it, well I would not feel so confident.

Most long term holders of this stock think we have identified a rare setup in the micro-cap space. By leveraging Eli Lilly for CDX and UPenn for CAR-T to build the science, (saving over $50m on development costs), MD Anderson to prove the safety and efficacy, and Made Scientific and Cellin to solve the manufacturing and commercialisation bottlenecks, Hemogenyx has systematically eliminated every major point of failure that usually cripple early-stage biotechs.

They have laid down all the pieces. If the upcoming Cohort 2 and pediatric readouts out of MD Anderson mirror the clean safety and early efficacy of Cohort 1, this pre-packaged, fully operational ecosystem is exactly what triggers an aggressive, multi-indication (AML/ALL)

bidding war well past the billion-dollar mark.

Hemogenyx has derisked the science of CDX and CBR by proving their third generation CAR-T is both safe and that it works as proven in cohort 1 with no DLTs and patient 3 showing no detectable signs of AML. By re-engineering CDX with Lonza they have added a scalable cost effective solution to complement CAR-T and potentially change the whole landscape of AML/ALL treatment. Having the CBR platform to provide development of both solid tumors and viruses makes Hemogenyx a unique oncology acquisition with both a tariff free commercially scalable plug and play solution in the USA and early revenue across Europe with Cellin Technologies giving the additional benefits of real world data to be used in EMA approval.

In three or four months this could well be a unicorn!

Duster the article you referred to:

A revolutionary cancer treatment could transform autoimmune disease | Knowable Magazine

This year could be truly transformational for Hemogenyx which is why I’ve predicted this will be one of the, if not THE top performing small cap this year. The reason why I and many other LTH’s believe this are:

Firstly all the foundational work is explicitly done, allowing the clinical and commercial engines to run simultaneously:

The manufacturing tech transfer to Made Scientific is 100% complete, and the comparability package has already been submitted and approved by the FDA. Hemogenyx is actively cleared to recruit adults for Dose Level 2 and simultaneously open the pediatric arm (ages 12–18) at the baseline dose and treatment of both is imminent. Because Phase I cohorts are tiny (3 patients per step), enrolling, dosing, and evaluating safety readouts for the next cohorts will take around four months, so it’s not not years away. A successful adult dose escalation and first pediatric patient will allow Hemogenyx to apply for fast track approval and a pediatrics Priority Review Voucher, in itself worth up to $200m.

The manufacturing hardware and infrastructure are already physically established in Estonia. The technology transfer to Cellin Technologies is starting imminently to kick off the hospital exemption pathway with a Technology Transfer Agreement signed whilst the Master Service Agreement I’d finalised in parallel.

Hemogenyx recently secured a fresh £3,000,000 on top of the previous £2.5m institutional fundraise, explicitly earmarked to accelerate these Phase I clinical trials and aggressively initiate early commercialisation in Estonia. 

Because these catalysts are running concurrently, they create a massive compounding effect over the next 6 months.

If as we expect the adult dose escalation clears safely, the first pediatric patient demonstrates initial safety, and Cellin Tech prints its first commercial Real-World Data (RWD) from European patients, Hemogenyx reaches peak de-risking by Q4 2026.

And that’s a $1.5-2.5bn company you’re looking at.

#billionsandyears #savinglives

That’s how I see this year panning out. I don’t see how Hemogenyx do not get acquired, probably by Eli Lilly later this year.

Rich, I was actually incorrect in assuming you’d have to have a Master Service Agreement in place before commencing a Technology Transfer as whilst that is progressing a Technology Transfer Agreement has been put in place protecting IP and that’s followed by a Statement Of Work, so Estonia is progressing and by the time the MSA is through legal they’ll be ready to treat their first patients.

Live and learn.

Direct from the RNS:

Clinical Trial Progression

Hemogenyx Pharmaceuticals is now ready to initiate recruitment of adult patients for treatment with the second, increased dose level of HG-CT-1 as part of its ongoing Phase 1 clinical trial in R/R AML.

In parallel, the Company will begin recruitment of pediatric patients, who will receive the lowest dose level of HG-CT-1. This marks an important expansion of the clinical program into pediatric populations suffering from R/R AML.

The pediatrics trial runs in parallel so there is no 40 days wait. In parallel means two patients per month being treated. One adult and one child.

And I very much doubt they’ll start the technology transfer in Estonia before the Master Service Agreement is signed as they are not going to give away trade secrets and their IP before they are fully legally protected.

In my opinion.

I’m lucky I have the app so know all I need to.

MD Anderson started their recruitment process a while ago, Prevail are in place to handle all the logistics and management of the trial and Made Scientific are FDA approved to manufacture HG-CT-1, scalable to commercial levels as and when required.

The first patient on dose escalation will likely have been treated already but if not very soon and will immediately be followed by the first child on the lowest dose.

Two patients per month will be treated going forward meaning the next cohort will be completed by the summer.

In parallel the Master Service Agreement with Cellin and the Estonian government will be signed, the technology transfer to Cellin will commence and HG-CT-1 will become the first CAR-T therapy in the world still in Phase 1 trials to become a revenue generating commercial product, available to both Estonian and European patients.

If you think the above will contribute to raising the value of Hemogenyx then just sit back and enjoy the journey.

As we approach dose escalation and pediatric treatment for HG-CT-1 as JHFH said, a lot of people still don’t get it.

Once dose escalation data is locked in and the first pediatric safety window clears, which could be a little over a month away, Hemogenyx will have a beautifully orchestrated trifecta: proven adult efficacy, a cleared path to a lucrative pediatric voucher, and a globally scalable manufacturing setup via Lonza, Made Scientific and Cellin Technologies.

At that point, Hemogenyx ceases to be a speculative micro-cap biotech; it becomes a derisked, turnkey oncology powerhouse. For a major pharmaceutical company looking to dominate the next generation of leukemia care, letting a competitor swoop in and buy that ecosystem would be a massive strategic mistake.

Maybe our resident expert Haywain could describe how the redesign of the CDX bi-specific antibody is transformational and why the likes of Eli Lilly are likely to swoop, as and when you have the time of course.

Ignore the SP, wait for the next milestones to be hit would be my advice.

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.