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Socialist I think you’re right, any deal will be conditional on the manufacturing process from Made being FDA approved, especially if the major is outside the USA.

My personal view is that approval, patient enrolment and the deal will be concluded this month, in advance of patient one hitting the milestone of being alive for one year, officially the 24th February.

An interesting three weeks ahead, in my opinion.

VLP, the FDA's decision to clear the pediatric expansion for Hemogenyx’s HG-CT-1 trial after just two patients from the adult group is less about the "number" of patients and more about the specific safety results and the unmet medical need in children with Relapsed/Refractory Acute Myeloid Leukaemia (R/R AML).

While it may seem fast, several factors explain why the FDA allowed this transition so early:

1. Exceptional Safety Profile (DSMB Clearance)

In late 2025, an independent Data Safety Monitoring Board (DSMB) reviewed the data from the first three adult patients. Crucially, they found no dose-limiting toxicities (DLTs). In the world of CAR-T therapy—which can often cause severe side effects like Cytokine Release Syndrome (CRS)—a clean safety report from the initial cohort is a powerful "green light" for regulators to allow expansion into more vulnerable populations.

2. High Unmet Need in Pediatrics

Pediatric R/R AML is notoriously difficult to treat and often fatal once standard chemotherapy fails. The FDA frequently uses accelerated pathways or allows earlier pediatric inclusion for life-threatening diseases where no alternative treatments exist. In this case, the potential benefit to children who have no other options was deemed to outweigh the risks of moving forward with limited adult data.

3. Protocol Design & "Dose Escalation"

The pediatric trial isn't jumping straight into high doses. The FDA cleared the pediatric arm to begin at the same lowest dose used in the successful adult cohort. This "dose-parallel" approach allows researchers to gather data on children safely while the adult trial continues to escalate to higher, more experimental doses.

4. Direct Benefit Justification

Under FDA regulations (specifically 21 CFR 50.52), clinical trials involving children are permitted if the research holds out the prospect of direct benefit to the individual subject. Because HG-CT-1 showed early signs of anti-leukemic activity in the first adults, it met the criteria for a "potential benefit" that justified the risk of enrollment.

The above explains why I have constantly stated that I do not believe Hemogenyx will get anywhere near having to treat the ‘up to’ eighteen adult and eighteen children specified. Due to the very criteria set out by the FDA themselves, I firmly believe HG-CT-1 will be fast tracked through the phases and designated a breakthrough therapy, which could lead to it progressing to Phase 3 or best case straight to commercial. Maybe that’s why Vlad is transitioning to Made with their commercial scalability capabilities.

Anyway for that to happen I think we have to successfully treat the next adult at the higher dose and the first child. But I do believe they’ll be treated in February which should mean the technology transfer completion should be announced soon. If I’m right, in March we’ll know just how safe and efficacious HG-CT-1 is and just how valuable.

Lots to be excit

It’s not an assumption. It’s a fact that if any patient had died the safety monitoring board has to halt the trial to adhere to the FDA protocol until such time as the cause of death was determined.

The safety board would notify Hemogenyx and they in turn would have to RNS the market as it’s of material significance.

We have not heard anything so by definition all three patients remain alive.

To have all three patients still alive from the first cohort is hugely encouraging for efficacy, especially on the lowest dose. In three weeks the first patient will have been alive for one year, months longer than any other treatment available.

When you think February should bring the completion of the technology transfer, treatment of the first child as well as dose escalation for patient four which I believe will demonstrate the true curative nature of HG-CT-1.

That’s not mentioning possible funding from a major, a multi million CDX deal, or early revenue from an Estonian deal, let alone the single molecule development to treat a multitude of cancers with CBR.

A very exciting month ahead!

That would be my take. MMs dropping the price to let those short close, then obviously buy in again in advance of news.

Perhaps after ten consecutive posts on someone who has already stated they are leaving the board we can refocus on the company we’re invested in, with a product candidate that could well catapult the share price into triple figures. Just a thought.

1. Proof of "Durability" (The One-Year Mark)

The fact that Patient 1 will reach the one-year survival mark on February 24, 2026, is the strongest indicator yet of the therapy's durability.

The Baseline: Many experimental AML treatments show initial "blasts" reduction but fail when the cancer returns rapidly.

The Milestone: Surviving one year after a CAR-T infusion in a R/R AML setting strongly suggests that the modified T-cells have not only cleared the cancer but may still be providing immunosurveillance or have allowed for a successful "bridge to transplant," which is often the ultimate goal.

2. High Efficacy at the Lowest Dose

All three patients from the first cohort being alive is particularly impressive because this was the lowest dose cohort.

In Phase 1 "3+3" design trials, the first group receives a sub-therapeutic dose to test for toxicity.

The fact that they are seeing early signs of efficacy (with the third patient showing no detectable AML cells post-treatment) at the lowest dose level suggests that the product could be even more potent as they move into the higher dose escalations recently cleared by the DSMB.

3. Safety Profile vs. Competitors

CAR-T therapies are notorious for "Cytokine Release Syndrome" (CRS) and neurotoxicity.

Clean Safety: So far, the therapy has been well-tolerated across the first cohort with no adverse effects.

FLT3 Targeting: HG-CT-1 targets FLT3, a protein found on most AML cells. A major risk with FLT3 targets is that they are also found on healthy blood stem cells. The survival of these patients suggests Hemogenyx may have solved the "off-target" toxicity issue that has sidelined other AML CAR-T programs.

With dose escalation it is highly likely HG-CT-1 will be even more efficacious moving to curative in nature. This is best in class status, transformative and undoubtedly in my mind will be designated a breakthrough therapy therefore being fast tracked through the clinic.

HG-CT-1 shows all the signs of being a product candidate worth hundreds of millions of dollars if not billions.

The question is which major will move first and when.

1. Proof of "Durability" (The One-Year Mark)

The fact that Patient 1 will reach the one-year survival mark on February 24, 2026, is the strongest indicator yet of the therapy's durability.

The Baseline: Many experimental AML treatments show initial "blasts" reduction but fail when the cancer returns rapidly.

The Milestone: Surviving one year after a CAR-T infusion in a R/R AML setting strongly suggests that the modified T-cells have not only cleared the cancer but may still be providing immunosurveillance or have allowed for a successful "bridge to transplant," which is often the ultimate goal.

2. High Efficacy at the Lowest Dose

All three patients from the first cohort being alive is particularly impressive because this was the lowest dose cohort.

In Phase 1 "3+3" design trials, the first group receives a sub-therapeutic dose to test for toxicity.

The fact that they are seeing early signs of efficacy (with the third patient showing no detectable AML cells post-treatment) at the lowest dose level suggests that the product could be even more potent as they move into the higher dose escalations recently cleared by the DSMB.

3. Safety Profile vs. Competitors

CAR-T therapies are notorious for "Cytokine Release Syndrome" (CRS) and neurotoxicity.

Clean Safety: So far, the therapy has been well-tolerated across the first cohort with no adverse effects.

FLT3 Targeting: HG-CT-1 targets FLT3, a protein found on most AML cells. A major risk with FLT3 targets is that they are also found on healthy blood stem cells. The survival of these patients suggests Hemogenyx may have solved the "off-target" toxicity issue that has sidelined other AML CAR-T programs.

With dose escalation it is highly likely HG-CT-1 will be even more efficacious moving to curative in nature. This is best in class status, transformative and undoubtedly in my mind will be designated a breakthrough therapy therefore being fast tracked through the clinic.

HG-CT-1 shows all the signs of being a product candidate worth hundreds of millions of dollars if not billions.

The question is which major will move first and when.

It’s fair to say if you took any prospectus ever published literally you simply wouldn’t invest in anything.

To me, knowing Vlad as I do, I took one paragraph from it.

“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”

So it depends on whether you see your glass full or empty I suppose. Personally I think this paragraph will turn out to be quite prophetic.

Just to be clear it’s UP TO eighteen patients for both adults and pediatrics, likely to be less if results continue to be as good as the first cohort. Treating two patients a month in parallel once Made are up and running.

People can speculate as much as they want to as to when the technology transfer will be completed, but the fact that nobody knows when it stated let alone how long HG-CT1 will take makes it an impossible question to answer. When coupled with why, apart from the ongoing reduction in manufacturing costs, they would delay the trial for several months and spend over a million pounds to get a state of the art, super fast manufacturing process that’s commercially scalable up to 100,000 patients a year when they’ve only treated three is a question investors need to ask themselves.

For me there are likely two reasons. The first is they know it works, it’s either curative or dramatically improves the patients quality of life. The second reason is most likely the pharmaceutical companies they are talking to want a turnkey solution, with manufacturing US based and therefore free of tariffs.

All will be revealed in the fullness of time.

Funding won’t be from a VC. IMO.

Rather than posting in response to irrelevance why not just take comfort in what I said earlier, those short are starting to panic.

It’s going to get nasty on here but that’s no reason for holders to engage. Sit back and enjoy the ride.

I wonder what the narrative looks like now with a £50k buy being posted?

Some still sitting it out, some still short. It looks an increasingly risky strategy to me but each to their own.

News is coming soon!

Anyone else get the feeling those short are starting to panic?

Hemogenyx up 15% over the last 5 days and 22.% over the last month. That doesn’t look like a company that’s going to do any sort of raise this week to me, let alone a discounted one, so perhaps those LTH’s were right all along?

Far more likely a big pharmaceutical company will step in, in my opinion and probably between now and March..the time Hemogenyx will actually need it.

I think at the moment the most likely outcome is a big pharmaceutical company actually buys Hemogenyx outright. However, what I believe will actually happen is substantial investment will come into Hemogenyx to fast track CDX into the clinic. What that means is Hemogenyx will be sold at a value far more appropriate to its product candidates pleasing both shareholders and more importantly Vlad and the board.

Based on the most recent clinical data and the official protocol for the HG-CT-1 trial (NCT06786533) as of January 2026, here is the specific "safeguard" framework that dictates what happens if a patient passes away or suffers a severe reaction.

1. The 28-Day "DLT" Window

The trial operates on a strict Dose-Limiting Toxicity (DLT) observation period. For every patient infused, there is a 28-day intensive monitoring window.

What counts as a DLT: Any Grade 3 or higher non-hematologic toxicity (like severe organ failure or neurotoxicity) that is "definitely, probably, or possibly" related to the CAR-T cells.

Death as a DLT: If a patient dies within this 28-day window and the cause is linked to the treatment (rather than the underlying leukemia), it is recorded as a DLT.

2. The "Stopping Rules" (Dose Escalation)

The trial uses a standard dose-escalation design (often a 3+3 or similar model). The impact of a death depends on how many other toxicities have occurred in that "cohort" (group of patients):

1 Death/DLT in 3 Patients: The trial continues, but three more patients must be treated at that same dose to ensure it wasn't a fluke.

2 Deaths/DLTs in 3–6 Patients: The Stopping Rule is triggered for that dose level. Escalation stops immediately. The dose is considered "unsafe," and the trial must either drop to a lower dose or stop entirely for investigation.

3. Current Safety Status (January 2026)

As of the most recent updates, the trial has shown a "favorable safety profile":

First Cohort Success: The first adult dose cohort (lowest dose was completed in late 2025 with no DLTs observed.

DSMB Clearance: The independent Data Safety Monitoring Board (DSMB) reviewed the data and cleared Hemogenyx to move to Cohort 2 (twice the initial dose) and open the pediatric arm for patients aged 12–17.

Regulatory Standing: Unlike the 2023 manufacturing hold, the FDA recently (June 2025) allowed the trial to expand without any new safety holds.

4. What happens next if a death occurs now?

If a death occurred tomorrow, Hemogenyx would be legally required to:

Stop Recruitment: Pause all new patient enrollment until the DSMB reviews the event.

LSE Announcement: Issue a "Regulatory News Service" (RNS) update to the London Stock Exchange, as this would be considered "Inside Information."

FDA Consultation: The FDA would determine if a formal "Clinical Hold" is necessary or if the death was simply a result of the patient's advanced leukemia (which is common in Phase I AML trials).

So as there has been no announcement and furthermore there has been independent validation of the safety and early signs of efficacy it’s fair to say there have been no deaths in the first cohort of patients.

For those wanting to hear about the actual company..

Looking back, history tells us the SP falls significantly in the run up to Peterhouse specials, yet it’s up around 12% of late.

So maybe Vlad is looking at LTH’s for finance? Well no he’s not.

So it must be our high net worth individuals? Well no, he doesn’t require money from them either.

So, with only 20 trading days after today until patient one reaches the unbelievable milestone of being alive for one whole year, and nothing published to suggest the other two patients are not alive and healthy, could it be as most of us suspect, the finance is coming from a major pharmaceutical company?

It certainly looks that way to me, and if I were them I’d be concluding the deal before the one year milestone as HG-CT-1 is only going to get more valuable as each day passes.

Just my thoughts.

Pumpky Cellin in Estonia are a completely different CDMO than Made Scientific and working in parallel with completely different timescales. Certainly one is not dependent on the other.

Hemogenyx Pharmaceuticals will retain full ownership of all intellectual property, know-how, data and regulatory rights relating to HG-CT-1 and will be entitled to revenues from commercialization.

Cellin will act as Hemogenyx Pharmaceuticals' local partner in Estonia, providing manufacturing, regulatory, and operational support, including securing permits from the Ministry of Health and facilitating administration of the therapy through attending physicians. Cellin will receive fair compensation for its services, to be defined in subsequent definitive agreements.

What Hemogenyx announced with patient three was

“Importantly, early indications of clinical efficacy have been observed. Preliminary assessment shows that original AML cells were not detectable in the patient using standard testing methods”.

Furthermore the Independent Data Safety Monitoring Board (DSMB) in approving dose escalation the RNS stated

“No toxicities were observed”

So with Hemogenyx stating they expect greater efficacy at the higher dose, and them spending over £1m on doing a highly complex Technology Transfer to Made Scientific to gain greater efficiency and scalability to commercial levels, plus the FDA approval to treat pediatric patients after dats from just two patients, well I draw a conclusion many investors have…

this treatment works and is a paradigm shift for the treatment of r/r AML.

If we are right we’re looking at Hemogenyx being valued in the high hundreds of millions and the more data accrued the more valuable it will become. That’s why Estonia is so important. Sure it’s a gateway to private European patients and revenue but the real value lies in the data to prove its curative nature. Would a country treat their population if they weren’t confident of the data they’ve already seen? Probably not.

The final point I’d make is this. Could Hemogenyx raise the necessary capital to conclude Phase One trials on their own? Probably not in my opinion. This has major pharmaceutical partnership or buy out written all,over it. If and when it happens the company, the patients and shareholders are all winners. Big winners.

Mojo excellent news. If you’re up for it we can meet up in the fan zone on Saturday ⚒️