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Peter, opinions and timescales are basically irrelevant. The only thing that matters is what Hemogenyx actually deliver.

Once people get their head around the fact that for all intents and purposes HEMO have funds for this year then that alone should see the SP test recent highs of £18.

Once Made Scientific prove manufacturing scalability I’d expect an SP of £22+.

Announcements on CDX and or CBR could easily propel the SP north of £30, as could securing early revenue from Estonia.

If Hemogenyx exhibit positive results from both patient 4 on dose escalation with enhanced efficacy and patient 1 from pediatrics, as i expect them to do then £40+ would be my expectation.

The largest pharmaceutical companies will either move quickly or slowly but if slowly it’ll just increase the value as more data is accrued so I’m comfortable with either scenario. This could, in a bullish scenario exceed £100 a share but that may obviously take some time.

I am extremely confident all of the above will happen and some in the very near future. But, if things take longer than I expect that’s not a problem, I’ll just wait.

People are entitled to disagree with me, I don’t care. Invest here or elsewhere, I honestly don’t care.

This isn’t a team sport, but chose who you listen to wisely and always do your own research.

I’m already in record as saying I think Hemogenyx will be the top performing stock this year, certainly from anything I’ve looked at.

What I will add, for probably the first time, is that if you’re thinking of getting on the train..now is the time because it really is about to leave the station. Tick tock.

Just my opinion.

You may ask AI for say purified tomatoes but when you’re dealing with leading edge science I find its always better to talk to the main man.

The recent buying would indicate news is not only due but it’s imminent. But here’s the thing..what will come first?

We know Vlad has been having ongoing discussions with pharmaceutical majors, so will one move early for HG-CT-1? Or has progressed discussions to enable the fast tracking of CDX into the clinic, enabling Hemogenyx to become a ‘platform’ company, in itself adding multiples to the value of the company.

Or has the technology transfer been approved by the FDA allowing Hemogenyx to begin treating two patients a month, one eagerly anticipated for dose escalation with improved efficacy, potentially curative and the other a child, potentially giving a route to fast track approval complete with access to substantial grants and tax credits.

Not to mention they’ll also have a ‘plug and play’ scalable manufacturing process to install at Cellin in Estonia generating real world data as well as ongoing early revenue.

Maybe it’s news on CBR, a potential partner or news of their ongoing testing of a single molecule to treat a multitude of cancers? As I say, nobody knows what is going to drop first.

What I do know because I’ve asked, is what the outlook for Hemogenyx and investors. The answer I got back was..FANTASTIC.

We know the first cohort of patients experienced no adverse effects, so HG-CT-1 is safe and we know even at the lowest dose patient three showed no detectable signs of AML. Personally I’m confident all three patients remain alive, one for over a year now and it’s an absolute fact that none have died as a result of the treatment as we would have been informed. Bearing in mind a 30% success rate in Phase 1 will be deemed a success, a 100% success to date is truly remarkable.

We’re now on the verge of finding out whether an increased dose improves on the curative nature of HG-CT-1 and with extremely positive efficacy already shown and durability enhanced everyday that passes, Hemogenyx to me looks pretty nailed on to have achieved a paradigm shift in the treatment of r/r AML with a best in class therapy.

If correct that not only substantially derisks their CDX bi-specific antibody but using Made Scientific to manufacture on industrial scale gives a turnkey, tariff free, commercial, efficient and highly scalable solution to not only any major pharmaceutical company, but any country or market in the world, such as Estonia, as a ‘plug and play’ allowing for rapid entry.

So whilst we wait for CAR-T and the technology transfer there is always the possibility of a curveball announcement on CDX or CBR, or both. We’re fully funded for many months and warrants to be exercised giving over a year of runway, so from where I stand, we just sit back, relax with patience and wait for the science to play out.

Some may chase rainbows but I’ve decided this is the least risky and highest return stock I could possibly be invested in for 2026.

How hard is it to read an RNS..

Third Patient Treated with HG-CT-1 CAR-T Therapy Successfully Passes Initial Safety Evaluation

Hemogenyx Pharmaceuticals plc is pleased to announce that the third patient has been successfully treated in the ongoing Phase I clinical trial of HG-CT-1, the Company's proprietary Chimeric Antigen Receptor T-cell (CAR-T) therapy for relapsed/refractory acute myeloid leukemia (R/R AML) in adults.

The treatment was well tolerated and met the trial's predefined initial safety criteria. 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.

Pumpky whilst you make take pleasure in people posting incorrect guesses on timescales, you are also correct that one day Mr India and others will be right. And that’s the only thing of importance.

People like you who are selling think news will take a while. People who are buying think news is imminent and people like Mr India and I, as well as a multitude of others simply don’t care, as we’re holding until news does arrive, because I absolutely guarantee you that eventually it will arrive and that’s the day people who are out will very much wish they were in.

All in my opinion of course.

Whilst predicting timescales for Hemogenyx has been a fools errand what is an absolute fact is news will come in the very near future. I believe we’ll be getting news on:

The technology transfer to Made being completed.

Patient 4 enrolled and treated on dose escalation.

Patient 1 pediatric patient enrolled and treated.

Patient 4 28 day safety report.

Patient 1 pediatric 28 day safety report.

In amongst that I think we’ll have the Master Service Agreement signed with Cellin and the Estonian government giving a path to first commercial revenue.

I also believe we’ll hear about a major partnership with a leading cancer institute to fast track CDX into the clinic.

When will the above news start to be released..as I’ve said that’s a fools errand. Buy, sell or hold as you see fit.

The G-Rex platform simplifies the transfer of the HG-CT-1 manufacturing process to Made Scientific (US) and Cellin Technologies (Estonia) by providing a highly reproducible environment. Unlike complex bioreactors that require stirring or perfusion, G-Rex uses a static environment that eliminates mechanical variables. Protocols developed at small scales correlate directly to larger clinical-scale devices, ensuring that the validated process at one site can be mirrored at others with identical results.

Using G-Rex reduces the technical barriers for third-party manufacturers, lowering the risk of human error during the transfer process. The "Fill and Forget" approach requires far fewer manual interventions than traditional methods, which is critical when outsourcing to a CDMO like Made Scientific.G-Rex utilises standard lab equipment (e.g., CO2 incubators), meaning partner sites do not need to invest in or learn to operate specialised, proprietary machinery. The $120,000 G-Rex grant HEMO were awarded was specifically intended to optimise a closed-system manufacturing platform to strengthen regulatory and CMC (Chemistry, Manufacturing, and Controls) strategies as required by the FDA. The G-Rex M-Series provides a functionally closed environment, helping Hemogenyx meet both the stringent FDA and European safety requirements for cell therapy production. The technology significantly lowers per-patient manufacturing costs—potentially to a $20,000 material cost standard—enhancing the commercial viability of commercial production in the states and the Estonian "Hospital Exemption" pathway.

Once this process is "locked," Hemogenyx intends to deploy the same validated G-Rex framework to Cellin Technologies in Estonia to initiate early-revenue patient treatments, with an unlimited number of patients to be treated. It should be noted that following the completion of the technology transfer to Made, Hemogenyx could deploy this process in any country or continent in the world that allows a form of exemption for a breakthrough therapy, and there are plenty that do.

Although not part of the US clinical protocol the recent changes to the FDA guidelines will allow both safety and efficacy data from around the world to be used in the fast tracking of approvals through various stages of the clinical trials, further reducing costs to Hemogenyx.

All investors need here is a little patience. In my opinion anyway.

Glass, excellent post, thank you.

Pumpky, your level of ignorance for the pharmaceutical industry is simply astounding. So you believe someone should only charge the customer what it costs to manufacture the product?

But you know that the vast majority of costs associated with CAR-T therapy comes from the hospital not the product?

And you know that health care providers and insurance companies will pay for curative therapies because a one off treatment is cheaper than providing ongoing care?

And you know that if companies like Hemogenyx only charged what their product candidates cost to manufacture there would be no money to pay their staff?

And you know that nine out of ten R&D products don’t even make it to the clinic so where does the tens of millions of dollars expenditure that never gets recouped come from?

And you know that even if a candidate gets into the clinic there is only a one in ten chance it’ll become commercial, so where does the hundreds of millions expenditure come from?

And you know that Intellectual Property is protected through a patent and that patent only has a definitive lifespan right, so companies try to make profits before others can copy their product, which would be impossible if they only charged things at cost?

And you know the only way any small cap could get any product through clinical trials is to partner with a major, who wouldn’t bother taking the risk if there was no way to make a profi?

And you know any innovation is initially funded through private investors who again wouldn’t bother if they knew a company would be doomed before starting?

And you know no company would even bother to start up if they were to follow your economic model?

So far from treating less patients I think you’d find no patients would be treated at all with your logic, so in my humble opinion I’d stick to investing in tomato extract if I were you. Perhaps it less complicated for you.

If there was a strategic partner that would fast track CDX into the clinic, my guess is it would be our current CAR-T partner, MD Anderson.

Personally I think we’re really close to substantial investment in CDX, which would automatically turn Hemogenyx into a platform company rather than a product company with a valuation of over a billion dollars.

I think that’s Vlads plan and only time will tell if I’m right. But if I am, we’re looking at an SP closer to £150.

https://www.news-medical.net/news/20251114/MD-Anderson-launches-historic-2425-billion-campaign-to-end-cancer.aspx

I think the yearly high of £17.90 is likely to be smashed in the coming days.

The technology transfer is virtually done which means HEMO will be treating the first adult on dose escalation as well as the first child. By passing the first adult dose escalation and initial paediatric safety tests it would be a major de-risking event, likely triggering a significant "value-inflection point". In the high-stakes biotech sector, such milestones often lead to substantial market re-ratings as the therapy moves from a "maybe" to a "must-have" asset.

Potential Valuation Impact

Analysts and market observers suggest several tiers of valuation following these specific milestones:

Platform De-risking: Successfully passing the second adult cohort and starting the paediatric arm could immediately lift the valuation toward £300 million to £400 million as the risk profile drops significantly.

Target Share Price: Conservative estimates for a buyout or asset-only valuation after successful safety and early efficacy in these cohorts suggest a price closer to £48 to £63 per share.

Major Re-Rating: Should the results eliminate all doubt for a potential pharmaceutical partner, some optimistic projections place the company’s value between £800 million and £1.2 billion, with a share price potentially reaching £155.

Now if what we believe is true, the technology transfer is all but done, then patients will be treated early next month. That means by the end of next month we could see the substantial re-rate we’ve been waiting for.

NHS costs as rumoured to be between £280,000 to £370,000 a patient, although nobody knows the confidential discounts NICE have been able to negotiate.

There is a move to adopt a more home grown approach from academic institutions in order to reduce costs, as some other European countries have done. But, if like Hemogenyx your treatment is unique, there’s a premium to be paid.

I’m pretty sure that once the imminent technology transfer to Made is announced it’ll afford Hemogenyx to adopt a plug and play approach to take the manufacturing model anywhere in the world, starting with Estonia. With an unlimited patient population and just two patients a month generating well over €4m a year in early revenue, it’s quite possible Vlads statement of being self sustainable could be closer than some imagine.

Hemogenyx will generate revenue through the Hospital Exemption Pathway, which was specifically amended by the Estonian government in April 2025.

Reimbursement Model: Under this pathway, Hemogenyx can apply for reimbursement of treatment costs directly from the Estonian National Health Fund (Tervisekassa). This allows them to get paid for their CAR-T therapy (HG-CT-1) even before it has full commercial marketing authorization from the EMA.

Dual Revenue Stream: Vlad has indicated that revenue will come from two sources:

Domestic Patients: Reimbursed by the Estonian government.

International Patients: "Medical tourists" who may travel to Estonia to access the therapy, likely paying through private insurance or out-of-pocket.

Partnership Structure: Hemogenyx retains 100% ownership of the intellectual property. Their local partner, Cellin Technologies, manages the manufacturing and logistics in exchange for a service fee, leaving the remaining reimbursement revenue for Hemogenyx.

2. How Much Money Do Estonian Health Authorities Have?

The Estonian Health Insurance Fund (EHIF / Tervisekassa) is the primary payer. Despite being a small nation, its budget is centralised and growing:

2026 Budget: Roughly €2.60 billion.

Reserve Funds: As of early 2026, the Fund holds approximately €626 million in reserves. It is specifically redirecting funds (about €25 million saved from lab service cuts) toward "modernising specialties" and "new cancer treatments."

Priority on Innovation: Estonia’s strategy involves becoming a hub for Advanced Therapy Medicinal Products (ATMPs). The government has signaled a willingness to fund these high-cost treatments to reduce long-term costs associated with chronic hospital care for leukemia.

3. Estimated Amount Per Patient

While Hemogenyx has not publicly disclosed the exact "sticker price" for HG-CT-1 in Estonia it is estimated at between €200,000-300,000 per patient.

Investors should be aware that there’s far more to Hemogenyx than their lead product candidate HG-CT—1. Not only do they have their immensely promising CBR platform but also their best in class bi-specific antibody.

Hemogenyx have already announced that it has utilised Lonza’s bYlok bispecific pairing technology to develop a new and improved version of CDX, which has demonstrated significantly enhanced efficacy in in vitro testing. Additional in vivo studies are currently ongoing. .

Dr. Vladislav Sandler said “The development of an improved version of our CDX bi-specific antibody holds significant promise for enhancing treatment outcomes for patients battling often incurable blood cancers. This advancement could accelerate the progress of this product candidate and allow us to resume its development toward the clinic. It may also attract new industry partners interested in fast-tracking the co-development of CDX.”

What this development actually means is that CDX is now as scalable as HG-CT-1 and the manufacturing is as efficient, giving a 95%+ usable off the shelf batch (as opposed to the previous 12%, obviously making it far more cost effective as well as improving the efficacy. Rest assured once the in-vivo tests are completed (expected imminently) a leading partner will step in, as eluded to by Vlad, to fund CDX and fast track it into the clinic.

With the FDA now only requiring one phase of a trial to prove a product and having two products in the clinic, Hemogenyx will rapidly become a platform company and that will mean the company will be valued in the billions.

The future reality is very exciting. In my opinion anyway.

As someone who spends their time trolling through historic posts, perhaps you should look at my post stating people should be buying at £1.40, but what’s another lie between friends.

You and the pumpkin are more than welcome to sit on the sidelines and watch the rise, but there’s a reason your watch is broken and ours are working. I, like a lot on here am sitting on a six figure investment whilst the only way you two will ever get to six figures is the next McDonalds Star Wars promotion.

Could it be investors know the technology transfer to Made is nearly completed or indeed has been completed? People know that’s when patients will be recruited and treated for both dose escalation and pediatrics in parallel right? And people know that passing safety on these patients IS the infection point for true value to be accrued?

That’s all common sense but I wonder if people realise that completing the technology transfer will also act as the template for the Estonian government by proving the scalability of HG-CT-1 to commercial levels. And don’t underestimate just how big Estonia will be for Hemogenyx and any potential buyer or partner:

Hemogenyx Pharmaceuticals is moving toward its first "near-term revenue" by utilizing a unique regulatory fast-track in Estonia. Based on the 2025 Letter of Intent (LOI) with Cellin Technologies and Estonia's recent healthcare reforms, here is the breakdown of how they will be paid and the financial landscape of the Estonian health authorities.

1. How Hemogenyx Will Get Paid

Hemogenyx will generate revenue through the Hospital Exemption Pathway, which was specifically amended by the Estonian government in April 2025.

Reimbursement Model: Under this pathway, Hemogenyx can apply for reimbursement of treatment costs directly from the Estonian National Health Fund (Tervisekassa). This allows them to get paid for their CAR-T therapy (HG-CT-1) even before it has full commercial marketing authorization from the EMA.

Dual Revenue Stream: Vlad has indicated that revenue will come from two sources:

Domestic Patients: Reimbursed by the Estonian government.

International Patients: "Medical tourists" who may travel to Estonia to access the therapy, likely paying through private insurance or out-of-pocket.

Partnership Structure: Hemogenyx retains 100% ownership of the intellectual property. Their local partner, Cellin Technologies, manages the manufacturing and logistics in exchange for a service fee, leaving the remaining reimbursement revenue for Hemogenyx.

2. How Much Money Do Estonian Health Authorities Have?

The Estonian Health Insurance Fund (EHIF / Tervisekassa) is the primary payer. Despite being a small nation, its budget is centralised and growing:

2026 Budget: Roughly €2.60 billion.

Reserve Funds: As of early 2026, the Fund holds approximately €626 million in reserves. It is specifically redirecting funds (about €25 million saved from lab service cuts) toward "modernising specialties" and "new cancer treatments."

Priority on Innovation: Estonia’s strategy involves becoming a hub for Advanced Therapy Medicinal Products (ATMPs). The government has signaled a willingness to fund these high-cost treatments to reduce long-term costs associated with chronic hospital care for leukemia.

3. Estimated Amount Per Patient

While Hemogenyx has not publicly disclosed the exact "sticker price" for HG-CT-1 in Estonia it is estimated at between €200,000-300,000 per patient.

I would think hope the next update would be about their pivot into Digital Assets. Personally I take great interest in them appointing someone of Lawrence’s experience and the fact he’s agreed an opinions package exercised at 50p.

Insig AI plc (AIM:INSG), a provider of AI-led analytics and machine learning solutions is pleased to announce that Lawrence Lundy-Bryan has been appointed its Digital Asset Adviser. This appointment follows the Company's recent announcement that it is considering various strategic options, one of which being establishing a fund dedicated to investments in digital assets and related enterprises.

Lawrence is an investor and strategist who combines early crypto experience with policy fluency and a broader technology lens. He was first involved in crypto in 2015 working with Intel on its distributed ledger technology strategy. He helped establish Outlier Ventures as Europe's first dedicated crypto fund in 2015 leading the investment strategy and research. Most recently, Lawrence has led research at Lunar Ventures, an early-stage deep tech venture fund.

Lawrence has contributed to policy through the UK Cryptoasset Taskforce led by HM Treasury, the FCA, and the Bank of England. He also participated in the EU Commission Observatory on Blockchain. Lawrence was an expert adviser to the World Economic Forum on Central Bank Digital Currencies.

The Company has granted to Lawrence Lundy-Bryan, options over 1,500,000 ordinary shares of 1 pence each in the Company ("Ordinary Shares") at an exercise price of 50p per Ordinary Share (the "Options").

Richard Bernstein, Chief Executive of Insig AI commented:

"We're delighted to have secured someone of Lawrence's experience, knowledge and network as we progress our strategy to target assets and opportunities with proven utility and overlooked fundamentals beyond the so-called headline of 'crypto assets'."

Lawrence Lundy-Bryan commented:

"I'm excited to now be working with Richard, Peter and the team at Insig AI in assessing the viability of what I hope will become London's leading listed digital asset vehicle. The scale of the opportunity is enormous."