Member Info for HereforHemo

Arch I believe it will be a billion dollar plus licensing deal with several hundred million as an upfront payment and the rest based on achieving milestones over several years. Bottom line is the longer Vlad waits the more valuable HG-CT-1 will become.

With money in the bank, a reduction in burn rate, cheaper manufacturing, warrants to exercise and potential early revenue Vlad holds a good hand.

JHFH I agree. As certain shareholders know, I fully expect this to be over £25 in the near term.

Socialist with CDX being an 'off the shelf' solution it's reasonable to assume it will be worth twice the amount of HG-CT-1. However with the synergy that exists between the two candidates I feel it unlikely a major would want one to compete with the other, so would they buy both? Or would economies of scale dictate they buy the company? Probably in my opinion.

The sensible option for Vlad would appear to be to just license HG-CT-1 with a few hundred million upfront and use that money to bring CDX and CBR to the clinic. Maybe.

Withoutt There is a late submission for abstracts for ASH, starting I believe the 16th of this month. With Vlad already presenting pre-clinical data there several years ago, I'd be VERY surprised if Hemogenyx don't present this year. If they do submit an abstract then it goes online tor all to see on 6th November.

Mid tier pharmas would have to move very quickly if they publish their data. It'll probably already be too late for them if they do.

One of the most enjoyable things I find about investing is doing the research, and more importantly getting the missing pieces, hopefully to complete the picture before others.

For example let's take Hemogenyx getting a major pharmaceutical company to progress HG-CT-1 through the trials, hopefully to commercialisation. To me, with adoption of the GRex advanced and super scalable CAR-T manufacturing coupled with partnering Made Scientific Hemogenyx have put the building blocks in place for commercial production. This has been augmented with another innovative partnership with Cellin in Estonia that allows for early-stage revenues as well as providing a pathway to Europe. All of the above are highly attractive factors in attracting a major to invest, especially when combined with positive results from the initial cohort of patients.

Will it be enough for a major to pounce, either through a licence agreement, a joint venture or an acquisition? Probably not. But with the forth patient treated and passing safety and the first patient in pediatrics doing likewise in parallel? I think the case for investment becomes far more compelling, and it's not too far away.

Of more interest to me at the moment is how the smaller $5-10bn range companies are viewing Hemogenyx. Do they wait and risk being priced out by companies worth hundreds of billions, or do they move quickly? I believe they'll move quickly and that's why my ears pricked when I heard about certain attendees at the recent high level DCNY summit Vlad was invited to present at. Corporate Venture Capitalists. They were attending on behalf of companies they represent for the purpose of doing due diligence. Thaf usually means for a large deal or potential takeover.

Now I could be arranging the pieces in the wrong position but I think I'm forming a picture and that picture looks very exciting. I mean £50-100 a share exciting. But, i also think this is becoming a very valuable product candidate.

Thsse ars just my personal thoughts and i continue to accumulate and hold a sizable six figure sum and will continue to hold them all until the final piece of the jigsaw is put into place. GLA

From the moment the FDA approved HG-CT-1 for pediatrics after seeing the data from the first one or two adult patients this was always going to be approved by the Internal Review Board at MD Anderson. Another clue was MDA recruiting for up to 18 pediatric patients in parallel with up to 18 adult patients on their website several weeks ago.

There’s also been several clues about the Safety Board approval of dose escalation following the first cohort. The latest in Vlads statement in today’s RNS.

Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "Securing IRB clearance to proceed with pediatric enrolment in our HG-CT-1 clinical trial is a major milestone. It marks the transition of HG-CT-1 into the pediatric setting, where treatment options remain limited, and demonstrates the continued momentum of our development program. This expansion not only increases the potential reach and impact of HG-CT-1 but also underscores the value of the Company's strong intellectual property portfolio, which underpins our pipeline and supports long-term growth."

The Company will provide further updates as both adult and pediatric patient enrolment progresses.

Just look at the last sentence. Approval is imminent.

Investors should note MD Anderson were recruiting for pediatric patients weeks ago on their website so the first patient will be lined up ready to go. Also note that because children have a better immune system than adults they will be much more likely to have a better response to CAR-T therapy.

Next up dose escalation approval and patient four being treated in parallel to pediatrics.

Things are getting very interesting in the run up to the ASH conference in early December!

As I said yesterday…

So with imminent approvals expected for both dose escalation and pediatrics, the fourth and first patients treated respectively, using the new cheaper faster and scalable manufacturing facilities from Made Scientific using GRex technology, the Master Services Agreement to be signed with Cellin initiating a commercial revenue stream from Estonia and ultimately Europe and beyond, not to mention other potential partnerships and product candidate announcements. I'd say the future for shareholders (as well as patients) is looking pretty damm good.

Get ready for more good news to come.

Tilly want meant to come across as condescending and wasn't actually in reference to you at all. I was merely making reference to individuals who prefer having individual conversations with each other rather than focusing on the company.

In June Hemogenyx confirmed that both the first and second patients had successfully passed their initial safety evaluations after being treated with HG-CT and with the third adult patient being treated in August they reported that this patient had not only passed the initial safety evaluation, importantly, that early signs of clinical efficacy were observed. "Leukemic cells were no longer detectable by standard assays", providing the first clear evidence that HG-CT-1 is delivering therapeutic benefit. With the safety data submitted to the independent Data Safety Monitoring Board ("DSMB"), subject to approval, Hemogenyx will proceed into dose escalation, a critical milestone in defining both the safety and therapeutic potential of HG-CT-1.

Hemogenyx have also prepared to broaden the scope of the trial. A paediatric protocol amendment was submitted in May, and in June regulatory clearance was obtained to initiate a paediatric expansion of the study, which will run in parallel to adults to address the particularly acute unmet need in childhood AML.

To ensure operational readiness Hemogenyx have entered into a strategic manufacturing partnership with Made Scientific, a US-based contract development and manufacturing organisation, to support the scale-up of HG-CT-1.

Hemogenyx also secured a US$120,000 G-Rex® grant to optimise and scale CAR-T production, up to 100,000 patients per annum, whilst supporting efficiency and cost-effectiveness as the programme expands, all designed to ensure that Hemogenyx Pharmaceuticals can meet the growing demands of its clinical trials and be well prepared for potential commercialisation.

Furthermore Hemogenyx has signed a letter of intent ("LOI") with Cellin Technologies OÜ ("Cellin"), a leading Estonian cell therapy company. This agreement contemplates the commercialisation of HG-CT-1 under Estonia's recently amended hospital exemption whilst also offering an early commercial pathway to Europe.

So with imminent approvals expected for both dose escalation and pediatrics, the fourth and first patients treated respectively, using the new cheaper faster and scalable manufacturing facilities from Made Scientific using GRex technology, the Master Services Agreement to be signed with Cellin initiating a commercial revenue stream from Estonia and ultimately Europe and beyond, not to mention other potential partnerships and product candidate announcements. I'd say the future for shareholders (as well as patients) is looking pretty damm good.

Whilst I'm disappointed with the continuous squabbling between individuals and the unhealthy fascination as to who is short or long, for me my focus is on one thing and one thing alone, the science.

Everything else is just noise.

How to follow someone else’s agenda.

6 green boxes.

9 responses to them.

Pointless reading. Pointless posting. Pointless BB.

A board full of green boxes and the posts I can read referring to the posts from the green boxes.

I'll ignore them all and have been buying more on the dip.

Why you ask? Well you didn't actually..you're too busy with each other.

As an aside I met up with Micky today. What a charming guy. We'll meet up again in the near future when hopefully more of you will be in attendance.

Enjoy the rest of your holiday Micky!

Rather than focus on individuals I would rather focus on what's coming.

The safety review board can take up to 4 weeks to approve dose escalation, so it will be approved in the next two weeks.

With pediatrics being approved by the FDA after only 2 patients it's a formality for the IRB at MD Anderson to rubber stamp and nominate the first child to be treated, again approval highly likely to be in the next two weeks.

With discussions underway with the Government and health officials in Estonia the Master Services Agreement will be signed and the fact Hemogenyx are already doing a technology transfer to Cellin in parallel shows the confidence Hemogenyx have in becoming commercial.

With all 3 patients still alive and well from the first cohort I believe it's highly likely Hemogenyx will be presenting their findings to ASH in early December. That means an abstract must be submitted by late October and the important thing for investors is we'll see the paper which is published online early November.

All the above means October will be a news rich period. We've also got patient 4 to be treated with dose escalation and patient 1 pediatrics to be treated, plus anything that comes out of the recent DCNY summit, or updates on candidates like CBR.

Try not to respond to goading, focus on the fundamentals as I believe proper value is very close to being realised. The majors will be circling especially in the run up to ASH.

“These steps are designed to ensure that Hemogenyx Pharmaceuticals can meet the growing demands of its clinical trial and be well prepared for potential commercialisation”.

Every building block being put in place!

The success of HG-CT-1 carries significant implications for Hemogenyx's future collaborations, primarily by enhancing its attractiveness as a partner for further development and commercialisation efforts.

This success demonstrates the company's scientific discipline, operational resilience, and commitment to patients, partners, and shareholders. The initial positive safety assessment and encouraging early signals of efficacy from the Phase I trial of HG-CT-1, including patient three showing no signs of cancer. validate Hemogenyx's lead clinical asset. This validation is crucial in attracting potential collaborators, as it de-risks future investments and partnerships.

The Letter of Intent with Cellin Technologies to commercialize HG-CT-1 in Estonia via the hospital exemption pathway represents a "first potential near-term revenue opportunity" and allows for the expansion of real-world clinical data. This early revenue generation and data collection can further strengthen Hemogenyx's position in future negotiations. The partnership with Cellin also positions Estonia at the forefront of advanced cell therapy in Europe, showcasing Hemogenyx's ability to forge strategic alliances that can accelerate market access and gather valuable clinical insights.

Furthermore, the expansion of the clinical program through a strategic partnership with Prevail InfoWorks and Prevail Partners for adult and pediatrics development and potential additional clinical sites in the U.S. indicates a proactive approach to scaling and reaching broader patient populations. This demonstrates Hemogenyx's capacity to manage complex multi-site clinical trials and collaborate effectively. The collaboration and grant from Wilson Wolf for GRex to develop an ultrafast, cost effective and scalable CAR-T manufacturing platform tailored to HG-CT-1 also highlights Hemogenyx's commitment to innovation in manufacturing, which could be a significant draw for partners looking for efficient and scalable production methods.

The successful fundraising efforts, even in a challenging biotech funding climate, reflect growing investor confidence in Hemogenyx's science and strategy, which is also a positive signal for potential collaborators.

Overall, the progress with HG-CT-1, including its clinical advancement, strategic commercialisation pathways, and manufacturing innovations, positions Hemogenyx as a more compelling and credible partner for future collaborations across its various product candidates and platform technologies.

I believe it's only a matter of time before a major pharmaceutical company takes an active interest in Hemogenyx as all the building blocks are in place.

Why would ScaleReady in collaboration with Wilson Wolf Manufacturing and CellReady give Hemogenyx a $120,000 grant in order for them to optimise and automate the manufacturing process, allowing them to scale commercial production up to 100,000 patients a year?

Could it be the FDA are about to fast-track this therapy to Phase 3 or even commercial?

https://youtu.be/tpuOklz60yQ?si=ysVTH4YcM_pTd6VM

Why do you think Carl June of the University of Pennsylvania and his team, the world leaders of CAR-T therapy would choose to assist Hemogenyx in bringing HG-CT-1 to the clinic?

Why do you think Prevail would invest in Hemogenyx at a premium that was hundreds of percent above the current share price?

Why would MD Anderson, arguably the leading cancer hospital in the world want to run the first trial of HG-CT-1?

Why would Made Scientific who specialise in large scale commercial roll-out of CAR-T therapy want to partner Hemogenyx?

Why would Cellin Technologies want to do the same to treat patients in Estonia, the EU and ultimately worldwide?

Why would the FDA give Hemogenyx approval to treat pediatric patients after seeing data from just two patients?

And why are all three patients from the first cohort treated with HG-CT-1 still alive when all other treatment options had been tried and had failed?

Here's what I think. With three patients treated, who literally had weeks to live, being alive after one month, five months and seven months respectively, at least one with zero sign of any cancer, we are witnessing a paradigm shift in the treatment of r/r AML. I believe HG-CT-1 will cure some patients whilst treating others, extending their lives for many months if not years.

I also believe HG-CT-1 is extremely valuable in financial terms, both to the company and also to investors. It is just a matter of time before a major becomes involved, either through licencing, a buy out of the product candidate or most likely the company. Investors should be mindful that Hemogenyx also have their CDX bi-specific antibody which is more valuable than HG-CT-1 and CBR, which is potentially more valuable than both of them combined. When Vlad talks about billions and years (and we're had the years) he is very serious.

So as an individual I'll watch the traders, the games the market makers play, the fear and panic they create. They can shake the tree with a hurricane force if they desire, I'm not going to budge. I haven't just got sticky fingers. I'm glued to it!

Blastoid keeping up with demand is the precise reason Hemogenyx have outsourced to contact manufacturing, in particular Made Scientific, and have moved to GRex which enables them to scale all the way up to 100,000 patients a year so I don’t think Hemogenyx will be constrained in any way whatever the global demand is.

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.

Https://youtu.be/ujn9yuum8wM?si=w6is9Y0jdbfT_P_O

There are two choices available to investors of Hemogenyx.

The first is to panic and trade on your emotions due to the extreme volatility of the share price.

The second and what I intend to do, is to remember why you invested and focus purely on the fundamentals.

Through the Estonian government Hemogenyx will be generating sizeable revenue, both from Estonian residents and ultimately through wealthy individuals across Europe and worldwide. Remember the criteria the Estonian health authority have set, treatment that demonstrates strong clinical data, that either cures or substantially improves a patients condition. Exactly what Hemogenyx have demonstrated in their first cohort for HG-CT-01.

Lots of positive news coming during October on a product that will be very valuable indeed.

It’s your choice how you play this just don’t have any regrets on what could have been.

With the safety data from the first three patients treated at the lowest dose of HG-CT-1 submitted to the independent Data Safety Monitoring Board (DSMB) for review a decision whether dose escalation to the next level may proceed is expected very soon, allowing patient 4 to be treated.

The IRB decision at MD Anderson is also expected imminently for the pediatrics trial to commence and run in parallel.

With an interview from Vlad expected tomorrow or Friday discussing the above, and the recent summit amongst other things it’s a very exciting time to be a shareholder.

Tremendous upside from here to come in my opinion.

Tilly excellent information, thx.

Having done some digging myself I can categorically state there is NO link from Cellin to ANY criminal or ANY fraudulent activities as at least one individual on here has stated and TW has included in his latest article. Now if you were to use every AI engine available the worst one on the market does indeed infer a link but the information and output is totally FALSE.

I would suggest one of TW’s minions on here inform him of his error as his actions are libellous and if he persists he will face the consequences.

With that, let’s get back to the science.