Member Info for HereforHemo

independent safety board approval allows formal recruitment of the next cohort of adults at increased dose.

at the same time, internal review board approval given to treat pediatric patients on the lowest dose.

the lowest dose is safe and independently verified by the committee.

we already have good signs of efficacy.

we are already talking to large pharmaceutical companies who may potentially aquire or licence this treatment.

exemption pathway in europe, may start getting revenue pretty soon.

reduced burn rate and raised £2.2m last month and are stable.

i hope that investors realise we are for real.

there seems to be a lot to be optimistic about, is that a fair statement? vlad "i think it is".

but, vlad also said patient recruitment would be slightly delayed due technology transfer and training of made scientific, hemo's manufacturing outsourcing partner, due to the more potent and more stable nature of hg-ct-1 (than other previous generation car-t's?). so what is a 'slight delay'?

definition: something will happen a little later than originally planned or expected. the word slight(ly) indicates a very small degree or amount of waiting.

so whilst people today have worn their finger tips out spreading uncertainty and doubt, and denounced individuals who may or may not have traded (not that i give a **** either way), personally i see everything going to plan.

i still think this is a superb opportunity and at the end of the day that's all that matters to me.

“Encouraged by early clinical findings”

https://www.proactiveinvestors.co.uk/companies/news/1081321/hemogenyx-shares-rise-after-safety-board-backs-next-trial-phase-for-car-t-therapy-1081321.html#

WealthWizard personally I find it highly significant Hemogenyx getting the dose escalation today. The Chair of the safety review board is aligned to MD Anderson who in turn make most of their money through grants. These grants are assigned from the industry learning of their research through abstracts, scientific studies and presentations.

From the following:

‘The DSMB's positive recommendation follows the successful completion of initial safety assessments for all three patients treated at the lowest dose, with NO dose-limiting toxicities observed. The trial will now proceed to the next planned dose cohort in accordance with the FDA-approved clinical protocol.

Importantly, clearance to proceed to the next adult dose also enables the initiation of pediatric patient recruitment for the Phase I clinical trial at the lowest dose of HG-CT-1, the same dose level already used in the first cohort of adults‘.

Now I’m no scientist but what I do know is with zero toxicity and side effects this is transformative for the treatment of r/r AML and my view is Dr Short will be very keen to present on the first cohort of patients.

If he does, expect the SP to at least double in price. Just my opinion but I’m now genuinely excited!

HH thank you. What excites me most is the partnership with Made and GRex. Moving to a low cost manufacturing solution that is scalable to commercial levels is highly significant in my opinion as it’s an important building block that any major pharmaceutical company would desire.

I suppose the important question is do you want to be a wealthy protective sheep, retired drinking vintage Bollinger or the wolf of Wrexham having to clock in for his night shift?

It’s all personal choice.

As I posted when £8.54.

in my opinion there is no better investment for substantial upside in the coming days, weeks, months and even years.

With two adult patients to be treated a month and pediatrics running in parallel the data and efficacy will soon be absolutely compelling for a major pharmaceutical company. With Estonia bringing in early revenue as well as providing even more data this share is set to explode to life changing amounts for investors.

All in my opinion but if you’d ignored the muppets on here and listened to me since the share was £1.47 you’d have done very well.

if only hemogenyx communicated like..avct?

over the last year they've risen by nearly 20%, but this is strange, hemo have risen 59% maybe ytd is a better comparison? they've risen 29%, acceptable but nowhere near hemo's 105%. perhaps vlad has been particularly quiet over the last 6 months? well avct haven't, they've risen 105% and poor hemo have only risen..371%!

so despite a severe retrace i know why i invested and i know why i post on the hemogenyx board, because i'm invested, heavily. this year a clinical trial started. 3 patients were successfully treated and all remain alive (fact), one into their 2nd month, one into their 6th and one into their 9th month.

also this year an fda annual report was submitted and accepted, a pediatric ammendment to the clinical protocol was submitted and approved by both the fda and the internal review board at md anderson, a manufacturing partnership with made scientific was set up with a technology transfer, a loi signed with cellin to commercialise hg-ct-1 in estonia providing early revenues and a gateway for european patients as well as hemogenyx being invited to present at a high level dcny summit.

so let's stop the bull****. hemogenyx are waiting for dose escalation approval to treat patient 4. at this dose they can then treat 2 patients per month, plus another from pediatrics that will run in parallel. they are in the process of signing the master services agreement with cellin and the estonian government and health authority upon which hg-ct-1 will become commercial, giving monthly revenue on top of the £2.2m approx they already have in the bank. they are progressing cbr with a single antibody to treat a multitude of cancers. it's also highly likely hg-ct-1 will be fast tracked as a breakthrough drug therapy by the fda and attract a major pharmaceutical company to fund further development through hospital trials.

in my opinion there is no better investment for substantial upside in the coming days, weeks, months and even years.

if people aren't convinced, fine. **** off and invest elsewhere.

If you think that Hemogenyx who own 100% of the IP for HG-CT-1, CDX and CBR is worth less than £46.5m then don’t invest in Hemogenyx.

If however, you think that a clinical company with a successful first cohort, with approval to now treat children and adolescents, that also has a commercial opportunity in Estonia to act as a gateway for European patients is worth more than £46.50m then you’ll see it as a buying and holding opportunity.

Everything else is just noise.

Coffee, whilst not knowing patient specifics what I do know is the median average which is 5.3 months.

Pingu, since you ask...

HG-CT-1 was designed to treat patients with an incurable disease. Patients that had exhausted all available existing treatments without success. And today is a big day as it marks eight months since the first patient was treated. With patient two into their sixth month and patient three into their third month, the fact that all three remain alive is quite incredible, for the patients and their friends and family, for Hemogenyx and for shareholders as the longer this continues the more curative HG-CT-1 appears to be.

As you know I believe dose escalation is imminent and with the first cohort all passing safety there's no reason why it wouldn't be. I suppose another strong clue is the FDA approval for the treatment of children and adolescents after just two patients, followed by approval of the Internal Review Board of MD Anderson themselves, who happen to be the leading cancer hospital in the world. It's just a thought but they might just know what they're talking about when treating patients with a deadly cancer. I suppose another clue would be MD Anderson actively enrolling patients for both the adult trial and the pediatric trial because it's just a thought, they might not be doing this if they thought the treatment wasn't safe.

Whilst I'm in thinking mode, maybe Wilson Wolf wouldn't have given a grant to Hemogenyx to move to the scalable GRex platform if they didn't think HG-CT-1 worked. After all why would you enable a therapy to be scalable up to 100,000 patients and for that matter why would Hemogenyx outsource manufacturing to Made Scientific to handle both clinical and commercial volume.

One could also ask why the health authority in Estonia would be comfortable for all of their patients suffering from r/r AML to receive HG-CT-1 as a treatment. On a commercial basis before it's even been approved.

Now one could come to a conclusion all of the above could signify HG-CT-1 actually works and is both safe and curative. You could also conclude that Hemogenyx will not only get dose escalation approval but is highly likely to be fast tracked as a breakthrough drug therapy. But if you did you'd have to recognise it would become a very valuable asset indeed.

Or I suppose you could just ignore everything I've just said. Don't invest in Hemogenyx and focus on irrelevant squabbling with individuals.

Your choice.

With pediatrics approval secured and dose escalation imminent it won’t be long before Hemogenyx are treating two adults per month (under the FDA protocol) as well as treating one child/adolescent in parallel.

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. The collaboration is expected to accelerate Company's ongoing Phase I clinical trial of HG-CT-1 in adult patients and to support the potential inclusion of additional cohorts for pediatric r/r AML patients.

The Company has already made significant progress in the trial, with early clinical data supporting growing confidence in both safety and potential efficacy.

Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:"Partnering with a trusted CDMO like Made Scientific is essential to the success of HG-CT-1, our lead CAR-T therapy. Made's expertise in cell therapy manufacturing will be instrumental in driving the continued progress of this potentially breakthrough therapy for patients with relapsed or refractory AML, fully in line with our identity as a life saving company."

Syed T. Husain, Chairman & CEO of Made Scientific, said:"Our collaboration with Hemogenyx Pharmaceuticals reflects Made Scientific's commitment to advancing next-generation cell therapies that address urgent, unmet medical needs.

Exciting times ahead.

Well if the website of MD Anderson is anything to go by, they’re confident of dose escalation approval..

Study #2024-1178

Phase 1 study of anti-FLT3 chimeric antigen receptor-redirected T cells in subjects with relapsed/refractory acute myeloid leukemia (AML)

MD Anderson Study Status Enrolling

Treatment Agent

Anti-FLT3 CAR-T cells

Description

This is a phase 1 dose escalation study to determine the safety of anti-FLT3 CAR-T in subjects with R/R AML. The primary objective is to assess safety.

Up to 18 evaluable adult and 18 evaluable pediatric subjects will be enrolled.

Matt no the board do not have a majority to force any deal through. On the structure I believe two things are most likely. Either a JV with a major who will take HG-CT-1 through the trial, probably paying hundreds of millions of dollars up front with a billion dollars plus in milestone payments over the years and royalties if it gets to commercial rollout. Or, as any major would likely want CDX as well as CAR-T they’d buy the company outright.

As for holding a large amount of shares, I’m sure you could sell them all but you’d get a lower price so an individual selling them in tranches would seem more likely to me.

Stevey nobody knows when the results will be announced but I’m certain HEMO will have passed safety from the first cohort and have approval for dose escalation and personally I believe that yes, I’ll be this month.

Moorscloud Haywain has answered your question as to when it would be known if Hemogenyx were going to present at the forthcoming ASH conference in Florida. There is every incentive for Vlad to want to be there, especially as he presented on the pre clinical data a few years back. But it's of equal importance for MD Anderson to have the clinical data presented as most of their funding comes through grants offered from their research and scientific papers.

It's also worth noting that the Chair of the safety review board is directly linked to MD Anderson who fund the said board, so I'm sure they'll make every effort to approve the dose escalation in a timely manner.

As regards when big pharma will know, be aware thar MD Anderson, being the number one cancer hospital in the world are in regular contact with all of the majors so I'm sure they are all very aware of the progress Hemogenyx are making.

ht for balance and clarity you're lying. again.

but you believe what you want. i've got no time for anyone who sulks and whines for years just because vlad blocked him on twitter.

as others have eluded to, the science is too compelling to attack, the comparison to others to weak to justify, so let's attack the individuals.

go ahead. i really don't give a ****. and if you think i did, you're even more stupid than i thought you were.

please be aware i only say that for clarity and balance.

Brenda I am no buddy of yours.

Have I ever been right on a share? Umm NCYT 40p to £12, SNG 34p to £2,40, HE1 25p to £1.04 and of late HEMO £1.47 to £17. How about you, have you ever been right on anything?

HT shock horror revaluation, man buys and sells shares. I’m horrified. Difference with me in HEMO is I was perfectly transparent, when I bought when I sold and when I bought again. Why did I ‘trade’ HEMO? Because I was trying to recoup my £50k they’d cost me from investing too early. Was it successful, well as you’re so interested yes it was. I now have a substantial six figure holding including warrants at £1.80 and £3.50. Thanks for your concern.

So Brenda, I look forward to hearing your share success stories. Judging by your posts I’d think you probably have about £3.50 left. Sad really..well not really, it’s quite funny.

The people who know me know me and have even met me. Am I bothered who else likes me, not really.

Enjoy your weekend.

Okay SurrenderBrenda let's compare histories. You've made 543 posts spread across three companies and all remarkably similar, abusive to anybody positive and comments the company is grossly overvalued.

I'm a little different as the vast majority of my posts are positive. Why's that you ask? Firstly it's because I research and secondly because I actually invest in the companies I post on.

Was I in HE1? Yes. History will show I was the first to call it commercial, the first to call it of global significance ohh and the first to say it was going to be worth billions of dollars. So why did I go quiet? Because unlike you I don't post about shares I'm not invested in. Did I lose money like you state? On the contrary I got out before it tumbled. If you knew the history of Hemogenyx you'd know why, a CLN death spiral finance agreement. Research and knowledge.

Will I get back in? Yes when the conversations and churn of millions of cheap shares are completed.

That leads me nicely onto Hemogenyx. Through research I was certain HG-CT-1 was a best in class therapy. Building your own manufacturing lab was a clue, working in partnership with Carl June at UPenn was s clue, having esteemed scientists like Feldmann and Shepard working with Vlad was a clue, 'curing" humanised mice..you get the picture. So again let's review positive histories, look back at me stating to everyone this is a strong buy..and look at the price I was saying it at..£1.47. I'm now saying pretty soon this'll be over £50, ultimately over £100.

So here's the message I'll give to you, as I've given to others. Some times it's better to keep your mouth shut and just listen.

Your choice. Enjoy your weekend.

HT you are correct, my mistake.

Hemogenyx have continued to build momentum, and with the third adult patient being treated, thereby completing the first adult dose cohort. Hemogenyx reported that this patient had passed the initial safety evaluation and, 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.

These achievements reinforced the emerging safety profile of HG-CT-1 at the opening dose level and provided the foundation for continued enrolment.

The safety data from the first three patients has now been submitted to the independent Data Safety Monitoring Board ("DSMB"), which will determine whether the trial can progress to the next dose level. Subject to DSMB 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 with a paediatric protocol amendment being submitted in May, and in June regulatory clearance was obtained to initiate a paediatric expansion of the study, that MD Anderson has since approved and commenced enrolment .This development reflects Hemogenyx’s determination to address the particularly acute unmet need in childhood AML.

Clinical progress must be matched by operational readiness and to that end, Hemogenyx have entered into a strategic manufacturing partnership with Made Scientific, a US-based contract development and manufacturing organisation, to support technology transfer and scale-up of HG-CT-1 production. This partnership enhances both their capacity and resilience in manufacturing.

Hemogenyx also secured a US$120,000 G-Rex® grant to optimise and scale CAR-T production, supporting efficiency and cost-effectiveness as the programme expands.

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.

A significant development has been the signing of 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 pathway for advanced therapy medicinal products.

This collaboration with Cellin represents Hemogenyx Pharmaceutical's first potential near-term revenue opportunity for HG-CT-1, while also offering the prospect of gathering valuable real-world patient data alongside our ongoing clinical trial.

Investors should note that this agreement not only provides a gateway to Europe but is not restricted to just AML.

Dose escalation approval by next week provides a timely window for an MD Anderson submission to ASH and would allow investors to see online data in little over two weeks.

Exciting times ahead!

Bear in mind the DSMB panel is not ‘pulled together’, most are done virtually.