Member Info for JustHereForHemo

"£1 is pushing incredulity as it would value Hemo higher than 1.5 billion." - Why?

Just saw this on my news feed and thought I would post it as a reminder of the end goal, worth noting that DTx Pharma are PRE CLINICAL:

"Novartis pulled the trigger after DTx Pharma generated a package of promising data in both rats and non-human primates"

Not saying Hemo are in talks or likely to be bought over in the immediate future but Hemo could very easily be valued at that if you compare that the main target of the acquisition is the FALCON platform. A completely different space to where Hemo operate but not dis-similar to the potential of CBR which arguably would have a much larger target market

https://www.pharmaceutical-technology.com/news/novartis-snaps-up-rare-disease-biotech-dtx-pharma-in-1bn-deal/

Do not take this as an attack, nor a ramp, purely an observation. The LTH'ers who put up with the BS here day after day, week after week, month after month, do so not for 5/10/20%.

If Hemogenyx was private, if all shareholders were II and off the books and we did not see a public mCap or share price and had zero clue of the current valuation..... Would people question a valuation of $1bn for a deal similar to DTx Pharma with Novartis if it were Hemogenyx? I certainly dont see people up in arms complaining that the DTx was over valued and indeed Novartis has seen a bump as a result of the acquisition.

Ok a final post :-)

Let me clarify because I dont disagree or thing we are as far apart as you may think.

Ok, lets begin with the most important: CAR-T, what we know is the FDA applied a clinical hold, we know know, though the RNS that its one single issue which he is very confident he can resolve and because of the nature of the FDA review we can be confident that once they reply to the FDA the CH will be lifted and trials can commence. I was VERY happy with this update and applaud the fact it was published and details provided. Where my amusement stops is when we have people posting "but actually there is a 2-3 weeks custom turn around coming from China".

This gives a window to a select few who are in a position to trade, then share what they know about such a delay, short as it may be, and buy back safe in the knowledge that the CEO almost guaranteed them a window.

Same thing RE the DoD meeting regarding CBR, posted out of context it made it sound like there would be no news on CBR in the immediate future, this may be correct, it may be false, it focused purely on DoD meetings which are I believe concerning future funding and will take time, however it does not address potential updates on other ongoing in vivo testing which is separate to the DoD talks.

What I want is Vlad to engage and talk about what Hemogenyx have TODAY, what has already happened and what they are currently working on. When they discuss CAR-T the conversation should stop at "We have the letter from the FDA, we know what they want, we are happy we can resolve it and we have already begun to rectify.." THAT is where the conversation should stop, in private it should not continue with ANYONE "....But it will take atleast x weeks for Customs etc...".

Regarding the website, how can anyone get an understanding of what Hemogenyx does, what they have achieved and the progress of their pipelines without going to the website? Delve though many pages of outdated RNS's? Watch ancient videos? What value can you, I or anyone else apply to Hemogenyx? What exactly do they have, what are they working on and what do they hope to achieve in the near future? According to the website its Hu-PHEC.

My goal is to be a very long term holder here until this company is bought over, but until that happens I do not want to see my holdings diluted more and more un-necessarily in the years to come because the CEO fails to address the PR issue and continues to raise funds at a pathetic valuation. Traders want a specific date, as accurate as possible, or windows they can sell or buy, they have short term interest and by trading and making a profit they are just removing equity from the remainder shareholder pool. I want Vlad to start telling us why we shareholders should hold. Be transparent, talk about CBR, CAR-T and CDX, say how good they are, say they have had positive talks, but STOP FEEDING TRADERS.

FINAL post before I disappear off again for a few weeks, please do not take my posts as negative or an attack on hemogenyx. IMO updates on CDX, CBR and CAR-T could be due at any point, the disjoint between valuation for what the company currently has and what the mCap is is just stupid at this point and its not sustainable, but to address this Hemogenyx NEED to sort out their PR.

They NEED to sort the Website and start shouting about what they have already achieved and they NEED to cut off any and all useful information to traders which has quite clearly been used to the detriment of the remaining shareholders who opt not to trade. And with this.... Goodbye for a while!

The TL;DR version:

IMO Dr Sandler continues to engage with traders because he believes its not inside information to say there are delays, the issue is this just feeds traders who grasp that with both hands to trade.

Hemogenyx has massive potential and they need to start telling people what they have TODAY and what they are working on TODAY whilst point blank refusing to give ANY insight in private to traders who contact them.

I have already contacted Hemogenyx and encourage others to do so, no offence Digitt, I have spoken to you in the past and find you to be a solid individual, but I am not happy that Vlad continues to reveal timeline sensitive information to anyone.

Taking this opportunity to post because yesterday I saw what went on but had Z E R O interest in joining in.

I have emailed the company this morning to express concern that it appears that Dr Sandler has continued to share information with traders to the detriment of investors. In my opinion, particularly with Hemogenyx, any time you introduce a "Safe" window to trade/sell/short you leave the company and investors vulnerable to attack and we see days like yesterday, concerted efforts by traders to basically sell, attack, introduce some fear, get others to sell, buy back lower then disappear for another few weeks.

By stating to certain traders that customs will take 2-3 weeks each way you are giving those traders a window when no update can come. Likewise when you tell traders "Dont expect immediate results" you are signposting that there wont be an update likely in the next few weeks. Without context of WHEN that conversation took place its hard to know exactly what trading action took place following the discussion.

I have contacted the company and received assurances that no inside information has been shared with anyone, I think the issue is that Dr Sandler or others in attempts to placate or remain polite with those who opt to brown nose shares information useful to traders. He may not consider it sensitive or inside, but providing windows when no news is likely is as bad as sharing news on an impending update.

I would request therefore that anyone who is in actual contact with Dr Sandler or others makes it clear to them that as much as they may THINK they are trying to remain professional and are not revealing inside information, the reality is ANY sort of positive OR NEGATIVE timeline information is useful to traders who will never act in the best interest of this company. And if any traders continue to get such information, unless your actively trading and have obvious motivations for doing so stop trying to make it sound like there will be no updates for X weeks etc.

Hemogenyx/Vlad should instead spend some time updating the Website to show what they have ALREADY achieved, what they have and why the company is worth investing in TODAY and not tomorrow. Stop making this a share for traders and make it a share for investors.

We are now far enough past the FDA CH that customs delays aside we are in the window where Hemo could have the re-manufactured CAR-T. When will they answer the FDA? I dont know and NEITHER SHOULD ANY OF US, best case scenario the documentation is enough and could be resubmitted any day. Worst case scenario, they might have to re-run tests so it could take a few months. VLAD SHOULD NOT DISCLOSE THIS TO ANYONE UNTIL THE RNS LANDS. Hours, days, weeks, months, THAT is the investment part and why the SP would recover.

Splicing is a process that occurs in cells when DNA is transcribed into RNA. The RNA is then spliced into smaller pieces, called exons, which are then joined together to form a functional protein. In the case of CAR-T cells, the lentivirus is used to insert a gene into the patient's T cells. This gene codes for a receptor that will allow the T cells to recognize and attack cancer cells.

The splicing deficiency probably means that some of the exons were not spliced correctly. This could potentially lead to the production of CAR-T cells that are not functional or that could cause harmful side effects. The company has identified the source of the deficiency and has already developed a method to eliminate it. This probably involves using a different enzyme to splice the RNA.

I believe Kite and Novartis experienced similar issues with Yescarta and Kymriah, both resolved and are now approved by the FDA

Vlad stated at the start he was confident they could resolve the issue, when the hold was applied he would have been told roughly what the issue was and per AGM already working to replace. I believe WuXi manufactured the lentivirus so the issue is that they used an enzyme the FDA did not approve and when Vlad looked this was obvious to him and has tasked them to re-manufacture the lentivirus, a process that can take 2-6 weeks. One would hope that WuXi give this high priority given it was their F up.

What does this mean in terms of delay?

https://www.fda.gov/files/drugs/published/Process-Validation--General-Principles-and-Practices.pdf

HEMO-CAR-T passed the previous PQ runs which is a validation that Hemogenyx can reliable reproduce an end to end CAR-T treatment in a safe process. Swapping out one component does not invalidate the tests.

I find it very unlikely they will require a full run of tests provided Hemogenyx can provide evidence of a like for like substitution with enhanced safety profile, but it is entirely possible they do ask for some end to end testing. It is also entirely possible that WuXi will deliver a new shipment with GMP documentation that Hemo will forward to the FDA and that will be it.

It is extremely positive that this is the ONLY blocking issue identified in the "Full FDA Review". Bottom line is we are 6 weeks post clinical hold where the hold was applied for a valid reason which Vlad accepted and immediately worked to rectify.

This should not detract or have any serious impact on CDX or CBR given the primary demand here is on WuXi.

This RNS is a rubber stamp for Hemogenyx, they have one more step to take caused by an oversight of a much larger third party. This validates Hemogenyx and be it a few weeks or a few months delay it is very probable Hemogenyx will be clinical in the very near future.

Probably post again when the next RNS drops.

Dont get excited... Happen to check back every now and to settle the matter: (Per recording)

52:56 Q: After you recieve the FDA letter, would you be in a position to tell the market when you expect to respond to their questions.

A: We will try. First we have to receive the letter....... We will try and give some guidance but its not going to be precise for sure.

35:20: Q, Will you release the FDA's letter or the main bits as an RNS?

A, We will never release the letter because it is confidential... We will try and explain whats the reason.

I cannot bring myself to return to this board beyond one post.

Todays meeting was FULL of optimism, Trolls can focus on CAR-T being delayed and pull numbers out of their behind, reality is they DONT KNOW. Vlad could have the letter today and ready to respond next week and FDA could technically lift the hold in days not months. OR it could take months, yes it could... will it? I do not know, Vlad does not know and certainly the trolls on here do not know, so anyone, connected to the company or not trying to make it sound like they know how long the delay will be is BS'ing.

What the trolls will not and refuse to address is that Hemo is NOT a one trick pony, it was made clear that progress continues on CDX and CBR. CDX Vlad confirmed they are in talks with 2 parties regards to licencing but could not go further, does that mean a licencing deal is days/weeks/months away? Nobody who actually knows would legally be allowed to say on this board.

CBR - Confirmation working with the government, Confirmation also with a third party who are testing in a lvl3 facility right now.

The trolls WANT people to think we are now in some horrible quagmire of no update for months until the IND is resolved, reality is IND COULD take many months but could just as easily be much sooner. Updates on CBR and CDX COULD take months but IMO much more likely to be updated sooner, in particular CBR with update from third party.

I quit this board because something happened that turned my life upside down for a few months but I have read the odd comment and I am so glad I quit and am not returning. The pure and utter filth and manipulation is repulsive.

Remember this is a company looking to save lives with cures for cancer and others, they are publicly listed. They carry out research using funds raised through share issues which is directly proportional to the mCap and Share Price. When trolls dedicate hours and hours each day to convince people to sell so they can carry out a successful trade they destroy the mCap and they hurt the reputation of the company. This makes it harder to raise funds, delays research, causes more dilution and hurts every other investor who does not sell.

These trolls want to sell themselves as gurus and saviours yet time and again they confirm how they have "traded" hemo. That is not an investor, its not someone who cares about the company doing well, its someone who cares about lining their own pocket.

TROLLS DO NOT DEDICATE hours posting here trying to convince people to sell out of the goodness of their heart, they do it for cold hard money and YES it works and YES it damages the company. They may have won by destroying the SP but its an ugly and immoral victory and does not make them right.

I hold, I buy, I accumulate, I do not trade and after today I am certain, this SP IS NOT SUSTAINABLE, it wont last for ever and I will return when the re-rate happens.

Everyone else buying as we approach the 30 day point, stu goes public days before clinical hold RNS with enough confidence to have sold 50%(or so he says). For me the first 14 days were the risky days, but for stu? nope the final few days. I believe in coincidences but come on? you publicly posted you sold half and expected a clinical hold??Does nobody else find this suspicious?????

OR answer the question, Are you in communications with Hemogenyx?

Stu i never suggested anything of the sort, I do however question why after accepting what I posted as correct, after it was confirmed by HK on here, you then out of the blue last week suddenly found the need to sell and tell us all about it. I think Dr Sandler is honourable, moral and a brilliant scientist, but perhaps naive in whom he communicates with...

I posted links to FDA, you posted fear and rumour with zero links to support, so where did your confidence come? Are you in communication with Dr Sandler?

I would be interested in finding out when the first indications of a clinical hold were received by hemogenyx and seeing if they correlate to stu's claim to have sold on 31 May 2023 18:53.

Me thinks someone doth protest too much.

Sounds like your panicking incase there is a sudden bounce, irrespective lets get a few points clear.

First you are NOT an investor you are a trader who probably HAS had some contact with Vlad and just because he does not view delays or no progress as inside information if that gives you the ability to trade in confidence knowing you wont be caught out that IS still inside trading.

Second, the ~95% + the IND process was posted with links to the FDA website and statistics, NO guarantees were given by anyone, when HemoKnowledge confirmed this was correct you agreed and went silent, then suddenly started posting again... Wonder why.

You claim to be supportive of Hemogenyx yet all you EVER do is try and persuade people why they should not buy or hold.

You may not be aware of this fact but Hemogenyx do NOT have a bank loaded with 100s of millions, they have over the years needed to raise cash and will in future, this is only possible on the open market IF they have an mCap which is high enough to allow them to raise a useful amount within the confines of the dilution they can accept, which means when you and other traders sell spend day in and day out trying to get people to sell you put the very company at risk. Anyone who actually cares about hemogenyx should instead be trying to tell the market what the company is about, you say you do all this research?

Prove it, What is CBR worth? What is the fair risk weighted discount, what is CAR-T worth and the appropriate risk weighted discount? The problem is that you and other traders dont want to talk about what Hemo is worth every day of the week, you just want to talk it down and buy just before any monumental news lands so you can trade. So fluff away at your own Ego and try and justify your existance but know that everyone can see though the act. You are a trader, you do not care about the long term success of hemogenyx only your ability to successfully trade the various inflection points.

Vlad needs to start the PR and STOP providing ANY information to those who brown nose, he needs to learn that he is just feeding traders who are stabbing him in the back then posting and gloating when the share goes red stroking their own ego.

Stu has sold, its blatently obvious, IMO many panic sellers will buy back because this is just a delay to ask questions, roll on the interview for some clarity!!

PS Stu one last point:

"Ps until i get shot of my remaining holding, I’ll correct any and all lies ."

You already sold HALF your holding on a day when there was only 2 sells the larger being 750k, so yea, dont make out like you had 10s of millions and you have any left, you dumped yesterday like the rest of the traders who over reacted, you have ZERO left,

"the ramp gang have done their job in exhausting me, so good bye for good." - So you lied the ONE good thing about the train wreck yesterday was seeing the back of you. But you LIED because your still posting.

So lets be clear you HAVE sold out and now like others have had time to reflect and realise it was an over reaction, so you WILL continue to post over the weekend because unfortunately you will buy back Monday like a bottom feeding trader.

FACTS:

Per FDA: "The clinical hold order will identify the studies under the IND to which the hold applies, and will briefly explain the basis for the action."

Per RNS: "We are confident that we will be able to address the FDA's questions and concerns regarding the IND"

Prior to making this statement Vlad knows BRIEFLY what the FDA want.

The FDA can use 21 CFR 312.42(b)(1)(iv) to justify this HOWEVER the root cause is staffing issues as one2one points out, they SHOULD have asked for this additional information in the first 14 days.

I am not wasting my time engaging, Vlad messed up the comms on this yet again, should have been an RNS AFTER close and follow up with an explanation or interview. Will see what he says in his interview.

Anyway, this crash WAS an over reaction, it will bounce and hopefully BEFORE stu gets back in.

The FDA process is defective, I said before they have 30 days OR clinical hold, there should be a way to delay without a clinical hold, there is not.

Signing off for the weekend,

Mr Ind.... I mean JHFH :P

95% no issues, but nope vlad had to be one of the 5%. to say i am ****3d off is an understatement, put a resolution in the agm to remove him because i am sick of him as ceo. should be stuck in a lab and let someone who knows what they are doing run the business. last post of the day, off to have a drink.

Oh for F sake....

The issue today is the same issue we have had for the past several years, complete and utter lack of visibility. Outside of this singular forum where we are all already loaded who KNOWS that we are in the final few days of the 30 day IND wait? I am sure there are investors out there who have bought but Hemogenyx does not come up in any publication, aside from the odd conference or interview that Vlad has done there is no PR. There is nothing on their website to imply how close Clinical status is.

I am not convinced that Vlad personally will do any better, HOWEVER Micky the point is we are not bound to Vlad at this point. The "wider audience" today is a tiny audience of LSE, with volumes averaging around 5m per day recently there is no wide audience. We get a small handful of larger investors and those volumes go though the roof and that could come from one single article at the right time with the right audience.

So WHY do I believe this time will be different? Because its NOT up to Vlad to decide if the FDA accept the IND or not, the FDA have their rules and regulations and THEY accept the IND on their timelines not Vlads.

Per the RNS its stated that a master agreement is ready to go pending the IND, once again this is a third party NOT Vlad or Hemogenyx. If they are someone large like J&J(Speculation from HFH) and THEY announce they are running a trial for Hemogenyx then the audience is THIER investor base and watchers and not just this miniscule LSE pool.

Then there is the funds/investors/professionals who I have spoken too and others have spoken too and posted here who have Hemogenyx on their watch lists but have been clear that it does not meet their criteria to invest. Agree or disagree with Stu and others about potential delays here and now at this point, the reality is I invested in Hemogenyx in 2018 expecting them to be clinical in 18 months, its now half way though 2023 and on the way the dilution has been severe, punishing and for no benefit to me as a shareholder. This is a story that is only too familiar and as such many will just not touch Pharma pre-clinical. The attrition rate is HUGE and most fail before clinical status. So if we are literally DAYS or maybe even hours from Clinical status WHY are those potential investors not buying in now? I don't know, maybe they don't obsessively watch every share every day on their watchlists, maybe, just maybe they have a rule that they wont buy pre-clinical and "close" is not close enough.

Going up 14% one day on total volume that day of just SIX million shares tells me we dont need LOTS of new investors, we are that cheap that even a few new investors will be enough to start us moving.

Lets get clinical and see where we stand, I personally expect the silence both internally and externally to come to an explosive end.

I said yesterday it looked like there was an order placed early in the morning, the SP moved up with no orders printed, at that time the buys just before had been 2.27p and sells thoughout the day were below that with MREX holding firm on the ask with NT to buy most of the day. I would be extremely confident that this 2m is the missing order that they took the day to fill. What is most striking is that 2m is not that big an order, not that long ago we saw 1-2m trades printed in real time, it goes to show that the MMs are not holding a lot of stock if they have to delay a 2m print to the next day. Bodes very well for the coming sessions :-)