Member Info for JustHereForHemo

Id love an update too, all I am saying is dont be surprised if there is none and the next we hear about it is the actual IND application. We know that vlad is frugal with RNS's and even I would question is the cessation of the PIND process market sensitive enough to justify an RNS? Its really up to Vlad to decide if he wants to tell us or not. All we can go on is what we know and that is the last RNS said things were on track and looking good and within the last day Vlad has advertised for a Director of Quality for CAR-T, people can draw their own conclusions from that, IMO its extremely positive.

"We are now at an advanced stage of completing our application for Investigational New Drug ("IND") status. Work on manufacturability, quality, safety and other key parts of the development of HEMO-CAR-T has continued and we expect to be in a position scientifically to commence trials once the IND designation has been granted."

Pair that with the qualifications required for the new job:
"• In-depth knowledge of 21 CFR Part 11, 21 CFR 210, 21 CFR 211, 21 CFR 600, 21 CFR 610, ICH Quality Guidelines, and Guidance to Industry
• 5+ years of experience as a Quality Professional in Pharmaceutical and/or Biological Manufacturing is required.
• Auditor certification with 3+ years conducting supplier audits is desired.
• Experience with Phase I/II IND clinical trials is desired."

And finally the new lab:
"These will commence with the manufacturing of HEMO-CAR-T cells for clinical trials in-house, a process that alone can save the Company over US$2 million compared with outsourcing this work."

I dont think its a stretch to say that things are looking positive, your right there may be hurdles, IMO thats where the Director of Quality comes it, it feels like that may be driven by the FDA response.

I am not saying trials will start tomorrow, or that there wont be an update on the PIND or even that the IND will be submitted in May. But every indication is that so far, touch wood all signs are good that the interactions with the FDA have been positive and we are on track to start clinical trials in the coming months as stated in the final results:

" and to bring our lead CAR-T product candidate close to being ready, subject to the work now being carried out, for human trials in the coming months."

Of course I have bought recently! I just think its irrelevant what I do, I have between 500-1k a month left over and often that goes on hemo shares, but I am sure nobody on here wants to hear when I buy shares. As for me accusing you of deramping, no... I am calling out that today you said you have sold most of your shares, this was after you said you had 6 mil shares and the total number of shares "TRADED" that means bought and sold is 2mil, so unless there is some big trade not yet printed your full of cr@p.

All these things that I lay out? What like IND and clinical trials?
Which I took from https://www.lse.co.uk/rns/HEMO/final-results-for-the-year-ended-31-december-2021-y1w6in568sbftqt.html
The clinical trials for CAR-T which YESTERDAY Vlad put up a job advert for a Director of Quality for CAR-T clinical trials? Those clinical trials that I said would happen that appear to be in fact happening? Just because the SP is low like every other pharma does not change the progress the company has made in recent months.

Seriously, in the past you were able to get away with it because on the days you went into post overload there was decent volume and it was never clear if you were selling or not. But today?????? You picked a day with TWO MILLION TOTAL SHARES TRADED... What an idiot! Seriously, did you not think we would notice?????? I can be a bit thick at times but come on.... really??

Be absolutely hilarious if there was an RNS in the morning after you sold today, would be comic gold, please Vlad :-)

You have to wonder why MrIndia would be hanging around having sold most of his shares telling us how bad this share is.... Almost as if he is just trading and wants to buy back lower. But here is the flaw in that plan.... When your pretty much the only seller and the volume is dead then your going to have to pay the spread to the MM's. You cant just drop the SP by selling and expect to buy the same shares back cheaper from the MMs unless lots of other people also sell. Its why with these low volumes trading is stupid.

MrIndia, I had stopped responding and was actually just tuning you out, but days like today you really do shine. Its easy to hide when there is alot of volume but honest to god, you tried it when the volume for the past 2 days has been <3mil??? Come on, seriously? Good effort, 15 posts today and put your money where your mouth was and sold, but your timing sucks, you really had to pick now??? All you have done is proven yourself a liar about the whole 6mil shares thing, and carrying on having sold instead of just leaving? Just proves you want to trade. What exactly did you hope to get out of it? SP drop to 1.1p when you sold at 1.34 so you could buy back cheaper, even though your pretty much the only seller??? Unless of course you didnt even have the 800k shares to sell in which case, honest to god if your wasting this much time here moaning about 150k shares then you have serious issues :P Wow.... cringe worthy.....

So by the sounds of this:
"Anyways, I only reported it because everyone told me to sell so i did. I still have some left " MrIndia sold most of his holding. He started posting at 13:47hrs which was not long after 2 block sells totalling about 900k shares. One of which was a NT far below the offered quote price which is just stupid so likely his.
Said this morning he had 6mil, now has "some" left so yea, probably means sold everything, took really bad price and now priced out of the market.

I remind everyone there has been a WHOPPING 2 mil shares traded today, of that:
92k - Buy
250k - Buy
130k - Buy
200k - Buy
25k - Buy
So assuming MrIndia really did sell and was that 900k sells..... There has been FA Selling except for him. Yet despite the fact that he is the only seller he asks why are people selling? Its almost comical, almost... Seriously though, again I repeat 2mil shares traded today and 800k traded yesterday? Thats peanuts!!!

As for the PIND, what exactly is news worthy about it? I am not saying they wont RNS that the whole PIND process is over, they might, but likewise we knew it was an engagement between FDA and Hemo to establish what exactly was required as part of the IND application to give it the best chance of success. We know it was ongoing and via email and there may or may not be a meeting if required at the end but probably not. I just dont see the need for a PIND update RNS, seems pointless, I want to see the IND filed and an RNS for that.

Read between the lines though, yesterday Vlad advertises for a Director of Quality to lead in CAR-T, coincidentally the same time we were expecting a PIND meeting if it was required. I dont think its too much a stretch to link the 2 events???

Great to see an active engaged investor base :-)
I was worried I would stop by and see a wall of trolls and people feeding trolls.
Great to see plenty of people discussing the IND process, what happens next, and how truly exciting it is to be this close to clinical trials with such massive potential for re-rate. Going to copy and paste, feel free to post lots of negative or trolling posts if you wish, they are really useful to potential investors who may stop by.... Is nice to see a few more tweets about Hemo though, thats where we will attract new investors, not here.

Well into May now, we are well and truly into the PIND Zone which could very well have already been cancelled:
"A pre-IND meeting will then be necessary only if the written responses leave any matters unresolved. In light of this written process now implemented by FDA, there is no anticipated impact from the deferment on the IND filing for HEMO-CAR-T."

Purely a hunch, but to me the hiring of "Director Of Quality" for CAR-T could have been directly driven by the responses from the FDA? If you read the responsibilities on https://www.linkedin.com/jobs/view/3069616234/ they are very specific and well defined such as:
"Develop, implement, and maintain corporate policy and procedures for the Quality Management System in accordance with ICH Q10 model." - A manufacturing associate they advertised for recently seemed obvious, but this DOQ seems an after thought and MIGHT have been an FDA suggestion?

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "The process toward our IND application remains on track and the change in the FDA's process is not expected to affect the outcome of the IND application or timetable for clinical trials."

Every indication is that Vlad is correct and they remain on track for clinical trials. The company has sufficient cash to pay for it so there will be no placing or dilution but yet this close to clinical status the company has an mCap of? 14mil?

To say this share is under the radar and a gift is an understatement. But there is little point telling each other on here and patting ourselves on the back for finding such a gem. Be good if a few could actually tell people about Hemo, not ramping or pumping, just point people to the recent RNS's and let them make up their own minds.

Spot on HFH
800k traded yesterday, 300k traded today, the sells at 1.375 are so tiny they are irrelevant. Small enough they could be to cover broker holding fees or something. Over 2 days we are talking like 1m shares? Thats nothing.

Well into May now, we are well and truly into the PIND Zone which could very well have already been cancelled:
"A pre-IND meeting will then be necessary only if the written responses leave any matters unresolved. In light of this written process now implemented by FDA, there is no anticipated impact from the deferment on the IND filing for HEMO-CAR-T."

Purely a hunch, but to me the hiring of "Director Of Quality" for CAR-T could have been directly driven by the responses from the FDA? If you read the responsibilities on https://www.linkedin.com/jobs/view/3069616234/ they are very specific and well defined such as:
"Develop, implement, and maintain corporate policy and procedures for the Quality Management System in accordance with ICH Q10 model." - A manufacturing associate they advertised for recently seemed obvious, but this DOQ seems an after thought and MIGHT have been an FDA suggestion?

Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: "The process toward our IND application remains on track and the change in the FDA's process is not expected to affect the outcome of the IND application or timetable for clinical trials."

Every indication is that Vlad is correct and they remain on track for clinical trials. The company has sufficient cash to pay for it so there will be no placing or dilution but yet this close to clinical status the company has an mCap of? 14mil?

To say this share is under the radar and a gift is an understatement. But there is little point telling each other on here and patting ourselves on the back for finding such a gem. Be good if a few could actually tell people about Hemo, not ramping or pumping, just point people to the recent RNS's and let them make up their own minds.

Its ok Seawolf, you dont need to lie down, I realise it LOOKS blue but thats only because of a UT after close yesterday which meant we opened up 6% and sat there all day. It was a fake blue day and makes it easier for the MMs to mark it down without anyone noticing or reacting. Reality is we are down about 2% or so. All on not even 1mil traded buy and sell all day.....

Hi Chancer, your not wrong, I think though that our experiences here of late have always been negative when it comes to traders. We have seen time and again the share get traded down and when there is alot of attention from traders they dump on news having no positive impact. Your right, healthy trading is essential and I would love nothing more than an increase in healthy trading and discussion. I am sure that at some point Hemo will be big enough that it does attract a much larger audience with a much larger share of the market. Until then, I think choice between no trading or the trading we have experienced in the last year and most of us prefer the quiet :-D TBH I am just happy people have stopped attacking, maybe its just perception and it was just the market conditions? But it certainly felt like Hemo was under siege, but now? Feels like things have changed for the better.
Anyway, great to see new(or old?) faces, perhaps with May being the PIND/IND date we will start to see more activity :-)

First dedicated manufacturing associate and now Director of Quality dedicated to CAR-T:
https://t.co/WZHMbxG5FL

"We are now at an advanced stage of completing our application for Investigational New Drug ("IND") status. Work on manufacturability, quality, safety and other key parts of the development of HEMO-CAR-T has continued and we expect to be in a position scientifically to commence trials once the IND designation has been granted."

Feels like Vlad remains very confident! Quiet? Yes but that just means no traders are trading, that's a good thing :-)

I dont know about everyone else but for me Hemo is doing pretty well on my watch list, everything is red (Except Love Hemp which has been suspended :P )
If BOD or anyone else notifiable wants to buy shares, I hope they do, but I would not want them to TR1 it on a day like today.

Good god MrIndia, go and play with a bus.
1.7m, whoopdie doo! And of that about 600k was buys! Grow a set of balls and dont regress back to your old self.
The traders are going around the old haunts and the small caps are in turn seeing spikes in trading, if you want to sell and go follow the herd and be too late everywhere else then fill your boots and dont let the door hit you on the way out. You said it yourself how good this one was, good god just give it a rest! Everyone is chasing a limited number of oilers today, they are pumping CLON and UKOG right now, if you want to get burnt go ahead and jump in. I know nothing about it but some of the people who started the ramping with VAST, CLON and UKOG now on about TMOR, so there you go, maybe it will do 40%.
But seriously, a delta of like 1mil shares sold...... stop going on like a spoilt child, its so pathetic! Dump your 4mil shares or whatever it is, one big sell, take whatever they offer and then I will comment and agree "Well that was a big sell, must be MrIndia decided to finally sell"

I really want to follow that up with a comment such as "Before embarrassing yourself by telling everyone its a massive trade, ask your partner their opinion..." But I will restrain myself!

So first off. Total volume today is 1.7m shares................................... Yea.......
Some are buys some are sells, so again...... Yea.....

They dont report it as a sell, they report it as a trade at 1.5175 and sites like this can decide to classify it as a buy sell or whatever based on mid price.

All that said, been in the telegram groups for a look, its all Oil Oil Oil, ramping away at the oil stocks hoping for a replication of Vast. But they have very short attention spans and very limited windows. There have been states in the US recently hit days with 100% renewable energy and countries in the EU with levels in the 90s. Germany has said they can now cope without Russian oil so production is being ramped up elsewhere, dont expect this oil bubble to last very long. Its like the covid bubble condensed into a few days. There is also the possibility that next Monday, 9th May, Putin decides to declare victory and start negotiations to withdraw in exchange for easing of sanctions.

While at the same time we are in May and expect either successful end to the PIND process or a straight IND application very soon. We are also waiting on some sort of website update and SOME sort of PR surrounding the new Lab, update on the work on CDX and updates on the in vivo tests that are expected with CBR. I understand they were busy with Final Results and this year was particularly hard due to changes in the audit process, but that excuse is gone, Results are out and they are excellent so that should be backed up with progress.

Several informed posters yesterday evening were discussing merits of investing now in staff vs locking themselves away and doing the science first and preserving cash. I have to be honest, I am firmly on the fence, I love knowing they are funded and that we are safe from dilition. But I do want them to improve their image. 40k would hire someone who can answer phones, handle the twitter account, post updates, order office supplies, post updates on their website. As was pointed out they ARE making the big name contacts, Eli Lilly, Orgenesis, J&J, WuXi so I believe Dr Walts is doing an excellent job. Literally EVERYTHING they are doing behind closed doors is fantastic, its all about the company image and lack of PR, that does not need a big price tag to improve.

We lack PR, we lack visibility, we do not lack cash, we do not lack progress, we do not lack potential. This is for sure a frustrating share to hold, but how can you not be excited? At some point its going to pop!

Nowhere does it say that there are no PIND meetings until May, the wording is:
"has received notification from the Food and Drugs Administration ("FDA") that the proposed pre-Investigational New Drug ("pre-IND") meeting relating to the Company's lead product candidate Chimeric Antigen Receptor ("CAR") T-cells ("HEMO-CAR-T") is to be deferred until May 2022 as a result of a general FDA policy prioritizing work on COVID-19."

Ergo, if your first in the queue like below you get PIND before May, if your after Hemo in the queue you go after May. I dont see anything unusual or suspicious here, they had an impact due to "Covid" and as a result everything got bumped back... Its not like they schedule every PIND for the same day..... All that said, its likely the FDA staff are all working form home taking advantage doing very little even though the new process is streamlined and much more efficient...

I know nothing more current than is in the Final Results:
"sufficient funds to take our key projects significantly forward and to bring our lead CAR-T product candidate close to being ready, subject to the work now being carried out, for human trials in the coming months."

As for the 21mil, thats from the balance sheet, includes cash, property, assets, but also counts loans to subsidiaries etc and Intellectual property. So patents owned outright, patents licenced from Eli Lilly, all add value. Value of Hemogenyx if you just wanted to slap a price tag on it to sell it at Home Bargains.

Valuation in terms of mCap what we SHOULD be worth? Lots of ways, very complicated, but some approaches:
https://www.investopedia.com/articles/stocks/06/biotechvaluation.asp = Discounted Cash Flow
https://www.toptal.com/finance/valuation/biotech-valuation - Really good read, Risk-adjusted NPV
Apply the calculations to each of the product lines and add it up for a fair valuation.

I asked vlad in one of he AGM's would he consider doing this and he said he had considered it, but gave up when he looked at CDX, his target market is just too many conditions. Same would go for CBR, he is targeting what? Every known virus both present and future??? You cannot try and value that market because its too big people would think your barking mad the figure would be too high.

For Hemogenyx I believe Vlad will licence when he proves candidates work in clinical trials and we will see the value, best to look at the industry as a whole, this link is a few years old but its the best I have seen and shows potential value of a licencing deal:
https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Finance/gx-finance-next-generation-therapies.pdf

Would be a good idea, but hopefully in time it wont be necessary, on some other pharma shares I have looked at there are investors posting on their boards that know the area inside out and post realistic values of Hemo, hopefully that starts when we start clinical trials, its frustrating but I can wait.

MrIndia, honest question for you, if you were not watching Hemogenyx would you have seen Fridays RNS?
I did not get any sort of indication via twitter or any other news feed that the RNS had been released. Its only because I have alerts set on Hemo that I saw it.
Now I dont think I am alone, I dont many apart from existing investors stumbled across the Final Results by chance. There was a poor interview with Zak but it didnt link the RNS. Hemo/Vlad tweeted it out but again only existing investors follow them.
I didnt see Peterhouse or TMS tweet about the final results either.

I dont have the answers, but what I see is time after time great updates being published and no reaction, but that does mean I am wrong to be excited or enthusiastic just because the market has not noticed yet.

It kind of reminds me of one of those MMO games where you have to gather resources, at the start you all spawn at random spots on the map. Sometimes you spawn beside the holy grail of top tier resources and you farm like there is no tomorrow, eventually the clans move in and either intimidate or kill you off and you have to settle for the scraps. There are events that are significant and bring with them media attention and the focus of the market. Passing the IND stage is an FDA milestone that will garner attention without Vlad paying for any PR. Curing someone of AML (Hopefully!) will be a human impact story and again will get free press. I am shocked there was not more interest in CBR because of the current pandemic situation but at some point it will get attention.

HH, your list of negative forces is good, but it fails to include the value adding developments which have coincided and seen zero added value. If the company was stagnant save additional capital then you could argue the fall vs the general market is explainable however in that same period:
Additional Pipeline CBR revealed with unique treatment for viral infections inc measles, HIV, Covid-19 etc
HEMO-CAR-T/SAFE-HEMO-CAR-T taken from discovery to pre-IND
CDX gone from development with IP partly owned by Eli Lilly to wholly owned and in manufacturability studies stage
Cash reserves to provide confidence against dilutions
+ some of that cash was used to pay off debt which existed 2 years ago, Orgenesis CLNs are gone.

In Hemogenyx I see an early retirement, I genuinely believe that this company will do well enough to allow me to quit my job, start a business and do something I love. I am probably over invested but I dont see the risk as unreasonable. I dont forsee placings in the near future so no dilution to inflate mCap locking in lower prices. We seem to be getting more attention on here which is good, hopefully people will start talking and volume will build. I am getting sick of saying it as I am sure your all sick of hearing it, but this SP is too low, its not realistic, its not sustainable and it will not last for ever.

#InVladWeTrust

MrIndia, this is fair, well thought out and I will not even try to find fault, great to see you back if this is how you will contribute :-) I agree, I am not calling for Vlads head, on the contrary, its reassuring having him at the top but he NEEDs to delegate, he needs help, positions like you highlight are not just nice to have, they are essential and will pay for themselves in spades.

It gives me hope to see so many posts lately of genuine investors who are not just ramping or pumping, who see the potential but are also not blinkered to the fact that there is work to be done and issues with PR.

I would not still be an investor here in spite of all my concerns if I did not believe in vlad and the company, Vlad is a brilliant scientist, the work he is doing will save lives and CBR potentially could be the next CAR-T.
Would you rather a CEO who is a brilliant Scientist but bad at PR, or one of the dozen CEOs that are great at PR but are all smoke and mirrors?

Hemogenyx HAVE the goods, they have a net asset Value of 21mil, they have patents on antibodies, CAR-T, Hu-PHEC, they have IP from Eli Lilly. Global Pharma have looked at hemo and decided what they have is real and have been working with Vlad for years. This is real.

Further more they ARE speaking to the FDA, they ARE in the final stages of IND application, they ARE going to start clinical trials in the coming months. All while being fully funded meaning us investors dont have to worry about placings or dilutions.

There is no debt, CAR-T has been proven in the lab, it may not reach NDA stages but certainly I am confident it will reach trials and THAT demands a significantly higher mCap than 14-15mil.

As an investment this share is going to deliver, I have zero doubt, even if Vlad fails to change in any way and carries on behaving like a chief scientific officer and not a CEO, Hemo will perform at some point. I will remain hopeful however that at some point he will start behaving more like a businessman and at some point the light switch will flick on and he will realise that performance of his stock can have a significant impact on his ability to deliver research.

Chest cleared, apologies for the wall of text, The posts below can be ignored, they have an audience of one who I know probably wont ever read but its cathartic getting it out :P