Member Info for JustHereForHemo

Morning all! What a dull and boring day... The spread here is wider than my jeans after binge eating all Christmas....
Yes great post brewsky, I actually had no idea there was more than one fast track so ofcourse I had to google...
Website from the FDA: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
No guarantees this is why they asked for Pre-IND meeting but it is certainly possible and makes sense, if you read through them normally the company has to ask to be fast tracked:
Fast Track designation must be requested by the drug company.
Breakthrough Therapy designation is requested by the drug company.
An applicant may expressly request priority review as described in the Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics.

That said, clinical trials still take time, even if they do go fast track we are still talking months before the first needle in arm, it just makes the process quicker when it starts as I understand.

I am massively more optimistic than those who have posted below, that said £1 per share is a big jump so really does depend on a number of factors. Funding, will vlad keep to his word and avoid any more dilution? If so then £1 per share = £1bn valuation which is where he views the company and what CAR-T is worth with clinical proof. Realistically if vlad wants to sell early as soon as he has clinical proof that could be early phase 1/2a or even IND stage but every level down reduces the returns. My personal guess is he licences phase 1/2a before the cash on hand runs out, its still early so won't get billions but clinical proof will be enough for perhaps 200-500m. That negates any need to fund raise for future trials or research. That's the only candidate we really know much about so based on that £1 is really difficult, 20-50p very achievable in 2022.
So for your £1 I really think we need something else as well, that could be CDX, CBR or Hu-phec. Hu-phec we know a good deal about and maybe they start it up, partner up and it takes off? No idea.
CDX is a big deal, but Eli get a slice of any licencing deal and also we don't know if any talks are currently taking place and if so are they likely to be fruitful? We know vlad was talking to other global cos about CDX last year but we have had zero updates on it so maybe or maybe not.
CBR is really the ace in the hole, maybe... We don't know how it works, we don't know how effective it is, how easy it would be to apply in bulk, we don't know how many indications it will treat or how many patents have been /will be filed and we don't know when we will be told all these details.
Potentially it's groundbreaking and vlad captures the market with a slew of patent applications and the industry scrambles to licence each indication of the from hemo off the mark in which case your £1 is blown out of the water. Or it could get a cold reception and take hemo years to prove before anyone wants it.
In reality I am alot more optimistic but after few years of disappointment trying to tone that down.
So short answer is, yes £1 is a possibility if vlad announces CDX licencing deal or CBR breakthrough but based on just known facts such as CAR-T pre-Ind and then IND +clinical trials with assistance of WuXi 10-20p in the next couple of months is a much safer bet.

Pre-IND application is pretty well documented by FDA, its 6-8 weeks/max 60 days from date of application. Either the meeting happens or day before Vlad accepts draft response from FDA and meeting is cancelled. Either way we should know pretty quickly if FDA like what they see or not. Personally I think they asked for the Pre-IND to see if they can get fast tracked which would be fantastic, but irrespective of that it will be great to see FDA verdict on Hemo CAR-T which will be very hard for the detractors to attack.

3-5 weeks left come Monday...

Ignore the noise, don't engage, pre-IND meeting is coming up fast, clock is ticking it was max 60 days few weeks ago, 4-6 weeks left.

At this point, let them, ain't getting my shares and anyone who thinks selling down here is a good idea might as well sell and go invest in coal or oil stocks. There is no dilution coming to lock in prices and FDA response in 1 month, so frankly right now I personally don't mind,(right now).
Grab the popcorn and enjoy the next month

There is a pre ind meeting in 4-6 weeks, who gives a toss about sp for the next 2-3 weeks, if your considering selling this close to clinical trials you need your head examined. Go enjoy the holiday period.

Markets close in just under 1 hr on what has been a staggering turn around in sentiment at Hemogenyx.
Vlad chose a path of letting the science do the talking and remaining quiet, it didnt work last year or most of 2021 but its starting to bear fruit. The level of belief in what he is doing and the progress now towards clinical trials is high. To those who had faith and held well done, to those who had doubts and are now returning, your welcomed with open arms.

2021 has not been a (positive) inflection year in terms of Share Price but it has been an incredible year in terms of intellectual property. The Patents secured and filed this year in the area of Monoclonal antibodies and bi-specific antibodies gives the company a very strong platform to aggressively target chemotherapy as the disease and remove it from many treatments. The work done by Eli Lilly was hugely important and expensive but now owned by Hemogenyx and whilst may cost significant profit share in future came at little up front cost today.
Some of the agreements signed including with Penn, WuXi ATU and Quality Systems LLC demonstrate that the company is utilising the best in field to achieve clinical status quickly and proficiently. Names matter and these partners have all demonstrated excellence and prior experience in doing exactly what Hemo hope to achieve which is clinical trials in the very near future. People may doubt Hemogenyx or Dr Sandler as unproven quantities, but people cannot question the partners who are happy to put their name to the project.

Value wise for shareholders we COULD have seen Hemogenyx take low ball offers of millions, potentially 10's of millions for candidates such as CDX or CAR-T but we have not. As we go into 2022 we are sitting with a company that owns 100% of CAR-T (TBC I dont know terms of WuXi partnership), 100% control of CDX (royalties to be paid from future sales), 100% of Hu-PHEC, 100% of CBR. Rather than partner out everything and give away piece by piece Hemo are expanding their facilities and building their own commercial production space in new custom labs, initially for CAR-T and CBR (Per brokers note).

We are still at historic lows due to that horrendous CLN fiasco which decimated the Share Price however on the flip side getting rid of the CLN via a huge placing has left the company with enough cash on hand to deliver clinical trials without any further dilution, in fact the CEO has confirmed in the past week there is no Placing. The partnership with WuXi may very well be part of this non-dilutive funding that Dr Sandler talked about, no clue but either way we are seeing that the CEO does care about restoring value to shareholders.

This has been a very long and difficult year, both in terms of Hemo, Covid restrictions and more, all I can say is Good F'in riddance to 2021! 2022 we welcome you with open arms!!! Merry christmas to all!

Wow.......

badger6023 Dec '21 - 11:30 - 6935 of 6936
Never thought I'd hear myself saying this but I've actually bought a token amount of Hemocasino.
I am going to see the shrink tomorrow.......

Welcome on board Badger, merry Christmas and I hope you do well here

Welcome back PK, Pingu :P play nice, we have ALL suffered alot here over the past few years, every one of us I am sure have had our faith tested more than once.
I am surprised to see this bounce happening before Christmas but I wont complain, I figured we would be quiet for a few weeks until the new year and then it would explode as we approach the window for PIND, but I am hopeful that this latest bounce is ex-LTH'ers deciding to get in early before the trading starts and are ready now to hold for clinical trials.

This will be something of a traders dream over the next month and if you look on twitter you can already see some of the names beginning to take up a position. Quiet time now with not much volume and SP still pretty much at all time lows. Known inflection date of around 1 month for the PreIND off the back of which you could see a quick progression to IND and clinical trials. Partnership few days ago with WuXi and recent reassurance from Vlad RE plenty of funds.

There is will probably be more hype and excitement in January as we approach the date range, people you have never seen near Hemo will likely be pumping for all its worth and there is every chance the SP will start to spike up. IMO this is just too easy a target for traders with a limited date range, low SP and tiny mCap. If you want to take a position for going clinical please consider doing it in the next week or so while its still cheap based on information you have read from Hemogenyx and partners.

It is a "strategic manufacturing partnership" I can see a similar example of this partnership with:
https://www.genengnews.com/topics/bioprocessing/vigeneron-and-wuxi-form-strategic-manufacturing-partnership/

If you check investors at Vigeneron: https://vigeneron.com/about/#investors
You will see that WuXi are series A investors and have taken them now to IND enabling stage

I am not saying that they are investing in Hemo, no idea what the actual arrangement is, would be great to find out!

Speeding ticket is more referred to when the Nomad orders a company to put out a statement saying a rise is unwarranted and some rumor or other is false. Not the case here, PME is an extension of the Auction period by 5 mins and basically gives the Market Makers more time to think what to do next. 4 PME's and a huge spread means the MMs put the breaks on the buying intentionally to kill off the rise. Why? Ask them.

Cov / Hemotruth(S in O) you have both been here for well over a year/years and have seen what this board gets like when it turns negative and personal. Pretty much all of us have been burned in Hemo at some point and its finally now looking good and like there is light at the end of the tunnel. Lets just enjoy this without bringing back old habits. IF we are right and Vlad gets this into clinical trials in a few months time then we are all going to be very happy indeed.

Morning all, nice start to the day!
Wise words Shardster and I fully agree, no need for targets lets just enjoy the ride :-)
Bline most of the content is in http://sharediver.com/wp-content/uploads/2021/11/Report.pdf but its way out of date now, nothing on this new collaboration

Vlad values CAR-T and CDX as "billions", there are plenty of examples of early stage pharma priced at 100-300m + and plenty of licencing deals/sale of patents etc right up to billions. I get we are only at 1.5p, but if CAR-T works its potentially worth billions, does Vlad sell it? Sell Hemo? licence? JV? Partnership?

Per WuXi ATU CEO Dr David Chang, they have begun production to "accelerate the beginning of its first clinical trial" .
I know it sounds mad but this is not hype or rumor or unfounded pump, professionals in 3rd party multi billion companies are stating they have begun manufacture to support the clinical trials. Penn and Randall Tlachac of Quality Systems LLC are doing the IND and your talking about experts who have done this time and time again.

Literally every indication is that Hemogenyx are going to be starting clinical trials for CAR-T in the very near future and the CEO Dr Sandler has stated they have enough cash to do so and dont have to raise before then. He has also stated true value of 20-30* the value is achieved only with clinical proof which could be as early as the start of Phase 1/2a.

I get we are only 1.5p and 15mil mCap but we are talking about an industry that does some mega price tag deals, the science is what it is, if it works people dont care that it came from some tiny company that had a disastrous CLN fiasco. Yes Vlad may not be able to demand as much as Eli Lilly, Novartis or Kite but he is not going to sell for 50mil.

Vlad keeps his word that they have funding for Phase 1/2a and gets us into clinical trials quickly and does not kill anyone? Then yes 100% 25p easily achieveable. Its not guaranteed, its still high risk, but its not a one product company, they have CAR-T, CDX, Hu-PHEC, CBR etc. We need just one single product to have early success in clinical trials and we are laughing.

Plenty of examples out there of licencing deals in similar fields, you will struggle to find licencing deals anywhere even close to the current mCap of £15m
https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Finance/gx-finance-next-generation-therapies.pdf
https://www.pharmaceutical-technology.com/news/abbvie-caribou-340m-deal - 340m to DEVELOP PRE-Clinical... IE up to the stage Hemo are at now.....

Oh god dhub, after the experience of the last few months I should not touch that question with a barge pole!!! ;-D *(but i will..)

I dont know because like you said there is too much power in the hands of the MMs and there is nothing logical about this share. Your guess is as good as mine, but from one extreme to the other:
If the FDA dont rubber stamp the IND application we remain pre-clinical for another year and they dont release news on CBR or CDX to boost SP then we could very well see a placing locking in lower SP in 2023 and a SP still ~2p but with significant additional dilution making it even harder to bounce.

OR

FDA do rubber stamp IND application and with the new partners on board clinical trials start early as they have been quite vocal about "accelerating" progress. On paper for an Oncology Phase 1/2 clinical pharma the mCap should be at least 200m so that is a SP of 20p+. If Vlad keeps to his word and does not take advantage of any spikes to raise funds in a placing then that is achievable, but will he raise if SP hits 10p+? I honestly dont know, thats the risk, I hope he does not. Assuming Hemo are able to actually cure a few people in humans in early phase1/2a and not kill anyone then thats the clinical proof with which Vlad has said makes the candidate worth 20-30times what it is worth today, IE a billion dollar product. Does he sell it? Licence? sell the company? Absolutely ZERO clue at this point but we can worry about that when we get there. Not going to start listing numbers higher now but go back and watch Vlads interviews, he views this as $bn's he always said true value was when its clinical proof and he has always said he would sell in early phase trials if the offer is right.

Again though this is JUST CAR-T, we still have CDX, wholly owned and targeting a replacement for Chemotherapy and he was in talks months ago about that, yet again a bn dollar product at some point in the future.

CBR? IF we believe the hype and its a cure for "Viruses" and cancer and they get first mover advantage? Then it alone is worth billions potentially.

Its really hard to put a figure on Hemo in 6 months time because there is too much going on. FDA could rubber stamp or put a clinical hold on CAR-T and from that they could have cured a dozen people or killed someone and halted trials. CBR could still be in the shadows or they could have 50 patent applications released. CDX could be dormant or they could have sub-licenced to multiple global pharma. Hu-PHEC could still be on the shelf or in clinical trials. Once we hit 50mil mCap I expect a significant growth as funds suddenly are able to invest here, right now many cannot touch hemo.

Shot in the dark, ignoring CBR potential..... Ill say by end Q2 they will have started trials but not sold or licenced yet so 25p

Thanks Jonny, MrIndia, I am with you, it is crazy to sell at this point but it does happen. Some holders here have publicly said that yes they are selling at a loss here but they are buying others that are equally as low but expect them to bounce first and plan to get back before we bounce. You cant fault that logic if you have absolute confidence in another share thats also at all time lows then taking a loss here is justifiable, risky but thats the game.
Its not just Hemo, we crashed spectacularly and early thanks to the CLNs but other small caps are catching up with us fast.
The new free money of last year has gone and people have debts to pay and fees on trading accounts to cover, many of the accounts offering leverage reduced the margin available on small caps like Hemogenyx forcing them to either add cash or reduce/sell their position. Some people will have been forced to take a huge loss here because they just cannot wait which is really really sad this close to Christmas.
I am quite an emotional shareholder here, had some sleepless nights over the past few years, plenty of nervous waits. I can honestly say because of the transparency shown with the partners, the FDA application, the confirmation about funding etc, the positive reviews from ASH, the new lab and the statements of intent I have never felt more informed or confident. I have not felt the need to bother the board for updates and its just really really nice to know what is going on and thats just for CAR-T which more than justifies a significant re-rate :-)
CBR, CDX or Hu-PHEC, any one of them could deliver a massive bonus surprise at any time. The madness cant go on too long, we should be looking at a fully clinical pharma in a few months!

Was expecting bit of a Santa rally this week but its more red across the board...... Thankfully Hemo has avoided much of the carnage but still being flat is nothing to be celebrating.
Pre IND meeting one day closer, or not.... Personally I hope the FDA response is positive and answers any questions raised by Hemo allowing the PIND to be cancelled so they can file the IND faster.

It is nice to see a more steady news flow in recent weeks and the quality of RNS + tweets is much better plus a willingness to stamp out rumours. You can tell the difference its making on this board, we are all frustrated at the SP but its actually a nice board again, people just seem more confident now.

Anyone switching off early for the holidays, have a Merry Christmas :-)

https://oxgene.com/news_and_views/news/77/hemogenyx_pharmaceuticals_partnership_with_wuxi_atu
They seem quite chuffed with the news also...

Thats the billion dollar question!
A few sold last week because they saw the Pre-IND RNS as a 6 week wait before more news. In anticipation of Covid spikes elsewhere they sold and went to various shares such as GDR, RMS/NNN, AVCT, NCYT and ODX hoping to be back before they miss Hemo...
Well as today has shown relying on no news is a risky bet here :P I personally think its a mistake and of all the times in the past year or so, 5-7 weeks before a known FDA Pre-IND meeting inflection point really does not seem like the best time to sell.

Maybe we stay flat for the next 5 weeks? Or maybe someone with a big wallet decides this is the point he buys back and starts loading up and we have plenty of small raises like today for the next month and those who sold don't get a chance to get back cheaper? God only knows, I personally am extremely confident that the Pre-IND will go well because of the level of experience Vlad has brought in and I cannot see how we could be anywhere near this SP when we get a rubber stamp.

Could do anything this share, never ever in a month of Sundays thought we would ever see 1.5p again, but we did, hold strong Micky, as quick as it fell it can shoot back up.