Member Info for HedgeHogarth

Assume 121 is getting desperate? he must be worried at what looks like some buys going through

Stu - sounds like a lot of common ground and I will be as disappointed as you if update on CAR-T is not clear enough - although i suggest our reactions will differ somewhat ;-)

However i disagree on the Comms - we get a lot of comms! I know far more what is happenging at Hemo that I do at most of the other companies I closely track or have tracked; that includes KDNC, YGEN, HFD, ECEL, XPF, XPP, AWE.
It's not realistic for a company to keep investors updates on everything outside of the 6mthly interim and annual reports. The company gives us a through audited update twice a year and on regulated or pivotal matters in between.

Unfortunately the things i would love to know, I have to wait for either the formal reports OR AGM OR webinars. There were only 3 of us at AGM and only two questions - despite having Vlad, Alexis, Peter and the CFO on hand to answer questions for as long as we wished.

Hi Stu,
It is a good question, thanks for your very reasonable post.

I'd love to know too - but then there are many things I'd love to know. I'd love to know how the CBR tests are going, I'd love to know what partner conversations are happening, I'd love to know more about the plans for the trials, I'd love an update on Vlad on where he sees' his fiercest competition is.

I imagine is harder to predict the amount of time to complete paperwork etc. Its sooo important and then will take as long as it needs. It's iterative, with changes coming from third parties (Wuxi) and whoever qualified the PQ runs and from the Consultants employed to support the paperwork.

I am very confident the annual report will give us some further guidance. It may say it's complete (hopefully) or 2nd best a statement guiding when it will be submitted. We may even be lucky and get opportunity to have a webinar to ask further questions.

Stu - my own personal opinion. I will be disappointed and frustrated if the IND is not submitted by the end of April. It would not alarm me though if the company indicates in the annual report when they expect it to complete. I do not think if the paperwork drifts into May that it constitutes a problem - it's more likely that the complexity is just greater that perhaps we as investor hoped. As you say, the company has stated it has been working on the submission for over a year.

For me though, it would be a minor blip if paperwork was not complete until May, the train is still full steam ahead heading for the clinic

Well done to all those who bought sub 5p and held.
Alas, i bought sub 5p, but got impatient and sold too soon. I chose to put my money in a stock where i felt better researched and better understood my risk.
Hope it goes higher and lots of PIs do well.
Dont forget to take profits where you can

Unbelievable - Mr India you have tempted me into a Final Final post ;-)

I don not know you either and mean no disrespect or offence but i have the following 'beefs' with you.

In a nutshell - you constantly contradict yourself AND you consistently do what you accuse others of doing. You are not consistent

1. You have accused others of not sticking to the FACTs - Yet, you make comments like "there are no new investors at the current price which is 25% below placing". There has been lots of buying and selling around 2p so there is every chance of new investors. You jump to conclusion that my post have no impact - i can assure you that i have had many new followers since sharing my posts and some lovely messages. I would argue that this will help play a small role to attract or retain some investors. How can you tell how many of the transactions are buys and sells - you are simply guessing.

2. You say that people cannot make money on Hemo - Yet the SP is up 30% in the last 12 months. It was up +200% in the latter part of January. I can assure you that many people will have made lots of money.

There are so many more, but quite frankly I cant be bothered to complete this post. Vlad HAS increased his RNS - 8 in 8 months on CAR-T alone, updating on every step in the manufacturing process.

Over and Out

Agree butchers bike - Good luck.
I'm leaving this forum to the de-rampers - a few good guys on here already know my thoughts and pointless trying to interact with about 5 posters on here who have no appetite to recognise the significant achievements or potential here. They just want to stir up fear and do their best to suppress the share price; this will undoubtedly cause a few weak hands to miss out. Well done Derampers - You win, but I am confident that i will WIN too in the medium and long term as and when the Hemo SP re-rates in tandem with the wonderful progress it continues to make.

Final comment for Mr India - anyone is welcome to get to KNOW me. Happy to talk or meet anyone in respect of Hemo - I will attend the AGM again this year and happy to have a beer with anyone who want to discuss Hemo. I have previously shared my Twitter profile on here (Fonzie). With due respect and NO offense intended, you posts have become increasingly delusional. I challenge you to find one thing i have posted about Hemo that is not a fact or stated "hope" that i have. I have even picked other users up for getting to excited about Biodefense grant - the company has never said they even applied!

If MR I has sold a lot, he has either helped those who shorted the stock or bet against it, exit their positions more easily.

Stu, you are clutching at straws when having to reference Pumpky, the biggest and dumbest wins up merchant on here. As I have said before for those who have command of the English language.
Hemo did say they were in final stage of getting to IND a year ago. This meant "just the manufacturing stage to go" after many years of lab development. It's is like reaching year 11 and school and entering your final year after 10 years at school. Within weeks, Vlad shared with investors a very detailed plan of how the manufacturing stage would be achieved. A minimum 6 month process. A year ago, Hemo were in their old antiquated premises with no capability to make CART cells.

The manufacturing is now complete and the results and conclusion are being or have been written up. It is also fair for Hemo to again declare they are at the final stage. Back to my school analogy, year 11 is now drawing to a close and it's the last week and almost time to celebrate at the graduation ball.

Good luck everyone, not much longer to wait now.

As I have shared with trusted to investors, the manufacturing stage could have gone pear shaped. Hemo may have failed to meet the standard required. Instead they have completed the stage SUCCESSFULLY and in just 9 months. We should all be celebrating that key milestone. Instead this cesspit forum is having to deal with manipulative and erroneous ballocks from derampers with a clear agenda to hold back the SP.

Stu, for whatever reason you appear up to your old tricks

Hemo stated 13 trading days ago that all was well in an RNS.

Do you want them to update YOU daily, hourly, on demand?

Only derampers would jump to conclusion that something has gone wrong so soon after an RNS that says all is well.

Derampers seems to have had a good week. Mr India has sold a few which probably has helped the derampers cause.

Weak hands being robbed of their chance to make money here.

I remain very confident and not selling a single share.

Only 12 trading days ago the company confirmed that the manufacturing is complete and they just need to complete the admin to submit. It's hardly waiting for Xmas - and you WILL get a further indication in the next 12 days in the annual report.

I think that is fair - Im not sure your need for more updates than that is realistic. As I have said before, perhaps you need to get a job there if you want to stay closer to it's progress.

The SP will re-rate when you least expect it Mr India - that's generally how the market works in my experience. Otherwise we'd all be very very rich.
Hence why I'm no trader, I am VERY confident that Hemo will be worth multiples of today at some point in the future - when the markets pick up and when Hemo makes more progress.

Mr I
I do not know whether IND has been submitted.
What i do know is that Hemo have RNSd very single step in the process (8 in all) since laying out the plan in July
So, logic says they have not submitted OR they only plan to RNS when it receives the green light from FDA

I am no ramper, i stick to the facts and just try and counter the lies or FUD on here.
I am LTH within sight of an 8 digit holding - am happy to add all day long at sub 5p.

At 4p, the value of Hemo was not a million miles of it's peak. It has taken a recent hit due to the placing and the liquidity a placing causes. It also upsets a few investors who dont enjoy the short term dilution.

I have not doubt the value of this company will be back to £50m+ in the next few months - i just cant predict when.

Mr India - you are one prize plonker

Synairgen is down 40% in the last 12 mths, HEMO is up 30% in the last 12mths. Lets see what price Synairgen is in a week....

I have NOT ignored your post as it happens, and i do NOT agree with you

How can you say you do not know what stage we are in the process towards IND - Vlad laid it all out in a webcast in July and we have had EIGHT RNS confirming when each and every milestone was hit. All finished now and HEMO either have completed or about to complete paperwork. Hemo are about to trial their drug on HUMANS, these things should not and cannot be rushed. Even If he spends another 6 weeks working on IND, I would expect the objective is to make it more likely to get approval and / or more likely to be safe to Humans. Failure to do so would do so much more harm to the share price and company.

I can only assume you are a trader, given you constant need for reassurance and concern on timelines.

Hemo have never said they have have applied for a grant, so why get so excited because a few people on this forum have guessed they may have. You cant blame Hemo for not confirming or denying every rumour on a sess pit forum like this

Good luck with your next investment, come back before Xmas and let us know how you have done.

So you think trials will have started in Aug / September Darwen.
I'd take that :-)

So it sounds like you do have more faith in Hemo that originally suggested and if SP is looking to the future - I expect it to start reflecting Hemo as a clinical Biotech anytime

Has anyone completed an IND submission on here?

From what i have researched it's a very detail and complex task - so would not surprise me if they had a few weeks work post final PQ runs to properly immerse the results into the submission.

That said, HEMO have been working on the document for over 1 year - they have also employed a third party to support.

Darwen, not sure if you are sharing your beliefs or those of the market?

I will plump for the former

What exactly are you thinking; do you NOT expect Hemo to be running Clinical trials in the summer??

Hey Stu - Good post
I do think you may be over thinking this though
The company have stated that the manufacturing piece was the final stage before submitting IND
Vlad provided a thorough, transparent plan of what was required to complete the manufacturing phase
Since that Webinar in July, HEMO have released 8 RNS in 8 months (Excluding the Interim Report) as and when they have achieved the steps and milestones in that plan:
1: New Facility Opened
2. Medical Director recruited
3. Director of Quality recruited
4. 2 Test runs completed successfully
5. 1st PQ Engineering run completed successfully
6. 2nd PQ Engineering run completed successfully
7. 3rd PQ Engineering run completed successfully
8. Confirmation that Hemo and a third party had completed the tests and analytics to confirm the manufactured CAR-T cells met the FDA requirements for safety and functionality

It is simply paperwork left to go....

What we do not know is at which point will Hemo next communicate:
1) When they submit IND
2) When FDA provide confirmation of receipt
3) The point at which FDA clearance achieved and Phase 1 trials can commence

My guess is that the annual report will confirm points 1 + 2. And then the clearance will following shortly in early May.
But i would not rule out Hemo having submitted IND very shortly after the last RNS and that we may get Point 3) as part of the annual report or in a separate RNS before the end of April.

I'm also looking forward to the next CBR update.

With news less than 12 days away, those buying today should find themselves well rewarded.

Nothing to stop Hemo going clinical, IMHO

They have stated they have engaged with FDA and had detailed feedback

They have stated that they have achieved the final manufacturing step: i.e. They have made CAR-T cells 3 times in the space of about 6 weeks to the standard required by the FDA on quality, safety and functionality, as confirmed by a third party (i.e. it kills AML cells)

Across the whole market, smaller companies are looking very cheap, it's not just a HEMO thing. In time, the market will wake up to the opportunity with the smaller companies both in the UK and US. Lots of chatter on Bloomberg TV about the value in small caps.

And...this ridiculously low valuation of HEMO cannot go on for ever - surely it will re-rate when they go clincial?

HT - you are sinking, don't do it......you are better than that....

29th April (1 year ago)
#Hemo stated the following:

We have made strong progress over the past two years in the development of HEMO-CAR-T. The programme has seen very encouraging results to date and promises to represent a major breakthrough in the treatment of AML. The Company is now focusing its greatest efforts on this asset, which remains proprietary and wholly owned by the Company.

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.

Simple translation: CAR-T is number 1 priority, after many years of progress they have reached advanced stage ahead of IND - i.e. actually making the stuff

July 2022 (9mths ago)
As per earlier post, the company shared the plan and some guidance on timescales in July. This confirmed that manufacturing would commence shortly after moving into new Lab in July and once Clean room qualified. It was clear that manufacturing phase would take a minimum of 6 months

29th Sept (6mth ago)

HEMO-CAR-T, a CAR-T therapy targeting Acute Myeloid Leukaemia ("AML"), is our lead product candidate, the intellectual property and development of which are in the Company's sole control. We have been working toward completing the necessary IND application for HEMO-CAR-T, having held detailed discussions with the US Federal Drug Administration ("FDA") during the period and received constructive feedback through a pre-IND submission that confirmed our development process and our proposals for clinical trials. Most of the data required for the IND application has been compiled and the components for manufacturing HEMO-CAR-T have been produced. We are now engaged in the final stages of establishing the production of HEMO-CAR-T cells for the treatment of patients. We are confident of completing the IND application in the near future and are working on detailed protocols for carrying out clinical trials.

The work is necessarily very detailed as the main concern in the process is to ensure patients' safety, which requires great care on the FDA's part and of course ours. We have been working with a group of Key Opinion Leaders in the treatment of acute leukaemias that has helped us to hone our approach to clinical trials. We are now in the process of finalising our trial protocol, which will involve a relationship with at least one major hospital, likely to include the University of Pennsylvania with whom we already have a working arrangement.

Simple translation: CAR-T very much on course, good FDA engagement, manufacturing process designed and manufacturing stage has commenced. IND submission is complex and detailed. Plans for Phase 1 trails are progressing.

In just 8 months, HEMO have reached the point of completing the manufacturing stages required to submit IND for CAR-T

They have not achieved this in such a short space of time, completing this QUICKER and significantly CHEAPER than using a third party.

A quick recap:

1 - They moved into brand spanking new facility to support that strategy to manufacturer their own CAR-T
2 - They set-up ISO 7 Clean rooms and received qualifications
3 - Recruited the talent required to manufacture CAR-T
4 - Set-up commercial relationship with WuXi to produce the Lentivirus required to produce HEMO CAR-T - a mult-stage complex process
5 - Set-up commercial relationship with Lonza Bioscience to develop CAR-T manufacturing process - Hemo team members spent time on site with Lonza in Canada to complete development
6 - 2 Process runs - completed successfully completed
7 - 3 Manufacturing qualification runs completed
8 - Manufactured CAR-T cells qualified by Hemo and a Third party to the standard requitred by FDA - viability, potency and sterility. Basically - they have been confirmed as being SAFE and that they will successfully ELIMINATE AML Cancer cells.

Roll on FDA clearance and Human Trials :-)

Well done Hemo