Member Info for HedgeHogarth

Tilly,

For me, the IND piece is relatively clear with the exception of the timelines. From the Get Go, Vlad stated their confidence (Initial CH RNS and TMS interview) in addressing the hold. Since then we have had a further confirmation and validation of their initial position.

What is less clear is exactly what steps (if any) are required following the manufacture of the lentivrus. Some on here have speculated that it could require a further 2-3mths of test runs + up to 30 days for FDA to respond. Others are fairly confident that Hemo will not be required to conduct a repeat of the 3 manufacturing runs.

In terms of "complete response" to FDA, I would like to think worse case is Oct (with FDA response by November) but could feasibly be much sooner if those people who think that it will not be a requirement to re-do the full testing prove to be correct.

Time will tell. (I did drop a note to Hemo to clarify the above; they were not able to confirm (as this would be insider knowledge) and advised that they will update the market on progress)

My personal opinion on the SP here...

There is clearly support at £1 per share - Looking at the 3 year chart, the SP has bounced up from £1 on at least 12 occasions. Only once has it ventured below £1

Whilst the progress and potential is astronomical - this is Biotech and history tells us that only a minority of drugs and other therapies make it successfully to commercial launch from this juncture. Avacta are still at an early stage of the development process.

However, the rhetoric from the company is incredibly positive and all the signs are very good. Given the potential, things could move very quickly in the next 12mths if clinical trials continue to yield positive results.

I have a (very) small position here; I've enjoyed following the progress and would kick myself if I was to miss out. It's great to see a home grown company with the potential and opportunity that Avacta has with its pipeline.

GLA

Thanks Digitt - I could not find anything documented. What I could find was that there are two manufacturing stages to what Wuxi do and they happen in two different divisions. So it may be that it could be both China and US

Are you sure it needs to go to China?

The Hemo agreement was with Wuxi ATU: (Dr David Chang, CEO) is based in Philadelphia

Wuxi ATU have multiple manufacturing facilities in the USA

https://advancedtherapies.com/locations/

Interius also work with Wuxi; a company based on the lab inventions of Dr. Saar Gill who until recently was the Principal Investigator from PENN University for Hemo

So strong link between HEMO-PENN-WUXI-PHILADELPHIA

I cannot personally recall hearing that the lentivirus was manufactured in China - so it could easily be Philapelphia. But apologies if i missed it

Ive seen far stranger things in this game than if Seed were to reach 5p. Its trading well below its NAV and it would only take one or two strong updates from Seed to get this moving North.

A change in the momentum of the overall market will also make a difference here.

Even if it does take longer to re-rate, 2p is a great entry point that is on the table now, it wont be forever

We're going to catch a big one 😉

Great to see a rare post from JHFH - it seems to have been received well on the forum and even been the catalyst for some other valuable contributions.

There has also been some great responses from most of the shareholders Im connected with in terms of the AGM. Hopefully we can enjoy some exciting times ahead.

I am no longer going post on here. I'm not in this to receive threats: LSE have removed the offending post (although I have a copy) but clearly are comfortable leaving the rest of the posts and presumably letting

the member continue posting.

I was not here to make trouble or attack anyone. I was here to learn and share thought about Hemogenyx - not find myself in a battle against members seemingly with an agenda to drive the share price down.

I've completed my dossier that captures activity over the last 6 weeks. I will not send it anywhere yet, but if we experience further suspicious activity, I will add it to what I already have and share with the FCA market abuse team. (But hopefully we have seen an end to it and as I stated above, I will also refrain from posting on this forum)

Here are some links the reasons why I find it hard to be here and tolerate the activity I have witnessed.

Kind Regards

Hedge

https://www.investopedia.com/terms/s/stockbasher.asp#:~:text=Financial%20Review%20Board-,What%20Is%20a%20Stock%20Basher%3F,an%20undervaluation%20of%20that%20security.

https://www.handbook.fca.org.uk/handbook/MAR/1/8.html?date=2016-03-07

Thank you Micky for those words - very generous.

I understand your point - and i genuinely apologise to everyone on here for any disruption i may cause in the course of interacting with them.

However, if you check my history you will see that I was very restrained with only 1 direct response to each of them until i was threatened.

The group of negative posters feel to me like a virus that this forum has contracted - let's hope its CBR that ironically cures this board

The Irony...

Stu wrote this on 2n June at 11:34am. I quote:

HH , I’m genuinely sorry for you and I truly hope your break from this stock is beneficial.

I would appreciate your return if and when you’re ready as you were the most informed and intelligent poster bar none.

I feel the company has let you down but admire your determination to defend what you thought and I’m sure still believe to be a noble cause."

So, one minute Stu is recognising me as the most informed and intelligent member on here (bar none) - The next he is threatening me?

Do the Math....

Pumpky - who knows but I know 'price manipulation' when i see it. So I can only hope they do. If they do not take a look - it wont be through a lack of effort, evidence and professionalism on my part in my request

I am not expecting a detailed update on CAR-T today.

I do think it will be commented on - largely reiterating what has already been said.

But we may be able to glean (1) if they remain as confident as they were 4 weeks ago and (2) what progress has been made.

The odds are stacked in Hemo favour still - majority of clinical holds are cleared withing 4/5 mths.

Having said that, the odds of not getting a clinical hold in the first place were also stacked in Hemo's favour

But hopefully lightning wont strike twice - it rarely does

To buy

The worm is turning....

Cant't even get a quote for 50k shares....

Nice post...

I will add though that those that see Gold - genuinely believe it based on the RNS, the development and other research.

Those that argue the other way are Traders - they may or may not agree with the long term prospects - but they will talk it down to suit their agenda.

So we are not really comparing apples with apples. Nobody will spend time talking about a stock they dont believe in - unless they stand to make money if the SP goes down

Micky - I think they WILL want to update the market as soon as possible - the only reason to delay IMO will be if they are 'days' or 'a week or so' away from fully resolving - in that scenario, waiting a few days may be the best outcome for everyone.

Lets see what is said today.

I'm probably wrong and just being optimistic, but I still have an inkling that the IND submission was complex and lengthy. That could explain why FDA may be choosing to use as much of the 2 30 days periods as they can - to ensure they are done the full due diligence.

Brendy...

I found a good link that talks about how companies should deal with a clinical hold (See Below)

My personal opinion - I think that Hemo should RNS when they have (1) Received the full documented feedback from FDA (not that the 30 days is not quite complete yet) (2) They have had the opportunity to fully digest the feedback, discussed as a team and with any relevant third parties (their partners) and (3) They have worked out what they feel they can share.

https://www.goodwinlaw.com/en/insights/publications/2020/02/02_27-clinical-holds-tips-for-handling-fda-call

Simon - I think we all know the answer to that question!

Guiness25 - this is the one and only response you will get from me. I suspect you are either an alias of the chief protagonist or an accomplice. (So don't even bother with a manipulative response along the lines of why cant they share more with shareholders ahead of FDA letter)

The FDA will have communicates at least once, almost certainly on a number of occasions throughout the 30 day initial period. They will have communicated the clinical hold via tele or video conference. Both the FDA and Hemogenyx would have wanted to resolve issue(s) within that 30 day period and would have had a conversation to either achieve that objective OR discuss whether it was feasible to meet that objective.

The fact that a clinical hold was place on CAR-T clearly suggest that more time was needed.

However, in the course of that engagement it's clear that Hemo will have understood the main reason for the hold; Vlad has also stated publicly that (1) he is confident in addressing the hold (2) that they think they know the main reason and (3) they are already working on the resolution

The reason for the hold really could range from something relatively straightforward to something more complex. Most Holds, as I stated above are lifted in 4 to 5 months - so there is reason to be optimistic. A minority could last a year - but everything I have learnt about Hemo suggests their initial IND will have been thorough and we know they sought early guidance from the FDA.

CASH

#HEMO raised £4m in January 2023; this was at a time when small companies were finding it very difficult to obtain funding. The few funding deals being done were very dilutive or with high interest payments and warrants attached.

The Hemo share prices was trading at 1.5p for most of 2022. However, Hemo managed to raise it’s £4m at 2.5p – a 60-70% premium on the FY22 avg price.

This should keep Hemo going for at least the next 12mth – but imagine they will need to raise early in FY24. Although, shareholders (and I assume the company itself) are very optimistic that they may identify non dilutive funding opportunities to realise the huge potential commercial value in CDX and CBR.

GLA – I personally hope that Hemo are making good progress behind the scens on lifting the hold and we’ll get a good update soon. I have submitted a couple of Qs into the AGM/ Shareholder Update tomorrow and will be listening remotely.

CDX

CDX is another therapeutic candidate the Hemo have developed that has the potential to cure or offer better outcomes for those with AML. It was jointly developed with Eli Lilly.

Eli Lilly chose not to ‘go big’ with it back in 2021 so Hemo took the decision to license it solely.

They have been working in the background with a third party, Selexis, to develop this important asset during the year. In January 2022, they entered into a service agreement to develop a "master cell line" that will be used to produce CDX antibodies for future clinical trials and patient treatments. They are utilising Selexis' SUREtechnology Platform™, a suite of cell line development tools and technologies that reduces the time, effort and cost in developing high-performance mammalian cell lines. The platform facilitates the rapid, stable, and importantly cost-effective production of recombinant proteins and vaccines, providing seamless integration of the development continuum from discovery to commercialisation. This is an important step in moving CDX towards clinical trials.

CBR

Hemo continue to develop and progress may their asset with the most potential of them all. It showed outstanding and game-changing results in the lab (In Vitrol) already and this year the plan was to test in on animals (in Vivo).

As announced in January 2023, Hemo scientists identified a target protein that can be incorporated into a single multipurpose CBR-based therapeutic capable of treating multiple viruses that belong to different viral families, instead of having to make a separate CBR construct for every virus. Among them are Dengue, Ebola, Marburg, Zika and Chikungunya. These viruses are among the most dangerous to humans, causing serious and often fatal diseases, and for which few effective treatment options exist.

The Company's technology utilises synthetic biology and artificial intelligence approaches to advance medicine to protect society from future pandemics that may challenge the global economy, health, and national defence. When fully developed, we would be able to create front-line treatments that may prevent the development of the next pandemic. Moreover, these new therapeutic tools can be used to protect against bio-terrorism, potentially rendering a universe of viral bio-weapons ineffective.

We continue to believe that this platform has the capacity to be extremely valuable.

Hemo has stated publicly that their aim is to progress CBR with partners; this candidate has broad potential (Cancers, Viruses etc) and they believe the best way to commercialise it will be to work with a partner or a number of partners. Being purely speculative, it would not surprise me if Hemo entered into a partnership with a big Pharam or even a public body based on what they have previously discussed.

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