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Whilst you might not like the tax (nobody does) it was almost pointless being on main market because it was no better than AIM with the dodgy goings on. However FCA have made some major changes this week to make a main market listing something actually worth having. Main market shares should start attracting a premium because of it.
Major correction on crypto, major changes to main market, small caps at massive discounts after a brutal bear run. The market is primed for small caps to bounce.
Hemo is at historic lows, alot of cash on hand and massive amount of potential updates expected, whilst others have been falling in recent sessions hemo has held firm, im very bullish about our chances even pre Christmas.
Word of warning to holders of other cheap shares, many of these shares have been bargain basement for a while. Most cheap shares are not profit making and will either be forced to raise irrespective of the sp or look to take advantage of any spike to raise. Vlad has committed to no dilutive fund raising for the foreseeable future and has enough cash to keep that promise. Not saying put everything in Hemo, there are plenty of bargains and diversity is good. But think very carefully before investing in any company with an empty bank balance or history of placing every few months.
Cheers Trek! All my punts recently have been on AIM shares, so I had forgotten about the dreaded stamp duty! Some chunky buys today, nevertheless. I think most of the "unknowns" (like mine), especially those at 1.725p, were buys. Strong support at these levels, it seems. All best everyone! Onwards and upwards.
Hi Glen,
Hemo is main market listed hence tax.
https://www.londonstockexchange.com/stock/HEMO/hemogenyx-pharmaceuticals-plc/company-page
Nice whisky btw!
Trek
Ditto, Trek, my buy @15:01 showing as "unknown". The other thing was I had to pay stamp duty (40-odd quid) - anyone know why? Here for the long haul, but definitely feels like a good entry price anyway. GLA.
No better feeling than getting your timing right, and no worse feeling than getting it wrong lol. Hopefully we’ll get an update on CBR this month to validate your decision and after that the following six months should see the performance people expected to see this year. Good luck!
This one has been in my watchlist since the last covid ‘vertical rise’ and subsequent fall. I hold ONC, their CEO mentioned Cart earlier which I thought was interesting.
The SP has now reached pretty silly lows imo so I have picked a few up. No I am not an expert trader it’s just that sometimes you happen to have the cash at the same time as a bottom appears!
I thought I had missed the best timing wise when it went through 2p. Can’t believe I have been lucky to get in now. Will be selling some more blue chips to add here tomorrow.
Well I hope I have been lucky with the timing. Time will tell!
Trek
Especially as this will be HEMO's first application ............ build the relationship for the future.
Thanks for the excellent post JHFH. Just one addition, as I understand it there are only 20 people participating in the trials so shouldn’t take too long to get them on board and once underway, I wouldn’t expect them to take too long to complete. On a side note, the FDA have said many refusals are due to companies not understanding the process and they do recommend companies talk to them in advance of an IND application, so very prudent of Hemogenyx to meet with them and increase the probability of success.
The IND application contains:
Animal Pharmacology and Toxicology Studies - Preclinical test results - As far as I know these are done, were with Penn so no issues here
Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. - I THINK as part of this they need to find doctors and locations willing to host the trial and detail the steps, I dont know if this is delaying or not, I would imagine for someone like Eli Lilly they have their own doctors and facilities, where as Hemo will have to partner with a hospital and find doctors willing to sign patients upto the trial. With that you have politics of insurance and risk assessment. Can only begin to imagine how complex this stage would be, thankfully they have Penn to assist.
Manufacturing Information - THIS is where I think the delay is, they have to produce details on the manufacturer, controls in place.... Big long list they have signed up 2 companies for the manufacture of vector and virus and are keeping the patent specific CAR in house? Its alot of information to be provided 3 times and because they are doing part of this in house having only just bought the equipment a few months ago only now are they in a position to provide details of the equipment, training safe practices and the rest that Vlad talks about. They may even be committed to producing CAR in a dedicated clean room such as the one being custom built.
Here is the info on IND, sounds like ALOT of paperwork, I think in vlads interview he said he was 80% there towards the IND and was speaking to FDA first just to make sure it was accepted first time:
https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application
You would like to hope that once Vlad has done this once, when their labs are up to spec and the equipment and training is all signed off future clinical trials such as CDX or CBR will be alot faster...
They can’t do an IND application until all the pre-clinical enabling studies are completed. With CAR-T it’s a very complicated process, with CDX they couldn’t really begin until they had reached agreement with ELi to license their IP.
Why is the IND application taking this long to submit?
Yea I heard March for the lab, I dont think thats the delay with clinical trials though, they could probably go ahead right now if they had IND approval as they are contracting out 2 parts and have a bio reactor to produce the remaining CAR in house.
Timeline wise I think its:
January/Feb: Meeting with FDA - 30 days later they issue a letter indicating if they are likely to approve or make suggestions to improve chances of IND passing.
Then really depends what the letter says, if they say go ahead you could have IND application as early as March or April, or it could take a few months to make any changes suggested so IND could be May, June. After that its a 30 day wait for FDA to reply if any objections. I THINK they can start clinical trials then straight away but its hemo... so probably another month or so. Best case scenario if FDA are happy clinical trials could start around May -June, but probably a few months later than that if we are realistic.
All that aside that does not mean there is no news until the summer. Each stage is significant:
Meeting with FDA actually happening (Jan - Feb)
Reaction to the published letter 30 days later(Feb-March)
IND application(March-June)
IND application approved(April-July)
First patient injected(May-Sept)
Early results(Depends on secrecy will they tell us before end of trial?)
These are JUST my estimations and apply only to CAR-T
Much more imminent is the CBR update which from the updated brokers note sounds like it will be bigger than any of us expect and likely to be much bigger than CAR-T or CDX for Hemo.
Then there is CDX - Vlad was talking to other pharma about CDX (sub-licence or partner with) months ago
Eli Lilly several months ago were working with Hemo to select a candidate for Lupus
Hu-PHEC was stalled due to lack of facilities and money, they have both now so yet again expect updates here.
There are just so many potential updates that the probability is we will see updates soon. The SP is disgusting right now but its stable and there wont be any dilution for a long time. I see plenty of people pumping dogs and PI's getting excited only to be slapped in the face with a placing a day later. Shares in companies with mCaps multiples of Hemo with no orders making physical products with the overheads associated with that. This is not a dog share, literally the only thing wrong with Hemo is the Share Price which puts off so many. They have funds, they have multiple candidates, they are growing staff and facilities, they are working with some big names. If the mCap was 150mil and not 17mil people would still consider it undervalued.
All that aside, the SP is a joke but the markets right now are a joke, Hemo is not alone in being decimated, just have to be patient and let the city boys have their fun.
Looks like it's going to be a very long wait for news...probably a year now.
Yep, New Lab WILL be ready Q1
I understand the lab will be ready end of Q1.
Correct, they won’t start until then. Besides they have to get an IND application approved before clinical trials can start. End of Q2 is the timeframe you should be looking at for trials to commence.
When is that happening?
Not being negative, But is this an indication that clinical trails wouldn't start until they get into Manhattanville.
https://mobile.twitter.com/HemogenyxPharma/status/1466314353720897536