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I forgot to add this, mea culpa, sorry! Looking at trials for Orphan Drugs in cancer:

https://www.bmj.com/content/381/bmj-2022-073242

Ice, afternoon, looking at the data so far released re Q3W - suggestions of efficacy and confirming safety - makes me think Q2W is the right thing to do. The drug safety committee of Avacta will be in close contact with the FDA, MHRA, EMA etc to make sure everyone is happy with the way the trial is proceeding. They want to get as much data as possible from this small group to safely design the ongoing trials. Literally building on very solid foundations. You raise an important point about other warheads. This Q2W trial will be adding data that will influence how newer agents get trialled. The Q2W study, to me, really is important.

Just to add to the discussion. We’ve got to remember AVA6000 has Orphan Drug Status, and its development pathway reflects this. Cancelling Q2W wouldn’t be a good idea. It will add essential data into the phase 2 and 3 trials of the drug.

A double blind study is the gold standard, but again because of Orphan Drug Status it MIGHT not be necessary. Excuse the block caps. I think the company has mentioned a AVA6000 vs plain doxorubicin trial. But because so much is already known about plain doxorubicin and its limitations in STS, a comparison trial might not be necessary. The small numbers of patients presenting with STS also makes it more challenging to get enough patients into a trial designed and powered to show a statistically significant difference. Not saying it won’t happen, but would be very surprised to see Q2W stopped.

Wyndrum, tbf if I’ve read this right “ So if shorts are being increased (again, an assumption you make with no evidence other than an increase in volume), then they believe it highly likely the next move is down.”:

This shows an increase in short position:

https://www.lse.co.uk/ShareShortPositions.html?shareprice=AVCT&share=Avacta-Group

I think notifications of short positions are triggered at 0.5% and above. Difficult to comment on the total number held short.

GSA Capital increased its short position from 0.6% to 0.7% on 9th May. Oh I’d love to win the lottery to buy enough shares to squeeze them into oblivion. Other opinions on shorting shares are available.

D-Geeman, very sorry to hear this. I hope your daughter makes a full, uneventful, recovery. It’s amazing (that’s replaced a lot of swearing) how a wheelchair changes the way people are perceived and treated.

Any pirates here? This share needs C P ARRRRGGGGHHH.

Very good points. Tiny free float makes things interesting. Being very selfish, I’d be happy if the sp stays here till I can buy some more. Then engines start and off the moon.

Being serious, I think this company has huge potential. We know about the vascular grafts, and we know Elast Eon is being trialed as a synthetic heart valve. I’m wondering if it has potential in reconstructive surgery? Breast implants, whether for cancer surgery or cosmetic surgery, need to meet very exacting specifications. I’m wondering if Elast Eon surpasses them? I might be completely wrong, and it’s not at all useful. If not, it’s another potential high volume market to be involved in. I know that reads as a pun. Not intended. This is too close to home for me to joke about.

Looking at the 6 month sp chart, it looks like we’re copying the previous fall back following a good news jump. I’m guessing it’s going to settle in the 9 - 10p range. Frustrating. Please don’t take this as deramping. The market is a joke, not the company.

Jimzi, couldn’t agree more. AIM couldn’t value a £10.00 note with “This is worth 10 pounds” on a Post It. The London market is fecked.

Tiger, thank you, Jimzi’s post is important:

“ And finally, latest RNS indicates profitability in H2 2024, so brokers note out of date. And when profitable, earnings multiples kick in. There’s more than the heart valve material side”

The very robust testing of Elast Eon that is taking place re heart valves will also benefit the rest of the product line manufactured from it. No better way of proving just how robust the polymer is. The ‘market’ might take a while to realise this, but the surgeons who actually use the implants will understand the patient benefits. Definitely a share worth having in a portfolio.

Totally agree Jimnzi. Very sorry for focusing on the heart valve development. RUA so much more than a one trick pony. It’s about time the market realised this.

Tiger, finally this might be of use. This is the most recent broker’s note I can find. Issued before the 20th December 2023 RNS re the heart valve testing, and the recent business update RNS. So the £62,000,000 (approximately £1.00 a share) value they put on the company is a marked undervaluation imo. They mention something similar themselves.

https://wp-aortech-2020.s3.eu-west-2.amazonaws.com/media/2023/12/20155651/RUA-Life-Sciences-plc-18-December-2023.pdf

Yet another review article on polymeric heart valves. Gives a good overview of the present state of development.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10034107/

Tiger, always very difficult to predict sp movements, especially on AIM. So many shares seem to need constant support from RNSs to maintain a fair value. People get bored and move into the next shiny unicorn.

The fundamentals of RUA are sound. The BoD is achieving its present objectives of increasing growth and profitability, whilst having a £4,000,000 buffer in the bank. All excellent.

What I can’t find is a breakdown of the manufacturing cost of an artificial heart valve. How much would a manufacturer pay to use Elast Eon per valve produced? Elast Eon is already in use in implantable devices, so it’s cost effective against other polymers. Not sure a premium can be charged for its use just because it’s going into the heart. Or I’m wrong here, and a premium is payable because of additional testing and certification required.

Hi all. IntraVnus, that’s very helpful - thank you 🙏

Tiger, I’m a newbie here as well. A new heart valve will need a minimum of 6 months bench top trials before any useful information will be released. But this is being done by a global heart valve manufacturer. They won’t necessarily update the market. RUA might be tied into a confidentiality agreement with the manufacturer, though market sensitive information might still need to be released as per AIM rules.

What we don’t know is how the manufacturer will test the RUA sample for. Then design or incorporate it into a new trial heart valve. Only then will the 6 month trial commence. So an update might not be imminent.

The sp dropped following dilutional funding and change in product development pathway - if I read it right. But this is also AIM, a market that is struggling.

What we can’t ignore is the potential for a takeover / M&A. If enough global heart valve manufacturers trial the RUA product, and realise its the ‘holy grail’, will we see a bidding war?

Excuse the blatant ramping!

Tiger “Is this good for us?” Good question! I think it is. Obviously RUA isn’t the only polymer producer with an eye on the biological implant market. They’re playing catch up to a certain extent with others already more established in this part of the medical devices industry.

But if they have developed a polyurethane with the ideal properties of prolonged life expectancy and no side effects ( thrombus, calcification, etc) then I think we’re onto a winner.

“ RUA Structural Heart has the opportunity to transform the global treatment of heart disease by delivering a synthetic heart valve that will be durable, so reducing the need for future replacement, and should not require lifelong drug treatment. As well as these clinical advantages, the manufacturing costs of a synthetic valve are expected to be considerably less than those of current valve technology making this a potentially disruptive advance in heart valve surgery.”

If other polymers match the life expectancy and safety profiles of the RUA product, manufacturing cost will determine which plastic is used. Simple economics. It looks like a polyurethane is easier and cheaper to use as a PHV base material. This is good for us.

Also worth remembering the bench top PHV tests RUA have been doing will still be ongoing. So they will be able to update the market with the results of this. Way beyond the 400,000,000 cycles - if memory serves - expected as part of the standard trial process for a new PHV.

Polymeric Heart Valves will replace mechanical and biological replacements:

https://www.mdpi.com/1422-0067/24/4/3963

In support of Tiger:

“ Rigorous testing

Both new valves are going through rigorous testing. Replacement heart valves are subject to International Organisation for Standardisation (ISO) standards, just like A4 paper and agricultural machinery. Currently, the ISO standard says: “There is, as yet, no heart valve substitute which can be regarded as ideal.”

It stipulates that a replacement valve must last 200 million heartbeats – about five years. Dr Moggridge is aiming for 400 million, or 10 years, as a minimum.

How can you test a heart valve outside the human body? You can use a homemade pulse duplicator (where water and glycerol flow through the valve to imitate blood) and then a durability tester. Dr Moggridge’s team have a new durability tester, costing £50,000 and funded by a BHF grant. “The tester can go at 30 times normal speed and test six valves at the same time,” he says. “It means we can simulate five years of use in six months.””

Agree Bella. Did AS jump or was he pushed? Can’t help thinking he’s been a hindrance to the development of the company. Still thinking it’s his personal plaything, and negotiating with BP from this position. Have BP had a quiet word? I agree big news is now more likely in the short - medium term.