Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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I have to hold onto the hope that the FDA state 75 days is the maximum period to await a schedule of a meeting. In theory a meeting can be held 1 month after submission of the PK Study. Bearing in mind that the Phase 3 trials were originally hoped to commence in 2021 it is a bit disappointing to say the least. The frustration here is that the Nov '21 Corporate Update stated that other news was expected in H1 2022. For example updates on BioAMB and potential commercial partnering discussions. Similarly updates on whether P140-CIDP moving into a Phase 2/3 adaptive registration clinical trial and again updates on the commercial partnering discussions. I am aware that some LTHs here date back to the start of the last Phase III and Fast Track designation by the FDA in Nov 2011.
They will raise money Dallo, FDA have 75 days to schedule a meeting which takes us until early September, they only had £1.6m left 6 months ago and burn £3,5m a year so it’s clear as day they will do a placing imo. But the amount needed should hopefully be small and supported by Avion so not too concerned about the placing tbh, it’s just a waiting game now, AGM was positive in the main, obviously a little disappointed that the FDA have 75 days to schedule a meeting but we cannot change how slowly the FDA work, more patience required, switch off time for me now and come back in two months when news will be close, GL all
Intuition allied to a bit of common sense tells me that Avion will take out IMM in the short term.
Price ??
17p.
Lambo
The change in the denomination of the authorised share capital is a pure Companies Act requirement following the consistent trading of the issued shares at a price below the nominal price .. ie 6p v 10p.
To accord with the Companies Act the company has now replaced the c285 m 10p nominal shares with c285 million 1p nominal shares which will come into effect next Monday ...each shareholder will effectively now have 1p nominal shares rather than 10p nominal shares.
There should be no change in the SP on Monday following the change nor does it mean an immediate funding raising imho.
I feel they will not issue under the 11p Placing price and are awaiting the FDA decision before raising more funds.
As you say flipper just have to see what the impact is next week, hopefully they can raise without too much of a hefty discount
Correction on my previous post,
exacting should have read exactly.
Alternately should have read Alternatively.
Blamed it on awful predictive texting.
If Avion have submitted the PK study data to the FDA via a type C meeting, then the submission must be at least one month prior to the formal Type C meeting. As mentioned the FDA will attempt to schedule all Type C meetings within 75 days of receiving the written meeting request.
Tim needs 5o get our money back from Incartha
Mute discussion now RNS has landed. Extract below. Will have to see what the impact on sp will be tomorrow and after the 4th July.
+++++++++++++++++++++++++++
RNS Number : 5391Q
At the AGM held earlier today, shareholders approved a resolution to sub-divide each existing ordinary share of £0.10 nominal value in the capital of the Company ("Existing Ordinary Shares")into one ordinary share of £0.01 each nominal value; and one deferred share of £0.09 each (these deferred shares have no voting rights, and no practical value).
Application has today been made for 284,984,933 ordinary shares of £0.01 ("New Ordinary Shares") to be admitted to trading on AIM. Admission is expected on or around Monday 4 July 2022
They will raise funds, that’s why they have changed the nominal share value at todays AGM from 10p to 1p so they can raise additional funds at levels 1p and above instead of 10p and above, that was the point in making this change, but any fund raise shouldn’t be huge, and btw Lupozor is there only drug, and is the drug used for CIDP trials… surely you know this?
IMM had a fund raise of £3.55m back late December 2021. The end of year result left as at 31st Dec 2021 was £1.6m. The question is was the £3.55m came after the £1.6m result which would mean £1.6m + £3.55m or the £3.55m has already factored in which would now be £1.6m is what left.
For the sake of argument, let just say it is exacting what is left £1.6m. If IMM is burning through £3.5m a year as someone said on this board and we are now half year 2022 then IMM is almost literally bankrupt right now. If your going to fund raise you don't wait until your down to your last pennies.
So why haven't IMM done so?
I'm not saying they won't. They may will do it in the next few days or weeks.
Alternately of course, is the licencing deal they are working on, on their CIDP. Normally for a drug awarded with a orphan drug designation depending on indication and is phase 3 ready, can command an upfront payment of $50m to $300m and royalty of 35% to 50% on sales. I'm not saying IMM will get that. After what happened to IMM's Lupuzor on their first phase 3 trial potential partners will be weary offering anything near that and according to IMM there two remaining suitors currently in discussions. If this was IMM (CIDP) first drug phase 3 ready (let say they never had Lupuzor) then this is the licencing sum I would expect.
As for fund raising, I expect they are holding out because of the CIDP deal and it will not be needed. But if they do fund raise it because the deal have not concluded in the timescale they hoped for and will do so to tie them up until it does.
Surely they would await till after the release of FDA decision before any further fund raising.
Nope I’m long and strong, they need to raise because they had £1.6m left at 31 Dec… and they burn through about £3.5m a year… hence changing the nominal share value from 10p to 1p so they can raise funds, it’s not rocket science it’s basic stuff
He's de ramping for sure. Not sure i believe a word he says. Why they need to raise? Avion are financing the trials.
Lambo222,
Was that your sell or are you back to your normal de ramping self ? :-)
I'm questioning this and also the fact they haven't put this important information in the AGM report RNS. Not everyone can attend the meeting.
500k sell just popped up, I imagine a few investors will be spooked at the nominal value been changed from 10p to 1p as now the BOD can issue shares in a placing from a nominal 1p level, rather that than a DDDD situation though where investors lost everything because they couldn’t raise funds, fingers crossed any placing here does not come with a hefty discount
Because your questioning if the type C meeting has taken place or not, If you were at the AGM you could hve asked for yourself
Why should i need to do that? The information you stated if true should be in the RNS.
Ask Lisa Baderoon, Head of Investor Relations & Non-Executive Director
It doesn't say that in the RNS. Your interpretation?
Avion have submitted the PK study data to the FDA via a type C meeting, the meeting has not yet taken place and the FDA have 75 days to schedule the meeting, latest date been early September.
The nominal share value has been changed from 10p to 1p… so now they have the ability to raise funds from a nominal value of 1p
Patience required
lambo - the RNS states "Further to our last update on 4th May 2022, Avion has submitted, via a Type C Meeting, the positive results from the Lupuzor™/P140 Pharmacokinetic ("PK") study to the FDA". To me, that suggests the Type C meeting has already taken place. What makes you think different?
Lambo not Lambourn..sorry
Lambourn
Well done
Can't make it myself as I am in the US.
Still holding 2.5m shares.
Appreciate it if you would post summary of meeting
Cheers