Member Info for olderbutwiser

I hear you Soup.

However I think the telegram chats from Dan are generally correct but with some element of slight mis-direction so as to avoid accusations of over-sharing/ being too specific - Dan is a canny operator.

So your on a long-shot Soup, and I am on a 50/50 odds (possibly swayed by my flagging hope).

All we can do is wait and see what mid-June or mid-July brings.

ATB

Well obviously we do not know which pharma it is.

There are a number of pharma's developing IPF drugs that could be applying.

But the deadline for submitting for it to be in todays COMP 60 day meeting just happens to be 27th February.

Dan was on Telegram chat on the 27th February and said "It will take up to 3 months to get orphan status. We want to start immediately".

Interesting coincidence or the gods being whimsical?

Formal EMA decision within 30 days of COMP meetings but they seem to show timetable for EMA decisions as below.

So the first we will know is by 12th June (if positive decision made this meeting), or on 12th July if it goes to a COMP 90 day meeting.

Fingers crossed

Shown on todays agenda as below - could this be NFX002 being discussed - hope so?:

Committee for Orphan Medicinal Products (COMP) Draft agenda for the meeting on 21-23 May 2024

Item 2.2.10. - EMA/OD/0000165100 Treatment of idiopathic pulmonary fibrosis (IPF) Action: For discussion/adoption'

chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.ema.europa.eu/en/documents/agenda/agenda-comp-meeting-21-23-may-2024_en.pdf

Thanks for the info Soup.

Article of some interest re combination drug therapy being used.

https://www.bbc.co.uk/news/world-australia-69006713

I think the 30M odd shares sold earlier this year were, almost certainly, the ‘single UK-based FCA regulated institutional investor’ from the subscription for 35M shares from 17 April 2023.

Being approached during late January/ February for the 01 March 2024 subscription gave them the heads up to sell their earlier subscription before the RNS announcement.

Institutions are always privy to information we lesser investors are not – it is not a level playing field .

The last few trading days have seen a lot of 'bed and isa ' transactions - indeed most of the large trades were on last three trading days.

Looks like todays 3 x 1,000,000 trades were sells from the non-isa account and with the 2.8m being the buy in the isa account.

Unfortunate it momentarily depressed the price - no doubt the hope by the investor to get a low buy-in price for the isa.

Just my take on it.

Jiving - 'During his Telegram exchange Dan gave no indication he intended to inform shareholders when an application for orphan status was made.' You are quite correct - Dan did not say that.

My three Telegram transcript posts on the 28th Feb were the verbatim comments from Dan ( I still have the screen grabs covering all his comments) and does not include saying when Orphan drug submission applied for.

My 'Newsflow' post on 29th Feb was a listing where I erroneously included the Orphan drug submission in the incorrect section, thereby incorrectly/ inadvertently inferring that Dan had said it. It should have been in the lower section of possible additional newsflow.

Apologies.

No Soupdragon for some time now. Hope he is okay.

Why not a subscription for existing shareholders?

Previous subscription for £70,000 on 17 April 2023 stated 'The Subscription has been undertaken with a single UK-based FCA regulated institutional investor.'

What favoured person/ s are involved in the subscription this time?

Who can subscribe for these new shares ?

After a period devoid of real news and the company silent about progress, it seems we have been given an insight into their progress and their path going forward and with a number of important news releases being mentioned by Dan over the coming weeks and months.

As follows:

• EU patent for 002 is in process of finalisation and will be announced imminently.

• Orphan drug status application submission.

• 004 patents progress and update

• The NEW plan mentioned by Dan, whatever that is, to promote company based upon BD progress and the massive potential (his words) they see.

• The company will update with company presentation soon.

• Grant of Orphan drug designation. (from looking at the European Orphan drug website it seems that if it passes the first review committee without questions then it only takes about 60 days for grant, but if there are clarifications/ questions it goes to a second review committee and can take up to 90 days)

In addition:

• AGM (there may be further statements/ info provided)

• BD activity continues throughout this period aided by the added incentives of European patent being granted plus orphan drug status being granted in just a few months’ time (thereby providing significant IP and commercial benefits).

Looking forward to the good news flowing and via more normal channels.

ATB

Dan responded to a few additional questions this morning.

To a question about submission dates for orphan status submission Dan replied 'No you can do it any time' and that 'orphan designation is seen as an asset transferable between companies'.

7. Dan asked for shareholders to vote for the agm resolutions.

8. Nxp004 situation asked about and Dan said ‘patent things going on and that an update on that very soon. But that nxp002 was main focus’.

9. Someone asked whether they are confident deals for 004 ad 002 will be achieved. Dan said ‘We all believe it’s absolutely worth pursuing. We know everyone and have kept our powder (dry) learning what we’ve needed to. And agreed that they have definitely achieved a lot of groundwork with the potential partners for 002 which will make closing a deal easier when we achieve orphan status’.

10. Someone asked whether Dan was able to say anything about funding runway. Dan just said ‘Obviously keeping things lean and focused on moving the company forward’. (I assume that would be price sensitive information and he could say nothing more)

11. Apparently ‘Applications for orphan status are free of charge’ but of course there will be some time involved by NFX to collate existing data into the required structure and submit.

That’s all folks!

So in short we should expect a few RNS’s and company presentation, plus agm, in the short term with orphan status within 90 days or so. Deal/s thereafter?

• There have been some massive failures in IPF. And there will be more. Drug companies have focussed on targeted therapies. And all will fail and continue to fail. We (the scientific community) are realising that IPF is not going to be a single target disease. Look at talks in the public domain by people like Prof Athol Wells – its complex disease with multiple codependent pathways – think of it like cancer and drug resistance. So the whole of pharma is kind of going ‘Oh sh*t – we spent billions and this isn’t working – what do we do now?’ And there isn’t an answer. Our answer is ‘well the only drugs that have shown clinical efficacy are multi-target drugs’. What you need is better multi-target drugs. So that’s our pitch. But it’s very counter-intuitive. But the fact we have inhalation as a delivery route and can speak about multi-target activity is I think a good thing. So this is what we are hoping to leverage in our story. The fact that we have something in inhalation that is also NOT single target based (and has a huge amount of clinical safety and efficacy data) is currently a huge asset and the right partner/ set of ears will get that.

• Ninedanib comes off patent next year so there’s some uncertainty about how much additional efficacy new drugs will need to achieve high pricing.

6. Someone asked Dan if they had any plans to use media / twitter to help promote the company a bit more and get new investors. Dan said they do have a plan and that ‘Fact that sp is so low but as always potential is massive so telling that story isn’t that difficult. The plan is new now we have a better feel of what drug companies want and why. We will also update with company presentation soon’.

For those not on Telegram here are the main issues Dan covered. I have used Dan’s own words but re-grouped some of his posts to make better sense.

1. His accident was Friday afternoon when he was walking and crossing a stream, slipped and fell over a 5m waterfall onto rocks! But he was wearing a helmet - so his injuries could have been a lot worse, but he was only in hospital for 2 days before flying home with his family.

2.Dan said they have been working really hard sorting a lot of patent issues, with a lot of progress dealing with some 'really grumpy patent examiners' (I assume that may refer to Japan patent issues).

3. EU patent is in process of finalisation and will be announced imminently.

4. Dan seemed to think that recent selling was final leftovers from Lanstead's last placing.

5. Dan mentioned 3 aspects they are dealing with, these are his own words:

• Most big pharma, not all, don’t like reprofiling (re-using known drugs). It wouldn’t surprise you if I said we’re speaking with AZ, you don’t have to be a genius to join the dots. They currently love IPF. We know them well. But they don’t like reprofiling. So the IP piece becomed more important, and the deal is just harder overall. We also don’t have orphan status. Every other asset out there has got orphan status already. To compete, I think personally we need that. Ideally from the European vs the US. If we go for European orphan designation, we have to present our existing data and rationale. If it’s accepted, it acts like a badge of honour – independent validation we’ve got potential – so drug companies like it. Plus they get a lot of downstream benefits. Shorter development pathways, R&D spend rebates, etc. So we really need to get that in place I think to close something. It will take up to 3 months to get orphan status. We want to start immediately.

NFT's posts are his usual negative fiction he has been spouting for the last 18 months.

I am on Telegram group and DG did not discuss or mention funding, although one person asked, to which Dan just replied ‘Obviously keeping things lean and focused on moving the company forward’. (I assume it would be price sensitive information and so he could say nothing more).

Another possible way to consider the situation is:

That family skiing holidays (with wife and three kids) are usually booked some time in advance.

That a pre-arranged holiday can be worked into whatever schedule Dan had for BD activities/ discussions.

I fail to see that it shows anything about the status of discussions.

It appears the accident occurred on friday and Dan was out of hospital by Sunday and flew home yesterday, so hopefully the accident is not too bad and Dan is fairly robust.

Dan has rescheduled his telegram chat to 5pm today - so he is off and running again.

'I don't think they've been ongoing since 2019. I'm not even convinced they've been in discussions at all.

They won't reveal who they were talking to even after the talks have stopped.'

ForFXSake - you don't seem to understand NDA's (Non-disclosure agreements).

They have almost certainly been in place and prevent ANY disclosure during or after any discussions have ended. So Nuformix could not disclose who they have been talking to, even after talks have eneded, without risking severe penalties and likely killing any talks with other potential pharma's .

I understand your frustration with timescales - your not alone on that.

Hopefully with the data they now have any current discussions will soon produce a half decent deal.

ATB

As an investor here, I have also been wondering why the sp has not risen with the continued good news for such a world-class graphite mine.

Are potential big investors worried about the many new developments in battery technology that are currently being reported, especially with respect to achieving fast charging and long battery life, and that many of these developments seem to be using totally different materials. Indeed some of these new systems dispense with cobalt, lithium and/ or even graphite altogether or at least reduce their need considerably!

It seems, if I believe the news reports, that some of these new systems are already in pre-production.

So there is a big question-mark over the materials needed in the near-future for battery manufacture. The Blencowe mine is some years from being operational and things could change before then.

Its a worry I have as an investor.