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Interesting short video/transcript. Expiring IP in rest of this decade will drive Biotech M&A:
https://citywire.com/funds-insider/news/ailsa-craig-big-pharma-has-a-problem-and-that-s-driving-biotech-manda/a2438448
Not likely to be. As I’ve said before MM’s don’t declare below 10%
...TR1 then?
Get your point Jiving.
Overall its a benefit to achieve orphan designation (fingers crossed they do so) as it definitely adds value of ten years market protection.
Hopefully we get confirmation that they have submitted the application.
You are correct Soup & I should have made my Orphan point in relation to IPF and not 'all' drugs. But I am just trying to get a discussion started on our chances of success, and if you include a whole list of qualifiers it reads like some dull legalistic prospectus or annual report.
Re-Chabs point - yes thats how I see it, first we needed a patent granting and only then can we apply for Orphan status. But also until you start approaching Pharmas to gauge their interest you cant find out what their JV parameters are at this particular point in time.
That said I would disagree with Jiving's generic comment 'It seems that Pharma's essentially require this as a necessary condition before examining whether to invest in a new drug.'
Given that orphan drugs are for rare disease only, by nature pharma's can't require orphan designation across the board otherwise all drugs would be orphan and no disease would be rare.
Personally I think it relates to the caution around repurposed drugs and wanting as much certainty around product protection as possible.
From the Allenby note 2 years ago.
'Note that many have Fast Track Designation and/or Orphan Drug Designation factors that can accelerate the review process and extend the period of market/data exclusivity and so this is also an option for NXP002. '
Since then the company has consistently said that they consider it an option.
I doubt you would seek orphan designation before patents are granted, as it would be strange to have the product protected as an orphan drug, but not patent protected.
Furthermore, with orphan designation you need to back up your claims with evidence so its seen as a validation of a drug rather than just patenting a method.
"It seems that Pharma's essentially require this as a necessary condition before examining whether to invest in a new drug."
And yet for years the company intimated discussions were on going. Yet this Orphan status has never been mentioned before.
Why if it's so very important?
From Dan's Telegram explanation I see the critical event in the next 12 months to be getting (or not) the grant of Orphan drug designation by the EMA for NXP002. It seems that Pharma's essentially require this as a necessary condition before examining whether to invest in a new drug. It provides them with two benefits - first, an objective third party has examined a new drug & deemed that it has potential - an important independent vindication, essentially 'for free'. Second, it provides real tangible benefits in terms of market exclusivity & access that provide tangible long term financial benefits & therefore directly impact IRR.
I was very impressed by the lengthy Allenby research report on NFX a few years ago, which set out a probabilistic valuation model for small biotech companies like NFX. This struck me as being the crux of the matter - getting a deal or not is entirely up to the whims & decision making processes of third parties. My unscientific probabilistic take of NXP002's likelihood of success over the next 12 months is - without EMA Orphan status less than 10%; with EMA Orphan status, south of 50:50 but north of one third - call it 40%.
What is the moral of Sisyphus?
Existentialism in The Myth of Sisyphus | Overview & Analysis ...
The moral of "The Myth of Sisyphus" is that there is no greater meaning in life but what we give it. When we accept that the universe has no inherent meaning or reason, we can be free of artificial expectations and embrace the absurd.
Think my average is 1p down from 4p. Not sure it is worth averaging down. What exactly are we expecting in the next 12 months? Seems very vague.
I think there are a few of us that are there or there abouts now.
ATB
I'm in at the placing price.
Christ on a bike…. Even Sisyphus didn’t have to suffer this fate.
"Or maybe, as those words were written in December"
Your words, I think.
‘If those words were written in December’
Well since the finals were issued at 7am on 3 January, I’m wondering what basis you have of saying ‘if’ they were written in December. Or perhaps you think they were written on New Year’s Day?
The point about the agm is, if you really cared you’d find the time. Nobody here can answer all your questions, and yet when you have the opportunity to ask them yourself to management you turn it down.
Your posting history shows you’re not that busy.
If those words were written in December then it just seems odd that 12 months resources no longer satisfy the likely run rates on expenditure? Things must have changed quite alot in the last couple of months?
Anyway orphan status seems to be the key now and that doesn't cost anything but time that we should already have budget for (3 months from now is early June). I'm just confused as to why they didn't wait until we knew the outcome of that before diluting shareholders holdings even more.
As for the AGM, there doesn't seem much point in taking time out of a busy schedule to ask questions if things are so fluid. Probably better to wait and see what happens with orphan progress or maybe see what comes out of the next Telegram session.
One of the big positives FX, is that the agm is just over two weeks away so you can ask Dan in person then.
Or maybe, as those words were written in December, the original plan was for outlicensing, but discussions over the past two months have led to fund raising happening first whilst orphan designation and nxp002 is progressed.
"..prudent expectations of income from out-licensing rights to its programmes OR a fundraising"
Well there's the fundraiser....so I guess they're not expecting much income from outlicensing?
We'll see 3 months after they get around to applying for orphan status
"...the Directors have prepared cash fow forecasts covering the period ending 31 December 2024 that take into account the likely run rate on overheads and research and development expenditure and the prudent expectations of income from out-licensing rights to its programmes or a fundraising."
Yes Chab, I also seem to vaguely recall reading words about having enough money to see us through for a while, something along the lines of:
"However, it is the Directors' reasonable expectation that the Group has adequate resources to continue to operate as a going concern for at least twelve months from the date of the approval of the accounts. In forming this assessment, the Directors have prepared cashflow forecasts covering the period ending 31 December 2024"
Ah well, the more the merrier, eh?
As for yesterday's question from Older: "Why not a subscription for existing shareholders?".
I think the question might have been a little naive. Do you not think long term shareholders can be a bit high maintenance? They tend to stick around, expect results and remember all the stuff that was promised and never delivered. Why go cap in hand to them if you can get money from more ethereal sources that appear to be able to profit from a quick exit without the need to get bogged down filing unnecessary notification paperwork? That sounds like a win - win to me.
PS. I also heard someone mention in recent posts that the board had stopped taking remuneration until the company was in a position to afford it. I'm not sure it's accurate to say it was entire board. However, it's a very noble gesture from those who have taken the hit:
"In addition, the non-executive directors have elected not to take payment of their salaries until such time as the business holds sufficient funds to enable them to do so."
Thanks again to Older for sharing what he heard at the recent Telegram trader huddle. One thing I think that did stand out from that was the importance of gaining orphan status if we want any kind of a meaningful deal with big pharma. That means we should all know whether or not this really has legs in about 3 months...and if we don't get it, well, maybe we can discharge the upkeep of any future costs of the patent estate in some other way.
Chab, not sure where anyone was saying funded through 2024.
My commentary was from the 30m odd sales a few weeks ago, my assumption being the conversion of the warrants which would net 85k to the company.
Might get some when they drop to 20p or shall i wait longer nft.
Dan and Jo hold 75 hasnt changed they will see it through and you
will be sitting without a ticket 🤣
No Redshoes 👞
That’s not why they have only done 10%. And yes you were saying they had plenty of funds to last.
Simply if they tried more the price would been a lot lower and the risk for those who will be dumping those shares over coming months will struggle.
Every year now this share has a large holding being dumped. When that finishes they will then raise the next tranche and so on. Sort of like Lanstead but just more conventional and easier.
I may have picked this up wrong, and apologies if it's incorrect, but wasn't it just a few weeks ago that folk were saying we were funded til end of 24? And therefore didn't need a raise ?
ATB