Member Info for Jiving

Link for these rumours please:

"If Rumours of AstraZeneca as one of the potential partners in discussions to progress with NXP002 is confirmed."

It looks to me like Dan is likely reacting to feedback from potential partners i.e. undertaking the updated tissue data analysis & possibly applying for orphan status in the US. He is clearly trying to both add value to the asset via orphan status benefits & seeking to present our existing results in the best possible light - realistically what else can he do given our very limited financial resources?

Confirmation of European ODD for NXP002

And stunning volume - over 400m traded today. A 300m placing (only some 15% of share capital btw) is long gone.

Fourprinces great spot today. One reason they may not be issuing an RNS for the ratification is that it is going to be accompanied by other critical news. For example, the company has to submit an application for Orphan Drug Designation to the U.S. Food and Drug Administration (“FDA”) using FDA Form 4035, which requires "..a summary of the regulatory status", thus they may well have had to wait for formal ratification from the EU before submitting their ODD application. So the fact they have not immediately issued an RNS on the EU news may actually be positive, we will find out....

And if you go to the 'Patent Family' on that WIPO link you can see that 4 patents from NFX regarding combination therapy were filed on 28.02.22, with 2 being published in 2023 & one in January of 2025. Highlights the importance of this combination approach to IPF treatment & the need to protect the IP with multiple US patents. It all seems to be falling into place in the US timing-wise: the patent publication; the presentation at the ATS last week; & the filing of an application for ODD status with the FDA (which has 90 days to respond).

So the WIPO link is for an additional patent (published 22.05.25 - so last week) regarding combining tranilast for the treatment of IPF with either pirfenidone or nintedanib. Have they been waiting to get this US patent in place, prior to applying for ODD status in the US?

Link as spotted by MillonAir below:

https://patentscope.wipo.int/search/en/detail.jsf?docId=US456549720&_cid=P21-MB6J0C-43010-1

Poolberg Pharma (POLB) have just announced they received notification from the FDA of orphan status ‘ODD’ for POLB001. Interestingly they have had a similar bumpy ride to NFX, with their share price down sixfold in the last 12 months prior to today's announcement, which sent the share up around 80% to over 4p. A couple weeks ago - like us - they also announced a placing at a price at 2.5p. It shows that once the placing is out of the way, the share price can react appropriately to positive news without fear of an imminent placing.

The company pointed out the following implications in addition to the legal, financial& marketing advantages of ODD:

“This ODD further validates POLB 001's scientific rationale and data which, if approved, has the potential to revolutionise cancer immunotherapy delivery by making it safer, enabling outpatient administration, reducing healthcare burden, and ultimately expanding patient access to these breakthrough immunotherapies.”

“ODD strengthens POLB 001's commercial appeal for prospective partners and the Company sees potential for partnering on positive data from its Phase 2a trial.

Jeremy Skillington, CEO: “We were delighted to receive Orphan Drug Designation from the FDA, which is a significant development for Poolbeg and for POLB 001, one that we believe will enhance the commercial appeal for prospective partners and help bring POLB 001 to the market faster.”

Surely its already a done deal, the placees will have sold forward their allotment well in advance & will simply use their allotment to cover those sales.

OSD I agree with your points. One to add is that with this placing out of the way we will have funds to last us till 2026. Which means the company will not have the threat of a placing hanging over it for the rest of the year. Which could lead to investors who have been on the sidelines taking positions. Let's face it the only practical alternative to not doing a placing would have been to go into administration, which would be crazy given the positive news around the orphan status in Europe & shortly the US.

I wonder how many biotech investors attend this type of event. It would surely be an excellent way of gauging hot areas & companies. From our perspective having just secured European orphan status, we are just about to apply for US orphan status via the FDA (a 90 day process) & Dan is presenting at a showcase US medical congress. Suddenly there is an interesting US domestic theme emerging & we are crazy cheap relative to any likely deal revenue. Looking at the various advisory bodies there are a sprinkling of financial participants involved - private equity & financial advisors;

https://conference.thoracic.org/program/ris/planning-committee.php

https://conference.thoracic.org/program/ris/advisory-board.php

It good timing to be presenting at a major US conference, having just received ODD from the European COMP, & having announced we will be applying for orphan status with the FDA.

OSD, it is a phenomenon across the whole AIM/smaller co sector from what I can see. Five years ago critical developments like getting ODD status & even applying for the US equivalent, would have led to a jump in the share price. But now the market awaits actual deal news & pretty much ignores everything else. It is frustrating but it is the new reality across the whole smaller company sector.

And given the pharma industry will be well aware that once the EMA approves orphan status it is highly likely the FDA will follow suit; applying for US orphan status could precipitate partnership interest in advance of the actual approval.

The FDA commits to giving a decision on orphan status within 90 days of application. My hunch is they are awaiting formal EU Commission approval of the ODD (which could come as early as next week, given recent COMP/Commission approval times). The EU, US & Japan have synchronised many aspects of the orphan drug process including standardising applications - the EMA is reckoned to be the toughest to obtain - so the FDA should be granted some time in the summer.

Begins this coming Friday 16 May. Dan mentioned in his last interview that he will be attending this. The critical US market could be all coming together quite nicely over the next few months, particularly once we get orphan status from the FDA.

I wonder if they are waiting for the European Commission's formal ratification before applying to the FDA?

Hopefully, US biotech investors will appreciate how crazily undervalued we are at this stage in the process.

Directors talk interviews dot com first 3 words as one

thats ok ffx my clarification wasn't aimed at anyone in particular just distancing myself from the 'insider' angle which was not my description.

more importantly here is the link to the explanatory dan interview on the benefits of the odd decision:

https://www.***************************/nuformix-plc-ema-backs-orphan-status-for-nxp002-in-pulmonary-fibrosis-breakthrough-video/4121194808

Because I was describing those involved in the UK listed smaller company sector as a whole, which clearly includes AIM as well as smaller companies listed on the main board like NFX.