Member Info for Jiving

I agree completely, it is the first time I have seen the critical "reverse disease/restore tissue function" emphasised to this degree. This is a potentially massive advantage over the inhaled IPF drugs being developed in the US by Avalyn & United Therapeutics. The fact we are now over halfway through the critical US FDA Orphan process is highly relevant to our marketability/valuation.

There was a single patient study carried out in Japan at the height of Covid that supports that statement. This used oral Tranilast rather than our (unavailable!) inhaled version. The conclusions of the study were:

1. Pulmonary fibrosis is one of the inconvenient complications of COVID-19 pneumonia.

2. We report a case of hypoxemic patient after COVID-19 pneumonia was successfully treated with antifibrotic agent tranilast.

3. Six months of tranilast administration showed remarkable amelioration of lung fibrosis and recovery of the patient’s lung function.

https://academic.oup.com/qjmed/article/115/4/249/6545300

You are right Soup, this is an excellent presentation. It is only 7 pages & highly recommended for any investors or potential investors.

It makes clear that NXP002 has an impact on all 4 'pathways' that trigger the disease. IMO it makes it at least as compelling as a standalone as Avalyn's combined AP03, which is a combination of their inhaled pirfenidone and nintedanib drugs. So although I see Avalyn as the best fit as a partner it also makes it very attractive to other players such as United Therapeutics, Roche & Boehringer.

Finally point 4 on P2, "Potential to reverse disease/restore tissue function' - this of course is the 'Holy Grail' of IPF treatment to not simply halt the fibrotic process but to reverse it & restore healthy lung tissue.

https://www.rns-pdf.londonstockexchange.com/rns/7219A_1-2025-9-24.pdf

Nibj. An awful lot of shares have changed hands in block trades over the last 2-3 months in a narrow band around 7.5p. Sellers have been matched with buyers to not disturb the price/market, & the consequence is a significant change of ownership (& voting rights) is likely taking place.

The big trades for the last couple of month have all taken place (as we have observed) in a narrow band around 7.50p, I would suggest one or more sellers are being matched with buyers at this level.

A 4.4m trade at 7.50p has just gone through. Like the other large trades we have seen recently, this went through without disturbing the market, I suspect these are 'matched' trades with a broker matching buyer & seller at a price & then passing the trade through the market.

It doesn't feel like a regular PnD, with large trades taking place 0.13-0.14. But equally its not the frenetic trading that takes place prior to a long awaited deal.

As per my Sunday posts, I am cautiously optimistic the FDA application could cause a partner to finally agree terms, and we could get a deal prior to an FDA decision.

There are some interesting large trades going through the market the last couple of days.

"As long as COPL remains suspended and not delisted, related parties still have a direct way to return value to shareholders if they choose, without needing to involve third parties."

Would Arthur Millholland be one of those "related parties" who would "return value to shareholders"?

2. Avalyn is a very well financed VC backed biotech that has raised just under $400 million in different staged financings with many of the top names in the investing & Pharma industry (including Glaxo & Novo subsidiaries). They just closed on 22 July 2025 a new US$100 million funding (oversubscribed) giving them a war chest.

3. They are regular attendees at industry/investor conferences. At the end of last month they released news that their CEO & CFO would be attending the Morgan Stanley Health Conference beginning Monday 8 September - meeting 1 on 1 with investors/partners but also giving a presentation/taking questions - a 'Fireside Chat'. https://www.globenewswire.com/news-release/2025/08/25/3138403/0/en/Avalyn-to-Participate-in-Multiple-Upcoming-Investor-Conferences-in-September.html

Given the importance of getting a licensing deal, there has been surprisingly little discussion of who the most likely candidates might be. I went back through the various RNS's and related materials and also worked from the list of competing IPF drugs listed in the Allenby research reports.

The one clear giveaway as to the identity was this phrase of Dan's in the funding RNS of 20.09.24 "....as we strive to reach a conclusion with a specialist development partner, who like us are keen to improve the treatment of IPF and PPF via inhalation." The key indicators I take from this are 'specialist' rather than a 'general' pharma, meaning potentially a specialist in IPF treatment and/or co-crystal/repurposed drugs. Also specifically 'inhaled' suggests a company already targeting IPF via inhaled rather than oral drugs.

Going through the list of possibilities one company stands out as essentially ticking all the boxes, and also very interestingly has flashed a couple of green lights in the last couple of months. The company is Avalyn Pharma, a specialist US biotech company focussed on repurposing existing IPF drugs to be delivered in inhaled form. Their two key drugs (going through Phase 1 & 2 trials already) are AP01 an inhaled version of pirfenidone & AP02 an inhaled version of nintedanib - the two main existing oral treatments for IPF. These of course are the two drugs NXP002 essentially enhances, as well as adding an additional pathway for treating the disease.

Given Avalyn are a specialist biotech specialising in repurposing drugs why don’t they create their own patented version of inhaled tranilast? Well maybe they were, but the NFX patent family - that has been created but not RNS’d - essentially stops that approach. Nuformix’s patent family, including US20240075023A1, protects the use of inhaled tranilast, alone or in combination with pirfenidone and/or nintedanib, for fibrotic diseases. This creates a defensive strategy, potentially blocking competitors like Avalyn from developing similar combinations without licensing from NFX.

Below I list the recent developments that indicate Avalyn is the most likely candidate partner that may have been haggling over terms for the last 18 months. This may now have come to a head with the filing of the ODD application with the FDA. Any partner seeking to incorporate NXP002 in a combination treatment would likely wish to fine tune the application & the ODD benefits to its specific future plans/needs. That means halting or joining the application in its early stages.

1. Avalyn has announced a 'new' drug AP03 that is a combination therapy consisting of AP01 & AP02 ie a potential 'blockbuster' inhaled treatment for IPF. This is currently in pre-clinical Phase 1 evaluation.

The most relevant clock I see ticking is the forthcoming annual Morgan Stanley Global Healthcare held this year in New York on 8-10 September. This is an important get-together of biotech companies, financiers & big pharma, as such its a prime time to announce a deal - doubly so when our most likely partners are themselves US VC backed.

The United Therapeutics Tyvaso Phase 3 trial results on Tuesday, & mentioned by Soup, added some $4.5 billion to the company's market cap the next day. Now of course, that reaction is after successful Phase 3 clinical results for a major established company, but it shows the positive sentiment among US investors for inhaled IPF drugs. As a major pharma pursuing an inhaled approach to IPF they are one of our most likely suitors & they are not short of a few bob.

Would the significant trades we have observed the last couple of months meet that definition of ‘orderly market provisions’ ?

There is a lot of unexplained stuff going on. A lot changed with Glencores departure, some of it clearly positive like releasing 80% of offtake, but the shareholder base & arithmetic also changed & is now consequentially more uncertain.

NIBJ, it may come down to having the funds to do that or maybe they wanted him to continue as Chairman? There was a similar 6 month lockup provision in the 2022 agreement with Glencore regarding their ZIOC shares, at that time it was assumed it was to stop them from walking.

Mitch, I think you are onto something here. The clear reason Elphick had disposal restrictions placed on him is because the new significant owners - Greymont Bay - feared/suspected he would bailout otherwise. So why would the guy who actually set up & brought the company into creation want to do that, what is he worries about? Remember Glencore bailed out entirely at 4.16p in March 2025 - having paid 5.25p for a tranche on 1 July 2024 - if its such a sure thing why would they do that?

I am quite optimistic we may get a licensing deal in September. The FDA application on 11 August will draw out potential licensees who would like to withdraw/amend/refine the application to suit their specific requirements/aims, they would need to do that in the early (say first 30 days) of the application. Of course if no deal emerges in September, as per the May prospectus, we will likely need to raise again in October. Truly a binary situation - I note the Morgan Stanley Annual Global Healthcare Conference 2025 will take place 8-10 September 2025 in New York - an excellent IR/PR time for an announcement.

With regard to de-listing, Elphick specifically blocked Glencore from doing this. The detailed document that set out the basis for the EGM vote on the 2022 Glencore deal included the following block on any de-listing attempt, see P20. Section 5.3 Relationship Agreement:

"Glencore Projects has also agreed to certain restrictions regulating the manner in which Glencore Projects exercises its voting rights in the Company including restricting Glencore Projects from using its shareholding to requisition a general meeting of the Company for the purposes of proposing any resolution to de-list the Shares from trading on AIM."

I cannot find any equivalent agreement with Greymont Bay .

Or is that the post of a man with a deal in his pocket?

I take it this was the snippet:

"2024 alone saw two HUGE drug repurposing deals - look at Karuna Therapeutics and Calliditas. $bn deals for drugs discovered in years with a 19- at the front! The perception that these concepts are not developable is fundamentally wrong - there are absolutely routes to regenerating IP and meaningfully differentiating drug performance. You just have to know how ;)"

This is the email of the longstanding company nomad, I get the impression he is diligent:

scott.mathieson@liberum.com