Loading…
Nuformix advances NXP002 for lung fibrosis with EU orphan status, but auditors flag going concern risk as cash runs low.
This article covers information on Nuformix PLC.
LON:NFXNuformix’s annual results for the year to 30 September 2025 are all about one thing: NXP002. The company has doubled down on its inhaled tranilast programme for idiopathic pulmonary fibrosis (IPF) and related lung diseases, while keeping the rest of the pipeline on a slow simmer. The science reads well; the balance sheet is thin. Here’s what matters for investors.
NXP002 is a novel, patent-protected crystalline form of tranilast optimised for inhalation. The idea is simple: get the drug to the lungs directly and avoid the systemic side effects that drive high discontinuation rates for current standards of care (SoC) in IPF and progressive pulmonary fibrosis (PPF) – up to 80% in certain patient groups.
Mechanistically, an in-depth pharmacology review suggests NXP002 may regulate four disease-driving pathways, including TGF-β, WNT/β-catenin and NLRP3. Those latter two are increasingly implicated in fibrosis progression, so this is useful contextual colour for partner discussions.
Regulatory momentum is building:
Nuformix’s model is to advance to value inflection and out-license. The board’s stated top priority is securing a business development partner for NXP002. Current priorities include:
Timeline for any deal is not disclosed.
IPF and PPF are devastating diseases with a median survival of 3-5 years. The IPF market is forecast to reach US$6.4 billion by 2031. Nintedanib (OFEV) did EUR3.8 billion in 2024; pirfenidone (Esbriet) peaked at USD1.2 billion in 2020 before generics. An effective inhaled add-on or alternative with better tolerability would be commercially meaningful.
| Metric | FY25 | FY24 |
|---|---|---|
| Revenue | £0 | £0 |
| Loss after tax | £652,586 | £3,641,487 |
| Loss per share | 0.04p | 0.46p |
| Cash at bank (30 Sep) | £97,550 | £20,210 |
| Net assets (30 Sep) | £754,934 | £715,571 |
| R&D spend | £95,325 | £70,910 |
There was no revenue in the year. Losses narrowed largely due to the prior year’s £3.14 million goodwill impairment not repeating. Operating costs remain lean given the virtual model.
Multiple small raises have kept the lights on but at the cost of material dilution. The company is candid that further fundraising will be required to allow time to conclude NXP002 business development discussions.
The auditor explicitly highlights a material uncertainty over going concern. At 30 September 2025, cash was £97,550. The November 2025 open offer added £228,081 gross, but this is not enough for 12 months of operations. The group is currently reliant on a single product, NXP002, and future funding has not been secured.
Mitigations include cost controls and directors electing not to take salaries until sufficient funds are available. However, the auditor notes that without a commercial agreement for NXP002, goodwill (£882,784) and the parent company’s investment value (£882,784) could ultimately be worth nil, and the group would not be a going concern.
Nuformix has discovered olaparib cocrystals with superior in vitro dissolution versus the marketed Lynparza, with potential to enhance bioavailability and simplify manufacturing. A US patent (No. 12012386) was granted on 14 June 2024. This is not a current priority, but it is being maintained for future line-extension or first-to-generic opportunities.
Nuformix sold its NXP001 patent portfolio to Oxilio in September 2023, retaining the right to milestones and royalties capped at £2 million per year. Oxilio is fundraising to progress development. No income was received in FY25.
On the positive side, NXP002 is showing consistent preclinical signals across models that matter, including ex vivo human IPF tissue, with compelling add-on efficacy to SoC and a tidy twice-daily profile. EU ODD is a meaningful de-risking step for partnering. IP looks robust and expanding.
On the negative side, cash is very limited, revenue remains at zero, and the auditor’s going concern warning is clear. The strategy depends on landing a partner or raising fresh capital. Shareholders have already absorbed substantial dilution through multiple low-priced placings.
Nuformix is a classic high-risk, high-reward small-cap biotech. The scientific narrative around NXP002 is strengthening and the ODD in Europe helps. But the company needs a deal or more capital to survive the next 12 months. If a partner arrives, the risk-reward could flip quickly. If not, the going concern risk is real. Position sizing and patience apply.
Related
Polar Capital Technology Trust sees 102% NAV growth in FY2026, beating its benchmark by 47 points thanks to AI and semiconductor exposure.
JoshuaJuly 10, 2026
Impax Q3 AUM rises to £23.3bn despite £1.7bn net outflows, driven by market gains and strong investment performance.
JoshuaJuly 10, 2026
MJ Gleeson FY2026 trading update: steady profits, mixed home sales with operational restructuring improving outlook.
JoshuaJuly 10, 2026
Last updated
Category
InvestingViews
50 viewsLikes
No ratings yet
No comments yet - start the conversation.