Nuformix Annual Results 2025: NXP002 Progress and Going Concern Uncertainty

Nuformix 2025 results: NXP002 advances, cash tight, and going concern flagged

Nuformix’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 scientific and regulatory progress in IPF and PPF

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.

• Delivery: Drug can be nebulised at the optimum droplet size for deep-lung deposition; very high doses appear well tolerated in vivo.
• Efficacy signals: A clear inhaled dose-response across inflammation and fibrosis biomarkers, consistent with earlier ex vivo work.
• Human tissue data: In ex vivo human IPF lung tissue (precision-cut lung slices), NXP002 was well tolerated and showed strong anti-fibrotic and anti-inflammatory effects.
• Add-on potential: At both high and low concentrations, NXP002 added to current SoC, with higher concentrations plus SoC delivering a near complete ablation of fibrosis biomarker release.
• Anti-inflammatory punch: Suppression of inflammatory cytokines by over 90% across all cytokines studied.
• Duration: A robust effect still present 12 hours post-dose in healthy human lung tissue challenged ex vivo, supporting a twice-daily target product profile.

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.

Orphan Drug Designation in Europe; FDA response pending

Regulatory momentum is building:

• EMA granted Orphan Drug Designation (ODD) in IPF on 29 May 2025, unlocking EU incentives including 10 years of market exclusivity, protocol assistance and fee reductions.
• An FDA ODD application was filed on 11 August 2025. The FDA requested clarification on one element on 12 November 2025; the company responded and awaits a further response. If successful, US ODD brings potential tax credits, a PDUFA fee waiver and seven years’ exclusivity on approval.

Partnering remains the core strategy

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:

• Assessing the likely inhaled human therapeutic window.
• Continuing to prosecute key NXP002 IP.
• Refining clinical development strategy, timelines and costs with external experts.
• Progressing discussions “with multiple parties” toward a licence, option or co-development agreement.

Timeline for any deal is not disclosed.

Market context: big need, big market, high discontinuation

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.

Financial highlights: fewer losses, very limited cash

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.

Fundraisings and dilution

• 4 November 2024 placing and subscription: £300,000 gross at 0.05 pence per share. A share capital reorganisation was required as the issue price was below the previous nominal value. The new shares represented 42% of the enlarged share capital.
• 11 February 2025 subscription: £168,750 gross at 0.0675 pence.
• 30 May 2025 placing: £210,000 gross at 0.07 pence.
• Post period end 11 November 2025 open offer: £228,081 gross at 0.2 pence.

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.

Audit focus: material uncertainty on going concern

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.

Pipeline beyond NXP002: useful options, low near-term spend

NXP004 (novel olaparib forms)

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.

NXP001 (new form of aprepitant)

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.

Intellectual property: NXP002 protection strengthened

• Substance of matter: Grants now issued in the US, Japan and Europe for the proprietary NXP002 drug form.
• Method of use: US grant on 14 June 2024 for treatment of various diseases including fibrotic lung diseases.
• Compositions for treatment: In national phases and progressing through examination.

My take: promise versus purse

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.

What to watch next

• FDA Orphan Drug Designation outcome for IPF – decision pending.
• Any partnering/licensing update for NXP002 – counterparties not disclosed, timing not disclosed.
• Data readouts refining the inhaled human therapeutic window – details not disclosed.
• Cash runway actions – further fundraises or cost steps.

Bottom line for retail investors

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.