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This just for 002

Then we have 004

NPX004 - blockbuster potential

The Group discovered novel forms of olaparib, a drug currently marketed by AstraZeneca, as Lynparza®. Lynparza® was first approved in December 2014 for the treatment of adults with advanced ovarian cancer and deleterious or suspected deleterious germline BRCA mutation. Since then, it has secured similar approvals in breast, pancreatic and prostate cancers with further trials on-going.

These approvals have propelled Lynparza® sales to US$2.6bn in 2022 with industry analysts forecasting annual sales of US$9.7bn by 2028.

Subsequently, further preformulation and in-vitro studies allowed Nuformix to identify lead cocrystals to be progressed for further development.

Results from in vitro dissolution studies demonstrated that the two lead NXP004 cocrystals OUT PERFORMED Lynparza®, both in terms of rate and extent of dissolution and release of olaparib.

Enhancement of dissolution in the currently marketed formulation of Lynparza® resulted in improved bioavailability versus the initial marketed product.

Therefore, NXP004 may offer potential to further increase olaparib's bioavailability. In addition, the potential simplicity of NXP004-based formulations may offer improvements in product cost-of-goods versus the currently marketed product, which requires complex manufacturing methods.

These attributes position NXP004 for applications in line-extensions for the currently marketed product, or for possible development in future first-to-generic product opportunities.This work will direct and support future out-licensing discussions for NXP004.

The Company's NXP004 programme is focused on the development of novel, proprietary, cocrystal forms of olaparib, a drug currently marketed by AstraZeneca, under the Lynparza® brand name.

On 14 June 2024 the US Patent and Trademark Office ("PTO") has granted the Company patent number 12012386 covering the lead cocrystals under development, representing the first granted patent in this second NXP004 cocrystal series.

Dr Dan Gooding, Executive Director of Nuformix, said: "I'm delighted we've received these multiple grants of key patents underpinning both our NXP002 and NXP004 programmes. The European patent grant represents the last major territory to confirm protection of the novel drug forms enabling NXP002's development as a potential novel IPF treatment. Granting of the method of use patent in the US further strengthens our IP position for this programme. The US PTO's decision to grant the patent protecting the NXP004 programme's lead cocrystals is also a first, with other territories soon to follow. The granting of these patents is very helpful and timely in progressing on-going discussions with potential development partners

Modulation of the release of multiple biomarkers of fibrosis and inflammation;

both high and low concentrations of NXP002 show an additive anti-fibrotic and anti-inflammatory effect to SoC;

in particular, the higher concentrations of NXP002 with SoC's deliver a near complete ablation of fibrosis biomarker release, yet at lower concentrations than have been seen in other preclinical models to date; and

the clear, pronounced additive benefit of NXP002 on top of SoCs observed suggests that NXP002 may provide additional efficacy, even in patients responding to SoC therapy.

This raises the possibility that NXP002 targets additional disease pathways to SoC's when increasing the combined anti-fibrotic and anti-inflammatory response. Following success in suppressing biomarkers of fibrotic disease progression in human IPF lung tissue, the same samples were analysed to assess additional mechanistic and anti-inflammatory benefits on top of SoC's and the results are summarised as follows:

NXP002 alone delivers a strong, consistent anti-inflammatory effect as demonstrated by suppression of the release of inflammatory cytokines by over 90% for all cytokines studied; and

the results further suggest that NXP002 may provide additional efficacy in combination with SoC's, even in patients not responding to SoC therapy alone.

Patents secured to protect the rights in

USA

Japan

Europe

The patents offer the opportunity for worldwide sales and as such the company could tie up a global deal package with potential annual sales of over $1bn made up of eligible patients of

USA 10,000 @ £50k+

Japan 4,000 @ £40k+

Europe 11,000 @ £25k+

Global deal now patents secured potential for hundred of million $ to NFX came

hTTps://nuformix.com/app/uploads/2021/06/Allenby-Initiation-Note-March-2021.pdf

Page 29 valuation

Bottom paragraph

Global sales deal $360 - 450mâ€�

Commercial discussions have been ongoing for some time, due to the amount of monies at stake and the number of different options to be discussed with each interested party- upfront payments and milestones, royalty payments but at a company valuation of £700k with discussions at an advanced stage now looks an opportunity to buy or add

£2.5 mkt cap

Listed for £12m

Recent IPF deal

hTTps://www.fiercebiotech.com/biotech/eli-lilly-pushes-pulmonary-fibrosis-99m-deal-mediars-midphase-prospect

NPX002

Lead project

NXP002 is the Group's preclinical lead asset and a potential novel inhaled treatment for IPF and PPF and possibly other fibrosing ILDs. NXP002 is a proprietary, new form of the drug tranilast. NXP002's enhanced physical property profile uniquely delivery to the lung in an inhaled, smart nebuliser formulation.

IPF and PPF are devastating lung diseases associated with a higher mortality rate than many cancers with median survival of 3-5 years. Thus, IPF and PPF represent a high unmet medical need such that the requirement for improved treatment options represents a significant commercial opportunity. IPF is classified as a rare disease and presents a global commercial market that is forecast to grow to US$8.8bn by 2027. Sales of standard-of-care ("SoC") therapies OFEV and Esbriet (now off patent) achieved US$3.5bn and US$0.8bn respectively in 2022.

The inhalation route is a well-known strategy for the treatment of lung diseases to yield greater efficacy and reduce systemic, off-target side-effects compared to oral treatment. Discontinuation of treatment in IPF and PPF patients is currently an issue in the treatment of these diseases with discontinuation rates for current SoCs up to 80% in certain patient groups due to their debilitating systemic side-effects. Effective inhalation therapies offer the potential to overcome these limitations of oral therapies.

NXP002 as a potential treatment for IPF, is a likely candidate for Orphan Drug Designation, which could provide additional product protection against potential future competitors in addition to product development advantages. Draft application submitted and initial Meeting expected this month Jan 25.

The positioning of NXP002 as an inhaled treatment for IPF and PPF could be either as added to SoC treatments or administered as a monotherapy for patients non-responsive to SoCs and those declining these therapies due to side effects which impact quality of life.

The Group's pre-clinical inhalation development strategy has significantly progressed NXP002 towards validation of its Target Product Profile ("TPP") demonstrating:

NXP002 can be delivered in-vivo by a range of nebulisers at the optimum particle size for delivery to the deep lung;

high doses appear to be well-tolerated; and

an in-vivo inhalation dose response was observed for inflammatory and fibrotic biomarkers that is consistent with ex-vivo human IPF tissue studies to date.

The Group conducted studies in a new iteration of a 3D human IPF lung tissue using a disease and species relevant model that has been advanced to significantly reduce output variability. The results from these studies of NXP002 alone and in combination with current SoCs, can be summarised as follows:

NXP002 is well tolerated in ex-vivo human lung tissue with no signs of toxicity events;

NXP002 alone delivers a strong, consistent anti-fibrotic and anti-inflammatory effect as demonstrated by modulation o

Seemed to be last 30mins of trading, maybe RNS logged , timing would also fit

So we await Update on ODD for NPX002 we know it's based on translit that already has ODD so hopefully all good, then we look forward to a conclusion of commercial discussions with interested parties

Recent update 002

April 2025

Dr Dan Gooding, Executive Director, Nuformix, said: "The PCLS lung tissue model has become the gold-standard disease model thanks to various close-to-patient benefits. We believe the dataset we have generated, in what we believe is one of the largest IPF patient tissue sample sets studied, gives us great confidence in NXP002. In what is a highly variable and heterogenous disease, to see such consistent activity across all donors towards pro-fibrotic mediators in both IPF and autoimmune ILD is impressive. The emergence of data supporting additional activity towards Col1A1 overexpression is exciting because this profile would be in contrast to high-potency, single target therapeutics, whose activity may negatively impact healthy tissue repair processes, leading to increased risk in long term use as observed in numerous recent IPF clinical studies. For patients with ILD's of an autoimmune origin, given such patients' background systemic therapies, an inhaled approach towards treatment would be highly advantageous in both development and treatment. We are excited by the results and continue discussions with potential partners, who also see advantages in NXP002 in terms of therapeutic optionality and future product positioning. I look forward to providing further updates in due course."

hTTps://www.lse.co.uk/rns/NFX/nxp002-update-j6igat9vm9jkrvi.html

Reminder what’s on offer

Current mkt cap £2.5m

IPO

NFX came to the market with a reverse takeover of Leverett plc at a price of £12m

Opportunity

Basement level opportunity with blue sky upside on a successful deal with NPX002 or NPX004, commercial discussions ongoing.

NPX001

on 18 September 2023, the Company announced that Oxilio had acquired ownership of its NXP001 patent estate for which Nuformix received new immediate and near-term undisclosed milestone payments, whilst retaining further development milestones and royalties capped at £2 million per year.

Some initial payments will received but more substantial payments were expected but havent materialised and I believe the company may be looking at selling the royalty

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