Nuformix Regulatory News (NFX)

27 March 2023

Nuformix plc

("Nuformix" or the "Company" or the "Group")

NXP002 Update

Nuformix plc (LSE: NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, is pleased to announce the following update regarding the Company's NXP002 programme, a proprietary new form of tranilast, being developed as a novel inhaled treatment for Idiopathic Pulmonary Fibrosis ("IPF").

The Company recently announced the commencement of studies using a new iteration of a 3D human IPF lung tissue model - a high-challenge, disease and species relevant pre-clinical model with its partner, Fibrofind. Advancements within this model were designed to significantly reduce output variability. The Company has now received results from these studies of NXP002 alone and in combination with current standards of care ("SoC"), and they 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 effect as demonstrated by modulation of the release of multiple biomarkers of fibrosis;

· Both high and low concentrations of NXP002 show an additive anti-fibrotic 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 pre-clinical models to date; and

· The clear, pronounced additive benefit of NXP002 on top of SoCs observed suggests that NXP002 will 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 response.

Overall, the results provide further support of NXP002's potential to increase efficacy of existing therapies with the benefits of inhaled delivery (e.g. added efficacy without increased side effects). They also support NXP002's potential as a monotherapy for patients declining SoCs - a meaningful proportion of IPF patients who choose against the side effects of SoCs, which impact quality of life.

Following the success achieved in these studies the Company's next steps include:

· Investigation of inflammation-related biomarkers in the same tissue sample sets to confirm additional mechanistic and anti-inflammatory benefits on top of SoC's, given the positive anti-fibrotic response;

· Expansion of the current study to include tissue from an additional two further human IPF tissue donors to demonstrate the robustness of NXP002's anti-fibrotic response alone and in SoC combinations in multiple patients; and

· To consider the expansion of the Company's on-going healthy lung tissue study investigating NXP002's duration of action to three donors, based on results when received.

Understanding the performance of new IPF therapies with SoC's has become critical to both potential development partners and regulators. Therefore, the Company believes completion of these steps is required for Nuformix to secure the interest of out-licensing partners.

Results will continue to be generated with further updates announced when appropriate.

Commenting, Dr Dan Gooding, Executive Director of Nuformix, said: "All parties are delighted with the results from this study, which are as good as we could have hoped for and are the first results from what is the most advanced iteration of this 'close to patient' IPF disease model to date. The reduced variability in the resulting data allows us to have high confidence in both NXP002's anti-fibrotic activity alone, but also in the added anti-fibrotic performance it can deliver on top of existing standards of care. Additivity to standard of care is the most important aspect because it's the simplest option to investigate in a clinical study and is therefore fast becoming a top priority for potential licensing partners. Having seen the quality of these results, our aim now is to generate datasets from three donors in both human IPF and healthy lung duration of action studies. These data can be generated quickly and will be essential in opening up new discussions with potential licensing partners and support overall progression of the NXP002 programme."

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About Nuformix

Nuformix is a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing. The Company aims to use its expertise in discovering, developing and patenting novel drug forms, with improved physical properties, to develop new products in new indications that are, importantly, differentiated from the original (by way of dosage, delivery route or presentation), thus creating new and attractive commercial opportunities. Nuformix has a pipeline of preclinical assets with potential for significant value and early licensing opportunities.

About Fibrosis

Fibrotic disease is typically associated with high patient mortality, increasing prevalence and a lack of safe and effective treatments. Whilst fibrosis treatments are in their infancy the emerging lung fibrosis market demonstrates their blockbuster potential. Idiopathic Pulmonary Fibrosis is classified as a rare disease and presents a global commercial market that is forecast to grow to $5bn by 2025. Sales of standard-of-care therapies OFEV and Esbriet achieved $2.58bn and $1.04bn respectively in 2021.