Nuformix Regulatory News (NFX)

27 June 2022

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 provide an update in relation to the Company's NXP002 asset, a new form of tranilast and a potential novel inhaled treatment for Idiopathic Pulmonary Fibrosis ("IPF").

The Company has previously generated positive data on NXP002, demonstrating that:

- NXP002 can be formulated in a simple and stable solution suitable for inhaled delivery via nebulisation;

- NXP002 formulations for nebulisation can be efficiently delivered to the lung; and

- NXP002 can dose-dependently regulate the production of mediators relevant to lung fibrosis and inflammation following a lipopolysaccharide ("LPS") challenge.

However, as announced on 30 May 2022, no conclusions could be drawn from an additional study undertaken to investigate the duration of action of NXP002 formulations.

The Company has now initiated further studies as it continues to generate a robust pre-clinical data package to support the progression of NXP002, both in terms of product development and business development discussions. These studies will directly address issues faced in the duration of action studies. Firstly, the Company will investigate a new formulation of NXP002 for inhalation, delivered using an alternative method designed to ensure consistent and controlled exposure is achieved. Secondly, the Company will explore a new range of doses to best optimise efficacy of treatment.

The eventual aim of the studies is to confirm the formulation's positive pharmacological profile towards the treatment of lung fibrosis and inflammation via inhalation and to assess its duration of action. The studies will begin in August 2022 with results generated throughout H2 2022 as development milestones are achieved. Data from these inhalation studies will add to the Company's current compelling pre-clinical dataset, to best support the development of NXP002 as a treatment for IPF and potentially other poorly treated fibrosing interstitial lung diseases. Further updates will be announced in due course, as appropriate.

Commenting, Dr Julian Gilbert, Non-executive Director of Nuformix, said: "NXP002 is our lead programme and after the frustrations of the study undertaken earlier this year from which no conclusions could be drawn, I am pleased that we are back on track to investigate the product opportunity further. The planned programme of studies is intended to ensure we have a robust pre-clinical data package for NXP002 to support the further progression of this asset. I look forward to providing further updates in due course as we progress."

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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 US$8.8bn by 2027. Sales of standard-of-care therapies OFEV and Esbriet achieved US$2.5bn and US$1bn respectively in 2021.