Nuformix advances NXP002 as EMA backs Orphan Drug status

Nuformix plc

Nuformix plc (LON:NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, has announced its unaudited results for the six months ended 31 March 2025.

Operational highlights (including post-period end)

·    The Board continues to believe NXP002 offers a potentially significant treatment of progressive fibrosing interstitial lung diseases (ILDs), including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), and is focused on generating data and initiating and further developing discussions with potential partners to support its efforts to secure a licensing or option agreement for NXP002

·    Post-period, data from previous studies of NXP002 in a precision-cut lung slice (PCLS) disease model using tissue explanted from lung-transplant receiving patients with IPF and autoimmune-related ILD were reanalysed as a consequence of on-going discussions with potential licensing and development partners for NXP002. Positive effects were seen

·    Post period, received notification from the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) of its positive opinion regarding Orphan Drug Designation (ODD) in Idiopathic Pulmonary Fibrosis (IPF) for tranilast, the active drug substance enabled for inhaled delivery in NXP002

 Financial Highlights

·    Loss on ordinary activities (after tax credit) of £376,668 (31 March 2024: loss of £242,529)

·    Loss per share 0.03p (31 March 2024: 0.03p)

·    Net assets of £807,653 (31 March 2024: £4,102,051) including £97,911 of cash and cash equivalents at 31 March 2025 (31 March 2024: £183,523)

·    A subscription for 160,000,000 new ordinary shares at a price of 0.05 pence per share raised gross proceeds of £300,000 completed in November 2024

·    A subscription for 250,000,000 new ordinary shares at a price of 0.0675 pence per share raised gross proceeds of £168,750 in February 2025

·    Post period on 14 April 2025, ‘broker’ warrants were exercised for a total consideration to the Company of £13,200

Dr Dan Gooding, Executive Director of Nuformix, said: “Our research efforts and external discussions to date demonstrate that inhaled treatment of IPF and related fibrotic lung diseases via NXP002 is a viable and attractive concept. Post period we were delighted to receive news of the COMPs positive opinion regarding NXP002’s eligibility for Orphan Drug Designation in IPF. The EMA’s procedure for awarding ODD status involves considerable scientific scrutiny. Therefore, the opinion serves as powerful independent third-party validation of NXP002’s underlying scientific rationale and existing data supporting its potential efficacy in treating fibrotic lung diseases such as IPF. We remain focused on generating data and initiating, and further developing, discussions with potential partners that will support our efforts to secure out-license deals on NXP002. I am excited by our future prospects and look forward to providing further updates in due course as appropriate.”

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