11 August 2025

Nuformix plc

("Nuformix" or the "Company")

US FDA Orphan Drug Designation Application Submitted for NXP002 Programme in IPF

Nuformix plc (LSE:NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, is pleased to announce, further to the Company's announcement on 29 May 2025, that the European Medicines Agency ("EMA") had granted Orphan Drug Designation ("ODD") in Idiopathic Pulmonary Fibrosis ("IPF") for tranilast, the active drug substance enabled for inhaled delivery in Nuformix's NXP002 lead programme, that the Company has now submitted an application to the US Food and Drug Administration ("FDA") for ODD in the United States using FDA Form 4035.

The components required for the submission of Form 4035 included:

•     information about Nuformix and the drug product;

•     description of the rare disease or condition of interest, along with reasons why such therapy is needed;

•     scientific rationale for the use of the drug for the rare disease or condition;

•     a summary of the regulatory status and marketing history of the drug in the United States and in other countries; and

•     documentation to demonstrate that the disease or condition meets qualifications to be a rare disease, defined as a disease or condition affecting fewer than 200,000 individuals in the United States.

The FDA will now review the application and, within 90 days of receipt, issue a designation letter, a request for more information or a denial.

If ODD is granted, Nuformix may be eligible for certain benefits such as tax credits for clinical trials or qualified clinical testing costs, a waiver of the Prescription Drug User Fee Act application fee when a marketing application is submitted, and the potential to receive seven years of marketing exclusivity upon product approval.

The Company is also pleased to confirm that constructive discussions continue with a number of potential partners with a view to the Company securing an out-licence or option agreement for NXP002.

Dr Dan Gooding, Executive Director, Nuformix, said: "We are very pleased to have submitted the FDA ODD application following confirmation that Orphan Drug Designation has been granted for our NXP002 programme in IPF in the EU by the EMA. Whilst we await the FDA's response we continue discussions with potential future licensing partners and will provide further updates in due course as appropriate."

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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 IPF

IPF is a chronic lung disease characterised by progressive tissue scarring that prevents proper lung function. It is a progressive, fatal, age-associated lung disease affecting approximately three out of every one hundred thousand people in Europe. IPF typically presents in adults 65 or older and is usually fatal within two to five years after diagnosis.