Nuformix plc (LON:NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, has announced, further to the Company’s announcement on 11 August 2025 regarding the Company’s application to the US Food and Drug Administration for Orphan Drug Designation 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 received a response from the FDA requesting further clarification for one specific element of the application.
As previously announced, as part of the ODD application process the FDA can request further information. The Company will submit a response to the FDA as soon as possible using existing data and information in the Company’s possession. Upon further review the FDA will issue a designation confirmation letter, a request for more information or a denial. Further announcements will be made in due course, as appropriate.
Dr Dan Gooding, Executive Director, Nuformix, said: “We will respond to FDA using the data we already have on file, having previously had a similar query from the EMA. I remain confident the process will reach a successful conclusion and whilst we await the FDA’s further response we continue to progress discussions with potential future licensing partners and will provide further updates in due course as appropriate.”
Nuformix plc also announced the results of its underwritten Open Offer to Qualifying Shareholders which was announced on 28 October 2025 and closed for acceptances, in accordance with its terms, on 11 November 2025.
The Company announces that valid acceptances have been received from Qualifying Shareholders for a total of 465,813,047 Open Offer Shares, representing a take-up of approximately 408.5% of the 114,040,535 Open Offer Shares available.
All Qualifying Shareholders who have validly applied for Open Offer Shares will receive their full Basic Entitlement. Applications for Open Offer Shares under the Excess Application Facility will be scaled back on a pro-rata basis, with the same scaling methodology to be applied to each Shareholder who applied for Excess Entitlements. Accordingly, subject to Admission becoming effective, 114,040,535 Open Offer Shares will be issued in connection with the Open Offer, raising approximately £228,081 (before expenses) for the Company at the Issue Price of 0.2 pence per Open Offer Share.
Capitalised terms used but not otherwise defined in this announcement bear the meanings ascribed to them in the Circular posted to shareholders on 28 October 2025.
Director participation in the Open Offer
The Directors have participated in the Open Offer, as follows:
| Director | No. of Ordinary Shares currently held | % of Existing Ordinary Shares | Number of Open Offer Shares subscribed for | No. of Ordinary Shares held on Admission | % of the Enlarged Share Capital |
| Julian Gilbert | 22,250,000* | 1.11 | 1,271,428 | 23,521,428 | 1.11 |
| Daniel Gooding | 49,500,000** | 2.48 | 2,828,571 | 52,328,571 | 2.48 |
| Madeleine Kennedy | 22,250,000*** | 1.11 | 1,271,428 | 23,521,428 | 1.11 |
* held beneficially through Hargreaves Lansdown (Nominees)
* 37,500,000 of which are held beneficially through Interactive Investor Services and 12,000,000 of which are held through Hargreaves Lansdown (Nominees)
*** held beneficially through a nominee appointed by the trading platform, IG Trading and Investments Ltd
The notifications below, made in accordance with the requirements of the EU Market Abuse Regulation (2014/596/EU) as it forms part of United Kingdom domestic law by virtue of the European Union (Withdrawal) Act 2018 and as modified by or under the European Union (Withdrawal) Act 2018 or other domestic law, provides further detail.
Admission and dealings
The Open Offer Shares will, when issued, be credited as fully paid and will rank pari passu in all respects with each other and with the Existing Ordinary Shares, including the right to receive all dividends and other distributions declared, made or paid after the date of Admission. Application has been made to the FCA for the Open Offer Shares to be admitted to the equity shares (transition) category of the Official List in accordance with Chapter 22 of the UKLR and to the London Stock Exchange plc for such Open Offer Shares to be admitted to trading on the London Stock Exchange’s main market for listed securities (“Admission”). Dealings in the Open Offer Shares and Admission are expected to take place on or around 8.00 a.m. on 13 November 2025.
Total voting rights
In accordance with the Financial Conduct Authority’s Disclosure, Guidance and Transparency Rules, the Company confirms that following Admission, the Company’s enlarged issued ordinary share capital will comprise 2,109,749,903 Ordinary Shares. The Company does not hold any shares in Treasury. Therefore, from Admission, the total number of voting rights in the Company will be 2,109,749,903 and this figure may be used by shareholders in the Company as the denominator for the calculations to determine if they are required to notify their interest in, or a change to their interest in the Company, under the Disclosure Guidance and Transparency Rules.
