Nuformix plc

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

Half year Report

14 December 2021: Nuformix plc (LSE: NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, announces its unaudited results for the six months ended 30 September 2021.

Operational highlights (including post-period end)

Financial Highlights

Dr Alastair Riddell, Executive Chairman of Nuformix, said: "The new positive data sets on NXP002, patent progress on NXP004 and the licensing deal for NXP001 form the basis for further value creation in the next 12 months. Both our current lead assets address billion-dollar markets in fibrosis and oncology. The results have given the Board the confidence to progress further work on our products and investment in additional business development resource for the Company."

Dr Anne Brindley, CEO of Nuformix, said: "We have made significant progress on all three of our assets including successfully completed the licensing deal for NXP001 with Oxilio, as well as significantly advancing the data package on NXP002 that has shown positive data to date and filing a new patent application on NXP004. We have achieved this with very prudent use of funds ensuring the Company is on a firm financial footing for the foreseeable future. Although regretfully I am moving on from Nuformix, I remain very optimistic that Nuformix has assets of value that the Group can advance to further develop the company and I wish the Board and the company much success in these endeavours."

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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 an early-stage pipeline of preclinical and Phase 1-ready assets with potential for significant value and early licensing opportunities.

Nuformix plc shares are traded on the London Stock Exchange's Official List under the ticker: NFX. For more information, please visit www.nuformix.com.

Executive Chairman's statement

Operational review

NXP002 (new form of tranilast) - Idiopathic Pulmonary Fibrosis (IPF)

NXP002 is the Group's pre-clinical lead asset and a potential novel inhaled treatment for IPF. It is a proprietary, new form of the drug tranilast, to be delivered in an inhaled formulation. IPF is a devastating lung disease associated with a higher mortality rate than many cancers and where there is a need for additional treatment options. Thus IPF represents a high unmet medical need and a significant commercial opportunity. Tranilast has a long history of safe use as an oral drug for allergies but there is evidence that supports its potential in fibrosis, including IPF. NXP002 is differentiated as it is a new form of tranilast that is being formulated for delivery direct to the lungs by inhalation, a new route of administration for this drug. The inhalation route is a well-known strategy for treatment of lung diseases to yield greater efficacy and reduce systemic side-effects compared to oral treatment. Nuformix has filed two patent applications on new forms of tranilast, one of which is granted globally and a second has been issued (granted) in the USA. The positioning of such an inhaled treatment for IPF could be either added to standard of care or administered as a monotherapy.

Within the last six months, since the fundraise in March 2021, the Group has utilised these proceeds to generate a robust data package with the goal of increasing the value of this asset and rendering it more attractive to licensing partners. The Company has successfully progressed studies on NXP002 as follows:

Overall, the Board is encouraged by the progress of the studies and the positive data generated to date and is considering next steps, including potential further R&D studies to add further value and licensing activities.

NXP001 (new form of aprepitant) - Oncology

NXP001 is a proprietary new form of the drug aprepitant that is currently marketed as a product in the oncology supportive care setting (chemotherapy induced nausea and vomiting). A disadvantage of aprepitant is that its sub-optimal properties necessitate a complex formulation. The Group has discovered new forms of aprepitant (NXP001) with improved properties and it has been granted patents on these new forms. Literature data suggests that aprepitant could have benefits in oncology, i.e., beyond the currently marketed indications.

To date, the Group has conducted preclinical studies and a Phase 1 study, which demonstrated bioavailability of NXP001, similar to the marketed product but without requiring a complex formulation. Further refinement of the formulation will be required ahead of initiating any future Phase 1 studies.

On 23 September 2020, Oxilio, a privately held pharmaceutical development company, was granted a six-month option to license NXP001 globally for repurposing in oncology. On 23 March 2021, Oxilio exercised the option and on 10 September 2021 a global license deal was executed. As a result, Nuformix has licensed its patent estate and know-how on NXP001 in return for an upfront payment, development milestones and a royalty on net sales, capped at £2 million per annum.

NXP004 (new forms of undisclosed drug) - Oncology

The Group has discovered novel forms of an undisclosed marketed oncology drug that is approved globally for the treatment of several cancers, which has significant sales (more than £1 billion per annum in 2020) and is showing further sales growth. The Group filed one patent application in September 2020 on new forms of this drug and has utilised certain of the proceeds from the March 2021 placing to do further research on novel forms. This research has been successful, identifying a new family of co-crystal forms and on 10 November 2021, post period, the Company filed a second patent application. This application complements the previous patent application on NXP004 co-crystals, thus expanding the Company's intellectual property portfolio. If the patent applications on these new forms are granted, there is potential for patent expiry to extend to 2040/2041. The Group will seek to license NXP004 to the originator of the marketed drug to potentially extend their patent protection, thus potentially adding significant value for the originator.

Board changes

In the period from April 2021 to September 2021 a number of Board changes have occurred:

On 1 December 2021 Dr Alastair Riddell was appointed as Executive Chairman to ensure there is a suitable executive in place for when Anne Brindley leaves the Company.

Outlook

The success of the fundraise earlier in the year has enabled the Company to continue to advance and exploit the current assets within the portfolio through additional R&D and business development activities as set out above. R&D studies have progressed successfully on both NXP002 and NXP004, while business development activities secured the license agreement for NXP001 and therefore good progress has been made on all fronts. Moreover, the successful fundraise has provided a good cash runway for the Company to fund limited operations for the foreseeable future.

The strategy of the Group is to continue to increase the value of its existing assets while maintaining tight control of costs, including conducting business development / licensing activities using a structured and data-driven approach, with the goal of seeking global licensing deals. The positive data from the R&D studies performed in the last six months has increased the Board's confidence that the Nuformix assets have significant value and thus further investment in and progression of these assets are warranted.

Financial Review

In the first half of the financial year, the Board has continued to focus expenditure on R&D activities that add value to the current assets while optimising the operation to minimise administrative expenditure and the operational cost-base. Revenue was received from the second instalment of the upfront payment from Oxilio on execution of the full licensing agreement for NXP001.

Dr Alastair Riddell

Executive Chairman

14 December 2021

Nuformix plc

Unaudited Interim Results

Consolidated Income Statement and Statement of Comprehensive Income for the six months ended 30 September 2021

Nuformix plc

Registration number: 09632100

Unaudited Interim Results

Consolidated Statement of Financial Position as at 30 September 2021

Nuformix plc

Unaudited Interim Results

Consolidated Statement of Changes in Equity for the six months ended 30 September 2021

Nuformix plc

Unaudited Interim Results

Consolidated Statement of Cash Flows for the six months ended 30 September 2021

Nuformix plc

Unaudited Interim Results

Notes to the Consolidated Financial Statements for the six months ended 30 September 2021

1. Basis of preparation of interim financial information

The consolidated interim financial statements have been prepared in accordance with the recognition and measurement principles of International Accounting Standards as endorsed by the UK Endorsement Board ("IAS").

On 31 December 2020, IFRS as adopted by the European Union at that date was brought into UK law and became UK-adopted International Accounting Standards, with future changes being subject to endorsement by the UK Endorsement Board. The Group transitioned to UK-adopted International Accounting Standards in its consolidated financial statements on 1 April 2021. Whilst this change constitutes a change in accounting framework, there is no impact on recognition, measurement or disclosure.

The consolidated interim financial statements are unaudited and do not constitute statutory accounts within the meaning of Section 434 of the Companies Act 2006. Statutory accounts for the year ended 31 March 2021, prepared in accordance with IAS, have been filed with the Registrar of Companies. The Auditors' Report on these accounts was unqualified and included a reference to which the Auditors drew attention by way of an emphasis of matter, without qualifying their report, that a material uncertainty existed that might cast significant doubt on the Group's ability to continue as a going concern at that time. The Auditors' Report did not contain any statements under section 498 of the Companies Act 2006.

The consolidated interim financial statements are for the 6 months to 30 September 2021.

The consolidated interim financial information does not include all the information and disclosures required in the annual financial statements, and should be read in conjunction with the group's annual financial statements for the year ended 31 March 2021, which were prepared in accordance with IFRS as adopted by the European Union.  As explained above, although this was a different accounting framework, there is no impact on recognition, measurement or disclosure. 

2. Basis of consolidation

On 16 October 2017 the Company acquired the entire issued ordinary share capital of Nuformix Technologies Limited and became the legal parent of Nuformix Technologies Limited. The accounting policy adopted by the Directors applies the principles of IFRS 3 (Revised) "Business Combinations" in identifying the accounting parent as Nuformix Technologies Limited and the presentation of the Group consolidated statements of the Company (the legal parent) as a continuation of financial statements of the accounting parent or legal subsidiary (Nuformix Technologies Limited).

3. Going concern

The consolidated interim financial statements have been prepared on the going concern basis of preparation which, inter alia, is based on the directors' reasonable expectation that the Group has adequate resources to continue to operate as a going concern for at least twelve months from the date of their approval. In forming this assessment, the directors have prepared cashflow forecasts covering the period ending 31 March 2023 which take into account the likely run rate on overheads and research expenditure and the prudent expectations of income from its lead programmes.

Whilst there can be no guarantee of the successful outcome of future trials, in compiling the cashflow forecasts the directors have made cautious estimates of the likely outcome of such trials, when income might be generated and have considered alternative strategies should projected income be delayed or fail to materialise. These strategies include postponing non-committed research expenditure, securing alternative licensing arrangements from those currently planned and using the Group's established network for fundraising.

These circumstances indicate the existence of a material uncertainty which may cast significant doubt on the Group's ability to continue as a going concern.  The consolidated interim financial statements do not include any adjustments that would result if the company or Group was unable to continue as a going concern.

After careful consideration, the directors consider that they have reasonable grounds to believe that the Group can be regarded as a going concern and, for this reason, they continue to adopt the going concern basis in preparing the consolidated interim financial statements.

4 Loss per Share

Loss per share is calculated by dividing the loss after tax attributable to the equity holders of the Group by the weighted average number of shares in issue during the period.

The basic earnings per share for each comparative period is calculated by dividing the loss in each of those periods by the legal entity's historical weighted average number of shares outstanding.

For impairment testing purposes, management consider the operations of the Group to represent a single cash-generating unit ("CGU") focused on research and development. Consequently, the goodwill is effectively allocated and considered for impairment against the business as a whole being the single CGU.

7. Share Capital

Allotted, called up and fully paid shares

8 Share Options and Warrants

The Group operates share-based payments arrangements to remunerate directors and key employees in the form of a share option scheme. Equity-settled share-based payments are measured at fair value (excluding the effect of non-market-based vesting conditions) at the date of grant. The fair value determined at the grant date of the equity-settled, share-based payments and is expensed on a straight-line basis over the vesting period, based on the Group's estimate of shares that will eventually vest and adjusted for the effect of non-market based vesting conditions.

Statement of Directors' Responsibilities

We confirm that to the best of our knowledge:

1.    this interim condensed set of financial statements has been prepared in accordance with UK adopted IAS 34 'Interim Financial Reporting';

2.    the interim management report includes a fair review of the information required by:

2.1.  DTR 4.2.7R of the Disclosure Guidance and Transparency Rules, being an indication of important events that have occurred during the first six months of the financial year and their impact on the condensed set of financial statements; and a description of the principal risks and uncertainties for the remaining six months of the year; and

2.2.  DTR 4.2.8R of the Disclosure Guidance and Transparency Rules, being related party transactions that have taken place in the first six months of the current financial year and that have materially affected the financial position or performance of the entity during that period; and any changes in the related party transactions described in the last annual report that could do so.

The directors of Nuformix plc are listed in the Group's 2021 Annual Report and Accounts and the current board are set out on the Investors Information section of Nuformix's website at: Investors Information - Nuformix

Dr Alastair Riddell

Executive Chairman

Further copies of this document are available from the company's registered address and will be available on the company's website later today.

Nuformix plc

Registration number: 09632100