Half-year Report

Nuformix PLC

18 June 2024

 

Nuformix plc

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

Half Year Report

18 June 2024: 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 31 March 2024.

Operational highlights (including post-period end)

·    The Board continues to be encouraged by the positive data generated to date on NXP002 in context to the evolving treatment landscape and understanding of future patient needs in the treatment of fibrosing interstitial lung diseases. Preliminary discussions have been initiated with potential partners and are on-going.

·    Notice of Allowance was received for the Japanese National Phase Patent Application No. 2020-555115 for NXP002 entitled "CRYSTALLINE TRANILAST SALTS AND THEIR PHARMACEUTICAL USE" which has now formally granted. Notice of Allowance has also been received from the European Patent Office for the European National Phase Application, with formal granting complete. This patent describes proprietary new forms of tranilast being progressed by the Company as NXP002 as a potential novel idiopathic pulmonary fibrosis ("IPF") treatment. These proprietary drug forms uniquely enable drug delivery via an inhaled nebulised formulation.

·    Just prior to the beginning of the period, on 18 September 2023, the Company announced that Oxilio had acquired ownership of its NXP001 patent estate for which Nuformix received new immediate and near-term undisclosed milestone payments, whilst retaining further development milestones and royalties capped at £2 million per year.

·    During the period the Company received proceeds from the Company's subscription and associated sharing arrangements with Lanstead Capital Investors L.P. ("Lanstead"). The sharing agreements ended in October 2023, concluding this arrangement and the Company is due no further funds from Lanstead.

·    A subscription for 75,000,000 new ordinary shares at a price of 0.20 pence per share raised gross proceeds of £150,000, representing approximately 9.2 per cent. of the Company's enlarged issued share capital.

 Financial Highlights

·    Loss before tax of £242,529 (31 March 2023: loss of £337,622)

·    Loss on ordinary activities (after tax credit) of £242,529 (31 March 2023: loss of £337,622)

·    Loss per share 0.03p (31 March 2023: 0.05p)

·    Net assets of £4,102,051 (31 March 2023: £4,228,204) including £183,523 of cash and cash equivalents at 31 March 2024 (31 March 2023: £259,259)

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. 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 and NXP004. Progression of these opportunities is being achieved using existing funds thanks to a lean operational model, which will continue to operate until our R&D and targeted partnering activities require further resource. I am excited by our prospects for the remainder of the year and look forward to sharing results as they emerge."

Enquiries:

Nuformix plc
Dr Dan Gooding, Executive Director	Via IFC Advisory
Stanford Capital Partners Limited
Tom Price / Patrick Claridge (Corporate Finance)	[phone]
Bob Pountney (Corporate Broking)	[phone]
IFC Advisory Limited
Tim Metcalfe Zach Cohen	[phone] [e-mail]

About Nuformix

Nuformix is a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing. The Group aim use its expertise in discovering, patenting and subsequently developing and novel drug forms with improved physical properties, to develop new product opportunities that are differentiated from the original product (by way of dose, delivery route or presentation), thus creating new and attractive commercial opportunities. Nuformix has an early-stage pipeline of preclinical 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.

Chairman's statement

Operational review

NXP002 (novel proprietary forms of tranilast): Interstitial Lung Diseases ("ILDs") including Idiopathic Pulmonary Fibrosis ("IPF") and Progressive Pulmonary Fibrosis ("PPF")

NXP002 is the Group's preclinical lead asset and a potential novel inhaled treatment for IPF and PPF and possibly other fibrosing ILDs. NXP002 is a proprietary, new form of the drug tranilast. NXP002's enhanced physical property profile uniquely delivery to the lung in an inhaled, smart nebuliser formulation.

There are more than 200 types of interstitial lung diseases ("ILD"), which are characterised by varied amounts of inflammation, scarring, or both, that damage the lung's ability to absorb oxygen. IPF is the most well-known form of ILD, affecting approximately 100,000 patients per year in the US. Progressive Pulmonary Fibrosis (PPF), previously referred to as Progressive Fibrosing ILD (PF-ILD), is a larger and even more poorly served segment of the ILD market, affecting more than 200k patients per year in the US.

IPF and PPF are devastating lung diseases associated with a higher mortality rate than many cancers with median survival of 3-5 years. Thus, IPF and PPF represent a high unmet medical need such that the requirement for improved treatment options represents a significant commercial opportunity. IPF 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 ("SoC") therapies OFEV and Esbriet (now off patent) achieved US$3.5bn and US$0.8bn respectively in 2022.

Tranilast has a long history of safe use as an oral drug for asthma, keloids and hypertrophic scarring, but while there is growing evidence that supports its potential use in other fibrotic conditions, including IPF, a combination of poor physicochemical properties, variable pharmacokinetics and challenging pharmacodynamics following oral delivery limit its potential use in ILDs. NXP002 is differentiated as it is a patent protected, novel form of tranilast that has been optimised for formulation and delivery direct to the lungs by inhalation, potentially overcoming the issues using tranilast orally as a chronic treatment for ILDs.

NXP002 as a potential treatment for IPF, is a likely candidate for Orphan Drug Designation, which could provide additional product protection against potential future competitors in addition to product development advantages.

The inhalation route is a well-known strategy for the treatment of lung diseases to yield greater efficacy and reduce systemic, off-target side-effects compared to oral treatment. Discontinuation of treatment in IPF and PPF patients is currently an issue in the treatment of these diseases with discontinuation rates for current SoCs up to 80% in certain patient groups due to their debilitating systemic side-effects. Effective inhalation therapies offer the potential to overcome these limitations of oral therapies.

The positioning of NXP002 as an inhaled treatment for IPF and PPF could be either as added to SoC treatments or administered as a monotherapy for patients non-responsive to SoCs and those declining these therapies due to side effects which impact quality of life.

The Group's pre-clinical inhalation development strategy has significantly progressed NXP002 towards validation of its Target Product Profile ("TPP") demonstrating:

• NXP002 can be delivered in-vivo by a range of nebulisers at the optimum particle size for delivery to the deep lung;

• high doses appear to be well-tolerated; and

• an in-vivo inhalation dose response was observed for inflammatory and fibrotic biomarkers that is consistent with ex-vivo human IPF tissue studies to date.

The Group conducted studies in a new iteration of a 3D human IPF lung tissue using a disease and species relevant model that has been advanced to significantly reduce output variability. The results from these studies of NXP002 alone and in combination with current SoCs, can be summarised as follows:

• NXP002 is well tolerated in ex-vivo human lung tissue with no signs of toxicity events;

• NXP002 alone delivers a strong, consistent anti-fibrotic and anti-inflammatory effect as demonstrated by modulation of the release of multiple biomarkers of fibrosis and inflammation;

• both high and low concentrations of NXP002 show an additive anti-fibrotic and anti-inflammatory effect to SoC;

• in particular, the higher concentrations of NXP002 with SoC's deliver a near complete ablation of fibrosis biomarker release, yet at lower concentrations than have been seen in other preclinical models to date; and

• the clear, pronounced additive benefit of NXP002 on top of SoCs observed suggests that NXP002 may provide additional efficacy, even in patients responding to SoC therapy.

This raises the possibility that NXP002 targets additional disease pathways to SoC's when increasing the combined anti-fibrotic and anti-inflammatory response. Following success in suppressing biomarkers of fibrotic disease progression in human IPF lung tissue, the same samples were analysed to assess additional mechanistic and anti-inflammatory benefits on top of SoC's and the results are summarised as follows:

• NXP002 alone delivers a strong, consistent anti-inflammatory effect as demonstrated by suppression of the release of inflammatory cytokines by over 90% for all cytokines studied; and

• the results further suggest that NXP002 may provide additional efficacy in combination with SoC's, even in patients not responding to SoC therapy alone.

Nuformix's TPP for NXP002 seeks twice daily inhalation administration. To assess NXP002's duration of action, the Group initiated work in an exploratory model in healthy human lung tissue. The model also bridges the Group's successful preclinical work across a variety of LPS-challenge studies. The results are summarised as follows:

• NXP002 suppresses the release of inflammatory cytokines by healthy human lung tissue following LPS challenge; and

• an anti-inflammatory effect remains at 12 hours post drug dosing demonstrated by continued suppression of the release of inflammatory cytokines following LPS challenge, confirming NXP002 has a duration of action that may support twice daily dosing.

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 to the programme and support on-going licensing activities.

NXP004 (novel forms of olaparib) - Oncology

The Group discovered novel forms of olaparib, a drug currently marketed by AstraZeneca, as Lynparza^®. Lynparza^® was first approved in December 2014 for the treatment of adults with advanced ovarian cancer and deleterious or suspected deleterious germline BRCA mutation. Since then, it has secured similar approvals in breast, pancreatic and prostate cancers with further trials on-going. These approvals have propelled Lynparza^® sales to US$2.6bn in 2022 with industry analysts forecasting annual sales of US$9.7bn by 2028.

Subsequently, further preformulation and in-vitro studies allowed Nuformix to identify lead cocrystals to be progressed for further development. Results from in vitro dissolution studies demonstrated that the two lead NXP004 cocrystals out-performed Lynparza^®, both in terms of rate and extent of dissolution and release of olaparib.

Enhancement of dissolution in the currently marketed formulation of Lynparza^® resulted in improved bioavailability versus the initial marketed product. Therefore, NXP004 may offer potential to further increase olaparib's bioavailability. In addition, the potential simplicity of NXP004-based formulations may offer improvements in product cost-of-goods versus the currently marketed product, which requires complex manufacturing methods.

These attributes position NXP004 for applications in line-extensions for the currently marketed product, or for possible development in future first-to-generic product opportunities. This work will direct and support future out-licensing discussions for NXP004.

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) initially exclusively licensed to Oxilio Limited ("Oxilio") for oncology indications. Oxilio has now acquired ownership of Nuformix's NXP001 patent estate. Nuformix retained rights to receive further development milestones and royalties capped at £2 million per year under the terms of the acquisition.

Outlook

The Company continues to advance and exploit the current assets within the portfolio through the R&D and business development activities as set out above.

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.

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.

Dr Julian Gilbert

Non-Executive Chairman

18 June 2024

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 condensed set of financial statements has been prepared in accordance with ASB's 2007 Statement Half-Yearly Reports;

3.    the condensed set of financial statements give a true and fair view of the asset, liabilities, financial position and profit or loss of the group and the undertakings included in the consolidation as a whole as required by DTR 4.2.4R; and

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

4.1.  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

4.2.  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 2023 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 Julian Gilbert

Non-Executive Chairman

18 June 2024

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

Nuformix plc

Registration number: 09632100

Unaudited Interim Results

Consolidated Income Statement and Statement of Comprehensive Income for the six months ended 31 March 2024

		6 months ending 31 March	6 months ending 31 March	18 months ending 30 September
		2024	2023	2023
		Unaudited	Unaudited	Audited
	Note	£	£	£
Revenue		-	-	-
Cost of sales		-	-	-
Gross profit		-	-	-
Total administrative expenses		(242,529)	(337,622)	(927,972)
Other operating income		-	-	-
Operating loss		(242,529)	(337,622)	(927,972)
Finance costs		-	-	-
Loss before tax		(242,529)	(337,622)	(927,972)
Income tax receipt		-	-	68,505
Loss for the period and total comprehensive income for the period		(242,529)	(337,622)	(859,467)
Loss per share - basic and diluted	4	0.03p	0.05p	0.12p

Nuformix plc Registration number: 09632100

Unaudited Interim Results

Consolidated Statement of Financial Position as at 31 March 2024

		31 March	31 March	30 September
		2024	2023	2023
	Note	Unaudited	Unaudited	Audited
		£	£	£
Assets
Non-current assets
Property, plant and equipment	5	-	-	-
Intangible assets	6	4,072,770	4,113,953	4,081,277
		4,072,770	4,113,953	4,081,277
Current assets
Trade and other receivables		31,136	128,547	66,857
Income tax asset		67,342	-	67,342
Cash and cash equivalents		183,522	259,259	202,548
		282,000	387,806	336,747
Total assets		4,354,770	4,501,759	4,418,024
Equity and liabilities
Equity
Share capital	7	819,309	709,309	744,309
Share premium		6,731,348	6,635,378	6,656,802
Merger relief reserve		10,950,000	10,950,000	10,950,000
Reverse acquisition reserve		(8,005,195)	(8,005,195)	(8,005,195)
Share option reserve		2,058,518	2,048,781	2,058,518
Retained earnings		(8,451,929)	(8,110,069)	(8,209,400)
Total equity		4,102,051	4,228,204	4,195,034
Current liabilities
Trade and other payables		252,719	273,555	222,990
		252,719	273,555	222,990
Total equity and liabilities		4,354,770	4,501,759	4,418,024

Nuformix plc

Unaudited Interim Results

Consolidated Statement of Changes in Equity for the six months ended 31 March 2024

	Share capital £	Share premium £	Merger Relief Reserve £	Reverse acquisition reserve	Share option reserve	Retained earnings £	Total £
At 30 September 2022	709,309	6,671,253	10,950,000	(8,005,195)	2,039,044	(7,772,447)	4,591,964
Loss for the half-year and total comprehensive income	-	-	-	-	-	(337,622)	(337,622)
Issue of share capital	-	(35,875)	-	-	-	-	(35,875)
Share and warrant based payment	-	-	-	-	9,737	-	9,737
As at 31 March 2023	709,309	6,635,378	10,950,000	(8,005,195)	2,048,781	(8,110,069)	4,228,204
Loss for the half-year and total comprehensive loss	-	-	-	-	-	(99,331)	(99,331)
Issue of share capital	35,000	25,724	-	-	-	-	60,724
Share issue costs	-	(4,300)	-	-	-	-	(4,300)
Share and warrant based payment	-	-	-	-	9,737	-	9,737
At 30 September 2023	744,309	6,656,802	10,950,000	(8,005,195)	2,058,518	(8,209,400)	4,195,034
Loss for the half-year and total comprehensive income	-	-	-	-	-	(242,529)	(242,529)
Issue of share capital	75,000	74,546	-	-	-	-	149,546
Share and warrant based payment	-	-	-	-	-	-	-
As at 31 March 2024	819,309	6,731,348	10,950,000	(8,005,195)	2,058,518	(8,451,929)	4,102,051

Nuformix plc

Unaudited Interim Results

Consolidated Statement of Cash Flows for the six months ended 31 March 2024

	6 months ending 31 March	6 months ending 31 March	18 months ending 30 September
	2024	2023	2023
	Unaudited	Unaudited	Audited
	£	£	£
Cash flows from operating activities
Loss for the year	(242,529)	(337,622)	(859,467)
Adjustments to cash flows from non-cash items:
Profit on sale of intangibles	-	-	(35,552)
Depreciation and amortisation	8,507	18,406	55,124
Income tax expense	-	-	(68,505)
Share and warrant based payment	-	9,737	31,854
	(234,022)	(309,479)	(876,546)
Working capital adjustments
(Increase) decrease in trade and other receivables	35,721	128,779	132,742
Increase (decrease) in trade and other payables	29,729	85,994	(14,870)
Cash generated from operations	(168,572)	(94,706)	(758,674)
Income taxes (paid)/received	-	-	162,442
Net cash flow from operating activities	(168,572)	(94,706)	(596,232)
Cash flows from investing activities
Proceeds from sale of intangibles	-	-	50,000
Net cash flows from investing activities	-	-	50,000
Cash flows from financing activities
Proceeds of share issue	149,546	(35,875)	284,685
Net cash flows from financing activities	149,546	(35,875)	284,685
Net (decrease)/increase in cash and cash equivalents	(19,026)	(130,581)	(261,547)
Cash and cash equivalents at start of period	202,548	389,840	464,095
Cash and cash equivalents at end of period	183,522	259,259	202,548

Nuformix plc

Unaudited Interim Results

Notes to the Consolidated Financial Statements for the six months ended 31 March 2024

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"), and are compliant with IAS34 "Interim Financial Reporting."

The Group prepares its accounts in accordance with applicable UK Adopted International Accounting Standards.

The accounting policies and methods of computation followed in the condensed consolidated interim financial statements are the same as those applied in the most recent annual report

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 30 September 2023, 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 condensed consolidated interim financial statements are for the 6 months to 31 March 2024.

The condensed 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 30 September 2023, which were prepared in accordance with UK adopted International Accounting Standards ("IFRSs").  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 December 2025 which take into account the likely run rate on overheads and planned research expenditure and the expectations of a further fundraise to be completed in H2 2024.

Whilst there can be no guarantee of the successful outcome of future studies, in compiling the cashflow forecasts the directors have made cautious estimates of the likely outcome of such studies, when a fundraise may complete and have considered alternative strategies should projected funding be delayed or fail to materialise. These strategies include postponing non-committed research expenditure, securing alternative licensing arrangements from those currently planned and additional corporate activity to support the business.

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.

	31 March	31 March	30 September
	2024 Unaudited £	2023 Unaudited £	2023 Audited £
Loss after tax	(242,529)	(337,622)	(859,467)
Weighted average number of shares	756,945,238	709,309,368	719,462,470
Basic and diluted loss per share	(0.03)p	(0.05)p	(0.12)p

5 Property, Plant and Equipment	Computer equipment	Total
	£	£
Cost or valuation
At 30 September 2022	1,561	1,561
At 31 March 2023	1,561	1,561
Disposals	(1,561)	(1,561)
At 30 September 2023	-	-
At 31 March 2024	-	-
Depreciation
At 30 September 2022	1,385	1,385
Charge	176	176
At 31 March 2023	1,561	1,561
On Disposals	(1,561)	(1,561)
At 30 September 2023	-	-
At 31 March 2024	-	-
Carrying amount
At 31 March 2023	-	-
At 30 September 2023	-	-
At 31 March 2024	-	-

6 Intangible Assets	Goodwill		Patents	Total
Cost	£		£	£
At 30 September 2022		4,023,484	364,576	4,388,060
At 31 March 2023		4,023,484	364,576	4,388,060
Disposals		-	(72,915)	(72,915)
At 30 September 2023		4,023,484	291,661	4,315,145
At 31 March 2024		4,023,484	291,661	4,315,145
Amortisation At 30 September 2022		-	255,878	255,878
Amortisation charge		-	18,229	18,229
At 31 March 2023		-	274,107	274,107
Amortisation charge		-	18,228	18,228
On Written Off			(58,467)	(58,467)
At 30 September 2023		-	233,868	233,868
Amortisation charge		-	8,507	8,507
At 31 March 2024		-	242,375	242,375
Net book value
At 31 March 2023		4,023,484	90,469	4,113,953
At 30 September 2023		4,023,484	57,793	4,081,277
At 31 March 2024		4,023,484	49,286	4,072,770

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

	31 March 2024 Unaudited		31 March 2023 Unaudited		30 September 2023 Audited
	No.	£	No.	£	No.	£
Ordinary shares of £0.001 each	819,309,368	819,309	709,309,368	709,309	744,309,368	744,309

On 1 March 2024, the company completed a capital increase through the issue of 75,000,000 shares of £0.001 each in a share placement at a price of £0.002 per share.

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.

 

END