N4 Pharma PLC - Interim Results

25 September 2025

N4 Pharma plc

("N4 Pharma" or the "Company")

Interim Results

N4 Pharma plc (AIM: N4P), the UK biotech developing Nuvec®, its proprietary drug delivery system to enable advanced nucleic acid therapies for cancer and other diseases, today announces its unaudited interim results for the six months ended 30 June 2025.

Highlights:

·    Reduced operating loss for the period to £470,216 (30 June 2024: £491,705) and R&D and general expenditure in line with budget.

·    Cash position remains strong, which at 30 June 2025 was £1,727,543 (30 June 2024: £1,204,946), following a successful placing in April 2025 to raise gross proceeds of £1,750,000.

·    Positive results from first in vivo efficacy study for N4 101 using an industry standard animal model of IBD showing a marked decrease in inflammation with both single and dual-loaded Nuvec® particles compared with controls across all key indicators of ulcerative colitis, including Disease Activity Index (DAI), colon length and body weight loss and a clear increase in efficacy using Nuvec® particles targeted to macrophages using mannose.

·    Appointment of Dr Alastair Smith as an independent Non-Executive Director in January 2025 and Edward Wardle as Non-Executive Director post period end.

·    World-class Senior Leadership Team established with leading expert consultants in drug development and research, commercial strategy and pharmaceutical manufacturing in May 2025.

·    Analysis of data from collaboration with world-renowned nonprofit R&D institute SRI International ("SRI") demonstrates the ability to specifically target cancer cells for the delivery of RNA using Nuvec®, which opens a massive market for targeted treatments in oncology.

·    Post-period collaboration with CMAC, based at the University of Strathclyde in Glasgow, to focus on advancing the Nuvec® platform towards clinical readiness and characterising additional dual-loaded Nuvec® preclinical candidates, both in vitro and in vivo.

Nigel Theobald, Chief Executive Officer of N4 Pharma plc, commented:

"The first half of the year has delivered strong progress with N4 Pharma's focus being on expanding the team to formalise the Company's data package with a view to securing commercial agreements with third parties, whilst advancing its lead preclinical programme, N4 101, and scoping out novel RNA drug development opportunities with Nuvec®.

"Following the Company's successful fundraising in April 2025, N4 Pharma is well placed to undertake the work required to hit key value inflection milestones, building on Nuvec's® proven ability in the use of oral and targeted drug delivery, two areas which represent, both in unison and individually, areas of massive commercial potential. The Company is delighted to have partnered with CMAC as a world-leading research institute in the field of nanoparticle drug delivery to further expand N4 Pharma's data to support deal-making and drug development."

Analyst briefing

An online briefing for analysts will be hosted by Nigel Theobald, Chief Executive Officer, at 9.30 am on Thursday, 25 September 2025, to review the interim results. Analysts wishing to attend should contact Sarah Hollins at Northstar Communications at sarah@northstarcommunications.co.uk.

Investor presentation

An investor presentation to cover the interim results will be held at 2.00 pm on Thursday, 25 September 2025. The presentation is open to all existing and potential shareholders, and questions can be submitted at any time during the live presentation.

Investors can sign up to Investor Meet Company for free and add to meet N4 Pharma plc via:

https://www.investormeetcompany.com/n4-pharma-plc/register-investor

Investors who already follow N4 Pharma plc on the Investor Meet Company platform will automatically be invited.

The information contained within this announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014 which has been incorporated into UK law by the European Union (Withdrawal) Act 2018.  Upon the publication of this announcement via Regulatory Information Service, this inside information is now considered to be in the public domain. 

- Ends -

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About N4 Pharma

N4 Pharma is a preclinical biotech company developing Nuvec®, its proprietary gene delivery system, to enable advanced therapies for cancer and other diseases.

RNA therapeutics are set to impact the treatment of a wide range of diseases and Nuvec® has several key advantages for RNA gene delivery including the ability to deliver multiple RNA therapies in a single particle, ease of manufacturing, protection of the RNA payload to allow for oral delivery, no unwanted immune response and excellent stability and storage.

N4 Pharma is building out its preclinical data set and working towards first-in-human clinical data to support significant licensing deals for its Nuvec® platform with gene therapy partners.

N4 Pharma's lead programme, N4 101, is an oral anti-inflammatory product for IBD which serves as a proof-of-concept programme showcasing all the benefits of the Nuvec® platform.

For further information on the Company visit www.n4pharma.com or sign up at https://investors.n4pharma.com/auth/signup.

Chairman's Statement

Half year financial results

I am pleased to report N4 Pharma's financial results for the six months ended 30 June 2025. During the period, £3,690 of revenue was generated by the Group (30 June 2024: £3,906).

The loss for the period was £470,216 (30 June 2024: £491,705) and in line with planned expenditure.

The Company's cash balance at 30 June 2025 was £1,727,543 (30 June 2024: £1,204,946), following a successful placing to raise gross proceeds of £1,750,000 in April 2025.

Operational update

The first half of the financial year has been about ensuring that the Company has the right team and finance in place to rapidly advance the Nuvec® platform with a view to securing commercial partners as quickly as possible. N4 Pharma has also continued the preclinical development of the Company's lead product, N4 101, following the first successful in vivo study results during the period, which confirmed that Nuvec® has the potential to deliver an oral inflammation therapeutic for the treatment of GI disorders, including Inflammatory Bowel Disease ("IBD") and Ulcerative Colitis ("UC").

N4 Pharma is increasingly aware of the strengths of Nuvec®, in particular its ability to target the RNA payload to specific cells, which is a key requirement for RNA therapeutics developers, and this has directed the Company's corporate strategy to deliver maximum value for shareholders. The Company believes that the ability to specifically target certain cell types is a major differentiator compared to other delivery systems.

The Company's resources will be focused in the near term on expanding N4 Pharma's data to support deal-making whilst continuing to advance N4 101 as a potential clinical candidate as well as a model system to exemplify Nuvec®'s key benefits. N4 Pharma is also carrying out initial work to identify further novel RNA therapeutic opportunities to expand the Company's in-house pipeline.

The key benefits of Nuvec® as a delivery platform are:

·    Its unique, patented spiky surface structure allows the loading of both DNA and RNA drugs and protects them from degradation;

·    It is relatively straightforward to manufacture and scale up;

·    It can be targeted to specific cells such as cancer and immune cells to reduce toxicities and broaden the range of applications of nucleic acid therapies;

·    In contrast to other delivery options such as viral vectors and lipid nanoparticles, which are known to evoke an immune response, the inert nature of Nuvec® nano-silica particles dramatically reduces immunogenicity at the concentrations used;

·    It is a straightforward process to load multiple siRNAs onto the same nanoparticle for combination therapies;

·    High loading capacity, efficient cellular uptake and endosomal release enables delivery of large numbers of RNA copies into each cell; and

·    Its protective capabilities allow for oral delivery of nucleic acid therapies.

Lead preclinical programme - N4 101, a potential oral treatment for inflammatory bowel disease (IBD)

Following the successful completion of in vitro profiling in December 2024, during the period under review, the Company completed its first in vivo study using an industry-standard mouse model of IBD. The study explored the therapeutic potential of orally administered Nuvec® particles loaded with siRNA alone and combined with mRNA.

Over a nine-day dosing period, mice with chemically induced acute IBD received single (siRNA) or dual (siRNA and mRNA) Nuvec®-loaded formulations with the Nuvec® particles modified to specifically target cells involved in gut inflammation. Samples were collected for analysis on day 15.

Key highlights from the study included:

·    Reduction in inflammation: both single and dual-loaded Nuvec® particles demonstrated marked improvements compared with controls across all key indicators of colitis, including Disease Activity Index (DAI), colon length, and body weight loss.

·    Marked increase in efficacy achieved with targeting: both the single and dual loaded Nuvec® combined with a targeting agent performed better and showed an even greater reduction in the inflammatory marker TNF alpha than the untargeted therapies.

·    Sustained therapeutic effect: six days after the final administration, both single and dual-loaded targeted Nuvec® particles showed a near complete reduction in TNF alpha levels in intestinal tissues.

·    Effective oral delivery: the study also provides clear in vivo evidence that Nuvec® particles successfully deliver therapeutic nucleic acid cargos (siRNA and mRNA) to the gut via oral administration, resulting in the sustained anti-inflammatory effects observed.

N4 Pharma believes the market for such an oral product to treat GI inflammation to be significant. Current therapies for immune-mediated inflammatory diseases, such as IBD, are sub-optimal, requiring regular, painful injections which can result in reduced patient compliance. Injectable products to treat these disorders represented 78% of a market worth US$20.4bn in 2023 and is expected to grow by a CAGR of 3.9% to over US$27.6bn by 2030¹.

The ability to deliver a medication orally targeting the same mechanism as the antibody-based therapeutics would represent a preferable form of treatment. With 5 million sufferers of the two main types of IBD (Crohn's disease and ulcerative colitis), there is huge potential for a product to address this market and it is estimated that the oral segment of this market could be worth US$7bn by 2030. There is a significant market opportunity for such a product, mainly as an oral substitute for the largest sector already of TNF inhibitors and to compete with the inhibitor drugs being developed. If such a product could take 50% share of the existing TNF inhibitor market and 25% of the oral market, it would potentially be worth US$12bn. Even achieving just 10% of this at US$1.2bn would give the product significant potential.

(¹ 2023 Grand View Research, Inc. Inflammatory Bowel Disease Treatment. Market Analysis, 2018-2030).

To date, the Company has worked closely with the University of Queensland ("UQ"), who were the original inventors of the Nuvec® technology. With the emphasis now on creating a data package more geared towards commercial collaborations the Company is migrating the ongoing work to a specialist contract research organisation, CMAC at Strathclyde University.

The focus of the work at CMAC over the next six to nine months is to:

·    develop a scalable and reproducible dual siRNA loading process;

·    fully characterise the loaded nanoparticles (physicochemical, cell-based);

·    assess different surface coatings;

·    generate stability data;

·    conduct an oral biodistribution study;

·    generate comparisons with competitive platforms such as lipid nanoparticles; and

·    explore other targeting moieties.

Targeting cells in Oncology

As recently announced, following the successful work with SRI combining its targeting molecules with Nuvec® to successfully deliver therapeutic RNA ("siRNA") payloads to non-small cell lung cancer cells the Company is developing a work programme to explore novel siRNA oncology targeting.

The key results from the SRI work showed:

·    Precision targeting achieved: Nuvec® particles were modified with a molecule binding to αvβ6 - a protein found at high levels in epithelial cancers such as lung, breast, prostate and pancreatic adenocarcinomas.

·    Selective uptake confirmed: siRNA payloads were successfully delivered only by the modified Nuvec® particles, with no uptake in controls, demonstrating that Nuvec® can be directed to specific cell types.

·    Broader validation of Nuvec®: The findings strengthen the platform's potential as a differentiated delivery system for RNA therapeutics across multiple disease areas.

Targeting RNA therapies to specific cells and tissues to maximise efficacy and reduce systemic toxicity is highly sought after by nucleic acid therapeutics developers and is challenging to achieve with established RNA delivery methods.

The ability to demonstrate the successful targeting of Nuvec® to cancer cells and immune cells, as the Company is doing in its lead, N4 101, programme, is something we believe sets Nuvec® apart from other delivery systems and, as N4 Pharma's data package increases, will attract partners in these multi-billion dollar sectors.

Legacy programme - Liptide® Glaucoma product, ECP105

N4 Pharma has a legacy siRNA programme (ECP105) which is designed to be a simple and effective anti-fibrotic therapeutic approach which maximises and increases surgical success in the treatment of Glaucoma by reducing post-surgical scarring whilst avoiding exposing patients to the risk of cytotoxic medication. ECP105 uses Liptide® as a delivery system and contains a siRNA sequence to silence the fibrotic gene MRTF-B without cytotoxic side effects. The programme is being developed by Nanogenics Limited ("Nanogenics"), the Company's 71% owned subsidiary.

As previously announced, the Company submitted an application for orphan drug designation in respect of ECP105 to the U.S. Food and Drug Administration ("FDA"), for the prevention of scarring following glaucoma surgery and this process is still ongoing. However, additional work is required, and the Company is awaiting quotes and scopes of work for this work to advance ECP105. When the ongoing costs of the ECP105 programme are known, the Board will take a view as to which direction would be most beneficial for its interest in Nanogenics.

Board and management

In January 2025, David Templeton retired and stepped down from the Board. As stated at the time, on behalf of all Directors, the Company would like to thank him for his contributions over the years and wish him well for the future.

At the same time, the Company welcomed Dr Alastair Smith to the Board as a Non-Executive Director. Alastair was the founder and former Chief Executive Officer of Avacta Group plc ("Avacta"), an AIM-quoted biotech company established as a spin-out from Leeds University in 2005 and listed on the London Stock Exchange AIM market in 2006.

Over his tenure, Avacta grew into a leading biotech company comprising two divisions: a clinical-stage oncology drug company advancing its proprietary pre|CISION^TM tumour targeting platform and a diagnostics business executing an M&A-led growth strategy in Europe focused on healthcare professionals.

Post period end, in July 2025, the Company appointed Edward Wardle as a Non-Executive Director representing the interests of Northern Standard Limited, which became our largest shareholder following the placing in April 2025.

As announced on 27 May 2025, the Company's newly configured Board is now supported by the formation of a Senior Leadership Team, reporting to Nigel Theobald, Chief Executive Officer, comprising leading expert consultants in drug development and research, commercial strategy and pharmaceutical manufacturing. The team is made up as follows:

Dr Fiona McLaughlin - Head of Research and Development

Dr Fiona McLaughlin is a highly experienced oncology drug developer and independent consultant, bringing over 25 years of experience in research and translational drug development in the pharmaceutical and biotech sectors, having led teams from early research through to clinical development. Fiona started her career at GSK and has subsequently held leadership positions in multiple biotech companies, including CSO of Avacta Therapeutics, VP New Opportunities at Algeta ASA (now Bayer), VP Translational Research at Antisoma plc and Director of Pre-clinical Development at BTG plc (now part of Boston Scientific). She is also a non-executive director of Hox Therapeutics.

Fiona received a PhD from the Haematology Department at Cambridge University and has a BSc in Biochemistry from Glasgow University.

Mark Edbrooke - Head of Strategy

Mark Edbrooke, PhD is an independent scientific consultant with a broad experience in pharmaceutical research and development. During 25 years at GlaxoSmithKline, he ran a transnational functional genomics department and then set up and led GSK's therapeutic nucleic acid unit. He then joined AstraZeneca's Oncology Division for three years, working with Ionis and Moderna.  Mark currently has a portfolio of clients, including UK and US-based investment companies, UK and European-based universities and small biotechs, including being Head of Translational Research at Argonaute RNA Ltd. and on the Senior Advisory Board for Deep Genomics.

Dr Simon Bennett - Commercial Director

Dr Simon Bennett is an independent consultant with over 28 years of experience in the bio-pharma industry. Over the last 15 years, Simon has worked with more than 70 clients of all sizes, from technology startups to Big Pharma, largely supporting business development and licensing, as well as technology scouting and fundraising.  Simon has been involved in over 80 commercial deals and mentors and advises early-stage businesses and management teams, primarily in specialty pharma and biotech.  Before moving into industry in 1997, Simon was a Wellcome Trust Research Fellow at the University of Oxford.

Dr Margaret Courtney - Head of Chemistry, Manufacturing and Controls (CMC)

Dr Margaret Courtney is an independent consultant with over 25 years of experience in transitioning active substances and drug products from the research laboratory into clinical studies and commercialisation. Margaret has worked in management positions in small biotech companies to large pharmaceutical organisations and following on from her pharmacy degree and doctoral studies, has developed specific expertise in drug delivery systems. Currently, she is working with a range of clients and providing CMC strategic advice as well as selection and management of contract organisations.

Outlook and strategy

The commercial potential for a superior RNA delivery platform that could be widely adopted in the industry is very significant. The key benefits of the Nuvec® platform have been validated by a number of historical studies and an extremely experienced drug development team has now been put in place to complete this process and populate a commercial data room to support deal-making in the near term. Licensing deals with third-party RNA drug developers is a major value inflection point for the Company and remains a key objective.

Development of in-house RNA therapeutic candidates, differentiated by use of the Nuvec® platform, offers an opportunity to grow significant shareholder value beyond platform deals and the team is therefore advancing its lead programme, N4 101, a targeted treatment for IBD, by using it as a model system in the ongoing studies. N4 Pharma's recent success with SRI demonstrates a second targeting application, in this case non-small cell lung cancer cells. The Company expects the ability to target RNA therapeutics to be a key driver in N4 Pharma's conversations with potential license partners.

The Board strongly believes that the greatest return for shareholders will be delivered by a strong focus on the Nuvec® platform to deliver validation through commercial partnerships and grow longer-term value through its in-house pipeline.

On behalf of the Board, I would like to thank all of N4 Pharma's shareholders for their continued support and look forward to providing further updates on the Company's progress.

Chris Britten

Chairman

25 September 2025

Condensed Consolidated Interim Statement of Comprehensive Income (unaudited) for the six months ended 30 June 2025

All activities derive from continuing operations.

The notes below form an integral part of these financial statements.