REG - N4 Pharma PLC - Business and Operational Update

N4 PharmaAnnouncement

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RNS Number : 8212L  N4 Pharma PLC  17 December 2025

 

17 December 2025

 

N4 Pharma plc

 

("N4 Pharma" or the "Company")

 

Business and Operational Update

 

N4 Pharma plc (AIM: N4P), the UK biotech developing Nuvec®, its proprietary
gene delivery system to enable advanced therapies for cancer and other
diseases, is pleased to provide an operational update and business review.

 

University of Strathclyde collaboration

 

The Company's collaboration with the Centre for Continuous Manufacturing and
Advanced Crystallisation ("CMAC"), the world-leading research institute in the
field of nanoparticle drug delivery, based at the University of Strathclyde,
is progressing well.  The programme remains on track towards key in vitro
and in vivo studies planned for the first half of 2026, and to build out the
commercial data to demonstrate Nuvec®'s key benefits and advance Nuvec®
towards clinical readiness.

 

As part of this programme, drug-loading procedures are being established to
optimise reproducibility, efficiency and stability, and direct comparisons are
being made with lipid nanoparticles, the current industry standard, to
demonstrate the competitive benefits of Nuvec®.

 

Latest studies indicate that Nuvec® nanoparticles would offer a significant
commercial advantage over lipid nanoparticles ("LNPs"), particularly in terms
of stability. This includes both the intrinsic stability of the nanoparticle
itself and the stability achieved following loading with siRNA.

 

All this work is essential both for the development of N4 101, an oral
anti-inflammatory product for the treatment of Inflammatory Bowel Disease
("IBD"), and any potential partnership collaborations for Nuvec® more
generally, as it lays the foundation for any future clinical work by N4
Pharma or by partners.

 

2025 highlights

 

In addition to the crucial CMAC work above, the Company has made further
excellent progress towards the key objectives set out following the April
2025 fundraising, focused on building out the Nuvec® data set to support
future commercial outreach.

 

Key achievements include:

 

·      Successful preclinical demonstration of oral delivery and
efficacy using Nuvec® in an animal model of IBD. The protection of the RNA
payload by Nuvec® represents a key differentiator versus competing delivery
technologies.

·      Successful targeting of Nuvec® particles, demonstrated both in
the IBD programme and in work conducted with SRI International in non-small
cell lung cancer ("NSCLC") cells. Effective targeting is widely regarded as
the 'holy grail' for pharmaceutical companies developing RNA-based
therapeutics.

 
Anticipated newsflow

 

The Company expects a strong flow of data-driven news in the coming months,
including:

 

·      Further comparative performance data for Nuvec® versus lipid
nanoparticles, which currently dominate RNA therapeutic delivery but suffer
from known drawbacks, including toxicity, limited targeting capability and
manufacturing complexity.

·      In vivo biodistribution and further targeting data will provide
critical insights into where Nuvec® distributes within the body and further
demonstrate how it can be directed to specific tissues.

·      Repeat of N4 101 in vivo study using two siRNA to reduce
inflammation.

·      Identification of assets that N4 Pharma will look to develop
itself into clinical trials, clearly positioning the Company as an RNA
therapeutic company as well as having a unique delivery platform.

 
Intellectual property

 

The Company has also strengthened its intellectual property position with the
PCT filing of its patent application relating to its IBD programme. The patent
now covers the use of Nuvec® for the delivery of dual-loaded siRNA therapies
as well as combined siRNA and mRNA payloads.

 

N4 Pharma has also been notified that the Japanese patent office has issued a
notice to allow the grant of its patent application for the use of Nuvec® to
improve the performance of viral vectors and now awaits the formal
notification of this application being granted in Japan. This patent is still
being prosecuted in the USA and Europe.

 

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

 

"We are very encouraged by the progress being made across the Nuvec®
programme and by the data emerging from our collaboration with the University
of Strathclyde. The stability, targeting and oral delivery data generated to
date reinforce our belief that Nuvec® has the potential to address several of
the key limitations associated with lipid nanoparticles, which remain the
current industry standard.

 

"N4 Pharma is building a robust, high-quality data package to support future
commercial discussions. With multiple important readouts expected in the
coming months, we believe Nuvec® continues to demonstrate its potential as a
differentiated and commercially attractive delivery platform for RNA
therapeutics and will provide the Company further opportunities to look at
developing its own RNA assets in the future."

 

- Ends -

 

For more information please contact:

 

 N4 Pharma plc

 Nigel Theobald, CEO                                                       Via N4 Pharma Investor Hub

 Luke Cairns, Executive Director

 Submit your questions directly to the management team via the N4 Pharma
 Investor Hub

                                                                           https://n4pharma.com/link/yaGp6r (https://n4pharma.com/link/yaGp6r)

 SP Angel Corporate Finance LLP                                            Tel: +44 (0)20 3470 0470

 Nominated Adviser and Joint Broker

 Matthew Johnson/Jen Clarke (Corporate Finance)

 Vadim Alexandre/Abigail Wayne/Rob Rees (Corporate Broking)
 Turner Pope Investments (TPI) Limited                                     Tel: +44 (0)20 3657 0050

 Joint Broker

 Andy Thacker

 Guy McDougall
 Northstar Communications Limited                                          Tel: +44 (0)113 730 3896

 Investor Relations

 Sarah Hollins

 

About N4 Pharma

 

N4 Pharma is a pre-clinical 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
(http://www.n4pharma.com) or sign up at
https://investors.n4pharma.com/auth/signup
(https://investors.n4pharma.com/auth/signup) .

 

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