N4 Pharma Plc Regulatory News (N4P)

N4 Pharma Plc

("N4 Pharma" or the "Company")

Nuvec® Update

N4 Pharma Plc (AIM: N4P), the specialist pharmaceutical company which reformulates existing drugs and vaccines to improve their performance, is pleased to provide an update on its Nuvec® program in respect of the delivery of DNA/RNA. Nuvec® is a novel therapeutic nanoparticle platform designed to deliver DNA/RNA into cells to generate proteins in situ.

The Company's strategy for the development of Nuvec® technology will be determined by the level of immune response directed towards a protein antigen generated from the DNA/RNA loaded onto the nanoparticles. We are now working with contract research organisations and collaborators to generate this data which will allow us to determine the most immediate therapeutic areas which Nuvec® will be most suited for.

MedImmune UK update

On 2 February 2018, N4 Pharma announced that it had been awarded a feasibility grant from Innovate UK to co-fund a collaboration with MedImmune UK, a leading global biologics R&D company, to explore the manufacture of a prototype nanomedicine using N4 Pharma's Nuvec® system. The collaboration has begun well and the Nuvec® team (the "Team") is making significant progress developing manufacturing methods for Nuvec® particles loaded with therapeutic DNA/RNA encoding protein antigens. Once completed, MedImmune will then conduct studies to demonstrate the capability of delivering such antigens to induce immune responses, the results of which are expected in Q4 2018.

Additional Research and Development pipeline

In addition to the immune response work referred to above, further research will be carried out this year to identify in which human cells Nuvec® nanoparticles are most effective for transfection, as well as characterising dose and duration of response at the site of injection, including rate of breakdown and distribution in the body. In addition, further work will be performed to optimise manufacture of Nuvec® nanoparticles and understand their stability in various media, which will be informative regarding formulation considerations.

The Company expects all of these results, along with our internal immune response work, to be available in Q4 2018 which, together with the MedImmune collaboration results, will be used to form the strategy for prioritising the development of therapeutic uses of the Nuvec® platform over the next year.

Nigel Theobald, CEO of N4 Pharma, commented:

"I am really encouraged by the early results from the Nuvec® team's experiments. The Board believes that data generated from studies this year will result in increased understanding of the mechanism of action and potential scope of the Nuvec® silica nanoparticle delivery platform enabling us to identify the development pathway for Nuvec® in 2019.

Our strategy for Nuvec® is similar to our generics work on sildenafil. We are undertaking initial priority research to determine exactly how Nuvec® behaves much like we are doing initial pharmacokinetic clinical studies for our sildenafil reformulation. This will allow us to focus the development of Nuvec® to enable N4 Pharma to target specific licensing deals with large pharmaceutical companies."

Enquiries:

About N4 Pharma

N4 Pharma is a specialist pharmaceutical company which reformulates existing drugs and vaccines to improve their performance.

N4 Pharma's reformulation work falls under two divisions:

· generic, already commercialised, drugs; and

· novel delivery system for nucleic acids.

N4 Pharma has identified a number of established drugs that could be improved upon through its reformulation techniques. N4 Pharma's most advanced reformulation is for sildenafil, widely marketed as Viagra, where N4 Pharma is seeking to improve the speed at which the drug takes effect whilst also extending its duration of action.

N4 Pharma's reformulation approach should take approximately three years to obtain regulatory approval as opposed to the traditional process for new drugs of on average ten years. The cost and risk profile of this model is also significantly less than the traditional process. N4 Pharma's business model for generics is to take reformulated drugs from its portfolio through to the stage where it will license its newly reformulated drugs to pharmaceutical companies to commercialise them. N4 Pharma's revenues should be derived from up front milestone and royalty payments associated with the licence.

N4 Pharma's business model for Nuvec® nanoparticles is to undertake the required pre-clinical work to demonstrate the capability of its nucleic acid delivery system as part of a vaccine and/or method to deliver DNA/RNA so that it can license the technology to major players developing treatments in this area, again in return for up front milestone and royalty payments associated with the licence.

About MedImmune UK

MedImmune is part of Astra Zeneca, having been acquired in 2007 for $15.6bn. It is a leading global biologics R&D company with one of the largest, most robust pipelines in the industry, including more than 120 research projects and product candidates, that comprise nearly half of AstraZeneca's overall R&D portfolio. It is focused on three core therapeutic areas: Oncology; Respiratory, Inflammation and Autoimmune; and Cardiovascular and Metabolic Disease. For further information visit:

https://www.medimmune.com/

About Innovate UK

Innovate UK is the UK's innovation agency. It works with people, companies and partner organisations to find and drive the science and technology innovations that will grow the UK economy. For further information on the recent announcement visit:

www.innovateuk.gov.uk

or

https://www.gov.uk/government/news/industrial-strategy-boost-for-uk-medicines-with-70-million-of-funding-to-help-develop-new-treatments