N4 Pharma Plc Regulatory News (N4P)

08 November 2017

N4 Pharma Plc

("N4 Pharma" or the "Company")

Results of latest nuvec® pre-clinical study

N4 Pharma Plc (AIM: N4P), a specialist pharmaceutical company which reformulates existing drugs and vaccines to improve their performance, announces the results of the latest study it has conducted for its nuvec® silica nanoparticles ("SiNPs") delivery system.

As well as investigating tolerability, the objective of this study (funded via a biomedical Catalyst Grant) was to determine the in-vivo capacity for the Company's SiNPs to deliver DNA to generate local expression of a protein. This is a key indicator as to whether a vaccine delivery system is likely to successfully generate an immune response. The Company completed two tests in this study, the first was an injection directly into a cancerous tumour and the second was a subcutaneous injection; two routes of administration typically used for vaccination.

In conclusion, a single injection of the SiNPs is effective in delivering DNA to generate localised protein expression at the site of the injection and draining lymph nodes and release cytokines into the systemic circulation. These are all crucial elements for successful cancer therapy treatment. No tolerability issues were encountered for the duration of the study.

Following these results, further in-vivo studies will be conducted to demonstrate the capability of the Company's SiNPs to deliver specific antigens to promote an adaptive immune response (i.e. as a vaccine) or to deliver functional proteins that can have a biological effect and to undertake comparison studies showing how the Company's SiNPs compare to lipid nanoparticles, which are widely used as delivery systems for cancer vaccines and therapies.

Nigel Theobald, CEO of N4 Pharma, commented:

"As well as preparing to take our sildenafil reformulation into clinic, we have been scoping out the potential for our nuvec® delivery system and continue to make encouraging progress demonstrating its capability. This signifies another prominent step forward on the road to commercialising nuvec® .

We now have evidence that our SiNPs have many desirable features for use in either a vaccine approach or to deliver therapeutic proteins to tissues and are uncovering key commercial advantages compared to lipid nanoparticles. This increases the scope of nuvec's® application which in turn enhances the value of the technology to potential commercial partners.

The value of the global nanotechnology drug delivery market is forecast to grow from $4.1 billion in 2014 to $11.9 billion in 2023*.

As nuvec® continues to meet its technical targets, it becomes very clear that we have the potential to become a significant player in this growing market. We will continue its development to determine how best to compete and to take the technology forward."

* source: Transparency Market Research July 2014

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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

• delivery of novel and existing vaccines.

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 vaccines is to undertake the required clinical work to demonstrate the capability of its delivery system as a cancer vaccine or therapeutic treatment 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.

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