N4 Pharma Plc (LON:N4P), the specialist pharmaceutical company developing Nuvec®, a novel delivery system for vaccines and cancer treatments, has announced its unaudited interim results for the six months ended 30 June 2020.
· Refined strategy to focus on three, clearly defined, work streams:
- the optimisation of production and loading of Nuvec® as a delivery technology platform for nucleic acid vaccines;
- the Covid-19 proof of concept research programme; and
- feasibility studies into Nuvec® for use in oral vaccines and other applications.
· Successful transfection in vitro of HEK 293T cells with Nuvec® loaded with the Coronavirus DNA Plasmid
· Move to full in vivo study with the Coronavirus and other DNA plasmids with measurement of production of antibodies
· Research Collaboration Agreement with Nanomerics Limited out of UCL’s School of Pharmacy
· Appointment of Ardena as technology transfer and manufacturing partner
· Operating loss for the period was £585,066 (30 June 2019: £552,160)
· Placing of 50,731,250 new Ordinary Shares to raise c.£2 million
· Issue of a further 3,886,562 new Ordinary Shares following warrant and option exercises raising £139,262.48
· Cash balance at period end of approximately £2.44 million
Nigel Theobald, Chief Executive Officer of N4 Pharma Plc, commented:
“The arrival of the Covid-19 pandemic during the period has thrown up considerable challenges globally but also opportunities. Whilst continuing with our optimisation work of Nuvec® as a delivery platform technology, the immediate need to address the threat of Covid-19 encouraged us to look at more specific, product driven, applications resulting in our proof of concept work with Nuvec® loaded with the Coronavirus DNA Plasmid. Our subsequent in vitro success was extremely pleasing but to maximise our chances of success in any full in vivo study we now need to incorporate the findings of our optimisation work. This is key as we look to further our work with the Coronavirus plasmid in parallel to working with more generic DNA plasmids which may be more applicable in collaborations on multiple other vaccines. To that end, we are excited to be moving towards our most comprehensive in vivo study to date and are in the process of scoping the different aspects of the study.
“At the same time, we aim to maximise the potential uses of Nuvec® as we continue to look at other applications including assessing its ability for use in the delivery of vaccines orally. We remain fully funded for the current work programmes and I look forward to providing further updates in due course.”
Half year results
During the six months to 30 June 2020, the Company raised an additional £1.9m, net of expenses, through the issue of 50,731,250 new ordinary shares.
The operating loss for the period was £585,066 (30 June 2019: £552,160).
Cash balance at 30 June 2020 was £2,443,518 (30 June 2019: £1,167,547).
Nuvec® development work
The first part of 2020 saw the Company focus on the optimisation of Nuvec® starting with the improved manufacture and dispersion of the particle. In parallel, we entered into a research collaboration agreement with Nanomerics Limited (“Nanomerics”) to focus on the stability of a number of different formulations of Nuvec® using both a well characterised plasmid DNA and a novel small interfering RNA (siRNA). Whilst these work streams remained ongoing, the advent of the Covid-19 pandemic presented significant local and global challenges but also created an opportunity as to how Nuvec® may be applied as a potential delivery technology to any of the multiple Covid-19 vaccines currently in development across the world.
Whilst we did not initially envisage a material disruption to our studies, the scale of lockdown created minor but inevitable delays to our optimisation work and the work with Nanomerics. As working practices have evolved against the backdrop of the pandemic these work streams are now very much on track and continue to expand our data set for Nuvec®. With such attention on Covid-19 and potential vaccines, we took the decision to undertake a proof of concept study prior to a full in vivo study to assess the efficacy of Nuvec® loaded with the Coronavirus plasmid DNA. This work was undertaken by an experienced contract research organisation, Evotec, and began in the period under review and has recently concluded resulting in the decision to move to a full in vivo study as set out further below.
In the period, we have also undertaken an appraisal of Nuvec® in the use of manufacturing viral vectors and how they might be used in ex vivo gene therapy. Whilst there is a viable market to be potentially addressed in the future the Board has concluded that the return on investment at this stage would not be suitably attractive. As a result, the Board has concluded that the best use of its resources would be better served focusing on its strategy for the next six to twelve months being:
· Completion of the optimisation work including the establishment of optimal dispersion, loading ratios and the tech transfer for consistent manufacture;
· The scoping and implementation of our most comprehensive in vivo study to date; and
· Feasibility studies on other applications for Nuvec® such as for oral vaccines and in oncology.
The strengthening of our balance sheet through the funds raised in May of this year means that we are well funded to complete all our currently planned work streams.
Over the last few months we have sought to refine our work streams in such a way that they align towards a definitive study which comprises the multiple learnings from the studies to date. These continue to be refined through the optimisation work which is expected to be concluded with our CRO partners over the coming months to then feed into our in vivo work. In parallel, we have begun our tech transfer work with Ardena to enable consistent manufacture of Nuvec® with the potential to GMP standards as and when required in the future.
Through our Covid-19 proof of concept work we have seen Nuvec® loaded with the Coronavirus plasmid DNA transfect human HEK cells in vitro. Following the recently announced results for the pilot in vivo work, we have decided to proceed to a full in vivo study to demonstrate the capability of Nuvec® loaded with the Coronavirus plasmid DNA to generate Covid-19 antibodies. This in vivo study will be our most comprehensive yet. Whilst we are still finalising the scope of the study, we will be looking to compare, amongst other variables, reactions of Nuvec® loaded with different DNA plasmids (including Coronavirus), as well as optimised Nuvec® and unoptimised Nuvec®.
Whilst our core work on Nuvec® continues positively as detailed above, the Board is mindful that it needs to expand its risk profile and there remains great potential in exploring other applications for Nuvec®. As announced in July, we feel Nuvec® could offer significant advantages in addressing issues in the oral delivery of vaccines and we are in the process of conducting preliminary feasibility studies as to its viability as a tool for oral vaccines. Likewise, in the area of oncology we are exploring the viability of Nuvec® as a tool in this substantial market.
In parallel to the work outlined above, the Company continues to see progress on its licensed patent application from The University of Queensland (“UQ”) and its own patent application. The UQ patent application has had responses from all the key patent examiners and dialogue is ongoing to clarify the list of claims being discussed. Our own patent application for improvements to how Nuvec® is made has now entered the national phases for Europe, USA, China, Japan, India and Australia.
Post the period end, Luke Cairns, previously a Non-Executive Director, became an Executive Director, overseeing the Company’s finance, corporate and investor relations activities allowing Nigel Theobald, Chief Executive Officer, more time to focus on driving the Company’s development programmes and potential commercial collaborations.
Fundamentally, our strategy remains the same and therefore the prospects and value potential for Nuvec® remain as previously stated. With every study result, we learn more about Nuvec® and so can better define the next study. This we are doing as we plan our next in vivo study taking what we are learning in the optimisation process, previous in vivo studies and the recent Covid-19 proof of concept work.
The combination of work with Nuvec® to address solutions for multiple injectable vaccines supplemented by our preliminary work on oral and oncology applications means we are looking to balance the inherent risk of development with the considerable reward of any one of these applications advancing to commercial collaborations.
The Board also remains open to adding other assets to its portfolio in the event any such opportunities arise.
On behalf of the Board, I would like to thank all of our shareholders for their continued support and look forward to providing further updates on our progress.
By order of the Board
N4 Pharma Plc