N4 Pharma Q&A “Nuvec is going to have massive commercial potential” (LON:N4P)

N4 Pharma plc (LON:N4P) Chief Executive Officer Nigel Theobald caught up with DirectorsTalk for an exclusive interview to discuss H1 highlights, their new refined strategy, how the COVID pandemic created opportunities for the business and what investors can expect for the rest of the year.

Q1: First off, congratulations on the interim results announced this morning. Nigel, can you talk us through the highlights in the first half of the year?

A1: We started the year looking at dispersion and formulation of Nuvec and how we can improve that and appointed a company called Nanomerics who are base out of UCL in London to help us with that work.

COVID lockdown came which hit the road hard and caused a lot of changes but that gave us an opportunity and a chance to look at how we can use Nuvec with the Coronavirus DNA Plasmid to see how Nuvec can deliver that which is a great chance to increase the exposure of the company.

In what were difficult market conditions, we raised £2 million in an oversubscribed placing to give us the funds that we need to really push on with all the Nuvec proof of concept work that we’ve announced.

Q2: You have a new refined strategy to focus on three clearly designed workstreams, can you talk us through these please?

A2: The first is a continuation of the optimisation work so we were looking to finalise that work and it’s been quite an intricate process. We’ve had lots to do over the last year because we have basic silica particle, we have to look at how we disperse the particle, how we functionalise it adding different rates of PEI and how we then load the DNA. So, we’ll be concluding that work shortly.

We’ve also appointed a company called Ardena to do the tech transfer so that we can make sure we can make the basic silica nanoparticle to a consistent GMP-type requirement in the future.

All of that work is going to directly feed into our second stream which is comprehensive in-vivo study that we would’ve done to date. That will be our first clinical in-vivo study using the Coronavirus Plasmid DNA with the optimised Nuvec, also seeing how it works alongside generic Plasmid’s.

I think it’s important to put the recent stage 3 work that we talked about in context, the protein expression work is just the step between in-vitro work and doing an in-vivo antibody study. We could’ve spent ages trying to measure that protein but we still need to go through and do the antibody work.

So, given that we saw it was quite a low expressor in the protein and that makes it slightly harder to pick up, it doesn’t mean that this is a failure stage, it just means that first experiment we looked at didn’t work as well as we wanted, we didn’t see anything with the control. So, we took the decision not to spend lots of time and money doing that because we’d still have to do the antibody work and given that we have raised those funds, we can go straight into a most comprehensive antibody study programme that we have done to date. So, it’s a good thing that we’re moving forward that way.

Finally, we’re doing work to look at how Nuvec might work as a tool for oral and oncology vaccines which again, the optimisation work will feed into that. So, if oral and oncology both look viable alongside  standard injections then we’re going to have very clear applications for which Nuvec is going to have massive commercial potential.

Q3: You mentioned that the COVID pandemic has presented opportunities for the business, can you tell us more on that?

A3: The pandemic has really brough a global focus on vaccine development in particular nucleic acids, a lot of the frontrunning vaccines are using DNA and Messenger RNA, the Pfizer work, the Inovio work, a lot of them are using this  nucleic acid approach.

As the majority of our work is being with genetics, it gave us the opportunity to look at a real disease in mind to bring N4 Pharma and Nuvec to the attention of these people developing the vaccines. We’ve also said we’re not developing the vaccine but we’re using COVID and the Coronavirus Plasmid to show the potential of Nuvec.

To give you a good example, those people who are developing DNA vaccines using electroporation which is a very expensive and very difficult to roll out commercially any vaccine that had developed that approach, show that Nuvec can deliver DNA Plasmids without the need for electroporation then all those guys should be knocking on our door as should others as well. It really raises the profile of the company through the work that we’re doing.

It also got us thinking about other delivery systems that were potentially more efficient than just doing vaccines that would require cold storage and would therefore be difficult to roll out a final vaccine. One such technique there is oral so we’ve already seen how good Nuvec is at staying in the upper intestines so we’re undertaking some feasibility work to see how Nuvec can be used to be taken orally and then still transfect in from the gut and therefore deliver antibodies through an oral administration route. That could be a very big opportunity, not just for COVID but for any vaccine development where people might be looking for oral technology.

Q4: Finally, what can investors expect from N4 Pharma for the remainder of the year?

A4: The next 6-9 months, I think, is going to be a defining period for us as a company as, we say, we’re embarking on our most comprehensive in-vivo study to date and the broadest number of arms in that study looking at both optimised and unoptimized Nuvec with Coronavirus and other vaccines.

There’s a lot coming on from there and as I mentioned, in parallel we‘re going to continue our feasibility work for oral delivery and how it might work in oncology. We’re now very well-funded to do all of that work as a result of that recent £2 million raise we did earlier so all ion all, I think we’re in very good shape as we move forward.

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