N4 Pharma Q&A: A pivotal time for the company (LON:N4P)

N4 Pharma plc (LON:N4P) Chief Executive Officer Nigel Theobald caught up with DirectorsTalk to discuss final results, updates on the three work streams, the European patent for Nuvec & what this means for the company and what investors can expect in the near future.

Q1: First off, congratulations on N4 Pharma’s final results announced this morning. Nigel, can you just talk us through the highlights of the year?

A1: I think the obvious thing that jumps out this year is we’ve taken two fundraises during the course of the year. That has allowed us to kick on substantially with all the research that we’re doing to build the case study pack for Nuvec, our delivery system so that we can keep presenting that to potential collaboration partners. So, that’s been absolute key for us.

In terms of utilising those funds, the first thing we’ve been able to do is we’ve accessed a DNA plasmid of the COVID virus from the NIH and that means that we can now do proof of concept work on a real live virus rather than just our academic proof of concept work. That will really help bring us to the attention of potential collaborators.

So, they have been the two key things and we’ve also started our transfers so that we can begin manufacturer of our particle with a GMP grade manufacturer and we’ve started to work on new uses for the Nuvec particles as well as the injectable vaccine programme.

So, in all, our data pack has become much much stronger as a result of those raises but we still have £3.5 million cash in the bank at the end of the year so that we can carry on that work and improve the data pack even further.

Q2: Now, you announced previously a new refined strategy to focus on three work streams, can we have an update on those please?

A2: So, the three streams, first off, we’re looking at how we optimise the production of a product combined with the Nuvec delivery system and we’ve done an awful lot of work on the dispersion of the Nuvec system once loaded with DNA or RNA. We’re pleased to say that we’ve pretty much completed most of that work now so we have a very good monodisperse available to us to test. We’ve then also been able to put that into what we call colloidal stable formulation, that means basically making it so that we can dry the product down once it’s loaded with DNA, store it either at room temperature or in a fridge at 4 degrees and then we can reconstitute with water without any drop in observed transfection capabilities so far in invitro tests.  So, that’s very important having Nuvec combined with DNA or RNA being stable and then being able to use, again not having to be stored at minus 70 degrees etc. so that’s something we feel collaborators are going to be very interested in. So, we’ve made a lot of progress on that first stream of the optimised product.

The second area is, as I mentioned, the COVID-19 proof of concept work, we’re testing both with the original material and the new material. The original material is well underway, we did mention in the results that there was a slight delay over Christmas because we had difficulties getting the plasmids through customs into Australia, Australia was on complete and utter lockdown before Christmas. With Christmas coming in, we took the decision to delay the start of that until the New Year so we had to wait until the New Year and that now means that’s underway and we’ll have results from that soon. The new optimised version, as I say now, we’ve got this more monodisperse format, we’ll be testing that with our partners Evotech and we’ll scope that work out and that will be starting very soon. So, the COVID proof of concept work is well underway and we’ll have the results of that soon.

There’s also the other uses so there’s a number of different uses you can use Nuvec for, our focus at the moment has been on injectable vaccines and obviously with the COVID situation, you can see why. It can also be used as a cancer treatment and we started work there with Nanomerics and we’ve also noted that it can have the potential with an oral delivery system so that’s another piece of work that we’re doing. Both of those are what we call early stage research, there nowhere as near as advanced as our injectable work but that work is still ongoing and we’ll keep doing that and updating the market as we get any new significant results in either of those spaces.

Q3: You announced that the University of Queensland has been notified by the European Patent Office for its intention to grant a European patent in relation to Nuvec. What does this mean for the company?

A3: Having the patent claim approved makes it much better when you’re having commercial conversations. So, when your patent is going through the examination process, there’s always a slight discussions you have to keep having with the examiner but once you have the patent is granted, it means you intellectual property is that much stronger.

So, it puts us in a much stronger position when we’re having conversations, initially obviously in Europe because it’s got the intention to grant and we’ve just been informed that Australia is going to move this same way as well. Other countries will follow so US, Japan, China, India, these countries should all follow now that we’ve had the first grant notification in European.

What this ultimately means is that no one else can make or commercialise a silica nanoparticle with that unique structure that Nuvec brings. So, that gives us a much much stronger position because if anybody wants to look at this area and they see that it works and we’re showing them how well it works then it means they have to come to us to work with the system.

So, it just strengthens the intellectual property position when we’re having commercial discussions.

Q4: Finally, what can investors expect from N4 Pharma in the near future?

A4: As I mentioned, the COVID proof of concept work both with the optimised and the original material is well underway on the injectable vaccine approach so there will be results coming out as we get that information. We’re also working hard behind the scenes to present the data we have and also the new data as it comes out, to potential collaborators. That’s especially true as the whole story of COVID and the fact there are vaccines now on the market, all of these vaccines are going to need some form of formulation, new methods of delivery in order for them to make them ongoing successful, very much like the flu jab gets reformulated every year.

So, it still gives a huge opportunity for companies like us to keep presenting our solution to people who are developing vaccines, reformulating them and all the countless new ones that will come to market as well. Also, there’ll be further findings on the other potential new areas of use in terms of cancer and oral.

We’re very much at a pivotal time for the company so we’re getting the results of a lot of our data that are coming through now. We’re well placed in terms of the balance sheet but we’re not having any set time for the work or the research, we will announce it as and when we get something pertinent to update the market on.

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