Avacta Group plc (LON:AVCT) Chief Executive Officer Alastair Smith caught up with DirectorsTalk for an exclusive interview to discuss interim results, major milestones in the next 3-6 months, COVID testing developments and appointing Stifel as joint broker.
Q1: Now, you have reported on progress for the six month period up to the 30th June, how would you summarise the progress made during this period?
A1: Well, given the extraordinary circumstances that everyone’s been through, to have achieved the financial and the operational performance that we have makes me very, very pleased indeed. I’ve said it before but I have to say that’s a reflection of the attitude and commitment of my colleagues in Avacta Group who have dealt with the challenges and the risks that the pandemic has presented and just simply got on with it.
So, it’s been a period of continued solid progress in the therapeutics division, moving AVA6000 towards the clinic with the CTA filing expected before the end of the year and we’ve maintained really good progress in our partner programs with LG, Daewoong and ADC Therapeutics.
It’s also been, and continues to be, a period of extraordinary growth really in the diagnostics division so there are multiple opportunities as everyone knows in the area of COVID testing created by the generation of Affimer binders to the virus.
In addition to that, the team in Wetherby has positioned the company for ISO 13485 accreditation later in the year and expanded the production and assay development facilities.
So, all in all, in spite of the pandemic, it’s been a really excellent period of growth from the Group.
Q2: Just looking forward, what are the next major milestones that you expect to be hitting in the coming months, say 3-6 months?
A2: So, I would put that into three groups, first of all the movement of AVA6000 pro-doxorubicin to the phase I clinical trial for that that asset. As I said, we’re aiming for a UK regulation filing, a CTA, before the end of the year and then expecting to dose first patients in the first quarter of next year as well as the back backend of the first quarter of next year. So, both of those very much newsworthy milestones. Then we would expect to see that first meaningful data from that phase I study around the middle of the year, Q3 next year, and again, that’s an important newsworthy milestone.
The second group of milestones I would place around the coronavirus antigens testing so in terms of the rapid antigen tests, the lateral flow test, aiming for clinical validation for professional by the end of the year. So, as I say, initial self-certification for professional use and then as much in parallel as we possibly can doing the work for CEO marking for consumer self-testing. Also, in this bucket is the additional commercial opportunities, not least with Adeptrix around the BAMS essay which we regard as a very interesting opportunity but potentially other partnerships, licensing of the Affimer spike proteins for third parties.
The third group, core business as it were so core diagnostics and therapeutic commercial progress, we’ve continued despite things being slowed down, of course, by the pandemic, we continue to make progress in terms of business development and technology evaluation. So, I would expect to be talking about new commercial partnerships in both of those divisions in the next three to six months.
Q3: In relation to the COVID testing developments, are you receiving any support from the government at all?
A3: I’ve been asked that a lot and I can’t talk about the interactions we’re having with the government in any detail of course but what I will say is I’m very pleased there’s now a detailed dialogue which is very helpful in guiding our developments so that we can directly address the national requirements, but I can’t really say more.
Q4: I think you answered this earlier, but the COVID-19 rapid antigen test, when will that be available?
A4: So, I think as everyone knows we’re in the process of technology transfer and manufacturing scale up which is being carried out by BBI Solutions, one of our manufacturing partners and Cytiva. That is very much a development process, developing large scale robust manufacturing processes and, as I’ve said a number of times, the key milestone that we need to get to is the pilot batch of test devices. At that time, when we have that pilot batch and we’ve gone through that development process, we’ll be able to get a much clearer timeline to product launch.
It’s essential that that manufacturing process development is done properly because it’s a significant de-risking step, rushing it and ended up with a process that isn’t robust is a mistake and it simply pushes the risks down the line to the clinical validation, which I’m not prepared to allow.
So, we expect to carry out the clinical validation in Q4, as I said, and as soon as we have that pilot batch, I will be able to give a much clearer timeline through that clinical validation, CE marking and product launch.
Q5: Finally, you announced the other day that you’ve appointed Stifel as joint broker, can you comment further on that?
A5: Well, Stifel provide us with additional life sciences specialist sales capability and a strong US capital markets reach so that will help us to continue the work that I’ve been doing over the last 18 months or so in the US getting Avacta Group’s technology platforms known and attracting US investment.
So, it’s a medium term project but one that we’re delighted to have Stifel on board to help us with.