Poolbeg Pharma plc share price, company news, analysis and interviews

Poolbeg Pharma plc (LON:POLB) Chief Executive Officer Jeremy Skillington caught up with DirectorsTalk for an exclusive interview to discuss financial and operational highlights from interim results and the outlook for the company.

Q1: Poolbeg Pharma announced interim results for the six months to the 30th of June. Could you just talk us through the financial and the operational highlights?

A1: Financial, we finished the end of six months, to the end of June, with £18.9 million pounds in the bank, and this is after our IPO last year of £25 million in July. So, we’ve said from the outset, from the get-go, that we’d be a capital-light model, we want to get early human clinical data, but not spend heavily doing that so we’re adhering to that strategy right now. So, again, we have a strong balance sheet and strong cash balance and that’ll take us forward many, many years. I’ll talk a little bit about the business model later on how we recoup investments, let’s say to our main programmes.

On the operational front we’ve been quite busy and quite productive advancing our products as well as our platforms so I can speak a little bit about that. Our lead programme POLB 001, again, stating at IPO last year that we planned to be in the clinic in the summer of 2022 and we’ve achieved that. Again, a great milestone for the company to be entering into clinical trials and this is an immunomodulatory therapy for severe influenza. So, we started an LPS challenge study, it drives the inflammatory response in humans, we started this in July and that’s progressing well with volunteer recruitments.  Data will be coming out before the end of the year, which again demonstrates the speed of execution, but also the speed of data generation, which is critical for our business models. We’ll get that early human data and partnering thereafter. So that was, as I say, a good I wouldn’t say start to the summer, it was kind of mid-summer but again, hitting our milestones is great and that was on the back of us  getting a US patent granted on POLB 001 back in May. So again, a good milestone for the company and for that programme, we are expanding potentially beyond severe influenza looking at other disease indications where POLB 001 can play a role, and again, that adds value to the programme. So that’s our starting point, let’s say POLB 001,  our lead programme.

We’ve got others coming behind it, the other products, POLB 002, we said we’d in licensed that  for the University of Warwick early this year so that’s advancing again, hoping to push that through manufacturing that into the clinic in the not too distant future. POLB 003 then where we have an option for this vaccine against the bacterial disease called Melioidosis and we’re transitioning that now into a full license after doing due diligence.

So again, very happy with the progress of our programmes, but as I say, spending lightly, given that the £18.9 million still left at the end of June, we know we have a long runway there.

On the platforms, we’re progressing as well and we’ve got multiple products out of these. We have two artificial intelligence collaborations to analyse our clinical trial challenge data and that’s a deal with OneThree around RSV – Respiratory Syncytial Virus –  and we’ll have results from that by the end of the year so potentially new targets and new drugs for RSV. With CytoReason, we’re identifying new targets for influenza and that’ll be pushed into 2023, but again, making good progress on this very unique data set. Lastly, as you can tell, there’s a lot going on, a lot of positive activity but we’ve licensed technologies around oral vaccine delivery from colleagues at AnaBio so again, progressing that into the development stage.

So, a very busy year, but a very productive year and as I say, spending lightly.

Q2: Now, I know that you’ve strong financial resources available and that you’re looking to capitalise on new opportunities as you identify them, but how do you see the outlook for Poolbeg Pharma?

A2: When we started last year, we had assets that we’d acquired, let’s say we inherited from hVIVO/Open Orphan when we spun out and we’ve actively in licensed two products as I spoke to 002 and 003, as well as expanding AI collaborations and vaccine or vaccine delivery.

We’re still looking, we still want to expand the pipeline looking for other products to bring in, because again, with the capital-light model, it’ll be multiple shots on goal so we want to bring in products that are close to the clinic, get that early clinical data and then partner with pharma. So we are being opportunistic filling out our pipeline from there. We have a number of opportunities we’re  actively doing due diligence on right there.

I think a key point of this, again, linking back to the capital-light model is that a number of programmes are looking at our contenders for non-dilutive funding, indeed our own pipeline are contenders for non-dilutive funding so we hope to supplement our £18.9 million with other funding,  non-dilutive, as I say from a share standpoint.

So, there’s plenty of opportunities in the infectious disease space for that so again, we we’re quite active in that space as well, building out a pipeline externally.

Poolbeg Pharma plc (LON:POLB) Chief Executive Officer Jeremy Skillington caught up with DirectorsTalk for an exclusive interview to discuss the in-licenced novel, first-in-class RNA-based immunotherapy for respiratory virus infections developed at the University of Warwick and the ultimate plan for the deal.

Q1: Jeremy, you’ve signed another deal for an infectious disease asset. Can you just tell us more about that?

A1: We’re building out our pipeline, we’ve talked about last year about having an internal pipeline when we IPO’d in July and now we’re in-licensing very exciting programmes from a variety of sources.

This morning, we in-licensed a novel defective interfering virus from the University of Warwick, this is a very interesting pre-clinical programme that has broad applicability across many different viruses from influenza to RSV to even Coronavirus. So, we’re very excited about the potential here, it’s not just one virus we’re going to be pursuing, it’s several.

So, it’s based on 20 years of work at the University of Warwick, very exciting pre-clinical data showing some efficacy and now we’ll bring it into our pipeline and move it forward very rapidly in a capital light model and get the human data then partner with pharma.

So we’re going to stick with our tried and tested Poolbeg Pharma development and commercialization strategies.

Q2: Can you talk to us about the terms of the deal?

A2: We’ve, again in line with capital light, modest financial terms and we’ll move this forward rapidly into human clinical testing, as I say, in a capital Iight model.

We’re very clever with our development, we’ll get the human data very, very quickly and, as I said, partner with pharma, they like to see human data so we’ll be very efficient with the cash spend on this programme.

Q3: Now, this product is at a late pre-clinical stage, what does that mean?

A3: We’ve a bit of work to do to get it into humans, as I say there’s pretty robust pre-clinical packages I mentioned, there’s efficacy data demonstrated in various animal models so, again, very excited that proof of concept is there.

So, we’ve got some steps to do around manufacturing, they have a process in place and it’s a very stable product, which terrific, and then following that manufacturing, safety in humans and then efficacy. We’ll run a human challenge study, this programme is ideal for that, which again is a very cost effective way of getting early human proof of concept data and then partnering with pharma.

So, we’ve a nice development path ahead of us and it’s clear and well laid out and again, a very exciting asset to put that to the test.

Q4: So, what’s the ultimate plan for this asset?

A4: As I say, as stated at IPO, we’re want to bring in a range of assets and so we’re not going to focus on one so we’re going to have multiple shots on goal and for this one, again, the goal is human data as quickly as possible.

We have a terrific relationship with our colleagues at Open Orphan who run these human challenge studies and we feel this as an ideal programme for that.

Again, we know, we’ve talked to pharma for over the years, we’re all very experienced in the pharma dealmaking space and talking to pharma over the years, they’re very interested in respiratory viral diseases right now because of the pandemic, they want to see what assets they can bring into their pipeline in the future. One of the box checking exercises is human data and I think that Poolbeg Pharma and our capital light model, our capital efficient and speed model, we’ll get that data as quickly as possible and then partnering with pharma.

So, it’s ultimately monetisation to the company will be through pharma deals.

Poolbeg Pharma plc (LON:POLB) Chief Executive Officer Jeremy Skillington caught up with DirectorsTalk for an exclusive interview to discuss their partnership with Eurofins Genomics, the ownership of the human challenge samples, the next steps in the data analysis programme, how AI analysis will be used to discover new drugs and the benefits of analysing the data through AI.

Poolbeg Pharma is a clinical stage infectious disease pharmaceutical company, with a novel capital light, clinical model which enables them to develop multiple products faster and more cost effectively than the traditional biotech model. This week, the company announced that it had partnered with the leading global biopharma services company Eurofins Genomics and joining me today to discuss the company is CEO Jeremy Skillington.

Q1: Now, you’ve partnered with Eurofins, it’s an exciting step in your AI data analysis programme, can you tell us more about that?

A1: We’ve partnered with Eurofins to do some genomic analysis of clinical trials samples that we acquired from Open Orphan. We’re going to focus these on RSV, which is another viral disease, maybe may people haven’t heard of it but it’s actually quite severe for the elderly and for the very very young.

So, basically, we’re going to look at transcriptomics which is analyse blood samples and see what genes are being regulated by the virus, what’s up regulated, what’s down regulated and what’s the immune system response to that virus. Again, with the ultimate goal of coming up with new targets and new therapies.

A very exciting step, we’re going to generate a lot of data from this initial step so that’s why we’re partnering with AI companies to analyse all of this data. They take in these very large data sets and break it down and come up with new targets for fighting diseases.

So, we’re very excited about this initial step but there’s more to come.

Q2: There’s been some confusion on the ownership of the Human Challenge samples, can you clarify this for us?

A2: When we de-merged from Open Orphan, when we spun-out out of Open Orphan, we received a non-exclusive licence to this Human Challenge data set so we can use it for our own purposes. Again, the ultimate goal, as I mentioned, is coming up with new drug targets, drug candidates.

Now, people have asked about the cost of this. When Poolbeg was formed, the shareholders in Open Orphan received shares in POLB as part of the spin-off so the payment came from the shares that these shareholders received.

From a clarification standpoint, we have non-exclusive access rights for a total of 30 months, we do pay for any work that Open Orphan needs to do to help us get access to this data and anything beyond 30 months, we can renegotiate a term.

The non-exclusive licence gives us those rights to mine this terrific data set, I hope that clarifies but it’s a little complicated, I appreciate, but as I say Open Orphan shareholders want to see us succeed so this is our way of achieving that.

Q3: What will be the next steps in the data analysis programme?

A3: We committed, during our IPO, that we would do data analysis of this large data set of viral challenge data. We are in discussions with a number of ASI companies and what these companies do is quite impressive, this is an industry that didn’t exist five years ago because the computers weren’t powerful enough.

It’s essentially taking these large amounts of data sets and analysing them, looking for patterns, looking for how the immune system responds to viruses, looking at the proteins that are in there, looking at the gene expression as I mentioned, the clinical responses, all of these are fed into these super-computers.

What comes out the other end are patterns or new targets so we have a number of proposals on the table so I expect an announcement in that space very soon.

We’ve got a very exciting time for the company to be mining this very exciting data set and, as I say, identifying new drug targets and drug candidates.

Q4: How will AI analysis be used to discover new drugs?

A4: When we get a virus, our immune systems kicks into gear, and the white blood cells, the B-cells, the T-cells, all of these immune cells start fighting the virus and what happens is they’re turning on genes, turning off genes and the virus is fighting back.

So, when you look at this in a large data set, or in a large scope, computers will be able to identify what targets are maybe pivotal in fighting back the virus, what targets are helpful to the virus. We can then come up with drugs that can hit those targets, we can block or enhance and again, help the body fight back stronger against these viruses.

AI will help us to identify these target candidates and also, identify drugs that hit these targets, that are available out there, that we bring in.

You did mention the outfit, we have a capital-light model so we plan to reposition drugs that already exist and run some human viral challenge studies to get early clinical data and then partner with pharma’s.

So, the work with the AI companies will help us to identify these drugs that then we can them put into the viral challenges and come up with human data. I’m not going to call it a shortcut as it’s a lot of work involved but, as I say, it’s just using super-computer powers to shorten to the timeline, the timeframe to getting these drugs and targets into tests in human challenge studies.

Q5: This will be the first time that challenge study data is analysed using AI, what are the benefits of analysing the data through AI?

A5: One of the things that I find most exciting about Poolbeg Pharma is accessing this data set.

To describe a human challenge – you get in a healthy volunteer, you bring them into the clinic and you take blood samples, all samples, from ‘day minus one’ we call it so this is when they’re at their healthiest. At day zero, you give them virus and you track the course of the disease, you track the immune response, you see how they’re reacting and responding and we take data samples every day.

So, what’s important about this AI analysis, compared to others, is that you can compare it to baseline so baseline is when they’re at their healthiest and you can see how these different proteins are expressing across the full disease cycle. They do recover very well in the end but having that ‘day minus one’ is an excellent baseline to have, data to compare to.

For other clinical programmes, you’re normally getting patients in that are already sick so you’ve nothing to compare them to, this is their disease state right now, but to be able to compare from ‘day minus one’ to when they’re sick, you can identify what proteins  are up regulated or how they’re fighting best against the virus and again, we can exploit that.

So, the data set that we have brought over from Open Orphan is very exciting and the AI companies we’re talking to are very excited about this too. This is the first time they’re able to get this baseline data and compare to disease data too, from a scientific standpoint, from a medical standpoint, from a clinical standpoint, very exciting to see what comes out the other end.