Pila Pharma AB (publ) (PILA) Earnings Call Transcript & Summary

Hello, and welcome to this H1 presentation with Pila Pharma. With us today, we have the CEO, Gustav Hanghoj Gram. First, there will be a presentation and afterwards, a Q&A where the CEO will answer questions submitted via Stokk.io. There have already been pre-submitted questions on Stokk.io and the Q&A is still open so that you can submit questions live as well. I will now hand over the mic to Pila Pharma to start the presentation. Gustav, your line is now open.

Yes. Hello, everyone. It's very nice to be back with Stokk to present our half year report for the first half of 2024. Today is August 27. My name is Gustav Gram. I'm the CEO of Pila Pharma. To those that don't know you, we are a biotechnology company that is based in Malmö, Sweden. We are developing a new type of oral drug for type 2 diabetes with potential effects on obesity as well as other cardiometabolic events. So I will briefly run through the main happenings for the first half of 2024 in Pila Pharma and of course, a little bit on the balance sheet and then a little bit about what we have included in the report that is of interest to you as investors. So if we go to the summary of the interim report, this is Page 1. you will see that we have had a relatively stable and nonexpensive first half year in Pila Pharma. We can see that the total amount of equity in Pila Pharma by the end of the first half year amounted to SEK 2.575 million. And this was, of course, something that we were pleased with that we had not had such a high burn rate throughout the first 6 months of other things to note. You have a list of significant events here on the right side. The primary thing here to note is the transitioning that we had within the team. So our founder and previous CEO, Ms. Dorte Gram, who is an inventor of the principle of treating obesity and obesity-related diseases and disorders like diabetes with these TRPV1 antagonists as they are called. She transitioned to Chairman of the Board and the company, and she suggested and had approved that I was due to succeed. So in April of 2024, this transition occurred. And on April 19, I took over as new CEO. So this is my first report, which is, of course, a lot of responsibility, but also a lot of fun. And I think everyone that has known us for some time will know that this is a company that is very dear to me as such. And of course, the development that we have seen in the company shows that this is definitely going in the right direction. Secondly, I would note that after the period in July, we conducted a small directed shares issue to selected individuals. These individuals were primarily current investors as well as a few outside new investors. The total amount for this directed shares issue was SEK 10 million, and this was extremely important for us to boost our balance as well as allowing us to commit to engaging a clinical research organization for conducting the next trial. And I will just move a little bit on. Yes, as you can see here, I mean, our operating result is not that different from 2023. So we have a relatively stable cash burn and not much has happened. Of course, what is important to note here is that the equity, which notes SEK 2.5 million by the end of the period should have an additional SEK 10 million added to it now with the extra fundraise. As well as, of course, that the outstanding shares at the end of the period is different to what they are now. So a total of 3.34 million new shares have been added. So it is around 27 million shares that we have currently. And of course, the shareholder list looks a little bit different now as well. We have 2 large shareholders. We have the founder, Ms. Dorte Gram and our Finnish family office, Vimpu Intressenter, who is always super supportive and also took a big participation in this funding round here in the summer. And aside from that, it is quite small positions that we have. But of course, we are always looking to expand our catalog of investors, and we're always very happy to see when new investors come and show an interest in our company. So I want to get back to a little bit about what we've shown in the report. So this is actually a graph, which is unpublished, but it is from Ms. Dorte Gram, our founder, who has, in the past, conducted a preclinical trial on these Zucker rats, which have been dosed with a TRPV1 agent, which is very similar to the one that we use. So it's not the same, but it is indicative of why we believe that we might also have an effect on regulating body weight. So what we see here is that the rats were dosed with 2 different dose levels. And subsequently, they decreased their body weight gain in only 2 weeks. Now this is, as far as I understand, translational to human studies. And in human studies, you would likely see a body weight decrease. So this is, of course, super interesting. And of course, I will just jump here to our pipeline. This is why we focus mainly on diabetes and obesity as our primary project. We're in Phase IIa. We signed a contract with a company called Lindus to help us conduct this trial, and this trial will commence here in the autumn. So that is, of course, super interesting. The CTA, the clinical trial application is about to be sent in. So hopefully, we can get a quick review from the authorities and an approval, and then we can get started to see how well this functions. This is, of course, a safety trial primarily. So we will dose escalate and see how far we can get and how far we can push these patients to see their tolerance. But of course, the main purpose of this fundraise was to include enough patients to also statistically be able to read out whether there is efficacy on regulating body weight. That is to say, reduce the body weight. We also have 2 other projects on the erythromelalgia and abdominal aorta aneurysm. These I don't have any news about for now, so I don't want to comment so much about it. And just coming back, we've seen quite nice developments across the board in the first 6 months. And I always like to see that there's a lot of new shareholders coming in. And I know some of our investors have asked me specifically what we're doing since there's so many new investors coming in. And I think it's mainly just a result of that there's not that many companies that are publicly listed that are doing obesity or obesity-related projects. So even if we don't have any results on obesity yet, it's nice to see that anticipation is building. And we hope, of course, that investors will follow through, and we'll see this to the end together with us. So I think for now, that is more or less it. I don't want to dive too deep into the results as there's not that much to note aside from the organizational changes and the fundraise and of course, the fact that we will soon be commencing our clinical trial, which is very pleasing.

Perfect. Thank you for that, Gustav. Let's then jump into the questions from the Q&A. So the first question here is, can you provide some more information on the partnership with Lindus Health? Is there any financial impact from the partnership? Or how do you expect it to impact Pila Pharma positively?

I mean, so there's no financial impact in the sense that they are co-funding or co-sponsoring as such. So this is a partnership with a British CRO, as we call it. A CRO is a clinical research organization that helps kind of be a middleman between a biotech company and patients. So they will help us organize the clinical setting, assisting the nurse and everything in between. So there's really not that much difference in that regard to any other kind of CRO, except that this particular CRO, Lindus is more milestone-based. So what we have seen and heard from ourselves, but also from other pharma companies is that often when they conduct trials, I mean, CROs will try to invoice for expenses, which may not have been completed. And this is, of course, challenging when you're a small biotech that has a limited cash position. So Lindus is very transparent with this that they are basically milestone paid. So whenever they reach a certain amount of patients, a fee is due. And I think that's a very nice way for us to also control the majority of the spending that is allocated for this project. So the project that we have now is for SEK 10 million. And of course, there's nothing more allocated to that. So it's not like it can just be drawn out forever. So in that sense, it has the financial implications that we have more financial security, I would say.

Yes. Then moving on to the next question. How long do you believe the SEK 10 million in capital increase will take you? What is the time frame for when you need to raise more capital? And can we expect to have new trial results at that point in time?

So the SEK 10 million that were raised now were allocated specifically for this trial. So that should last for the duration of this trial. And from the estimates that I have been given from our clinical team, they expect that from around the commencement of the trial, we should have results within 1 year. So this is the expectance from us. In regards to more capital raises, of course, this is not something I can comment on here and now, but we are always looking to optimize and find ways from which we can progress the company. And of course, pending how successful this trial is, we will need to move into larger clinical trials afterwards, and we have not secured financing for this. So this is something that the Board is continuously discussing like the financing strategy and how we need to move forward. But for now, I don't have any updates as to that.

Yes. What therapeutics in the development/approval pipeline are competitive threats to Pila Pharma?

In the pipeline, I mean, of course, there's already a few GLP-1s on the market, and there's quite a few in development. You're now starting to see combination treatments where you have GLP-1s combined with other receptors like GIP or maybe glucagon. I know a big American company is doing tri-receptor agonist now as well where they are including all 3 of them. We've also seen a big company in Denmark that is also on the market for obesity that has bought a Canadian biotech last year, which are doing CB1 agonists, which are something very different. And I think this is the way the market is going to go. I think you're looking into a future where a lot of larger pharma companies are looking to get a stake in this market. and they will be sourcing opportunities across different modalities. So they will be looking for molecules that are different to GLP-1s as well. Of course, GLP-1s are very good for regulating body weight. But I mean, of course, the main thing that is the talking point right now is that they regulate body weight in the sense of patients losing both fat mass and muscle mass. And of course, losing muscle mass is not ideal. So I think pharma companies are really looking to innovate. And I'm very hopeful that us having the approach that we have with a TRPV1 antagonist, which is so differentiated to everyone else. I think that mark -- that makes for a very unique value proposition and hopefully, a project that could catch the eye of some of these companies. So I mean, that is, of course, the strategy that in a not-too-distant future, we would like to engage in a partnership with a bigger pharma company because the road to the market is, of course, extremely long and expensive. So that was a small list of very complicated names for someone who's maybe not in the pharma business. But it's just to say that, of course, it is hugely competitive. So -- but we think we have -- I mean, we -- to our knowledge, we're the only ones developing TRPV1 antagonist for metabolic conditions like this. So we feel pretty confident that we have a good position in that space, if you will.

Yes. Can you explain why Pila Pharma was one of the most traded non-Danish companies on Nordnet last time?

No, actually not. We were quite surprised as well. I only got -- I got a newsletter from Nordnet in my own inbox as well, my personal inbox, which said here's the list of the most popular stocks for July. And somehow, we were on it, which was pretty interesting and a very good company, of course, with some huge American companies across in different sectors. But I think it's largely a result of awareness campaigns that we started a long time back. And I think the project resonates with a lot of Danish investors, in particular, maybe, I mean, Danish investors have been really spoiled for choice when it comes to companies that operate in the space of diabetes and obesity. So they have had some very nice experiences with them. And perhaps some have noted our name in the past. And then at some point, let's say, they had a successful experience with investments in other companies, then they might choose to allocate some money into our stock. But that's pure speculation from my part. I mean if you look at our press releases, you can see that we haven't really said that much. So I'm not sure as to what's going on. But it's really nice to see. And we can see across, I mean, multiple spectrums. It is not -- I mean, across investor -- amounts of investors that are in the company. And I mean, daily trading and liquidity is also like through the roof compared to if you benchmark other companies in Sweden or on the First North exchange. So it's pleasing. I mean we, of course, want to make it an attractive stock to be a part of.

Yes. When do you expect to be able to announce your next test results?

Well, like I said before, I think it's as soon as we get a clinical trial application approved, we can start treating patients and testing them. And from then on, it should be well within a year, I would say. But I don't have any definitive endpoint as to when we expect it. I think the more important point here is that we are getting started now, and we will be getting some results. And I think after some years where it has been a little bit more stagnant because we had to go back and do longer preclinical trials. This will be our first clinical trials in some years. And of course, that is what investors are interested in because that's where the real value comes from.

Yes. And I think we have already talked a bit about this, but I will also read the question here, then you can see if you can put any more context to it. As a result of Pila Pharma's liquidity forecast and cash flow analysis, how long is the liquidity to finance the ongoing investigation of the project in relation to Phase II?

I mean, as we noted before, I mean, we've allocated the SEK 10 million that we raised just now to the project. So the forecast is that, that project is fully funded. And aside from that, I mean, there's not much to comment on. So I mean we don't have liquidity yet in the bank for a Phase IIb, for example. And this is something that, of course, will need to be addressed by the Board, like what's the strategy and what parameters are we looking at? What positioning are we expecting this molecule to potentially have? I mean we have data on regulating blood glucose, which is a typical marker for diabetes, and we've also seen a very big reduction in a biomarker for heart failure. So it could also be that this drug has very good properties for cardiovascular disease. So this is, of course, an ongoing strategic -- strategy kind of discussion that is ongoing. And I think this is something that we will, of course, develop also around how the results are shaping up in the Phase IIa because when we increase the dosings, we, of course, expect to see what are the effects of increasing the dose here. We've seen trends on 1 month of treatment. So what happens when we go up to double or triple the dose and for 3 months. And of course, that's going to be super interesting to see. And we know from other molecules like GLP-1s, I mean, they had to go up into high dosage levels in order to produce body weight losses. So it seems relevant to think that it would -- the same would apply to us.

Yes. Do you see increased or decreased acquisition interest in the field you operate in compared to last year?

I would say -- well, it's -- I'm not sure if it's increased or decreased, it's just high in general. But I also think valuations of other companies have really gotten up to a point where it's maybe tough for big pharmas to commit plus $10 billion to buy out other companies. So -- but generally speaking, I would say the interest is high and big pharma companies are mostly looking to buy up biotechs with, let's say, preclinical or Phase I studies that they can scoop up and they can shape from early on or alternatively, they're looking for more late-stage companies like Phase IIa, Phase IIb, perhaps Phase III. And of course, that comes with a premium because you don't have all the development costs included. But it varies, I would say. And I think you're having companies that want to enter the market and you have companies that want to keep others from entering the market. So there's a lot of competition going on in terms of this dynamic of shaping the market for the next 5, 10, 20 years.

Yes. You have an exciting project. Do you have plans to actively increase investor awareness?

Of course. This is why we work with you. This is why we, of course, engage and have Q&As and try and elaborate a little bit on how we think it could fit in the market. And we consider ourselves fortunate to have a project that is made it this far because I mean majority of projects they fail before they -- before they reach the market. So of course, we're in Phase IIa now. We're definitely not done. But we, of course, intend to try and progress this as far as we can because we believe it's a solution that would benefit patients. And if you benefit patients, then subsequently, you benefit investors as well. So I mean, of course, it's -- the majority of value is created in the clinic, as we usually say. But with that being said, of course, we would like to heighten investor interest and maybe broaden our investor base a little bit more as well. I mean we are -- we're still a very like micro-cap, small cap sized company. So with time, of course, it's up to me as well as my colleagues to try and increase our exposure and our depth in our investor catalog to include funds and pension funds, et cetera, et cetera, so that we have some more stability. I mean, I think we're at a -- we also have a project that is very liquid in the sense that there's a lot of speculation around it. And of course, that can be good and bad. But primarily, we're looking to solidify and really make it a serious project that the investors can trust that they can see it to the end and at least know that there's going to be a high level of liquidity so that they can buy in and they can buy out. And I think that's imperative to making a stock interesting.

Yes. After you have seen the liquidity increase the past few months, are you beginning to see any interest from micro-cap, small cap biotech funds to invest more into Pila Pharma? Or is it still too early in that case?

No, for sure. We also -- I mean, there was a biotech fund that participated in this directed shares issue. I don't think they would have if they weren't expecting to be able to get rid of the shares. I don't think they are, but I don't know. So I mean, for sure, I mean, I think it starts small. But I mean, if you build a little bit on and get more participation, I mean, that increases the confidence of others to participate. So I think it's very promising. And I think with time, hopefully, we can build upon it and get the market cap to a level where we can expand to have more participate.

Yes. Then we are at the final question here. And again, I think we have talked about the question here. But again, I will read it to you, then you can put some context to it. Can we expect any milestones here in H2 2024 or potentially in H1 2025?

I mean if everything goes to plan, we can hopefully announce that the clinical trial application has been sent, the clinical trial application has been approved. And let's say that, that trial has started. And I mean, to some extent, we will maybe be communicating when it has reached certain milestones like 50% recruitment or 100% recruitment or yes. So there will be -- I mean, that's my expectation as well that there will be activity, but it also depends on having the trial approved in the first place. So this is the main objective for us. And this is what we work with Lindus on right now is to finalize these preparations, have it sent in. And then we will see what the ethics committee in the U.K. are saying. But we, of course, expect it to be approved. And when it is approved, then we can start right away.

Perfect. Thank you, Gustav, for the answers, and thank you for the questions from investors. That finalizes the Q&A. But before we end the webcast, I would just hand over the word for you, Gustav, if you have any final remarks to end with.

No, I think we're looking into -- I mean, just as we mentioned just before, I mean, I think we're looking into a second half year that is going to be very interesting because now we will get started, and we can hopefully put the [ speeder ] down. And of course, it's in our interest to create something that is of interest to larger pharma companies. And if we have designed the protocol correctly and we get the results that we're all hoping and aiming for, of course, that amounts to increase in shareholder value as well. I think that goes without saying. So we're looking to -- we're positive, I would say. And we're -- of course, we're super ambitious and we're very happy to move forward, which is a great feeling.

Thank you, Gustav, and thank you, everyone, for listening in. See you next time.