Good evening, and welcome to this investor after-work Q&A with Pila Pharma. With us today, we have the CEO, Gustav Hanghøj Gram. There have already been pre-submitted questions on Stoc .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 Gustav just to give a short welcome and introduction before we start the Q&A. So, Gustav, welcome to you.
Thank you. Have you unmuted me? Okay, great. Yes. So yes, so my name is Gustav Gram. I am the CEO of Pila Pharma. We have already conducted a couple of Q&As with Stock in the past, so I'm sure some of you know us from there.
But in case there's new listeners coming in, then we are a small biotech company based in Malmö, Sweden, and we are developing a new type of oral drug for type two diabetes and potentially obesity, cardiovascular disease, et cetera. And today, today is primarily from our side, seen as a Q&A, where we can address some of the questions that we see most often in various stock forums. It could be on our Facebook page, it could be on our LinkedIn page.
So we've tried to gather together all, like, the open, unanswered questions and see if maybe we can answer some of them today. So if you want a bit more in-depth presentation material, I suggest you check out our YouTube channel, where a majority of my presentations are uploaded from time to time. So with that, I'm hopeful that we have some good questions for today, and I'm sure Anders can provide a good moderator service to me.
Yeah, perfect. We have a lot of questions to go through, so let's-
Great
... just jump directly into it.
Yeah
... with the first question here. So question number one: Does the Pila Pharma pill have a positive effect on weight reduction?
I mean, we hope so, but we don't have any data yet. So for now, that's, like, the open million-dollar question for us as well. And for those who have followed us for at least in 2024 have witnessed that we have verbally expressed more interest in seeing if we can address this in the next clinical trial.
So we have fundraised in the summer, and we've tried to design the trial so that we can include a little bit more patients in order to get a statistical you know readout in the trial when it comes to, let's say, defining whether or not it can regulate body weight, which, of course, in this instance, it would be to decrease the body weight.
So, to summarize, we don't know, but we're very hopeful, and we can see from other drugs in obesity, for example, that, you know, they will not really get a strong weight loss profile until they go up in doses. And this is exactly the purpose of our next trial. It's a dose escalation trial, where we will, you know, up the dose to see how much patients can tolerate. So we're hopeful that we can potentially see, yeah, an added beneficial effect on body weight on this as well.
Yeah. And the next question: When can we expect results from Phase IIa?
So we've communicated in the past that we expect results within a year from when the trial starts. Now, of course, the trial has not started yet, so I can't really comment directly on when investors can expect it, but this being biotech, you know, one year from trial start is a pretty short timeline, and this is not a huge, you know, clinical trial as such. So I wouldn't... You know, sometime in 2025, but I would hope, I mean, if everything goes well, now we're in end of 2024. So but, I mean, I'm not gonna put a specific date on it here and now.
I think it would be much more beneficial if we stick to the traditional way of sending out press releases when we have more concrete timelines to communicate to the market.
Yeah. When does Pila expect the first human trials to begin?
We've already done them. I mean, this is a molecule we took over from another biotech company. So this molecule has already been tested in 300 human people, so it is very well documented that this is, you know, a type of molecule that has been tested and proven to have a pretty good safety profile at one dose level, so of course,
we've done two trials in type two diabetic people, and of course, this was mostly because of the authorities wanted us to be a bit more precautious. Because when you live with diabetes, you have a whole range of problems, of course, and they wanted us to be a bit more sure that they could handle this type of drug.
So far we've seen good safety and signs of efficacy. To summarize, we've already been in humans, and of course, we intend to build upon the data we already have, and hopefully we can be successful with this.
Yeah. Perfect. Is the funding from the 12-15 investors enough to finance Pila until results are achieved?
I mean, this is... This, of course, depends on whether or not we want to include even more things. I mean, last week or the week prior, we sent out a press release now stating that we want to change the protocol a little bit to for the trial to be conducted in a hospital setting.
Now, normally, I would say that being, if a trial takes place in a hospital setting, then it's actually cheaper.... but, if we then want to, let's say, add more measurements or more advanced analyses, then it could be somewhere, you know, around the same kind of, you know, the same range, I would say.
But this is something that we're working on right now, and of course, as soon as we have more information regarding this, we will communicate to the market what you know what the status is. And of course, if we want to do even more so, I mean, we have seen a lot of interest lately in regards to the cardiovascular aspect of the molecule.
So of course, we're constantly monitoring and assessing what we can do. We already have a collaboration ongoing with a university up here in Stockholm regarding a cardiovascular disease, so we're hopeful we can communicate something a little bit around about this soon. But nothing to disclose as of right now.
Yeah. Many new investors have joined on the Nordnet platform, doubling over the last five to six months.
Yes.
Is Pila actively doing anything to expand its reach? And if so, what specifically?
Not specifically with Nordnet. I wouldn't say so. But I think we I mean, both myself and our chairman and founder, Dorte, we're Danish, and I think we have tapped into into some communication channels in specifically in Denmark, that has attracted some Danish investors.
Danish investors have been spoiled for choice when it comes to new companies coming through with obesity and diabetes treatments. So there has, generally speaking, been a lot of awareness among both private and institutional investors, and I think we have maybe had some luck in being mentioned in those groups of companies. And of course, we're very thankful that people check us out and sometimes choose to invest, and we of course hope that we can build upon this.
I mean, we're still at a relatively small company when it comes to the amount of shareholders, so, there's space enough. I mean, I read the other day that Nordnet has passed, I think it's 500,000 investors in Denmark, and two million in the Nordics. So, as far as I can see on their statistics, we're roughly around 2,000. So there's about 1,998,000 investors left to tap. And I think that's a good goal to have, that we want to hopefully get out to every one of them.
Perfect. Where will the next roadshow be held? Are there places and times where one can register?
Yeah, I mean, we start today, sort of, right? So, we start today online, and then, Wednesday this week, I will be with Økonomisk Ugebrev in Denmark, for their life science conference, which will also be recorded. I'm actually not sure whether that presentation will be in Danish or in English, but, we will see.
Next couple weeks, we will be traveling to the U.S. for some big obesity and cardiovascular disease conferences. And, in between that and after that, I also have a presentation with the Danish Shareholders Association, and a couple of other, you know, locations in Denmark and Sweden specifically.
My November schedule is very packed, and there will be plenty of opportunities to come and see us live and meet us in person. I suggest you just check out our website, because all the events that we attend are on the front page, and it's very easy to get an overview and sign up there.
Perfect. Is Pila currently in dialogue with any specific big pharma companies?
I mean, we don't mention names, but we do talk occasionally with the common players in this field that do diabetes and obesity medicine, because we have an interest in knowing what they're on the lookout for. You know, they're interested to hear how it's going with our project.
So but what we can see is that there's a big range of like medium to large-sized pharmaceutical companies that don't have a history in diabetes or obesity that are showing an interest now, and that is, of course, quite nice and interesting. But that being said, it takes a long time to develop a relationship with these types of companies, and you know, their strategies can change overnight.
So I think we're diligent, and we're just focused on creating some clinical data now that is valuable. If we can create something that is great, then you know, then the interest will come to us, then we don't have to chase it.
Yeah. Is there a lock-up period for investors who participated in the private placement this summer?
No. Pretty simple. No, there wasn't, but it was also a very minor, minor investment, right? It was 10 million SEK, so one million EUR. So it was a small sum, and we deemed that it wouldn't be attractive for investors to come in with such small sums if they had to be locked up for an extended period of time, so no, there was no lock-up, and for that matter, none of the management or the board has been locked up as well, but we don't intend to sell our shares as well. At least I don't, I can say.
Yeah, and when might the next share issuance be expected? Has this been planned yet?
Yeah, you know that I can't comment on this, but it's, you know. We, of course, are always looking for the best way to finance the company going forward. So if there are investors sitting out there and looking at us and thinking we have an interesting project, then I'd suggest they get in contact with us. I mean, now we did a directed issue in the summer, and that was something we'd never done before, but it, it worked out very well for us, and it kept costs to an absolute minimum, and also dilution of existing shareholders.
So if there are, you know, it's a welcome opportunity to say to anyone out there who's listening, that if there's an interest to participate or potentially participate in future financing rounds, then I suggest you to get in contact with us, and we have lists of people we would contact if we were to engage in something. But a formal timeline I cannot give you, no.
No. Does Pila have other products in the pipeline if the next trial has a negative outcome?
I mean, on our webpage, you can find the pipeline as it is right now, where we have a diabetes track, with hopefully potentially added benefits on obesity or weight loss, and then we have a rare disease track for a painful indication called erythromelalgia. This is a disease that we already have what's called an orphan drug designation in the U.S. from the FDA there. So it's basically like we send an application to the FDA asking if they think that this type of molecule could work in this disease, and they've said yes. So there's nothing more to it than that.
It's a designation, but if we can prove that it actually works in terms of, in this case, it would be alleviating patients from the pain that they get from this disease, we would get something called orphan drug status. And this is of course interesting because this means you get many years of market exclusivity, especially in the U.S.
And if you get this, like, let's say, if we produce proof-of-concept data, we would also have orphan drug status in the E.U. So that could be quite lucrative, but this is a rare disease, so it's quite hard to define what the market size is or how to find the patients.
But what we can say is that there's currently no treatments on the market, and it's a very debilitating disease. So we're hopeful that we can hopefully get this going pretty soon, and I'm confident that we can find opportunities so we can explore this track as well, because it would give us an edge in something that's very different than the metabolic space than what we're in.
And then, as I mentioned earlier, we have a small preclinical collaboration with Uppsala University to investigate whether our drug can reduce, like, the risk of developing what's called aortic aneurysm, which is when the aorta in, like, in the stomach, it dilates to the point where it bursts.
There's quite a high death rate among men, especially when men get older. Currently, there's no pharmaceutical treatments to, you know, to reduce the size of the aorta in time, so preventive measures. This is kind of like the purpose for us, is to investigate whether we can regulate this in a safe manner.
This starts in the preclinical setting. Yeah, hopefully, we can tell you more about this pretty soon, because it's a very interesting field. Of course, if we can showcase more data on, you know, more beneficial data on cardiovascular disease, that would really bring a lot of added value to the whole portfolio, I would say.
Yeah, and maybe we should take this question in the line of this. I don't know if you have anything more to add, but what is the status of your orphan plan?
The development plan is developed. Right here now, we're working on trying to basically figure out how we can conduct this proof-of-concept trial. It's very anecdotal. It's not very many patients, and it shouldn't be very costly. This is something that we would likely look to finance and maybe not say so much until we have a result. Right now, I can't tell you that there's been any progress since the last time, but it's still a big focus point for us, for sure.
Does the U.S. election have any impact on Pila's processes?
Without taking too much side here, I think it's evident that, regardless of who wins in a, you know, a political election, there's still gonna be quite a few overweight or diabetic patients in the U.S. and elsewhere in the world.
So, I don't think that like the business case or the investment case dramatically changes overnight, depending on the results on Tuesday. I will actually myself be in Texas, so that's of course an interesting place to be, right near the border and near the infamous Trump wall. So that should be an interesting experience, but from our point of view, it doesn't change much. I think it only will...
Whoever is getting elected will inherit a lot of issues, health issues in the general public, and they will want to try and fix it, so for us, I mean, we are proposing to come with a solution that is like easy to produce and scale and to manufacture and to distribute, and best of all, for patients to ingest,
so I think, you know, the narrative that we present kind of fits into whatever narrative that winner would also like to see, and then again, we're not near the market anytime soon, but of course, we develop a product that could have tremendous effects for a lot of people, hopefully.
Yeah. What is the status of the preclinical cardiovascular collaboration announced last year?
I think I updated on that just a second ago, but it's going well. I hope to have more to tell soon. We're still engaged with the professor up in Uppsala, and he's very engaged, and he really firmly believes that this could actually work.
So of course, we are crossing fingers and you know, making as much due diligence we can to kind of understand the disease in case you know, the initial tests come out successful, because then we would likely need to build upon it with the bigger preclinical trial and subsequently a clinical trial, and I think I mean, the more cardiovascular beneficial effects you can showcase for one molecule, the better.
If I can just touch upon one thing I forgot with the painful indication we had, is that, you know, this is the same molecule that we work with, so we're quite confident, you know, that, for example, if that can showcase like an element of pain treatment, that would actually be quite a big advantage to some degree.
Because no other diabetes or obesity drugs have pain-relieving effects, to our knowledge, at least. So that could be an interesting additional angle, if you will. If we were to negotiate for a partnership sometime down the line, then we could say that, you know, like, "Okay, we have something that is very good for cardiovascular disease.
It can regulate many of the different factors that you see with diabetes, can regulate weight, body weight, maybe, and it can actually alleviate patients of pain, and many patients with diabetes have a lot of pain. So that would be of huge interest. But to summarize on the cardiovascular disease, I mean, it's still very early, but we're working hard to progress it, and I think we could look into a future where this type of drug is associated with a lot of you know, beneficial effects when it comes to treating cardiovascular disease.
Yeah. And then there, there's a question I would believe is from someone in your Swedish investor network.
Mm-hmm.
Why don't you release announcements in Swedish?
First of all, I'm not Swedish, so I think it's to benefit everyone here. So there wouldn't be too many spelling errors and mistakes. No, but in all seriousness, we're a small company, and we're based in Sweden, but we work in a field and with a topic that is very much global.
In order to take care of all stakeholders and to address all stakeholders, we have decided to have our corporate language in English, and I think that's for the benefit of everyone. So that's the main reason. Of course, we have to file it. We have to publish our financial year report in Swedish, but that's about all.
Yeah.
This is all we do, and I think that's okay, and I'm happy to speak my best Swedish-Danish mixture whenever I meet people in person at different events. So if whoever wrote this, I'm hopeful that the person will come and shake my hand at a physical event sometime soon, and then we can discuss whether we need to change our routines.
Perfect. "How are you different from Gubra?
Oh, that's a good question, actually. I mean, Gubra, to my knowledge, they're still very early stage, right? I mean, they are. Until a few years ago, they were mostly considered as a CRO, so, like a company that was running, preclinical, trials for other companies, and now they are doing, preclinical trials themselves and doing licensing agreements with Big Pharma.
So very interesting companies. I think they are one of future companies that can rival, the good, stock development that we've had this year as well. And I think it's a company that has gotten a lot of media exposure in Denmark, especially, but maybe goes a little bit under the radar elsewhere.
And I think it's been interesting to see how they have developed the case, and from my knowledge, they focus a lot on Amylin, which is also one of these new up-and-coming kind of areas like drug classes within obesity treatment specifically. So, no, huge respect from my side. But, I mean, it's hard to compare.
We are a small Swedish biot ech company with absolutely no revenue, and they have a different engine because they have a CRO arm, kind of, that can generate some money for them. And they've been very talented and smart to develop some drugs that could get partnerships straight away.
So they could get money inflow directly from there as well. So, yeah, but I mean, if we look at the investor angle, I think, you know, Gubra has seen a dramatic rise from, I think they listed at 100 DKK or something a couple of years ago, and I'm not sure what it is at today, but it's substantially higher.
So I think it, I mean, they have seen some of the same movements as, for example, Zealand and Novo Nordisk, who's also battling for the obesity market. And of course, I'm hopeful that we can do the same at some point. We're, of course, still not at the same valuation at all, but... If we get the right results, I'm hopeful we can see some of the same upwards curves that they, their share prices have had, that's for sure.
Yeah. And then we stay a bit in the same line here.
Yeah.
How are you different from Zealand Pharma?
Yeah, I mean, so sort of similar answer, right? I mean, Zealand has been around for many years, and they have a big organization with multiple hundred people employed. A great CEO who's very visionary and very simple in his narrative around what Zealand wants to do and what do we want to become.
And I think that's why a lot of investors are really positively influenced by them here and now. Of course, they've also been fantastic in terms of the way that they have been fundraising. They have been taking in both loans from the European Investment Bank, but then they've also, you know. You know, they did sort of the same maneuver as we did in the summer.
I think we drew a lot of inspiration from them in the sense of they capitalized on a good development in the share price to go out and do a directed issue and really bolster the coffers with money so that they can do what they need to do. I think it's been really nice to see. I'm also a Dane as well, so, of course, it is nice for me to see that the Danish companies are doing well, and I don't consider them, you know, competitors or anything like this. I think we can draw a lot of inspiration from each other.
But they are also in the same boat as both Novo and Gubra. I mean, they're focusing on GLP-1s, and they're focusing on amylin, as far as I understand. So in that sense, we're a completely different fruit since we do TRPV1. But who's to say that they can't all function and be a part of a massive, let's say, competitive landscape with different types of drugs for the market?
Yeah. What trends do you see subjectively that support Pila in the obesity market?
No, but something along the lines of what I just mentioned, I think with Gubra and Zealand, like, there's a lot of small... medium or smaller companies coming through now with different mechanisms of actions, not just GLP-1s anymore. It's, like, companies are looking a little bit to expand, you know, their thinking and, like, look at what other mechanisms are out there.
I know that, you know, Novo, for example, will come with Phase 3 data from their amylin GLP-1 combination here in Q4. And I know that Eli Lilly will come with data from their triple agonist sometime in 2025, I think it is.
So, you know, these companies are trying all kinds of combination treatments now, as we call it, where you have GLP-1 with something else, or you have amylin with something else. And I mean, we're the only ones doing TRPV1.
But if I'm very confident that if we can push this and showcase that it works, then there will be quite a lot of interest from other companies to see, you know, what will the effect be if we combine a GLP-1 with our molecule, for example. And I mean, this is, of course, something that we can aspire to.
But I think right here and now, I mean, internally in the team, we're just focused on producing results to showcase that it works, and then in the aftermath, we can look at you know what the opportunities are.
But we're already getting interest from companies to you know to discuss like what the opportunities are, what kind of molecule do we own? Like, it's a small molecule, can we combine it with this theoretically? But I mean it's on a very early stage, I would say. So no, I think the market and the world is for sure shaping to be of a kind where we could fit in, but it all depends on data. So if we don't get data, then the door shut, right?
I think that's the most important thing to remember, is that this is high risk. You can make a mistake, or you can fail your next trial, and then it's more or less over. We're not, you know, a huge company, so we're doing everything that we can to try and succeed and make it happen. And we're confident we have something that is both new and differentiated to attract, you know, to attract interest.
Yeah. And then there's a question here that might be a bit difficult to answer specifically, but-
Okay
... the question is: What could be the value for shareholders if you achieve more positive cardiovascular results?
Yeah, I don't know. I mean, currently, I think, now the market just closed today, but I think the share prices has been relatively stable for a long time, but we're still substantially below what the, you know, the price we listed at was.
And I think at least, for us as majority shareholders, and I believe many other investors as well, who've been there since the start, I mean, they would like to see us go to at least double of what we started at, in 2021. So, but if this works, I mean, I don't see why this couldn't be, you know, valued a lot higher than it is currently. But that being said, there's a long way there.
And I looked the other day to, you know, the previous three years of development that we'd gone through and the three years of financing as well, and according to the perspectives that we released in anticipation of our IPO, we've only gotten about half of the money that we basically said that we would need back then.
So of course, we've been a little bit delayed, but I'm very hopeful that we can get moving again and move forward with a positive attitude and, you know, the belief that we have something that is working well, and I think we're a lot smarter as well than we were three years ago.
So ideally, you know, we would go up 10 to 20 times from the current level, but then again, it's hard to say what the, you know, the value of a molecule like ours would be or a company like ours. I can say that many companies in this field are almost too small to get acquired if they are not worth at least $1 billion, and they are maybe too big if they're above $10 billion.
So there's kind of the sweet spot between $1-$5 billion. I think, you know, that's what Big Pharma likes, and then... But this is of course, it has so many factors involved in relation to, you know, what their appetite is, for example, as well.
With that being said as well, we haven't defined as such whether we want to be an acquisition candidate or go for a partnership and build up the whole company. So but we're keeping every option open, and we're just yeah focused on making results now.
Maybe that already answers the next question here-
Yes
... but what price does Pila need to reach for a sale to be attractive?
I don't know. I mean, it's hard to say, right? And I think there's some questions we need to ask ourselves as well. If our valuation suddenly goes up dramatically, do we need to change to larger lists, for example, as well, in order to attract more institutional investors? So this is of course gonna be a gradual thing.
I don't think it's gonna happen overnight. If it does, so I'm not gonna put a specific price target on the end goal as such. But let's just continue the good development that we've had so far. I mean, this year, we're doing well, and we aspire to do well next year as well. So I think it's just it's up...
Of course, it's up to me to inspire investors to be engaged and everything, but also keep some realism when it comes to the expectations. Because, of course, it's... Realistically, it's not gonna go up 5,000% overnight. Of course, would be nice, but everything, it needs to be sustainable as well.
I mean, if you have a high rise, you're also gonna have a big drop, is my impression. So, so without saying so much about about the, you know, specific share prices or anything, I think it's just to say that we're working hard to get it up. And I know there's a lot of the old-time investors that want to see this through at least to a much higher level than today.
There's a trend of new molecules emerging in the obesity treatment, such as Amylin.
Yeah.
Could yours be something new?
Yeah, for sure. I mean. This is just the type of molecule that we work with that's been associated with pain traditionally. So no, you know, it hasn't traditionally been seen as a molecule to, or like a target for treating metabolic diseases such as diabetes or obesity.
So it could be something brand new in this setting, and I think that gives us some confidence and a bit of a belief that we have an edge, and I think you need to have an edge in order to make it, you know, through to a point where you are interesting to other companies.
I mean, yeah, everyone's, or not everyone, but a large amount of companies are focusing on amylin now as well, and I know there's some companies focusing on different types of receptors and cannabinoid receptors, and it just seems as if horizons are broadening, and I think that's great, and I think it speaks into what we're looking, you know, to take advantage of as well.
Because if we can position ourselves as some company that has a very different mechanism of action, but we're very late stage, and we have a lot of human trial data, and we're relatively affordable in a pharma setting, I think, you know, we just need to keep spreading the word and, of course, keep creating good data. I think that's what it's all about.
Yeah. And that actually takes us to the final question here in the Q&A. It's a question from a younger investor regarding the events and roadshows coming up, and the question is-
Yeah
... will there be any young investors meetings in real life?
We can, for sure. I met an organization in Denmark for young investors in April, and we discussed whether we should do something, but nothing has materialized yet. So, but I would love to come if they want me to swing by for an evening event or for a session. But other than that, I would say we're coming out quite often, so there's a lot of opportunities to come and meet us. Whether you're young or old or somewhere in between, I mean, we're hopeful to meet everyone.
I mean, of course, I can see, you know, I think you, myself, and you, Anders, we're still quite young as well, relatively speaking. So, you know, I think we understand maybe the younger investment demographics a little bit differently than some of the peers in the industry, and I think that's a nice thing for us. So of course, I mean, I'm very happy to come out to a young investor event if there's anything being hosted and where I can contribute with something. That would be a big pleasure.
Yeah. And that finalizes the Q&A. But before we end the webcast here today, let's just hand over the word for you to give your final remarks, Gustav.
No, great questions all along. I think it was a lot and, I mean, of course, you kind of get into the rhythm of just talking, but I think we got around many things, and hopefully it clarifies a little bit for some investors what we intend to do or what our focus is. And of course, I can't comment so much on timelines or when the share price will reach a certain level.
But hopefully, you know, we can, you know, investors can feel that we wanna take them seriously, and I think this was a great way to do it, you know, to try and collect some questions and doubts that have been written or listed at different places on stock forums or social media.
Yeah, we can definitely do this again some other time. I mean, if there's any questions in the meantime, I mean, everyone's always welcome to send me an email or to just send us a message on our company LinkedIn page or Facebook page. I mean, everything will be channeled through to me, and then we will try to address any questions as good as we can.
Of course, just to reiterate that I will be around at very many events in the near coming future, starting Wednesday here in Copenhagen, then again on 11th of November in Copenhagen with you, Anders. That will be good to see you there.
And then I will also be in, I will be in Aalborg in Denmark, I will be in Kolding in Denmark, and I will be in Stockholm twice, on in end of November and start of December. So there's plenty of opportunity to come and meet me, and have a chat if there's something pressing. And of course, always looking to meet current or potential investors.
Perfect. Thank you, Gustav, for providing the answers, and thank you everyone for posting questions.
Pleasure
... and for listening in.
It was great. Thank you.
Perfect. Have a good evening, everyone.