Q2 2026 Pila Pharma AB (publ) Earnings Call
Speaker #1: Of Sweden, listed on Nasdaq Stockholm First North, have opened the books for H1, the first half-year of 2026. I have the pleasure of welcoming Pila Pharma CEO Gustav H.
Speaker #1: Gram to the studio. Hello, Gustav.
Speaker #2: Thank you. How are you?
Speaker #1: And let's start off with the financial status. You improved your numbers compared to H1 2025. What are the main drivers?
Speaker #2: Well, I would say it's very positive that we quarter over quarter, or half-year after half-year, showcased a very consistent cash burn. We are very prudent with our spending in general, but of course now, at least looking forward, we're looking into periods where our capital expenditures will be higher.
Speaker #2: That being said, we're in a good financial position. I think we are coming into H2 of this year in an improved state, and we're following through on the objectives that we set out when we last raised capital in the summer of 2025, when we launched our bed on obesity strategy.
Speaker #2: So overall, we're confident and we're positive, and we're very excited for the second half.
Speaker #1: I can see why. Like I said, you raised money to make the preclinical and clinical studies. And can you update us on where you are in that strategy now?
Speaker #1: You're after half your showcase—a very consistent cash burn. We are very prudent with our spending in general, but of course now, at least looking forward, we're entering periods where our capital expenditures will be higher.
Speaker #2: So having access to treatment is going to be a lot easier if you have simple oral solutions. So, from my—from my understanding, it's very good that we have GLP-1 products that have now been launched.
Speaker #2: Sure. So I mean, we launched capital last summer in a heavily oversubscribed rights issue. For developing a clinical path for our TRPV1 antagonist, where we would have liked to assess how it could potentially become a new oral solution for treatment of obesity and related disorders.
Speaker #2: They showcase great weight loss, but they carry the same nature as the injectables, which is that you do get nausea, constipation, diarrhea, etc. So, having alternative oral solutions is definitely in favor for any company wishing to play a role in this area.
Speaker #1: That being said, we're in a good financial position. I think we are coming into H2 of this year in an improved state, and we're following through on the objectives that we set out when we last raised capital in the summer of 2025, when we launched our Bet on Obesity strategy.
Speaker #2: So we got the capital in. We engaged a preclinical CRO. That was primarily for the purpose of deepening our conversations and partnering interests with other pharma companies.
Speaker #1: Mm-hmm. Can you say anything, without giving details, regarding partnership discussions, and what is the plan for financing going forward?
Speaker #1: So, overall, we're confident and we're positive. Mm-hmm.
Speaker #2: From a partnership perspective, I mean, we of course are— we're super delighted now that we got the green light from the authorities to conduct this study. We will be approaching the contacts we have at various pharma companies to update them on this news and to share a little bit of detail around why we chose to design the study the way we did.
Speaker #2: So it was not necessarily a key part of the overall development strategy as such. The results came out in Q1 and was unfortunately not as we had hoped.
Speaker #2: But anyhow, the team and I myself were still very much confident, and I think that was also the very evident when we were last here in Q1.
Speaker #2: And when do we expect to see some data? And then, of course, when it comes to financing currently, it's only the part one—the safety component—that is financed.
Speaker #2: That it's all about clinical data in the end. So that is why we took progressive measures to ensure that we could move on, really make a very, very good clinical trial application together with a clinical CRO that we had announced in February.
Speaker #2: But myself, as well as the Board, we're, of course, looking into all the solutions that are possible to ensure that we can actually progress beyond this and ensure that we can get efficacy data on the backside of a full PPC-04.
Speaker #2: Sorry, end of January. And that work has gone on over the spring. We sent in a clinical trial application just before summer. We got responses back from the authorities in the middle of summer with very, very few questions, which is indicative to us that this is a very detailed and very thorough application that we sent.
Speaker #2: It's a, how can we say, it's a project that is very well defined. It has a very long investigative brochure. And there's a lot of safety data already, which authorities like.
Speaker #2: So that meant that we here in the middle of August actually received approval to conduct what's called PPCT 04, which is our next clinical study which is a safety study that is parted up in two, whereas the first component or the first part is a very heavy safety study, if we can say so, where we have a number of patients coming into the clinic.
Speaker #2: Where there will be monitored when they are dose escalated. So the idea is that we want to test higher doses, but also longer durations.
Speaker #2: So overall, we're in a very positive spot, and we're very much following through on what we set out, not just in our rights issue last year, but also going all the way back to what we wrote in our prospectus for our IPO.
Speaker #2: So yeah, very positive developments.
Speaker #1: And is this first part of the study that is going on for 12 weeks?
Speaker #2: Yes. So part one will be we will be up escalating every week, basically from one level to another, until patients can no longer tolerate it, for example.
Speaker #2: And then they would stay on the dose that is deemed tolerable for another eight weeks. So it will be like this. But in the subsequent part two study, we would like to enroll quite a much larger number of patients where we would run them on doses that have been defined in the part one.
Speaker #2: And we would run those on three months on those dose levels.
Speaker #1: And so follow-up question from a viewer here. What would constitute a successful PPCT 04 outcome is success defined as tolerability at the target dose, a directional body weight signal, or else?
Speaker #2: So for the first part, it's definitely to determine a dose. So TRPV1 antagonist has historically not been easy to work with. Many projects have been discontinued due to adverse effects.
Speaker #2: So for us, it's very, very important to move forward in a very diligent manner in a clinical setting where we can ensure that the safety requirements are in place once we dose escalate.
Speaker #2: So we really find that window where we could potentially have effects. So for us, it's a matter of establishing the window and then in subsequent studies in obesity or in diabetes, or in erythromelalgia, or in whatever disease it may be, we will have a much better knowledge of what is the best starting point for these patients to ensure that we could potentially achieve effects in those studies.
Speaker #1: And you represent a first-in-class oral solution for this field. The fact that there are now other oral solutions from the GLP-1 companies, what does that mean to Pila?
Speaker #2: I think for us, it's actually positive because now the market is really getting defined. It's getting matured. We do see that in many ways, analysts as well as bankers, banks are starting to recognize that oral solutions will take a larger part of the obesity market purely because it's also becoming a very consumer-based area of business.
Speaker #2: So having access to treatment is going to be a lot easier if you have simple oral solutions. So from my understanding, it's very good that we have GLP-1 products that have now been launched.
Speaker #2: They showcase great weight loss, but they carry the same nature as the injectables, which is that you do get nausea, constipation, diarrhea, et cetera.
Speaker #2: So having alternative oral solutions are definitely in favor for any company wishing to play a role in this area.
Speaker #1: And can you say anything without giving details regarding partnership discussions and what is the plan for financing going forward?
Speaker #2: From partnership perspective, I mean, we of course are super delighted now we got the green light from the authorities to conduct this study, and we will be approaching the context we have at various pharma companies to update them on this news and to share a little bit of detail around why we chose the study design the way we did.
Speaker #2: And when we expect to see some data. And then, of course, when it comes to financing currently, it's only the part one. So the safety component that is financed.
Speaker #2: But myself as well as the board, we're of course looking into all the solutions that are possible to ensure that we can actually progress beyond this and ensure that we can get efficacy data on the backside of a full PPCT 04.
Speaker #2: So overall, I would say we're in good financial position now, but we also have work to do, but we are quite confident that specific investors will see quite a lot of upside in the potential of being on board in anticipation of getting three months readout in obese patients where the window is defined.
Speaker #1: OK. And could you put some color to where you stand with your process regarding clinical study in erythromelalgia EM?
Speaker #2: I mean, it's a disease we would really love to do more with. Right now, we have taken the decision to actually await the outcome in the first part of PPCT 04 purely because we do feel that knowing the therapeutic window better will also be of benefit to erythromelalgia patients.
Speaker #2: So from our point of view, it's a hugely interesting disease. It's like from a mechanistic standpoint, using a TRPV1 antagonist has should have very clear effects.
Speaker #2: So, overall, I would say we're in a good financial position now, but we also have work to do. We are quite confident that specific investors will see quite a lot of upside in the potential of being on board for the anticipation of getting, yeah, a three-month readout in what these patients—where the window is defined.
Speaker #2: And I believe that's also why the FDA gave us an orphan drug designation to treat this disease some years ago. So it is something we would love to progress with.
Speaker #1: Mm-hmm.
Speaker #2: Okay.
Speaker #1: And could you add some color to where you stand with your process regarding the clinical study in erythromelalgia, EM?
Speaker #2: Right now, we've paused it for the moment purely to ensure that we have a much better starting point, which is derived from the outcome of PPCT 04's part one.
Speaker #2: Mm-hmm.
Speaker #1: I mean, it's a disease we would really love to do more with right now. We've taken a decision to actually await the outcome in the first part of PPC 04, purely because we do feel that knowing the—the therapeutic window better will also be of benefit to erythromelalgia patients.
Speaker #2: And then once we have those therapeutic windows, established, we would feel confident to actually progress and start a smaller pilot study in erythromelalgia to understand if it could potentially alleviate these patients of their pain.
Speaker #1: OK. And kind of technical question regarding saying like this, what is the relationship between the parent company and the Danish subsidiary? Is there any IP tied to the Danish company?
Speaker #1: So for—from our point of view, it's a hugely interesting disease. It's, like, from a mechanistic standpoint, using a TRPV1 antagonist should have very clear effects, and I believe that's also why the FDA gave us an orphan drug designation to treat this disease some years ago.
Speaker #1: And does the Swedish parent own 100% of the subsidiary?
Speaker #2: Let me start backwards. Yes, the parent company owns 100% of the Danish daughter company. And the daughter company is established to conduct the R&D operations.
Speaker #1: So it is something we would— we would love to progress with. Right now, we've paused it for the moment purely to ensure that we have a much better starting point, which is, you know, derived from the outcome of PPC204's part one.
Speaker #2: That being said, all IP is owned by the Swedish mother company.
Speaker #1: OK. Thank you. And if we look forward, there are a lot of questions about this. When and what milestones do you see in H2 regarding the clinical studies and potential other projects?
Speaker #1: And then, once we have those—those therapeutic windows established, we would feel confident to actually progress and start a smaller pilot study in erythromelalgia to understand if it could potentially alleviate these patients of their pain.
Speaker #2: So right now, the preparations and final preparations for the upcoming safety part is ongoing. We haven't communicated any timelines yet. We will as soon as we have them established.
Speaker #2: Mm-hmm. Okay.
Speaker #1: kind of technical question.
Speaker #2: Mm-hmm.
Speaker #1: Regarding, well, saying it like this, what is the relationship between the parent company and the Danish subsidiary? Is there any IP tied to the Danish company?
Speaker #2: And once that becomes clear, of course, investors can expect to see that we will be starting up clinical trials again. It's been a little bit of time since we were in that space.
Speaker #1: And does the Swedish parent own 100% of the subsidiary?
Speaker #2: Let me start backwards. Yes, the parent company owns 100% of the Danish daughter company.
Speaker #2: So that overall is very positive. There will of course be announcements from us when we have the first patients coming in, when first patients are being treated.
Speaker #1: Mm-hmm.
Speaker #2: And the daughter company is established to conduct the R&D operations. That being said, all IP is owned by the Swedish mother company.
Speaker #2: I've escalated as well as when it finishes and what dose levels have been determined to be the best. So overall, I would expect a good flow of news coming from us related to this study that is coming here in the remainder of the year.
Speaker #1: Okay, thank you. And if we look forward, there are a lot of questions about this. When and what milestones do you see in H2 regarding the clinical studies and potential other projects?
Speaker #2: So right now, the preparations and final preparations for the upcoming safety part are ongoing. We haven't communicated any timelines yet.
Speaker #1: OK. And that was all my questions for you today. Thank you so much, Gustav H. Gram, for taking your time.
Speaker #2: We will as soon as we have them established. And— and once that, becomes clear, of those investors as well, you know, investors can expect to— to— to see that we will be in, you know, starting up clinical trials again.
Speaker #2: It's been a little bit of time since we were—since we were in that space, so that overall is very positive. There will, of course, be announcements from us when we have the first patients coming in, when the first patients are being treated.
Speaker #2: I've escalated, as well as when it finishes and what dose levels have been determined to be the best. So overall, I would expect a flow of news coming from us related to this study that is coming here in, yeah, in the remainder of the year.
Speaker #1: Okay, that was all my questions for you today. Thank you so much, Gustav H., for taking your time.
