BioArctic AB

Welcome to BioArctic Q3 Report 2025. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing pound key 5 on their telephone keypad. Now I will hand the conference over to CEO Gunala Oswald, CFO Anders Martin Loft, and colleagues. Please go ahead.

Thank you. Good morning and welcome to Bioartic's presentation for the third quarter of 2025. Bioartic is continuing in a great way in our new era. with yet another quarter where we see more and more patients are getting access to Lekembe. And we are broadening our collaborations, utilizing our brain transporter technology. And we are also broadening our portfolio with new projects and new modalities. And we will talk more about that in today's presentation. Next slide, please. Biotic is listed at nasdaq.com large cap, and this is our disclaimer. Next slide, please. So I'm Gunilla Osvald and I'm the CEO of Bioartic and I will share today's presentation with our CFO Anders Martin Lööf and our Chief R&D Officer Johanna Felting and our Chief Commercial Officer Anna-Kaja Grönblad. Next slide please. So I will start our presentation today by giving some key highlights. We go to next slide please. So before I come into this quarter and the presentation, I just want to give a high level introduction to Biotic, if we have any new listeners today. Bioartic is among the world's leading innovators in precision neurology. And we have two key platforms. The first one is about innovation and generation and development of highly selective antibodies targeting aggregated misfolded forms of toxic proteins. And examples here are, for example, leucanumab, leucanbin and exodanumab. The second one is when we are utilizing our brain transporter platform in innovative ways to deliver antibodies and different modalities to come better into the brain. In today's presentation, we will talk about both selective antibodies like Lekembe, Exedabnimab, and our new project for Huntington's disease with Huntingtin. as well as our brain transporter technology, which we have utilized now for all our internal targets. And we have also started to use it for external projects. And we now have three different partnerships utilizing the brain transporter technology, including the recently signed deal with Novartis. Next slide, please. During the second quarter this year, we held our first capital markets day, and then we presented our ambitions for 2030. And I'm really pleased to say that we are already delivering on our ambitions. So if we start with the first one, Lekembe, to be an established treatment in Alzheimer's disease, I'm really happy to see how Lekembe's demand continues to grow. The second one is to have a balanced and broader pipeline with projects in all stages of development. And our pipeline is already broader and continue to increase and develop. The third one is additional successful global partnerships. And of course, we are very happy with the new collaboration with Novartis and we have more positive discussions ongoing. The fourth one is our aim to be profitable and to have recurring dividends in the future. And we expect to be highly profitable this year. And Anders will come back to this. Next slide, please. As I said, we are already delivering on our ambitions, and now I will go through a bit about how. We start with Lecambi, and I think now we are really well on our way to get Lecambi established as a treatment for Alzheimer's disease, a disease-modifying treatment affecting the underlying disease. Thanks to our partner, A-Size, their great work with Lecambi, it's now approved in 51 countries around the world. with Canada being the latest one. The iClick, the subcutaneous autoinjector, like a subcutaneous pen, was called iClick, was approved for maintenance dosing in the US during the quarter. And ASI has already initiated a rolling submission for initiation dosing as well. And launch has already started for maintenance dosing in the U.S. after the quarter. Next thing I want to say is about Europe. And there the launch has been initiated in Germany and Austria. And we're really happy to see that Finland has got the first patients that have been treated in a private clinic. Of course, this is great news from us from a Nordic perspective, since we are preparing for launch together with ASI in the Nordic countries. And Anna-Kaja will come back and talk more about this. Then there has been several presentations on Lekembe during the period and after the period. And those have shown that long-term data over four years treatment show continued increasing benefits over time. And also really reassuring to follow the real-world data coming for Lecambi when it's being used in clinical practice. And we have heard presentations both from the US, Japan and China. And the data have shown that the benefit and the safety profile are at least in line with the phase three results, which I think is great and encouraging. Subcutaneous administration data has also started to be presented and that supports this great further opportunity for patients to in a more easily way get the injection by an auto-injector and possible to do that at home in an easier way. Then I also want to mention that, of course, we follow with great interest the fantastic progress with the blood-based biomarkers. And the guidance was launched earlier or during the quarter about how to utilize the blood-based biomarkers. And they can now be used both for confirmation and for triaging. And we'll come back to that. If we then look at the second part of the pipeline, which is progressing really well and growing with new projects, I want to mention Exedavnamab, our alpha-s-nuclein antibody, currently in phase 2a, with a second part of the study ongoing in both Parkinson's disease patients and in multiple systemic atrophy patients. And I'm also really happy to be able to communicate that we're also now working on another misfolded protein target called Huntingtin for Huntington's disease. And here we are working with antibodies, but we are also broadening it into other modalities, utilizing our brain transporter technology. And Johanna will talk more about this in today's call. The third one is to have additional successful global partnerships. And as I said, we are very happy about the new collaboration with Novartis regarding an undisclosed target for neurodegenerative diseases. And we will re-engineer their antibody to include our brain-transported technology and enabling then a better penetration into the brain. I also want to mention the other brain-transporter collaborations that we have so far is one with ASI on Band 2802, where we're generating great data, and Band 2803, which we are completing now the tech transfer to Bristol Myers Squibb. It's also great to see that we have continued strong interest for our projects and for our brain transporter technology for antibodies, as well as for other modalities. The fourth part about the financials, we have strong financials and we are highly profitable this year with increasing royalties, as well as several milestones from ASI and upfront payments from Bristol Myers Squibb and Novartis. Next slide, please. If we think about the Alzheimer's field, it's evolving in a very nice way. And I want to highlight five different areas. The first one is that we see that we're getting easier and easier diagnosis by blood-based biomarkers. And I think this is important in helping to build the market in an easier way and to help to get the right patients to come to specialists to get a treatment initiated. The first tests are now available as confirmatory for specialists as well as for triaging for primary care. If we then look at the second one, we see more and more data that shows that earlier initiation of treatment of Lekembe shows better effect. So when we're looking at the earlier patients in the phase three Clarity 80 open labor extension study, where now 48 months data are available. we see that the majority of leucanumab-treated patients were stable or even improved after 48 months treatment. I think this is very encouraging. And I think it also further supports the ongoing AHEAD 345 study in pre-symptomatic individuals with amyloid pathology, but yet without symptoms. The third one is also really important, and that is the data that are being presented show the importance with maintenance treatment to maintain the treatment and the benefit of continued treatment with Lecambi, even after the plaques are cleared in order to continue to clear the toxic protofibers. And that's possible due to the mechanism of action and the low immunogenicity that we see with Lecambi. The fourth one is about more convenient dosing with Lecambi iClick, the subcutaneous autoinjector. And I think this is a really important next step for Lecambi. And it's making dosing so much easier for the patients and the care partners to handle the dosing at home. And we are also pleased to note that it was awarded as one of the top innovations for 2025 by Time Magazine. And the fifth one is that in the future, we expect to see more combination treatments for even better outcomes. And there is currently an ongoing study with leucanumab and A-sized tau antibody. And I think in the future, we will see more and more combination treatments. So to summarize, the key is to identify patients at an early stage, and here we can use the blood-based biomarkers, and we can start Lecambi treatment early and continue treatment with convenient dosing with Lecambi iClick. So great progress in this field for Lecambi. Next slide, please. So now we come to the R&D update, and I hand over to our chief R&D officer, Johanna Felting.

Thank you so much, Gunilla. Next slide, please. As Gunilla mentioned, BioArctic is among the world's leading innovators in precision neurology, where we have two key platforms. The antibody platform with highly selective antibodies targeting aggregated forms of toxic proteins. These are intended to treat severe neurodegenerative diseases with high unmet medical need. such as Lekembe in Alzheimer's disease, Exedavnimab in synucleinopathies, Parkinson's or MSA, and also the TDP43 project for ALS. Bioarctic is also developing a brain transporter technology that facilitates the passage of antibodies and other drugs across the blood brain barrier. And the aim with this platform is to improve the brain exposure and distribution of the drug and thereby allow for lower dosing, improved convenience, reduced manufacturing costs and potentially also better efficacy. And in addition now, we're also further developing our brain transporter technology and expanding this into new modalities other than antibodies, such as enzyme proteins and even genetic medicines. And the development of the platform that will enable us to address different diseases by tailoring the modality target combination with the highest potential clinical benefit. Next slide, please. So this is an overview of our R&D portfolio with the two platform antibodies and brain transporters and the cross program synergies. The portfolio is the combination of fully funded projects run in partnership with global pharmaceutical companies, innovative in-house projects and technology platforms with significant market and out licensing potential. So far, our brain transporter platform has generated three collaborations with ASI, BMS and Novartis, and all of these collaborations are progressing really well. They are all with different targets, but importantly, the brain transporter technology is BioArchitect's own proprietary and has the potential to generate more collaborations in the future. You will also note a new brain transporter project in the portfolio, the HDBT4801 for Huntington's disease. And I will come back to this specific project later in the presentations. So to summarize, we are both advancing and broadening our R&D portfolio with new projects into new disease areas and with new collaborations. Next slide, please. Exidabnimab is an antibody that selectively targets the pathological alpha-synuclein aggregates while sparing the physiological monomers. EXIST is a Phase IIa study testing the safety and tolerability of Exidabnimab. In this study, we're also exploring a wide range of biomarkers, both biochemical and digital. And we have a quite unique approach in including the right patients in the study with a smell test that is an early sign of Parkinson's if you have an impaired smell, and also a CSF seeding amplification test to really make sure that we have the correctly diagnosed patients with the alpha-synuclein pathology in the study. The high-dose cohort is currently ongoing, both in Parkinson and multiple systemic atrophy, and the results are expected mid-2026. So following this success study, there are several potential possibilities for future development in different synucleinopathies, such as Parkinson, MSA, and DLB, and we're currently preparing for the next stage of development. Next slide, please. So this is very exciting to me that we are now expanding our portfolio into a new neurodegenerative disease, the Huntington's disease. And this is an inherited progressive neurological neuropsychiatric disorder that is caused by impaired function and degradation of nerve cells in specific areas of the brain. Huntington's disease is caused by a toxic mutant Huntingtin protein in the brain and the mutations in this gene results in a buildup of toxic aggregated Huntington protein causing Huntington's disease. The disease onset is between 30 and 50 years old of age and it's fatal within 10 to 30 years. Current treatments are only symptomatic and there is a large unmet medical need for better treatments. So next slide please. Targeting the Huntington protein in the Huntington's disease is an excellent strategic fit into our portfolio at BioArctic and with our capabilities. So this project is built on BioArctic's extensive experience in developing antibodies against misfolded aggregated toxic proteins and also our brain transporter platform that will enable us to increase the brain delivery of the drug. In this project, several modalities is being explored in parallel, antibodies as well as genetic medicine approaches. And since this is a brain target, we have of course also combined it with our brain transporter technology. So we are excited that we now expand our portfolio with yet another neurodegenerative disease in addition to Alzheimer's, alpha-synucleinopathies, ALS and Gaucher's, with the potential to bring hope for even more patients. Next slide, please. So with that I will hand over to our chief commercial officer Anna-Kaja Granblad for a commercial update.