BioArctic AB

Welcome to BioArctic Q2 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 and CFO Anders Martinloff. Please go ahead.

Thank you. Good morning and welcome to BioArctic's presentation for the second quarter of 2025. Bioartic is now entering a new era. It's an era of profitable growth and I think it's signified by yet another strong quarter and a lot of activities throughout the different parts of the business. We see increasing Lecambi royalties and we are very pleased with the new partnership with Novartis. It's the third partnership utilizing our brain-transporter technology, and it's the first of its kind. And I'll talk more about that in today's presentation. Next slide, please. Biotic is listed at Nasdaq Stockholm large cap, and this is our disclaimer. Next slide, please. I'm Gunilla Asvold, and I'm the CEO of Biotic. And today, I will share the presentation with our CFO, Anders Martin Lööf, and also with our Chief R&D Officer, Johanna Felting, and our chief commercial officer, Anna-Kaja Grönblad. Next slide, please. I will start our presentation, and I will be giving some key highlights. Next slide, please. But before I do that, I just want to do a high-level introduction to Bioartic, if we have any new listeners today. Bioartic is among world-leading innovators in precision neurology. We have two different platforms. The first one is innovation and generation and development of highly selective antibodies that are targeting aggregated, misfolded forms of toxic proteins like leucanumab or leucanbin and exudanumab. The second part is utilizing our brain transporter platform in innovative ways in order to deliver antibodies and different modalities better into the brain. In today's presentation, we will talk more about both selective antibodies like Lekembe and Exidabnema, as well as the brain transporter technology, which we have utilized now for all our internal targets. And it's also now being used for external projects. And an example of that is the JustSign deal with Novartis. Next slide, please. During the second quarter this year, we held our first Capital Markets Day. And there, I presented our ambitions for 2030. And we have already started to deliver on our ambitions. And I'll just go through them briefly. The first one is Lekembe to be established as a treatment for Alzheimer's disease. The second one is balanced and broader pipeline with projects in all stages of development. And the third one is additional successful global partnerships. And this is an area which I enjoy and engage heavily in. And the fourth one is, of course, also very important to be profitable with recurring dividends. And Anders will come back to this later during the presentation. Next slide, please. So as I said, we have already started to deliver on our 2030 ambitions, and I will tell you how. If we start with Lekembe, it's well on its way to be an established treatment for Alzheimer's disease. Thanks to our partner ACI and their great work, Lekembe is now approved in close to 50 countries and also in Europe since the 15th of April this year. The European launch has been initiated this week with Austria started this Monday. And Germany is preparing for initiation of launch on Monday, next week, 1st of September. Our partner, ACEI, has submitted the HTA dossier in the four Nordic countries, Sweden, Finland, Denmark, and Norway. And at the world's largest Alzheimer Congress, which was held in Toronto in July, more very encouraging data was presented. It was a great Congress with about 10,000 participants with a lot of positives in the field. There were many presentations on Lecambi, including long-term data over four years treatment showing increased benefit over time. And real-world data for Lecambi being used in clinical practice was also presented, both from the US and from China. And here data showed that the benefits and the safety profile were in line with the phase three results, which also is very encouraging. ASI also presented data with the subcutaneous administration of Lecambi. And this supports a great opportunity for patients to administer Lecambi in an easier way by getting the injection by an auto-injector at home, for example. I think it was a very positive meeting with a lot of hope for patients. There was also reporting on blood-based biomarkers and their great progress and a launching of guidelines for them. The second aspect I want to talk about is the pipeline and that we are growing with further projects in development and the projects are progressing well. An example of that is Exidavnimab, our alphas-nuclein antibody, which is currently in phase 2a. And during the second quarter, it passed its safety evaluation and has now progressed into the next part of the study with higher doses. And that is now both in Parkinson's patients and in MSA patients. And so we are broadening indications for Exidavnimab. We're also very happy that we got orphan designation in both the U.S. and in EU for Excedamnumab with regard to the MSA indication. We have also broadened our portfolio, linked to the New Deal with Novartis, with a new neurodegeneration project with Brain Transporter, which of course is their project, but we are supporting. Then we come to partnerships. And here we said we should do additional successful global partnerships. And as I said, I'm very happy with the new collaboration with Novartis regarding an undisclosed target for never degenerative diseases. We will re-engineer their antibody to include our brain transporter technology, enabling a better penetration into the brain. Our brain transporter collaboration that we had previously, and which is ongoing with ASI on BAM 2802, is progressing according to plan, and the tech transfer of VAN 2803 to Bristol-Myers Gribbs is on track. It's also great to see that we have continued strong interest for our brain transporter technology. Our financials are strong, and we are highly profitable with record royalties, as well as the European regulatory milestone from ASI during the second quarter. And the new agreement with Novartis will bring further on an upfront of 30 million US dollars to Bioartic. Next slide, please. I'll just talk a little bit also about the agreement with Novartis, which is our third agreement to include our brain transporter technology. And it is the first one where another company brings their cargo antibody for us to re-engineer into a new antibody to introduce our brain transporter technology. I think this agreement shows that Bioartic now is also a platform company. Importantly, the brain transporter platform is Bioartic's proprietary technology. And in our business model, we're making deals linked to different targets while keeping the platform to ourselves. Novartis agreement encompass one undisclosed target for neurodegenerative disorders. and it is distinctly different from our other collaborations and targets. The Novartis agreement starts with a generation and evaluation phase, after which Novartis has the option for a full license. Bioartic is entitled to 30 million US dollars upfront, and the total deal value of this agreement is up to 802 million US dollars plus mid single digit royalties if the product reaches the market. The three agreements we have so far with the brain transporter technology platform are all with antibodies. But I also want to mention that we are investing and expanding our efforts into other modalities as well, where we also would like to see better brain penetration. in order to have a better efficacy. We have further business development discussions ongoing, and we aim to establish more collaborations in the future. But we have to realize that these kinds of discussions take time. Next slide, please. So by that, I will now hand over to our chief R&D officer, Johanna Felting, for an update on the R&D.

Thank you so much, Gunilla. Next slide, please. So starting with an overview of our R&D portfolio, we have two world leading platforms as Gunilla described in precision neurology with cross program synergies. First, we have our antibody projects with highly selective antibodies targeting aggregated forms of toxic proteins intended for the treatment of severe neurodegenerative diseases with high unmet medical need. And then we have projects based on our brain transporter platform that delivers biopharmaceuticals better into the brain. And for those of you familiar with our portfolio, you will now note a new project in the portfolio, the NDBT8825. And that is the Novartis collaboration on a non-disclosed target in neurodegeneration, combining the Novartis antibody with the bioarctic brain transporter technology. We're very happy now to have three BT collaborations in the portfolio with distinct and different targets. And importantly, like Gunilla said, the brain transporter technology is bioarchitects proprietary and it will have possibility to generate more collaborations in the future. So to summarize the portfolio, our R&D portfolio is a combination of fully founded projects run in partnership with global pharmaceutical companies and innovative in-house projects and technology platforms with significant market and licensing opportunity. Next slide, please. So a major challenge working with brain disorders is that only a small fraction of the antibody or the biopharmaceutical administered via the blood enter into the brain. So the aim with our brain transporter technology is to improve the brain exposure, allowing for lower doses, improved dosing convenience, reduced manufacturing and cost of goods, and potentially also improved efficacy and better brain distribution. So we have a unique approach targeting active brain transport via the transferrin receptor. And this platform has been preclinically validated in non-human primates. showing an improved brain exposure up to 70 fold without affecting reticulocytes, which is a safety concern with this approach. And what we now are doing is that we are currently working with different modalities, as Gunilla described, such as antibodies and enzymes, but we are evolving the technology also to other modalities, such as proteins, peptides, or even antisense. And this will also bring new modes of actions and expand the target space in the brain. So the Brain Transporter Technology Platform unlocks an enormous potential, not only for internal projects, but external opportunities. And as Camilla mentioned, we see a high external interest in our platform. Next slide, please. So Exidavnimab is an antibody that selectively targets pathological alpha-synuclein aggregates while sparing the physiological monomers. Exidavnimab is in phase 2a in the EXIS study and this is a study with a primary endpoint safety and tolerability of Exidavnimab but we are of course also exploring a wide range of biomarkers both biochemical digital and imaging biomarkers And this is a very innovative study, I would say, and unique in its approach of including the right patients into the study. And we do this by a smell test and also a CSF seeding amplification assay to ensure that the patients included in the study have the correct diagnosis and have the alpha-synuclein pathology that we are targeting. And in June, we had a safety review after cohort one with Parkinson's patients supporting progression into the higher dose. And cohort two is now initiated both in Parkinson's and multiple systemic atrophy. So Exedabnimab is progressing well in phase 2A, and the study results are expected mid-26th. As Gunilla mentioned, Exidabnamab has reached orphan designation for MSA, which is a rare progressive neurodegenerative disorder, both in the US and in the EU. And following the EXIST study, we see several possibilities for further development in different synucleinopathies, such as Parkinson, MSA, or DLB. And we are currently evaluating and preparing for the next phase of development. Next slide, please. And as Gunilla mentioned, everything that we have seen coming out from the AAIC meeting in Toronto this summer has been very positive, especially when looking at the Lecambi data. ASI presented new data from the phase three open label extension study and new data from patients treated with Lecambi for up to 48 months are shown on this slide. And to start with the efficacy, treatment effects continue to expand compared to the natural course of disease shown by ADNI or BioFinder data. And another way of describing the efficacy is to talk about time saved or time that you stay in an earlier stage of disease. And in this analysis, time saved is up to 13 months after 48 months of treatment. And also in terms of safety, long-term safety profile continues to be in line with previous data. So next slide, please. So in addition to the full ClarityAD study results, subgroup analysis has also been done. And I would like to highlight this one in patients treated with leucanumab and patients that have a low tau. So this subgroup is likely to have an earlier stage of the disease. And they seem to benefit even more from treatment looking at the CDR somavoxes. And a large percentage of patients being unstable, being stable or even improving after 48 months. And this is, of course, very, very exciting data, but it's also smaller studies. We have to be mindful that this is a small population, but it shows the importance of starting treatment early on. And we are really looking forward to the head study results testing that can be in earlier AD patients. So next slide, please. So in addition to the presented long-term efficacy and safety data of leucanumab, important presentations during the Congress covered real-world evidence data from leucambi being used in clinical practice. These data confirm the clarity AAD phase 3 data, and it's very reassuring that the real-world evidence data is in line with the clinical study, both with regard to safety and efficacy. Also, ASI presented encouraging data on the sub-Q autoinjector maintenance treatment. And of course, a more convenient sub-Q dosing will allow patients to easily be treated at home, enabling continued treatment without visiting infusion centers. And Anna-Kaja will talk more about this. And also, in addition to the ASI presentations at AAEC, new guidelines for blood biomarkers were presented, and Anna-Kaja will talk more about this as well. So taken together, all of the data presented will help to expand Lecambi usage. Next slide, please. And I now will hand over to our chief commercial officer, Anna-Kaja Grönblad, for a commercial update.