BioArctic AB

Thank you so much and good morning and welcome to Biotic's presentation for the second quarter of 2026. LeCambi continues to progress really well with new approvals and launches and Biotic has signed additional strategic partnerships and we will talk more about this in today's webcast. Next slide please. Biotic is listed at Nasdaq Stockholm large cap, and this is our disclaimer. Next slide, please. I'm Gunilla Osvald, the CEO of Biotic, 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. I will start our presentation by giving some key highlights. Next slide, please. Biotic is among world leaders in two different areas. The first one is regarding highly selective antibodies, where we are innovative and we are generating highly selective antibodies targeting aggregated, misfolded forms of toxic proteins. And here we have the front runner, leucanumab, and we also have projects targeting alphasnuclein and TDP43, for example. The second area is when we are utilizing our brain transporter platform in an innovative and differentiated way to deliver antibodies. And I also want to highlight that we are broadening the platform to enable more efficient transportation into the brain of other modalities with innovative approaches. This could be utilized for enzymes and genetic medicines like ASOS and siRNA. A lot of new innovation is coming from biotic. Next slide, please. We are already delivering on our 2030 ambitions, and they are in four different areas. The first one is regarding Lekembe to get it as an established treatment for Alzheimer's disease. And the Lekembe demand shows a steady growth to more and more patients on a global level. Sales are progressing in line with our partner ASI's guidance. A true highlight during this summer was the FDA approval of iClick, the subcutaneous formulation with an autoinjector. And we got the approval from the FDA 13th of July, and the US launch was started this week. This means that there is an increased convenience for the patients to have the possibility to get their treatment at home instead of going to the infusion center. So I think it looks really bright also for further approvals and implementation of blood-based biomarkers, which also will simplify the diagnosis for patients. So these two aspects, the subcutaneous formulation together with the blood-based biomarkers for diagnosis are important for patients and for healthcare and is less costly for society and can lead to a broader uptake on the market. The second area is with regard to a balanced and broader pipeline with projects in all stages of development. Here I want to highlight Exidavnimab, our alpha-synuclein project, which is in phase 2a in both Parkinson's disease and multiple systemic atrophy. We had a planned safety review during this summer and it was concluded that Exidavnimab showed a favorable safety profile and it supports progression into phase 2b, which is in planning. The other alpha-synuclein follow-up compound, called BAN2238, is a follow-up compound to Exidavnimab with Brain Transporter. Here we selected a candidate drug late last year, and the IND-enabling activities are progressing really well. The pipeline overall continues to expand, and we have added new projects, for example the ones due to new partnerships. The third area is to have additional successful global partnerships. And we are very pleased with our new license agreement and collaboration with Eli Lilly, as well as our previous collaborations together with Bristol Myers Squibb and Novartis. And of course, our partner since long time ago, ASI. And all these are working in every generation in different approaches. Our latest research collaboration with Messentia, a small Swedish biotech company, opens up utilization of our brain transporter in a new area, oncology, where better penetration into the brain is wanted. And here we are focusing to start with on glioblastoma. I think it's great to see the continued strong interest in our brain transporter technology, as well as in our proprietary programs. The fourth area is that our aim is to be profitable and have recurring dividends in the future. We were highly profitable last year and our strong financial position allows us to continue to invest heavily in our business as well as giving dividends to our shareholders. We have a strong financial position with about 2 billion Swedish crowns in cash at the end of the second quarter. And this is even without the upfront payment from Eli Lilly of 30 million US dollars. And we expect to be profitable this year. Next slide, please. Partnerships is the cornerstone in our business model and the key component behind our success. Our focus has been on big pharma and different business models. So we have two different business models here. The first category, we can see ASI, AbbVie and Bristol-Myers Squibb, where they have done in-license agreements on innovative biotic developed programmes. The second category is Novartis and Eli Lilly, who are utilizing Biotic as a platform company. So they bring their compounds to Biotic. We re-engineer the compounds and build in our brain transporter technology into new compounds. And we check then the transferrin receptor functionality and then hand it back to the partner who drives and finance the program further. Then I also want to add a new kind of addition to our business model is what we are doing with Mesenchia. I think this represents another category that we now are starting with a small research collaboration that could also lead to future business. Next slide, please. Now I hand over to our chief R&D officer, Johanna Felti.

Thank you so much, Gunilla. Next slide, please. So our R&D portfolio continues to advance, as Gunilla has described, and this is really built on two complementary platforms, the antibodies and the brain transporter platform. A balanced mix of funded partnerships with ACI, BMS, Noritis and Lilly, together with proprietary programs, provide both external validation and significant long-term value creation opportunities in the portfolio. All brain-transporter collaborations are progressing well. During the quarter, we have further strengthened the platform through two new collaborations, the Lilly Partnership that represents a major validation by a leading neuroscience company and highlights also the platform's broad utility or potential in CNS. And then we have the Mesenchia collaboration that marks our first step into oncology, expanding the brain transporter platform beyond neurodegenerative diseases and broadening its future application potential. So overall, we continue to advance the diverse, increasingly partner validated pipeline with expanding scientific and commercial potential, both for antibody and our brain transport platform. Next slide, please. So taking a closer look at our Alphas & Nuclein portfolio, it is moving forward and expanding. So for Exidabnimab during the quarter, we have evaluated the safety data from the Phase IIa exit study of Exidabnimab in both Parkinson and multiple systemic atrophy. And the results confirmed a favorable safety profile of the antibody, which is an important milestone for the program. So this data will provide a strong foundation for the next step of development. And we are currently planning for Phase IIb studies in both multiple systemic atrophy and Parkinson. disease-related dementia with the ambition to initiate these studies during next year. So Exidabnimab remains the most advanced alpha-synuclein targeting programs in our pipeline and addresses a significant unmet medical need in neurodegenerative diseases. And for BAN 2238, our brain transporter enabled alpha-synuclein antibody. We continue to make progress with the ING enabling activities during the quarter. And BAN 2238, it combines our disease expertise in alpha-synuclein biology with the brain transporter technology. which is then designed to enhance the antibodies delivery across the blood-brain barrier. This program is progressing according to plan and we are currently expecting to initiate clinical development in next year. So together Exidavnimab and BAN2238 represent a complementary strategy combining the most advanced clinical stage asset with the next generation brain transporter enabling program targeting the same underlying disease biology. So next slide, please. So one of the quarters key highlights for us was really the new brain transporter collaboration with Lilly. Lilly selection of the brain transporter for next generation CNS therapies provide a strong validation from a leading pharmaceutical company and reinforces the importance of efficient blood brain delivery for CNS drug development. And this collaboration expands, of course, the further potential of the application of the brain transporter beyond our internal programs. And it combines bioarctic neuroscience expertise with Lilly's global development capabilities, further strengthening the platform for long term strategic and commercial value. The Mesenchia collaboration in oncology marks Bioarctic's entry into the oncology target space and expands the application of the brain transporter beyond neurodegenerative diseases. And the main focus here is glioblastoma, which is a highly aggressive brain cancer with significant unmet medical need. And together with Mesenchia we are now evaluating a novel approach by combining the brain transporter with Mesenchia's HVM targeting antibody, enhancing the drug delivery to the brain and also the capability to reach the tumor cells associated with reoccurrence and treatment resistance. So this initial goal is to generate a drug candidate and establish a preclinical proof of concept in the program, further demonstrating the versatility of the brain transporter platform. So taken together, the Lilly and the Mesenchia collaboration highlights the broad potential of the brain transporter. Lilly validates the platform in newer generation, while Mesenchia extends its application into oncology, demonstrating its versatility across multiple disease areas. So next slide, please. And then I will hand over to our chief commercial officer, Anna-Kaja Granblad.

Thank you, Johanna. So let me go back to Lekembe and the global rollout of the subcutaneous initiation treatment, as Gunilla already mentioned. This is clearly an important step in really expanding the patient access and further strengthening our continued growth. So in the US, the FDA approved, the approval came in July for the Lecambia iClick initiation treatment, and it is available as of this week. So this will increase clearly the momentum as we now move into the second half of 2026. This will allow people the option to inject the drug themselves instead of going to the hospitals. So they can do this at home for the whole course of treatment. So without having to come to the clinic for the time-consuming and more invasive infusions. So this change is really expected to broaden uptake, especially for the people who live far from the clinics or travel frequently. Looking at other benchmarks in the industry, we believe the uptake in the US will happen gradually as the coverage will broaden at different time points within an expected shift, potentially coming in the beginning of 2027. And we hope that the Medicare Party coverage for both the initiation and maintenance can beginning in January 2027. But we believe it will clearly be a commercial game changer and an advantage versus the competition. In Japan, we expect approval soon in this third quarter of 2026 and reimbursement a bit later expected to follow in the fourth quarter. And in China, the product is currently under priority review and we expect the approval in the first half of 2027. So importantly also is that data presented in July this summer at the AAIC Congress in London, it showed really that the efficacy and the safety of the subcutaneous administration is comparable to the IV treatment. So it's clearly supporting the potential of this more convenient treatment option. ACEI also continued to make progress across other international markets. So during the second quarter, Lecambi was launched in Australia, Belgium, Brazil and India. And at the same time, as market interest unfortunately is generally slower in Europe, the process continued to improve patient access across Europe. Here, the less frequent IV maintenance dosing is currently under EMA regulatory review. And if approved, this could not only enhance the convenience of continuous treatment, but also facilitate access discussions in some other countries in Europe. In the UK, commercial discussions between ASI and the NHS England are ongoing. And finally, we are seeing some encouraging interest from several private clinics in the Nordic countries. And as we progress also the discussions for more broader public care reimbursement. So overall, we're very pleased with the progress and together with the uptake of the usage of blood-based biomarkers, we see really significant opportunities to further expand patient access and growth. If you go to the next slide. Coming back to the AI Congress in London this summer, several speakers showed data on how the drug is performing in the real world. Here I'm highlighting a US post-market study called LEADER, which now includes 16 clinical sites across the country. In London, data were presented for more than 400 patients from 13 sites. After an average of 17 months of Lekembe use, approximately 83% had not progressed to more advanced disease, as assessed by a clinician. Of these, 76% remained at the same disease stage and 6.5% improved. For a bit more than 200 people who have reached two years of treatment, the data are similar. 74% were stable and 9% improved. Among the a bit more than 200 patients that has been on treatment for more than 18 months, almost 80% transitioned to maintenance treatment, either with Lecambi IV or subcutaneous iClick. Finally, safety observations in this real-world study were consistent with the FDA-approved label. We're looking forward to the next data cut of approximately 600 patients that will probably be presented in November at the CTET Congress. By that, I hand over to Anders, our CFO.