Ascelia Pharma AB (publ)

Welcome to Acellia Pharma Q3 2025 report presentation. For the first part of the conference, 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 Magnus Corfitzen, CSO Andreas Norlin, and Deputy CEO Julie Warris Brogren. Please go ahead.

Hi, everyone, and welcome to the webcast for Celia Fama Q3 Financial Report 2025. On this call, we will be making forward-looking statements. On today's call, we will start with recent key events and then head into our portfolio update before moving to financials and priorities ahead. After the presentation, we will open up for questions as usual. At Acelia Pharma, we identify, develop, and commercialize novel drugs that address unmet medical needs within rare cancer conditions. We're based in Malmö, Sweden, and are listed on nasdaq.com. We have two drugs in our pipeline. Orbic Lans is in the registration phase as we have successfully completed the pivotal phase three clinical study, SPICLE, and have submitted the new drug application to the FDA. The FDA is currently reviewing the application. OrbeGlance has orphan drug designation from the FDA and is targeting an addressable market opportunity of $800 million. Our other asset, Oncral, is a patented tablet formulation of virenotekin with encouraging results in phase one and potential to treat a range of solid tumors. We have a clinical collaboration with Tidal Oncology and are initially targeting treatment of gastric cancer. The key milestone in the third quarter was our submission of the Overglans NDA to the FDA, which took place in early September. Also in September, Fenja Capital converted their 7.5 million Swedish kronor convertible. And at the end of September, we completed a directed share issue of 30 million SEK before cost based on inbound investor interest. With these financing events, we now have a clean balance sheet and a stronger cash balance. On Monday this week, we announced the appointment of Anton Hansson as our new Chief Financial Officer. Anton has a background in corporate finance and most recently worked with KPMG. In conjunction with the appointment of Anton, we made some changes to the management team to prepare our organization for the next phase of growth for Acelia Pharma. We have focused on some key value creation opportunities, in particular with AuricLens. The first objective is a timely submission and approval of OverGlance with the optimal label. The key milestones to read this objective are first the submission of the OverGlance NDA, which was done on the 3rd of September. This means we expect to receive a PDUFA date from the FDA, and this is likely to be shared with us in the middle of November. The approval of the OverGlance NDA is expected after a standard 10-month review by the FDA. As we submitted in early September, that would imply a timeline around early July. In parallel, the second objective is to progress all we can for commercialization. The key activities are to continue to advance our launch readiness, fine-turing manufacturing and supply chain is ready for launch, as well as working with medical experts and key opinion leaders, payers, patient advocacy groups, and other key stakeholders. Another important part of that is entering into a commercialization partnership. I'm very happy with the progress we're making in Acelia Pharma and the efforts made by our team to ensure we will meet our objectives and create value for shareholders. Now we will move into the portfolio section of our presentation and we'll start with OrbitGlance. We are very excited about OrbitGlance and here's why. Orbig Lens is addressing a well-defined unmet medical need for a subgroup of people living with cancer. This is an $800 million global market opportunity and Orbig Lens is a first-in-class product to target this and has an orphan drug designation from the FDA. We have commercial scale manufacturing in place and we have strong data from nine different clinical studies, including compelling phase three data. As mentioned, the Orbig Lens new drug application has been submitted to the FDA and the review is ongoing. Now we'll go further into the OrbeGlance opportunity, and I'd like to hand the word over to Julie. Please go ahead.

Thank you, Magnus. OrbeGlance is a first-in-class MRI contrast agent. It addresses an unmet need for cancer patients for whom there are no good alternatives available today. Liver metastases are common in many cancer types. An adequate visualization of liver tumors and metastases is critical for making timely and appropriate treatment decisions and for following up on the effect of treatment. Contrast-enhanced MRI is the gold standard procedure for examination of patients with suspected unknown tumors or metastases. And the most used contrast agents are based on the toxic heavy metal gadolinium. In patients with severe renal impairment, the use of gadolinium-based contrast agents has been associated with an increased risk of a very severe side effect called NSF, nephrogenic systemic fibrosis, which may even have a lethal outcome. Both the European and US regulatory authorities issued warnings for the use of gadolinium-based contrast agents in this group of patients. Patients with impaired kidney function will therefore typically receive an MRI without contrast, which can result in liver images of suboptimal quality, risking that their cancer is not managed in the best possible way. We envision that OrbeGlance, which is based on manganese, not gadolinium, will address this unmet medical need and in the future become an efficacious non-gadolinium liver imaging contrast agent for cancer patients with impaired kidney function. The addressable market for OrbeGlance has a global value of 800 million US dollars annually. The US represents almost half of this. This market opportunity for OverGlance addresses the unmet need for a well-defined patient population, the cancer patients who need imaging of their liver and who also have severely impaired kidney function. Our strategy for commercialization is to launch through partners. This strategy supports our ambition to secure the optimal balance between future revenues and investment required. Our focused, ambitious launch strategy and the plans are built on advanced market insights, and they are ready and in place to support this partnering strategy and the launch of Orgogans. As mentioned, the U.S. is the largest commercial opportunity. In the U.S. alone, our real-world data, i.e. data from realized procedures in our target patient population, show that every year, 100,000 abdominal imaging procedures are performed in around 50,000 patients, patients that fall under the black box warning for gadolinium contrast agents. And this is about 4% of people with cancer undergoing abdominal imaging. The well-defined patient population with a clear unmet need also drives an attractive pricing opportunity. And we have extensive input from market access and pricing experts with whom we've tested different pricing levels and collected insights on the evidence needed to support access and reimbursement. And we have investigated pricing and access benchmarks of other innovative diagnostics in the U.S. And 90% of healthcare professionals are concerned with issues related to gadolinium contrast agents, including the severe side effect associated with our target patient population, NSF. In fact, 16% of providers have experienced cases of NSF in patients exposed to gadolinium. These insights come from market research for 270 US healthcare professionals. And the insights confirm the concerns with gadolinium in clinical practice and the unmet need for Orbitlams. When speaking with experts, whether in radiology or nephrology, they confirmed that an attractive alternative to gadolinium for our target patient population would address concerns of today with the potential to become a valuable addition to their clinical practice. The momentum for options for patients without gadolinium is strong. Beyond the risk of NSF in kidney impaired patients, gadolinium is well known to be retained in the brain and other tissue in all patients. And scrutiny over the possible safety effects is a key concern of regulatory and medical bodies. It's also well known that gadolinium is excreted via the kidneys and urine, and because it's difficult to remove in our sewage system, it's discharged into the environment and into our drinking water. There's an urgency from regulators and medical bodies to find a viable alternative to the growing use of toxic gadolinium, an alternative that's not associated with these potential safety and environmental concerns for patients and for the environment with gadolinium. And the industry is responding. Gatolinium or overglams will be the first in class liver MRI contrast agent for a future with less Gatolinium and improved outcomes for our target patient population. Recent developments from large Gatolinium manufacturers are focused on an early stage injectable manganese contrast agent, which is not liver specific like overglams, or focused on smaller doses of Gatolinium. And we're excited that we have a head start with the upcoming approval and launch of OverGlance. The go-to-market strategy for OverGlance is to launch with commercialization partners. This strategy supports our objective to maximize the value of OverGlance. OverGlance is an attractive partnering opportunity. With clinical development completed, we offer a de-risked asset in the process of FDA approval. There's a clear unmet need for and with a focused launch with synergies from many types of commercial stage companies working with hospital decision makers. And our dialogue with potential partners for the successful commercialization of overgrams is progressing. In summary, we're excited about the opportunity to bring OverGlance to approval and to market with a partner. A market representing 800 million US dollars annually in an addressable market for an unmet need for very vulnerable patients. We've come a long way with the successful completion of clinical development and our data supporting efficacy and safety of OverGlance is well received by the medical community. With this, I will hand over to Andreas to talk about our NDA submission and the review process ahead with the FDA.