Ascelia Pharma AB (publ)

Welcome to a Celia Pharma Q2 2026 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, CFO Anton Hansen, and CSO Andreas Norlin. Please go ahead.

Thank you and welcome everyone to the webcast for Acelia Pharma's Q2 report for 2027. On this call we will be making forward-looking statements. On today's call we will start with an overview of Acelia Pharma and recent key events and then head into our portfolio update with an emphasis on the recent complete response letter for AuviGlance before moving to financials and priorities ahead. After the presentation we will open up for questions. At Ascelia Pharma, we identify, develop and commercialize novel drugs that address unmet medical needs within rare cancer conditions. We're based in Malmö in Sweden and we're listed on Nasdaq.com. We have two drugs in our pipeline. Orbiglans is a diagnostic drug and we have submitted a new drug application to the FDA to obtain approval in the US. We received a complete response letter in early July, and we'll meet with the FDA on 9th September to find the path to approval. Oncorel is a patented tablet formulation of iminotecan with encouraging results in phase one and potential to treat a range of solid tumors. In April, we raised 20 million Swedish kroma in a directed share issue. And in May, we had our annual general meeting as usual. In June, OverGlance data was presented at the ESCA conference, the major European conference for gastrointestinal and abdominal radiology. At the end of the quarter, we filed a patent application regarding packaging and manufacturing, and thus further strengthened the IP position of OverGlance. After the end of the second quarter, we received a complete response letter from the FDA, regarding our new drug application submission for OB-GYNs. This was unexpected, and we'll talk more about it later on this call. We also announced that our Chief Financial Officer, Anton Hansen, will be leaving Acilia Pharma, and that we have implemented cost reduction actions to improve our financial flexibility. I'd like to thank Anton for his contributions at Acilia, and wish him best of luck going forward. We will start the portfolio section of our presentation with OrbeGlance. Despite the setback with the complete response letter, we continue to be excited by OrbeGlance and here is why. OrbeGlance is addressing a well-defined unmet medical need for a subgroup of people living with cancer. This is an $800 million global addressable market opportunity with OrbeGlance as a first-in-class product to talk We have commercial scale manufacturing in place and we have strong data from nine clinical studies, including compelling phase three data. As mentioned, the OrbiGlands new drug application has been submitted to the FDA and undergone the review process. Unfortunately, the FDA sent a complete response letter with some specific issues, but many areas of the new drug application were reviewed that didn't result in issues being raised. Our focus is on agreeing with the FDA on what is required to obtain approval for OrbiGlands. Orbiglans is an attractive asset and we will work with our partner who will drive the commercialization once the product is approved. Based on the NDA submission and the data, the unmet medical need that Orbiglans addresses, the progress of the review process including the audits conducted, we were expecting an approval of Orbiglans in July. In the complete response letter, the FDA raised some issues that we will discuss with them at the Type A meeting in September. and align so we can find an efficient way path forward for Orviglans. We continue to be confident that the Orviglans new drug application is supported by substantial evidence of efficacy and safety for its intended patient population, which we think should support approval and are committed to bringing Orviglans to patients. We'll now go into more details on the regulatory process and I'd like to hand over to Andreas.

Thank you, Magnus. As Magnus just mentioned, receiving the complete response letter was not the outcome we expected, given the interactions we had with FDA throughout the development and the review process. The questions in the response letter relate primarily to aspects of the image read methodology, including the justification of the reread and interpretation of the results, together with comments on the product quality. Importantly, this gives us a focused set of issues to work through rather than a broad challenge to the overall program. Our team has moved quickly to analyze the FDA feedback and evaluate the most appropriate path forward, which we have outlined in the type A meeting briefing package submitted to the FDA. And we continue to believe strongly in the clinical value of the product and are fully committed to addressing the agency's questions in a collaborative manner. So let me now briefly explain how we view these topics. First, I want to acknowledge that the FDA's conclusion differs from our own assessment of the data. The agency has requested additional clinical evidence and we take that conclusion very seriously. At the same time, after extensive internal review and consultation with external experts, we continue to believe that there is a strong scientific rationale supporting the decisions that were made in the NDA application originally. Specifically, we believe that image reread was justified by the systematic bias of the image scoring that was identified. We also believe that the training of the new readers was appropriate and that assessment of T1-weighted images represents a clinically relevant measure of efficacy for a T1-enhancing contrast agent, such as Orbit Lounge. The discussion around T1 can sound highly technical, but the principle is actually quite simple. Liver MRI relies on multiple imaging sequences, each contributing different and complementary information. T1 is the sequence where OrbitBounce is designed to work. T2 and diffusion weighted imaging remain important parts of the examination, but they provide different types of diagnostic information. So based on this, we believe there is a strong scientific rationale for evaluating lesion visualization using T1 weighted images when assessing the effect of a T1 enhancing contrast agent. At the same time, we recognize that the FDA has taken a different view and we remain committed to maintaining an open and constructive dialogue with the agency as we work toward the most appropriate path forward. Regarding product quality, we have aligned with the FDA's recommendations and implemented the requested actions related to product specifications. So let me conclude by putting this into perspective. The FDA inspections carried out during the review were completed without critical findings for the NDA. and the product quality observations have been addressed in alignment with the agency's recommendations. This is highly reassuring for the continued dialogue with FDA. The remaining discussion is centered on the interpretation of the clinical imaging data, and the upcoming Type A meeting provides an important opportunity to align with FDA on the path forward. While we are disappointed by the outcome of the review, our confidence in OverGlance remains unchanged, and we continue to believe that the totality of the imaging efficacy and safety data supports approval, and we remain fully committed to bringing OverGlance to patients. So, Magnus.