Ascelia Pharma AB (publ)

Welcome to a Celia Pharma Q3 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 five on their telephone keypad. Now I will hand the conference over to CEO Magnus Corfitzen and CSO Andreas Norlin. Please go ahead.

Thank you and welcome everyone to the webcast for Acelia Pharma's third quarter report for 2026. 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 the portfolio update with an emphasis on the recent Type A meeting with the FDA before moving to on-crawl and 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 are listed on Nasdaq Stockholm. We have two drugs in our pipeline. Orviglans is a diagnostic drug that has been submitted to the FDA to obtain approval in the US. We had a type A meeting with the FDA in September to discuss the path to approval. Oncoral is a patented tablet formulation of irunotecin with encouraging results in phase one and potential to treat a range of solid tumors. In early July, we received a complete response letter from the FDA for our NDA submission for the class. Later in July, we communicated organizational changes as well as implementation of cost reduction actions to improve our financial flexibility. In September, we announced the publication of our hepatic impairment clinical study in the peer-reviewed Journal of Magnetic Resonance Imaging. And in September, we had the Type A meeting with the FDA to discuss the path to approval for reglands in the US. After the end of the quarter, we received the official minutes. The complete response letter was a significant setback. We continue to believe in the value of OrbiGlance and how it can help patients and build an attractive commercial potential. Our strategic direction remains steady and our strategic priorities are to continue the partnering process for OrbiGlance. We envisage a partnership to now include both development and commercialization. We're preparing a meeting with the FDA to create alignment on an appropriate endpoint for reread of the SPARC images that can lead to approval in the US. And we are also preparing a dialogue with the regulatory agencies in Europe to obtain their feedback on the probability of overglance based on the existing data package that we have. In a cost conscious manner, we're also preparing on-crawl development and also partnering dialogues. So we'll start the portfolio section of our presentation with OrviGlance. So despite the setback with the complete response letter, we continue to be very excited by OrviGlance. OrviGlance is addressing a well-defined unmet medical need for a subgroup of people living with cancer. This is an $800 million addressable global market opportunity and OrviGlance is a first-in-class product to target this and has orphan drug designation from the FDA. We have commercial scale manufacturing in place and we have strong data from nine clinical studies. We think Oroglands is an attractive asset and we will work with a partner who will drive the final part of development and commercialization. Let's talk about how Oroglands can help patients. Cancer in the liver is a significant challenge in cancer care. Many different cancer types metastasize to the liver, meaning they start in another organ and spreads to the liver. This accounts for approximately 90% of cancer in the liver in the US and Europe. The remaining 10% of cancer in the liver is when cancer originated in the liver. The liver is often the first organ where the cancer spreads to and often also the cause of death. That is why cancer in the liver is a major issue in cancer care. Therefore, it's important to perform high-quality imaging to determine if the cancer has spread to the liver or how the cancer in the liver is responding to therapy or for use in surgical planning. The best way to do this is with liver MRI and today use a gadolinium-based contrast agent. For most patients, this works well. However, patients with severe renal disease are at risk for a potentially fatal gadolinium-induced side effect known as nephrogenic systemic fibrosis. Regulatory agencies have requested black box warning on gadolinium products because of this risk. It is exactly these patients that we aim to help with OrbeGlance. OrbeGlance provides high quality imaging and because it's based on manganese, there are none of the gadolinium associated risks. This translates into, this automatically translates into a global addressable market opportunity of $800 million on an annual basis. The US market is almost half of this and therefore the US market has been prioritized by Celia. Asilia will work with partners to drive the commercialization of Orboglance. And now I will hand over to Andreas to discuss the path for approval.

Thank you, Magnus. So the Type A meeting with FDA was an important and constructive step forward for the Orboglance program. And while FDA continues to require additional clinical evidence for approval, the meeting substantially reduced uncertainty around both the product quality and clinical components of the complete response letter. Several important areas of alignment were established during the discussions and FDA acknowledged the significant unmet medical need in patients with severe renal impairment, which is a patient population with limited access to contrast-enhanced MRI today. The agency also acknowledged a favorable safety profile of Orvoglans and its technical performance as a liver-specific T1-enhancing contrast agent. and importantly FDA confirmed that the existing clinical data package retains value and may contribute as supportive evidence in a future submission. On the product quality side we reached alignment on the proposed strategy to address the observations raised in the CRL and this is important because it removes a significant area of uncertainty and FDA expectations are now understood and then implementation activities have already started. Finally, the meeting clarified that the key remaining regulatory question relates to demonstration of clinical utility. This was the most important outcome of the meeting. In the CRL, FDA's recommendation was to conduct a new clinical study with new patients. During the Type A meeting, FDA confirmed that this remains one possible route of approval. However, the agency also acknowledged an alternative approach. FDA indicated that additional clinical evidence could potentially be generated through a new evaluation of the existing SPARQL image database using a different primary endpoint than originally used. We view this as a significant and encouraging development. Rather than having a single path forward based on a completely new clinical study, there is now the possibility of leveraging the substantial clinical data that have already been generated. Additional work is still required and our immediate focus is to identify endpoints that appropriately address FDA's concerns and demonstrate clinical utility. Before initiating any image reading process, we intend to align with FDA on the selected endpoint through a type C interaction. So having discussed the regulatory progress for Orvoglans, I would now like to spend a few minutes on our second oncology asset, OncGrawl. While the company's immediate focus remains advancing Orvoglans towards approval and partnering, OncGrawl continues to represent an important long-term value opportunity. Over the last decade or so, oncology has seen tremendous progress through targeted therapies and immunotherapies. Despite these advances, chemotherapy continues to be used in the majority of patients with solid tumors and remains a cornerstone of cancer treatment. At the same time, patients are living longer, making treatment burden, cumulative toxicity and quality of life increasingly important considerations. Regulators, clinicians and oncology societies are paying greater attention to these aspects when assessing treatment value. This creates a significant opportunity for treatment approaches that preserve anti-tumor efficacy while reducing toxicity and improving quality of life. We believe this trend is highly relevant to Oncoral and forms part of the rationale behind our development strategy. Oncoral is designed to fundamentally change how arenotecan is delivered. Conventional arenotecan is administered intravenously at relatively high doses every few weeks, and this results in high peak drug concentrations that are frequently associated with toxicities, followed by prolonged periods with minimal exposure. Oncoral enables a very different dosing strategy through daily oral administration. The goal is to create a more sustained exposure profile over time, and this approach, sometimes referred to as metronomic dosing, has the potential to improve tolerability while maintaining anti-tumor activity. Sustained exposure may also allow arenotechin to affect not only tumor cells directly, but also biological processes within the tumor microenvironment that are difficult to target with conventional intermittent dosing. So in simple terms, we believe Oncroil may allow us to use a proven chemotherapy in a smarter and potentially more effective way. So these slides explain why we believe Oncroil is more than simply an oral formulation of Irinotecan. Many groups have attempted oral aeronautic and development over the years. The challenge has been achieving sufficiently predictable pharmacokinetics and bioavailability to support reliable chronic dosing. The proprietary Ancoral tablet technology addresses this challenge and enables daily administration with a pharmacokinetic profile suitable for metronomic treatment. Our phase one studies provided encouraging evidence supporting this concept and we observed predictable drug exposure, favorable tolerability and stable disease in a number of heavily pre-treated patients. Taken together, these findings support the feasibility of transforming arinotecan from an intermittent infusion therapy into a continuous metronomic treatment strategy. That is why we like to describe Oncoral as a dosing platform rather than a simple reformulation. So Oncoral is more than just another dosage form of arinotecan and this distinction is important. on broad differs from conventional arena chicken in several ways. First, the pharmacology is different because patients receive continuous low dose exposure rather than intermittent high dose treatment, as I just described. And second, the biology may be different. Metronomic chemotherapy has been associated with anti-angiogenic and immunomodulatory effects that extend beyond direct tumor cell killing. And third, the treatment feasibility is different. Daily chronic arenotecan treatment is simply not practical using intravenous administration. And finally, the clinical opportunities may be different. This approach could potentially be applicable in maintenance settings and combination regimens, where conventional arenotecan is difficult to use. For these reasons, we believe Oncoral should be viewed as a platform enabling a distinct therapeutic approach, rather than merely an oral substitute for existing arenotecan products. Our current development focus is gastric cancer and this indication represents a significant unmet medical need and is an area where arenotecan already has established clinical irrelevance. An important part of the rationale comes from preclinical data demonstrating synergy between arenotecan and Lonesurf and these studies suggest greater antitumor activity when the two agents are combined. This combination is particularly attractive because both treatments are administered orally, creating the possibility of a fully oral treatment regimen. While gastric cancer is our lead indication, we view it as a beginning rather than the end of the opportunity. ARENOTECAN has established anti-tumor activity across multiple solid tumors and remains included in treatment track guidelines for several major cancer types. The broader vision for ONCRAAL is therefore to apply the daily oral dosing concepts wherever ARENOTECAN biology and clinical experience support such an approach. And as shown on this slide, several of these indications represent very substantial patient populations and commercial opportunities. This gives Oncora the potential to evolve from a single product opportunity into a broader platform capable of generating value across multiple cancers. In summary, we are not simply developing an oral arimotecan product. We are developing a new way of using arimotecan with the potential to improve patient experience while preserving and potentially enhancing therapeutic benefits. So with that, I will hand over back to Magnus to discuss financials and outlook.