Ascelia Pharma AB (publ)

Thank you and welcome everyone to the webcast for Acelia Pharma's Q2 report for 2025. On this call we will be making a number of forward-looking statements. On today's call we will start with recent key events and then head into our portfolio update before we move to financials and priorities ahead. After the presentation we will open up for questions as usual. At the Senior Pharma, we identify, develop, and commercialize novel drugs that address unmet medical needs within rare cancer conditions. We have two drugs in our pipeline. OrbeGlance is in the registration phase, as we have successfully completed the pivotal phase three clinical study known as SPARQL, and we're preparing the NDA submission, which will be submitted soon. OrbeGlance has orphan drug designation from the FDA and is targeting an addressable market opportunity of $800 million. Oncoral is ready to start phase two clinical development for the treatment of gastric cancer based on encouraging results in phase one and a high level of unmet medical need. Our company is headquartered in Malmö in Sweden and we're listed on Nasdex.com. The second quarter of 2025 was focused on finalizing the Oreglands NDA submission following our meeting with the FDA in Q1. I'd like to briefly mention some of the key highlights. The interest in Orvi glands in the scientific and medical community continues. And in April, we announced acceptance of a poster presentation at the eSport conference about the burden of disease for the Orvi glands target patient population. We also announced an Orvi glands publication in investigative radiology. This publication is a phase two clinical study where we have used a reader evaluation setup similar to the one we've used in our phase three study. where all the glans is evaluated alongside unenhanced and gadolinium-based contrast agents. In connection with the rights issue we did last year, we issued the TO1 warrants. The exercise period was in the first half of April this year, and there was strong interest, and 96% of the warrants were utilized, and the gross proceeds for the company was approximately 43 million Swedish kronor. Furthermore, we held the annual meeting in May as usual, and the bulletin has been communicated. Last week, we announced that the FDA submission file is essentially complete, and the final electronic configuration known as publishing is expected to be completed in a few weeks, after which the FDA NDA will be submitted to the FDA. So we're pursuing some important value creating opportunities with OverGlance. One part is the timely submission and approval of OverGlance for the optimal label. We've met milestones here in terms of completing the OrbitGlands clinical study report in early Q4 last year. We also had a meeting with the FDA in Q1 and we are submitting the NDA for filing for approval in a few weeks. The second objective is to progress OrbitGlands for commercialization. And the activities is to continue to advance our launch readiness activities, including manufacturing and supply chain things and working with the medical community. The other part is entering into a commercialization partnership, and that activity is ongoing. I'm 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 to shareholders. Now we will be moving into the portfolio section of our presentation, and we'll start with Overglance. We're very excited about Overglance, and here's why. OrbeGlance 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 OrbeGlance is a first-in-class product to target this, and it has orphan drug designation from the FDA. We have strong data from nine clinical studies, including strong Phase III data, and the manufacturing has been upscale to commercial scale. As mentioned, we are a few weeks from submitting the OrbeGlance new drug application to the FDA, and look forward to the process towards approval. Now we'll go further into the OverGlance opportunity, and I'd like to hand it over to Andreas.

Thank you, Magnus. Yeah, so OverGlance is a first-in-class liver MRI contrast agent, which addresses a very specific medical need for which there are no good alternatives available today. Adequate visualization of liver tumors and metastasis is critical for making the right treatment decisions. And contrast-enhanced MRI is the gold standard procedure for examination of patients with suspected or known tumors or metastases. The most used contrast agents are all based on the heavy metal gadolinium. In patients with severe kidney impairment, 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 lethal outcomes. Both the European and US regulatory authorities have for that reason issued warning for the use of gadolinium-based contrast agents in this group of patients. And the consequence is that patients with impaired kidney function typically will get an MRI without contrast, which will result in liver images of suboptimal quality with a risk for that their cancer is not managed in the best possible way. We envision that Orviglance, which is based on manganese, will address this unmet medical need and in the future become an efficacious non-gadolinium contrast agent for liver cancer patients with impaired kidney function. We have completed a comprehensive clinical program, including a total of 286 patients and healthy volunteers across nine clinical studies. which consistently have demonstrated positive efficacy and safety of organ glands. The pivotal study in the development program, the phase three SPARTA study, clearly demonstrated the superior visualization of focal liver lesions in the target population of patients with severe kidney impairment and an adverse event profile consistent with what we observed in the other studies. In summary, We are now going to submit the NDA for overglance to the FDA. The NDA file, which in addition to the clinical data just mentioned, also includes non-clinical and CMC, so chemistry and manufacturing data, has been completed. And after the final step in making the file ready for submission, we are looking very much forward to the submission in early September. So with that, I will hand it over to Julie.

Thank you, Andreas. About the commercial potential for OverGlands. The addressable market for OverGlands has a global value of 800 million US dollars annually. The US represents almost half of this. This market opportunity for OverGlands addresses the unmet need for a well-defined patient population. 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 the investment required. Our focused, ambitious launch strategy and plans are built on advanced market insights and are in place to support this partnering strategy and support the launch. As mentioned, the US is the largest commercial opportunity for overgrams. In the US 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 that fall under the black box warning for gadolinium contrast agents. 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've investigated pricing and access benchmarks of other innovative diagnostic drugs in the US. 90% of healthcare professionals are concerned about issues with gadolinium contrast agents. This includes 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 with 270 US healthcare professionals and answers from radiologists, nephrologists, and oncologists. And these insights confirm the concerns with gadolinium in clinical practice and the unmet need for overgrams. When speaking to experts, whether in radiology or nephrology, they confirmed that an alternative to gadolinium for our target patient population would address concerns of today with the potential to become a very valuable addition to their clinical practice. And 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 in urine. Because it's difficult to remove in our syringe system, it's discharged into the environment and into our drinking water. There's an urgency to find a viable alternative to the growing use of toxic gadolinium. An alternative that is not associated with these potential safety concerns for patients and for the environment. And the industry is responding. Recent developments from the large gadolinium manufacturers are focused on smaller doses of gadolinium. And there's even an early stage injectable manganese contrast agent, which is not liver specific like overglands. So in short, the momentum for an alternative to gadolinium is getting better and better. We are excited that we have a head start and that gadolinium is expected to be a first in class to lead a future with less gadolinium and improved outcomes for our target patients. The go-to-market strategy for OverGlance is to launch with commercialization partners and our dialogue with potential partners continue to progress. This supports our objective to secure the optimal balance between future revenues and the investment required. The strategy also allows us to leverage commercial capabilities already established by a partner. And our dialogue with these potential partners for successful launch of OverGlance is ongoing and continues to progress. We're also working in parallel to ensure that OverGlance and a partner is ready to launch on approval. For example, we want to ensure that manufacturing is ready for the first product launch. We are excited to see the successful acceptances of SPARQL data for presentation at major scientific conferences. In total, four oral presentations and five abstract presentations have been accepted at major conferences thus far, underscoring the interest in overglams in the medical and scientific community. As Maunus mentioned, we also announced the publication of a scientific article in Investigative Radiology. This publication presents the outcomes of a phase two study previously conducted at Karolinska Institute, utilizing the same independent reader methodology and approach as our phase three study with Orvik Lens. The results are consistent with our other studies and show superior visualization and a greater number of detected focal liver lesions with overglans compared to unenhanced. It also shows that overglans and the gadolinium agent used in the study performed similarly in the visualization and detection of lesions. So with this, I will pass it over to Andreas to talk about on graph.