Ascelia Pharma AB (publ)

Thank you and welcome everyone to the webcast for Acelia Pharma's Q1 report for 2025. On this call, we will be making forward-looking statements. On today's call, we'll start with the 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 mentioned, I am Magnus Krofertson, CEO of Acelia Pharma, and with me today I have Julie Veras Broeckren, Deputy CEO, and Andreas Norlin, Chief Scientific Officer. At Acelia Pharma, we identify, develop, and commercialize novel drugs that address unmet medical needs within rare cancer conditions. We have two drugs in our pipeline. Orviglands is in registration phase as we have successfully completed the pivotal phase three clinical study SPARQL and we are preparing the MDA submission. Orviglands has orphan drug designation from the FDA and is targeting an addressable market opportunity of $800 million globally. Oncrawl is ready to start phase two in the treatment of gastric cancer based on encouraging results in phase one and a high level of unmet medical need. We're based in Malmö, Sweden, and are listed on NASDAQ Stockholm. The first quarter of 2025 was eventful as we continued our preparation for the submission of the OverGlands NDA. I'd like to briefly mention some of the key highlights. The interest in the scientific and medical community continues to be strong, and in Q1, we announced the acceptance of three abstracts here of two oral presentations at ESCAR, which is the European Society of Gastrointestinal Radiology, which took place this week in Amsterdam. After the end of the quarter, we announced acceptance of a poster presentation at the ISPO conference in Canada, which is also this week about the burden of disease for the over-glands target patient population. In February, an extraordinary general meeting was held to approve an option program to replace a program that expired late 2024 without being exercised. In Q1, we also announced the outcome of our meeting with the FDA. Andreas will talk more about it. And we are, as mentioned, very pleased with the results from the meeting where FDA provided clear and constructive feedback so we can finalize the NDA according to their interest. The TO1 warrants were issued in connection with our rights issue in the fall of 2024 and the exercise period was in the first half of April, so after the quarter. There was very strong interest and 96% of the warrants were utilized and the gross proceeds were approximately 43 million Swedish kronor. Last week we held the annual general meeting and the bulletin has also been communicated. We're very excited about OrbitGlance and here's why. OrbitGlance is addressing a well-defined unmet medical need for subgroup of people living with cancer. This is an $800 million global market opportunity and OrbitGlance is a first-in-class product to target this and has orphan drug designation from the FDA. We have strong data from nine clinical studies and manufacturing has been upscaled to commercial scale. With the strong phase three data, OverGlance has now been advanced to regulatory phase and we're preparing for an NDA submission. We're pursuing some important value creation opportunities with OverGlance. The first objective is a timely submission and approval of OverGlance with the optimal label. The key steps on the way are that we completed the SPARTA clinical study report in early Q4. We've also announced the outcome from the meeting with the FDA here in Q1 as planned. And the FDA feedback is being incorporated into the NDA and the submission is on track for the middle of this year. We expect the most likely timing for the submission to be in the first half of August. The second objective is to progress OverGlance for commercialization, and the key activities are to continue to advance the launch readiness by ensuring the manufacturing and supply chain is ready for launch, as well as working with medical experts, including key opinion leaders, payers, patient advocacy groups, and other key stakeholders. The other key objective is entering into a commercialization partnership for OverGlance. I'm very happy with the progress we're making in Asilia and the efforts made by our team to ensure we will meet our objectives and create value for shareholders. We will start the portfolio section of our presentation with OrbeGlance and I'd like to hand the word to Andreas. Thank you, Magnus.

OrbeGlance is a first-class liver MRI contrast agent, which addresses a very specific unmet 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 metastasis. 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 outcome. Both the European and the US regulatory authorities have, for that reason, issued warnings for the use of gadolinium-based contrast agents in this group of patients. 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 Orvigans, 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. Our clinical phase three study SPARQL, completed last year, has clearly demonstrated that over glass enhanced liver MRI is superior to unenhanced MRIs. The primary efficacy evaluation in the study was done by three independent radiologists or readers. And they all show that visualization of focal liver lesions when having access to both unenhanced and unenhanced MR images was significantly improved compared to visualization of lesions in unenhanced images. And the statistical analysis demonstrated p-values below 0.001 for all the relevant tests of improved imaging. Furthermore, the results from secondary endpoints consistently demonstrated the superiority of Orviglance over unenhanced MRI, with no analysis favoring unenhanced MRI. No serious adverse drug reactions were observed, and more than 80% of reported adverse reactions were mild and short-lived, primarily related to the gastrointestinal tract, including nausea, diarrhea, and vomiting. And the safety results from this vulnerable patient population were consistent with previous studies. All in all, the study met its primary objective by demonstrating that overglans significantly improved visualization of focal lever lesions while being well tolerated by the patients. With SPARQL, we have completed the clinical development and the comprehensive clinical program includes a total of 286 patients and healthy volunteers in nine clinical studies. Taken together, these studies have consistently demonstrated positive efficacy and safety of overglans. And with the phase 3 SPARQL study confirming 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, we are moving ahead with the submission of the marketing approval application, the NDA, for Orbit Lens. In March, we announced that we received the final minutes from a meeting with the US FDA at which the authority provided clear and constructive feedback on the preparation of the NDA file. The meeting was an important step towards the NDA submission and it was held to present our plan for the NDA and agree on details pertaining to, among other things, the analysis and presentation of the clinical data, manufacturing documentation and generally how to organize the data and documents in the file. We are implementing the feedback by the FDA to the NDA file and continue to aim for the submission mid 2025, most likely in the first half of August. In summary, we are now taking the last step towards the NDA submission. Having completed the reporting of the SPARQL study that shows that OrbeGlance provides superior imaging compared to unenhanced MRI and successfully completed the meeting with the FDA, we focus our efforts on making the NDA file ready. We continue this work according to our plans and anticipate submission mid-2025. First half of August, most likely. After submission, we expect a standard 10-month review period from the FDA. With that, I will hand over to Julie.

Thank you, Andreas. The addressable market for over glands has a global value of 800 million US dollars annually. The US represents almost half of this. This market opportunity for over glands addresses the unmet need for a well-defined patient population. Cancer patients who need liver imaging and who also have severely impaired kidney function where gadolinium may not be recommended. 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 plans built on advanced market insights are in place to support this partnering strategy and the launch. As mentioned, the US is our largest commercial opportunity. 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 value and 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 diagnostic drugs in the US. In clinical practice, 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 with 270 US healthcare professionals and answers from radiologists, nephrologists, and oncologists. The insights confirm the concerns with gadolinium in clinical practice and the unmet need for OBGYNs. When speaking to experts, whether in radiology or nephrology, they confirm that an alternative to gadolinium for our target patient population would address concerns of today. 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 is also well known that gadolinium is excreted via the kidneys in urine. And 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 from regulators and medical bodies to find a viable alternative to the growing use of toxic gadolinium, an alternative that is not associated with these potential safety and environmental concerns for patients and for the environment with gadolinium. 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 Overglanz is. A more recent point of concern for gadolinium contrast agent manufacturers is that almost all gadolinium is today exported from China. Beyond having seen significant price increases over the past years, there's a more urgent concern about supply continuity and impact of trade barriers and import taxes for these manufacturers. In short, the momentum for an alternative to gadolinium is getting better and better. And we're excited that we have a head start and that OverGlance 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 is progressing. This supports our objectives to secure the optimal balance between future revenues and investment required. This strategy also allows us to leverage commercial capabilities already established by a partner. We're also working in parallel to ensure that Overglance and a partner is ready to launch upon approval. For example, 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. Data around ovig glands has been presented in total in four oral presentations and four abstract presentations at major conferences this far, underscoring the interest of ovig glands in the medical and scientific community. This week, data from SPARQL was presented at the European Society of Gastrointestinal and Abdominal Radiology, ESCA, in two presentations by leading radiologists. Another key stakeholder group for Orviglands is payers and policymakers. A poster with real-world data on the vulnerability and unmet needs for the target patient population of Orviglands was presented And this week at the Professional Society for Health Economics and Outcomes Research, ISPO. I will now hand it over to Andreas to talk about Oncoral.