Ascelia Pharma AB (publ)

So welcome everyone to the webcast for Acelia Pharma's Q2 report for 2024. So we will be making forward-looking statements. On today's call, we will start with Acelia Pharma highlights and recent key events. This is followed by a portfolio update before moving to financials and priorities ahead. After the presentation, we will open up for questions. 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. Orviglans has now been advanced to registration phase as we have completed the pivotal phase three clinical study. Orviglans has orphan drug designation from the FDA and is targeting an addressable market opportunity of $800 million annually. Oncoral 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. Q2 was a remarkable quarter where we met the most significant milestone in the history of Azalea Pharma. We started the quarter by announcing completion of the image reading phase by the independent readers of SPARQL, and were able to narrow the guidance for announcing the results to the first half of May. In April, we also drew the 15 million on the loan facility that we established in February with FOMO Nord, which is now known as Finja Capital. On May 2nd, we announced strong headline results from SPARQL. a highly successful outcome of our registration-enabling Phase 3 clinical study. A few days after the announcement of the results, we had an investor update to go through the data and the plans ahead. After the close of the second quarter, we announced a rights issue. This will allow our shareholders to participate in the value-creating milestones ahead of us. The extraordinary general meeting was held yesterday on August 14, and all attending shareholders voted to proceed with the financing as planned. The strong phase three data sets all the glands on the path for approval and provides a solid position for entering into an attractive partnership for commercialization. To finance our major value inflection points ahead, a rights issue has been put in place to raise up to 105 million Swedish kronor, of which 70 million is guaranteed by subscription commitment from board and management, as well as external guarantors. As mentioned, the right issue was approved at the Extraordinary General Meeting yesterday, and the timetable is on the right-hand side of this slide and has also been communicated in our press releases. Of particular note is that the subscription period runs from August 20 to September 3, and the final outcome will be announced on September 5. We do this because we are very excited about OrbeGlance 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 the 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, Orviglands has now been advanced to the regulatory phase, and in parallel with the NDA activities, we are working to establish commercialization partnerships. We focus on three objectives to create value to shareholders. The first objective is a timely submission and approval of Orviglands with the optimal label. The key steps on the way are completion of the SPARQL clinical study report in early Q4, conclusions from the pre-submission meeting with the FDA, which is expected to be in Q1, and submission of the NDA in the middle of next year. The second key objective is to progress all the plans for commercialization to patients in need. The key activities are continuing to advance our launch readiness by ensuring 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 part of this is, as mentioned, entering into commercialization partnerships. The third objective is to develop the potential in the pipeline. We're excited about Oncrawl and the planned phase two study where we will evaluate it in combination with LUNSERV. In our pipeline, we also have a second generation Orvigland program that we would like to advance as well. Our proceeds from the rights issue will be prioritized on all the glance activities, and very limited activities are ongoing in our third objective here. We look forward to accelerating those opportunities at a later stage. All in all, there is tremendous potential in Acelia to create value for shareholders as we move forward. This concludes the highlights and key events, and now we will move into the portfolio. So as we move into the portfolio part of our presentation with OrbitGlance, I'd like to hand over to Andreas to continue the presentation. Thank you, Magnus.

So we will start with OrbitGlance. And OrbitGlance is a first-in-class liver MRI contrast agent, which addresses a very specific unmet medical need for which there are no good alternatives available today. Treatment of liver cancer and liver metastasis is an important challenge within oncology. An adequate visualization of liver tumors and metastasis is critical for making the right treatment decisions. 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. And 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 the US regulatory authorities have, for that reason, issued warnings for the use of gadolinium-based contrast agents in this group of patients, and the consequences 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 the cancer is not managed in the best possible way. We envision that Orviglans, 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. In early May, we announced the highly encouraging headline data from the SPARCA Phase III study. The study clearly demonstrated strong superior enhancement of the visualization of focal liver lesions with orbigrans compared to unenhanced MRI. The strength of the data is emphasized by the fact that all three independent readers who evaluated the efficacy in the study confirmed superiority of orbigrans with p-values for the statistical test lower than 0.001. Furthermore, for the study to be successful, at least two of the three readers needed to observe a statistically significant improvement. And the unanimous reporting of a highly significant effect with acceptable levels of variability made the conclusion that over-glance-enhanced MRI is superior to un-enhanced MRI very strong. Common adverse events in the study were primarily mild to moderate nausea, and in line with the previous phase one and two studies with oral balance. And no serious adverse drug reactions were observed in the study. With the SPARQL, we have completed the clinical development. The comprehensive clinical program includes a total of 286 patients and healthy volunteers in nine clinical studies. And taken together, these studies have consistently demonstrated positive efficacy and safety of all events. So with a phase three 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 for orbiglans. Our primary goal now is to secure approval of orbiglans with an optimal label in the USA, offering a new choice for patients who can't use gadolinium-based contrast agents for liver imaging today. And we are on track to submit the NDA for Overgrounds by mid-2025. Following the submission, we anticipate a standard 10-month review process by the FDA. On the way towards the submission, we are looking forward to key milestones, such as the delivery of the full study report for SPARQL in early Q4 this year, and the completion of the pre-NDA meeting with FDA by Q1 2025. The pre-NDA meeting is a critical project in its own right, with the purpose to lay out the groundwork for the NDA submission and review. And this ensures that we are on the same page as the FDA, and we facilitate a seamless review process when we file the NDA. To wrap it up, with the strong headline data from SPARQL demonstrating superior imaging with OrbeGlance compared to unenhanced MRI, we are now advancing OrbeGlance into the registration phase. So with that, I would like to hand over to Julie.

Thank you, Andreas. The addressable market for overglans has a global value of 800 million US dollars annually. The US represents almost half of this. This market opportunity for overglans addresses the unmet need for a well-defined patient population. Cancer patients who need liver imaging 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 plan and the strategy built on advanced market insights are in place to support this partnering strategy and to support the launch. As mentioned, the US is the 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 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 omit 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 benchmarks of other innovative diagnostics in the U.S. 90% of healthcare professionals are concerned with issues related to gadolinium contrast agents, including the severe side effect for our target patient population, nephrogenic systemic fibrosis, or NSF. In fact, 16% of providers have experienced cases of NSF in patients exposed to gadolinium. These insights come from market research with 270 U.S. healthcare professionals and answers from radiologists, nephrologists, and oncologists. And the insights confirm the concerns with gadolinium in clinical practice and the unmet need for overglans. When speaking in clinical practice, the unmet need for our target patient population is also well recognized. Physicians tell us that patients who need liver imaging and fall under the black box warning for gadolinium today receive MRIs that balance the trade-offs between being either without a contrast agent, i.e. an inferior image quality, or by being, for example, half-dose gadolinium. These are around 80% of the patients. And sometimes with a full dose of gadolinium, with the awareness that gadolinium is not recommended for these patients due to the black box warning. In addition, we're both excited and optimistic that almost all physicians tell us that they would like to use overglans when it is available on the market. 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 by the kidneys in urine. And because it's difficult to remove in our syringe systems, it is 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 gadolinium. an alternative that is not associated with these potential safety and environmental concerns for patients and for the environment with gadolinium. In short, the momentum for an alternative to gadolinium is getting better and better. And the industry is responding. Recent developments from the large gadolinium manufacturers are focused on smaller doses of gadolinium and thus even an early stage injectable manganese-based agent which is not liver-specific like OrbeGlands. We are excited that we have a head start and that OrbeGlands is expected to be the first in class to lead a future with less gadolinium and improved outcomes for patients. The go-to-market strategy for OrbeGlands is to launch with commercialization partners. 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. The focus of Acelia Pharma is to continue the dialogue with potential partners and reach an attractive agreement for the commercialization of overglands. We will also ensure that overglands and their partner is ready to launch upon approval. In summary, OverGlance addresses a well-defined unmet need and represents an attractive commercial opportunity. Our focus is to ensure that OverGlance is ready and our efforts to help patients and to launch OverGlance are already well recognized by experts and partners in the industry. With this, I will hand over to Andreas to talk about Ancora.