Ascelia Pharma AB (publ)

everyone to the webcast for Aselia Farmer's Q4 report for 2024. We will be making a number of forward-looking statements on this call. On today's call, we will start with 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. I'm Magnus Corforsen, CEO of Aselia Farmer, and with me today I have Julie Brogren, Deputy CEO. Andreas Nollin, our Chief Scientific Officer, is unable to join us today and he will join us at our next quarterly call. At Aselia Farmer, we identify, develop, and commercialize novel drugs that address unmet medical needs within rare cancer conditions. We have two drugs in our pipeline. OrbyGlance is in the registration phase as we have successfully completed the pivotal phase clinical study SPACO and we're preparing an NDA submission to the FDA. OrbyGlance has orphaned drug designation from the FDA and is targeting a global addressable market opportunity of $800 million. Encroal 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. Aselia is based in Malmö in Sweden and we are listed on Nasdaq.com. The fourth quarter of 2024 was busy with a lot of announcement that followed the successful outcome of the SPACO clinical study earlier in 2024. I'd like to briefly mention some of the key highlights. The interest in the scientific and medical community to learn about the SPACO result has been significant and data was presented at the RS&A in December 2024. We have also announced an additional five accepted abstracts here of three oral presentations at SAR, Society of Abdominal Radiology and at ESCAR, European Society of Gastrointestinal Radiology. We are proud of this high level of interest in OrbyGlance. The full study report from the SPACO study was also completed in Q4 and I was very pleased with the data which reinforces the positive outcome of the study. In the fourth quarter Mariana Koch was also elected to the board of directors of Aselia Pharma. Mariana has a long experience from Pharma including global expertise in drug development, regulatory affairs and commercialization and she is already adding significant value to Aselia. We are very excited about OrbyGlance and here's why. OrbyGlance is addressing a well-defined unmet medical need for subgroup of people living with cancer. This is an 800 million dollar global market opportunity and OrbyGlance is a first in class product to target this and has often dropped designation from the FDA. We have strong data from nine clinical studies and manufacturing has been upscaled to commercial scale. With a strong phase three data OrbyGlance has now been advanced to regulatory phase and we are preparing for an FDA submission. We're pursuing some important value creation opportunities with OrbyGlance. The first objective is a timely submission and approval of OrbyGlance with the optimal label. The key steps to achieving this is completion of the SPACO clinical study report which was done in early Q4. The next milestone is the conclusions from the pre-submission interaction with the FDA in Q1 and we are on track to deliver on this. Next milestone in line is the submission of the NDA to the FDA which is in the middle of this year where we are also on track for delivering on that. The second objective is to progress OrbyGlance for commercialization. The key activities are continue to advance launch readiness by ensuring manufacturing and supply chain is ready for launch as well as working with medical experts and key opinion leaders, payers, patient advocacy groups and other key stakeholders. In addition to this as we have announced we're pursuing a partnership for commercialization and we continue to make progress here as well. I'm very happy with the progress we're making in the CD Pharma and the efforts made by our team to ensure we will meet our objectives and create value for shareholders. We will now start the portfolio section of our presentation with OrbyGlance and as Andreas is not here I will continue. OrbyGlance is a first in class liver MRI contrast agent which addresses a very specific unmet medical need for which there are no good alternatives today. Treatment of primary liver cancer and liver metastasis is an important challenge within oncology. Good visualization of cancer in the liver is critical for making the right treatment decisions. Gatlingian based contrast agents are the gold standard procedure for examining examination of patients with suspected unknown tumors or metastasis as they improve the information from the imaging procedure. In patients with severe kidney impairment use of Gatlingian based contrast agent has been associated with an increased risk of a very severe side effect called NSF, Nephrogenic Systemic Fibrosis. This may have even fatal side effects and therefore both the European and US regulatory authorities have issued warnings for the use of Gatlingian based contrast agents in this group of patients. The consequence is that patients with impaired kidney function will often have an MRI without contrast which will result in liver images of suboptimal quality with a risk for that that cancer is not managed in the best possible way. Our ambition is to make OrbitGlance which is based on manganese the product of a choice for this patient population in need of liver imaging where use of Gatlingian may be medically inadvisable. The FDA has granted an orphan drug designation for OrbitGlance for use in this population. In May we shared positive results from the SPARCLA phase 3 study. We found that OrbitGlance enhanced liver MRI was superior to unenhanced MRI. As a quick reminder I'd like to share the key highlight from the study. The primary statistical evaluation compared visualization of focal liver lesions when reviewers had access to both the enhanced and unenhanced MRI images versus the unenhanced images alone. The primary endpoint is the mean pair differences that means the difference on the same patient along with their 95% confidence intervals and this is presented in the graph to the right. Notably all mean pair differences are positive showing that the combined OrbitGlance MRI is superior in visualizing focal level lesions compared to unenhanced. The analysis yielded a p-value of less than 0.001 for both visualization variables across all readers. To further validate our findings subgroup analysis were conducted and in every subgroup combined MRI was preferred over unenhanced MRI. The results from secondary endpoints consistently demonstrate superiority of OrbitGlance over unenhanced MRI with no analysis favoring unenhanced MRI. The safety analysis indicated that no serious adverse drug reactions were observed. More than 80% of reported reactions were mild and chock-lift primarily related to the gastrointestinal tract including nausea, diarrhea and vomiting. The safety result from this vulnerable patient population were consistent with previous studies. With the completion of the SPARCL phase 3 clinical studies we have completed the clinical development. 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 OrbitGlance. With the phase 3 study confirming the superior visualization of focal level lesions in the target population of patients with severe renal impairment and an adverse event profile consistent with what we were observed in the other studies we are excited to move forward with the submission for marketing authorization to the FDA. We are on track to submit the NDA for OrbitGlance in the middle of this year. Having completed the full study report we are now focusing on finalizing our pre-NDA interaction with the FDA here in the first quarter. This step is crucial for finalizing our NDA submission to ensure alignment with the FDA to facilitate a smooth review process. In summary the strong results from the SPARCL studies show that OrbitGlance provides superior imaging compared to Unenhanced MR and allows us to move forward towards market authorization. We are excited about this opportunity to provide a better option for patients in need of liver imaging where use of gadolinium may be medically inadvisable. Now I would like to hand it over to Julie so she can talk about the commercial opportunity for OrbitGlance.

Thank you Magnus. The addressable market for OrbitGlance has a global value of 800 million dollars annually. The US represents almost half of this. This market opportunity for OrbitGlance addresses the unmet need for 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. We have a focused ambitious launch strategy and plans built on advanced market insights in place and these will support this partnering strategy and the launch. As mentioned the US is the largest commercial opportunity for OrbitGlance. In the US alone our real world data i.e. data from realized procedures in our target patient population show that every year a hundred thousand abdominal imaging procedures are performed in around 50,000 patients that fall under the black box warning for gadolinium contrast agents. So this is about four percent of people with cancer that undergo abdominal imaging. The well-defined patient population with this clear unmet need also drives an attractive pricing opportunity. We've extensive input from market access and pricing experts with whom we've tested different price 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. 90 percent of healthcare professionals are concerned with the issues related to gadolinium contrast agents. This includes the severe side effect associated with our target patient population NSF. In fact 16 percent of providers have experienced cases of NSF in patients exposed to gadolinium. These insights come from market research with 270 US healthcare professionals and the answers from radiologists, nephrologists and oncologists. And the insights confirm the concerns with gadolinium in clinical practice and the unmet need for obulence. Beyond the risk of NSF in kidney impaired patients gadolinium is well known to be a key concern of regulatory and medical bodies. It's also well known that gadolinium is excreted by the kidneys in urine. Because it's difficult to remove in our search 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 this toxic gadolinium. An alternative that is not associated with these potential safety and environmental concerns for patients and for the environment with gadolinium. So in short the momentum for an alternative is getting better and better and the industry is responding. Recent developments from the large manufacturers of gadolinium are focused on smaller doses of gadolinium and there's even an early stage injectable manganese contrast agent which is not liver specific like over glance. We are excited that we have a head start and that over glance is expected to be a first in class to lead a future with less gadolinium and improved outcomes for patients. The -to-market strategy for over glance is to launch with commercialization partners and our dialogue with such partners is progressing. This supports our objective to secure the optimal balance between future revenues and the investment required. This strategy also allows us to leverage the commercial capabilities already established by a partner. So our dialogue with these potential partners for the successful commercialization of over glance is progressing. We're also working in parallel to ensure that over glance and a partner is ready to launch upon FDA approval. For example that manufacturing is ready for the first product to be available in the US. We are very excited to see the successful acceptances of SPARCLE data for presentation at major scientific conferences. Early October we announced the acceptance of the primary results from SPARCLE as an oral presentation in the cutting edge research at the annual conference of the Radiology Society of North America, the RSNA. This is the largest radiology conference globally. Later in October we announced the acceptance of an abstract on SPARCLE data as part of the late breaking science session at the American Society of Nephrology's Kidney Week Congress. Other key scientific conferences have subsequently also welcomed the presentation of SPARCLE data. This includes the Society of Abdominal Radiology and the European Society of Gastrointestinal and Abdominal Radiology. In total four oral presentations and three abstract presentations have been accepted at major conferences this far. This underscores the interest in over glance within the medical and scientific community. I will now move to talk a little bit about Encaral, the other asset in our development portfolio. Encaral is a daily tablet formulation of Irene Ticken, a well established, intravenous chemotherapeutic agent. A daily tablet formulation enables a frequent low dose regimen that could offer advantages on both efficacy and on safety compared to the infrequent high dose intravenous administration used today. We have completed a phase one study which demonstrated a promising safety profile and an uptake of the drug after all dosing consistent with the daily dosing concept. We are now ready for taking Encaral into clinical phase two. The objective in phase two is to generate clinical proof of efficacy data in metastatic gastric cancer in combination with Lonserv. Lonserv is another oral cancer treatment approved for gastric cancer. Animal data has demonstrated a synergistic effect of Irene Ticken as IV formulation when combined with Lonserv. This makes this oral combination very interesting. The plan phase two study is designed to study Encaral plus Lonserv against Lonserv alone. The study will randomize approximately 100 patients and involves a clinical collaboration with Taiho Oncology, the manufacturer of Lonserv. Taiho Oncology will provide clinical advice and supply of Lonserv for the study. Irene Ticken is a well-established chemotherapy with recognized antitumor effect in solid tumors. Our strategy is to start Encaral development in gastric cancer which is today a three billion dollar market. For these patients there's a high unmet medical need for improving outcomes and there's an opportunity for an orphan indication. We also see opportunities for developing Encaral in other solid tumor indications where a daily dosing tablet formulation can demonstrate an attractive efficacy and safety profile. Irene Ticken as an IV formulation is already approved in colorectal and pancreatic cancer and in addition it's clinically demonstrated and recognized in guidelines for other cancer types. So we are assessing these opportunities as part of our ongoing strategic planning for Encaral. I will now move to the update on our financials and priorities ahead. In Q4 our operating result was a loss i.e. cost of 21.9 million kroner. This is a slightly increased cost level compared to Q3 in 2004 driven by our cost for the NDA preparations. At the end of December 2024 we had 75 million kroner in the bank with the fully subscribed issue of 105 million Swedish kronor in Q3 2024. We have a cash runway to late 2025 well beyond the NDA submission. This cash runway excludes the repayment of the remaining 27.5 million kronor loans to Finja but it can be extended significantly with financing from partnering and from warrants. The proceeds from the issued T01 series warrants alone can provide up to 70 million Swedish kronor in April. To wrap up we have substantial value creation opportunities ahead for Overglens and for Acelia Pharma. With Overglens we're bringing to market a first in class diagnostic drug addressing an 800 million dollar market for patients with a high on mid-need. We have two key objectives. One is a timely submission and approval of Overglens with the optimal label. The key steps on the way are the completion of the SPARCL clinical study report, a milestone we achieved early November last year and which reinforced the successful study outcomes of the SPARCL phase three studies primary and secondary endpoints and which supports the NDA process. We are on track to share conclusions from a meeting with the FDA in Q1 2025 and we plan to submit the NDA in the middle of this year. Our other objective is to progress Overglens for commercialization for patients in need by entering into a partnering agreement for the launch in the U.S. and by securing that a partner and Overglens is ready for launch by approval. All in all the strong headline results from SPARCL mark the completion of clinical development for Overglens and reinforce our confidence in the regulatory and commercial path ahead for Overglens. We look very much forward to executing on these priorities ahead for Overglens and for Aselia Farmer in 2025 and beyond. So this was the end of our presentation part and we are ready to take your questions. So back to the moderator.

If you wish to ask a question please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question please dial pound key six on your telephone keypad. The next question comes from Ludwig Svensson from Carnegie. Please go ahead.

Yeah thank you very much for taking my question. So I just have one question for you today. Did you have your pre-MDA meeting with the FDA yet?

So we will not talk specifically. What we'll say is that we have the conclusion from the meeting in Q1 and we are on track for that. And as you know there is a you know when you have the meeting then the you could say the final minutes from the meeting will be sent by the FDA no later than 30 days after the meeting has been stopped. And that is the time when you can conclude on the outcome of the meeting. And we expect to communicate on the outcome of the meeting in Q1.

All right great looking forward for that. Thank you very much.

Yeah thanks.

The next question comes from Johan Unneris from RIDAI. Please go ahead.

Thank you for taking our questions. I have a few follow-up or clarification then. Josh by the previous question it seems like you are likely to be in this process given that it's a 30-day period and you expect to receive the minutes then by Q1. So out of the process is completed.

Yeah so you could say you're right. So when we receive the minutes then of course we will carefully review them as quickly as absolutely possible and then be able to conclude if that has any implications on the plan that we already have in place or if there are any sort of edits that have a material impact. So what we will do is that we will do that of as quickly as possible and then we will share that information with everyone.

Great so the minutes as such will not be published but you will sort of publish the conclusion or the fact that you receive them of course as well.

Yeah so we will do like as everyone else these minutes are you would say highly confidential because it's the it's a confidential dialogue we have with the FDA and I'm not aware of any companies that have ever shared that communication. So we will of course share the information in terms of what does it have any impact to the plan that we have. We are very well on track for submitting in the middle of this year and yeah we have the information and we've been listening to FDA feedback. So I think that is the scenario. So we are looking into this process and looking forward to receiving the minutes at some point and communicating the results.

Excellent and also there is a potential that you will could benefit from a faster review process and that decision and clarification could that come then sometime after submission?

Yeah so the way it works for the prior to review is that at the time of submission you ask for a prior to review by the FDA and then the FDA will make a decision on whether they will grant it or not and that's how the process works.

And time wise, assuming that you will sort of complete by mid submit by mid 25 when could that clarification come?

Yes I don't it's probably somewhere on the FDA webpage in terms of the how quickly they will respond but it's in the FDA's initial part of the review process. It's

often as part of the comments you receive after around three months calendar time but they have variations in when they respond to this but that's not uncommon.

Yeah we've seen that before that well there is some flexibility and they could respond faster sometimes and a bit later other times. Yeah another question if you could share some dynamics on the partner conversations and also the related aspect of you being rather successful in sort of featuring your candidate at conferences, international conferences presumably that's an important arena to expand the network and AOLs and perhaps even add new partner conversations.

Yeah I mean this dialogue is ongoing and progressing and so as you said it's really great to see that the results from SPACL get interest in the medical and scientific community of course that also means something to a partner. So it's all part of that kind of due diligence you can say both the clinical data from phase three and the full study report and this recognition in the community as you say also by key opinion leaders and which includes the ones presenting our data and then of course FDA process and so forth. So it's moving forward and yeah.

Thank you and finally could you perhaps share something about the benefits and differences of overglance 2.0 so to speak you that subject in China Asia I suppose.

Yeah so you're referring to the granting of a patent in China for our second generation overglance and the second generation overglance is an effervescent tablet formulation of also a manganese so also oral agent for liver imaging. So in that sense we see it really as a life cycle management opportunity for the overglance franchise. We think it's an opportunity so to sort of extend the total life cycle of the asset and since there are markets such as markets where you will always be required to have some local clinical data perhaps it's a good opportunity to combine that with the development of the second generation asset that there could be some synergies in that. So we of course expect that it's as as leader as least as good as overglance that's the indication we have so far.

Interesting and presumably that would be sort of an investment decision that you would take once a partner is established.

Yeah we think a partner would also be interested in clarifying what the roles are for this second generation asset but also of course geographically and so forth so it's part of plans. Yeah excellent

that's all from me thank you. Thank you.

As a reminder if you wish to ask a question please dial pound key five on your telephone keypad.

So we have some additional questions put in here so one is a question relating to our announcement about an extraordinary general assembly in February instead of our regular annual general meeting in May. So the board proposed this extraordinary general assembly to ensure as they write in the invite that there is a you could say an valuable incentive program to ensure you could say retention and motivation of all employees who are working on important milestones and as is also described the the current value of all the combined incentive programs are is expected to be maximum 400,000 matching shares which is a very small overall value and that's why they have decided to implement it now and make hopefully that there is no retention risk score and everybody is aligned on the objectives which is also of great value to the shareholders. So that's why the implementation is now. It's also very comparable to the previous option program that has been implemented which expired end of last year. So there's another question whether we would have you know prefer either one or several partners you know splitting geographies etc. Julie do you want to comment on that?

Well I think this is a high value very focused launched for a small but well defined patient population so there are a lot synergies in the work around the medical community the key opinion leaders and also the payers so it makes good sense for to focus around geographies so I think it makes good sense to have one fully dedicated partner to key geographies so if someone wants to take a more than the US of course that's the table it could also be that someone else is higher value would provide higher value for us if it's another partner for Europe and other geographies so it could be more than one if we look at the global landscape but within a country it does higher value for a partner and for us likely if it's only one.

There's also a question here on whether we would sort of promote the Aselia sort of in a broader context and I'm assuming that is related to investor communication and so forth. So we are having our quarterly calls we're participating in conferences and working through various you could say communication channels. And spending some good deal of time and money on that we're always looking into how we can do this in the in the best possible way and if any of you have some some good ideas about how we could that even more effectively we're very I don't see any more questions here in the feed so if there are no further questions thank you all for joining our Q4 2024 call we're very excited about the progress we made in in 24 and looking forward to continuing successful meeting the milestones here in 2025. Thank you and have a great day.