Thank you, and welcome everyone to the webcast for Ascelia Pharma's Q1 report for 2021. I am Magnus Corfitzen, I have the entire technical team here to update you on our progress. Please turn to page number two. We will be making certain forward-looking statements on this call, so please pay attention to this. Turn to page number three. Ascelia Pharma is focused on improving the life of people with rare oncology-related conditions by developing novel drugs to address unmet medical needs. We have two drugs in clinical development. Mangoral is in phase III development, and we expect to complete the study in the second half of this year. It will be the only product targeting an addressable market of $500 million-$600 million annually. Oncoral is being prepared for phase II in the treatment of gastric cancer based on encouraging data from phase I. We have a very strong and experienced team headquartered in Malmö, Sweden, with a strong track record in late-stage drug development and commercialization. We have a solid financial position. We have built an extensive global network to help us bring our drug candidates to the patients who need it. Now please turn to page number four. Ascelia Pharma is in a transformative phase as we're moving from late-stage development into the commercial stage. Our lead program, Mangoral, is expected to be launched in the U.S. at the end of 2022 or first half 2023, and we are highly engaged in the preparations. In the same timeframe, we expect that the phase II of Oncoral will be nearing completion. As part of our strategy, we might expand our portfolio with additional drugs that fit our orphan oncology strategy to where we can make significant benefits to patients. This is truly an exciting time for Ascelia Pharma, and we see tremendous value creation potential as we progress. Please turn to page number five. In Q1, we continued to make solid progress. In January, we presented an in-depth development plan for Oncoral and how we can bring it to address unmet medical needs for people with gastric cancer. In March, we opened our U.S. office in Woodbridge, New Jersey. This is one of the many steps we're taking to prepare for a successful launch of Mangoral. Later in March, we completed a directed share issue to raise SEK 200 million gross, which will fund an acceleration of our Mangoral launch preparations and our Oncoral phase II clinical study. Please turn to page number six. Now we'll go into more depth on our pipeline, and I'd like to hand the word over to our Chief Medical Officer, Carl-Johan Dalsgaard. Thank you, Magnus. Mangoral, which is a novel oral contrast agent for liver MRI, addresses a very specific unmet medical need. The contrast agents available today are all based on gadolinium, a heavy metal. Gadolinium should not be given to patients with poor kidney function, since it is excreted through the kidneys, and slow elimination can cause serious side effects. In the future, this unmet medical need can be met by Mangoral. This specific target population is approximately 4% of all patients requiring a liver MRI, which corresponds to an addressable market of approximately $500 million-$600 million annually in the major markets. The right side of the slide illustrates how Mangoral works. This is a real patient with colorectal cancer from one of our phase II studies. The left picture shows an unenhanced MRI scan without the contrast agent, standard procedure today for our target population. The right scan shows the same patient after administration of Mangoral, the contrast-enhanced scan. The liver has taken up Mangoral and appears bright. There's one dark area that's only visible after Mangoral enhancement, highlighted in red ring on the right image. This is metastasis, which would not have been detected without Mangoral. This illustrates the importance of a contrast agent. In this case, a detected nodule occurs, and the metastasis can be removed, significantly improving the prognosis. We're making good progress, which is also aided by the orphan drug designation from the FDA and the ongoing pivotal phase II study, which I'm going to be highlighting later this year. It's important to note here that Mangoral is the only liver-specific contrast agent in development with a range of mechanisms. This motivates patient excitement. Our ongoing pivotal phase II study COCKTAIL investigates the efficacy and safety of Mangoral in our target population with focal liver lesions and poor kidney function. As shown on the left, with a strong interim look concept for 16 individuals at one or phase II studies, a completion will be done. These data were confirmed by an independent read analysis by blinded readers, which show highly significant effects on the endpoint studies are also in our pivotal phase II study. The primary endpoint is visual representation based on the co-primary parameters lesion delineation and lesion contrast enhancement. The results are highly significant. Existing data also contains a direct comparison of gadolinium-based contrast agents, which demonstrates similar effects on visualization. The right side of the slide illustrates the phase II design. The study is a global study with 200 patients that's agreed with FDA and EMA. The strategy Sorry there, you're a little bit faint. We can't quite hear you properly. Are you able to get a little bit closer to the microphone? I'll do that. Thank you. That's much better. Thank you. Right. Okay. I was talking about the right side of the slide and this study, which is a global study with 200 patients, has been agreed with FDA and EMA. The strategy is to repeat and confirm the phase II results using the same endpoints. Since there is no available contrast agent for patients with impaired renal function, the comparator will be unenhanced MRI, which is currently the standard procedure in these patients. Finally, the follow-up for each patient is very short compared to most clinical studies, and this simplifies the operational procedure, and we will also have the finalized study results relatively sooner than a typical phase III study. As mentioned, the study is expected to be completed this year. Next slide please, number nine. Thank you, Carl. I will share key highlights on our progress preparing for the launch of Mangoral. First, we estimate that the value of the addressable market for Mangoral to be between $500 million-$600 million in our key markets, the U.S., the EU, and Japan. This estimate is certified solid market research into both the volume potential patients and the features potential, and the price potential based on extensive input from market access and pricing experts in these markets. Secondly, our market research shows that decision-makers understand the unmet need for our target patient population and the value that Mangoral provides. Our preparations for launch progress planned, and we continue to see a strong case for building our own commercial team in the U.S. In March this year, we opened our U.S. legal entity and office in New Jersey, which marks an important step in our launch preparation. Lastly, in December 2020, a patent was granted in the U.S. for our second, which provides patent protection until 2030. Please move to slide 10. For the U.S., the attractiveness and clear market path provides a strong case for commercializing Mangoral on our own. That means building a U.S. commercial affiliate. We already have strong relationships with leading radiologists among our phase III clinical study principal investigators. We've also partnered with specialists and organizations within manufacturing and radiology. We now also have our own U.S. office, Ascelia Pharma, Inc., which represents an important step to engage more closely with key partners and the clinical community on the journey to make Mangoral available to physicians and patients in the U.S. The target patient population for Mangoral has multiple health complications, liver metastases, and poor performance. This means that decision makers for its use are centered around 2,000 radiologists who can be found at around 400 hospitals. Therefore, a sales team of around 20 HD can reach directly decision makers at launch. Building our own U.S. commercial team in the U.S. allows us to create an attractive top line and retain value in the future. For other markets, E.U. and Japan represent the most attractive opportunities in size and value to the healthcare system as a leader. In these markets, our strategy is to maximize the value of Mangoral by working with partners with existing relationships with decision makers. Sorry, could you come a little bit closer to the microphone again? Sorry. Let's move to slide 11. Okay. Thank you. Slide 11, please, where I will now continue with our second compound in clinical development, Oncoral, and can go directly to the next slide, number 12. Thank you. The active substance of Oncoral is irinotecan, which is an established chemotherapy with well-documented anticancer effects. It's currently used in several solid cancer indications, and it's approved for colorectal cancer and pancreatic cancer. In Japan, it's also approved for gastric cancer. Today, the administration is intravenous bolus infusion, typically every third week and typically high dose. Oncoral is a novel oral formulation of irinotecan. It's a tablet for daily dosing that could offer a valuable treatment option for cancer patients in the future tomorrow. There are several potential advantages of oral daily dosing. Most important, efficacy. It's well known that many cancer types have suboptimal treatment outcomes today. Oral daily dosing may improve efficacy through a favorable pharmacokinetic and pharmacodynamic profile based on more constant therapeutic plasma levels of the active substance. There are both non-clinical and clinical data supporting this concept. There is tolerability or safety. Intravenous dosing of chemotherapy is frequently associated with severe side effects, for example, gastrointestinal and hematological side effects. An oral daily dosing has the potential for improved tolerability by avoiding high plasma levels and by offering dosing flexibility. In addition, there's convenience and cost. It's more convenient and cost-effective to take a tablet at home than going into the hospital and prepare for an intravenous administration. Next slide, please. 13. This is an example of improved outcome, in this case, overall survival with a more frequent dosing. These are patients with metastatic breast cancer, where overall survival was improved from 20% with dosing every third week, high dose, to 32% with weekly dosing with a slightly lower dose. This is, if you will, a proof of principle. Next slide, please. 14. The concept of frequent low-dose administration is called metronomic dosing. The figure to the left illustrates a simulation model comparing levels of the active substance, SN-38, after irinotecan IV dosing every third week, which is the gray line, and oral Oncoral daily dosing, which is the orange line. Over a three-week cycle, the exposure or area under curve is comparable, although the plasma peaks associated with toxicity are avoided by daily dosing. Approximately one-third of the side effects observed after intravenous dosing are reported as severe or even life-threatening. That's Grade three or four. Metronomic dosing may not only reduce the peak-related toxicity but may also bring the possibility to adjust the dosing quickly if adverse events should occur. Our own Oncoral phase I results show that Oncoral was well-tolerated overall, importantly, the hematological toxicities were mild to moderate, Grade one or Grade two only. In addition, our phase I data with Oncoral indicated activity or stable disease, even in patients that previously progressed on irinotecan given intravenously. Next slide, please. 15. This program is supported by a very high-profile advisory board. We have Professor Tabernero from Barcelona, Spain, former president of ESMO. We have Professor Ajani from the University of Texas, Professor Van Cutsem from Belgium. We have Professor Jeff Evans from the University of Glasgow. Here's the joint view that Oncoral will be an important treatment option for cancer patients in the future. Next slide, please. 16. Now we are preparing for phase II, and the objectives of the phase II study are several. First, to establish a clinical proof of concept in metastatic gastric cancer. gastric cancer is chosen partly because of strategic reasons. There's a potential for orphan drug designation in gastric cancer, and the clinical guidelines and clinical data support efficacy of irinotecan in gastric cancer. Subsequently, there is a potential for label expansion into other solid tumor indications. Another objective is to generate compelling phase II data for further development, potentially with a partner. The study is a randomized, controlled, multi-center, multinational study comparing Oncoral to the top standard of care with standard of care on top of standard of care with standard of care alone. Primary endpoint is typical for phase II in oncology, progression-free survival, and then a battery of secondary endpoints, response rate, PK, safety, and overall survival. This will include approximately 100 patients. We anticipate the study to start second half of 2021 and continue into 2024. Next slide, please. This slide shows how Oncoral will differentiate from the intravenous products shown in the lower left corner. Their indications are colorectal cancer and pancreatic cancer, although both are also used for gastric cancer in the clinic. For Oncoral, the intended indication is gastric cancer. This is a severe cancer form with a significant unmet need and a significant potential market. As mentioned, gastric cancer is a rare orphan indication, which provides several potential advantages from a drug development perspective. With that, I'd like to hand over to Kristian to address the financials. Okay, thank you, Carl. The development in earnings compared to the corresponding quarter last year, that is on slide 19. The development is the same as we have seen in recent quarters, i.e., an increased loss year-over-year, which is as expected and reflects the increased R&D activity related to primarily the Phase III clinical program for Mangoral. We now turn to page 20. The key message on the liquid position is that we have a solid cash balance that was further amplified by the recent capital raise. At the end of the quarter, we had SEK 165 million in the bank, and adding to this is the capital raise with around SEK 107 million in net proceeds, which was obtained in April, i.e., after the quarter. Consequently, we have a very solid cash position after the fund raise. The cash position will primarily be used for the ongoing clinical program for Mangoral, as well as the launch preparations, and also to initiate and finance the Oncoral phase II, which we expect to start, as Carl mentioned, later this year. With that, I will leave the word over to Magnus. Thank you, Kristian. Now please turn to page number 21. I'd like to end this quarterly update with our focus for the rest of the year. The clinical development of Mangoral is highly important to us. This work continues despite COVID-19 impact, and we continue to work with investigators, consultants to make this study a success and are adapting to the circumstances to ensure patients, medical staff, employees, and everybody else are safe. We also continue our preparation for Mangoral commercialization and have many activities ongoing to enable us to detail and implement the value-maximizing strategy. Another important activity is our preparations for the Oncoral phase II program, which we expect to start in the second half of this year. This was our final slide, and we'd be happy to take any questions. Thank you. If you would like to ask a question, please press zero one on your telephone keypad. There will now be a brief pause while questions are being registered. We have a question from Johan Unnérus from Redeye. Please go ahead. Your line is open. Good morning. Johan Unnérus from Redeye. Thank you for taking my questions. The first one could be the timing on SPARKLE. On the slide, you mentioned that there is potential, of course, potentially some effect of COVID situation. How much room for time slippage is it in the ambition to complete and have the results in the second half of this year? Well, thank you for the question. This is Carl here. Well, the base plan and what we're working towards is to finalize the study later this year. Then we're taking the COVID situation into consideration, and we're taking all possible measurements to mitigate the effects of COVID. I think the design of our study is advantageous in that respect because it's a very short study, where the patients only come in for five days in the study and then they are out. These are cancer patients that need to come to the hospitals anyway. Then there's also operational things like home care, nurse service, and remote visits and things like that. We're taking all that mitigations in. Then having said that, we don't know how COVID will develop for the rest of the year or the second half of this year. We anticipate that there will be some improvement, given that the vaccinations are spreading and are setting in now. There is no guarantee, the plan now and the anticipation is that we will finalize the study this year. Thank you. You're in a situation where you will get feedback from the center pretty soon. Absolutely. That's a good point. Yeah, we are in constant dialogue and contact with the sites almost on a daily basis where we monitor the situation. The situation differs also from country to country. We're talking about COVID now. Yeah. Of course, that's something that we monitor very closely, and also the guidelines for specific restrictions and so for specific countries and specific sites. Yes, the interaction with authorities on Oncoral ahead of the study, what's the status there? The status for Oncoral is that we are currently not decided exactly how we got to go ahead on that. It's very possible that we will have some interactions. Have to remember that this is still in phase II. The study we are planning now is a phase II study. It's not a pivotal study, so there's not an end of phase II or a meeting that you usually have with regulators before preparing the last state of clinical development. We will most likely have some kind of interaction, but the specifics there we have not decided on yet. Okay. Thank you. On your direct sales strategy and the ambition to secure about 20 reps, when can that be in place? The launch preparations will be gradual, and then we're looking into the right timing of start ramping up in the U.S. Typically, the sales effort comes really towards the end. Typically, you would need the team trained and on board when you have approval to balance the risk, but you want to start some things a little earlier. The most important before launch is to talk to physicians and key opinion leaders and some of the stakeholders who decide on price and reimbursement. The plan is to have it all ready when we launch, trained and ready to go. Yeah, we certainly hope so. Yeah. Finally, if I may, when are you in a position to give any more details and feedback on the pricing and that aspect? Of course, reimbursement will come at a later stage, perhaps you will be in a situation to be more specific about indication ahead of that. Yes. A couple of things are needed before a price is public. We also need to see the phase III results. Even the final label will have an impact. We now want to be in the best possible situation to talk to these stakeholders, and therefore it's not in the interest of Ascelia to go into details now about the specific price. As we progress, there will be times where it makes more sense. Yep. Excellent. I think that could be all for me for now. Thank you so much. Yep. Thank you, Johan. Thank you. you. The next question comes from the line of Sten Westerberg from Aktiespararna. Please go ahead. Well, good morning. Thank you for taking my questions, two of them this time. Firstly, if you could give some more flavor how the COVID situation is impacting you in the daily procedures. Is it simply a tough competition for the MRI devices, which makes the progress difficult? Are the clinicians so occupied by doing things which is mandated by the COVID situation? If you could give some more flavor, I would appreciate. My second question is if you could update us on your plans for Mangoral outside the U.S. When do you intend to submit an application to European authorities, and what are your thoughts about the strategies for commercialization in Europe? Thank you. Okay. Thank you for a very relevant question. I'll take the first one there. How does COVID impact? I mentioned some of this, and it's hard to give a general answer, because it differs, as I said, from country to country and region to region. In some cases, it's business as usual at some sites. Some are obviously restricted, and that could be not so much the MRI devices, but it's more resources in general. This could be guidelines and instructions from the hospital management that you should down-prioritize clinical research and focus your resources on the clinical care and clinical practice. Another example could be that they are reluctant to bring in study patients that are pure study patients into a study given the risks of contamination or that they've been infected. They have to prioritize more acute and urgent cases. That could be one limitation. Another one is obviously travel. That could be both for patients, but it could also be for us from the sponsor, from the company, that we want to go out and support the sites. It could also be for the ones on the operational teams, for example. Having said that, we've tried to mitigate that with remote visits, and many of these operational procedures are now transformed to online or digital meeting, and that adaption has gone very well. As I mentioned, some sites are open now. This fluctuates. We see that over the first month of this year or the last month of the previous year where we saw a deterioration in many regions, but where we now see an improvement. Also we have sites in both hemispheres. We have on northern hemisphere, we have countries and sites, but we also have Latin America now, and they're slightly different developments now. We foresee an improvement, as I mentioned, in line with the vaccines having an effect. I hope that answers the question here. Just to summarize, I think we are doing quite well mitigating these effects. They are there, and we have to work with them. That was the first. I hope that was the first question, and then there was the second question, which was more from us. Can you repeat the second? Yeah. I think it was timing for Europe. Yes. For Mangoral. Yeah. At this point, we have not provided any guidance on the specific timelines for Europe. We have communicated that our strategy is to work with a partner, and we think also the submission timelines will also depend a little bit on the optimal time for that. When timing is right, we will give more guidance on this. Okay. Thank you. I'll get back in line. Yeah. Thank you. Thank you. Thank you. Just a reminder that if you would like to ask a question, please press zero one on your telephone keypad. We have no further questions, I will pass back for any closing comments. Yeah. Thank you everybody for listening in to our Q1 report year of 2021. As mentioned, we are continuing to make solid progress on our important activities to bring new medicines to patients suffering from rare cancer conditions who are in need of better options than they have today. We look forward to updating you on our further progress as we develop. Thank you.
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