Welcome to the Cantargia Q1 presentation for 2023. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing star five on their telephone keypad. Now I will hand the conference over to CEO, Göran Forsberg. Please go ahead. Thank you so much. It's a pleasure to present Cantargia's quarter one report. It's been a good start of year for Cantargia. During this period, or directly after the period, we had a really good news flow. We started out strongly by presenting new data in triple-negative breast cancer, which was part of the phase I, part of the lead in phase of a randomized trial called TRIFOUR. We will have a quick look at those data later on. What's noted is that directly afterwards, the first patient started treatment in randomized phase of this trial, and recruitment is now ongoing. In our second program, CAN10, we also made some progress during the period. The GLP tox study was successfully completed. Later on, we could send in the application to start the first clinical trial. We'll come back with timelines around that. We also made a change to chief financial officer position with Bengt Jöndell winding down and Patrik Renblad starting out. What I'm going to say here is that we're just in the middle of the transition period. Patrik is going to start in June. The final date is still pending. We will obviously inform you once we have the final date. Bengt cannot join this quarter one report today. I will take all the questions on the financials. Then in the lead program, we did a significant step forward in treatment of pancreatic cancer by new data that was presented in April at the AACR 2023 conference. I will spend more time on that later on. One key message is that the data looks strong in all the patients that have been treated with nadunolimab in combination with chemotherapy. We also have a subgroup, the patients with, let's say, the highest levels of the targets for the therapy, IL1RAP are those that are benefiting the most. That's a really great signal 'cause it's both validating the program but also de-risking the program if we continue development in that subgroup. Much more to come. The AACR conference also gave us the opportunity to present more preclinical results by showing that nadunolimab also has anti-metastatic effects, and that could contribute to the efficacy we're seeing in the patients. We are taking a next step in pancreatic cancer. What's very important here is that we have made a strategic change based on these new data that were presented at AACR. We see that the best development plan is to continue to examine these findings in a randomized phase 2 trial rather than going into potential registration trial directly. All our efforts are now put on that trial, and we'll come back again on timelines for that and a little bit more on design. With the strength of the data in pancreatic cancer, the very interesting activities in triple-negative breast cancer, we decided to halt recruitment in non-small cell lung cancer and make sure that we analyze the data properly before taking the next step. There'll be more data coming up at ASCO. We're trying to focus activities where we see the strongest signals and where we believe that competition is manageable in a better way. Moving away from the new slope to just quickly mention the key findings. Just to remind you here is the pipeline. Obviously, nadunolimab is our lead program, and pancreatic cancer PDAC is the lead indication. Here we have generated phase II results and are now planning for a phase II-B trial, which is really a strong focus to get started as quickly as possible. Triple-negative breast cancer, phase I is finalized, and phase II is now ongoing randomization. In non-small cell lung cancer, similar story. We are halted recruitment, analyzing data, and before deciding on how to take the next step forward. All these opportunities are down in as chemotherapy combinations where we believe that we have strong synergies between nadunolimab and the chemotherapy. The CAN10 program entering phase I, as soon as we have clearance from regulatory authorities. Then we have finally the CANxx program to continue to fill the pipeline as we advance. To illustrate what we're trying to do in, for instance, pancreatic cancer and how these, how this strategy is now supported by our clinical results. If we look at to the left here is a pancreatic cancer patient who has been diagnosed with a primary tumor and most likely with metastasis as well. The really only treatment option for this patient is chemotherapy. In some patients, there is benefit here, so you will get a short-term response. Unfortunately, it is a short-term response. Very often the resistance mechanisms are built up or toxicity are also coming into play and the chemotherapy is stopped, which is obviously not very good news for this patient. Our treatment idea here is to add nadunolimab to the chemotherapy to get some, a much more durable and more meaningful long-term response, which will lead to longer survival of the patient. If you look to the right here on this slide, you can see a so-called waterfall diagram. What you see here is that each bar represents each patient in the trial, and you can see the best change in tumor size during the trial. You would like to have lots of patients with a clear decrease in tumor size, and responses are defined as more than 30% decrease, and you would typically like to have seen 50% or more. What is very clear here is that you have a large group of patients with 50% or more or almost 100% reduction in tumor size, which is then clearly driving efficacy. If we then look at the overall data in all 73 patients we've treated to date, we can see that what's most important for these patients is to get the longer survival and the median overall survival, we have seen it 12.9 months, which compares very favorable to historical controls of 8.5 months, for instance, in the original article describing gemcitabine or a very recent data published earlier this year in the NAPOLI-3 trial of 9.2 months. Clearly a huge improvement compared to those data. To further support that the progression-free survival is better than you would expect from this type of therapy is 7.2 months, which compares favorable to the 5.3 or 5.6 months described previously, and response rate is higher as well. The real exciting stuff starts when you look into the subgroups. What we noticed is that if we divide the patients here, according to levels of the target for therapy IL1RAP, we can see that there is to the left a statistically significant difference in overall survival. It's 14.2 months in patients with high IL1RAP versus the 10.6 in the low IL1RAP group. Notably, but both are better than you expect from chemotherapy alone. If you look to the right and in the waterfalls, you can see that it is really the patients in the IL1RAP high group that are driving this efficacy signal. It's here you see the deep responses. In the IL1RAP low group, you see some deep responses, but you get an illustration which more looks like you would expect from chemotherapy alone. So the clear signal that we could focus on IL1RAP high patients to de-risk the program or go for all comers as we still believe that the all comer population is doing very well. That's what we're going to examine in the phase II. We can also look at the patients, how long they stay on therapy, how long they live. It's more looking at the long-term effects rather than the antitumor effect. Again, you can see the IL1RAP patients stay on therapy or live much longer. You can see that's the gray or blue bars here. You can also see the orange arrows to see patients that are still alive or still being studied for survival. There are much more of those patients in the IL1RAP high group, while in the IL1RAP low group, most of these patients have documented death by this point in time. Very encouraging results to build on. Moving over to triple-negative breast cancer, we are at much earlier stage. Again, what we see here is that we have much more patients having responses than you would expect from chemotherapy alone. We had 50% of patients or six out of the 12 in the phase I with a confirmed response. Responses are deep and meaningful, including one complete responder. We will present more data from phase I during H2 of this year. We also plan to present an interim futility analysis in the phase II randomized phase during H2 of Q4 next year. If we look at all our clinical trials, the CANFOUR trial, well, I think I described that quite well. Key point here is that preparations are ongoing for pancreatic cancer in the next stage and the phase II trial. The lung cancer, new results will be presented at ASCO, and we'll finalize recruitment. Other trials which were started during 2021 and where we stopped recruitment during 2022, we are looking at opportunities outside the our, let's say, sweet spot of pancreatic cancer, non-small cell lung cancer, and triple-negative breast cancer to see if there is additional value. The recruitment has been finished, and we expect to present results during H2 once we have more mature findings from these, not lots of patients, but still significant amount of patients. More to come here. Sorry. In the TRIFOUR, randomized phase is ongoing. We're planning up to 98 patients in the randomized phase, plus 15 run in the phase I. The interim analysis is done for Q4 2023. Quickly moving over to the CAN10 product status. GLP tox study was finalized. It looked very good. We have documented safety both as an IV injection as well as a subcutaneous formulation. We have not seen any major safety findings, which is very, very promising for next step. The clinical trial application was submitted in April 2023, and the plan is to do a phase I, single-dose study in healthy volunteers, according to European guidelines. Then we will enter the multiple dosing phase, but we will do that in patients with mild forms of psoriasis in order to get the skin biopsies and to get more data on mechanism of action. Really designed to create good news flow and a good biological understanding of our drug. Then quickly moving over to the finances. The operating expenses during Q1 decreased compared to 2022. There are several reasons behind this. One is that 2022 contained lots of production costs, which are now going down as we have produced most of nadunolimab for quite a lot of time, long time in the future. It's also because the clinical trials were then not expanded as we planned when it comes to broadening outside the lung cancer and pancreatic cancer. Obviously, it's the R&D that is driving our costs here. The personnel is 24 people as of March 31. The financial position. We have approximately SEK 350 million on the bank or in short-term investments. That will give us a runway until at mid 2024 as it looks right now. Still a quite solid financial position. If there's need, we can always extend the runway. Then go more into the news flow and what to expect here. In pancreatic cancer, the main focus now is to obviously get the phase II-B trial started. It's going to be a three-arm trial in somewhere between 150 and 200 patients. The reason for doing a three-arm trial is that we will then also satisfy the new guidelines from the FDA in the Project Optimus initiative. We plan to do a submission during H2 of 2023, and we plan to have aggressive inclusion timelines, so we can have a meaningful top line results during 2025. In lung cancer, we will present the updated efficacy and biomarker data at ASCO, and we will continue to focus on biomarker evaluation to really find the signatures of patients most likely to respond in order to advance lung cancer in a very competitive environment. Triple-negative breast cancer, as I said several times, the randomized phase II is ongoing, futility analysis during Q4, and we will also present more details and longer term efficacy data from the phase I leading phase II in the H2. The CAN10 program treatment of first subject mid-2023 is a clear goal. We have lots of things in front of us, lots of exciting news flow to come, both in our lead indications, pancreatic, non-small cell lung cancer, and triple-negative breast cancer, but also from preclinical activities or from the broadening attempts performed during 2021 and 2022. CAN10, again, a rich news flow to be expected. By that, I would like to thank you for the attention, and I'm very happy to take questions. If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from Viktor Sundberg from Nordea. Please go ahead. Hi, hi, thank you for taking my question. On the news here that you will start a new phase II-B trial in pancreatic cancer, I just wanted to get some more color on what the FDA gave you as feedback before you decided to start this trial. Is it any particular adverse effect that you think is not well investigated at the different dose levels at the moment? What have they said on what doses that should be investigated in this trial? Is it the same, 5 mg per kg-7.5 mg per kg that you had in the poster here at the AACR, or is it more to the lower levels of 1 mg per kg-2.5 mg per kg, that you just show here in the poster? Thank you. Thank you, Viktor. The FDA feedback was more concerning, let's say, how we have optimized the dose rather than specific safety findings. Just to remind, we've done 20 patients on 1 mg per kg, we've done 20 patients on 2.5, we've done more than 20 patients on 5, and then we've done 8 patients on 7.5. 7.5 we have concluded is the higher than we intend to go with. We suggested to go ahead with one dose level in the phase II/III trial called Precision Promise with PanCAN. The FDA wanted us to either start the lead-in of 2 different dose levels or do a separate phase II trial. I think the intention is really to see if there are clear differences in efficacy or safety to really verify which dose is most suitable for Phase III. We had the choice of doing both. It was, however, much more straightforward to do your own Phase II trial rather than trying to fit the this type of lead-in phase into an already existing protocol. That was one driver. The second driver is that we cannot do the same type of IL1RAP high versus low analysis in the Precision Promise trial, because we cannot really go ahead and do that in type of analysis in the control groups. It's quite challenging in the active groups. We decided that the new route is much more optimal and much better when it comes to risk management and also for shareholders in the long way. No specific safety findings. It was rather that it was very difficult to see which dose level gave the best, let's say, efficacy versus safety ratio in the existing material. The dose levels, we believe that 2.5 is the best dose level, and we will most likely investigate 1 and 2.5 in the upcoming trial. Okay. Thanks for clarifying. That was all for me. Thank you. The next question comes from Arvid Necander from Carnegie. Please go ahead. Good morning and thanks for taking my question. I had a question on the encouraging signal of higher treatment benefits in IL1RAP high patients. Are you planning for any clinical or translational work to further validate this signal before randomized data emerges? Would you, for example, also expect to have a high IL1RAP expression in the stroma of patients benefiting the most, if these samples are available from CANFOUR, or are there any other findings that could help you validate your hypothesis before top line data in 2025? I'll start there. Thanks. Yeah. Thank you, Arvid. This is a great question. The well, the stromal analysis is ongoing here as well to see what impact the stromal IL1RAP levels would have on efficacy as well. To remind the data, the ACR was only focusing on the tumor cells and not the rest of the tumor microenvironment. In the new phase II trial, obviously we will maybe... All patients entering the trial in both the active groups as well as the control groups, we will measure IL1RAP. We will not pre-select patients with high or low IL1RAP. We will instead measure everything and obviously have a predefined analysis of high versus low to understand more. There'll probably be much more exploratory analysis as well. The... The stromal component may very well be involved here, and we will also be looking for other markers in the tumor or in blood that could further guide which patients are the best responders. Obviously, it's going to be much easier to take a blood sample rather than base everything on biopsies. All that work is ongoing and in planning right now. You should also expect data on how the stroma component in the existing trial is contributing to efficacy here. We have not decided which conference to do that. Okay, great. Thanks. Secondly, does the TRIFOUR protocol allow for the same analysis? Can we expect this type of data from that trial as well? Short answer is that yes, we're taking biopsies in the TRIFOUR trial. Obviously IL1RAP is a key component here. Yes, definitely. What is a little bit more complex is that we've seen in lung cancer that IL1RAP levels are to some extent induced by platinum. Since platinum is part of a treatment, we'll do the analysis, but we need to be cautious on how the baseline level affect, let's say, pre-treatment levels later on. Much more to come. Okay, great. The last question, if I may. How optimistic are you about being granted a breakthrough therapy designation in pancreatic cancer if you would replicate the results you showed in CANFOUR in the randomized study? Will there be any sort of adaptability built into the randomized study that could allow you to upsize it, should data pan out well? Yeah. That's ongoing discussions right now. There is very little precedence in pancreatic cancer on where is the bar for breakthrough designation. Obviously, that is a desired outcome of the phase II trial for sure. If that can be then let's say built upon in a registration trial is also discussions we need to have with the FDA. More to come here. Okay, great. That was everything from me. Thanks, guys. The next question comes from Richard Ramanius from Redeye. Please go ahead. Hello, good morning. I wanted to continue this discussion of the IL1RAP. I was thinking what might be interesting to see a result from all trials 'cause you have enrolled around 250 patients in total in cancers. Are you planning on doing some sort of aggregate study of IL1RAP expression across all the cancer types you're studying where it's possible? I mean, where do you have and where you have the biopsies? It's... No, it's a, it's a very good question. Yes, these analyses are ongoing. With approximately 250 patients, I don't have the exact number of baseline biopsies that we have, but we have quite a few. Yes, we are now retrospectively looking backwards to see if there are more relationships outside of the pancreatic cancer with between baseline IL1RAP and, for instance, survival or other benefits here. I had a question about the CAN10 study. Could you say something more about the design of the phase I? For example, how many patients do you plan to recruit? The phase I, as it is today, we're, there are very specific guidelines on how you should perform this trial. What you normally do is that you have patients both on drug as well as on placebo on the different dose levels. We probably have to do seven dose levels, but it is clearly a discussion with the authorities, and we'll probably have less patients on the lower dose levels and then go to higher. Typically, you would find four or six patients on the lower dose levels and perhaps a little bit more on the higher. We will also Sorry, not patients, healthy volunteers. Then, we're also building in some biological studies. We're taking blood from the patients to see what impact the antibody would have on the immune system, so basically replicating some of the in vitro work we've done. We will do skin biopsies. There is a variation of patients between the various dose levels, but it's certainly going to be a big trial, in the range of at least 100 individuals. You mentioned earlier in the conference call that you intended to do the multiple ascending dose part on psoriasis patients. Is that correct? Yes. That's correct. That would also be seven dose levels. No, that will be less dose levels. Yeah. I think this is clearly one of the things that are going to be reviewed by regulatory authorities. I would rather come back once the protocol is granted by all, everyone involved. Yeah. Sure. My last question was a financial one. Since you've halted a large number of trials now, I wondered how. Does that mean, have any effect on how long your cash will last? Since, for example, you haven't halted the study of lung cancer patients. Yeah. No, it has some effect, but as it looks right now with the current plans and upcoming trials, we will have cash until mid 2024. Then obviously if we. We can extend that runway if we find it necessary. Clearly. Okay. Thanks. Well, clearly with trial, the stop recruiting patients, the cash positioning improves for sure. Okay. Thanks. That's all for me. Thanks. There are no more dialed in questions at this time, so I hand the conference back to the speakers for any written questions and closing comments. There are two questions coming from the web, and the first one is connected to the last question, and that is, are there any effects on the decision to rather focus on the phase II- B study in PDAC rather than the previous plans in terms of burn rate and cash decisions? The phase II-B is obviously going to be a very important trial to focus on and I think in general when cancer lead program, it is to run my trial. It is the TRIFOUR trial and the upcoming phase II-B trial, which is going to be our focus in the foreseeable future in the lead program, or at least being planned during 2023 and early 2024. It is obviously CAN10. There is always an opportunity to perform these trials in or especially the CAN10 trial in tranches with if again it's necessary. Thank you. The last one is partly connected to another question, but it is if you see the same clinical benefits as in the planned phase II-B trial, would you see any sort of possibilities on a conditional approval or an Accelerated Approval followed by that trial, and that will then be confirmed in a phase III trial? I think. First of all, when it comes to the FDA, they a few weeks ago, they released completely new guidelines regarding Accelerated Approval to fit with Project Optimus. Exactly what that means for sponsors, there needs to be discussions with the FDA around this. I cannot comment on that at this point in time. Okay. Of course, of course, we would, we would do anything we can do to get into such a position. I think, with completely new guidelines on the table, it's still speculative to start guiding for an Accelerated Approval at this point in time. The trial is more designed for getting robust data that can be used in the future. Obviously, we all know that if data are very positive, it opens up lots of new opportunities. Thank you. That was all the questions coming in from the web. Okay. By that, I'd like to thank you for your attention, and I can assure you that we are extremely motivated to continue our important work and are very encouraged by all the clinical results we have. There is also going to be new results being presented at ASCO in a week or two away from now. Thank you.