Earnings Call: Q2 2021

Aug 19, 2021

Quarterly report

Hello, and welcome to Cantargia Q2 Report 2021. Throughout the call, all participants will be in a listen-only mode, and afterwards, there'll be a question and answer session. Today, I'm pleased to present Göran Forsberg, CEO, and Bengt Jöndell, CFO. Please begin your meeting. Thank you so much. It's a pleasure to be here after summer and present our half-year report. If we move to slide 3, it's me, Göran Forsberg, CEO, together with Bengt Jöndell, who will do the presentation. I will start by going through the most important events during the period, and also give a little bit more depth and flavor of our ongoing clinical trials and the upcoming news flow. Bengt will take on and go through the financials in more detail. If we move to slide 4, it's been a busy period for Cantargia, and it's been a very good period for Cantargia when it comes to the development. We presented very interesting and positive results both for our lead program nadunolimab clinical data in pancreatic cancer, and also in our second preclinical project, we presented new and very intriguing data when it comes to treatment of myocarditis in preclinical models. We have also advanced the broadening of the program of nadunolimab with the submission or regulatory approvals of a number of trials, and we'll go through these trials in more detail. If we go ahead and move over to slide number 6, we can have a look at the pipeline. As you can see for nadunolimab, we have the lead trial in phase IIa clinical trial for pancreatic and non-small cell lung cancer. We have presented the data in those indications. Based on the readout of those data, we have decided to take the next step, which is, let's say, a broadening of the program to really identify the best opportunities. At the same time, we are obviously advancing the programs in non-small cell lung cancer and pancreatic cancer. It is development in two directions here. To broaden the program, we are doing activities in other segments of both pancreatic cancer, non-small cell lung cancer with new combination therapies. We're starting activities in triple-negative breast cancer later on this year, and we have a new big trial in three different indications in lung cancer, in biliary tract cancer, and in colorectal cancer that's about to start later this year. All these trials have a common theme. It is combination with different chemotherapies, and the main reason is that both preclinical and clinical data suggest that we can act in synergy with chemotherapy and both prolong and deepen responses. We're also doing combination with immunotherapy. We have 1 trial where we do a combination with pembrolizumab, and we'll come back to that and also the recent news flow from earlier today in that trial. Beside nadunolimab, we also have CAN10, where we intend to start clinical trials early next year. It's a different antibody than nadunolimab, but it's directed against the same molecular target. It's being developed for myocarditis and systemic sclerosis, and there is obviously more to come on this program. Finally, we have the CANxx project, which is, let's say, a platform where we have now more than 100 different antibodies against the molecular target, with the opportunity to develop new programs not competing with the two lead programs. Before going into, let's say, where are the trials, I'd just like to remind you a little bit of what we've seen in pancreatic cancer, non-small cell lung cancer. If we move to slide number 7, we present the data in May, which we think are very intriguing and very positive when we used nadunolimab in combination with gemcitabine ABRAXANE in first-line therapy of pancreatic cancer. What we've seen is that we get responses that are much more durable than you would expect from chemotherapy alone. The median rate in this interim analysis was 6.8 months, which is about twice as you would expect from chemotherapy alone. We've also seen that several patients benefit in a perhaps more unorthodox way when it comes to pancreatic cancer, but they get something called pseudoprogression, which means that they, again, really benefit from a therapy even though it's not a response. Adding all these positive findings leads to a promising progression-free survival, which was 7.8 months, which is much longer than the 5 to 6 months you would expect from chemotherapy alone. The overall survival, which is very preliminary, was longer than 1 year, which again, is much longer than expected from chemotherapy alone. The side effect profile is interesting. We do see an increased neutropenia, which to some extent was an expected side effect, but this trial was not really optimized to handle neutropenia. It was more designed to characterize the safety, and neutropenia can be counteracted by additional G-CSF and in all our future trials, we're doing that in a more proactive way. Notably, other serious side effects introduced by chemotherapy like neuropathy and fatigue was much lower than expected. In non-small cell lung cancer, we are going to present data later on this quarter. To remind you again, we see a higher response rate than you would expect from chemotherapy alone when we combine with the standard therapy of gemcitabine cisplatin in first-line chemotherapy setting. Again, the side effect profile is similar to what we see in pancreatic cancer. We see increased neutropenia, but we can also hopefully manage that by adding G-CSF. Moving into slide number 9, we are in a position where we now can give some more, let's say, flavor to our clinical program. The CAN04 trial, it's ongoing. It's in the end of the recruitment phases in both non-small cell lung cancer and in an extension part of the pancreatic cancer. In pancreatic cancer, we have already recruited 33 patients, which was the data I presented, and we're now doing another 40 patients in the extension phase. In non-small cell lung cancer, we are targeting 31 patients, and we expect that first patient to be dosed therapy during Q3. We're also planning to present the next interim data set in non-small cell lung cancer during Q3, and it will be presented at ESMO, the European cancer conference later on in September. We presented the interim data on pancreatic cancer in May, and we believe that the data will have reached enough maturity to do an update during the fourth quarter this year as well. We also will communicate more about what the next step both in non-small cell lung cancer and pancreatic cancer will be in the not-too-far-away future. Going to the next slide, which is slide number 10. The CIRIFOUR trial. Here we communicated today that this is a trial where we are combining CAN04 with pembrolizumab, and the pembrolizumab arm got fully recruited recently, and we could get that confirmed and communicated to the market earlier today. We plan to report the initial results during the fourth quarter of this year. What I can say, though, is that the safety profile of the combination looks very good, and that has, let's say, formed the basis of going into the next step of the trial, which is to combine CAN04 with pembrolizumab and chemotherapy, and it will be carboplatin pemetrexed in non-squamous non-small cell lung cancer, and that group is planning to be started during the fourth quarter of this year. If we go to slide number 11, the CAPAFOUR trial, it got approved during June, and recruitment has started, and we have now 3 different centers open in France. We had hoped to get the first patient in earlier this summer. Unfortunately, it hasn't happened, but the sites are all screening patients, so we expect that to happen in the near future. The goal is to reach approximately 30 patients here in 2 different steps. One initially is the dose-finding phase, and then it is an expansion of the safe dose level. If we go to slide number 12, which is the TRIFOUR trial, it is going to be performed in triple-negative breast cancer, and it is going to be in collaboration with the Spanish Breast Cancer Group. It is a combination with carboplatin gemcitabine. We submitted this trial in June. The plan is to open up approximately 24 centers in Spain, and then two phases here as well. It is an initial safety phase, but it is also going to be followed by a randomized part. Together, we are targeting 120 patients in this trial. We expect the patients to start treatment in November. Finally, on slide 13, the TERZA-4 trial. It is three different indications. It is non-small cell lung cancer, biliary tract cancer, and colorectal cancer. In non-small cell lung cancer, we're combining with docetaxel. In biliary tract cancer, it's cisplatin gemcitabine, and in colon cancer, it's FOLFOX. This trial was also submitted in June, we expect to start treating patients late September. This trial will be performed at 20 different centers in France, Spain, and U.K. Again, this is a big trial. It's safety phase in each indication of about 15 patients, which is then followed by approximately 40 patients in each indication in an expansion phase. Thereby I finish, let's say, the development update, and I let Bengt continue with the finance, and I guess we'll then go to slide 15. Okay. Thank you, Johan. Yes, page 15, please. The financial overview Q2 2021. Cantargia’s operating expenses the first half-year increased significantly by 106% compared to last year to in total 159.8 million SEK. As you can see in the graph at the left, this increase is more or less entirely related to R&D. The total investment in R&D amounted 94% of the operating expenses. The increased R&D investments is, as before, I would say, mainly related to Cantargia’s main project, CAN04, and especially the broadening of the clinical program with the studies CIRIFOUR and CAPAFOUR. CMC in CAN04 and also the preclinical part in CAN10 increased. As you also can see, we’re increasing our employee to a total of 23 full-time employees end of June 30. This increase is also entirely related to R&D. Page 16, please. Financial position. Cantargia has continued a very strong financial position with a solidity of 91%, and we have total available funds at June 30 of in total SEK 760.7 million. This available funds will, with present plans, last until first half year 2023, so about two years from now. This concludes the financial overview, so back to Johan. Thank you, Bengt. Now we are moving into the final slide, which is related to the news flow, and after that, I'm very happy to take some questions. Slide 18. I'm extremely enthusiastic about the opportunities for Cantargia. I think we have a very interesting clinical data set to lean upon, and we have a very interesting news flow in front of us, and we are well-financed to take the next steps. Over the next 6 months, I plan to present new data in all our lead trials, both in pancreatic cancer, in non-small cell lung cancer, and with the KEYTRUDA combination. We definitely are going to be more concrete about what are our next steps when it comes to combination therapies in pancreatic cancer and non-small cell lung cancer outside the trials that have already started at the earlier stage. The company is also performing lots of preclinical translational results. We're looking into biomarkers, we're looking into biopsies, and trying to explain more about the mechanism of action, also try to target which patient groups that are benefiting the most from our different therapies. Once we have the results on this, our idea is really to be transparent and present it. Obviously our 3 new clinical trials, CAPAFOUR, CESTAFOUR, and TRIFOUR are in the starting phase, but there are significant milestones as these trials get started, which would also be communicated. In the second product, CAN10, we obviously have lots of development milestones and preclinical progress. For instance, we are planning to present more data in other disease models like systemic sclerosis later on this year. Obviously the goal is to initiate the clinical trial early next year. By here, I think I'm ready to finish my part of the presentation, and I'm very happy to take some questions. Thank you. If you'd like to ask a question, please telephone keypad. If you wish to withdraw your question, you may do so by pressing zero two to cancel. That is zero one if you would like to ask a question. Our first question is from Mark Breidenbach from Oppenheimer. Please go ahead. Hey, congrats on the progress, and thanks for taking my questions. I guess I'm wondering with all the recently announced trials, it seems like you're covering a lot of bases in terms of tumor types and treatment settings, but we're not seeing any exploration of adjuvant or neoadjuvant settings like we're seeing with Novartis' CANOPY-A and CANOPY-N trials. I'm just wondering if you have plans to look at these settings in any tumor types, maybe something along the lines of dosing ahead of or immediately after Whipple surgery in pancreatic cancer. That's one question. Another question is just on the upcoming clinical updates from CAN04. If you can maybe give us a sense for how many new efficacy evaluable lung cancer patients we should expect to see at ESMO. I'd appreciate it. Thanks so much for taking the questions. Okay. Thank you, Mark. That's 2 very good questions. If we start with number 1, doing trials in the adjuvant or neoadjuvant setting. That's, let's say, initially the scientific type of trial to get more input, let's say, biologically of what's happening in the tumor. Basically, the idea is to treat the patient before surgery, they do the surgery, then have a big lump of tumor to see what's going on. I have no, let's say, cannot guide on any timelines, there is an interest to perform these trials, I think we've been, in a way, waiting to get solid safety data on various combinations before starting those trials. That has been the bottleneck. When it comes to adjuvant, which is after surgery, that's often very big trials, and we're not really ready to take that step yet, even though arguably, I really agree that it's a great opportunity. Let's say, given more flavor of the lung cancer data set to be presented at ESMO. We will try to be as transparent as we possibly can be. We are close to getting 31 patients started therapy, but obviously, we need to lock a database. We have recently locked the database for ESMO and are currently analyzing those data. You should expect to get not 31 patients, but a number not too far away from 31. Terrific. Yeah, that's very helpful. Thank you. You're welcome. Our next question is from Rene Wolters from Kempen. Please go ahead. Yeah, good afternoon, Göran and Bengt. Thank you for taking the questions. First of all, coming back also on the question by Mark on ESMO, I think it will be an exciting year this year also as Novartis will present the CANOPY-2 trial results. Anything in that presentation that you will be mostly looking at? That's my first question. Secondly, I was just wondering which of these new trials you're actually most excited about. Okay. What we know about the CANOPY 2 trial is really that it didn't reach the primary endpoint, but I think there is most likely lots of interesting data around that, which could be subgroup analysis, and it could be, let's say, more flavor of the total data set, how close was it to be a successful trial and also getting more information around safety. All that will be very helpful. There are probably limitations on how much Novartis is ready with when it comes to analysis and what they can present. Obviously, our expectation is to learn much more, and that's going to help us in our next step activities almost regardless of how data looks like. Secondly, of all these new trials, which I'm most excited about, I think I'm excited about all of them, but for various reasons. We have obviously some trials which perhaps are a little bit more high-risk but also very high opportunity, like biliary tract cancer, where the number of treatment alternatives are very limited. Let's say the upside, if we see a signal, it's very interesting, and that's also an indication where gemcitabine plus platinum is used standardly and where we have interesting data from non-small cell lung cancer. That obviously excites me a lot, but I think we have been sitting in front of a smaller board of different opportunities, and we have picked the ones that was most exciting. I would say the less exciting are already gone. Hopefully that answer your question. Yeah. Super. Thank you very much. Our next question is from Niklas Elhammar from Redeye. Please go ahead. Good afternoon. Thank you. I have a question regarding the expansion of the CESTAFOUR trial in non-small cell lung cancer. Can you elaborate a little bit on the design, and would you include then spine patients here? Yes. Thank you, Niklas. There was actually a little bit of a disturbance when I got your question, so I'm not sure if I got it correctly. The SERAFIN trial is now being expanded to look into combination with pembrolizumab and carboplatin together with pemetrexed. Carboplatin pemetrexed is, let's say, probably the standard choice today for treatment of non-squamous non-small cell lung cancer when it comes to choice of platinum doublets. In a way we are now, let's say, moving into a patient population which is still very big. It's somewhere 75% to 80% of all non-small cell lung cancer cases that are non-squamous. It's a first-line opportunity now when we combine with KEYTRUDA plus the chemotherapy. It's a big patient group, and initially we were interested to just look at the safety, but clearly we are also looking into biomarkers and efficacy parameters here to learn more about the opportunities of CAN04 to increase this already very effective therapeutic option. Sorry. Is it those escalation parts? Yes. Initially it's a dose escalation part starting at a lower dose and then increasing sequentially based on how the safety looks like in a certain number of patients. Once we've reached, let's say, the desired dose level or highest tolerable dose level, we will expand on that dose level. Okay. Thank you very much. Thank you. Just as a reminder, if you do wish to ask a question, please press 01 on your telephone keypad now. Our next question is from Sean Conroy from Edison. Please go ahead. Hi there, and thanks for taking my questions. First question sort of following on from Niklas' there, just wondering, just a point of clarification, are you going to be sort of pre-screening for PD-L1 status in that extension arm? Yes, we will be looking at PD-L1 status. As you know, if patients have a high PD-L1, the investigator has an option to go for pembrolizumab monotherapy or pembrolizumab combination therapy. That's certainly a parameter that will be part of the trial. Excellent. Just the sort of second question on the ongoing thoughts of the design of a phase III in pancreatic cancer. You might have clarified this at the IND day, could you just remind me how you're thinking about chemo combinations in this? Are you just going to initially focus on the gemcitabine/ABRAXANE combination and then look at potentially further down the line once you have the CAN04 data? Are you considering waiting for the CAN04 data and looking at both concurrently in the study and leaving it up to investigator's choice? Yeah. No, I think the ABRAXANE data, it's one or two years ahead of getting solid CAN04 data. ABRAXANE is standing on its own. Right now we have this CAN04 dataset. We're letting that dataset maturing. We are having necessary discussions with the KOL and regulatory authorities about potential next steps. In parallel with that, we are getting more and more data from the extension arms which have been designed to look into various dose levels and some other details here like G-CSF therapy and everything. Hopefully in a quarter or two, we would be in a situation where we have a complete picture of the ABRAXANE and what is the next logical steps, if it's a phase III or if it's something else. We're not waiting for FOLFIRINOX data to read out before taking a phase III decision if it looks good. Yes. Thank you. If the data continues to look good. Yes. No, definitely. Excellent. Just as a final reminder, if you do wish to ask a question, please press 01 on your telephone keypad now. There are currently no further audio questions. I will hand the word back to the speakers. Yeah, and there's one question coming through the web, and that is, do you have established a recommended phase II dose for the PDX study? Yeah. In principle, we're investigating 1, 2.5, and 5 mgs per kg. I think we would like to have all the phase II data here before we decide on exactly which dose level to go for. Having said that, let's say establishing We can continue the development because the finding phase here, it's more fine-tuning. We're pretty confident that the 5 is good if we need to go with that. There could be other aspects here, like do we want to, let's say, go for more fixed dose for all patients and everything, and we're doing all these PK/PD analysis right now based on the data we have. We could go ahead if we like, but we could probably do some more fine-tuning as well to get it even better. Thank you. There is no additional questions coming through the web. No further audio questions, so I'll hand over any final comments. Well, I'd like to thank you for your attention. As I said, I'm very excited about Cantargia and what we have in front of us during the next couple of quarters, and look forward to continued interactions with you, and very happy to meet you again at the next quarterly report.