Earnings Call: Q2 2021

Aug 19, 2021

Quarterly report

Hello, and welcome to Kantagia Q2 Report 2021. Session. Today, I'm pleased to present Joran Forsberg, CEO and Bank Junde, CFO. Please begin your meeting. Session. Thank you so much. It's a pleasure to be here after summer and present our half year report. And It will be so if we move to Slide number 3, it's me, Johan Forsberg, CEO, Together with Venk and Del who will do the presentation. And I will start by going through The most important events during the period and also give a little bit more answer. That's and the flavor of our ongoing clinical trials and the upcoming news flow. Session. And then Benk will take on and go through the financials in more detail. So if we move to Slide number 4, It's been a busy period for Chemtarg and it's been a very good period for Chemtarg and it comes to the development. So we presented very interesting and positive results both for our lead program KAN04 on nadunilimab, clinical data in pancreatic cancer. And also in our second preclinical project, we presented And very intriguing data when it comes to treatment of myocarditis in preclinical models. We have also Advanced the broadening of the program of the Kano 4 with submission or the regulatory approvals of the number of trials, and we'll go through these trials in more detail. So if we go ahead and move over to Slide number 6, We can have a look at the pipeline. So as you can see for KANO-four, 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 session. And 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. But at the same time, we are Obviously advancing the programs in Alzheimer's cell lung cancer and pancreatic cancer. So it is development in 2 directions here. And to broaden the program, we are doing activities in other segments of both pancreatic cancer and non form 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 point. In 3 different indications in lung cancer, in biliary crack cancer and in colorectal cancer About to start later this year. All these trials have come on theme. It is combination with different chemotherapies. And the main reason is that both preclinical and clinical data suggest that we can have in synergy with chemotherapy And both prolong and deepen responses. We also do in combination with Immune therapy, so we have one trial where we do combination with pembrolizumab and we'll come back to that and also the Recent news flow from earlier today in that trial. Beside channel 4, we also have Canten, Where we intend to stop clinical trials early next year, it's a different antibody than session. Channel 4, but it's directed against the IMLEC targets. It's being developed in myocarditis and systemic sclerosis And there is obviously more to come on this program. And finally, we have the CAM XX project, which is, let's say, a platform where we have Now more than 100 different antibodies against the molecular targets, with the opportunity to develop new programs, not competing with So 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, not on cell lung cancer. So if we move to Slide number 7, We presented data in May, which we think are very intriguing and very positive when we used KANO4 in combination with session. In cytopenabrrexin in first line therapy of pancreatic cancer. So 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 pseudo progression, which means that they again Bring the benefits from the therapy even though it's not a response. And adding all these positive findings Leads to a promising progression free survival, which was 7.8 months, which is much longer than 5 to 6 months you would expect from chemotherapy alone. And the overall survival, which is very preliminary, longer than the year, which again is much longer than expected from chemotherapy alone. The side effects profile is interesting. We do see an increased neutropenia, which to some extent was an expected side effect. But this trial was It's not really optimized to handle neutropenic. It was more designed to characterize the safety. And neutropenia can be counteracted by addition of ECSF and in all our future trials, we're doing that in more proactive ways. But notably, other severe 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 Q3. But to remind you again, we see higher response rates than you would expect from chemotherapy alone when we combine with answer. As a standard therapy of temsitabine, vistratin in first line chemotherapy setting. And Again, the side effect profile is similar to what we see in pancreatic cancer. We see increase in neutropenia, but we can answer session. Also, hopefully, manage that by adding to your CSL. So then 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. So the CANFOR trial is 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. So 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 both patients to be self impacted during Q3. We're also planning to present the next interim data set in non small cell line 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 It's not maturity to do an update during the Q4 this year as well. And we also We'll 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 in the future. Then going to the next slide, which is Slide number 10, The Series 4 trial, here we communicated today that the SOVISC is a trial where We are combining 1,004 with pembrolizumab. And the pembrolizumab arm got fully recruited recently, and we could We get that confirmed and communicated to the market earlier today. And we plan to report the initial results during the Q4 of this year. What I can say though is that the safety profile of the combination looks session. Very good. And that has, let's say, a 400 basis of going into the next step of the trial, which is to combine 1004 with tepembrolizumab and the chemotherapy and this will be carboplatin pemetrexed In non squamous non small cell lung cancer and that group is planning to be started during Q4 of this year. If we then go to Slide number 11, the KAPA-four trial, it Got approved during June and recruitment has started and we have now 3 different centers open in France. Session. We had hoped to get the 1st patient in earlier this summer. Unfortunately, it hasn't happened. But answer session. The sites are all screening patients, so expect that to happen in the near future. And the goal is to reach Approximately 30 patients here in 2 different steps. 1, initially, it's the dose finding phase and then it will be an expansion of answer session. And if we go to Slide number 12, which is the TRIFOR trial, it was it's going to be performed in triple negative breast cancer and it's going to be in collaboration with the Spanish Breast Cancer Group. It's the combination with cabozantin gemcitabine. And we submitted this trial in June. The plan is to open up approximately 24 sensors in Spain and then 2 phases here as well. It's an initial safety phase, but It's also going to be followed by a randomized thought and together we are targeting 120 patients in this trial. And we expect answer session. Patients will start treatment in November. Finally, on Slide 13, the TESSA-four trial. It's 3 different indications. So it's non small cell lung cancer, biliary tract cancer and colorectal cancer. Answer. In non Hodgkin Lancaster, we're combining with diltiazil in Bivir track cancer, it's cystatin gensitabine and the colon cancer, it's called FOG. This trial was also submitted in June and we expect to start session. Treating patients late September and this trial will be performed at 20 different centers in France, And again, this is a big trial. It's safety phase in each indication of about 15 patients, which is then followed by answer. Approximately 40 patients in each indication in an expansion phase. So whereby I Let's say the development update and I let bank continue with the finance And I guess we'll then go on to Slide 15. Okay. Thank you. Yes. Page 15 please. The financial overview, Q2, 2021. Cantagia's operating expenses, the first half year Increased significantly by 106% compared to last year to in total call. SEK159.8 million. And as you can see in the graph at the left, this The increase is more or less entirely related to R and D. The total investment in R and D amounted 94% of the operating expenses. And the increased R and D investments is as before I would say mainly related to Cantagas main project answer. And especially the broadening of the clinical program with the studies SERI-four and kappa-four. CMC in K104 and also the preclinical part in K10 increased. Session. As you also can see, we're increasing our employee to in total 23 full time employees End of June 30. And this increase is also entirely related to R and D. Page 16 please. Financial position. Kantagia has continued a very strong financial position with a solidity of 91%. Session. And we have the total available funds at the June 30 of in total SEK 760,700,000 and this Available funds will with present plans last until first half year twenty twenty three, session. So about 2 years from now. This concludes the financial overview. So Back to you, Rann. Thank you, Bengt. So 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. So Slide 18. So I'm Extremely enthusiastic about the opportunities for Cantaglia. 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. So over the next 6 months, I session. Plan to present new data in all our, let's say, lead trials, so both in pancreatic cancer, In non small cell lung cancer and with the KTRUDA combination. And we definitely are going to be more concrete about what our next steps when it comes to combination therapies in pancreatic cancer and non small cell line cancer outside the trials that have already started at the earlier stage. The company is also performing lots of preclinical and translational results. We're looking into biomarkers. We're looking into biopsies and Trying to explain more about the mechanism of action and also try to target which patient groups answer. That are benefiting the most from our different therapies. So once we have the results on this, we our idea is We need to be transparent and presented. And obviously our 3 new clinical trials, KAPA-four, Cetra-four and TRY-four Are in the starting phase, but there are significant milestones as these trials get started, which will also be communicated. And in the second project, Canton, we obviously have lots of development milestones and preclinical progress. For instance, we are planning to present more data in our disease models answer. Like stem sclerosis later on this year. And obviously, the goal is to initiate the clinical trial early next year. Session. So by here, I think I'm ready to finish my quarterly presentation and I'm very happy to take some questions. Answer session. Thank you. Our first question is from Mark for 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' CANOPHE A and CANOPHE N trials. 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, so that's one question. Another question is just on the upcoming clinical updates from CANFOR. Answer. If you can maybe give us a sense for how many new efficacy evaluable lung cancer patients we should expect to see it as well. Answer session. I appreciate it. Thanks so much for taking the questions. Okay. Thank you, Marc. That's 2 very, very good questions. So if we start with number 1, doing trials in the ad event or new ad event setting. So we have interest from investigators and we are in discussions about call. Various neoadjuvant trials in diseases. And that, Let's say initially the scientific type of trial to get more input, That is biologically what's happening in the tumor. So basically, the idea is to treat the patient before surgery, to do the surgery and then have a big lump I have no, let's say, cannot guide on any timelines, but there is an interest to perform these trials. And I think we've been in a way waiting to get solid safety data on various combinations before starting both trials. So that has been the bottleneck. When it comes to ADVANCE, Which is after surgery, but 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. And then let's say give a more flavor of The line cancer data is set to be presented at ESMO. So we will try to be as transparent as we possibly can be. We are close To get in 31 patients, we started therapy and but Obviously, we need to lock a database. So we have recently locked a database for IFRS and are currently analyzing Those data. So you should expect to get not 31 patients, but the number not too far away from 31. Terrific. Thanks for yes, that's very helpful. Thank you. You're welcome. And our next question is from Rene Walters from Kempen. Please go ahead. Yes, good afternoon. Hi, Geron 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 CANOPTY 2 trial results. Anything in that presentation that you will be mostly looking at? That's my first question. And secondly, I was just wondering which of these new trials you're actually most exciting about? Okay. So when it comes to so What we know about the PENELPY II trial, it's really that it didn't reach the primary endpoint, but I think there is session. Most likely lots of interesting data around that, which could be answer. Subgroup analysis and it could be, let's say, more flavor of the total answer. Data set, how close was it to be a successful trial and also getting more information around safety, all that will be very helpful. Session. And then there are probably limitations on how much Novartis answer. It's ready with the assumption that is on what we can present. So but obviously our expectation is to learn much more and That's going to help us in our next step activities, almost regardless of what it answer. How data looks like? And then 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. So we have obviously some trials which Perhaps are a little bit more high risk, but also very high opportunity like the bigger track cancer where The number of treatment alternatives are very, very limited. But let's say the upside if we see signal, it's very interesting. And we That's also an indication where gemcitabineciflatin is used standardly and where we have Interesting data from non small cell lung cancer. So that obviously excites me a lot. But I think we have been sitting in front of a smaller spot of different opportunities and we have picked the ones that was most Exciting, I would say, less exciting are already gone. Hopefully that answers your question. Yes, super. Thank you very much. And our next question is from Miklas Gjellhammer from Ravejell. Please go ahead. I have a question regarding the expansion of the Q4 trial in non small lung cancer. Can you elaborate a little bit on design? And session. Would you include then the sustained patients here? Yes. So thank you, Niklas. So and Bertha actually, I wanted a little bit of a disturbance when I got your question, so I'm not sure if I got it correctly. The SERI-four trial is now being expanded to look into combination with pembrolizumab And carboplatin together with pemetrexed. And carboplatin pemetrexed is, let's say, Probably the standard choice today for treatment of non squamous non small cell lung cancer, lung cancer choice of platinum doublet. So 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. And it's a first line opportunity now when we combine with KEYTRUDA, that's the chemotherapy. So answer session. It's a big patient group. And initially, we're interested to just look at the safety. But clearly, we're also looking into answer. Biomarkers and efficacy parameters here to learn more about the opportunities of can afford to increase with already very effective therapeutic options. Answer session. Answer. Yes. So initially, it's the dose escalation parts that start getting at lower dose and then increasing So sequentially based on how the safety looks like and that's answer session. In a certain number of patients and then once we have reached the, let's say, The desired dose level or the highest tone rated dose level will expand on that dose level. Session. Okay. Thank you very much. Thank you. Our next question is from Sean Connery from Edison. Please go ahead. So first question sort of following on from Nicholas' there. Just wondering, just a point of clarification, are you going to be sort of prescreening the PD L1 status in that extension arm? So yes, we will be looking at PD L1 status. As you know, if patients have high PD L1, the investigator has an option Go for tembrolizumab monotherapy or tembrolizumab combination therapy. So that's certainly answer. That will be part of the trial. Excellent. And then Just the second question on the ongoing thoughts of the design of a Phase III in pancreatic cancer. You might have clarified this at the O and D, David. Could you just remind me how you're thinking about chemo combinations in this? Are you just going to initially focus on the Same combination. And then you look at potentially FOLFIRINOX further down the line once you have the KAPA-four data? Or are you considering waiting for the CAPP-four data and looking at both concurrently in the study and moving up to investigator choice? Yes. No, so I think the gemobrascene data, session. It's 1 or 2 years ahead of getting Capa, solid step forward data. So genobraxim is standing on its own. And right now we are answer session. So we have disclosed 1 data set. We're letting that data set maturing. We are Having necessary discussions with the JOLs and regulatory authorities about potential next steps. And in parallel with that we are getting more and more data from the extension arms Which has been designed to look into various dose levels and some other details here like PC, death treat, And hopefully in a quarter or 2, we would be in a situation where we Have a complete picture of the genobracks then and what is the next logical steps, if it's a Phase 3 or if it's something else. So but we're not waiting for Feerenosteika to read out before taking a Phase III decision if it looks good? Answer session. Thank you. Thank you. The company needs to look good. Yes, no, exactly. Excellent. And there are currently no further audio questions. I will hand the word back to the speakers. Yes. And there's one question coming through the web and that is, do you have established a recommended Phase 2 dose for the PVAX study. Yes. So session. We are worried so in principle we're investigating 1, 2.5 and 5 mgs per kg. And I think we would like to have all the safety data here before we decide on exactly Which dose level is to go for? But having said that, let's say, establishing answer. We can continue the development because the finding place here, it's more fine tuning. Answer. We're pretty confident that the size is good if we need to go with that. But 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 answer. PD analysis right now based on the data we have. So 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's no additional questions coming through the web. And no further questions, so I'll hand over to Alberto for any final comments. Well, Alex, thank you for your attention. As I said, I'm very excited about Kantar again and what we have in front of answer during the next couple of quarters and look forward to continue interactions with you and