Earnings Call: Q1 2021

May 26, 2021

Quarterly report

Thank you very much. It's a pleasure to present the ChemTargets Q1 report today. And if we move to Slide 2, there is some information. And then we can move directly to Slide 3 to introduce myself, Joran Forsberg, I'm CEO of KantarGA. And I'm here, as you said, together with Bengt and Ded, who is CFO. And if we move to Slide 4, we'd like to highlight what our most significant events are for this period. And it's very much related to our ongoing and clinical trials and clinical trials that are about to start. So very much has been focused on pancreatic cancer, where we started an extension trial earlier this year, and we'll come back a little bit on the purpose of that one. We're also starting a parallel trial in pancreatic cancer where we combine Canopor with Fotirinox in contrast to the first trial where we combine in first line with chemsakivinabraxane. During the Q1, we also and in the Q2, we presented need new data on our Canten antibody, which is in preclinical development for systemic sclerosis and myocarditis, and it was presented at an American Association of Immunology Conference where we presented new data on especially in myocarditis that are very exciting, and there's more information on our web page around that. We also are about to start a trial in triple negative breast cancer with Canofor, and this is going to be in in collaboration with the Spanish breast cancer group called GACAM. And the letter of intent was signed during Q2. And this trial, the submission of the protocol is about to start during the Q2 as well. And then finally, we presented new clinical data in pancreatic cancer, which we are very excited about, and we will come back to that in much more detail during this call. So if we move to Slide 6, you can see how the pipeline in Cantavia around our project and especially around the Canal 4 have been developing. So in pancreatic cancer, we are doing 2 different trials. So we're doing first find combinations in Phase IIa, which gemcitabineabraxane. And as I said, we're about start a new trial, which will be a Phase 1b trial in combination with FOLFIRINOX. Our second lead indication is non small cell lung cancel again, we are in Phase IIa combining with gensychodine cystatin and we'll come back to the news flow. We are very much focusing development on the combination therapies and we are in addition to what's being done in non muscle lung cancer pancreatic cancer with chemotherapy, also doing a trial where we combine with immune therapy with KEYTRIBDA, which is the most important player in non small cell lung cancer at the moment, and that's being performed in it's a solid human trial and performed in the U. S. In a Phase I setting. Lennox has said the triple negative breast cancer is about to start and we're also doing other trials in which are about to start later on in other cancer forms, which I'll come back to. And then CanX is being developed for systemic sclerosis and myocarditis, and we also have a platform project called CanXx, which is designed to develop new opportunities within our have expertise and more to come around that later on. So then if we get to Slide 7, and this is really the new clinical data we got in pancreatic cancer. And this it's then in combination with the chemotherapy. And I think the take home messages are really that we see durable responses, we or that's the first take on message. And the durable responses are very important because patients do it with chemotherapy alone in pancreatic cancer, even if they get responses, they are often very short in time. And once the patient progress, unfortunately, very little term is less treatment. Having durable responses, it's a surrogate market for increased survival. And with the durable responses and also with something called pseudo progression, which we have observed in 15% of the patients, we get very promising progression free survival. And even though it's early days, the survival data looks promising as well. And just a word about what pseudo progression might be. So pseudo progression is something which has been well described with other immune agents like to take through that in, for instance, melanoma and in lung cancer, and it has been, let's say, been a unique feature of immunotherapy and nothing you expect from chemotherapy alone. So in one way, it's really strengthening us in our belief that our drug makes a difference for these patients, and it's also something which can be observed to have long term effects. So if we go to Slide 8, we can actually illustrate what the see the progression mean. And I think if you just look at the patient which is called Subject 1, it's pretty clear that if you look at the blue line here, that the patient has a significant tumor burden well at 0 weeks with the treatment starts, but the tumor blood is increasing in the first CT scan, which is done 2 months later, but since the patient is responding on the biomarker for CA99 and also felt much better clinically, it was decided that patients should continue therapy anyway. And what you'll see then is that patient tumor is actually shrinking and that biomass goes further down. And this patient has now been treated for 14 months and this will be on therapy and it's doing very well. So this is a very successful outcome of the therapy. And then we have different patterns, but in principle, it's the same story. In W2, 3, 4 and 5, they all increase in tumor size initially. And then the situation either stabilizes like in Patient 3 or improves like in the other patients. In the end of the day, all these patients need to benefit from a therapy, which is obviously magnificent in this type of disease. So if we go to Slide 9, this is just showing the results on regression free survival, where patients have 7.8 months. Right now, there are still some 7 patients being treated, so this number can change a little bit. But 7.8 months, it's much longer than you would expect from chemotherapy alone, where it's somewhere between 5.5 months has been described previously. And this is a significant difference. And the overall survival here is even earlier now. So we have 7 patients on treatment, as I said, and actually 58% of the patients are still alive in this analysis. So this is preliminary data, but the overall survival is 12.6 months, which is much, much longer than approximately 8 to 9 months, the patients are expected to live on average, you've seen chemotherapy alone. So all those data makes us very excited. So we can then go to Slide 10. I would just like to comment on the safety in the trial because that just is important. And what we see when we do treatment is that one of the side effects for XL2 are more pronounced than you would expect from chemotherapy alone, and that's neutropenia and then something called febri neutropenia, which is an infection as a result of neutropenia. Since this was the first in man trial, we didn't do anything to proactively counteract side effects, it's important to document side effects. But what we do nowadays it's that we add some pharmaceutical called GZF of proactive dissertations. And the neutropenia is, let's say, much is under control right now in patients treated right now. But in this set of patients, we didn't include G CSF in the same way, therefore neutropenia and fever neutropenia was higher than expected. Having said that none this was easily treated with G CSF and antibiotics and the patients could continue in the trial. On the very positive side on the side effects are that we there are serious side effects on tumor related or chemotherapy induced fatigue end neuropathy and these side effects were much lower with the therapies and that should be explained by can for actually being anti inflammatory and for instance counteracting new inflammation, we need to study this in much more detail. But in reality, it means that patients do not have stopped chemotherapy, which is a major problem with in pancreatic cancer, so even if patients are responding, they have to start therapy for a while because of neuropathy. Now they can continue, which makes them much more likely to respond. So altogether, we are very intrigued and very positive to the data we've seen, and obviously, we are planning on next steps now in pancreatic cancer. If we go to Slide 11, we have not updated the market on non small cell lung cancer for a while, but these are the data we presented in autumn last year. It's a 9 first patient with non small cell lung cancer. And to summarize, the patients are also here doing very well. Actually all 9 patients have tumor shrinkage when they are treated for in combination with gemcitabine cystatin and 6 of these patients have a tumor regression, which is higher than 30% and one patient has a complete response, that's the patient that had initially been treated with immunotherapy and did not no longer respond. That patient was then given Canofor in chemo and both the primary tumor and lung metastases vanished within 2 months and the patient has been tumor free for a year in this analysis. So obviously, a very interesting result. And it fit with our strategy to come that Canofor and Chemotherapy will combine very well. So if we go to Slide 12, we can just look at our current trials and what the milestones are. So in non small cell lung cancer in the ongoing trial, we expect the recruitment to be finished in hopefully not too far away and that we can present results during Q3. In pancreatic cancer, in the ongoing trial, present the results last week, obviously, we expect to give you more information during the second half of especially the overall survival. And we are also doing an extension phase right now since regulatory forces will require slightly more information regarding dose, treatment at different dose levels, for instance. There are also some other fine tuning as well as adding GCSF. So we're doing an extension phase right now, and we expect that one to be fully recruited June Q3 as well. Then we have our 2nd trial, which is a combination with KEYTRUDA. Recruitment is ongoing. We expect it to be fully recruited during Q3. And then obviously results sometimes during the second half this year. And then we have the new trials, which are about start in pancreatic cancer in first line combination with Fulpyrinox, we are awaiting regulatory approval, but we take first patient in the Q2. And then we have the triple negative breast cancer and the collaboration we're doing it with the Spanish Breast Cancer Group, we expect submissions in Q2. And finally, we have some kind of basket like trial with 3 different cancer forms and 3 different chemotherapists, we are preparing for submission and the plan is to submit during Q2 here as well. So with that, I have tried to give you some flavor of what happened during the period and on what the direction in our clinical programs are. So by that, I would like to hand over to Bengt, who can go through the finances. And I think that will be Slide 14. Correct. Thank you, Jan. The financial overview. Basically, there are 2 take off from the finance part. And the first one is on this slide, that Kantagia increasing its investments in R and D, we are increasing operating with 83% Q1 compared to last year to SEK 73,200,000. And as can be seen in the graph to the left, this increase is related to R and D entirely. The R and D also accounts for the major parts of the operating expenses, 94%. The increase itself is, as before, I would say, related to KANO4, especially the clinical studies, KANO4 and CIMC related to that. But we can also see that the preclinical studies in Chem 10 is increasing. And to match these increased activities, we're also increasing our staff. End of March, we had 19 full time employees. Next page, please. And then we have the 2nd take off in the financial position. We have continue, I would say, a very strong financial position with a solidity of 94%. And the total available funds, which meaning cash and short term investments end of March this year, it's SEK 842,400,000. And this will take us approximately 2 years with present plans and full speed ahead. And yes, this concludes the financial overview. So back to Johan. Well, thank you, Bengt. So let's go to the final slide, which is then just showing the news flow. And I think this is just more or less a summary of what I presented beforehand. So I would leave this one as some kind of inspiration for questions. The only remark I would like to make is besides all the clinical news flow, you should be expecting over next 6 to 9 months. There is also news flow from the second project, Canton, where we expect to present more preclinical data during the second half and around new disease models. And the plan is then to initiate the clinical trials early 2022. So whereby I'd like to thank you for your attention, and I'm very happy to answer any questions. Thank you. We have a question from the line of Mark Brumberg from Oppenheimer. Please go ahead. Your line is open. Hey, thanks for taking the question and congrats on the forward progress. Just on the topic of pseudo progression, I'm wondering if you saw evidence of this also in the non small cell lung cancer cohort and if not, why not? And also in the pancreatic patients, were you able to confirm pseudo progression would biopsy or see evidence of inflammation by any other means besides simply the CT scans? Thanks. So thank you, Mark. So I think it's a great question. So the first when it comes to non small cell lung cancer, we haven't seen any pseudo progressions. And the reason is that we haven't seen any progressive disease since whatsoever initially. All the patients have got tumor shrinkage to start with, it's a small patient number. So I think we need to, let's say, look into a bigger patient population to see if we see sort of progressive events. So we need to come back to see if there is a difference between the different chemo combinations or different diseases here. But right now, all patients have benefited with tumor shrinkage? And then the second question is, have we seen, let's say, evidence for, let's say, tumor inflammatory response in the biopsies, we are currently performing all these analysis, so we have not been able to conclude all the data and there are still buy it's being analyzed. So we need to come back on this issue, but it's intriguing if we can see it. Got it. Thanks for taking the question. We have a question from the line of Rene Wouter from Kempen. Please go ahead. Yes. Hi, Geron and thanks. Thank you for taking my question as well. I actually have a couple. First one is actually a follow-up question from Mark's question. So regarding the pseudo progression, did you see this phenomenon also in the primary tumor? So I think the scans that you showed were from liver metastasis. Have you seen this in the pancreas as well? So as I recall, we have seen it in the the data that was presented here is obviously the sum of all the target regions. I have to go back to see what the data looks in the primary tumor. But as I recall, we've seen this was pronounced both in the primary tumor as well as in the metastases. Okay. That's clear. And then second question is about the monotherapy arm in the COMFOR trial. When do you expect to present the biopsy and biomarker data for this arm? And what can we expect from this update? And can you remind us on why these results are important to have? Yes, so I had hoped to give you some guidance here, but the biopsy analysis have taken much longer time to perform than originally planned. But what we're trying to achieve in the let's say both in monotherapy, so let's say in combination therapy and then also to compare these and then compare with what we can see on the CT scan and what we can see when cancer biomarkers in the blood. So it's really to make all these correlations that's important, perhaps primarily from a mechanistic, mechanistional action analysis point of view. But hopefully, we can see that, let's say, inflammatory or anti inflammatory responses in the blood, it can also be correlated with something happening in the tumor. And also, if there are, let's say, responses in the or pseudo progression, which I think is even more important to understand what's happening inside the tumor in these cases. So trying to, let's say, get that puzzle ready is what we're trying to achieve. But I think this is the type of data we will present at the scientific conference when ready. All right. That's clear as well. And just one last question around the extension part in the PDEC come forward part of the trial. So we expect to finalize recruitment in Q3. And this is about 1 year behind the last patient enrolled in the main study. So do you expect to have top line results for the extension part around this time next year then as well. And as a follow-up to that, and I think we spoke about it last week during the R and D Day as well already, but do you believe you will be able start a Phase 3 with Kano4 in combination with Gemabraxa in this setting already before you will have the results of the extension part or would you have to wait for these results? Yes. So that's a good question. So the extension target has primarily been designed to provide additional, let's say safety data on various dose levels as well as some more safety data on GCSF, but the plan is not really to include the long term efficacy data in the preparations of the Phase III trial. So the plan is really to go ahead and have regulatory interactions, basically based on the data set we have right now and on the safety data that it's reading out from the extension phase. But then obviously, we will have more data next year, 2%. That's absolutely fair. Okay. That's very clear. Thank you very much, and congratulations on the progress. Thank you so much. We have a question from the line of Sean Conroy from Edison Group. Please go ahead. Hi there, and thank you for taking my questions. Firstly, just regarding the ongoing KEYTRUDA combination study, you guided for recruitment to complete next quarter. But I was just wondering if you could give any insight as to what specific types of cancer you've seen predominantly being recruited into the study. And then following on from that, just generally how you're thinking about investigating PD-one based regimens going forwards? Yes, that's another great question. So the trial is primarily designed to investigate the safety and let's say, obviously, Biomox is now early efficacy, but it's done in relatively up to 18 patients, we're recruiting 4 different indications, non small cell lung cancer, head and neck cancer, melanoma end bladder cancer. And we so far, we got recruitment in all of these cancers except blather right now. So it's a pretty even distribution between the others. And then what are the next steps? So obviously, we need to see what the data looks like. But one thing we have already said that once we have safety data with the PD-one combination and since we have safety data with the in combination, we will go ahead and explore platinum, KEYTRUDA and Cano 4 as one next step and if we see signs of efficacy or let's say, biomarker effects with the PD-one combination only, we need to take the next step into appropriate testing of that combination as well. Have more to come. Excellent. No, thank you. And are you able to just confirm what you think the cash runway is going to be just given the new trials that you recently announced you're going to start? And so all these trials we are talking about are part of the financing plan. So we have about a 2 year run by right now. Excellent. Thank you. And yes, congratulations on the recent results. Thank you so much. Our next question comes from the line of Youssaline Persson from Nordea. Please go ahead. Hello. Thank you for taking my question. So another question on the ongoing CHF4 study. So you presented a median survival of 12.6 months, which is about 48% better than 8.5 months with chemotherapy alone. And in the CMD, you mentioned that the expected improvement in median survival needs to be about 50% to become standard of care. Can you elaborate a bit more on that? And what improvement might be needed for regulatory approval? Yes, so that's good. So I think the question at the Capital Markets Day or at least how it was interpreted by our key opinion leader was whether it's about 50% improvement would be good enough to become standard of care, and he was of opinion that, that was the case. We normally, you're talking about have the ratio of 0.75, sometimes 0.8 if there are certain circumstances. And then it's also dependent on what the safety and other parameters look. But as a rule of thumb, have the ratio of 0.75%, which would be somewhere 25% -ish improvement in overall survival is what regulatory authorities are looking for. But for us, we need to have those discussions with the regulators before we can go out and guide. Okay, good. But you so you expect a 25% improvement Need it for regulatory approval, at least. Yes. Yes. Thank you. Our next question comes from the line of Niklas Elmer from Redeye. Please go ahead. Yes. Hello. Good afternoon and thank you for taking my question. I just wondering about can pull the lung cancer arm, how if you have any comments on Recruitment, I know you had some challenges in recruitment before. So You have an update on that. Yes. So yes, it's absolutely correct that it's been it's much easier to recruit pancreatic cancer patients than lung cancer patients. And I think there are several reasons why lung cancer has been challenging. Competition is 1, and COVID has definitely been 1 since, let's say the hospital resources for treating COVID patients very much overlap with the same resources taking part in clinical trials in lung cancer. But we do recruit patients. And as I said, we expect recruitment to finish in hopefully not too far away from now, but if the patients seem to come not, let's say, individually 1 by 1 at the, let's say, predefined frequencies. So we cannot guide, but we expect to present the data during Q3 for sure. Okay, great. And then just a clarification, if I heard you correct, That pre medication for this neutropenia side effect, what you have seen so far, I I believe you said you were they were promising, but yes, so what we do so in let's say the original thank the African population where we presented the data, we did not attempt to proactively counteract took the neutropenia, instead of patients were treated with the TCSF as a reaction to neutropenia. But what we're doing in the extension phase and what we're doing now in the lung cancer phase is to proactively give TCS before they enter into have, let's say, serious neutropenia, and that seemed to be doing the trick. And but we need more patients and then we're ready to present the data. Okay. Thank you. Thank you. There are no further audio questions registered. So I hand back to the speakers. There are 2 questions coming in through the web, and I think you've been touching upon the first one. But could you please again, tell us when you expect to release the next update on the PayDeck study? And will that be the final Phase 2 AA data? Yes, so we expect an update during the second half for sure and if you think about the last patient in entered the trial in early October last year and we have a median survival of more than 12 months right now, so obviously we need to follow all patients for more than 12 months before we can make a final conclusion on what the survival would look like, at least if it's going to be more than a year. And then there are 7 sessions still on therapy and that can still, on a positive note, influence the efficacy parameters here. So we need to say it's too early to say if it's going to be the final data, but I think it's going to be, let's say, a very complete data set, even though no fine not completely final during second half of this year. Thanks. And the final question is, you have been talking about interactions with the regulatory forces. Could you please describe which ones those are. Yes. So ahead of, let's say, the starting pivotal trials, there are really 2 parts here we need to go. So one is with the European Medical Agency, or you have something called a scientific advice, which is quite long process. And the second is to have what's called an end of Phase 2 meeting with the U. S. FDA, ahead of those meetings, you can have other types of meetings as well to can clarify some technical questions and there are also, let's say, a lot of questions to be clarified when it comes to production and things like that. So there will be a number of interactions between us and those 2 regulatory authorities, let's say, during the end of summer and during the autumn and perhaps winter and we will try to be, let's say, transparent a little around the more important ones because that's really what's deciding what the next step would be here in our development. But as a company, we are committed to go ahead as quickly as possible in collaboration with regulatory authorities. Back it out, those were the questions that were coming in for the web. Thank you very much. We thank you. If there are no further questions, I would really like to take the opportunity to thank you for your attention and I look forward to continue to present data, and I'm sure there will be more to come here, we have a good news flow ahead of us. Thanks.