11/15/2024

speaker
Joran
CEO, Kantarga

Thanks a lot. It's with great pleasure we're here to present our Q3 report from Kantarga. It's been an exciting period with a rich news flow. And if we quickly summarize the news flow during or after this period, we've seen that we made progress in both of our clinical programs, both the NADUNILMAP and the KANTEN program. And in the program, some of the material events has been that the FDA gave us clearance to start a leukemia study, which is also fully funded by a grant from the US Ministry of Defense. We got the first results in randomized phase two trial more clearly defined when to expect and it's going to be in the first half of 2025. So obviously something to look forward to later on. We presented new clinical data first at the ESMA Congress on adenolumab combination therapy. after relapse on PDA1 inhibitor therapy. And that shows some very exciting data points and we'll go through that in a second. And we also did a number of clinical trials that were started in 2021, but due to the changing market conditions, we changed strategy and did not go all the way through with those clinical trials. But now that the results are ready, we can see that we have clear support in our ongoing strategies from those trials. The content program then is not in cancer, so now we're switching gear towards immunological or inflammatory diseases. And lots of focus has been on the phase one clinical trials where we made progress. For instance, safety analysis has looked very good and an independent committee recommended continuation to the multiple dosing, which was then started in September. But we also had lots of positive results regarding biomarkers and pharmacodynamic effects in the phase 1 clinical trial. And again, something we'll go through. And we presented more results on CAN10 in the thesis at the conference. And then, very importantly, obviously, based on all this progress, we are now committed to continue to develop both programs and we are now announcing a rights issue which obviously pending EGM approval but we will go through that in a second as well so Then to take you through our program. So the CANTEN program is a unique molecule. It is designed to basically inhibit three different inflammatory and disease promoting cytokine systems at the same time. So it's IL-1, IL-33 and IL-36 systems. And the inhibition is very potent. It binds with picomolar affinity and has, as I said, shown very good effects on blocking of these cytokines, but also very good effects in various in vivo models of both inflammatory and fibrotic diseases. And the lead indication we're going through right now is a skin disease called Hydrodinitis suppurativa. It is quite common. It affects about 1% of the Western population. And it starts as inflammation in the hair follicles, which is then further progressing into something called draining tunnels, which is on the inside of the skin and are causing severe problems and pain. And these patients are treated with antibiotics or steroids in the early stages. And once we do not respond to those, antibody therapy is used. But nevertheless, only 50% of patients respond to those therapies. And in the end of the day, they will stop responding. and the disease will go into two more serious stages. So we believe that this is really a great opportunity for a compound like CANTEN and we are even more encouraged because there are clinical evidence suggesting that both IL-1 blockade and IL-36 blockade has an impact on the disease. So if we benchmark to the IL-36 receptor and blocking antibodies, especially MAP from Boehringer Ingelheim, There has been a clear effect, as you can see up to the right on this slide, on the draining tunnels, which is a severe problem of this disease. But also, if you look down to the right corner, you can see that there is an antibody called lutecizumab from AbbVie, which is then targeting another part of disease-promoting cytokines via IL-1 system, and that has a good effect on the inflammatory part of the disease. So Ascan10 is blocking both IL-36 and IL-1. We believe that we have a really unique opportunity to design something which works much better. And to simplify this, the I1 receptor blockade or the I1 cytokine blockade will block the inflammation as proved by ABV, and the IL-36 receptor blockade will have a strong effect on the draining tunnels. And potentially, and a little bit more speculatively, the IL-33 blockade, which we also have built into CANTEM, will block the itch component, which is also a serious part of HS. So we are super enthusiastic about taking this drug forward from phase one and into phase two in HS. And we believe that we're ready to do that during the second half of next year. So then quickly on what we've seen so far. The CANTEN results previously or presented to date is all from single dose studies. And to summarize, we've seen a really, really good safety. So we have no safety signals, which is very encouraging. But we do see that the drug is biologically active. So if you look down to the left, you can see that the drug binds to two of the immune type of immune cells, which are driving a disease like HS above monocytes and neutrophils. So basically, the higher the doses, the higher number will be on the SAD cohort. And you can see that with increasing doses, we get increased binding. What's really interesting is that if you look to the right, is that when we analyze these immune cells in whole blood, After treatment with Can10, we can see that they are no longer responding to cytokine like IL-36. And again, it's dependent on the dosing. So the higher dose we give, the better the effect we will have. So in the end of the day, we believe that we have a drug which is basically turning off the inflammatory properties of these drugs. disease-promoting cells, and this is creating lots of interest. So then moving into our second program, nadunilumab. So IL-1-RAP, which is a target for both CANT10 and nadumumab is overexpressed on a large number of solid tumors. And therefore, we believe that we have a unique opportunity to treat cancer as well. And IL-1 rap is not only expressed on the cancer cells, but it's also found on immune cells or fibroblasts in the tumor microenvironment. And not going to do a deep dive into all the data we have. We treated more than 300 patients right now and we presented data from more than 200. But some of the strongest data has been observed in pancreatic cancer. And here we treated patients in first, so basically patients that are newly diagnosed with pancreatic cancer, which has spread in the body. And these patients have a poor prognosis and are typically treated with chemotherapy like gemcitabine and braxane. And what we do see is that in the total population, we have a very nice effect, but we've done a more sophisticated analysis to see if they have higher or lower levels of IL-1 RAP in the tumor tissue. And interestingly, it's really the patients with the higher values or levels of IL-1 RAP, which is driving the response here, which you can see Both to the right in the waterfalls where the, let's say the best decreases in tumor size are observed in the IL-1 RAP high group. And also to the left where you look at the survival, which is about 14.2 months versus 10.6 months in the high IL-1 RAP group versus the low group. Interestingly, IL-1 rep is linked to worse prognosis, and it's also linked to specific KRAS mutations, which are supposed to drive the disease. So again, this is a really, really important finding, and we're now going forward into randomized trials, and the exact design is not ready yet but it's going to be a phase two or phase three trial where we will include a diagnostic method to really select the patients with high IL-1 rep to maximize chances of a positive result and minimize the risk and the high IL-1 rep group in first line setting we estimate it to be around 60 percent of the patients so it's a significant group of patients where we can make a difference And then another exciting observation is that the Nadulun Mab So when you add something to chemotherapy, you have to be really cautious because chemotherapy is really on the borderline of what the patient can cope with. And interestingly, we have seen when we add an adenolumab that we actually increase tolerability. So one of the side effects is of chemotherapy is neuropathy. And we see that when we add nadunilamab, the patients have less neuropathy than you would expect from chemotherapy historical controls. And we also see that there is a dose response here. So the higher dose levels of nadunilamab, the more pronounced this effect is. And you can see that to the right. And this fits extremely well with our mechanism of action where immune cells that accumulate in the nerves is contributing to this really, really horrible side effect. And we are very excited to continue to do this. And we also not only seen these effects with Abraxane in the study, but we also seen it later on with Oxaliplatin in the later trials that were recently presented but also with the next generation chemotherapy which is antibody-dry conjugates we have good reasons to believe that we can have similar effects so so this is definitely a finding with very high potential future value And finally, the data in lung cancer. So this is obviously a busy slide, but the key point here is that patients that have been treated with the PD-1 inhibitors, so these are lung cancer patients treated with PD-1 inhibitors, which is really standard first-line therapy. They get changes in the tumor microenvironment that make them most likely more sensitive to nadonimab. And you can see that to the right when you look at all these tumor tissues that these patients have much more IL-1 rep containing immune cells in the tumor microenvironment. And they also have lots of other immune cells. which should react positively to Nadirulimab treatment. And the clinical results we then observe in this group is very encouraging with more than 90% response rate, as well as 26 months overall survival in non-squamous second line, non-small cell lung cancer group. So clearly a result which is creating interest and gives us a way forward in the lung cancer area as well. So in summary, in adulimab, we treated more than 300 patients. We have a pretty solid database with robust data, and we are starting to see more and more data that we can identify the subgroups, both in pancreatic cancer and lung cancer, which are really the key patients to target. And we are developing diagnostic tests to be used. And we also seen that the safety is good and we actually counteract neuropathy. So with that, we're in a good position, but we're also generating more data, both in triple negative breast cancer and leukemia through the ongoing and more upcoming trials. So very exciting future for this program as well. So by that, I'm finishing off with what you as an investor can expect from milestones. So in pancreatic cancer, there is the upcoming trial in the high IL-1 RAP subgroup starting age two next year. And in triple negative breast cancer, we expect the first randomized data set with nadolumab and top line data will be presented later on during H1 next year. The leukemia trial we hope to include the first patients during Q4 this year and it's in collaboration with MD Anderson as we previously discussed. And then the CAN10 program Recruitment is ongoing to the MAD phases. We expect the Phase 1 data to come sequentially during H1 with final data during Q2 next year. And then starting with Phase 2 during the second half of 2025. So by that I've covered where we are with the projects and what's in the near future and hand over to Patrick to go through the finances as well as the upcoming rights issue.

speaker
Patrick
CFO, Kantarga

Thank you, Joran, for that. And I'm going to present a few highlights. You can see the most important numbers from our recently issued financial statements presented here. And I'm not going to read the numbers. You do that as well. Good as I do. But I want to give you a few comments to what you see here in the numbers. and I'll focus on the year to date. And maybe just to repeat what we've said a few reports now continuously, that we are at the lower level of activity and spend compared to previous years. And you can see that in the year to date number for our R&D, we are more than 40% lower than previous period. And that is the result of having closed now, also formally closed and reported CAN-4, CERA-4, CESTA-4, and CAPA-4, and running, actively recruiting, I wouldn't say only, but I'll say it anyway, so TRI-4 and CAN-10 phase one. Very important studies, but overall the activity is lower in that area, and we're also, as we have reported previously, well supplied with drug substance. So we have not made any new investments in CMC in this year. So we are disciplined in the activities that we approve and start making sure that they are activities that drive the projects forward and generate value for the company and for the investors. And the same discipline applies in G&A and we report it in a combination with OOI, OOE and just We can't ignore it, but OIOA is basically things we can't impact, such as the currency fluctuations. But if we look at the GNA, so our general and administrative expenses, we have reduced that by 5% year on year. And that is, again, as a result of scrutinizing what we do and making sure that we don't do anything necessary. Overall, our reported loss, just to mention one number, 122 million for year to date. That was then positively impacted by financial items of north of 5 million Swedish. And that is significantly less than last year. And that is because we have simply less capital to invest and earn interest from. And that's also what we see here. We have a cash balance now, end of September, of approximately 60 million. And that is also the main reason why we have... Well, the board has asked our shareholders to approve a rights issue. And if approved at the upcoming general meeting on December 2nd. We expect that to run during December and proceeds should be available by the end of the year. We expect, well, if fully subscribed, we expect to receive 170 million in gross proceeds and 120 million in case of subscription up to the guaranteed level. And that will suffice to do the activities that's needed to bring the projects forward until middle of or end of the first half of 2026 if fully subscribed and a little bit into 2026 if subscribed in accordance with the guaranteed amount. And that is all from

speaker
Operator
Conference Operator

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