Cantargia AB (publ)

Thanks a lot and welcome to Kantarga Q1 report 2024. It's a pleasure to present the progress we made with the company. It's been a very good period and a good start of the year for us and during the first quarter we presented the first clinical results in our CanTen program And the results were good, so obviously we showed good safety, and we could also show receptor occupancy, similar to what we expected from a model. But on a broader scale here, it actually means that Kantarga now has two clinical projects with clinical results, and this is a major step forward for the company. We also presented new clinical data on our lead program, nadunilumab, and around a very exciting finding that nadunilumab not only can have anti-tumor activity or propose anti-tumor activity, but it can also reduce neuropathy, which is a very serious side effect of several chemotherapies and also ADCs. There is going to be a presentation around this at ASCO in two weeks from now. So we very much look forward to update you on that at a later time point. Also with nadumalumab, we got regulatory approval to start the phase 2b trial in pancreatic cancer. And after a period, we also had lots of new data or being presented in various journals, and it was all related to the Can-10 program. Today, atherosclerosis was published. Very exciting data was presented in systemic sclerosis in a very high-impact journal. And finally, we also got a paper on structure-function relationships and contents mechanism of action being published in another high-quality journal. And finally, just a few days ago, and we'll come back to this later on, we had, let's say, clearance of one of our remaining patent appeals or oppositions so there has been an appeal around one of our not not the core patents but an obviously important patent but the third party withdrew that appeal and that is obviously very good because now we can continue to to focus on the map and moving the project forward So if we look into the status of a project and look at our pipeline, so Nadunrimab is being developed quite broadly in cancer. And the most mature data has been generated in pancreatic cancer, triple negative breast cancer, non-small cell lung cancer. And we'll come back to where we are in those programs. But the CAN10 program is also making progress now. It's still in clinical phase one. but advancing quickly towards phase two starting next year. And the lead indications here are myocarditis and systemic sclerosis. And finally, we have our platform program CanXX, which is consisting of a number of antibodies that can be moved forward in the future. So in 2024 and 2025, there is lots of things happening. So we have data coming up from two clinical programs, both Cam10 and NADUNAMAB. And there are several other clinical milestones from the ongoing programs or new trials to start during 2024 and 2025. And there are publications and conferences coming up. So we made presentations at the ACR with NADUNAMAB. We're presenting at ASCO, and I'm sure it's going to be much more. And already with CanTen, we have three publications and impactful journals and presentations at one conference. And again, I expect much, much more during the rest of the year and next year. So now I would like to focus a little bit more on the CanTen program to start with. It is a program where lots of things are happening, both within the program, but also in the environment around, which really increases the attention of this program. And the main reason is that it is a unique molecule because it's not only targeting specific cytokines, it's really targeting a whole family, the IL-1 family. And there are lots of evidence that the IL-1 family, which is IL-1, IL-33 and IL-36, are driving inflammatory diseases by working in pair or as a family. So there are lots of diseases, and we'll come back to that, showing that V-shaped cancer are upregulated and operate together. And even more excitingly, there are lots of data showing that, for instance, IL-1 beta blockade, IL-36 blockade, give some signal of activity or even works in diseases where these systems are highly upregulated. But in most cases, it's not really translated into strong clinical efficacy. And we, there's more and more data being accumulating, but it's because it's only blocking of one of these compounds being done, which leads to a signal not activity, but if you block them together, you will get some kind of additive or synergistic effect. And I think that's really triggering the interest around this compound. So. So so basically, what can 10 is doing, if you look at this slide, is that it's binding to one rep. which is a co-receptor for IL-1, IL-33, and IL-36, and it's blocking all of them by binding IL-1 rapid. It blocks the binding of IL-1 receptor, IL-33 receptor, or IL-36 receptor, and thereby shuts down activity of these molecules completely. And if you look down here on this slide, this is really trying to illustrate what we're trying to achieve. If we have a biological system where IL-1, IL-33, and IL-36 are all active and try to block one of the molecules, say if you're trying to block IL-1 with anakinra here in this example, IL-33 with the IL-33 receptor, or IL-36 with an IL-36 blocker, they are not very effective. But if you look at the blue line, you have a very potent inhibition with Cantan. And this is really illustrating what we're trying to do in these diseases. And the first in human studies ongoing, we're doing a sad part, which means that we're doing single dose and it's going very well. We have not seen any safety signals and we documented receptor occupancy. During Q3, we expect to start with subcutaneous administration in the med part, so that's multiple dosing. And here we will now switch to psoriasis patients where there is a strong rationale for blocking all of these cytokines. So if you look to the right, you can see in psoriasis, which is a gray bar here, you have an upregulation of IL-1-alpha, IL-1-beta, IL-36. So obviously, blocking all of them at the same time could have a very interesting effect. And that's what you're trying to document. But clearly, psoriasis is an indication which is not of choice for the initial phase two. There are very active agents out there, and it would be a major commitment to start there. But in the future, who knows? But we've done animal models as well to prove that we can have efficacy in psoriasis models, which is only picked up with CAN10 and not with, for instance, anti-I1 beta. And in the MAD part, we will do lots of biomarker analysis in addition to what's already done in the SAD. And very quickly, going through some of the preclinical data that was presented during the period, and this is in systemic sclerosis, where we've taken fibroblasts from patients. And what we can show here is that if we block the activity of these fibroblasts, which is part of the disease in systemic sclerosis, We can do that very efficiently with Can10, even if we block and stimulate with TGF-beta or with IL-1, IL-33, and IL-36. So this is clearly a very strong signal that we're on the right track. And we have previously presented animal models showing that, for instance, in this bleuomycin model, that we have an active compound when it comes to skin fibrosis. which is on par with nintendonib, which is used to some extent in systemic sclerosis, but to some extent also limited by toxicity. So then moving over to nadunilumab. And here the news that were presented during the period was the neuropathy signal and neuropathy It is a very serious medical condition, which is unfortunately induced by several chemotherapies. And one central component in this chemotherapy-induced neuropathy relates to new re-inflammation, which is driven by the IL-1 system. And we have previously presented that We had very low incidence of grade three neuropathies in these patients in our pancreatic cancer trial, where we studied gemabraxane combination with nadulinumab. So we had only 1% versus expected more than 10% from historical controls. But the signals have now been taken forward. We can also see a signal in, if you look at the lower grade neuropathy, And that's something that will be presented at ASCO. And we also done animal models and we present that work as well at ASCO. So I hope this will be something very exciting, which will be disclosed in the near future. And then just to put this in perspective, so the new data will show that we can get rid of or minimize some very serious side effects of chemotherapy. But we've already previously shown that when we add the nadunidimab to chemotherapy, that there is a signal of activity both on survival and PFS. So the survival of 13.2 months is much, much better than you expect from historical controls, which is more in the nine to 10 months. And to further strengthen those data, we also seen that Patients with the highest IL-1 rep have the strongest activity signals. So here the survival is more than 14 months. And this is very logical given that we have an antibody therapy targeting IL-1 rep. So the more IL-1 rep is mature, the more antibody can get in and bind and have activity. Triple negative breast cancer. Here we have a randomized phase two trial ongoing. It's going to be about two times 50 patients in the trial. We started with a leading phase, which has been presented before. And again, we have good response rates and we have promising PFS and survival. And we very much look forward to present randomized data late this year. So really to summarize, Nadenumab varies lots of activities and it would be, so we have one randomized trial ongoing, we have two clinical trials starting this year. So we have pancreatic cancer phase 2b, and we also have an investigator sponsored trial in leukemia, which is also funded by a very prestigious grant from the US Department of Defense. And there is more to come. So before going into the financials, I would just highlight that Kantarga has a very strong IP position. We have composition matter patents on both nadirimab, which is expiring 2045. We have a Kant10 composition matter expiring 2041. We also have patents around the targets and those patents have been subject to several oppositions and appeals. But all of these oppositions have ended up in a very favorable way for Kantarga. And the final appeal we had in front of us was relating to the solid tumor patent. But here the third party who filed the appeal decided to withdraw, which means that all these patents are now valid and remain in force. So this is obviously a very good step forward for Kantarga. So by that, I would like to hand over to Patrik, who can present a little bit around the finances.

Thank you, Joran, and good afternoon, everybody. So this morning, we reported an almost 50% reduction in our operating expenses in the first quarter of 2024 compared with the same period last year. And the main reason for this is explained by R&D, where we are dropping 35 million from or to 38 million in the quarter. The explanation to that is that we have two clinical studies actively recruiting in the period. And that's TRIFOR or the triple negative breast cancer study for nadinolamab. And the first in human study for Clantan driving cost. And that is then compared to a full study program for nadinolamab one year ago. Also worth noting is that in the first quarter of 2023 we recorded relatively high cost for production of drug substance for Nandenonimab and we've had no such investments incurred or reported in the first quarter this year. So our G&A expenses, we constantly challenge those, and we've been able to reduce them by a little more than a million Swedish compared to Q1 2024, and we're very happy with that. But all in all, we reported loss in the period of 37 million SEK, and that then also includes a positive impact from net financial items of 5 million Swedish. So we reported net available funds and we keep reiterating that that is comprised of our cash and cash equivalents as well as what's defined as short-term investments. So net available funds were 143 million in the end of the quarter following a net burn of 52 million in the quarter and we expect that that liquidity will suffice to cover the ongoing activities for the next year. With that I hand over to you again Joran.

Thank you so much so I would just like to conclude that the year has started well for Kantarga but clearly we have very high expectations on the remaining part of 2024 with the rich news flow in pancreatic cancer, in triple negative breast cancer with the obvious value inflection point of start of the leukemia trial with lots of data in can 10. So more phase one data being presented during 2024 as we make material progress. And also like to highlight that the whole plan is to start phase two in 2025 and get the USID in place. And we also have lots of other activities where we expect to present more data to give more clarity of where we're going. So by that, I really like to thank you for your attention. And if there are questions, I'd be very happy to respond to them now.

If you wish to ask a question, please dial pound key 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Richard Romanious from Red Eye. Please go ahead.

Good afternoon. Thanks for taking my questions. So I have a few. The first one, as you have a better runway now, will the readouts from Trifor and CanTen be covered during your financial plan?

So yes, the plan is definitely to have TTNBC and can tend data being covered by this runway.

That's perfect. A phrase in the Q1 report caught my attention. I wondered if you could comment on this. It says that the board assesses that the company has good prospects of securing future financing for example for a licensing deal. I don't think I've seen that wording before. Your business development discussions progressed, would you say, since before?

So I cannot comment in detail on our commercial discussions, but what it says is that we believe that we will have good opportunities to continue to finance companies and the partnerships is one way of doing that.

Okay. I was also wondering about what path forward you might take with Can10, especially considering this interesting news in HS. And what do you think would be the indication for the Phase 2 study?

So you're absolutely right that there has been several reports in hydrodinitis superativa, which is a very serious and quite common dermatological disease, both using blockade with IL-1 alpha slash IL-1 beta through glutekizumab and also from IL-36 blockade using spezolimab. And clearly, if you combine those two data sets, it would really argue that CANTEN would be a very active molecule. So we are certainly incorporating that information into our development strategies. And we have ongoing KOL discussions and upcoming advisory boards here during the summer. to further investigate, let's say, how a phase two trial and development plan would look like in the lead indication, systemic sclerosis and myocarditis. But we're also including some other opportunities, and the AHS is one of those.

Great. Thanks. Those were my questions.

The next question comes from Louisa Morgado from Van Lanshot Kempen. Please go ahead.

Hi, Tim. Thank you for taking my questions. I have a couple. Maybe first to start off with the PEN4 trial. Could you perhaps provide a bit more color on why the start was delayed?

Yeah. So I think there are several reasons why you try to estimate the timelines to start and then getting everything in place. But one very clear aspect is that the trial is not fully financed yet with what we had cash on hand. And we are very seriously trying to get the best possible financing for this trial. And we have a number of interesting discussions on the next step financing for the company. But we cannot stop the trial until those have finished. And unfortunately, I cannot go into more details around this at this point in time.

Okay, that was very clear, thank you. And maybe moving on to CAN10, is there anything that you can already advance in terms of the phase two that you plan to start next year? And considering that, I think you mentioned in the report that the enrollment of the psoriasis patients will start in Q3. Will we already see any data for this patient this year or only next year?

So let's start with the second question on psoriasis. So we will start the treatment phase during Q3 and depends a little bit how quickly all the biomarker analysis takes before you can get that type of data. But you can clearly get the safety data during this year. So hopefully if we find anything material to communicate, we will do that from this trial, regardless if it's the sad part or the mad part. And we have no reason to delay this type of communication. And then the first question was around phase two. So clearly we are already now thinking ahead of starting a phase two in one of the indications that I responded to previously. We also want to start a trial as quickly as we possibly can after the MAD part. So we're targeting H2 2025. It will be tough to start already during H1, but as quickly as we have, as soon as we have safety data from the final MAD cohort, basically we will go ahead and finalize protocols and go ahead with the submission.

Okay, very clear. And maybe one final question in terms of operating expenses. How do you see this to develop throughout the rest of this year? Will we see a further decrease as we've seen this quarter? Or do you consider that this will stabilize from now on?

So, it's Patrick here. And thank you for the question, Louisa. It's a very good one. So as Jørgen said, we are working actively on establishing financing for the company, which then will help us or enable the studies that we believe are important. So with that said, and if and when that is secured, expenses will increase. What we have in the guiding for the runway is excluding those activities and in that more hypothetical scenario you can expect that the costs and burn will go down. It's a little bit of balance response to your question. I hope it answers.

Very helpful, thank you. That's all for me.

There are no more questions at this time. So I hand the conference back to the speakers for any closing comments.

There are no further questions coming from the web either, so I hand over to you, Jørn.

Yeah, so I can only conclude by saying we are extremely satisfied with how we have, let's say, the start of the year and the exciting data we have prepared. And we also very much look forward to continue to deliver on all the opportunities we have at hand right now and upcoming milestones and value inflation points. So look forward to a very interesting 2024 and second half of this year.