Welcome to the Cantargia Q1 2024 report presentation. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now, I will hand the conference over to the speakers. CEO, Göran Forsberg, and CFO, Patrik Renblad. Please go ahead.
Thanks a lot, and welcome to Cantargia Q1 report 2024. It's a pleasure to present the progress we made with the company. So it's been a very good period, and a good start of the year for us. During the first quarter, we presented the first clinical results in our CAN10 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 Cantargia now has two clinical projects with research clinical results, and this is a major step forward for the company.
We also presented new clinical data on our lead program, nadunolimab, and around a very exciting finding, that nadunolimab not only can have antitumor activity or proposed antitumor activity, but it can also reduce neuropathy, which is a very serious side effects 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 nadunolimab, we got regulatory approval to start the phase II-B trial in pancreatic cancer. After the period, we also had lots of new data being presented in various journals, and this was all related to the CAN10 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 CAN10's 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 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 focus on nadunolimab and moving the product forward.
So if we look into the status of a project and look at our pipeline, nadunolimab 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 will come back to where we are in those programs. But the CAN10 program is also making progress now. It's still in clinical phase I, but advancing quickly towards phase II, 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 CAN10 and nadunolimab.
There are several other clinical milestones from the ongoing programs or new trials to start during 2024 and 2025. There are publications and conferences coming up. So we made presentations at the ACR with nadunolimab. We're presenting at ASCO, and I'm sure it's going to be much more. And already with CAN10, we have had three publications in impactful journals and presentation 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 CAN10 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.
The main reason is that CAN10, 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 these cytokines 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 gives some signal of activity or even works in diseases where these systems are highly upregulated. But in most cases, it's not really translating into strong clinical efficacy.
There's more and more data being accumulating, but it's because it's only blocking of one of these cytokines being done, which leads to a signal, but 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 basically, what CAN10 is doing, if you look at this slide, is that it's binding to IL-1RAP, which is a co-receptor for IL-1, IL-33, and IL-36, and it's blocking all of them. By binding IL-1RAP, 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, so 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, that they are not very effective. But if you look at the blue line, you have a very potent inhibition with CAN10, and this is really illustrating what we're trying to do in these diseases. And the first in human study is 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 MAD part, so that's multiple dosing. Here we will now switch to psoriasis patients, where there is a strong rationale for blocking all of these cytokines. 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 we're trying to document. Clearly, psoriasis is an indication where which is not of choice for the initial phase II.
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-IL-1 beta. And in that 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.
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 stimulate with TGF-beta or with IL-1 beta, IL-33 and IL-36. So this is clearly a very strong signal that we're on the right track. We have previously presented animal models showing that, for instance, in this bleomycin model, that we have an active compound when it comes to skin fibrosis, which is on par with nintedanib, which is used to some extent in systemic sclerosis, but to some extent also limited by toxicity. Then moving over to nadunolimab, here the news that were presented during the period was the neuropathy signal.
Neuropathy, it is a very serious medical condition, which is, unfortunately induced by several chemotherapies. One central component in this chemotherapy-induced neuropathy relates to neuroinflammation, which is driven by the IL-1 system. 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 gem/Abraxane in combination with nadunolimab. So we had only 1% versus expected more than 10% from historical controls. But the signals have now been taken forward, and 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. We've also done animal models, and we'll present that work as well at ASCO.
So I hope this will be something very, 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 at least minimize some very serious side effects of chemotherapy. But we've already previously shown that when we add the nadunolimab 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've also seen that the patients that with the highest IL-1RAP have the strongest activity signal.
So here, the survival is more than 14 months, and this is very logical, given that we have an antibody therapy targeting IL-1RAP. So the more IL-1RAP there is in the tumor, more antibody can get in and bind and have activity. In triple-negative breast cancer, here we have a randomized phase II trial ongoing. It's going to be about two times 50 patients in the trial. We started with a lead-in 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, nadunolimab, various 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 II-B, and we also have an investigator-sponsored trial in leukemia, which is also funded by a very prestigious grant from the U.S. Department of Defense. And there is more to come. So before going into the financials, I would just highlight that Cantargia has a very strong IP position. We have composition of matter patents on both nadunolimab, which is expiring 2035. We have a CAN10 composition of matter expiring 2041. We also have patents around the targets, and those patents have been the subject of several oppositions and appeals. But all of these oppositions have ended up in a very favorable position for Cantargia. 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 Cantargia. So by that, I would like to hand over to Patrik, who can present a little bit around the finances.
Thank you, Göran, 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. The main reason for this is explained by R&D, where we are dropping SEK 35 million from or to SEK 38 million in the quarter. The explanation to that is that we have two clinical studies actively recruiting in the period, and that's TRIFOUR or the triple-negative breast cancer study for nadunolimab, and the first-in-human study for CAN10, driving cost, and that is then compared to a full study program for nadunolimab 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 nadunolimab, 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 SEK 1 million compared to Q1 2024, and that's. We're really happy with that. But all in all, we reported loss in the period of SEK 37 million, and that then also includes a positive impact from net financial items of SEK 5 million. 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.
Net available funds were SEK 143 million in the end of the quarter, following a net burn of SEK 52 million in the quarter. We expect that that liquidity will suffice to cover the ongoing activities for the next year. With that, I hand over to you again, Göran.
Thank you so much. So I would just like to conclude that the year has started well for Cantargia, 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 CAN10. So more phase I data being presented during 2024 as we make material progress. And also like to highlight that the whole plan is to start phase II in 2025 and get a U.S. IND 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.
With that, I really like to thank you for your attention, and if there are questions, I would be very happy to respond to them now.
If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Richard Ramanius from Redeye. 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 TRIFOUR and CAN10 be covered during your financial plan?
So yes, the plan is definitely to have the TNBC and the CAN10 data being covered by this runway.
Yeah, yeah, that's perfect. A phrase in the Q1 report caught my attention. So I wondered if you could, 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. So how have 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 the companies, and the partnerships is one way of doing that.
Oh, okay. I was also wondering about what path forward you might take with CAN10, especially considering this interesting news in HS. And yeah, what do you think would be the indication for the phase II study?
So you're absolutely right that, there has been several reports in, hidradenitis suppurativa, which is, a very serious and quite common, dermatological disease, both using blockade with the IL-1 alpha/IL-1 beta through lutikizumab, and also from IL-36 blockade using spesolimab. And clearly, if you combine those two datasets, it would really argue that CAN10, would be a, 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, to further investigate the... let's say, how a phase II trial and development plan would look like in, in the lead indication, systemic sclerosis and myocarditis. But we're also including some other opportunities, and HS is one of those.
Great. Thanks. Those were my questions.
The next question comes from Luísa Morgado, from Van Lanschot Kempen. Please go ahead.
Hi, team. Thank you for taking my questions. I have a couple. Maybe first to start off with the PANFOUR 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 have 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 steps financing for the company. But we cannot start the trial until those have finished. 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 us in terms of, the phase II 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 these patients 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 II. So clearly, we are already now thinking ahead of starting a phase II in one of the indications that I responded to previously.
We also want to start that 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?
Hi, it's Patrik here, and thank you for the question, Luisa. It's a very good one. So, as Göran 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 guidance for the runway is excluding those activities, and in that broad, more hypothetical scenario, you can expect that the costs and burn will go down.
Okay. Very helpful. Thank you.
So it's a little bit of balance, response to your question. I hope it answers.
Yeah. Yeah, yeah, 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, Göran.
Yeah. I can only conclude by saying we are extremely satisfied with how we have, let's say, the start of a year and the exciting data we have prepared. We also very much look forward to continuing to deliver on all the opportunities we have at hand right now and upcoming milestones and value inflection points. Look forward to a very interesting 2024 and second half of this year.