Hello, and welcome to Cantargia Audiocast For Teleconference Q1 2022. Throughout the call, all participants will be in a listen-only mode, and afterwards, there'll be a question & answer session. Today, I'm pleased to present Göran Forsberg , CEO. Please begin your meeting.
Thank you so much. It's a pleasure to present our Q1 report. If we move to slide two and then to slide three, I can say that it's me, Göran Forsberg, and the CFO of Cantargia, Bengt Jöndell, who will do this presentation. Then, going to slide number four. We've been through, in a way, a period with lots of news flow. But most of the news flow, when it comes to the lead project, has been around starting up new trials, the first patient in, and things like that. It's just a very important event because it means that new activities are starting.
From the results point of view, we have had much more, let's say, progress in the second project, the CAN10 program, where we present new results in systemic sclerosis during the period. Yesterday we could present some very exciting results in atherosclerosis, which is not the lead indication, but still very exciting and really a new opportunity for our program. Another important event was also which happened already early January, is that we signed an agreement with the U.S. organization, PanCAN, to participate in a potentially pivotal trial in pancreatic cancer, and we will come back to that during the presentation.
Even though the period was not lots of results, it was a period with lots of activities and lot of preparations for what we believe will be a highlight coming in the next week or so. That is new clinical results being presented at that conference in pancreatic cancer, in non-small cell lung cancer, and also in our second trial, CANFOUR, where we have started combining nadunolimab with Keytruda. Lots of things cooking and lots of things to happen. If we then go into slide six, we will go through the product status. Just to remind everyone of what our pipeline looks like. Lead program nadunolimab is most advanced and let's say focused on pancreatic cancer and non-small cell lung cancer.
Very much of what we're doing is combination therapy. We really decided to work with what we believe is the most low-hanging fruit, which is chemotherapy combinations. To follow up, we also believe that we have lots of opportunities when it comes to immune therapy combinations. The lead study is called CAN04, and that's where we are examining nadunolimab in combination with gemcitabine nab-paclitaxel in pancreatic cancer, and that's what's entering the potential pivotal trial later on this year. Also it is that gemcitabine in non-small cell lung cancer, where we have presented very exciting clinical results, or actually very interesting results in both indications.
Based on this, we decided to broaden the program to investigate much more chemotherapy combinations and also include pembrolizumab combinations to learn more about which cancer forms and which chemotherapies or combination agents are giving, let's say, the most obvious signals of activity. We have our second program, CAN-10, which is in development for myositis systemic sclerosis. Here we are in a late-stage development with a plan to go into phase one early next year. Finally, we have a platform program called CANxx, which is basically everything around new opportunities in our IL1RAP platform, new antibodies, new antibody-based designs like ADCs or bispecific antibodies, and much more to come on that program as we develop it. If we then go to slide number seven, just to remind everyone of the PanCAN trial.
It is a phase two/three trial that PanCAN designed together with the FDA. The whole idea is to investigate up to four different promising agents in combination with chemotherapy, obviously individual arms in one controlled arm. Then there are some predefined criteria after 100 patients. If fulfilling those criteria, each agent may proceed to the phase three part, which is in over 75 patients. Right now we're having additional meetings with the regulatory authorities and having discussions with those.
If everything goes well, the plan is to submit the trial application as quickly as possible afterwards. Also, to state the obvious, it is a trial where we are participating with funding, but the cost for this trial is significantly lower than if we would do it on our own, which is obviously very positive for a company like Cantargia. If we go to slide number eight , again, just to remind everyone of where we're coming from in the results in pancreatic cancer. As I said before, we are doing combination with gemcitabine and nab-paclitaxel. We presented data from 33 initial patients.
To make a long story short, we've seen very promising survival, and we've seen very promising progression-free survival. We also see deep durable responses and patients benefiting from therapy, either through responses or from some kind of delayed benefit beyond progression. At ASCO in June, this data will be updated, and it will be a significant update. Now we have data on 73 patients. The last patient in among these 73 was in September last year, which means that it would be a mature data set. Very much look forward to presenting that. Next slide, which is slide 9. It's the combination results in non-small cell lung cancer. We have not, let's say, come as far in non-small cell lung cancer as in pancreatic cancer.
Again, the results are very exciting. Here we observe higher response rates in the order of 50%, which is about twice as high as you would expect on chemotherapy alone. We are treating patients in the first-line chemotherapy setting, which means that some have received Keytruda monotherapy beforehand or some are treatment-naive. We do see very good response rates in patients after Keytruda, and the strongest results would be in the nonsquamous non-small cell lung cancer patient population. The results here were based on 27 patients presented at ESMO last year. We now have more than 30 patients in the trial. What's also more important is that these patients have now been treated for a much longer period.
The data set will be much more mature when it comes to response rates and progression-free survival. If we go to the next slide, which is slide 10. As I said, here we go through, let's say, just the different clinical trials from cancer lead programs. You get an understanding of where we are. Pancreatic cancer, I discussed in detail, don't need to go through that. Non-small cell lung cancer, besides the new results at ASCO, we are also expanding the program in non-squamous non-small cell lung cancer and recruiting up to 14 new patients. And that recruitment is currently ongoing. We obviously plan to, once we have enough data to know how a randomized trial would look like, we will take the next step based on that.
There's probably more to come around that during second half this year. If we go to slide 11. The second trial, CIRIFOUR, which is pembrolizumab or Keytruda combination. We will present an update here as well at ASCO. Previously, we presented data around safety, which looks very good. Much more details as well as efficacy we'll present at ASCO in one and a half weeks. Finally, we're also planning to expand this trial by combining pembrolizumab and chemotherapy. We had hoped to get the first patient in during quarter one. It's not going to happen. It more looks like quarter two now. If we go to the next slide, which is slide 12. We have the three trials that started last year, CAPAFOUR, CESTAFOUR, and TRIFOUR .
All of these trials investigate new cancer forms and new combinations, and we are currently going through the safety evaluation phases. Once we have the safety and initial efficacy defined, we will be in a position to prioritize the most promising opportunities here. Much more to come around that during H2. Finally, when it comes to Precision Promise and the preparation, it's ongoing according to plan. The IND discussions are ongoing. Once we finalize, obviously we will file the IND application. To slide 14. Since this is new data presented yesterday at the European Atherosclerosis Society, the CAN-10 program is an antibody blocking IL-1, IL-33 and IL-36, and it has very intriguing properties that may be useful in lots of inflammatory diseases.
As you already know, systemic sclerosis and myocarditis is a lead indication, and we have presented very exciting preclinical results in those two diseases or in disease models of those. If you look at on the lower part of this slide, this is really the new data that was presented yesterday. What it shows is that the antibody will reduce plaque formation in the atherosclerosis model. It's doing that by attacking various forms of inflammatory cells in the plaques, and this could be extremely useful for the long-term treatment of atherosclerosis. It's not. I'd like to point out, it's not. This is a long-term opportunity. The initial focus is still systemic sclerosis and myocarditis.
By that, I've gone through where we are currently, and I would like to hand over to Bengt, who can then present the financials.
Okay, thank you, Göran. Page sixteen, please. Financial overview, Q1 2022. As you can see, Cantargia's operating expenses increased 66% compared to last year to a total SEK 121.6 million. As seen in the graph at the left, this was, you know, all essential part related to the R&D. In the third quarter, the R&D accounted for 96% of all operating expenses. The increase investments in R&D were mainly related to the main project, nadunolimab CAN04, and especially the broadening of the clinical program with the studies CAPAFOUR, CESTAFOUR, TRIFOUR , and Precision Promise. We also made significant investments in CMC during the period. Clinical, preclinical studies and CMC development in CAN10 also increased. The personnel increased to 21 people end of March compared to 19 last year.
Next page, please. Financial position. Cantargia has continued a strong financial position. Total available funds March 31 amounted to SEK 442.8 million. With present plans, these funds will last to second half of 2023, but still with the flexibility to stretch out the runway significantly if needed. This concludes the financial overview. Back to Jan.
Okay. Thank you so much, Bengt. If we go to the final slide 19. Basically what I'm going to say is that we're very excited about the position where we are right now. We believe that we have a strong position with the base in good clinical data, with lots of trials up and running with an expected news flow. We definitely think that obviously ASCO and having three presentations, including two of them selected as, let's say, to be discussed in a broader context at the meeting, it's a great opportunity for us to get our visibility internationally. We have, let's say, the preparations for a phase II/III trial together with PanCAN Precision Promise.
We will be transparent about once we have any material progress in the preparations and hope that we can start treating patients later on this year. Then when it comes to what we're doing to support, it's very much around preclinical and translational results. Obviously, whenever there is meaningful results to present, we will present that to the market. Finally, all these clinical trials that are now starting up, CAPAFOUR, CESTAFOUR, and TRIFOUR , very quite substantial information package when it comes to both safety and early efficacy, which is going to be presented during second half of this year.
Finally, we have a CAN-10, product which is progressing really well with lots of exciting results, and we very much look forward to initiating the clinical trial in early 2023. Obviously, as we progress in preparations, we will keep the market updated. By that, I'd like to thank you for your attention, and I'm very happy to take questions.
Thank you. If you do wish to ask a question, please press zero one on your telephone keypad now. We have a question from the line of Richard Ramanius from Redeye. Please go ahead.
Hi there. I'd like to start with one question about your CAPAFOUR, CESTAFOUR and TRIFOUR programs. And that's namely how will you prioritize. You hinted that you might make a prioritization among these programs in your report. Could you give some more details or could you. Because I guess you will need to focus on one of them or do you have the financial ability to do these two follow-up trials after the phase I part is concluded?
Thank you, Richard. I think that's a great question. What we are doing right now is that we are updating the commercial analysis. All these trials were planned and started up about a year ago. And obviously the oncology field is advancing also for, on competitor side. The prioritization will basically be based on an updated commercial analysis. It will be based on the safety data we obtain, obviously how easy is it to combine the CAN04 with all these new agents, and then finally with the initial efficacy. I think we have not really decided if it's one or two opportunities that are going to continue.
I think the data and the commercial analysis will guide us exactly what will happen in H2. I will certainly be transparent about that as we progress.
Okay, thanks. A short question about the CMC which was mentioned. Is this fully developed for the upcoming phase IIb trials?
Yes. We do have. I assume you mean for CAN04. We have a very robust pre-production process, which certainly is good enough for this stage. Then there are some validation that needs to be performed in parallel with the ongoing trials, but we're definitely on track.
My last question's about CAN10 atherosclerosis. What kind of uses do you see and what the economic potential, 'cause this is a huge indication if you think about statins, for example.
Yeah. You're absolutely right. What the data suggests is that we are targeting a very important pathway in the development of atherosclerosis. We know that patients are often, let's say, on statins for a long time before they develop any major problems. I think the commercial opportunity which is most obvious is in patients that have had, for instance, myocardial infarction and are at high risk of getting secondary events. That's probably where we would focus more attention later on. Let's say short term now we're trying to do more research around it to understand more about where that opportunity would be in parallel to all the clinical trials that are coming up during 2023.
Okay. Thanks. Those were my questions.
Just as a final reminder, if you do wish to ask a question, please press zero one on your telephone keypad now. We have another question from the line of Joseph Hedden from Rx Securities. Please go ahead.
Good morning. Thanks for taking my questions. The first one on the phase II-III trial in pancreatic cancer. Is that potentially a registrational trial? Have you had any dialogue with the regulators as to whether that could serve the clinical study? Just on the non-small cell lung cancer, on CIRIFOUR, I'm just interested in what you see as the regulatory strategy there if you get positive results. I know that the kind of standard of care is kind of moving towards PD-1 treatment now in first-line for patients who can't have the targeted therapies. Thank you.
Yeah. So that's. Thank you so much. When it comes to, let's say, the upcoming phase two stage three trial in pancreatic cancer, we are in re-discussions with both the FDA and EMA around this trial. Since it is a trial which is powered for overall survival, it's primary endpoint. It's very much a standard trial. It's been designed together with the FDA. We certainly hope it will be a trial designed for approval, but we need to finalize those discussions before we can be 100% certain. That's obviously the target here is to have a pivotal trial. When it comes to non-small cell lung cancer, yes, you're absolutely right.
PD-1s, our standard therapy. The window of opportunity we see in non-small cell lung cancer would be patients, or one of the windows of opportunities. Let's say, the most obvious ones where we do see very strong effect. It's patients that have high PDL1 levels in their tumor that receive pembrolizumab monotherapy and who are eligible to chemotherapy and platinum-based chemotherapy once they relapse. That's an obvious opportunity for us to continue our efforts once we get into later stage clinical trials.
Okay, great. Thank you very much.
Thank you.
As there are no further questions, I'll hand it back to the speakers.
There are two questions coming in from the web. The first one is could you elaborate a bit on the PanCAN timeline? It has been pushed back a bit compared to the original plan.
Okay. The PanCAN timeline, but I'm not sure if it has been pushed back compared to, let's say, the PanCAN clinical trials. Obviously we were in a situation last year where we could go ahead and do a pivotal trial on our own and finance it on our own or take this opportunity to work with the leading US clinical centers and an established organization like PanCAN at a significantly lower cost. Also let's say, de-risk it financially since it's a phase II/III trial design. We found that to be a very attractive opportunity. The timelines here is that we are planning to, as we've been discussing here, is to have all these regulatory discussions now that protocol is in final draft format.
We are planning to include the first patients later on this year. That's where some questions we need to sort out with the regulatory authorities could be minor. It could be, let's say, more important questions. We have no reason to believe there will be any major questions, but you never know. Since it has a phase II/III design, it takes a little bit longer period of time. We expect to have results ready by 2027, which is obviously a little bit longer than would have been expected if we would do a phase III trial fully sponsored by us directly. It is a trial designed for an overall survival signal. It would take probably three years to perform such a trial with that type of endpoint.
It's also been clear, let's say during all discussions that survival is the most robust endpoint, which is strongly preferred by regulatory authorities. Obviously results by 2027 or earlier, as I said, it probably has to do with how many of these four drugs that are entering the phase II part who actually can proceed to phase III on how long time it will take to perform the trial. In 2027 it's conservative based on the test for several drugs.
Thank you. The other question is, when do you expect that you need to find a partner to expand your clinical development with CAN04 in non-small cell lung cancer?
I'm not going to speculate around timelines because there are different scenarios which are very attractive. Partnering will happen when it happens. We certainly are fine. We're in contact with the major partner players. We know what they'll be looking for. In non-small cell lung cancer, as I said, we're planning for a randomized trial depending on which segment we are approaching. Obviously the complexity will be very different and so will also be the cost and the dimensioning of the trials. We understand the need for partnering, let's say, well ahead of commercialization for sure.
We're certainly also interested to do this at the right time point for a company and for the shareholders to get to do what they expect for our shareholders. Get the right price, of course.
Thank you. That was all the questions coming in from the web.
Thank you.
Okay. This now concludes the conference call. Thank you all for attending. You may now disconnect your line.