Cantargia AB (publ)

Welcome to Kandarja Q3 Report 2025 presentation. During the questions and answers 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 Hilde Steininger and CFO Patrik Renblad. Please go ahead.

Thank you. Can you see the slides? I cannot see it. All right. Good afternoon, everyone. And thank you for joining the presentation of our financial report for the third quarter and an update from the company. My name is Hilde Steininger. And as you probably are aware, newly appointed as CEO of Contariga.

Next slide.

Patrick, may I ask you to change the slides?

All right. Slide two, safe harbor. And slide three.

Patrick?

Okay, let me just finish. With me today, we have our newly appointed medical officer, Dr. Wolfram Dembke, and our CFO, Patrik Renblad. Slide four. We reported this morning our interim report for the third quarter and the first nine months of the year. It has indeed been a transformative period for the company with the Otsuka transaction as the main event. About the same time. About the same period, we communicated the over a primary endpoint from our TRIFOR phase two study on the objective response rate, ORR. And the results show no difference in ORR between the control group treated with chemotherapy and the patients treated with Nadenolumab in combination with chemo. We are awaiting the mature overall survival data, which is expected around year end 2025. I joined Contarga as CEO on September 1st, and I have extensive experience from leadership roles in the pharmaceutical R&D and business development, as well as background in the financial sector as an analyst and venture capitalist. I'm also very happy to introduce Dr. Dempke, who's joined Contaria as chief medical officer. And I would like to hand it over to Dr. Dempke for a brief introduction of himself.

Thank you, Hilde, and thank you very much for inviting me here. It's a pleasure for me attending this meeting. So my name is Wolfram Dempke. Just a brief overview about my career. I'm born and raised in Germany, holding a German passport. I studied medicine in Germany, in Essen, and I'm a fully qualified and board certified hematologist and oncologist. I'm also holding an MBA in international financing. I worked in the industry for quite a while. and i'm still seeing patients at munich university and from time to time at cambridge university as i'm a full professor at munich university hematology oncology And in Cambridge, I'm a senior lecturer. I'm also holding a passport in the UK. So I worked at several pharmaceutical companies and I have an extensive experience in clinical drug development. And just to give you a few examples, I was responsible for bringing the Zatinib Sprycel to the market while working at a bostomized group for the CML indication. I was the mastermind behind ipilimumab for malignant melanoma. I was responsible for the relaunch of gefitinib, Iressa in 2014 while working for AstraZeneca and at least in part, let's say 50% for the launch of Tagressa, which is osimertinib. I was the European representative for Mogamolizumab while working at KHK. I was responsible for the launch of cabmatinib from Novartis. At that time I was working at Insight and Novartis had hired me to get cabmatinib, which is a C-Met inhibitor, to the market. And lastly, I was responsible, I'm in a way responsible at the moment as I'm a board member at Moleculin. I'm responsible, I was responsible for bringing Moleculin from Phase 0, if you like, to the currently active Phase 3. My last role was at Osuka, especially at TAIO, and therefore I was responsible for the development of Cipalertinib. which is AAEGF mutant TKI and the drug is currently in phase three and the filing will be at some stage next year. My research focus is, as you can see, mainly on GI tumors, especially on pancreatic carcinomas. I did my PhD on RAS in England quite some time ago. And for the last two decades, I worked on my lung cancers and acute leukemias. From my clinical perspective, I'm seeing pancreatic carcinoma patients on a regular basis. I'm actually treating them. I do know how these patients are suffering from their disease as pancreatic carcinomas, a very tough disease. And I'm now overlooking 35 years in medical oncology and hematology. And during that time, I've seen everything. every trend on the market, including CAR T-cells on treating patients, the CAR T-cells, autologous and allergenic transplantations. And it is a metadata of my heart to point out that NADO is Definitely the best drug I've ever seen for patients with pancreatic carcinomas. And therefore, I was really keen joining Cartagena and to bring that drug to the market as soon as possible. And that is my driver. And that is something that thrives me and it is very important for the sake of the critical ill patients. Thank you.

Thank you, Wolfram. So let me then go into detail a bit into the Otsuka transaction that we now announced in July and closed in September. As I said, it was in many ways transformational for Katarga because it provided us with the financial flexibility that has enabled us to reinvest into the next generation of anti-IL-1 RAP antibodies. But equally important, the company sees the deal as a validation of both the target and the technological and commercial value of Comtargia's antibody platform. So when the deal closed, Contarga received 33 million dollars and we are eligible for receiving up to 613 US dollars in upfront and milestones, in addition to up to double digit royalties. Now, let me review our pipeline and our strategic priorities. Bringing now the Nolumab to forward in pancreatic ductal adenocarcinoma or PDAC remains our key strategic focus based on our very compelling phase two data, which I will elaborate a little bit later on in this presentation. we have observed promising results in non-small cell lung cancer particularly in a subgroup of patients receiving second-line treatment following immunotherapy more specifically in those with non-squamous tumor types while these findings are encouraging they are derived from a limited sample size of only 11 patients so at present there are no plans to pursue further development based on these preliminary data regarding triple negative breast scanner as mentioned we have previously shared the results from our primary endpoint orr this summer we are now in tested in tests in anticipating more mature overall survival data and expect to provide an initial readout before the end of the year. As mentioned, Otsuka deal provided means to invest in our very promising pipeline. With CAN14, we intend to develop an anti-IL-1 wrap by specific antibody for inflammatory and or autoimmune disease. We are in parallel exploring the options related to IL-1 RAP antibody drug conjugates, or ADCs, also as a next step in oncology under our CANXX umbrella and platform project. Last but not least, Canten remains a very important asset in our portfolio, even though it's in very capable hands of Ötsükö Pharmacyrkull. We will continue to follow and report on the assets as it progresses through development and hopefully later on for in approval and commercialization. If successful in all of these steps, the product will provide important non-diluting funding for Kantarga in the future. So let's dive into Nadenolumab in PDAC. And once again, I want to emphasize that Nadenolumab in PDAC remains our primary strategic focus. A crucial link between our target IL-1 RAP and patient is analyzed both with us and several other groups. Several studies have shown that high tumor expression levels of IL-1 RAP serve as a marker of poor prognosis, as demonstrated here. uh in the three graphs on the left the data from cancer genome atlas mrna database shows a connection between high il-1 rap levels and poor survival in addition the middle middle figure from pancab shows the same and our own study together with harlev university uh on on biopsies we could also show the results from protein expression that will show the same pattern interestingly also we were approached by an ai company who has access to a large rna database they had identified aisle wrap as an interesting marker of disease and saw that two genes in two sub networks enriched for IL-1 high RAP correlated with worse overall survival. So to us, these studies confirm that elevated levels of our target molecule IL-1 RAP in PDAC form the basis for our convictions and are strongly linked to poor patient survival outcomes. PDAC is a devastating disease, often diagnosed at an advanced stage when treatment options beyond chemotherapy are extremely limited. The prognosis remained poor with medium survival between 9 and 12 months. Current chemotherapy regimens have been standard of care for decades, and unfortunately, there has been little progress in improving these outcomes. That said, The field is seeing promising new agents in development, and there has been significant recent investments driving innovation in PDAC. And these emerging therapies provide hope for meaningful advances and improve survival for patients in the coming years. In our Phase 1b-2a CAN-4 study, we enrolled 73 patients with first-line metastatic PDAC who received a combination of nadonolumab and gemcitabine nabpaclizetaxel, or GM. We observed deep and durable tumor responses, as shown in the figure to the right, which translated into a median overall survival of 13.2 months. Although this was a single arm study, comparison with historical controls marked here in gray line indicate that expected medium overall survival with chemotherapy alone is approximately eight to nine months. These findings suggest a meaningful improvement in outcomes with the addition of nadonolamide. Then our scientific team analyzed tumor biopsies from 49 patients to assess the expression levels of IL-1 RAP. These analysis revealed two distinct groups, 29 patients with high IL-1 RAP expression, while 20 was deemed as low expressors. When we then correlated these expression levels with overall survival, the findings were remarkable. Patients in the high IL-1 RAP group demonstrated statistically significant medium overall survival of 14.2 months compared to 10.6 in the low expression group. As shown in the previous slide, the high IL-1 RAP expression in PDAP tumor is clearly associated with poor patient survival. reinforcing the significance of targeting this molecule and the overall survival in patient population. In this study, the data suggests that IL-1 RAP expression is associated with better clinical outcomes, underscoring the therapeutic promise of targeting IL-1 RAP with non-Nolumab. By selecting patients with elevated IL-1 RAP levels who are most likely to benefit from NADO-Nolumab treatment, we hypothesis that we will be able to maximize the potential with clinical impact. So in conclusion, Nadenolimab has now been investigated in over 300 patients and the accumulated data continue to demonstrate promising safety and efficacy profiles. Clinical results strongly point to a potential unique first in class opportunity for Nadenolimab in PDAC and also in non-small cell lung cancer. Notably, PDAC patients with high IL-1 RAP expression who traditionally have a poor prognosis responds best to Nodonolamab in combination with GM. Over the last year and a half, our team has developed a robust assay to test IL-1 RAP in tumor biopsies, which we intend to use in the next pivotal study to test and select patients that are expected to respond the best. Importantly, we shared our results and discussed our next steps with the FDA this summer, which led to the fast-track designation for Nadenolumab in PEDAC patients with high IL-1 RAP. Building on these foundations, we plan to advance Nadenolumab into a pivotal trial, which, pending funding and regulatory approval, is anticipated to commence mid-26. Now, let me spend a few moments outlining our existing early pipeline, which we are further investing in. As previously discussed, our CANXX platforms continues to offer robust opportunities for antibody innovation. CAN14 is the next initiative emerging from this platform, and we intend to build on the preclinical and clinical experience gained through our CAN10 program, and we are advancing an anti-IL-1RAB bispecific antibody for CAN14. For intellectual property and competitive reasons, the second target remains undisclosed, but we anticipate it will address inflammation or autoimmune disease mechanisms. We expect to select a formal drug candidate of CAN14 around year-end 2026. Earlier this year, our scientists shared also promising preclinical data on antibody drug conjugate, or ADCs, and this approach combines cytotoxic payload with targeted IL-1 RAP binding which may offer higher efficacy with reduced side effects. We continue to evaluate this ADC concept within our CANXX project, and we will assess to move forward with this dedicated progress after evaluating the preclinical results. With this overview, I'm pleased then to hand over to our financial update to Patrick.

Thank you, Hilde. Our quarter three was indeed transformational. For the first time ever, Kentagio reported revenues and profits. When the Otsuka payment had been duly recognized and converted into Swedish kronor, our revenues amounted to 308.6 million SEK. With operating expenses of 41.7 million in the quarter, our operating profit amounted to 267 million SEK. From that, we deducted 1.5 million in net financial items to reach a profit for the quarter of 265.5 million. It is worth noting that despite reporting a profit, no tax will be triggered due to our accrued tax losses. Our reported earnings per share were 1.07 Swedish per share. For the full reporting period or year-to-date, our revenues were obviously the same, with operating expenses amounting to 126.2 million. We reported operating profit of 182.5 million. Net financial items at 3.2, leading to a net profit of 179.3 million, corresponding to earnings per share of 0.72 SEC. Looking at our operating expenses, both quarter and year-to-date overall costs were similar to the respective comparison periods. With the comment that our R&D costs were significantly lower, both in the quarter and in year-to-date, due to a ramp down both for Nadenolimab and Cantent. This was then obviously offset by increased spend in general and administration, driven by our transformation, both in regards to transaction-related costs, but also the leadership transformation that we have reported earlier in the year. End of September available funds amounted to 339 million Swedish. And we estimate a cash runway into 2028 with our current and ongoing commitments on Nadenolimab and the investments that Hilde mentioned for CAN14 and CANXX. But excluding a pivotal program for Nadenolimab, and also excluding any potential milestone payments payable to Cantagia from Utzuka in that timeframe. And with that, I hand the word back to Hilde for closing remarks.

Thank you, Patrick. So as a closing remark, we have a significant potential to become both first in class with an IL-1 antibody in treatment of metastatic PDAC. The development is bolstered by a clear biomarker strategy that guides patient selection. We anticipate being ready to initiate a pivotal study by mid-2026, contingent upon secure and necessary funding and regulatory approvals. In addition, strategic partnership with Otsuka has provided crucial external validation as well as financial flexibility, enabling us to reinvest the development of the promising next generation of anti-IL-1 RAP antibodies. With these initiatives, we expect to achieve and report several key milestones in the near future. So thank you for your attention, and I now welcome any questions that you might have.

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.

Hello, and good afternoon. I'll start with a question about adenolimab. How long would the proposed pivotal study take? And could you tell us something about what funding options you foresee?

We have yet to land on the exact design of the study and also the number of patients. So it's a bit difficult to commit to any timelines. This has also to be cleared with the FDA and EMA, of course, the design. But if you look at our competitors, they spend around two and a half to three years in their pivotal trial. And with regards to funding, we will, of course, continuously explore all opportunities to support and accelerate our programs. While partnerships can play an important role in this funding strategy, we do not have any specific commitments for the moment. So we remain flexible on financial resources.

Okay. I noticed this, there's an increased, to me it seems you are focusing even more on the autoimmune space with CAN14. And, okay, maybe if someone could confirm that there, from what I've seen, there are no approved bispecific antibodies in that space. Is that correct? And... Would you say that this is a more attractive area for investment compared with oncology right now?

So maybe Wolfram, do you want to comment on the oncology part and I can take the biospecific afterwards?

I'm not sure whether I got the question right. Was it the rule of biospecifics in this indication?

I mean, I haven't seen any approved bispecifics for autoimmune diseases.

Yeah, this is right. There are some early trials ongoing, but you are right. Currently, no bispecifics are approved for autoimmune diseases. You are right. So that is new and that is, in a way, a land of opportunity for the company.

Yeah, great. That's just my thought. It seemed like an open space with not so much competition as in oncology. Yeah, my last question was about the significant increase in administrative costs compared with previous quarters. Could you expand on why that is?

Patrick, do you want to?

Yeah, it's cost related to the transaction itself. So it's one of costs to advisors and consultants and lawyers.

Okay, very well. Thanks for taking my questions.

The next question comes from Sarah Nick from HC Wainwright. Please go ahead.

Hello, team, and thank you for taking the question. I just had one regarding the Triforce study in the triple negative breast cancer. I know, as you stated, it didn't show difference in OR versus chemo alone. And as we're awaiting more mature survival data, I was wondering if you could walk us through maybe how you interpret that data in context of pursuing your strategy in pancreatic and non-small cell lung cancer and maybe specifically if there are any key biological or clinical learnings and how those are shaping your development strategy going forward. Thank you.

Thank you, Sarah. And I'll leave that question to Wolfram.

Yeah, I'm afraid. Yes. So first of all, there is no one fits it all. You can't lump all the tumors together. You can't say this is the drug and this drug is the panacea for everything. We have a very good signal in non-small lung cancers, and we do have an excellent signal in pancreatic carcinomas. The biology of breast cancer is totally different. Breast cancer is normally a multicentric disease, as we call it, a systemic disease of the breast. is a totally different biology. So we cannot expect that the drug is equally effective in all of these cancers tested. In addition, breast cancer is in a way an endocrine-dependent cancer and that might alter the effect of interleukin-1 RAP inhibitors as well. So we do see a signal, certainly not strong enough to move on. But this is not our target cancer. And therefore, we are focusing on the other two. We do not expect that we see a negative result in all the other cancers and vice versa.

Yeah, and just to clarify, although the primary endpoint was ORR, we are still awaiting the mature overall survival data. And the biology of this that we can learn from this study will, of course, help us to make a final decision.

Okay, thank you. That's very helpful.

And again, I think there are other logistic aspects as well. This was a study in a single country, in a single or more or less single institution or few institutions, oligocentric. So that will explain some discrepancies in the result as well. It is not a standard phase three trial with well-defined criteria.

Okay, thank you for the extra color as well. Appreciate it.

Next question. The next question comes from Merth Beinvoort from Van Lanchet in Kempen. Please go ahead.

Thank you for taking my question. Could you provide any color or an estimate on how much the Phase III trial in PDAC is expected to cost? Thank you.

um yes hi uh again i think we um as i alluded to uh with the regards question uh we have not uh formally decided on the the design and uh we're not ready to share our design right now we need to run this through our regulatory interactions both with fda and ema so um stay tuned thank you

As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. There are no more phone questions at this time, so I hand the conference back to the speakers for any written questions and closing comments.

The first question from the web is related to the triple negative breast cancer study. And do you expect any negative results from that trial on OS? And why do you think that CanO4 will work in PDAC if it doesn't work in triple negative breast cancer?

Yeah, I think we touched on that. And I think we can reiterate that even though ORR is the primary endpoint and showed no difference between the two treatment arms, we still would like to see the mature overall survival data before we conclude. And I think also what Wolfram did sort of run through with the previous question, why we expect a difference or why we expect an effect when we enter into development of PDAC.

Sorry, let me chime in here. Obviously, this is something that is in the mind of all participants. So let me make it perfectly clear. There is no panacea for all cancers. All cancers are different and therefore we need to treat them in a different way. This is the first thing we have to learn. The second thing is the mammary and carcinoma breast cancer is a very difficult thing and a very heterogeneous tumor. I give you a striking example. Pembrolizumab plus napakitaxel resulted in a triple negative breast cancer and a huge overall survival benefit. Pembrolizumab plus pacitaxel did not show anything. So why is that? So we don't know. It is the same medication. It is obviously the same drug and it is the same tumor. And there are different results. So that is something that we know for breast cancer, which is very tricky. But this does not apply to non-small lung cancers. And I'm overseeing 25 years research in non-small lung cancers and even pancreatic carcinomas. This is a totally different type of cancer with a well-defined and a very distinct molecular biology behind. And therefore, this is in a way not very unexpected for us. Hope this clarifies.

Yeah, thank you. And I think I just wanted to add that we do have overall survival data connected to high IL-1 rep in PDAC while we are still awaiting that analysis in triple negative.

Thank you. And the second question is related to the CanTen project. As there are other companies advancing their own programs within that area, could you comment on your patent position and your competitive standing relative to the other programs being active in that area?

Well, We first need to know which indication Otsuka will want to target, so it's a bit difficult to be precise on the competitive landscape. I also would like to say that the product is in excellent hands with Otsuka Pharmaceutical and We are not at the time for the time being able to disclose any specific details of where they want to go. So we'll keep you posted as soon as we know more.

Yeah. And another question related to the CanTen program is the the handover to Zouka fully finalized and are all responsibilities on their hand now going forward?

Yes, all the responsibility of the product is in Otsuka's hands. They acquired the product, so they have full freedom to operate in their future clinical development. However, of course, the program is important for Kantarga, so we will monitor the progress tightly.

Yeah, and going over to the PDAC study, how confident are you that you will manage to require the funds needed to start this study mid next year?

Well, we will look at all different combination of financing this study, but as I'm sure everyone is aware, a pivotal study in PDAC requires quite a substantially large amount. So we will come back to our strategy with regard to financing when we have bit more insight in where we want to go.

Thank you. And also related to that study, will that study be a combination with other drugs like GeneNav or what's the thinking on the combination strategy for that study?

We'll have a study in combination with standard of care. Now, how standard of care will look like at the time of when we conduct the study, we don't really know yet because Revolution Medicine is approaching the market when we are in our study. However, it will be a randomized two-arm study on top of standard of care.

Thank you.

And to financially... Let me chime in here. I know what you are driving at and what you're alluding to. So, Revolution Medicine is conducting or has conducted a second-line trial, which will have a readout and has already the database log, and that will come to be filed in a due course but this is second line we are talking about first line and the the refmed study which might have the potential to change the control arm is not even enrolling one patient so that is 300 and that will take quite a few times. So at the end of the day, both first-line studies will run in parallel. So this will actually minimize the risk of changing the control arm during the trial.

Thank you. And two questions related to the financial aspects. What do you expect in enrolling cost per quarter in the coming next 18 months, excluding the new studies? And could you elaborate a bit on the upcoming milestone payments that you see in the future?

Patrick, do you want to take both of them?

Yeah, so we have approximately 340 million by the end of September. And we have said in our cash runway estimate that it will suffice a bit into 2028. We can assume that that's 10 quarters. You don't need a calculator to calculate what the quarterly burn rate would be then, I think. But that is sort of a linear and things in this business seldom happened, linear. But that's the best answer I can give right now.

Thank you. And if possible, could you elaborate around the potential correlation between high cross expression and high L1 wrap expression, where high L1 wrap expression indicate high responses to CanO4 and further elaborate around your thinking in the strategy around the targeting hard to treat cross driven cancers through the IL-1 pathway.

I'm not 100% sure I understood the question, but is it sort of how many other, which indications we can target? Jonas, do you think that was the question?

It's more about the correlation between high cross expression and high IL-1 rep expression and how that sort of affects your strategy.

Okay, we are targeting indications that we see a good correlation of where high IL-1 rep is a prognostic marker for poor prognosis. There are at least four or five indications where this is the case. But for now, our focus is on PDAC. I think you can understand that the small company we need to focus. And right now, PDAC is our sole focus.

Thank you. And the final question is related to whether you will be organizing any presentation together with Utsuka in the near future around the CanTen project.

We don't know, but we don't expect to do that. But if we do, we'll of course keep you updated.

Thank you. And there's no more questions coming in from the web.

Okay. Well, thank you everyone. And thank you for listening and all of your good questions.