Now I will hand the conference over to the speakers, CEO Hilde Steineger and CFO Patrik Renblad. Please go ahead.
Good afternoon, everyone, and welcome to Cantargia's year-end presentation for the fourth quarter and full year of 2025. I'm Hilde Steineger, CEO, and with me, I have our CFO, Patrik Renblad. We'll walk you through the operational highlights, pipeline updates, key clinical developments, and financial results, and then open the line for Q&A. Next slide. Before we begin, please note that today's discussion includes forward-looking statements. These statements involve risk and uncertainties, and actual outcomes may differ materially. We do not undertake any obligation to update them except required by law. Please review the safe harbor slide for details. Once again, I'm Hilde Steineger, joined by Patrik. I'll start with the strategic and clinical overview. Patrik will then cover the financials and cash positions. We will conclude with closing remarks and time for questions. Next slide. In Q4, we appointed Dr.
Wolfram Dempke as our Chief Medical Officer, adding deep clinical and regulatory expertise to our leadership team. During the quarter, we also reported overall survival data from our phase Ib/2 TRIFOUR triple-negative breast cancer trial, which showed no difference in median overall survival between nadunolimab plus standard of care compared to standard care alone. Importantly, after the period, the first patient was dosed in an investigator-initiated trial at Mount Sinai, New York, evaluating nadunolimab's in combination with a checkpoint inhibitor in colorectal cancer. The initiation of this externally sponsored study by a leading U.S. academic cancer center underlies the growing recognition among prominent clinical institutions of nadunolimab's potential and scientific relevance across tumor types. Such institutional engagement reinforce confidence in the clinical rationale of our program and underscore the third-party validation of our science, quality, independent collaboration, and party validation of our science.
Next slide. Cantargia's target, as all of you are aware, is IL-1RAP, and we have three main initiatives that is depicted here on this figure. First, nadunolimab in oncology, where we are now pivotal trial-ready in first-line metastatic pancreatic cancer, supported by FDA Fast Track designation. This is a clear late-stage value driver with potential to address large and high-need patient population. Second, CAN10 in inflammatory diseases, where the target is already validated through our strategic partnership with Otsuka. Their commitment to develop and commercialize CAN10, including a substantial upfront and substantial total deal value, is a strong external endorsement of both the biology and our technology. Third, we have a broad IL-1RAP antibody library, comprising of roughly 200 monoclonal antibodies.
This gives us a unique, highly versatile platform to generate next-generation IL1RAP, directed, across oncology and inflammation, and potentially additional modality over time. Our strategy remains clear: advance nadunolimab in oncology with a biomarker-driven approach and continue building on our differentiated IL1 platform, expanding into next-generation modality, where we see strong scientific and clinical rationale. Next slide. This slide summarizes the breadth of our IL1RAP-based portfolio. As mentioned, you can see at the top nadunolimab, our lead asset in oncology. In addition, we have strong clinical results from non-small cell lung cancer. But as a small biotech, we have chosen to focus on the development efforts in PDAC. In addition to nadunolimab, we are advancing CAN14, our IL1RAP bispecific antibody for autoimmune diseases.
This program is progressing through discovery and will soon enter into IND-enabling work, opening the door for IL1RAP biology to be translated into chronic inflammatory indications. Alongside CAN14 sits our CAN10 program, which capture new development program generated from our unique IL-1RAP platform. Finally, at the bottom, you can see CAN10, our partnered IL1RAP program in autoimmune diseases that we have partnered with Otsuka. This asset has already ended our phase one program, and the collaboration provides both external validation and meaningful shared investments. Strategically, this partnership allows us to participate in the upside of a late-stage autoimmune program while focusing our own resources on oncology and next-generation IL-1RAP innovation.
Overall, this slide illustrates how a single powerful target can support a diversified portfolio across cancer and inflammation, with a mix of proprietary and partnered assets and multiple shots at goal. Next slide. We strengthen our balance sheet during 2025, and the strengthening has made us well-positioned for the next stage of growth, maintaining financial flexibility and in the dynamic biotech environment. We have evolved our leadership team, bringing new expertise that complemented our scientific depth and enhances our operational discipline. Clinically, we have sharpened our focus, prioritized the programs with the strongest potential to deliver meaningful patient impact and long-term value. This disciplined approach allows us to channel resources where they matter the most. Finally, we broaden the validation of our platform, not only with our own pipeline, but also through collaborations and partnerships that extends to our reach across multiple therapeutic areas and modalities.
Together, these achievements set a solid foundation for the next phase of execution and growth into 2026. Next slide, please. We have ongoing investigator-initiated trials with nadunolimab, and we have two investigator trials ongoing, which underscores the growing recognition of our science by leading U.S. institution. Together, these trials highlight the top U.S. research centers are choosing to partner with us to explore new therapeutic avenues grounded in our unique biology. The first, initiated by Texas MD Anderson Cancer Center in 2025, and supported by U.S. Department of Defense, evaluates our IL1RAP targeting antibody in patients with AML and MDS, a strong testament to our translational potential of our platform. Next slide, please. The second investigator-initiated clinical study, conducted at Mount Sinai, is exploring new treatment approach for patients with metastatic colorectal cancer that no longer respond to chemotherapy.
The research focus on combining nadunolimab with an immune checkpoint inhibitor, two types of therapies that may work together to overcome resistance in this difficult-to-treat cancer. For most colorectal cancers that are microsatellite stable or MSS, standard immunotherapy has not shown much success. One reason is that these tumors have a very suppressive environment that prevents immune cells, especially T- cells, from doing their job. Interestingly, when T cells are able to infiltrate these tumors, outcomes tend to be much better, so improving the immune activity is a key goal. The tumor microenvironment in MSS colorectal cancer often contains several immunosuppressive components, like IL1RAP-dependent signaling pathways, and specific IL1RAP-expressing cells. These elements together help tumor resist immune attack. Preclinical research has given us promising clues.
By blocking IL1RAP with nadunolimab, it may be possible to reprogram that tumor environment, making it more susceptible to checkpoint inhibitor therapy. Essentially, the combination could help the immune cell recognize and fight cancer more effectively. Next slide. With that, I will turn it over to Patrik for the financial summary of the quarter.
Thank you, Hilde, and I'll now walk through the financials, the Q4 performance, full year results, operating expenses, and our cash position and runway. All the numbers that I will describe today, except for the earnings per share, are in millions of SEK. In the fourth quarter of 2025, we recorded SEK 8 million in revenues. We had operating expenses of SEK 36.4 million and reported a loss for the period of SEK 32.3 million, corresponding to a negative earnings per share of SEK 0.13. Q4 reflects disciplined cost control, with continued investments in our prioritized programs. Turning to full year, our revenues ended up at SEK 316.7 million.
We had operating expenses of SEK 162.6 million, and a profit for the period of SEK 147 million. Earnings per share were fifty-nine, no, point fifty-nine Swedish krona. This marks a step change, financially for Cantargia, the first ever with revenues and profits. If you look at operating expenses, they remain well controlled. R&D continues to represent the majority of our spend, and that is fully aligned with our development priorities and, administrative costs remain disciplined, year-over-year. And this expense profile support our strategy to invest, where the probability of value creation is the highest.
Looking at cash flow, available funds at the end of the year were approximately SEK 282 million, and we continue to forecast a cash runway into 2028 based on our current commitments. And again, note that this runway excludes any potential milestones related to our CAN10 partnerships, and also excludes the pivotal program for nadunolimab. We had an operating cash flow of SEK 53 million in the quarter, reflecting continued investments in our core program. And with that short summary of our financials, I'll hand over to Hilde.
Thank you, Patrik. Next slide. To summarize, Cantargia has a unique next generation IL1RAP antibody platform, with opportunity across oncology and immunology. In PDAC, nadunolimab is positioned to move towards pivotal development, supported by Fast Track and Orphan Drug Designations, and a clear companion diagnostic strategy to identify patients with high IL1RAP. Our 2025 partnership with our CAN10 underscores our external validation of the biology and our platform. Looking ahead, our near milestones include initiation of the pivotal trial in 2026, with an interim analysis and accelerated approval window in 2028, subject, of course, to regulatory approvals and funding. CAN14 candidate selection is planned for year-end 2026. We will continue to allocate capital based on data, durability of advantage, and potential for meaningful patient benefit.
Thank you, and thank you for your time, and I will now open up for questions.
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 Sara Nik from H.C. Wainwright. Please go ahead.
Hi, Hilde and Patrik, and thanks for taking the question. I was just curious regarding your ongoing regulatory engagements for the start of the PDAC trial. Will you be updating the street or investor community upon regulatory alignment on the study design? And as much as you can, and provide any color today, is there a current, like, outstanding wish list you have that you're working with the regulatory agency to align on in particular? Thank you.
Hey, Sara. Good morning to you. Well, we are in regulatory preparations and communication, and when we feel that we have a substantial update, we will, of course, update the market. There will be several interactions, as you can imagine, with both CMC, clinical, and assay development, but right now, we unfortunately don't have any update for you.
Okay. Thank you.
The next question comes from Richard Ramanius from Redeye. Please go ahead.
Hi, good afternoon. I, let's start with a question about funding. Could you say anything more about whether it's possible to find international capital for a pivotal study in PDAC, and whether the sentiment has changed anything after the success with the KRAS inhibitors thus far?
I don't know if I got the last part of your question, but why don't you start, Patrik, and we can take the last part afterward?
We explore all the options we can to fund the pivotal program. Partnering is part of that, and as you alluded to, also specialist investors. It doesn't have to be international, but specialist investors.
I think-
I also didn't capture the last part, Richard.
The question was whether you have noticed any change in the sentiment for studies in pancreatic cancer after the successes with the RAS inhibitors?
Oh, yeah. Yeah, okay. Yes, perfect. So first of all, I think we, we are in alignment with many in the biotech industry, that there is a change in sentiment in general. After JP Morgan, I, I would say that there is a more, more optimistic trend. However, we, we still need to see that translate into investment also in Europe. With regards to PDAC, with the Revolution Medicines and Immunoering funding and success, that has absolutely opened the investors' interest into PDAC. I think Revolution Medicines' product has shown that PDAC is treatable, and that there is a possibility for other products also to treat this disease. So, for us, Revolution Medicines has really opened up the field for us.
Talking about Revolution Medicines, they've started lots of studies, and I'm thinking especially about the ones in combination with nab-paclitaxel with their first RAS inhibitor. If that's a similar, or should I say, the same indication as you are aiming for with the same combination. Do you see that as a potential threat or... Yeah, how do you, what do you think about that?
Yeah, well, first of all, they are finishing up their second line study in combination with Gem. Now, we are targeting first line. However, of course, it might be a change in the treatment landscape with more off-label use, but it's only when they can show clinical research results in first line that we will be able to conclude whether or not we have a competitive advantage or not.
Okay, great. Just a final quick question. Do you have any news from trial for any interesting subgroup or biological data?
No, we don't. We will close the study closer to summer, so, any updates will come around mid-2026.
Okay, that's, that's all for me. Thank you.
Mm-hmm. Thank you.
The next question comes from Arvid Niklasson from DNB Carnegie. Please go ahead.
Good afternoon, and thanks for taking my questions. So first one on CAN14 and the ADC project you have ongoing. What sort of development milestones are you expecting to reach in 2026, and what can we expect to hear more from these projects during the year? And secondly, just following up on the studies that Revolution Medicines are making and how that may impact you. Is it fair to assume that you will not start any studies in PDAC before the second line study reads out, at least? Yeah, those are my questions. Thanks.
Hi, Arvid. I'll just start with the second question. We are aiming at first line, and there's no plans of entering into second line treatment of PDAC. When Revolution Medicines or other KRAS products read out, we might need to change or add to our clinical trials. But for now, there is no good clinical evidence on first line that we feel would change our clinical setup. And your first, your first question yeah, CAN14. So with regard to CAN14, we reiterate that we will be able to disclose the second target for the bispecific product. As you know, a bispecific will have IL1RAP as one arm, and then another target will be disclosed closer to Christmas this year.
Great. Thank you. I'll jump back in the queue.
Mm-hmm.
With that, we shift over to the questions coming in from the web, and the first one is regarding that you stated in the report that you will not be getting any milestone payments in 2026 from Otsuka. Could you elaborate on the reasoning behind that?
Yes. Patrik, do you want to-
Shall I take that? Yeah.
Yes.
Yeah, I can take that.
Yeah.
So, yeah, we always strive to be as transparent as possible in our communication, and we have previously said that we are unable to disclose information about the milestones. But we are unable to disclose the specific events that would trigger a milestone, and we are also not able to specify any amount associated with them. Now, we have assessed that it's reasonable to inform the market that we don't expect any CAN10-related milestones during fiscal year 2026.
Okay, thank you. And, relaying back to the ADCs, could you elaborate a bit on the external interest in IL1RAP as a target for the ADCs and the sort of development landscape for that target?
Well, as you might know, the ADC development environment is pretty crowded, and there are a lot of initiatives on different ADCs, especially in oncology. However, we have not seen any clinical candidates that are moving into an ADC setting with IL1RAP. So it has attracted quite a lot of academic interest and also investor interest. So any sort of concrete elaborations around that, I can't give you, but it has created interest.
Thank you. And another question is that, connected to Immunoering's, that they released data a while ago showing, quite similar data as you have been showing in, in regards of overall survival as the-
Mm-hmm.
... IL-1 high result group. Any thoughts on that?
Well, again, I think we welcome any product and company that can show that PDAC is not as devastating disease as it has been previously. The MEK inhibitor to Immunoering has only nine months of overall survival. Our data is based on up to two years' overall survival, so quite more mature data. We'll have to wait and see until we see the full breadth of the data of Immunoering, how we compare. But we believe, especially with our high IL-1RAP biomarker strategy, that we can be competitive with our 14.2 months overall survival and our 35% two years overall survival.
Thank you. Dr. Dempke joined this autumn. Which qualities made him particularly well-suited for the role as CMO at Cantargia?
Well, he's a certified oncologist, and he treats patients on a weekly basis. And so he sees the patients on a regular interval, the same patient that we are trying to find a cure or a treatment for. In addition, he has been quite heavily involved in multiple products in clinical development, so he has 3 decades of clinical development in big pharma and biotech. So for us, the clinical knowledge, the hands-on experience with treating patients and clinical development is a perfect mix.
Thank you. Is there any talks or development with PanCAN ongoing, or any other organization that relates to the pivotal study?
No, there's not.
Thank you. And, another question relates to the pivotal study. When do you expect this to start?
Well, we are actively advancing our preparations, as mentioned earlier, with the goal to initiate the trial during 2026. However, the exact timing will depend on the various factors, including the regulatory approvals and interactions, as discussed with Sara, but also funding availability, and operational readiness, which we feel, is sort of the part that we have a good handle on. Funding availability is something that we are always working on. And when the time is right, we'll be able to update the market.
Thank you, and that were all the questions coming in from the web.
Thank you, Jonas. Okay, then I think, it remains to say thank you, everyone, for joining, and I wish you all a great weekend.