Cantargia AB (publ) ($CANTA)
Earnings Call Transcript · May 19, 2026
Earnings Call Speaker Segments
Hilde Steineger
ExecutivesThank you. Good afternoon, everyone, and thank you for joining us. I'm Hilde Steineger, CEO of Cantargia. Today, I will present our Q1 2026 update and progress across all our IL1RAP platform, including how we are adapting our oncology strategy to an evolving treatment landscape. Next slide, please. Before we begin, I'd like to include forward-looking statements. These reflects our current expectation and involve risks and uncertainties that could cause actual outcomes to differ materially. I'd ask everyone to read this statement carefully and keep it in mind throughout the presentation. Next slide, please. I'm joined today by Patrik Renblad, our Chief Financial Officer. Together, we'll take you through the developments in the last quarter. We'll start with the strategic perspectives, then move through the portfolio, clinical updates and key financials. Next slide, please. So today, I wanted to outline how we are refining our development focus across the company's core value drivers. In PDAC, recent clinical advances have increased focus to this disease area and the treatment landscape is evolving quickly with RAS inhibitors poised to become an important part of future care. Against that backdrop, we see a clear opportunity for nadunolimab in combination settings, and we are refining the design and timing of our planned Phase IIb/III study to better position the program in this emerging landscape. In hematology, we see early and encouraging signals from the MD Anderson study in MDS, supported by a strong scientific rationale for IL1RAP in hematologic malignancies. Beyond this, we are maintaining a long-term pipeline perspective, including our next-generation bispecific work in inflammation building on the biology behind CAN10. Finally, Wolfram Dempke will transition from the role of Chief Medical Officer to continue to support Cantargia as Chair of our PDAC Scientific Advisory Board, thereby ensuring continuity as we align the organization with the next phase of development. Next slide. This slide provides an overview of the pipeline built around IL1RAP. In oncology, nadunolimab remains a significant value driver with continued opportunity in PDAC, supported by regulatory designation, including Fast Track and orphan drug status by the FDA. At the same time, the program has gained further momentum from encouraging new data in the investigator-initiated MDS AML study at MD Anderson, which adds an important second clinical opportunity for nadunolimab. Beyond the lead program, Cantargia continues to advance a broader discovery engine for the next-generation IL1RAP-based therapies. Together, these activities reflect the breadth of the platform with multiple clinical and preclinical opportunity built around a biologically validated target. Next slide. High IL1RAP expression is linked to poor outcome in patients with pancreatic tumor as shown before. And we have shown together with other groups that IL1RAP is a clear prognostic marker. In practice, high IL1RAP marks a more aggressive and harder-to-treat form of disease. Taken together, these findings reinforce the relevance of IL1RAP in PDAC, particularly in patients with the greatest unmet need. Next slide, please. Moving then from biologically rationale to clinical relevance. Patients with high IL1RAP expression treated with nadunolimab in combination with GM showed a clearly stronger overall survival signal than the low expression group. Median overall survival was 14.2 months versus 10.6 with statistical significance. We also saw a strong 12- and 24-month overall survival rates in the IL1RAP high group. Together, this suggests that IL1RAP expression may help to identify the patients where nadunolimab has the greatest potential clinical impact. Our confidence in nadunolimab's future role in PDAC is grounded in the biology. KRAS and IL1RAP appear to act in concert, shaping both tumor biology and the inflammatory tumor microenvironment. This provides a strong rationale for combination strategies, particularly as RAS inhibitors become a more important part of future PDAC treatment. Importantly, IL1RAP remains relevant in both KRAS mutant and nonmutant settings, supported by broad applicability. These findings suggest that opportunity extends beyond a single pathway and supports nadunolimab as a potential relevant combination partner in a broader PDAC treatment landscape. PDAC remains one of the most lethal solid tumors and survival in advanced disease is still measured in months despite incremental treatment progress. First-line standard of care continues to rely on chemotherapy while with limited improvement in overall outcomes. At the same time, the field is rapidly evolving, and particularly in, as mentioned, the emergence of RAS inhibitors, bringing greater attention and renewed hope for PDAC patients. These agents have the potential to become an important component of future treatment while also creating new opportunities for differentiated combination partners. Next slide. So, nadunolimab is positioned to fit into this changing PDAC treatment environment in several complementary ways. As standard of care shifts towards more targeted and biomarker-driven approaches, its profile could allow us to integrate it into different combination strategies rather than being tied to a single regimen of line of therapy. With this slide, what this slide highlights is the development flexibility that nadunolimab may offer in PDAC. It may have a role with chemotherapy alongside RAS-targeted therapy or in combination strategy that reflects how the standard of care evolves. From a strategic perspective, it broadens the path available for nadunolimab's development in PDAC and supports relevance across multiple future treatment settings. Next slide. So, this next step reflects the strategy in practice. We are preparing a Phase Ib study of nadunolimab in combination with most likely Daraxonrasib in PDAC patients with disease -- in patients whose disease has progressed after first-line standard of care. The initial objective is to establish safety and tolerability while also exploring early signs of efficacy and relevant inflammatory and immune biomarkers. Timing is currently expected to start in Q4 2026 into the Q1 '27 period, subject to funding, regulatory approval and drug availability. Strategically, this study is important because it expands Cantargia's PDAC opportunity beyond current chemotherapy-based combination and helps position nadunolimab with a more biomarker-driven and targeted treatment landscape. Next slide. Now turning to hematology. The rationale -- next slide, please. Thank you. The rationale for IL1RAP in MDS and AML is grounded in core disease biology. In both settings, IL1RAP is associated with leukemic stem cells, placing it close to mechanism of disease persistence and progression. From the patient's perspective, that matters because higher-risk MDS still carries a substantial risk of progressing to AML, while the durability of current treatment remains limited for many patients. In AML, outcomes also remains challenging despite targeted advances. Taken together, AML and MDS remain an area with high unmet need where a target like IL1RAP positioned close to core disease mechanism may have particular clinical relevance. Next slide. In high-risk MDS, the opportunity is supported by both significant patient need and a meaningful market backdrop. The disease affects a substantial global patient population. Outcomes are particularly poor in key subgroups and many patients are not eligible for potentially curative transplant. Hypomethylating agents remain the treatment backbone, but response rates and durability still leave a large gap, especially after treatment failure. In that context, the indication combines clear medical needs with attractive market characteristics, which could make it a strategically important product or clinical indication for Cantargia over time. Next slide. Leukemic stem cells are thought to contribute to relapse and treatment resistance, making them important therapeutic targets. IL1RAP is expressed on these cells in AML and high-risk MDS while being much less relevant in normal hematopoietic stem cells, which provides a biological attractive basis for selective targeting. Nadunolimab is designed to block IL-1-driven signaling and to enable immune-mediated killing through ADCC. Together, this supports an approach aimed not only at reducing disease burden, but at intervening closer to the drivers of the disease. The target is also clinically relevant beyond mechanism alone. IL1RAP has been associated with poor survival in AML, supporting its relevance in more aggressive disease biology. That links well to the PDAC program discussed earlier today where the IL1RAP was likewise associated with worse outcome and helps reinforce IL1RAP as biologically and clinically meaningful target. All in all, the early leukemia data and the broader biology strengthen the rationale for continued development of nadunolimab in hematologic malignancy. The investigator-initiated study at MD Anderson Cancer Center in Houston, supported by the U.S. Department of Defense has now completed Phase Ib and is progressing into Phase IIa. Nadunolimab in combination with azacitidine or azacitidine plus venetoclax,has shown an acceptable safety profile across cohorts. Most notably, in the high-risk MDS cohort, 5 out of 5 evaluable patients achieved complete remission with the 6 pending at the time of reporting. While these are still early days, the signals is clearly encouraging and if confirmed in a larger cohort could support advancing the hematologic program of Cantargia. Next slide, please. So beyond nadunolimab, we are continuing to build the next phase of the platform through CAN14 and the broader CANxx engine. This reflects Cantargia's ambition to extend its IL1RAP expertise across a broader portfolio of next-generation therapeutics, supporting by -- supporting sorry, both long-term value creation and platform durability. CAN14 represents a bispecific inflammatory approach designed to build on IL1RAP biology while adding further functionality. While the ADC program represents an oncology-directed approach aimed at selectively delivering cytotoxic payloads to IL1RAP-expressing tumors. Together, this program broadens the potential reach of the platform across both inflammatory diseases and cancer. CAN14 represents the platform expansion into inflammatory diseases through IL1RAP1-based bispecific antibodies. Together with CAN10, which is already advancing clinically, it helps validate our IL1RAP-driven approach beyond oncology. This bispecific strategy enables dual targeting for improved efficacy, can help overcome pathway redundancy or resistance and offers the potential to direct activity towards specific tissues. We see broad opportunity across dermatology, gastroenterology, respiratory disease and rheumatology and systemic inflammatory conditions, and we expect to announce the second target for CAN14 by year-end 2026. With that, I will now hand over to Patrik Renblad, who will take you through the financial results for the quarter.
Patrik Renblad
ExecutivesThank you, Hilde, and let's turn to the financials. So, in Q1 2026, we reported modest revenues of SEK 0.5 million, all derived from the work services provided to Otsuka in relation to the CAN10 transaction. While our operating expenses were SEK 37.4 million. And you can see here on this slide, ultimately, we reported a loss in the period of SEK 33 million with earnings per share coming in at SEK 0.13. The right way to interpret these numbers is not as near-term profitability metrics, but a reflection of Cantargia continuing to prudently invest behind our pipeline. And we have a financial profile that remain aligned with advancing key programs while maintaining discipline. This slide shows a little bit more detail on our operating expenses and our total quarterly operating expenses decreased from SEK 45 million in Q1 last year to SEK 37.4 million. That tells us 2 things. First, there is an ongoing investment in R&D and the core business; and second, that investment is managed with discipline. So -- turning to cash flow. Cash flow in the quarter was minus SEK 26 million, improved from minus SEK 34 million in the same period last year. And available funds stood at SEK 258 million at the end of the quarter compared with SEK 282 million at the end of 2025. Based on that and our current plan, we expect to fund the ongoing commitments on nadunolimab, continued investment in the next generation of anti-IL1RAP antibodies and our operations into 2028. And importantly, that runway forecast excludes any potential milestone payments from Otsuka, which could represent additional upside. We do not, however, expect any milestone payments related to the CAN10 transaction for fiscal 2026. And with that, I hand back to Hilde.
Hilde Steineger
ExecutivesThank you, Patrik. So, this slide summarizes the core elements of Cantargia's strategic positioning. IL1RAP is a differentiated target at the intersection of inflammation and cancer biology with growing evidence of clinical relevance across multiple disease areas. Nadunolimab appears to have broad therapeutic potential while continuous progress in PDAC, MDS and AML and the next-generation IL1RAP modalities reinforce the strength of the platform. Taken together, this supports an investment case built on differentiated biology, expanding clinical relevance and multiple avenues of future value creation. And with that, we open up for questions.
Operator
Operator[Operator Instructions] The next question comes from Richard Ramanius from Redeye.
Richard Ramanius
AnalystsI was wondering when do you think you could initiate a Phase III program in pancreatic cancer? And how would it look like considering the new KRAS inhibitors that looks like they will be available perhaps also in the first line.
Hilde Steineger
ExecutivesRichard, thank you for your question. Did I understand you correctly if you asked whether -- when we can start our Phase III in PDAC?
Richard Ramanius
AnalystsYes.
Hilde Steineger
ExecutivesYes. Well, that's a good question. We are, as mentioned, in an evolvement of treatment paradigm in PDAC. And as you know, daraxonrasib is in the 303 study, also studying its relevance in first-line treatment. Those data will come out maybe 2 years from now, and then it's easier to align with the current standard of care. We don't really know how these data will look like. So this is why we choose to open up for more possibilities with the combination study. So in a couple of years, we will know much more how to position [nadu] in a treatment landscape.
Richard Ramanius
AnalystsYes, makes sense to plan for the future, sounds reasonable. In the other hematologic program, are you targeting MDS or AML or both?
Hilde Steineger
ExecutivesYes. Also a good question. The first indication, the first data points that we've seen is really impressive in MDS, albeit in a small patient population. AML data needs longer maturation. So, we don't really know yet how the cohort looks in AML. So, we need to see more data before we can be precise whether or not we will go both in MDS and AML. These data most probably will be available in -- at ASH. So, late this year, we'll have a clearer picture of where and how to progress in hematologic cancers. However, the MDS data is extremely encouraging.
Operator
OperatorThere are no more phone questions at this time. So I hand the conference back to the speakers for any written questions and closing comments.
Unknown Executive
ExecutivesThanks. And the first written question is, how does the agreement with Otsuka develop?
Hilde Steineger
ExecutivesPatrik, do you mind taking that question?
Patrik Renblad
ExecutivesNo, I don't mind, definitely. So, as you all know, Otsuka took over formally in September last year. We have, of course -- Cantargia has, of course, supported them Otsuka in the handover transition period. And we also reflect that in the Q1 through our net sales that we have supported them in their work. They have now taken over, while we assist them, also Cantargia assist them with our knowledge in IL1RAP biology and the antibody as and if needed. We have regular collaboration meetings with Otsuka, and we will inform the markets when there are important or as soon as there are important updates on the program.
Unknown Executive
ExecutivesAnd related to that, why is no CAN10 milestone expected in 2026 as Phase I results needs to be reported by November 2026. Otherwise, you will face substantial penalties from FDA for late reporting.
Hilde Steineger
ExecutivesPatrik, please go ahead and I can and the I talk [indiscernible].
Patrik Renblad
ExecutivesMaybe -- sorry, maybe not from the FDA because it's a European study -- it was a European study. But anyway, let's not -- so we have basically concluded that we don't expect any milestone payments for 2026 fiscal year.
Unknown Executive
ExecutivesAnd could you elaborate on the interest from partners and investors on the back of the publication of the earliest clinical signals in MDS?
Hilde Steineger
ExecutivesYes, I can take that. Well, it's been a very exciting time for Cantargia. I have to say that the initial results has created quite a lot of interest from -- well, both strategic partners, but also investors. We have to caution everyone that these are early days. It's only 5 patients, but then with 5 out of 5 complete remissions, that has raised eyebrows around in our discussions. So, very encouraging feedback.
Unknown Executive
ExecutivesAnd regarding the RAS combination study, this is twofold. Will you need a formal collaboration agreement with Revolution Medicine? And will you still target the high expression IL1RAP target group when combining with Daraxonrasib.
Hilde Steineger
ExecutivesVery good question. We -- Revolution Medicine has now received early access program. So, that means that patients are already receiving Daraxonrasib. And whether or not we can get early access to the study drug itself remains still open. We will, of course, enter into dialogue with Revolution Medicine about this. But as of today, our assumption is that we should be able to get a hold of the study drug when we are ready to start. The start as reiterated, is then contingent on funding and regulatory approval. And then retrospectively, we will also measure the levels of IL1RAP. It's only in the Ib part, it's only 15 patients. So, it's difficult to get a huge data set to be able to conclude definitively. But we are -- we will absolutely measure levels of IL1RAP in this combination study.
Unknown Executive
ExecutivesThanks. And by that, I'm handing over for a final remark from you, Hilde.
Hilde Steineger
ExecutivesYes. Well, thank you, everyone, for joining, and thank you for listening in. And with that, I wish everyone a nice afternoon.
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