Welcome to Oncopeptides third quarter earnings call for 2026. 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 CEO Sofia Heigis and CFO Henrik Bergentoft. Please go ahead. Hello, everyone, and welcome to the presentation of Oncopeptides report for the third quarter of 2026. My name is Sofia Heigis, and I am the CEO of Oncopeptides. Before we begin, please note our standard disclaimer regarding forward-looking statements. Today's presentation is led by me and our CFO, Henrik Bergentoft. Together, we will walk you through our third quarter commercial performance and the major clinical and regulatory milestones we have achieved over the past few weeks. Let's look at where we stand right now. During the third quarter, we delivered net sales of SEK 28.5 million, representing a 41% increase compared to the third quarter of 2025, when we delivered SEK 20.2 million. For the first nine months of the year, net sales reached just under SEK 85 million, up 62% compared to the SEK 52.6 million reported for the same period last year. Also, for the first time in Oncopeptides history, sales for the 12 last months exceeded SEK 100 million, reaching SEK 103.5 million. Our cash position at the end of the third quarter stood at SEK 116.8 million, which was further strengthened after the period by approximately SEK 100 million in gross proceeds from the directed share issue completed in October. The positive CHMP opinion to expand Pepaxti into third-line treatment and the potential approval by the European Commission expected to follow in Q4 could unlock significant new sales potential. We remain on track to achieve positive cash flow during 2027. Importantly, our cash flow guidance is based on our commercial operations for Pepaxti in Europe to become self-sustaining. Our clinical program in glioblastoma is ring-fenced as a separate value-creating venture, with its upcoming CMC and clinical activities funded by the SEK 100 million raised in October. Looking at some of the significant events from July to September. In September, CHMP, the European Medicines Agency Committee for Medicinal Products for Human Use, issued a positive opinion of label expansion of Pepaxti into third-line treatment. We achieved our first expansion milestone in Central and Eastern Europe by receiving an official list price for Pepaxti in Slovenia. On the scientific front, we highlighted our clinical progress and presented new multiple myeloma data at the IMS annual meeting in Glasgow. In neuro-oncology, we presented preclinical and translational glioblastoma data at the EANO Congress in Rome, where we were also nominated for the prestigious EANO Poster Award for demonstrating encouraging data of overcoming resistance in preclinical models. It has also been an eventful period after the close of the quarter. First, we confirmed blood-brain barrier penetration in humans based on initial data from the first three patients in our glioblastoma window of opportunity study. To move on with clinical development of glioblastoma, we completed a directed share issue of approximately SEK 100 million. I want to thank both our new investors and our largest shareholder, HealthCap, for their continued support and trust in Oncopeptides. Finally, just yesterday, we announced that two new independent real-world studies from Spain and Italy have been accepted for presentation at the upcoming American Society of Hematology annual meeting in December. Acceptance of RWD data to be presented at ASH is demonstrating how important it is to understand how the real patients are doing on different drugs in a rapidly evolving treatment landscape. To remember is that these patients are commonly older, have more comorbidities, and are more frail than in the clinical studies. With that introduction, I will now hand over to Henrik for a walkthrough of the third quarter financials. Thank you, Sofia. Q3 provides further evidence of the positive commercial trajectory we are building. Net sales reached SEK 28.5 million, an increase of 41% year-on-year, and sales for the first nine months grew 61% to SEK 84.9 million. Importantly, this growth continues to translate into attractive economics, with a gross margin of approximately 98% for the nine-month period. At the same time, we maintained tight cost control, which contributed to a material improvement in EBIT and net result compared with last year. Taken together, the quarter shows stronger sales, continued high gross margins, and improving operating leverage. We continue to allocate capital with a clear focus on growth and value creation. Operating expenses were SEK 66.1 million in the quarter, approximately 3% lower year-on-year. Sales and marketing investment of SEK 36.5 million supports our commercial activities in Germany, Spain, and Italy, where we remain focused on expanding the reach of Pepaxti. At the same time, G&A costs decreased materially to SEK 11.7 million, reflecting disciplined overhead management and focused activities. R&D spending of SEK 17.9 million remains focused on selected high-potential opportunities, including the ongoing glioblastoma window of opportunity study, where we have published promising results already. Overall, we are combining continued commercial investment with lower overhead and focused pipeline execution, creating a stronger foundation for sustainable growth. We ended the quarter with SEK 117 million in cash. Following the quarter, we further strengthened our financial position through a directed share issue of SEK 100 million before transaction cost. The financing provides dedicated capital to advance CMC activities, complete study preparations, and fund the next clinical phase in glioblastoma. Meanwhile, allowing us to maintain disciplined commercial execution, moving the commercial part of Oncopeptides towards positive cash flow during 2027. The clear message is that Oncopeptides is entering its next phase with growing Pepaxti sales, attractive gross margins, a more efficient cost base, and the financial capacity to advance an additional potential value driver in glioblastoma. We believe the combination of commercial momentum, improving operating leverage, and upcoming clinical execution creates an increasingly compelling opportunity for Oncopeptides. With that, I hand back over to you, Sofia. Thank you, Henrik. Let's now turn to the business update. Third quarter net sales of SEK 28.5 million were in line with our expectations. As we also saw the last years, the third quarter is affected by the European summer vacation period, with demand naturally softer during August and September. Despite this seasonal effect, we delivered 41% growth compared to Q3 last year. We have now treated more than 1,200 patients with Pepaxti across Europe since our EMA approval in 2022. These heat maps are comparing Q3 from 2023 up to 2026. Our geographic footprint and prescriber base have expanded substantially across Germany, Italy, and Spain. This growing real-world clinical experience triggers independent RWD publications, which in turn fuels the peer-to-peer recommendations that are so critical to physicians managing patients that requires individualized treatment. Following an approved label expansion into an earlier line, we would have the potential to double both our addressable patient population and the average treatment cycle length in third line. Looking at our clinical position, under our current fourth-line label, real-world data and clinical experience consistently points to three distinct patient profiles where Pepaxti makes a clear difference. First, an option for patients unable to receive immunotherapy due to comorbidities, frailty, infections, and quality of life limitations. Second, as an ideal bridge between immune-based therapies, offering non-cross-resistant disease control while allowing for T-cell recovery or antigen reset. Third, as a proven salvage option for patients who have relapsed or become refractory after BCMA or CAR-T therapies. Following a potential EC approval, this positioning would become even stronger. As part of our pre-launch activities for the third line, we have gathered extensive insights from key opinion leaders across Europe. The feedback is remarkably consistent and confirms an unmet need in the third line for non-immunotherapy mechanisms that complement the first and the second line's regimens. Moving into the third line would mean Pepaxti is a strategic option for both patients who cannot receive immunotherapy and as an ideal bridge between immunotherapies earlier in the treatment journey. Just yesterday, we announced that two independent multicenter real-world studies from Spain and Italy have been accepted for presentation at ASH in December. The studies covering in total 82 heavily pre-treated patients further validates Pepaxti's clinical utility and manageable safety profile, both post-immunotherapy and as a bridge to subsequent immunotherapies. Let's look closer at our key markets, starting with Germany. Germany is the European market with the largest potential for us, and it is also the market where the summer vacation period had the most pronounced seasonal impact. According to September competitor sales data, the overall market in Germany was flat, meaning this is not only the case for us, but for competition as well. Through commercial discipline and the sharpened business model we implemented earlier this year, we continue to steer our German operations steadily towards country-level profitability. In parallel, our prospective real-world evidence study, MARINA, is progressing and helping us generating experience with office-based hematologists. Post a hopefully positive EC decision, the MARINA study team at IQVIA will submit an amendment for the inclusion criteria to reflect the new label with inclusion of patients from already third line. As you can see on the map and the graph on the right, our German prescriber base continues to grow quarter-over-quarter. Once physicians gain clinical experience with Pepaxti, they appreciate its profile and continue to prescribe it. Our German team is fully focused on unlocking both new prescribers and earlier line usage, as we are still in later lines in Germany. Moving to Italy. Even if August and September did slow down due to the vacation period, Italy remains a key growth contributor. Italy is our most mature market in terms of clinical experience and fourth line usage, demonstrating the highest estimated number of treatment cycles per patients based on our sales data, but also confirmed by the real-world data that will be presented at ASH. This success is driven by established market access all the way down to the hospital level and a very positive clinical experience that drives accurate patient identification and demand. This positive real-world experience is further reinforced by the Italian multicenter study of 42 heavily pre-treated patients accepted for ASH. This study demonstrates a strong 48% overall response rate and a 13.5-month median overall survival across a median of five treatment cycles. By providing reliable disease control and manageable tolerability, Pepaxti enabled 67% of these patients to proceed to a subsequent treatment, including novel immunotherapies such as bispecific antibodies and CAR-Ts. In Spain, even though the third quarter was affected by the summer vacation period, sales continued at higher level than in the previous quarter. Our team has worked with great resilience alongside key opinion leaders to keep expanding our footprint across the country, as illustrated by the heat map. A great example of the scientific engagements in Spain is the Spanish registry study of 40 heavily pre-treated patients accepted for ASH. The study demonstrates a 32.5% overall response rate, an 8.3-month duration of response, and an encouraging 15.7-month median overall survival. Even among the subgroup of last resort patients previously exposed to anti-BCMA and/or anti-GPRC5D immunotherapies, treatment achieved a 26% response rate and a 23.2-month median overall survival. Looking at our broader European commercialization roadmap, our phased rollout has been built around an estimated SEK 1.5 billion annual market potential, and our fourth line label protected by market exclusivity until 2037. Phase one markets Germany, Spain, Italy, Austria, and Greece represent roughly 50% of that potential where we are already established. We are actively evaluating strategic options, including new partnership discussions, to ensure we capture the full potential of Europe over time. Let's look at what a European Commission approval of our Type II variation could mean in practice. Currently, Pepaxti is indicated for fourth line plus patients who have received at least three prior lines of therapy and are triple-class refractory. Following a positive EC approval, our label would expand to adult patients who have received at least two prior lines of therapy, meaning third line and later, and whose disease is refractory to lenalidomide and their last line of therapy. Removing the triple-class refractory requirement is a major shift that could facilitate earlier and much more frequent patient identification for clinicians. This potential label expansion acts as a powerful commercial and financial multiplier across three dimensions. First, on the commercial side, removing the triple-class refractory barrier, moving to earlier lines effectively would double our addressable European patient population. As shown in the phase III OCEAN trial, earlier intervention allows patients to remain on therapy longer, doubling the average number of treatment cycles per patient in third line, which would unlock potential far beyond our SEK 1.5 billion estimate currently. Second, regarding market access and pricing, the German basket pricing approach averages modern third line therapies, establish an attractive comparative price anchor. The German rules would allow immediate launch, giving third line patients access to Pepaxti already while we are negotiating the price. This is very positive for both patients and our commercialization. Third, on medical need and scalability. Pepaxti fills a growing gap for a non-immunotherapy mode of action, following first and second line relapse, which can support our direct presence in Germany, Austria, Italy, and Spain, and the value of our partnerships, such as Salus in CEE. Looking at the timeline, we have this far executed on this regulatory process rapidly. Following our submission to EMA this summer, we received the positive CHMP opinion in September and expect the formal European Commission decision in the coming weeks, as it should follow no later than 60 days following a CHMP decision. Our immediate priority following a positive decision is to submit a German reimbursement dossier within approximately one month of the EC decision, enabling an immediate commercial launch in the third line in Germany. In parallel, we are preparing our third line launches in Italy and Spain and stand ready to submit our market access dossiers as soon as local procedures allows. To illustrate this at patient level, multiple myeloma is a marathon, it is not a sprint. With each relapse, the tumor burden accelerates and patients become increasingly frail from both the disease, but also from side effects of prior treatments. By expanding our indication to support third line and less refractory fourth line patients, we would be able to bring the benefits of Pepaxti to patients earlier in their disease course when they are fitter and can stay longer on treatment. Looking at the overall treatment landscape of myeloma, it has evolved with multiple launches in the first, second, and fourth line the last years. Patients now have several options with immunomodulators, anti-CD38 antibodies, proteasome inhibitors, bispecifics, CAR-Ts, and ADCs. What is important to notice is that many of these drugs are targeting BCMA and utilizing the immune system. As many of these options are already used in earlier lines, physicians increasingly need a differentiated non-cross-resistance mode of action like our PDC in the third line and beyond. Turning to our partnership and geographic expansion. In Central and Eastern Europe, our partner, Salus, made rapid progress by securing the list price in Slovenia in line with the German list price in August. While Slovenia is a smaller market in terms of volume, it serves as a critical reference pricing anchor across the entire CEE region, providing a solid foundation as Salus now begins to submit reimbursement dossiers in other countries. In Japan, our partnership dialogue have continued through active engagements, both remotely, but also in person in Japan, with multiple potential partners during the third quarter. In addition, we have met the top KOLs of Japan and got confirmed that they do see the need of Pepaxti as an option that complements immunotherapies. Japan is slightly behind in experience with immunotherapy, but the trend is clear. There are patients progressing on immunotherapy, and there are patients that cannot get immunotherapy due to comorbidities and frailty, also in Japan. Let's now move to our pipeline, where we have just recently achieved a clinical breakthrough. We have advanced our pipeline into clinic with focus on CNS tumors, starting with glioblastoma. The single greatest hurdle in neuro-oncology is the lack of blood-brain barrier penetration, which causes more than 90% of systemic cancer drugs to fail because they simply cannot reach the tumor. Rather than jumping straight into a costly phase I trial, we designed the capital-efficient INSULA window of opportunity study of approximately 10 patients at Oslo University Hospital using our approved PDC drug as a clinical probe to test human brain penetration rapidly. In October, data from the first three patients was concluded to be positive. Let's look closer at what we announced on October 9th from the INSULA study. First, we confirmed blood-brain barrier penetration. Biopsies from resected tumor tissue in the first three evaluated patients demonstrated clear and consistent presence of the active compound, meeting our primary objective. We achieved pharmacological concentrations completely in line with our preclinical models. Second, we saw a consistent and favorable safety profile. Treatment has been well tolerated with no major drug-related toxicity and no unexpected surgical complications. Remarkably, the first patient transitioned into the study's open-label extension and has received five monthly cycles without any new tumor-related neurological symptoms. Together, this marks a critical clinical proof of concept for our PDC platform in CNS tumors, transforming our brain cancer program from an ambitious preclinical scientific premise into a clinically validated opportunity in a market projected to grow into the size of approximately $8 billion by 2035. What will happen next? First, we will complete the pharmacokinetic analysis in cohort one, which includes five patients. Second, we have obtained approval to open cohort two from the Safety Review Committee, and will, once fully recruited, conclude the pharmacodynamic data analysis, which is exploratory, but we do hope it will give us some further scientific insights. Third, we will follow the open-label patients, and observe how they are doing on a PDC. The INSULA patients have recurrent glioblastoma, meaning the focus is not only on efficacy, but safety, and the quality of the time they have left is also of importance. Finally, this human proof of concept has triggered us to advance our CMC manufacturing activities, complete clinical study preparations, and execute the next clinical development phase for our PDC pipeline in neuro-oncology. This will, of course, happen in dialogue with regulatory authorities to ensure we generate the evidence needed while we also reach patients without any treatment options as soon as possible. With a positive CHMP opinion and a European Commission decision around the corner for Pepaxti, a human proof of concept in glioblastoma, and dedicated financing in place, we look forward to keeping you updated on an exciting fourth quarter. By that, I would like to thank you for listening, and we will now open up the line 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 Richard Ramanius from Redeye. Please go ahead. Good morning. I have a few questions, starting with one on sales. What expectations should we have for Q4 sales, compared with the sales in Q3 and Q2 this year? Thank you, Richard, for your question, and good morning. When it comes to, I mean, now we have been launching for some years, right? We started with Germany, and then we added some markets. When it comes to Q3, it is clear that the summer vacation period continuously is affecting our sales. So, it is a bit of an outlier. If we talk about kind of last year's Q4, that was also an outlier, because then we had a strike happening in Spain, and our sales dropped in December very rapidly. Without kind of commenting on the fourth quarter, I would expect the trend to be more similar to the year before. Of course, granted that nothing really unexpected happens. Great. A question for Henrik. How should we view costs for the rest of this year and for 2027? Yes, Richard, thanks for that question. We have previously guided cost base with a reference to the actions for 2025, where we had total operating cost just below SEK 300 million. We expect that to be a relevant benchmark for the full year 2026 as well. But as you can see, we are running a bit lower than that. If you do the math, you can get the expectations for the fourth quarter. Now, moving into 2027, we expect that the commercial part of Oncopeptides will run more or less on the same cost base. But here it is important to add that we are now advancing with glioblastoma into the next clinical phase, and that will also generate cost. We will, of course, be very clear on communicating what is what. But these are, so to speak, two different value drivers with separate investment cases, if you will. Okay. Thanks. A final question for Sofia. How long, in the base case, would you expect clinical development in glioblastoma to take? So, when could the drug be on the market? We need to interact with regulatory authorities to be more specific on a timeline. But with that said, if I'm going to reason a bit around glioblastoma as a disease and how it usually works, glioblastoma is, as you know, a very aggressive disease. There is a high unmet need, and there is a rapid progression, a desperate need of new drugs. So, I would assume that if we continue to show good clinical progress and the evidence is positive along the way, that there is an opportunity for different regulatory mechanisms that can bring a PDC to the market rather sooner than later. If you compare to an average time to market, I would assume a glioblastoma development program would be much shorter, including, for example, accelerated approval in the U.S., potential faster approval in a geography like Europe as well, most likely orphan drug designation, et cetera. But as said, we now have the initial data, and we will, once we have some more data from INSULA, interact with the regulatory authorities, and then we will, of course, keep you posted on our plans. Excellent. Thanks for answering my questions. Thank you so much, Richard. As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. The next question comes from Georg Tigalonov-Bjerke from ABG Sundal Collier. Please go ahead. Yeah. Hi, good morning. This is Georg from ABG. Congrats on the steady progress. I have two questions, please. Yes. Firstly, I am wondering if you would be able to comment on how the development of Pepaxti has been so far in Q4. Secondly, in glioblastoma, I am wondering if you could perhaps elaborate on what is in your base case, the patient subgroup and treatment line that you will be targeting, of course, given that you show the potential that is in the drug and the platform. Thank you. Thank you so much, and good morning. When it comes to Q4, I would basically like to repeat my answer as I gave to Richard. We are not commenting on the current quarter, but if you look at the trend of the different quarters, Q3, we did see encouraging growth year-over-year, and we're very happy about that because it shows the need and the progress of Pepaxti in Europe. But if you look more short-term and quarter-over-quarter, it's of course a weaker quarter than Q2. When it comes to Q4, it's then commonly stronger than Q3, and the trend is turning up. But as I said, last year in Q4, we had a very unfortunate strike coming into Spain, and we had a bit of a slower development in Germany, so we were surprised. We don't anticipate that kind of surprising events again, but of course, I mean, the nature of surprises is that you don't know about them, right? When it comes to Q4, I would assume, granted nothing unexpected is happening, that we are more into the 2024 trend rather than the 2025 trend. When it comes to your question on glioblastoma, it's too early to say exactly what subgroup we will address, but of course, we have different hypotheses based on our preclinical data, and that is what I can reason around at this time point. Then it's important to note that, as we said before, we have to interact with regulatory authorities to agree on a clinical development program, including then, of course, the target population. But if we look at our preclinical data, I allude to what we are seeing there. Glioblastoma is a very resistant disease, and there are different types of mutations. One quite common mutation is that you have a mutated MGMT promoter. That means that you have an upregulation of DNA repair. As alkylators and temozolomide, that is the standard of care today, that is an alkylator, are damaging the DNA, the kind of upregulation of the repair mechanism is then preventing the efficacy of the drug. If we look at our preclinical data, it looks as if we have the same result in killing tumor cells with both mutated MGMT and without MGMT mutations. That is, we can overcome this resistance, so it doesn't matter if there is an upregulation of the DNA repair because this is most likely, back to our mode of action, due to that we are damaging the DNA double-stranded in both the mitochondria and in the nucleus. This upregulation of DNA repair does not seem to be effective in the mitochondria. Looking then to your question and what population would we target, I mean, 60% of all patients already in first line do have this mutation and have limited efficacy of today's standard of care. Obviously, we will bring our preclinical data to the regulators, and we will discuss with them whether it would be possible to go for a first-line population fairly early on in the clinical development program. With that said, when you start, like in the INSULA study, and most likely in phase I, you would have to go for recurrent glioblastoma as it's first in man when you do a dose-finding study with a new PDC. That was a quite long answer, trying to educate a bit about how we're reasoning and our preclinical data, but was that clear enough for you, or do you have any follow-up questions? Well, definitely appreciate that detailed response. So, yeah, thanks again. Thank you so much for your questions. 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. There is a question regarding Japan, as always, I was going to say. In earlier presentations, you have indicated that the Japan partnerships might have been expected a bit earlier than we are now in time. What has caused this delay, if we call it that, and have negotiations progressed to commercial terms currently with potential partners? Thank you for the question. To remind of our Japanese history, we started the discussions, to your point, already in, I think it was 2024 even, with multiple companies. We progressed very well and quite rapidly, and we decided, once we kind of entered into more sharp discussions, to give one partner exclusivity, as that was kind of demanded. Unfortunately, this company had several delays then in the process, and it took long time. We, all the time, pressure tested and thought that we would be able to close a deal with this partner, but at the end of the day, the company unfortunately had a kind of financial issue based on that one of the products at the company was withdrawn, and they put all of their licensing efforts on hold. It had nothing to do with Pepaxti specifically, but more the situation of that company. They are still on hold, trying to sort their financial situation. With that, we then initiated a new round of discussions with a new set of partners, and that is where we are now. I've myself been to Japan twice this year to both initiate new discussions, but also, of course, go deeper into the diligence, et cetera. When I was there now the last time, we progressed with some of the companies that we initiated earlier this year, and I also spoke to the KOLs because we are also progressing in Europe. Now, when a potential new label in Europe, we of course wanted to speak to the KOLs to understand whether that potential could also be realized in Japan over time. I'm really, really happy to say that, because Japan is a quite hierarchical country and there are just few top KOLs that are really deciding the kind of treatment landscape, and all of them are very supportive and have kind of promised to educate partners on Pepaxti should it be needed. From that perspective, we are progressing well as the need is still confirmed. There may be an even greater potential and greater opportunity for Japanese patients, and we have several companies that we're discussing with. Great. Another question. You have reiterated your target of positive cash flow from the commercial business during 2027. Could you clarify whether this target depends on a significant contribution from the third line expansion, and what approximate quarterly sales level would be required to reach break-even? Yes, thank you so much for that question. So perhaps starting with the final part of the question, the cost base that the company is currently running at is pretty much about the commercial operation. Current running rate cost base is what would be required in revenue to be on a cash flow positive basis for the commercial part of the company. With regards to the third line, our target of becoming cash flow positive was expressed before we got this opportunity to expand ourselves into the third line. But obviously, this will help reach our target of becoming cash flow positive for sure. Just to build on Henrik, because I am repeating myself over and over again when I say that the market landscape is really evolving, so our position is also changing. That is, the potential in the fourth line is changing as the bispecifics are moving from the fourth line to the second line, but obviously also the position in the third line becomes even stronger based on that move. So, I would argue it is difficult to say that what was true when it comes to market dynamic and kind of share per line is also true now, because it is changing so much all the time. I see a potential approval in third line as kind of a perfect timing based on how the other drugs are moving. So, I would not be surprised if we can gain maybe an even higher market share in third line going forward than what we would have expected a year ago. Just to kind of give you a sense of the complexity, but also of kind of, I would argue, like the opportunity with the third line. So when it comes to, of course, then feeding into us becoming cash flow positive, I mean, when the positions are starting to move around, we have to consider the holistic and full picture. What is really good with Oncopeptides is that we have a team that is really seasoned in hematology. They are super well-connected to KOLs. I am myself very well-connected to the KOLs, so we can follow the trends very, very closely, and we are never far away from the insights to understand how the market is changing. Great. That is all the questions we have time for. Sofia, back to you for any final words. I just want to thank everyone for joining us today, for the questions, and your continued support and interest in Oncopeptides. I do believe we have really exciting times ahead, and I wish you a good day.
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