Good afternoon, and welcome to Lytix Biopharma's Q1 2026 Presentation. Let me briefly outline what you will hear today. We will start with the science, how ruxotemitide works, and why the mechanism is relevant for neoadjuvant melanoma. We will take you through the ATLAS-IT-05 melanoma data, including the presentation at AACR. We will move into the neoadjuvant melanoma, why we believe it is the right strategic focus, what the NeoLIPA interim results show, and how we are positioned in the competitive landscape. We will then cover the Verrica's partnership and the basal cell carcinoma program. This is a second independent and strong proof of concept for ruxotemitide. We will summarize Q1 operational highlights. Gjest will present the financial results and our capital position before we open the floor for questions.
Let me briefly introduce the presenting team. I am Øystein Rekdal, CEO and Co-Founder of Lytix Biopharma. With me is our CFO, Gjest Breistein, and our CMO, Karim Benhadji, who many of you have not met before. Karim is an experienced oncology drug developer with more than 20 years in the field, including senior clinical roles at Inspirna, GV20 Therapeutics, Taiho Oncology, and Eli Lilly. He has contributed to FDA approvals in cholangiocarcinoma and colorectal cancer, and he brings the depth of late-stage oncology experience Lytix needs as we move toward potential registrational studies. Karim's role is to ensure that our trial design, regulatory strategy, and clinical execution are fully aligned with what the regulators and future partners expect. We are fortunate to have him leading the clinical program at this stage of Lytix evolution.
Let's give you the company overview and start by explaining our oncolytic molecule platform. Lytix was founded on a discovery rooted in the body's own defense mechanisms. It all started with a naturally occurring host defense peptide, lactoferricin, and through extensive medicinal chemistry studies, we generated the shorter peptide ruxotemitide, a chemically modified peptide of just nine amino acids. Ruxotemitide is designed as an oncolytic molecule that combines two properties, direct destruction of cancer cells and activation of the immune system. That dual mode of action is what differentiates it from other approaches. Our second asset, LTX-401, extends the platform into small molecules intended for deep-seated tumors that are less accessible for intratumoral injection, and that program is in late-stage preclinical development.
Let's look more closely at how ruxotemitide works because this mechanism underpins our entire strategy. Ruxotemitide acts in two phases. First, locally. When injected into a tumor, it kills cancer cells by disrupting the cancer cell membrane, resulting in release of tumor antigens and immune-stimulating signals. Second, this local destruction of cancer cells trigger a broader systemic immune response. The immune system is exposed to the released tumor antigens in a context that teaches it to recognize and attack cancer cells elsewhere in the body. This is called the abscopal effect. In our trials, we have seen shrinkage of lesions that were never injected, which is a clear sign that the immune system is being engaged beyond the injection site. This mechanism, local destruction plus systemic immune activation, is exactly why we see neoadjuvant melanoma before surgery as a particularly attractive setting. These slides make the mechanism tangible.
In sarcoma and triple-negative breast cancer patients treated with intratumoral ruxotemitide in monotherapy or in combination with pembrolizumab, respectively, we observed regression not only in the injected tumors but also in distant non-injected lesions. These are difficult-to-treat tumor types, yet still we saw evidence of a systemic immune response. That gives us confidence that the biology is working and not limited to one indication or one combination. The melanoma data from ATLAS-IT-05, which Karim will soon review, build on this and show the same pattern of systemic activation. Here you see the status of our pipeline. ATLAS-IT-05, our combination study of ruxotemitide plus pembrolizumab in PD-1/PD-L1 refractory melanoma, is complete and provides promising results.
NeoLIPA, our phase II neoadjuvant melanoma study, is ongoing and progressing well. Through our partner Verrica, ruxotemitide, mentioned as VP-315 by Verrica, has completed phase II in basal cell carcinoma, with the company now preparing for a phase III registrational trial planned for 2026. LTX-401 is in late-stage preclinical preparation, with clinical entry targeted for 2027.
With this overview, I will hand over to Karim to walk you through ATLAS-IT-05 in more detail.
Thank you. Thank you, Øystein. I would like to start by putting the study ATLAS-IT-05 into context. This is a phase II study that was conducted in a very challenging population. Patient had advanced or metastatic melanoma who have already failed prior immunotherapy, and that they have poor prognosis. We will go through the results that were presented recently at the American Association for Cancer Research, AACR meeting. Next slide, please. This is an important slide. It is showing a representative case of melanoma, a patient with melanoma. What you see on the left panel are the melanoma lesions. As you see there, that following the injection of ruxotemitide in the tumor lesion, you see disappearance of the tumor. In the middle panel, you do see that this patient had a metastatic lesion in the muscle.
As described by Øystein previously, we have an abscopal effect, meaning that this lesion disappeared also with a complete response without being injected. This is very important effect of the study drug. Overall, we have seen in a number of patient responses, including in non-injected lesions, named abscopal effect. The safety profile in this population remain consistent with the safety profile of intratumoral therapy and pembrolizumab and remains manageable. Next slide. This is an important slide. We call it waterfall plot of change in tumor size. Each bar represents an individual patient and represent a patient with lesion that were not injected. If you see the bar going above zero, it meaning an increase in the tumor size. If it's below zero, it's showing a shrinkage.
What you see on the right and the bottom, that are a fair number of patients who had a decrease in the tumor size of non-injected lesions, which is really meaningful in this refractory population. Next slide, please. This is another slide representing the population in a different manner. Again, each bar represents an individual patient, and they are classified by the duration of treatment. The patient with the shorter duration of treatment is on the top, and the patient with the longest duration of treatment is on the bottom. You see a few dots. The green dots represent the patients who had partial responses. As you see, the last three patients on the bottom had partial responses, and those responses were durable.
We had a number of patients who stayed on treatment for over two years, which is really meaningful in this refractory population that failed prior immunotherapy. This is why we are really excited about these findings in refractory melanoma patients and beyond standard of care. Next slide. In the study, we studied also overall survival, so how long patients survived from the start of the study, and the survival was really outstanding in this population. The data is not mature, what we see here is that at the one-year mark, at least 90% of subjects was still alive. At the two-year mark, we had at least 70% of the population still alive, which is really meaningful in this population. Where do we go from here? Neoadjuvant melanoma is an attractive indication, both from the biological standpoint point of view and clinically.
Biologically, ruxotemitide is designed to activate the immune system after tumor cell killing by exposing to the tumor antigens and the danger signals, as described by Øystein. Before surgery, the tumor is still present and can serve as a powerful antigen source, and this will give the drug a chance to educate and prime the immune system to fight the tumor. In addition, clinically, this patient haven't been exposed to prior immunotherapy, and they still have a more functional immune system as compared with patients in a later stage of therapy. This increases the likelihood that the immune system can mount a robust, sustained response, which may translate into a better long-term outcome. Previous slide, please. Yes, thank you. There are currently no approved drugs for the neoadjuvant treatment of high-risk melanoma.
However, two regimens are considered as standard of care in this setting, are included in different guidelines in the U.S. and Europe, including the ESMO guidelines. These regimens are pembrolizumab monotherapy or nivolumab and ipilimumab combination. These two regimens have improved outcome of patient. There is still room to improve the outcome of patient because there are still many patient who do relapse, and there is still room for improvement and improve the long-term outcome. Our goal is not to replace anti-PD-1 therapy, but to make it work better by inducing the inflammation of the tumor microenvironment and increasing the antigen presentation before surgery. Ruxotemitide is positioned to increase and enhance the effect of standard anti-PD-1 treatment.
As you know, we have an ongoing phase II study, a NeoLIPA study in the University of Oslo. This is an investigator-initiated phase II study led by Dr. Henrik Jespersen and his team. They are evaluating the intratumoral ruxotemitide therapy in combination with standard of care pembrolizumab before surgery in patients with high-risk melanoma. They have presented last year at the Nordic Melanoma Meeting the preliminary results, the results were encouraging, showing a major pathological response rate of 55%, including a complete pathological response rate of 44%. This is really meaningful. To put things into context, the SWOG S1801 , the randomized study that showed the benefit of pembrolizumab in neoadjuvant setting in melanoma, reported a pathological complete response rate of 21%. The top-line results of NeoLIPA study are on track to be available end of this year, in the second half of this year.
Finally, in terms of competition, the field in neoadjuvant high-risk melanoma remains open. There is a phase I study, a phase II study led by Regeneron, and one phase III study that was previously reported by Philogen. These approaches are really different from Lytix approach. The field remains open. Ruxotemitide is unique, as we described, as an intratumoral therapy and designed to prime the immune system to recognize the antigens and enhance the efficacy of PD-1. We are not intending to replace anti-PD-1 therapy, but enhance the outcome of patients who receive standard of care with PD-1. Our data, as showed before, support this mechanism, and we are really focusing on this combination to improve the outcome of this patient with a high-risk melanoma that is still requiring improvement of their outcomes.
With that, I would hand it to Øystein.
Thank you, Karim. The commercial opportunity in melanoma is significant. Independent third-party analysis suggests a substantial net revenue potential across the U.S. and E.U. Sorry. If ruxotemitide can demonstrate clinical meaningful benefit in this setting. Neoadjuvant melanoma is attractive because it's aligned with our strongest evidence, melanoma clinical data, systemic immune activation, and a clear rationale for treating before surgery. Beyond melanoma, the same mechanism supports expansion into other types of solid tumors, and our strategy is to prioritize the most compelling near-term opportunity while maintaining flexibility to broaden the development program and pursue value-creating partnership.
As you know, ruxotemitide has also been shown strong clinical activity outside melanoma through our partner Verrica Pharmaceuticals. In basal cell carcinoma, Verrica has reported positive and strong phase II data with ruxotemitide, including high overall response rate, meaningful tumor size reduction, and pathological complete responses. Let's now turn to the highlights from the quarter and the period after quarter end. Let me summarize two concrete areas of progress in the quarter and since quarter end. First, on the Verrica partnership, Verrica has confirmed that they are planning to start the phase III registrational trial with VP-315, ruxotemitide, oral oncolytic peptide, in basal cell carcinoma in 2026. In addition, new phase II data presented at the Society for Investigative Dermatology show that VP-315 induced regression not only in the treated tumor lesion, but also in untreated non-target basal cell carcinoma lesions.
This is important external validation of ruxotemitide's systemic activity and its potential in a second indication beyond melanoma. Second, NeoLIPA continues to be the key near-term value driver in melanoma. Enrollment is progressing well with about 75% of patients now included, and we have opened a new clinical site at Haukeland University Hospital. The additional site reduces execution risk and support our guidance that we remain on track for NeoLIPA top-line results in the second half of 2026. I also want to connect two important strategic pillars, our growing clinical evidence base, and the concrete steps toward a registrational path in neoadjuvant melanoma.
First, ATLAS-IT-05. The final results from this study were presented on April 20th at the AACR meeting in San Diego. Later this month, safety and efficacy data with ruxotemitide plus pembrolizumab in both melanoma and triple-negative breast cancer will be presented at ASCO in Chicago, and I mean in June. These presentation at two major international conferences underline that the data are strong enough to stand on a global stage and provide an important foundation for discussion with regulators and potential partners. Second is the registrational path. We now have an FDA meeting scheduled for the second half of 2026 to gain alignment on the proposed registrational trial design in neoadjuvant melanoma, which we see as a key enabler for future partnership around ruxotemitide.
Subject to that dialogue and the NeoLIPA data, our current plan is to start a registrational study of ruxotemitide plus anti-PD-1 in 2027. I also want to highlight how we are thinking about the broader pipeline beyond ruxotemitide. Starting with LTX-401, phase I planning is ongoing, and we are making the necessary preparation to bring LTX-401 into the clinic in 2027. Turning to business and financials, we completed two capital raises in Q1 2026 with gross proceeds of NOK 77.3 million. This has materially strengthened our financial flexibility. At the end of the quarter, cash and short-term financial investment stood at NOK 120 million , which supports continued execution of the key value-creating activities we have discussed today.
During the quarter, we also completed an independent strategic commercial assessment of ruxotemitide, which reinforced that the market potential, across multiple indication. Finally, we have maintained active engagement with investors and potential partner through major industry meetings such as J.P. Morgan, BIO-Europe, BioEquity , and LSX Europe. Overall, the message is that we are investing where it matters, keeping optionality in the broader pipeline, and maintaining a balance sheet that allow us to reach the next clinical and regulatory milestones.
I will now hand over to our CFO, Gjest Breistein, who will take you through the financial results and outlook.
Thank you, Øystein. As Øystein and Karim have highlighted, the first quarter was characterized by continued strategic and operational progress across the organization. I will now walk you through the financial results supporting this activity. We continued to execute on our development strategy during the first quarter with progress across both ruxotemitide and our broader oncolytic molecule platform. Clinical development priorities for 2026 and 2027 remains on track, and we have continued preparatory activities supporting the potential next stage of development for ruxotemitide in the adjuvant melanoma. The successful capital raise completed in Q1 significantly strengthened the balance sheet and provided increased strategic flexibility as we continue advancing the pipeline. Total operating expenses for Q1 2026 was NOK 27 million, compared to NOK 13 million in Q1 2025. It is important to note that Q1 2025 reflected a period with relatively limited activity.
Q4 2025, at approximately NOK 21 million in operating expenses, represents a more relevant recent comparison point. The increase in activity levels during Q1 primarily reflects a deliberate investment following the strong interim NeoLIPA results presented in Q4 2025. The main drivers were the completion activities related to ATLAS-IT-05, including finalization of the clinical study report and presentation of additional data at AACR. Strategic and commercial assessments relating to ruxotemitide and 401, supporting ongoing development planning and broader strategic positioning. Clinical and regulatory preparation activities, supporting evaluation of future development pathways for ruxotemitide. Other operating expenses also increased during the quarter, primarily reflecting the transaction costs related to the successful financing. This slide illustrates the development in operating expenses and liquidity over the quarters.
On the left-hand side, you can see quarterly operating expenses from Q2 2024 through Q1 2026. The increase to NOK 27 million in Q1 reflects the clear increase in strategic and operational activity. Direct R&D expenses remains the largest component at the cost base of NOK 14 million. On the right-hand side, you can see development in cash and short-term financial investments. The financial position was strengthened significantly during Q1, increasing from NOK 72 million at the end of 2025 to NOK 120 million at the end of Q1. This improvement reflects the successful completion of the private placement and subsequent offering, which together raised NOK 77 million. Importantly, this financing significantly strengthened the companies ahead of several potential value-defining activities. The increased activity level in Q1 reflects the focused investments intended to strengthen the long-term commercial and strategic positioning of both ruxotemitide and 401.
Turning to the balance sheet. As of March 31st, 2026, total assets amounted to NOK 129 million. The balance sheet remains highly liquid, consisting primarily of cash and cash equivalents of NOK 58 million and short-term financial investments of NOK 62 million. Together, this provides liquid assets of approximately NOK 120 million. Total liabilities were NOK 14 million, compared to NOK 35 million one year ago. The reduction primarily reflects completion and settlement of obligations related to ATLAS-IT-05, resulting in a cleaner and more normalized balance sheet structure. Overall, the company enters the coming quarters with a strengthened balance sheet, increased strategic flexibility, and the financial foundation required to continue advancing key value-driving activities across the pipeline.
With that, I'll hand it back to Øystein.
Thank you, Gjest. Clinical development priorities remain on track with registrational path planning and balancing in accordance with Lytix's established development strategy. The clinical data generated to date provide a strong foundation for this work, and our focus is now on preparing ruxotemitide for the next stage of development through disciplined planning, regulatory engagement, and continued clinical execution. For NeoLIPA, top-line results remain expected in the second half of 2026. This study continues to be central to our strategy in neoadjuvant melanoma, where we believe ruxotemitide is well-positioned based on its mechanism of action, clinical profile, and potential to enhance immune activation before surgery.
In basal cell carcinoma, Verrica is continuing to prepare towards the phase III trial. Beyond ruxotemitide, we continue to advance partnering discussion for LTX-401. Our focus remains on creating value from the broader platform while maintaining disciplined capital allocation. Across the company, our strategic focus is clear. Advance late-stage development opportunities, pursue commercialization through value-creating partnership, and continue building the clinical and regulatory foundation required to move ruxotemitide towards its next milestones.
Thank you. With that, we will open for a Q&A session that will be led by Mats.
Thank you, Øystein. Thank you, Øystein, Gjest, and Karim for a very good and enlightening presentation. We will now open up for questions that you can submit through the presentation browser. We have received a lot of questions in advance and also during the presentation, and we will try to answer some of them today. The questions that we can't answer, we will follow up after the presentation with written answers. You can also submit questions to post@lytixbiopharma.com. Let's dive into it. The first question is a high-level one. In previous reports, you have stated that you are accelerating path to market. How does the registrational study fit into this?
We have built a quite strong clinical portfolio of results, and we are strong believe of the capabilities of our technology and are very focused on bringing this to the patient as fast as possible. We have shared that Verrica is moving towards a phase III study. With this result we see in neoadjuvant melanoma, late-stage melanoma, we are also now focused to bring ruxotemitide towards a registrational study in melanoma. This total aim is really to bring the ruxotemitide to the patients as fast as possible. This is what we mean with the accelerating now towards market, and also that this registrational study will be a very core focus for Lytix going forward.
Thank you, Øystein. We have received a couple of questions related to the FDA meeting and also the timeline of the FDA meeting. The first one is, what is the purpose of the FDA meeting, and when is it planned for?
I will let Karim answer that question. Please, Karim.
Yes, thank you, Øystein. The purpose of the meeting with the FDA is to align on the registrational plan. This is really a typical step that we do before starting a registrational study. We ask a lot of questions about the design of the study and that strategy. Regarding the timeline, we are planning to have the meeting in the second half of this year.
Thank you. On the financing side, how do you intend to finance a registrational trial in neoadjuvant melanoma? Is Lytix planning to do it alone, and how much will it cost?
I'll answer that question. As we are in the planning phase of that trial, we don't have final estimates of the cost of the trial. It's important to mention that part of doing this planning, we're also looking for partners. We would like to do this in partnership with others. We are planning this as well as we can, and also with a plan to actually execute to take ruxotemitide to market.
Thank you. If you get encouraging top-line results for NeoLIPA, what is the next step? Do we need a deeper phase II study before advancing to phase III?
I think also Karim, since he is with us, would be the right person to answer that question.
Yes, our plan right now is to move to a registration plan, a registration study in neoadjuvant melanoma based on the result that we saw so far, and then the planned results that will be disclosed later this year. This is what we are going to propose with the FDA and get their feedback and align about the strategy, about the nuances of the design of the registration study.
Thank you. We have two questions on a potential up-listing to the main list on the Oslo Stock Exchange. Have Lytix applied for an up-listing?
We successfully converted Lytix to a public limited liability company earlier this winter. That will enable us to do a up-listing when we want. There's no ongoing plans of doing it in the near future.
Thank you. On the financing side and the cost side, given the step-up in operating expenses this quarter, how long does your current cash position realistically last, and what assumptions are you making about the burn?
We raised the capital early in 2026, strengthening the balance sheet, and that was an important move. We have communicated earlier that this cash will take us through first half of 2027. That's our current estimate.
Thank you. A question on Verrica and the partnership with Verrica. Verrica said they were advancing towards pivotal phase III studies. They haven't started. What's the hold-up, and how much visibility do you have into their timeline?
First of all, we cannot share more than what is public, and we don't have much information of non-public information anyhow. To start a registration study, which we also ourself experience take time. You need to prepare protocol. It's manufacturing processes. You have to find sites, establish CRO activities. It's a time-consuming process to get ready to plan for phase III, but our position is to really support them, to enable them to start the phase III study as soon as possible.
Thank you. On the partnering side, what are the key elements that you are looking for in a partner? Has the full readout of ATLAS-IT-05 resulted in any new interest from the other pharma companies?
We can, of course, not share any concrete on that. There are interest for sure in both ruxotemitide and also our second generation asset, LTX-401, because ruxotemitide validate now this technology. We differentiate from a number of other companies and address some of the major challenges in current immunotherapy. We have now achieved and de-risked our technology significantly with strong phase II data and moving into phase III. I think what a company in our situation needs to do is, one, develop further, show that you move your drug forward towards the market, and at the same time work actively to partner meetings and be active on that side.
What will happen when is difficult to know and to share, but we can secure that there are interest for our technology, and we will share more when we can later on when that happens.
Can you say something about what you're looking for in a partner?
Thank you for mentioning that. Of course, we all want also a big partner, have the financial and the manpower to do more than a biotech is doing. A larger partner will be able to do not only maybe make development faster but also broader. Lytix has, of course, limitation how many different indication we can develop in, but we see this technology has a very large commercial potential in a number of indication. With a partner on board, you can do a much broader development. I think that's the core element we would like to see in a partner with the manpower and resources to really accelerate in a broader fashion, the development.
Thank you, Øystein. On your second-generation drug, how much do you expect the phase I study will with LTX-401? Are you planning to cost?
To cover the cost?
Yeah. What is the cost related to that?
We're planning to start the phase I study with LTX-401 in 2027. At the current stage, we're not in a position to share the cost of that study. Being a phase I study with a limited number of patients, it's not as expensive as the more later stage clinical trials.
Thank you. I think we will conclude with that, and then we will revert to all of you that have sent questions in advance. We will also be back after the summer with the next quarterly presentation.
Thank you, and thank you all for following this quarterly report.
Thank you.