Lytix Biopharma ASA ($LYTIX)

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 ruxotemetide works and why the mechanism is relevant for neoadjuvant melanoma. Then we will take you through the ATLAS-IT-05 melanoma data, including the presentation at AACR. From there, we will move into the neoadjuvant melanoma, why we believe it is the right strategic focus, what the NELPA interim results show and how we are positioned in the competition -- competitive landscape. We will then cover the Americas partnership and the basal cell carcinoma program. This is the second independent and strong proof of concept for rxotmetide. After that, we will summarize Q1 operational highlights. Finally, Jes 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 Oystein Rekdal, CEO and Co-Founder of Lytix Biopharma. With me is our CFO, Jes Breyststein; and our CMO, Karim Benhaji, 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 InspirnaGV20 Therapeutics, Thiro Oncology and Eli Lilly. He has contributed to FDA approvals in colangiocarcinoma 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 align with what the regulators and future partners expect. We are fortunate to have him leading the clinical program at this stage of Lytix's evolution. So 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, lecture -- and through extensive medischemistry studies, we generated the shorter peptide ruxotemitide, a chemically modified peptide of just 9 aminoasis. Ruxotemitide is designed as an oncolytic molecule that combines 2 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, extend the platform into small molecules intended for deep ceded tumors that are less accessible for intratumoral injection. And that program is in late-stage preclinical development. align let's look more closely at whole Ricotta work because this mechanism underpins our entire strategy. Ruxotemetide acts in a first locally -- when injected into tumor, it kill 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 immune system immune response. The immune system is exposed to the release tumor indigents 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 immuno activation is exactly why we see edamame malenoma before surgery as a particularly attractive setting. These slides make the mechanism changeable. In sarcoma and triple-negative breast cancer patients treated with infatuated in monotherapy or in combination with pembrolizumab, respectively, we observed regression not only in injected tumors but also in distant non-injected lesion. 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 1 indication or 1 combination. The melanoma data from Atlas ITOV, which Karen will soon review, build on this and show the same pattern of systemic activation. Here you see the status of our pipeline, Atlas ITOV, our combination study of ruxotemitide plus pembrolizumab in PD-1/PD-L1 refractory melanoma is complete and provides promising results. NEO LIPA, our Phase II neoadvanted melanoma study is ongoing and progressing well. Through our partner, Erica, ruxotemetide as mentioned as VP315V by Verca has completed Phase II in basal carcinoma with the company now preparing for a Phase III registrational trial planned for 2026. LTX-401 is in late-stage preclin preparation with clinical entry targeted for 2027. And with this overview, I will hand over to Karim to walk you through Atlas I2V in more detail.

Thank you. Thank you, 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 saved prior immunotherapy and that they have poor prognosis. We will go through the results that were presented recently at the American Association of Cancer Research, AACR meeting. Next slide, please. So this is an important slide. It's showing a representative case of melanoma patients with melanoma. What you see on the left panel are the melanoma lesions -- and as you see there that following the injection of restricted in the tumor lesion, we see disappearance of the tumor. In the middle panel, you do see that this patient had a metastatic lesion in the muscle. And as described by Ossen previously, we have an agroscope effect, meaning that this lesion disappeared also with a complete response without being injected. And this is a very important effect of the study work. So overall, we have seen in a number of patient responses, including in non-injected lesions. Named abscopal effect, the set profile in this population remain consistent with the safety profile of iatumoratherapy and pembrolizumab and remains manageable. Next slide. This is an important slide recorded water for blood of change in tumor size -- this -- each bar represents an individual patient and represent a patient with lesions that were not injected. If you see the bar going above 0, it meaning an increase in the tumor size, if it's below 0, it's showing a shrink what we see on the right and the bottom there 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 elation. The 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 a shorter duration of treatment is on the top and the patient with the longest duration of treatment is on the bottom. And you see a few thoughts, the cream Dutch represent the patients, who had partial responses. As you see, the last 3 patients on the bottom had partial responses and all responses were durable. We had a number of patients who were state-heatment for over 2 years, which is a really meaningful in this refractory population that failed prior immunotherapy. And this is why we are really excited about these findings in refractory melanoma patients and beyond standard of care. Next slide. Finally, in the study, we studied also over survival or how long patients survive from the start of the study and the survival was really outstanding in this population. The data is not mature. But what we see here is that at the 1-year mark at least 90% of subjects was still alive. And at the 2-year mark, we had at least 70% of the population still live, which is really meaningful in this population. So where do we go from here? Neoadjuvant melanoma is an attractive indication both from the biological dental auto view and clinically. Biologically, rexotomitide is designed to activate the new system after tumor cell killing by exposing to the tumor antigens and the Tanger signals, as described by Alison. Before surgery, the tumor is still present and can serve as a powerful antigen source, and this will give the drug a chance to indicate on the prime new system to fight the tumor. In addition, clinically, this patient hasn't been exposed to prior immunotherapy, and they still have a more functional immune system as compared with patients in the later stage of therapy. And this increase is the likelihood that the immune system can mortar robust, sustained response, which may translate into a better loan-term outcome. There are currently no approved drugs for the new adjuvant treatment of high-risk melanoma. However 2 regimens are considered as standard of care in this setting are included in different guidelines in the U.S. and Europe, including the SCCM guidance. These regimes are pembrolizumab monotherapy or nivolumab and ipilimumab combination. These 2 regimens have improved the outcome of patients. However, there is still room to improve the outcome of patients because there are still many patients 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 tumor the inflammation of the tumor microenvironment and increasing the antigen presentation before surgery. Ruxitongetide is positioned to increase and enhance the effect of Sander anti-PD-1 treatment. As you know, we have an ongoing Phase II study, a NEOLIPAstudy in the University of Oscothisis NPC-initiated Phase II study led by Dr. Henrik Reses and his team, they are evaluating the intratumoral ruxitomitide therapy in combination with start of care pembrolizumab before surgery in patients with high-risk melanoma. They have presented last year at the Nordic melanoma meeting the preliminary results, and the results were encouraging. -- showing a major pathological response rate of 55%, including a complete pathological response rate of 44%, and this is really meaningful. To put things into context, the swap S-180, the random in 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 Monica study are on track to be available end of this year. Finally, in terms of competition, the field in neoadjuvant high-risk melanoma remains open. There is a Phase I. There is a Phase I study, a Phase II study led by Regeneron and 1 Phase III study that was previously reported by Favre. These approaches are very different from latex approach. The fleet remains open. Olectomitide is unique, as we described, is an intratumoratherapy and designed to prime the immune system to recognize antigens and enhance the efficacy of PD-1. We are not intending to place anti-PD-1 therapy, but and hence, the outcome of patients who received 1 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 highest melanoma that is still required improvement of other outcomes. With that, I will hand it to Oystein.

Thank you, Karin. So the commercial opportunity in melanoma is significant. Independent third-party analysis suggests a substantial net revenue potential across the U.S. and EU. If ruxotemitide can demonstrate clinical meaningful benefit in this setting. Novant 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 support 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, Richard Termite has also been shown strong clinical activity outside melanoma through our partner, Vera Pharmaceuticals. In basal cell carcinoma, Veritas reported positive and strong Phase II data with rixotemetide, 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 2 concrete areas of progress in the quarter and since quarter end. First, on the Verrica partnership, Berica has confirmed that they are planning to start the Phase III registrational trial with VP315, ruxotemitide, our oncolytic peptide in basal cell casinoma 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 nontarget based on cell carcinoma lesions. This is important external validation of ruxotematide systemic activity and its potential in a second indication beyond melanoma. Second, Neo Lipa 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 Hakan University Hospital. The additional site reduces execution risk and support our guidance that we remain on track for NerLIPA top line results in the second half of 2026. I also want to connect 2 important strategic pillars or growing clinical evidence base and the concrete steps towards a registrational path in Neodent melanoma. First, Atlas ITOV, the final results from this study were presented on April 20 at the AACR meeting in San Diego. And later this month, safety and efficacy data with [indiscernible] plus pembrolizumab in both melanoma and triple-negative breast cancer will be presented at ASCO in Chicago, and I mean in June. This presentation at 2 major international conferences underlying 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 Neodent melanoma, which we see as a key enabler for future partnership around ruxotemitide. Subject to that dialogue and the Neolipadata, our current plan is to start the registrational study of ruxotebutide plus anti-PD-1 in 2027. I also want to highlight how we are thinking about the broader pipeline beyond rixotemitide. Starting with LTX-41, Phase 1 planning is ongoing, and we are making the necessary preparation to bring X1 into the clinic in 2027. Turning to business and financials. We completed 2 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 rixotamitide which reinforced that the market potential across multiple indications. And finally, we have maintained active engagement with investors and potential partners through major industry meetings such as JPMorgan Bio Europe, Bioequity and LSX Europe. Overall, the message is that we are investing where it matters, keeping optionality in the broader pipeline and then 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, Oystein. As Oystein 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 continue to execute on our development strategy during the first quarter with progress across both roxotematide 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 or development for exatematide in naive 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 SEK 27 million compared to SEK 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 Melita results presented in Q4 2025. The main drivers were the completion activities related to Atlas, including finalization of the clinical study report and presentation of additional data at AACR. Strategic and commercial assessments related to ruxatematide and 401, supporting ongoing development planning and broader strategic positioning. Clinical and regulatory preparation activities supporting evaluation of future development pathways for exotemetide. 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 for Q2 2024 through Q1 2026. The increase to SEK 27 million in Q1 reflects a 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 the 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 SEK 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 company ahead of several potential value-defining activities. Increased activity level in Q1 reflects the focused investments intended to strengthen the long-term commercial and strategic positioning of both rexotemotide and Foran. Turning to the balance sheet. As of March 31, 2026. Total assets amounted to SEK 129 million. The balance sheet remains highly liquid, consisting primarily of cash and cash equivalents of SEK 58 million and short-term financial investments of SEK 62 million. Together, this provides liquid assets of approximately NOK 120 million. Total liabilities were $14 million compared to SEK 35 million, 1 year ago. The reduction primarily reflects completion and settlement of obligations related to Atlas I 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 Oystein.

Thank you, Gjest. So clinical development priorities remain on track with registrational path planning and balancing in accordance with Lite's established development strategy. The clinical data generated to date provide a strong foundation for this work, and our focus is now on preparing ruxotermatide 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 the Advent melanoma, where we believe oxotebetide is well positioned based on its mechanism of action, clinical profile and potential to enhance immuno activation before surgery. In Basel cell carsinoma, Berica is continuing to prepare towards a Phase III trial. And beyond ruxotumitide, we continue to advance partnering discussion for LTX-401. Our focus is to remain on creating value from the broader platform, while maintaining disciplined capital allocation. Across the company, our strategic focus is clear, advanced late-stage development opportunities, pursue commercialization through value-creating partnership and continue building the clinical and regulatory foundation required to move ruxotemetide towards its next milestones. Thank you. And with that, we will open for a Q&A session that will be led by Matt.

[Operator Instructions] 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 written with written answers. You can also submit questions to post atlitixpeopharma.com. Let's dive into it. The first question is it's a high level one. In previous reports, you have stated that you are accelerating past the market. How does the registrational study fit into this?

So we have built a quite strong clinical portfolio of results. And -- we are a strong belief of the capabilities of our technology and are very focused on bringing this to the patient as fast as possible. We have shared that Berica is moving towards a Phase III study. And we, with this result we see in advent melanoma, as melanoma, we are also now focused to bring ruxotemetide to or registrational study in melanoma. So this total aim is really to bring the luxotemetide to the patients as fast as possible. And this is what we mean with the aerating towards market and also that this registration study will be a very core focus for lytics going forward.

Thank you, in. And then we have received a couple of questions related to the FDA meeting and also the time line of the FDA meeting. So the first 1 is what is the purpose of the FDA meeting? And when is it planned for?

So I will let Karim answer that question. So please, Karim?

Yes. Thank you, Austin. So the purpose of the meeting with the FDA is to align on the recessional plan. So this is really a typical step that we do before starting a registrational study. So we asked a lot of questions about the design study in that strategy. Regarding the time line, we are planning to have the meeting in the second half of this year.

And then on the financing side, how do you intend to finance a registrational trial in advent melanoma? And is politics 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 a final estimate 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 the partnership with others. But we are planning this as well as we can and also with the plan to actually execute to take Rexotemita 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 will be the right person to answer that question.

So yes, our plan right now is to move to a special plan a registrational study in new adjuvant melanoma based on the results that we saw so far. And then planned results that will be disclosed later this year. This is what we are going to propose at the FDA and the feedback and line out the strategy about the nuances of the design of the rechain.

Thank you. And then we have 2 questions on a potential uplifting to the main list on the Oslo Stock Exchange, have Lytix applied for at listing?

So we successfully converted Lite to a public limited liability company earlier this winter. That will enable us to do listing when we want. There's no current -- like there is no ongoing plans of doing it in the near future.

Thank you. And then on the financing side and the cost side, given the step-up in operating expenses this quarter, does -- how long does your current cash position realistically last? And what assumptions are you making about the burn?

We raised capital in 2026, strengthening the balance sheet, and that was an important move. We have communicated earlier that this cash will take us through the first half of 2027, and 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, but they haven't started. What's the holdup? And how much visibility do you have into their time line?

So first of all, we cannot share more than what is public and we don't have much information of nonpublic information and now. But to start the registration study, which we also ourself experience take time. You need to prepared protocol. It's manufacturing processes. You have to find sites establish CRO activities. So this -- it's a time-consuming process to get ready to plan for Phase III. But we our position is to really support them to enable them to start the Phase III study as soon as possible.

Thank you. And on the partnering side, what are the key elements that you are looking for in the partner and has the full readout of Atlas 05 resulted in any new interest from the other pharma companies.

So we can, of course, not share any concrete on that, but there are interest sure in both reclotemetide and also our second generation asset LTX-41 because orthotematide Vale, they know this technology and we differentiate from a number of other companies and address some of the major challenges in current immunotherapy. So we are now achieved and derisked our technology significantly with strong Phase II data and moving into Phase III. And I think what a company in our situation needs to do is one, develop further may show that you move your drug forward towards the market and at the same time, work actively to partnership partner meetings and be active on that side. And what will happen when it's difficult to know and to share, but we can secure that there are interests for our technology. and we will share more when we can later on when that happens.

And can you say something about what you are looking for in a partner?

Yes. Thank you for mentioning that. Of course, we all want as a big partner have the financial and the manpower to do more than biotech is doing. So a partner -- a larger partner will be able to do not only maybe make the development faster, but also broader Luytix has, of course, limitation hole money different indications we can develop in. But we see this technology as a very large commercial potential in a number of indications. And with a partner on board, you can do a much broader development. So I think that's the core element we would like to see in a partner with the manpower and resource to really accelerate in a broader fashion development.

And on your second-generation drug, how much do you expect the Phase I study will with LTX 401 are you planning to cost?

Cover the cost?

Yes. What is the cost related to...

We're planning to start 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. But 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, and 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.