Good afternoon, and welcome to Lytix Biopharma's Q2 2026 presentation. Before I walk you through the agenda, let me set out where this company now stands and what our strategy is, because the second quarter changed the picture for Lytix. We have received feedback from the FDA that clears the path to a registrational phase III study of ruxotemitide in combination with pembrolizumab in high-risk resectable melanoma. The central question for our lead asset, ruxotemitide, is no longer unanswered. We have a defined registrational path, and our strategy from here has three parts. First, we continue the registrational enabling work to ensure the program remains partner-ready. Second, we are actively pursuing partnerships to fund and execute the study and evaluating alternative options to advance the program.
A global registration study of this kind requires capital well beyond our current resources, and regulatory clarity of this type is precisely what the potential partner requires before committing the capital. Third, we continue to broaden the clinical evidence based behind ruxotemitide with two investigative-initiated studies at limited cost to Lytix. NeoLIPA top-line results in the second half of this year and the new investigator-led ALETTTA study, which extends us into the second standard of care regimen in neoadjuvant melanoma. Everything you will hear today is related to that strategy. A defined path to registration, a partnering process to fund it, and a widening of clinical data to support it. With that, 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.
Then we will take you through the highlights, including the feedback from the FDA on our proposed registration study in melanoma, the new investigator-initiated study, ALETTTA, and the continued progress with our partner, Verrica, in basal cell carcinoma. After that, I will introduce our new Chief Business Officer, Timothy Herpin, who joined us in August and who leads our partnering process. Finally, Gjest will present the financial results and our capital position before we open the floor for questions. Let me briefly introduce the team for today's meeting. I'm Øystein Rekdal, CEO and Co-founder of Lytix Biopharma. With me today is our CFO, Gjest Breistein, and our Chief Business Officer, Timothy Herpin, who I will introduce properly a little later in the presentation. Our Chief Medical Officer, Karim Benhadji, continues to lead the clinical program and the regulatory dialogue we will discuss today.
Karim's role is to ensure that our trial design or regulatory strategy and our clinical execution meet what the regulatory authorities and future partners expect. The FDA feedback we recently received is a direct result of that work. 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 medicine chemistry studies, we generated the shorter peptide ruxotemitide, a chemically modified peptide of just nine amino acids. Its 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 program is in late-stage preclinical development, and we are preparing for clinical entry in 2027.
Let us look more closely at how our drug candidates work because their mechanism address some major challenges in current cancer therapy. Lytix Biopharma has built an innovative oncolytic molecule platform with molecules that work through a two-step mode of action. First, our drugs kill cancer in a way that destroys their cell wall. This result in exposure of mutated proteins or tumor antigens that can be recognized by the immune system. Second, molecules that stimulate the immune system are also released from the destroyed cancer cells. This two-step event is followed by activation of immune cells that target cancer cells that have not been killed by the drug directly, which results in further cancer cell death and durable anticancer effects. This mechanism, local destruction followed by systemic immune activation, make our molecules ideal for being used before surgery.
Before surgery, the tumor is still present and can serve as a powerful source of mutated proteins or tumor antigens. These slides clearly illustrates the power of the two-step mode of action. In the left panel, injection of ruxotemitide in this patient's tumors resulted in cancer cell killing and complete tumor regression of all the treated melanoma lesions. In the middle panel, you see a distant cancer lesion that was never injected, which still regressed completely over time. This is what we define as an abscopal effect, and it's happening due to activation of the patient's own immune system. Importantly, the response were durable in some patients beyond 24 months. The overall safety profile in ATLAS-IT-05 was manageable and consistent with what is expected from local immunotherapy and pembrolizumab.
I would remind you that these patients were heavily pre-treated and already failed to respond to prior immunotherapy and had a poor prognosis. The final results were presented at AACR in San Diego in April, and pooled data from ATLAS-IT-03 and ATLAS-IT-05 in melanoma and in triple-negative breast cancer were presented at ASCO in Chicago on May 30th. In the NeoLIPA study, the same combination is used in a neoadjuvant setting, which means treatment before surgery. It is an ongoing investigator-initiated phase II trial led by Dr. Henrik Jespersen at The Norwegian Radium Hospital, evaluating intratumoral ruxotemitide plus pembrolizumab in patients with high-risk resectable melanoma. The interim data presented at the Nordic Melanoma Meeting were encouraging. Among the first nine evaluable patients, 88% achieved an overall pathological response, including 55% with a major pathological response and 44% with a complete pathological response.
There were no relapses reported at that time of the interim analysis. In the neoadjuvant setting, complete pathological response is an important indicator of antitumor activity and can correlate with longer-term outcomes. For reference, the SWOG S1801 study, which established the benefit of neoadjuvant pembrolizumab, reported a pathological complete response rate of 21%. Enrollment is progressing well with 85% of planned patients included as of August, and top-line results remain on track for the second half of 2026. How could ruxotemitide potentially be used in future clinical practice? There are currently no approved drugs for the neoadjuvant treatment of high-risk resectable melanoma, but two regimens are considered standard of care in this setting and are included in the practice guideline in both the U.S. and Europe: nivolumab plus ipilimumab and pembrolizumab.
These regimens have improved outcomes for patients, but many patients still relapse, and there is still room to improve long-term outcomes. Our goal is not to replace immune checkpoint inhibitors. Our goal is to make them work better. Ruxotemitide has the potential to activate many immune cells that can attack cancer cells. Immune checkpoint inhibitors release brakes on these immune cells so they can attack and kill cancer cells elsewhere in the body. Ruxotemitide works like a cancer vaccine, but it is made inside the patient from the patient's own cancer. Immunotherapy has to do two things. It has to show the immune system what the tumor looks like, and it has to alert the immune system. Ruxotemitide does both and uses the tumor itself as a vaccine. That is why we treat before surgery.
Here you see the status of our pipeline. ATLAS-IT-05, our combination study of ruxotemitide plus pembrolizumab in anti-PD-1 and PD-L1 refractory melanoma, is completed and provides promising results. NeoLIPA, our phase II neoadjuvant melanoma study, is ongoing and progressing well, and it is now supported by a defined registration plan, which we will come to shortly. A second phase II study in neoadjuvant melanoma, ALETTTA, is designed and conducted independently by the Netherlands Cancer Institute and the European Institute of Oncology. That study is due to start in early 2027, and we will come back to it later in the presentation. Through our partner Verrica, ruxotemitide, known as VP-315 in their programs, has completed phase II in basal cell carcinoma, and Verrica is preparing for a phase III program. LTX-401 is in late-stage preclinical development. We are continuing preclinical activities with clinical entry planned for 2027.
I will now hand over to Karim, who will spend two minutes on some promising news in our field in August, which is highly relevant for our technology.
Thank you, Øystein. Indeed, very exciting news. Moderna and Merck & Co. reported that in a study with over 1,100 melanoma patients, adding a personalized cancer vaccine on top of standard immunotherapy following surgery reduced the risk of cancer relapse. This is the first large success of its kind. There was a very positive market reaction that tells you what investors think of the biology. Moderna's share price more than doubled that day of the announcement, adding roughly $30 billion of value in a single day. I want you to be clear that a reaction of that size in a large company is not something you can translate directly to Lytix. But the core principle they proved here is the principle we are built on. The difference is how you do it.
Their approach requires a vaccine designed and manufactured for each individual patient based on a selection of predicted tumor antigens or mutated protein fragments. Our approach is off-the-shelf product injected into the tumor that will lead to killing the tumor and releasing the patient-own tumor material. The whole repertoire of mutations, not a subgroup of it, not a selection. It is simpler to make and available to any patient. Next, please.
Yeah. We turn on to the highlights of the quarter and the period after the quarter end, and Karim will continue on the great news.
Thank you, Øystein. This is the most important slide in the presentation today. In July, we had a meeting with the FDA in the U.S. to discuss our planned registrational trial of ruxotemitide in combination with pembrolizumab in high-risk resectable melanoma. The FDA raised no objection to the general design of the proposed randomized, open label Phase III trial of neoadjuvant ruxotemitide plus pembrolizumab against pembrolizumab alone. The FDA also raised no objection to the event-free survival as the primary endpoint of the trial, nor to the single agent pembrolizumab as the comparator. The FDA further stated that a single and well-controlled trial may be sufficient evidence to support registration and approval of ruxotemitide in combination with pembrolizumab. The final determination of approvability from the FDA will depend on the totality of the data that submitted for the New Drug Application.
Let me explain why this matters in few points. First, the core design now is settled in its main elements. The size, the comparator, and the primary endpoint can be fixed, which means the scope, the cost, and the duration of the registrational Phase III trial can be planned with great precision. Second, the primary endpoint event-free survival is an established regulatory endpoint in neoadjuvant setting, and the control arm, as discussed previously, is one of the established standard of care in neoadjuvant melanoma. Finally, one trial rather than two. A single well-designed, controlled Phase III trial may provide substantial evidence of effectiveness, subject obviously to the totality of the data to support the registration in this setting. This is the most capital-efficient route to the market.
We now have defined the registrational plan, and we have a much clearer basis for partnership discussions intended to fund it. We are continuing registrational activities to keep the program partner-ready, and activities include protocol finalization, CRO evaluation, and site selection, while we are also actively pursuing partnerships to fund and execute the study and also evaluating alternative options to advance the program. As mentioned by Øystein earlier, we have also announced a new investigator-initiated study. We are adding a second clinical study in ruxotemitide program in neoadjuvant melanoma. Ruxotemitide is now included in the ALETTTA study as an investigator-initiated multi-arm Phase II study in patient with resectable Stage 3 melanoma. The study is designed and conducted independently by the Netherlands Cancer Institute and European Institute of Oncology and is led by Professor Christian Blank.
Professor Blank is a global key opinion leader and one of the pioneers of neoadjuvant immunotherapy in melanoma. His practice-changing trials, including the NADINA trial, have established nivolumab and ipilimumab as standard of care in this disease. The arm relevant for us in this randomized trial is a randomized comparison of ipilimumab and nivolumab, the standard of care alone versus ipilimumab, nivolumab, and ruxotemitide in a biomarker-selected patient who have low interferon gamma signature. Those patients are known to not respond well to standard immunotherapy. Approximately 47 patients will be randomized in that comparison in each arm within a multi-arm study that will enroll over 260 patients in total. The trial is planned to start in early 2027. Let me explain why this matters strategically. As we mentioned earlier, there are two standard of care regimens in neoadjuvant melanoma.
Pembrolizumab that we are pursuing as a comparator as an add-on for our Phase III trial, and ipilimumab and nivolumab. ALETTA will generate the first randomized controlled data in ruxotemitide combined with ipilimumab and nivolumab. The evidence base will span both of standard of care regimens that are used in this setting.
Thank you.
I will hand it over to Øystein.
Thank you, Karim. Let me now connect the evidence base to that regulatory path. Final results from ATLAS-IT-05 were presented on April 20th at the annual American Association for Cancer Research conference in San Diego. Safety and efficacy results with ruxotemitide and pembrolizumab in melanoma and in triple-negative breast cancer were presented on May 30th at the annual American Society of Clinical Oncology conference in Chicago. Presentation at the two major international cancer conferences underlined that these data are strong enough to stand on a global stage, and they provide an important foundation for our discussion with regulatory authorities and with potential partners. NeoLIPA remains the key near-term value driver. Enrollment is progressing well, with 85% of patients now included, and we are on track for top-line results in the second half of 2026. Those results will provide additional phase II data to support the partnering discussion.
Turning to our partner, Verrica, and to the organization, Verrica is preparing for a phase III program with VP-315 or oncolytic ruxotemitide in basal cell carcinoma, including CRO selection and manufacturing of phase III clinical supplies. Verrica had previously indicated a 2026 timeline for initiation of this study, and it no longer guides to a specific start date. The timing of the study initiation is therefore not currently known. New phase II data on May 15th at the Society for Investigative Dermatology showed a 67% overall reduction in untreated non-target basal cell carcinoma lesions and complete histological clearance in 21% of these non-treated lesions following treatment of the injected lesion. These findings provide further evidence of a potential abscopal effect consistent with the data from our own ATLAS-IT-05 study. That is important external validation of ruxotemitide's systemic activity and of its potential in a second cancer indication beyond melanoma.
We also strengthened the leadership team with two key hires during this period. Renée Christine Amundsen joined as Chief Operating Officer in April, and Timothy Herpin joined as Chief Business Officer in August. On the financial side, cash and short-term financial investment amounted to 91.4 million NOK at the end of the second quarter, supporting continued execution of our key value-driving activities. Gjest will take you through the details shortly. Before we turn to the financial, I would like to introduce our new Chief Business Officer. Timothy Herpin joined Lytix in August to lead our partnership discussion as we advance toward the registrational study. He brings more than 20 years of business development experience in biotech and pharmaceuticals, with strategic partnering and transaction across oncology and infectious disease.
With regulatory clarity now in hand, the partnering process becomes an important value-creating activity in front of this company. It was important for us to bring in a leader with exactly that background at exactly this point. Timothy, could you please say a few words?
Thank you, Øystein. I joined Lytix because of the combination of a differentiated mechanism, clinical data in two independent indications, and now a defined registrational path in high-risk resectable melanoma. This is a compelling package to bring to prospective investors and partners. My focus is straightforward, to find business development opportunities that unlock value for ruxotemitide and lead to the funding and execution of the registrational study, and then subsequently approval and commercialization of the product. Those discussions are ongoing, and we will update the markets as they progress. Back to you, Øystein.
Many thanks, Tim. With that, I will now hand over to our CFO, Gjest Breistein, who will take you through the financial result and outlook.
Thank you, Øystein. Before I turn to the numbers, I want to say something about what they represent. The second quarter was one of the most important quarters in the company's history. Following our meeting with the FDA, the agency raised no objection to our proposed randomized phase III trial. I want to be clear about what that means, because it is easy to understate. We went into that meeting not knowing whether we would be asked to run another phase II first. We came out with a defined path to a registrational study. That is a step change for this company. It did not happen by itself. It is a result of a company-wide effort over several quarters, clinical, regulatory, CMC, and manufacturing work carried out in parallel. Total operating expenses for the second quarter were NOK 26.8 million.
That is essentially unchanged from the first quarter, which was also NOK 26.8 million. The comparison against the second quarter of last year needs one qualification. That quarter shows only NOK 5.2 million because we reversed NOK 10.2 million of ATLAS-IT-05 accruals. Adjusted for that reversal, the second quarter of 2025 was around NOK 15.4 million. The real year-on-year increase is meaningful, but it is not the fivefold jump the reported figures suggest. Direct R&D was NOK 15.9 million, the largest single component. This is the line where the FDA outcome lies. It covers the closeout and the final reporting of data, less ATLAS-IT-05 study, and also the clinical, regulatory, and CMC work that went into the FDA submission. For the first half as a whole, operating expenses were NOK 53.6 million, and the loss for the period was NOK 52.6 million. I would put it this way.
We invested a defined amount of capital in the first half of the year, and what we bought with that was regulatory clarity on the fastest available route to registration. That is the return on the spend. Two things to take from the left-hand chart. First, the step-up happened in first quarter and has held. The two quarters are flat. Second, direct R&D is the largest component in both, which tells you where the money is going into the program and not into overhead. On the right-hand side, cash and short-term investments were NOK 91.4 million. At the end of June, against NOK 120.2 million at the end of March. Operating cash outflow was approximately NOK 29 million in each of the first two quarters. Let me be straightforward about what that means. On the current run rate, that is a runway of roughly three quarters.
A couple of things are worth understanding alongside it. First, we are not currently running an expensive clinical trial. NeoLIPA is an investigator-initiated study. The registrational study has not started, so our spending is preparatory work which we control directly quarter by quarter. That is real flexibility and is very different position from a company locked into a fixed cost of running a phase III trial. Second, funding a global registrational study of this kind requires capital well beyond our current resources. Our stated strategy is to advance the study through development partnerships. The FDA outcome is precisely what makes ruxotemitide a compelling proposition for such a partner. We are also preparing to fund the program through equity financing if that is the best route for our shareholders. We are evaluating both, and we are not dependent on either one alone. Turning to the balance sheet.
Total assets were NOK 100.3 million. The balance sheet remains highly liquid, NOK 29 million in cash and NOK 62.4 million in short-term financial investments. Total liabilities were NOK 13.7 million, down from NOK 19.8 million at the year-end. Equity was NOK 86.6 million. Let me close on what this half-year represent financially. We deployed just under NOK 54 million in operating expenses over six months. What we bought was a defined registrational path, the most valuable thing the company could have acquired this year. The financing task ahead is real, and we are working on it with focus. But there is difference between needing capital to fund a defined, regulatory-endorsed program and needing capital to find out whether you have one. We firmly are in the first position. To our knowledge, no Norwegian immuno-oncology company has taken a proprietary asset into phase III regulatory study.
Subject to securing a necessary funding and completing the remaining regulatory and operational preparations, we believe Lytix could be the first. Øystein will now take you through what that path look like across the pipeline.
Thank you, Gjest. Let me summarize where this leaves us. In melanoma, the FDA raised no objection to our proposed phase III design with event-free survival as the primary endpoint and stated that the single registrational study may support a New Drug Application. Registrational enabling work is advancing on plan, as we have heard, and NeoLIPA top-line result remained on track for the second half of 2026. We have also added a second opportunity in melanoma through the investigator-initiated ALETTTA study, which is due to start in early 2027 and will generate the first randomized data for ruxotemitide in combination with ipilimumab and nivolumab. For both these investigator-initiated studies, the ongoing NeoLIPA study and the planned ALETTTA study, the majority of costs are covered by the study sponsor, enabling Lytix to generate highly relevant clinical data for ruxotemitide in a cost-efficient manner.
In basal cell carcinoma, Verrica is preparing for Phase III program, including CRO selection and drug manufacturing. Following the recent FDA feedback in melanoma and our discussion with Verrica in BCC, Lytix will continue to work both internally and with Verrica to maximize the commercial potential of ruxotemitide across all skin cancer indications for the benefit of the patient. Beyond the ruxotemitide, LTX-401 continues in preclinical activities with clinical entry plan for 2027. Our strategic focus is clear and unchanged. Our strategy is to actively pursue partnerships to fund and execute the registration study and to evaluate alternative options to advance the program to generate and to generate supportive clinical data that strengthens those discussions and to maintain the disciplined capital allocation that has brought us up to this point.
With FDA feedback that clears the path, a strengthened organization, and a defined route to approval, Lytix enter the second half of 2026 from a meaningful, de-risked position. Thank you. With that, we will open for the Q&A session that will be led by Petter Tandberg.
Thank you, Øystein, and all the presenters for a good presentation today. I will start off the Q&A with Verrica that we had some questions on here. You addressed this in the presentation, Øystein, but I will start off with this here. Verrica has provided limited details on its phase III timeline since announcing preparation. When should investors expect a clear readout on Verrica's progress, and what visibility do you currently have into their program?
Verrica report independently their progress with VP-315. They have reported that the first half of year 2026, they have been focusing on CRO selection and manufacturing of the phase III clinical supply. They have earlier indicated start of phase III in 2026, and at the moment, we have no specific date for when the phase III will start. We expect that Verrica will announce that as soon as that is concluded.
Thank you. On the point of Verrica, there is another question here. This might go to you, Gjest. What does lack of or delay of milestone payment for starting VP-315 mean for the investment strategy and capital need for Lytix?
Thank you. For our budgeting, we never use uncertain milestone payments as a source of funding. With our current strategy, we haven't really put that into consideration. The timing of it would not affect what we are planning to do further.
Thank you. There's also some questions here on the recent developments and results in the immunotherapy space. Maybe this goes for you, Karim. Has the positive Moderna results had a positive effect on the investor and pharma sentiment for neoadjuvant oncology treatments?
Thank you. The results from Moderna trials where they are not really available, but the announcement is highlighting a big win for personalized vaccines. This is the first of its kind that we discussed, and it's really changing the sentiment overall melanoma and immunotherapy approaches. It really covers the whole field in melanoma. In neoadjuvant specifically, we have already established the standard of care pembrolizumab or nivolumab and ipilimumab provided the proof that it can improve the outcome of patients. The approach of Lytix with vaccination approach by releasing the antigens before surgery might lead to a good outcome. We have to prove it with the phase III. But overall, the sentiment in immunotherapy for melanoma and for personalized vaccines have completely changed with the announcement from Moderna.
Great. Thanks. Also here a question on the new ALETTA study. I'll give this to you, Gjest. ALETTA is an investigator-initiated study beyond supplying drug product. What costs will Lytix bear for this trial? Are those already built into your current cash runway, or could they represent an unbudgeted draw on it?
We have already budgeted for the cost for the ALETTA study. All in all, the cost for the ALETTA study is very limited. It is an investigator-initiated study. What we are going to pay is going to be timed over the course of the actual study. So there's not going to be a big impact on our cash position.
And continuing on ALETTA. Can you say something and when you will expect to get top line from the ALETTA study?
Maybe, Karim, you are more into detail about the trial itself, how long it will be ongoing. I have some idea, but I think you can give a bit more accurate answer to that.
So yeah, it's a bit too early to comment on that. As we mentioned, the trial is about to start beginning of next year. There are different analysis that are embedded in the study that includes interim analysis that will show some readouts. So we would expect that the first readouts from the study might come in 2028. But again, this is really high-level, and the study hasn't been reviewed by regulatory authorities yet and haven't started yet. But just to give you an idea.
Good. Thanks, Karim. There's also here a few questions on the registrational phase III trial. Obviously, as you mentioned, the key part of that is pursuing it through a partnership. There's some questions here on that. Maybe Tim, you could say something about what you expect for a timeline in terms of securing partnership agreements and elaborate a bit on that.
Yeah. We are not going to speculate on timeline for discussion. As you know, these are typically uncertain and confidential. What we can say is we are having active discussions, and we will provide further information when the timing is right.
Thank you. We also have a question on the financing options and cash runway. Gjest, what can you say on the current cash runway and financial position?
Yeah. Already addressed in the presentation, we have estimated cash runway of approximately three quarters with the current spend. We do not have any exact financing plans for the moment. We are considering different ways to fund the preparation phase and the clinical trial, both via partnerships and equity. We will come back to the market when there is something accurate to say.
Thank you. That is all we have time for today. I will leave the word quickly back to you for some closing remarks.
Thank you, Petter. Thank you for listening in on today's Q2 reporting. We hope you share some of the enthusiasm we have for really taking a big step forward with no objection for FDA clearing the path for a registrational study. That can mean also seeing the horizon of a drug on the market if we come to positive with that study. I also think it's very positive to see that the really expert in the field are really open and inviting us for participating in their study. I think it's also very important for you shareholders that we are doing studies that are quite cost efficiently, but still give us very relevant clinical data to the package we bring forward with ruxotemitide. With that, I will say thank you for listening in.