Good afternoon and welcome to Lytix Biopharma's Q3 2026 Presentation. We have a great deal of positive progress to share with you today. Recent months have brought an important clinical milestone, progress in our regulatory preparations, and new opportunities to broaden the development of ruxotemitide. Our phase II NeoLIPA study with ruxotemitide and pembrolizumab before surgery in melanoma, we are very pleased to see that the study met its primary endpoint of pathologic complete response and that the results will be presented orally at ESMO IO. Our focus now is to build on this momentum and translate it into the next stage of development. Our strategy has three clear priorities. First, we are progressing the study protocol, CRO selection, and site assessment to ensure that the phase III program is well prepared for execution with a partner.
Second, we are actively engaging with potential partners on funding and conducting the registration study. Our recent clinical progress provides a stronger foundation for those discussions. Third, alongside NeoLIPA, the investigator-led ALETTA study planned for early 2027 will evaluate ruxotemitide with another established immunotherapy regimen. This will help us to explore its potential across different treatment combinations in neoadjuvant melanoma. Together, these priorities give us a clear direction, advance towards registration, secure the partnership to support that development, and continue building evidence for ruxotemitide's potential. With that, let me briefly outline today's presentation. We will begin with the science, how ruxotemitide works, and why its mechanism is particularly relevant to treatment before surgery. We will then review our key highlights, and finally, Gjest will present our final financial results and 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, and with me is our CFO, Gjest Breistein, and our CMO, Karim Benhadji. Now I will hand over to Karim, who will walk you through our approach to melanoma.
Thank you, Øystein. Neoadjuvant treatment means giving therapy before surgery. For resectable melanoma, two immunotherapy regimens are listed in the guidelines as standard of care. The first one is nivolumab plus ipilimumab, which blocks two immune checkpoints, PD-1 and CTLA-4. Patients receive two cycles before surgery, and further treatment after surgery is guided by how the tumor responded to treatment. The second regimen is pembrolizumab, which blocks PD-1. Patients receive three doses before surgery, and pembrolizumab continues after surgery. These regimens have improved outcomes for patients, but there is still room to deepen responses and prevent recurrence, and that is what we focus on. Ruxotemitide is designed to work in neoadjuvant setting, meaning before surgery, in three steps. Step one, we inject ruxotemitide directly into the tumor. This causes tumor cells death and exposes the tumor antigen to patient own immune system.
The second step, the antigens are taken by the antigen-presenting cells, which primes T-cells against cancer. The checkpoint inhibitor then release the brakes, and those T-cells can attack the tumor cells. The last step, the tumor is removed after the immune system has been primed, with the aim of reducing the chance of recurrence. The key idea is timing. Before surgery, the tumor is still there to serve as a source of antigens, and we use the patient's own broad range of tumor antigens. Timing really matters for a second reason. Earlier in the course of the treatment, the patient immune system is more responsive than in advanced disease, so it's better able to mount a stronger immune response. That is what we aim to take advantage by priming immunity before surgery. Merck and Moderna are also pursuing antigen-primed immunity in melanoma with intismeran autogene.
Let me be clear about how the two different approaches differ. Merck Moderna vaccine is built from 34 antigens selected by sequencing the patient tumor. Ruxotemitide exposes a broad range of patient-owned tumor antigens. Also, ruxotemitide is an off-the-shelf peptide injected into the tumor with no patient-specific manufacturing, while intismeran autogene is individualized mRNA product made for each single patient. The timing differs as well. Merck Moderna vaccine is given after the surgical removal of the tumor, while ruxotemitide is given before surgery, when the tumor is still available for injection and immune priming. Here you see the status of our pipeline. ATLAS-IT-05, our combination study of ruxotemitide plus pembrolizumab in PD-1 and PD-L1 refractory melanoma is complete and fully reported, and it provided promising results.
NeoLIPA, our phase II neoadjuvant melanoma study of ruxotemitide in combination with pembrolizumab met its primary endpoint, and the results will be presented at ESMO IO in December. It is now our lead program moving toward a registrational study in advanced, in resectable melanoma. ALETTA, a phase II study of ruxotemitide with ipilimumab and nivolumab in neoadjuvant resectable melanoma is planned to start in the first quarter of 2027. Through our partner, ruxotemitide has completed phase II in basal cell carcinoma. And finally, LTX-401, our small molecule for solid tumors in deep-seated lesions, is preparing for phase I as single agent and in combination. With that, I will hand it back to Øystein for Q3 updates.
Thank you, Karim. Let's now turn to the highlights from the quarter and the period after quarter- end. I will start with NeoLIPA, which is our phase II study of ruxotemitide plus pembrolizumab before surgery in resectable melanoma. I'm pleased to report that NeoLIPA met its primary endpoint of pathologic complete response, or pCR. Pathologic complete response means that after treatment, no viable tumor cells were found in the tissue removed at surgery. The pCR rate met the protocol's pre-specified success criterion of at least 40%, and no new safety signals were identified. We are also now pleased to report that all 27 patients are enrolled in the study. A late-breaking abstract has been accepted for oral presentation at ESMO Immuno-Oncology in London on December 15th.
This is a very strong recognition that we have achieved clinical results that are relevant to the global cancer research community and show that the quality and relevance of the study is recognized by international oncology experts. Looking ahead, ALETTA is on track to start in early 2027. This is a multi-arm phase II study in resectable stage III melanoma led by Professor Christian Blank. If it validates ruxotemitide with ipilimumab and nivolumab, ruxotemitide would be positioned for combination with both standards of care backbones in the neoadjuvant melanoma. Christian Blank is one of the leading experts in using immunotherapy before surgery in melanoma, and we are very proud to be invited to participate in this study led by Dr. Blank. The second highlight is the FDA feedback which outlines the path to U.S. approval.
The FDA has confirmed that a single well-designed phase III study may be sufficient to apply for market approval in the U.S., depending on the overall results. The FDA raised no objection to our proposed design, ruxotemitide combined with pembrolizumab compared with pembrolizumab alone, given before surgery in melanoma patients at high risk of the cancer returning. With NeoLIPA meeting its primary endpoint, the basis for moving into phase III is stronger. Work is progressing on the study protocol, the selection of a CRO, which is the company that will run the trial, and the assessment of clinical sites. Verrica announced at their earnings call presentation yesterday that they are exploring the development of ruxotemitide for patients with Gorlin syndrome. Gorlin syndrome is a rare inherited condition that causes a very high number of basal cell carcinoma lesions and repeated surgery.
According to Verrica, a proof-of-concept study could clarify VP-315's role in multiple lesion BCC, in addition to the ongoing BCC program with more sporadic and fewer BCC lesions. Turning to our business and financial highlights, we have made progress in strengthening both our team and the development of our technology. In August, we welcomed Timothy Herpin as the Chief Business Officer. His appointment strengthened our business development capabilities as we advance our partnering strategy and prepare for the next phase of Lytix's development. Following the quarter- end, we are also pleased to be awarded NOK 12 million by the Research Council of Norway, thanks to a great effort by our team. This grant will support the development of formulation of our oncolytic molecules for intratumoral injection, helping us further develop the potential of our platform.
Finally, we ended the third quarter with NOK 67.3 million in cash and short-term investments. These resources support continued execution of our key activities, with a clear focus on the milestones that offer the greatest potential to create value. I will now hand over to Gjest Breistein, our CFO, who will take you through the financial results.
Thank you, Øystein. Before I go through the numbers, let me say why I am very excited about where Lytix is today and why I believe in this company. As the CFO, I look for evidence outside the company. This quarter gave us three pieces of it. First, NeoLIPA met its primary endpoint, making it a successful trial. Second, the results have been accepted for an oral presentation at ESMO IO. It tells us that our data are attracting the attention of the specialists who matter the most in this field. Third, the Research Council of Norway has awarded Lytix NOK 12 million through its IPN program. That is a competitive process. The funding is non-dilutive, and it supports the new formulations of our molecules. Taken together, the data are getting external recognition.
We are generating them in a capital-efficient way, and that is the context for the numbers I will show you now. Total operating expenses were NOK 27.9 million in the third quarter, compared to NOK 26.8 million in the second quarter and NOK 24.3 million in the same quarter last year. The year-on-year comparison needs one qualification. Last year, the third quarter included NOK 11.8 million in non-cash share option costs. This quarter, it was NOK 3.2 million. Excluding those, operating expenses were NOK 24.8 million compared to NOK 12.5 million a year ago. That increase is almost entirely direct R&D expenses, which was NOK 14.3 million for this quarter and NOK 4.8 million last year. This is the cost of preparing the phase III. Protocol work, CRO, and preparation of sites and manufacturing. Net financial items were positive with NOK 1.8 million.
Of this, NOK 0.9 million is an unrealized gain on our money market funds that relates to the second quarter and should have been recognized then. It has no cash effect, and the nine-month figures are correct. The loss for the period is NOK 26.1 million. On the left, you can see that the quarterly cost stepped up at the start of the year when we began the preparing for the phase III and have been stable since. Direct R&D cost is the largest component. On the right, cash and short-term financial investments were NOK 67.3 million at the end of September compared to NOK 91.4 million at the end of June. Cash burn in the quarter is NOK 24.1 million compared to around NOK 29 million in each of the first two quarters. At the current run- rate, our cash funds operations into second quarter of 2027.
Two points alongside that. First, NeoLIPA and ALETTA are investigator-initiated, with the majority of the cost carried by the sponsor, and the phase III has not started. Most of what we spend is preparatory work that we control quarter- by- quarter. Second, the IPN grant is non-dilutive funding. It does not change the bigger picture, but it is exactly the kind of capital we want more of. The balance sheet is simple. Liquid assets of NOK 67.3 million make up close to 90% of the total assets of NOK 75.8 million. Of this, NOK 54 million sits in low-risk money market funds that we can draw on a short notice. Liabilities have come down to NOK 12.1 million from NOK 19.8 million at year- end. And we have no interest-bearing debt other than leases. Let me close with why I believe in Lytix.
We have a drug candidate that has met its primary endpoint. We have FDA feedback indicating that a single phase III study may be enough to apply for approval in the U.S. We have data that the oncology community has chosen to hear in an oral session, and we have built this position with a cost base that is stable and directed towards the program. Starting the phase III will require capital beyond our current resources. That is the task ahead of us. There's a big difference between raising capital to take a drug with positive phase II data along a defined regulatory path and raising capital to find out whether you have one. We are in the first position. Specialist investors and partners follow the data.
Our data are now drawing their attention, and our job over the coming months is to turn that attention into the funding the Øystein will now summarize where this leaves us across the pipeline.
Thank you, Gjest. Lytix enters the final weeks of 2026 with strong clinical momentum and a clearer regulatory path for our lead program. We have made important progress, and we now have a stronger foundation for the next stage of the company's development. In melanoma, our phase II NeoLIPA study met its primary endpoint. Alongside with this, FDA feedback indicates that a single well-designed study may be sufficient to support an application for U.S. market approval, depending on the overall results. Together, these developments strengthen the basis for advancing ruxotemitide into phase III and give us a clear direction for our development and partnering activities. Our next major milestone is the late-breaking oral presentation of the NeoLIPA results at ESMO in London on December 15. This is an important opportunity to bring our data directly to the international oncology community and support further discussion with potential partners.
I'm very much looking forward to sharing these results. Looking ahead to early 2027, ALETTA will evaluate ruxotemitide in combination with ipilimumab and nivolumab. This complements our phase III plans with pembrolizumab and could broaden ruxotemitide's future role across two key treatment backbones in neoadjuvant melanoma. In basal cell carcinoma, our partner, Verrica, is exploring a study in VP-315 in patients with Gorlin syndrome. These patients can develop many BCC lesions over their lifetime and face the burden of repeated surgery. This represents a potential extension of the BCC program into a population with unmet needs. Beyond ruxotemitide, we continue to prepare LTX-401 for phase I, bringing forward the next opportunity within our platform. Our strategy is focused with disciplined use of capital. We are advancing the phase III preparation to keep the program partner-ready while pursuing discussion on how the study package can be funded and delivered.
With that, we go for a Q&A session.
Thank you, Øystein. First question here, let me see, is on ESMO. Can you explain more on what it means for Lytix being selected for late-breaking oral presentation at ESMO IO?
Yeah. During the last few years, Lytix has matured into a very de-risked company with a very robust platform. With the positive melanoma data, we are also considering entering into additional large cancer indication like breast cancer and head and neck cancer. External commercial assessment indicates a multi-dollar billion potential within these three indication. Our second asset, LTX-401, which is based on the same mode of action, is also de-risked based on ruxotemitide's data and has the potential to target more deep-seated cancer like liver cancer and lung cancer, et cetera. In just a few weeks, we will present our data at ESMO IO, which is a big milestone for us where we really can discuss this with oncology expert, meet partners, and really get the feedback on how this stands according to other studies.
And of course, again, being invited for late-breaking abstract is really an honor and means also we have something very strong, interesting results to be shared within the oncology community and the experts. This give us a strong confidence that we are really on the track to develop potential treatment for future cancer therapies.
Thank you, Øystein. Second question here, I think that maybe goes to you, Karim. Does NeoLIPA prove that ruxotemitide adds benefit to pembrolizumab?
We communicated that NeoLIPA phase II has met its primary endpoint as designed. We are not able to comment on the full results yet. The trial also is a non-randomized trial. From the medical standpoint, to confirm results, we need to run the trial, the phase III trial. Our aim is built on the results of the phase II from NeoLIPA to move forward, confirm the result in a registration of randomized trial that we have discussed with the FDA this summer.
Sounds good. Thanks, Karim. On the financials side, maybe for you, Gjest, how long runway do you have, and does that cover phase III?
Thank you. At the end of the quarter, we had NOK 67.3 million in cash and short-term financial instruments, and that will bring us through into Q2 2027 with the current activity level. For Q3, the cash burn rate was NOK 24.1 million, a bit down since the previous quarter. The current run- rate does not include a global phase III trial. That we need more funds for. We are working on multiple fronts, both trying to secure a development partnership, but also look at how we can secure equity financing to move the program further.
Thank you. Then there's another question here. Karim, this one maybe is for you. Can you tell us how many patients were evaluable in NeoLIPA and whether the rate is in line with the 44% interim?
I'm not able to comment on that. What we say today is that the study has completed enrollment, and the results will report on the evaluable population. The results as of now are under embargo by ESMO, and we have to comply with those, and we will be able to share with you the full details in a few weeks in London. We'll be happy to discuss further in details once the results, once the embargo is lifted.
Sounds good. Thank you. Øystein, how have partnering discussions around the planned phase III developed since the readout?
Yesterday I'm coming back from BIO-Europe together with our CBO, Tim Herpin. There are good dialogues, and we use this momentum up to ESMO IO. Of course, when the results are released and discussed among oncology experts, we will take the opportunity at ESMO to meet with partners, but also preparing for JP Morgan in San Francisco in early January, which is the largest industry health conference. We are really using the momentum now in partner activities, starting quite intensively last week. We have an intensive period and positive period in front of us, so we will take all opportunities with the momentum we now have.
Great. Thank you. A final question here. What will be the biggest value driver for Lytix over the next 12 - 24 months, and which specific milestones will unlock that value?
Of course, the biggest value driver for us is now based on the NeoLIPA to move forward for phase III. Starting phase III in melanoma will absolutely be the most important value driver. In addition to that, a near-term, for us, big value driver is, milestone, is the presentation in four weeks in London. Also, starting the phase II study in combination with Ipi/Nivo, together with Christian Blank, in early 2027, will show us or indicate the opportunity to broaden the use of ruxotemitide in broader population in melanoma, resectable melanoma. Of course, later next year, moving into starting, preparing for starting the phase III. For one, also, we are working to prepare for a clinical entry late 2027, early 2028.
We are also a big, important value driver for us is really to continue the partnering discussion we started last week and really try to find partners and alternative ways to fund the phase III study, which is quite costly. That will be a very, very important process and value driver for us.
Perfect. Thank you. I'll give the word back to you, Øystein, for some closing remarks.
Yeah. Thank you for joining us today, and especially to the longstanding shareholders, for your patience and committed continued trust. We do not take that support for granted, and our team is determined to translate our science to treatment, better treatments for patients, and lasting value for you. We are entering into a very new, important chapter and look forward to sharing our results at ESMO IO, and I would like to inform you that we plan to have a webcast after the ESMO IO to really share the data, the feedback, and put it into context. We will come back to that in detail. Stay tuned. Thank you for today.