Good morning, and welcome to Lytix Biopharma's third quarter result presentation. We thank you for taking the time to join us today. This quarter has been very active in terms of clinical data readouts, and I'm excited to share the most recent data with you today. We have continued to operate with discipline and purpose as we prepare for a period of key clinical milestones in 2026. These milestones will guide the path forward for Lytix Biopharma, and I'm excited to walk you through where we stand today and what lies ahead. My name is Øystein Rekdal, and I'm the CEO and co-founder of Lytix Biopharma. With me today is our CFO, Gjest Breistein , who will later take you through the financial results and outlook. Before presenting the highlights, let me introduce you to our company, our technology, and the clinical progress we have made.
Lytix Biopharma has built an oncolytic molecule platform that overcomes immunosuppression within the tumor microenvironment via a two-step mode of action. First, the drugs destroy the membranes of cancer cells, which releases both tumor antigens and potent immunostimulatory molecules. This is followed by activation of immune cells that target cancer cells that have not been killed by the drug directly. The result is death of cancer cells and a broad and durable anti-tumor immunity. For patients, this means not only are their tumor cells killed, but their immune system remembers how to fight the cancer to also kill metastases and ultimately prevent tumor recurrence. Our oncolytic approach has been clinically validated across multiple skin cancers, both as monotherapy and in combination with immune checkpoint inhibitors, and has the potential to redefine the standard of care for patients prior to surgery.
Today, Lytix Biopharma is approaching the commercialization of our first asset, ruxotemitide, and is expanding our pipeline with our second asset, LTX-401. Our molecules are highly synergistic and safely combinable with immune checkpoint inhibitors, the current standard of care for many cancers. Our vision is to bring our drugs to patients early in their treatment journey prior to surgery to allow their immune systems to continue to fight the cancer long after it has been removed. Utilizing immunotherapy in early cancer treatments is gaining momentum in the industry, and Lytix is positioned to be first in class. As many of you are aware of, the common standard of care for resectable tumors involves surgically removing the tumor together with immune checkpoint inhibitor therapy. There are two reasons why this approach does not work optimally.
One, surgical removal of a tumor comes with a high risk of recurrence since the immune system has limited anti-tumor immunity. Two, the highly immunosuppressive nature of many tumors results in a modest pathological response to immune checkpoint inhibitors. At Lytix, we can do better. Our approach to treating patients with resectable tumors is to first treat them with our oncolytic molecules to kill cancers within the tumor and to induce a durable anti-tumor response to prevent recurrence and to fight distant metastases, either as a monotherapy or in combination with immune checkpoint inhibitors. We firmly believe this is the best option for patients, as not only do we reduce the risk of recurrence, but we also have primed the patient's immune system to respond to the immune checkpoint inhibitors by overcoming the immunosuppression that causes low response rate. Let's now turn to the Q3 highlights.
Today, we'll be sharing an update on the ongoing phase II study in basal cell carcinoma led by our partner, Verrica Pharmaceuticals. For our investigator-initiated NeoLipa trial, we will describe the recent interim data that was presented at the Nordic Melanoma Meeting. For ATLAS ITO5, we are currently proceeding through the closeout process. For our preclinical asset, LTX-401, we are carefully reviewing development strategy options and optimal timing to enter the clinic. On the financial front, we maintain discipline, cost control, and a stable burn rate. Let's look into the clinical and operational update. Here you see an overview of our pipeline and the status of each program. I will take you through the Q3 updates for each of these programs.
Regarding the completed phase II study in basal cell carcinoma, Verrica Pharmaceuticals has recently reported additional clinical data from its completed phase II study with ruxotemitide in basal cell carcinoma, which strengthens our conviction in the commercial potential of ruxotemitide in this indication. It was earlier reported that all patients experienced a reduction in tumor size, with 51% of the patients achieving complete histological clearance. There was a 71% reduction in tumor size for the remaining half of the patients with residual carcinomas, an 86% overall tumor size reduction, and a 97% overall calculated objective response rate. Recently, Verrica reported that abscopal effects were observed with histological reduction in the size of all non-treated basal cell carcinomas that were studied, which is consistent with broad systemic immune activation that we have observed in other cancers.
Verrica also presented immune data at the Society for Immunotherapy of Cancer's annual meeting in early November. These data demonstrated a strong increase in the density of CD4 and CD8 positive T cells, as well as B cells, all of which support activation of an anti-tumor response within the tumors. Additionally, there was a reduction in immunosuppressive cell population within the tumor microenvironment. These findings are compelling evidence that ruxotemitide, a first-in-class oncolytic peptide immunotherapy, reprograms the tumor microenvironment to increase the infiltration of immune cells and transform an immunosuppressed tumor into an immune-activated one. The mountain of evidence that ruxotemitide is a potent, safe, and well-tolerated cancer immunotherapy continues to grow for superficial tumors such as basal cell carcinoma.
As a part of their Q3 financial report, Verrica has indicated alignment from the FDA to conduct two phase III studies with 100 patients each, both placebo-controlled, with a primary endpoint of complete clearance as assessed at week 14. The potential of ruxotemitide as a non-surgical first-line immunotherapeutic approach for basal cell carcinoma patients is strong, and we remain committed to working alongside Verrica to ensure this breakthrough therapy reaches patients as fast as possible. Moving to our NeoLipa study, the interim data that was presented by Dr. Hendrik Gjest Breistein's team at the Nordic Melanoma Meeting reinforced our belief that resectable melanoma patients who have not received any previous treatment will benefit from treatment with ruxotemitide prior to surgery together with immune checkpoint inhibitor therapy. Neoadjuvant melanoma remains a clear strategic priority indication for Lytix moving forward.
Not only do we have the opportunity to enter a large commercial market with limited competition, but we also have the potential to cure patients and their disease. Whilst the data is limited to the first nine of evaluable patients, the data is consistent with previous findings, and importantly, patients are experiencing both a high overall pathological response rate of 88% on top of a favorable safety profile and complete pathological responses in 44% of the patients. These promising interim results showing responses in the majority of patients support ruxotemitide's ability to be developed for neoadjuvant therapy in combination with immune checkpoint inhibitors. Let's now turn to LTX-401. We strongly believe in the ability of our preclinical asset, LTX-401, to provide a highly differentiated therapy for deep-seated tumors.
We have demonstrated proof of concept in several cancer models, including liver cancer models, and are in the final stages of formulation development for LTX-401, which enables us to move forward into IND-enabling studies. We have received positive regulatory feedback in Europe that supports our clinical path forward, and we are currently assessing clinical development strategies in order to identify the optimal timing and pathway for advancement into the clinic. I will now hand over to our CFO, Gjest, for the financial updates.
Thank you, Øystein. I'll now take you through the financial performance for the third quarter. Q3 was a stable and predictable quarter from an operational cost perspective, with only major deviation coming from the new option program implemented in September. Overall, our financial position remained solid and was well capitalized going through into 2026. The headline item for this quarter was the non-cash share option expense of NOK 11.9 million related to the new option program launched in September. This accounting charge temporarily increases the reported net loss. If we exclude this one-off option cost, the underlying net loss for Q3 was NOK 11.5 million, which is consistent with recent quarters. This reflects our continued cost discipline and a leaner operating base now that ATLAS ITO5 is in its closeout phase. Total operating costs remained consistent with previous quarters when adjusted for the one-off option expense.
Direct R&D expenses of NOK 4.8 million were in line with Q1 and Q2. This reflects a natural shift from the late-stage clinical activity of ATLAS ITO5 towards the startup and enrollment of the NeoLipa study, which continues to progress steadily. Overall, we continue to maintain tight control of operating costs and continue to strategically invest in the most value-accurate assets in the pipeline. At the end of the quarter, cash and short-term financial investments stood at NOK 90 million. Cash flow for the period was primarily driven by ordinary operating activity, with no extraordinary cash items affecting the quarter. With this position, we remain well-funded to deliver in the upcoming clinical milestones, including the NeoLipa top-line readout in 2026 and continued preparations for LTX-401 to enter the clinic.
On the balance sheet, you will see that we have maintained a continued decline in total liabilities, which now stands at NOK 17 million, down from NOK 38.6 million at year-end. This reflects the adjustment to ATLAS ITO5 accruals made in Q2 and the closeout of that study. The balance sheet is now normalized and reflects a company focused on strategic growth as we approach commercialization. Our path to value creation is both strategic and de-risked. Ruxotemitide is progressing towards commercialization via two paths. First, our internal efforts in neoadjuvant melanoma and NeoLipa study. Second, working closely with our partner, Verrica, on bringing ruxotemitide to the market as a non-surgical first-line immunotherapic treatment for basal cell carcinoma. Together, this represents near and mid-term opportunities to establish both clinical and commercial value. With ruxotemitide squarely focused on superficial tumors, we continue to expand into deep-seated tumors with LTX-401.
With strong supportive regulatory feedback and a very strong preclinical data package, we are continuing to assess strategic development pathways for this asset. Our pipeline is focused, our finance is disciplined, and we are positioned to create significant value for our shareholders. Thank you. I'll hand it back to Øystein for closing remarks.
Thank you, Gjest. Before we move into Q&A, I want to take a moment to reflect upon the last quarter and how it has prepared us for a strong 2026. We have now two independent clinical data sets in two different indications that clearly demonstrate the ability of ruxotemitide to activate tumor-specific immune responses and ultimately deliver clinically meaningful outcomes for patients. We have a drug that is potent, safe, well-tolerated, and positioned to enter two commercially attractive markets. Therefore, the path forward is very clear. While we are advancing ruxotemitide towards market approval, we remain open to value-creating partnerships that can accelerate development and maximize the global potential of the program to ensure that patients can access this drug as quickly as possible. At Lytix, we remain deeply committed to being strategic, being disciplined, and remain focused to ensure the maximum potential of this drug. Thank you.
With that, we will open up for a Q&A session that will be led by Peter Tunberg.
Thank you, Øystein. We have received quite a few questions today, so let's just go ahead with the first one. What exactly do you mean by your statement that you now are accelerating your development strategy?
We have delivered solid clinical data over time, and recently, we have been seeing both data presented in the U.S. and at the Nordic Melanoma Meeting that are very positive. That means that these molecules deserve to be developed forward towards commercialization to help more cancer patients. We are dedicated to do that, and we are looking at different strategic options, including, of course, partnerships. By any means, this needs to be moved forward, and that's what we are now planning. We cannot go into any detail on how we are doing that, but that's really now summing up everything we have. We are very convinced that this deserves to come to the market, has a big potential, and we will come back to more detail on that at a later stage.
Thank you. There is a few questions on Verrica's development. Can you say something about how big the expected milestone payment from Verrica at the start of a phase III study?
Yeah. Gj est.
Thank you. This is a question we have received several times before, and the next milestone payment is very important for us. We have said that it is expected when Verrica is initiating the phase III study, more accurately around the timing of recruiting the first patient. The size of the milestone payment is confidential, but what we have said before is that we have so far received $3.5 million from Verrica in milestone payments, and the next milestone payment is bigger than what we have received this far. Thank you.
Thank you. In the extension of that, can you comment on Verrica's current cash position and how could Verrica fund two phase III programs in BCC?
Yeah, it's not up to us to comment on Verrica's financial position. They released their Q3 report on Friday and had a presentation yesterday. We remain committed to Verrica as our partner and strongly believe that what they sit on is well worth raising the capital for phase III.
Thank you. And then finally, on Verrica, maybe back to you, Øystein. How important is the immune response demonstrated in BCC in terms of competitive edge or positioning in the space?
As all of you listeners are aware of, we have shown immune responses in cancer patients before with ruxotemitide. What was demonstrated in this immune analysis was that we are not only increasing the infiltration of active immune cells, but reducing the cells that deactivate the immune system. This was also seen together with abscopal effect that you see some effects or effects in all non-treated lesions in different patients in this study, indicating that this immune system not only works locally, but systemically. With this abscopal effect, this even further strengthens the potential of ruxotemitide as a first-line treatment in basal cell carcinoma.
Thank you. Moving on to your own clinical portfolio, what does the NeoLipa interim result mean in comparison to pembrolizumab as a standalone treatment?
Yes. As mentioned, pembrolizumab alone has shown some efficacy, pathological complete responses. The interesting findings we show is that we saw pathological responses in eight of the nine patients, whereas with immune checkpoint, it has effect in some patients, and there are more resistance in other patients. We see no efficacy in most of the patients. Still early, could be lucky with the patient population, but there is an indication here that we do something in the patient population that is not responsive to immune checkpoint alone due to immune suppression.
Can you say something about how is recruitment going in NeoLipa, and when do you expect top-line results from the study?
Last week, at the Nordic Melanoma Meeting, it was reported that 13 patients were enrolled. That was last week. That's almost half of the patients. It's still our aim to report top-line results mid-2026.
On the ATLAS ITO5, when do you expect final results to be published?
ATLAS ITO5, we are waiting for finalizing the clinical study report first quarter of 2026, and the plan is then to present the data at the cancer conference later that half a year.
Thank you. There is a question here. Will there be phase III for one or both of the studies, ATLAS ITO5 or NeoLipa, and how do you intend to finance any phase III studies?
Phase III studies are larger pivotal studies to enter into the market, which has to be done one or the other way with ruxotemitide. Normally, you join a partnership to do a larger phase III study, but we are planning to move forward and see all options how to move this forward, and we'll come back to that in more detail later.
There's a question on do the immune data in BCC and the interim NeoLipa readout assist your business development activities?
I think, first of all, these together continue to demonstrate ruxotemitide's strong ability to work locally and induce systemic immune response. I think regarding business development in the basal cell carcinoma is, of course, up to Verrica, but I think this abscopal effect with this strong immune system activated strengthens the possibility to be a first-line treatment and should increase interest from partners in that area, but that's, of course, not our business. I think these data also support our data that this reprogramming of tumor microenvironment, abscopal effects showing that we're working in combination with immune checkpoint inhibitors and enhance the number of patients responding to it, really strengthen also ruxotemitide's potential to be combined with immune checkpoint inhibitors, which should be of great interest for some of these companies with immune checkpoint inhibitors in their portfolio.
Thank you. And then a final question on this topic. It says here how many patients are needed to have the indication which is explored in NeoLipa approved for marketing?
This is a study with an investigator-driven study with 27 patients. You need to do a phase III study anyhow, a larger study that, and also often you need a randomized study, meaning that you have a comparator with and without ruxotemitide to really demonstrate the enhanced effect by ruxotemitide. You need to do more to reach the market, but another question is what do partners want to see? When is it sufficient data to create interest from those who have immune checkpoint inhibitors? That is a different question, which may happen earlier.
Thank you. There is a question on the financial or funding side. Has Lytix Biopharma considered or explored the possibility of applying for public funding schemes such as those offered by Innovation Norway, the Research Council, et cetera? If so, what assessments have been made regarding eligibility criteria and the relevance of support of the company's current and future projects?
Thank you. We have active support from public grants today, and we are also actively applying for new grants. That's something we always work for, and we try to understand how our projects, development projects, are in line with different regional and national and international public grants that we can and may apply for.
Thank you. There's coming in another question here. I mean, you've addressed the NeoLipa recruitment. It's asking why you think this is realistic to have a readout in mid-2026.
What we are saying and have been saying is that we are going to present top-line results. Remember, the final results will not only be the short readout, but you will follow up the patients to see. I think the most important we are looking for is the time to relapse after surgery. Patients are experiencing relapse and also patients with immune checkpoint inhibitors. The really long-term interesting result is to see how many patients are getting a relapse and get tumor back. I think that's the most important. This is several. We have top-line data. We will follow patients for a time. This is an ongoing process to really see. We also know that the Radium Hospital will do a lot of immunological analysis, so there will be several results coming.
What we have said is that top-line data will be presented at mid-2026.
A final question here. If I understand you correctly, the preferred path for financing any phase III for NeoLipa is through partnerships.
That's often the normal situation for a biotech. Phase III is a big study, very costly, very many patients. You need a lot of resources. We are not there to announce that we are going to be a mid-size pharma yet. We will look into the opportunity to partner opportunities. This is too early to talk about how we are doing that phase III study.
Thank you. That's all the questions for today. I'll leave the word back to you, Øystein, for some closing remarks.
Okay. I would like to thank you all for following us in this very exciting time. We hope you also continue to follow us to see what's happening in a very exciting 2026 with upcoming phase III studies run by Verrica Pharmaceuticals and also how we are moving forward, having these very exciting results ongoing and studies ongoing. Thank you.