Lytix Biopharma AS (LYTIX) Q4 FY2025 Earnings Call Transcript & Summary

Good morning, and welcome to Lytix Biopharma's fourth quarter results presentation. We thank you for taking the time to join us today. As we close out 2025, we can confidently say that Lytix Biopharma has entered a new phase. We have strong and consistent clinical data in hand and multiple opportunities available to accelerate the development and commercialization of both ruxotemitide and LTX-401. Our recent commercial external assessment of ruxotemitide positions Lytix Biopharma as a company with multiple blockbuster opportunities that extend well beyond a single indication. We recently attended the JPMorgan Healthcare Week in San Francisco, which is widely regarded as the premier global investment and partnering meeting, and we were very pleased with how positively our data was received. Our focus for 2026 will be to continue building upon our strong foundation of clinical data that we have generated. My name is Oystein Rekdal, and I'm the CEO and Co-Founder of Lytix Biopharma. And 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 provide you with a brief overview of 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 2-step mode of action. First, our drugs destroy the membranes of cancer cells, which releases tumor antigens and potent signaling that stimulate the immune system. This is followed by activation of immune cells that target cells that have not been killed by the drug directly, which results in further cancer cell death and durable antitumor immunity. We have generated a very strong foundation of clinical data that supports our oncolytic approach with our lead asset, ruxotemitide, demonstrating durability beyond 24 months post treatment. Much of our early clinical work focused on nonresectable heavily pretreated patients, meaning that they were very ill with severely compromised immune system and had failed many lines of therapy. The unmet need is high for these patients, so this population was a strategic focus for Lytix and ruxotemitide. In our ATLAS-IT-05 study, we treated patients with a combination of ruxotemitide and pembrolizumab, and disease was controlled in roughly 40% of patients for up to 24 months. As seen to the left, many of the treated lesions went into total regression and in the middle, impressively, even nontreated lesion went into regression. Our learnings from this study are clear: Pretreatment with ruxotemitide improved patient's response to pembrolizumab. Be aware that many of the patients had previously been treated with pembrolizumab and had not responded. Encouraged by these findings, our strategic focus shifted towards resectable tumors. The current standard of care for resectable tumors is to surgically remove the tumor and then follow on with immune checkpoint inhibitors therapy. There are 2 reasons why this approach does not work optimally. One, surgical removal of tumor comes with a high risk of recurrence since the immune system has limited antitumor immunity. And two, the highly immunosuppressive nature of many tumors result in a modest pathological response to immune checkpoint inhibitors. We believe our approach to treating resectable tumors will be better for patients since not only do we reduce the risk of recurrence, but we also prime the immune system to respond better to immune checkpoint inhibitors. We have already demonstrated that this approach in nonresectable tumors, and we believe the response could be even stronger in resectable patients as they are less immunocompromised than late-stage patients. Now let me describe to you the road map forward and how we intend to create value for you, the shareholders. As today, we have ruxotemitide approaching commercialization, and we have done an external commercial assessment from a professional vendor, which tell us that this first opportunity is very valuable. In order to realize the value of opportunity, we must either raise capital to complete the pivotal study or find a pharma partner. We are actively pursuing both paths to increase the likelihood of creating that value. And based upon the positive feedback we received in San Francisco, I very much look forward to continuing these conversations. Beyond what we are pursuing today, the potential of ruxotemitide and LTX-401 extend well beyond single indication and each asset assessed by this external vendor represent a multibillion-dollar opportunity. And in order to unlock that value, we must actively assess all partnering and investment options. And we will remain disciplined and strategic as how and when we will partner and access capital. Let's now turn to the Q4 highlights. Today, we will describe the recent interim data from our investigator-initiated NeoLIPA trial that was presented at the Nordic Melanoma Meeting and give an update on the study progress. For our preclinical asset, LTX-401, we will continue to carefully assess our development strategy options, and we will also be sharing a data update from our partner, Verrica Pharmaceuticals, as well as high-level details of the recently completed results. On the financial front, we recently completed a private placement and subsequent offering of NOK 77.3 million, which will extend our runway into mid-2027 and allow us to have partnering discussion and evaluate the most efficient path to pivotal studies for ruxotemitide and clinical entry for LTX-401. Following our meetings with potential partners in San Francisco at JPMorgan in early January, we are continuing discussion with many interested parties and are exploring avenues to advance ruxotemitide into pivotal clinical studies across multiple indications and LTX-401 into Phase I. Now let's move into the clinical update. Here, you can see an overview of our pipeline and the status of each program. We are assessing multiple options for a ruxotemitide pivotal study in patients with resectable tumors. We believe partnership will be the fastest way to bring this important medicine to patients and partnering discussions on this front are a clear strategic priority for 2026, while in parallel, we continue our internal development planning. Ruxotemitide is also being assessed in parallel in 2 additional Phase II studies. The first is being led by our first partner, Verrica Pharmaceuticals in basal cell carcinoma. And the second is an investigator-initiated study being led by Dr. Henrik Jespersen at the Oslo University Hospital. For LTX-401, we are preparing to enter into the clinic, including a pre-IND meeting with FDA to get their feedback on our Phase I development plan. Regarding the completed Phase II study in basal cell carcinoma, Verrica Pharmaceutical presented immune data at the Society for Immunotherapy of Cancer Annual Meeting in early November. This data demonstrated a strong increase in the density of CD4 and CD8 positive T cells, which are important immune cells to attack cancer cells as well as B cells, all of which support the activation of an antitumor response within the tumors. Additionally, there was a reduction in immunosuppressive cells population within the tumor microenvironment. These findings are compelling evidence that ruxotemitide, a first-in-class oncolytic peptide immunotherapy reprograms a tumor microenvironment to increase the infiltration of immune cells and transform an immune suppressed tumor into an immune active one. Verrica has indicated that they are preparing for a Phase III program in basal cell carcinoma through non-dilutive development opportunities. And this data, in combination with the positive feedback from the FDA on Verrica's Phase III design, give us the confidence to move forward with our internal pivotal study planning. Moving on to our NeoLIPA study, the interim data update that was presented by Dr. Henrik Jespersen's team at the Nordic Melanoma Meeting confirmed our data-driven decision to shift our focus to patients with resectable tumors. And this remains a clear strategic priority. As of February, 15 of 27 patients have been enrolled and the enrollment is progressing smoothly. But to ensure we deliver top line results in 2026, we are bringing a second hospital online in the coming months, and this is a standard derisking strategy for clinical development. Interim data from NeoLIPA was presented at the Nordic Melanoma Meeting in Tromso in November. And among the first 9 evaluable patients, a 44% pathological complete response and 55% major pathological response were obtained. Overall pathological response were obtained in nearly 90% of the patients. Additionally, no relapses have been observed to date. So even though the patient number is small, the data is very promising. Let's now turn to LTX-401. External assessments, again, of LTX-401 program have provided validation that LTX-401 also represents a highly attractive asset for deep-seated tumors. With proof-of-concept preclinical data in hand, we continue preparation for clinical entry and are actively evaluating all strategic opportunities to accelerate the development of LTX-401. Now I will hand over to our CFO, Gjest Breistein for the financial update.

Thank you, Oystein. I'll now take you through the financial performance for the fourth quarter. Q4 was a stable and predictable quarter from an operational cost perspective. And with the completion of the recent financing, we're well capitalized into 2027. I'll walk you briefly through the financials of the fourth quarter and full year, starting with the P&L. Total operating expenses in Q4 were NOK 21 million, down from NOK 33 million in the same quarter last year. This reduction is primarily driven by the completion of the ATLAS-IT-05 study, which significantly lowered our direct R&D activity during the period. Other operating expenses were NOK 5.5 million, up from NOK 2.5 million last year. This increase reflects a deliberate strengthening of the organization, particularly within business development, Investor Relations and Finance as we prepare the company for the next phase of value creation. Overall, this illustrates a lean cost base with spending increasingly in line to strategic and commercial priorities. If we look a bit deeper into the cost structure, direct R&D expenses were NOK 6 million in Q4, reflecting reduced clinical activity following the completion of the patient treatment in ATLAS-IT-05. At the same time, we continue to support our ongoing NeoLIPA study, which remains our key clinical value driver. The chart on the right-hand side shows the development in cash and short-term financial investments. At the end of Q4 2025, cash and short-term financial investments amounted to NOK 72 million. Importantly, subsequent to quarter end, we completed the private placement and the subsequent offering, raising gross proceeds of NOK 77 million, further strengthening the balance sheet and support execution of key value-driving milestones into 2027. Turning to the balance sheet. Total liabilities decreased to NOK 20 million at year-end 2025, down from NOK 39 million at the year-end 2024. This reduction primarily reflects the reversal of ATLAS-IT-05 accruals as the study was finalized. This illustrates the continued normalization of the balance sheet with fewer clinical obligations and a cleaner financial structure. Overall, the balance sheet today is better aligned with our current development stage and strategic focus. From a financial perspective, our role is to ensure that this road map is properly funded, disciplined and value focused. With a lean cost base, a strengthened organization and capital in place, we believe the company's financial position to support the clinical and partnering milestones Oystein just walked you through. With that, I'll hand it back to Oystein to continue on strategy and outlook.

Thank you, Gjest. Before we move into Q&A, I want to take a moment to reflect on the last quarter and how it has prepared us for a strong 2026. We have a drug that is potent, safe, well tolerated and positioned to enter multiple commercial attractive markets. The path forward is very clear. We are advancing ruxotemitide forward -- towards market approval and are, in parallel, actively discussing value-creating partnerships that can accelerate development and maximize the global potential of the asset. Our team remains deeply committed to being strategic, disciplined and focused to ensure we maximize the potential of this opportunity for all our stakeholders. Thank you. With that, we will open for the Q&A session that will be led by [indiscernible].

Thank you, Oystein, and thank you for a good presentation. We will now kick off with some questions from the audience. And please also note that you can submit questions to the team on [email protected]. The first question here is about the recruitment of patients. How is recruitment in NeoLIPA going?

Yes. As we mentioned briefly, the recruitment is going smoothly and to ensure that we maintain time lines and are able to deliver top line results in 2026, we are bringing in a second hospital online, and this is a standard derisking strategy for clinical trial recruitment.

What is Lytix' next value inflection point?

So to get -- pivotal studies are needed to bring ruxotemitide to the market, and that could either be done through partnership, which could be a potential next value inflection point or through internal development. We are in a very good position with a very strong foundation of our assets with a big commercial potential and will do whatever to bring it to the market.

And here is a question from the audience, when it comes to the time line, when is it likely that you will start Phase III studies for LTX-315.

So we are in a very good planning of preparing for Phase III studies. We have to anchor that together with the Board, and we will let the shareholders and provide that information when we are ready to share it later on. This is under planning. And as I said, we are considering multiple pathways to get -- to bring ruxotemitide to the market.

And what do you know of Verrica's plans to fund Phase III?

So what I can share today is that Verrica is actively looking for nondilutive funding and partnership to bring this forward. And we are looking forward to hear more about this on this front.

Please note that you can also submit questions on the web browser. Yes. Here is another one. What does the pivotal study look like if Lytix is funding it themselves?

So as mentioned, this is a discussion ongoing, how we do that, how we can optimize the path forward, doing a pivotal study either through partnerships or ourselves. And we will share that externally when we have that plan ready, but this is under planning.

Thank you, Oystein. Let's move on with another question. How do you plan to use the funds from the bridge round? I suppose that's a question to the CFO, maybe.

Thank you. Yes, we're very happy with raising NOK 77 million now in January from all the existing shareholders. We plan to use this money both for the clinical preparations -- for the continued development of ruxotemitide, but also the preparations to bring LTX-401 into clinical stage.

Here is another question. Do you plan to run a pivotal study before Verrica?

So we do not know the timing of when Verrica is doing their Phase III, but we are very confident that both the clinical data generated by Verrica and ourselves has a strong foundation and a big commercial potential. So we will do whatever we can to accelerate and move into -- bring this forward to commercialization.

Another question here. According to the Verrica agreement, is Lytix able to advance ruxotemitide alone?

So Verrica's rights for ruxotemitide is limited to certain types of skin cancer, whereas Lytix own all the rights -- the rights for all other oncology indication. And as I said, both we and Verrica can develop and bring ruxotemitide forward in these 2 separate market areas independently of each other.

You touched upon the partnership strategy and your opportunities there. How long will it take to find a partner?

So normally, to close a partnering deal takes between 9 to 18 months. With the bridge funding, we are in a strong position, as Gjest said, to pursue our business development activities, considering partnerships and at the same time, bring ruxotemitide forward internally.

A couple of more questions from the audience. First one, can you elaborate on the competitive situation?

So what we -- we have been -- we are and have been the leading group within oncolytic molecule therapy. As many of you may know, oncolytic viruses have been the frontrunner within oncolytic therapy. They have some limitation. We strongly believe and have evidence that oncolytic molecules is a better way for treating cancer patients because viruses have some limitation, also some advantages, and we are also in front of the oncolytic molecule therapy. As we know, there are no other close competitors within the oncolytic therapy in a clinical stage at least.

Another question here about a Phase III -- potential Phase III study. How long do you expect the Phase III study for LTX-315 will last?

So that's very dependent on the indication. For example, the Phase III study in basal cell carcinoma with ruxotemitide monotherapy is different compared to doing a study in combination with other immunotherapies that we are doing. So Phase III study will recruit a high number of patients and will take time. Our job is to really engage a high number of sites to move this as fast as possible. So it's very difficult at the moment to tell how long time it will take to finalize the Phase III pivotal study.

Another question about the recruitment of patients. Is it a delay when it comes to the numbers that you have recruited in the study?

So patient recruitment will vary from time to time, from quarter-to-quarter. So we are really seeing an effort from the [indiscernible] to recruit patients. And I think -- believe strongly that a very motivated second hospital will also bring more patients. So anyhow our plan is to come close to the time lines that we have initially announced.

Thank you. I think that was everything for now, and we will revert with the Q1 presentation in May, and thank you so much.

Thank you. Thank you for attending.

Thank you.