Lytix Biopharma ASA (LYTIX) Earnings Call Transcript & Summary

Good morning, everyone, and welcome to Lytix Biopharma's Second Quarter Results Presentation for 2025. Thank you for taking the time to join us today. While this quarter has been relatively quiet in terms of new data releases, we are entering a period with several important milestones just ahead of us. These milestones that could strongly influence the path forward for Lytix, and I'm excited to walk you through where we stand and what lies ahead. My name is Øystein 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 introduce you to our company, our technology and the clinical progress we are making. Lytix Biopharma is built on decades of pioneering research in tumor immunology. Our technology has already shown clinical proof of concept with strong Phase II results in basal cell carcinoma. And we are now approaching a pivotal Phase III study together with our partner, Verrica Pharmaceuticals. We have a robust pipeline with several Phase II studies completed or ongoing in 2 different types of skin cancer and the next-generation molecule, LTX-401 with a potential for deep-seated cancer. This combination of validated science, late-stage development and commercial partnership provides a strong promise for the next period. As probably most of you know, immunotherapy has revolutionized cancer treatment lately. But the reality is that the majority of patients still do not respond to immune checkpoint inhibitors. And the main reason is that the tumors lack active immune cells. This challenge is addressed by our technology. By their unique mode of action, our drug candidates enhance the number of active immune cells, making the tumors more responsive to the immune checkpoint inhibitors. And this activation of the patient's immune system is happening through 2 phases: local tumor cell killing followed by systemic immune activation. This means we are not only attacking the treated tumor, but also enabling the immune system to attack distant non-treated metastases. This dual action makes our approach very promising, both as monotherapy and in combination with checkpoint inhibitors. With this brief introduction, let's turning to the second quarter highlights. First, our partner, Verrica had a successful end of Phase II meeting with the FDA for LTX-315 in basal cell carcinoma, and with an alignment for planning for the pivotal Phase III program, preparation for the Phase III study are now underway. Later this year, Verrica will present a comprehensive update, including new genomic and immune response data from the Phase II trial at an international conference. Second, our new study in early-stage melanoma, NeoLIPA is progressing well. 1/3 of patients have been enrolled and treated and interim data from these first patients will be presented at the Nordic Melanoma Meeting in Tromsø in November, where several international melanoma key opinion leaders will be present. Third, the ATLAS-IT-05 study in late-stage melanoma has completed patient treatment. Results show disease control in 40% of these heavily pretreated patients with responses in both injected tumors and distant non-treated metastases, giving us a strong rationale for moving into earlier-stage settings. On the pipeline side, LTX-401 continues to deliver very encouraging preclinical results and optimization is ongoing to select the best formulation for clinical advancement. Finally, our Q2 net loss was substantially reduced mainly due to the reversal of prior accruals linked to ATLAS-IT-05. We closed the quarter with NOK 100 million in cash and short-term investments, providing a solid runway for -- into 2026. Finally, we strengthened our Board and management with individuals bringing extensive commercial expertise as a part of preparing for late-stage development and partnerships. We then move to our clinical and operational update. Here, you see the breadth of our pipeline at a glance. LTX-315 in basal cell carcinoma with Verrica, which is advancing towards Phase III. LTX in late-stage melanoma with a Phase II study, ATLAS-IT-05 completed. NeoLIPA is the ongoing study in early-stage melanoma with LTX-315 and our next-generation molecule, LTX-401, which are moving closer to clinical development. Together, these programs clearly demonstrate the depth and potential of our platform. Let me start with an update on Verrica's development of LTX-315 in basal cell carcinoma. Today, most BCC patients are treated by surgery. While surgery is effective, it's often invasive and can leave patients with visible scars, particularly when lesions are located on the face. This creates a clear need for less invasive options. In Verrica's Phase II trial, LTX-315 showed very strong tumor reduction and with complete clearance in more than 50% of the patients, providing a potential alternative treatment that could combine efficacy with improved cosmetic outcomes. Based on the promising Phase II results and constructive feedback from the FDA, the clear next step is to advance into a pivotal Phase III trial. Preparations are already underway, and Verrica will present a comprehensive update, including new immune and genomic data later this year. For patients, this represents the possibility of a first nonsurgical treatment option in basal cell carcinoma. And for Lytix and Verrica, it opens up for a very significant commercial opportunity in the most common form of skin cancer. Moving to ATLAS-IT-05 study in melanoma. The ATLAS-IT-05 study is now completed. And in this very difficult late-stage patient population, we achieved disease control in 40% of the patients with some patients maintaining benefit for up to 2 years. Importantly, we also observed complete regression in both injected and non-injected tumors, highlighting LTX-315's ability to combat cancer that has spread to other locations in the patients. At the same time, the ATLAS-IT-05 study highlighted a well-known key limitation for immune therapy. Late-stage patients often have a weakened immune system, making it harder to achieve durable responses. This is why our strategy now shifts to earlier-stage melanoma patients where the immune system is stronger and the potential for long-term benefit is greater. This brings us to the NeoLIPA trial where LTX-315 is combined with pembrolizumab before surgery with the aim to both shrink tumors and prime the immune system against recurrence. These trials enroll earlier-stage melanoma patients, which have less advanced disease and a more robust immune system, increasing the likelihood of response to LTX-315. Here, LTX-315 is combined with pembrolizumab and given before surgery in treatment-naive earlier-stage melanoma patients where the goal is twofold: shrink the tumor before surgery and at the same time, prime the immune system to reduce the risk of recurrence afterwards. 1/3 of the patients are already treated and interim results will be shared at the Nordic Melanoma Meeting in November. And with positive results, LTX-315 could have a commercial potential in this early-stage cancer setting and potentially also across multiple cancer types. This study is, therefore, a key value driver for Lytix going forward. Finally, let's look at our second lead candidate, LTX-401. This is a small oncolytic molecule with a similar dual mode of action as LTX-315, but more suitable for treating deep-seated cancers such as liver cancer. Our formulation not only enhances the anticancer effect, but could also extend the patent life, which is a critical factor for commercial value. LTX-401 has also shown strong synergy with checkpoint inhibitors, and we are considering the optimal timing and pathway for advancement of LTX-401 to the clinic. So to summarize, our pipeline, combined with our commercial focus and a strong partnership puts Lytix in a promising position for the future. And with this, I will hand it over to Gjest Breistein, who will provide you with a financial update.

Thank you, Øystein. Let me take you through our financial performance for the second quarter of 2025. The most striking feature this quarter was the significant reduced net loss compared to previous quarters. This improvement was mainly driven by a one-off accounting adjustment. Specifically, we identified that accruals related to the ATLAS-IT-05 study had been overstated because earlier estimates of KEYTRUDA costs were based on the U.S. prices rather than the lower European prices. Correcting this overaccrual resulted in a NOK 10.2 million reversal in Q2. It is important to stress that this is purely an accounting effect with no impact on our cash position. Excluding this reversal, the financial picture is consistent with expectations, lower direct R&D spend as ATLAS-IT-05 moves into closure phase, partly offset by continued investments in development activities such as NeoLIPA and LTX-401. Turning to operating expenses. The numbers reflect our disciplined cost control and sharper focus on LTX-315 development. With ATLAS-IT-05 concluding, we no longer carry the heavy costs of late-stage metastatic melanoma trial. Instead, resources are directed toward high-value initiatives, most notably NeoLIPA study in early-stage melanoma and preparations for longer-term development planning. Overall, this leaner cost base helps us preserve financial flexibility ahead of 2 important value-driving events in second half, the interim readout from NeoLIPA and Verrica's Phase III development plans in basal cell carcinoma. On the balance sheet. Cash and short-term financial investment stood at NOK 100.3 million at the end of June. This provides a solid runway well into 2026 and passed several important clinical milestones. Total liabilities decreased sharply from NOK 38.6 million at year-end 2024 to NOK 20 million now, with the main driver again being the reversal of ATLAS-IT-05 accruals. This adjustment strengthens our balance sheet, reduce future expense recognition and highlights the benefit of careful review of our financial assumptions. Altogether, the balance sheet continues to provide a strong platform to support our ongoing clinical programs. This slide outlines how Lytix create long-term value for shareholders. Our lead candidate, ruxotemitide, LTX-315, is progressing on 2 fronts: Verrica's pivotal program in basal cell carcinoma and our own efforts in earlier-stage melanoma through the NeoLIPA. Together, these represent near and midterm opportunities. to establish clinical and commercial value. Beyond this, LTX-401 remains a longer-term growth option with potential in deep-seated tumors. In short, our strategy is clear, focus resources on value-driving milestones for ruxitametide while maintaining future upside through pipeline innovation. Thank you. And with that, I'll hand it back to Øystein.

Thank you, Gjest. And as we look ahead, the coming months will be very eventful. Completion of ATLAS-IT-05 has confirmed the rationale for moving into early-stage patients. This is followed up by the NeoLIPA study and presentation of interim results at the Nordic Melanoma Meeting in November represent a key inflection point for Lytix. Verrica is preparing for the pivotal Phase III study in BCC and we'll give an update on this program tied to the presentation of immune and genomic data at an international conference later this year. For LTX-401, optimization continues and strategic timing for clinical entry remains under review. Taken together, these milestones underline that Lytix is entering an exciting phase with clear opportunities to advance our technology towards commercializations and patients benefit. And with this, I would like to thank you for your attention, and I will now hand it over to Petter Tandberg, who will take you through -- take us through the Q&A session.

Thank you, Øystein. Thanks for your presentation. Let's take the first question. In the last quarter report, you stated that you expect Verrica to announce additional genomic and immune response data from the Phase II VP-315 study by mid-2025. Now this has been delayed to later this year. Do you know the reason for why they have delayed the announcement?

Yes, I very well understand that question. So as I said, they announced that they will present this data in mid-2025. So I guess the reason when you get an opportunity to present it at the international cancer conference, you have the opportunity to get a much broader audience than only for the shareholders. Of course, that make a bit delay, but maybe give the opportunity for Verrica to really present this more internationally in addition to the shareholders. So I guess that's the main intention here that you had -- if they have got the opportunity to present at a larger conference and has been invited to do that, I guess that's the decision they have decided to take. And we could also comment the same on our NeoLIPA study. We also have promised to come out with some data in Q3. Since this is going to be presented at the Nordic Melanoma Meeting in November, where a lot of key opinion leaders in melanoma will be present, we also think this is a good opportunity to present the exciting NeoLIPA study and results for important key people in this field. So we can almost say this is similar. But then we also have a very exciting time later this year, both with Verrica's presentation and NeoLIPA at the melanoma meeting.

Thank you. And on the topic of NeoLIPA, how is recruitment going in the NeoLIPA study? And do you still expect top line results in first half 2026?

So the recruitment is going well. As we have reported, 1/3 of the patients are now recruited and treated. So this will continue into 2026, and the aim is to finalize recruitment before summer 2026 with the possibility to have some top line data then. Of course, the final data will then need to be later into second half year. But I guess we can give an update in the end of next half year, yes.

Thank you. And then another one on Verrica. When is the next milestone payment from Verrica?

Yes. We have earlier said that the next milestone payment is linked to Verrica starting the Phase III study, and that is still the case. We don't know exactly when they are planning it and are waiting on the scientific conference later this year when Verrica is giving a comprehensive update on that clinical development program. But earlier, they have pointed towards first half 2026.

Thank you. And there's also a question on what are the funding options for Verrica's Phase III study?

So we cannot really comment on that other than referring to what they have said that they are now looking into the funding opportunities for Phase III. And they have mentioned that, that could include non-dilutive funding, but that's -- we have to wait to see the concrete announcement later this half year, how they are going to fund it. But they have been very clearly stated that they are actively now planning for a Phase III study and the funding opportunities.

Thank you. And then we have also received a couple of questions on LTX-401 and the development towards clinical phase. So maybe to address this more in detail, can you provide any more color on the LTX-401 development?

So as you probably understand that we are now approaching very important value -- key milestones time lines for 315. 315 is a Phase II drug moving into Phase III and marketing. So of course, this is creating the largest value at the moment for Lytix shareholders. So we have to focus to maximize the opportunity to get the value out of 315. So we are really now looking at the timing to also follow 401, which is we continue to, of course, development and preparing for Phase I. But the timing and that will be very much dependent of the -- our main focus to really bring 315 forward towards the market and give exit possibilities and commercial revenues for the shareholders. So this is really about the timing. But 401 is very promising, have shown very good efficacy in liver cancer, and we are really planning to move this forward as soon as possible.

Thank you. And then maybe to round it off here, the last couple of questions we received is more on the finance side for you, Gjest. So I'll merge them into one. One, how long is your cash runway? Maybe you answered that before, but let's restate that. And then are there any costs remaining for ATLAS-IT-05?

Thank you. The cash runway is, as said in the presentation, well into 2025. We expect it to take us to mid -- sorry, well into 2026 and expect it to take it through the first half. Regarding the remaining cost on ATLAS-IT-05, it's still ongoing in the sense that it is in the closure phase. We are wrapping the study up. We are writing the clinical study report. So there are some remaining costs. But when it comes to the bigger chunk of the cost related to patient treatment, that has all already been accrued for. So it's a limited remaining cost for the ATLAS-IT-05.

Thank you. That concludes all the questions we received today. I'll leave the floor to you, Øystein.

Thank you, Petter. Well, I would like again to thank you for your attention. As mentioned, this has been a bit of a event-free period, but I think you can share with us the enthusiasm for the next period with several important value inflection points are ahead with both our studies in melanoma and Verrica's announcement of more data from the Phase II study and more information about the pivotal Phase III study, taking 315 into a very exciting and huge commercial opportunity in basal cell carcinoma. So I would like to thank you again.