Good morning, everyone. Thank you for joining us today, and welcome to our Fourth Quarterly Results Presentation for 2024. Today, we are excited to share with you significant progress we have made in our mission to develop the future of cancer treatment. Our innovative approach, which combines the killing of cancer cells with the activation of the immune system, continues to show promising results. Looking ahead to 2025, we remain committed to driving forward our strategy to generate clinical results and commercialization through partnership. I am Øystein Rekdal, CEO of Lytix Biopharma, and I'm joined by our CFO, Gjest Breistein. Before presenting the highlights, I will give a short introduction to our company and our technology. Our innovative technology approach combines the benefits of direct killing of cancer cells and immunotherapy, leveraging molecules derived from a part of nature's own defense system.
Our licensing partner, Verrica Pharmaceuticals, has achieved compelling results in the phase II study for basal-cell carcinoma, potentially positioning it as a first-line treatment. We are also excited about the two clinical studies we are running in late and early-stage melanoma patients with our lead drug candidate. Our next-generation molecule opens new avenues into deep, deep-seated cancer types. The robust clinical results obtained with our lead drug candidate and a commercial agreement already in place significantly reduce risks and position us to capitalize on the growing market potential for intradermal immunotherapy. Lytix is addressing major shortcomings in current cancer immunotherapy. Since 2010, modern cancer treatment has been revolutionized by checkpoint immunotherapy, with particularly good response in melanoma. However, the majority of cancer patients in most cancer types do not respond to immune checkpoint therapy due to a lack of immune cells within the tumor.
Our technology addresses this challenge by enhancing the number of immune cells in the patient's tumor. In other words, we complement the shortcomings of today's checkpoint inhibitors, providing a solution to challenges faced in current cancer treatment. Our solution works through two phases: killing tumors locally and activating a systemic broad immune response. This dual approach ensures a comprehensive attack on cancer cells throughout the body. Let's take a look at the highlights from the fourth quarter of 2024. We achieved solid results in the phase II basal-cell carcinoma study with our licensing partner, Verrica Pharmaceuticals. The impressive 97% calculated objective response rate and overall reduction in tumor size of 86% indicates that LTX-315 has the potential to be a first-line therapy in basal-cell carcinoma. The positive results were presented in three different posters at the 2025 Winter Clinical Dermatology Conference in Miami, Florida.
Verrica plans an end-of-phase II meeting with the US FDA in the first half of 2025 to determine the next steps. In the newly started NeoLIPA study, patient recruitment is ongoing, and where the impact of LTX-315 early-stage melanoma is investigated. Encouraging interim data from the ATLAS ITO5 study show a 40% disease control rate up to 22 months in these heavily pretreated patients with a progressive disease when they enter into the study. The new superior formulation of LTX-401 represents a significant advancement for our second lead candidate. These new formulations have demonstrated substantially improved anti-cancer effects and will potentially extend patent life. Clinical trial preparations are underway, targeting a launch in 2026. We have successfully secured a US patent for the combination of LTX-315 with PD-1 immune checkpoint inhibitors.
This US patent not only fortifies Lytix Biopharma's intellectual property portfolio by protecting the use of LTX-315 in combination with anti-PD-1 antibodies, but also enhances our competitive edge in the rapidly growing pharmaceutical market in the US. We are excited to strengthen our management team with the appointment of Mette Husom as our new CTO. She brings extensive experience in all aspects of developing new pharmaceutical products. We successfully raised NOK 111 million from both existing and new shareholders, providing operational stability for the coming period. We are strengthening our focus on late-stage development and commercialization through partnership. Interim results from the NeoLIPA study will be an important milestone for these activities. Now, let's move on to the clinical and operational updates. Sorry. Here is an overview of our clinical progress across various studies and product candidates.
We have three phase II studies, one led by Verrica Pharmaceuticals showing strong results in basal-cell carcinoma, and two ongoing studies in melanoma with the ATLAS ITO5 study in late-stage melanoma, and a NeoLIPA study where LTX-315 is evaluated in combination with PD-1 immune checkpoint inhibitors, pembrolizumab, in early-stage melanoma and pre-surgery. Our second lead candidate, LTX-401 with a new formulation, is being prepared to enter into clinical phase I study. When it comes to phase II study in basal-cell carcinoma that was run by Verrica Pharmaceuticals, LTX-315 with its impressive results in basal-cell carcinoma offers a potential paradigm shift in the treatment of this type of cancer.
Today, about 95% of the patients are treated by surgery, which can cause pain, discomfort, bleeding, infection, and scars, as exemplified with a person that had to remove a part of his nose due to a basal-cell carcinoma lesion on his nose. LTX-315 provided less invasive treatment and with the potential to protect against the formation of new lesions. Our partnership with Verrica Pharmaceuticals is a commercial validation of our technology. Verrica has a worldwide license to develop and commercialize LTX-315 for certain dermatological oncology indications. Under their license agreement, Lytix may receive aggregate payments up to $110 million upon achieving certain development and sales milestones, along with the tied royalty payments in the double-digit teens. In November 2024, Verrica raised about $42 million in new capital.
We are fully committed to supporting Verrica in driving efficient development and future commercialization efforts for LTX-315 for BCC and are looking forward to their end-of-phase II meeting with FDA within this half a year. When it comes to the ongoing ATLAS ITO5 study, LTX-315 is tested in combination with a PD-1 immune checkpoint inhibitor in late-stage patients, melanoma patients that have previously failed to respond to a number of cancer therapies and had progressive cancer disease when they enter into the ATLAS ITO5 study. These patients had also failed to respond to the same type of immune checkpoint inhibitors that has been combined with LTX-315 in this study.
In this heavily pretreated patient population with a progressive melanoma, LTX-315 is showing promising interim results from 20 patients with a disease control in 40% of the patients and now up to 22 months, including two patients with a durable partial response. The impressive effects in both injected and non-injected lesions highlight the potential of LTX-315 in patients with a metastatic disease. In the NeoLIPA study in early-stage melanoma, we are expanding the potential of LTX-315. This study evaluates LTX-315 in combination with pembrolizumab, PD-1 inhibitor, administered prior to surgery in early-stage patients which are expected to have a more responsive immune system. The study is ongoing and is led by Dr. Henrik Jespersen at Oslo University Hospital, where the aim is to shrink tumors before surgery while boosting tumor-specific immune response, potentially lowering relapse after surgery.
The patient population for this study is larger, translating into significant commercial potential. Interim data are expected Q3 this year and top-line results end of first half year of 2026. Regarding our second lead candidate, LTX-401, which is a small molecule that seems to have a large commercial potential in solid tumor, including deep-seated cancer. With increased commercial interest and good feedback from preliminary meetings with regulatory authorities, preparations are underway to advance LTX-401 in this new formulation towards human clinical trials. The new superior formulation of LTX-401 has demonstrated improved anti-cancer effects and a potential to extend the patent life of LTX-401. Additionally, LTX-401 shows strong synergy with checkpoint inhibitors, making it a promising candidate alone and in combination with immune checkpoint inhibitors in various solid tumors, including deep-seated lesions like primary liver cancer and other cancer types with liver metastasis.
I will hand it over to Gjest, who will provide you with a financial update.
Thank you, Øystein. Let me now take you through our key financial updates for the fourth quarter and the strong financial foundation we have built heading into 2025. First and foremost, our most significant achievement in Q4 was the capital raise of NOK 111 million. Given the current challenges in the capital markets, this is a major accomplishment and a strong testament to the confidence investors have in Lytix. We received strong support from both existing and new investors, and we were pleased to see over 200 retail investors participate through the PrimaryBid platform. This broad investor interest reinforces our strategic direction and potential of our clinical platform.
With this capital in place, Lytix is now in a strong financial position to reach value inflection points in 2025, ensuring we continue to advance our clinical programs while maintaining strategic flexibility. Moving on to costs. We saw an increase in expenses during Q4. However, it is important to highlight that these costs were largely one-time in nature, and we expect our expense profile to decline in 2025. The biggest driver of increased expenses was higher R&D expenses, particularly related to ATLAS ITO5. As we near the completion of this study, we conducted a thorough financial review and accrued NOK 11 million in expenses due to delayed invoicing from clinical sites. This means that most costs for ATLAS ITO5 are now fully recognized. What does this mean for 2025? First, we expect a lower cost base, as these accrued expenses will not recur.
Second, with ATLAS ITO5 wrapping up, our spending will shift to areas with the highest potential return, such as the NeoLIPA study and the next steps for LTX-401. Finally, we remain disciplined in capital allocation, ensuring that every krone spent is driving us closer to commercialization and long-term value creation. With this capital raise completed and our cost structure stabilized, let's take a closer look at our liquidity position. At the end of Q4, our cash balance stood at NOK 131 million, a significant increase from NOK 27 million at the end of 2023. This gives us a solid runway well into 2026, allowing us to execute on our clinical and strategic objectives without short-term financing concerns. In addition to our own cash position, our licensing partner, Verrica Pharmaceuticals, raised $42 million in Q4.
Together, this financial strain, both for Verrica and Lytix, significantly de-risked the development and commercialization of LTX-315. Total liabilities increased to NOK 39 million, up from NOK 30 million at the end of last year, primarily due to accrued expenses related to the ATLAS ITO5 study. With our strengthened financial position, we remained focused on delivering long-term value through strategic commercialization efforts. Our molecules have a huge commercial potential. In previous studies, we have demonstrated efficacy in several different indications, and we are now focusing on the areas where we believe we have the best chances of success. At this stage, Lytix has the opportunity to make significant progress relatively quickly on multiple fronts. Verrica has already presented highly promising phase II data, indicating great potential for 315 in BCC, which will generate revenue for Lytix the fastest.
Strong results from NeoLIPA will demonstrate the value of our technology in metastatic cancer and position us to engage in discussions with larger companies. 401 is a highly attractive drug candidate, validated by LTX-315 results, yet representing entirely new opportunities. With that, I will hand it back to Øystein for closing remarks.
Thank you, Gjest. As we conclude our presentation, I want to emphasize our persistent dedication to advancing our immuno- oncology pipeline throughout 2025. The positive phase II results for LTX-315 in basal-cell carcinoma from our partner, Verrica Pharmaceuticals, have set the stage for critical discussion with the FDA in early 2025, guiding towards a phase III study. Our ATLAS ITO5 study in late-stage melanoma continues to show promise, and the ongoing NeoLIPA study in early-stage melanoma at Oslo University Hospital marks a significant milestone for Lytix.
We anticipate interim results from the NeoLIPA study in Q3 2025, which will further highlight the commercial potential of LTX-315. We are also making progress with LTX-401 in an improved formulation, and we anticipate launching a first human trial in 2026. Our successful capital raise of NOK 111 million has strengthened our financial foundation, allowing us to start focusing on strategic partnerships to maximize stakeholder value. With a clear strategy and a robust financial position, Lytix is well positioned to drive our innovative therapies towards commercialization, benefiting both patients and shareholders. Our differentiated approach based on groundbreaking science sets us apart in the biotech landscape, and we look ahead to 2025 with great optimism. Thank you for your attention, and I will now hand it over to Petter Tandberg, who will take you through the Q&A session.
Thank you, Øystein, and Gjest for the presentation.
We have received quite a few questions, so let's just kick it off. I'll start with a question on Verrica. What patient population will Verrica target in phase III with VP-315? For example, locally advanced BCC or located in the phase. What is the size of this population and market potential?
I think it's important to say that this will very much be decided after meeting with the FDA. They will have a thorough discussion with the FDA to plan for the phase III study, based on the results and safety from the phase II study. I think that will tell a lot. We know that 80% of these BCC tumors are very defined tumors or lesions, which represent a large part of this very large cancer population. I think it's a majority of BCC patients that will be eligible for treatment with LTX-315.
Again, the FDA will tell that. This is the most prevalent cancer among all cancer types globally, and it's a huge potential. In the U.S., annually, there are 3.6 million cases per year, and it's an increasing market. There is a large commercial potential for LTX-315 in this largest cancer population, and I think we look very much forward to seeing the detailed feedback from the FDA. We expect that the majority of the BCC cancer patients can be treated. When it comes to more advanced BCC patients, I will not comment on that and wait to see what the FDA is coming back with their decisions.
Would such a patient population be more challenging in phase III than that of phase II?
That's a good question.
When you do a phase II study, you have some limited number of sites and a limited number of patients. In this case, it was 90 patients, and you have to expand to more sites and a higher number of patients, of course. We have experienced that results can change in the good way or in the negative way because it's—and I would say from my perspective, I think it is a very critical factor that all these sites get a good understanding on how to administer the drug properly, which seemed to have worked well in these sites that were involved in the phase II study. With the 97% calculated overall response rate, these results are so strong, so I will be very surprised if it is a big change in the phase III population with regards to results.
What advantages does LTX-315 provide versus other local therapies, such as imiquimod or chemotherapy-based creams?
Ninety-five percent of the patients are treated by surgery. These 5% of patients are treated with different types of systemic and local therapies. Some of these systemic therapies have shown quite a high grade of toxicity. With regards to these two types of local therapies, immunotherapy like imiquimod and chemotherapy, I would say that LTX-315, in a way, covers both. We both kill like chemotherapy, but in a different and more efficient way. We also stimulate the immune system like imiquimod. By this, I think 315 has some very strong advantages compared to these other localized use drugs. I think that's the reason why they have not succeeded to replace surgery.
Thank you. Moving on, we have a question on LTX-401.
What is the reason for delaying the clinical phase I for LTX-401, and what is the time estimate for conducting the phase I?
That's also a relevant question. We were developing 401 alone, but then we had looked into investigating whether there was a possibility to make a new formulation to extend patent life. Surprisingly, this formulation resulted in much more effective results with the formulation compared to LTX-401 alone. We get two advantages here: prolonged patent life potentially and superior efficacy. We had a meeting with the regulatory authorities to discuss the way forward to look at this new formulation, which consists then of more than only 401, which makes it a bit more complex, of course. That will take some more time to prepare all the results with a combination of a formulation with LTX-401.
When we say 2026, nothing is carved in stone. This will be a development. I think based on the feedback from regulatory authorities, we are more or less aligned on what we need to do. There was no negative feedback from the regulatory authorities. This is moving, and we will keep updates on how this is moving and when we can see more concrete information about the start of phase I. We see this as a very promising improvement of this second generation. I would also like to mention that LTX-315 is now in the same class of molecule of therapies. 315, in a way, validates also 401. As we mentioned here, we are also looking for commercial opportunities, and it is also an open possibility that some pharma interested in 315 also would like to be interested in 401.
Here are several avenues possible for 401.
Thank you, Øystein. Gjest, turning to you, you maybe addressed this a bit earlier on, but if you have anything to add, what is your financial runway now?
Yeah, thank you. With the capital raise in Q4, the estimated runway is well into 2026.
Thank you. A question more specific to Verrica. Do you have a backup plan if Verrica fails to meet its financial obligations to you regarding milestone payments? Are you tied to Verrica at any cost when it comes to VP-315?
Yeah, I can understand that question is raised. Verrica is a very good partner for us. We work very closely with Verrica, and we see how they recruited patients and delivered results with LTX-315. They have shown the ability to bring other drugs to the market.
Still, as everybody sees, there is a big struggle there with the sales of the market-approved drug. We can clearly see that Verrica is really focusing on developing 401 and has a focus. I think the three posters at this big large dermatology conference in Miami show that they really want to push this forward and expose the results they have to also get attention from the dermatology indication. To answer more concrete on that specific question, yes, we have backup plans. We have rights in our contract with Verrica to get rights back if things are not moving according to what is expected in drug development.
Thank you. We have a question here. Yesterday, you were stating that the patent—so this is regarding the patent for LTX-315 in combination—the patent will extend the effective patent life of LTX-315.
What do you specifically mean by the effective patent life since it's hard to see any real extension for the LTX-315 patent?
Yeah, also a good question. LTX-315 per se has a certain patent life. What we always try to do is to strengthen patent with new formulation, which we do with 401, composition of matter, combinations, method of use. Here is a potential prolonged patent life with LTX-315 in combination with pembrolizumab. For example, we get a protection for 315 in combination with anti-PD-1 and anti-PD-L1 inhibitors. As you clearly see, we are working with that strategy, 315 in combination with anti-PD-1 inhibitor. That means that the patent life for this moving forward with this combination has an extended patent life compared to LTX-315 alone.
It is correct that it is not extending the patent life of 315 alone, but there are other strategies and combinations, formulation, patent protection. This is a continuous strategy, as you see, to prolong patent protection of our products.
Great, thanks. We have a couple of questions on NeoLIPA study. Let me just probably merge these two. There is one on how many patients have you currently recruited. We have one on that you plan to release in terim results or present in terim results Q3 2025. Will that include all patients in the study or estimate how many of the patients?
What we are saying and also today is that we will present top line together with Radium hospitalet at the end of the first half year of 2026. That means that not all patients are recruited this summer.
The recruitment is going well. We will not, at the moment at least, say anything about the recruitment or the number of patients. It is an investigator-driven study done by Radiumhospitalet . It is not our study per se, but we have a very good combination and collaboration with the team at Oslo University Hospital. The recruitment is going smoothly, and therefore we will be able to present interim results Q3 this year based on a proportion of the patients. As we have clearly said, we will present top line results first half year of 2026.
Thank you. That seems to be all the questions we had today. Thanks to both Øystein and Gjest. If you have any additional questions, please feel free to reach out. You will find the contact information on lytixbiopharma.com.
We will release the annual report 10th of April and Q1 report 15th of May. See you then, and thanks for watching.
Thank you.
Thank you.