Earnings call transcript: Lytix Biopharma Q2 2025 sees reduced net loss, strategic focus

Lytix Biopharma (LYTX) reported a significant reduction in its net loss for the second quarter of 2025, as outlined in its recent earnings call. The company highlighted its cash position, strategic product developments, and a promising outlook in the immunotherapy space. According to InvestingPro data, the stock has shown remarkable strength with an 83.37% gain over the past six months, though it experienced a slight decline of 1.99% post-earnings. Notably, the company’s stock typically moves counter to market trends, with a beta of -0.39.

Key Takeaways

• Lytix Biopharma significantly reduced its net loss in Q2.
• Cash reserves are strong, extending the runway into 2026.
• Strategic focus on lead candidate LTX-three fifteen in cancer treatments.
• Stock price declined by 1.99% post-earnings call.

Company Performance

Lytix Biopharma demonstrated a robust improvement in its financial health by significantly reducing its net loss for the second quarter of 2025. InvestingPro analysis reveals the company maintains strong liquidity with a current ratio of 3.86, while holding more cash than debt on its balance sheet. The company reported a strong cash position, with reserves of NOK 100 million, supporting its operations well into 2026. Lytix has strategically focused on developing its lead candidate, LTX-three fifteen, targeting basal cell carcinoma and early-stage melanoma, aligning with emerging trends in immunotherapy. (Get access to 8 more exclusive InvestingPro Tips for LYTX and comprehensive analysis through the Pro Research Report.)

Financial Highlights

• Net loss: Significantly reduced from previous quarters.
• Cash and short-term investments: NOK 100 million.
• Total liabilities: Decreased from SEK 38.6 million to SEK 20 million.
• One-time accounting adjustment: NOK 10.2 million due to KEYTRUDA cost correction.

Outlook & Guidance

Lytix Biopharma is optimistic about its future, with key milestones set for the second half of 2025. These include a comprehensive data presentation on basal cell carcinoma with Verica Pharmaceuticals and interim results from the Nordic Melanoma Meeting. The company is also preparing for a Phase III study in basal cell carcinoma and evaluating the clinical entry timing for its next-generation molecule, LTX-four zero one.

Executive Commentary

"Our technology has already shown clinical proof of concept with strong phase two results in basal cell carcinoma," stated Euston Rechtall, CEO. Jes Breijsteyn, CFO, emphasized, "Our strategy is clear, focus resources on value driving milestones for ruxotemitide."

Risks and Challenges

• Potential delays in data presentations due to international conference schedules.
• Funding for Phase III studies is still being explored.
• Market competition in immunotherapy remains intense.
• Regulatory hurdles for new treatments could impact timelines.

Q&A

During the earnings call, analysts inquired about the timing of data presentations and the status of the NEO LIPA study, which is on track with patient recruitment. Questions also focused on funding strategies for the upcoming Phase III study, with management indicating ongoing explorations of various options. With the next earnings report scheduled for November 13, 2025, investors can access detailed financial metrics, valuation analysis, and expert insights through InvestingPro’s comprehensive research reports, available for over 1,400 US stocks.

Full transcript - Lytix Biopharma AS (LYTIX) Q2 2025:

Euston Rechtall, CEO and Co-Founder, Lytex Biopharma: Good morning everyone and welcome to Lytex 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 Litix, and I’m excited to walk you through where we stand and what lies ahead. My name is Euston Rechtall and I’m the CEO and Co Founder of Lytex Biopharma and with me today is our CFO Jes Breijsteyn who will take later take you through the financial results and outlook.

And before presenting the highlights, let me introduce you to our company, our technology and the clinical progress we are making. Lytex Biopharma is built on decades of pioneering research in tumor immunology. Our technology has already shown clinical proof of concept with strong phase two results in basal cell carcinoma. And we are now approaching a pivotal phase three study together with our partner Verica Pharmaceuticals. We have a robust pipeline with several phase two studies completed or ongoing in two different types of skin cancer.

And the next generation molecule LTX four zero one with a potential for deep seated cancer. This combination of validated science, late stage development and commercial partnerships partnership provides a strong promise for the next period. As probably most of you know, immunotherapy has revolutionized cancer treatment lately, but 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 two 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 metastasis. 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 Verica had a successful end of Phase two meeting with FDA for LTX-three fifteen in basal cell carcinoma and with an alignment for planning for the pivotal Phase three program preparation for the phase three study are now underway.

Later this year, Verica will present a comprehensive update including new genomic and immune response data from the phase two trial at an international conference. Second, our new study in early stage melanoma, NEO LIPA is progressing well. One third of patients have been enrolled and treated, and interim data from these first patients will be presented at the Nordic Melanoma Meeting in Tromso in November, where several international melanoma key opinion leaders will be present. Third, the ATLAS ITO5 study in late stage melanoma has completed patient treatment. Research showed disease control in forty percent of these heavily pretreated patients with responses in both injected tumors and distant non treated metastasis, giving us a strong rationale for moving into earlier stage settings.

On the pipeline side, LTX-four zero one 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 ITO5. We closed the quarter with NOK 100,000,000 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 the glance. LTX three fifteen in basal cell carcinoma with Verica, which is advancing towards phase three. LTX in late stage melanoma with a phase two study ATLAS I two zero five completed. Neolipa is the ongoing study in earlier stage melanoma with LTX three fifteen, and our next generation molecule LTX four zero one, which are moving closer to clinical development. Together, these programs clearly demonstrated the depth and potential of our platform.

Let me start with an update on Verica’s development of LTX-three fifteen in basal cell carcinoma. Today, most BCC patients are treated by surgery. While surgery is effective, it’s often invasive and can leave patient with visible scars, particularly when lesions are located on the face. This creates a clear need for less invasive options. In Verica’s phase two trial, LTX three fifteen showed very strong tumor reduction and with complete clearance in more than fifty percent of the patients, providing a potential alternative treatment that could combine efficacy with improved cosmetic outcomes.

Based on the promising phase two results and constructive feedback from the FDA, the clear next step is to advance into a pivotal phase three trial. Preparations are already underway and Verica will present a comprehensive update including new immune and genomic data later this year. For patients, this represent the possibility of a first non surgical treatment option in basal cell carcinoma. And for lytics and verica, it opens up for a very significant commercial opportunity in the most common form of skin cancer. Moving to ATLAS I t o five study in melanoma.

The ATLAS I t o five study is now completed and in this very difficult late stage patient population, we achieved disease control in forty percent of the patients with some patients maintaining benefit for up to two years. Importantly, we also observed complete regression in both injected and non injected tumors highlighting LTX-three fifteen’s ability to combat cancer that have spread to other location in the patients. At the same time, the ATLAS I two five 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 bring us brings us to the NEO LIPA trial where LTX three fifteen 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 three fifteen. Here, LTX three fifteen is combined with pembrolizumab and given before surgery in treat them treatment naive earlier stage melanoma patient 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. One third of the patient are already treated and interim results will be shared at the Nordic melanoma meeting in November.

And with positive result, LTX three fifteen could have a commercial potential in this earlier stage cancer setting and potentially also across multiple cancer types. This study is therefore a key value driver for lytics going forward. Finally, let’s look at our second lead candidate LTX four zero one. This is a small oncolytic molecule with a similar dual mode of action as LTX three fifteen, but more suitable for treating deep seated cancers such as liver cancer. Over from over formulation not only enhances the anti cancer effect, but could also extend the patent life, which is a critical factor for commercial value.

LTX three four zero one has also shown strong synergy with checkpoint inhibitors and we are considering the optimal timing and pathway for advancement of LTX four zero one to the clinic. So to summarize, our pipeline combined with our commercial focus and a strong partnership puts Litix in a promising position for the future. And with this, I will hand it over to Jes Preisdain, who will provide you with a financial update.

Jes Breijsteyn, CFO, Lytex Biopharma: Thank you, Jesper. Let me take you through our financial performance for the 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 ITO-five study had been overstated because earlier estimates of KEYTRUDA costs were based on The US prices rather than the lower European prices.

Correcting this over accrual resulted in a NOK10.2 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 and D spend as Atlas ITO5 moves into closure phase, partly offset by continued investments in development activities such as Neolipa and LTX401. Turning to operating expenses. The numbers reflect our disciplined cost control and sharper focus on LTACHs three fifteen development.

With ATLAS ITO5 concluding, we no longer carry the heavy cost 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 two important value driving events in second half: the interim readout from Neolipa and Verica’s Phase III development plans in basal cell carcinoma. On the balance sheet, cash and short term financial investment stood at $100,300,000 at the June. This provides a solid runway well into 2026 and past several important clinical milestones.

Total liabilities decreased sharply from SEK 38,600,000.0 at the year end 2024 to 20,000,000 now, with the main driver again being the reversal of Atlas’ ITO5 accruals. This adjustment strengthens our balance sheet, reduces 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 Lutix create long term value for shareholders. Our lead candidate, ruxotemitide, LTX-three fifteen is progressing on two fronts: Verica’s pivotal program in basal cell carcinoma and our own efforts in earlier stage melanoma through the Neolipa.

Together, these represent near and mid term opportunities to establish clinical and commercial value. Beyond this, LTX-four zero one 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 ruxotematide, while maintaining future upside through pipeline innovation. Thank you. And with that, I’ll hand it back to Ester.

Euston Rechtall, CEO and Co-Founder, Lytex Biopharma: Thank you, Jest. And as we look ahead, the coming months will be very eventful. Completion of ATLAS ITO five has confirmed the rationale for moving into early stage patients. This is followed up by the Neolipas Studer and presentation of interim results at the Nordic Melanoma meeting in November represent the key inflection point for lytics. Verica is preparing for the pivotal phase two three study in BCC and will give give an update on this program tied to the presentation of immune and genomic data at an international conference later this year.

For LTX four zero one, optimization continues and strategic timing for clinical entry remains under review. Taken together, these milestone underline that Lytex is entering an exciting phase with clear opportunities to advance our technology towards commercialization and patients benefit. And with this, I would like to thank you for your attention and I will now hand it over to Petr Thannberg, who will take you through take us through the Q and A session.

Petr Thannberg, Moderator/Q&A Facilitator: Thank you, Eisen, and thanks for the presentation. Let’s take the first question. In the last quarter report, you stated that you expect Verica to announce additional genomic and immune response data from the Phase II VP315 study by mid-twenty twenty five. Now this has been delayed to later this year. Do you know the reason for why they have delayed the announcement?

Euston Rechtall, CEO and Co-Founder, Lytex Biopharma: Yeah. I very well understand that question. So as I said, they announced that they will present this data in mid twenty twenty five. 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’s make a bit delay, but maybe give the opportunity for America to really present this more internationally in addition to to the shareholders.

So I I guess that’s the main intention here that you had if they have got the opportunity to present at the larger conferences 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 NELIPA study. We also have promised to come out with some data in q three. 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 Verica’s presentation and Neolipa at the melanoma meeting.

Petr Thannberg, Moderator/Q&A Facilitator: 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 twenty twenty six?

Euston Rechtall, CEO and Co-Founder, Lytex Biopharma: So the recruitment is going well as we have reported one third of the patients are now recruited and treated. So this will continue into 2026 and the aim is to finalize recruitment before summer twenty twenty six with with the possibility to have some top line data then. Of course, the final data will then need to be later into ’20 into second half year. But I guess we can give an update in the end of next half year. Yes.

Petr Thannberg, Moderator/Q&A Facilitator: Thank you. And then another one on Verica. When’s the next milestone payment from Verica? Yeah.

Jes Breijsteyn, CFO, Lytex Biopharma: We have earlier said that the next milestone payment is linked to Verica starting the phase three 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 Verica is, giving a comprehensive update on that clinical development program. But earlier, they have pointed towards first half twenty twenty six.

Petr Thannberg, Moderator/Q&A Facilitator: Thank you. And there’s also a question on what are the funding options for Verica’s phase three study?

Euston Rechtall, CEO and Co-Founder, Lytex Biopharma: So we cannot really comment on on that other than referring to what they have said that they are now looking into the funding opportunities for phase three. And they have mentioned that that could include the 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 there are actively now planning for phase three study and and the funding opportunities.

Petr Thannberg, Moderator/Q&A Facilitator: Thank you. And then we have also received a couple of questions on LTX-four zero one and the development towards clinical phase. So maybe to address this more in detail, can you provide any more color on the LTX four zero one development?

Euston Rechtall, CEO and Co-Founder, Lytex Biopharma: So as you probably understand that we are now approaching very important value a key milestones timelines for 03/15. 03/15 is a phase two drug moving into phase three and marketing. So of course, this is creating the largest value at the moment for Vittix shareholders. So we have to focus to maximize the opportunity to get the value out of 03/15. So we are really now looking at the timing to also follow August, which is we continue to, of course, development and preparing for phase one.

But the timing and and that will be very much depend on all of the main our main focus to really bring 03/15 forward and towards the market and give exit possibilities and commercial revenues for the shareholders. So this is really about the timing. But for one is very promising, have shown very good efficacy in liver cancer and we are really planning to move this forward as soon as possible.

Petr Thannberg, Moderator/Q&A Facilitator: Thank you. And then maybe to round it off here, the last couple of questions we received is more on the on the finance side for you, Jest. So I’ll I’ll merge them into one. One, how long is your cash runway? Maybe you answered that before, but but let’s state that.

And then are there any costs remaining for ATLAS ITL five?

Jes Breijsteyn, CFO, Lytex Biopharma: 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 us to take it through the first half. Regarding the remaining cost on Atlas Article five, 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 already been accrued for. So it’s a limited remaining cost for Thassa-two fifty five.

Petr Thannberg, Moderator/Q&A Facilitator: Thank you. That concludes all the questions we received today. I’ll leave the floor to you, Istijn.

Euston Rechtall, CEO and Co-Founder, Lytex Biopharma: Thank you, Berthoud. 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 in melanoma and Verica’s announcement of more data for the from the phase two study and more information about the pivotal phase three three study taking 03/15 into a very exciting and huge commercial opportunity in basal cell carcinoma. So I’d like to thank you again.

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