Lytix Biopharma AS

OSE:LYTIX

Earnings Call Transcript 2023-Q4

[Oystein Rekdal, executive]

Good afternoon, everyone, and welcome to Lytix Biopharma Q4 report presentation where we will present the company's latest highlights, clinical progress, and outlook. My name is Oystein Rekdal, and I am the CEO and Co-Founder of Lytix Biopharma. I'm joined by Gjest Breistein, our CFO, Graeme Currie, our Chief Development Officer. And today, we also have the pleasure to be joined by the renowned expert in immuno-oncology, Dr. Robert Andtbacka, who will give some high-level perspectives on our clinical program.

Today's presentation will be available on our website later today. And at the end, there will be a Q&A session. To ask a question, follow the instructions via the webcast platform.

Cancer is still one of the deadliest diseases globally with more than 10 million deaths each year. And the one main reason why it's so difficult to cure cancer is that each solid tumor consists of different cancer cells with unique mutations, making it very difficult to kill all the different cancer cells in a tumor. And this is a major reason why many cancer patients do not respond to current available cancer therapies. Our unique technology platform represents a novel class of immunotherapy that is addressing this challenge by activating broad immune responses towards each patient's unique set of cancer cells.

Lytix is a clinical state public company listed in Oslo with a unique technology platform derived from world-leading research. We are currently testing our lead product candidate, LTX-315, in 2 Phase II studies in the U.S. and Europe with positive early results so far. Our lead candidate is injected directly into the tumors, where it kills the cancer cells. And our [ intratumoral ] technology is commercially validated through our licensing deal with the NASDAQ-listed company, Verrica Pharmaceuticals for treatment of certain types of skin cancer. To the right is an illustration of our development program and an update on the development of our 2 lead candidates will be presented later today -- report.

The global market for immunotherapies is predicted to grow significantly through this decade. The growth is currently dominated by immune checkpoint inhibitors, which help the patient's immune system to fight cancer. And due to the shortcomings, other types of immunotherapies are highly needed.

Since Lytix drug candidates address a major reason why a high number of cancer patients do not respond to immune checkpoint inhibitors, our drug candidates have a large commercial potential in combination therapies. In total, the market for immunotherapy is expected to grow more than 20% annually going forward.

Let's then move on to the highlights for the fourth quarter of 2023 and some post-quarter events. In August 2023, Verrica reported positive early-stage results from their ongoing Phase II trial in basal cell carcinoma, which is the most common type of skin cancer. And in January 2024, Verrica announced that all patients have been dosed and that they will complete the entire Phase II study within first half of 2024. And today, Verrica has reported that they expect to also have top line data first half of 2024, which are positive news.

Sorry. ATLAS-IT-O5, we have announced complete enrollment of melanoma patients in this study where our lead candidate, LTX-315, is tested in combination with pembrolizumab, an immune checkpoint inhibitor, in patients that have previously failed to respond to immune checkpoint inhibitors. Interim analyses on all 20 patients show encouraging results with the stabilization of the disease in approximately half of the patients and up to a year indicating durable responses. In one patient, the total tumor burden was significantly reduced and characterized as a partial response.

As Graeme will explain in more detail later today, Lytix has decided to investigate the effect of LTX-315 in patients with earlier-stage disease and a more robust immune system. An investigator-led Phase II study where melanoma patients will be treated before surgery is planned in collaboration with Oslo University Hospital. An application for this study was submitted to the regulatory authorities December 2023 with the aim to start the study first half of 2024.

In December, clinical data from the completed study with LTX-315, in combination with T-cell therapy in sarcoma patients, were published in the high-profile journal, OncoImmunology. And last week, another paper was accepted for publication in the high-profile journal, Frontiers in Immunology, describing LTX-315's ability to activate specific immune cells that are critical for activation of immune cells that are able to kill cancer cells.

To further strengthen and prolong patent protection of our drug candidates, two patent applications were filed December 2023. In October 2023, we received approval from Norwegian Research Council for financial support up to NOK 14.4 million (sic) [ NOK 14.3 million ] for our lead program.

This takes us to the clinical and operational update for the quarter, and I will then hand over to Graeme Currie, our Chief Development Officer, for a clinical update.

[Graeme Currie, executive]

Thank you, Oystein. We'll move to the next slide. Thank you.

Verrica holds an exclusive worldwide license agreement with Lytix to develop and commercialize LTX-315 for certain types of skin cancer, including basal cell and squamous cell carcinoma, and is currently conducting a Phase II clinical study in basal cell carcinoma. In August, Verrica presented positive early-stage data from Part 1 of their ongoing Phase II study with LTX-315, referred to as VP-315 by Verrica. In 4 of the 6 patients that were treated with the highest dose, no cancer cells were found in the treated lesions. The other 2 patients showed a partial response, one with 95% tumor clearance and the other with 30% tumor clearance. To the right, you see photographs of the basal cell carcinoma tumors and histology analysis of tumor tissue from the same tumors, both before and after treatment with VP-315, showing necrosis following VP-315 treatment of these two representative patients.

As Oystein stated earlier, in January of this year, Verrica reported that all patients have been dosed. Data from Verrica's Phase II study is expected by the middle of 2024, which is a significant milestone in Verrica's commitment to advancing innovative solutions for patients facing this very prevalent form of skin cancer.

Basal cell carcinoma patients have traditionally treated with invasive surgery, and VP-315 emerges as a potential alternative therapeutic regimen offering significant advantages over surgery such as reduced pain, no risk of infection, no risk of bleeding, or limited risk of bleeding, hyperpigmentation, and scarring. VP-315 could potentially represent a better alternative to surgery because it may lower the risk of relapse and will cause less damage to the patient's skin.

BCC is the most common form of cancer in the U.S. with a global increase in incidents. It is a market that is expected to increase to more than USD 11 billion by 2028.

Under the terms of the license agreement, Lytix has received milestone payments -- is entitled to receive up to USD 111 million in potential milestone payments over the course of the development program and teen to mid-teen royalties based on Verrica's worldwide annual sales. The next milestone payment is initiation of a Phase III clinical trial study.

We move to the next slide. The ATLAS-IT-05 trial is designed to assess the efficacy of LTX-315 in patients with Stage 3 and 4 melanoma who fail to respond to checkpoint inhibitors, anti-PD-1 or anti-PD-(L)-1 inhibitors. LTX-315 is being studied in combination with the immune checkpoint inhibitor pembrolizumab, also known as KEYTRUDA, which blocks tumor cells' ability to prevent the body's immune response. The trial involved a total of 10 sites, 4 in the U.S. and 6 in Europe, including well-known cancer centers such as MD Anderson Cancer Center in Houston, Texas, which is one of the leading cancer hospitals in the world. In August 2023, Lytix announced the completion of recruitment of 20 patients in the study. All the enrolled patients have late-stage melanoma and the majority have failed to respond to 2 or more lines of therapies, including dual checkpoint inhibition, BRAF/MEK inhibitor therapy, or treatment with oncolytic viruses. These patients generally have a very poor prognosis with rapid disease progression and with few or no additional treatment options available to them.

We move to the next slide. The combination of LTX-315 and pembrolizumab demonstrates stabilization of disease in this challenging patient population with approximately half of the patients achieving disease control, including 1 patient achieving a partial response to date. Some patients have shown prolonged stabilization of disease, up to 1 year after starting treatment, which highlights the impact of the treatment in these patients who were rapidly failing. The analysis also showed that patients with the greatest tumor burden, either multiple metastatic lesions or very large tumors, were the patients who didn't tend to respond to treatment. This is consistent with other immune-focused therapies where the burden of disease can be overwhelming. Some of the patients are still at a very early stage of the study and further updates will be shared in future presentations as the study progresses.

This next slide is just a slide [indiscernible] that really shows these patients who have really managed to control a disease which was progressing on disease entry.

We move to Slide 15. As LTX-315 is injected in certain tumors, we also analyze the effect on non-injected lesions. So these were tumors that weren't injected at all with LTX-315. And in a number of patients, the nontreated lesions were reduced in size. This shows that we're not only having a local effect but a systemic effect. This patient had multiple metastases and have progressed after failing to respond to immune checkpoint inhibitor and BRAF/MEK therapy. In this patient, 4 lesions were injected, resulting in complete regression of those lesions. And to the right is shown an almost 3-centimeter large lesion that is reduced to 3 millimeters without any injection of LTX-315, indicating that T-cells in the patient have been activated and are not only able to fight where the LTX-315 is administered but also to traffic to other locations and fight cancer there. So even though this patient is a late-stage melanoma patient that failed multiple therapeutics, LTX-315 is able to stop the progression of cancer and reduce the tumor burden in this patient.

We move to Slide 16. When it comes to the injected lesions, complete regression was observed in a number of these. The figure to the left shows changes in size of the injected lesions in the patient with a partial response over time. A second patient had several lesions on the forearm, shown to the upper right here on the slide, and a third patient had a lesion that existed behind the knee, shown to the lower left. All these lesions were totally eradicated following treatment with LTX-315.

So, in summary, the combination of LTX-315 and pembrolizumab is effective in treating patients that have previously failed to respond to anti-PD-(L)-1 therapy and other therapies. The combination regimen demonstrates tumor shrinkage in both the injected and the noninjected lesions, so both a direct and a broader effect in these patients. In this patient population, which are very advanced and the majority of them progressed on multiple treatments, prolonged stabilization in almost half of these patients with extensive prolongation in some patients is very encouraging.

It's important to remind you that the trial is still ongoing, and further results will be shared in a future presentation.

In order to document the real impact of LTX-315, we have decided to move to patients with earlier-stage disease and a more intact immune system. We move to Slide 18. We've previously documented that LTX-315 is able to induce a strong and very broad tumor-specific T-cell response in the majority of cancer patients treated so far. Since research has demonstrated that the immune system is more responsive and more intact at earlier stages of disease, LTX-315 can potentially show an even greater effect in early-stage cancer patients.

If we move to Slide 19, we are working in collaboration with Dr. Henrik Jespersen at Radiumhospitalet at Oslo University Hospital. He has decided to initiate a study in patients with -- at early stage of melanoma. The study will be an investigator-led study where LTX-315 in combination with the standard of care, pembrolizumab, will be given prior to the surgical excision of the tumor. Treatment prior to the surgery is also known as neoadjuvant therapy.

While neoadjuvant checkpoint inhibition has demonstrated a significant reduction in the risk of patients relapsing with high-risk melanoma, compared to treatment after surgery, many patients still experience limited or short-term effects. Consequently, there exists an unmet medical need for innovative and more effective neoadjuvant treatment regimens. Since LTX-315 has the potential to treat -- shrink tumors before surgery as well as inducing this broader and tumor-specific immune response, LTX-315 in combination with checkpoint inhibition could potentially reduce the risk -- further reduce the risk of relapse in a higher proportion of patients.

The neoadjuvant study, NeoLIPA, will be a Phase II open-label study recruiting 27 patients with clinically detectable and resectable Stage III and Stage IV melanoma. In December 2023, the clinical trial application for the NeoLIPA trial was submitted and the study is planned to start in the first half of this year, marking a significant step forward by advancing LTX-315 development into earlier stages of melanoma. The commercial potential in a neoadjuvant setting is also significantly larger compared to the more advanced population I talked about earlier.

We move to the next slide. Alongside our lead candidate, LTX-315, we are also developing our second-generation drug candidate, LTX-401, and are looking to move that into clinical studies. Whereas LTX-315 is a peptide, LTX-401 is considered a small molecule. And this has demonstrated superior activity in very hard-to-treat preclinical cancer models, including a model for liver cancer. Based on these preclinical research studies in collaboration with reputable oncology research institutions, LTX-401 seems to be ideal for patients with more advanced disease, with deep-seated tumors and has a large commercial potential. LTX-401 is currently being prepared for a Phase I study, and we are in dialogue with clinical oncology experts to map the optimal way forward.

I'll now hand back to Oystein.

[Oystein Rekdal, executive]

Thank you, Graeme. It is then a great pleasure for me to introduce you to Dr. Robert Andtbacka, who will share his perspective on our clinical results and our clinical development program. Robert is an internationally renowned surgical oncologist with more than 25 years of experience in immuno-oncology and a highly reputed leader in melanoma and intratumoral therapies. He has led over 50 clinical studies evaluating the activity of 20 novel immuno-oncology therapies, including the Phase III study which led to the approval of the oncolytic virus TVEC in patients with metastatic melanoma. We are very happy to have a leading expert in intratumoral immuno-oncology with us today to share his perspectives on our clinical progress and development program. And with that, I will hand over to you, Robert.

[Robert Andtbacka, executive]

[Foreign Language] I'm trying to decide if we're going to take this in Norwegian or Scandinavian or in English, but we'll probably take it in English. Now, so, Oystein, so I'm actually looking at the data that you have at Lytix. So, I'm very excited about this.

And to put it into perspective, so if you look at your ATLAS-05 study that you have, it's really important to recognize that these patients, these melanoma patients, that have been on prior therapies, it's extremely difficult to treat these tumors. And I think that we have to recognize that, when they look at your data, you have some of these patients who have the stabilization of their disease for over a year. That is, many times, unheard of. We just don't see that in patients with metastatic melanoma, especially with these patients. So, although you don't necessarily see radiographic evidence from the response, the fact that you're prolonging the stabilization of disease, clinically, the way we look at that, it gives more patients more runway, though, that you have stabilization of their disease, they're tolerating the treatment very well. And it gives them then an ability that, should the tumor at some point in time grow, at least they have more runway and there are new treatments that are coming online. So, I think that this is something that cannot be emphasized enough.

The fact that also you're seeing -- in some patients, you're seeing radiographic responses, specifically often we want to see this in the injected lesions, but also in non-injected, it really indicates that the immune system is activated. And this is the challenge that we have with many of these tumors, is that tumors find a way to overcome the immune system and the effect of the immune system. So, we need to find then ways to reactivate the immune system, and that's what LTX-315 does. It reactivates the immune system and really then brings the new system up to speed so it can have an effect not only on tumors that you inject but also the noninjected tumors. So this -- and I think that we have to recognize that this is in a fairly small group of patients. So the fact that you are seeing responses radiographically, you have stabilization of the disease. All of these accounts for almost 50% of patients in there. That, to me, clearly indicates that there is a potential path forward in this setting.

And I think, as more patients are enrolled, we'll get a better understanding of what's the difference between the tumors that respond or stabilize versus the ones that don't respond. And Lytix has done a fantastic job, especially under your leadership, Oystein, to really understand the immune effects behind this. And that's really going to guide, I think, Lytix as you move forward and when you look at this patient population.

That also then brings us into that, as Graeme was talking about, the earlier patients in the neoadjuvant setting. And what we've learned over the past few years is that sort of -- or let me say the traditional way we would treat patients that come in with cancer, in our mind, we say, well, we need to take that out. We need to do surgery as soon as we can to take that out. But we've learned that sometimes keeping the tumor in place may be a beneficial thing because we can then, with the tumor in place, activate the patient's own immune system against that tumor, because when we do surgical [indiscernible], ultimately what we want to do, we want to try to prevent the tumor from ever coming back. And if the tumors grow big that we can sort of find them on physical examination, they develop mechanisms to overcome the immune system. So, having the tumor in place, reactivating the patient's own immune system against the tumor we believe is beneficial.

And there's data, there's a study that dialed that we use with TVEC, and we used it intralesionally into tumors. And we show that, by doing that before surgery, we decreased the risk of the tumor coming back, and we actually could also improve the survival for patients. So, the fact that Lytix is now moving in that direction I think is actually very appropriate. And also it lends itself -- I think LTX-315 truly lends itself to be very effective there because we know that, when you inject that, especially in melanoma patients, into lymph nodes with melanoma in them, we can activate the immune system locally so that you don't have an effect. And that local activation then can go to other lymph nodes that you haven't injected. And you can also, with the combination there, using a checkpoint inhibitor, you can also have an effect on tumors that have spread to distance sites away from that local area. So, I think that this is an appropriate way of moving forward, and I'm actually very excited to see this. And I think that really it sets a sort of -- from a Lytix perspective, it really sets the path forward as potential sort of treating patients earlier. Now, you're doing this in melanoma.

But I'd like to comment on one thing that also, Graeme, you talked about. You have your basal cell carcinoma as well that you're doing sort of in collaboration with other companies. I think that this also shows the potential of a compound such as LTX-315, that this is not just for melanoma. But this can be used in other tumor types as well. I think melanoma is a good initial step to evaluate it in. But we have to remember that there are many other tumors where this also could be beneficial in. So, I think that -- and I think that also, from a Lytix perspective, that you're looking at other compounds that you have in your armamentarium and specifically going after hepatocellular carcinoma. I think that really shows the breadth of your research and I think your development platforms.

So, I'm very excited for you at Lytix. I think that you're doing a fantastic job at moving this forward. And I very much look forward to seeing the rest of the patients on the ATLAS-05 study and on your neoadjuvant study. I think that this is really going to change the direction -- has the potential to change the direction in the way we treat patients with metastatic melanoma, especially in those very difficult-to-treat patients that have been on previous therapies and we currently really have no good therapies for. So kudos to you, Oystein and all the team at Lytix. I think this is terrific for you.

[Oystein Rekdal, executive]

Thank you so much for taking your time, Robert, for sharing your views and perspective, very highly appreciated. With this, I will now hand it over to our CFO, Gjest, who will provide you with a financial update.

[Gjest Breistein, executive]

Thank you, Oystein. Following the promising interim results from both Verrica and our Phase II studies, the clinical development of 315 has progressed steadily through Q4. In January, Verrica reported that all patients have been dosed with 315. And this is great news for Lytix as it confirms Verrica's commitment to complete the entire study by the end of first half 2024. The licensing agreement with Verrica is an important value driver as Lytix is entitled to receive contingent milestone payments and royalties from future sales.

Our own Phase II study, ATLAS-IT-05, has also progressed, and the updated readout showed good interim results. The fact that our treatment is able to stabilize the disease in very sick patients that only have few or no alternatives left is very encouraging.

Now, over to the key financial figures, in October, the Research Council of Norway approved Lytix' application for up to NOK 14.3 million of non-dilutive financial support over a 3-year period. Following this approval, NOK 4.8 million was recognized as other operating income in Q4, which explains the increase of total operating income to NOK 5.1 million. The remaining income for the period is a grant from Oslo Regional Research Fund.

Total operating expenses decreased by NOK 0.7 million to NOK 24.7 million compared to the same period last year. The major cost driver for the period is the ATLAS-IT-05 trial.

In 2023, Lytix introduced a cost-saving initiative aimed at enhancing our operations and organizational efficiency to prioritize the company's clinical development efforts. These measures result in substantial cost savings, thereby prolonging the runway on existing resources through first half of 2024. The initiative involves downsizing the workforce and maintaining a continuous focus on lowering other operational expenses. This action is imperative to safeguard Lytix operations amidst the current challenging global economic conditions.

Lytix is a R&D company dedicated to developing next-generation immunotherapy. Lytix has a lean organization that strongly focuses on generating clinical data and creating shareholder value.

With the recruitment of patients to ATLAS-IT-05 completed, the study has progressed steadily. Patients are continuing on the study as the combination regimen is resulting in prolonged stabilization in these heavily pretreated patients with poor prognosis.

Direct R&D expenses increased slightly by NOK 0.5 million to NOK 15.3 million compared to the same period last period. Other operating expenses decreased by NOK 1 million to NOK 3.4 million compared to the same period last year. Net financial items amounted to NOK 1.4 million in Q4 and are mainly a result of the USD exchange rate fluctuations.

Our cash position, including short-term financial investments, amounted to NOK 50.5 million at the end of the period compared to NOK 178 million at the end of the Q3 and NOK 145 million at the end of 2022. Due to robust efforts and controls established last year, Lytix has extended its cash runway through first half of 2024. The company continues to explore strategic partnering opportunities as well as other ways to finance its development plans.

Entering 2024, Lytix is looking forward to continuing the clinical development of LTX-315 and create shareholder value while ensuring financial support for our endeavors.

I will now hand it back over to Oystein.

[Oystein Rekdal, executive]

Thank you, Gjest. Looking forward, there are a few key messages we would want you to take with you from this presentation.

The ATLAS-IT-05 study is still ongoing, and we will report additional data from this study at a later stage. Verrica plans to present final results from the Phase II study mid-2024 with, as you heard today -- read today, top line data within this half year and which represent an important milestone and further validation of our technology.

Focusing on early-stage melanoma represents a large commercial potential for LTX-315, and we expect to have the first interim data from this planned study first half year 2025. We are in dialogue with clinical oncology experts to map out the optimal way to go forward for our second-generation asset, LTX-401. And we see a large commercial potential for this global asset. We are actively exploring new industrial research collaborations that can open additional commercial avenues, and our main strategy is to out-license our drug candidates with solid Phase II data.

I will now hand over to Gjest, who will take us through the Q&A session.

[Gjest Breistein, executive]

Thank you, Oystein. We have received quite many questions today, and I'll just jump straight into it.

The first question is regarding the ATLAS-IT-05 study. And it asks [indiscernibel] why are you not starting the expansion cohort for ATLAS-IT-05? I guess Graeme can answer that.

[Graeme Currie, executive]

Yes, happy to, Gjest. So we believe, from the ATLAS-IT-05 study, that we've seen clear evidence of efficacy. We have shown clearly in patients with advanced disease that are refractory, which is a really hard patient population to treat, that we're able to stabilize the disease. But we know that we rely on the patient's immune response, so moving to earlier-stage disease seems an obvious move where we can really benefit patients. So, I think we have enough promising data in this patient population, and we think moving to the earlier stages of disease will give us even better results.

[Gjest Breistein, executive]

And the second question we have received, which several have asked, is regarding financing. And I think I should answer that. And as mentioned in the presentation, we have done the homework and try to cut costs, which has helped significantly. We have prolonged the runway on current cash to end of -- or through the first half of 2024. And we are continuously exploring strategic marketing opportunities as well as other ways to finance the company.

But according to our long-term capital plan, the funding of this company's future growth and clinical progress will happen during 2024, and we will revert back to the market as soon as we have something substantial on this matter.

Next question, this is regarding Verrica and how Verrica and Lytix is going to diversify 315 from each other.

[Oystein Rekdal, executive]

Yes. So, we are continuing to develop LTX-315 in certain cancer diseases, whereas Verrica is also developing the same drug -- same drug called VP-315 in certain skin cancers like basal cell carcinoma and potentially also squamous cell carcinoma.

What we see here is -- regarding the differentiation is that basal cell carcinoma lesions are much smaller and flatter lesions which needs less dosing of LTX-315 versus the larger lesions we are treating. So Verrica will have vials with much lower doses, which is not practical for being used in larger lesions where you need many times more of LTX-315. So, we think that's a very good starting point to differentiate where it will be impractical to use Verrica's doses in our programs and opposite in all cancer indications -- and opposite.

[Gjest Breistein, executive]

Thank you. And we received some questions regarding the neoadjuvant study. And it goes like this, the first one, there are only -- there are no approved neoadjuvant treatments for melanoma. Is that correct? What is the status of the programs with pembro and nivo in this setting?

[Oystein Rekdal, executive]

Would you answer that, or should I answer that, Graeme?

[Graeme Currie, executive]

Why don't you answer that, Oystein?

[Oystein Rekdal, executive]

Yes, I can start. So, it's correct that there are no approved immune checkpoint inhibitors for [ neoadjuvant ] therapy. There are a number of studies with pembrolizumab, which we are planned to combine with, and with nivolumab, which is an [ analog ] to pembrolizumab from 2 different companies. So, not approved [indiscernible] but they have shown that -- the largest study with pembrolizumab has shown 20% pathological complete response in this population, so still a large bar to -- a possibility to enhance that efficacy, and 72% event-free survival after 2 years.

[Gjest Breistein, executive]

Thank you. The second question, regarding these studies, could you go into more detail about the difference between the patients in ATLAS-IT-05 and the new adjuvant study since both studies will include Stage III and Stage IV melanoma patients? Graeme, would you?

[Graeme Currie, executive]

Yes, I will answer that. So the ATLAS-IT-05 study is a study where we've been looking at patients who have gone through multiple rounds of therapy. They tend to have end-stage disease and metastatic disease, so they tend towards the Stage IV. And there's multiple stages of Stage IV that I won't go into, but they tend to be a more advanced disease stage, certainly with metastatic disease.

In the neoadjuvant setting, we are really around the Stage III. Now, we can enter some patients -- some patients with Stage IV, but it's going to be more focused on late Stage III. And these are patients who have tumors that are still resectable. They don't have advanced widespread visceral disease. So, there's an opportunity that we're able to access these tumors, shrink them before excision. So, yes, all advanced melanoma, but subtly different stages of disease with ATLAS-IT-O5 being the most advanced and those in NeoLIPA less advanced. And that gives us the advantage as well that there are not as many resistance mechanisms and a more intact immune response likely in those patients.

[Gjest Breistein, executive]

Thank you, Graeme. And one last question, and this is regarding your lifileucel product of Iovance. What do you think about the combining 315 with lifileucel, a T-cell therapy, which was approved by the FDA in melanoma 2 weeks ago?

[Oystein Rekdal, executive]

Yes, maybe I can answer that. That's a very good question. So, that T-cell therapy that was approved, it's a technology that you take out the T-cells from the patient's tumor or blood, but I think [ it is the ] tumor. And you multiply the immune cells to billions before you bring it back to the patients. And this is very good news that we have gotten approval of the first T-cell therapy in cancer patients.

The challenge, however, is that this T-cell therapy is totally dependent on the presence of T-cells in the patients. And we know that the majority of cancer patients still don't have these T-cells in the tumor -- [ cold ] tumors. And even in this T-cell -- even in the patients where you have T-cells, it can be irrelevant T-cells. So by combining a T-cell therapy with 315, that -- it boosts the right T-cells, and a broad T-cell response could be ideal to combine with T-cell therapy. Take out these T-cells generated by 315, use this technology to multiply them and bring them back. I think this is a very exciting way forward, and we are, in fact, exploring possibilities there.

[Gjest Breistein, executive]

Thank you, Oystein. I believe this ends the Q&A session. I would like to thank you all for joining the webcast today and for all the questions we have received. Thank you.