Q2 2023 Earnings Call. I am Greta Eklund, Investor Relations and Communications Manager. I will be introducing today's call. With me are CEO Søren Bregenholt, CFO Marie Svensson, and CMO Sumeet Ambarkhane. They will walk you through the latest developments from Q2 2023 and the upcoming news flow, after which they will be happy to answer any questions you might have. Before we begin, I would like to share a quick reminder with our listeners that during today's call, management may make forward-looking statements that involve known and unknown risks, uncertainties, and other important factors beyond the company's control, that could cause the company's actual results, performance, or achievements to be materially different from the expected results, performance, or achievements expressed or implied by such forward-looking statements.
These statements are subject to risks and uncertainties that could cause actual results to differ materially from those contained in the forward-looking statements. Actual results and the timing of certain events may differ materially from the results or timing predicted or implied by such forward-looking statements, and reported results should not be considered as an indication of future performance. Please note that these forward-looking statements made during this call speak only as of today's date, and the company undertakes no obligation to update them to reflect subsequent events or circumstances other than to the extent required by law. This call is being webcast and will be available through the Alligator website. With these formalities out of the way, I would now like to turn the call over to Søren.
Thank you, Greta, and welcome to this Q2 earnings call in Alligator Bioscience. I'm Søren Bregenholt, I'm the CEO of Alligator, and with me today, I have Marie, our CFO, and Sumeet, our Chief Medical Officer. As you can probably see from the setting, this is a truly virtual call from several locations in Europe. If we take the next slide, I'd like to begin by highlighting the latest set of outstanding data we released this quarter, in which our lead asset, mitazalimab, continued to demonstrate highly encouraging and differentiated efficacy in our OPTIMIZE-1 phase II study, which is in first-line pancreatic cancer. As you may remember, we reported last January an interim objective response rate of 52% in the first 23 patients treated in the study.
We now have an update on this group of patients, as well as a strong interim response rate for the entire patient cohort of the study, that is expected to improve further as patients remain on therapy, in the months to come, towards the final, top line read out in the beginning of 2024. The duration of response of treat to the treatment is very promising, and we expect it to translate into progression-free survival and survival benefits as the data matures. We are now looking forward to top line results from the study, with thanks to the dedicated and the hard work of the Alligator team, I expected, significantly earlier than initially anticipated in the beginning of the Q1 of next year, as I already mentioned.
I will be going into more details for OPTIMIZE-1 in a moment, but first, I'd like to recap Alligator's proprietary capabilities and our broader strategic overview. Although investor interest has naturally been very focused on the mitazalimab data and pancreatic cancer, our 4 proprietary platforms that have ability to deliver compounds optimized for safety, efficacy, and potency are starting to deliver, and are expected to provide significant optionality going forward. I remain convinced that mitazalimab is only the tip of the Alligator iceberg, if I may. Across our projects and compounds, we have repeatedly shown our ability to identify and develop high-quality therapeutics with optimal stability and excellent manufacturing potential.
Our third-generation CD40 agonist, which we call ATOR-4066, has even shown the ability to remodel the tumor microenvironment while inducing strong antitumor responses in a wide range of tumors in preclinical studies. Our business development efforts are focused on building partnerships around our proprietary technologies and assets. Over the years, we have established a strategic network of international pharmaceutical companies with common goals and values of bringing innovative, safe, and efficacious immune therapies to patients with hard to treat cancers. Under these agreements, Alligator is eligible for development, approval, and sales milestone payments, in addition to royalties, if the partner continue to develop and commercialize the product candidates. These partnerships provide an external validation of our technology platform. They de-risk our development of product candidates through the sharing of knowledge and resources, and facilitate rapid preclinical development.
They can also provide significant revenue streams for the company, with the potential to develop into distinct business ventures of their own. With this strategy, Alligator has the ability to increase the number of indications we target within our pipeline, extend our patient reach as far as possible, and secure long-term financial benefits for the company and our shareholders. In the next slide. We can have a look at the highlights from the Q2 of this year, and we'll start with our lead asset, mitazalimab, and the latest positive clinical data from the OPTIMIZE-1 phase II study in first-line metastatic pancreatic cancer. Firstly, we conducted a second interim analysis on the 23 patients that we included in the January analysis. This initial interim analysis looked at the response rate developed at the first 17 weeks of treatment.
The second analysis, though, was conducted with a later follow-up and demonstrated, importantly, a deepening of tumor responses amongst the patients, with the objective response rate increasing to 57% from the initial 52% reported. It is great to see that the objective response are improving over time like this, and it is a strong indication of the treatment provides durable benefits to the patients and also a validation of the immune stimulatory mechanism of mitazalimab. We also conducted a full interim analysis on the 57 patient cohort in the study, in which 25 patients responded to the treatment, resulted in an interim objective response rate of around 44%.
While this figure may be, or is, numerically lower than what we reported for the initial cohort, it's highly encouraging, as we believe it will improve further as the time have longer opportunities to stay on treatment towards the top line readout in the beginning of next year, mimicking what we saw with the response rate in the first 23 patient cohort. Recruitment of OPTIMIZE-1 was completed ahead of schedule in April. Thereby eliminating operational risk of this important phase II study and placing us in an excellent position to deliver top-line data in early Q1 2024, much earlier than initially anticipated, as I already touched upon. It is clear from these advancements that we are continuing to make excellent progress with the clinical development of mitazalimab and its route to market.
I'm pleased to report that we received orphan drug designation from the US Food and Drug Administration for mitazalimab in pancreatic cancer. This designation confers significant benefits in the form of marketing exclusivity, cost saving once the drug candidate receives approval. The FDA also cleared our investigational new drug application for mitazalimab, which allow us to initiate the clinical evaluation of the drug in a new indication, urothelial carcinoma, the most common malignancy involved in the urinary system. This is a welcome expansion to our mitazalimab clinical program and further demonstrate that CD40, our CD40 agonist, has potential beyond pancreatic cancer.
In another mitazalimab development this quarter, our partner, Amphera and Erasmus Hospital in Rotterdam, successfully dosed the last patient in the REACtiVe-2 study, which is a phase I study in pancreatic cancer, evaluating mitazalimab in combination with a dendritic cell vaccine called MesoPher. It's in patient with metastatic pancreatic cancer. The data that mitazalimab is generating also generates significant traction with the scientific community. We held presentations at this year's ASCO conference in Chicago in June, outlining the comprehensive data from the January OPTIMIZE-1 readout. ASCO is the leading global scientific conference for cancer therapies and was an excellent opportunity for us to showcase mitazalimab's strong clinical performance to the world's top oncologists.
I'm pleased to say that we've been receiving significant interest in mitazalimab, both from the medical community, but also importantly for potential partners, as seen as a combination therapy for pancreatic cancer and beyond. Following up on the partnership front, our research collaboration and license agreement with Orion Corporation is making rapid progress, and I think it's fair to say that both parties are very pleased with the progress. We have generated several attractive options for Orion to select candidates for final development in our first collaboration projects. Orion has now exercised its development option in that first collaboration, triggering a milestone payment to Alligator.
Finally, our preferential rights issue raised SEK 181 million, ensuring that we remain well-financed to deliver our OPTIMIZE-1 top line data, while keeping dilution of our current shareholders to a minimum. We greatly value the support of our investors, and we are grateful for the trust they continue to place in our company and our drug candidates. As you see, it has been a very busy and productive quarter for Alligator. We expect the remainder of the year to continue this trend and what is proving to be a period of dynamic development for the company. With that, I would now like to hand over to our Chief Medical Officer, Sumeet, for some more details around the OPTIMIZE-1 interim readout and put them into concept with the current standard of care in this debilitating disease. Sumeet, over to you.
Thanks. Thank you, Søren. Next slide, please. This is a brief introduction to pancreatic cancer, which is the lead indication for mitazalimab clinical development and also the focus of our ongoing OPTIMIZE-1 clinical trial. pancreatic cancer is a very aggressive disease, associated with a lot of burden to the patients. This is typically diagnosed in late 60s or early 70s. Currently, this is the 4th most common cause of cancer-related death in both men and women, and it is expected that the cases of this disease will be increasing substantially in the coming years and decades as the life expectancy increases worldwide.
Majority of the times, the disease has already progressed and spread to other organs, unfortunately, in the body, at the time it gets diagnosed, and this essentially rules out surgical cure for most of the patients. For the minority of the patients who can undergo surgery because the disease get diagnosed early, they experience, unfortunately, a relapse, or eventually a metastatic progression of the disease. This stage of the disease, which is typically called as the metastatic pancreatic ductal adenocarcinoma, is the case pretty much for every patient who has a diagnosis of pancreatic cancer. Treatment options for patients with metastatic pancreatic cancer are limited, essentially to chemotherapy, and the choice of chemotherapy drugs depends on how fit the patient is.
For patients who are fit enough for strong and potentially more effective treatment, either a four-drug regimen called as FOLFIRINOX, or a two-drug regimen called as gemcitabine, combined with paclitaxel, is administered to the patient over multiple months. The results of these chemotherapies are quite unsatisfactory, and majority of the patients survive typically only for approximately a year after they get the diagnosis. For patients who are less fit, treatment is often comprising of single agent gemcitabine chemotherapy, and survival with that is even shorter to few months. This is a disease area where better treatments are needed very urgently, and that is where an immune-stimulating drug, like mitazalimab, has the potential to improve patient outcomes. Next slide.
As mentioned by Soren, the interim analysis objective response rate for the entire cohort of 57 patients in the OPTIMIZE-1 study is currently at 44%. On the left-hand side, you can see that from the chart that this response rate compares strongly to the standard of care chemotherapy regimens such as gemcitabine or FOLFIRINOX, which are down at 23% and 32%, respectively. I should also repeat that the 44% response rate that we are seeing in the OPTIMIZE-1 study is actually expected to increase by the time we get the primary analysis or the top line results of the trial. Indeed, the response rate of our initial 23 patient cohort was 52%, as was published in the first analysis earlier in January this year.
Whereas in the current analysis it is 57%, with an increased treatment and follow-up duration. These response rates are a strong indication that mitazalimab, combined with FOLFIRINOX, offers significant clinical benefit for pancreatic cancer patients over the standard of care, chemotherapy alone. Similarly, in the chart on the right-hand side, we can see that the median duration of response, with OPTIMIZE-1 study, was 8.7 months, significantly longer than the 5.9 month median duration of response, which is reported for FOLFIRINOX chemotherapy alone. This is an important finding because this is an indication of the immuno-stimulatory effect of mitazalimab, which also potentially points towards a benefit in terms of progression-free as well as overall survival in this patient population.
Additionally, I'd like to mention that, 19 patients, that is 33% of the overall evaluable patients in the trial, achieved a stable disease to the treatment, and that resulted into a 77% of disease control rate. This, together with mitazalimab's manageable and good tolerability profile in combination with modified FOLFIRINOX, was again confirmed with this additional interim analysis that we recently published. Next slide, please. Following our reporting of the second interim analysis from OPTIMIZE-1 study, and also subsequent to our publication of the study data at the ASCO annual meeting in Chicago in June, we held a key opinion leader webcast. This was.
This event featured Professor Zev Wainberg, who is a globally recognized medical oncologist, heading the division of gastrointestinal malignancies at the University of California in Los Angeles, and well known for his expertise in the field of pancreatic cancer. In this webcast, we discussed the current treatment landscape in pancreatic cancer, also the OPTIMIZE-1 phase II interim data, and also how mitazalimab could transform the treatment paradigm and provide clinically relevant benefit to these patients. This event, although online, was very well attended by a number of our stakeholders and also by potential strategic partners, equity research analysts, and also qualifying institutional investors.
Wainberg expressed his excitement about the recent results mitazalimab has achieved in the clinic, and the potential this treatment combination is demonstrating in pancreatic cancer, especially when compared to the current therapeutic options and their outcomes, which are essentially unsatisfactory. Of particular interest was the information Dr. Wainberg discussed about the median duration of response of 8.7 months, which he described as impressive. And he also pointed out that better duration of response usually corresponds with a better progression-free survival. This sort of gives us a hint on the potentially increased survival benefit of mitazalimab. Dr. Wainberg also highlighted the good safety profile demonstrated by mitazalimab, both as a single agent in the previous trials, but also, even more importantly, in combination with the FOLFIRINOX chemotherapy.
This can potentially allow patients, even with higher ECOG performance scores, meaning, so to say, less fit patients, who can also be treated with mitazalimab and the modified FOLFIRINOX chemotherapy combination. This webcast finished with a very lively and informative discussion and question and answer session. Indeed, this was a very valuable and worthy event that happened recently. Next slide, please. Looking ahead now to the key inflection points for mitazalimab in the coming months. So we are planning to initiate discussions with regulators in the US as well as in Europe in the second half of this year on what the optimal route to development and commercialization, including entry to the market for mitazalimab in pancreatic cancer, would be.
We are also anticipating to complete our enabling toxicology work as a part of our preparations for the mitazalimab phase III clinical development preparation in pancreatic cancer. Following on from the orphan drug designation from the U.S. FDA in May, we are also expecting to hear about potentially receiving the same orphan status also from the European regulators, this would afford us similar financial and regulatory benefits, including market exclusivity. All in all, this sets up perfectly for the OPTIMIZE-1 phase II studies, primary or the top line readout, which, as we have mentioned, it is due in early part of Q1 of next year, 2024, and several months, almost nine months ahead of schedule.
Moving further into the first half of next year, we will also leverage mitazalimab further, with the expected start of our second phase II study in the new indication of urothelial carcinoma. With that, I'd like to turn it back to Soren.
Thank you, Sumeet. Before we take the next slide, let me just reemphasize that based on these very encouraging interim phase II data, Alligator is continuing to invest in IND-enabling toxicology or phase III enabling toxicology, as Sumeet just said. We are also continuing investing in manufacturing process development, both for phase III and commercial, as this is believed to, or not believed, this will minimize the time to be able to initiate a phase III clinical development and will definitely also prove valuable for a future partner. Talking about partners, we are intensifying our dialogue with the, with interested global pharma and big global biotech, who have taken a lot of interest in mitazalimab after these interim phase II data.
We expect, again, that a deal will be imminent in the quarters after the top line readout, as just outlined by Sumeet. If I could have the next slide. Here you can see an overview of our internal programs, which give you a good sense of our robust immuno-oncology pipeline that we built internally and that we continue to develop with substantial clinical and commercial potential. Our antibodies address key immune activation pathways and are designed with features that make them complementary to existing cancer therapies, whether that is chemotherapy, as we see with mitazalimab and OPTIMIZE-1, or together with the checkpoint inhibitors. We believe that this puts our antibodies in a unique position as part of tomorrow's combination therapy, allowing them to help patients with hard to treat cancers.
We see a number of inflection points coming up which are worth looking out for. We have already mentioned OPTIMIZE-1 top line data, early Q1 2024, and OPTIMIZE-2 initiation. We are also expecting to see the first intermediate data from our phase I study with ALG.APV-527, co-developing with Aptevo Therapeutics, and we expect to see those data in the second half of this year. On the next slide, please. We have an overview over our existing partnerships, and I bring this up because I think that's an aspect of Alligator's development that I feel is often overlooked by our investors. We have built these over the last five to six years.
And they're now starting to delivering value with already two assets in the clinic, together with Aptevo and our collaboration with, AbClon and Henlius. In addition, we have the partnership we have entered into in 2019 and 2021. As you already heard about the Orion collaboration, these partnerships are moving ahead and are providing our significant optionality in how we develop Alligator in the future. Now, with these words, let's turn to our CFO, Marie Svensson, to review our latest financial results, for the quarter. Marie?
Thank you, Søren. Next slide. Yes, thank you. I will start with going over the financial figures for the quarter. Net sales for the Q2 2023 amounted to SEK 17.4 million, up from SEK 5.2 million in the prior year period. Operating loss for the quarter resulted in SEK 63.7 million, an increase from SEK 45.9 million in the prior year. Cash flow for the quarter amounted to SEK 115.6 million, compared to negative SEK 41.7 million in the prior year period. For the six-month period, January to June, net sales amounted to SEK 27 million, up from SEK 10.5 million in the prior year. Operating loss for the half year period resulted in SEK 125.9 million, an increase from SEK 88.9 million in the prior year period.
Cash flow for the half year period was positive SEK 63.4 million, compared to negative SEK 85.5 million for the same period last year. Revenue in the quarterly and half year periods for 2023 was a result of the research and license agreement with Orion, mentioned earlier, where a second program started earlier this year, so now 2 programs are running in parallel. In addition, Orion exercised the development option in the first program, which generated a milestone payment in Q2. Operating expenses for both period was mainly connected to costs for the ongoing clinical trials for mitazalimab and 527, as well as phase III enabling activities for mitazalimab. In the figure down to the left, you can see how expenses are distributed between our projects in Q2.
Not surprisingly, 50% of our resources has been focused on the mitazalimab project. An important point I would like to bring to your attention is the focus on financial resources behind our R&D efforts. While Alligator dedicated around 70% of the operational expenses to R&D in 2020 and 2021, this level was significantly increased in 2022, reaching 81%, and our efforts have continued, leading us to dedicate 86% in Q2. Next slide, please. If we look at Alligator's operating cost on a rolling 12-month basis, we note an increase due to the expansion of our clinical trial activities and the increasing number of patients being enrolled and staying on in the trials, as well as the phase III enabling activities Søren mentioned before. At end of June 2023, Alligator's cash at hand amounted at SEK 160.6 million.
Our preferential right issue in the quarter secured SEK 181 million before transaction costs. In order to support the continued development of our key assets, the company is continuously working on opportunities for partnership, out licensing deals, and equity financing. This includes both business development for new partnering agreements with an upfront payment upon signing, as well as other financing options. With that, I will turn the call back to Søren.
Thank you, Marie. That was crisp and clear. Can I have the next and final slide, which is an overview over the significant news flow from Alligator over the next 12 months? As you can see, here, we, and, already discussed in, in the webcast here, we expect to hear back from the European authorities about orphan drug designation during Q3 this year. We will continue our discussion with the U.S. and European regulators on the best development path for mitazalimab in pancreatic cancer during the late Q3 and Q4 of this year. That will lead to a readout of the phase II top line data in pancreatic cancer early Q1 2024.
With respect to our collaboration on 527, which is currently in phase I, as already mentioned, we expect to be able to share the first preliminary data from that study in the second half of the year, probably most likely Q4. With that, we will now continue with the Q&A, you will be able to post your questions directly in the chat. We have a number of questions coming in directly here. These are a number of questions from Richard Ramanius from Redeye, I think we'll have the first one going to you, Sumeet. How is the recruitment in the 527 phase I study progressing?
Yeah. The program had started, the recruitment is taking place as we are, yeah, continuing to monitor it. We expect that it will continue as... I mean, this is a phase I first human trial, and it follows a dose escalation scheme. Exactly, so the recruitment will continue as per plan, and this is currently the case.
Thank you, Sumeet. Let's move on to a number of questions here. There is a number of questions coming in around the same topic here that I'll also address to you. This is from Patrick Boily. Why do you see a lower objective response rate in the full cohort versus what you reported in the smaller cohort? All 23 patients in the interim had crossed the 17-week period, which is 4 months. Was that the case with the full patient population?
Yeah, in fact, yeah, the second part of the question is probably the answer to the first part. Exactly. A lot of patients in this full analysis that we reported as an interim update recently have been in the treatment for a relatively short period of time. And that means that they have not had sufficient length of exposure to the treatment while they are ongoing with the treatment, but they need to have a couple of scans. In the previously published analysis, majority of the patients had crossed the 17-week period, which was not the case in this analysis.
A lot of them are ongoing, have not crossed this particular sort of time point where they had a couple of scans, and that's pretty much the reason why we see a slightly lower response rate in terms of, in terms of %, but we anticipate it to go up clearly in the coming, I mean, as they continue the treatment and follow up.
Thank you. I think just to reemphasize that point, we have a question from another investor here to say: Do you think the trend of deepening the response, the deepening of responses will continued therapy will also be seen as the treatment continues and you continue with a longer follow-up in OPTIMIZE-1?
Mm-hmm. Yeah, this is quite a remarkable finding because late onset of response, and it's deepening over a continued long treatment is sort of unusual, in the context of pure chemotherapy-based treatments.
Mm-hmm.
This is also a classical effect that can be attributed to immunotherapies such as mitazalimab. That has been the case, as we reported that from the 23 patients which were included in our first analysis, several of them had a deepening of their response and with the continued and long ongoing treatment. The longest ongoing treatment has been 17 months, and I think we expect the trend to also come up and even be confirmed with our upcoming top-line results.
Good. We continue a little bit with mitazalimab here. one investor here asked whether you could comment on the safety profile of mitazalimab in combination with FOLFIRINOX, as other CD40s has been hampered by, if not, it says here, severe side effects, but at least somewhat severe side effects.
Right. This is quite an important aspect, and also was highlighted by Professor Wainberg in the webcast that was recently conducted. Classically, with the CD40-based treatment that have been evaluated so far, toxicity has been not the easiest thing to manage. There have been some sort of dose-limiting and treatment-limiting toxicities, whereas with mitazalimab combined with FOLFIRINOX, the safety profile that we observed is essentially reflecting FOLFIRINOX chemotherapy and giving a good strong sign that mitazalimab is not adding substantially to the toxicity profile of FOLFIRINOX. Importantly, the CD40 sort of associated limiting toxicities, such as cytokine release, which was seen with other CD40 antibodies, is absent so far in our trial.
This is a very positive signal as far as safety is concerned. Also, other types of limiting toxicities which are affecting liver and so on, was also in a very small proportion of patients, indicating, again, the differential safety advantage that comes along with mitazalimab as the CD40 component in the treatment.
Okay, thanks, Sumeet. We have another question from Patrick Boily here. Again, on mitazalimab, what points will you be discussing with the regulators in the second half of the year? What are the expectations about an accelerated approval in pancreatic cancer?
Right. In fact, these are exactly going to be the points that we will be focusing in our interactions with the regulatory authorities. Essentially, our approach will be to discuss what can be the most efficient and sort of the fastest development pathway for mitazalimab. How could this confirmatory development program look like, what could be the endpoints and so on and so forth. I mean, this is very much under preparation, and we are actually looking forward to these interactions.
Yes. Then one last question on mitazalimab, at least of what I have here on the chat. What data do you think a potential partner would want to see before partnering with mitazalimab?
Yeah, this is a very important aspect in terms of the program development. As Søren mentioned, and as we saw on the slides, the primary endpoint of the trial, OPTIMIZE-1 being a phase II trial, is objective response. However, what is equally and even more important from a patient's point of view is how long the patient can stay free of disease progressing, and eventually, how long can the patient survive with this combination treatment. Quite importantly, the proportion of patients who respond, meaning the objective response rate, also how long the response lasts, which is the duration or the durability of the response, as well as other time to even endpoints, such as progression-free and overall survival.
These are going to be the key cornerstones of the data, the results, and also something that a potential partner would be looking for and interpret and basically be able to interpret that as a differential advantage coming from mitazalimab, combined with FOLFIRINOX. I think that can. In fact, that is going to be the important part of decision-making or, yeah, what a partner will be looking for as far as this program is concerned.
Thank you, Sumeet. Stay tuned as more questions may come in. Now we shift a little bit to you, Marie. A question here that is not directly on mitazalimab. I'm sure that the answer might be. Your operating costs are increasing. What is the reason for that, and will that continue?
As I mentioned before, you know, we have more patients in the study, and they are staying on in the study, and that's, of course, very good. That leads to some increased cost for us due to a lot of patients in the study. Hopefully, that will continue. There are also big investments to make this, you know, to have CMC production and the toxic quality, phase III enabling activities that cost quite a bit. The CMC process for this is around SEK 100 million. That will continue for some year, but it will be spread over time, of course. The increased cost will stay on for a bit.
Thank you, Marie. I have 2 questions here, where one may be the answer to the other. Your FT number grew by 20% compared to the same period a year ago. Which department grew most, and what functions were added? We have a question. Actually, the investor here answers his or her own question. The 2nd largest portion of your R&D resources goes to discovery. Do you have anything developing from there?
The main resources are, you know, added, the last year because we have 2 programs running with Orion, so that has increased. And that staff is in discovery because that's where they, you know, make these molecules. The revenue is also covering more than the cost for this staff.
Thank you, Marie. We will also get back to you. I think we have a couple more questions from Richard, from Redeye. I will try to answer them. One is: What is your plan with 1017? 1017 is our 4-1BB monoclonal that has successfully completed phase I. We have decided not to continue investing in until further notice. We see both 1017 and 527 as, or we have a great optionality around these two molecules. Currently, they are in our pipeline. We see both of them as potential clinical investments after mitazalimab license.
But we also would see them as potential diversity targets if we get the right balanced offer for those. Another question from Richard: Can we expect any more milestone payments or other income before the Q4 or Q1 2024 readout of mitazalimab? You know very well that we cannot comment on that. But the programs that you are probably alluding to are progressing according to plan. We have another question here. Let me just see, and I think that's the last one, also from Richard. When do you plan to start the second trial of mitazalimab, and how will you finance it? That's the OPTIMIZE-2 trial with mitazalimab being combined with a checkpoint inhibitor in metastatic urothelial carcinoma.
We see that as an opportunity to expand the use of mitazalimab, expand the number of patient reached and the number of patient benefiting from the drug. We have the IND approved, we have the clinical plans ready. Right now, as Marie is alluding to, we are seeing increased cost in OPTIMIZE-1, associated with the patient staying longer on trial. Right now we are dedicating all our finances to be able to deliver on that promise to deliver data in Q1 2024. With that, there are no more questions in the chat. Thank you, Sumeet. Thank you, Marie, and thank you, Greta. Thank you, all of you who has been following this call.
Have a great day, a great evening, wherever you are. Thank you.
Thank you.