Good afternoon. Thank you, Nomura-san. My name is Chris Cargill, CEO of Nxera Pharma. Thank you for joining our 2025 R&D Day. Let me start by welcoming our new Chief Scientific Officer, Dr. Patrik Foerch. Patrik is an accomplished R&D leader with over two decades of experience across immunology, oncology, and neuroscience. He has deep expertise in working in both pharma and venture capital-backed biotech companies, and in supporting the development of AI-driven drug discovery platforms. Patrik brings a very sharp, execution-oriented focus to our R&D business. We're very excited to have Patrik on board to drive delivery of the research pipeline to support nearer-term value creation. Please turn to slide six. Yesterday, we announced a focused restructuring to enhance our path to profitability and to increase the returns across the portfolio. We have completed a review of the pipeline and prioritized programs with the greatest potential.
For commercial reasons, several programs will be partnered or terminated. We will remain very active in drug discovery, and we will prioritize targets with de-risked biology, and we'll leverage our NxWave platform to design oral small molecules that can win with superior product profiles. Obesity, metabolism, and endocrinology is where we're going to focus a lot of our effort. Our first-in-class drug for schizophrenia, NXE' 149 has completed phase I studies and will potentially be licensed by our partner, Boehringer Ingelheim, in the near term. We will stop investing further in our first-in-class drug for IBD, NXE' 732, as this is simply too complex and expensive an area for us to develop going forward, and we will seek a partner for this novel product. In addition to pipeline changes, we announced we are slimming down the leadership and the workforce and a reset of the cost base.
We expect to achieve significant cost savings, and these changes create a leaner, more execution-oriented company focused only on the highest potential opportunities. Please turn to slide seven. Despite the business changes announced yesterday, our long-term vision remains unchanged: JPY 50 billion of annual revenues and operating profit margins above 30% by the end of 2030. Now, the goals for our Japan commercial business remain unchanged as well: five medicines launched in Japan by the end of 2030, and we are actively hunting for new medicines for patients in Japan. The changes are about how we execute research, the biggest value driver, and this is how we can get back to creating asymmetric upside returns for our investors.
Now, effective today, our investments will focus on best-in-class product opportunities, as I mentioned, to tackle obesity and chronic weight management, as we announced in August 2025, plus other metabolic and endocrine disorders. 80% of the research portfolio will be allocated to these therapeutic areas. These are therapeutic areas where we believe we can deliver programs with speed to an early safety efficacy signal and measure physiological changes in early patient cohorts, resulting in a better probability of success. Please turn to slide eight. As I said at the beginning, we have done a focused restructuring to enhance our path to profitability and increase return across the portfolio. The R&D focus is clear, the prioritized programs are clear, and Patrik will lead the execution and delivery. Now, for commercial reasons, several programs are no longer a priority, and they will either be partnered or terminated.
Either way, we will not allocate capital or resources to these programs anymore. Our operations will be streamlined. We are removing layers of management to enable faster decision-making and to align our resources with the renewed R&D focus. These actions will drive a cost-based reset that will enhance our path to profitability. There will be one-time restructuring charges, JPY 500 million booked in FY 2025. We have a near-term cost-based reduction of over JPY 1 billion from FY 2026. Cash R&D expenditure at our research facility in Cambridge, U.K., is expected to decline by approximately JPY 3.5 billion in FY 2026. Of course, these changes will impact our people, and these decisions are always very difficult and were considered deeply.
We will say goodbye to many talented colleagues that have poured enormous effort into Nxera over the years, but the changes are necessary to simplify how we work and operate with discipline and speed in the current environment. Now, please turn to slide nine. The reset puts us in a very strong position to capitalize on the momentum we have in discovery and in the clinic, as well as the commercial growth we are achieving in Japan. Our existing programs, both in-house and partnered, have real momentum at the moment. Our partner, Neurocrine, is advancing the muscarinic M4 agonist, now known as Direclidine, for schizophrenia through phase III registrational trials in the U.S., and soon an additional phase II trial will begin for patients with bipolar mania.
Our partners in Centessa last week demonstrated the potential best-in-class profile of ORX750 for the treatment of narcolepsy type one, narcolepsy type two, and idiopathic hypersomnia in initial cohorts of an ongoing phase II A study and expect to initiate a registrational program in Q1 2026. Our in-house program, NXE' 732, the EP4 antagonist, has advanced to phase II A expansion studies across tumor types for patients suffering from cancer. Our in-house program, NXE' 149, the GPR52 agonist to treat schizophrenia, will soon complete phase I, meaning our partner, Boehringer Ingelheim's decision to license is near term, a decision that could bring a EUR 60 million milestone. As we approach next year, our medicines are poised to make an impact for our partners and, most importantly, for patients.
We have the potential to generate important financial milestones next year, which, when combined with the focused restructure, enhance our path to profitability. Thank you. I'll now pass over to Maeda-san, the President of Nxera Pharma Japan, to update you on the growth of our commercial business in Japan and APAC. Thank you, Maeda-san.
はい、よろしくお願いします。
Thank you very much. So my video is...
これ、ビデオをオンにできますかね。
Can you turn my camera on?
あ、音声聞こえてますでしょうか。
Can you hear me?
あ、音声は聞こえてます。
Yes. Your voice is fine.
あ、コントロールできませんので。
I'm sorry, I cannot operate my camera, so...
あ、すいません。
Thank you so much. Thank you. Sorry for the wait. I am Maeda, Group CEO. Next, I will explain our Japan and APAC business. Next slide, please.
はい。
First, let me explain the market environment in Japan and APAC. On the left side, Japan serves as the base, the most important market for the APAC market expansion, and is the world's third largest market. The key characteristics of the Japanese market include a comprehensive national healthcare insurance system and the ability to achieve rapid insurance reimbursement within 90 days after regulatory approval. The Japanese government is advancing policies to reduce drug loss and drug lag. We can see that the market is in a favorable condition. Now, on the far right, regarding APAC, it is the world's second fastest growing pharmaceutical market, with a population exceeding 700 million in ASEAN alone and continuing to grow. It is expected to become an even more promising market in the future. Leveraging these favorable market conditions, we will accelerate our business expansion in APAC, centering on Japan.
Next, the update on individual products. PIVLAZ, this is our first marketed product. PIVLAZ is a therapeutic agent intended for the prevention of cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage. Its market share reached 73% as of August 2025, and by September this year, the number of patients treated with PIVLAZ reached 23,000. It has firmly established itself as the standard of care in Japan. One highlight to mention this year is the practical guidelines for clazosentan administration, currently being developed by the relevant subarachnoid hemorrhage academic societies. Currently, this explains, puts together the opinion on the proper use of clazosentan. Currently in the public comment phase, it is scheduled for final publication in February 2026. It is rare for a society to issue such proactive guidance. We will maximize this opportunity in next year's commercial activities, focusing on further growth and market expansion for PIVLAZ.
Next slide is QUVIVIQ. QUVIVIC is a novel dual orexin receptor antagonist, DORA. In Japan, where conventional anti-anxiety drugs and Z-class drugs tend to be avoided by physicians, DORA is rapidly gaining traction. Japan is the world's largest DORA market, with its market size estimated at up to $1 billion or approximately JPY 150 billion. Regarding QUVIVIC, while there is currently a two-week prescription limit, the restriction will be lifted next month. Significant sales growth is anticipated starting next month. Next slide, please. Now, I will explain the sales and profit structure of QUVIVIC. As you can see in the graph, for the time being, revenue comes from royalty income, but in the future, profit growth is expected through cost reduction effects.
We are advancing a comprehensive strategy to optimize the supply chain, and up to now, we have completed establishing Nxera's independent supply chain separate from the licensor. Most recently, in October last month, we also obtained a regulatory approval for our second API manufacturing facility. Usually, API cost is the largest cost item, and the second API manufacturing facility approval means that we have a clear roadmap towards cost reduction. Moving forward, we will steadily implement actions to optimize costs, such as raw material procurement and formulation packaging process optimization. This end-to-end supply chain is now being revisited to continue reducing costs and strengthen our profit structure. Lastly, let me explain 2025 sales guidance.
はい。こちらのガイダンスですね、当初、もともとお示ししているガイダンスから変更はありません。
No change from the initial guidance. For PIVLAZ, target sales of JPY 13 to 14 billion, while QUVIVIC aims for JPY 4 to 5 billion in royalties and product supply. Sales trends remain strong, with PIVLAZ projected to grow +7% year- on- year and QUVIVIC over 200%. We will continue to focus on expanding the market for both products and maximizing their profitability. Thank you. That is all for the APAC update.
Hello. I will be giving the research update, and as Chris has alluded, Nxera is entering a new chapter, focused, data-driven, and ready to deliver best-in-class GPCR medicine with precision and speed. We are a global leader in GPCR drug discovery, built on the strengths of our NxWave platform. We solved nearly 500 molecular structures across 60 receptors, and our portfolio has delivered 24 clinical stage programs to date. Today, I'll share how we're advancing our strategy with a sharp focus on best-in-class programs where the biology is de-risked and the opportunity for patient impact is the greatest. Please turn to the next slide. As you're aware, we launched a new wave of oral small molecule programs targeting high potential targets in obesity, metabolic, and endocrine disorders, leveraging our NxWave platform to deliver novel and differentiate small molecules.
149, our first-in-class schizophrenia candidate, is approaching pivotal phase I readout, which will trigger a license decision from our partner, Boehringer Ingelheim. NXE' 732 is a novel molecule as an add-on to immunotherapy for advanced solid tumors that is being progressed through clinical trials with our partner, Cancer Research UK. I will provide further updates on these programs over the next few slides. Please turn to the next slide. NXE' 732, our EP4 antagonist, is our candidate that we're progressing in solid tumors. The rationale behind EP4 antagonism is strong and well established. When EP4 is activated, it dampens the immune response and promotes tumor growth by allowing tumors to evade immune surveillance. Currently, less than 20% of patients are eligible for checkpoint inhibitors that would deliver lasting benefit. However, EP4 antagonism offers a way to restore immune surveillance and enhance the efficacy of those existing therapies.
Interestingly, ONO's recent success with their EP4 antagonists validates the mechanism and highlights the opportunity for this target class. NXE' 732 is destined to deliver a high-potent, selective, and safe molecule, positioning Nxera to lead this next wave of innovation in immuno-oncology. Please turn to the next slide. I will now be sharing some results from our phase I study together with Cancer Research UK, which was recently published in a poster format. The phase I study was evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics, as well as anti-tumor activity of NXE' 732 as a monotherapy and in combination with a checkpoint inhibitor in patients with advanced solid tumors that are resistant to standard therapy. As you can see on this slide, we were extremely encouraged to see two partial responses in two patients in renal and in colorectal cancer in the combination arm of our study.
This showed more than 30% tumor reduction, especially in these tumor types, which are typically refractory to immunotherapy. Please turn to the next slide. On this slide, you can see very strong target engagement on the left-hand side of this slide, which is in line with our preclinical observations, and our population PK model confirmed that at 160 mg daily dose, we achieve greater than 90% receptor occupancy. Importantly, this was exactly the same dose received by these two patients who achieved a partial response, and more importantly, that dose was not limited by safety. We retained the flexibility to potentially explore higher doses if we need to. With those data in hand, the study moved into a phase II expansion in September 2025 in colorectal cancer, in GOJ, clear renal cell carcinoma, and metastatic prostate cancer.
This combination of safety, tolerability, and early efficacy signals demonstrates a real best-in-class potential to overcome the immune resistance in these hard-to-treat tumors as we move forward into our expansion cohorts. Please turn to the next slide. NXE' 149 is our first-in-class GPR52 agonist offering a novel mechanism in schizophrenia. GPR52 is a unique target that is expressed both in the striatum as well as in dopaminergic neurons in the prefrontal cortex. An activation of these pathways has the potential to replicate benefits of the dopaminergic mechanism while also enhancing cognition, something that is not currently treated. NXE' 149 has completed its phase I single ascending dose study, confirming excellent safety and a PK profile that enables convenient once-daily dosing. The phase I B, including pharmacodynamic measures of GPR52 activation in the brain, is currently on track to deliver data by the end of the year.
As you are aware, we're advancing this program in collaboration with Boehringer Ingelheim under an option to license agreement. The decision point is expected near-term, positioning NXE' 149 as a potential first-in-class asset in this very important indication. Please turn to the next slide. We are leveraging our NxWave platform to design the next generation of small molecules for obesity, metabolic, and endocrine disorders. As we communicated earlier this year, we launched a broad new pipeline strategically focusing on best-in-class therapeutics to achieve long-term weight maintenance through convenient oral small molecules in a market that is currently dominated by peptide drugs. We are focusing on improving outcomes for patients with obesity-related comorbidities such as cardiovascular, renal, and liver diseases, which is a very rapidly expanding market. We are targeting a number of receptors, for example, GLP-1, GIP, amylin, plus multiple others.
Our focus with our unique platform and small molecules is safety, tolerability, and expanding access to a diverse patient population. Our metabolic portfolio underscores the versatility of our NxWave platform, our commitment to tackle global health challenges, and applying the same data-driven approach with aggressive timelines that have defined our success in GPCR drug discovery in the past. With this, I will now provide a couple of updates on our partner portfolio. Please turn to the next slide. I will start with our long-standing collaboration with Neurocrine, showcasing Nxera's GPCR discovery world-leading muscarinic pipeline. Neurocrine's muscarinic portfolio now includes four clinical stage assets spanning selective M4, M1, and dual M1, M4 autosteric agonists addressing cognitive and psychotic syndromes across a range of neuropsychiatric diseases. Our most advanced candidate is the M4 selective molecule, NBI-'568.
This is currently in phase III in schizophrenia, and a phase II is initiated this year in bipolar mania, which is ahead of schedule. NBI-'570, the dual M1/M4 agonist, is scheduled to initiate phase II in schizophrenia in Q4 of this year. Two phase I studies are ongoing for a preferring M1 molecule, ''567, and a preferring M4 molecule, 569, and the data for these ongoing studies will likely be shared from Neurocrine Biosciences during their R&D day on the 16th of December. This continued momentum underscores the quality of the assets and the robustness of the underlying muscarinic platform while avoiding the off-target effects that historically have limited the utility of muscarinic agonists in the clinic. Please turn to the next slide.
Our partner, Synthesa, recently reported strong positive phase II a data for ORX750, the oral orexin receptor agonist for the treatment of narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Across all three endpoints, ORX750 showed a strong dose-dependent efficacy on mean sleep latency that increased more than 20 minutes at a 1.5 milligram dose, and we've also seen at a lower dose group achieving over 30 minutes improvement. Equally, the ESS score did fall significantly at the two doses relative to placebo. Also, the WCR improved significantly with an 87% reduction. These initial data communicated covers only a small cohort, but they mark a first robust demonstration of the oral orexin agonist addressing wakefulness needs of patients across all three indications with efficacy that seemed to match rival molecules.
Centessa plans to initiate a registrational phase III program in Q1 2026, positioning ORX750 as a potential best-in-class treatment for these diseases. Now we'll pass over to Nomura-san, who will go through our Q4 financial results.
ありがとうございました。
Patrik, thank you very much for your presentation. This is an R&D day, yet I'd like to give a short summary of the financial results for the third quarter, fiscal year 2025. Next slide, please. This shows the summary of financial results together with the historic trend. Upper half is net sales. Against the JPY 21.9 billion at the same period last year, it was mostly flat at JPY 21.8 billion. While the product sales increased driven by growth of PIVLAZ and the addition of the product supply and royalty revenue from QUVIVIC, we did not have in the prior year, milestone revenue decreased from JPY 10 billion last year to JPY 6.4 billion.
Now, this decline may mainly reflect the fact that in the previous year, we recorded more than JPY 5 billion in milestone revenue from Neurocrine Biosciences, equivalent to JPY 35 million. Turning to operating income shown in the lower part of the slide, core operating income was the loss of JPY 0.9 billion for the first half of this year compared with the profit of JPY 4.4 billion in the third quarter last year. As I will explain shortly, this was mainly due to the higher R&D expenses driven by investment in clinical stage development programs and ending obesity franchise. This page summarizes the breakdown of business domain and also distinguishing the financial results on accounting purposes. On far left blue is our platform business bio-venture type of a business model. Right red bar is a pharma type of business model, which is rather traditional.
Now, although the profitability of the platform business depends on milestones and other payments from partners, it is therefore less directly controllable. Yet, commercial red part needs to be grown more so that we'd like to generate the profits at the company level. There's no change in our direction. In the third quarter, core operating income turned negative mainly due to R&D expenses in blue, particularly in the U.K., increased by 36% year- over- year. Therefore, it posted a loss. As Chris mentioned from the beginning, we tried to optimize our spending. Next slide. Now, regarding the increase in U.K. R&D expenses, after the announcement of the third quarter results, we were asked to answer the breakdown. I'd like to show. Now, this is the changes from the previous period.
EP4 antagonist, EP4 agonist, and GPR52, the development items like this, these are having the peak spending year. Also, what we have announced in August, investment in obesity has increased tremendously. These are the major changes from the previous year. Next slide. Now, R&D expenses and SG&A costs, this is the four-year forecast at this moment. There's no change from the original announcement. In fact, we are going to finish within the range. There's no update. We will conclude very shortly. That is all from the company's prepared remarks. Now, we now would like to move on to the Q&A. Those institutional investors, analysts, and members of the media, please click the raise hand button to signal that you have a question. Our MC is going to call out your name, so unmute yourself and proceed with a question.
Please speak slower because we are using the interpreters and be clear in questions. For the others, please cast your questions in the Q&A boxes, and we will pick as much as possible while the time allows. First question, we would like to direct to Citigroup. Yamaguchi-san, please. Yamaguchi-san, Citigroup Securities, please unmute yourself and start your question.
Hello, this is Yamaguchi from Citigroup. Thank you very much. My first question is the Boehringer Ingelheim project. According to what you said, license out seems possible, but readout has not happened yet. Are there any changes in the situation, if you could update us? That is my first question. Thank you very much. Chris, could you answer this question?
Yeah, sure. Thanks, Yamaguchi-san. No, there is no real change here. We are rounding out the phase I package.
What that then catalyzes is a review period for the partner. I would expect that by the end of this year, the phase I package will be nearing completion. That means the partner has a period of time to review that data and then effectively make their decision around either licensing the program into their portfolio or not. We remain confident. We have had a great collaboration with Boehringer Ingelheim, fantastic team to work with. We think the asset would fit very nicely in their portfolio. If for whatever reason they chose not to, the phase I data package is strong. There would be many companies in this therapeutic area that would like to take this program on, I suspect.
But of course, our focus is solely on making sure that this product ends up in the portfolio of Boehringer Ingelheim, who've been just truly a fantastic team to work with.
ありがとうございます。もう一個簡単にお願いします。35。
Thank you very much. Another $35 million, U.K. R&D reduction, you said. In the case of development, if you reduce the number of projects, the development cost can go down. Your other core is research. Research side is also decreasing. The number headcount or capacity on the research side is reduced this time. What was the background, the reason that led to your decision? The amount is quite large. If you could quantify this, how many people, for example, if you could elaborate? Thank you very much. Chris, could you answer this one again? I will also add if any.
Yeah, sure. Thanks, Yamaguchi-san.
I won't comment specifically on personnel or headcount. What I would say is, if you think about where the majority of expenditure occurs, once you move into early clinical development, for example, phase IA, phase IB, and then phase IIA, the costs in the U.K. escalate rapidly. The cost of doing early clinical development in the U.K., as it is in the United States as well and other Western markets, has been increasing steadily over the years, and it is very expensive. If you think about where we are today, we are terminating any further investment in the EP4 agonist program. That program, we will finish the phase I data package, and we will seek a partner. There is no further expenditure for us on that program going forward. We will not be taking it ourselves into phase IIA. That is the EP4 agonist.
There is a significant decline in forward expenditure as a result of that. Similarly, on GPR52, that is a program that we are responsible for spending on. Again, the phase I study package is basically complete. There is no further expenditure on our side for that program going forward. It now turns into the phase whereby Boehringer Ingelheim will soon have the opportunity to assess that data and make a decision to take the program into their portfolio. With the cessation of investment in those programs, it does drive a very significant decline. On the research side of things, actually, we are probably spending more, quite candidly. Because the programs are very early stage, they are, compared to the early clinical development programs, markedly more cost-effective.
As you have heard, we are working through early discovery on multiple targets across obesity, chronic weight management, metabolic disorders in general, and also endocrine disorders. It's just that progressing programs through that stage of research is much more cost-effective. It is our bread and butter, so to speak. It's what we're very, very good at. With the cessation of investment going forward in early clinical development, that's what's driving the significant decline in early clinical development expenditure. Of course, as I mentioned at the outset, this will have an impact on some personnel, I expect, within our company. If we have no programs that we are developing ourselves in early clinical development, then there will be an impact on resourcing in the U.K. In our press release, you would have also noticed it's not just the U.K. that is impacted.
There is going to be some small headcount reductions that will take place in Japan as well as we further optimize the business that we acquired two years ago. As Toshi said, the sales of that product are growing very well. We have very, very good market penetration and market share. The product has clearly become the standard of care. On the second product, QUVIVIC, Shionogi is the commercial partner. They are responsible for the expenditure. We have been taking cost out of our Japanese business as well. I hope that concludes my response, and I hope that answers your question.
すいません、私から一つだけ補足させてください。
Thank you, Yamaguchi-san. I would like to add one point. U.K.'s R&D strength until now. You may be worried that the strength that we have may be reduced in the U.K., but that is not the case at all. We will continue maintaining our strength.
That part is intact. The key point is the left side of page eight. It says a strong message of best-in-class. And 80% is obesity. Obesity tends to take focus, but best-in-class research and development. The new mechanism exploration or unvalidated target validation. We do not need to use resource in these areas. That is the big change. Structure-based strength will be retained, but by changing the way of doing things, we can reduce the cost. That is where the headcount reduction is also coming into play. Thank you very much. Thank you.
それでは次の質問者様に行きたいと思います。
Moving on to the next question. SMB Singniko, Wera-san, please unmute yourself and start your question. Wera speaking of SMB Singniko. Can you hear me? Thank you. I'd like to refer to the business performance.
Now, timing of start generating profits is something that I'd like to explore. I know it may be a bit difficult to answer, but for instance, there's a one-time milestone money will be paid before the end of this year by Boehringer Ingelheim. Can you make further profits in the next fiscal year? That's my simple question. If the payment is being made this year, and that's probably a bit making the whole situation a bit difficult for us to make profits in the next year, EUR 64 million will make us big profits for this fiscal year. If Boehringer Ingelheim milestone payment be made, what about next fiscal year? I believe that the company's performance is shifting based upon the milestone payment.
New York Crime, unofficially, said that they are going to start the phase II, and Centessa is prepared to start the pivotal phase III study. They already disclosed that information. Therefore, milestone payment from the partners are relatively easy to forecast at this moment. Therefore, it's all up to the partner. That's a bit difficult to answer to you. Boehringer Ingelheim, if it is paid before this fiscal year, even beyond that, milestone payment candidates are quite rich in the next fiscal year. Let's say that how do you rate the R&D expenses for this fiscal year? Your plan has already been shown. For the next fiscal year, what about the absolute amount of R&D expenses? What is your projection? Do we expect that the R&D expenses are going to decline in the next year? Correct. That is our forecast as well.
Thank you very much. One point, if I may ask, is EP4 inhibitor, I would like to ask about. It seems that your company is still going to work on your own, and then Cancer Research UK is going to cover the cost, and therefore that should be okay. What about the cancer type? Ono is the gastric cancer, and probably you're expending a lot, and Ono is actually spending more cost for targeting at the breast cancer and so forth. CRC or the CCRCC are the target now. That is where the PD-L1 is not really working, and therefore it is going to be co-administration with others and try to pursue the development going forward. Patrik, can you take this question?
Yes, happy to take that question.
Giving the data for ONO-4578, that is obviously very encouraging for us, seeing that they have seen a positive outcome for their gastric GOJ cancer. It's certainly an area that we will be focusing on. We expect that Ono will publish more data at ASCO GI earlier in the year, and that will be very informative for us to adapt our strategy together with CRUK, which patient population we will be focusing on, and also to make sure that we're progressing with our biomarker strategy in parallel.
あと1点お伺いしたいのが、これなので。
Thank you very much. May I ask a further question? PD-L1 is going to be the co-administration drug, combination drug, and therefore you need to buy this medicine at the time of phase II or phase III, in my opinion. It's probably difficult for you to pursue on your own.
What timing, which timing that you are going to enter into the partnership?
この質問はクリスの方からお答えさせてください。
Thank you. We would like to have Chris to answer this question.
Yeah, sure. I think one thing that is important to make clear is we will still contribute investment to this program, but it is not 100% our responsibility. CRUK covers the majority of the costs, and we contribute a minority of the costs. They run all of the trial execution, so we are not committing resources to this program, just financial contribution. We retain the rights to this program. If we see good results through the phase II A expansion, there is opportunity to partner this program early. As you say, this is not a program that we would conduct ourselves through phase III trials. It is simply too complex and too expensive for a company of our size.
You can imagine that the way that this mechanism works in combination with checkpoint inhibitors, it could become very interesting to some of the major oncology players, particularly after that ASCO conference in June next year, where we expect Ono to release more phase II data on what they saw in their study with ONO-4578. This is definitely all going well. If we can follow the trajectory that has been set by Ono, we think there's a very high probability that this product will end up in the arms or in the portfolio of a very large oncology company. Yes, we won't be conducting the phase III studies ourselves. Globally, we would not be doing that.
ありがとうございます。以上です。
Thank you very much. That is all. Thank you.
ありがとうございます。それでは続いての。
Thank you very much. Next question. Pathology Associate Dion-san. Pathology Associate Dion-san, please unmute yourself and ask your question.
Thank you very much. This is Dion, Pathology Associate. I do not know if this is maybe for Chris or for Patrik, but I wonder if you can speak a little bit about the profile of GPR52, given that you are now nearing the completion of the phase I data package. It seems that at least all indications that we are looking at, it looks like Boehringer will go ahead. In the event that they do not, what do you think are really the key differentiations relative to the emerging class of M1, M4 agonists? Do you think it is cognitive benefit or functional improvement or tolerability? Could you say anything about the competitive profile of the product? Thank you very much.
パトリックから答えていただきたいと思います。
Patrik, if you could please answer that question. Yes, happy to do so.
Seeing that it's a novel mechanism, and when you look at the expression of GPR52, where you have expressed in two major brain regions where you effectively can trigger or address cognitive function as well as address positive symptoms, we believe that is a very clear differentiation to what is currently on the market with the Muscarinics. Based on the data that we have collected so far, we are very confident that the overall package they will get will be very strong. As the study goes on, we will need to evaluate the data and first discuss with our partners, BI. If they want to take the decision not to take this forward, then obviously position this ourselves. Before having seen the data, it's probably a bit too premature to do a head-to-head comparison versus other mechanisms.
Understood. Thank you very much, Patrik.
Can I just maybe also ask about your obesity program? Among GLP-1, GPR, and Amylin, I was wondering about your process for selecting a lead molecule and when you might anticipate the first program to be moving forward toward the clinic. You mentioned liver and kidney, which I think is very interesting. Is there other specific markers that you could mention, maybe lipids, maybe hemoglobin A1c, maybe blood pressure, anything else that you would particularly be looking at in moving a first program toward the clinic? Thank you.
Yes, just to be precise, kidney and liver, I think it was probably more a long-term positioning of the molecule. Obviously, first clinical readout would be a shorter study with relevant biomarkers, just to be very clear. That is what we would be looking for.
In terms of timelines, we're expecting to move our programs forward where we're expecting a couple of programs to reach candidate stage towards end of next year, beginning of the following year, again with a very specific profile with our small molecules. At least for one of the targets, also very differentiated chemistry, while for that particular target, the industry has been struggling finding chemical matter or has had very limited chemical space they could explore. We are quite hopeful. As we are progressing the program, obviously, we are cognizant that we need to build the differentiation over peptide drugs and other competitors that are currently ahead of us.
Understood. Thank you very much. Nimrasan, can I ask one more question?
I wonder if perhaps Chris may have any comments regarding ORX750, which seems to be very much a first-in-class molecule regarding DEA scheduling or generally access for arachnogenists with payers in the United States, but also globally. Thank you.
Yeah, thanks, Dion. Look, I'll be a bit cautious here because at the end of the day, this is the core product of partners in Centessa, so I don't want to speak out of turn. What I would say is, for anyone that's been following the story, there are multiple companies that are pursuing this mechanism.
It has always been our long-held belief that the structural insights that we brought to the initial joint venture, which was called Orexia Therapeutics almost five years ago, were very enabling for the teams, both our teams in drug discovery, but also the team at Orexia and Medici and Centessa brought to bear that they're really looking at creating a drug that has the potential for a best-in-class profile versus all of the competition. They have been very clear that NT1, NT2, and idiopathic hypersomnolence is really just the beginning here. There are a lot of areas where they would hope to expand this mechanism of action and the molecules that they are advancing. They have done a really great job to date. It's very exciting. If you just watch the share price growth Centessa has experienced over the last little while, it's an amazing story to follow.
They've raised capital again recently, so they are sufficiently capitalized to really test and move forward a bunch of molecules over the course of the next two to three years. We are very excited to see in which direction they will go. I think that's probably all I would say on that point because I think otherwise I'll be speaking out of turn. Obviously, Centessa being a publicly listed company, shareholders, institutional investors, and analysts can follow all of their press releases and publications and disclosures and meeting events very readily. Thanks, Dion.
Excellent. Thank you very much.
ありがとうございます。
Thank you very much, Dion. We already hit the six o'clock, but if there's anything, we'd like to enter one more question. Hashiguchi-san of Daiwa Securities, please go ahead. Please unmute yourself.
ありがとうございます。 ハシグチ・ダイワ・セキュリティーズ。
In regard to research asset allocation, I'd like to ask furthermore.
Earlier, in regard to the in-house development products and where the allocation is going to be made, and we were able to hear in regard to the drug discovery partnership, what is your approach, Eli Lilly and AbbVie, that you are having partnership? What activity or what are the positioning of that type of activities going forward in your company? Such a partnership, do you be hoping to be regarded as an attractive partner? Do you maintain capabilities to be being regarded as an attractive partner? Or are you focusing more resources on developing your own pipeline? Which way are you going to pursue? Thank you very much. Chris, can you answer the question?
Of course. Thank you so much for the question. It's a very good one. Right now, as you are aware, we have two ongoing and active multi-target discovery collaborations.
One is with Lilly in the metabolic disease space, and the other is with AbbVie in the neurology space. Now, those discovery collaborations are slightly different. For Lilly, we are almost at the completion, I guess, of the research plan, and we will be handing over our work, and Lilly will be taking that work into their portfolio and taking those programs forward. With AbbVie, it is slightly different. We are responsible for continuing the development of those programs basically all the way up to an IND-enabling package. We have quite a long time to go working with AbbVie. That is the status of the current discovery collaborations. Do we remain an attractive company to work with on a discovery basis? Absolutely, we do. We will always consider the opportunity to work with major companies that want to do a discovery collaboration with us.
However, what I would say is when we do a discovery collaboration with a big company such as Lilly or AbbVie, it can be quite resource-intensive. It requires us to spend a lot of our resource and effort supporting those programs. We have some goals now, which are to move a number of programs in obesity, metabolic disease, endocrine disorders rapidly through discovery and towards phase I. To do so, we need to spend a lot of our resource on pushing those programs forward. We will never say no to a potential discovery collaboration. However, in the future, I think you'll probably see us do less major discovery collaborations going forward unless there is a very large financial benefit of doing so. You will probably see the pace of those discovery collaborations slow down. We continue to work on AbbVie.
Lilly will be handed over to Lilly very shortly, and we will be focused certainly next year on advancing the prioritized programs that Patrik wants to go very fast on. Hopefully, that completes the answer. Nomura-san, you may want to add some additional comments, perhaps, unless I was very clear.
効率のいいものをやっていって。
We would like to focus on more efficient programs, and others will gradually decrease. Did we answer your question, Hashiguchi-san? Yes, understood fully. Thank you very much. Thank you very much. Sorry, we are five minutes longer, but we've received some Q&A, so we'd like to pick one question from the Q&A box. The questions which we received on Q&A, we are responding via blog as much as possible.
If there are some people who are still raising hands, if you could write your questions in Q&A boxes as soon as possible, we will answer on the blog. While we are answering the last question, please quickly type in your questions into the Q&A.
一つピックアップしたいと思います。
We received many questions in the Q&A in licensing in Japan. You were targeting one this year. What is the progress so far? That is the question. Chris, could you update us on this?
Yes, certainly. We remain pretty confident, actually. I think we will be able to find one more very interesting product to license for the Japanese market. As shareholders and investors and the analysts are aware, we have a commercial footprint in Japan. We have a clinical development team in Japan.
We are very focused on helping Japan close the gap when it comes to approved medicines overseas that have not yet been made available to patients in Japan. We are currently in an exclusive diligence process with a potential partner, and we are hopeful that if we work very, very hard over the next four to five weeks, we may be able to complete bringing an extra product into our Japanese portfolio by the end of this year. That would be very exciting for all of us. We've been working very hard. We've looked at lots of potential products. We think we've found a really good one that will make a difference for patients in Japan, and we're very hopeful that we can complete it by the end of this year, at the very latest, before the JP Morgan Healthcare Conference in January.
But we are working very hard to complete it as soon as possible. Thank you.
ありがとうございます。すいません、こちら。
Thank you very much. I am sorry, but we would like to close the Q&A session. There are so many that we have not been able to answer. To repeat myself, we will answer them later in our blog. I think the questionnaire will show up later. If you could write it in the questionnaire or in this Q&A section, I would appreciate it. Thank you very much for your attendance today. The video will also be uploaded to the web later. We would like to bring this R&D Day to a close. Thank you very much for your attendance.