Hello and welcome to the BioArctic audio cast with teleconference Q4 2021. Throughout the call, all participants will be in listen only mode, and afterwards there will be a question and answer session. Just to remind you, this conference call is being recorded. Today, I am pleased to present CEO Gunilla Osswald and CFO Jan Mattsson. Please go ahead with your meeting.
Thank you. Good morning, and welcome to BioArctic's full year report for 2021. I will also give some highlights from the Q4 . I'm Gunilla Osswald, and I'm the CEO of BioArctic, and I will share today's presentation with our CFO, Jan Mattsson. It has been a great year for BioArctic and lecanemab, and it is a time of hope for Alzheimer's patients. Lecanemab got fast track and breakthrough therapy designation by the FDA during the last year. Our partner, Eisai, has had interactions with the FDA, and after that they have initiated a rolling submission, which is ongoing for an accelerated approval for lecanemab in the U.S. I think that this year will be the most exciting year for BioArctic. We will see the results from the phase III Clarity AD study, which is being expected in September.
There is also potential for an accelerated approval in the U.S. If we get approval, lecanemab could then thereby potentially be helping patients even earlier than previously expected. I will talk more about that also here today. Next slide, please. BioArctic is listed on Nasdaq Stockholm Mid Cap, and this is our disclaimer. Next slide, please. If we have some new listeners, I will start by giving an introduction to BioArctic. BioArctic is a unique Swedish biopharma company with the aim of improving lives for patients with brain disorders. I think that the company is unique based on four different aspects. The first one is that we focus on R&D of innovative treatments for brain disorders, where there is a high unmet medical need like Alzheimer's disease and Parkinson's disease, and now also ALS.
These diseases affect large patient populations like Alzheimer's and Parkinson's and their relatives, and it comes with large cost for society. There is a high medical need for disease modifying treatment affecting the underlying disease and slowing down the disease progression. The second aspect is that we have a great organization with very experienced and engaged coworkers, and we have important fruitful collaborations with universities, and we have two great strategic partners, Eisai in Alzheimer's disease and AbbVie in Parkinson's disease. The third aspect is that we have an attractive and well-balanced project portfolio. We have projects spanning from early discovery all the way to phase III and now also in the regulatory process. We have partner projects that already are generating revenues by milestones. Our strategic partners carry the cost for clinical trials.
The earlier fully owned projects, we think have substantial marketing and out-licensing potential. The fourth aspect is that we're well-financed, and we have a strong cash position, close to SEK 850 million in the bank. We have valuable collaboration agreements with big pharma like Eisai and AbbVie, at a value of up to SEK 9.1 billion plus royalties if we come all the way to the market. I think that BioArctic is a dynamic and very exciting company with huge potential. Our most advanced program has now, as I said, initiated the regulatory process towards marketing approval. We have also started to build our commercial organization in the Nordics. Next slide, please. On this slide, we see BioArctic's attractive and well-balanced project portfolio.
As you can see, we focus on brain disorders, and Alzheimer's is our largest area. Lecanemab, which is our most advanced program, the regulatory process is ongoing in the U.S. by our partner, Eisai. Also we have two parallel large phase III programs ongoing. Even if the first step of the first disease modifiers for Alzheimer's disease will be successful, there is still a large medical need for more treatment options and for combination of therapies. Therefore, it's important for us and others to continue to work on more alternative treatments for Alzheimer patients. We have six early Alzheimer disease modifying programs ongoing. Two of them have now also been combined with our BrainTransporter technology. In Parkinson's disease, our partner, AbbVie, recently presented encouraging results from the phase I program, and we expect them to start phase II late this year.
I'm also pleased to see that our whole portfolio is progressing really well, and I'm also pleased to see that we also have now been able to communicate that we're also working on ALS. Next slide, please. A couple of words about our long-standing successful partnerships with Eisai in Alzheimer's disease since 2005 and with AbbVie in Parkinson's disease since 2016. We start with Eisai. They are very committed to dementia and very committed to lecanemab. We have so far received EUR 66 million out of the total aggregated value of EUR 222 million. There is still a lot to receive that if everything continued to progress well, and we still have ongoing research collaborations with Eisai. The next potential milestone could be linked to regulatory submissions and approvals of lecanemab.
We have also the right to commercialize lecanemab in the Nordic region, and that's what we are preparing for and very much looking forward to. In Parkinson's disease, we have a successful collaboration with AbbVie, and we have so far received $130 million out of the total aggregated value of $755 million. There is also a substantial amount to receive here. In both cases, of course, if we come all the way to the market, we could expect royalties. For Eisai, they are high single-digit value, and for AbbVie, they are tiered royalties. Both of them could be substantial, since there are large patient population. I think that we have a great business model with our two partners.
Our strategic partners, they finance the expensive clinical programs in these large patient populations, whereas we finance the less expensive preclinical phases and increase the value of the programs before partnering. We have a great track record in delivering innovative and high-quality projects. Next slide, please. As I said, it has been a great year for BioArctic and a great last quarter as well. If we start with Alzheimer's disease and lecanemab, our partner, Eisai, has, after discussions with the U.S. FDA, a rolling submission ongoing for an accelerated approval of lecanemab in the U.S. In December, the second of the three parts of the rolling submission was submitted to the FDA, and this included the clinical part and the proposed label. The last part of the accelerated approval application is expected to be submitted during the Q2 of this year.
In December, we also got Fast Track designation for the FDA. During the last quarter of last year, lecanemab data was also presented at a further Alzheimer Congress, CTAD, in November, where both BioArctic and Eisai presented data on lecanemab. All the data continues to strengthen and differentiate lecanemab towards the competitors. The data which is coming continuously is confirming the encouraging results that we saw in the large phase II-B study. During the last quarter, we also announced that lecanemab was selected as the anti-amyloid background therapy to be explored in combination with tau treatments in the DIAN-TU Tau NexGen study for individuals with dominantly inherited Alzheimer's disease. We are pleased to note that the study also has started now in the beginning of this year.
Other highlights during the last quarter were that we also announced that we are focusing on developing antibodies for TDP-43, which is an important protein in the devastating disease ALS. We are continuously building our commercial organization, and we have just recently recruited four new persons with vast commercial experience to our commercial operations organization. Next slide, please. Eisai is strongly committed to lecanemab, and they have a broad clinical program underway, as you can see on this slide. I will start with Clarity AD, which is the phase III confirmatory study in early Alzheimer's patients, the most important study. Here, patient enrollment was completed in March last year, and there is 1,795 early Alzheimer's patients included in the study.
In order to prepare for a Chinese regulatory application, Chinese patients are also included in this study on top of the 1,795 patients, and they are now also fully recruited and will be also treated for 18 months. The study is progressing really well, and there is a very low discontinuation rate, which is great. There is a data safety monitoring board that continuously reviews safety data, and they have not identified any differences in the safety profile, including ARIA from what was observed in the large phase II-B study. I think this is great news, and gives us confidence for the future. In the U.S., there is an active debate on minority groups to be included in Alzheimer's trials since African American and Latino groups have a higher risk of getting Alzheimer's disease.
Clarity AD study have approximately 25% of the U.S. subjects from these minority groups, and that mirrors the U.S. society, and this could be important in the future for reimbursement of lecanemab in the U.S. I said that Clarity AD is the most important trial, and Eisai targets to have the 18-month data available at the end of September. I think that we have super exciting times ahead of us. Linked to the Clarity AD study, there is an open label extension study ongoing when all patients get lecanemab. In that part, we now have more than 620 patients included. Eisai has just communicated this morning that they planned to evaluate a new dosing regimen with reduced frequency by utilizing blood biomarkers in this open label extension study.
They will also evaluate optimal dosing of subcutaneous injection formulation later on in this open label extension study. Eisai has during the autumn of last year performed a clinical study with the subcutaneous formulation of lecanemab. That is a way to make the administration of lecanemab more convenient for patients and to be able to do self-administration at home. Data is currently being evaluated, and those data will form the basis for deciding the doses for subcutaneous administration in the open label extension study. There is also the open label extension study linked to the phase II-B study, which is ongoing in early Alzheimer's disease. This is an open study where data is coming along continuously and being reported at different congresses.
All the data we have seen so far continues to further strengthen and confirm the positive phase II-B results, where we have seen profound amyloid clearance from the brain and the continued low frequency of the side effects ARIA-E. The other phase III program is in pre-symptomatic Alzheimer's subjects, very early stages of the disease before the individuals have any symptoms. This program is called AHEAD 3-45, and it's driven by Eisai together with Alzheimer's Clinical Trials Consortium, and it's a global program around the world as well. The DIAN-TU Consortium has selected lecanemab as the anti-amyloid therapy to be explored in combination with tau treatment or placebo in the Tau NexGen study for individuals with dominantly inherited Alzheimer's disease. In this study, all the patients will receive lecanemab.
In half of the patients, they will receive Eisai's tau antibody, and half of them will receive placebo. We're very much looking forward to following all of these, clinical studies in the impressive broad program that Eisai is driving in Alzheimer's disease. Next slide, please. Lecanemab was specifically generated to be selective for the toxic, the harmful soluble aggregated forms of amyloid that we call protofibril. You can see them in the red box or the red frame, that are boxed in, so to say. In November at CTAD, the Alzheimer's Congress, our founder, Professor Lars Lannfelt, presented lecanemab's unique binding profile with strong preference for the protofibrils. This is in contrast and differentiates lecanemab from other late-stage, anti-amyloid antibodies like aducanumab and gantenerumab, who both prefers binding to the insoluble and less toxic fibril.
All three have a similarity in that they are selective versus monomers, which we think is important, but they differ in the binding profiles to the aggregated forms of amyloid. This we believe is important and might be the reason behind the differences that we see in the clinical situation with these antibodies. Next slide, please. This slide describes the lecanemab's favorable profile versus three other late-stage anti-amyloid competitors. To the left, you see a graph that shows that all four eliminate amyloid aggregates from the brain. You can also see that lecanemab has the strongest reduction of amyloid of the brain. 93% lowering was shown in the phase II-B study. In the open label extension study, it has also been shown that the reduction of amyloid in the brain is rapid.
The first measurement was at three months, where we already saw a clear reduction that continued over 12-18 months. At 12-18 months time, more than 80% of the patients in both the phase II-B study and in the open label extension study has converted to being amyloid negative. This is a very strong effect and better than any of the others have shown. If we then turn to the right side of the graph and we look at the side effect ARIA-E, which is some kind of a brain edema that you mainly see on MRI, and very few patients get symptoms. APOE4 carriers are more sensitive to this side effect. Lecanemab has less than 10% of the patients in the phase II-B study and in the open label extension study that has had ARIA-E.
In spite of that, lecanemab is the only one of these antibodies that is given with a therapeutic dose directly without any titration. I think that this looks very good for lecanemab, and I'm eager to see the results from the Clarity AD study, both on efficacy and biomarkers and tolerability. Next slide, please. Lecanemab has the potential to lead the paradigm shift in the treatment of Alzheimer's disease. We have a high likelihood of success based on the positive and consistent response that we saw in the large phase II-B study, and all the data that are coming from the open label extension study or from the phase II-B continues to strengthen and confirm the phase II result. Importantly also, the pivotal phase III study, the Clarity AD study, is designed to be very similar and confirm the positive phase II-B result.
I want to point out that, of course, all drug development is connected with some risk. I believe that lecanemab has a high likelihood of success. We have the opportunity to be first with a full approval in the U.S., and the first disease modifying treatment for Alzheimer's disease in Europe and Japan. The rolling BLA submission to the FDA under the accelerated approval pathway is ongoing by Eisai. As I said, two of the three parts in the rolling submission has been submitted. In that second part included the clinical section and the proposed label. The third and final part is expected to be submitted during the Q2 of this year. At that time point, BioArctic can also expect a milestone of the regulatory submission. There is also a potential for an accelerated approval in the U.S. already this year.
If you think about a full BLA submission, which is very important, to get a full approval, in the U.S. and submission in Europe and Japan, all those are expected to be submitted by the Q1 of next year. There is then a potential for a full approval in the U.S. next year, and in Europe and Japan next year or the year after. Lecanemab seems to be the best anti-amyloid antibody with a great opportunity to differentiate versus other late stage competitors, as I've mentioned. I think it's differentiated based on four different aspects. First is that we have a rapid and profound clearance of brain amyloid. We have an early onset of clinical effect in slowing of cognitive decline. We have so far seen that we have a better tolerability with a low frequency of ARIA-E versus competitors, even without titration.
lecanemab is the only one of the late stage compounds that give the full therapeutic dose from day one. Importantly is also to continue with more work, and Eisai are driving subcutaneous injection very aggressively forward since this is an important alternative to be able to do self-injections and more convenient administrations at home. Blood biomarkers are also making great progress in parallel with the therapeutic. In Eisai, we utilize the blood biomarkers to explore less frequent dosing as maintenance dosing after that the amyloid has been cleared from the brain. There are also other clinical studies ongoing in other Alzheimer's populations, which will be interesting to follow. I think that it looks great for lecanemab, and of course, nothing is ready until it's ready, but I think that we have a very exciting year ahead of us. Next slide, please.
We are actively working on the next step in the transformation of BioArctic as a company. This is to also include a commercial organization for the Nordic market. We are building the organization stepwise and in a timely manner. We are very happy about our new recruits. We now have six very experienced coworkers preparing for the potential launch of lecanemab in the Nordics. We are aware of that it's a lot of work for us to prepare for a potential launch in about two years' time in the Nordics. Especially if you consider that we have the opportunity to be the first disease modifying treatment for Alzheimer's disease in the Nordics. Next slide, please. I'm also pleased to say that the rest of the BioArctic project portfolio also has progressed well during the last year.
If we look at the Parkinson's disease area, both BioArctic and AbbVie presented really encouraging preclinical and clinical phase I results of ABBV-0805 at the Movement Disorders Congress last year. Preparations are ongoing at AbbVie for start of phase II. I think that if you look at our BrainTransporter technology platform, that we also have had great progress, and I will show you some nice data on my next slide. As you know, we have also combined it now with a couple of our early Alzheimer's projects. I will also tell you a little bit about our TDP project for ALS. Next slide, please. We start with our blood-brain barrier technology platform that we call BrainTransporter or BT for short.
The BT technology facilitate transport of antibodies across the blood-brain barrier, and this is done through active transport via the transferrin receptor. We have learned that it's important to bind lagom, which is a great Swedish word, which means not too much and not too little. We are now working on our second generation BrainTransporter technology. We were proud of our first generation, but the second generation seems to be even much better, as you can see on the graph on the top there, where it provides a very high brain exposure. You, if you compare it with a naked antibody with the dotted line, you can see great increase in brain exposure. If you look at the pictures, you can see that we also get a broad global distribution of the antibody in the brain.
If you look at the picture in the bottom right, the green color shows when the antibody, in this case, mAb158, which is the murine version of lecanemab, is combined with the amyloid target in the brain when it was transferred through our BT technology. You compare that with when you give mAb158 alone, which is the graph on the top. You see that much more of the antibody is coming to the target when utilizes the BrainTransporter technology. As I said, we have now come this far, so we can combine this with a couple of our internal programs, and we are looking forward to being able to combine it with more of our internal programs.
In the future, we could also see an opportunity to combine our BT technology with other external antibodies or proteins through several non-exclusive license deals. I think this is a very exciting technology that I think we will see a lot of in the future. Next slide, please. Just a couple of words also about our effort in helping ALS patients. As you know, ALS is a devastating progressive neurodegenerative disease. It's an orphan drug indication, and it has high unmet medical needs. What we are working on is TDP-43, which is a promising target for ALS. Almost all ALS patients have elevated levels of aggregated TDP-43. Those pathological aggregations of a TDP-43 can also be found in about half of Alzheimer's and frontotemporal dementia patients.
Our project at BioArctic is called ND3014, and we intend to start with ALS as the first indication. I think there are more opportunities as well for the future. I think it's great with this target because it really fits BioArctic's unique expertise in this kind of misfolded proteins. Next slide, please. By that, we come to our financial summary, and I will hand over to our CFO, Jan Mattsson.
Thank you, Gunilla. My comments relate to the quarter numbers. For those of you that don't know our company so well yet, at present, our revenues consist of milestone payments and compensation from collaboration agreements, meaning that we don't have any steady revenues yet. Net revenues amounted to SEK 5 million in the quarter, compared to SEK 8 million in Q4 of previous year. Total costs in the quarter were higher than in last year, and costs will continue increase as we continue to build a commercial organization and further progressing our expanded portfolio. Operating loss was SEK 39 million in the quarter, compared to SEK 30 million same quarter of last year. Operating expenses are now expected to be in the range of SEK 220 million-SEK 260 million for the FY 2022, compared to 166 in 2021.
The reason for this increase is the buildup of the commercial organization prior to the potential launch of lecanemab and costs for the expanded in-house project portfolio. Next slide, please. Cash balance amounted to SEK 848 million at the end of 2021. Operating cash flow amounted to -39 during Q4, compared to -27 in Q4 2020. Net result for the quarter was -19, compared to -13 last year. In summary, BioArctic continues to have a strong financial position. By that, I hand back to Gunilla. Next slide, please.
Thank you, Jan. I will finish with some upcoming news and some closing remarks. Next slide, please. We're now on slide 19. Some upcoming news flow. We will of course focus on Alzheimer's disease with Eisai, who are progressing the broad clinical program of lecanemab, which I described. Data will be continuously presented at international congresses with lecanemab, and the next one we're looking forward is ADPD in March. It will be a hybrid meeting, partially virtual and partially on-site in Barcelona. With our founder, Professor Lars Lannfelt, we'll be presenting data comparing lecanemab with late-stage competitors. There will be more presentations as well on lecanemab. We also look forward to providing more information on our other projects when relevant. Next slide, please. Just close by saying that BioArctic is built on great science.
We have great projects, we have great partners, and we have great people working for BioArctic. Everything we do is with patients in mind, and our aim is to help patients with brain disorders. I think that we are very much on our way now to be able to help Alzheimer's patients. I think that we have very exciting a year ahead of us. Next slide, please. By that, I say thank you for your attention, and we're happy to take some questions.
Thank you. Ladies and gentlemen, if you do have a question for the speakers, please press zero one on your telephone keypad now. If you wish to withdraw your question, you may do so by pressing zero two to cancel. Our first question comes from the line of Dr. Joseph Hedden from Rx Securities. Please go ahead. Your line is now open.
Good morning, and thanks very much for taking my question. Firstly, we recently saw the Medicare National Coverage Determination, which affects aducanumab at this time, and it limits reimbursement of that drug based on, you know, the aducanumab data package. They've not looked at the lecanemab or any of the other anti-amyloid mAbs. I'm just wondering if you've had any interaction with Eisai and what the thoughts are about how this might affect you come accelerated approval time. What's your take? You're obviously in a stronger position if you produce positive Clarity AD results. Is there anything that Eisai is doing at this time to, you know, reassure us that there's gonna be a good reimbursement scenario in the future? Thanks very much.
Thank you, Joseph. Excellent question. I think that Eisai has made it very clear, communicated clearly that they have reacted to the draft decision that has been made so far by NCD with coverage with evidence development. That would be for Aduhelm. At the moment, it was also included for all anti-amyloid antibodies. That was a draft decision which came February 11. There is now a thirty-day review period. Eisai have said that they have reacted and interacted with NCD. April 11, that will be the final decision with regard to reimbursement for Medicare and Medicaid by the CMS. I think if you think about it for lecanemab, I think the most important part would be Clarity AD data, which is coming in September this year.
We will see what the final decision will be April 11. I think that when clear evidence of clinical efficacy has been shown, I would have a hard time saying that that shouldn't be a reimbursement and a good access for these kind of treatments for Alzheimer patients in the U.S. I think for the future, I have a positive view. We will see what the final decision will be April 11. I'm confident in that if lecanemab confirms the phase II-B results, there is a high likelihood that that will be a good reimbursement situation in the U.S. as well.
Okay. Thank you. Just on your guidance for operating expenses this year, is that primarily the increase over 2021, is that reflecting primarily that you're hiring more for Nordic commercialization of lecanemab or are there increased R&D expenses in there as well?
I would say it's both. It's about the same amount in both these two circumstances.
I think that's a good sign because it shows that we have a broadened portfolio, which is progressing well. The more it progress, the more it will cost. I think it's a good sign for BioArctic.
Sure. On TDP-43 program, can you give us an idea of the pipeline dynamics there? Are there any potential competitors against that target in ALS or other indications? What stage are they at?
I think that for all targets where there seems to be science is breaking, there will be more companies focusing on those. We are not alone. I think that if you look at the great work we are doing with, for example, amyloid beta in Alzheimer's disease, alpha-synuclein in Parkinson's disease, and then TDP-43 in ALS, there is a lot of similarities and learnings that we can draw from one program to another. I think that our unique expertise that we have in this area of complex misfolded proteins, which has in all these three diseases, really makes BioArctic suitable to drive a program like this in an innovative way. Of course, we're not alone, and that's a good thing, I think.
Okay. Thanks. Thank you very much.
Thank you, Joseph.
Thank you. Just as a reminder, if you do wish to ask a question, please press zero one on your telephone keypad now. Our next question comes from the line of Chien-Hsun Lee from Pareto Securities. Please go ahead. Your line is now open.
Hi. Thank you very much for the presentation. I think this next gen combination trial with tau treatment seems really interesting. I wonder if there's any preclinical data to support the trial, and if so, when is that expected to be published? Since lecanemab seems to be the first anti-amyloid agent in combination trial with tau treatment, could you comment a bit on why do they choose lecanemab instead of other antibodies and what's the rationale behind it? Thank you.
Thank you so much. Great questions. I think that we are very, very excited about that DIAN-TU selected lecanemab to be a background treatment or backbone treatment in a trial. This trial that DIAN-TU is going to drive in, which is called NextGen, is a possibility to have three different tau treatments. The first one is Eisai's tau antibody, which will be combined with lecanemab. All patients will be getting lecanemab. Half of them will get the Eisai's tau treatment, and half of them will get placebo. It's a great way to be able to see a combination therapy between an anti-amyloid treatment and an anti-tau treatment. We are of course very pleased to see that they selected lecanemab even though there is another antibody already on the market, but still they selected lecanemab.
I think that's due to the encouraging phase II-B results and the good safety tolerability profile. I think that as the study is designed, it will be important to show that we decrease amyloid from the brain as we have shown repeatedly with lecanemab. We also have shown repeatedly that we have a good safety tolerability profile. I think we are very pleased to see that they selected lecanemab in front of the other competitors. When will we see some data? I think we have to be patient unfortunately. We're happy that the study just started. These kind of trials, and it's driven by consortium and so forth, it will take some time before we will see any clear results.
Also, consortium trials are often describing the progress of the study and what the patient population looks like. That kind of data I think we can be expecting continuously at Alzheimer's congresses.
Okay. Thank you. Is there any preclinical data for that or
Nothing that I can disclose.
Another question from me. About Biogen, the price of Aduhelm is $28,000. I know it's up to the partner, but could you comment a bit on the potential pricing of lecanemab? Do you think $28,000 is on the reasonable range?
I would be happy to talk about the price of lecanemab when it's time for that, and it very much of course depends on the results and so forth and the health economic evaluation and so forth. I think it's a little bit too early for me to comment on that for lecanemab.
Okay. Thank you very much.
Thank you.
Our next question comes from the line of Gergana Almquist from Redeye. Please go ahead. Your line is now open.
Good morning everyone. I have a question about the rollout in the Nordics and specifically, you're offering a full package, diagnostics, delivery, follow-up maintenance of the disease. How do you apply this in practice? Do you have any conversations with doctors, with hospitals? How would you make sure this rollout is happening, that the patient gets treated and doctors get trained and all that? The on-the-ground implementation, so to say.
I think it's excellent questions, Gergana. Thank you so much for that. I think we will be coming back to this question over and over again. Of course, as I said, when we come with a new kind of treatment to a new kind of patient population, I mean, there are no disease modifying treatments yet in the Nordic region. There are a new population with that regard that we are going to mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease. There will be then also potential to use blood biomarkers. There is a lot of work in order to increase awareness about the disease and about the blood-based biomarker progress and the possibility with a priority shift of disease modifying treatment. Of course there is a lot of work to be done here.
I will not be able today to reveal exactly how we're going to do this. I'm sure we will be describing that more and more in detail coming on. I'm really happy that we've now been able to recruit more people with a vast experience in commercialization in the Nordic market. There is a lot of work that needs to be done in order to prepare for market access and to help the infrastructure because the infrastructure needs to be improved. There are many hurdles that we need to work on in order to make sure that there is an access for patients to the treatments when they are available.
Our aim, I mean, what we really would like to see is that all patients who are eligible and can have a benefit of lecanemab should have access to that. That's what we, that's our aim. There is a lot of work that we will be doing here. We will talk more about when ASI has done more work on the blood-based biomarkers, how they best are utilized and what dosing. We know what dose that will be used for the first 18 months. That is clear, and that's what's being done in the Clarity AD study. Then there is exploration about what the maintenance dose can be and what doses it could be with subcutaneous formulation.
There is a lot of work which is ongoing that can help us to see how we can best help the patients in the future. Again, please just be a little bit patient with us, and we will come back with more and more information stepwise.
Have you had any feedback from doctors?
Yes, of course. I mean, we have different kind of advisory boards. I was missing the word in English, advisory board meetings and so forth. Also interact with the doctors. It's important for us to listen and understand what are the medical needs, what are the hurdles, how can we help in different ways to make sure that there will be a good access to patients when lecanemab comes to the market. Of course, assuming and the pending results that we have to wait and see in September. Assuming that everything continues to go well, I think that will be important work that we are doing the coming two years in front of a potential launch in 2024.
The subcutaneous solution, where would this potentially be available?
I can't say exactly when it will be available more than in the clinical trials, but it will be included in the open label extension part. For those patients who were part of the Clarity AD study, and if they go into the open label extension study, they will be able to be part of that. When it comes to market, I can't really say exactly. I can tell you that Eisai are working very aggressively on this because it's an important good complement and alternative for the patients to have subcutaneous administration. A lot of work is ongoing, but I cannot say exactly when it will come to the market.
Thank you very much, Gunilla.
Thank you, Gergana.
Thank you. At this stage, we have no further questions. I will hand back to the speakers for any final remarks.
I just want to say thank you so much for all great questions and for your attention, and have a great day. Thank you.