Welcome to BioArctic's first quarter report 2021. I'm Gunilla Osswald, and I'm the CEO of BioArctic. I will share the presentation here today with our CFO, Jan Mattsson. This year has started really well for BioArctic. Our most advanced program, Lecanemab BAN2401 in Alzheimer's disease, has further been strengthened by new data and other data in the Alzheimer field. Our partner, Eisai, has completed enrollment of patients into the pivotal Clarity AD study, and our phase II-B results have been published. Our project portfolio has progressed well and expanded during the first quarter of this year, I will describe more about this in the presentation here today. Next slide, please. BioArctic is listed on Nasdaq Stockholm Mid Cap, This is our disclaimer. Next slide, please. BioArctic is a unique Swedish biopharma company with the aim of improving lives for patients with disorders in the central nervous system.
When I say that I think it is a unique company, I base that on four different areas combined. The first one is that we focus on R&D of innovative treatments for central nervous system disorders, where there is a high unmet medical need, like Alzheimer's disease and Parkinson's disease. These diseases affect large patient groups and their relatives with a large cost for the society. Today, there are only symptomatic treatments available, and we work with disease-modifying treatments meant to affect 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 important fruitful collaborations with universities and with our two 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 all the way from early discovery to late phase III. We have partner projects that generate revenues by milestone and where our strategic partners carry all the cost for clinical trials. We have also early fully owned projects with substantial marketing and out-licensing potential. The fourth aspect is that BioArctic is well-financed with a strong cash position with approximately SEK 1 billion in the bank. We have valuable collaboration agreements with Eisai and AbbVie at the value of up to SEK 8.9 billion, plus royalties if we come all the way to the market. In summary, BioArctic is a dynamic and very exciting company with huge potential, which I'm happy to lead. Next slide, please. Some highlights so far this year, and I will start with our most advanced program, Lecanemab, for Alzheimer's disease.
I will start with the press release that we had yesterday. We announced that the phase II-B trial with Lecanemab has been published in Alzheimer's Research & Therapy. We also announced that our partner, Eisai, has expanded the confirmatory phase III study called Clarity AD with approximately 200 patients with early Alzheimer's disease. Now the study has completed enrollment, and in total, 1,795 early AD patients are part of this trial. They will now be treated for 18 months, and we expect the readout in September 2022, next year. This study is, of course, aiming to confirm the promising results that we saw in the big phase II-B trial. The next aspect is what happened at different Alzheimer's congresses earlier this year, and there was a huge congress, AD/PD, in March, where BioArctic presented data.
There we showed that we had significantly elevated levels of soluble Abeta protofibrils, those harmful forms of amyloid beta. Those were seen in Down syndrome patients in a similar way to Alzheimer's patients, and this in contrast to normal controlled person. The binding of Lecanemab to these harmful forms of amyloid beta, the protofibrils, and to plaques was for the first time demonstrated in Down syndrome patients. These data together suggest that Lecanemab could help preserve brain function in adults with Down syndrome with dementia. I think that is an important step forward for this indication. Eisai also presented results, updated results from the phase II-B open label extension study at the Congress. There they have shown that the effects of Lecanemab on amyloid reduction that persist for up to two years following Lecanemab discontinuation.
If you look at the little graph there to the right, for those patients who are part of the core study of the phase II-B, there we see that Lecanemab dramatically decreased amyloid in the brain. They are normalizing the levels in the brain of amyloid. When they are without treatment until the open label extension study started, there we see that the low levels remained for those patients who had got the treatment of Lecanemab. For those patients who had placebo in the core study and no treatment, they continue on a high level. When they have then started the open label extension study, for those patients who previously had placebo, they had now a dramatic decline of amyloid in the brain. A clearance that is dramatic, normalizing the levels of amyloid in the brain.
For those who already have had the clearance of amyloid from the brain, there was only a small further decline. Importantly also was that Lecanemab when it was dosed 10 mg per kg bi-weekly, was shown to reduce amyloid levels in the brain to normal levels in more than 80% of patients who participated in the core and in the open label extension study. This as early as 12 months into treatment. Other really important findings and presentations at the AD/PD was that we now can note that three different anti-amyloid antibodies have shown clinical effects and reduction of amyloid in the brain of Alzheimer's disease patients. I think that all supports the anti-amyloid hypothesis, and further strengthens Lecanemab. When we compare Lecanemab with other late-stage competitors, we can note that Lecanemab is very competitive. Next slide, please.
Other highlights during the first quarter were that we had important learnings at the Alzheimer Parkinson Congress in Parkinson's disease in that field. That supports now AbbVie, our partner, when they are defining the phase II program. Right now we are discussing with AbbVie about the design of phase II and preparing for the phase II program. Other highlights was that we had a European patent granted for new antibodies targeting truncated forms of amyloid beta. Our patent portfolio has expanded further during the beginning of this year. Now it includes more than 230 granted patents and 60 pending patent applications. This is within 13 patent families. Our project portfolio has also expanded, and I'm really excited about this, that we have now two new Alzheimer's disease projects that are coupled to our BrainTransporter technology.
That technology platform has evolved in a great way, and it's now linked to two of our Alzheimer's projects. For myself personally, I also had a highlight when I had the opportunity to present BioArctic and our important research in Alzheimer's disease to the Swedish royal family. I was really impressed by that high level of engagement in this area. In summary, BioArctic has got a great start of this year. Next slide, please. BioArctic has an attractive and well-balanced portfolio, and it's all focused on central nervous system disorders, and we have divided it in five different areas. Alzheimer's disease is the largest area. When I say it's balanced, I mean it on three different ways. That we have several projects in different areas, and that we have also projects spanning from early discovery all the way to late phase III.
The third is that we have a combination of fully financed partner projects and innovative, fully owned projects with great potential. Our strategic partners finance the expensive clinical programs in Alzheimer's disease and Parkinson's disease, whereas BioArctic finance less expensive preclinical phases, where we can increase the value of the projects before going into partnering discussions. We can also notice that for this quarter, we have expanded the project portfolio with two new early discovery projects together then with our Brain Transporter technology, and you see them as AD-BT2802 and AD-BT2803. Next slide, please. BioArctic has two longstanding successful partnerships together with Eisai in Alzheimer's disease all the way back since 2005. Eisai is a great partner, and they are very committed to dementia and to Lecanemab.
We have so far received EUR 65 million out of the total aggregated value of the agreement of up to EUR 222 million. There is still a lot to receive if the program continues to progress well. If we come all the way to the market, we can also expect royalties of substantial value. I think that they could be like blockbuster revenues for BioArctic, and that means that we could see revenues of more than $1 billion US per year. I think this is quite impressive if you consider that we are not having any cost for the clinical program. Furthermore, we also have the right to other indications, and we also have the right to commercialize Lecanemab in the Nordic region for Alzheimer's disease. I really think that BioArctic has a great business model.
That model is also applied in Parkinson's disease where our partner is AbbVie, and we have a very successful collaboration with them as well. In this collaboration, we have so far received $130 million out of the total aggregated value of $755 million. If we come all the way to the market, we could also expect substantial royalties here. AbbVie has already mentioned that they are planning to start with Parkinson's disease for ABBV-0805, but they are also looking into other potential indications for ABBV-0805. Such indications like Multiple System Atrophy and Lewy Body Dementia. This collaboration could also lead to substantial revenues for BioArctic if it all continues to progress well. I'm really happy and proud of these two collaborations. Next slide, please.
We'll talk a little bit more about Lecanemab, where our partner, Eisai, are strongly committed. They have a broad program. There are now three different clinical studies underway. We'll start with Clarity AD, the phase III confirmatory study in early Alzheimer's patients. The study is progressing well. Patient enrollment was completed earlier this year, as I said. We now have 1,795 early Alzheimer patients who will be part of the primary endpoint readout with 18-month data, which Eisai expects to be available in September 2022. The second study in the same patient population, which is mild Alzheimer's disease and MCI. Those two together are called early Alzheimer's disease. The second study there is the open label extension study linked to the phase II-B study, which is ongoing with about 180 patients.
This is where we get data continuously, since this is an open study, which is being presented at congresses, and we just had this presentation at AD/PD and other congresses earlier this year, as I just mentioned. The second phase III program is in even earlier stages, very early stages. Now we talk about individuals who are not yet having any symptoms. This stage is called preclinical Alzheimer's disease. These individuals, they have increased levels of amyloid in the brain, and they are then part of this phase III program called AHEAD 3-45. This is a study where the Alzheimer's Clinical Trials Consortium has selected Lecanemab together with Eisai to be part of being explored as more of a prevention program at this very early stages.
The aim here is to see that we can reduce amyloid levels in the brain and normalize them, and then also evaluate therapeutic effect of Lecanemab on the progression of this disease. We're very impressed by how our partner, Eisai, are driving Lecanemab in a broad approach to support and help Alzheimer's patients. We are really looking forward to following the progress here. Next slide, please. What about our early-stage portfolio? Well, our early-stage portfolio continues to progress well and according to plan despite the COVID-19 pandemic situation. I think the ways that we have adjusted, and of course we work a bit differently, but so far we have managed to progress our early-stage portfolio without any noticeable disturbances. I think it's important to have several different possibilities to target Alzheimer's disease since it's a huge disease affecting many patients around the world.
We say that about 30 million patients around the world are affected by Alzheimer's disease, and it's really increasing and increasing since it is linked to age and the population around the world is getting older and older. Therefore, we are working on different targets. I think in the future, we will also most likely see combination of different targets in order to give the patients the best outcome of the treatment. We have six fully owned disease-modifying antibodies now in our Alzheimer portfolio, and we also have out-licensed a backup compound to BAN2401 in collaboration with Eisai which also is in early stage. This quarter, as I said, we have expanded the early-stage portfolio with two new Alzheimer projects linked to our BrainTransporter technology. Our pre-clinical programs in Parkinson's disease and in other CNS disorders is also progressing well.
We are also, as I said, progressing the Down syndrome with dementia patient segment with new data as I just reported. I'm really excited about how well the Brain Transporter technology platform is progressing. Also, as I said before, we're working on this diagnostics, and this is another area where important things are happening in the field around us where blood markers are looking to be more and more promising. That will be an important complement to the disease-modifying treatments in order to identify the patients at an early stage. Also great progress for the early-stage portfolio during the beginning of this year. Next slide, please. By that, we are now coming to the financial summary, and I will hand over to our CFO, Jan Mattsson.
Thank you, Gunilla. For those of you that don't know BioArctic so well yet, I'd like to point out that we currently don't have any steady revenues, but we have a business model that is focused on partnership agreements, which means that our financials are very much linked to milestones, and that income is related to research projects with our partners. With that, let's start looking at our numbers, and my comments here relate to the quarter's number. Net revenues were SEK 7 million for the quarter, compared to SEK 36 million in the same period last year.
The decrease in the quarter compared to last year relates to lower revenue from the Parkinson's disease program, which is according to plan, together with the fact that during last year, in the same quarter, we had a one-off of SEK 23 million that was recorded, attributable to a remeasurement of total costs of the Parkinson program. Looking at OPEX, total costs are in line with last year, from SEK 36- SEK 38, of which project expenses in total increased to SEK 11 from SEK 10 in the first quarter. This was mainly related to and explained by our increase in our own projects and our expanded portfolio. Moving to operating results, it was down to SEK -29 million in the quarter, compared to SEK +4 in Q1 of last year. Just as for net revenues, this relates to the Parkinson's disease program.
To look at our costs in the coming year, we forecast to have costs in the range of SEK 180 million-SEK 220 million. Next slide, please. Looking at cash and net result. The cash balance continues to be in good health and amounted to just below SEK 1 billion at the end of the quarter. Cash flow from operating activities was SEK -38, compared to SEK -36 in Q1 of last year. Net result for the period was SEK -29, compared to SEK +4 same quarter last year. In summary, we continue to be in good financial shape. With that, I hand back again to Gunilla.
Thank you, Jan. By that, we are now coming to upcoming news and closing remarks. Now we are on slide 14. Upcoming news flow. Eisai are progressing the broad clinical program for Lecanemab in Alzheimer's disease in a great way. We expect more data to be presented at coming international congresses. The next one to look out for is the AAIC Congress in July, which will be partly virtual. Everyone in the Alzheimer's field is also, of course, very excited to follow the FDA decision on Aducanumab, where the review period is until the 7th of June. In Parkinson's disease, we look forward to the continued phase I study being completed by AbbVie and with AbbVie's preparation of the phase II programs, where we got a lot of important learnings from the competitors at the AD/PD congress.
The diagnostics area, there we have seen great progress in the Alzheimer field, where we will follow this closely. I want to point out especially the blood biomarkers like phospho-tau217, which looks really promising. This could be a very important contribution to the disease-modifying treatment for Alzheimer's disease. Our brain barrier technology platform, we will also continue to develop that and see when we can do further sharing of results there. We can conclude that we have had a very good start of 2021, and that we have exciting times ahead. Slide 15, please. I just want to close by saying that BioArctic is built on great science. We have great projects. We have great partners, and it's all being done by our 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 on our way to help Alzheimer's patients within not too long. Next slide, please. By that, I thank you for your attention, and we are happy to take questions.
Thank you. Ladies and gentlemen, if you have a question for the speakers, please press zero one on your telephone keypad. Our first question comes from the line of Joseph Eden from Rx Securities. Please go ahead. Your line is open.
Good morning. Thanks very much for taking my questions. This morning's release, you announced for the first time programs where you're coupling antibodies with your Brain Transporter technology. I was just wondering if you could give any more color on those programs. For instance, targets for the antibodies, their timeline to preclinical data or clinical data. The second question I had, it looks like the preclinical data on the Down syndrome, there's proof of mechanism there that was quite promising. What steps do you see that you still need to complete to get to a phase I trial, and when might that be? Thank you.
Thank you, Joseph. I wish I could reveal more information for you on the BrainTransporter, but I think what we can say now is that our BrainTransporter technology platform has progressed so well, and we are working on a broad potential for the platform as such. We have selected two Alzheimer programs that will be the front runners with this technology. I'm not in the position right now that I can reveal the targets and the timelines, but I can say that we are very encouraged and pleased to see that it's now being applied into some of our projects as the first step. I think it's really exciting. Your second question on Down syndrome, where I also agree with you, it's exciting that we have been able to show the proof of mechanism, at least in the laboratory stage.
We have had a presentation at AD/PD. We also have had one publication so far come out just recently, now in April. There are some more steps that we can take before we would go into, and I would say we could go directly into phase II here since we have so much learnings already about Lecanemab. Important for this patient population is to have a subcutaneous formulation, and that is one of the things that we are working on. That's why it still will take a bit of time before the clinical trials will start. I think we can start with phase II. I hope that was the answer to your question.
Yes. Thanks very much. If I could just possibly ask a follow-up on the blood-brain barrier technology. Is that technology something that you are open to license? It's just I know that certain other companies in neurodegenerative space have their own technologies, and it's becoming quite a hot field. Are you getting any interest from potential partners coming to you to use that technology, or is that something that you would be open to?
Absolutely. Great question. As you have heard me say before, I'm really excited about this technology, and I think that we have something which is really in the front run in this area where we are competing with some big players as well. What we are thinking about is, of course, several non-exclusive licenses here. I think the first step is to start with a couple of our own, but then definitely we're open to discussions as we are all the time if any big pharma want to have collaborations with us and so forth. That door is always open. Our approach is that we would like to start now with our two internal programs.
Okay. Thanks very much, Gunilla.
Thank you.
Thank you. Our next question comes from the line of Gergana Almquist from Redeye. Please go ahead. Your line is open.
Hello, and good morning, everyone. My first question is about the article that was published yesterday. How did the study results from the II-B study inform the Clarity AD? I mean exactly the endpoint, the design, and the measurement. Why were they selected exactly in that way in the new Clarity AD study, and what was learned from the II-B study? That's my first question.
Excellent question. Thank you so much, Gergana.
Of course, I'm very pleased to know that we now have got the phase II-B results published in Alzheimer's Research & Therapy. The phase II-B trial was a specific study in order to first of all to see that we have an effect and a good tolerability profile, and importantly, select the right dose for phase III. There are some really important learnings from that study that is being applied in phase III, especially with regard to the dosing and patient population is the same as in phase II-B. That I think is very important. When there are interactions with regulatory authorities, they prefer CDR-SB as the primary endpoint, and CDR-SB was one of the clinical outcomes in the phase II-B trial.
Now in the phase III trial, which is aimed to confirm the encouraging results of the phase II-B, the primary endpoint is CDR-SB, and secondary endpoints are the other clinical scales like ADAS-Cog, the cognition scale, and ADCOMS. Then it's also important to see that and to confirm that Lecanemab is clearing amyloid from the brain and normalizing the amyloid levels in the brain. Also confirm the good tolerability profile with a low level of the side effect ARIA-E that we have seen so far. Then the difference is, of course, with regard to the design of the trials, the phase III program is a very traditional study with two arms, placebo versus one dose of Lecanemab. I'm very pleased that the article is out so everyone can see.
It's the same information that we have been providing all the time, which I also think is very reassuring. It's now a peer-reviewed article, which is in great consistency with the communications that has been going on since the results came out.
Thank you. My second question actually comes from a retail investor who wrote it to me. He asked, how do you think if the Aducanumab and Lecanemab both get approval, how would then the market split, because they both are promoted by the same company. How would this look like in terms of marketing and sales of the two parallel treatments, hypothetically?
You were breaking up a little bit, but I think I understood your question. What if both Aducanumab and Lecanemab comes out on the market?
Yes. How would it look like in terms of sales and marketing?
Yeah.
For the two drugs.
I think that first of all, this is a huge patient population. It's an enormous number of patients around the world who suffer from Alzheimer's disease. There is room for many different treatments. I think if we look at what we have shown with Lecanemab, is that we have a very consistent result in our phase II-B trial on clinical outcomes. We have also seen that we have an early effect at six months, which will increase more and more over time, and a dramatic effect in clearing plaques rapidly. Where we differ also, in contrast to this earlier effect and so forth, is on the side effect profile, where we have shown that we have a very low frequency of the ARIA-E, and a very low frequency of any patients having any symptoms.
Lecanemab is the only treatment which can be given with a top dose directly without any titration by giving the doses slowly titrated upwards like others. I think that Lecanemab is very well positioned no matter what other compounds that will be coming into the market. I think definitely there is room for difference. If you compare just Aducanumab with Lecanemab is the only one that really targets those toxic forms of amyloid, the protofibril, and clears those. Whereas aducanumab has a slightly different profile and targets more the fibril. I definitely think there is room for several.
Thank you, Gunilla.
Thank you.
Have a good one.
Thank you. I remind you that if you want to ask a question, you will have to press zero or one on your telephone keypad. There are no further questions at this time. Please go ahead, speakers.
Okay. I thank you so much for your attention and for the great questions, and I wish you all a great day. Stay safe.