Annual Report • Feb 4, 2021
Annual Report
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October – December 2020
| Q4 | Jan-Dec | ||||
|---|---|---|---|---|---|
| MSEK | 2020 | 2019 | 2020 | 2019 | |
| Net revenues | 8.4 | 26.4 | 62.3 | 281.8 | |
| Other operating income | 1.4 | 0.0 | 3.6 | 14.8 | |
| Operating profit/loss | -30.2 | -21.1 | -85.0 | 112.5 | |
| Operating margin, % | -360.7 | -79.8 | -136.4 | 39.9 | |
| Profit/loss for the period | -13.2 | -17.1 | -68.5 | 88.5 | |
| Earnings per share before dilution, SEK | -0.15 | -0.19 | -0.78 | 1.00 | |
| Earnings per share after dilution, SEK | -0.15 | -0.19 | -0.78 | 1.00 | |
| Equity per share, SEK | 10.30 | 11.07 | 10.30 | 11.07 | |
| Cash flow from operating activities | -25.3 | -54.2 | -90.9 | 327.2 | |
| Cash flow from operating activities per share, SEK | -0.29 | -0.62 | -1.03 | 3.72 | |
| Equity/assets ratio, % | 86.4 | 82.4 | 86.4 | 82.4 | |
| Return on equity, % | -1.44 | -1.74 | -7.28 | 8.88 | |
| Share price at the end of the period, SEK | 95.40 | 94.90 | 95.40 | 94.90 |
Unless otherwise stated, this Interim report refers to the Group. Figures in parentheses refer to the corresponding period last year.
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"New clinical data provide additional support for drug candidate lecanemab (BAN2401) in the treatment of Alzheimer's disease."
2020 was an eventful year, with positive momentum and advanced positions in our drug development projects. While the COVID-19 pandemic has entailed tremendous hardship for the world around us, we have done our utmost to keep the pandemic from impacting our operations. By changing our work procedures, BioArctic's important efforts to improve the quality of life for patients with diseases of the central nervous system could be carried on according to plan. Our ambition remains: together with our partners, we intend to be one of the first companies to successfully develop disease-modifying treatments for Alzheimer's and Parkinson's diseases.
BioArctic's drug candidate BAN2401, which was recently assigned the international nonproprietary name lecanemab by the World Health Organization, continues to show promising results. Baseline data for the patients participating in Clarity AD, the confirmatory Phase 3 study, were shown to be consistent with baseline in the Phase 2b study. The participants in the Clarity AD study are also representative of a population with early Alzheimer's disease. BioArctic's partner Eisai recently communicated that it had implemented a small expansion of the number of participants in the confirmatory Phase 3 study. The decision was taken proactively to ensure a robust dataset and to mitigate the potential impact of patients who temporarily missed doses due to the COVID-19 pandemic. Eisai also confirmed that time for data readout for Clarity AD remains unchanged and is still expected by September 2022.
We are also pleased with the findings from the open-label extension of the Phase 2b study with lecanemab, which demonstrated a rapid and continual decrease in amyloid levels in the brain after three, six and twelve months of treatment in the patients who previously received placebo. Another finding supporting the safety of lecanemab is that even though patients were treated with the highest dose of lecanemab right from the start, the frequency of the side effect ARIA-E, was at the same low level as in the Phase 2b study. This distinguishes lecanemab from other drug candidates in late-stage clinical development that demonstrate higher frequencies of these side effects. Lecanemab therefore can be administered at the intended dose already from the start, without titration.
During the year, Eisai initiated an additional global Phase 3 program: AHEAD 3–45, the purpose of which is to study and delay the development of the disease through treatment with lecanemab at the very earliest stages of the disease. Positive study results could be of great help for more individuals in slowing the disease at an early stage, and would entail additional market potential for lecanemab.
As regards Parkinson's disease, our partner AbbVie is preparing a Phase 2 program with drug candidate ABBV-0805 based on the Phase 1 study.
BioArctic's early-stage proprietary projects are also continuing to perform well. The preclinical data for our bloodbrain barrier technology are extremely promising, and work is under way to obtain additional patent protection. Initially, the technology will be used in existing projects in our pipeline, but there are also business opportunities in offering the technology for antibodies from other companies.
In January, the European Patent Office approved our application for a patent on antibodies against truncated amyloid beta, which has a pronounced ability to form toxic aggregates that could cause Alzheimer's disease. This approval further demonstrates the strength of the company's research and its ability to find new and innovative ways to intervene in various stages of the course of Alzheimer's disease. In the future, several alternatives and combinations of treatments may be needed to address different types of Alzheimer's disease patients.
BioArctic's research rests on a solid scientific foundation, and our value-driven leadership supports the work of developing the company further. I am extremely proud that our goal-oriented diversity initiatives are yielding results; one proof of this is that we were awarded the Allbright Award for gender equality in 2020. I can conclude that, together with our partners, we have a fantastic opportunity to create the medicines of the future and to improve life for patients and their loved ones.
Gunilla Osswald CEO, BioArctic AB
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BioArctic AB (publ) is a Swedish biopharma company developing new drugs based on groundbreaking research for patients with central nervous system disorders. For a global market, the aim is to generate transformative medicines that can stop or slow down the progression of Alzheimer's disease, Parkinson's disease and other neurological diseases. BioArctic was founded in 2003 based on innovative research from Uppsala University, Sweden. BioArctic's B-share is listed on Nasdaq Stockholm Mid Cap (ticker: BIOA B).
BioArctic's vision is to generate innovative medicines that improve life for patients with disorders in the central nervous system. Our work is based on groundbreaking scientific discoveries, and the company's researchers collaborate with strategic partners such as research groups at universities and major pharmaceutical companies.
The company has scientific excellence and vast experience in developing drugs from idea to market. Under BioArctic's business model, the company at an early stage itself pursues project development and then, at an appropriate juncture, licenses commercial rights and late phase development to global pharmaceutical companies. In recent years, BioArctic has successfully delivered high quality drug projects that have resulted in significant strategic license and partnership agreements in two major disease areas with high unmet medical need.
Three important cornerstones of BioArctic's strategy are:
BioArctic conducts its research in five focus areas:
Neurodegenerative disorders are conditions in which cells in the brain degenerate and die. Normally the neurodegenerative processes begin long before any symptoms appear. Neurodegenerative disorders affect the lives of millions of people and constitute a growing health care problem.
A key cause of Alzheimer's disease and Parkinson's disease is believed to be misfolding and aggregation of proteins. The spreading of aggregated soluble forms of proteins leads to neuronal dysfunction, cell death, brain damage and symptoms of disease. Each neurodegenerative disorder is characterized by different aggregated proteins. The protein amyloid beta (Aβ) is involved in Alzheimer's disease, while the protein alpha-synuclein (α-synuclein) is involved in Parkinson's disease. BioArctic's aim with the antibodies currently in clinical phase, is to achieve a disease-modifying effect through the selectivity of antibodies, binding and elimination of the harmful soluble aggregated forms of the amyloid beta protein (oligomers/protofibrils) in the brain.
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BioArctic has a balanced, competitive portfolio consisting of unique product candidates, technology platforms and methods for diagnostics. All projects are focused on disorders of the central nervous system. The projects are a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market- and out-licensing potential. The projects are in various phases: from discovery to late clinical phase.
As of December 31, 2020, the project portfolio consisted of:
| Project | Partner | Discovery | Preclinical | Phase 1 | Phase 2 | Phase 3 | |
|---|---|---|---|---|---|---|---|
| ALZHEIMER'S DISEASE | Lecanemab (BAN2401) Clarity AD |
Eisai1 | Early Alzheimer's disease4 | ||||
| Lecanemab (BAN2401) AHEAD 3-45 |
Eisai1 | Preclinical (asymptomatic) Alzheimer's disease5 | |||||
| BAN2401 back-up | Eisai | ||||||
| AD1801 | |||||||
| AD1502 | |||||||
| AD1503 | |||||||
| AD2603 | |||||||
| PARKINSON'S DISEASE | ABBV-08052 | AbbVie | |||||
| PD1601 | AbbVie | ||||||
| PD1602 | AbbVie | ||||||
| OTHER CNS DISORDERS | Lecanemab (BAN2401) | Down's syndrome3 Traumatic brain injury3 |
|||||
| ND3014 | |||||||
| BLOOD-BRAIN BARRIER TECHNOLOGY |
BBB technology platform | ||||||
| DIAGNOSTICS | Imaging and biochemical biomarkers – Alzheimer's disease |
||||||
| Imaging and biochemical biomarkers – Parkinson´s disease |
AbbVie |
1) Partnered with Eisai for lecanemab for treatment of Alzheimer's disease. Eisai entered partnership with Biogen regarding BAN2401 (lecanemab) in 2014
2) AbbVie in-licensed BAN0805 in late 2018 and develops the antibody with the designation ABBV-0805
3) Dementia and cognitive impairment associated with Down´s syndrome and with traumatic brain injury
4) Mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease 5) Normal cognitive function with intermediate or elevated levels of amyloid in the brain
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BioArctic has developed several unique and selective antibodies with the potential to slow the progress of Alzheimer's disease. The most advanced drug candidate, lecanemab (BAN2401) is currently being evaluated in two Phase 3 studies: Clarity AD for early Alzheimer's disease and AHEAD 3-45 for preclinical (asymptomatic) Alzheimer's disease. Lecanemab previously showed convincing results in a large Phase 2b study in patients with early Alzheimer's disease. The development of lecanemab against Alzheimer's disease is being financed and pursued by BioArctic's partner Eisai, which also owns the rights to the BAN2401 back-up in Alzheimer's disease. BioArctic has four additional antibodies against Alzheimer's disease in its project portfolio.
In Alzheimer's disease, the amyloid beta protein clumps together into increasingly larger aggregates in the brain – from the harmless form with a normal function (monomers) to larger forms such as oligomers, protofibrils, fibrils and finally amyloid plaques containing fibrils. Oligomers and protofibrils are considered the most harmful forms of amyloid beta that initiate the process of Alzheimer's disease. Lecanemab is a drug candidate which functions by eliminating these forms of amyloid from the brain and thereby has the potential to slow down the progression of disease. BioArctic's partner Eisai is responsible for the clinical development of lecanemab in Alzheimer's disease and the project is based on research from Uppsala University, Sweden.
Eisai is conducting two global Phase 3 studies with lecanemab, one in patients with early Alzheimer's disease (Clarity AD) and one in cognitively unimpaired individuals with intermediate or elevated amyloid levels in the brain who have not yet developed symptoms of Alzheimer's disease (AHEAD 3-45).
Clarity AD is the pivotal and confirmatory Phase 3 study. It is based on the Phase 2b study with lecanemab in 856 patients with early Alzheimer's disease which demonstrated dose dependent, clinically meaningful, and statistically significant effects of lecanemab on several clinical endpoints and on biomarkers and showed good tolerability.
This Phase 3 study is a global placebo-controlled, doubleblind, parallel-group, randomized study in approx. 1,760 patients with early Alzheimer's disease i.e. mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's disease. Patients are allocated in a 1:1 ratio to receive intravenous infusion twice a month, either with placebo or with lecanemab 10 mg/kg. The primary endpoint is the change from baseline in the cognition and function scale Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment. Changes in the clinical scales AD composite score (ADCOMS), AD Assessment Scale-Cognitive Subscale (ADAS-Cog) and a clinical scale focusing of activities of daily living particularly relevant in mild cognitive impairment, (ADCS-ADL-MCI), will be key secondary endpoints together with brain amyloid levels as measured by amyloid-PET. According to Eisai, the goal is to
be able to present results from the study in 2022 and thereafter submit an application for marketing approval.
An open-label extension study, without placebo control, with continued treatment with lecanemab with the highest study dose for all the participants in the Phase 2b study is in progress. At the Alzheimer's Association International Conference 2020 (AAIC) and at Clinical Trials on Alzheimer's Disease 2020 (CTAD), Eisai presented new data from the study showing that the patients who had previously received placebo in the Phase 2b study had rapidly and continually decreasing amyloid levels in the brain after three, six and twelve months of treatment with lecanemab. Additionally, with treatment with lecanemab less than 10 percent of patients experienced ARIA-E side effects, consistent with previously reported data.
Lecanemab's unique binding profile has been confirmed in laboratory analyses, which are ongoing in parallel with the clinical development program. These results strengthen BioArctic's conviction that lecanemab has a unique binding profile that distinguishes it from other amyloid beta antibodies. BioArctic has an ongoing research collaboration with Eisai in order to further deepen the knowledge about the drug candidate lecanemab's unique binding profile.
Lecanemab was selected by the Alzheimer's Clinical Trials Consortium (ACTC) and Eisai to be evaluated in a second clinical Phase 3 program which aims to evaluate the effects of lecanemab on preclinical asymptomatic Alzheimer's disease (AHEAD 3-45). The clinical program, that was recently started, include individuals that are at a very early stages of Alzheimer's disease with a high risk of developing the disease. The program that is being conducted with funding from the United States National Institute on Aging (NIA) and Eisai, consists of two clinical sub-studies: A3 and A45. After a joint screening process, the participants are included in one of the randomized, double-blind and placebo-controlled substudies based on amyloid levels in the brains of the specific individuals. AHEAD 3-45 is a global program that is expected to include approximately 1,400 individuals.
The antibody is a refined version of BAN2401 for the treatment of Alzheimer's disease. The antibody was developed by BioArctic in collaboration with Eisai, which resulted in a new license agreement in 2015. The project is driven and financed by Eisai and is in the preclinical phase.
BioArctic has four additional antibody projects against Alzheimer's disease in its project portfolio, all of which are in the research phase. These antibodies have different targets, and each has the potential to become a disease-modifying treatment for Alzheimer's disease. All of them are being developed to treat early Alzheimer's disease. AD1801 is an antibody project where the mechanism of action is linked to ApoE, which is the most common genetic risk factor for Alzheimer's disease. AD1503 is an antibody project against a shorter (truncated) form of amyloid beta, which has a
pronounced ability to aggregate and create toxic forms that could cause Alzheimer's disease.
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In the Parkinson's disease treatment area, BioArctic has been collaborating with AbbVie since 2016. In 2018, AbbVie acquired a license to develop and commercialize BioArctic's portfolio of antibodies against alpha-synuclein for Parkinson's disease and other potential indications.
The drug candidate ABBV-0805 is a monoclonal antibody that selectively binds to and eliminates oligomers and protofibrils of alpha-synuclein. The goal is to develop a disease modifying treatment that stops or slows down disease progression.
In February 2019, the U.S. Food and Drug Administration, FDA, approved the application to conduct a clinical study with ABBV-0805 and the Phase 1 study started in March 2019. In July 2020, AbbVie decided to develop a detailed plan to accelerate ABBV-0805 into a Phase 2 study in Parkinson's disease patients. AbbVie finances and progresses the clinical development of ABBV-0805.
The scope of the drug candidate ABBV-0805 may be expanded to include, for example, Lewy body dementia and multiple system atrophy.
The project is based on research from Uppsala University.
The antibody projects PD1601 and PD1602 target alphasynuclein for treatment of Parkinson's disease. The goal is to develop a disease modifying treatment that stops or slows down disease progression. The projects are included in the collaboration with AbbVie.
BioArctic aims to improve the treatment of a number of central nervous system disorders. The company is evaluating the possibility of developing its existing as well as new antibodies against other diseases in the central nervous system.
Drug candidate lecanemab (BAN2401) (indications other than Alzheimer's disease, owned by BioArctic)
Lecanemab (BAN2401), which is currently being clinically evaluated for Alzheimer's disease, can potentially also be used for other indications. BioArctic owns the rights for all such indications. The antibody lecanemab is in the preclinical phase as a potential treatment of cognitive disorders in conjunction with Down's syndrome and traumatic brain injury.
Research to develop new antibodies for treating neurodegenerative disorders is ongoing at BioArctic. ND3014 is intended to be a disease modifying treatment with potential
to address various neurodegenerative disorders. The project is in an early research phase.
The blood-brain barrier controls the passage of substances between the blood and the brain. It protects the brain from harmful substances, but at the same time it can make the delivery of therapeutic agents to the brain more difficult. BioArctic and researchers at Uppsala University are collaborating on developing technology that facilitates the passage of antibodies across the blood-brain barrier. Together with Uppsala University, BioArctic received grants from Sweden's Innovation Agency, Vinnova, for continued research in the blood-brain barrier project. The technology, which is at an early stage, has shown highly encouraging results and has significant potential in the treatment of several different diseases of the brain.
BioArctic is engaged in the development of new diagnostic methods that improve the ability to diagnose and monitor the treatment of Alzheimer's and Parkinson's disease. The company conducts a number of projects in collaboration with commercial and academic partners. Among other things, BioArctic is developing biochemical methods based on the company's antibodies to be applied to cerebral spinal fluid (CSF) testing. Beyond this, the company is exploring the possibilities to measure biomarkers with a simple blood test. BioArctic is also active in projects to improve the diagnostic imaging (PET) of the brain of patients. The goal is to create tools to better diagnose the disease, follow the disease progression and objectively measure the effect of drug treatment.
BioArctic's clinical study of SC0806, with the aim to restore motor function in patients with complete spinal cord injuries, has been terminated. As no clinical effect had been observed in an interim analysis of this study at the end of 2019 the company decided to wind-down the study and close the project. This does not impact BioArctic's research and development of drugs for Alzheimer's disease, Parkinson's disease and other disorders of the central nervous system.
The clinical study of SC0806 received partial financing from the EU Horizon 2020 research and development program (Grant Agreement No. 643853).
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Revenues consist of milestone payments, payments from research agreements and research grants. Because of the nature of the business operations, there may be large fluctuations in revenues for different periods, as revenues from milestone payments are recognized at the point in time when performance obligations are fulfilled.
Net revenues in the fourth quarter amounted to MSEK 8.4 (26.4). Net revenues for the period January – December amounted to 62.3 MSEK (281.8). The decrease in the quarter compared to last year relates to lower revenue from the Parkinson's program, which was according to plan. The decrease for the period January –December is attributable to the milestone payment from Eisai of MEUR 15 or MSEK 162, which was received in the second quarter 2019, and to lower revenue from the Parkinson's program.
Other operating income relates to research grants and operating exchange rate gains. Other operating income amounted to MSEK 1.4 (0.0) for the fourth quarter and for the period January – December to MSEK 3.6 (14.8). The decrease is mainly attributable to exchange rate gains.
Total operating expenses for the fourth quarter amounted to MSEK 39.9 (47.5) and to MSEK 151.0 (184.1) for the period January – December. Project expenses for the fourth quarter and for the period January – December decreased compared to the previous year due to lower activity in the Parkinson's program as planned, offset by increased expenses for own projects. The expenses for personnel in the fourth quarter and for the period January – December increased as a result of an increase in the number of employees. Other external costs decreased during the year by MSEK 7.8 million as a result of reduced consultant costs and travel. Other operating expenses mainly consist of realized operating exchange rate losses. The reversal of untaxed reserves in the Parent Company in 2020 resulted in a decrease in deferred tax liability in the Group, and the change is recognized in the income statement.
Since BioArctic's own projects are in an early research phase they did not meet all the conditions for R&D costs to be capitalized and thus, all such costs have been charged to the income statement. The external projects are owned by our partners and BioArctic has no costs for the clinical programs.
Operating profit before financial items (EBIT) amounted to MSEK -30.2 (-21.1) for the fourth quarter and to MSEK -85.0 (112.5) for the period January – December. The decrease in operating profit both for the quarter and for the full year compared with the same period last year was primarily attributable to the milestone payment that was received from Eisai in the second quarter last year but also due to lower revenue from the Parkinson's program, which was according to plan.
Net financial items totaled MSEK -1.1 (-0.5) for the fourth quarter and to MSEK -1.7 (0.4) for the period January – December. Financial income consists of financial exchange rate gains and financial expenses consists of negative interest on cash and cash equivalents and interest on leasing liabilities according to IFRS 16 Leases.
Profit (loss) amounted to MSEK -13.2 (-17.1) for the fourth quarter and to MSEK -68.5 (88.5) for the period January – December.
Earnings per share before and after dilution amounted to SEK -0.15 (-0,19) for the fourth quarter and to SEK -0.78 (1.00) for the period January – December.




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Equity amounted to MSEK 907.3 (974.5) as of December 31, 2020. This corresponds to equity per outstanding share of SEK 10.30 (11.07).
The equity/asset ratio increased from 82.4 percent as of December 31, 2019 to 86.4 percent as of December 31, 2020.
The Group's cash and cash equivalents consist of bank balances that at the end of the period amounted to MSEK 999.9 (1,112.8). The decrease in right of use assets of MSEK 5.7 is attributable to depreciation in accordance with IFRS 16, which is mainly related to the head office's lease. The leasing liabilities of MSEK 20.8 MSEK (27.4) is related to the above described right of use assets. The reduction in deferred tax liabilities of SEK 18.0 million is due to the dissolution of untaxed reserves in BioArctic AB. There were no loans as of December 31, 2020 and no loans have been taken since this date. The Group has no other credit facility or loan commitments.
In order to neutralize foreign exchange rate exposure some liquid funds are held in foreign currency. This has reporting effects in connection with the recalculation of currency to the current rate. These effects are recognized in the operating profit and in financial income and expenses.
Cash flow from operating activities for the fourth quarter amounted to MSEK -25.3 (-54.2) and to MSEK -90.9 (327.2) for the period January – December. The cash flow for the full year period from the preceding year included milestone payments of MUSD 50, or MSEK 460, received from AbbVie and MEUR 15, or MSEK 162, from Eisai.
Investments in the fourth quarter amounted to MSEK 8.9 (0.4) and for the period January – December to MSEK 14.0 (3.3). The investments are mainly related to laboratory equipment.
Cash flow from financing activities amounted to MSEK -1.3 (-1.5) for the fourth quarter and relates to the amortization of leasing liabilities. During the period January – December cash flow from financing activities amounted to MSEK -6.6 (-138.5). Cash flow from financing activities 2019 included a dividend of MSEK 132.1.
All of the Group's business operations are conducted in the Parent Company.



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Patents are crucial to the company's future commercial opportunities. BioArctic has therefore an active patent strategy covering all major pharmaceutical markets including the US, EU, Japan and China. At the end of the period, BioArctic's patent portfolio consisted of 12 patent families with more than 160 granted patents and more than 70 ongoing patent applications.
Collaborations and license agreements with leading pharma and biopharma companies are an important part of BioArctic's strategy. In addition to financial compensation, BioArctic benefits from the expertise the company's partners contribute in drug development, manufacturing and commercialization. BioArctic has entered into a number of such agreements with the Japanese global pharma company Eisai and the American global biopharma company AbbVie. These strategic partnerships with leading global companies confirm that BioArctic's research is of very high quality. In the future BioArctic may enter into additional agreements that can contribute further funding and research and development competence for BioArctic's product candidates in preclinical and clinical phase, manufacturing and marketing competence, geographic coverage and other resources.
BioArctic has been collaborating with Eisai in the field of Alzheimer's disease since 2005. The company has signed research and licensing agreements concerning the lecanemab and BAN2401 back-up antibodies. The total value of these agreements may amount to MEUR 222 in addition to royalties. To date, approximately MEUR 65 has been received and recognized.
BioArctic has been collaborating with AbbVie in the field of Parkinson's disease since 2016, when a research agreement was signed that included products such as the antibody BAN0805, now designated ABBV-0805. At the end of 2018, AbbVie exercised its option to license BioArctic's alphasynuclein antibody portfolio for Parkinson's disease and other potential indications. BioArctic has had primary responsibility for the preclinical development work and AbbVie is responsible for the clinical development. The total value of the agreement could amount to MUSD 755 in addition to royalty payments. To date, MUSD 130 has been received. For more information regarding BioArctic's two large collaboration partners, please see the Annual Report 2019 on pages 18, 25 and 40.
Collaborating with universities is also of great importance to BioArctic. The company has ongoing collaborations with academic research groups at a number of universities.
The management makes assumptions, judgments and estimates that affect the content of the financial statements. Actual results may differ from these assumptions and estimates, as is also stated in the accounting principles. The objective of the Group's risk management is to identify, mitigate, measure, control and limit the risks of the business. Significant risks are the same for the Parent Company and the Group.
BioArctic's operational and external risks mainly consist of risks related to research and development, clinical trials and dependence on key employees.
A detailed description of exposure and risk management is presented in the Annual Report 2019 on pages 46-49. In addition to the risks described in the annual report for 2019, the board of directors concluded that COVID-19 has not had any major impact on operations during the year. The company routinely monitors the development of the pandemic to manage any risks over the longer-term.
Currently, BioArctic does not have any drugs on the market. The company develops a number of drug candidates and diagnostics for Alzheimer's and Parkinson's diseases in collaboration with global pharmaceutical companies. The company also conducts research for wholly owned projects including new potential antibody treatments, diagnostics, as well as a blood-brain barrier technology platform. The company signs research and licensing agreements with partners and then receives remuneration for research as well as milestone payments and royalties, which the company uses to finance current and new projects. Milestone payments are normally received when the project reaches predetermined development targets – the start of clinical trials, for example – or when clinical trials move from one phase to a later phase. Thus, these payments arise unevenly over time.
The company enjoys a strong financial position and has a business model in which its revenue and earnings are currently primarily based on non-recurring revenue from research and licensing agreements the company signed. The company's liquidity facilitates continued development of the projects covered by strategic partnership agreements as well as financing of the company's own projects in early phase and therefore are less costly. BioArctic's focus areas comprise unique drug candidates, innovative blood-brain barrier technology and diagnostics, areas with high unmet medical need. All projects are focused on disorders of the central nervous system and have great market potential. BioArctic's ambition is to generate the medicines of the future for patients with central nervous system disorders.
Operating expenses are expected to be in the range of MSEK 180 – 220 for the fiscal year January – December 2021. During 2020 operating expenses were MSEK 151, which was in the range of the forecast of MSEK 150 – 170. During the last three years the average annual level of the operating expenses has been approximately MSEK 190.
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At the end of the period, the number of employees was 45 (42) of which 18 (16) are men and 27 (26) women. Just over 80 percent work in R&D and approximately 70 percent are PhDs. In the organization there is one Associate Professor, two Professors and three medical doctors.
A cost-efficient organization at BioArctic is achieved by hiring consultants for specific assignments and tasks in competence areas that the company lacks or only has need for periodically. As of December 31, 2020, these corresponded to 12 (11) full-time positions.
The share capital in BioArctic amounts to SEK 1,761,200 divided by 88,059,985 shares which is split between 14,399,996 A-shares and 73,659,989 B-shares. The quotient value for both A- and B-shares is SEK 0.02. The A-share has 10 votes per share and the B-share has 1 vote per share.
| Number | Share of (%) | |||
|---|---|---|---|---|
| A-shares | B-shares capital | votes, | ||
| Demban AB (Lars Lannfelt) | 8,639,998 | 22,628,052 | , % 35.5 |
% 50.1 |
| Ackelsta AB (Pär Gellerfors) | 5,759,998 | 15,086,301 | 23.7 | 33.4 |
| Fourth AP-Fund | - | 4,300,000 | 4.9 | 2.0 |
| Third AP-Fund | - | 3,203,492 | 3.6 | 1.5 |
| Gladiator | - | 2,532,785 | 2.9 | 1.2 |
| Unionen | - | 2,391,835 | 2.7 | 1.1 |
| Swedbank Robur Fonder | - | 1,843,058 | 2.1 | 0.8 |
| Handelsbanken Fonder | - | 1,609,175 | 1.8 | 0.7 |
| Investment AB Öresund | - | 1,530,000 | 1.7 | 0.7 |
| Wellington Management | - | 1,314,848 | 1.5 | 0.6 |
| Tot. 10 largest shareholders 14,399,996 | 56,439,546 | 80.4 | 92.1 | |
| Other | - | 17,220,443 | 19.6 | 7.9 |
| Total | 14,399,996 | 73,659,989 | 100.0 | 100.0 |
The Annual General Meeting (AGM) for BioArctic will be held on 6 May. As a measure to reduce the risk of spreading the coronavirus and in the light of the uncertainty about what restrictions and guidelines will apply to meetings at the time of the meeting, the Board of Directors of BioArctic has
1) Source: Monitor by Modular Finance AB. Compiled and processed data from various sources, including Euroclear, Morningstar and Swedish Financial Supervisory Authority (Finansinspektionen).
decided that the AGM will be held solely through advance voting using the postal voting method. There will thus be no possibility of physically attending the AGM, either in person or by proxy. More information on the AGM and how to register will be presented in the notice to attend. BioArctic also intends to invite to a digital information meeting that will be held well in advance of the meeting.
In accordance with the resolution at the 2020 AGM, the Nomination Committee for the 2021 AGM has been appointed and announced. The Nomination Committee consists of: Gunnar Blix, Chairman (Third Swedish National Pension Fund), Margareta Öhrvall (Demban AB) and Claes Andersson (Ackelsta AB).
The Board proposes that no dividend be paid for the 2020 financial year.
The Annual General Meeting 2019 approved the Board of Directors' proposal for resolution concerning an employee warrant program for the company's management, researchers and other staff, a directed issue of warrants and the transfer of warrants or shares in the company to the participants in the employee warrant program.
The employee warrant program 2019/2028 shall include not more than 1,000,000 warrants. To enable the company's delivery of shares under the employee warrant program 2019/2028, the Annual General Meeting approved a directed issue of a maximum of 1,000,000 warrants.
The dilutive effect of the employee warrant program 2019/2028 is estimated to be a maximum of 1.1 percent of the share capital and 0.5 percent of the votes in the company (calculated on the number of existing shares in the company), assuming full exercise of all employee warrants. The employee warrants can be exercised three years after allocation at the earliest. As of the end of the period, 540,000 employee warrants were allocated, of which 5,000 were allocated in the first quarter, 25,000 in the second quarter and 35,000 in the fourth quarter. The allocation of employee warrants had a dilutive effect corresponding to 500,000 shares, or 0.57 percent, at the end of the period. More information is available on www.bioarctic.com
In addition to the employee warrant program described above, BioArctics's two principal owners Demban AB and Ackelsta AB, independent of the company, issued stock options in 2017 to board members and senior executives. During the second quarter 2020, all outstanding options had been exercised and the program was terminated.
The information was submitted for publication, though the agency of the named contact persons, at 8:00 a.m. CET on February 4, 2021.
This interim report has not been subject to review by BioArctic´s auditors.
Stockholm, Sweden, February 4, 2021
Gunilla Osswald CEO, BioArctic AB (publ)
BioArctic invites investors, analysts and media to an audiocast with teleconference (in English) today, February 4, at 9:30–10:30 a.m. CET. CEO Gunilla Osswald and CFO Jan Mattsson will present BioArctic, comment on the interim report and answer questions.
To participate in the conference, please call: +46 8 505 583 56 (Sweden), +45 781 501 07 (Denmark), +31 207 219 496 (Netherlands), +47 239 636 88 (Norway), +41 225 675 632 (Switzerland), +44 333 300 92 60 (UK), +49 692 222 203 80 (Germany) or +1 833 526 8382 (USA)
Annual report in Swedish published March 31, 2021 Interim report Jan-Mar 2021 April 21, 2021, at 08:00 a.m. CET Annual General Meeting 2021 May 6, 2021 Half-Year report Jan-Jun 2021 July 9, 2021, at 08:00 a.m. CET Interim report Jan-Sep 2021 Oct 21, 2021, at 08:00 a.m. CET Full Year Report Jan-Dec 2021 Feb 3, 2022, at 08:00 a.m. CET
Gunilla Osswald, CEO, [email protected], phone +46 8 695 69 30 Jan Mattsson, CFO, [email protected], phone + 46 70 352 27 72 Oskar Bosson, VP Communications & Investor Relations, [email protected], phone +46 70 410 71 80
Swedish Corporate Identity Number 556601-2679 Warfvinges väg 35, SE-112 51, Stockholm, Sweden Telephone +46 (0)8 695 69 30 www.bioarctic.com
This report has been prepared in a Swedish original version and translated into English. In the event of any inconsistency between the two versions, the Swedish language version applies.



| Q4 | ||||
|---|---|---|---|---|
| kSEK | 2020 | 2019 | 2020 | 2019 |
| Net revenues (note 4) | 8,360 | 26,422 | 62,347 | 281,772 |
| Other operating income | 1,359 | 35 | 3,597 | 14,826 |
| Operating revenues | 9,719 | 26,457 | 65,943 | 296,598 |
| Operating expenses | ||||
| Project related expenses | -13,376 | -20,971 | -50,242 | -72,422 |
| Other external expenses | -6,084 | -7,804 | -23,370 | -31,169 |
| Personnel expenses | -16,523 | -15,268 | -62,977 | -59,715 |
| Depreciations of tangible assets | -3,076 | -2,024 | -11,013 | -9,199 |
| Other operating expenses | -818 | -1,463 | -3,353 | -11,554 |
| Operating profit/loss | -30,158 | -21,073 | -85,012 | 112,538 |
| Financial income | -227 | -164 | 7 | 1,630 |
| Financial expenses | -866 | -301 | -1,686 | -1,192 |
| Profit/loss before tax | -31,251 | -21,538 | -86,691 | 112,976 |
| Tax | 18,052 | 4,443 | 18,174 | -24,507 |
| Profit/loss for the period | -13,198 | -17,096 | -68,517 | 88,468 |
| Earnings per share | ||||
| Earnings per share before dilution, SEK | -0.15 | -0.19 | -0.78 | 1.00 |
| Earnings per share after dilution, SEK | -0.15 | -0.19 | -0.78 | 1.00 |
| Q4 | Jan-Dec | |||
|---|---|---|---|---|
| kSEK | 2020 | 2019 | 2020 | 2019 |
| Profit/loss for the period | -13,198 | -17,096 | -68,517 | 88,468 |
| Other comprehensive income | - | - | - | - |
| Comprehensive income for the period | -13,198 | -17,096 | -68,517 | 88,468 |
| kSEK | 31 Dec 2020 | 31 Dec 2019 |
|---|---|---|
| ASSETS | ||
| Tangible fixed assets | 18,120 | 9,590 |
| Right-to-use assets | 21,820 | 27,544 |
| Deferred tax assets | 452 | 298 |
| Other financial assets | 1,562 | 1,511 |
| Current assets excluding cash and cash equivalents | 8,420 | 31,619 |
| Cash and cash equivalents | 999,940 | 1,112,770 |
| TOTAL ASSETS | 1,050,313 | 1,183,332 |
| EQUITY AND LIABILITIES | ||
| Equity | 907,299 | 974,497 |
| Deferred tax liabilities | 20,666 | 38,685 |
| Non-current lease liabilities | 13,627 | 20,927 |
| Current lease liabilities | 7,141 | 6,439 |
| Other current liabilities | 17,887 | 24,030 |
| Accrued expenses and deferred income | 83,692 | 118,753 |
| EQUITY AND LIABILITIES | 1,050,313 | 1,183,332 |
| 31 Dec 2020 | 31 Dec 2019 | |
|---|---|---|
| Opening balance at 1 January | 974,497 | 1,017,736 |
| Comprehensive income for the period | -68,517 | 88,468 |
| Share-based payments | 1,319 | 383 |
| Paid dividend | - | -132,090 |
| Closing balance | 907,299 | 974,497 |
| Q4 | Jan-Dec | ||||
|---|---|---|---|---|---|
| kSEK | 2020 | 2019 | 2020 | 2019 | |
| Operating profit | -30,158 | -21,073 | -85,012 | 112,538 | |
| Adjustment for non-cash items | 1,767 | -23,240 | -19,991 | -107,485 | |
| Interest received/paid | -859 | -56 | -1,679 | -757 | |
| Income tax paid | -367 | -2,067 | -12,217 | -80,919 | |
| Cash flow from operating activities before changes in working capital | -29,617 | -46,436 | -118,899 | -76,622 | |
| Change in working capital | 4,306 | -7,771 | 28,018 | 403,787 | |
| Cash flow from operating activities after changes in working capital | -25,311 | -54,207 | -90,881 | 327,165 | |
| Cash flow from investing activities | -8,907 | -408 | -13,984 | -3,273 | |
| Cash flow from financing activities | -1,257 | -1,544 | -6,598 | -138,506 | |
| Cash flow for the period | -35,475 | -56,159 | -111,463 | 185,385 | |
| Cash and cash equivalents at beginning of period | 1,036,295 | 1,170,178 | 1,112,770 | 917,307 | |
| Exchange rate differences in cash and cash equivalents | -881 | -1,249 | -1,367 | 10,077 | |
| Cash and cash equivalents at end of period | 999,940 | 1,112,770 | 999,940 | 1,112,770 |
| 2020 | 2020 | 2020 | 2020 | 2019 | 2019 | 2019 | 2019 | |
|---|---|---|---|---|---|---|---|---|
| MSEK | Q4 | Q3 | Q2 | Q1 | Q4 | Q3 | Q2 | Q1 |
| Income statement | ||||||||
| Net revenues | 8.4 | 10.5 | 7.0 | 36.4 | 26.4 | 20.6 | 171.3 | 63.4 |
| Other operating income | 1.4 | 0.9 | -2.1 | 3.4 | 0.0 | 8.6 | -0.7 | 6.9 |
| Operating expenses | -39.9 | -32.2 | -42.9 | -36.0 | -47.5 | -39.7 | -43.8 | -53.0 |
| Operating profit/loss | -30.2 | -20.7 | -37.9 | 3.8 | -21.1 | -10.5 | 126.8 | 17.3 |
| Operating margin, % | -360.7 | -196.3 | -541.5 | 10.4 | -79.8 | -50.9 | 74.0 | 27.3 |
| Profit/loss for the period | -13.2 | -20.7 | -38.2 | 3.6 | -17.1 | -8.3 | 100.3 | 13.6 |
| Balance sheet | ||||||||
| Fixed assets | 42.0 | 36.1 | 35.4 | 36.7 | 38.9 | 40.2 | 41.0 | 42.6 |
| Current assets | 8.4 | 3.7 | 14.5 | 28.6 | 31.6 | 29.2 | 15.9 | 16.3 |
| Cash and cash equivalents | 999.9 | 1,036.3 | 1,049.9 | 1,077.3 | 1,112.8 | 1,170.2 | 1,218.4 | 1,255.6 |
| Equity | 907.3 | 920.2 | 940.5 | 978.4 | 974.5 | 991.3 | 999.5 | 1,031.4 |
| Deferred tax liabilities | 20.7 | 38.7 | 38.7 | 38.7 | 38.7 | 32.5 | 32.5 | 32.5 |
| Lease liabilities | 20.8 | 22.0 | 22.9 | 24.6 | 27.4 | 28.5 | 30.0 | 31.5 |
| Current liabilities | 101.6 | 95.2 | 97.8 | 100.9 | 142.8 | 187.3 | 213.2 | 219.0 |
| Cash flow | ||||||||
| From operating activities | -25.3 | -9.4 | -19.8 | -36.3 | -54.2 | -49.4 | 97.2 | 333.6 |
| From investing activities | -8.9 | -3.3 | -1.5 | -0.3 | -0.4 | -1.6 | -0.7 | -0.6 |
| From financing activities | -1.3 | -0.9 | -1.6 | -2.8 | -1.5 | -1.5 | -133.6 | -1.8 |
| Cash flow for the period | -35.5 | -13.7 | -22.9 | -39.4 | -56.2 | -52.5 | -37.1 | 331.2 |
| Data per share | ||||||||
| Earnings per share before dilution, SEK | -0.15 | -0.23 | -0.43 | 0.04 | -0.19 | -0.09 | 1.14 | 0.15 |
| Earnings per share after dilution, SEK | -0.15 | -0.23 | -0.43 | 0.04 | -0.19 | -0.09 | 1.14 | 0.15 |
| Equity per share, SEK | 10.30 | 10.45 | 10.68 | 11.11 | 11.07 | 11.26 | 11.35 | 11.71 |
| Cash flow operating activities per share, SEK | -0.29 | -0.11 | -0.22 | -0.41 | -0.62 | -0.56 | 1.10 | 3.79 |
| Share price at the end of the period, SEK | 95.40 | 88.95 | 73.35 | 61.50 | 94.90 | 61.75 | 74.40 | 78.00 |
| Number of shares outstanding at the end of the period, thousands |
88,060 | 88,060 | 88,060 | 88,060 | 88,060 | 88,060 | 88,060 | 88,060 |
| Average number of shares outstanding before dilution, thousands |
88,060 | 88,060 | 88,060 | 88,060 | 88,060 | 88,060 | 88,060 | 88,060 |
| Average number of shares outstanding after dilution, thousands |
88,355 | 88,082 | 88,060 | 88,060 | 88,060 | 88,060 | 88,060 | 88,060 |
| Q4 | Jan-Dec | |||||
|---|---|---|---|---|---|---|
| kSEK | 2020 | 2019 | 2020 | 2019 | ||
| Net revenues | 8,360 | 26,422 | 62,347 | 281,772 | ||
| Other operating income | 1,359 | 35 | 3,597 | 14,826 | ||
| Operating revenues | 9,719 | 26,457 | 65,943 | 296,598 | ||
| Operating expenses | ||||||
| Project related expenses | -13,376 | -20,971 | -50,242 | -72,422 | ||
| Other external expenses | -8,095 | -9,680 | -31,161 | -38,265 | ||
| Personnel expenses | -16,523 | -15,268 | -62,977 | -59,715 | ||
| Depreciations of tangible assets | -1,241 | -786 | -3,829 | -2,961 | ||
| Other operating expenses | -818 | -1,463 | -3,353 | -11,554 | ||
| Operating profit/loss | -30,335 | -21,711 | -85,618 | 111,681 | ||
| Financial income | -227 | -164 | 7 | 1,630 | ||
| Financial expenses | -642 | -24 | -707 | -110 | ||
| Profit/loss after financial items | -31,203 | -21,898 | -86,318 | 113,200 | ||
| Change in tax allocation reserves | 81,865 | -28,857 | 81,865 | -28,857 | ||
| Profit/loss before tax | 50,662 | -50,755 | -4,453 | 84,344 | ||
| Tax | 22 | 10,685 | 75 | -18,390 | ||
| Profit/loss for the period | 50,684 | -40,070 | -4,378 | 65,954 |
There are no items recognized as other comprehensive income in the Parent Company. Accordingly, total comprehensive income matches profit for the year.
| 31 Dec 2020 | 31 Dec 2019 | |
|---|---|---|
| ASSETS | ||
| Tangible fixed assets | 18,120 | 9,590 |
| Deferred tax assets | 325 | 250 |
| Other financial assets | 1,612 | 1,611 |
| Current assets excluding cash and cash equivalents | 9,882 | 31,619 |
| Cash and cash equivalents | 999,892 | 1,112,672 |
| TOTAL ASSETS | 1,029,831 | 1,155,742 |
| EQUITY AND LIABILITIES | ||
| Equity | 833,628 | 836,687 |
| Tax allocation reserve | 94,809 | 176,674 |
| Other current liabilities | 17,702 | 23,810 |
| Accrued expenses and deferred income | 83,692 | 118,571 |
| EQUITY AND LIABILITIES | 1,029,831 | 1,155,742 |
This Interim Report for the period January – December 2020 covers the Swedish Parent Company BioArctic AB, Swedish Corporate Identity Number 556601-2679, and the fully owned subsidiary LPB Sweden AB, Swedish Corporate Identity Number 559035-9112. All the Group's business operations are conducted in the Parent Company. The Parent Company is a Swedish limited liability company registered in and with its registered office in Stockholm. The head office is located at Warfvinges väg 35, SE-112 51, Stockholm, Sweden.
The consolidated financial statements for BioArctic AB have been prepared in accordance with IFRS (International Financial Reporting Standards) as adopted by the EU, the Annual Accounts Act and the Swedish Financial Reporting Board's RFR 1 Supplementary Accounting Rules for Groups. The Parent Company's financial statements are presented in accordance with the Swedish Annual Accounts Act and RFR 2 Accounting for Legal Entities.
The Interim Report for the period January – December 2020 is presented in accordance with IAS 34 Interim Financial Reporting and the Swedish Annual Accounts Act. Disclosures in accordance with IAS 34 are presented both in notes and elsewhere in interim report. The accounting principles and calculation methods applied are in accordance with those described in the Annual Report 2019. New and amended IFRS standards and interpretations applied from 2020 have not had a material impact on the financial statements.
The guidelines of the European Securities and Markets Authority (ESMA) on alternative performance measures have been applied. This involves disclosure requirements for financial measures that are not defined by IFRS. For performance measures not defined by IFRS, see the Calculations of key figures section.
An operating segment is a part of the Group that conducts operations from which it can generate income and incur costs and for which independent financial information is available. The highest executive decision-maker in the Group follows up the operations on aggregated level, which means that the operations constitute one and the same segment and thus no separate segment information is presented. The Board of Directors is identified as the highest executive decision maker in the Group.
| Q4 | Jan-Dec | ||||
|---|---|---|---|---|---|
| kSEK | 2020 | 2019 | 2020 | 2019 | |
| Geographic breakdown of net revnues | |||||
| Europe | 2,291 | 26,422 | 33,805 | 119,796 | |
| Asia | 6,069 | - | 28,541 | 161,976 | |
| Total net revenues | 8,360 | 26,422 | 62,347 | 281,772 | |
| Net revenues per revenue type | |||||
| Milestone payments, recognized at a given point in time | - | - | - | 173,407 | |
| Income from research collaborations, recognized over time | 8,360 | 26,422 | 62,347 | 108,366 | |
| Total net revenues | 8,360 | 26,422 | 62,347 | 281,772 |
BioArctic's net revenues essentially consist of income from the research collaborations concerning Parkinson's disease with AbbVie and Alzheimer's disease with Eisai. Under the collaboration agreement with AbbVie, BioArctic received an initial payment of MSEK 701.6, or MUSD 80, during the third quarter 2016. This payment is related to compensation for the preclinical development work that BioArctic will carry out under the agreement. Of the initial payment, MSEK 70.4 was reported as a one-time payment in 2016. The rest of the payment will be accrued based on the costs incurred up until the completion of the project. The project is continuously evaluated with the regard to status and remaining costs. In conjunction with a restatement of the total costs of the Parkinson's program in light of better performance than originally planned, a positive lump sum of MSEK 22.8 in revenue has been
recorded during the first quarter 2020. As of December 31, 2020, MSEK 634.7 has been recognized as revenue and the remaining amount to be recognized as a revenue up until the completion of the project is MSEK 66.9. A new research collaboration agreement with Eisai began in January 2020. Payments to BioArctic under this agreement originally totaled up to a potential MEUR 3.25, or MSEK 34, and runs through the end of June 2021. Following additional orders from Eisai, the potential payments to BioArctic amount to approximately MEUR 3.6. Income from the research collaboration is recognized over time based on fulfillment of performance criteria. As of December 31, 2020, MSEK 28.5 has been recognized as revenue.
In this financial report BioArctic reports key financial ratios, some of which are not defined by IFRS. The Company's assesses that these key ratios are important additional information, since they enable investors, securities analysts, management of the company and other stakeholders to better analyze and evaluate the company's business and financial trends. These key ratios should not be analyzed separately or replace key ratios that have been calculated in accordance with IFRS. Neither should they be compared to other key
ratios with similar names applied by other companies, as key ratios cannot always be defined in the same way. Other companies may calculate them in a different way than BioArctic.
The key ratios "Net revenues", "Result for the period", "Earnings per share" and "Cash flow from operating activities" are defined according to IFRS.
| Key ratios | Definition |
|---|---|
| Other income | Other income than net revenue |
| Operating profit | Result before financial items |
| Operating margin, % | Operating profit divided by net revenues |
| Cash flow from operating activities per share, SEK |
The cash flow from operating activities for the period divided by the weighted number of shares |
| Equity/asset ratio, % | Adjusted equity divided by total assets |
| Return on equity, % | Net income divided by equity expressed as a percentage |
| Equity per share | Adjusted equity divided by the number of shares at the end of the period |
ADAS-Cog (Alzheimer's Disease Assessment Scale cognitive subscale) is a well-established cognition scale whereof parts are included in ADCOMS.
Alzheimer's Disease Composite Score – A cognition scale consisting of parts from three different scales (CDR-SB, ADAS-cog and MMSE) developed by Eisai. The cognition scale enables a sensitive detection of changes in clinical functions of symptoms in early Alzheimer's disease.
ADCS-ADL-MCI (Alzheimer's Disease Cooperative Study - Activities of Daily Living - Mild cognitive impairment) is a clinical scale focusing of activities of daily living particularly relevant in mild cognitive impairment.
A naturally occurring protein in the body that, in conjunction with Parkinson's disease, misfolds and forms harmful structures in the brain.
A naturally occurring protein in the brain that, in conjunction with Alzheimer's disease, misfolds into harmful structures in brain cells. Amyloid beta form the plaque around brain cells visible in patients with Alzheimer's disease.
A biological molecule originating in the immune system that binds to a target molecule with a high degree of accuracy.
ApoE transports fats in the blood. ApoE comes in three forms. Individuals expressing the ApoE4 form are at greater risk of developing Alzheimer's disease.
A form of cerebral edema that occurs in some patients treated with anti-amyloid monoclonal antibodies for Alzheimer's disease.
A binding profile specifies in which way and to which forms of a protein (such as amyloid beta or alpha-synuclein) an antibody binds.
A measurable molecule, the levels of which can indicate a change in the body and enable diagnosis of a patient or measurement of the effect of a drug.
A structure of tightly bound cells that surround blood vessels in the brain. This barrier regulates the exchange of nutrients and waste and protects against bacteria and viruses.
CDR-SB (Clinical Dementia Rating Sum of Boxes) is a cognition and function scale which is part of ADCOMS.
The part of the body's nervous system comprising the brain and spinal cord.
Drug trials performed in human subjects.
A complete injury means that the spinal cord is complete severed. In an incomplete injury there are still a few nerve contacts left.
A treatment that interferes with the processes of the disease and changes it in a positive way.
Increased effect at higher dose.
A drug under development that has not yet gained marketing approval.
Mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease.
A statistical analysis conducted during an ongoing clinical trial to evaluate preliminary findings.
Agreement where a company that has invented a drug gives another company the right to further develop and sell the drug for certain payments.
Financial remuneration received as part of a project or collaboration agreement once a specified goal has been achieved.
An individual molecule with the ability to bind to other similar molecules to form larger structures such as oligomers and protofibrils.
A disorder that entails a gradual breakdown and degeneration in brain and nervous system function.
Molecules consisting of a number of monomers.
Clinical study conducted after a completed randomized and placebo-controlled study in which all patients receive active substance.
Positron emission tomography, an imaging method used to perform medical examinations.
Studies of the safety and tolerability of a drug. Performed in a limited number of healthy human volunteers or patients.
Studies of the safety and efficacy of a drug. Performed in a limited number of patients. Later portions of phase 2 studies can be called phase 2b and evaluate the optimal dose of the studied drug.
Studies of the efficacy and safety of a drug. Performed in a large number of patients.
Study design in research which means that some of the patients receive inactive substance to get a relevant comparison group.
Normal cognitive function but with intermediate or elevated levels of amyloid in the brain.
Stage of development where preclinical studies of drug candidates are conducted to prepare for clinical studies.
Studies conducted in model systems in laboratories prior to conducting clinical trials in humans.
A product under development that has not yet gained marketing approval.
A harmful aggregation of amyloid beta formed in the brain, which gives rise to Alzheimer's disease, or a harmful aggregation of alpha-synuclein formed in the brain that gives rise to Parkinson's disease.
Shortened (truncated) forms of the amyloid beta protein.
Early research is focused on studying and elucidating the underlying molecular disease mechanisms and development of potential drug candidates.
Tendency of a molecule to bind to a specific receptor.
The degree of side effects from a drug that can be tolerated by a patient.

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