Quarterly Report • Nov 8, 2018
Quarterly Report
Open in ViewerOpens in native device viewer
| About BioArctic | 4 | Full Year Report 2018, Feb 14, 2019 |
|---|---|---|
| CEO statement | 5 | Annual Report 2018, week commencing |
| Project portfolio | 6 | April 15, 2019 |
| Comments on the report | 9 | Interim Report Jan – Mar, May 9, 2019 |
| Other information | 11 | Annual General Meeting, May 9, 2019 |
| Financial reports | 12 | Interim Report Jan – Jun, Jul 11, 2019 |
| Notes | 16 | Interim Report Jan – Sep, Oct 24, 2019 |
| Consolidated quarterly data | 18 | |
| Definition of key ratios | 19 | |
| Goal and strategies for | 21 | |
| sustainable growth | ||
| Glossary | 22 | |
Unless otherwise stated in this report, all data refers to the Group. Figures in parentheses relate to the corresponding period in 2017.
| Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Jan-Dec | |
|---|---|---|---|---|---|
| SEKm | 2018 | 2017 | 2018 | 2017 | 2017 |
| Net revenues | 94.0 | 31.5 | 198.6 | 89.7 | 140.7 |
| Other operating income | 0.6 | 2.8 | 15.6 | 8.7 | 19.0 |
| Operating profit | 33.1 | 0.6 | 58.5 | 4.6 | 19.3 |
| Profit for the period | 25.9 | -0.1 | 46.4 | 3.3 | 15.2 |
| Operating margin, % | 35.2% | 2.0% | 29.4% | 5.1% | 13.7% |
| Earnings per share, SEK 1, 2 | 0.29 | 0.00 | 0.53 | 0.05 | 0.22 |
| Equity per share, SEK 1, 2 | 7.75 | 1.02 | 7.75 | 1.02 | 7.22 |
| Cash flow from operating | |||||
| activities | -31.5 | -23.6 | -110.8 | -89.6 | -135.3 |
| Cash flow from operating | |||||
| activities per share, SEK 1, 2 | -0.36 | -0.37 | -1.26 | -1.42 | -1.99 |
| Equity/assets ratio, % | 66.1% | 10.5% | 66.1% | 10.5% | 55.8% |
| Return on equity, % | 3.9% | -0.2% | 7.0% | 5.3% | 4.3% |
| Share price end of the period 3 | 118.90 | - | 118.90 | - | 26.00 |
| Number of shares | 88,059,985 | 63,059,985 | 88,059,985 | 63,059,985 | 88,059,985 |
1 There are no potential shares, thus there is no dilutive effect
2 The comparative figures have been recalculated as a result of the 15:1 split executed on August 1, 2017
3The company was listed in October 2017, so no observable share price exists before the listing
For further information, please contact:
Gunilla Osswald, CEO, [email protected], telephone + 46 (0)8 695 69 30 Jan Mattsson, CFO, [email protected], telephone + 46 (0)703 52 27 72
BioArctic invites to an audiocast with teleconference (in English) for investors, analysts and media today, November 8, at 09:30 – 10:30 a.m. CET. CEO Gunilla Osswald and CFO Jan Mattsson present BioArctic, comment on the Interim Report for the period January – September 2018 and answer questions.
Webcast:https://tv.streamfabriken.com/bioarctic-q3-2018
Sweden: + 46 850 639 549 Denmark: + 45 354 455 75 Germany: + 49 692 222 290 46 The Netherlands: + 31 207 168 416 Switzerland: + 41 225 675 548 UK: + 44 203 008 9815 US: + 1 855 831 5947
BioArctic AB (publ) is a research-based biopharmaceutical company focusing on disease modifying treatments and diagnostics for neurodegenerative diseases, such as Alzheimer's disease and Parkinson's disease. The company also develops a treatment for complete spinal cord injury. The company focuses on new types of treatments in areas with great unmet medical needs. BioArctic was founded in 2003 based on innovative research from Uppsala University, Sweden.
The company has cutting-edge scientific competence and experience in developing drugs from idea to market. Collaborations with universities are of great importance to the company together with the strategically important global partners in the Alzheimer and Parkinson projects. BioArctic conducts its own clinical development in the field of complete spinal cord injury. Through long-term collaboration agreements with global pharmaceutical companies, BioArctic has demonstrated high skills and great ability to deliver innovative pharmaceutical projects.
In Alzheimer's disease, BioArctic has collaborated with Eisai since 2005. The company has entered into three research agreements and two license agreements relating to the antibodies BAN2401 and BAN2401 back-up. The total aggregated value of these agreements may amount to EUR 218 million and, in addition, payments of royalty. So far, EUR 47 million has been received. In Parkinson's disease, BioArctic has collaborated with AbbVie since 2016, when a research collaboration agreement was entered including i.a. the antibody BAN0805. The total aggregated value of the agreement may amount to USD 755 million and, in addition, payments of royalty. So far, USD 80 million has been received.
The project portfolio consists of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market and out-licensing potential. For information about the projects, see the section Project portfolio. BioArctic's B-share is listed on Nasdaq Stockholm Mid Cap (ticker: BIOA B).
In early July BioArctic reported positive topline 18 months results of the BAN2401 Phase 2b study in 856 early Alzheimer's disease patients. More detailed results were presented later in July by our partner Eisai. BAN2401 demonstrated a dose-dependent effect on clinical and biomarker endpoints. The highest BAN2401 dose showed clinically meaningful effect compared to placebo. All doses of BAN2401 strongly reduced amyloid in the brain as measured by PET techniques. 81% of patients, in the highest BAN2401 dose group, converted from Alzheimer positive to Alzheimer negative status. That is, an improvement in which the former diseaserelated degree of amyloid has disappeared. BAN2401 was well tolerated across the dose-range.
In October, Eisai presented additional results that further support the positive effects of BAN2401 in all sub-groups of early Alzheimer patients. A correlation was shown between the dose-dependent amyloid reduction in the brain and the clinical effects of BAN2401, and the clinical effects were shown to increase over time. The positive clinical results were further supported by consistent biomarker data indicating that BAN2401 reduces neurodegenerative processes in Alzheimer's disease.
Eisai is currently discussing the next steps for BAN2401 with regulatory authorities and preparing for further clinical studies. The patients who participated in the Phase 2b study are offered continued treatment with BAN2401. The results mark an important advancement in the future treatment of Alzheimer's disease and give new hope for the patients and their families.
I am also very pleased with how well BioArctic's research collaboration with AbbVie has developed. During the period, the work
has been intense delivering the projects and preparing for an IND-application to start the first clinical study with BAN0805 in the US next year. It is; therefore, very exciting that AbbVie earlier than expected announced that they exercise their option to license our alphasynuclein antibody portfolio, pending clearance under the U.S. antitrust legislation.
In the project for treatment of complete spinal cord injury, the inclusion of patients in the first of three panels in the company's ongoing Phase 1/2 study has been completed. BioArctic has regulatory approvals to include patients from Sweden, Estonia, Norway and Finland. The first patients from Estonia are currently in screening phase. An interim analysis of the first panel is planned for Q4 2019/Q1 2020.
BioArctic's ambition is to improve the quality of life for patients with disorders in the central nervous system. Our project portfolio is progressing well, and I am pleased to notice yet another period with a positive financial result. The company is well positioned to advance the projects towards our goals and new potential collaborations, in line with the company's strategy. I am looking forward to continue to progress our innovative projects in our three disease areas each with high unmet medical need.
Gunilla Osswald CEO, BioArctic AB
| PRODUCT CANDIDATE | INDICATION | PARTNER | DISCOVERY | PRECLINICAL | PHASE 1 | PHASE 2 | PHASE 3 | |
|---|---|---|---|---|---|---|---|---|
| BAN2401 yboditna BA-itna |
Alzheimer's disease | Eisal Biogen |
||||||
| BAN2401 anti-Aß antibody |
Down's syndrome ** Traumatic Brain Injury |
|||||||
| BAN2401 back-up anti-AB antibody |
Alzheimer's disease | $\begin{pmatrix} 1 & 1 \ 1 & 1 \end{pmatrix}$ | ||||||
| 홆 | AD1801 undisclosed information |
Alzheimer's disease | ||||||
| AD1502 undisclosed information |
Alzheimer's disease | |||||||
| AD1503 undisclosed information |
Alzheimer's disease | |||||||
| BAN0805 anti-α-synuclein antibody |
Parkinson's disease | abbvie | ||||||
| PD1601 anti-α-synudein antibody |
Parkinson's disease | abbvie | ||||||
| PD1602 anti-α-synuclein antibody |
Parkinson's disease | abbvie | ||||||
| Imaging and blochemical biomarkers AB |
Alzheimer's disease | |||||||
| DIAGNOSTICS & TECHNOLOGY |
Imaging and blochemical biomarkers |
Parkinson's disease | abbvie | |||||
| a-synudein BBB-technology blood-brain barrier |
Multiple application areas | |||||||
| SC0806 FGF1/medical device |
Complete Spinal Cord Injury |
1) Partner with Eisai on BAN2401 for treatment of Alzheimer's disease. Eisai partnered with Biogen on BAN2401 in 2014 2) Dementia and cognitive impairment associated with Down's syndrome and Traumatic Brain Injury
Two projects in the clinical phase: BAN2401 for Alzheimer's disease and SC0806 for patients with Complete Spinal Cord Injury.
Three drug projects in preclinical phase: BAN2401 for Down's Syndrome with dementia and Traumatic Brain Injury, BAN2401 back-up for Alzheimer's disease; and BAN0805 for Parkinson's disease and biomarker and diagnostics projects for Alzheimer's disease.
Three projects in the research phase for Alzheimer's disease (AD1801, AD1502, AD1503) and two projects for Parkinson's disease (PD1601, PD1602) and biomarker and diagnostics projects for Parkinson's disease, as well as a blood-brain barrier technology project.
The key molecular event in Alzheimer's disease and Parkinson's disease is believed to be protein misfolding and aggregation. The spreading of soluble aggregates leads to neuronal dysfunction, cell death, brain damage and symptoms of disease. Each neurodegenerative disease is characterized by its unique aggregated protein. The hallmark of Alzheimer's disease is amyloid-beta (Aβ), whereas alpha-synuclein (α-synuclein) is the signature protein of Parkinson's disease.
BioArctic's disease modifying treatment strategy is to eliminate toxic aggregated forms (oligomers/protofibrils) in the brain by means of the company's selective antibodies.
Alzheimer's disease: The antibody BAN2401 selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (Aβ) aggregates that are thought to contribute to the neurodegenerative process in Alzheimer's disease. BAN2401 is highly selective for Aβ oligomers/protofibrils and binds more than 1,000 times stronger to Aβoligomers/protofibrils than to Aβ
monomers and 10 - 15 times stronger than to Aβ fibrils.
Eisai presented the 18 months analysis of BAN2401 Phase 2b study with 856 patients with early Alzheimer's disease at the Alzheimer's Association International Conference® 2018 (AAIC®) 2018 in Chicago, in the U.S., on July 25. The results demonstrated consistent dose-dependent, clinically meaningful and statistically significant effects of BAN2401 on several clinical endpoints as well as dose-dependent and significant effects on PET and other biomarkers with a good tolerability profile. At the final readout after 18 months of treatment a dose-dependent slowing of cognitive decline from baseline on the main parameter ADCOMS was demonstrated. The highest BAN2401 dose of 10 mg/kg twice a month demonstrated a significant slowing of clinical decline of 30% compared to placebo at 18 months (p=0.034). A statistically significant slowing of decline on ADCOMS was observed as early as 6 months (p< 0.05) as well as at 12 months (p< 0.05). Dose-dependent slowing of cognitive decline from baseline measured by the wellestablished cognition scale ADAS-Cog was also observed for BAN2401, with the highest treatment dose demonstrating a significant slowing of clinical decline compared to placebo at 18 months (47% slower decline, p=0.017). On CDR-SB a slowing of clinical decline at the highest treatment dose, compared to placebo, also surpassed 25%. This level was pre-specified as clinically relevant. Compared to placebo at 18 months the difference was 26% (p =0.125).
The early effect of BAN2401 in the two highest dose-groups resulted in more patients being randomized to these doses according to the Bayesian randomization study design. The highest BAN2401 dose 10 mg/kg twice a month was demonstrated to be the best dose.
Highly statistically significant and dosedependent biomarker effects of all dose groups were observed with amyloid PET. BAN2401 demonstrated a dose- dependent reduction in amyloid in the brain at 18 months, and this reduction was significant at all doses. At the highest dose of BAN2401 (10 mg/kg twice a month), using standardized PET as measured at the Centiloid scale, the mean reduction in accumulated amyloid in the brain was approximately 70 units at 18 months (p< 0.0001). The observed baseline mean was 74.5 units, observed 18-month mean was 5.5 units. In amyloid PET image visual read BAN2401 demonstrated a dose-dependent improvement with 81% of patients converting from amyloid positive to amyloid negative status at 18 months (p< 0.0001) at the highest dose.
This is the first late stage clinical study demonstrating potential disease-modifying effects on cognition as well as reduction in accumulated amyloid-beta in the brain.
At the CTAD conference (Clinical Trials on Alzheimer's Disease) on October 25 in Barcelona, Spain, Eisai presented additional results from sub-group and biomarkers analyses. Consistent and pronounced effects on BAN2401 with significantly reduced amyloid-burden on PET were demonstrated in the broad early AD population as well as across all subgroups; ApoE carriers and noncarriers, mild cognitive impairment due to AD (MCI) or mild AD and with or without concomitant symptomatic AD medication. Clinical effect variables also demonstrated support for treatment with BAN2401 in these sub-groups. A correlation was further shown between the dose-dependent amyloid reduction in the brain and the clinical effects and the clinical effects were shown to increase over time. Additional biomarker effects in CSF were shown indicating that BAN2401 reduces neurodegenerative processes in AD.
As presented at both conferences BAN2401 was well tolerated during the 18 months of study drug administration. The incidence rate of treatment-related adverse events was 26.5% for the placebo arm, 53.4% for the 10
mg/kg monthly treatment arm and 47.2% for the 10 mg/kg twice a month treatment arm. The most common treatment emergent adverse events were infusion-related reactions and Amyloid Related Imaging Abnormalities (ARIA). Infusion related reactions were mostly mild to moderate in severity. Incidence of ARIA-E (edema) was not more than 10% in any of the treatment arms and the vast majority of the observed ARIA-E cases in the study were asymptomatic (43 of 48 subjects, 90%). Incidence of ARIA-E (edema) was 9.9% at the highest treatment dose and the incidence of ARIA-E in APOE4 carriers (who may be more sensitive to this adverse event) was 14.6% at this dose in the study. Per protocol, all patients presenting with ARIA-E on Magnetic Resonance Imaging (MRI) were discontinued in the study.
The study will be completed in the fourth quarter of 2018 and includes a further 3 months follow-up (at 21 months) after completion of the 18 months treatment. As reported in December 2017 there was a primary endpoint analysis on ADCOMS after 12 months treatment, which aimed to enable a faster start of phase 3, the high hurdle set for early stop of the phase 2b study was not met.
Eisai is currently discussing the next steps for BAN2401 with regulatory authorities and preparing for further clinical studies. An openlabel extension study for the participating patients in the Phase 2b clinical study is being initiated later this year.
Eisai is responsible for the Phase 2b study and the development of BAN2401 in Alzheimer's disease. The project is based on research at Uppsala University, Sweden.
Down's syndrome with dementia: BAN2401, which is now being clinically evaluated for the treatment of Alzheimer's disease, can potentially also be used for other indications, such as Down's syndrome with dementia, as these patients develop dementia at around 40 years of age.
Traumatic brain injury (TBI): BioArctic has submitted a patent application for the antibodies BAN2401/BAN2401 back-up for the treatment of Traumatic Brain Injury. Some of these patients develop dementia after the injury.
The antibody is a further developed version of BAN2401 for the treatment of Alzheimer's disease. The antibody was developed by BioArctic in collaboration with Eisai, which led to a new license agreement in 2015. The project is driven by Eisai and is in late preclinical phase.
In August 2018, BioArctic obtained exclusive rights to develop antibody treatments for Alzheimer's disease from a research project jointly owned with Eisai. The partner Eisai has the rights to develop small molecule treatment from this research project with a different target than those in the projects BAN2401 and BAN2401 back-up.
At BioArctic research is in progress to develop new antibodies for the treatment of Alzheimer's disease aimed at slowing down or stopping disease progression by addressing two new targets.
BAN0805 is an antibody against alphasynuclein and a drug candidate for the treatment of Parkinson's disease. The goal is to develop a disease modifying treatment that stops or slows down disease progression. A collaboration with AbbVie started in 2016 regarding the continued development of BioArctic's Parkinson program, focusing on BAN0805 and additional antibodies as well as diagnostics. BioArctic is preparing for the application to the U.S. Food and Drug Administration (FDA) for the initiation of a clinical study of BAN0805 in the U.S., an IND. The project is based on research from Uppsala University.
The antibodies PD1601 and PD1602 are targeting alpha-synuclein for treatment of Parkinson's disease. The aim is to develop a disease modifying treatment that stops or slows down disease progression. The projects are also conducted in collaboration with AbbVie.
Alzheimer's disease diagnostics: In collaboration with Uppsala University, BioArctic is developing a new type of PET tracer for imaging of the brain in Alzheimer's disease by using BioArctic's antibodies. The goal is to create tools to better diagnose the disease, follow the disease progression and objectively measure the effect of drug treatment.
Improved biochemical methods: BioArctic develops improved biochemical methods for the identification and precise measurement of responses to treatment of Alzheimer's disease and Parkinson's disease, and for the measurement of disease progression. This is done in collaboration with the University of Gothenburg, Sweden.
Blood-brain barrier technology: Together with Uppsala University, BioArctic is developing a technology that enables better passage of antibodies into the brain across the bloodbrain barrier. This technology has great technical and commercial potential and could be a general technology for improved and more effective treatment of brain diseases.
SC0806 is an innovative treatment for patients with traumatic complete spinal cord injury. The product candidate is a combination of a biodegradable medical device and a drug substance (FGF1). The first patient was treated in 2016 with subsequent rehabilitation for 18 months. Since August 2017, the patients receiving SC0806 treatment in the ongoing Phase 1/2 clinical trial have been given the option of 12 months additional
participation in an extension study. The inclusion of patients with complete spinal cord injury to the first of three panels of BioArctic's ongoing clinical Phase 1/2-study was completed in April 2018. An interim analysis will be performed after 18 months participation in the study. Preparations for starting the next panel is on-going. The study is approved by the regulatory authorities and ethics committees in Estonia, Norway and Finland. The product obtained orphan drug designation in 2010 in the EU and in 2011 in the U.S., which gives the company 10 and 7 years of market exclusivity in Europe and the US, respectively.
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. BioArctic's patent portfolio consisted at the end of the period of 12 patent families with 151 granted patents.
The Group is referred to unless otherwise stated in this interim report. Figures in parentheses refer to the corresponding period last year. Amounts are expressed in kSEK (SEK thousands) unless otherwise stated. All amounts stated are rounded up or down, which may lead to some totals not matching exactly.
BioArctic has decided to change from income statement by function to income statement by nature of expense starting from the previous interim report. The reason for the change is that management and the Board control the operations in this way. The comparative periods have been changed accordingly. The calculation of the key ratios has not been changed.
Because of the nature of the business operations, there may be large fluctuations between revenue for different periods.
Net revenues in the third quarter amounted to SEK 94.0 million (31.5), an increase of SEK 62.6 million compared with the same period the previous year. The increase during the quarter is attributable to the increased activities in the Parkinson program in collaboration with AbbVie. Net revenues for the period January – September amounted to SEK 198.6 million (89.7), which is an increase of 109.0 MSEK. The increase is attributable to increased activities in the Parkinson program. During the quarter, a positive one-off effect of SEK 20.1 million was recognized. The effect is related to a re-assessment of the Parkinson program's total cost, based on a more positive progress of the program compared to the original plan.
Other operating income relates to research grants, operating exchange rate gains and rental income and amounted to SEK 0.6 million (2.8) for the third quarter and to SEK 15.6 million (8.7) for the period January – September. The decrease during the third quarter relates to currency effects and the increase for the period January – September is explained by the exchange rate gains due to the weakening of the Swedish krona.
Operating expenses amounted to SEK 61.5 million (33.6) for the third quarter and to SEK 155.7 million (93.8) for the period January – September. The increase for the third quarter as well as the period January – September is primarily explained by increased project expenses mainly attributable to the Parkinson program and other projects in the portfolio. Other operating expenses consisted of operating exchange rate losses.
Since BioArctic did not meet all the conditions to capitalize R&D costs, all such costs have been charged to the P&L.
Operating profit before financial items (EBIT) amounted to SEK 33.1 million (0.6) for the
third quarter and to SEK 58.5 million (4.6) for the period January – September. The increase in the operating profit is attributable to the increased activity in the Parkinson program with AbbVie and to operating exchange rate gains.
Net financial items totaled SEK 0.1 million (-0.7) for the third quarter and to SEK 1.2 million (-0.2) for the period January – September. Financial income consists of financial exchange rate gains and financial expenses consists of negative interest on cash and cash equivalents.
Profit for the period amounted to SEK 25.9 million (-0.1) for the third quarter and SEK 46.4 million (3.3) for the period January – September.
Earnings per share before and after dilution amounted to SEK 0.29 (0.00) for the third quarter and to SEK 0.53 (0.05) for the period January – September.
Equity amounted to SEK 682.5 million (64.1) at September 30, 2018. This corresponds to an equity per outstanding share of SEK 7.75 (1.02) before and after dilution.
The equity/asset ratio has increased from 10.5% at September 30, 2017 to 66.1% at September 30, 2018. The increase is due to the share issue that took place in connection with the listing of BioArctic on Nasdaq Stockholm in October 2017.
The Group's cash and cash equivalents consist of bank balances that at the end of the period amounted to SEK 1,008.5 million (590.7). There were no loans at September 30, 2018 and no loans have been taken since this date. The Group has no other credit facility or loan commitments.
The Group's liquid funds are intended to be used mainly for agreed commitments and for progressing the internal projects in the portfolio. In order to reduce foreign exchange exposure some liquid funds are invested 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.
Investments in the third quarter amounted to SEK 0.5 million (2.8) and SEK 1.4 million (3.3) for the period January – September. The investments are mainly related to laboratory equipment.
Cash flow from operating activities for the second quarter amounted to SEK -31.5million (-23.6) and SEK -110.8 million (-89.6) for the period January – September.
At the end of the period, the number of employees in the Group was 30 (26) of which 12 (10) are men and 18 (16) women. Approximately 90 percent are active in R&D and approximately 80 percent are PhDs; of these, one is Associate Professor and two are Professors.
A cost efficient organization at BioArctic is achieved by hiring key consultants for specific assignments and for tasks in competence areas that the company lacks or only has a need for periodically. As of September 30, 2018, these amounted to a total corresponding to 13 (12) full-time positions.
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, measure, control and limit the risks of the business. Significant risks are the same for the Parent Company and the Group. The risks can be divided into financial risks on the one hand and operational and external risks on the other. 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 for 2017, pp 41-42.
All the Group's business operations are conducted in the Parent Company.
| kSEK | Jul-Sep 2018 |
Jul-Sep 2017 |
Jan-Sep 2018 |
Jan-Sep 2017 |
Jan-Dec 2017 |
|---|---|---|---|---|---|
| Net revenues (note 4) | 94,045 | 31,493 | 198,650 | 89,685 | 140,706 |
| Other operating income | 556 | 2,764 | 15,552 | 8,678 | 19,044 |
| Total operating income | 94,602 | 34,257 | 214,202 | 98,363 | 159,750 |
| Operating expenses | |||||
| Project related expenses | -42,738 | -12,667 | -97,327 | -36,556 | -63,641 |
| Other external expenses | -6,675 | -8,959 | -21,907 | -22,869 | -36,197 |
| Personnel expenses | -11,039 | -7,408 | -33,410 | -23,651 | -32,936 |
| Depreciations of tangible assets | -624 | -507 | -1,392 | -1,399 | -1,993 |
| Other operating expenses | -402 | -4,097 | -1,692 | -9,326 | -5,689 |
| Operating profit | 33,125 | 619 | 58,474 | 4,563 | 19,294 |
| Financial income | 453 | -401 | 2,283 | 138 | 1,043 |
| Financial expenses | -342 | -295 | -1,067 | -307 | -647 |
| Profit before tax | 33,236 | -77 | 59,689 | 4,394 | 19,690 |
| Tax | -7,379 | -39 | -13,292 | -1,073 | -4,534 |
| Profit for the period | 25,856 | -116 | 46,397 | 3,321 | 15,157 |
| Earnings per share |
Earnings per share, SEK 2, 3 0.29 0.00 0.53 0.05 0.22 1 BioArctic has decided to change to income statement by nature of expense and the comparative periods have been changed accordingly
2 There are no potential shares. Thus; there is no dilutive effect
3 The comparative figures have been recalculated as a result of the 15:1 split executed on August 1, 2017
| Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Jan-Dec | |
|---|---|---|---|---|---|
| kSEK | 2018 | 2017 | 2018 | 2017 | 2017 |
| Profit for the period | 25,856 | -116 | 46,397 | 3,321 | 15,157 |
| Other comprehensive income | - | - | - | - | - |
| Comprehensive income for the period | 25,856 | -116 | 46,397 | 3,321 | 15,157 |
| kSEK | Sep 30, 2018 |
Sep 30, 2017 |
Dec 31, 2017 |
|---|---|---|---|
| ASSETS | |||
| Tangible fixed assets | 7,065 | 7,580 | 7,093 |
| Deferred tax assets | 180 | 215 | 230 |
| Other financial assets | 2,675 | 2,675 | 2,675 |
| Current assets excluding cash and cash equivalents | 13,824 | 9,774 | 20,119 |
| Cash and cash equivalents | 1,008,522 | 590,677 | 1,110,367 |
| TOTAL ASSETS | 1,032,266 | 610,921 | 1,140,483 |
| EQUITY AND LIABILITIES | |||
| Equity | 682,531 | 64,080 | 636,134 |
| Deferred tax liabilities | 5,487 | 4,136 | 5,487 |
| Other current liabilities | 18,538 | 9,837 | 12,160 |
| Accrued expenses and deferred income | 325,710 | 532,868 | 486,702 |
| EQUITY AND LIABILITIES | 1,032,266 | 610,921 | 1,140,483 |
| kSEK | Sep 30, 2018 |
Sep 30, 2017 |
Dec 31, 2017 |
|---|---|---|---|
| Opening balance at 1 January | 636,134 | 60,760 | 60,760 |
| Comprehensive income for the period | 46,397 | 3,321 | 15,157 |
| Transactions with shareholders: | |||
| Share issue | - | - | 600,000 |
| Expenses for share issue | - | - | -39,782 |
| Closing balance | 682,531 | 64,080 | 636,134 |
| Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Jan-Dec | |
|---|---|---|---|---|---|
| kSEK | 2018 | 2017 | 2018 | 2017 | 2017 |
| Operating profit | 33,125 | 619 | 58,474 | 4,563 | 19,294 |
| Adjustment for non-cash items | -93,925 | -27,911 | -211,526 | -80,273 | -143,453 |
| Interest received/paid | -342 | -305 | -1,067 | -307 | -582 |
| Income tax paid | -2,067 | -163 | -8,822 | -7,353 | -7,739 |
| Cash flow from operating activities | |||||
| before changes in working capital | -63,209 | -27,761 | -162,942 | -83,371 | -132,481 |
| Change in working capital | 31,752 | 4,150 | 52,139 | -6,257 | -2,846 |
| Cash flow from operating activities | |||||
| after changes in working capital | -31,456 | -23,611 | -110,803 | -89,628 | -135,327 |
| Cash flow from investing activities | -498 | -2,781 | -1,364 | -3,334 | -2,813 |
| Cash flow from financing activities | - | - | - | - | 560,218 |
| Cash flow for the period | -31,954 | -26,392 | -112,168 | -92,962 | 422,078 |
| Cash and cash equivalents at beginning | |||||
| of period | 1,041,740 | 622,063 | 1,110,367 | 692,530 | 692,530 |
| Exchange rate differences in cash and | |||||
| cash equivalents | -1,264 | -4,994 | 10,323 | -8,891 | -4,241 |
| Cash and cash equivalents at end of | |||||
| period | 1,008,522 | 590,677 | 1,008,522 | 590,678 | 1,110,367 |
| kSEK | Jul-Sep 2018 |
Jul-Sep 2017 |
Jan-Sep 2018 |
Jan-Sep 2017 |
Jan-Dec 2017 |
|---|---|---|---|---|---|
| Net revenues | 94,045 | 31,493 | 198,650 | 89,685 | 140,706 |
| Other operating income | 556 | 2,764 | 15,552 | 8,678 | 19,044 |
| Total operating income | 94,602 | 34,257 | 214,202 | 98,363 | 159,750 |
| Operating expenses | |||||
| Project related expenses | -42,738 | -12,667 | -97,327 | -36,556 | -63,641 |
| Other external expenses | -6,675 | -8,959 | -21,907 | -22,868 | -36,196 |
| Personnel expenses | -11,039 | -7,408 | -33,410 | -23,651 | -32,936 |
| Depreciations of tangible assets | -624 | -507 | -1,392 | -1,399 | -1,993 |
| Other operating expenses | -402 | -4,097 | -1,692 | -9,326 | -5,689 |
| Operating profit | 33,125 | 619 | 58,474 | 4,564 | 19,295 |
| Financial income | 453 | -401 | 2,283 | 138 | 1,043 |
| Financial expenses | -342 | -295 | -1,067 | -307 | -647 |
| Profit after financial items | 33,236 | -77 | 59,689 | 4,395 | 19,691 |
| Change in tax allocation reserves | - | - | - | - | -6,141 |
| Profit before tax | 33,236 | -77 | 59,689 | 4,395 | 13,550 |
| Tax | -7,379 | -39 | -13,292 | -1,073 | -3,183 |
| Profit for the period | 25,856 | -116 | 46,397 | 3,322 | 10,367 |
1 BioArctic has decided to change to income statement by nature of expense and the comparative periods have been changed accordingly
There are no items in the parent company recognized as other comprehensive income, thus comprehensive income conforms to the result for the year.
| kSEK | Sep 30, 2018 |
Sep 30, 2017 |
Dec 31, 2017 |
|---|---|---|---|
| ASSETS | |||
| Tangible fixed assets | 7,065 | 7,580 | 7,093 |
| Deferred tax assets | 180 | 215 | 230 |
| Other financial assets | 2,775 | 2,775 | 2,775 |
| Current assets excluding cash and cash equivalents | 13,824 | 9,774 | 20,119 |
| Cash and cash equivalents | 1,008,424 | 590,578 | 1,110,269 |
| TOTAL ASSETS | 1,032,268 | 610,922 | 1,140,484 |
| EQUITY AND LIABILITIES | |||
| Equity | 663,078 | 49,417 | 616,682 |
| Tax allocation reserve | 24,941 | 18,800 | 24,941 |
| Other current liabilities | 18,538 | 9,837 | 12,160 |
| Accrued expenses and deferred income | 325,710 | 532,868 | 486,702 |
| EQUITY AND LIABILITIES | 1,032,268 | 610,922 | 1,140,484 |
This Interim Report covers the Swedish Parent Company BioArctic AB, Swedish Corporate Identity Number 556601-2679, and the two fully owned subsidiaries SpineMedical AB, Swedish Corporate Identity Number 559003-7080, and 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 BioArctic Group's Interim Report for the period January – September 2018 was approved by the Board on November 8, 2018.
The consolidated financial statements for BioArctic AB have been prepared in accordance with IFRS (International Financial Reporting Standards) as adopted by the EU, the Swedish 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 RFR2, Accounting for Legal Entities.
The Interim Report for the period January – September 2018 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 the Interim Report.
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.
IFRS 15 Revenue from Contracts with Customers regulates the reporting of revenues and came into force on January 1, 2018. IFRS 15 replaces IAS 18 Revenue and IAS11 Construction Contracts as well as the appropriate SIC and IFRIC. According to IFRS the company shall recognize revenue when or over time as the company meets a performance commitment by transferring the promised service to a customer, who thereby obtains control of the asset. Most of BioArctic's revenue from contracts with customers relates to research collaborations and milestone payments. The transition to IFRS 15 means that the revenue is recognized over time, which corresponds to the previous reporting based on degree of completion. In exceptional cases BioArctic also receives one-time payments from customers, which are then recognized when the right to compensation has been established. This point in time corresponds to the time when performance commitments are met according to IFRS 15. The amount recognized as revenue is the compensation the company expects to be entitled to in exchange for transferring promised services to a customer. The Group has not identified any differences in reporting at the transition to IFRS 15, neither regarding amounts, nor when in time the revenue is recognized. The transition has only meant increased disclosure requirements.
IFRS 9 Financial instruments replaces IAS 39 Financial instruments: Recognition and Measurement. IFRS 9 comes into force for financial years commencing on January 1, 2018 or later. BioArctic has elected not to apply this standard in advance. In principle BioArctic always receives payment from agreements with customers in advance. There are thus no bad debt losses. The Group has thus not identified any differences in reporting when transferring to IFRS 9.
IFRS 16 replaces IAS 17 Leases and the appropriate interpretations IFRIC 4, SIC-15 and SIC-27. This standard requires that assets and liabilities attributable to all leasing agreements, with a few exceptions, are recognized in the balance sheet. This reporting is based on the view that an asset is used for a specific period of time and at the same time an obligation arises to pay for this right. The standard is to be applied for financial years commencing on January 1, 2019 or later. BioArctic has elected not to apply the standard in advance. Information regarding the financial effects will be reported in the Full Year Report.
BioArctic has decided to change from income statement by function to income statement by nature of expense starting from the previous Interim Report. The reason for the change is that management and the Board control the operations in this way. The comparative periods have been changed accordingly. The calculation of the key ratios has not been changed.
The accounting principles and calculation methods applied are in all other respects in line with those described in the Annual Report for 2017.
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.
| Jul-Sep | Jul-Sep | Jan-Sep | Jan-Sep | Jan-Dec | |
|---|---|---|---|---|---|
| kSEK | 2018 | 2017 | 2018 | 2017 | 2017 |
| Geographic breakdown of net revnues | |||||
| Europe | 94,045 | 30,298 | 197,169 | 85,667 | 135,494 |
| Other | - | 1,194 | 1,481 | 4,018 | 5,212 |
| Total net revenues | 94,045 | 31,493 | 198,650 | 89,685 | 140,706 |
| Net revenues per revenue type | |||||
| Income from research collaborations | 94,045 | 31,493 | 198,650 | 89,254 | 140,275 |
| Other items | - | - | - | 431 | 431 |
| Total net revenues | 94,045 | 31,493 | 198,650 | 89,685 | 140,706 |
A breakdown of the Group's Net revenues is shown below:
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 SEK 701.6 million (USD 80 million). This payment is related to compensation for the preclinical development work that BioArctic will carry out under the agreement. Of the initial payment, SEK 70.4 million 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. During the third quarter, the total costs were assessed to be lower than in the previous assumptions. A positive one-off effect amounting to SEK 20.1 million has been recognized, and the future margin in the project will increase. As of September 30, 2018, SEK 425.8
million has been recognized and the remaining amount to be recognized as a revenue up until the completion of the project is SEK 275.9 million. The main part of the project is estimated to be completed by December 31, 2019 after which date up to SEK 40 million would remain to be recognized until the project assignments have been completed which is estimated to occur in 2024.
Mikael Smedeby, who was elected to the Board of Directors at the Annual General Meeting, is active as lawyer and co-owner of Advokatfirman Lindahl KB, which provides ongoing business legal advice to BioArctic against compensation in line with market rates. During 2017, Advokatfirman Lindahl invoiced fees amounting to approximately SEK 5.2 million, which mainly consisted of costs due to the IPO in October 2017, and in the January – September 2018 period an amount of approximately SEK 0.4 million was invoiced.
In addition to the compensation to Advokatfirman Lindahl described above, as well as consulting and director fees to Lars Lannfelt and salary to Pär Gellerfors, no significant transactions have taken place between the Group and related parties. All transactions have been in line with market rates.
| 2018 | 2018 | 2018 | 2017 | 2017 | 2017 | 2017 | 2016 | |
|---|---|---|---|---|---|---|---|---|
| SEKm | Q3 | Q2 | Q1 | Q4 | Q3 | Q2 | Q1 | Q4 |
| Income statement | ||||||||
| Net revenues | 94.0 | 52.3 | 52.3 | 51.0 | 31.5 | 32.0 | 26.2 | 94.4 |
| Other operating income | 0.6 | 3.6 | 11.4 | 10.4 | 2.8 | 5.2 | 0.7 | 32.6 |
| Operating profit | 33.1 | 6.4 | 18.9 | 14.7 | 0.6 | 2.5 | 1.5 | 97.3 |
| Profit for the period | 25.9 | 5.1 | 15.4 | 11.8 | -0.1 | 2.3 | 1.1 | 75.0 |
| Operating margin, % | 35.2% | 12.3% | 36.1% | 28.9% | 2.0% | 7.7% | 5.6% | 103.1% |
| Balance sheet | ||||||||
| Fixed assets | 9.9 | 10.0 | 9.6 | 10.0 | 10.5 | 8.2 | 8.2 | 8.5 |
| Current assets | 13.8 | 12.0 | 20.3 | 20.1 | 9.8 | 8.6 | 13.2 | 7.0 |
| Cash and cash equivalents | 1,008.5 | 1,041.7 | 1,078.7 | 1,110.4 | 590.7 | 622.1 | 650.3 | 692.5 |
| Equity | 682.5 | 656.7 | 651.6 | 636.1 | 64.1 | 64.2 | 61.9 | 60.8 |
| Deferred tax liabilities | 5.5 | 5.5 | 5.5 | 5.5 | 4.1 | 4.1 | 4.1 | 4.1 |
| Current liabilities | 344.2 | 401.6 | 451.6 | 498.9 | 542.7 | 570.5 | 605.7 | 643.1 |
| Cash flow | ||||||||
| From operating activities | -31.5 | -37.3 | -42.0 | -45.7 | -23.6 | -27.6 | -38.4 | 705.6 |
| From investing activities | -0.5 | -0.7 | -0.2 | 0.5 | -2.8 | -0.4 | -0.1 | -1.7 |
| From financing activities | - | - | - | 560.2 | - | - | - | -105.1 |
| Cash flow for the period | -32.0 | -38.0 | -42.2 | 515.0 | -26.4 | -28.1 | -38.5 | 598.8 |
| Data per share, SEK 1, 2, 3 | ||||||||
| Earnings per share | 0.29 | 0.06 | 0.18 | 0.16 | 0.00 | 0.04 | 0.02 | 1.19 |
| Equity per share | 7.75 | 7.46 | 7.40 | 7.22 | 1.02 | 1.02 | 0.98 | 0.96 |
| Cash flow operating activities | -0.36 | -0.42 | -0.48 | -0.60 | -0.37 | -0.44 | -0.61 | 11.19 |
| Share price end of the period | 118.90 | 21.80 | 21.40 | 26.00 | - | - | - | - |
1 There are no potential shares. Thus; there is no dilutive effect
2 The comparative figures have been recalculated as a result of the 15:1 split executed on August 1, 2017
3 The company was listed in October 2017, so no observable share price exists before the listing
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. These key ratios should not be compared to other key ratios with similar names applied by other companies. This is due to the fact that key ratios cannot always be defined in the same way and 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 revenues |
| Operating profit | Result before financial items |
| Cash flow from operating activities | The period's cash flow from operating activities divided by |
| per share, SEK | the weighted number of shares |
| Equity/asset ratio | Adjusted equity as a percentage of the balance sheet total |
| Return on equity | Net income divided by equity as a percentage |
| Equity per share before and after | Adjusted equity divided by the number of shares at the end of |
| dilution | the period |
The Board and the CEO confirm that this Interim Report provides a true and fair overview of the Company and the Group's operations, position and earnings and describes the material risks and uncertainly factors faced by the Parent Company and the companies within the Group.
This Interim Report has been subject to review reviewed by BioArctic's auditors.
Stockholm, Sweden, November 7, 2018
Wenche Rolfsen Ivar Verner Hans Ekelund Chairman Deputy Chairman Board member
Pär Gellerfors Lars Lannfelt Mikael Smedeby Board member Board member Board member Board member
Eugen Steiner Gunilla Osswald Board member President and CEO
We have reviewed the accompanying balance sheet of BioArctic AB (publ) as of September 30, 2018 and the related statements of income, changes in equity and cash flows for the nine-month period then ended, and a summary of significant accounting policies and other explanatory notes. Management is responsible for the preparation and fair presentation of this interim financial information in accordance with IFRS. Our responsibility is to express a conclusion on this interim financial information based on our review.
We conducted our review in accordance with International Standard on Review Engagements 2410, "Review of Interim Financial Information Performed by the Independent Auditor of the Entity." A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with International Standards on
Auditing and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.
Based on our review, nothing has come to our attention that causes us to believe that the accompanying interim financial information does not give a true and fair view of the financial position of the entity as at September 30, 2018, and of its financial performance and its cash flows for the nine-month period then ended in accordance with IFRS.
Stockholm, November 7, 2018
Grant Thornton Sweden AB
Mia Rutenius Rutger Nordström Authorized public accountant Authorized public accountant Auditor in charge
BioArctic's goal is to improve the quality of life for patients with diseases in the central nervous system. We would like to contribute to the society by developing innovative disease-modifying treatments based on antibodies (immunotherapy) for neurodegenerative diseases, i.e. disease where the nervous system atrophies.
BioArctic develops entirely new types of treatments that hopefully may halt or delay the disease progression in patients with Alzheimer's disease and Parkinson's disease, unlike today's symptomatic treatments. The company is also developing a new treatment concept for complete spinal cord injuries.
During the year, BioArctic's strategy work has been strengthened in order for the company to make full use of its opportunities and to manage future challenges. Today the company is well positioned for new successful collaborations and continued growth.
BioArctic focuses on building unique and competitive portfolio of product candidates, diagnostics and technology in the company's indication areas. This is done partly through internal research and development, partly through research collaborations with strategic partners in the form of research groups at universities, in pharma companies, and the health care sector.
Our strategy is to outlicense certain commercial rights to global pharma companies at an appropriate time. In line with this strategy, BioArctic's research and development work continues. Important elements of BioArctic's strategy are:
Collaborations and license agreements with leading pharma and biopharma companies are important parts of BioArctic's strategy. In addition to financial compensation we get access to our partners' skills in drug development, manufacturing and commercialization. BioArctic has entered into a number of such agreements with the Japanese international 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 product candidates in preclinical and clinical phase, manufacturing and marketing competence, geographic coverage and other resources.
For more information regarding BioArctic's two large collaboration partners, please the Annual Report 2017 on page 11.
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
A protein in the nervous system, present in Lewy bodies in some structures of the brain in Parkinson's disease
A 40-42 amino acids long peptide, split from the parent protein APP, amyloid precursor protein. Aβ is the main constituent of the plaques found in the brain of Alzheimer patients
Protein used by the body's immune system to detect and destroy foreign substances
Apolipoprotein E (ApoE) transports fats in the blood. Individuals expressing ApoE4 develop more Alzheimer changes in the form of plaques and amyloid-beta in the brain blood vessel walls.
Amyloid-Related Imaging Abnormalities (ARIA) are brain-changes seen in Magnetic Resonance Imaging of Alzheimer's disease patients, which are commonly observed in clinical trials of amyloid-modifying therapies
There are two types of ARIA; ARIA-E and ARIA-H. ARIA-E refers to observations of edema and the other ARIA-H to observations of small hemorrhages
A study where collected data is combined with known facts for a complete conclusion. A Bayesian Adaptive Randomization Design enables automatically allocation of newly enrolled patients into the study to treatment arms showing higher probability of efficacy based on interim analyses
A measurable indicator of a medical condition
A physiological mechanism in which merged capillary walls in the brain's blood vessels regulate the transport of molecules between the blood and the brain tissue, with the function to protect the brain against viruses and other harmful agents
CDR-SB (Clinical Dementia Rating Sum of Boxes) is a cognition and function scale which is part of ADCOMS
When integrating and assessing biomarkers of the change in Aβ accumulation measured by different tracers, it is necessary to compensate for the difference in measured values between the PET tracers. This has led to the development of a 100-point scale by the GAIIN Centiloid project, termed "Centiloid," which is an average value of zero in "high certainty" amyloid negative subjects and an average of 100 in "typical" Alzheimer's disease (AD) patients (Klunk et al., 2015)
The central nervous system consists of the brain and the 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
Dose dependent
Increased effect at higher dose
A drug under development that has not yet gained marketing approval
An antibody in which the sequence has been changed to resemble a human antibody
In clinical trials and other scientific studies, an interim analysis is an analysis of data that is conducted before data collection has been completed
Application to the U.S. Food and Drug Administration (FDA) for the initiation of a clinical study in the US.
Molecule that binds to the desired target in the body
A medical device that is intended to be totally or partially introduced, surgically or medically, into the human body, or through a medical procedure in a body opening, and intended to remain there after the operation
Financial compensation obtained within the framework of a project or collaboration agreement when a certain specified objective has been achieved
An antibody that can be produced so that all copies are exactly alike
A monomer is the starting molecule in polymerization. The monomers are joined into long molecular chains through the polymerization, resulting a in a polymer with the monomer as the repeating unit
Disease in which the nervous system atrophies
A molecular chain consisting of several monomers aggregated
Drugs for patients with rare and serious disease
A molecule made up of amino acids connected into a short chain
Positron emission tomography, an investigation imaging method
Studies mainly of the safety and tolerability of a drug. Performed on a limited number of healthy human volunteers or patients
Studies of the safety and efficacy of a drug and dose finding. Performed on a limited number of patients
Confirmatory studies of the safety and efficacy of a drug in a clinical setting. Performed on a large number of patients
Preclinical studies of drug candidates to prepare for clinical studies
Studies performed in model systems, i.e. not in humans
A product under development that has not yet gained marketing approval
A molecular chain consisting of several monomers aggregated
Early research is focused on studying and elucidating the underlying molecular disease mechanisms and development of potential drug candidates
A clinical study result is defined as statistically significant in accordance with the preset
criteria for the study or in adherence to a generally recognized standard, most commonly defined as less than 5% probability of obtaining a similar or stronger result due to chance, i.e. p<0.05
This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure through the agency of Christina Astrén, Director IR & Communications, at 08:00 a.m. CET on November 8, 2018.
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 should have precedence.
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.