BIOARCTIC AB (PUBL) NASDAQ STOCKHOLM: BIOA B An introduction to BioArctic Pareto September 3, 2020 Gunilla Osswald, PhD, CEO BioArctic AB
Disclaimer • This presentation has been prepared and produced by BioArctic AB (publ ) (“ BioArctic ”) solely for the benefit of investment analysis of BioArctic and may not be used for any other purpose. Unless otherwise stated, BioArctic is the source for all data contained in this presentation. Such data is provided as at the date of this presentation and is subject to change without notice. • This presentation includes forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause BioArctic’s actual results, performance, achievements or industry results to be materially different from those expressed or implied by these forward-looking statements. Forward-looking statements speak only as of the date of this presentation and BioArctic expressly disclaims any obligation or undertaking to release any update of, or revisions to, any forward-looking statement in this presentation, as a result of any change in BioArctic’s expectations or any change in events, conditions or circumstances on which these forward-looking statements are based. • This presentation does not constitute or form part of, and should not be construed as, an offer or invitation for the sale of or the subscription of, or a solicitation of any offer to buy or subscribe for, any securities, nor shall it or any part of it or the fact of its distribution form, or be relied on in connection with, any offer, contract, commitment or investment decision relating thereto, nor does it constitute a recommendation regarding the securities of BioArctic. • The information in this presentation has not been independently verified. • No regulatory body in Sweden or elsewhere has examined, approved or registered this presentation. 2 BioArctic AB
BioArctic – a unique Swedish biopharma company Improving life for patients with central nervous system disorders High unmet need for disease- modifying treatments for Alzheimer’s and Parkinson’s diseases creates large commercial opportunity World-class research and development driven organization with basis in founder’s breakthrough discoveries and fruitful collaborations with leading academic researchers and pharma companies generating and developing innovative projects Attractive and well-balanced project portfolio with projects from discovery through Phase 3 and combination of both proprietary projects with substantial marketing and out-licensing potential and partnered projects generating income Well-financed with BSEK >1 (MUSD >100) in cash, net profitable during the last seven years and valuable collaboration agreements totaling BSEK 9.6 (BUSD ~1) plus royalties 3 BioArctic AB
We focus on disease modifying agents and diagnostics/biomarkers for neurodegenerative diseases Neurodegenerative disease therapy TODAY Neurodegenerative disease therapy TOMORROW ILLUSTRATIVE ILLUSTRATIVE Biomarkers used as diagnostic tools to identify and to monitor the therapeutic effect of disease modifying treatments Clinical diagnosis DISEASE PROGRESSION DISEASE PROGRESSION Agents that modify disease pathology (thereby slowing or delaying the onset and Symptomatic disease progression) treatment AGE AGE Significant unmet medical need to be addressed by disease modifying agents and reliable diagnostics/biomarkers 4 BioArctic AB
Attractive and well-balanced project portfolio combines fully- financed partner projects and cutting-edge proprietary projects Project Partner Discovery Preclinical Phase 1 Phase 2 Phase 3 ALZHEIMER’S DISEASE Eisai, Biogen 1 BAN2401 BAN2401 back-up Eisai AD1801 AD1502 AD1503 AD2603 PARKINSON’S DISEASE ABBV-0805 2 AbbVie PD1601 AbbVie PD1602 AbbVie OTHER CNS DISORDERS BAN2401 Down’s syndrome 3 Traumatic brain injury 3 ND3014 BLOOD-BRAIN BARRIER BBB technology platform TECHNOLOGY DIAGNOSTICS Imaging and biochemical biomarkers – Alzheimer’s disease Imaging and biochemical AbbVie biomarkers – Parkinson’s disease as of June 30, 2020 Partnered with Eisai for BAN2401 for treatment of Alzheimer’s disease. Eisai entered partnership with Biogen regarding BAN240 1 in 2014 1) 2) AbbVie in-licensed BAN0805 in late 2018 and develops the antibody with the designation ABBV-0805 5 BioArctic AB Dementia and cognitive impairment associated with Down’s syndrome and Traumatic brain injury 3)
Long-standing and extensive partnerships – an important part of our business model Alzheimer’s disease Parkinson’s disease Partner track record Collaboration and license Partner track record Collaboration and license MEUR 63 MUSD 130 World’s all -time best-selling received received Discovered and developed medicine (BUSD 20) MEUR 221 world’s best -selling MUSD 755 medicine for symptoms in Total value Total value Alzheimer’s agreements agreements 10 different indications Royalties in immunology Royalties High single Approved product for Tiered % symptoms associated with digit % Parkinson’s disease Industry-leading pipeline • BioArctic retains rights to • AbbVie global rights to alpha- in dementia area BAN2401 in other indications synuclein portfolio for all and option to market in the indications Nordics Sources: Eisai, AbbVie and BioArctic corporate information 6 BioArctic AB
Why should we succeed where many others have failed? 7 BioArctic AB
BAN2401: potential disease modifying antibody for Alzheimer’s disease with positive Phase 2b results now in Phase 3 High unmet medical need BAN2401 unique profile BAN2401 has positive Phase 2b results • Large trial: 856 early Alzheimer’s No existing disease- Unique and targeted binding modifying treatment profile patients • Highly selective for toxic forms of • Consistent effects on clinical misfolded Abeta outcomes, imaging and (oligomers/protofibrils) neurodegenerative biomarkers Unique clinical fingerprint • Effect increase over time • Rapid onset of clinical effect • Good safety profile • Consistent effects IN 20 YEARS • No titration required due to low frequency of ARIA – E doubling TODAY >30 million people with Alzheimer’s 8 BioArctic AB
Broad BAN2401 clinical program – driven by BioArctic’s partner Eisai Disease stage Preclinical AD MCI Mild AD Moderate Severe FDA guideline Stage 1 Stage 2 Stage 3 Stage 4 Stage 5 Stage 6 AHEAD 3-45 Phase 3 Program – Clarity AD Phase 3 confirmatory study – ongoing ongoing • • Eisai and ACTC initiated Phase 3 study Primary endpoint readout expected 2022 in 2020 • Target of 1566 early AD patients • A total of 1400 participants will be enrolled in the study. OLE Phase 2b open-label • extension study – ongoing Pre-clinical, asymptomatic, AD subjects with intermediate or elevated amyloid levels in the brain • Approximately 200 patients with early AD • Baseline data presented in December 2019 showed maintenance of benefit after BAN2401 treatment conclusion 1) PACC5: Preclinical Alzheimer’s Disease Cognitive Composite 5 9 BioArctic AB
ABBV-0805: potential disease modifying antibody for Parkinson’s disease with strong preclinical results now in Phase 1 High unmet medical need Unique profile Preclinical proof of concept No existing disease- Unique and targeted binding Reduction of neurotoxic alpha-synuclein modifying treatment profile oligomers/protofibrils • 1,000 Highly selective for toxic forms of misfolded alpha-synuclein 800 protofibrils (pM) 65% (oligomers/protofibrils) Alpha-syn lower 600 Built on genetic and pathology 400 rationale 200 • Alpha-synuclein mutations lead to 0 Younger patient group, still Parkinson’s mAb-treated Placebo at working age Delays disease progression and • Alpha-synuclein increases lifespan oligomers/protofibrils are elevated in Parkinson’s TODAY 100 mAb 80 PBS >6 million 1 Percent survival 60 people with Parkinson’s 40 20 0 0 50 100 150 200 250 Treatment duration (days) 1) Dorsey and Bloem, JAMA Neurology 2018;75:9-10 10 BioArctic AB
Continued progress in collaboration with AbbVie on alpha-synuclein Collaboration highlights ABBV-0805 advancing in clinical trials • ABBV-0805 targeting disease modification in December January February March 2020 Parkinson’s disease 2018 2019 2019 2019 • Potential to expand to earlier stage Parkinson’s Alpha-synuclein ABBV-0805 AbbVie started Phase 1 study antibody portfolio IND-application Phase 1 with ongoing disease patients and other licensed by AbbVie approved by ABBV-0805 diseases where alpha- Aim to evaluate the US FDA synuclein plays a role Milestone of safety and • 50 MUSD for the tolerability AbbVie is responsible for license clinical development Phase 1 MAD • study canceled BioArctic is responsible for delivering follow-up Detailed plan for antibodies in the Phase 2 being continued collaboration prepared with AbbVie 11 BioArctic AB
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