BioArctic AB Company presentation Gunilla Osswald, PhD, CEO RedEye CNS Event, October 4, 2018
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 an y 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
Helping Patients with Disorders in the Central Nervous System by Developing Innovative Treatments Three key areas with high unmet medical needs – all lacking effective Alzheimer’s Disease treatments today Disease modifying treatment in Alzheimer’s and Parkinson’s Disease – areas with huge and growing markets due to aging populations BAN2401 Phase 2b study in early AD in collaboration with Eisai – first late stage study demonstrating potential disease modifying effect on both Parkinson’s Disease cognition and biomarkers BAN0805 for PD in collaboration with AbbVie – preparing for clinical development and IND in the U.S. Unique regenerative treatment for patients with Complete Spinal Cord Injuries in Phase 1/2 Complete Spinal Cord Injury Attractive combination of fully financed partner projects and innovative pipeline with substantial market and out-licensing potential Strong science based research and highly educated engaged teams with vast experience in drug development and great track record of high quality deliverables 3
Long History of Research Achievements Within Disorders of the Central Nervous System (CNS) Background to founding Company history ▲ Scientific discoveries by Professor Lars Lannfelt laid the foundation for BioArctic ▲ The Swedish mutation 2016 – Today demonstrated for the first time in a • BAN2401 Ph 2b study - clinical setting that amyloid-beta (A β ) 2013 – 2015 Positive results presented peptide initiates the disease • BAN2401 entered Phase 2b by Eisai July 2018 2010 – 2012 • BAN2401 back-up candidate • BioArctic and AbbVie • BAN2401 entered out-licensed entered research clinical development 2007 – 2009 • Extended research for AD collaboration in PD collaboration with Eisai • BioArctic and Eisai • PD Alpha-synuclein • BAN0805 in prep for US entered partnership • BAN0805 in preclinical mAb patent filed 2004 – 2006 IND on BAN2401 development for PD • SC0806 orphan drug • SC0806 in Ph 1/2 • mAb158 isolated • SC0806 program • SC0806 entered clinical designation in EU & US • SCI Horizon 2020 • New transgenic mouse initiated at BioArctic development • Vinnova grants expansion ▲ The Arctic mutation revealed that model for AD • PD program initiated • Horizon 2020 grants • developed Vinnova grants • Vinnova grants soluble aggregated forms of A β , • Several AD patents filed • Patent portfolio 2003 oligomers and protofibrils, are toxic • BioArctic and Eisai expanded BioArctic founded and likely driving the disease entered research • Listed on Nasdaq collaboration in AD Stockholm Mid Cap Partnerships & research collaborations Soft money funding Source: Company data Successful collaborations with pharmaceutical industry validating potential value and commercialization potential for BioArctic 4
Long-standing and Extensive Partnerships AbbVie collaboration agreement Parkinson’s Disease Eisai collaboration and license agreements Alzheimer’s Disease Description of agreements Milestone / royalty potential Description of agreements Milestone / royalty potential • Two research collaborations • Research collaboration – • Total potential value of the • Total aggregated value of – disease modifying alpha-synuclein antibodies agreement is up to USD the research collaborations therapies for AD – resulted as disease modifying 755m incl. an up-front fee, and license agreements is in two licenses for A β therapies for PD incl. option exercise fee, and approx. EUR 218m in oligomer/protofibril BAN0805 to IND, follow-up success-based milestones signing fee and milestones, antibodies: BAN2401 and compounds and diagnostic plus tiered royalties plus high single digit BAN2401 Back-up royalties • Option for AbbVie for • BioArctic has received an • Third research collaboration • BioArctic has received a license to develop and USD 80m up-front payment – new target as a disease commercialize the for the research approx. EUR 47m for the modifying therapy for AD antibodies collaboration research collaborations, signing fees and milestones Strategic collaborations with pharmaceutical industry validating potential value and commercialization potential for BioArctic with proven track record of delivering on research collaborations 5
Strategic Partnerships and Cutting-Edge Proprietary R&D per June 30, 2018 PRODUCT CANDIDATE INDICATION PARTNER DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3 BAN2401 Alzheimer’s disease 1) anti- Aβ antibody BAN2401 Down’s syndrome 2) anti- Aβ antibody Traumatic Brain Injury BAN2401 back-up Alzheimer’s disease NEURODEGENERATIVE DISEASES anti- Aβ antibody AE1501 Alzheimer’s disease undisclosed information AD1502 Alzheimer’s disease undisclosed information AD1503 Alzheimer’s disease undisclosed information BAN0805 Parkinson’s disease anti- α -synuclein antibody PD1601 Parkinson’s disease anti- α -synuclein antibody PD1602 Parkinson’s disease anti- α -synuclein antibody Imaging and biochemical DIAGNOSTICS & biomarkers Alzheimer’s disease TECHNOLOGY Aβ Imaging and biochemical biomarkers Parkinson’s disease α -synuclein BBB-technology Multiple application areas blood-brain barrier SC0806 SPINE Complete Spinal Cord Injury FGF1/medical device 6
BAN2401 – Learnings from Previous Clinical Trials in AD Incorporated in Phase 2b Study Design Positive 18 Month Results reported in July 2018 Important parameters Right patient Right dose & Right Right target Right safety population exposure measurements • Address the soluble protofibrils – • Early AD – MCI due to AD & Mild • Selecting doses with exposures • More sensitive cognition scales • Well tolerated with a benign • Biomarkers for disease a toxic form of amyloid AD above preclinical IC50 safety profile • Identify right patients – • Adaptive design testing several • Low cardiovascular risks and progression and disease biomarkers doses and dose regimens modification amyloid related imaging abnormalities (ARIA) etc. Phase 2b study design Patient inclusion Treatment 12 months Treatment 18 months Multinational Placebo Key analyses: Primary analyses: recruitment: • ∆ from baseline in ADCOMS, • ∆ from baseline • 100 clinical centers 2.5 mg/kg bi-weekly CDR-SB, ADAS-cog at 18 in ADCOMS at included months Double-blind, placebo 12 months Inclusion • Inclusion criteria: • ∆ from baseline in brain controlled, parallel- 5 mg/kg bi-weekly • Safety and completed with MMSE >22-30 ➔ ➔ group study with amyloid as measured by tolerability 856 • Stable concomitant Bayesian adaptive amyloid PET 10 mg/kg bi-weekly ➔ patients ➔ medication design • ∆ from baseline in CSF • Positive amyloid biomarker and MRI (total 5 mg/kg once every four weeks PET/CSF hippocampal volume • Safety and tolerability 10 mg/kg once every four weeks BAN2401 18 months treatment demonstrated an effect on both cognition and biomarkers with a good tolerability profile Completion of study after 18 months treatment and 3 months follow-up - Q4 2018 Source: Company information Note: ADCOMS = Alzheimer’s Disease Composite Score, an evaluation tool developed by Eisai 6
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