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Arctic Bioscience Investor Presentation 2021
3536_rns_2021-05-25_9e23eb90-1925-4c2b-bea9-f8a6407db7a3.pdf
Investor Presentation
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Arctic Bioscience AS
ABGSC Life Science Summit 25th May 2021
Presenters: Ole Arne Eiksund (CEO) Runhild Gammelsæter (Medical Director)
Company highlights
Arctic Bioscience was founded based on unique knowledge and know-how about the benefits of herring roe
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B2C subscription is launched in Norway
2020
First clinical study results published
Dr. Mercola sales in USA pass 3m in single order
2020
Scientific Advice from the EMA
2020
B2B bulk sales surpass NOK 20m
2019
Pilot clinical trial completed
Strategic partnership entered with Kotler
2017
Pilot clinical trial initiated
2019
2019
2020
2019-2020: Developing the organization to prepare for future growth
2017-2020: Building the foundation framework for a robust clinical program
Two unique businesses shaped around a proprietary platform technology
12 weeks
18 weeks
26 weeks
PASI: 2.7
PASI: 8.9
PASI: 10
Proprietary technology platform and value chain integration provide sustainable competitive advantage
Sustainable raw material + State-of-the-art manufacturing
Herring capture Production
Arctic Bioscience's comprehensive value chain
Extraction
Patented technology and advanced know
how
Significant gross margin
Building state-of-the-art GMP
manufacturing facility, enabling company
to retain proprietary product know-how, IP
and control of the value chain1
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improvement
By-product: Immature roe
Valuable source of marine lipids
Geographical proximity to Norwegian
herring fisheries
Cash generating nutraceutical business with clear growth strategy
China – an ideal target market for Romega
Gross
Subscription
revenues
NOK 3.4m
Total
revenue
NOK 20.6m
margin
~30%
Philip Kotler & Ole Arne Eiksund (CEO)
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Developed strong relationship with Kotler for efficient market entry and sales growth
Foundation for long-term export success story set – strategic partnership model to be replicated
Unique pharma opportunity in mild-to-moderate psoriasis
Randomized, double-blind placebo controlled clinical trial showed statistically significant improvement in mild to moderate psoriasis compared to placebo
- § Trial: Randomized, placebo-controlled pilot clinical trial in patients with mild to moderate psoriasis (Psoriasis Area Severity Index, PASI <10)
- § Results: Clinical signals of efficacy combined with beneficial safety profile
§ The drug candidate HRO350 will be produced according to GMP
few existing treatment alternatives
PASI: Psoriasis Area and Severity Index. GMP: Good Manufacturing Practice
Before treatment
§ Potential for a first-in-class therapeutic treatment for a global population with
Greatest efficacy seen in subjects with moderate psoriasis
Statistically significant improvement in PASI versus placebo
- § Randomized, placebo-controlled pilot clinical trial in mild to moderate psoriasis (PASI<10, n=64)
- § Primary end-point: Change in mean Psoriasis Area Severity Index (PASI) at week 26
- § Statistically significant improvement in mean PASI with HRO versus placebo at week 26
- § Overall PASI reduction of 38% at week 26
- § Greatest PASI reduction at week 26 observed in subjects with moderate psoriasis
- § Subjects with baseline PASI >5.5 showed average reduction of -2.4 PASI score
- § Well tolerated, no serious adverse events were related to the administration of active treatment or placebo at week 26
0
Week 0 6 12 18 26 32 40 46 52 60
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65
Mean change in PASI score at week 26 estimated to -2.4 with a 95% confidence interval <-4.3, - 0.5>, p = 0.0157 (n=31 with
PASI>5.5). Week 26 – 60 was an open label extension with no placebo-control (n=28 with PASI>5.5)
HRO Placebo (switched week 26)
Subgroup analysis | Subjects with PASI baseline>5.5
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Mild psoriasis
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3
4
5
6
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Moderate psoriasis
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9
10
PASI score
Efficacy is sustained and increases over time
Supported by secondary variable (PSGA) at week 65 (n=58)
Reference: Tveit KS et al. Long Term Efficacy and Safety of Herring Roe Oil in the Treatment of Psoriasis, a 39-week Open-label Extension Study. International Journal of Clinical and Experimental Medical Sciences. Vol. 7, No. 1, 2021, pp. 13-20. doi: 10.11648/j.ijcems.20210701.13.
Note: For sources, references and addition context recipients of this presentation are referred to the Company Presentation March 2021 found on Arctic Bioscience website, https://arctic-bioscience.com/investors/reports-presentations/
0%
10%
20%
30%
40%
40%
PSGA: Physicians Static Global Assessment
50%
60%
70%
80%
90%
100%
§ All patients had PSGA scores ≥2 and
§ 40% of patients achieved clear-or-
almost clear skin after 65 weeks
§ After 65 weeks no patient had a
§ In total, 46.6% of patients had a
reduction in their PSGA score
PSGA score higher than 3
≤4 at inclusion
Unmet medical need in mild-to-moderate psoriasis
PASI: Psoriasis Area and Severity Index
ü Administration
ü
ü
ü
ü
ü
ü
ü
Active substance
Oral
No other product with active product ingredient
Few treatment options for non-severe disease
Efficacy in mild to moderate disease demonstrated in pilot clinical trial
Improvement in quality of life demonstrated in pilot clinical trial
50% of competitive products require monitoring – unlikely needed
Mild to moderate disease
Well tolerated in pilot clinical trial
HRO350 scores well against competitors
for HRO350
Psoriasis indication
Severity at inclusion
Efficacy level
Quality of life
Safety profile
Monitoring
Large-scale Phase IIb study to drive pharma forward
To investigate efficacy, safety and dose of drug candidate HRO350 versus placebo
Milestones overview for Phase IIb clinical trial
Phase IIb Dose Response Six months data read out
Primary endpoint read out (efficacy)
Phase IIb Dose Response Twelve months
data read out
Phase IIb Publications
OLE Follow up
Read out Phase IIb
USD 20bn+ market opportunity in moderate psoriasis alone
Moderate psoriasis offer an accessible market opportunity of USD 20 bn+
Peak revenue opportunity for Arctic Biosciences of USD 1 bn+, on conservative assumptions on pricing and market shares
Severe
~10% of patients
Moderate
~30% of patients
Mild
~60% of patients
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Further significant upside potential in the
market for mild psoriasis
New drug candidate for normal brain development in extremely premature infants
Strong management team with broad experience within the pharmaceutical and nutraceutical industries
Management team with top expertise and experience
Runhild Gammelsæter, PhD
Global Medical Director
+15 years experience
Former positions include medical leadership roles in GSK, Abbvie and Abbott, as well as experience from start-up biotech
Lauren Jensen, MBA
SVP Sales and Marketing
+15 years experience Former positions within global marketing, branding and communications for mid-size and large enterprises
Daniele Mancinelli, MSc CTO
+20 years experience R&D specialist in omega -3 fatty acids and responsible for concept testing, verification and up-scaling
Yuming Feng, PhD
EVP Global Business Dev
+30 years experience Former positions include Procurement Manager at Campbell's, EVP at Zoneco and CEO at Holley Int.
Ole Arne Eiksund, MSc, MBA
CEO
+30 years experience
Former positions include Commercial Director in GSK and VP Global Sales in Hofseth Biocare and EVP Rimfrost.
Hogne Hallaråker, MSc CSO
+15 years experience Founder of Arctic Bioscience and more than 15 years of experience from nutra industries
Per Christian Sæbø, MSc
COO
+20 years experience
Former positions include Lipid
Development Director in Natural ASA
and Site Manager at EPAX,
Hovdebygda
Danielle Glenn, BA
CFO
+20 years experience
Harvard educated, former hedge fund manager at Goldman Sachs and Caxton, CEO, CFO and CSO of multiple startups in US, UK and Norway
Advisors with long experience in pharmaceutical development
Åge Nærdal Cand. Pharm. Former positions include CEO GlaxoSmithKline AS, 30 years experience from pharmaceutical industry. Advises on pharmaceutical business development
Kari Grønås, Cand. Pharm. Broad experience from the pharmaceutical/biotech industry and securing regulatory approvals. Advises on regulatory processes and CMC development of GMP product
Knut Smerud, MSc, biochemistry. Owner of the CRO Smerud Medical Research. Advises on clinical development program, clinical trial design and regulatory processes
Kåre Steinar Tveit, MD. Dermatologist at the Haukeland University Hospital, Norway. Advises on clinical treatment of psoriasis
Company highlights
Contact
CEO Ole Arne Eiksund: [email protected] CFO and Investor Relations Danielle Glenn: [email protected]
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