Arctic Bioscience — Investor Presentation 2024

Oct 16, 2024

Arctic Bioscience Pioneers in the natural resolution of inflammation

Webcast October 16th 2024

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Summary

• The ongoing phase IIb-trial (HeROPA) is a 52-week trial with 521 patients recruited, studying efficacy and safety of the medical candidate HRO350 in mild-to-moderate psoriasis
• The primary endpoint (PASI50 at 26 weeks) was not met, mainly due to a higher than expected Placebo response
• Secondary endpoints at week 52 will be critical to understand the potential of HRO350 and the long-term efficacy in mild-to-moderate psoriasis

HRO350 Role in the resolution of inflammation in Psoriasis

HRO350 is a unique lipid matrix with biologically active phospholipids

API: PEHeRo (Phospholipid Esters from Herring Roe) IRIS Substance ID: 300000046327 EV Medicinal Product Code: PRD9919073

HRO350 is produced under GMP conditions and is planned marketed as a per oral prescription medicine

Herring roe is rich in polyunsaturated fatty acids with high phospholipid content

Phospholipids esters have metabolites with immunomodulatory properties, and can function as both carriers and active molecules1

Mode-of-action data in psoriasis from cell studies2

Core structure of phospholipid esters from herring roe

Example phospholipid: PC(22:6n3/16:0)

API: Active Product Ingredient; GMP: Good Manufacturing Practices

References: 1) Cook CM, Hallaråker H, Sæbø PC, et al. Bioavailability of long chain omega-3 polyunsaturated fatty acids from phospholipid-rich herring roe oil in men and women with mildly elevated triacylglycerols. Prostaglandins Leukot Essent Fatty Acids. 2016;111:17-24. doi:10.1016/j.plefa.2016.01.007; 2) Forskningsradet (Research Council of Norway), Properties of phospholipids d Herring Roe in Psoriasis, available online 5

Properties of drug candidate HRO350

HRO350 is a first in class asset with phospholipid esters as API

Specialized pro-resolving mediators (SPMs)

• Bioactive lipids that actively terminate inflammation and drive the restoration of tissue homeostasis through activating signs of resolution1,2
• Lipid mediators are elevated in lesional psoriatic skin3
• SPMs' effects have been demonstrated in-vitro (e.g. Maresin-1 [MaR1]); MaR1 has been shown to suppress IL-17A production in a murine psoriasis model4

Cellular research on SPMs supports the anti-inflammatory mechanism of HRO350⁵

• HRO350 activates the production of SPMs that promote a shift towards a protective and possibly reparative phenotype of monocyte derived macrophages • Data demonstrates a promising treatment modality in inflammatory conditions

• Data supports the anti-inflammatory actions of API PEHeRo specifically
• including psoriasis

References: 1) Basil MC, Levy BD. Specialized pro-resolving mediators: endogenous regulators of infection and inflammation. Nat Rev Immunol. 2016;16(1):51-67; 2) Chiurchiù V, Leuti A, Maccarrone M. Bioactive Lipids and Chronic Inflammation: Managing the Fire Within. Front Immunol. 2018;9:38. Published 2018 Jan 29; 3) O' Serhan CN, Levy BD. Resolvins in inflammation: emergence of the pro-resolving superfamily of mediators. J Clin Invest. 2018;128(7):2657-2669; 3) Sorokin AV, Norris PC, English JT, et al. Identification of proresolving and inflammatory lipid mediators in human psoriasis. J Clin Lipidol. 2018;12(4):1047-1060; 4) Saito-Sasaki N, Sawada Y, Mashima E, et al. Maresin-1 suppresses imiquimod-induced skin inflammation by regulating IL-23 receptor expression. Sci Rep. 2018;8(1):5522. Published 2018 Apr 3. Ongoing research: Forskningsradet (Research Council of Norway), Properties of phospholipids d Herring Roe in Psoriasis, available online . 5) Ringheim-Bakka T, Mildenberger J, Dalli J, Saliani A, Petrucelli F, Busygina M, Mancinelli D, Gammelsæter R. Phospholipid Esters from Herring Roe promotes SPM biosynthesis in human monocyte-derived macrophages with implications for the treatment of psoriasis. Poster (37) at the 9th European Workshop on Lipid Mediators, June 26-28th, 2024. 6

Bioactive lipids´ role in inflammation mediation

Lipid-mediators, metabolic products of phospholipid esters from herring roe, are proposed to play a role in inflammatory diseases, including psoriasis

Specialized pro-resolving mediators (SPMs) are a type of bioactive lipids that actively terminate inflammation and drive the restauration of tissue homeostasis 1

Lipid mediators are elevated in lesional psoriatic skin3.

Most existing drugs are designed to reduce inflammation by inhibiting pro-inflammatory cytokines

Data on SPMs supporting an anti-inflammatory action of HRO350, and PEHeRo specifically

• upregulating the production of SPMs which promote a shift towards a protective and possibly reparative phenotype of monocyte-derived macrophages

The API (PEHeRo) promotes SPM biosynthesis in immune cells with implications for the treatment of psoriasis Resolve - not block - inflammation: a therapeutic frontier

Fullerton, J., Gilroy, D. Resolution of inflammation: a new therapeutic frontier. Nat Rev Drug Discov 15, 551–567 (2016).https://doi.org/10.1038/nrd.2016.39

Park J, Langmead CJ, Riddy DM. New Advances in Targeting the Resolution of Inflammation: Implications for Specialized Pro-Resolving Mediator GPCR Drug Discovery ACS Pharmacol. Transl. Sci. 2020, 3, 1, 88–106;

Serhan CN, Chiang N, Dalli J. The resolution code of acute inflammation: Novel pro-resolving lipid mediators in resolution. Seminars in Immunology. 2015 May;27(3):200-215. DOI: 10.1016/j.smim.2015.03.004. PMID: 25857211; PMCID: PMC4515371. Ringheim-Bakka T, Mildenberger J, Dalli J, Saliani A, Petrucelli F, Busygina M, Mancinelli D, Gammelsæter R. Phospholipid Esters from Herring Roe promotes SPM biosynthesis in human monocyte-derived macrophages with implications for the treatment of psoriasis. Poster (37) at the 9th European Workshop on Lipid Mediators, June 26-28th, 2024.

Psoriasis is an inflammatory disease associated with elevated levels of the cytokines IL-17 and IL-23

• Cellular studies were conducted to investigate effects of HRO on macrophages and T-cells, and a psoriatic skin cell model of keratinocyte and fibroblast co-culture.

Cellular research on support an anti-psoriatic mechanisms of HRO350

• Phospholipid Esters from Herring Roe can have immunomodulatory anti-psoriatic effects by affecting signaling on the IL-17/23 axis in immune cells and psoriatic skin cell models.

This increases the understanding of the potential mode-of-action of HRO350

Reference: Mildenberger J, Solberg N, Østbye TK, Høst V, Petruccelli F, Gammelsæter R, Rønning SB, Pedersen ME. "Phospholipid Esters from Herring Roe promotes SPM biosynthesis in human monocyte-derived macrophages with implications for the treatment of psoriasis". Poster 3243 at the EADV congress, Amsterdam, September 25-28th, 2024. 8

Anti-psoriatic effects of herring roe oil in immune cells and skin cells

Cellular studies show effects on the phospholipid esters from herring roe on signaling on the IL-17/23 axis in immune cells and psoriatic skin cell models

HRO350 Drug Development Program

PASI: Psoriasis Area and Severity Index (0–72-point scale where < 10 is mild-moderate disease); RCT: Randomized Controlled Trial b.d. = twice daily; iii = three capsules; DDD = defined daily dose 10

Phase IIb clinical plan & development milestones

Large phase IIb study to investigate efficacy, safety, and dose of HRO350 versus placebo in mild-to-moderate psoriasis

• One year treatment, placebo controlled, international, multicenter Phase IIb study with 521 randomized patients
• Protocol designed based on Scientific Advice from the EMA
• Approved and ongoing in the UK, Germany, Poland, Finland and Norway
• Study endpoints include PASI score and multiple secondary endpoints

Secondary Endpoints at week 52 Including Change in PASI
Period B : RCT (week 26-52)	Follow-up (week 52-60)

Endpoints analysed at 26 and 52 weeks

HeROPA phase 2b clinical trial in mild-to-moderate psoriasis

Secondary endpoints at 52 weeks include:

Physical symptom assessments

Comparisons of Psoriasis Area and Severity Index (PASI) scores Body Surface Area (BSA) static Physician Global Assessment (sPGA) Scalp PGA (ScPGA)

Patient Reported Outcomes

SF-36 Dermatology Life Quality Index (DLQI)

Safety

Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Primary endpoint:

The proportion of patients with ≥50% reduction in Psoriasis Area and Severity Index (PASI50). [From Baseline to Week 26]

HeROPA Six-month read-out

Primary endpoint not met: PASI50 responders The proportion of patients with ≥50% reduction in Psoriasis Area and Severity Index (PASI) from baseline to

week 26 was compared between HRO350 and placebo

Results of the readout

• The response rate in the HRO350 high dose group was close to the estimated effect level
• Number of patients with response in the placebo group was higher than predicted, thus no statistical difference demonstrating difference from placebo
• No safety concerns so far in the HeROPA trial, and no unexpected serious events related to the study medication have been reported to date.

Limitations on details from readout

• Numeric data results cannot be provided as the study is ongoing and patients are still being treated
  • International guidelines on conducting clinical trials dictates that patients and investigators should not be provided with information which may impact the integrity of treatment and avoid bias
  • For ethical reasons and to safeguard patients who are participating in the trail
  • Secondary endpoints at week 52 will be extremely important to understand the placebo rate
• Data will be disclosed after all patients have completed the trial and analysis has been conducted

Psoriasis is a disease with natural fluctuations

• Psoriasis is a chronic disease
• It is not uncommon for the symptoms of psoriasis to fluctuate through the seasons
• Spontaneous improvements in summer months can be observed as for light treatment
• The HeROPA study was designed with 52 weeks of placebo control to address this

High placebo rates

• an inherent challenge in clinical trials in milder disease states

• In randomized parallel placebo-controlled trial, the observed relative treatment difference gives an estimate of an apparent treatment effect which does not reflect the full treatment effect due to the dilution resulting from the presence of placebo responders.

• High placebo rates of success can be related to: Disease severity – more difficult to assess changes in mild disease states Diseases with natural fluctuations – spontaneous improvements

Arctic Bioscience The way forward

What it means for patients

HRO350 as a potential treatment option for mild-to-moderate psoriasis

Data after 52 weeks of treatment will give further information about the benefit-risk profile of HRO350 and longterm treatment results versus placebo in a population with fluctuating disease.

• No safety concerns so far in the HeROPA trial, and no unexpected serious events related to the study medication have been reported to date.

HRO350 could still be a unique oral treatment option for mild-to-moderate psoriasis

• New mode of action in resolution of inflammation
• Natural raw material

What it means for Arctic Bioscience

Considerations in continued development of HRO350 as a treatment option for mild-to-moderate psoriasis

• Analyse 52-week data to look at long term outcomes of HRO350 versus placebo in this patient population
• Wait with planning phase III clinical trial in mild-to-moderate psoriasis until 52 weeks data are evaluated
• Wait with setting up production line until the further drug development program is clarified
• Explore potential alternative routes (non-prescription) to market for HRO350

What it means for Arctic Bioscience Financials

• The liquidity situation has been closely monitored over time and various financing alternatives are being considered to secure the future funding of the company's activities - post the primary data readout
• Cash preservation initiatives are implemented to ensure that the available financial resources will sustain the company into 2025, enabling the achievement of upcoming key inflection points in Q1
• The company will perform a full strategic and organizational assessment to secure a sustainable financial platform going forward
• The Company expect to continue delivering double digit annual nutra revenue growth towards profitability in 12-18 Months

Contact

Arctic Bioscience AS

Business address: Industrivegen 42 6155 Ørsta Norway www.arctic -bioscience.com

CEO: Christer Valderhaug christer@arctic -bioscience.com Phone: +47 92084601

Medical Director: Runhild Gammelsæter runhild@arctic -bioscience.com Phone: +47 95933436