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Arctic Bioscience Investor Presentation 2025

Jul 1, 2025

3536_rns_2025-07-01_b570bdb6-d4b1-4054-a593-7b53c1159aa8.pdf

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Data read-out July 2025

HeROPA study HRO350 in mild-to-moderate psoriasis Arctic Bioscience AS

EU CT number: 2022-501850-12-00 EudraCT number: 2021-003684-96 ClinicalTrials.gov ID: NCT06125808

Foundation for commercial discussions established, subgroups show statistical significance

Key findings

  • Primary endpoint PASI50 difficult to reach due high placebo rate; endpoint sensitive to disease fluctuations (as reported in October 2024)
  • Stricter endpoints like PGA 0/1 on per protocol population approaching significance (p = 0.07)
  • Relevant subgroups show statistical significance (p < 0.05)
  • Robust safety data with no serious concerns observed in the period and HRO350 is well tolerated by the patients
  • Combination of statistical significance in subgroups, responder analysis and robust safety data as base for planning future phase III and clinical development
  • Promising results going into further partner discussion this fall

Primary endpoint PASI50 difficult to measure in mild population

Natural disease fluctuations and limited precision on lower end of PASI scale makes it hard to show differences in PASI50 between groups for patients with mild-to-moderate psoriasis

mild-to-moderate population (PASI 3-10) who naturally experience seasonal variation and episodes of spontaneous remission or worsening, versus a severe patient with PASI 30 at baseline achieving PASI50 (biologics trial).

PASI50: The proportion of patients with ≥50% reduction in Psoriasis Area and Severity Index (PASI, scale from 0-72) from baseline. PP: Per Protocol Population for PASI. Week 52 n = 273. Data as observed. ITT: Intention to treat. N = 521, data not shown. p = 0.472 high dose, p = 0.626 low dose (week 52) 1) Papp KA et al., Dermatol Ther (Heidelb) (2021) 11:1079–1083. https://doi.org/10.1007/s13555-021-00572-2

  • Comments
  • PASI50 compared between HRO350 and placebo at 6 months was the primary endpoint, which was not met
  • Efficacy of HRO350 observed as assumed in protocol for patients who completed 1 year of treatment
  • Placebo response-rate was much higher than predicted
  • PASI scale has less precision in mild disease1

Stricter endpoint differentiates better: PGA 0/1 (clear or almost clear)

Key secondary endpoint: Physician's Global Assessment (PGA 0/1) is easier to measure and more difficult to achieve

  • Nearly half of patients treated with HRO350 achieved clear-or-almost
  • PGA 0/1 is a much harder endpoint to reach than PASI50
  • 47% of patients in the high dose arm achieved a PGA 0/1 at week 52, versus 34% in the placebo group (p = 0.073)
  • In the previous Haukeland study1 40% of patients achieved PGA 0/1
  • All patients had PGA scores ≥ 2 and ≤ 4 at inclusion

Static PGA (sPGA) measures physician's impression at a single time point. Static form is standard due to reliability

  1. 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. 2) 3) Stein Gold L, et al. Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. J Am Acad Dermatol. 2022 Jan;86(1):77-85. doi: 10.1016/j.jaad.2021.07.040. PMID: 34343599..

PP: Per Protocol population for sPGA for patients who completed 52 weeks: n = 272. Data as observed. ITT: Intention to Treat population for sPGA: N = 521.

(Non-Responder Imputation analysis not shown. p = 0.490 for high dose vs placebo and p = 0.608 for low dose vs placebo)

Higher placebo rate in patients with milder disease at baseline

Subanalysis identified differentiators on placebo response: Baseline severity

  • Post-hoc analysis: Placebo response is higher in patients with PASI < 6 at baseline
  • Patients with PASI ≥ 6 and < 6 respond similarly in the high dose arm

Static PGA measures physician's impression at a single time point. Static form is standard due to reliability.

Comments

Post-hoc analysis on the Per Protocol (PP) Population for sPGA. Week 52 n=272. Data as observed. ITT: Intention to treat. N = 521 all time points. (Non-Responder Imputation analysis not shown. p = 0.490, p = 0.995, and p = 0.391 for high dose vs placebo)

Lower placebo rate in patients ≥ 50 years

Subanalysis identified statistically significant subgroup: Impact of age

  • Post-hoc analysis: Lower placebo rates ≥ median age( ≥ 50 years)
  • Younger age with shorter duration of psoriatic disease may increase chance of spontaneous improvement in the placebo group
  • Patients of all ages respond similarly in the high dose arm

Static PGA measures physician's impression at a single time point. Static form is standard due to reliability Post-hoc analysis on the Per Protocol (PP) Population for sPGA. Week 52 n = 272. Data as observed. ITT: Intention to treat. N = 521 all time points. (Non-Responder Imputation analysis not shown. p = 0.490, p = 0.254, and p = 0.946 for high dose vs placebo)

Comments

Higher response rates in active arm for patients with weight ≤ 98 kgs

Subanalysis identified statistically significant subgroup: Impact of weight

• Post-hoc analysis showed that more patients in lower three weight quartiles (patients weighing ≤ 98 kgs) in PP achieved a PGA 0/1 at week 52 than patients in the highest weight quartile

Static PGA measures physician's impression at a single time point. Static form is standard due to reliability Post-hoc analysis on the Per Protocol (PP) Population for sPGA. Week 52 n = 272. Data as observed. ITT: Intention to treat. N = 521 all time points. (Non-Responder Imputation analysis not shown. p = 0.490, p = 0.469, and p = 0.868 for high dose vs placebo). Missing weight: n = 2 PBO

Comments

Robust safety on HRO350

No Serious Safety Concerns

No drug-related Serious Adverse Events (SAEs) or Suspected Unexpected Serious Adverse Reactions (SUSARs) were reported

Independent Oversight Confirmed Safety

Periodic reviews by the independent Data Monitoring Committee (DMC) raised no safety concerns throughout the trial

Well Tolerated Over 1 Year

HRO350 demonstrates a favorable safety profile throughout 12 months of treatment and 2 months post-treatment follow-up Few drug-related adverse events (AEs) and low drop-outs due to drug-related AEs Adverse events observed were consistent with expectations and those seen in the Haukeland study

Regulatory-Ready Documentation

Full safety data analysis, including frequency tables and SAE narratives will be detailed in the Clinical Study Report

-

-

HRO350 safety from HeROPA patients (N = 521) treated for up to 1 year

Well tolerated with no serious safety concerns

Plan going forward

  • Nutra business is growing strongly (~30 % annually)
  • We strongly believe there is a major market potential for HRO350 in mild-to-moderate psoriasis
  • Arctic Bioscience will seek partnerships for further development of HRO350 with a potential Phase III clinical program

Appendix

HRO350 in mild-to-moderate psoriasis Market and value proposition

*Split between mild and moderate patients varies in the literature.

Sources: HRO350 Commercial Opportunity Assessment in Psoriasis, IQVIA; WHO Global Report on Psoriasis; Rendon. Int J Mol Sci. 2019 Mar; 20(6): 1475; UpToDate; American Academy of Dermatology Association; Papp. Dermatol Ther. 11:1053; 2021; National Psoriasis Foundation; Evaluate Pharma 2022 Psoriasis Market Size, November 2022 Analysis.

In the U.S.,

In the EU5,

~18.7M mild-to-moderate patients in the U.S. and EU5

HRO350 Strategic Positioning: mild-to-moderate psoriasis

  • ~22.5M total psoriasis patients across severity types (~10.7 U.S. and ~11.8 EU5)
  • ~80% of U.S. patients and ~90% of EU5 patients have mild-to-moderate psoriasis
  • HRO350 is targeting a total addressable market of ~18.7M mild-to-moderate psoriasis patients

  • Drug development program for children <18 years of age with psoriasis
  • Component of the regulatory drug development journey for HRO350
  • Prerequisite for filing for marketing authorization (MA) for new medicines in Europe

Limited approved products in standards of care High unmet medical need

Paediatric Investigation Plan (PIP) agreed with the Paedatric Committee* of the EMA

• A future paediatric indication would increase patient population who could have benefit from HRO350

• Limited treatment options – potential first line treatment for mild-tomoderate psoriasis in children

  • 1% of children under age 18 suffer from psoriasis
  • Plan for expanded indication for HRO350
  • US

• Unmet need for oral treatments – only apremilast currently in clinical trials for mild-to-moderate pediatric psoriasis (> 6 yrs) in the

*The Paediatric Committee of the EMA provides opinions on the quality, safety and efficacy of a medicine for use in the paediatric population

References: Augustin M, Glaeske G, Radtke MA, Christophers E, Reich K, Schäfer I. Epidemiology and comorbidity of psoriasis in children. Br J Dermatol. 2010 Mar;162(3):633-6. doi: 10.1111/j.1365-2133.2009.09593.x. Epub 2009 Nov 18. PMID: 19922529; Haulrig MB, Zachariae C, Skov L. Off-Label Treatments for Pediatric Psoriasis: Lessons for the Clinic. Psoriasis (Auckl). 2021 Feb 11;11:1-20. doi: 10.2147/PTT.S268462. PMID: 33604269; PMCID: PMC7886293.; Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients [published correction appears in J Am Acad Dermatol. 2020 Mar;82(3):574]. J Am Acad Dermatol. 2020;82(1):161-201.

Potential first-line treatment for children with mild-to-moderate psoriasis

Paediatric indication for HRO350: upside potential

PASI: Psoriasis Area and Severity Index (0-72 point scale where >10 is moderate-to-severe and severe disease) Source: HRO350 Commercial Opportunity Assessment in Psoriasis, IQVIA report *Oral (e.g. fumarates, methotrexate, apremilast) ** Injectables (e-g-. adalimumab, ustekinumab, ixkizumab)

Oral (soft capsules)

  • First-in-class active pharmaceutical ingredient (API)
  • Mild-to-moderate disease

Few treatment options for non-severe disease

HRO350 could meet an unmet medical need for patients with non-severe psoriasis

HeROPA study HRO350 in mild-to-moderate psoriasis

Study design

Large phase IIb study investigated efficacy, safety, and dose of HRO350 versus placebo

HeROPA Phase IIb clinical trial design

  • Included 521 patients started late January 2023 in the UK and March 2023 in Germany, Poland, Finland and Norway
  • Protocol designed based on Scientific Advice from the EMA

PASI: Psoriasis Area and Severity Index (0–72-point scale where < 10 is mild-moderate disease); RCT: Randomized Controlled Trial. U CT number: 2022-501850-12-00 EudraCT number: 2021-003684-96

b.d. = twice daily; iii = three capsules; DDD = defined daily dose

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

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

HRO350 is a unique lipid matrix with biologically active phospholipids

Proprietary lipid extract of phospholipid esters from herring roe (Clupea harengus)

Manufactured according to GMP

Cellular data on API and immunomodulation1-3

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

Core structure of phospholipid esters from herring roe

A

B

D

E

C

FATTY ACID

ALCOHOL

GLYCEROL

PO4

A

B

C

D

E

FATTY ACID

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

API: Active Product Ingredient; GMP: Good Manufacturing Practice

References: 1) Forskningsradet (Research Council of Norway), Properties of phospholipids d Herring Roe in Psoriasis, available online 2) Ringheim-Bakka, TA et al. Herring roe PLs promote SPM biosynthesis in macrophages and a keratinocyte/fibroblast co-culture as model of psoriasis, PREPRINT, bioRxiv 2025.02.20.639253; doi: https://doi.org/10.1101/2025.02.20.639253. 3) Mildenberger, J et al. Herring roe oil exerts anti-psoriatic and immunomodulatory effects on the IL-17/23 signaling axis in macrophages, T-cells and a keratinocyte and fibroblast co-culture, PREPRINT, bioRxiv 2025.04.22.650092; doi: https://doi.org/10.1101/2025.04.22.650092.

HRO350 Mode of action & resolution of inflammation

Resolve - not block - inflammation: a therapeutic frontier

HRO350 API (PEHeRo) promotes SPM biosynthesis in immune cells with implications for the treatment of 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

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.

HRO350 Clinical development plan

HRO350 drug development program in psoriasis Updated plan

HeROPA investigators and clinics:

Norway:

Haukeland University Hospital Ålesund hospital Stavanger University Hospital Nordlandssykehuset

United Kingdom:

Salford Royal hospital Kiltearn Medical Centre Newquay Health Centre Waterloo Medical Centre Heart of Bath Surgery University Hospitals Dorset Sherbourne Med Centre University Hospital of Durham The practice of health Trowbridge Health Centre St Clare Medical centre Kingsmill Hospital Lakeside Medical Research Suffolk Primary Care - Haven Health Breckland Alliance - Grove Surgery Concord Medical Centre Royal Primary Care Ashgate Honiton Surgery Hathaway Medical Centre Rowden Surgery West Walk Surgery Clarence Medical Centre Carn to Coast Health Centres

Finland: CRST Helsinky Oy CRST Turku Oy

Germany:

Fachklinik Bad Bentheim Derma-Study-Center-FN GmbH Universitätsklinikum Münster (UKM) Hautarztpraxis Dr. med. Matthias Hoffmann Universitätsklinikum Heidelberg TU Dresden Haut- und Laserzentrum Hunsrück Studienzentrum Dr. Leitz Tri-Derm Pro Derma University Clinic UKSH Kiel Isa Research Universitätsklinikum Essen Hautmedizin Bad Soden Studienzentrum LMU Klinikum Studienzentrum an der Hase GbR Rosenpark Research GmbH Dermatologie Quist Zentrum für Dermatologie und Ästhetik, Friedrichsdorf Universitätsklinikum Erlangen MensingdermA research GmbH, Hamburg

Poland:

MICS Centrum Medyczne Toruń Klinicznych Centrum Medyczne All-Med KO-MED Centra Kliniczne Sp. z o.o Pulawy Osrodek Wsparcia Badan Klinicznych KOMED at Narodowy Instytut Geriatrii Dermoklinika Centrum Medyczne RENEW Clinic Klinika Ambroziak Klinika Osipowicz I Turkowski sp. zo.o. Dr. Sękowska Klinika Leczenia Bólu Instytut Zdrowia Dr. Boczarska-Jedynak

Our CRO:

Smerud Medical Research International

Thank you:

Norwegian Research council Innovation Norway Sparebank1 SMN Eksfin

Our gratitude to the patients who participated in the HeROPA study

THANK YOU

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Contact

Arctic Bioscience AS

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

CEO: Christer Valderhaug [email protected] Phone: +47 92084601

Medical Director: Runhild Gammelsæter [email protected] Phone: +47 95933436

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