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XBiotech: Harnessing Natural Immunity in Dermatology

Explore the innovative approach of XBiotech in transforming medicine through natural immunity. Learn about its groundbreaking antibody discoveries and clinical studies in dermatology.

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XBiotech: Harnessing Natural Immunity in Dermatology

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  1. XBiotech Harnessing Natural Immunity to Transform Medicine A platform overview and review of recent findings in dermatology

  2. FORWARD LOOKING STATEMENT This presentation contains forward-looking statements, including declarations regarding management's beliefs and expectations that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "would," "could," "expects," "plans," "contemplate," "anticipates," "believes," "estimates," "predicts," "projects," "intend" or "continue" or the negative of such terms or other comparable terminology, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to inherent risks and uncertainties in predicting future results and conditions that could cause the actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties are subject to the disclosures set forth in the "Risk Factors" section of certain of our SEC filings. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this presentation. Any forward-looking statements that we make in this presentation speak only as of the date of this presentation. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this presentation.

  3. XBiotech Manufacturing & R&D Center

  4. Mine the Human Antibody Repertoire …And We Develop the Best that the Human Antibody Repertoire has to Offer Healthy Human Volunteers with Natural Immunity to Disease 4

  5. Opportunities • Skin Disease (ie. Inflammatory disease) • Cardiovascular Disease • Infectious Disease • Cancer • Acute Infectious Outbreaks 5

  6. Innovations for Antibody Discovery 6

  7. Reducing the Cost Barrier for Commercialization: Manufacturing Innovation

  8. XBiotech designed and engineered manufacturing technology 8

  9. 250 Issued and Pending Patents World-Wide

  10. Pipeline Bermekimab

  11. Targeting a Master Regulator of Inflammation Interleukin-1a

  12. Bermekimab: a new kind of antibody • First-In-Class (only antibody therapy derived from human) • Derived from a Natural Human Response—NOT animal derived or so called “fully human” • No engineering of antibody binding • Naturally neutralizes Interleukin-1a—the master regulator of inflammation

  13. Bermekimab Clinical Studies in Dermatology DBPCRS = Double blind placebo controlled randomized study POC = Proof of concept clinical study s.c. = subcutaneous

  14. XBiotech’s Published Primary Clinical Research for Bermekimab in Dermatology • Bermekimab Targeting Interleukin-1Alpha for Moderate to Severe Hidradenitis Suppurativa not Eligible for Adalimumab: A Randomized Study Kanni T, Argyropoulou M, Spyridopoulos T, Pistiki A, Stecher M, Dinarello CA, Simard J, Giamarellos-Bourboulis EJ. J Invest Dermatol. 2018 Apr;138(4):795-801 • Open-label trial of Bermekimab, a true human monoclonal antibody targeting interleukin 1α, for the treatment of psoriasis Coleman KM, Gudjonsson JE, Stecher M. JAMA Dermatol. 2015 May;151(5):555-6. • An open label, phase 2 study of Bermekimab monotherapy for the treatment of acne vulgaris and psychiatric comorbidity Carrasco D, Stecher M, Lefebvre GC, Logan AC, Moy R. J Drugs Dermatol. 2015 Jun;14(6):560-4.

  15. Recent Reviews for Bermekimab in Dermatology Investigational Drugs in Clinical Trials for Hidradenitis Suppurativa Peter Theut Riis, Linnea R. Thorlacius & Gregor B. Jemec. Expert Opinion on Investigational Drugs. 2018 Jan;27(1):43-53. The Role of Interleukin‐1 in Inflammatory and Malignant Human Skin Diseases and the Rationale for Targeting Interleukin‐1 Alpha Mayassa J. Bou-Dargham et al., Med Res Rev. 2017 Jan;37(1):180-216.

  16. Bermekimab, an Anti-IL-1α Monoclonal Antibody, Shows Efficacy for Treating Hidradenitis Suppurativa (HS) with Breakthrough Reduction in Pain Hidradenitis Suppurativa Data Presented at the American Academy of Dermatology, March 2019 Alice Bendix Gottlieb MD, PhD Clinical Professor of Dermatology Icahn School of Medicine at Mount Sinai New York, NY 16

  17. Phase II Open Label, Study of Bermekimab in Patients with Moderate to Severe Hidradenitis Suppurativa Week 12 Week 0 Patients who have previously failed anti-TNF Therapy (“Failures”) 400mg Every Week (n=24) Endpoint Data After 12 injections Baseline Data 1st Injection Week 12 Week 0 Patients with no prior treatment with anti-TNF Therapy (”Naïve”) 400mg Every Week (n=18) Endpoint Data After 12 injections Baseline Data 1st Injection

  18. Bermekimab vs HumiraPositive HiSCR at week 12 Subjects Achieved % p<0.001 p=0.003 * * PIONEER I N=18 N=24 Humira Humira + Oral antibiotics *Source: N Engl J Med. 2016 Aug 4;375(5):422-34. doi: 10.1056/NEJMoa1504370. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. https://www.ncbi.nlm.nih.gov/pubmed/27518661 18

  19. Bermekimab vs HumiraPatients with total abscess and inflammatory-nodule count of 0, 1, or 2 at week 12 Subjects Achieved % * * N=24 N=18 p=0.961 Humira Humira + Oral antibiotics p=0.010 *Source: N Engl J Med. 2016 Aug 4;375(5):422-34. doi: 10.1056/NEJMoa1504370. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. https://www.ncbi.nlm.nih.gov/pubmed/27518661

  20. Bermekimab vs Humira: PainPatients with 30% reduction and ≥1 unit reduction in pain Score Subjects Achieving % * * N=24 N=18 Humira + Oral antibiotics Humira 20 *Source: N Engl J Med. 2016 Aug 4;375(5):422-34. doi: 10.1056/NEJMoa1504370. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. https://www.ncbi.nlm.nih.gov/pubmed/27518661

  21. Double-Blind, Placebo Controlled, Phase II Study of Bermekimab in Patients with Hidradenitis Suppurativa Refractory to Adalimumab Kanni T, Argyropoulou M, Spyridopoulos T, Pistiki A, Stecher M, Dinarello CA, Simard J, Giamarellos-Bourboulis EJ. J Invest Dermatol. 2018 Apr;138(4):795-801

  22. Primary study endpoint *Fisher’s exact test **Mantel-Haenszel’s statistics CIs: confidence intervals OR: odds ratio ORHiSCR(+) MABp1: 13.50** (95%CIs: 1.19-152.51, p: 0.035)

  23. HiSCR to 24 Weeks 2° endpoint *Fisher’s exact test

  24. 2° endpoint Abscesses & Inflammatory Nodule Total Counts * Comparison of AUCs by the Students “t-test”

  25. BermekimabAn Anti-IL-1α Monoclonal Antibody Shows Efficacy for Treating Atopic Dermatitis (AD) with Breakthrough Reduction in Itch ATOPIC DERMATITIS Data Presented at the American Academy of Dermatology, March 2019

  26. Treatment Regimens Week 4 Week 0 200mg Every Week Endpoint Data After 4 rounds Baseline Data 1st Injection n=10 Week 8 Week 4 Week 0 400mg Every Week Midpoint Data After 4 rounds Endpoint Data After 8 rounds Baseline Data 1st Injection n=28

  27. EASI Subjects Achieving EASI-75 Mean % reduction % Change from Baseline % Subjects Achieving P<0.001 400mg (N=28) 200mg (N=10) 27 Any missing patient data imputed using LOCF

  28. Bermekimab vs DupilumabEASI-75 Week 8 Week 16 Patients achieving EASI 75 % * Bermekimab Dupilumab (400mg Group, N = 28) * N Engl J Med. 2016 Dec 15;375(24):2335-2348. Epub 2016 Sep 30. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. https://www.ncbi.nlm.nih.gov/pubmed/27690741

  29. SCORAD Bermekimab vs Dupilumab Week 8 Week 16 Improvement %

  30. Bermekimab vs Dupilumab HADS Combined Score Improvement Week 7 Week 16 Point Reduction SOLO2 SOLO1 Bermekimab Dupilumab (400mg Group, N = 28)

  31. Patients achieving ≥ 4 points improvement in worst itch NRS score @ week 4 Patients achieving ≥ 4 improvement % (400mg Group, N = 28) Dupilumab

  32. NRS Pain Mean % Reduction Subjects Achieving ≥4 NRS Score Reduction in Pain Mean Reduction % % Subjects Achieving (400mg Group, N = 28) (400mg group, Subjects having ≥ 4 at baseline N = 20) Any missing patient data imputed using LOCF

  33. A shining star on the dermatology horizon: Bermekimab % http://investor.dermira.com/static-files/7f79814c-812d-4938-8ab3-e0166fc2cc71 * N Engl J Med. 2016 Dec 15;375(24):2335-2348. Epub 2016 Sep 30. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis.https://www.ncbi.nlm.nih.gov/pubmed/27690741 # https://news.abbvie.com/news/abbvies-upadacitinib-abt-494-meets-primary-endpoint-in-phase-2b-study-in-atopic-dermatitis.htm

  34. HS Data Echo the Story for AD *Source: N Engl J Med. 2016 Aug 4;375(5):422-34. doi: 10.1056/NEJMoa1504370. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. https://www.ncbi.nlm.nih.gov/pubmed/27518661

  35. Thank you

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