Avalo Therapeutics, Inc. · NASDAQ:AVTX

Avalo Therapeutics — Investor Presentation (December 2024)

24 slides from Avalo Therapeutics's investor presentation, Dec 5, 2024

  1. Slide 1: December 2024 Corporate Presentation

    December 2024 Corporate Presentation Avalo Therapeutics, Inc. (AVTX) Exhibit 99.1

  2. Slide 2: Forward-Looking Statements

    Forward-Looking Statements This presentation may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward- looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and un

  3. Slide 3: Avalo Therapeutics: Developing Targeted Therapies for Immune Dysregulation

    Avalo Therapeutics: Developing Targeted Therapies for Immune Dysregulation 3 • Lead compound: AVTX-009 (anti-IL-1β mAb) has the potential for "best-in-disease" profile in hidradenitis suppurativa (HS) – Favorable POC validation in HS:  Abbvie’s lutikizumab (IL-1α/β) demonstrated comparable efficacy

  4. Slide 4: Avalo Management Team

    A proven track record of successful leadership, product development, and commercialization in pharma and biotech Avalo Management Team 175+ Years of Experience in Biotech/Pharma 4 Lisa Hegg, PhD SVP, Program Management, Corporate Infrastructure, Clinical Operations Colleen Matkowski SVP, Global Regu

  5. Slide 5: AVTX-009: A Highly Potent, Specific Inhibitor of IL-1β

    AVTX-009 A Highly Potent, Specific Inhibitor of IL-1β 5 • Originally developed by Eli Lilly1,2 • Stable 150 mg/mL dosage formulation3 – SC and IV administration – Initial presentation: prefilled syringe Post-approval plan: autoinjector • Clinical experience: 245 patients studied in phase 1 and phase

  6. Slide 6: IL-1β is a Master Regulator of Inflammation

    IL-1β is a Master Regulator of Inflammation 6 • IL-1β is a central driver of the inflammatory process1 and activates immune cells that generate proinflammatory cytokines including IL-6, TNF-α, and IL-17 • Clinically validated and de-risked MOA – Inhibition of IL-1β has been shown to be effective and

  7. Slide 7: AVTX-009 Opportunity in Hidradenitis Suppurativa (HS)

    7 AVTX-009 Opportunity in Hidradenitis Suppurativa (HS)

  8. Slide 8: Chronic Inflammation in Hidradenitis Suppurativa Progresses to Tissue Destruction

    Chronic Inflammation in Hidradenitis Suppurativa Progresses to Tissue Destruction 8 Photos from Mendes-Bastos P, et al. Front Med (Lausanne). 2024;11:1403455; Ovadja ZN, et al. Brit J Dermatol. 2019;181:243-244; Cotter C, Walsh S. Skin Health and Disease. 2021;1(1):e7. CC-BY-4.0 License. 1. Diaz MJ,

  9. Slide 9: Large Unmet Need in HS with Majority of Patients Failing to Respond Adequately

    There is a Large Unmet Need in HS with a Majority of Patients Failing to Respond Adequately to anti-TNF and anti-IL-17 biologics​ 9 HS, hidradenitis suppurativa. aCurrent treatments include antibiotics, retinoids, steroids, Cosentyx®, Humira®. 1. Ingram JR, et al. J Eur Acad Dermatol Venereol. 2022;

  10. Slide 10: IL-1β Dominates the Pathophysiology of HS

    IL-1β Dominates the Pathophysiology of HS1 10 DAMP, damage-associated molecular pattern molecule; DC, dendritic cell; HS, hidradenitis suppurativa; IL, interleukin; R, receptor; PAMP, pathogen-associated molecular pattern molecule. Figure adapted from Agnese ER et al. Cureus. 15(11):e49390. Creative

  11. Slide 11: Phase 2 Lutikizumab Data Validates the Role for IL-1 in HS

    0% 20% 40% 60% Pr op or tio n of p at ie nt s ac hi ev in g en dp oi nt HiSCR75 Phase 2 Lutikizumab Data Validates the Role for IL-1 in HS; Comparable Efficacy in a Refractory Population 11 HiSCR, hidradenitis suppurativa clinical response; IL, interleukin; JAK1, janus kinase 1; MOA, mechanism of ac

  12. Slide 12: AVTX-009 Profile Advantages vs Lutikizumab

    AVTX-009 Profile Advantages: IL-1β Specificity, Higher Affinity, Bioavailability, and Longer Half-Life than Lutikizumab 12 KD, dissociation constant; pM, picomolar. 1. Lacy SE, et al. mAbs. 2015;7(3):605-619; 2. Wang SX, et al. Osteoarthritis Cartilage. 2017;25(12):1952-1961; 3. Bihorel S, et al. AA

  13. Slide 13: IL-1β is the Predominant Isoform that Drives Chronic Inflammation in HS

    IL-1β is the Predominant Isoform that Drives Chronic Inflammation in HS 13 aFigure adapted from Kim JK et al. Creative commons license. CC-BY 4.0. HiSCR, hidradenitis suppurativa clinical response; HS, hidradenitis suppurativa; IL, interleukin; mAb, monoclonal antibody; QW, weekly, Q2W, every other

  14. Slide 14: AVTX-009: Affinity Matters in HS

    Pressurized environment Tissue infiltration IL-1β binding and inhibition AVTX-009: Affinity Matters in HS 14 mAbs, monoclonal antibodies. 1. Ryman JT & Meibohm B. CPT Pharmacometrics Syst Pharmacol. 2017.6:576-588; 2. Humira. Package insert. AbbVie Inc.; 2024; 3. Cosentyx. Package insert. Novartis P

  15. Slide 15: Phase 2 LOTUS Trial Design: Efficacy and Safety of AVTX-009 in HS

    Key Secondary Endpoints: • TEAEs • HiSCR50, HiSCR90 • International HS Severity Score System (IHS4) • AN count, draining fistula count • Patient’s Global Assessment of Skin Pain (PGA Skin Pain) (NRS30) • Percentage of subjects with flares • ADA Exploratory Endpoints: • PK • HiSQOL, DLQI, PHQ-9 • Bio

  16. Slide 16: Diagnosed and Treated HS Population Projected to Grow into a $10B+ Market by 2035

    Overall HS prevalence2 HS diagnosed and treated3 Moderate- to-severe HS4 Biologics treated5 Diagnosed and Treated HS Population is Projected to Grow Substantially into a $10B+ Market by 20351 16 aHS diagnosis and treatment rates and biologic treatment rates are expected to increase over time. CAGR,

  17. Slide 17: Timelines: Looking Forward

    Timelines: Looking Forward 17 aProjected; bPending readout from phase 2. IND, investigational new drug application. 2026 LOTUS (phase 2) readouta 2027 Initiate phase 2b/3b 2H 2025 Final site activated for LOTUSa 2H 2024 First patient enrolled in phase 2 LOTUS March 2024 Merger with AlmataBio July 20

  18. Slide 18: Broad Potential for Indication Expansion

    18 Broad Potential for Indication Expansion

  19. Slide 19: Additional Indications with Established Clinical Proof of Concept

    Arthritis Indications Inflammatory Bowel Disease Additional Indications with Established Clinical Proof of Concept Clinical Rationale for IL-1 Targeting Therapies in Additional Disease States 19 CRP, C-reactive protein; DIRA, deficiency of interleukin receptor 1 antagonist; HS, hidradenitis suppurat

  20. Slide 20: Executive Summary

    Executive Summary AVAIO THERAPEUTEES

  21. Slide 21: Avalo Therapeutics: Developing Targeted Therapies for Immune Dysregulation

    Avalo Therapeutics: Developing Targeted Therapies for Immune Dysregulation 21 • Lead compound: AVTX-009 (anti-IL-1β mAb) has the potential for "best-in-disease" profile in hidradenitis suppurativa (HS) – Favorable POC validation in HS:  Abbvie’s lutikizumab (IL-1α/β) demonstrated comparable efficac

  22. Slide 22: www.avalotx.com

    22 NASDAQ: AVTX www.avalotx.com

  23. Slide 23: Appendix

    Appendix AVAIO THERAPEUTEES

  24. Slide 24: Avalo Capitalization and Cash Position

    Avalo Capitalization and Cash Position 1Inclusive of share issuances from warrant exercises in 4Q 2024; 2Does not include 2.6M stock options and restricted stock units outstanding resulting in a fully dilutive share count of 38M24 As of November 8, 2024 Number of shares • Common shares outstanding1

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