Avalo Therapeutics, Inc. · NASDAQ:AVTX

Avalo Therapeutics — Investor Presentation (July 2023)

29 slides from Avalo Therapeutics's investor presentation, Jul 21, 2023

  1. Slide 1: Avalo Therapeutics July 2023 Corporate Presentation

    1 © Copyright 2023. Avalo Therapeutics. All rights reserved. FOR DISCUSSION PURPOSES ONLY Avalo Therapeutics, Inc. July 2023 Corporate Presentation (AVTX) EX-99.1

  2. Slide 2: Forward-Looking Statements

    2 © Copyright 2023. Avalo Therapeutics. All rights reserved. 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 su

  3. Slide 3: Avalo Therapeutics (AVTX) Summary

    3 © Copyright 2023. Avalo Therapeutics. All rights reserved. Exclusive consulting arrangement with Carl Ware, PhD, Sanford Burnham Prebys (discoverer of the LIGHT-signaling network) LIGHT, Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprotein D for HVEM, a receptor expr

  4. Slide 4: Pipeline and PEAK trial update, funding plans

    4 © Copyright 2023. Avalo Therapeutics. All rights reserved. Avalo continues to evaluate the topline data results of the Phase 2 PEAK trial in NEA, while also pursuing funding for its programs, including financings and out-licensing, strategic alliances/collaborations or sale of its core and non-cor

  5. Slide 5: AVTX-002 (quisovalimab) Anti-LIGHT mAb

    5 © Copyright 2023. Avalo Therapeutics. All rights reserved. AVTX-002 (quisovalimab) Anti-LIGHT mAb

  6. Slide 6: LIGHT is a Key Driver of Acute & Chronic Inflammation

    6 © Copyright 2023. Avalo Therapeutics. All rights reserved. Ware, C., Croft, M., and Neil, G. J.Exp Med. 2022 Jul 4;219(7):e20220236. 10.1084/jem.20220236. CD4Tem, CD4 effector-memory T cells; DC, dendritic cell; HVEM, herpes virus entry mediator; LTβR, Lymphotoxin beta receptor; MAC, macrophage; N

  7. Slide 7: AVTX-002: First-in-Class Neutralizing Anti-LIGHT mAb

    7 © Copyright 2023. Avalo Therapeutics. All rights reserved. • Fully human monoclonal antibody to LIGHT • CMC at 2,000 L scale; 6-month toxicology study near completion • Positive proof of concept in COVID-19 ARDS • Positive Phase 2 trends: – Crohn’s Disease – NEA in sub-population of patients with

  8. Slide 8: TNF SuperFamily of Ligands and Receptors

    8 © Copyright 2023. Avalo Therapeutics. All rights reserved. TNF SuperFamily of Ligands (TNFSF) and Receptors (TNFRSF) C. F. Ware, Ruddle, N.H. TNF Superfamily of Cytokines and Receptors. M. F. Flajnik ed. Paul's Fundamental Immunology. Publisher: Wolters Kluwer Health 2022 8th ed. Vol. Ch 10, 308-3

  9. Slide 9: Significant Reduction in COVID-19 Induced Respiratory Failure and Mortality

    9 © Copyright 2023. Avalo Therapeutics. All rights reserved. Perlin, D. S. et al., Randomized, double-blind, controlled trial of human anti-LIGHT monoclonal antibody in COVID-19 acute respiratory distress syndrome. J Clin Invest. 2022; 132(3):e153173 LIGHT Levels (pg/mL) Over Treatment Period Percen

  10. Slide 10: AVTX-002 (quisovalimab) Non-Eosinophilic Asthma

    10 © Copyright 2023. Avalo Therapeutics. All rights reserved. FOR DISCUSSION PURPOSES ONLY AVTX-002 (quisovalimab) Non-Eosinophilic Asthma

  11. Slide 11: Non-Eosinophilic Asthma

    11 © Copyright 2023. Avalo Therapeutics. All rights reserved. Non-Eosinophilic Asthma 1. Asthma and Allergy Foundation of America. Asthma facts and figures. https://www.aafa.org/asthma-facts/. Accessed January 3, 2022; 2. McGrath KW et al., Am J Resp Crit Care Med. 2012;185(6):612-619; 3. Jiang Y et

  12. Slide 12: Phase 2 PEAK Trial in Poorly Controlled NEA

    12 © Copyright 2023. Avalo Therapeutics. All rights reserved. Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial that Enrolled a Total of 91 Patients to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled NEA • The trial did not meet its prima

  13. Slide 13: Significant and Sustained Reduction in LIGHT Levels in PEAK Trial

    13 © Copyright 2023. Avalo Therapeutics. All rights reserved. NEA PEAK Trial: Significant and Sustained Reduction in LIGHT Levels in Patients Treated with AVTX-002 LIGHT Levels (pg/mL) Over Treatment Period AVTX-002 Placebo

  14. Slide 14: LIGHT (TNFSF14) in Asthma and Pulmonary Fibrosis

    14 © Copyright 2023. Avalo Therapeutics. All rights reserved. LIGHT (TNFSF14) in Asthma and Pulmonary Fibrosis Persistent insults: antigens toxins viruses Human Patients* • LIGHT expression in lung inflammatory cells (T and NK cells), alveolar epithelial, fibroblasts, goblet cells • LIGHT expression

  15. Slide 15: LIGHT-Signaling Network & AVTX-008 BTLA agonist fusion protein

    15 © Copyright 2023. Avalo Therapeutics. All rights reserved. LIGHT-Signaling Network & AVTX-008 BTLA agonist fusion protein

  16. Slide 16: The LIGHT-Signaling Network

    16 © Copyright 2023. Avalo Therapeutics. All rights reserved. • BTLA - B and T lymphocyte attenuator (Ig superfamily checkpoint) – Co-expressed with HVEM in T and B cells – “Dampens” the immune response • LIGHT activates HVEM – Inhibits BTLA signaling, allowing immune stimulation • LIGHT activates L

  17. Slide 17: AVTX-008 MOA: Distinct from Other Autoimmune Therapeutics

    17 © Copyright 2023. Avalo Therapeutics. All rights reserved. Activation of the BTLA inhibitory receptor by its ligand HVEM turns on SHP phosphatases* limiting lymphocyte activation and inflammatory cytokine signaling AVTX-008 MOA: Distinct from Other Autoimmune Therapeutics Ward-Kavanagh, et al., I

  18. Slide 18: AVTX-008: BTLA Agonist Fusion Protein

    18 © Copyright 2023. Avalo Therapeutics. All rights reserved. Fully human, bioengineered HVEM, specific and high-affinity agonist for BTLA Stage • Immunoregulatory disorders: potentially SLE, GVHD and non-responders to TNF inhibitors • Inhibition of inflammatory cytokine production predicts efficacy

  19. Slide 19: World Class Scientific Advisor

    19 © Copyright 2023. Avalo Therapeutics. All rights reserved. • Carl Ware, PhD, Head of Avalo Scientific Advisory Board – Director, Sanford Burnham Prebys (SBP) Infectious and Inflammatory Diseases Center – Professor, SBP Immunity and Pathogenesis Program – Director, SBP Laboratory of Molecular Immu

  20. Slide 20: Finance Update

    20 © Copyright 2023. Avalo Therapeutics. All rights reserved. Finance Update

  21. Slide 21: Financial & Investor Information

    21 © Copyright 2023. Avalo Therapeutics. All rights reserved. NASDAQ: AVTX Financial & Investor Information The following data is as of June 30, 20231 • Cash and cash equivalents – $6.3M2 • Outstanding common shares – 14M • Fully diluted shares – 21.4M3 Financial Highlights 1 Preliminary, has not be

  22. Slide 22: Experienced Management Team

    22 © Copyright 2023. Avalo Therapeutics. All rights reserved. Decades of successful leadership, product development, and commercialization in pharma and biotech Garry A. Neil, MD Chief Executive Officer Chairman of the Board Lisa Hegg, PhD SVP, Program Management, Corporate Infrastructure Colleen Ma

  23. Slide 23: Avalo Therapeutics (AVTX) Summary

    23 © Copyright 2023. Avalo Therapeutics. All rights reserved. Exclusive consulting arrangement with Carl Ware, PhD, Sanford Burnham Prebys (discoverer of the LIGHT-signaling network) AVTX-002, quisovalimab (anti-LIGHT mAb) – Positive proof of concept in COVID-19 ARDS. Positive trends in Crohn’s Dise

  24. Slide 24: Appendix

    24 © Copyright 2023. Avalo Therapeutics. All rights reserved. Appendix

  25. Slide 25: AVTX-002 (quisovalimab)

    25 © Copyright 2023. Avalo Therapeutics. All rights reserved. FOR DISCUSSION PURPOSES ONLY AVTX-002 (quisovalimab)

  26. Slide 26: PEAK Trial Design and Endpoints

    26 © Copyright 2023. Avalo Therapeutics. All rights reserved. Key Secondary/Exploratory EndpointsPrimary Endpoint Final Enrollment (n=91) • Proportion of patients who experience an asthma related event defined as:  ≥6 additional reliever puffs of SABAʈ (compared to baseline) in a 24-hour period on

  27. Slide 27: Efficacy Signal Observed in Crohn's Disease Phase 1b Trial

    27 © Copyright 2023. Avalo Therapeutics. All rights reserved. Phase 1b Escalating Dose, Open-Label, Signal-Finding Trial to Evaluate the Safety, Tolerability, and Short-Term Efficacy of the Anti-Light Monoclonal Antibody AVTX-002 in Adults with Moderate to Severe Active Crohn’s Disease (CD) who have

  28. Slide 28: AVTX-002 Crohn's Disease Phase 1b Trial Design

    28 © Copyright 2023. Avalo Therapeutics. All rights reserved. AVTX-002 Crohn’s Disease Phase 1b, Proof of Concept Trial Design * SES-CD, Simple Endoscopic Score for Crohn’s Disease; † CDAI, Crohn’s Disease Activity Index; ‡ IBDQ, Inflammatory Bowel Disease Questionnaire; Screening (Visit 1) Open-Lab

  29. Slide 29: TNF SuperFamily: Proven Target-rich Opportunities

    29 © Copyright 2023. Avalo Therapeutics. All rights reserved. TNF SuperFamily: Proven Target-rich Opportunities TNF inhibitors (Autoimmune) Humira Cimzia Remicade Simponi ENBREL LIGHT inhibitor AVTX-002 TL1A inhibitors PRA023 PF-06480605 HVEM mimetics - BTLA agonists: AVTX-008, LY3361237, MB272, ANB

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