Avalo Therapeutics, Inc. · NASDAQ:AVTX
Avalo Therapeutics — Investor Presentation (May 2025)
24 slides from Avalo Therapeutics's investor presentation, May 8, 2025
Slide 1: May 2025 Corporate Presentation
May 2025 Corporate Presentation Avalo Therapeutics, Inc. (AVTX) Exhibit 99.1
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
Slide 3: Developing Targeted Therapies for Immune Mediated Inflammatory Diseases
Avalo Therapeutics: Developing Targeted Therapies for Immune Mediated Inflammatory Diseases 3 Lead compound: AVTX-009 (anti-IL-1β mAb) has the potential for "best-in- disease" profile in hidradenitis suppurativa (HS) • Abbvie’s lutikizumab (IL-1α/β) demonstrated comparable efficacy to market leaders
Slide 4: Avalo Management Team
A proven track record of successful leadership, product development, and commercialization in pharma and biotech Avalo Management Team 200+ Years of Experience in Biotech/Pharma 4 Lisa Hegg, PhD SVP, Program Management, Business Development & Corporate Infrastructure Colleen Matkowski SVP, Global Re
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
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
Slide 7: AVTX-009 Opportunity in Hidradenitis Suppurativa (HS)
7 AVTX-009 Opportunity in Hidradenitis Suppurativa (HS)
Slide 8: Chronic Inflammation in HS 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,
Slide 9: Large Unmet Need in HS with Majority of Patients Failing to Respond
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 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% General pain/discomfort Restricted/painful movement Pain on sitting Malodorous drainage Low mood/depression Pr op or tio n of p a
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
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 *NS, not statistically significant HiSCR, hidradenitis suppurativa clinical response; IL, interleukin; JAK1, j
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
Slide 13: IL-1β is the Predominant Isoform Driving 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
Slide 14: AVTX-009 High Affinity and Specificity in Tissue Distribution
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 Pharmaceuticals Corporation; 2024; 4. Witte-Händel E, et al. J Invest Dermatol. 2019;139:1294-1305. IL-1β b
Slide 15: Phase 2 LOTUS Trial Design
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
Slide 16: Diagnosed and Treated HS Population Projected to Grow into $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,
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 pivotal programb 2H 2024 First patient enrolled in phase 2 LOTUS March 2024 Merger with AlmataBio July 2024 Active IND for AVTX-009
Slide 18: Broad Potential for Indication Expansion
18 Broad Potential for Indication Expansion
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; CV, cardiovascular; DIRA, deficiency of interleukin receptor 1 antagonist; HS, h
Slide 20: Executive Summary
Executive Summary AVAIO THERAPEUTEES
Slide 21: Developing Targeted Therapies for Immune Mediated Inflammatory Diseases
Avalo Therapeutics: Developing Targeted Therapies for Immune Mediated Inflammatory Diseases 21 Lead compound: AVTX-009 (anti-IL-1β mAb) has the potential for "best-in- disease" profile in hidradenitis suppurativa (HS) • Abbvie’s lutikizumab (IL-1α/β) demonstrated comparable efficacy to market leader
Slide 22: www.avalotx.com
22 NASDAQ: AVTX www.avalotx.com
Slide 23: Appendix
Appendix AVAIO THERAPEUTEES
Slide 24: Avalo Capitalization and Cash Position
Avalo Capitalization and Cash Position 1Does not include 4.3M stock options and restricted stock units outstanding resulting in a fully dilutive share count of 39.8M, 2Cash, common shares outstanding and preferred shares outstanding as of March 31, 2025 are preliminary, unaudited and subject to chan
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