Avalo Therapeutics, Inc. · NASDAQ:AVTX
Avalo Therapeutics — Investor Presentation (November 2024)
26 slides from Avalo Therapeutics's investor presentation, Nov 12, 2024
Slide 1: November 2024 Corporate Presentation
November 2024 Corporate Presentation Avalo Therapeutics, Inc. (AVTX) EXHIBIT 99.2
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
Slide 3: Executive Summary
Executive Summary IL, interleukin; IND, investigational new drug application; mAB, monoclonal antibody; MOA, mechanism of action. 3 AVTX-009 (anti-IL-1β mAb) has the potential for a best-in-disease profile in hidradenitis suppurativa (HS) with: • Clinically validated and derisked MOA • Highly potent
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
Slide 5: IL-1β Is Increasingly Recognized as a Master Regulator of Inflammation
IL-1β Is Increasingly Recognized as a Master Regulator of Inflammation • IL-1β is a central driver of the inflammatory process1 and activates immune cells that generate proinflammatory cytokines including: – IL-6 – TNF-α – IL-17 • IL-1β is involved in the pathogenesis of many autoimmune and autoinfl
Slide 6: AVTX-009 Is a Highly Potent and Specific Inhibitor of IL-1β
AVTX-009 Is a Highly Potent and Specific Inhibitor of IL-1β IL, interleukin; IV, intravenous; KD, dissociation constant; Q4W, every 4 weeks; SC, subcutaneous. 1. 2. 3. Chakraborty A, et al. Clin Pharmacokinet. 2012;51(6):e1-e18; 4. Data on file; 5. NCT04983732. Clinicaltrials.gov. Accessed September
Slide 7: AVTX-009 Has High Affinity, High Bioavailability, and Long Half-Life
AVTX-009 Has High Affinity, High Bioavailability, and Long Half-Life 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. AAPS J. 2014;16(5):1009-1017. 7 IL-1β KD (pM) 44 <3 Subc
Slide 8: Hidradenitis Suppurativa (HS)
8 Hidradenitis Suppurativa (HS)
Slide 9: Hidradenitis Suppurativa: a Chronic Disease with a High Unmet Need
Hidradenitis Suppurativa: a Chronic Disease with a High Unmet Need HS, hidradenitis suppurativa. 1. Ingram JR, et al. J Eur Acad Dermatol Venereol. 2022;36(9):1597-1605. 9 • Hidradenitis suppurativa is a chronic, often debilitating inflammatory skin disease that causes painful lumps, abscesses, and
Slide 10: HS Causes Severe Pain and High Patient Burden
HS Causes Severe Pain and High Patient Burden Photo from Cotter C, Walsh S. Skin Health and Disease. 2021;1(1):e7. CC-BY-4.0 License. HS, hidradenitis suppurativa; IL, interleukin. 1. Johnston L, et al. J Cutaneous Med Surg. 2023;27(5):487-492; 2. Ingram JR, et al. J Eur Acad Dermatol Venereol. 2022
Slide 11: Chronic Inflammation in Hidradenitis Suppurativa Progresses to Tissue Destruction
Chronic Inflammation in Hidradenitis Suppurativa Progresses to Tissue Destruction 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, e
Slide 12: Diagnosed and Treated HS Population Projected to Grow into a $9.5B+ Market by 2035
Overall HS prevalence2 HS diagnosed and treated3 Moderate- to-severe HS4 Receiving biologics5 Diagnosed and Treated HS Population is Projected to Grow Substantially into a $9.5B+ Market by 20351 aHS diagnosis and treatment rates and biologic treatment rates are expected to increase over time. CAGR,
Slide 13: IL-1β is Strongly Implicated in the Pathophysiology of HS
IL-1β is Strongly Implicated in the Pathophysiology of HS1 • The inflammatory cascade in HS is triggered by various external stimuli including: – Smoking – Dysbiosis – Mechanical stress • IL-1β is a key driver of the inflammatory cascade that leads to the destruction of the pilosebaceous unit • HS p
Slide 14: HS Patients Often Have Other Comorbidities That Could Impact Treatment
Hidradenitis Suppurativa Patients Often Have Other Comorbidities That Could Impact Treatment 1. Chen WT, Chi CC. JAMA Dermatol. 2019;155(9):1022-1027; 2. 4. Garg A et al. Am J Clin Dermatol. 2023; 24: 977–990; 5. Rinderknecht F-AB, Naik HB. Int J Womens Dermatol. 2024;10(1): e130. Krajewski PK, et a
Slide 15: Warnings and Precautions in Commonly Used Immunologic Drugs
Warnings and Precautions in Commonly Used Immunologic Drugs HS, hidradenitis suppurativa; IBD, inflammatory bowel disease; IL, interleukin; JAK1, janus kinase 1; MOA, mechanism of action; TNF, tumor necrosis factor. 1. Rinvoq. Package insert. AbbVie Inc.; 2024; 2. Humira. Package insert. AbbVie Inc.
Slide 16: Previous Clinical Trials Validate and Derisk Our MOA
Previous Clinical Trials Validate and Derisk Our MOA HiSCR, hidradenitis suppurativa clinical response; IL, interleukin; JAK1, janus kinase 1; MOA, mechanism of action, TNF, tumor necrosis factor; wk, week; QD, daily; QW, weekly, Q2W, every other week; Q4W, ever 4 weeks. 1. Kirby JS, et al. JAAD. 20
Slide 17: Phase 2 LOTUS Trial Design: Endpoints and Inclusion Criteria
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 18: Timelines: Looking Forward
Timelines: Looking Forward aProjected; bPending readout from phase 2. IND, investigational new drug application. 18 2026 LOTUS (Ph 2) readouta 2027+ Initiate Ph 2b/3b 2H 2025 Final site activated for LOTUSa 2H 2024 First patient enrolled in phase 2 LOTUS (Ph 2) March 2024 Merger with AlmataBio July
Slide 19: Potential Additional Indications
19 Potential Additional Indications
Slide 20: Role of IL-1β in IBD
Role of IL-1β in IBD • IL-1β plays a central role in inflammation in IBD1 – IL-1β is a key cytokine produced upon inflammasome activation – Dysregulated inflammasome activation has been implicated in the pathogenesis of Crohn’s disease • IL-1–driven stromal–neutrophil interactions define a subset of
Slide 21: Recent IL-1 Trial Initiations in IBD
Recent IL-1 Trial Initiations in IBD • The goal of IBD therapeutics is remission, yet only a minority of IBD patients obtain remission with current therapies • AbbVie is currently conducting studies to evaluate lutikizumab, a dual variable domain IL-1α/1β antagonist as monotherapy in ulcerative coli
Slide 22: Executive Summary
Executive Summary AVAIO THERAPEUTEES
Slide 23: Executive Summary
Executive Summary IL, interleukin; IND, investigational new drug application; mAB, monoclonal antibody; MOA, mechanism of action. 23 AVTX-009 (anti-IL-1β mAb) has the potential for a best-in-disease profile in hidradenitis suppurativa (HS) with: • Clinically validated and derisked MOA • Highly poten
Slide 24: www.avalotx.com
24 NASDAQ: AVTX www.avalotx.com
Slide 25: Appendix
Appendix AVAIO THERAPEUTEES
Slide 26: 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 38M26 As of November 8, 2024 Number of shares • Common shares outstanding1
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