Avalo Therapeutics, Inc. · NASDAQ:AVTX
Avalo Therapeutics — Investor Presentation (March 2022)
22 slides from Avalo Therapeutics's investor presentation, Mar 16, 2022
Slide 1: March 2022 Corporate Presentation
1 © Copyright 2022. Avalo Therapeutics. All rights reserved. Avalo is a leading clinical-stage biopharmaceutical company that employs a precision medicine approach to discover, develop, and commercialize highly targeted therapeutics in areas of significant unmet clinical need. Innovation Driven by C
Slide 2: Forward-Looking Statements
2 © Copyright 2022. 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
Slide 3: Experienced Management Team
3 © Copyright 2022. Avalo Therapeutics. All rights reserved. Experienced Management Team Decades of successful leadership, product development, commercialization in pharma and biotech *Presenter Garry A. Neil, MD President, Chief Executive Officer* Lisa Hegg, PhD SVP, Program Management and Corporat
Slide 4: Avalo Therapeutics (AVTX)
4 © Copyright 2022. Avalo Therapeutics. All rights reserved. Avalo Therapeutics (AVTX) 1POC: Proof of Concept studies; 2COVID-19 ARDS: SARS-COV2 associated acute respiratory distress syndrome (ARDS), program also has Fast Track designation from FDA 3RPDD: Rare pediatric disease designation ; 4CDG: C
Slide 5: AVTX 2022 Corporate Highlights
5 © Copyright 2022. Avalo Therapeutics. All rights reserved. New management team: Experienced experts who know the pipeline and people Drive value for shareholders: allocate capital to most promising programs: – Focus on highest value indications for promising novel biologics: AVTX-002 and AVTX-007
Slide 6: Clinical-Stage Pipeline
6 © Copyright 2022. Avalo Therapeutics. All rights reserved. Clinical-Stage Pipeline * The Company is considering a possible randomized, double-blind, placebo-controlled clinical trial in moderate to severe refractory patients with IBD ** Further development of AVTX-002 for treatment of COVID-19 ARD
Slide 7: AVTX-002 Anti-LIGHT mAb
7 © Copyright 2022. Avalo Therapeutics. All rights reserved. AVTX-002 Anti-LIGHT mAb
Slide 8: AVTX-002: First-in-class anti-LIGHT (TNFSF14) mAb
8 © Copyright 2022. Avalo Therapeutics. All rights reserved. • Fully human monoclonal antibody (mAb) to LIGHT • POC in 2 indications: COVID-19 ARDS & IBD1 • Currently in phase 2 for non-eosinophilic asthma (NEA) AVTX-002: First-in-class anti-LIGHT (TNFSF14) mAb *Worldwide rights licensed from Kyowa
Slide 9: LIGHT is a Key Driver of Acute & Chronic Inflammation
9 © Copyright 2022. Avalo Therapeutics. All rights reserved. LIGHT is a Key Driver of Acute & Chronic Inflammation • LIGHT/TNFSF14 is an immunoregulatory cytokine • Critical for neutrophil, NK, T and B cell function • 2 primary receptors: LTβR, HVEM receptors • Pivotal role in lung, GI tract, & othe
Slide 10: AVTX-002 Significantly Reduced Respiratory Failure and Mortality in Phase 2 POC COVID-19 ARDS Study
10 © Copyright 2022. Avalo Therapeutics. All rights reserved. AVTX-002 Significantly Reduced Respiratory Failure and Mortality in Phase 2 POC COVID-19 ARDS Study Perlin, D. S. et al. Randomized, double-blind, controlled trial of human anti-LIGHT monoclonal antibody in COVID-19 acute respiratory dist
Slide 11: AVTX-002 POC in COVID-19 ARDS
11 © Copyright 2022. Avalo Therapeutics. All rights reserved. • A single dose rapidly reduced serum free-LIGHT levels by ⋍ 85%1 • Well-tolerated; no increase in serious adverse events vsplacebo • Evidence of clinically important anti-inflammatory effect in the lung • Granted Fast Track designation b
Slide 12: AVTX-002 for Non-Eosinophilic Asthma (NEA)
12 © Copyright 2022. Avalo Therapeutics. All rights reserved. FOR DISCUSSION PURPOSES ONLY AVTX-002 for Non-Eosinophilic Asthma (NEA) New Indication
Slide 13: Non-Eosinophilic Asthma (NEA)
13 © Copyright 2022. Avalo Therapeutics. All rights reserved. Non-Eosinophilic Asthma (NEA) 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
Slide 14: AVTX-002 for NEA: Trial Design
14 © Copyright 2022. Avalo Therapeutics. All rights reserved. Key Secondary / Exploratory EndpointsPrimary Endpoint Estimated Enrollment: N=80 AVTX-002 8 mg/kg (max 600 mg) q4wks (n=40) AVTX-002 for NEA: Trial Design *LABA, long-acting beta-agonist; †ICS, inhaled corticosteroid; ‡FEV1, forced expira
Slide 15: Efficacy signal observed in Crohn's disease phase 1B study
15 © Copyright 2022. Avalo Therapeutics. All rights reserved. • Open-label uncontrolled study in patients with moderate - severe Crohn’s disease who previously failed anti-TNFα mAb1 and other biologics • Rapid reduction in serum free LIGHT levels • Well-tolerated: no drug-related serious adverse eve
Slide 16: Congenital Disorders of Glycosylation (CDGs) AVTX-803
16 © Copyright 2022. Avalo Therapeutics. All rights reserved. Congenital Disorders of Glycosylation (CDGs) AVTX-803
Slide 17: AVTX-803: Leukocyte Adhesion Disorders (LAD-II)
17 © Copyright 2022. Avalo Therapeutics. All rights reserved. AVTX-803: Leukocyte Adhesion Disorders (LAD-II) LAD-II (SLC35C1-CGD) Pathophysiology LAD Type II: Absence of Sialyl Lewis X of E-selectin (SLC35C1 mutation) • Type II (LAD-II) caused by LOF mutation in SLC35C1 gene resulting Inability to
Slide 18: AVTX-803 (L-fucose) for Treatment of LAD II (SLC35C1-CDG)
18 © Copyright 2022. Avalo Therapeutics. All rights reserved. Key Secondary / Exploratory EndpointsPrimary Endpoint AVTX-803 (L-fucose) for Treatment of LAD II (SLC35C1-CDG) *100-300 mg/kg up to 5x/d based on clinical response • Restoration of sialyl Lewis X biomarker • Leukocyte function assay • Ne
Slide 19: Clinical-Stage Pipeline
19 © Copyright 2022. Avalo Therapeutics. All rights reserved. Clinical-Stage Pipeline * The Company is considering a possible randomized, double-blind, placebo-controlled clinical trial in moderate to severe refractory patients with IBD ** Further development of AVTX-002 for treatment of COVID-19 AR
Slide 20: Finance Update
20 © Copyright 2022. Avalo Therapeutics. All rights reserved. Finance Update
Slide 21: Financial & Investor Information
21 © Copyright 2022. Avalo Therapeutics. All rights reserved. NASDAQ: AVTX Financial & Investor Information The following data is as of December 31, 2021 • Cash – $54.6M* • Outstanding common shares – 112.8M • Fully diluted shares – 132M • Average daily trading volume – 0.5M Key Financial Highlights
Slide 22: 2022: A Transformational Year for AVTX
22 © Copyright 2022. Avalo Therapeutics. All rights reserved. New Management Team and Pipeline Focus Multiple Meaningful Clinical Catalysts • AVTX-002 NEA data from 80-patient Phase 2 trial in 4Q22 • AVTX-803 LAD II (SLC35C1-CDG) pivotal data 4Q22 • AVTX-801 pivotal study initiation 2022 New Busines
Avalo Therapeutics — Investor Presentation (March 2022) on 6ix