Avalo Therapeutics, Inc. · NASDAQ:AVTX
Avalo Therapeutics — Investor Presentation (August 2022)
26 slides from Avalo Therapeutics's investor presentation, Aug 16, 2022
Slide 1: Avalo Therapeutics August 2022 Corporate Presentation
1 © Copyright 2022. Avalo Therapeutics. All rights reserved. FOR DISCUSSION PURPOSES ONLY Avalo Therapeutics, Inc. August 2022 Corporate Presentation (AVTX) EX-99.1
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: Avalo Therapeutics (AVTX) highlights
3 © Copyright 2022. Avalo Therapeutics. All rights reserved. Exclusive consulting arrangement with Carl Ware, Ph.D., Sanford Burnham Prebys Medical Discovery Institute (discoverer of the LIGHT-signaling network) LIGHT, Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprote
Slide 4: Pipeline programs
4 © Copyright 2022. Avalo Therapeutics. All rights reserved. * The Company will assess the next stage of development for these indications as well as potentially others, upon or close to, data readout of the NEA trial. ARDS, acute respiratory distress syndrome; BTLA, B and T lymphocyte attenuator, I
Slide 5: AVTX-002 (Anti-LIGHT mAb)
5 © Copyright 2022. Avalo Therapeutics. All rights reserved. AVTX-002 (Anti-LIGHT mAb)
Slide 6: LIGHT is a Key Driver of Acute & Chronic Inflammation
6 © Copyright 2022. Avalo Therapeutics. All rights reserved. 1. 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
Slide 7: AVTX-002: First-in-class neutralizing anti-LIGHT mAb
7 © Copyright 2022. Avalo Therapeutics. All rights reserved. • Fully human monoclonal antibody to LIGHT • CMC at 2,000 L scale; 6-month tox study near completion • POC in 2 indications: COVID-19 ARDS & Crohn’s Disease • Currently in phase 2 for non-eosinophilic asthma • Additional indications in imm
Slide 8: POC demonstrated in Phase II COVID-19 ARDS study
8 © Copyright 2022. Avalo Therapeutics. All rights reserved. • Demonstrated target engagement: 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 • Gr
Slide 9: Significant Reduction in COVID-19 Induced Respiratory Failure and Mortality
9 © Copyright 2022. 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 (2021) doi:10.1172/jci153173. LIGHT Levels (pg/mL) Over Treatment Period
Slide 10: AVTX-002 Non-Eosinophilic Asthma (NEA)
10 © Copyright 2022. Avalo Therapeutics. All rights reserved. FOR DISCUSSION PURPOSES ONLY AVTX-002 Non-Eosinophilic Asthma (NEA)
Slide 11: Non-Eosinophilic Asthma (NEA)
11 © 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 12: PEAK Trial design
12 © Copyright 2022. Avalo Therapeutics. All rights reserved. Key Secondary/Exploratory EndpointsPrimary Endpoint Estimated Enrollment (n=80) • Proportion of patients who experience an exacerbation of asthma defined as: ≥6 additional reliever puffs of SABAʈ (compared to baseline) in a 24-hour peri
Slide 13: LIGHT Signaling Network & AVTX-008 (BTLA agonist fusion protein)
13 © Copyright 2022. Avalo Therapeutics. All rights reserved. LIGHT Signaling Network & AVTX-008 (BTLA agonist fusion protein)
Slide 14: The LIGHT Signaling Network
14 © Copyright 2022. 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
Slide 15: AVTX-008 MOA is distinct from other autoimmune therapeutics
15 © Copyright 2022. Avalo Therapeutics. All rights reserved. SHP1/2 Inhibitory Signaling Lymphocyte Activation • Eliminates effector cells that mediate chronic autoimmune disease • Activation of the BTLA inhibitory receptor by its ligand HVEM turns on SHP phosphatases limiting lymphocyte activation
Slide 16: AVTX-008: BTLA Agonist Fusion Protein
16 © Copyright 2022. Avalo Therapeutics. All rights reserved. • Bioengineered HVEM fusion protein • Specific and high affinity agonist for BTLA • Fully human • IND expected 2024 • Target indications: immune dysregulation, SLE, GVHD SLE, Systemic lupus erythematosus; GVHD, Graft versus host disease A
Slide 17: Executive Summary, AVTX-008
17 © Copyright 2022. Avalo Therapeutics. All rights reserved. Molecule AVTX-008 Bioengineered HVEM, specific and high affinity agonist for BTLA B and T lymphocyte attenuator, an immune checkpoint MOA • Novel mechanism of action • Inhibits lymphocyte activation and effector cells through BTLA Unmet N
Slide 18: World Class Scientific Advisor
18 © Copyright 2022. Avalo Therapeutics. All rights reserved. • Carl Ware, PhD, Head Avalo SAB • Director, infectious and Inflammatory Disease Center • Professor, Immunity and Pathogenesis Program • Directory, Laboratory of Molecular Immunology • Discoverer of LIGHT signaling network SAB, Scientific
Slide 19: Finance Update
19 © Copyright 2022. Avalo Therapeutics. All rights reserved. Finance Update
Slide 20: Financial & Investor Information
20 © Copyright 2022. Avalo Therapeutics. All rights reserved. NASDAQ: AVTX Financial & Investor Information The following data is as of June 30, 2022: • Cash – $11.2M; subsequently received approximately $15M in August related to the transfer of AVTX-007 to Apollo Therapeutics • Outstanding common s
Slide 21: Experienced Management Team
21 © Copyright 2022. Avalo Therapeutics. All rights reserved. Decades of successful leadership, product development, commercialization in pharma and biotech Garry A. Neil, MD President, Chief Executive Officer Lisa Hegg, PhD SVP, Program Management and Corporate Infrastructure Colleen Matkowski SVP,
Slide 22: Avalo Therapeutics (AVTX) summary
22 © Copyright 2022. Avalo Therapeutics. All rights reserved. AVTX-002 (anti-LIGHT mAb) POC completed in COVID-19 ARDS and IBD; Non-Eosinophilic Asthma PEAK trial underway – Phase 2 topline data 1H23 Exclusive consulting arrangement with Carl Ware, Ph.D., Sanford Burnham Prebys Medical Discovery Ins
Slide 23: Appendix
23 © Copyright 2022. Avalo Therapeutics. All rights reserved. Appendix
Slide 24: AVTX-803 Leukocyte Adhesion Deficiency Type II
24 © Copyright 2022. Avalo Therapeutics. All rights reserved. AVTX-803 Leukocyte Adhesion Deficiency Type II (LAD II, also known as SLC35C1-CDG)
Slide 25: LAD II (SLC35C1-CDG) Pathophysiology
25 © Copyright 2022. Avalo Therapeutics. All rights reserved. LAD II (SLC35C1-CDG) 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 in the inability to fucosylate certain critical proteins • Ab
Slide 26: AVTX-803 for LAD II: Pivotal Trial Design
26 © Copyright 2022. Avalo Therapeutics. All rights reserved. Key Secondary/Exploratory EndpointsPrimary Endpoint Estimated Enrollment (n=2) *100-340 mg/kg up to 5x/d based on clinical response • Restoration of sialyl Lewis X biomarker • Leukocyte function assay • Neutrophil counts • Known SLC35C1 m
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