Avalo Therapeutics, Inc. · NASDAQ:AVTX
Avalo Therapeutics — Investor Presentation (September 2023)
26 slides from Avalo Therapeutics's investor presentation, Sep 11, 2023
Slide 1: Avalo Therapeutics, Inc. September 2023 Corporate Presentation
1 © Copyright 2023. Avalo Therapeutics. All rights reserved. FOR DISCUSSION PURPOSES ONLY Avalo Therapeutics, Inc. September 2023 Corporate Presentation (AVTX) Exhibit 99.1
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
Slide 3: Avalo Therapeutics (AVTX) overview and near-term catalysts
3 © Copyright 2023. Avalo Therapeutics. All rights reserved. Exclusive consulting arrangement with Carl Ware, PhD, Sanford Burnham Prebys (discoverer of the LIGHT-signaling network) and Head of Avalo SAB BTLA; B and T Lymphocyte Attenuator; COVID-19 ARDS, SARS-COV2 associated acute respiratory distr
Slide 4: AVTX-002 (quisovalimab): First-in-Class Neutralizing Anti-LIGHT mAb
4 © Copyright 2023. Avalo Therapeutics. All rights reserved. • Fully human monoclonal antibody to LIGHT • CMC at 2,000 L scale; 6-month toxicology completed • Positive proof of concept in COVID-19 ARDS • Positive Phase 2 trends: – Crohn’s Disease – NEA in sub-population of patients with elevated bas
Slide 5: TNF SuperFamily of Ligands and Receptors
5 © 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
Slide 6: LIGHT in IBD
6 © Copyright 2023. Avalo Therapeutics. All rights reserved. LIGHT in IBD There are multiple lines of evidence regarding the involvement of LIGHT in IBD • Animal models of IBD demonstrate: – LIGHT overexpression leads to intestinal inflammation1 – Anti-LIGHT treatment amelioration of inflammation2 •
Slide 7: LIGHT in IBD: Patient and Biomarker Data
7 © Copyright 2023. Avalo Therapeutics. All rights reserved. LIGHT in IBD: Patient and Biomarker Data doi: 10.4049/jimmunol.2200652 Serum free LIGHT is higher in pediatric CD compared to healthy controls Single center, non-interventional biomarker study Elevated mRNA levels of LIGHT were detected in
Slide 8: quisovalimab: Phase 1b Study in Crohn's Disease
8 © Copyright 2023. Avalo Therapeutics. All rights reserved. quisovalimab: Phase 1b Study in Crohn’s Disease
Slide 9: quisovalimab Crohn's Disease Proof-of-Concept
9 © Copyright 2023. Avalo Therapeutics. All rights reserved. quisovalimab Crohn’s Disease Proof-of-Concept CDAI, Crohn’s Disease Activity Index; IBDQ, Inflammatory Bowel Disease Questionnaire; SES-CD, Simple Endoscopic Score for Crohn’s disease. Screening (Visit 1) Open-Label Treatment Period (Visit
Slide 10: Efficacy Signal Observed in Crohn's Disease Phase 1b POC Trial
10 © Copyright 2023. 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 11: quisovalimab: Proposed UC POC Trial
11 © Copyright 2023. Avalo Therapeutics. All rights reserved. quisovalimab: Proposed UC POC Trial
Slide 12: Proposed Phase 2 Trial in Ulcerative Colitis
12 © Copyright 2023. Avalo Therapeutics. All rights reserved. Key Secondary/Exploratory EndpointsPrimary Endpoint CLINICAL REMISSION: • The proportion of subjects in the 3-component Modified Mayo Score clinical remission (as defined by endoscopic subscore of 0 or 1, rectal bleeding subscore of 0, an
Slide 13: quisovalimab Other Recent Clinical Trials
13 © Copyright 2023. Avalo Therapeutics. All rights reserved. quisovalimab Other Recent Clinical Trials
Slide 14: COVID-19 ARDS Trial Results
14 © 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 Perce
Slide 15: NEA PEAK Trial: Reduction in LIGHT Levels
15 © Copyright 2023. Avalo Therapeutics. All rights reserved. NEA PEAK Trial: Significant and Sustained Reduction in LIGHT Levels in Patients Treated with quisovalimab LIGHT Levels (pg/mL) Over Treatment Period AVTX-002, quisovalimab Placebo Data on file
Slide 16: NEA PEAK Phase 2 Trial Results
16 © 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
Slide 17: LIGHT-Signaling Network & AVTX-008 BTLA agonist fusion protein
17 © Copyright 2023. Avalo Therapeutics. All rights reserved. LIGHT-Signaling Network & AVTX-008 BTLA agonist fusion protein
Slide 18: The LIGHT-Signaling Network
18 © 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
Slide 19: AVTX-008: BTLA Agonist Fusion Protein
19 © 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
Slide 20: Avalo Therapeutics (AVTX) summary and near-term catalysts
20 © Copyright 2023. Avalo Therapeutics. All rights reserved. Exclusive consulting arrangement with Carl Ware, PhD, Sanford Burnham Prebys (discoverer of the LIGHT-signaling network) and Head of Avalo SAB AVTX-002, quisovalimab (anti-LIGHT mAb) – Positive proof of concept in COVID-19 ARDS. Positive
Slide 21: Appendix
21 © Copyright 2023. Avalo Therapeutics. All rights reserved. Appendix
Slide 22: Financial & Investor Information
22 © Copyright 2023. Avalo Therapeutics. All rights reserved. NASDAQ: AVTX Financial & Investor Information The following data is as of June 30, 2023 • Cash and cash equivalents – $6.3M1 • Outstanding common shares – 14M • Fully diluted shares – 21.4M2 1 Reflects $6M prepayment of principal on the C
Slide 23: Experienced Management Team
23 © 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
Slide 24: World Class Scientific Advisor
24 © 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
Slide 25: quisovalimab Treatment of COVID-19 ARDS: POC Trial Design
25 © Copyright 2023. Avalo Therapeutics. All rights reserved. quisovalimab Treatment of COVID-19 ARDS: POC Trial Design 1:1 Randomization AVTX-002 (16 mg/kg [maximum 1200 mg]) on Day 1 by SQ injection + Standard of Care at the site Placebo-matched SQ injection + Standard of Care at the site Hospital
Slide 26: NEA 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
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