Avalo Therapeutics, Inc.

(AVTX)

Corporate Presentation

September 2023

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 uncertainties that are subject to change based on various factors (many of which are beyond the control of Avalo Therapeutics, Inc. ("Avalo" or the "Company")), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Avalo's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "might," "will," "could," "would," "should," "continue," "seeks," "aims," "predicts," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential," or similar expressions (including their use in the negative), or by discussions of future matters such as: the future financial and operational outlook of the Company; the development of product candidates or products; timing and success of trial results and regulatory review; potential attributes and benefits of product candidates; business strategies; and other statements that are not historical.

These statements are based upon the current beliefs and expectations of Avalo's management but are subject to significant risks and uncertainties, including: Avalo's debt and cash position and the potential need for it to raise additional capital; drug development costs, timing of trial results and other risks, including reliance on investigators and enrollment of patients in clinical trials, which might be slowed by the COVID-19 pandemic or other national or global health emergencies; reliance on key personnel; regulatory risks; general economic and market risks and uncertainties, including those caused by the COVID-19 pandemic and the war in Ukraine; and those other risks detailed in Avalo's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Avalo expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Avalo's expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

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Avalo Therapeutics (AVTX)

  • Portfolio emphasizing potential high value, first-in-class biologics focused on dysregulated inflammation via the LIGHT-signaling network
  • AVTX-002,quisovalimab (anti-LIGHT mAb) - Positive proof of concept in COVID-19 ARDS. Positive trends in Crohn's Disease and NEA sub-population.
  • AVTX-008(BTLA agonist fusion protein) - IND enabling stage
  • Exclusive consulting arrangement with Carl Ware, PhD, Sanford Burnham Prebys (discoverer of the LIGHT-signaling network) and Head of Avalo SAB
  • Near term catalysts, subject to funding: 1) Initiate quisovalimab Phase 2 POC placebo- controlled trial in UC and 2) File IND for AVTX-008

BTLA; B and T Lymphocyte Attenuator; COVID-19ARDS, SARS-COV2 associated acute respiratory distress syndrome (ARDS); IND; investigational new drug; LIGHT, Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprotein D for HVEM, a receptor expressed by T lymphocytes; mAb, monoclonal antibody; NEA, non-eosinophilic asthma; POC, Proof of concept studies; SAB, Scientific Advisory Board; UC, ulcerative colitis

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AVTX-002 (quisovalimab): First-in-Class Neutralizing Anti-LIGHT mAb

  • Fully human monoclonal antibody to LIGHT
  • CMC at 2,000 L scale; 6-month toxicology completed
  • Positive proof of concept in COVID-19ARDS
  • Positive Phase 2 trends:
    • Crohn's Disease
    • NEA in sub-population of patients with elevated baseline LIGHT levels
  • Strong preclinical and clinical rationale to support UC as next indication

CMC, Chemistry, manufacturing and control

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© Copyright 2023. Avalo Therapeutics. All rights reserved.

TNF SuperFamily of Ligands (TNFSF) and Receptors (TNFRSF)

Inflammation, Immunoregulation and Homeostasis

Ligands

LIGHT is a member of a select group of key immunomodulator cytokines (TL1A, FasL) that are "regulated" by Decoy Receptor 3 (DcR3)

DcR3 loss of function has been associated with autoimmune diseases including Crohn's disease

Receptors

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, 308-343.

Cardinale CJ, et al.,Targeted resequencing identifies defective variants of decoy receptor 3 in pediatric-onset inflammatory bowel disease. Genes Immun. 2013 Oct;14(7):447-52. doi: 10.1038/gene.2013.43. Epub 2013 Aug 22.

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© Copyright 2023. Avalo Therapeutics. All rights reserved.

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Avalo Therapeutics Inc. published this content on 07 September 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 11 September 2023 11:24:06 UTC.