Avalo Therapeutics, Inc. · NASDAQ:AVTX
Avalo Therapeutics — Investor Presentation (June 2024)
25 slides from Avalo Therapeutics's investor presentation, Jun 24, 2024
Slide 1: Avalo Therapeutics Corporate Presentation June 2024
1 Avalo Therapeutics, Inc. (AVTX) Corporate Presentation June 2024 Exhibit 99.1
Slide 2: Forward-Looking Statements
2 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 subj
Slide 3: Avalo Therapeutics & AlmataBio: A Strong Strategic Fit to Drive Long-Term Growth
3 Experienced team with a proven track record of late-stage immunology development NASDAQ Listed: AVTX Private company largely consisting of Phase 2-ready Anti-IL-1βmAb and related assets De-risked MOA in target indications AlmataBio, Inc. Leader in biologics to treat inflammation with a focus on AV
Slide 4: Avalo Therapeutics Pipeline
4 Anticipated MilestonesP3P2P1PreClinIndicationCompound P2 Topline Results 2026Hidradenitis suppurativa (HS) AVTX-009 Anti-IL-1 mAb TBDAutoimmune Indication TBD TBD--Next Generation IL-1 (extended half-life) Under strategic review--Quisovalimab AVTX-002, Anti-LIGHT mAb Under strategic review--AVT
Slide 5: Investment highlights: AVTX-009 in HS
5 • Potential for a Best-in-Disease Profile in HS – High potency and favorable half-life may allow for improved efficacy and convenient dosing – Potential in other autoimmune diseases • Key Clinical Evidence Supporting IL-1 in HS – In a large, well controlled Phase 2 trial (NCT05139602), lutikizuma
Slide 6: Experienced Management Team
6 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, Clinical Operations Colleen Matkowski SVP, Global Regulatory Affairs,
Slide 7: AVTX-009 Highly Potent and Specific Inhibitor of a Validated Immune Target
7 • High-affinity humanized antibody that potently neutralizes IL-1 – Originally developed by Lilly – Exceptional Kd of <3 pM (picomolar) Superior potency vs ILARIS in vitro – t1/2 ~19 days (SC and IV) – Bioavailability ~73% • Clinical experience: 245 patients studied in Phase 1 & Phase 2 trials3
Slide 8: IL-1 is a Validated Target in Inflammatory Diseases
8 • IL-1is acentral driver of the inflammatory process1: activates immune cells that generate pro-inflammatory cytokines including IL-6, TNF-, and IL-17 • Inhibition of IL-1 has been shown to be effective and safe in a variety of inflammatory diseases including Hidradenitis Suppurativa (HS)2 •
Slide 9: Hidradenitis Suppurativa (HS)
9 Hidradenitis Suppurativa (HS)
Slide 10: Hidradenitis Suppurativa (HS)
10 • Chronic, often debilitating inflammatory skin disease – Lumps, abscesses and scars develop under the arms, in the groin and other areas • Current treatments: – Antibiotics – Retinoids – Steroids-topical, oral, injections – Cosentyx, Humira • HS has an estimated prevalence of 0.7–1.2% in the Eur
Slide 11: IL-1 is Strongly Implicated in the Pathophysiology of HS
11 • Inflammatory cascade in HS is triggered by various external stimuli – Smoking, dysbiosis, or mechanical stress • IL-1 is a key driver of the inflammatory cascade that leads to the destruction of the pilosebaceous unit – Increased IL-1 levels in lesional skin2,3 – Genetic associations4 – Clini
Slide 12: Baseline Patient Characteristics of Biologics from Recent HS Trials
12 Baseline Patient Characteristics of Biologics from Recent HS Trials Lutikizumab Trial Enrolled More Severe Patients than Competitor Trials 1. Kimball AB et al. N Engl J Med. 2016; 375:422-34; 2. Kimball AB et al. Lancet. 2023; 401:747-7613; 3. Presentations at American Academy of Dermatology (AAD
Slide 13: Lutikizumab Efficacy Comparable to Other Agents in a More Severe Patient Population
13 Lutikizumab Efficacy Comparable to Other Agents in a More Severe Patient Population that Failed TNF- Therapy1 HiSCR75 Lower response rates observed in patients that have been previously treated with biologic agents or Hurley Stage 32-4 1. Kimball AB, et al. Presented at: American Academy of Derm
Slide 14: IL-1 is Unlikely to be an Important Driver of HS Pathophysiology
14 • Phase 2, bermekimab (IL-1 mAb) (NCT04019041)1 – Moderate to Severe Hidradenitis Suppurativa – Loading doses and then either 400 mg QW or 400 mg Q2W – Primary endpoint: HiSCR50 at week; Efficacy not demonstrated • Phase 2, bermekimab (NCT04988308)2 – Moderate to Severe Hidradenitis Suppurativa
Slide 15: MAS825 May Provide Further Clinical Evidence for IL-1 in HS
15 MAS825 May Provide Further Clinical Evidence for IL-1 in HS 1. ClinicalTrials.gov identifier: NCT03827798. Updated January 21, 2023. Accessed March 24, 2024. https://clinicaltrials.gov/search?term=NCT03827798 2. Kimball AB, et al. Presented at: American Academy of Dermatology; March 8-12, 2024;
Slide 16: Large Unmet Need in HS
16 • An estimated 28% of HS cases are Hurley Stage 2, and an additional 4% are Hurley Stage 34 • There is a large population of patients with a marked need for improved treatment options 1. Independent Market Analysis by Biotech Value Advisors LLC 2. Nguyen TV, et al. J Eur Acad Dermatol Venereol. 2
Slide 17: Key Secondary/Exploratory Endpoints
17 Key Secondary/Exploratory Endpoints Efficacy and Safety of AVTX-009 Treatment in Participants With Hidradenitis Suppurativa (HS) Key Secondary Endpoints: • Adverse Events (AEs) and tolerability • HiSCR50, HiSCR90 • International HS Severity Score System (IHS4) • AN Count, Draining Fistula Count •
Slide 18: Potential Additional Indications
18 Potential Additional Indications
Slide 19: Role of IL-1 in IBD
19 • IL-1 plays a central role in inflammation in IBD1 – IL-1β being a key cytokine produced upon inflammasome activation – Dysregulated inflammasome activation has been implicated in the pathogenesis of Crohn’s Disease (CD) • IL-1-driven stromal–neutrophil interactions define a subset of patients
Slide 20: Recent IL-1 Trial Initiations in IBD
20 • The goal of IBD therapeutics is remission – Only a minority of IBD patients obtain remission with current therapies • AbbVie plans to evaluate lutikizumab, dual-variable-domain interleukin (IL) 1/1 antagonist as monotherapy in UC and in combination with SKYRIZI in Crohn’s – “…we believe lutik
Slide 21: Executive Summary
Executive Summary AVAIO HERA PE Uses a
Slide 22: Investment highlights: AVTX-009 in HS
22 • Potential for a Best-in-Disease Profile in HS – High potency and favorable half-life may allow for improved efficacy and convenient dosing – Potential in other autoimmune diseases • Key Clinical Evidence Supporting IL-1 in HS – In a large, well controlled Phase 2 trial (NCT05139602), lutikizum
Slide 23: Appendix
Appendix AVAIO HERA PE Uses 23
Slide 24: Financial & Investor Information
24 Financial & Investor Information 1 Based on 1.0 million shares of common stock outstanding, 22.4 million shares of common sock underlying outstanding convertible non-voting Series C preferred stock, 12.0 million shares of common stock outstanding warrants and 7,513 shares of common stock underlyi
Slide 25: www.avalotx.com
25 NASDAQ:AVTX www.avalotx.com
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