Avalo Therapeutics, Inc. · NASDAQ:AVTX
Avalo Therapeutics — Investor Presentation (September 2024)
23 slides from Avalo Therapeutics's investor presentation, Sep 9, 2024
Slide 1: Avalo Therapeutics, Inc. (AVTX) Corporate Presentation September 2024
1 Avalo Therapeutics, Inc. (AVTX) Corporate Presentation September 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: Executive Summary and AVTX-009 Development Timeline
3 • 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-1β in HS – In a large, well controlled Phase 2 trial (NCT05139602), lutikizuma
Slide 4: Experienced Management Team
4 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, Quality Assurance Dino C. Miano, PhD SVP, CMC, Technical Operations Chris Sullivan Chief Financial
Slide 5: AVTX-009 Highly Potent and Specific Inhibitor of a Validated Immune Target
5 • High-affinity humanized antibody that potently neutralizes IL-1β – 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 6: IL-1β is a Validated Target in Inflammatory Diseases
6 • IL-1β is a central driver of the inflammatory process1: activates immune cells that generate pro-inflammatory cytokines including IL-6, TNF-α, and IL-17 • Inhibition of IL-1β has been shown to be effective and safe in a variety of inflammatory diseases including Hidradenitis Suppurativa (HS)2 •
Slide 7: Hidradenitis Suppurativa (HS)
7 Hidradenitis Suppurativa (HS)
Slide 8: Hidradenitis Suppurativa (HS)
8 • 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 Euro
Slide 9: IL-1β is Strongly Implicated in the Pathophysiology of HS
9 • Inflammatory cascade in HS is triggered by various external stimuli – Smoking, dysbiosis, or mechanical stress • IL-1β is a key driver of the inflammatory cascade that leads to the destruction of the pilosebaceous unit – Increased IL-1β levels in lesional skin2,3 – Genetic associations4 – Clinic
Slide 10: Baseline Patient Characteristics of Biologics from Recent HS Trials
10 Baseline Patient Characteristics of Biologics from Recent HS Trials Lutik izumab 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 (AA
Slide 11: Lutikizumab Efficacy Comparable to Other Agents in a More Severe Patient Population
11 Lutikizumab Efficacy Comparable to Other Agents in a More Severe Patient Population that Failed TNF-α 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 12: IL-1α is Unlikely to be an Important Driver of HS Pathophysiology
12 • Phase 2, bermekimab (IL-1α 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 13: MAS825 May Provide Further Clinical Evidence for IL-1β in HS
13 MAS825 May Provide Further Clinical Evidence for IL-1β 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 14: Large Unmet Need in HS
14 A third of moderate to severe HS patients, or over 100,000 patients, are treated with biologics *Independent Market Analysis by Biotech Value Advisors LLC Over 3 million people in the US have hidradenitis suppurativa (HS) An estimated 1% of US population or 3.34 million people suffer with HS in t
Slide 15: Key Secondary/Exploratory Endpoints Efficacy and Safety of AVTX-009 in HS
15 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 16: Potential Additional Indications
16 Potential Additional Indications
Slide 17: Role of IL-1β in IBD
17 • IL-1β 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 18: Recent IL-1 Trial Initiations in IBD
18 • 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) 1α/1β antagonist as monotherapy in UC and in combination with SKYRIZI in Crohn’s – “…we believe lutik
Slide 19: Executive Summary
Executive Summary AVAIO THERA P EUs Les
Slide 20: Executive Summary and AVTX-009 Development Timeline
20 • 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-1β in HS – In a large, well controlled Phase 2 trial (NCT05139602), lutikizum
Slide 21: Appendix
Appendix AVAIO THERAPEUTLES
Slide 22: Financial & Investor Information
22 Financial & Investor Information 1 As of August 13, 2024, Avalo has 9.7M shares of common stock outstanding. On August 13, 2024, upon stockholder approval and subject to certain beneficial ownership limitations, Avalo issued 8.7M shares of common stock pursuant to the automatic conversion of 8,64
Slide 23: www.avalotx.com
23 NASDAQ:AVTX www.avalotx.com
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