Avalo Therapeutics, Inc. · NASDAQ:AVTX
Avalo Therapeutics — Cerecor — Investor Presentation (May 2020)
24 slides from Avalo Therapeutics's investor presentation, May 28, 2020
Slide 1: Patient Inspired Science
Exhibit 99.2 Patient Inspired Science Establishing a leading, pediatric rare and orphan disease-focused biopharmaceutical company to deliver impactful new medicines to patients May | 2020 Corporate Highlights | COVID-19 ARDS
Slide 2: Forward-Looking Statements
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 unc
Slide 3: Highlights
Highlights • Recent Merger of Cerecor and Aevi has created a rich pipeline of novel, 1st in class assets all with proven mechanistic rationale • Only known anti-LIGHT mAb in the clinic, offers potential to treat cytokine storm-induced COVID-19 ARDS in the near-term and broader ARDS indication beyond
Slide 4: Clinical-Stage Pipeline
Clinical-Stage Pipeline Core Research & Development Stage Therapeutic Mechanism Development Program Lead Indication Area of Action Areas Preclinical Phase 1 Phase 2 Phase 3 Upcoming Milestone Initial Data Anti-LIGHT mAb ARDS CERC-002 4Q 2020 Initial Data Immunology Inflammation Anti-LIGHT mAb Crohn’
Slide 5: CERC-002: Anti-LIGHT monoclonal antibody in clinical studies for COVID-19 ARDS
CERC-002 Anti-LIGHT monoclonal antibody in clinical studies for COVID-19 ARDS
Slide 6: The Impact of Cytokine Storm Induced COVID-19 ARDS
The Impact of Cytokine Storm Induced COVID-19 ARDS The outbreak of coronavirus disease 2019 (COVID-19) has created a global health crisis The viral infection triggers a hyperactive Approximately 1,500* people in immune response leading to cytokine the United States die each day storm and Acute Respi
Slide 7: LIGHT is a Potential Key Driver of Inflammation in the Lung
LIGHT is a Potential Key Driver of Inflammation in the Lung LIGHT Impacts Lung Function Recent peer-reviewed publications implicate LIGHT in viral pneumonia and acute lung fibrosis 7|
Slide 8: Hyperactive Immune Response Leads to Cytokine Storm
Hyperactive Immune Response Leads to Cytokine Storm Cytokine storm induced ARDS is a major driver of poor COVID-19 outcomes Protective Immune Response Hyperactive Immune Response Immune cells arrive at the site of Excessive cytokines lead to over-recruitment of infection but do not overwhelm immune
Slide 9: LIGHT is Potentially a Key Driver of the Inflammatory Response in Cytokine Storm in ARDS
LIGHT is Potentially a Key Driver of the Inflammatory Response in Cytokine Storm in ARDS LIGHT Releases Inflammatory Cytokines and Activates both T Cells and B Cells FasL LIGHT TL1A HVEM-mediated LTβR-mediated Signaling Pathways Signaling Pathways • Highly expressed in neutrophils and macrophages an
Slide 10: LIGHT Linked to Ventilation and Mortality in Hospitalized COVID-19 Patients
LIGHT Linked to Ventilation and Mortality in Hospitalized COVID-19 Patients Very Recent Data Implicate LIGHT in COVID-19 ARDS • Free LIGHT levels are significantly elevated in the serum of hospitalized patients with COVID-19, with the greatest statistical significance in patients who are ventilated
Slide 11: LIGHT is Significantly Elevated in Hospitalized COVID-19 Patients
LIGHT is Significantly Elevated in Hospitalized COVID-19 Patients LIGHT Levels in Hospitalized LIGHT Levels in Both Non-Ventilated COVID-19 Patients and Ventilated Patients P < 0.0001 P < 0.0001 P < 0.0001 Free LIGHT levels are significantly elevated in serum of hospitalized patients with COVID-19,
Slide 12: Elevated LIGHT Levels are Linked to Mortality in Ventilated Patients
Elevated LIGHT Levels are Linked to Mortality in Ventilated Patients Elevated LIGHT Levels Associated with Key Implications Increased Mortality in Ventilated Patients • In ventilated patients, LIGHT levels were higher in those patients that eventually died than in those patients that recovered. This
Slide 13: Elevated LIGHT is Most Strongly Linked to Mortality in Patients 60+
Elevated LIGHT is Most Strongly Linked to Mortality in Patients 60+ Association Between Elevated LIGHT and Key Implications Mortality Strongest in Patients Over 60 P = 0.021 • In patients over 60, LIGHT levels were significantly higher in those that eventually died than in those patients that recove
Slide 14: Cytokine Storm Drives ARDS Across Etiologies
Cytokine Storm Drives ARDS Across Etiologies Patients may progress rapidly and often require invasive mechanical ventilation Pre-ARDS Disease Course ARDS Progression Mild ARDS Moderate ARDS Severe ARDS COVID-19 infection COVID-19 ARDS All etiologies of ARDS have high unmet need, with COVID-19 infect
Slide 15: Potential Beyond COVID-19 ARDS
Potential Beyond COVID-19 ARDS CERC-002 may be applicable to the broader ARDS population CERC-002 COVID-19 ARDS High Morbidity and Mortality Broader ARDS Patients High ICU / Ventilation Cost Patients ($90 – $125 K per patient) • Viral / Bacterial Infections • Trauma Rationale for LIGHT as a Target •
Slide 16: COVID-19 and Broader ARDS Target Populations
COVID-19 and Broader ARDS Target Populations COVID-19 ARDS provides a potential path to treat a larger patient population in broader ARDS U.S. COVID-19 Related ARDS Patients U.S. Broader ARDS Patients Excluding COVID-19 416 427 392 404 380 367 340 354 19 ARDS Incidence ARDS 19 - COVID Diagnosed Broa
Slide 17: CERC-002: A Novel First-in-Class Anti-LIGHT mAb
CERC-002: A Novel First-in-Class Anti-LIGHT mAb The only known clinical stage anti-LIGHT antibody Free LIGHT Assay Developed in Collaboration with Myriad RBM Enables a biomarker / precision VH VH medicine development approach NH NH 2 2 CH VL VL Positive Toxicology Profile CL 225 CL 8-week monkey tox
Slide 18: Clearance from the FDA to Initiate Clinical Trial in COVID-19 ARDS
Clearance from the FDA to Initiate Clinical Trial in Cytokine Storm- Induced COVID-19 ARDS with CERC-002 Clear path for clinical development in COVID-19 ARDS, creating a path for development in generalized ARDS Planned Development Path for CERC-002 1H 2H 1H 2H 1H 2H 2020 2020 2021 2021 2022 2022 Q2
Slide 19: CERC-002 Treatment of Cytokine Storm-Induced COVID-19 ARDS
CERC-002 Treatment of Cytokine Storm-Induced COVID-19 ARDS Primary Endpoint: Respiratory Failure and Mortality Over 28 Days Proof-of-Concept Trial Design Randomized, Double-blind, Placebo-controlled, Multi-Center, Proof-of-Concept Clinical Trial of CERC-002 in Adults with COVID-19 ARDS Inclusion Cri
Slide 20: Physician Perspectives on CERC-002
Physician Perspectives on CERC-002 Front line physicians1 (n=14) with significant experience in COVID-19 and ARDS broadly viewed CERC-002’s mechanism as novel with potential to fill an urgent unmet need Urgent Medical “There are very few options for ARDS patients so I would Need definitely want to u
Slide 21: Highlights through 2022
Highlights through 2022 • Multiple catalysts and 3 potential PRV awards from first-in-class medicines for diseases with no approved treatment options CERC-801 CERC-801 TOP LINE DATA Potential NDA APPROVAL CERC-803 CERC-803 TOP LINE DATA Potential NDA APPROVAL Initial Data from CERC-802 CERC-802 CDG
Slide 22: www.cerecor.com
NASDAQ:CERC www.cerecor.com
Slide 23: Select Board and Management Team Members
Select Board and Management Team Members Michael F. Cola Chief Executive Officer Garry A. Neil, MD Chief Scientific Officer Sol J. Barer, PhD Chairman 23|
Slide 24: References
References • LIGHT: Lymphotoxin-like, exhibits Inducible expression, and competes with HSV Glycoprotein D for HVEM, a receptor expressed by T lymphocytes; encoded by TNFSF14 (Tumor Necrosis Factor Superfamily 14). • Bellani G, Laffey JG, Pham T, et al. Epidemiology, Patterns of Care, and Mortality f