Slide 1: CERC-002 Crohn's Disease - Phase 1b Initial Data (Cohort 1)
July | 2021 CERC-002 Crohn’s Disease - Phase 1b Initial Data (Cohort 1) Patient-Inspired Science Exhibit 99.3
Slide 2: Forward-Looking Statements
2 | 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
Slide 3: Today's Agenda
3 | Today’s Agenda Executive Summary and Brief Introduction Mike Cola Chief Executive Officer IBD, Crohn’s Disease, and Ulcerative Colitis Overview ‒ Overview of IBD (Crohn’s Disease and Ulcerative Colitis) ‒ Significant Burden of Illness and Unmet Need; Disease Pathology ‒ Treatment Options and Com
Slide 4: Executive Summary: CERC-002 Demonstrates Potential Proof-of-Concept in Initial Low-Dose Cohort
4 | Executive Summary: CERC-002 Demonstrates Potential Proof-of-Concept in Initial Low-Dose Cohort Open-label proof-of-concept study in patients with moderate to severe Crohn’s disease who previously failed 3 or more lines of biologic therapies, including anti-TNFα* Clinically meaningful mucosal
Slide 5: Inflammatory Bowel Disease, Crohn's Disease, and Ulcerative Colitis Overview
Inflammatory Bowel Disease, Crohn’s Disease, and Ulcerative Colitis Overview
Slide 6: Inflammatory Bowel Disease Overview
6 | 1. Centers for Disease Control and Prevention. Inflammatory bowel disease. https://www.cdc.gov/ibd/features/IBD-more-chronic-diseases.html. Accessed July 17, 2021. 2. Atreya R et al. Front Med (Lausanne). 2020;7:517. 3. Knowles SR et al. Inflamm Bowel Dis. 2018;24(4):742-751. 4. Byron C et al. J
Slide 7: Substantial Opportunity Remains in the Treatment of IBD
7 | 1. Atreya R et al. Front Med (Lausanne). 2020;7:517. 2. Clearview Healthcare Partners. Crohn’s disease and ulcerative colitis. Initial disease landscape overview. May 2021. Substantial Opportunity Remains in the Treatment of IBD Majority of patients are designated moderate/severe and treated w
Slide 8: CERC-002: Clinical Rationale for Use in Treatment of IBD
CERC-002: Clinical Rationale for Use in Treatment of IBD Role of LIGHT in IBD, Crohn’s Disease, and Ulcerative Colitis
Slide 9: LIGHT Is a Key Driver of Inflammation
9 | LIGHT Is a Key Driver of Inflammation LIGHT Inflammation HVEM-Mediated Signaling Pathways LTβR-Mediated Signaling Pathways LIGHT (TNFSF14) is a pro-inflammatory cytokine and a co-stimulator of T cells and Th1 cytokines, including interferon (IFN)-γ1 LIGHT is expressed on activated T cells, n
Slide 10: Multiple Lines of Evidence Support Importance of LIGHT in IBD
10 | 1. Data on file, Cerecor, Inc. 2. Moraes L et al. Inflamm Bowel Dis. 2020;26(6):874-884. 3. Cohavy O et al. J Immunol. 2005;174(2):646-653. 4. Wang J et al. J Immunol. 2005;174(12):8173-8182. 5. Shaikh RB et al. J Immunol. 2001;167(11):6330-6337. 6. Jungbeck M et al. Immunology. 2009;128(3):451
Slide 11: Elevated LIGHT Levels Detected in Pediatric Crohn's Disease
11 | Data displayed as box-and-whiskers graph. *Determined by Mann-Whitney U test. Plasma samples from CHOP Biobank; controls are matched for age and gender. Source: Cardinale C et al. Manuscript in preparation. Elevated LIGHT Levels Detected in Pediatric Crohn’s Disease Approximately 83% of pedia
Slide 12: CERC-002: Previous Clinical Study Safety and Efficacy in COVID-19 ARDS
CERC-002: Previous Clinical Study Safety and Efficacy in COVID-19 Acute Respiratory Distress Syndrome (ARDS)
Slide 13: CERC-002: A Novel First-in-Class Anti-LIGHT mAb
13 | CERC-002: A Novel First-in-Class Anti-LIGHT (TNFSF14) mAb In-licensed From Kyowa Kirin Co., Worldwide Exclusive Rights* for All Indications (2021) (2021) *Kyowa Kirin has an option to retain the rights in Japan. Novel, first-in-class fully human subcutaneous (SQ) monoclonal antibody (mAb) O
Slide 14: A Single Dose of CERC-002 Reduced LIGHT Levels Dramatically and Rapidly
14 | Source: Perlin DS et al. CERC-002, a human anti-LIGHT mAb reduces respiratory failure and death in hospitalized COVID-19 ARDS patients (https://medrxiv.org/cgi/content/short/2021.04.03.21254748v1). A Single Dose of CERC-002 Reduced LIGHT Levels Dramatically and Rapidly Rapid and significant red
Slide 15: CERC-002 Significantly Reduced Respiratory Failure and Mortality in Phase 2 Trial
15 | *Prespecified analysis. Source: Data on file, Cerecor, Inc. CERC-002 Significantly Reduced Respiratory Failure and Mortality in a Phase 2 Clinical Trial in Patients Hospitalized With COVID-19 ARDS Primary Endpoint: Percentage of Patients Alive and Free of Respiratory Failure at Day 28 Efficacy
Slide 16: CERC-002: Phase 1b Study in Crohn's Disease Preliminary Initial Safety and Efficacy Results (Cohort 1)
CERC-002: Phase 1b Study in Crohn’s Disease Preliminary Initial Safety and Efficacy Results (Cohort 1)
Slide 17: CERC-002 Crohn's Disease Proof-of-Concept Trial Design
17 | Screening (Visit 1) Open-Label Treatment Period (Visits 2-10) (8 weeks) Safety Follow-Up (Visit 11) CERC-002, SQ injections every 14 days (N=8, 4 subjects in each cohort; Cohort 1: 1mg/kg; Cohort 2: 3mg/kg) Telephone Visit Eligibility & Washout Week: -10 0 1 2 3 4 5 6-8 127 8 Visit #: 1 2 3 4 5
Slide 18: Clinical Study Patient Population
18 | Source: clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT03169894). Clinical Study Patient Population Inclusion Criteria Male or female, ≥18 to ≤75 years of age Documented diagnosis of CD via endoscopy/colonoscopy and histological confirmation Moderate to severe, active CD ‒ Colonosc
Slide 19: Phase 1b Initial Data (Cohort 1) Patient-Level Data
19 | CERC-002 Crohn’s Disease Proof-of-Concept: Phase 1b Initial Data (Cohort 1) Patient-Level Data Disease severity according to SES-CD score1: Remission: 0-2 Mild: 3-6 Moderate: 7-15 Severe: >15 Subject # Age (yrs) Prior Therapy / # of Prior Lines SES-CD LIGHT (pg/mL) Response Baseline 8 Weeks Bas
Slide 20: Preliminary Efficacy Results (Patient-Level Data)
20 | Preliminary Efficacy Results (Patient-Level Data) SES-CD ScoresPlasma LIGHT Levels Clinically meaningful mucosal healing, determined by colonoscopy, in 3 of 4 subjects (SES-CD) SE S- CD S co re 25 Baseline (Day 0) Week 8 20 10 5 0 15 Pl as m a LI G HT L ev el s ( pg /m L) 500 Baseline (Day 0)
Slide 21: Independent Preliminary Safety Data Results
21 | 1. Perlin DS et al. CERC-002, a human anti-LIGHT mAb reduces respiratory failure and death in hospitalized COVID-19 ARDS patients (https://medrxiv.org/cgi/content/short/2021.04.03.21254748v1). Independent Preliminary Safety Data Results – CERC-002, SQ Injection (1mg/kg) No serious adverse eve
Slide 22: Initial Low-Dose Cohort Data Demonstrates Potential Proof-of-Concept
22 | Initial Low-Dose Cohort Data Demonstrates Potential Proof-of-Concept Open-label proof-of-concept study in patients with moderate to severe Crohn’s disease who previously failed 3 lines of biologic therapies, including anti-TNFα* Clinically meaningful mucosal healing, determined by colonosco
Slide 23: Next Steps CERC-002 Clinical Program
23 | *TNFα, tumor necrosis factor alpha. Next Steps CERC-002 Clinical Program Crohn’s Disease ‒ Further evaluation of cohort data, including tissue LIGHT levels ‒ Cohort 2 (3 mg/kg dose) fully enrolled; complete data anticipated in 2H21 Ulcerative Colitis ‒ Expand clinical study to patients with
Slide 24: Summary Comments
Summary Comments -.:” (ceREcoR
Slide 25: Summary
25 | Summary Second positive proof-of-concept with CERC-002, which we believe further validates the LIGHT mechanism of action in inflammatory diseases (both acute and chronic) Biomarker-driven approach elucidates novel indications and de-risks clinical programs Precision medicine approach is b
Slide 26: Clinical-Stage Pipeline
26 | Clinical-Stage Pipeline Core Research & Development Areas Therapeutic Area Program Mechanism of Action Lead Indication Development Stage Anticipated Milestone Preclin Phase 1 Phase 2 Pivotal Trial Immunology Inflammation CERC-002‡ Anti-LIGHT mAb COVID-19 ARDS Received FTD* CERC-002 Anti-LIGHT m
Slide 27: www.cerecor.com
NASDAQ: CERC www.cerecor.com