Contrafect Corporation · OTC:CFRXQ
Contrafect — Investor Presentation (October 2019)
44 slides from Contrafect's investor presentation, Oct 2, 2019
Slide 1: ContraFect October 2019
ContraFect October 2019 Differentiated, first-in-class direct lytic agents (DLAs) for life-threatening, drug-resistant infections Exhibit 99.1
Slide 2: Forward-looking statements
This presentation contains, and our officers and representatives may from time to time make, “forward-looking statements” within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “beli
Slide 3: ContraFect company overview
©2019 ContraFect Corporation ContraFect is a late clinical-stage biotechnology company leading the development of direct lytic agents (DLAs), which include lysins and amurin peptides, as new medical modalities for the treatment of life-threatening and antibiotic-resistant infections
Slide 4: Resistant Infections are Expensive and Cost Lives
Resistant Infections are Expensive and Cost Lives Estimated deaths (per 100,000 cases) Estimated global mortality Estimated annual costs Up to $20 billion (direct costs in the U.S.) Up to €1.5 billion in the EU (additional hospital days alone) Sources: Review on Antimicrobial Resistance, O’Neill, 20
Slide 5: Direct Lytic Agents (DLAs) Are Not Antibiotics
lipoglycopeptides Vibativ Dalvance Orbactiv beta-lactams fluoroquinolones oxazolidinones Zerbaxa Vabomere Avycaz Baxdela Sivextro Direct Lytic Agents (DLAs) Are Not Antibiotics Source: IDSA 10 x ‘20 Initiative
Slide 6: DLAs Are A Potential New Medical Modality
Amurin Peptides We have discovered a new class of antimicrobial peptides that have potent activity across a wide range of resistant Gram-negative pathogens, including the ESKAPE pathogens. GN Lysins We have discovered and engineered lysins which target and kill Gram-negative pathogens, including mul
Slide 7: Favorable Environment for New Anti-Infective Modalities
Potential for streamlined development June 2018 draft FDA guidance, Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) August 2017 FDA Guidance for Industry for “Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases” 21st C
Slide 8: Lysins – DLAs to Potentially Treat Serious, Resistant Infections
Lysins – DLAs to Potentially Treat Serious, Resistant Infections Lysins are direct lytic agents derived from bacteriophage In nature – highly potent bacterial killer Novel mechanism of action Enzymes targeting the bacterial cell wall leading to immediate death Recombinantly produced and purified bio
Slide 9: Exebacase (CF-301) for Staph aureus Bacteremia
Exebacase (CF-301) Novel, First-In-Class, Direct Lytic Agent (DLA) for Staph aureus Bacteremia, Including Endocarditis
Slide 10: Exebacase: First Phase 3 Targeting Superiority in Neglected Disease
1940s Penicillin Vancomycin Exebacase: The First Phase 3 Targeting Superiority in This Neglected Disease 1958 Daptomycin 2006 Penicillin Resistant β-Lactamase 48 Year Void of New Agents Exebacase 2019 13 Year Void of New Agents Sources: Predictors of Mortality in Staphylococcus aureus Bacteremia, va
Slide 11: Exebacase (CF-301): First-in-Class Lysin Candidate
Exebacase (CF-301): First-in-Class Lysin Candidate Key attributes 26 kDa modular bacterial cell wall hydrolase enzyme Highly potent against Staph aureus Rapid and unique lysis and eradication of Staph biofilms Potent synergy with broad range of anti-staphylococcal antibiotics Clinical-stage program
Slide 12: Phase 2 trial design
First human DLA trial to report positive results in Staph aureus bacteremia Objective of improving clinical response rates over antibiotic treatment alone International, multi-center, randomized, double-blind, placebo-controlled trial for the treatment of Staph aureus bacteremia including endocardit
Slide 13: Demographics/Baseline Characteristics Were Balanced
Demographics/Baseline Characteristics Were Balanced Majority of patients enrolled in the US (79%) Latin America, EU, Russia and Israel also enrolled patients A total of 121 patients randomized into the study Primary analysis group – microbiological intent-to-treat (mITT) population 116 patients with
Slide 14: Exebacase Was Safe and Well Tolerated
Exebacase Was Safe and Well Tolerated Through Day 180 Exebacase + SOC N = 72 n (%) SOC antibiotics N = 47 n (%) Adverse events (AEs) through Day 7 48 (66.7) 31 (63.8) AEs leading to study drug discontinuation 0 0 Hypersensitivity AEs related to exebacase 0 Serious Adverse Events (SAEs) through Day 1
Slide 15: Immunologic Response Data
Immunologic Response Data Through Day 180: Consistent with Phase 1, ~50% of exebacase-treated Staph aureus patients developed treatment-emergent anti-drug antibodies in Phase 2 Only 6 of exebacase-treated patients developed treatment-emergent IgE antibodies, which were generally very low titer and t
Slide 16: Topline Efficacy at Day 14
Topline Efficacy at Day 14 after study drug: 42.8% Higher Responder Rate with Exebacase in Prespecified MRSA Subgroup All Staph aureus % Responders Difference = 42.8% p=0.010 Difference = 10.4% p=0.314 50/71 27/45 20/27 5/16
Slide 17: Higher Responder Rates in MRSA Subgroups: Standard-of-Care Antibiotics
Exebacase Was Associated with Consistently Higher Responder Rates in Key MRSA Subgroups: Standard-of-Care Antibiotics 3/5 16/21 1/1 4/13 1/3 % Responders Clinical Responder Rates at Day 14
Slide 18: Higher Responder Rates in MRSA Subgroups: Sources of Infection
Exebacase Was Associated with Consistently Higher Responder Rates in Key MRSA Subgroups: Sources of Infection 6/7 7/7 5/6 1/4 2/3 % Responders Clinical Responder Rates at Day 14 0/1
Slide 19: Higher Responder Rates: Bacteremia and Complicated Bacteremia
Exebacase Was Associated with Consistently Higher Responder Rates in Key MRSA Subgroups: Bacteremia and Complicated Bacteremia 18/22 13/17 5/5 3/13 5/15 % Responders Clinical Responder Rates at Day 14 2/2 Difference = 48.5% p=0.005 Difference = 53.4% p=0.009
Slide 20: Health Economic Data for US Patients
Health Economic Data for US Patients: Length of stay for MRSA was reduced with exebacase Median number of hospital days from study drug administration through discharge was 6.0 days in the exebacase-treated group vs 10.0 days in SOC-alone group 30-day hospital readmission rates among MRSA patients d
Slide 21: 30-Day All-Cause Mortality in Phase 2 Study
Total Population MRSA MSSA Exebacase + SOC N = 72 n (%) SOC antibiotics N = 47 n (%) Exebacase + SOC N = 27 n (%) SOC antibiotics N = 16 n (%) Exebacase + SOC N = 44 n (%) SOC antibiotics N = 30 n (%) Deaths through Day 30 7 (9.7) 6 (12.8) 1 (3.7) 4 (25.0) 6 (13.6) 2 (6.7) Note: One (1) patient dose
Slide 22: Successful End-of-Phase 2 Meeting Supports Pathway to Registration
Successful End-of-Phase 2 Meeting Supports Pathway to Registration Exebacase is advancing under a streamlined development approach Single, pivotal Phase 3 superiority design trial, conducted in the US only Randomized, double-blind, placebo controlled Comparing the efficacy of a single IV dose of exe
Slide 23: Other Phase 3 Study Design Elements
Other Phase 3 Study Design Elements Secondary and exploratory endpoints: Clinical response rate at Day 14 in All Staph aureus patients Clinical response rates at Day 30 and Day 60 in both MRSA and All Staph aureus patient populations 30-day all-cause mortality in MRSA patients Evaluation of impact o
Slide 24: Phase 2 Results in Phase 3 Primary Efficacy Population
Phase 2 Results in Phase 3 Primary Efficacy Population % Responders 20/27 5/16 Difference = 42.8% p=0.010 Pre-specified MRSA Subgroup, Phase 2 Study MRSA Patients with Bacteremia, Including Right-Sided Endocarditis, US Only Difference = 49.7% p=0.005 19/23 5/15 Day 14 Day 14
Slide 25: Phase 2 Results: MRSA/MSSA Populations
Phase 2 Results of Phase 3 MRSA/MSSA Populations Clinical Responder Rates at Day 14 Bacteremia, Including Right-Sided Endocarditis, US Only 19/23 5/15 22/26 14/21 41/49 19/35 % Responders Note: One (1) patient dosed with SOC antibiotics alone had both MRSA and MSSA All S. aureus
Slide 26: Phase 2 Results: MRSA Population
Phase 2 Results of Phase 3 MRSA Population Clinical Responder Rates, MRSA Bacteremia, Including Right-Sided Endocarditis, US Only 17/23 7/15 19/23 5/15 13/23 5/15 % Responders
Slide 27: Phase 2 Results: MSSA Population
Phase 2 Results of Phase 3 MSSA Population Clinical Responder Rates, MSSA Bacteremia, Including Right-Sided Endocarditis, US Only 21/26 17/21 22/26 14/21 20/26 14/21 % Responders
Slide 28: Phase 2 Results: All Staph aureus Population
Phase 2 Results of Phase 3 All Staph aureus Population Clinical Responder Rates, All S. aureus Bacteremia, Including Right-Sided Endocarditis, US Only 38/49 23/35 41/49 19/35 33/49 19/35 % Responders
Slide 29: Exebacase Value Proposition
Exebacase Value Proposition* Exebacase, a direct lytic agent, is an entirely new treatment modality, potentially offering a superior treatment for patients with challenging MRSA infections: Superior clinical responder rates at Day 14 compared to antibiotics alone for patients with MRSA bacteremia, i
Slide 30: MRSA Provides Potential Opportunity for Clinical and Commercial Impact
Sources: (1) Based on ContraFect estimations; (2) Ben-David, Infection Control and Hospital Epidemiology, May 2009, Vol. 30, No. 5, pp. 453-460; (3) Zimlichman, JAMA Internal Medicine, September 2, 2013 Hospital Cost for ICU Patients with a Nosocomial Staphylococcus aureus Bloodstream Infection (BSI
Slide 31: GN Lysins Combating Multi-Drug Resistant Gram-Negative Infections
GN Lysins Combating Multi-Drug Resistant Gram-Negative Infections Based on Novel Lysin Platform
Slide 32: Lysins Against GN Pathogens: Potential for Next IND
Lysins Against GN Pathogens: Potential for Next IND Based on novel lysin platform Engineered to bypass the outer membrane of GN bacteria and for potent activity in human blood Potential to improve clinical response and cure rates for resistant gram-negative infections Preclinical-stage program In vi
Slide 33: GN Lysins: Engineered for Greater Potency
GN Lysins: Engineered for Greater Potency MICs (µg/mL) against a carbapenem-resistant clinical P. aeruginosa isolate were determined CAA (cationic adjusted media) plus human serum Reduction in median MICs against MDR P. aeruginosa from 16 down to 1 Source: Sauve et al., ASM Late Breaker Abstract (Su
Slide 34: GN Lysins: Highly Potent Anti-Biofilm Activity
GN Lysins: Highly Potent Anti-Biofilm Activity Eradication of biofilms formed by P. aeruginosa strain ATCC 17646 was examined in the Minimal Biofilm Eradicating Concentration (MBEC) assay. MBECs of <1 against P. aeruginosa biofilms Source: Sauve et al., ASM Late Breaker Abstract (Sunday-HMB LB14), 2
Slide 35: GN Lysins Re-sensitize Resistant GN Pathogens
GN Lysins Re-sensitize Resistant GN Pathogens: Carbapenem-Resistant P. aeruginosa Re-sensitized to Imipenem Imipenem MIC (µg/mL) GN121 (µg/mL) FICI Interaction Isolates Alone Combination* Alone Combination CFS 1557 32 (R) 1 (S) 1 0.125 0.155 Synergy CFS 1558 16 (R) 0.25 (S) 1 0.25 0.265 Synergy CFS
Slide 36: Amurins Targeting Resistant Gram-Negative Pathogens
Amurins Targeting Resistant Gram-Negative Pathogens Based on Novel Amurin Peptides
Slide 37: Amurins are Broadly Active Against GN Pathogens
Amurins are Broadly Active Against GN Pathogens Novel lytic agents Potent activity in human blood Potential to improve clinical response and cure rates for resistant gram-negative infections Preclinical-stage program In vitro data demonstrates the same key features as lysins Rapid, potent and target
Slide 38: Therapeutic Potential of DLAs (Lysins and Amurins)
Attributes Rapid bacterial killing Biofilm eradication Synergy with SOC antibiotics Potential to re-sensitize antibiotic resistant strains Potential therapeutic uses In addition to conventional antibiotics to improve clinical cure rates compared to antibiotics alone To treat infections caused by XDR
Slide 39: Corporate Information
Corporate Information Pe ccccccccccccccccccccs
Slide 40: ContraFect Pipeline
Exebacase (CF-301) Staphylococcus aureus CF-296 Staphylococcus aureus GN lysins Pseudomonas aeruginosa Klebsiella pneumoniae Escherichia coli Enterobacter cloacae Acinetobacter baumannii Amurins Broad-spectrum Gram-negative GP lysins Streptococcus pneumoniae Enterococcus faecalis Group B streptococc
Slide 41: ContraFect Leadership
ContraFect Leadership Proven Track Record of Creating Long-Term Shareholder Value Roger Pomerantz, MD – Chairman Sol Barer, PhD – Lead Independent Director Former Chairman and CEO of Celgene Steven C. Gilman, PhD – Vice Chairman Former CEO ContraFect Former EVP, R&D and CSO, Cubist Pharmaceuticals;
Slide 42: ContraFect Financial Information
Cash and Investments $14.2 million Total Debt $0.0 million Basic Shares Outstanding 79.4 million ContraFect Financial Information Key Metrics As of June 30, 2019 Analyst Coverage Chardan Keay Nakae JanneyEsther Hong MaximJason McCarthy Piper JaffrayEdward Tenthoff ZacksDavid Bautz
Slide 43: ContraFect: Pursuing DLAs, A Potential New Medical Modality
ContraFect: Pursuing DLAs, A Potential New Medical Modality DLAs are not antibiotics Rapid, potent and targeted bactericidal activity Eradication of biofilms Synergy with conventional antibiotics Low propensity for resistance Exebacase: First-in-Class DLA Phase 3 Substantial improvement in MRSA pati
Slide 44: ContraFect Corporation
ContraFect Corporation NASDAQ: CFRX First in class anti-infectives for life-threatening, drug-resistant infections