Contrafect Corporation · OTC:CFRXQ
Contrafect — Investor Presentation (January 2019)
44 slides from Contrafect's investor presentation, Jan 7, 2019
Slide 1: ContraFect January 2019
ContraFect January 2019 Differentiated, first-in-class anti-infectives 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 is a clinical-stage biotech developing first-in-class biologics
ContraFect is a clinical-stage biotech leading the development of differentiated, first-in-class biologics for the treatment of life-threatening and drug-resistant infections ©2019 ContraFect Corporation
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: Potential for streamlined development
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 6: ContraFect Portfolio Overview
Lysin platform Novel class of anti-infectives Preclinical data supports multiple advantages as therapeutics Exebacase (CF-301) – first-in-class lysin candidate for Staph aureus bacteremia Demonstrated substantial additional clinical benefit over and above conventional antibiotic therapy in Phase 2 s
Slide 7: ContraFect Pipeline
Exebacase (CF-301) Staphylococcus aureus CF-296 Staphylococcus aureus GN lysins Pseudomonas aeruginosa Klebsiella pneumoniae Escherichia coli Enterobacter cloacae Acinetobacter baumannii GP lysins Streptococcus pneumoniae Enterococcus faecalis Group B streptococcus Bacillus anthracis CF-404 Influenz
Slide 8: Lysin Platform: A Novel Class of Antimicrobials
We have produced lysins as purified recombinant therapeutic proteins, enabling the hydrolysis of peptidoglycan bonds of bacterial cell walls Lysin Platform: A Novel Class of Antimicrobials Lysins are enzymes that rupture the bacterial cell wall leading to the disintegration of the bacterial cell Lys
Slide 9: Lysins: Hallmark Features of a New Class
Synergy with conventional antibiotics Eradicates biofilms Low propensity for resistance Rapid, potent and targeted bactericidal activity Lysins: Hallmark Features of a New Class
Slide 10: Lysins Exhibit Rapid and Potent Bactericidal Activity
Lysins Exhibit Rapid and Potent Bactericidal Activity
Slide 11: Exebacase (CF-301)
Exebacase (CF-301) Novel, First-In-Class Anti-Infective for Staph aureus Bacteremia, Including Endocarditis
Slide 12: 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, including antibiotic-resistant strains Rapid eradication of Staph biofilms Potent synergy with broad range of anti-staphylococcal antibiotics Clin
Slide 13: Exebacase Eradicates Biofilms
Before exposure to exebacase After 15 min exposure to exebacase *minimum biofilm-eradicating concentration Biofilm: A major medical problem Biofilms harbor and protect bacteria from immune defenses Conventional antibiotics cannot clear or penetrate biofilms Biofilms can increase antibiotic resistanc
Slide 14: Exebacase Eradicates Human Staphylococcal Biofilms
Demonstrated susceptibility of MRSA biofilms to exebacase Infected hemodialysis catheter removed from a patient as part of clinical care Biofilm from MRSA and other staphylococcal species found inside catheter Daptomycin was ineffective *LOD = Limit of detection Reduction of Staph species on explant
Slide 15: Exebacase: Synergy with SOC in Rat Endocarditis Model
DAP alone at human therapeutic equivalent dose daily x 4 days 3 log reduction in CFUs Single dose of exebacase (CF-301) plus DAP daily dose x 4 days 6 log reduction in CFUs p≤0.001 vs. DAP alone 4/9 Rats tested culture-negative tissues with CF-301/DAP combo Vegetations, Kidney, Spleen 9/9 Dap Monoth
Slide 16: Exebacase: Synergy Confirmed in Rabbit Endocarditis Model
Single dose of exebacase (CF-301) plus DAP daily dose x 4 days ~6-log reduction in CFUs at all CF-301 doses vs. vehicle (p≤0.001) > 3 log reduction in CFUs at all CF-301 doses tested vs. DAP alone (p≤0.002) Efficacy maintained at the lowest CF-301 dose tested (0.09 mg/kg) (p≤0.001) Similar efficacy
Slide 17: Exebacase: Low Propensity For Drug Resistance
After serial passage for 26 days, exebacase (CF-301) minimal inhibitory concentration remained stable (MIC increased <2 fold) Combination with CF-301 suppresses resistance to DAP. Similar results seen with vancomycin or oxacillin Source: Schuch et al JID 2014:209 In vitro Drug Resistance Studies - M
Slide 18: Exebacase Demonstrated Safety and Tolerability in Phase 1
Single escalating IV dose, double-blind, placebo-controlled 20 healthy volunteers; 4 dosing cohorts (0.04, 0.12, 0.25, 0.40 mg/kg) Well tolerated; no clinical adverse safety signals No serious adverse events (AEs) No exebacase-related hypersensitivity AEs 5 non-serious AEs were mild, transient and r
Slide 19: Phase 2: A 'First-in-Patient' Study with Superiority Design
Staph aureus bacteremia and endocarditis patients have unmet need Approximately 200,000 hospitalizations per year in the US Clinical cure rates of <50% with current antibiotic therapy Mortality rates of at least 20% First antibacterial trial of its kind Endeavoring to improve clinical response rates
Slide 20: 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 21: Imbalance in Distribution of Subcategories in mITT by Diagnosis
Imbalance in Distribution of Subcategories in mITT by Diagnosis *used in addition to antibiotics * Final diagnoses were determined by an independent clinical Adjudication Committee
Slide 22: Exebacase Improved Responder Rate in mITT Population at Day 14
Exebacase Improved Responder Rate in mITT Population at Day 14 exebacase responders exebacase non – responders % of Patients antibiotics alone N=45 exebacase* N=71 10.4% Improvement 70.4 60.0 28.9 0 10 20 30 40 50 60 70 80 Indeterminate responses: 3 exebacase patients (4.2%) and 5 antibiotics alone
Slide 23: Responder Rate in Bacteremia Including Right-Sided Endocarditis
exebacase antibiotics alone antibiotics alone N=42 exebacase* N=60 20.5% Improvement (p=0.028) 80.0 59.5 0 10 20 30 40 50 60 70 80 N=18 N=13 n=25 n=48 Exebacase Improved Responder Rate in Staph aureus Bacteremia Including Right-Sided Endocarditis % Responders *used in addition to antibiotics
Slide 24: Responder Rate in Staph aureus Bacteremia
exebacase antibiotics alone antibiotics alone N=39 exebacase* N=55 20.3% Improvement (p=0.035) 81.8 61.5 0 10 20 30 40 50 60 70 80 N=18 N=13 n=24 n=45 Exebacase Improved Responder Rate in Staph aureus Bacteremia % Responders *used in addition to antibiotics
Slide 25: Exebacase Improved Responder Rate in MRSA Infected Patients
Exebacase Improved Responder Rate in MRSA Infected Patients MSSA MRSA 42.8% Improvement (p=0.010) 74.1 68.2 73.3 0 10 20 30 40 50 60 70 80 31.3 exebacase antibiotics alone Results in the MSSA subgroup are confounded by the unequal distribution of left-sided endocarditis patients between the exebacas
Slide 26: Responder Rates Overall and in Key Subgroups
antibiotics Clinical response at Day 14 exebacase* alone p-value Overall mITT population 70.4% 60.0% 0.314 Bacteremia + right-sided endocarditis 80.0% 59.5% 0.028 Bacteremia only 81.8% 61.5% 0.035 MRSA infection 74.1% 31.3% 0.010 MSSA infection 68.2% 73.3% 0.796 Exebacase Improved Responder Rates Ov
Slide 27: Exebacase Was Safe and Well Tolerated in Phase 2 Study
Exebacase Was Safe and Well Tolerated in Phase 2 Study Treatment emergent adverse event (TEAE) is any untoward medical event that occurred after study drug administration until 28 days after last dose of standard of care, regardless of whether or not the event was considered related to study drug. *
Slide 28: First Step to a Potential New Treatment Paradigm
First-in-Patient Phase 2 study with positive efficacy signals and robust safety and tolerability profile Identified Phase 3 study population with exebacase responder rates that were 20% higher than antibiotics alone Staph aureus bacteremia including right-sided endocarditis First non-traditional ant
Slide 29: GN Lysins Combating Multi-Drug Resistant Gram-Negative Infections
GN Lysins Combating Multi-Drug Resistant Gram-Negative Infections Based on Novel Lysin Platform
Slide 30: Lysins Against GN Pathogens: Next IND Candidates
Lysins Against GN Pathogens: Next IND Candidates 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 cure rates for resistant gram-negative infections Discovery-stage program In vitro data demonstra
Slide 31: GN Lysin Discovery Program
GN Lysin Discovery Program Escherichia coli Klebsiella pneumoniae Enterobacter cloacea 2 lysin candidates cloned 10 lysin candidates cloned 10 lysin candidates cloned 500+ lysins cloned 15 leads with potent in vitro activity In vivo studies ongoing Primary target In vitro characterization under way
Slide 32: 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 33: 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 34: GN Lysins: Synergy with Antibiotics
GN Lysins: Synergy with Antibiotics Synergistic across a broad range of antibiotics tested* *Fractional inhibitory concentrations (FICs) are the sum of MICs for two drugs used in combination to inhibit growth and are determined by a standard methodology; values of ≤0.5 are represent a synergistic in
Slide 35: Therapeutic Potential of GN Lysins Against P. aeruginosa
Attributes Rapid bacterial killing Biofilm eradication Synergy with SOC antibiotics Potential to re-sensitize antibiotic resistant strains Therapeutic Potential of GN Lysins Against P. aeruginosa Potential therapeutic uses In addition to conventional antibiotics to improve clinical cure rates compar
Slide 36: CF-404 Inhaled Combination of mAbs for Influenza
CF-404 Inhaled Combination of mAbs for Influenza
Slide 37: CF-404: Overview
Based on a combination of three novel recombinant, fully-human mAbs CF-401 ─ Influenza A, Group 1 CF-402 ─ Influenza A, Group 2 CF-403 ─ Influenza B of both Yamagata and Victoria linages Preclinical-stage program Novel inhaled delivery facilitates direct viral neutralization in the upper and lower a
Slide 38: CF-404: Aerosolized Formulation Potent At Low Doses
Aerosolized CF-404 in a mouse model of H1N1 influenza (3xLD50), dose response study Results: Mice treated with 0.8mg/kg were protected from both morbidity and mortality Inhaled administration more effective at lower doses than higher systemic dose CF-404 IP (5mg/kg) CF-404: Aerosolized Formulation P
Slide 39: CF-404: Extends Treatment Window
% Survival Tamiflu (Twice Daily x 5) CF-404 (Single Dose) Mice with H1N1 Influenza (Survival at 14 Days) CF-404: Extends Treatment Window CF-404 in a mouse model of H1N1 influenza, study of time to initiate therapy Results: Mice treated with CF-404 were fully protected from mortality with delay in t
Slide 40: Corporate Information
Corporate Information Pe cccccccccccccccccce
Slide 41: ContraFect Leadership
ContraFect Leadership Proven Track Record of Creating Long-Term Shareholder Value Steven C. Gilman, PhD – Chairman Sol Barer, PhD – Lead Independent Director Former Chairman and CEO of Celgene Roger Pomerantz, MD – Vice Chairman President, CEO and Chmn Seres Therapeutics Former Global Head of Inf. D
Slide 42: Key Financial Information
Cash and Investments $37.6 million Total Debt $0.0 million Basic Shares Outstanding 79.4 million Key Financial Information Key Metrics As of September 30, 2018 Analyst Coverage Chardan Keay Nakae JanneyEsther Hong Piper JaffrayEdward Tenthoff William BlairKatherine Xu ZacksDavid Bautz
Slide 43: ContraFect Portfolio Overview
Lysin platform Novel class of anti-infectives Preclinical data supports multiple advantages as therapeutics Exebacase (CF-301) – first-in-class lysin candidate for Staph aureus bacteremia Demonstrated substantial additional clinical benefit over and above conventional antibiotic therapy in Phase 2 s
Slide 44: ContraFect Corporation
ContraFect Corporation NASDAQ: CFRX First in class anti-infectives for life-threatening, drug-resistant infections