Contrafect Corporation · OTC:CFRXQ
Contrafect — Investor Presentation (July 2017)
40 slides from Contrafect's investor presentation, Jul 11, 2017
Slide 1: First in Class Anti-Infectives for Life-Threatening, Drug Resistant Infections
July 2017 First in Class Anti-Infectives for Life-Threatening, Drug Resistant Infections Exhibit 99.1
Slide 2: Forward Looking Statements
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
Slide 3: ContraFect: Biologics for Serious Infections
ContraFect: Biologics for Serious Infections Lysin Platform: Novel Alternatives to Conventional Antibiotics Potent, selective antibacterial enzymes Derived from bacteriophage; recombinantly produced Independent lysin discovery program and active Research Collaboration with The Rockefeller University
Slide 4: The Global Threat of Antibiotic Resistance
The Global Threat of Antibiotic Resistance “…the world is headed for a post-antibiotic era…” Dr. Keiji Fukuda, WHO “…one of our most serious health threats.” Dr. Tom Frieden, CDC “…back into the dark ages of medicine where treatable infections and injuries will kill once again.” - David Cameron, For
Slide 5: Drug Resistance is a Health Crisis Today
Drug Resistance is a Health Crisis Today Significant Burden of Drug Resistant Infections Sharp Decline in Antibiotic Development New Antibiotic Drug Approvals Years
Slide 6: The Right Time to Invest in Anti-Infectives
The Right Time to Invest in Anti-Infectives Predictive Efficacy Favorable Climate Acquisition Activity Regulatory Janet Woodcock “FDA Reboot” Legislation GAIN Act: QIDP, Fast Track, Priority Review, Exclusivity 21st Century Cures Act: Limited population pathway Streamlined approval Improved reimburs
Slide 7: Lysins: Rapid, Targeted Bactericidal Action
Lysins: Rapid, Targeted Bactericidal Action
Slide 8: Lysins: Breakthrough Alternatives to Antibiotics
Novel Mechanism of Action Boosts Efficacy of Conventional Antibiotics Biofilm Clearance Strong Resistance Profile Lysins: Breakthrough Alternatives to Antibiotics
Slide 9: CF-301 Breakthrough Alternative to Antibiotics for Serious Staph Aureus Infections
CF-301 Breakthrough Alternative to Antibiotics for Serious Staph Aureus Infections
Slide 10: CF-301 Is A Novel Anti-Staphylococcal Agent
Bactericidal Cell Wall Hydrolase Recombinantly-Produced 26 kD Therapeutic Protein Exclusive World-Wide License for Human Therapeutic Use from The Rockefeller University Fast Track Status Granted by FDA Patent for Composition of Matter in effect until 2032 Staph aureus Peptidoglycan CF-301 Is A Novel
Slide 11: CF-301 Displays Rapid, Potent Killing
Control CF-301 VAN DAP In vitro Timekill (1X MIC) LOD In vivo efficacy - Mouse Bacteremia Model: CF-301 Dose Response as Mono-therapy % survival BUFFER 0.025 mg/kg 0.5 mg/kg 2.5 mg/kg *LOD = Limit of Detection Source: Schuch et al JID 2014:209 Rapidly Cidal; Efficacious In vitro and In vivo CF-301 D
Slide 12: CF-301 Displays Targeted Killing
Gram Positive Gram Negative >512 Source: Schuch et al, Oral Presentation, CLSI, 2016 Highly Targeted to Staph and Strep Pathogens No Effect on Gram Negative Pathogens (low C. difficile risk) CF-301 Displays Targeted Killing
Slide 13: CF-301 Has Low Propensity for Resistance
After 26 days of serial passage, CF-301 MIC remained stable (increased <2 fold) CF-301 suppresses resistance to daptomycin (DAP), vancomycin or oxacillin CF-301 Has Low Propensity for Resistance Source: Schuch et al JID 2014:209 In vitro Serial Passage Resistance Studies - MRSA
Slide 14: Biofilms: A Major Medical Problem
Biofilm matrix protects bacteria from immune defenses Conventional antibiotics are not able to clear biofilms Can increase antibiotic tolerance 1,000-fold Biofilms harbor dangerous, semi-dormant persister bacteria ContraFect holds patent until 2033 Methods for prevention, control, disruption and tre
Slide 15: CF-301 Eradicates Biofilms
MRSA-Infected Catheter with Biofilm Before Exposure to CF-301 15 min Exposure to CF-301 CF-301 Eradicates Biofilms Source: ICAAC Poster 2013
Slide 16: CF-301 Is Synergistic with Antibiotics
In vitro Timekill (< 1x MIC) In vivo Survival (mouse) (high inoculum model) Combination with Daptomycin Provides Maximum Killing and Efficacy Similar Synergy Seen With Vancomycin and Oxacillin (Data Not Shown) CF-301 Is Synergistic with Antibiotics Source: Schuch et al JID 2014:209
Slide 17: S. aureus Bacteremia and Endocarditis: High Unmet Medical Need
S. aureus Bacteremia and Endocarditis: High Unmet Medical Need For New Treatments Feared Bug S. aureus Bacteremia, including Endocarditis, is responsible for ~200,000 Hospitalizations/Year in the US Daptomycin clinical cure rates only ~50%; non-inferior to vancomycin Current Treatments Source: 2012
Slide 18: CF-301 Boosts Daptomycin Activity In Rat Endocarditis Model
Daptomycin Alone at Human Therapeutic Equivalent Dose Daily x 4 Days 3-log reduction in CFUs Single Dose of CF-301 Plus Daptomycin Dosed Daily 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 rats gi
Slide 19: CF-301 Boosts DAP Efficacy in the Rabbit Endocarditis Model
CF-301 Boosts DAP Efficacy in the Rabbit Endocarditis Model Using Doses Equivalent to or Below the CF-301 Phase 2 Study Dose Daptomycin alone dosed daily x 4 Days ~3-log reduction in CFUs Single dose of CF-301 Plus Daptomycin Dosed Daily x 4 Days ~6-log reduction in CFUs at all CF-301 Doses vs. vehi
Slide 20: CF-301 Targets Invasive S. aureus Infections
Target Indication Treatment of Staphylococcus aureus bloodstream infections (bacteremia), including infective endocarditis, when used in addition to conventional anti-staphylococcal antibiotics Dosage and Administration Single IV infusion given over 2 hours Administered in addition to conventional a
Slide 21: CF-301 Phase 1 Study – Complete
CF-301 Phase 1 Study – Complete Single Escalating IV Dose, Double-blind, Placebo-Controlled 20 healthy volunteer; 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 CF-301-related hypersensitivity AEs 5 non-serious AE
Slide 22: Recent Progress
Recent Progress Complete Phase 1 Study Results Including Long -Term Extension Submitted to FDA ✔ End of Phase 1 Meeting with FDA ✔ Scientific Advice Meeting with MHRA (UK) ✔ SME Status Granted in EU ✔ Clinical & Laboratory Standards Institute (CLSI) Endorsement of New MIC Methodology for use in Phas
Slide 23: Chemistry, Manufacturing and Controls (CMC) Update
Chemistry, Manufacturing and Controls (CMC) Update In late 2016, fill/finish procedures at vendor unexpectedly resulted in the loss of a single batch of CF-301 and ~5 month delay of the start of Phase 2 Subsequent, multiple, non-product-related FDA and European regulatory inspections identified proc
Slide 24: CF-301 Phase 2 Study – Ongoing
CF-301 Phase 2 Study – Ongoing Study Population Adults with Complicated Bacteremia, Including Endocarditis, Caused by MRSA or MSSA, receiving conventional, standard of care (SOC) antibiotic therapy Design Superiority Comparison: CF-301 + SOC vs. Placebo + SOC International, Multicenter, Randomized,
Slide 25: Phase 2 Study Design
Phase 2 Study Design . Abbreviations: EOT = End of standard-of-care antibacterial therapy; Pbo = placebo; SOC = standard-of-care antibacterial therapy; TOC = test-of-cure visit 28 days after the EOT EARLY CLINICAL RESPONSE (14 days post CF-301/Pbo)
Slide 26: Phase 2 Study Centers
Phase 2 Study Centers Approximate Number of Study Sites By Region/Country North America: United States (~25) Europe: Belgium (5), Bulgaria (3), Czech Republic (4),France (4),Germany(6), Greece (4), Italy (4), Spain (5), UK (5) Latin America: Argentina (5), Chile (2), Guatemala (2) Rest of World: Isr
Slide 27: CF-301 Value Proposition
CF-301 Value Proposition Our Aspirational Value Proposition Assumes Clinical Results Replicate Expectations From Animal Models and Ultimate Regulatory Approval CF-301 is an anti-bacterial lysin with a novel MOA, offering the best option for treating challenging S. aureus infections used in addition
Slide 28: CF-301's Product Attributes Will Be Important to Patients, Payers and Providers
CF-301’s Product Attributes Will Be Important to Patients, Payers and Providers PATIENTS HEALTHCARE PROVIDERS INSURERS, HOSPITALS, INTEGRATED HEALTH SYSTEMS More Effective Treatment for S. aureus Bacteremia and RIE* Well Tolerated Decreases Length of Stay Reduces Overall Costs to Treat S. aureus Pot
Slide 29: Gram Negative Lysins
Gram Negative Lysins
Slide 30: Gram-Negative Infections Represent a Major Global Health Threat
Gram-Negative Infections Represent a Major Global Health Threat Emerging Strains of Gram Negative Pathogens Have Extreme Drug Resistance (XDR) And Are Resistant To All Or Nearly All Available Antibiotics. Source: CDC: Antibiotic Resistance Threats in the United States, 2013
Slide 31: Carbapenem-Resistant Enterobacteriaceae (CRE) Cases Reported to CDC
Carbapenem-Resistant Enterobacteriaceae (CRE) Cases Reported to CDC Rise in Carbapenem-Resistant Cases in US: Hospital Reports to Center for Disease Control (CDC) Source: CDC, CRE Toolkit, 2015 2001 2015
Slide 32: ContraFect Gram-Negative Lysin Program
ContraFect Gram-Negative Lysin Program Initial Target Pseudomonas aeruginosa Treatment challenges: biofilm formation and multi-drug resistance (MDR) Urgent unmet medical need for effective new treatments Compared to susceptible isolates, MDR P. aeruginosa results in greater: All cause mortality (> 2
Slide 33: CF-404 Triple Antibody Cocktail for Serious Influenza Infection
CF-404 Triple Antibody Cocktail for Serious Influenza Infection
Slide 34: Broad Spectrum Triple Antibody Cocktail for Serious Life-Threatening Influenza
Broad Spectrum Triple Antibody Cocktail for Serious Life-Threatening Influenza Extends Treatment Window Compared to Small Molecules (e.g., Tamiflu) in Mouse Models CF-404 Summary Cocktail of Antibodies CF-401 A Group 1 CF-402 A Group 2 CF-403 B CF-404
Slide 35: ContraFect Pipeline Summary
ContraFect Pipeline Summary Discovery Preclinical Phase 1 Phase 2 CF-301 (Staph aureus Bacteremia) Gram-negative Lysin CF-404 (Influenza)
Slide 36: ContraFect Corporate Information
ContraFect Corporate Information
Slide 37: Team Track Record of Creating Shareholder Value
Team Track Record of Creating Shareholder Value Steven C. Gilman, Ph.D. – Chairman and CEO EVP, R&D and CSO, Cubist Pharmaceuticals Natalie Bogdanos – General Counsel & Corporate Secretary Assoc General Counsel Memorial Sloan-Kettering; General Counsel Enzo Biochem Cara Cassino, MD FCCP – EVP, Resea
Slide 38: Financial Information Summary
Financial Information Summary Information At 3/31/2017 Cash and investments $28.9 million Shares outstanding 41.7 million Key analyst coverage Ted Tenthoff, Piper Jaffray Katherine Xu, William Blair
Slide 39: Investment Highlights
Investment Highlights Novel Anti-Infective Technologies that Address Drug-Resistance Lysins: Potential Breakthrough Alternatives to Antibiotics CF-301: for Staph aureus Infections Including MRSA First and Only Lysin to Enter Clinical Trials in the U.S. Granted Fast Track Status by FDA Phase 2 Underw
Slide 40: ContraFect Corporation
ContraFect Corporation NASDAQ: CFRX