Slide 1: SCYNEXIS, Inc. January 2015
@¢‘SCYNEXIS SCYNEXIS, Inc. January 2015
Slide 2: Forward-looking Statements
1 Certain statements regarding SCYNEXIS, Inc. (the “Company”) made in this presentation may constitute forward-looking statements, including, but not limited to, statements regarding our business strategies and goals, plans and prospects, market size, adoption rate, potential revenue, clinical valid
Slide 3: Investment Highlights
Investment Highlights Lead Asset: SCY-078 Novel oral and IV antifungal compound in Phase II development − Effective in vitro and in vivo against clinically relevant Candida and Aspergillus spp., including drug-resistant strains − Well-tolerated in Phase 1 studies in ~100 healthy subjects − Favorable
Slide 4: Invasive Fungal Infections Pose a Serious Clinical Problem
Invasive Fungal Infections Pose a Serious Clinical Problem Invasive candidiasis • Most common invasive fungal infection and 4th most common cause of hospital acquired blood stream infection in US • Mortality 25 to 40% despite treatment • Identified by CDC as an antimicrobial resistance threat in 2
Slide 5: Limitations of Current Antifungal Treatments
Limitations of Current Antifungal Treatments Antifungal Class Approved Antifungal Drug IV/Oral Mkt Size I. Azoles voriconazole, fluconazole, posaconazole IV/Oral $2.1bn1 Voriconazole Sales2: $747mm • Increasing Resistance in C. glabrata, C. krusei, Aspergillus spp • Newer agents have broader spectru
Slide 6: SCY-078 Mechanism of Action
Ergosterol SCY-078 Mechanism of Action Kartsonis et al, Drug Resistance Update, 2003 5 SCY-078 targets synthesis of -(1,3)-glucan in fungal cell wall; Target validated by echinocandins
Slide 7: SCY-078 Key Product Attributes
SCY-078 is a first-in-class enfumafungin antifungal − New chemical class issued from natural compound − Strong IP with long patent life − First non-azole with IV and oral formulations − IV formulation IND enabling studies underway, FIM 2H-15 − Oral formulation entering Phase 2 1H-2015 − Activity a
Slide 8: SCY-078 Significantly De-risked vs. Phase Assets in Other Therapeutic Areas
SCY-078 Significantly De-risked vs. Phase 2 Assets in Other Therapeutic Areas Development in anti-infectives is unusual − The target (a microbe) can be isolated − The drug works on the microbe, not the patient − Studies in a test tube (MICs) and in animal models reliably predict efficacy in man
Slide 9: SCY-078: Well-tolerated in Phase 1
SCY-078: Well-tolerated in Phase 1 SCY-078 evaluated in seven Phase 1 studies in ~100 healthy subjects − Half life supports once daily dosing − Predicted human efficacious dose of ~ 500mg daily based on murine disseminated candidiasis PK/PD studies Favorable safety and tolerability profile − Gen
Slide 10: Favorable Regulatory Environment
GAIN Act − SCY-078 oral formulation granted QIDP designation by FDA for invasive candidiasis and invasive aspergillosis Fast Track − SCY-078 oral formulation granted Fast Track designation by FDA for invasive candidiasis and invasive aspergillosis DISARM Act (Introduced) − Allowing value based
Slide 11: SCY-078 Clinical Development Program
SCY-078 Clinical Development Program Phase 1 IV formulation Ongoing Regulatory Agency Interactions Phase 3 Invasive Aspergillosis Primary therapy: SCY‐078 vs. voriconazole and/or SCY‐078 as Salvage therapy Phase 2 Invasive Candidiasis Oral SCY‐078 vs. Standard of care after IV micafungin SCY‐078 dos
Slide 12: Phase 2: Invasive Candidiasis Oral Step-down from IV Micafungin
Phase 2: Invasive Candidiasis Oral Step-down from IV Micafungin Micafungin IV 100 mg/d x 5-7 days Blood (and site of infection) culture prior to and during dosing until negative Study Days 5-7 Study Days 6 to 28 (14 days after first negative culture) Oral SCY-078 (500mg) 1000mg X 1 day then 500mg QD
Slide 13: Phase 2 Invasive Candidiasis Study Objectives
Phase 2 Invasive Candidiasis Study Objectives Primary Objectives PK, Safety − Determine the dose of SCY-078 that achieves target AUC of 15 μM⋅hr in ≥ 80% of patients (day 1 and end of therapy) − Based on Phase 1 data and modeling and simulation, a sample size of 30 patients would be sufficient − Eva
Slide 14: Invasive Candidiasis: First Indication
Invasive Candidiasis: First Indication Invasive candidiasis − Most common invasive fungal infection with high morbidity and mortality − Echinocandins currently preferred therapy − Ability to demonstrate efficacy and safety in area of unmet need due to increasing resistance SCY-078 potential for
Slide 15: Additional Indications
Additional Indications Invasive Aspergillosis − Salvage therapy in patients refractory to or intolerant of approved treatment (data support indication for prophylaxis, pre-emptive therapy) − Option to explore first line treatment compared to voriconazole Prevention of Candida and Aspergillus inf
Slide 16: Projected Milestones
Projected Milestones SCY-078 for invasive antifungal infections − First patient enrolled in oral formulation Phase 2 study for the treatment of invasive Candida infection 1Q--15 − IV formulation selection and IND-enabling studies 1H-15 − FIM IV formulation 2H-15 − Complete Phase 2 Data 1H-16 Mon
Slide 17: Financials
Financials Initial Public Offering May 2, 2014 − $62mm Raised − Top-tier Life Sciences Investors Cash Balance $34mm as of September 30, 2014 − Funds SCY-078 Development Through Q1-2016 − Non-Core Assets Potential Source of Non-Dilutive Capital Share Count − 8.5mm Shares Outstanding − 9.3mm Ful
Slide 18: Management Team
Management Team CEO and a Member of Board of Directors since 1999 20-year international pharmaceutical career with Aventis Pharma and Rhône-Poulenc Rorer Former Infectious Diseases Director Yves Ribeill, PhD President & CEO CFO since November 2003 Former CFO of Nobex Corporation and VP of
Slide 19: SCYNEXIS Key Highlights
SCYNEXIS Key Highlights 18 Pharmaceutical company committed to the discovery, development and commercialization of novel anti-infectives to address significant unmet therapeutic needs SCY-078 Ph II, novel, next generation antifungal addressing a large and growing unmet medical need of increasing ant