Scynexis, Inc. · NASDAQ:SCYX
Scynexis — Investor Presentation (January 2016)
20 slides from Scynexis's investor presentation, Jan 6, 2016
Slide 1: A New Path for Antifungal Treatments
Investor Presentation January 2016 A New Path for Antifungal Treatments
Slide 2: Forward-looking Statements
1 Certain statements regarding SCYNEXIS, Inc. (the “Company”) made in this presentation 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 validity
Slide 3: SCYX: A New Path for Antifungal Treatments
SCYX: A New Path for Antifungal Treatments 2 Mission • Developing and commercializing innovative anti-infectives Objective • Moving beyond current antifungal therapies to address unmet needs Status • SCY-078: Introducing a new class of antifungals with a novel combination of attributes
Slide 4: SCYX: Highlights
SCYX: Highlights - SCY-078, a new antifungal class with a novel combination of attributes: • Validated mechanism of action • Both IV and oral formulations • Activity against Azole- and Echinocandin-resistant strains • Targeting multiple indications • Data from two Phase 2 studies expected in 2Q 2016
Slide 5: SCY-078: A New Antifungal Class
SCY-078: A New Antifungal Class IV and oral formulations enable optimal flexibility for in- and out-patient treatment and to target other indications such as Invasive Aspergillosis and refractory fungal infections Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Oral Formulation: Invasive Candidiasis
Slide 6: Experienced Senior Management Team
Experienced Senior Management Team 5 Management team with significant experience in drug development and commercialization Developed more than 40 drugs – more than 10 of them in anti-infectives / antifungals Marco Taglietti, MD Chief Executive Officer Eric Francois Chief Financial Officer David An
Slide 7: 2015: A Year of Transition for SCYX
Board Changes • Added: Guy Macdonald (Chair), Marco Taglietti, Steve Gilman, David Hastings, Patrick Machado • Four Directors retired New Team • Marco Taglietti, CEO (April) • David Angulo, CMO (June) • Eric Francois, CFO (November) Corporate Changes • Completed $41MM Offering (April) • Expected suf
Slide 8: Favorable Environment for Anti-infectives
7 Favorable Environment for Anti-infectives - Positive impact of GAIN Act (July 2012) and pending legislation (DISARM, ADAPT, 21st Century Cures): 1. Faster development and approval process 2. Increased access to regulatory agencies 3. Additional 5 years of market exclusivity 4. Potential for better
Slide 9: Evolution of the Antifungal Landscape
Evolution of the Antifungal Landscape 8 * Numbers indicate Peak year WW sales Data on File (Study commissioned by the Company, IMS Consulting Group, 2015) POLYENES (e.g., amphotericin B) + Effective - Significant, rate-limiting toxicity - Only IV administration AZOLES (e.g., Diflucan $1.1B*, Vfend $
Slide 10: SCY-078: A New Path for Antifungal Therapy
SCY-078: A New Path for Antifungal Therapy 9 Selected Product Attributes Oral Formulation IV Formulation “Cidal” Activity vs. Candida Active vs. Azole-Resistant Active vs. Echinocandin-Resistant 1st Line Invasive Candidiasis ** 1st Line Aspergillosis ** 1st Line VVC ** Approved Therapy for rVVC Limi
Slide 11: SCY-078: A New Class with Novel Attributes
SCY-078: A New Class with Novel Attributes - β-(1-3)-glucan synthase inhibitor antifungal - A triterpene chemically distinct from Echinocandins - First non-Azole with IV and oral dosing in clinics - Oral formulation currently in Phase 2 • 7 Phase 1 studies in ~100 healthy subjects • Linear, well-cha
Slide 12: SCY-078: Validated Mechanism of Action
Ergosterol SCY-078: Validated Mechanism of Action 11 Adapted by Kartsonis et al, Drug Resistance Update, 2003 Anderson Freitas Pinheiro et al. International Journal of Quantum Chemistry, 2012 - SCY-078 targets synthesis of β-(1,3)-glucan in fungal cell wall • Mechanism validated by echinocandins • D
Slide 13: SCY-078: Microbiology Profile
SCY-078: Microbiology Profile * itraconazole-resistant Aspergillus spp. (MIC, 4 g/ml) as determined by CLSI broth microdilution methods Pfaller M. A and Col., J. Antimicrobial Agents and Chemotherapy, 2013; 68(4); 858-863 & 2013; 57(2); 1065-1068. MIC90 μg/mL (MIC range) Fluconazole Caspofungin SCY-
Slide 14: SCY-078 Targets Multiple Infections
SCY-078 Targets Multiple Infections 13 Invasive Aspergillosis - 46K* annual cases in the US - High mortality rate (40-50%) - Long treatment (8-12 weeks) - Azoles as 1st line - Need for alternative IV/oral therapies Invasive Candidiasis - 98K* annual cases in the US - High mortality rate (20-40%) - R
Slide 15: SCY-078: Ongoing Development Path
SCY-078: Ongoing Development Path 14 Clear path to registration for 1st indication: Invasive Candidiasis - Targeting both primary and salvage treatments in refractory infections - 4 ongoing workstreams with expected data in 2Q 2016
Slide 16: SCY-078: Ongoing Phase 2 in IC
- Oral step-down following IV Echinocandin • Randomized, open-label, assessing two doses of SCY-078 vs. Standard of Care • Primary Endpoints: Safety, Tolerability and Pharmacokinetics • Exploratory Endpoints: Efficacy at end of antifungal therapy and relapse rates • First patient enrolled in March 2
Slide 17: SCY-078: Ongoing Phase 2 in VVC
- Oral treatment for vulvovaginal candidiasis • Randomized, evaluator-blinded study • Patients with moderate to severe VVC • Two dose-regimens of oral SCY-078 (5 or 3 days) compared to standard dose-regimen of Fluconazole • Primary Endpoints: Safety and Efficacy (clinical & microbiological outcome)
Slide 18: Timelines and Financial Highlights
Timelines and Financial Highlights 17 H1 2016 H2 2016 • QIDP and Fast Track status for IV • Top-line results Phase 2 Oral Invasive Candidiasis • Complete IV Phase 1 Program • Top-line results Phase 2 VVC • Additional in vitro / in vivo data • $53.8mm Cash as of 9/30/15 – expected sufficient funds in
Slide 19: SCYX: Highlights
SCYX: Highlights - SCY-078, a new antifungal class with a novel combination of attributes: • Validated mechanism of action • Both IV and oral formulations • Activity against Azole- and Echinocandin-resistant strains • Targeting multiple indications • Data from two Phase 2 studies expected in 2Q 2016
Slide 20: www.scynexis.com
NASDAQ: SCYX www.scynexis.com 19