Scynexis, Inc. · NASDAQ:SCYX
Scynexis — Investor Presentation (August 2018)
23 slides from Scynexis's investor presentation, Aug 9, 2018
Slide 1: Corporate Presentation – Aug. 2018
Corporate Presentation – Aug. 2018 Ibrexafungerp (formerly SCY-078) First Representative of a Novel Oral/IV Triterpenoid Antifungal Family “Committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections”
Slide 2: Forward-Looking Statements
Forward-Looking Statements 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 re
Slide 3: Ibrexafungerp (SCY-078): Novel Triterpenoid Antifungal
Ibrexafungerp (SCY-078): Novel Triterpenoid Antifungal Ibrexafungerp is an investigational drug. Items listed on this slide illustrate ibrexafungerp target attributes Safe and Well-Tolerated 450+ subjects exposed Oral Formulation Entering Phase 3 IV in pre-clinical development 20-hour Half-Life High
Slide 4: Ibrexafungerp MoA: Glucan Synthase Inhibitor
Ibrexafungerp (SCY-078) MoA: Glucan Synthase Inhibitor C. auris before SCY-078 C. auris after SCY-078 Larkin E., et al. The Emerging Pathogen Candida auris: Growth Phenotype, Virulence Factors, Activity of Antifungals, and Effect of SCY-078, a Novel Glucan Synthesis Inhibitor, on Growth Morphology a
Slide 5: Key Attributes vs. SoC Agents
Ibrexafungerp: Key Attributes vs. SoC Agents ü ü ü ü ü ü ü ü ü ü ü ü ü ü ü * Active against most echinocandin-resistant Candida isolates Ibrexafungerp is an investigational drug – items listed on this chart illustrate its target attributes. 2021 target market intro based on estimated 2020 NDA filing
Slide 6: Oral Development Plans
Ibrexafungerp Oral Development Plans 8 Vulvovaginal Candidiasis Invasive Aspergillosis Combination Refractory Invasive Fungal Infections CARES Study (open-label, emergency protocol, C. auris) P2 study (start in Q3’18) DOVE P2b study (reported in Jul. 2018) FURI Study (open-label, refractory IFIs) FD
Slide 7: IV Development Plans
Ibrexafungerp IV Development Plans Ibrexafungerp is an investigational drug >70 subjects exposed to IV ibrexafungerp No systemic safety concerns (i.e., renal, hepatic, etc.) Local injection site reactions to address Liposomal formulation to improve local tolerability in pre-clinical development Prot
Slide 8: Vulvovaginal Candidiasis (VVC)
Vulvovaginal Candidiasis (VVC) “Many of the unresolved clinical issues in managing women with rVVC would disappear if truly fungicidal drugs and regimens were available.” Dr. Jack Sobel Curr. Infect. Dis. Rep.2006,8:481–486
Slide 9: Positioning in VVC
Ibrexafungerp Positioning in VVC Ibrexafungerp is an investigational drug Preliminary assessment (to be further validated). Sources: Blue Print/SCYNEXIS Primary HCPs and Payers Market Research Moderate/Severe (~1.6M cases) Mild (~5.2M cases) Recurrent (~650K cases) Fluconazole Ibrexafungerp High and
Slide 10: U.S. Opportunity in VVC
Ibrexafungerp U.S. Opportunity in VVC Ibrexafungerp U.S. Sales Potential ~$450-600M Conservative estimates à Ibrexafungerp potential sales represent ~6% of overall fluconazole prescriptions in VVC ROW opportunity expected to be similar to U.S. market U.S. TARGET POPULATION IBX PENETRATION RATES IBX
Slide 11: Phase 2b DOVE Study
Ibrexafungerp Phase 2b DOVE Study Randomized, multi-center, double-blind, active-controlled, dose-finding study to identify optimal oral dose of ibrexafungerp for Phase 3 program 186 ITT patients with moderate-to-severe acute VVC (S&S ≥7) 153 mITT patients (cultured-confirmed primary efficacy popula
Slide 12: Phase 2b DOVE Study Key Findings
Phase 2b DOVE Study Key Findings Ibrexafungerp 600mg dose for one day (given as 2 doses of 300mg 12 hours apart) as optimal dose High clinical and mycological activity with sustained clinical response over time Clinical data consistent with ibrexafungerp’s attributes: Fungicidal vs. Candida High vag
Slide 13: Key Efficacy Results of P2b DOVE Study – Ibrexafungerp 600mg Dose
Key Efficacy Results of P2b DOVE Study – Ibrexafungerp 600mg Dose Results based on mITT population | * No rescue antifungal use. Signs and Symptoms [S&S] score defined as a composite endpoint of the subject’s reported symptoms (burning, itching and irritation) and the investigator’s assessed signs (
Slide 14: Additional Efficacy Parameters of P2b DOVE Study
Additional Efficacy Parameters of P2b DOVE Study – Ibrexafungerp 600mg Dose Results based on mITT population. Mean signs and symptoms score based on 0-18 scale. P value based on change from baseline score mean difference between SCY-078 600mg and FLU. P=0.01 Ibrexafungerp is an investigational drug
Slide 15: Path Forward for VVC
Ibrexafungerp Path Forward for VVC Planned Activities Pending discussion with FDA, plan to initiate Phase 3 VVC program in 4Q18: Two Phase 3 acute VVC (~300 patients per study à superiority vs. placebo) One Phase 3 recurrent VVC (~300 patients à superiority vs. placebo) End of P2 Meeting Potential N
Slide 16: Invasive Aspergillosis (IA)
Invasive Aspergillosis (IA) “Invasive fungal infections will not go away any time soon. Therefore, we need to circumvent resistance to treatment by continued discovery and development of new antifungal agents and strategies.” Dr. John Perfect Nature Reviews/Drug Discoveries (2017)
Slide 17: Invasive Aspergillosis: Improving Outcomes in High-Mortality Infection
Invasive Aspergillosis: Improving Outcomes in High-Mortality Infection Why Oral Ibrexafungerp? High activity vs. azole-resistant spp. High penetration to the lungs Optimal for combination therapy Oral Safe and well-tolerated Low risk of DDIs Emergence of A. fumigatus Resistance Need for New Treatmen
Slide 18: IA In Vivo Data to-Date
Ibrexafungerp IA In Vivo Data to-Date Neutropenic rabbit model of pulmonary aspergillosis evaluating ibrexafungerp alone and in combination with isavuconazole Doses: (IV) ibrexafungerp (SCY-078) 2.5, 7.5 mg/kg; (PO) isavuconazole 40 mg/kg for 12 days Combination therapy resulted in better efficacy v
Slide 19: IA Development Plan
Ibrexafungerp IA Development Plan Ibrexafungerp is an investigational drug Planned Activities Phase 2 Oral à ~60 patients Oral ibrexafungerp allowing combination for the entire treatment duration One Phase 3 required for approval in IA à ~250 IA patients Superiority Design à Comparing oral ibrexafun
Slide 20: Refractory Invasive Fungal Infections (rIFI)
Refractory Invasive Fungal Infections (rIFI) “Invasive fungal infections will not go away any time soon. Therefore, we need to circumvent resistance to treatment by continued discovery and development of new antifungal agents and strategies.” Dr. John Perfect Nature Reviews/Drug Discoveries (2017)
Slide 21: rIFI Ongoing Studies
Ibrexafungerp rIFI Ongoing Studies Open-label Phase 3 Studies (FURI and CARES) vs. historical controls FURI study: Severe or invasive refractory Candida infections CARES study: Infections caused by Candida auris, a pathogen that is often multidrug-resistant and associated with high mortality. Study
Slide 22: SCYX: Experienced Management
SCYX: Experienced Management Positive track record in drug development & antifungal expertise CEO: Marco Taglietti, M.D. Schering-Plough, Stiefel, Forest Labs CMO: David Angulo, M.D. Schering-Plough, Stiefel, Brickell Biotech CFO: Eric Francois Cowen, Lazard, Topi General Counsel: Scott Sukenick Coo
Slide 23: SCYX: Conclusion
SCYX: Conclusion ~$1bn market opportunity in the U.S. Potential BD opportunities IBREXA Potential first NDA in 2020 (First new class in over 20 years) Phase 3 registration program to start by end of 2018 Fulfilling Unmet Needs & Improving Patient Outcomes Oral formulation progressing in multiple ind