Scynexis, Inc. · NASDAQ:SCYX
Scynexis — Investor Presentation (January 2018)
27 slides from Scynexis's investor presentation, Jan 8, 2018
Slide 1: SCY-078 – First Representative of a Novel Oral/IV Triterpenoid Antifungal Family
SCY-078 – First Representative of a Novel Oral/IV Triterpenoid Antifungal Family CORPORATE PRESENTATION | January 2018
Slide 2: 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 revenue, clinical validity an
Slide 3: SCYX: Investment Opportunity
SCYX: Investment Opportunity A novel triterpenoid oral & IV broad spectrum antifungal EXPERIENCED TEAM SCY-078 FAVORABLE TECHNICALS Committed to positively impacting the lives of patients suffering from difficult-to-treat and often life-threatening infections
Slide 4: Foundation: 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 Cooley Diverse backgrounds & ope
Slide 5: Foundation: Favorable Technicals
Market value (as of 1/4/18): $2.42 mm Total cash (as of 9/30/17): $48mm $15mm debt agreement (Solar Capital) 3-month trading volume (as of 1/4/18): 200K shares Foundation: Favorable Technicals Q3’17 TOP SHAREHOLDERS RESEARCH COVERAGE Excludes Insiders and Index Funds. NASDAQ: SCYX Firm Name % O/S Q3
Slide 6: SCY-078: A Novel Triterpenoid Antifungal
SCY-078: A Novel Triterpenoid Antifungal SCY-078 is an investigational drug. Items listed on this slide illustrate SCY-078 target attributes. Flexible Dosing IV / Oral Safe Well-Tolerated High Tissue Penetration Low Risk of DDIs Validated MOA Fungicidal vs. Candida Broad Spectrum (MDR Strains) World
Slide 7: SCY-078: Strong Scientific Evidence De-Risked Clinical Plan
SCY-078: Strong Scientific Evidence SCY-078 is an investigational drug. De-Risked Clinical Plan 2 Phase 3 open-label studies ongoing ( rIFI ) à oral only Potent antifungal activity à 1,500+ strains of Candida & 500+ strains of Aspergillus tested Favorable safety profile à 400+ subjects exposed to SC
Slide 8: SCY-078: Validated MoA
SCY-078: Validated MoA SCY-078 is an investigational drug. Items listed on this slide illustrate SCY-078 target attributes. Minimal Limited off-target effects High distribution to key tissues Oral bioavailability ~ 36% Mean half-life of ~20 hours
Slide 9: SCY-078: Effect on Candida spp. Cell Wall
9 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 and Biofilm Formation. Antimicrob Agents Chemother. 2017 May; 61(5). Potent activity of SCY-078 vs. M
Slide 10: SCY-078: Key Attributes vs. SoC Agents
SCY-078 is an investigational drug – items listed on this chart illustrate SCY-078 target attributes. a. IMS Data 2013 Fungicidal vs. Candida spp. IV and Oral Formulations Available Azole SCY-078 Active vs. Candida albicans Active vs. Candida glabrata Active vs. Azole-Resistant Active vs. Echinocand
Slide 11: SCY-078: Platform of Differentiated Indications
Additional indications under consideration: Chronic Fungal Infections, Prophylaxis Vulvovaginal Candidiasis Invasive Aspergillosis Combo Refractory Invasive Fungal Infections Preclinical Phase 1 Phase 2 Phase 3 CARES (open-label, C. auris) P2 (exp. to start in Q3 2018) P2b (exp. to start in Q4 2018)
Slide 12: Opportunity in Invasive Candidiasis
SCY-078 Broad Spectrum Of Activity vs. Azole-resistant strains vs. Majority of echinocandin-resistant strains vs. MDR C. auris Fungicidal vs. Candida High volume of distribution and excellent penetration into relevant tissues Validated MOA (Glucan Synthase Inhibitor) Flexible Dosing with IV/Oral All
Slide 13: Invasive Candidiasis Opportunity: US
Invasive Candidiasis Opportunity: US * Preliminary assessment (to be further validated) Source: IMS MIDAS 2015 (SU), CDC SCY-078 is an investigational drug. SCY-078 provides an alternative to current echinocandin use in empiric and confirmed cases of IC, and a significant improvement vs. fluconazole
Slide 14: Invasive Candidiasis Development Plan
Invasive Candidiasis Development Plan 1 P2b IV-Oral 1 P1 IV 1 P3 IV-Oral Planned for Q3 2018 Planned initiation Q4 2018 2 doses of SCY-078 (IV and oral) vs. SoC 1 P3 study required 1 dose of SCY-078 (IV and oral) vs. SoC ONGOING: Open-label Phase 3 Studies (FURI and CARES) vs. historical controls FU
Slide 15: Phase 2a - Objectives & Design and Results
Phase 2a - Objectives & Design Identify an oral dose of SCY-078 that would achieve the target exposure in patients with invasive candidiasis Collect safety and tolerability data of oral SCY-078 in the invasive candidiasis population Provide an initial efficacy evaluation of SCY-078 in invasive candi
Slide 16: Invasive Candidiasis Upcoming Studies
Main design of both Phase 2 and Phase 3 trials Double-blind, randomized, multi-national, active comparator, non-inferiority (Phase 3) vs. Standard of Care ~ 60 anticipated patients for Phase 2b ~ 200 anticipated patients for Phase 3 Main endpoints Primary: Global response at end of antifungal therap
Slide 17: Opportunity in Vulvovaginal Candidiasis
SCY-078 Broad spectrum of anti-Candida activity (including albicans and non-albicans spp.) Active against azole resistant strains Fungicidal vs. Candida Excellent penetration into vaginal tissue Potent antifungal activity in vaginal pH Novel Oral Glucan Synthase Inhibitor Safe and well tolerated Hig
Slide 18: Vulvovaginal Candidiasis Opportunity: US
Vulvovaginal Candidiasis Opportunity: US SCY-078 is an investigational drug Source: NIH and CDC VVC statistics. 8% 20% 1-3 day of therapy 6-9 days of therapy ~158M of total women ~6M VVC women ~500K recurrent VVC ~4.5-9MM DOT ~1.3M severe/ complicated 4% ~1.5-2.5 MM SCY-078 DOT 30% SCY-078 provides
Slide 19: Vulvovaginal Candidiasis Data To-Date
Proof of concept: show anti-Candida clinical activity in VVC model Active reference arm performed as expected, validating the study Evidence of efficacy and lower relapse rates in VVC Positive systemic safety No serious AEs and discontinuations Higher frequency of GI mild/moderate, short-duration AE
Slide 20: Vulvovaginal Candidiasis Development Plan
Vulvovaginal Candidiasis Development Plan SCY-078 is an investigational drug. * complete resolution of signs and symptoms | ** negative fungal culture. ONGOING: Phase 2 dose-finding study (DOVE) vs. oral fluconazole Top-line results expected mid-2018 Baseline Day 1 Randomization Screening SCY-078 5
Slide 21: Opportunity in Invasive Aspergillosis Combo
SCY-078 Oral Formulation High penetration to the lungs Combination therapy may provide an improvement in survival Pre-clinical synergistic activity with azoles Novel Oral Glucan Synthase Inhibitor Safe and well tolerated Low risk of DDIs Emergence of A. fumigatus Resistance Need for New Treatment Op
Slide 22: Invasive Aspergillosis Data To-Date
Neutropenic rabbit model of pulmonary aspergillosis evaluating SCY-078 alone and in combination with Isavuconazole (n=6 / group) Doses: (IV) SCY-078 2.5, 7.5 mg/kg; (PO) Isavuconazole 40 mg/kg for 12 days Study endpoints included survival, lung fungal burden, lung weight and lung infarct score Preli
Slide 23: Invasive Aspergillosis Development Plan
Invasive Aspergillosis Development Plan 1 P3 IV-Oral IA Combo 1 P2a Oral IA Combo Planned for Q3 2018 SCY-078+SoC vs. SoC alone 1 P3 study required SCY-078+SoC vs. SoC alone Global, open-label Phase 3 Study (FURI) vs. historical controls FURI study: Severe or invasive refractory Aspergillus infectio
Slide 24: SCYX: Discovery Platform/Pipeline
SCY-078 analogues Benefit: Build upon proof-of-concept already established with SCY-078 Effort completed to date: 28 structural analogues screened against a panel of yeasts, molds and dermatophytes 3 identified as compounds of interest Further evaluation and characterization planned for 2018 SCYX: D
Slide 25: Key Milestones 2018
2017 Our Vision for 2018 2019 SCY-078 is an investigational drug. Vulvovaginal Candidiasis Invasive Aspergillosis Combination Refractory Invasive Fungal Infections CARES Study (open-label, emergency protocol, C. auris) P2 (start in Q3 2018) P2b (start in Q4 2018) DOVE P2b study (results exp. mid-201
Slide 26: SCYX: Conclusion
SCYX: Conclusion Adequate cash balance, liquidity, research coverage and holders Worldwide Rights & Long Exclusivity (IP up to 2035) QIDP, Fast Track & Orphan Drug Status for Invasive Candidiasis and Aspergillosis Broad Spectrum, including MDR Strains Validated MOA Fungicidal vs. Candida High Tissue
Slide 27: Thank You
Thank You SCY-078 – First of a Novel Oral/IV Triterpenoid Antifungal Family