Scynexis, Inc. · NASDAQ:SCYX
Scynexis — Investor Presentation (March 2018)
28 slides from Scynexis's investor presentation, Mar 5, 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 | Mar. 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: General Information
General Information SCY-078 – First 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 4: SCYX: Investment Opportunity
Positive track record in drug development & antifungal expertise Diverse backgrounds & operating experience in healthcare Experienced Management Team and Board SCYX: Investment Opportunity SCY-078 is an investigational drug. Items listed on this slide illustrate SCY-078 target attributes. SCY-078: N
Slide 5: 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. * Including pre-clinical and clinical trial results. Flexible Dosing IV / Oral Multiple indications possible Safe and Well-Tolerated 400+ subjects exposed Hig
Slide 6: 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 and Biofilm Formation. Antimicrob Agents Chemother. 2017
Slide 7: SCY-078: Key Attributes vs. SoC Agents
SCY-078 is an investigational drug – items listed on this chart illustrate SCY-078 target attributes. 2021 target market intro based on estimated 2020 NDA filing. a. Company-reported Sales (filings) and IMS data Azole SCY-078 7 Echinocandin SCY-078: Key Attributes vs. SoC Agents * Active against mos
Slide 8: Clinical Update - Last Twelve Months
8 Clinical Update - Last Twelve Months Liposomal IV SUPERIOR in Head-to-Head Comparison (preclinical) Clinical Hold (March 2017) Cyclodextrin IV Formulation Liposomal IV Formulation Invasive Candidiasis stopped Accelerate/expand SCY-078 Oral programs Address IV Clinical Hold and expedite development
Slide 9: Our Vision for 2018 and Beyond
Our Vision for 2018 and Beyond 9 SCY-078 is an investigational drug. Vulvovaginal Candidiasis (oral) Invasive Aspergillosis Combination (oral & IV/oral) Refractory Invasive Fungal Infections (oral & IV/oral) CARES Study (open-label, emergency protocol, C. auris) P2 (start in Q3 2018) P2b IV/Oral (st
Slide 10: Vulvovaginal Candidiasis (VVC)
Vulvovaginal Candidiasis (VVC) SCY-078 – First of a Novel Oral/IV Triterpenoid Antifungal Family
Slide 11: VVC: Low Risk / High Reward Opportunity
SCY-078 is an investigational drug – items listed on this chart illustrate SCY-078 target attributes. 11 VVC: Low Risk / High Reward Opportunity *Lack of renal, hepatic, CNS toxicities and low risk of drug-drug interactions. Pregnancy Risk SCY-078 Active vs. Candida albicans Active vs. non-albicans
Slide 12: SCY-078 U.S. Opportunity in VVC
12 SCY-078 U.S. Opportunity in VVC SCY-078 U.S. Sales Potential ~$450-600M SCY-078 potential sales represent ~4% of overall fluconazole prescriptions in VVC ROW opportunity expected to be similar to U.S. Market U.S. TARGET POPULATION SCY-078 PENETRATION RATES SCY-078 PRICING – PER COURSE SCY-078 U.S
Slide 13: SCY-078 VVC Phase 2a Clinical Data
13 Demonstrated activity vs. Candida Numerically higher Clinical Cure Rates than fluconazole High long-term efficacy Low relapse rate at 4 months No serious AEs or discontinuations GI events were mild to moderate, of short-duration and mostly related to SCY-078’s loading dose M. Roman et al: A multi
Slide 14: ONGOING: Phase 2b Dose-Finding Study in VVC
14 ONGOING: Phase 2b Dose-Finding Study in VVC Top-line results expected mid-2018 Enrollment: 180 patients with moderate to severe VVC Endpoints: % of patients with clinical cure* and mycological eradication** at day 10 and day 25 SCY-078 VVC Development Plan Baseline Day 1 Randomization Screening S
Slide 15: Invasive Candidiasis (IC)
Invasive Candidiasis (IC) SCY-078 – First of a Novel Oral/IV Triterpenoid Antifungal Family
Slide 16: IC: Oral Option with Broad Anti-Candida Activity
SCY-078 is an investigational drug – items listed on this chart illustrate SCY-078 target attributes * Voriconazole can also be used for step-down therapy per new guidelines; however, Fluconazole is the most commonly used. 16 IC: Oral Option with Broad Anti-Candida Activity Safety SCY-078 Active vs.
Slide 17: SCY-078 U.S. Opportunity in IC
17 SCY-078 U.S. Opportunity in IC U.S. TARGET DAYS of THERAPY SCY-078 PENETRATION RATES SCY-078 PRICING PER DAY SCY-078 U.S. NET SALES IV ORAL ~1.8M ~1.3M ~6% ~35% ~$600 to $800 ~$450 to $600 ~$63-$85M ~$205-$275M SCY-078 U.S. Sales Potential ~$275-$360M ROW opportunity expected to be similar to U.S
Slide 18: SCY-078 IC Clinical Data To-Date
18 PK/Efficacy 27 patients with IC enrolled 500 mg QD and 750 mg QD of oral SCY-078 compared to fluconazole 400 mg after IV echinocandin SCY-078 Oral dose of 750mg QD achieved target exposure in patients Safety/Tolerability Safe and well-tolerated Most common AEs were mild or moderate GI-related eve
Slide 19: SCY-078 IC Development Plan
Only one Phase 3 required for approval in IC Comparing SCY-078 (IV and oral) vs. SoC (IV echinocandin + oral fluconazole) Primary Endpoint: Global Response at end of treatment 19 SCY-078 IC Development Plan ONGOING: Open-label Phase 3 Studies (FURI and CARES) vs. historical controls FURI study: Seve
Slide 20: Invasive Aspergillosis (IA)
Invasive Aspergillosis (IA) SCY-078 – First of a Novel Oral/IV Triterpenoid Antifungal Family
Slide 21: IA: Opportunity to Improve Outcomes in a High-Mortality Infection
21 SCY-078 High activity vs. azole-resistance 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 Treatment Options Triazoles safety profiles vary Risk of DDIs Unsatisfactory Clinical Outcomes M
Slide 22: SCY-078 IA In Vivo Data To-Date
Neutropenic rabbit model of pulmonary aspergillosis evaluating SCY-078 alone and in combination with Isavuconazole Doses: (IV) SCY-078 2.5, 7.5 mg/kg; (PO) Isavuconazole 40 mg/kg for 12 days Combination therapy resulted in better efficacy vs. monotherapy for all efficacy parameters, including signif
Slide 23: SCY-078 IA Development Plan
23 SCY-078 IA Development Plan Global, open-label Phase 3 Study (FURI) vs. historical controls Protocol to be amended in H2 2018 to add Aspergillus infections Potential eligibility to Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) SCY-078 is an investigational drug. Only on
Slide 24: Conclusion
Conclusion SCY-078 – First of a Novel Oral/IV Triterpenoid Antifungal Family
Slide 25: SCYX: Key Milestones
SCYX: Key Milestones Recent Milestones Initiated Phase 2b DOVE study in VVC(Q3 2017) Accelerated development of new IV liposomal formulation Two on-going clinical trials for refractory infections (FURI & CARES) Upcoming Milestones Mid-2018: Phase 2b DOVE study read-out Q3 2018: Initiate Phase 2 Comb
Slide 26: 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 Cooley Diverse backgrounds & ope
Slide 27: SCYX: Conclusion
SCYX: Conclusion SCY-078 is an investigational drug. $1B+ market opportunity in the U.S. Potential BD opportunities SCY-078 Potential first NDA in 2020 No new class in over 20 years New IV formulation into humans by Q3 Fulfilling Unmet Needs & Improving Patient Outcomes Oral Formulation progressing
Slide 28: Thank You
Thank You SCY-078 – First of a Novel Oral/IV Triterpenoid Antifungal Family