Scynexis, Inc. · NASDAQ:SCYX
Scynexis — Canaccord Conference 2015
18 slides from Scynexis's conference presentation, Aug 11, 2015
Slide 1: SCYNEXIS, Inc. Speed and Innovation in Anti-Infectives
SCYNEXIS, Inc. Speed and Innovation in Anti-Infectives Canaccord Conference Boston, August 12-13, 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: Experienced Management Team
Experienced Management Team 2 CEO effective April 2015 Former CMO of Forest Labs and President of the Forest Research Institute Former Head of R&D at Stiefel Labs and of Anti-Infectives at Schering-Plough Marco Taglietti, MD Chief Executive Officer Interim CFO from CMF Associates, LLC Prev
Slide 4: Investment Highlights
Investment Highlights Significant unmet medical needs in a $3.6B+ antifungal market Favorable regulatory environment with clear path to registration − Multiple FDA QIDP product approvals in the past year, including Dalvance (Durata), Sivextro (Cubist), Orbactiv (Medicines), Zerbaxa (Cubist), Cre
Slide 5: Significant Unmet Medical Needs
Candidiasis and Aspergillosis are serious and life threatening fungal infections with growing resistance Invasive Candidiasis remains a serious clinical problem − 4th most common cause of hospital-acquired blood infection in US − Mortality rate of 27 to 40% despite treatment − Identified by CDC
Slide 6: Limited number of antifungal options
Limited number of antifungal options -- Only three classes of antifungals -- POLYENES Ambisome ($450M1), amphotericin B Effective vs a broad range of fungi Significant toxicity (renal, cardiac, infusion) Limited activity against C. glabrata Only IV administration AZOLES voriconazole ($754M2)
Slide 7: SCY-078: Validated Mechanism of Action
Ergosterol SCY-078: Validated Mechanism of Action Adapted by Kartsonis et al, Drug Resistance Update, 2003 Anderson Freitas Pinheiro et al. International Journal of Quantum Chemistry, 2012 6 SCY-078 targets synthesis of b-(1,3)-glucan in fungal cell wall − Mechanism validated by echinocandins − Di
Slide 8: SCY-078: Unique Product Attributes
SCY-078: Unique Product Attributes SCY-078 is a first-in-class enfumafungin antifungal in clinical development − New chemical class from natural compound − First non-azole with IV and oral formulations in development − Composition-of-matter IP with long patent life − Activity against Candida and A
Slide 9: SCY-078: Microbiology profile
SCY-078: Microbiology profile Broad activity against Candida species * Activity against multi drug resistant Candida strains Ongoing microbiology studies to further characterize activity of SCY- 078 in recent clinical isolates and resistant strains C andid a s p p . MIC90 μg/mL (MIC range) Flu
Slide 10: Favorable Environment for Anti-Infectives
Development risks in anti-infectives are lower than in other areas − The pathogen is an external target with predictive in vitro and in vivo models − Well established PK/PD models − Significantly de-risked development projects once in the clinical stage Favorable current regulatory environment s
Slide 11: SCY-078: Well-tolerated in Phase 1
SCY-078 evaluated in seven Phase 1 studies in ~100 healthy subjects − Well characterized oral PK − Half-life supports once daily dosing − Predicted human efficacious oral dose of ~500-750mg daily based on murine disseminated candidiasis PK/PD studies Favorable safety and tolerability profile − S
Slide 12: SCY-078: Clinical Plan in Invasive Candidiasis
SCY-078: Clinical Plan in Invasive Candidiasis 11 Clear path to registration in Invasive Candidiasis − Targeting both primary and salvage treatment in refractory infections − Phase 2 Study in VVC to strengthen evidence of clinical efficacy against Candida
Slide 13: SCY-078: Ongoing Phase 2 in IC, Study Design
Oral step-down following IV Echinocandin − Randomized, open-label study to assess two different doses of SCY-078 versus standard of care as an oral step-down treatment following an IV echinocandin − Primary Endpoint: Safety, tolerability and PK/PD of two oral doses of SCY-078 − Secondary and explo
Slide 14: SCY-078: Planned Phase 2 in VVC
Randomized, evaluator-blinded to assess two different dose regimens of Oral SCY-078 versus standard of care (Fluconazole) in subjects with moderate to severe VVC Two dose-regimens of oral SCY-078 (5 days or 3 days) compared to standard dose-regimen of Fluconazole. Assessment − Day 24 (Primary Te
Slide 15: SCY-078: Target Indications
Invasive Candidiasis is the first target indication − Primary and salvage therapy in Invasive Candidiasis SCY-078 Positioning in Invasive Candidiasis − Treatment for refractory, multi-drug resistant pathogens − Alternative IV treatment to echinocandins allowing step-down option − Step-down optio
Slide 16: SCYNEXIS Milestones Achieved and Projected
SCYNEXIS Milestones Achieved Jan-2014 QIDP Status for Oral May-2014 IPO Completed Oct-2014 Waterstone Deal (SCY-635) Dec-2014 IV Formulation Selected Dec-2014 Fast Track for Oral Mar-2015 IV IND GLP Tox Started Mar-2015 First Patient in Phase 2 Oral Apr-2015 Follow-on Public Offering
Slide 17: Financial Highlights
Financial Highlights 16 Initial Public Offering May 2014 − $62mm raised (gross proceeds) − Repaid $15mm debt − Top-tier Life Sciences Investors $41mm Follow-On Offering Completed April 2015 (gross proceeds) $57mm Cash as of June 30, 2015 − Funds company into H1-2017 − SCY-078 development − Ong
Slide 18: SCYNEXIS Summary
SCYNEXIS Summary SCY-078: Innovative QIDP / Fast Track product in Phase 2 − Unique combination of attributes of safety, efficacy and flexibility of administration − Activity against resistant fungal strains, including multi-drug resistant pathogens − Well tolerated orally in ~100 subjects − IV and