Scynexis Fully Integrated Drug Discovery & Development 2011 Overview
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Scynexis Fully Integrated Drug Discovery & Development 2011 Overview

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SCYNEXIS provides fully-integrated contract research solutions including medicinal chemistry, discovery biology, ADMET-PK, bioanalysis and analytical chemistry, process chemistry and cGMP......

SCYNEXIS provides fully-integrated contract research solutions including medicinal chemistry, discovery biology, ADMET-PK, bioanalysis and analytical chemistry, process chemistry and cGMP manufacturing. We have delivered 11 Preclinical Candidates (PCCs) to our clients since 2005. We are FDA and DEA inspected.

Ask yourself - Do you want compounds... Or do you want DRUGS?

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  • 1. Fully-Integrated Drug Discovery & Development Solutions March 28, 2011SCYNEXIS® Proprietary and Confidential Information
  • 2. About SCYNEXIS SCYNEXIS delivers integrated, efficient and innovative drug discovery and development SOLUTIONS to our global health and pharmaceutical partners. Our record of success is exemplified by the delivery of 11 pre-clinical drug candidates over the last five years. SCYNEXIS also developed the chemical manufacturing process for a customer’s NDA. We are registered with and inspected by both the FDA and DEA. SCYNEXIS provides Fully-Integrated Contract Research SOLUTIONS including: ● Medicinal Chemistry ● Lead Optimization ● Computational Chemistry ● ADMET-PK ● Bioanalysis ● Process / cGMP Chemistry ● Analytical ChemistryWe provide more than just compounds… We provide you with DRUGS SCYNEXIS® Proprietary and Confidential Information
  • 3. About SCYNEXIS: Founding & Personnel ● Founded in July 2000 in Research Triangle Park, NC ● Former Sanofi-Aventis (Rhône-Poulenc) Researchers ● 140+ Team Members across the 120,000 ft2 Facilities ● Experienced Leadership ◆ Merck, GSK, Sanofi-Aventis, Pfizer, BMS, AstraZeneca, BASF, Lilly, Trimeris, DSM ● Flexible Teams & Unique Risk/Reward Partnering Business ◆ FTE’s, Time & Materials, Fixed-Bid Project Work Proposals ◆ Profitable Service Business ◆ Product and Partnership UpsidesSCYNEXIS® Proprietary and Confidential Information
  • 4. SCYNEXIS: By the Numbers● 140+ Employees Across Two Campuses 18+ Years of Experience (Average) +60% Ph.D.’s on Chemistry Teams● 120,000 ft2 facilities in RTP, NC 64 Fume Hoods Largest “Chemistry House” in Southeast LC/MS/MS, HPLC, GC/MS, NMR, DSC● 100+ Clients Spanning the Globe Virtual/Biotech/Midsize/Top 25 MedChem/Process/DMPK● Strong Financials & Proven Success $29M for 2010 Service/Milestones/Royalties >60% CAGR of Revenues 11 Preclinical CandidatesSCYNEXIS® Proprietary and Confidential Information
  • 5. Why SCYNEXIS? Drug Discovery & Development Expertise Innovation & Creativity Fully-integrated Research Units (DMPK-MedChem-GMP API)World-class Scientists & Proven Track Record Concept to Marketed Drugs 11 PCC’s, multiple IND’s/NDA’s ~18 years Experience per FTE Integrity & Confidentiality Focus on Teamwork CLIENT US Operations, Data Security, Clients own IPIntegrated Project Management & Weekly Client Updates Proven Success with Customer Service Excellence SCYNEXIS >90% Return Rate of Business 11 Compounds Nominated as Clinical Candidates SCYNEXIS® Proprietary and Confidential Information
  • 6. Publicly Disclosed SCYNEXIS Clients *All publicly disclosed prior to January 2010SCYNEXIS® Proprietary and Confidential Information
  • 7. Innovative Drug Pipeline Solutions SCYNEXIS Process Chemistry Dr. Bob Rodebaugh Director, Process & Analytical Chemistry Robert.Rodebaugh@scynexis.comSCYNEXIS® Proprietary and Confidential Information
  • 8. The SCYNEXIS Process TeamProcess Development Focused Expert Problem Solvers 24 Team MembersDeveloped Chemical Process for NDA 12 Ph.D.’s / 13 Process Chemists / 11 Analytical Chemists CLIENT Experienced Leadership Merck, GSK, Aventis, Pfizer, BASF, DSM, Lilly FDA Audited PAI – October 2009 No Observations No 483’s 65+ Global Clientele ~ 600 Completed Projects 81 in 2008, 85 in 2009, 128 in 2010 $1K - $2 M RangeSCYNEXIS® Proprietary and Confidential Information
  • 9. Process Chemistry Expertise● Broad range of expertise in numerous chemistries including: ◆ Natural Products ◆ Nucleosides ◆ Carbohydrates ◆ Hydrogenations ◆ Chiral Resolutions ◆ Heterocyclic Chemistry ◆ Chiral Syntheses ◆ Pressure Reactions ◆ Biopolymers & Polymers ◆ Inorganic Complexes ◆ Cross-coupling Reactions ◆ Controlled Substances ◆ Asymmetric Syntheses ◆ Stable-labeled Compounds
  • 10. SCYNEXIS Process Development● Rapid Turnaround & Efficient Custom Synthesis Intermediates Reference Standards Process Impurities Analog Synthesis Preparative Chromatography High Pressure Reactions ● Chemical Development Expertise Scale-Up of Medicinal Chemistry Routes Novel Route “Scouting” & Development Route & Process Optimization Developed Process for NDA SCYNEXIS® Proprietary and Confidential Information
  • 11. SCYNEXIS cGMP Manufacturing● FDA Registered, Inspected● Controlled Access, World-Class Facilities ◆ Chemical Development Labs ◆ Kilo Scale Lab for non-GMP Scale up ◆ GMP Kilo Scale Manufacturing Suite● Small Scale Commercial Manufacturing ◆ PAI October 2009 – No Observations/483s● <15kg GMP API / <25kg GMP Intermediate● State of the Art Equipment ◆ 25L to 200L Capacity ♦Glass-Lined Stainless Steel ♦Glass Fixed Reactors, -80 to +200 ° C ♦ Huber Temperature Controllers ◆ Dedicated Air Handlers ◆ Parr 2 Gallon Pressure Reactor ◆ Preparative Chromatography SCYNEXIS® Proprietary and Confidential Information
  • 12. SCYNEXIS Analytical R&D● Capabilities & Expertise 1:1 Ratio of Process : Analytical GMP/GLP Method Development by Ph.D. Level Scientists Validation & Stability Studies to ICH Guidelines Impurity, Degradation Product, Structural Identification ● Key Analytical Instrumentation 29 HPLC Systems (Waters/Agilent) PAD, ELSD, UV-Vis, Fluorescence, UPLC 12 LC/MS & LC/MS/MS Systems 3 GC/MS & GC/FID Headspace/Liquid GMP 400 & 500 MHz Varian NMR 4 Semi-prep Chromatography Systems DSC/TGA, K-F, TOC, FTIRSCYNEXIS® Proprietary and Confidential Information
  • 13. SCYNEXIS Quality Systems GMP Regulatory Mission FDA Regulatory Guidelines Ensuring Quality, Purity & Strength 21 CFR Parts 210 & 211 FDA Audited GMP General Inspection & Pre-Approval Inspection (PAI) October 2009 No Observations, No Form 483s Issued GMP FoundationsMaster Validation Plan / SOPs & Document Control / Production & Testing Controls / Project Documentation GMP Foundations Qualified Personnel / Qualified Equipment / Validated Software / Facility Design SCYNEXIS® Proprietary and Confidential Information
  • 14. Innovative Drug Pipeline Solutions SCYNEXIS Medicinal Chemistry Dr. Mike Peel Director, Medicinal Chemistry Mike.Peel@scynexis.com
  • 15. The SCYNEXIS Medicinal Chemistry Team Medicinal Chemistry Expertise 51 Team Members Globally Recognized Excellence 27 Ph.D’s / Medicinal / Computational Experienced Leadership CLIENT GSK, AstraZeneca, Sanofi-Aventis, Pfizer, Lilly, Merck Broad Expertise Multi-factorial Optimization,Parallel Synthesis/Purification, KITTM Numerous Therapy Areas Computational & Cheminformatics Support HEOS® Data Management & Collaboration Software Suite SCYNEXIS® Proprietary and Confidential Information
  • 16. Medicinal Chemistry Expertise● Broad range of expertise in multiple therapeutic areas including: ◆ Natural Product Optimization ◆ Oncology ◆ Antifungals ◆ Kinases ◆ Antivirals ◆ Inflammation ◆ Antibacterials ◆ Pain ◆ Antiparasitics ◆ Central Nervous System (CNS) ◆ Nuclear Hormones ◆ Ophthalmology ◆ Ion Channels ◆ Prodrug Design
  • 17. Innovative Drug Pipeline Solutions SCYNEXIS DMPK & Biology Dr. Steve Wring Director, DMPK-Tox & Bioanalytical Steve.Wring@scynexis.com
  • 18. The SCYNEXIS DMPK & Biochemistry Team Full Discovery DMPK Function Integrated into MedChem Decision Process Broad Areas of Expertise 17 Team MembersFull Support for Discovery - Development 7 Ph.D.’s / 3 MSc / 7 BSc’s 5 LC/MS/MS Systems Cell Culture Suite CLIENT Experienced Leadership Large and Small Pharma/Biotech Experience & Research InvestigatorsMultiple Concurrent Programs Hits-to-Lead to Lead-Opt Lead-Opt to Candidate Selection Exploratory Development Supporting Broad Healthcare Initiatives Neglected Diseases, CNS, Anti-Infectives, Oncology, Metabolic Diseases, Ophthalmology, Pain, Animal Health SCYNEXIS® Proprietary and Confidential Information
  • 19. HEOS® Drug Development Collaboration Tool Secure web-based portal for real-time data sharing and communication O NH2Ar N PDF N … TXT SDF Third-Party SoftwareSCYNEXIS® Proprietary and Confidential Information
  • 20. SCYNEXIS Values Integrity We will treat all employees with respect Teamwork and ethically conduct business We will work together towards achieving company goals Innovation SCYNEXIS We will continuously generate creative solutions to both technical and business challenges. QualityWe will deliver superior products and services exceeding our customer’s expectations Safety Safety concerning employees, customers, public and the environment. Safety impacts every action and decision SCYNEXIS® Proprietary and Confidential Information
  • 21. Working with SCYNEXIS● SCYNEXIS’ Goal ◆ Develop Long-Term Relationships via Dedicated Project Resources Fully-integrated Research Units Dedicated Project Team Project Leader Medicinal Chemists Computational Chemists Analytical & Bioanalytical Chemists DMPK & Toxicology Biochemistry & Screening Scientists Process Chemists ● Key Attributes ◆ Flexibility of the Team ◆ Multiple Scientific Disciplines ◆ Seamless Functional Transitions ◆ 1 – 35 FTE’s
  • 22. SCYNEXIS SummarySCYNEXIS is a fully-integrated drug discovery & development company: ◆ Experienced & Highly-Skilled Personnel ◆ Proven Record of Success ◆ Delivered 11 Preclinical Candidates (IND’s) ◆ Integrated Drug Development Solutions ◆ State of the Art Facilities ◆ FDA & DEA Registered ◆ Commercial API Supplier – PAI October 2009 ◆ Rapid DMPK / Lead-Optimization Studies ◆ Dedicated Project Management ◆ Desire Long-Term RelationshipsProviding more than just compounds… SCYNEXIS provides you with DRUGS!
  • 23. Thank You! Contact Information Mike Peel, Ph.D. Director, Medicinal Chemistry Mike.Peel@SCYNEXIS.com Steve Wring, Ph.D. Director, DMPK Steve.Wring@SCYNEXIS.com www.scynexis.com Bob Rodebaugh, Ph.D. Director, Process, GMP & Analytical Chemistry Robert.Rodebaugh@SCYNEXIS.com Bryce Chaney, M.B.A. Market Development Manager, Process & Analytical Chemistry Bryce.Chaney@SCYNEXIS.com Terry Marquardt Executive Director, Market Development Terry.Marquardt@SCYNEXIS.com SCYNEXIS Inc. 3501-C Tricenter Blvd Durham, NC 27713 www.scynexis.comSCYNEXIS® Proprietary and Confidential Information