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Skinomics
- 1. SKINOMICS Transforming Cutaneous Therapy by Defining the Human Skin Microbiome January 2016 Presented by: Emma Taylor, MD | President 626-260-1230 | emmatayl@skinomicsinc.com
- 2. 2 Overview Skinomics Illustration: Charis Tsevis Skinomics — Skinomics is comprehensively defining the human skin microbiome for drug discovery in skin disease — Developing the first skin- derived topical probiotic therapeutic for acne — Like yogurt for the skin
- 3. 3 Opportunity – Antibiotic Alternatives — Antibiotic Market-$45 billion — CDC/NIH initiative to reduce Abx – Multi-drug resistant infections – Cost US $4-5 billion annually – Dermatologists-long course Abx — Current Approach – Race against time and bacterial evolution to develop new antibiotics — Why this fails – Evolution-Millions of years – Antibiotics-less than 100 years – Nature is always one step ahead Copyright CDC
- 4. 4 Opportunity – Antibiotic Alternatives Illustration: Charis Tsevis The Skinomics Solution 1. Human Natural Defense – Trillions of commensal bacteria – Proprietary informatics Database to comprehensively define the skin microbiome 2. Therapeutics – Human skin-derived biologics w Bacteriophage w Bacterial Probiotics w Prebiotics 3. Maintenance – Probiotic
- 5. 5 Problem – Acne – First Skin Probiotic Model 85% Life)me Incidence Acne — $4.5 Billion market — 40–50 million US — 55–75% resistant to antibiotics — Long-course antibiotics are mainstay therapy — Dominated by generics — No personalized therapies — Side effects are common — No durable responses
- 6. 6 Solution – 1st Skin-Derived Probiotic Acne Therapy Probiotic — Using NGS/qPCR we profiled the human microbiome and found there are healthy bacteria and acne-associated bacteria — Good bacteria outcompete bad bacteria — No side effects-normal commensual bacteria — Long term maintenance — Restore natural skin biome Coloniza)on by “Bad” Bacteria (An)bio)c Resistant) Coloniza)on by “Good” Bacteria
- 7. 7 Validity for Host Defense Mimicry — Fecal transplant as treatment for C. Difficile — Yogurt prevention of yeast infections with antibiotic therapy — Early life antibiotics increases risk of IBD — Probiotic/yogurt ingestion in pregnancy reduces childhood atopy — Immunotherapy revolution in cancer therapy Copyright Microbiome HQ Good and Bad Bacterial Flora
- 8. 8 Acne – Initial Target Market Global Acne Market ~ $4.5B by 2018 Global Acne Sales ($ Billions) 3.8 4.0 4.5 2012 2013 2018 Global Rx Acne Sales Are Expected to Reach $1.7B by 2016 Customer 40–50 Million US Product Beachhead Market Product Mild Acne Monotherapy probiotic Maintenance therapy probiotic Moderate/ Severe Acne Probiotic as adjuvant therapy Maintenance therapy probiotic Currently No Acne Diagnostics or Probiotic Therapies First to Market with Skin-derived Probiotic Treatments Penetrate OTC and Rx
- 9. 9 Acne Eczema Psoriasis Rosacea Expanded Probiotic Markets $4.5 Billion — First to market with acne therapeutic claims probiotic — Evidence different microbial signatures — Recurrent Staph Aureus infections in eczema — Evidence that bacteria are associated with inflammatory response in psoriasis — Overgrowth of Demodex is causative in Rosacea $3.8 Billion $8.9 Billion $2 Billion
- 10. 10 Competition Diagnostic NGS Species Level An)bio)c Resistance Data Research Service Model Skin Focus Skinomics
- 11. 11 Therapeutic Claims Treatment Maintenance Lower SE Skin Flora Retinoids Rx NA SA and BP OTC NA OTC Probiotics NA Aobiome Rx-Skin Seres Therapeutic Rx-Gut Evelo Rx-Onc Skinomics Rx/OTC Competition of Probiotic Therapeutics
- 12. 12 Competition In 2009, the Human Microbiome Project & NIH Funded 15 Labs to Study the Human Microbiome 3 of Those Were Dermatology Focused 1 of Those Specialized in Acne >$3 Million of NIH Funding Has Been Invested in Huiying’s Lab to Study the Human Microbiome
- 13. 13 Business Model Pathway to Development Acne Probiotic POC Trial FDA Probiotic Regulatory Trial Product Pipeline — 3 arms — 3 month treatment — 3 month maintenance — Rx claims acne — Acne probiotic — Probiotics for other skin diseases — Database for discovery — POS diagnostic
- 14. 14 Leadership Team & Bios Management Team Emma Taylor, MD-Co-Founder, President Assistant Professor, UCLA Medical Center — Division of Dermatology — Department of Pathology — Inventor, combination Res/BP Iman Famili, Consultant Business and Corporate Development — Former work at Intrexon, GT life sciences, Genomatica as executive director/VP cell systems informatics, director R&D with 12 years biotech experience Huiying Li, PhD-Co-Founder, Scientific Advisor — Assistant Professor, UCLA — Molecular and Medical Pharmacology — Inventor diagnostic, bacteriophage, probiotic Board & Advisors TECH Clive Taylor, MD PhD Roy Doumani Lyn Baranowski William James, MD Noah Craft, MD PhD MARKET REG
- 15. 15 Seed Financing Why is This Attractive? — Accelerator access to boost capital allows matching for any funds we raise between $1-5 million from Viking Global Venture — Boost capital will fund proof of concept clinical trial with major inflection point 700 K 300 K 1500 K 250 K 300 700 100 1200 200 500 License & IP development Formulation Development Legal Fees POC Trial Accelerator Trial Employee
- 16. 16 Current Operating & Fundraising Plan * Includes licensing, salary, consulting, travel, legal, conferences, service providers Activity 2016 2017 2018 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q1 Database Probiotic 3 Mo 3 Mo 2 Mo 10–12 Mo 15 Mo Estimated Probiotic Budget $150K $500K $500K Technology Skinomics Ops Budget* $70K $70K $70K $70K $70K $70K $70K $70K Financing (Budget x 2) Data Collection Study Establish CRO Partnership Formulation/ Regulatory IND Phase I/II Phase III License IP Seed Raise $1.5 million $3 Million Total SEED ($1.5 Million Raise Matched with $1.5 Million Viking Capital) Pre-IND meeting SEED Financing Closed (can delay triggering boost until end of Q3) Series A Financing Closed (~$250K Covers) Accelerator goals Series A raise $5-10million
- 17. 17 Company Long-Term Vision Spinouts Database Probiotics Sublicensing/ Partnership $$$ — Acne — Eczema — Psoriasis — Rosacea — Seborrheic Dermatitis — Bacteriophage — Vaccine — Drug Discovery — Diagnostic point of service test — Res/BP — Prebiotics — Anti-Aging