RepliCel Life Sciences Inc. · OTC:REPCF
RepliCel Life Sciences — BioJapan 2014
21 slides from RepliCel Life Sciences's conference presentation, October 2014
Slide 1: Treating Functional Cellular Deficits
Treating Functional Cellular Deficits BioJapan 2014 October 2014
Slide 2: Safe Harbor Statements
Safe Harbor Statements Statements included in this presentation that do not relate to present or historical conditions are “forward looking statements”. Forward-looking statements are projections in respect of future events or our future financial performance. In some cases, you can identify forward
Slide 3: BioJapan 2014
BioJapan 2014 “Japan is on the leading edge in regenerative medicine. We will make it possible to generate cells at private-sector factories.” - Prime Minister Shinzo Abe, World Economic Forum, Davos, Jan. 22, 2014 “The international race for regenerative medicine leadership is on and Japan is leadi
Slide 4: RepliCel Overview
RepliCel Overview • Autologous cell therapies for large commercial applications – Strong IP covering process/use of hair follicle cells in a variety of indications Chronic tendinosis RCT-01 1/2 2014 Canada Aging and sun damaged skin RCS-01 1 2014 Germany Pattern Baldness RCH-01 2 2014 Germany Patter
Slide 5: Platform Technology from Hair Follicle Cells
Platform Technology from Hair Follicle Cells RCT-01 Phase 1/2 (Tendon), RCS-01 Phase 1 (Skin Aging) • Based on non-bulbar dermal sheath (NBDS) fibroblast cells • NBDS cells are prolific type I collagen producing fibroblasts NBDS • Active fibroblasts are required for, and promote tendon healing and d
Slide 6: How it Works
How it Works Proprietary delivery device 1. Condition is diagnosed 6. Cells injected back 2. Biopsy taken from into patient scalp NBDS Fibroblasts 5. Cells mixed with carrier 3. Cells isolated from (RCT-01, RCS-01) and frozen hair follicle 4. Cells grow (5-8 weeks) Dermal Sheath Cup Cells (RCH-01) 6
Slide 7: Phase 1 Chronic Achilles Tendinosis - 63 Yr-old Male
Phase 1 Chronic Achilles Tendinosis - 63 Yr-old Male • 3-years of chronic pain Ultrasound Image Before Treatment – Day 1 • Failed physio, casting & platelet rich plasma • Image: Unorganized tissue formation & swelling • Pain free & thickness Ultrasound Image After Treatment – 6 Months reduction • Or
Slide 8: Phase 1 Chronic Achilles Tendinosis
Phase 1 Chronic Achilles Tendinosis Past Clinical: Phase 1 Achilles Tendinosis1 (D. Connell et al., Royal National Orthopaedic Hospital) Function Treatment – dermal fibroblasts • 24 patients (unilateral disease) – 12 treated, 12 controlled – Mean age 45.2 years (20 male, 12 female) – VISA questionna
Slide 9: Chronic Tendinosis – Fibroblast Deficit
Chronic Tendinosis – Fibroblast Deficit • Proposed Phase 1/2 Trial for Achilles Tendinosis 2014 (UBC) – Primary interim and final end points are safety – 28 patients, 21 treated & 7 placebo – 3 months to complete enrollment – Secondary endpoint – efficacy at 26 weeks • Function, pain, tendon appeara
Slide 10: RCS-01 Proposed Phase 1 Trial 2014
RCS-01 Proposed Phase 1 Trial 2014 • Treatment: Injection of RCS-01 fibroblasts RCS-01 Injection – Prolific producers of type I collagen BEFORE • 28 healthy volunteers (22 treated, 6 placebo) • Primary endpoint – local safety & tolerance • Secondary endpoints – Efficacy at 6 and 12 months – 16 patie
Slide 11: Dermal Sheath Cup Deficit: Pattern Baldness
Dermal Sheath Cup Deficit: Pattern Baldness • Human scalp follicles develop with a fixed amount of dermal papillae (DP) cells (approx. 500) • Total # of DP cells determines the # and thickness of hair fibers • Diminishing volume of active DP cells leads to pattern baldness • Drug treatments do not i
Slide 12: Current Standard of Care
Current Standard of Care • Micro-transplant surgery is the current gold standard – Highly dependent on surgeon’s skill • Rogaine (minoxidil) – topical solution suitable for men and women – Approx. 8-16% density increase from baseline (at 12 months) – Treatment maintenance required or gains are lost
Slide 13: RCH-01: Phase 1 Safety - Six Month Results
RCH-01: Phase 1 Safety - Six Month Results • 63% of subjects responded - density > the 6-month 5% target1 • Average density increase of 11.8%1 • 70% of responders were above 10% - average 14.3%1 • Mean density change all patients at 6-months = 6.1% vs 5.0% target1 Change in total hair density after
Slide 14: RCH-01: Phase 2 Pattern Baldness
RCH-01: Phase 2 Pattern Baldness • Planned Phase 2 Trial for Pattern Baldness 2014 (Charité, Freiburg and Münster) – 160 participants – 396 RCH-01 treatment group sites (vs. 16 in P1), with 244 placebo sites – Designed to measure dosing and treatment frequency – Primary commercial endpoint – efficac
Slide 15: 3rd Party Validation & Value Creation
3 rd Party Validation & Value Creation • 2013 licensing partnership with Shiseido (July 2013) – Geographic license for pattern baldness only for Japan, China, Korea and ASEAN nations – $35 Million ($4M upfront, $31M in sales milestones and royalties) – Shiseido is the 4th largest cosmetic company WW
Slide 16: Injector Devices
Injector Devices Generation 1 Injector • Dermal injector Generation 2 Injector (RCI-02) • Devices for RCS and RCH • Programmable depth and dose • Built-in freezing replaces anaesthetic (Pelletier Element) • Treatment specific interchangeable heads • Prototype build stage • CE mark, 510K pathway • Fo
Slide 17: Potential Therapeutic Applications
Potential Therapeutic Applications Hair Loss Aged and Damaged Skin Gingivitis Rotator Cuff Tennis Elbow Golfer’s Elbow Patellar Achilles 17
Slide 18: Upcoming Development and Strategic Milestones
Upcoming Development and Strategic Milestones Program Event Est. Timing RCT-A-01 – Tendon Initiate Phase 1/2 trial in chronic Achilles tendinosis 2014 RCS-01 – Skin Initiate Phase 1 trial in sun damaged and aging skin 2014 RCH-01 – Hair Initiate Phase 2 trial in pattern baldness 2014 RCH-01 – Hair S
Slide 19: Pro-Forma Financial Highlights
Pro-Forma Financial Highlights Stock Listing TSXV: RP / OTCQB: REPCF in $CAD Recent Share Price (CDN) $0.51 52 week high/low (CDN) $0.99 - $0.50 Market Cap. (approx.) $34.0 M Cash & Equivalents (06/30/14) $4.3 M Current Monthly Burn Rate $350,000 Shares Outstanding (Basic/FD) 54.9/67.4M Share Owners
Slide 20: RepliCel Overview
RepliCel Overview • Autologous cell therapies for large commercial applications – Strong IP covering process/use of hair follicle cells in a variety of indications Chronic tendinosis RCT-01 1/2 2014 Canada Aging and sun damaged skin RCS-01 1 2014 Germany Pattern Baldness RCH-01 2 2014 Germany Patter
Slide 21: RepliCel Life Sciences Inc.
RepliCel Life Sciences Inc. David M. Hall CEO & President Tel: 604.248.8730 OTCQB: REPCF R. Lee Buckler TSXV: RP VP Business & Corporate www.replicel.com Development info@replicel.com Tel: 604.248.8693