Replicel Life Sciences Inc. · OTC:REPCF
Replicel Life Sciences — Stem Cell Meeting on the Mesa 2015
23 slides from Replicel Life Sciences's conference presentation, Oct 8, 2015
Slide 1: Using Cells for Healing
Using Cells for Healing Stem Cell Meeting on the Mesa October 8, 2015
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: RepliCel Introduction
RepliCel Introduction A regenerative medicine company developing autologous cell therapies Goal: address conditions caused by a deficit of healthy cells required for normal healing and function Current focus: rejuvenate hair growth, restore damaged skin, repair chronically injured tendons Product Pi
Slide 4: RepliCel Platform
RepliCel Platform 1. Condition diagnosed 6. Cells injected back into patient using proprietary 2. Biopsy taken from delivery device scalp 5. Cells mixed with carrier 3. Cells isolated from NBDS and frozen hair follicle Fibroblasts (RCT-01, RCS-01) 4. Cells grow (5-8 weeks) Dermal Sheath Cup Cells (R
Slide 5: Potential Therapeutic Applications
Potential Therapeutic Applications Hair Loss Aged and Damaged Skin Periodontal Rotator Cuff Tennis Elbow Golfer’s Elbow Potential products from NBDS Platform Patellar DSC product 2015 trial launch Achilles 5
Slide 6: RepliCel Licensing Strategy
RepliCel Licensing Strategy • Develop early-to-mid-stage assets for license to partners for joint development and commercialization – Partner assets prior to late-stage trials to leverage expertise, cash and infrastructure – Only commercialize through experienced commercial partners – Structure part
Slide 7: RepliCel Business Strategy
RepliCel Business Strategy • Minimize overhead by utilizing contract service providers and infrastructure to maximize R&D output per dollar spent • Rolling 18-month plan to prioritize programs around maximizing shareholder value • Prioritize large-markets characterized by considerable consumer pull
Slide 8: RepliCel Technical Strategy
RepliCel Technical Strategy K.I.S.S. • Understand functional characteristics of a well-defined cell population • Grow more of them (don’t modify them in any way) • Use those cells in indications where there is a clearly understood functional cellular deficit • Deliver them locally (not systemically)
Slide 9: Platform Technology from Hair Follicles
Platform Technology from Hair Follicles Fibroblast Platform (NBDS) • Non-bulbar dermal sheath (NBDS) fibroblast cells are prolific type I collagen production (5x dermal fibroblasts)1 • Active fibroblasts promote tendon healing and dermal matrix rejuvenation • RCT-01 Phase 1/2 (Tendon), RCS-01 Phase
Slide 10: Chronic Tendinosis – Fibroblast Deficit
Chronic Tendinosis – Fibroblast Deficit • Phase 1/2 Trial for Achilles Tendinosis (University of British Columbia) – Primary endpoint - safety through 6 months - then • volunteers 18 month follow-up study submitted to Health Canada – 28 patients, 21 treated & 7 placebo – Currently enrolling particip
Slide 11: 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 – Adipose derived dermal fibroblasts • 24 patients (unilateral disease) – 12 treated, 12 controlled – Mean age 45.2 years (20 male, 12 female) –
Slide 12: 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 eccentric loading, casting & platelet rich plasma • Chronic tendinosis: unorganized tissue formation • Pain reduction Ultrasound Image After Treatment – 6 Months • Tendon
Slide 13: Aging & Sun Damaged Skin – Fibroblast Deficit
Aging & Sun Damaged Skin – Fibroblast Deficit • Skin damage caused by aging, UV exposure, lifestyle factors • As we age fibroblasts in the skin produce less collagen causing skin to lose its elasticity and structure • Injection of collagen-rich fibroblasts is designed to reverse skin damage Histolog
Slide 14: RCS-01 Phase 1 Trial
RCS-01 Phase 1 Trial • Treatment: Injection of RCS-01 fibroblasts RCS-01 Injection – Prolific producers of type I collagen BEFORE • 30 healthy volunteers (24 treated, 6 placebo) • Currently enrolling participants • Primary endpoint – local safety & tolerance • Secondary endpoints – Efficacy at 6 and
Slide 15: RCH-01: Phase 1 Safety - Six Month Results
RCH-01: Phase 1 Safety - Six Month Results • 63% of subjects responded with increases in density greater than the 6-month 5% target – Mean change in total hair density at 6-months = 6.1% vs 5.0% target • 70% of responders were above 10% - average 14.3% Change in total hair density after 6 months 19.
Slide 16: Shiseido Partnership – RCH-01 – Asia
Shiseido Partnership – RCH-01 – Asia • 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 2013 •
Slide 17: RCH-01: Phase 2 Pattern Baldness
RCH-01: Phase 2 Pattern Baldness Planned Phase 2 Trial for Pattern Baldness 2015 (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 – efficacy
Slide 18: Japanese Expedited Approval System Under PMD Act
Japanese Expedited Approval System Under PMD Act Benefits of new Conditional Approval System: to shorten lengthy review processes normally required by the traditional system to evaluate safety and efficacy of heterogeneous cellular products. allowing for timely provision of safe regenerative medic
Slide 19: RCI-02 Dermal Injector Device
RCI-02 Dermal Injector Device • Prototype build stage • CE mark, 510(k) pathway • Focused licensing program for dermal filler applications 19
Slide 20: RCI-02 Dermal Injector Features
RCI-02 Dermal Injector Features Comfort Grip for Ease of Use • Designed to deliver cells, dermal fillers, drugs and biologics • Digital controls for: – Programmable depth – Volume – Rate of dispersion • For cells it protects against sheer force • For dermal fillers provides repeatable dispersion acr
Slide 21: 2015 Accomplishments
2015 Accomplishments Program Event RCT-A-01 – Tendon Initiate Phase 1/2 trial in chronic Achilles tendinosis RCS-01 – Skin Initiate Phase 1 trial in sun damaged and aging skin RCI-02 – Injector Lock up design specifications Independent Analyst Coverage Initiated (Douglas Loe – Analyst Coverage
Slide 22: Upcoming Development and Strategic Milestones
Upcoming Development and Strategic Milestones Program Event Est. Timing RCH-01 – Hair Initiate pattern baldness trial (Japan) 2015/6 RCI-02 – Injector CE mark (marketing) approval 1H 2016 RCI-02 – Injector Global license (HA injections) 2016 RCT-01 – Tendon Phase 1/2 data on chronic Achilles tendino
Slide 23: RepliCel Life Sciences Inc.
RepliCel Life Sciences Inc. OTCQB: REPCF TSXV: RP R. Lee Buckler VP Business Development 604.248.8693 [email protected]
RepliCel Life Sciences — Stem Cell Meeting on the Mesa 2015 on 6ix