Replicel Life Sciences Inc. · OTC:REPCF
Replicel Life Sciences — Shareholder Meeting (June 2012)
32 slides from Replicel Life Sciences's shareholder meeting presentation, Jun 11, 2012
Slide 1: Developing a cell-based solution to hair loss
Presentation from June 11, 2012 Annual General Meeting Developing a cell-based solution to hair loss
Slide 2: Regulatory Disclaimer
Regulatory Disclaimer The information in this presentation contains forward-looking statements, as that term is defined under applicable securities laws. Statements in this presentation, which are not purely historical, are forward-looking statements and can include, without limitation, statements b
Slide 3: Introduction
Introduction RepliCel has developed a minimally-invasive hair regeneration procedure based on the extraction and replication of specific hair root cells and their re-introduction into areas of hair loss. This patented technology has been developed by RepliCel’s team of scientists and dermatologists.
Slide 4: Origins of the Science
Origins of the Science RepliCel’s scientists’ landmark study published in peer-reviewed Journal of Investigative Dermatology. 4 Patents filed protecting technology.
Slide 5: Dermal Sheath Cup Mesenchymal Pluripotent Cells
Dermal Sheath Cup Mesenchymal Pluripotent Cells 5
Slide 6: Dermal Sheath Cell Implantation to SCID Mice + 4 Months
Dermal Sheath Cell Implantation to SCID Mice + 4 Months 6
Slide 7: Hair Replication – Hair Follicle Micro-Dissection
Hair Replication – Hair Follicle Micro-Dissection (a) (b) Isolation of the hair follicle dermal papilla (a) and dermal sheath cup (b) cells. Tissues are dissected from a hair follicle using sterile needles under a microscope. 7
Slide 8: DSCC Cell Migration
DSCC Cell Migration Dermal Sheath Cup cells Dermal Sheath Cup cells Green fluorescent cells collected from culture and injected in a saline solution. Dermal sheath cup cells formed new hair follicles (left) and also entered resident follicles (right). 8
Slide 9: Pre-clinical Data Conclusions
Pre-clinical Data Conclusions RepliCel’s pre-clinical work showed that: 1. Cultured dermal papilla cells and dermal sheath cup cells are capable of inducing new hair follicle development. 2. It also showed that dermal sheath cup cells induced hair growth through the formation of a new dermal papilla
Slide 10: RepliCel Conducts First-in-man Trial
RepliCel Conducts First-in-man Trial Based on RepliCel’s pre-clinical findings a first-in-man Phase I/IIa clinical trial commenced in December 2010. 10
Slide 11: Treatment Procedure for Phase I/IIa Trial
Treatment Procedure for Phase I/IIa Trial Step 1 - Cell Biopsy 1 2 3 1. Health hair follicles are isolated from the back of the scalp 2. A small punch biopsy of skin plus hair follicles is extracted from the patient 3. The biopsy is approx. 4mm in diameter 11
Slide 12: Treatment Procedure: Cell Shipment & Replication
Treatment Procedure Step 2 – Cell Shipment & Replication • Cell biopsies are shipped in European Union approved packaging for tissue transport • Biopsies are cultured and replicated in a GMP Laboratory in Austria • Cell replication takes approx. 3 months 12
Slide 13: Treatment Procedure: Injection of Replicated Cells
Treatment Procedure Step 3- Injection of Replicated Cells Once the cells are replicated into the millions they are injected back into the patient using RepliCel’s proprietary injection device. Injector device and syringe loaded Injector template 13
Slide 14: Treatment Procedure: Injection of Replicated Cells Continued
Treatment Procedure Step 3 Continued – Injection of Replicated Cells 1. Injection sites selected - transitional area of hair loss between normal terminal hair and the balding area of the scalp 2. Sites marked with a tattoo 3. Area shaved for hair growth analysis and digital images taken for analysis
Slide 15: Phase I/IIa First-in-man Safety Trial: 6-month Results
Phase I/IIa First-in-man Safety Trial 6-month Results • Patient Enrolment and Final Participants – Screened 30 patients (16 Male, 14 Female) – Harvested 25 biopsies (12 Male, 13 Female) – 19 patients injected (10 male, 9 female) – Please note that 3 patients had to be excluded from efficacy result a
Slide 16: Phase I/IIa First-in-Man Safety Trial: 6-month Results Cont'd
Phase I/IIa First-in-Man Safety Trial 6-month Results Cont’d Primary Endpoint of Safety – Accomplished – No serious adverse events Secondary Endpoint of Early Efficacy - Accomplished – Significantly more patients demonstrated a 5% increase in hair density at dermal sheath cup cell treated sites
Slide 17: Phase I/IIa Trial: Image from One Patient
Phase I/IIa First-in-Man Safety Trial 6 Month Post Injection Image from One Patient Visit 1 – Pre-Injection (Baseline) Visit 7 – 6 Months Post-Injection Increase in vellus hair density of 24.9% Increase in terminal hair density of 14.5% Total hair density increased by 19.2% Cumulative thickness per
Slide 18: Phase I/IIa Total Hair Density: Percent Change from Baseline
Phase I/IIa Total Hair Density Percent Change from Baseline (Per-Protocol) At 6 Months 20.0% 19.6 19.2 14.3% Average 17.2 13.6 Percent Change from Baseline 15.0% 12.0 11.2 10.6 10.0% 9.6 Average 6.2 5.1 6.1% 5.0% 2.1 1.9 1.1 0.0% 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 -5.0% -3.7 -4.6 -6.2 63% subjec
Slide 19: Trial Perspectives
Phase I/IIa First-in-Man Safety Trial Trial Perspectives • RepliCel first-in-man trial was designed to show proof of safety. Injections of autologous dermal sheath cup cells shown to be safe • Designed to give an early look at efficacy at the 6-month interim analysis. This was a business strategy
Slide 20: Trial Perspectives Cont'd
Phase I/IIa First-in-Man Safety Trial Trial Perspectives Cont’d… • Biopsies from patient treatment sites will be collected at 6, 12 and 24 months post-injection. • Biopsies are sent to a lab in the USA for high-powered microscopic analysis (histopathology). • Eight (8) biopsies were analyzed at the
Slide 21: Trial Comparisons
Phase I/IIa First-in-Man Safety Trial Trial Comparisons • Micro-transplant Surgery – It is currently the gold standard for hair replacement, however, the results are subject to the skill of the surgeon. • Rogaine also known as (Minoxidil) – Is a well-known topical solution. – At 12-24 months users c
Slide 22: Proposed Clinical Trial (Phase IIb)
Proposed Clinical Trial (Phase IIb) • RepliCel’s pre-clinical team is currently working on optimization of the RepliCel™ procedure with the objectives of: – Enhancing cell yield from scalp biopsies – Improving target cell isolation – Improving cell replication yield and processing time – Extending t
Slide 23: Proposed Clinical Trial (Phase IIb)
Proposed Clinical Trial (Phase IIb) • RepliCel’s Phase IIb dose-ranging trial is designed to: – Optimize treatment regimen for hair growth – Collect more safety data • Several different treatment regimens will be tested: – Different concentrations of cells – Different treatment schedules • Single in
Slide 24: Proposed Clinical Trial (Phase IIb)
Proposed Clinical Trial (Phase IIb) • The current draft of the RC002-2013 trial is designed as follows: – 60 male patients – 24 month duration – Four treatment zones per patient (240 treatment areas) • Three zones; each treated with a different concentration of cell products (or saline [placebo]) •
Slide 25: Proposed Clinical Trial (Phase IIb)
Proposed Clinical Trial (Phase IIb) • Efficacy Measurements – Hair growth measurements • Hair density (total, vellus & terminal), hair thickness, cumulative hair – Treatment response • patients demonstrating 5% increase from baseline measurement • Safety Measurements – Local tolerance • Assessment
Slide 26: Proposed Clinical Trial (Phase IIb) 12-month Interim Analysis
Proposed Clinical Trial (Phase IIb) 12-month Interim Analysis • Performed once data is collected from the 12-month post-baseline follow-up visits from all study participants • This analysis will include: – 48 patients that received injections of DSCCs • 24 single injections at each of three treatmen
Slide 27: Value Development Pathways
Value Development Pathways Pathway 1 Pathway 1 (in clinical trials) • Autologous Cell Replication Process – Manual cell isolation – Manual cell replication • Generation 1 Injector – Patents filed • Human Clinical Trials – Phase I/IIa first-in-man – Phase IIb dosing study – Phase III approval 27
Slide 28: Value Development Pathways
Value Development Pathways Pathway 2 Pathway 2 • Autologous Cell Replication Process – Cell markers (19 identified, 4 in testing) – Automated cell isolation – Automated cell replication – Improved culture media • Generation 2 Injector – Patents filed • Human Clinical Trials – Phase I/IIb – Phase III
Slide 29: Balance Sheet – March 31, 2012
Balance Sheet – March 31, 2012 Stated in CDN $ Cash $1,597,790 Sales tax receivable 17,006 Prepaid expenses 63,775 Equipment 18,241 Total Assets $1,696,812 Current Liabilities 493,560 Non-Current liabilities - warrants denominated in a 483,777 foreign currency Shareholders’ Equity 719,475 Total Liab
Slide 30: Financing
Financing • Total Financing in 2012 – $2,796,740 CDN – 1,875,046 units issued • Issued and Outstanding Share Capital – 45,025,054 Common Shares 30
Slide 31: Summary
Summary • Phase I/IIa Interim Analysis Complete – Safety – Accomplished – Interim Efficacy - Accomplished • Phase IIb development underway – Pre-filing meeting targeted for summer 2012 – On timeline for late 2012 • Data accepted for podium presentation at the European Hair Research Society – Barcelo
Slide 32: THANK YOU
THANK YOU This brings our presentation to an end.
RepliCel Life Sciences — Shareholder Meeting (June 2012) on 6ix