RepliCel Fact Sheet April 29-15
Transcription
RepliCel Fact Sheet April 29-15
FACT SHEET Using Cells for Healing About RepliCel RepliCel Life Sciences is a regenerative medicine company focused on developing autologous cell therapies that address conditions linked to a deficit of healthy cells required for normal healing and function. Partnerships. Shiseido has an exclusive license for RCH-01 in certain Asian countries including Japan, China and South Korea. The company is actively engaging potential partners for its other products. Products / Markets. The company’s RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic tendinosis, damaged or aged skin, and pattern baldness. RepliCel is also developing a propriety, next-generation injection device (RCI) for optimal clinical delivery. Each condition is related to a deficit of a specific cell type which we believe is critical to the restoration of normal function. Strategy. Management initiated a clearly defined 18month value creation plan in Q1 2015. The Company is launching multiple clinical trials anticipated to start in 2015 in addition to Shiseido’s own clinical trial of RCH-01, finalizing prototype development and obtaining a CE mark for the RCI injector device, initiating other clinical trials, executing other licensing deals, multiple manufacturing improvements, and specific research programs targeting other products and applications. Technology / IP. Innovative technology protected by both patents (issued and filed) and trade secrets on the cell isolation, product composition, manufacturing and clinical applications. The company is structured to minimize its own infrastructure and leverage partners for commercialization. Investment Highlights 1. Innovative products with significant best-in-class commercial applications 2. Proprietary technologies to harvest, expand and reintroduce hair follicle derived cells 3. Three immanent clinical trial starts with 2016 readouts for tendon and skin 4. Strong IP covering process/use of the company’s technology 5. One of the few global regenerative medicine companies to have a Japanese partnership positioned to leverage the opportunity for expedited market approval now available through recent Japanese regulatory reforms 6. Partnership with Shiseido, 4th largest cosmetics company worldwide ($31 M plus royalties) 7. 2015 focus on geographic licensing for tendon, skin and injector device Pipeline of Products RepliCel’s product pipeline leverages the unique cellular properties of the hair follicle to develop a portfolio of products that treat functional cellular deficits as a result of injury, normal aging or genetic predisposition. Shiseido Clinical Trial in Japan Shiseido has built a cell-processing facility to handle all aspects of their RCH-01 clinical trial to be conducted in Japan. All product and clinical development, as well as data, will be shared with the goal of commercializing a safe and effective treatment for pattern baldness. This Fact Sheet is provided by RepliCel Life Sciences Inc. as a convenience for potential investors. More details about the business and its risks can be found in the company’s press releases and filings with the U.S. Securities and Exchange Commission or the Canadian Securities Administrators. This Fact Sheet may contain forward-looking statements and actual results may differ materially from such statements. RCT-01: NBDS Fibroblast Therapy Treatment for Chronic Tendinosis • • • • Uses non-bulbar dermal sheath (NBDS) cells derived from the hair follicle NBDS cells are prolific producers of type I collagen (5x dermal fibroblasts) These cells and the collagen they produce play an important role in tendon healing Phase 1/2 in chronic Achilles tendinosis: 2015 (Cleared by Health Canada Nov. 2014) RSC-01: NBDS Fibroblast Therapy Treatment for Aging & Sun Damaged Skin • Uses non-bulbar dermal sheath (NBDS) cells derived from the hair follicle • NBDS cells are prolific producers of type I collagen (5x dermal fibroblasts) • These cells and the collagen they produce play an important role in reversing skin aging and damage • Phase 1 in aging and sun damaged skin: 2015 RCH-01: DSC Cell Therapy Treatment for Androgenetic Alopecia • Utilizes dermal sheath cup (DSC) cells derived from the hair follicle • DSC cells regulate the volume of dermal papillae (DP) cells which are responsible for thickness and growth of hair fibers • Phase 2 in pattern baldness: 2015-6 RCI-02 Dermatology Injector Device Dermal Applications • • • • Programmable depth and volume with improved control and precision Cooling plate replaces need for local anesthetic Interchangeable heads for different applications Prototype build stage How it Works For all products, specific cells are isolated from a small biopsy taken from the back of a patient’s scalp. Specific cells are isolated and replicated per proprietary manufacturing processes, stored in cryogenic vials for shipment to the clinic and thawed for re-injection into the area of the patient’s cellular deficit. Market Data April 30/15 Exchange: OTCQB/TSXV Management Team 52 Wk H/L CAD: David Hall, BSc – CEO, President & Director Lee Buckler, LLB - VP Business & Corporate Development Rolf Hoffmann, MD - CMO & Director Kevin McElwee, PhD - Chief Scientific Officer Tom Kordyback, CA - Chief Financial Officer Darrell Panich, MSc CPM - VP Clinical Affairs Hisae Nakamura, PhD - Director, R&D Symbol: REPCF / RP Issued and Out: 54,947,288 Fully Diluted: 67,807,343 Market Cap: $0.30-$0.80 $24 M R. Lee Buckler VP Business & Corporate Development 604.248.8693 [email protected] / www.replicel.com