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May 07, 2018 - RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents.
- RepliCel now has key strategic regional partners each of which are now investing heavily in the further clinical testing and development of RepliCel's products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide.
For more information, please contact:
Lee Buckler, CEO and President
604-248-8693
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.", "Weighting": 0, "DisableForSiteSearch": false, "CreatedByMemberId": "0", "ItemCategories": [ "News - Press Release", "Product - RCI-02" ], "ItemCategoryIdList": [ 2397, 2398 ], "ItemTags": [ "Partnerships", "Press Release", "RCI-02" ], "Author": 0, "Author_Name": "", "Author_Url": "", "Item_Rating": 0, "Image": "/Blog/2017/RP-press-release.jpg", "ShowPageForSearchEngine": true, "MetaTitle": "", "SEOTitle": "", "MetaDescription": "", "CanonicalLink": "", "SocialMetaTags": "", "SeoPriority": 0.5, "EnableAMP": false, "AMPContent": "", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ExternalId": 0, "Params": { "type": "module", "source": "Blog Post", "layout": "List", "displaypagination": "true", "filterby": "itemtags", "limit": "20", "filtervalue": "Partnerships", "sortby": "releasedate", "sortorder": "DESC", "collectionvariable": "posts" } }, { "Id": 3136, "Name": "RepliCel Terminates License Agreement with Shiseido ", "Url": "/news/replicel-terminates-license-agreement-with-shiseido", "Url_List": [ "/news/replicel-terminates-license-agreement-with-shiseido" ], "UrlSlug": "replicel-terminates-license-agreement-with-shiseido", "ParentId": 1929, "ParentId_List": [ 1929 ], "ParentName": "News", "ParentUrl": "/news", "TemplateName": "", "Module_Alias": "BlogPost", "Module_ID": 1534, "Enabled": true, "ReleaseDate": "2021-12-21T09:00:00", "ExpiryDate": "2099-12-31T00:00:00", "SiteSearchKeywords": [], "Description": "
VANCOUVER, BC, CANADA – 21 December 2021 – RepliCel Life Sciences Inc. (OTCPK: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, announced today that the dispute between Shiseido and RepliCel has led to the Company electing to terminate the license agreement with Shiseido. The Company’s decision is a legal step in its pursuit of a resolution of its disagreement with Shiseido that is the subject of ongoing arbitration proceedings under the aegis of the International Center for Dispute Resolution (ICDR).
The dispute between Shiseido and RepliCel is related to a license for Asia to RepliCel’s cell therapy technology for androgenetic alopecia, which is the leading cause of male and female pattern hair loss. Legal counsel for RepliCel filed a Notice of Arbitration that was announced in a Company press release on October 18, 2021.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.
The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 was exclusively licensed in Asia to Shiseido Company Limited (an agreement which is currently under dispute). RepliCel maintains the unfettered rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.
RepliCel has also developed a proprietary injection device, RCI-02, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the RCI-02 device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe. Please visit www.replicel.com for additional information.
Notable Facts:
- RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents.
- RepliCel has key strategic partners in the United States, China, and Japan each of which are now investing heavily in the further clinical testing and development of RepliCel's products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide.
For more information, please contact:
Lee Buckler, CEO and President
604-248-8693
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.", "Weighting": 0, "DisableForSiteSearch": false, "CreatedByMemberId": "0", "ItemCategories": [ "News - Press Release" ], "ItemCategoryIdList": [ 2397 ], "ItemTags": [ "Partnerships" ], "Author": 0, "Author_Name": "", "Author_Url": "", "Item_Rating": 0, "Image": "/Blog/2017/RP-press-release.jpg", "ShowPageForSearchEngine": true, "MetaTitle": "", "SEOTitle": "", "MetaDescription": "", "CanonicalLink": "", "SocialMetaTags": "", "SeoPriority": 0.5, "EnableAMP": false, "AMPContent": "", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ExternalId": 0, "Params": { "type": "module", "source": "Blog Post", "layout": "List", "displaypagination": "true", "filterby": "itemtags", "limit": "20", "filtervalue": "Partnerships", "sortby": "releasedate", "sortorder": "DESC", "collectionvariable": "posts" } }, { "Id": 3137, "Name": "RepliCel Closed Final Tranche of Strategic Investment Commitment ", "Url": "/news/replicel-closed-final-tranche-of-strategic-investment-commitment", "Url_List": [ "/news/replicel-closed-final-tranche-of-strategic-investment-commitment" ], "UrlSlug": "replicel-closed-final-tranche-of-strategic-investment-commitment", "ParentId": 1929, "ParentId_List": [ 1929 ], "ParentName": "News", "ParentUrl": "/news", "TemplateName": "", "Module_Alias": "BlogPost", "Module_ID": 1534, "Enabled": true, "ReleaseDate": "2021-12-21T03:00:00", "ExpiryDate": "2099-12-31T00:00:00", "SiteSearchKeywords": [], "Description": "
VANCOUVER, BC, CANADA – 21 December 2021 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce that it has closed the final tranche of the investment by MainPointe Pharmaceuticals (“MainPointe”) as outlined in the share purchase agreement signed by the parties earlier this year.
The final tranche involved the issuance of 1,479,882 common shares (the “Shares”) by RepliCel in exchange for CAD$998,921 which has now been received by the Company. The Company received an aggregate of CAD$2,698,921 from all tranches and issued an aggregate of 3,986,684 Shares at a price of CAD$0.675 per Share.
“The timing of this final share purchase by MainPointe,” stated RepliCel’s President and CEO, R. Lee Buckler, “coincides nicely with the increasing level of collaboration between RepliCel, the European firm conducting the DermaPrecise development, testing, and manufacturing (A.M.I.), and MainPointe’s regulatory department committed to handling all aspects of the regulatory submission to the U.S. Food and Drug Administration seeking marketing approval for the injector and related single-use consumables.”
All Shares issued are subject to a statutory hold period expiring four months and one day from the date of the issuance of the Shares. None of the securities sold in connection with the investment will be registered under the United States Securities Act of 1933, as amended, and no such securities may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements. This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.
The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 was exclusively licensed in Asia to Shiseido Company (an agreement which is currently in dispute). RepliCel maintains the undisputed rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.
RepliCel has also developed a proprietary injection device, RCI-02, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the RCI-02 device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe.
Please visit www.replicel.com for additional information.
Notable Facts:
•RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents having been successfully reviewed by three regulatory agencies.
•RepliCel has key strategic partners in the United States, China, and Japan each of which is now investing heavily in the further clinical testing and development of RepliCel's products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide.
For more information, please contact:
Lee Buckler, CEO and President
info@replicel.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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VANCOUVER, BC, CANADA – 28 October 2021 – RepliCel Life Sciences Inc. (OTCPK: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, announced today the DermaPrecise trademark for its dermal injector product portfolio.
“The DermaPrecise Injector is an electronic injection system which will bring new levels of control over any injection into the dermal and subcutaneous layers for which precision of depth, dose and/or delivery matters, “ states dermatologist and clinical researcher Dr. Rolf Hoffmann who has been a clinical advisor on the injector’s development.
Immediate high-value medical applications being explored for the DermaPrecise Injector are for dermal and subcutaneous delivery of cell and gene therapies, antibody therapeutics, toxins, and certain medical dermatology applications.
Aesthetic applications for the DermaPrecise Injector will include the injection of enzymes for fat dissolution, platelet rich plasma (PRP) for skin and hair applications, fat transfers, and certain applications of toxins and dermal fillers where there is a need to minimize injection pain and/or ensure broad, even dispersion of product as broadly as possible.
“RepliCel is very proud of the DermaPrecise injection product line which promises not only a high-level of electronic precision with control over pre-fixed depths and dose but a cooling system to numb the skin’s sensitivity immediately prior to injection and, for those holding the injector, a simple push-button rather than a plunger,” stated the company’s President and CEO, R. Lee Buckler.
The DermaPrecise injection system is supplied with single-use cartridges and multi-needle heads for use with injectables of varying viscosity including highly viscose products such as some of the newer crosslinked hyaluronic acid-based dermal fillers and antibody therapeutics.
RepliCel initially developed the DermaPrecise injection system to ensure optimized, precise, and consistent delivery of its cell-based regenerative medicine products in development to reverse hair loss due to androgenetic alopecia and to regenerate the extracellular matrix under aging skin. For the rapidly growing cell and gene therapy industry, injection-related shear force can threaten to burst cells during the delivery process thus obviating the product’s effectiveness. In the coming weeks, RepliCel intends publish data demonstrating the superiority of the DermaPrecise Injector, over traditional methodologies, for the delivery of cells into the skin and subcutaneous layer.
About the DermaPrecise Injector Product Line
The DermaPrecise Injector Product Line is comprised of a desktop touchscreen control unit wired to a handheld electronic injector wand with a push-button trigger rather than a manual plunger. In addition to offering unparalleled electronic control and consistency of injection depth and dose, the injector includes a cooling element intended to cool the skin to minimize sensation prior to injection. The proprietary consumables include two different multi-needle heads, syringe cartridges, and liners.
RepliCel management and advisors have engaged key clinical opinion leaders on the identification of high-value market applications for the device including the injection of various substances into the dermal and subcutaneous layers. Such substances include toxins, dermal fillers, drugs, biologics, PRP, fat, and cells. Potential uses for the devices include injections to treat hair loss, hyperhidrosis, migraines, skin aging/damage, skin pigmentation, and wounds, as well as cosmetic procedures such as skin rejuvenation, aesthetic sculpting, and reduction of fine wrinkles.
Commercial, clinical-grade units of the consumables and injector are now in production and testing for the purpose of gathering all necessary data to complete the submission to regulatory agencies seeking marketing approval. Plans are actively underway to pursue regulatory approvals for market launch initially in the United States, Europe, Hong Kong, and Japan to be followed by other markets globally.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.
The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company Limited. RepliCel maintains the rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.
RepliCel has also developed a proprietary injection device, DermaPrecise, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the DermaPrecise device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being approved for market launch in either the United States or Europe. Please visit www.replicel.com for additional information.
Notable Facts:
- RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents.
- RepliCel now has key strategic partners in the United States, China, and Japan each of which are now investing heavily in the further clinical testing and development of RepliCel's products for their markets. Data from each of the clinical programs will strengthen the product development initiatives for RepliCel and its other partners worldwide.
For more information, please contact:
Lee Buckler, CEO and President
604-248-8693
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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- RepliCel signs an Option to License agreement related to a filed US patent application
VANCOUVER, BC, CANADA – 16 September 2021 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce that the first-stage of a research project with the University of Victoria Centre for Biomedical Engineering (“UVic”) has led to significant milestones in terms of technology advancements, patent filings, grant funding, and a license option agreement.
As a result of the innovations coming out of the collaboration to-date, RepliCel has signed a Technology Evaluation and Option to License agreement pertaining to a patent filed with the US Patent Office (“USPTO”) on “multifunctional microcarriers with thermal-responsive biomaterials coatings”. The agreement grants RepliCel an option to license the patent and related technologies for global applications related to therapeutic cell culture in RepliCel’s fields of interest.
Additionally, the parties have now executed a new research collaboration agreement intended to optimize the innovations for use with RepliCel’s technologies and are pleased to announce that this next phase of the collaboration has been awarded new grant of funding over three years from the Mitacs Accelerate program.
“Based on the success of the NSERC-funded first phase of this collaboration, we are very pleased to have now procured significant funding support from the Mitacs Accelerate Program which focuses on scientific innovations with significant industrial or commercial application. This is a tremendous endorsement of our innovations, progress, and the technology’s potential utility,” stated RepliCel’s President and CEO, R. Lee Buckler.
“We are also very pleased to continue this collaboration with Dr. Akbari and his team at UVic. He is one of the world's emerging experts on biomedical engineering and the employment of advanced materials and micro-technologies for cell and tissue culture. The collaboration represents a unique opportunity to leverage his expertise and non-dilutive grant funding to innovate around RepliCel's technologies in ways expected to improve the Company's commercial-scale manufacturing”.
The UVic-RepliCel Micocarrier Cell Culture Project
The first phase of the two-year RepliCel-UVic project, announced in late 2018 and extended due to COVID-19 implications, was performed at the University of Victoria Centre for Biomedical Engineering, Laboratory for Innovations in Microengineering under the leadership of Dr. Mohsen Akbari with input from RepliCel Chief Scientific Officer, Dr. Kevin McElwee. The project was co-funded by RepliCel Life Sciences and a grant from the Natural Science and Engineering Research Council of Canada (\"NSERC\") under the NSERC Collaborative Research and Development (\"CRD\") program. This first phase of the project resulted in further development of a proprietary microcarrier technology which is the subject of a U.S. patent application, employing certain advanced materials and properties designed as an innovative platform for adherent cell culture in small volumetric footprints with the potential to reduce media consumption, culture time, and/or the use and disposal of single-use plastics.
This newly launched second phase of the collaboration will focus on approaches to optimize therapeutic cell culture platforms, such as those employed in RepliCel's cell therapy manufacturing, for eventual commercial-scale production. This phase of the project will focus on optimizing the proprietary microcarrier technology for use in culturing RepliCel’s therapeutic cell therapy products as part of RepliCel’s vision for its next-generation manufacturing. This phase of the project will be co-funded by RepliCel and the Mitacs Accelerate program and co-led by Dr. Mohsen Akbari, Associate Professor at the University of Victoria and Director of the Laboratory for Innovations in Microengineering (LiME), and RepliCel’s Dr. Kevin McElwee.
About Dr. Mohsen Akbari
Dr. Mohsen Akbari received his PhD (2011) in Applied Sciences from Simon Fraser University (Vancouver, British Columbia). He also conducted research from 2012-2015 as a postdoctoral fellow at Brigham and Women's Hospital (Boston, USA), Harvard Medical School, and Wyss Institute for Biologically Inspired Engineering. Dr. Akbari is currently an Associate Professor of Mechanical Engineering at the University of Victoria, Canada. He is also affiliated with the Centre for Advanced Materials and Related Technology (CAMTEC) at the University of Victoria, International Collaboration on Repair Discoveries, and the Djavad Mowafaghian Centre for Brain Health. His research lies at the interface of cellular biology, biomaterials, and microtechnologies with a focus on the biofabrication of engineered tissue substitutes for regenerative medicine, development of biomimetic tissue models using microengineering techniques for disease modeling and drug discovery, and development of advanced drug delivery systems for therapeutic applications.
Dr. Akbari has published more than 90 peer-reviewed articles in high-impact journals including Small, Science Translational Medicine, Advanced Functional Materials, Advanced Science, Nature Microtechnologies and Nanoengineering, Biotechnology Advances, and Advanced Materials. He has also published 7 book chapters, 3 patent applications/disclosures, and more than 50 conference presentations in prestigious conferences such as µTAS, World Biomaterials Congress, IMECE, and ASME. He has been cited +5300 times according to Google Scholar and has an h-index of 35. Dr. Akbari is the recipient of several institutional, national, and international awards such as the British Columbia Innovation Award, the Natural Sciences and Engineering Research Council of Canada (NSERC) postdoctoral fellowship, and the Kaiser Foundation Award. Recently, he was recognized as a rising Canadian star in global health. He also serves on the editorial board of Micromachines, Gels, and Transactions of Canadian Society for Mechanical Engineering (CSME), and is the chair of the micro and nanotechnology technical committee at CSME.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function.
Headquartered in Canada with a base of operations in Europe, RepliCel has existing partnerships in the United States, Japan and China as well as long-standing and ongoing research collaborations with the University of Victoria and the University of British Columbia.
The Company’s cell therapy product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. All RepliCel’s cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles. RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents and successfully reviewed by three different regulatory agencies.
RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration of its products and licensable for use with other dermatology applications. Certain commercial rights for RCI-02 have been licensed to YOFOTO for Greater China and a limited-term exclusive distributorship to MainPointe for the United States.
The commercial rights for RCH-01 for most of Asia have been exclusively licensed to Shiseido Company. Though the legal status of this license is currently the subject of some disagreement between the parties, Shiseido continues to finance the development of the licensed product based on RepliCel’s technology in their territory. The commercial rights for RCT-01 and RCS-01 have been exclusively licensed to YOFOTO (China) Health for Greater China. YOFOTO is also committed to financing the co-development of these products in their territory.
For more information, please visit www.replicel.com or contact:
For more information, please contact:
Lee Buckler, CEO and President
info@replicel.com
MainPointe Pharmaceuticals Completes Initial Share Purchase per Investment Agreement
VANCOUVER, BC, CANADA – 10 February 2021 – RepliCel Life Sciences Inc. (OTCPK: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, announced today it has closed the first tranche of the investment by MainPointe Pharmaceuticals (\"MainPointe\") as outlined in the share purchase agreement signed earlier this year by the parties.
MainPointe’s investment commitment, totaling CAD $2.7M, will be made over a series of four tranches involving the purchase of four million common shares at CAD $0.675 per share. The final trance is scheduled to be closed in August 2021.
This first tranche involved MainPointe’s purchase of 729,024 common shares issued by RepliCel in exchange for CAD $492,091 which has now been received by the Company. The second tranche of CAD $1.2M is scheduled to be closed before the end of February 20201.
All common shares issued are subject to a statutory hold period expiring four months and one day from the date of the issuance of the common shares. None of the securities sold in connection with the Offering will be registered under the United States Securities Act of 1933, as amended, and no such securities may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements. This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
About MainPointe Pharmaceuticals
MainPointe Pharmaceuticals, founded by John Schutte, is one of a portfolio of companies managed by a multi-generational family of healthcare investors and entrepreneurs based in Louisville, Kentucky. Specializing in sales and innovative distribution of consumer health differentiated brands and valued supplements that often utilizes unique technologies to improve patient outcomes and enhance consumer wellness, MainPointe is a company lead by management with more than 50 years of industry experience, established relationships, and superior reputations. MainPointe’s unique access to capital and nimble company structure makes it unique among similar sized pharmaceutical companies. Since its launch in 2017, MainPointe has brought nine products to market in the United States and is aggressively pursuing new products to bring to market.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function.
Headquartered in Canada with a base of operations in Europe, RepliCel has existing partnerships in the United States, Japan and China.
The Company’s cell therapy product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. All RepliCel’s cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles. RepliCel's three cell therapy products have now been tested in over 100 patients in four countries on three continents and successfully reviewed by three different regulatory agencies.
RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration of its products and licensable for use with other dermatology applications. Certain commercial rights for RCI-02 have been licensed to YOFOTO for Greater China and a limited-term exclusive distributorship to MainPointe for the United States.
The commercial rights for RCH-01 for most of Asia have been exclusively licensed to Shiseido Company, Though the legal status of this license is currently the subject of some disagreement between the parties, Shiseido continues to finance the development of the licensed product based on RepliCel’s technology in their territory. The commercial rights for RCT-01 and RCS-01 have been exclusively licensed to YOFOTO (China) Health for Greater China. YOFOTO is also committed to financing the co-development of these products in their territory.
For more information, please visit www.replicel.com or contact:
Lee Buckler, CEO and President
604-248-8693
info@replicel.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
RepliCel and MainPointe Pharmaceuticals Sign Strategic Investment and Collaboration Agreement
MainPointe Deal Positions RepliCel for entry into the U.S. market and significant milestones in Japan
VANCOUVER, BC, CANADA – 25 January 2021 – RepliCel Life Sciences Inc. (OTCPK: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, announced today it has signed three strategic agreements with MainPointe Pharmaceuticals (\"MainPointe\") headquartered in Louisville, Kentucky (the “Transaction”). These are the definitive agreements contemplated by the Binding Term Sheet signed by the parties and announced in November 2020. Closing of the Transaction represented in the signed agreements between the parties is subject to approval of the TSX Venture Exchange.
The agreements signed between RepliCel and MainPointe include a Share Purchase Agreement for the purchase of common shares at a price which is equal to the greater of $0.675 per share or the discounted market price per share (as defined in the policies of the TSX Venture Exchange) for a total investment of CAD $2,700,000 spread over an 8-month period. RepliCel’s shares closed market trading yesterday at CAD $0.20 per share. MainPointe has also agreed to pay the costs related to securing FDA approvals to market launch RepliCel's dermal injector and consumables (the “RepliCel Injector Product Line”) in the United States.
In return for MainPointe’s agreement to pay an over-the-market price for shares of RepliCel plus the FDA approval costs cited above, the parties signed two other agreements: a Royalty Participation Agreement and a Distribution Agreement. The Distribution Agreement provides MainPointe with a limited term, exclusive distribution partnership for the “RepliCel Injector Product Line” in the United States. The Royalty Participation Agreement provides MainPointe with a right to be paid a portion of RepliCel's future royalty revenue stream earned from the sale of RCS-01, RCT-01 and RCH-01 products and any derivatives.
Management Commentary
\"This investment and commercial partnership with MainPointe represents the next step in management's strategy to secure material investments from long-term partners motivated to enhance RepliCel share value by moving RepliCel programs forward,\" stated President and CEO, R. Lee Buckler.
The Distribution Agreement with MainPointe represents RepliCel's first footprint in the U.S. market and the Company's second distribution partnership for its near-commercial RepliCel Injector Product Line. RepliCel's partner, YOFOTO (China) Health, committed in 2018 to being the distributor of the RepliCel Injector Product Line in Greater China, where it is expected to first launch in Hong Kong after either European or American regulatory approval is obtained and registered in the Chinese territory. This regulatory registration will also trigger a $500,000 milestone payment by YOFOTO to RepliCel.
The Transaction with MainPointe represents the third strategic partnership secured by RepliCel and second major investment into RepliCel by a co-development and commercial partner. In 2013, RepliCel signed a co-development and licensing transaction with Shiseido Company including $4,000,000 upfront and over $31,000,000 in potential post-commercial milestone and sales royalty payments. In October 2018, YOFOTO invested CDN $5,090,000 in RepliCel by purchasing 5,357,000 common shares at CDN $0.95 per Share along with 1,071,580 share purchase warrants which have now expired. That deal also includes pre-commercial milestone payments of up to CDN $4,750,000, sales royalties, and a commitment by YOFOTO to spend a minimum of CDN $7,000,000 in five years (2018-2022) on the RepliCel programs and associated cell processing manufacturing facility in Greater China.
Primary Deal Terms
The exclusive distribution rights shall commence upon receipt of regulatory approval to launch the RepliCel Injector Product Line in the U.S. market and continue for a period expiring on the earlier (a) four (4) years, or (b) when MainPointe has earned a minimum return of USD $2,000,000 plus certain defined cost recoveries in gross income from the sale of the products in the RepliCel Injector Product Line. The Company will have the right, in its discretion, to buy out this exclusivity right for an amount equal to the net-present value of profit to be earned on USD $2,000,000 in gross income.
The royalty right will be equal to (a) 5% of the amounts earned by and paid to the Company from the sale of any of its “NBDS Products” defined as its RCS-01 (NBDS Fibroblast Therapy – Treatment for Aging Skin), RCT-01 (NBDS Fibroblast Therapy – Treatment for Chronic Tendinosis), and any other product which is comprised of the non-bulbar dermal sheath cells patented by the Company, and (b) 20% of the amounts earned by and paid to the Company from the sale of any of its \"DSC Products\" defined as its RCH-01 (DSC Therapy for Treatment Androgenic Alopecia) and any other product which is comprised of the dermal sheath cup cells patented by the Company. The term of the Royalty Participation Agreement will continue until MainPointe has been paid USD $16,000,000 in royalties, unless it is otherwise terminated pursuant to its terms.
Closing of the transactions pursuant to the agreements is subject to receipt of approval of the TSX Venture Exchange.
About the RepliCel (RCI-02) Injector Product Line
The RepliCel Injector Product Line is comprised of a desktop touchscreen control unit wired to a handheld electronic injector wand with a push-button trigger rather than a manual plunger. In addition to offering unparalleled electronic control and consistency of injection depth and dose, the injector includes a cooling element intended to cool the skin to minimize sensation prior to injection. The proprietary consumables include syringe cartridges, liners, and two different multi-needle heads.
RepliCel management and advisors have engaged key clinical opinion leaders on the identification of high-value market applications for the device including the injection of various substances into the dermal and subcutaneous layers. Such substances include toxins, dermal fillers, drugs, biologics, PRP, fat, and cells. Potential uses for the devices include injections to treat hair loss, hyperhidrosis, migraines, skin aging/damage, skin pigmentation, and wounds, as well as cosmetic procedures such as skin rejuvenation, aesthetic sculpting, and reduction of fine wrinkles.
Commercial and clinical-grade units of the consumables and injector are now in production. Once these units are available, functional and clinical testing will be launched for the purpose of gathering all necessary data to complete the submission to regulatory agencies seeking marketing approval. Plans are actively underway to pursue regulatory approvals for market launch initially in the United States, Europe, Hong Kong, and Japan to be followed by other markets globally.
About MainPointe Pharmaceuticals
MainPointe Pharmaceuticals, founded by John Schutte, is one of a portfolio of companies managed by a multi-generational family of healthcare investors and entrepreneurs based in Louisville, Kentucky. Specializing in sales and innovative distribution of consumer health differentiated brands and valued supplements that often utilizes unique technologies to improve patient outcomes and enhance consumer wellness, MainPointe is a company lead by management with more than 50 years of industry experience, established relationships, and superior reputations. MainPointe’s unique access to capital and nimble company structure makes it unique among similar sized pharmaceutical companies. Since its launch in 2017, MainPointe has brought nine products to market in the United States and is aggressively pursuing new products to bring to market.
About RepliCel Life Sciences
Headquarted in Canada with a base of operations in Europe, RepliCel has existing partnerships in Japan and China. RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function.
The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration of its products and licensable for use with other dermatology applications.
The commercial rights for RCI-02 have been secured by YOFOTO for Greater China and MainPointe has committed to a limited-term distributorship in the United States. RCH-01 is currently being co-developed with Shiseido Company under exclusive license for certain Asian countries. RCT-01 and RCS-01 is currently being co-developed with YOFOTO (China) Health under exclusive license for Greater China. All RepliCel’s cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.
For more information, please visit www.replicel.com or contact:
Lee Buckler, CEO and President
604-248-8693
info@replicel.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding: that the Transaction with MainPointe will be approved by the TSX Venture Exchange and that the Transaction will be completed, that the Company will receive regulatory approval in Europe or the United States for its dermal injector products and consumables, that the Company will commercialize its dermal injector product line in Europe and the United States, that the Company will complete the final steps needed to prepare for clinical testing of its skin and tendon regeneration cell therapy products in Japan, that the dermal injector products will be launched in the United States, Europe, Hong Kong, Japan and other markets globally.
These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: the risk that the Transaction will not be approved by the TSX Venture Exchange; the risk that MainPointe will not complete the investment as agreed; risks related RepliCel’s programs and related infrastructure; risks that the Company’s products may not perform as, or have the benefits, expected; risks that the Company’s products may not be accepted and adopted by the public; the risk that the Company will not obtain regulatory approval for its dermal injector device as anticipated or at all; the risk that there will be delays enrolling clinical trial participants or commencing any clinical or research programs as anticipated or at all; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risk that the Company may not obtain any further data from Shiseido; risks associated with the Company obtaining all necessary regulatory approvals for its various programs; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2019 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
", "Weighting": 0, "DisableForSiteSearch": false, "CreatedByMemberId": "0", "ItemCategories": [ "News - Press Release" ], "ItemCategoryIdList": [ 2397 ], "ItemTags": [ "Financing", "Partnerships" ], "Author": 1931, "Author_Name": "Kirsten Henderson", "Author_Url": "/_author/kirsten-henderson", "Item_Rating": 0, "Image": "/Blog/2017/mainpointe.png", "ShowPageForSearchEngine": true, "MetaTitle": "", "SEOTitle": "", "MetaDescription": "", "CanonicalLink": "", "SocialMetaTags": "", "SeoPriority": 0.5, "EnableAMP": false, "AMPContent": "", "OpenGraphProperties": { "title": null, "type": null, "url": null, "locale": null, "image": null }, "ExternalId": 0, "Params": { "type": "module", "source": "Blog Post", "layout": "List", "displaypagination": "true", "filterby": "itemtags", "limit": "20", "filtervalue": "Partnerships", "sortby": "releasedate", "sortorder": "DESC", "collectionvariable": "posts" } }, { "Id": 2699, "Name": "RepliCel Announces a Binding Term Sheet For Strategic Investment and U.S. Partnership", "Url": "/news/replicel-announces-a-binding-term-sheet-for-strategic-investment-and-u-s-partnership", "Url_List": [ "/news/replicel-announces-a-binding-term-sheet-for-strategic-investment-and-u-s-partnership" ], "UrlSlug": "replicel-announces-a-binding-term-sheet-for-strategic-investment-and-u-s-partnership", "ParentId": 1929, "ParentId_List": [ 1929 ], "ParentName": "News", "ParentUrl": "/news", "TemplateName": "News Template", "Module_Alias": "BlogPost", "Module_ID": 1534, "Enabled": true, "ReleaseDate": "2020-11-10T07:00:00", "ExpiryDate": "2099-12-12T09:00:00", "SiteSearchKeywords": [], "Description": "- \r\n
- Transaction represents RepliCel's entrance into the US market \r\n
- Investment terms minimize dilution and puts RepliCel on-track for US FDA marketing approvals of the RepliCel\r\n Dermal Injector Product Line \r\n
VANCOUVER, BC, CANADA – 10 November 2020 – RepliCel Life Sciences Inc. (OTCPK: REPCF) (TSXV:\r\n RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and\r\n orthopedics, announced today its intent to enter into a strategic partnership with MainPointe Pharmaceuticals\r\n (\"MainPointe\") headquartered in Louisville, Kentucky.
\r\nThe Company has signed a binding term sheet with MainPointe for an investment of CAD $2,700,000 and a limited term\r\n distribution partnership for RepliCel's dermal injector and consumables (the “RepliCel Injector Product Line”) in\r\n the United States. As part of the partnership, MainPointe has agreed to pay all costs related to securing FDA\r\n approvals to launch the RepliCel Injector Product Line in the U.S. market.
\r\nThe partnership with MainPointe would represent RepliCel's first footprint in the U.S. market and the Company's\r\n second distribution partnership for its near-commercial RepliCel Injector Product Line. RepliCel's partner, YOFOTO\r\n (China) Health is committed to being the distributor of the RepliCel Injector Product Line in Greater China, where it\r\n will first launch in Hong Kong after either European or American regulatory approval is obtained and registered in the\r\n Chinese territory. This regulatory registration will also trigger a $500,000 milestone payment to RepliCel.
\r\nLee Buckler, CEO of RepliCel commented, \"We are very pleased with the opportunity this partnership with a\r\n US-based shareholder and experienced healthcare distributor represents. The injection of capital from MainPointe\r\n will finance both the European and U.S. commercialization of our Dermal Injector Product Line, as well as completing\r\n the final steps needed to prepare for clinical testing of our skin and tendon regeneration cell therapy products in\r\n Japan. In combination with YOFOTO’s product development activity in China, we believe this represents a very\r\n significant series of milestones over the coming months.\"
\r\nJohn Schutte, CEO of MainPointe commented, \"As a serial healthcare entrepreneur, an investor, and the founder CEO\r\n of MainPointe Pharmaceuticals, I am proud of our track record in identifying high-value products which are backed by\r\n great science and positioned for our team’s regulatory and sales expertise in commercial value creation. Our\r\n long-term experience with the FDA has allowed us to bring a wide variety of healthcare products to market in the\r\n United States and drive phenomenal year-over-year sales growth with early-stage and novel products. The RepliCel\r\n investment and distribution partnership represents an exciting opportunity for MainPointe Pharmaceuticals to move\r\n into the fast-growing spaces of regenerative medicine and next-generation injection delivery technology.\"
\r\nPrimary Deal Terms
\r\nIn consideration for an investment of CAD $2,700,000 and the payment of all costs related to obtaining FDA approval\r\n for Company's dermal injector and consumables, RepliCel has agreed to issue MainPointe up to an aggregate of four (4)\r\n million common shares, a right to participate in RepliCel's royalty revenue stream up to a defined ceiling, and\r\n certain distribution rights of RepliCel Injector Product Line in the United States. The investment will be made\r\n as to CAD $500,000 within five (5) days of receipt of conditional approval from the TSX Venture Exchange, CAD $500,000\r\n by December 15, 2020, CAD $700,000 by January 21, 2021, CAD $700,000 by April 21, 2021 and CAD $300,000 by August 21,\r\n 2021. The common shares will be priced at the greater of CAD $0.675 or the Discounted Market Price as such term\r\n is defined in the Policies of the TSX Venture Exchange.
\r\nThe royalty right will be equal to (a) 5% of the amounts earned by and paid to the Company from the sale of any of\r\n its “NBDS Products” defined as its RCS-01 (NBDS Fibroblast Therapy – Treatment for Aging Skin), RCT-01 (NBDS\r\n Fibroblast Therapy – Treatment for Chronic Tendinosis), and any other product which is comprised of the non-bulbar\r\n dermal sheath cells patented by the Company, and (b) 20% of the amounts earned by and paid to the Company from the\r\n sale of any of its \"DSC Products\" defined as its RCH-01 (DSC Therapy for Treatment Androgenic Alopecia) and any other\r\n product which is comprised of the dermal sheath cup cells patented by the Company.
\r\nIn consideration for paying all expenses required to obtain regulatory approval for the RepliCel Injector Product\r\n Line, the exclusive distribution rights shall commence upon receipt of regulatory approval to launch the RepliCel\r\n Injector Product Line in the U.S. market for a period expiring on the earlier (a) four (4) years, or (ii) when\r\n MainPointe has earned USD $2,000,000 in gross income from the sale of the products in the RepliCel Injector Product\r\n Line. The Company will have the right, in its discretion, to buy out this exclusivity right for an amount equal\r\n to the net-present value of profit to be earned on USD $2,000,000 in gross income.
\r\nClosing of the transactions contemplated under the binding term sheet is conditional on the parties entering into\r\n definitive agreements and receipt of regulatory approval.
\r\nAbout the RepliCel (RCI-02) Injector Product Line
\r\nThe RepliCel Injector Product Line is comprised of a desktop touchscreen control unit wired to a handheld electronic\r\n injector wand with a push-button trigger rather than a manual plunger. In addition to offering unparalleled electronic\r\n control and consistency of injection depth and dose, the injector includes a cooling element intended to cool the skin\r\n to minimize sensation prior to injection. The proprietary consumables include two different multi-needle heads,\r\n syringe cartridges, and liners.
\r\nRepliCel management and advisors have engaged key clinical opinion leaders on the identification of high-value market\r\n applications for the device including the injection of various substances into the dermal and subcutaneous layers.\r\n Such substances include toxins, dermal fillers, drugs, biologics, PRP, fat, and cells. Potential uses for the devices\r\n include injections to treat hair loss, hyperhidrosis, migraines, skin aging/damage, skin pigmentation, and wounds, as\r\n well as cosmetic procedures such as skin rejuvenation, aesthetic sculpting, and reduction of fine wrinkles.
\r\nCommercial and clinical-grade units of the consumables and injector are now in production. Once these units are\r\n available, functional and clinical testing will be launched for the purpose of gathering all necessary data to\r\n complete the submission to regulatory agencies seeking marketing approval. Plans are actively underway to pursue\r\n regulatory approvals for market launch initially in the United States, Europe, Hong Kong, and Japan to be followed by\r\n other markets globally.
\r\nAbout MainPointe Pharmaceuticals
\r\nMainPointe Pharmaceutics is owned and managed by a multi-generational family of healthcare investors and\r\n entrepreneurs who founded the company. Specializing in sales and innovative distribution of consumer health\r\n differentiated brands and valued supplements that often utilizes unique technologies to improve patient outcomes and\r\n enhance consumer wellness, MainPointe is a company lead by management with more than 50 years of industry experience,\r\n established relationships, and superior reputations. MainPointe’s unique access to capital and nimble company\r\n structure makes it unique among similar sized pharmaceutical companies. Since its launch in 2017, MainPointe has\r\n brought nine products to market in the United States and is aggressively pursuing new products to bring to market.
\r\nAbout RepliCel Life Sciences
\r\nHeadquarted in Canada with a base of operations in Europe, RepliCel has existing partnerships in Japan and China.\r\n RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic\r\n conditions affecting what the Company believes is approximately one in three people in industrialized nations,\r\n including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often\r\n associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. \r\n
\r\nThe Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for\r\n hair restoration. RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration\r\n of its products and licensable for use with other dermatology applications. RCH-01 is currently being co-developed\r\n with, and under exclusive license by, Shiseido for certain Asian countries. All product candidates are based on\r\n RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles. \r\n
\r\nFor more information, please visit www.replicel.com or contact:
Lee Buckler, CEO and\r\n President
604-248-8693
info@replicel.com
\r\n\r\nNeither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX\r\n Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
\r\nThis press release contains forward-looking statements and information that involve various risks and uncertainties\r\n regarding future events, including, but not limited to, statements regarding: that MainPointe will complete its\r\n investment, that the Company will receive regulatory approval in Europe or the United States for its dermal injector\r\n products and consumables, that the Company will commercialize its dermal injector product line in Europe and the\r\n United States, that the Company will complete the final steps needed to prepare for clinical testing of its skin and\r\n tendon regeneration cell therapy products in Japan, that the dermal injector products will be launched in the United\r\n States, Europe, Hong Kong, Japan and other markets globally.
\r\nThese statements are only predictions and involve known and unknown risks which may cause actual results and the\r\n Company’s plans and objectives to differ materially from those expressed in the forward-looking statements,\r\n including: risks related YOFOTO spending the required amounts on RepliCel’s programs and related\r\n infrastructure over the next 5 years in Greater China; risks that the Company’s products may not\r\n perform as, or have the benefits, expected; risks that the Company’s\r\n products may not be accepted and adopted by the public; the risk that the Company will not\r\n obtain CE mark clearance for its dermal injector device as anticipated or at all; the risk that there will be\r\n delays enrolling clinical trial participants or commencing any clinical or research programs as anticipated or at\r\n all; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of\r\n government regulation on the Company’s business; risk that the Company may not obtain any further data from\r\n Shiseido; risks associated with the Company obtaining all necessary regulatory approvals for its various programs;\r\n risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and\r\n uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the\r\n Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements\r\n are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking\r\n statement speaks only as of the date on which such statement is made and, except as required by applicable law, the\r\n Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after\r\n the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge\r\n from time to time, and it is not possible for management to predict all of such factors and to assess in advance the\r\n impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may\r\n cause actual results to differ materially from those contained in any forward-looking statement. Readers should\r\n consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the\r\n Company’s annual report on Form 20-F for the fiscal year ended December 31, 2019 and other periodic reports filed\r\n from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia\r\n Securities Commission on SEDAR at www.sedar.com.
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Initial run of commercial-grade units is delayed by plant shutdown in China affecting the production of cooling element
VANCOUVER, BC, CANADA – 09 March 2020 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, announces the first production run of commercial-grade automated RepliCel dermal injectors has been delayed to plant shutdowns in China which produce a critical component of the device.
\"While we have been informed that the plant is expected to be operational again in early March, we have already experienced several weeks' delay in our production timeline,\" stated RepliCel President and CEO, R. Lee Buckler. \"We are actively pursuing alternative suppliers and manufacturers in the event this does not resolve quickly, and are confident we will find a solution which supports our goal of market approval and product launch this year,\" Buckler concluded.
While the single component delayed from China will delay complete device testing, all other parts and device assembly are still in production.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is currently being co-developed with, and under exclusive license by, Shiseido for certain Asian countries. All product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles. RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration of its products and licensable for use with other dermatology applications. Please visit www.replicel.com for additional information.
For more information, please contact:
Lee Buckler, CEO and President
604-248-8693
info@replicel.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
RepliCel's Partner, YOFOTO (China) Health, Unveils its Inaugural Cell Therapy Manufacturing Facility in China
YOFOTO (China) Health Now Commissioning its Manufacturing Facility in Preparation for Technology Transfer of Skin and Tendon Product Manufacturing and Applications for Clinical Trials
VANCOUVER, BC, CANADA – September 10, 2019 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce that its Licensee, YOFOTO (China) Health Co. (“YOFOTO”), headquartered in Ningbo, China, has now completed the construction of its cell therapy manufacturing facility.
In a recent update to the RepliCel Board of Directors, the YOFOTO team reported that construction of its 4,700 sq metre facility dedicated to cell therapy manufacturing is now complete being commissioned for active production with capacity for clinical research manufacturing, material handling, purified water processing, research and development labs, QC/QA testing, cryopreservation storage, clinical biopsy/treatment space, and an exhibition hall.
YOFOTO also reported that it now has over 20 people employed in the facility and is actively engaged in:
- the pursuit of the facility's certification;
- initiation of technology transfer training by RepliCel at its contract laboratory at the University of British Columbia laboratory (Vancouver, Canada); its contract manufacturing facility in Europe (Innsbruck, Austria), and at clinical trial sites in China; and
- preparing the initial applications to the Chinese regulatory authorities seeking approval to commence clinical trials of the RCS-01 skin and RCT-01 tendon products in China.
\"The speed at which YOFOTO has designed and built this facility is impressive,\" stated RepliCel President and CEO, R. Lee Buckler, \"and certainly is indicative of their commitment to the portfolio of products they licensed from and are co-developing with RepliCel.\"
\"YOFOTO is very committed to rapidly moving forward the development and commercialization of RCT-01, RCS-01, and RCI-02 in Greater China,\" stated YOFOTO (China) Health Vice-President, Larissa Huang. \"We now look forward to working with some of China's leading clinical hospitals and clinicians as well as China's regulatory authorities to prepare for clinical studies in tendon regeneration and skin rejuvenation in China.\"
RepliCel’s Greater China Strategy: A Portfolio View
RCT-01 - Current plans suggest a clinical trial of RCT-01 treatment for chronic tendinopathy will be conducted in China by YOFOTO overlapping with a clinical trial of RCT-01 in Japan leading to multiple clinical readouts. Applications for such trials are now being prepared. The timing of such trials will depend on regulatory approvals.
RCS-01 - Current plans suggest that a clinical trial of the RCS-01 treatment for aging and sub-damaged skin will be conducted in China by YOFOTO overlapping with a clinical trial or RCS-01 in Japan leading to multiple clinical readouts. Applications for such trials are now being prepared. The timing of such trials will depend on regulatory approvals.
RCI-02 - RepliCel’s next-generation, dermal injector, a medical device designed to optimize the controlled injection of cell therapies and other injectables, is expected to be launched in Europe, Hong Kong and other market accepting CE mark approval next year. It is anticipated that YOFOTO will be marketing the device in Hong Kong at the same time as using the device in a clinical study of RCS-01 in China in anticipation of regulatory approval to launch the product on the market in the People’s Republic of China. Simultaneous to this activity in Greater China, RepliCel will be submitting the necessary applications to obtain market approval for the device in Japan and to use it there for clinical testing.
RCH-01 – RepliCel’s RCH-01 treatment in development for hair loss due to androgenic alopecia is licensed to Shiseido Company for Asia including Greater China.
About YOFOTO
YOFOTO (China) Health Industry Co., Ltd was established in 2004 as a company engaged in the health and consumer products industry. With a wide range of successful commercial products in the food, personal health care, and household categories, YOFOTO is now diversifying into higher-value health-related products and services such as genetic and blood testing, regenerative medicine, and destination health-treatment clinics. As part of its strategy, YOFOTO has made several investments outside of China.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.
The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company. RepliCel and Shiseido are currently co-developing the product in Japan. RepliCel maintains the rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.
RepliCel has also developed a proprietary injection device, RCI-02, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the RCI-02 device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being CE marked. Please visit www.replicel.com for additional information.
For more information, please contact:
Lee Buckler, CEO and President
604-248-8693
info@replicel.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding: that YOFOTO is rapidly building momentum on its licensed programs for Greater China; that YOFOTO will obtain certification of its facility; that YOFOTO has hired over 20 people, that YOFOTO will submit the initial regulatory documentation to the Chinese regulatory authorities seeking approval to commence clinical trials of the RCS-01 skin and RCT-01 tendon products; that a clinical trial of RCT-01 treatment for chronic tendinopathy will be conducted in China by YOFOTO overlapping with a clinical trial of RCT-01 in Japan leading to multiple clinical readouts; that a clinical trial of the RCS-01 treatment for aging and sub-damaged skin will be conducted in China by YOFOTO overlapping with a clinical trial or RCS-01 in Japan leading to multiple clinical readouts; that RepliCel’s next-generation, dermal injector, a medical device designed to optimize the controlled injection of cell therapies and other injectables, is expected to be launched in Europe, Hong Kong and other market accepting CE mark approval next year; that YOFOTO will be marketing the device in Hong Kong at the same time as using the device in a clinical study of RCS-01 in China in anticipation of regulatory approval to launch the product on the market in the People’s Republic of China; that simultaneous to the activity in Greater China, RepliCel will be submitting the necessary applications to obtain market approval for the device in Japan and to use it there for clinical testing;that YOFOTO is now diversifying into higher-value health-related products and services such as genetic and blood testing, regenerative medicine, and destination health-treatment clinics; that RepliCel’s proprietary injection device, RCI-02, is expected to improve the administration of its cell therapy products and certain other injectables; and that YOFOTO is expected to first launch the RCI-02 device and consumables in Greater China for dermatology applications in Hong Kong upon it being CE marked.
These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: risks related YOFOTO spending the required amounts on RepliCel’s programs and related infrastructure over the next 5 years in Greater China; risks related YOFOTO not completing its stated goals; risk related to YOFOTO paying $4.5M CDN in milestone payments and sales royalties; risks that the Company’s products may not perform as, or have the benefits, expected; risks that the Company’s products may not be accepted and adopted by the public; the risk that the Company will not obtain CE mark clearance for its injector device as anticipated or at all; the risk that there will be delays enrolling clinical trial participants or commencing any clinical or research programs as anticipated or at all; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risk that the Company may not obtain any further data from Shiseido; risks associated with the Company obtaining all necessary regulatory approvals for its various programs; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2017 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
RepliCel's Licensee Building Momentum in China with Facility and Team
YOFOTO (China) Health Announces Initiation of Facility Build-Out, New Hires, and Preparation to Submit Applications to China’s Regulators
VANCOUVER, BC, CANADA – March 26, 2019 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce that its Licensee, YOFOTO (China) Health Co. (“YOFOTO”), headquartered in Ningbo, China, is rapidly building momentum on its licensed programs for Greater China, since closing the transaction with RepliCel in October last year.
In a recent update to the RepliCel Board of Directors, the YOFOTO team reported it had:
- completed the facility design and engineering plans for a laboratory, clinic, and research manufacturing facility build-out to be done in a building it already owns near its headquarters in Ningbo as well as new construction of an adjacent building for administration;
- obtained the necessary regulatory permits and approvals to commence certain demolition and construction;
- retained the contractors;
- commenced construction of a 4,700 sq metre facility in its existing building to hold clinical research manufacturing, material handling, purified water processing, research and development labs, QC/QA testing, cryopreservation storage, clinical biopsy/treatment space, and an exhibition hall; and
- hired several team members for its new cell therapy division and are engaged in recruiting several others for QC/QA, clinical, operations and regulatory positions.
YOFOTO has announced that by mid-2019 it expects to have:
- hired over 20 people;
- completed primary facility construction and initiated technology transfer, training, and validation testing; and
- submitted the initial regulatory documentation to the Chinese regulatory authorities seeking approval to commence clinical trials of the RCS-01 skin and RCT-01 tendon products.
RepliCel’s Greater China Strategy: A Portfolio View
RCT-01 - Current plans suggest a clinical trial of RCT-01 treatment for chronic tendinopathy will be conducted in China by YOFOTO overlapping with a clinical trial of RCT-01 in Japan leading to multiple clinical readouts. Applications for such trials are now being prepared. The timing of such trials will depend on regulatory approvals.
RCS-01 - Current plans suggest that a clinical trial of the RCS-01 treatment for aging and sun-damaged skin will be conducted in China by YOFOTO overlapping with a clinical trial or RCS-01 in Japan leading to multiple clinical readouts. Applications for such trials are now being prepared. The timing of such trials will depend on regulatory approvals.
RCI-02 - RepliCel’s next-generation, dermal injector, a medical device designed to optimize the controlled injection of cell therapies and other injectables, is expected to be launched in Europe, Hong Kong, and other market accepting CE mark approval next year. It is anticipated that YOFOTO will be marketing the device in Hong Kong at the same time as using the device in a clinical study of RCS-01 in China in anticipation of regulatory approval to launch the product on the market in the People’s Republic of China. Simultaneous to this activity in Greater China, RepliCel will be submitting the necessary applications to obtain market approval for the device in Japan and to use it there for clinical testing.
RCH-01 – RepliCel’s RCH-01 treatment in development for hair loss due to androgenic alopecia is licensed to Shiseido Company for Asia including Greater China.
About YOFOTO
YOFOTO (China) Health Industry Co., Ltd was established in 2004 as a company engaged in the health and consumer products industry. With a wide range of successful commercial products in the food, personal health care, and household categories, YOFOTO is now diversifying into higher-value health-related products and services such as genetic and blood testing, regenerative medicine, and destination health-treatment clinics. As part of its strategy, YOFOTO has made several investments outside of China.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.
The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company. RepliCel and Shiseido are currently co-developing the product in Japan. RepliCel maintains the rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.
RepliCel has also developed a proprietary injection device, RCI-02, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the RCI-02 device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being CE marked. Please visit www.replicel.com for additional information.
For more information, please contact:
Lee Buckler, CEO and President
604-248-8693
info@replicel.com
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding: that YOFOTO is rapidly building momentum on its licensed programs for Greater China; the laboratory, clinic, and research manufacturing facility build-out to be done by YOFOTO in a building it already owns near its headquarters in Ningbo as well as new construction of an adjacent building for administration; that YOFOTO will commence certain demolition and construction; that YOFOTO is engaged in recruiting several other team members for QC/QA, clinical, operations and regulatory positions; that by mid-2019 YOFOTO expects to have: hired over 20 people, completed primary facility construction and initiated technology transfer, training, and validation testing, and submitted the initial regulatory documentation to the Chinese regulatory authorities seeking approval to commence clinical trials of the RCS-01 skin and RCT-01 tendon products; that a clinical trial of RCT-01 treatment for chronic tendinopathy will be conducted in China by YOFOTO overlapping with a clinical trial of RCT-01 in Japan leading to multiple clinical readouts; that a clinical trial of the RCS-01 treatment for aging and sub-damaged skin will be conducted in China by YOFOTO overlapping with a clinical trial or RCS-01 in Japan leading to multiple clinical readouts; that RepliCel’s next-generation, dermal injector, a medical device designed to optimize the controlled injection of cell therapies and other injectables, is expected to be launched in Europe, Hong Kong and other market accepting CE mark approval next year; that YOFOTO will be marketing the device in Hong Kong at the same time as using the device in a clinical study of RCS-01 in China in anticipation of regulatory approval to launch the product on the market in the People’s Republic of China; that simultaneous to the activity in Greater China, RepliCel will be submitting the necessary applications to obtain market approval for the device in Japan and to use it there for clinical testing; that YOFOTO is now diversifying into higher-value health-related products and services such as genetic and blood testing, regenerative medicine, and destination health-treatment clinics; that RepliCel’s proprietary injection device, RCI-02, is expected to improve the administration of its cell therapy products and certain other injectables; and that YOFOTO is expected to first launch the RCI-02 device and consumables in Greater China for dermatology applications in Hong Kong upon it being CE marked.
These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: risks related YOFOTO spending the required amounts on RepliCel’s programs and related infrastructure over the next 5 years in Greater China; risks related YOFOTO not completing its stated goals; risk related to YOFOTO paying $4.5M CDN in milestone payments and sales royalties; risks that the Company’s products may not perform as, or have the benefits, expected; risks that the Company’s products may not be accepted and adopted by the public; the risk that the Company will not obtain CE mark clearance for its injector device as anticipated or at all; the risk that there will be delays enrolling clinical trial participants or commencing any clinical or research programs as anticipated or at all; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risk that the Company may not obtain any further data from Shiseido; risks associated with the Company obtaining all necessary regulatory approvals for its various programs; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2017 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
RepliCel is excited to have been chosen to present at next year's EBD Biotech Showcase in San Francisco January 7-9, 2019. Hope to see you there!
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VANCOUVER and VICTORIA, BC, Oct. 18, 2018 /CNW/ - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA: P6P2) (\"RepliCel\" or the \"Company\") is pleased to announce it has signed a collaborative research project agreement with the University of Victoria (\"UVic\") in Victoria, B.C., Canada. The project will be co-funded through a grant from the National Science and Engineering Research Council of Canada (\"NSERC\") under the NSERC Collaborative Research and Development (\"CRD\") program.
The collaboration will focus on approaches to optimize cell culture platforms, such as those employed in RepliCel's cell therapy manufacturing, for eventual commercial-scale production. The project aims to employ microfluidic technology and advanced materials to develop an innovative platform for larger scale adherent cell culture in small volumetric footprints.
The project will be led by UVic's Dr. Mohsen Akbari, Assistant Professor at the University of Victoria and Director of the Laboratory for Innovations in Microengineering (LiME). Co-leading the project will be RepliCel's Chief Scientific Officer, Dr. Kevin McElwee who is also Professor of Biomedical Sciences at the University of Bradford, West Yorkshire, UK.
\"We are very pleased to have NSERC CRD support to work with Dr. Akbari and his team at UVic. He is one of the world's emerging experts on biomedical engineering and the employment of advanced materials and micro-technologies for cell and tissue culture. The collaboration represents a unique opportunity to leverage his expertise and non-dilutive grant funding to innovate around RepliCel's technologies in ways expected to improve the Company's eventual commercial-scale manufacturing,\" stated RepliCel President and CEO, R. Lee Buckler.
The two-year NSCERC CRD funding commitment and collaboration agreement with UVic may result in publications, patents, and/or the development of technologies with potential applications and value broader than RepliCel's immediate uses. New intellectual property arising from the project will be the sole and exclusive property of UVic with a fully paid, non-exclusive, royalty-free license to RepliCel for any commercial purposes. RepliCel has the option to negotiate an exclusive license to such intellectual property from UVic for commercial purposes important to the Company.
About Dr. Mohsen Akbari
Dr. Mohsen Akbari received his PhD (2011) in Applied Sciences from Simon Fraser University (Vancouver, British Columbia). He also conducted research from 2012-2015 as a postdoctoral fellow at Brigham and Women's Hospital (Boston, USA), Harvard Medical School, and Wyss Institute for Biologically Inspired Engineering. Dr. Akbari is currently an Assistant Professor of Mechanical Engineering at the University of Victoria, Canada. He is also affiliated with Center for Biomedical Research (CBR) and Centre for Advanced Materials and Related Technology (CAMTEC) at the University of Victoria. His research lies at the interface of cellular biology, biomaterials, and microtechnologies with a focus on the biofabrication of engineered tissue substitutes for regenerative medicine, development of biomimetic tissue models using microengineering techniques for disease modeling and drug discovery, and development of advanced drug delivery systems for therapeutic applications.
Dr. Akbari has 46 peer-reviewed articles (citations=+1650, h index=21) in high impact journals including Science Translational Medicine, Nature Microtechnologies and Nanoengineering, Biotechnology Advances, and Advanced Materials, three book chapters, three patent applications/disclosures and more than 30 conference presentations in prestigious conferences such as µTAS, World Biomaterials Congress, and IMECE, and ASME. Dr. Akbari is the recipient of several institutional, national, and international awards such as the British Columbia Innovation Award, the Natural Sciences and Engineering Research Council of Canada (NSERC) postdoctoral fellowship, and the Kaiser Foundation Award. Recently, he was recognized as a rising Canadian star in global health.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function.
The Company's product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is currently being co-developed with, and under exclusive license by, Shiseido for certain Asian countries. All product candidates are based on RepliCel's innovative technology, utilizing cell populations isolated from a patient's healthy hair follicles. RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration of its products and licensable for use with other dermatology applications.
Please visit www.replicel.com for additional information.
Forward-looking information
Certain statements in this news release are forward-looking statements, which reflect the expectations of management regarding the results of the project outlined in this release. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Forward-looking statements in this news release include statements relating to the statements that (i) data from this project is expected to improve the Company's eventual commercial-scale manufacturing; and (iii) the results will improve our product manufacturing, clinical outcomes, and assays critical to regulatory approval and commercialization. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking statements, including risks that the Company's products may not perform as, or have the benefits, expected; risks that the Company's products may not be accepted and adopted by the public; the risk that the Company will not obtain CE mark clearance for its injector device; the risk that there will be delays enrolling clinical trial participants or commencing any clinical or research programs; the risk that the Company will receive negative results from the Company's clinical trials; the effects of government regulation on the Company's business; risks associated with the Company obtaining all necessary regulatory approvals for its various programs; risks associated with the Company's ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company's ability to raise additional capital; and other factors beyond the Company's control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2017 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
![\"\"](\"https://rt.newswire.ca/rt.gif?NewsItemId=C7396&Transmission_Id=201810180600CANADANWCANADAPR_C7396&DateId=20181018\")
For further information: Lee Buckler, CEO and President, 604-248-8693, info@replicel.com
The National Sciences and Engineering Research Council of Canada has funded a University of Victoria project aimed at collaborating with RepliCel to optimize cell culture and manufacturing technologies
VANCOUVER and VICTORIA, BC, Oct. 18, 2018 /CNW/ - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA: P6P2) (\"RepliCel\" or the \"Company\") is pleased to announce it has signed a collaborative research project agreement with the University of Victoria (\"UVic\") in Victoria, B.C., Canada. The project will be co-funded through a grant from the National Science and Engineering Research Council of Canada (\"NSERC\") under the NSERC Collaborative Research and Development (\"CRD\") program.
The collaboration will focus on approaches to optimize cell culture platforms, such as those employed in RepliCel's cell therapy manufacturing, for eventual commercial-scale production. The project aims to employ microfluidic technology and advanced materials to develop an innovative platform for larger scale adherent cell culture in small volumetric footprints.
The project will be led by UVic's Dr. Mohsen Akbari, Assistant Professor at the University of Victoria and Director of the Laboratory for Innovations in Microengineering (LiME). Co-leading the project will be RepliCel's Chief Scientific Officer, Dr. Kevin McElwee who is also Professor of Biomedical Sciences at the University of Bradford, West Yorkshire, UK.
\"We are very pleased to have NSERC CRD support to work with Dr. Akbari and his team at UVic. He is one of the world's emerging experts on biomedical engineering and the employment of advanced materials and micro-technologies for cell and tissue culture. The collaboration represents a unique opportunity to leverage his expertise and non-dilutive grant funding to innovate around RepliCel's technologies in ways expected to improve the Company's eventual commercial-scale manufacturing,\" stated RepliCel President and CEO, R. Lee Buckler.
The two-year NSCERC CRD funding commitment and collaboration agreement with UVic may result in publications, patents, and/or the development of technologies with potential applications and value broader than RepliCel's immediate uses. New intellectual property arising from the project will be the sole and exclusive property of UVic with a fully paid, non-exclusive, royalty-free license to RepliCel for any commercial purposes. RepliCel has the option to negotiate an exclusive license to such intellectual property from UVic for commercial purposes important to the Company.
About Dr. Mohsen Akbari
Dr. Mohsen Akbari received his PhD (2011) in Applied Sciences from Simon Fraser University (Vancouver, British Columbia). He also conducted research from 2012-2015 as a postdoctoral fellow at Brigham and Women's Hospital (Boston, USA), Harvard Medical School, and Wyss Institute for Biologically Inspired Engineering. Dr. Akbari is currently an Assistant Professor of Mechanical Engineering at the University of Victoria, Canada. He is also affiliated with Center for Biomedical Research (CBR) and Centre for Advanced Materials and Related Technology (CAMTEC) at the University of Victoria. His research lies at the interface of cellular biology, biomaterials, and microtechnologies with a focus on the biofabrication of engineered tissue substitutes for regenerative medicine, development of biomimetic tissue models using microengineering techniques for disease modeling and drug discovery, and development of advanced drug delivery systems for therapeutic applications.
Dr. Akbari has 46 peer-reviewed articles (citations=+1650, h index=21) in high impact journals including Science Translational Medicine, Nature Microtechnologies and Nanoengineering, Biotechnology Advances, and Advanced Materials, three book chapters, three patent applications/disclosures and more than 30 conference presentations in prestigious conferences such as µTAS, World Biomaterials Congress, and IMECE, and ASME. Dr. Akbari is the recipient of several institutional, national, and international awards such as the British Columbia Innovation Award, the Natural Sciences and Engineering Research Council of Canada (NSERC) postdoctoral fellowship, and the Kaiser Foundation Award. Recently, he was recognized as a rising Canadian star in global health.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function.
The Company's product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is currently being co-developed with, and under exclusive license by, Shiseido for certain Asian countries. All product candidates are based on RepliCel's innovative technology, utilizing cell populations isolated from a patient's healthy hair follicles. RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration of its products and licensable for use with other dermatology applications.
Please visit www.replicel.com for additional information.
Forward-looking information
Certain statements in this news release are forward-looking statements, which reflect the expectations of management regarding the results of the project outlined in this release. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Forward-looking statements in this news release include statements relating to the statements that (i) data from this project is expected to improve the Company's eventual commercial-scale manufacturing; and (iii) the results will improve our product manufacturing, clinical outcomes, and assays critical to regulatory approval and commercialization. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking statements, including risks that the Company's products may not perform as, or have the benefits, expected; risks that the Company's products may not be accepted and adopted by the public; the risk that the Company will not obtain CE mark clearance for its injector device; the risk that there will be delays enrolling clinical trial participants or commencing any clinical or research programs; the risk that the Company will receive negative results from the Company's clinical trials; the effects of government regulation on the Company's business; risks associated with the Company obtaining all necessary regulatory approvals for its various programs; risks associated with the Company's ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company's ability to raise additional capital; and other factors beyond the Company's control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2017 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
For further information: Lee Buckler, CEO and President, 604-248-8693, info@replicel.com
Canada-based biotech company signs major deal with Chinese partner to advance groundbreaking technology in the skin and tendon rejuvenation space.
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YOFOTO (China) Health and RepliCel Life Sciences finalize investment and commence collaboration activity in Greater China
VANCOUVER and NINGBO, China, Oct, 11, 2018 /CNW/ - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA: P6P2) (\"RepliCel\" or the \"Company\"), a company developing next-generation technologies in aesthetics and orthopedics, announced today it has completed the anticipated strategic investment (the \"Transaction\") with YOFOTO (China) Health Industry Co. Ltd. (\"YOFOTO\").
YOFOTO has invested CDN $5,090,000 in RepliCel by the purchase of 5,357,000 common shares (each, a \"Share\"), at CDN $0.95 per Share, and 1,071,580 share purchase warrants (each, a \"Warrant\") with each Warrant exercisable at CDN $0.95 per Share for a period of two years. The Transaction also includes the grant of an exclusive license to YOFOTO of the Company's tendon regeneration cell therapy technology (RCT-01), skin rejuvenation cell therapy technology (RCS-01), and its injection technology for dermal applications (RCI-02) (excluding hair-related treatments) in Greater China(Mainland China, Hong Kong, Macau, and Taiwan) (the \"Territory\") in consideration of milestone payments, sales royalties, and a commitment by YOFOTO to finance, over the next five years, the included RepliCel programs and an associated cell processing manufacturing facility in Greater China.
RepliCel and YOFOTO are now ready to launch the first phase of their strategic collaboration in the Territory and RepliCel's next stage of activity outside of Asia. The joint effort with YOFOTO will focus on the further development and commercialization of RepliCel's tendon regeneration cell therapy technology (RCT-01), skin rejuvenation cell therapy technology (RCS-01), and injection technology for dermal applications (RCI-02) (excluding hair-related treatments) in the Territory.
All of the Shares and Warrants issued to YOFOTO will be subject to a statutory hold period expiring four months and one day after issuance of the Shares and Warrants.
About YOFOTO
YOFOTO (China) Health Industry Co., Ltd was established in 2004 as a company engaged in the health and consumer products industry. For example, YOFOTO has registered 31 different nutraceuticals with the State Food and Drug Administration (China). With a wide range of successful commercial products in the food, personal health care, and household categories, YOFOTO is now diversifying into higher-value health-related products and services such as genetic and blood testing, regenerative medicine, and destination health-treatment clinics. As part of its strategy, YOFOTO has made several investments outside of China. Its current expansion includes a global R&D production base, organic food base, natural cosmetic R&D center, a conference center, yacht club and health spa resort.
At present, YOFOTO has registered over 700 trademarks and attained over 60 patents. YOFOTO has 32 provincial branches in China and, in 2009, began international expansion into Russia, Vietnam, Thailand and Cameroon. At the same time, YOFOTO began active participation in the Asia-Pacific Economic Cooperation (APEC) forum. YOFOTO Chairman of YOFOTO, Mr. Huang Jin Bao, was elected to be the member of the first APEC Chinese Industry and Commerce Council.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. The Company's product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is currently being co-developed with, and under exclusive license by, Shiseido for certain Asian countries. All product candidates are based on RepliCel's innovative technology, utilizing cell populations isolated from a patient's healthy hair follicles. RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration of its products and licensable for use with other dermatology applications. Please visit www.replicel.com for additional information.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Disclaimer for Forward-Looking Statements
This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding the milestone payments, sales royalty payments and the program funding commitments to be made by YOFOTO in connection with the Transaction.
These statements are only predictions and involve known and unknown risks which may cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking statements, including: risks that the parties will not execute on their respective commitments in connection with the Transaction,risks that the Company's products may not perform as, or have the benefits, expected; risks that the Company's products may not be accepted and adopted by the public; the risk that the Company will not obtain CE mark clearance for its injector device; the risk that there will be delays enrolling clinical trial participants; the risk that the Company will receive negative results from the Company's clinical trials; the effects of government regulation on the Company's business; risks associated with the Company obtaining all necessary regulatory approvals for its various programs; risks associated with the Company's ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company's ability to raise additional capital; and other factors beyond the Company's control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2016 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
YOFOTO (China) Health and RepliCel Life Sciences now cleared to close investment transaction and commence collaboration activity in Greater China
VANCOUVER and NINGBO, China, Sept. 24, 2018 /CNW/ - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (\"RepliCel\" or the \"Company\"), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce it has received, from the TSX Venture Exchange, the conditional approval required to complete the investment which is part of a previously announced collaboration agreement (the \"Transaction\") focused on commercialization of select RepliCel products in Greater China.
The Company also announces that YOFOTO (China) Health Industry Co. Ltd. (\"YOFOTO\") has received all the approvals from the Chinese regulatory authorities required to finalize the transaction.
With the required approvals in place, the parties expect to close the investment portion of the Transaction shortly allowing them to then immediately and actively launch their strategic partnership in Greater China (Mainland China, Hong Kong, Macau, and Taiwan) (the \"Territory\") and RepliCel's next stage of activity outside of Asia.
The investment portion of the Transaction is a CDN $5,090,000 purchase of common shares (each, a \"Share\") at CDN $0.95 per Share and will include 20% warrant coverage exercisable at CDN $0.95 per Share for a period of two years. The deal structure also includes milestone payments, sales royalties, and a commitment by YOFOTO to finance, over the next five years, the included RepliCel programs and an associated cell processing manufacturing facility in Greater China.
In addition to being a shareholder in RepliCel, YOFOTO will collaborate with RepliCel on the further development and commercialization of RepliCel's tendon regeneration cell therapy (RCT-01), skin rejuvenation cell therapy (RCS-01), and its injection technology for dermal applications (RCI-02) (excluding hair-related treatments) in the Territory.
\"This investment represents a positive valuation of RepliCel by a commercially successful company having performed significant due diligence,\" stated RepliCel President and CEO, R. Lee Buckler. \"We are very excited about what we have put in place while awaiting the completion of this transaction. Upon the closing of the investment, shareholders should expect to see RepliCel's programs and activity gain significant momentum over the coming months with a particular focus on bringing its medical device to market. We will provide shareholders with more details on what this means in a comprehensive update as soon as the transaction has closed,\" Buckler concluded.
About YOFOTO
YOFOTO (China) Health Industry Co., Ltd was established in 2004 as a company engaged in the health and consumer products industry. For example, YOFOTO has registered 31 different nutraceuticals with the State Food and Drug Administration (China). With a wide range of successful commercial products in the food, personal health care, and household categories, YOFOTO is now diversifying into higher-value health-related products and services such as genetic and blood testing, regenerative medicine, and destination health-treatment clinics. As part of its strategy, YOFOTO has made several investments outside of China. Its current expansion includes a global R&D production base, organic food base, natural cosmetic R&D center, a conference center, yacht club and health spa resort.
At present, YOFOTO has registered over 700 trademarks and attained over 60 patents. YOFOTO has 32 provincial branches in China and, in 2009, began international expansion into Russia, Vietnam, Thailand, and Cameroon. At the same time, YOFOTO began active participation in the Asia-Pacific Economic Cooperation (APEC) forum. YOFOTO Chairman of YOFOTO, Mr. Huang Jin Bao, was elected to be the member of the first APEC Chinese Industry and Commerce Council.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. The Company's product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is currently being co-developed with, and under exclusive license by, Shiseido for certain Asian countries. All product candidates are based on RepliCel's innovative technology, utilizing cell populations isolated from a patient's healthy hair follicles. RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration of its products and licensable for use with other dermatology applications. Please visit www.replicel.com for additional information.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Disclaimer for Forward-Looking Statements
This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding: (i) the completion of the Transaction with YOFOTO; and (ii) the fact that YOFOTO will make certain milestone payments, sales royalty payments and finance, over the next five years, the included RepliCel programs and an associated cell processing manufacturing facility inGreater China. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking statements, including: risks related to YOFOTO making all payments required in connection with the Transaction; risks that the Company's products may not perform as, or have the benefits, expected; risks that the Company's products may not be accepted and adopted by the public; the risk that the Company will not obtain CE mark clearance for its injector device; the risk that there will be delays enrolling clinical trial participants; the risk that the Company will receive negative results from the Company's clinical trials; the effects of government regulation on the Company's business; risks associated with the Company obtaining all necessary regulatory approvals for its various programs; risks associated with the Company's ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company's ability to raise additional capital; and other factors beyond the Company's control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2016 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
For further information: Lee Buckler, CEO and President, 604-248-8693, info@replicel.com
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RepliCel Life Sciences Inc. (RP:TSX.V; REPCF:OTCQB) and YOFOTO Health Industry Co. Ltd. received approval from their respective countries to complete the investment part of the partnership agreement between them, and that transaction is expected to occur soon.
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Skin rejuvenation and tendon regeneration products to be commercialized in Greater China in partnership with YOFOTO (China) Health Industry Co. Ltd
VANCOUVER and NINGBO, Zhejiang Province, China, July 11, 2018 /PRNewswire/ - RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (\"RepliCel\" or the \"Company\"), a company developing next-generation technologies in aesthetics and orthopedics, is pleased to announce it has now signed definitive agreements with YOFOTO (China) Health Industry Co. Ltd. (\"YOFOTO\") sealing its partnership to commercialize three of RepliCel's programs in Greater China.
The deal between the parties represents an investment in RepliCel by YOFOTO along with milestone payments, minimum program funding commitments, and sales royalties in exchange for an exclusive 15-year license to three of RepliCel products for Greater China (Mainland China, Hong Kong, Macau, and Taiwan) (the \"Territory\").
The RepliCel-YOFOTO collaboration is focused on the development and commercialization in Greater China of RepliCel's tendon regeneration cell therapy (RCT-01), skin rejuvenation cell therapy (RCS-01), and its injection technology in development for dermal applications (RCI-02) (excluding hair-related treatments).
YOFOTO's up-front investment will be a CDN $5,090,000 purchase of shares at CDN $0.95 per Share and will include 20% warrant coverage exercisable at CDN $0.95 per Share for a period of two years. The deal structure also includes milestone payments (of up to CDN $4,750,000), sales royalties, and a commitment by YOFOTO to spend a minimum of CDN $7,000,000 on the RepliCel programs and associated cell processing manufacturing facility over the next five years in Greater China.
\"In 2017 RepliCel delivered successful phase I data in all three of its cell therapy programs and functioning prototypes of its next-generation dermal injector,\" stated RepliCel President & CEO, R. Lee Buckler. \"We were committed to delivering a landmark partnership to RepliCel shareholders in 2018. The partnership with YOFOTO represents such a deal and provides RepliCel with not only an outstanding partner in Greater China but capital to move our programs forward in Europe and North America.\"
\"YOFOTO is a fast-growing company built on values related to beauty and healthy, active lifestyles,\" stated YOFOTO Chairman Mr. Huang Jin Bao. \"As a key part of developing and commercializing products related to these core values for our consumers, we are committed to being a leader in China in the commercialization of regenerative medicines. The RepliCel cell therapy and injection technologies focused on skin rejuvenation and tendon repair, are important building blocks in YOFOTO's strategic healthcare vision. We are pleased to have structured a deal with RepliCel which results in YOFOTO not only being a development partner and commercial licensee but also an investor committed to contributing to RepliCel's global success.\"
The Deposit already paid by YOFOTO pursuant to the earlier signing of the binding term sheet remains in escrow pending closing. As part of the Transaction, the Company has agreed to grant YOFOTO certain financing participation rights along with a board seat nomination. Upon YOFOTO meeting certain defined conditions, relevant Chinese patents, once issued in China, will be assigned to a YOFOTO-owned Canadian subsidiary, with detailed assignment reversion rights upon failure to meet defined targets.
Closing of the Transaction represented in the signed agreements between the parties is subject to approval of the TSX Venture Exchange, and other applicable regulatory authorities including but not limited to the reviews and approvals by the State Administration of Foreign Exchange of China and other Chinese foreign investment regulatory authorities.
About YOFOTO
YOFOTO (China) Health Industry Co., Ltd was established in 2004 as a company engaged in the health and consumer products industry. For example, YOFOTO has registered 31 different nutraceuticals with the State Food and Drug Administration (China). With a wide range of successful commercial products in the food, personal health care, and household categories, YOFOTO is now diversifying into higher-value health-related products and services such as genetic and blood testing, regenerative medicine, and destination health-treatment clinics. As part of its strategy, YOFOTO has made several investments outside of China. Its current expansion includes a global R&D production base, organic food base, natural cosmetic R&D center, a conference center, yacht club and health spa resort.
YOFOTO employs a winner of Nobel Prize in physiology and medicine, Professor Richard Roberts, who heads the YOFOTO Global Products Advisory Committee, and also leads collaborations with several leading scientific research institutions. At present, YOFOTO has registered over 700 trademarks and attained over 60 patents. YOFOTO has 32 provincial branches in China and, in 2009, began international expansion into Russia, Vietnam, Thailand and Cameroon. At the same time, YOFOTO began active participation in the Asia-Pacific Economic Cooperation (APEC) forum. YOFOTO Chairman of YOFOTO, Mr. Huang Jin Bao, was elected to be the member of the first APEC Chinese Industry and Commerce Council.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. The Company's product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is currently being co-developed with, and under exclusive license by, Shiseido for certain Asian countries. All product candidates are based on RepliCel's innovative technology, utilizing cell populations isolated from a patient's healthy hair follicles. RepliCel has also developed a proprietary injection device, RCI-02, optimized for the administration of its products and licensable for use with other dermatology applications. Please visit www.replicel.com for additional information.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Disclaimer for Forward-Looking Statements
This press release contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding: (i) the completion of the Transaction with YOFOTO; (ii) the terms of the Transaction and the milestone, program funding and royalty payments to be made in connection with the Transaction; and (iii) the closing of the Transaction.
These statements are only predictions and involve known and unknown risks which may cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking statements, including: risks related to the Company and YOFOTO being able to negotiate and enter into the definitive agreements required for the Transaction, risks related to the Company obtaining the approval of the TSX-V and its shareholders, risks related to YOFOTO obtaining consent for the Transaction from the required parties and applicable regulatory authorities; risks that the Company's products may not perform as, or have the benefits, expected; risks that the Company's products may not be accepted and adopted by the public; the risk that the Company will not obtain CE mark clearance for its injector device; the risk that there will be delays enrolling clinical trial participants; the risk that the Company will receive negative results from the Company's clinical trials; the effects of government regulation on the Company's business; risks associated with the Company obtaining all necessary regulatory approvals for its various programs; risks associated with the Company's ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company's ability to raise additional capital; and other factors beyond the Company's control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2016 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
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New opportunities are arising at every turn for the regenerative medicine community.
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The information in these press releases is historical in nature, has not been updated, and is current only to the date indicated in the particular press release. This information may no longer be accurate and therefore you should not rely on the information contained in these press releases. To the extent permitted by law, RepliCel Life Sciences Inc. and its employees, agents and consultants exclude all liability for any loss or damage arising from the use of, or reliance on, any such information, whether or not caused by any negligent act or omission.
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