Partnerships

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A revised binding term sheet reflects improved terms and positions the parties for closing the transaction

VANCOUVER, BC, CANADA & Ningbo, Zhejiang Province, P.R. China – 02 May 2018 – 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 now has a new Binding Term Sheet (the “Term Sheet”) with YOFOTO (China) Health Industry Co. Ltd. (“YOFOTO”) which both parties believe represents a stronger deal for both sides and positions them to finalize the transaction in the very near-term.

In January, RepliCel and YOFOTO announced their intent to form a strategic partnership (the “Transaction”) in Greater China (Mainland China, Hong Kong, Macau, and Taiwan) (the “Territory”). This was reflected in the announcement of a binding term sheet and the payment of a deposit of USD $650,000 (the “Deposit”). The Parties then began negotiating the definitive agreements encompassing the terms of the transaction and ongoing partnership.

“During the course of negotiating the full agreements,” stated RepliCel President & CEO, R. Lee Buckler, “both parties learned a great deal about what was critical to each side as well as what would be beneficial in terms of setting up the relationship for long-term success. We are close to definitive agreements on these new terms, excited to close this transaction and proceed immediately to implementation in what is one of the largest and most exciting markets in the world.”

The deal structure in the revised and original binding term sheets remains the same – an exclusive license to three RepliCel products for the Territory in exchange for payment by way of investment, milestones, program funding and sales royalties.

The original term sheet involved an up-front investment of USD $6,500,000 by way of the purchase of common shares (each, a “Share”) at CDN $0.54 per Share (plus 10% warrant coverage exercisable at CDN$0.54 per Share for a period of two years), pre-and post-commercial milestone payments, dedicated program funding in Greater China over the next five years, and future royalty payments calculated on gross product sales in the Territory.

The revised term sheet, similarly structured, involves a smaller up-front investment of CDN $5,090,000 at CDN $0.95 per Share plus 20% warrant coverage exercisable at CDN $0.95 per Share for a period of two years. The deal structure continues to include 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 over the next five years in Greater China.

The Deposit already paid by YOFOTO pursuant to the original term sheet, remains in escrow to be applied to the investment upon execution of the final agreements which the parties currently anticipate will be complete within the next several weeks.

As part of the Transaction, YOFOTO will receive an exclusive license for RepliCel’s tendon regeneration cell therapy (RCT-01) in development, skin rejuvenation cell therapy (RCS-01) in development, and its injection technology in development for dermal applications (RCI-02) (excluding hair-related treatments) for the Territory. Under certain 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.

As part of the Transaction, the Company has agreed to grant YOFOTO certain financing participation rights along with a board seat nomination. Closing of the Transaction is subject to execution of definitive agreements for the Transaction, receipt of approval of the TSX Venture Exchange, and other applicable regulatory authorities including but not limited to the reviews and approvals by State Administration of Foreign Exchange of China and other Chinese foreign investment regulatory authorities.

For more background to the Transaction, see RepliCel’s 16 January 2018 press release.

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.

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.

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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Echelon Wealth Partners detailed the terms and impact of this cell therapy developer's recent alliance in Asia.

READ ARTICLE

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RepliCel lands Asian partnership to optimize the development of its biotech solutions for chronic conditions.

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YOFOTO (China) Health Industry Co. Ltd to Invest in Becoming RepliCel's Strategic Partner for Greater China

Terms Include an Up-front Investment of USD $6.5 Million with Direct Non-Dilutive Program Funding Commitments and the Potential for Significant Milestone Payments and Sales Royalties

VANCOUVER, BC, CANADA & Ningbo, Zhejiang Province, P.R. China – 16 January 2018 – 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 signed a Binding Term Sheet (the “Term Sheet”) with YOFOTO (China) Health Industry Co. Ltd. (\"YOFOTO\") to form a strategic partnership (the “Transaction”) in Greater China (Mainland China, Hong Kong, Macau, and Taiwan) (the \"Territory\").

The deal reflected in the Term Sheet, involves an up-front investment of USD $6,500,000 and potential pre-commercial, non-dilutive milestones payments of another USD $2,800,000. Additionally, the Term Sheet commits YOFOTO to another USD $1,000,000 in potential post-commercial non-dilutive milestone payments, several million in dedicated program funding in Greater China over the next five years, and future royalty payments calculated on gross product sales in the Territory.

The investment is by way of the purchase of common shares (each, a “Share”) at CDN$0.54 per Share, which is a premium over the 20-day average market price to reflect the accompanying license to YOFOTO in the Term Sheet. The Company has also agreed to issue share purchase warrants (each, a “Warrant”) equal to 10% of the number of Shares issued, which warrants will be exercisable at CDN$0.54 per Share for a period of two years.

YOFOTO has already paid a deposit of USD $650,000 (the “Deposit”) pursuant to the agreement. As part of the Transaction, YOFOTO will receive an exclusive license for RepliCel's tendon regeneration cell therapy (RCT-01) in development, skin rejuvenation cell therapy (RCS-01) in development, and its injection technology in development for dermal applications (RCI-02) (excluding hair-related treatments) for the Territory.

According to sources, the Chinese cosmetic treatment market is growing up to six times faster than the global average by number of treated people with the number of procedures increasing as much as 40% year-on-year. Most experts now agree China now represents the third largest cosmetic treatment market behind only the United States and Brazil but closing in fast.[1]

In 2013, RepliCel executed a co-development and license agreement with Shiseido Company, which covered all of Asia for its product (RCH-01) in development for the treatment of androgenetic alopecia. With the completion of the YOFOTO deal, RepliCel's current technologies will be fully licensed in Greater China.

RepliCel's business model is focused on leveraging its expertise in developing assets that can then be licensed to partners for co-development and commercialization. The Company maintains exclusivity over its entire portfolio outside of Asia. The Company is pursuing both its own continued development and commercialization of its assets as well as other collaborative partnerships for its programs in different regions of the world.

\"This is precisely the kind of transformational deal and collaboration we were focused on delivering as we ended 2017,\" stated RepliCel President and CEO, R. Lee Buckler. \"We are very pleased to have secured a partnership with a company committed to bringing novel health products to Greater China and the principle of investing in regenerative medicines,\" he continued. \"YOFOTO has the vision, financial capacity, and infrastructure to be a key part of RepliCel's success overall and certainly capable of exceeding our goals for Greater China.\"

\"YOFOTO is committed to being a leader in China in the commercialization of regenerative medicines which fit into our core values related to beauty and healthy, active lifestyles,\" stated YOFOTO Chairman Mr. Huang Jin Bao. \"RepliCel Life Sciences, with its cell therapy and injection technologies focused on healthy skin and tendon health, fit perfectly with YOFOTO's vision for providing innovative treatments to consumers. As an investor, we are committed to contributing to RepliCel's global success and as a strategic partner in Greater China, we look forward to collaborating with RepliCel on quality product development leading to the launch of several successful product lines.\"

As part of the Transaction, the Company has agreed to grant YOFOTO certain financing participation rights and board seat nominations and YOFOTO has agreed to certain voting and trading restrictions. Closing of the Transaction is subject to execution of definitive agreements for the Transaction, receipt of approval of the TSX Venture Exchange, the Company’s shareholders and other applicable regulatory authorities including but not limited to the reviews and approvals by State Administration of Foreign Exchange of China and other Chinese foreign investment regulatory authorities.

[1] According to statistics release by the Chinese Association of Plastics and Aesthetics (see https://www.pressreader.com/china/china-daily/20160215/282029031282786) and the Chinese plastic surgery mobile app.

SoYoung (see http://www.plasticsurgerypractice.com/2017/08/about-face-chinas-plastic-surgery-market-grows-six-times-faster-than-global-average/).

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.

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

Disclaimer for Forward-Looking Statements

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RepliCel presented and conducted one-on-one partnering meetings.

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Click here to read the full article as it appears in the Streetwise Reports: The Life Sciences Report (10/26/17)

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Due diligence and confidential discussions now moving into negotiations for products in both the tendon repair and aesthetics franchises

VANCOUVER, BC – September 13, 2017 – 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 anticipates maturing discussions will lead to one or more new partnership agreements in the near-term. The Company’s strategic focus on partnering has resulted in it being currently engaged in multiple negotiations with potential strategic partners.

“The release of our positive clinical data earlier this year and the recent unveiling of our next-generation dermal injector prototypes have aggressively bolstered partnership negotiations,” says RepliCel President and CEO, R. Lee Buckler. “We remain confident of our ability to execute one or more partnerships for the dermal injector on our way to it being CE-marked by mid-2018, and have also generated significant partnership interest in our biologic assets among strong regional players. We believe it is highly likely that one of these will culminate in a partnership transaction in the near-term.”

RepliCel’s partnership strategy is driven by an intent to identify and negotiate transactions with partners prepared to be investors and co-development partners for defined regional markets that will eventually provide access to their established commercial distribution channels.

In Asia, partnership discussions are focused on the Company’s dermatology and tendinopathy programs, as well as the Company’s next-generation dermal injector, which is expected to be European market-ready next year. The Company is working with a Canadian firm specializing in Canada-China transactions, to move multiple parties in China/Hong Kong through due diligence into term sheet discussions and negotiations.

In Japan, RepliCel is working with CJ Partners, the country’s leading business development experts in regenerative medicine, to explore potential partnerships for its dermatology and tendinopathy programs with potential Japanese industry partners. The Company’s fibroblast program (underlying RepliCel’s dermatology and tendinopathy programs) has already been the subject of the first stages of review by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).

RepliCel is also engaged in a number of other partnership discussions, at various stages of due diligence, in other parts of the world, including the United States, Europe, and the Middle East. These discussions span the range of the Company’s product portfolio, including the co-development of RCH-01 for men and women with hair loss due to androgenetic alopecia outside of Asia (where it is already exclusively licensed to Shiseido Company).

The partnership discussions are primarily focused on regional licensing and co-development by commercialization partners with strong track records in their region, as well as proven market expertise in dermatology, aesthetics, or orthopedics. Each is expected to involve material investment (both upfront and upon milestones), as well as the commitment of expertise, capabilities, finances, and infrastructure to the co-development and eventual commercialization of the products under discussion.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of three clinical-stage products: RCT-01 for tendon repair, RCS-01 for skin rejuvenation and RCH-01 for hair restoration. RCH-01 is under exclusive license by Shiseido Company 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 is also developing a proprietary injection device (RCI-02) optimized for the administration of its products and licensable for use with other dermatology applications. Please visit http://replicel.com/ for additional information.

For more information, please contact:
Lee Buckler, CEO and President
604-248-8693
info@replicel.com

Forward-Looking Statements
Certain statements in this news release are forward-looking statements within the meaning of applicable securities laws. 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 status of the Company’s current partnership discussions; the expected results and timing of same, including that the Company anticipates entering into partnership agreements in the near-term; the benefits the Company may obtain from any partnership; the timing in which the Company’s dermal injector is expected to become market-ready; and that each partnership is expect to involve material investment and other components. Forward-looking 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 Company may be unable to agree on definitive partnerhsip agreement terms with any party; the risk that any proposed partnership will fail in the due diligence process; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the business of the Company and any potential partners; risks associated with future approvals for clinical trials; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in applicable jurisdictions; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties related to potential litigation; 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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Regenerative Medicine Company to Adopt ThawSTAR® Cell Thawing Systems to De-Risk Cell Therapy Clinical Trial

VANCOUVER, British Columbia & SAN RAFAEL, Calif.–(BUSINESS WIRE)–MedCision, LLC, the world leader in next-generation automated cell thawing for advanced therapies, and RepliCel Life Sciences, Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel”), a regenerative medicine company, today announced that RepliCel has joined MedCision’s ThawSTAR® Early Adopter Program, a novel program that helps companies and investigators de-risk thawing of cell therapies in early stage clinical trials through to commercialization and point-of-care. Each participant will receive a ThawSTAR® System on loan that is custom engineered for their unique cell therapy product.

Click here to view the full press release

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To preview the interview with Tina Tan as it appears on Medtech.com, click here. (6/23/17)

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Data from this project expected to take RepliCel’s products to next level of potential commercial viability

VANCOUVER, BC – June 13, 2017 – 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 British Columbia (“UBC”). The project will be co-lead by the UBC’s Dr. Kevin McElwee and Professor Youwen Zhou.

The project is designed to deliver a gene and protein expression “map” of healthy hair follicle cells expected to be critically important to improving key components of the manufacturing, regulatory, and clinical profile of RepliCel’s cell therapy products.

“We are very excited to be working with UBC on a project we’ve spent considerable time designing to mature our understanding of the cell populations we work with to improve our product manufacturing, clinical outcomes, and assays critical to regulatory approval and commercialization,” stated RepliCel President and CEO, R. Lee Buckler.

This study will examine different cell groups from human hair follicles and look for differences, and similarities, in gene and protein expression. Additionally, the project will analyze array data from select subjects who participated in RepliCel’s phase I/IIa clinical trial of its RCH-01 product in development for the treatment of androgenetic alopecia which completed earlier this year. This includes data from patients who had the best clinical hair growth response at six months and a sustained positive response at 24 months.

In the study with UBC, the gene expression profiles of the cultured cells from these clinical trial subjects who had a strong hair growth response will be compared to the gene expression profile of subjects who had a reduced hair growth response. The analysis is anticipated to allow RepliCel to better identify specific genes with high or low expression in the cultured cells that correspond to strong hair growth promotion.

About Professor Youwen Zhou, M.D., Ph.D.

Dr. Youwen Zhou is a physician scientist who is a Professor at UBC’s Department of Dermatology and Skin Science. He received his BS degree from Nankai University, China, a PhD in Molecular Genetics from the State University of New York, and an MD degree from the University of Toronto. After completing dermatology specialty training at UBC, he joined UBC Faculty of Medicine as a physician scientist in dermatology in 2000, and was promoted to full professor in 2013. He founded the UBC Molecular Medicine Lab and Chieng Genomics Center at Vancouver Coastal Health Research Institute (VCHRI) with infrastructure funding from Canada Foundation for Innovation in 2001. Dr Zhou’s research is centered on biomarkers of skin diseases such as skin lymphoma, melanoma, and vitiligo, using a wide variety of methods and approaches, including genome-wide association studies (GWAS), linkage analysis, next generational sequencing, transcriptional profiling, cellular and animal models, as well as genome editing.

Dr Zhou has published more than 100 articles in journals such as Nature, Cell, Nature Genetics, and Blood, and holds multiple patents in skin lymphoma diagnostic biomarkers. In 2013, Dr Zhou was awarded a Barney Usher Award for Outstanding Achievements in Dermatology Research from the Canadian Dermatology Association. Dr Zhou specializes in the diagnosis and treatment of skin cancers and skin pigmentation disorders, and is a consultant dermatologist at Vancouver General Hospital and British Columbia Cancer Agency. He teaches graduate students, medical students, dermatology residents and postdoctoral fellows. Dr Zhou is the past president of the Canadian Society of Investigative Dermatology, and served as a board member for Canadian Institutes for Health Research (CIHR) Institute of Musculoskeletal Health and Arthritis (IMHA). He is also a grant reviewer for CIHR, the Canadian Dermatology Foundation, and the Natural Sciences Foundation of China.

About Dr. Kevin McElwee, Ph.D.

Dr. Kevin McElwee is an Associate Professor at the UBC’s Department of Dermatology and Skin Sciences and Director of the Hair Research Laboratory at VCHRI. His research is funded by competitive grants awarded by multiple organizations including the Canadian Institutes for Health Research. Dr. McElwee is one of only a small group of research scientists worldwide who studies hair biology and associated diseases. He has worked as a hair research scientist for 19 years and has published over 100 medical journal articles, as well as research abstracts and academic book chapters on hair loss research. Dr. McElwee received his Bachelor of Science degree from the University of Aberdeen, Scotland and his PhD from the University of Dundee, Scotland. Postdoctoral training included three years at the Jackson Laboratory in Maine and four years at the University of Marburg, Germany, studying hair loss diseases and hair biology. Dr. McElwee is a co-discoverer and patent holder of RepliCel’s technology and continues to serve as the Company’s Chief Scientific Officer.

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of three clinical-stage products: RCT-01 for tendon repair, RCS-01 for skin rejuvenation and RCH-01 for hair restoration. RCH-01 is under exclusive license by Shiseido Company 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.

For more information, please contact:
Lee Buckler, CEO and President
604-248-8693

info@replicel.com

Forward-looking information

Certain statements in this news release are forward-looking statements, which reflect the expectations of management regarding the results of the UBC 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 take RepliCel’s products to next level of potential commercial viability; (ii) the gene and protein expression map will improve key components of the manufacturing, regulatory, and clinical profile of RepliCel’s cell therapy products; 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: 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 future approvals for clinical trials; risks associated with the Company obtaining approval for its clinical trial in Germany; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties in connection with the outstanding issues alleged by Shiseido in connection with the License and Co-development Agreement; 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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VANCOUVER, BC – February 28, 2017 – RepliCel Life Sciences Inc. (OTCQB:REPCF) (TSXV:RP) (FRA:P6P2) (“RepliCel” or the “Company”), a clinical stage regenerative medicine company developing unique biologic products for pattern baldness and thinning hair, aging and sun-damaged skin, and chronic tendon degeneration, today announced it has recently signed agreements with two European firms both of whom have committed to work with RepliCel to get the Company’s commercial-grade RCI-02 dermal injector prototypes manufactured and tested.

“The execution of these agreements covers what we believe to be the final stages needed to prepare RCI-02 for a market authorization application in the form of a CE mark in Europe,” stated RepliCel President and CEO, R. Lee Buckler. “With our first functional protoypes scheduled for this summer, we continue to work toward having this device ready for a CE mark application and in the hands of a licensing and commercial partner next year,” stated Buckler. “Meanwhile,” he concluded, “while we had originally hoped to receive some of our clincal data in February, we remain confident all three clinical data sets will be received and announced very shortly and all still before the end of the Quarter.”

AMI is an Austrian manufacturer of medical technology based near the shores of Lake Constance, within easy reach of Germany and Switzerland. AMI develops, manufactures and distributes their medical products throughout the world. All of them are made according to the highest quality standards and enable doctors to take even better care of their patients.

“We are proud of our unique working relationship with AMI given that they typically only work on their own products,” stated RepliCel’s Co-Founder and Chief Medical Officer who is also a practicing dermatologist in Germany. “Their commitment to working with us on our device is a testament to their belief in the product’s value and its ultimate potential to be widely adopted by the aesthetics industry.”

Art of Technology (“AoT”), based in Zurich Switzerland is an independent contract developer specializing in the design, development and miniaturization of complex customer specific electronic devices and embedded systems for use in industrial, medical and space applications. Certified in accordance with ISO9001 and ISO13485, the firm emphasizes consistent quality documentation throughout the duration of a project including risk analysis, management and technical documentation to support CE approval.

About RCI-02
The RCI-02 injector was designed with input from dermatologists, industrial designers, and electronic and medical device engineers to improve the delivery of a variety of injectables in a controlled, precise manner, removing the risks and uncertainties of injection outcomes currently resulting from manually operated, single-needle syringes.

RCI-02 is the world’s first motorized injection device with programmable depth and volume, a built-in Peltier element for pre-injection anaesthetising, and interchangeable needle head configurations. It is designed to deliver a variety of injectable substances including cells, dermal fillers, drugs or biologics intradermally (dermis), subcutaneously (fat) or intramuscularly (muscle) via an array of needle configurations ranging from a single needle to a 16 needle configuration (4×4) on one head. These interchangeable heads can be used to perform a variety of procedures, increase surface area coverage and speed-up procedure times.

About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of two ongoing clinical trials (RCT-01 for tendon repair and RCS-01 for skin rejuvenation) as well as its RCH-01 hair restoration product under exclusive license by Shiseido Company 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 http://replicel.com/ for additional information.

For more information, please contact:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com

Forward-Looking Statements
This and related press release contain forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding: (i) that the dermal injector device will result in a near term commercial opportunity for revenue generation; (ii) that the dermal injector will improve the injection of hyaluronic acid-based dermal fillers; (iii) that the device’s simplicity and programmability is expected to enable less-experienced injection specialists to deliver predictable and consistent outcomes; (iv) that the dermal injector will be RepliCel’s next licensing deal; (v) that the dermal injector, once developed, will represent game-changing reliability, reproducibility, and programmability of three dimensional skin injections; (vi) that future iterations of the technology and device will be optimized for other injectables such as drugs, biologics, vaccines, fat grafts, etc.; (vii) that the device will be ready for a CE-mark application and potential market launch in 2018; (viii) that the overall benefits of dermal injector technology include improved handling, reduction or elimination of the need for local anesthetic, quicker procedure times, improved patient experience, and a significant expansion of the areas that can be addressed with dermal fillers due to the ability to conduct broad, shallow, and evenly-dispersed injections; (ix) that the device will have a profound impact on all dermal injections; and (x) the dermal injector device will be able to be used for fine wrinkles across broad areas, like fine wrinkles in the face, hands and décolleté. 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 Company will not obtain CE mark clearance or other necessary regulatory approvals; 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 approval for its clinical trial in Germany; risks associated with the Company obtaining all necessary regulatory approvals for its various programs in Canada, the USA and Germany; 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, 2015 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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RepliCel presented and conducted one-on-one partnering meetings.

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VANCOUVER, BC – September 26 2016 – RepliCel Life Sciences Inc. (OTCQB: REPCD) (TSXV: RP) (Frankfurt: P6P2), (“RepliCel” or the “Company”), a clinical-stage regenerative medicine company focused on the development of autologous cell therapies, is pleased to provide an update on the licensing and co-development of its RCH-01 product with Shiseido Company.

As announced in July, RepliCel’s RCH-01 product, for the treatment of androgenetic alopecia, is now under clinical investigation at Tokyo Medical University Hospital and Toho University Ohasi Medical Center, by Drs. Tsuboi and Niiyama.

The product being tested in the clinical study, RCH-01, is an autologous cell therapy developed by RepliCel. Shiseido has an exclusive marketing license to the product for certain Asian countries under a License and Co-development Agreement signed by the parties in 2013.

The study is being financed by Shiseido Company and each product being injected will be manufactured by Shiseido at their SPEC (Cell-Processing and Expansion Center) facility in Kobe, Japan. RepliCel helped Shiseido design, validate, and prepare the SPEC facility for certification by Japan’s PMDA (Pharmaceuticals and Medical Device Agency). Shiseido’s SPEC team was also trained by RepliCel and Innovacell in the GMP (Good Manufacturing Practice) compliant production protocols for RCH-01.

While Shiseido’s manufacturing facility is certified by the Japanese PMDA, the clinical study is hospital-initiated and governed which means that Shiseido’s role in the trial is restricted to funding and manufacturing. Any eventual commercialization of the product in Japan as a result of this study would be done as a treatment provided in partnership with hospitals under the authority of the Ministry of Health, Labor and Welfare and its Act on the Safety of Regenerative Medicine.

“The pathway under which Shiseido has decided to conduct clinical investigation of RCH-01 in Japan means the product may be the subject of early commercialization in Japan,” stated RepliCel’s President and Chief Executive Officer, R. Lee Buckler “While we are unclear how the clinical strategy Shiseido is pursuing may impact the product’s commercialization in their markets, we remain supportive of Shiseido’s decisions,” continued Buckler.

“Since the license and co-development agreement was executed with Shiseido in 2013, RCH-01 has been carefully co-developed by the parties through a Joint Steering Committee established and governed by the agreement,” stated RepliCel’s Board Chairman and former CEO, David Hall. “The parties have been consistently cooperative and transparent as we work to collaboratively address the challenges and optimal product development strategy for RCH-01,” continued Hall.

“Because of financial constraints, RepliCel has not been able to proceed with its previously announced plans to initiate a phase 2 clinical trial of RCH-01,” stated RepliCel’s Buckler. “This has caused Shiseido to allege breach of our co-development obligations which we deny and vigorously oppose. While there is a clear obligation on our part to transfer data from such a trial when it is available, there is no express or implied obligations in the agreement as to when such a trial would have to be initiated or completed,” continued Buckler.

RepliCel owns unfettered market and development rights to RCH-01 outside of Shiseido’s territory in Asia. In the Agreement there are milestone payments and sales royalties flowing from eventual commercialization of the product in Shiseido’s territory. “In a worst case scenario wherein Shiseido is able to show breach of contract by RepliCel, we may lose some or all rights to milestone and royalty payments from Shiseido but still be in a position to capitalize on the product’s enormous potential everywhere else in the world. In the meantime, we remain steadfast to our position that the mutual obligations in the agreement remain intact,” Buckler concluded.

In the Agreement, Shiseido committed to sharing the clinical data from this study with RepliCel thus further strengthening the collective data package being created on RCH-01. While such data may be sufficient for Shiseido to bring RCH-01 to market in Japan, it will also be valuable to RepliCel to inform further product development and clinical testing decisions, for use in submissions to other regulatory agencies, and/or to support license negotiations for this product to parties for market rights outside of Shiseido’s exclusive territory.

Since the signing of the development Agreement, RepliCel has been working closely with Shiseido on the technology transfer, optimizing several features of the product’s manufacturing, and continuing to add to the body of science as it relates to the product and its intended function.

“We are excited that RCH-01 has the potential to be launched in the Japanese market by Shiseido sooner than anywhere else in the world,” stated RepliCel CEO, R. Lee Buckler, “and in the interim we continue to actively explore our global development and commercialization options for the product.”

About RCH-01

RCH-01 is an autologous cell therapy utilizing dermal sheath cup (DSC) cells isolated from the hair follicle to treat androgenetic alopecia. To manufacture RCH-01, dermal sheath cup cells are isolated from a small punch biopsy taken from the back of a subject’s scalp. These cells are replicated in a GMP compliant cell production facility and the cells are then injected into balding areas on the same subject’s scalp. In clinical trials, after injections are performed, subjects return to the clinic at regular intervals for assessment of total, terminal and vellus hair density and cumulative hair thickness, as well as for safety and data collection.

Since signing the regional licensing and co-development agreement, ReplCel and Shiseido have optimized the product and its manufacturing including building, validating, and obtaining PMDA certification of Shiseido’s facility purpose-built for this product, successfully completed the transfer of the manufacturing protocols and the product manufacturing validations, selected the clinical sites, trained all related personnel, and obtained regulatory clearance for the clinical study.

Market: $3.5 billion was spent on hair loss treatments in 2015 according to the Washington Post, with $2.5 billion of this spent on surgical procedures according to the International Society of Hair Restoration Surgery. We believe RCH-01 has the potential to capture a good percentage of that surgical expenditure, but also to significantly grow the market as most hair loss sufferers elect to avoid hair transplant surgery due to the invasiveness and variability associated with the procedure.

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing autologous cell therapies that address conditions caused by a deficit of healthy cells required for normal tissue healing and function. The Company’s product pipeline is comprised of two ongoing clinical trials (RCT-01 for tendon repair and RCS-01 for skin rejuvenation) as well as its RCH-01 hair restoration product under exclusive license by Shiseido Company 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:

CONTACT:
Lee Buckler, CEO and President
Telephone: 604-248-8693 / lee@replicel.com

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Find full article here online, at The Asahi Shimbun.

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RepliCel presented and conducted one-on-one partnering meetings.

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Click here to view the article on Cantech Letter

Vancouver-based RepliCel Life Sciences (TSXV:RP) concentrated on hair regeneration until 2011, participating in the $3 billion annual male pattern baldness industry. But when the far-reaching effects of its solution became apparent to its founders, RepliCel began expanding its offer to apply the technique of using cell therapy to encourage the healing of damaged or injured tissues to other body parts.

The company recently partnered with Tokyo-based cosmetic giant Shiseido, offering RepliCel access to the vast Asian market.

Cantech Letter talked to RepliCel as part of our “Five Questions” series. Our “Five Questions” Series runs all this week, posing the same five questions to up-and-coming Canadian innovation sector companies.

What does your company do?

RepliCel Life Sciences Inc. is a regenerative medicine company focused on developing autologous cell therapies for the treatment of musculoskeletal tissue injuries, aging and UV-damaged skin and pattern baldness. All product candidates are based on RepliCel’s innovative technology utilizing cell populations isolated from a patient’s own healthy hair follicles.

RepliCel’s strategy is to license its assets to partners for late-stage development and commercialization. Shiseido, one of the world’s largest cosmetic companies, has an exclusive license for RepliCel’s pattern baldness product, RCH-01, in certain Asian countries including Japan, China and South Korea.

What problem are you trying to solve?

RepliCel is developing autologous cell therapies which address conditions caused by a deficit of the healthy, active cells required for normal healing and function.

RepliCel’s propriety injector device (RCI-02) is programmed to control depth, dose, and volume of the injection and allows for widespread injections across broad areas. In addition, RepliCel’s device has a built-in peltier element which numbs the skin just prior to injection eliminating the need for anesthetic. These features distinguish Replicel’s dermal injector from any others currently on the market.

How is your solution better than what is currently offered?

The regeneration of chronically injured tendon, the natural rejuvenation of the extra-cellular matrix under the dermis of those with aging or sun-damaged skin, and the regrowth of hair for those people suffering from pattern baldness attributed to androgenic alopecia are not conditions which can be resolved by currently available products or treatments.

How big is the market you are addressing?

The combined total addressable market size for pattern baldness, skin rejuvenation, tendon repair, and a next-generation dermal injector potentially valuable for any kind of dermal injection is understandably large – easily estimated at >$2 billion annually.

What will you be working to accomplish in the next year?

2015 is on track to be a transformative year for RepliCel as we move each of our assets into next-stage of clinical development. We anticipate accomplishing the following over the next 12 months:

-Clinical data from the RCT-01 (chronic Achilles tendinosis) trial in Canada and from
-Clinical data from the RCS-01 (aging and sun-damaged skin) trial in Germany
-Receipt of a CE mark clearing the RCI-02 dermal injector for sale in Europe
-Execution of a licensing partnership in Japan for RCT-01 or RCS-01
-Execution of a global licensing partnership for RCI-02 for select product(s)
-Launch of our phase 2 RCH-01 (pattern baldness) clinical trial in Germany
-Shiseido’s launch of its RCH-01 (pattern baldness) clinical trial in Japan
-Technology transfer complete to a contract manufacturing facility in North America

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RepliCel Targets Low-Risk, Near-Term Opportunities in Regenerative Medicine

By: Gail Dutton

The regenerative medicine company RepliCel Life Sciences is developing potential cures for chronic tendinosis, damaged or aging skin, and pattern baldness by reseeding affected areas with specific cell populations isolated from patients’ own healthy hair follicles.

RepliCel is picking the low-hanging fruit of regenerative medicine—low technological risk, underserved markets, clear clinical indications. Furthermore, commercial success is not dependent on successful reimbursement negotiations.

“On the technical level, we’re not asking these cells to do anything other than what they naturally do, or be anything more than they are,” CEO David Hall says. “These are adult, somatic cells derived from the patient which we simply isolate and grow. We’re not differentiating, genetically modifying, or manipulating these cells in any way.

At present, there is no therapy to treat the underlying causes of tendinosis, which include a deficit of collagen-producing tenocytes (fibroblasts). RepliCel’s approach to the treatment of tendinosis uses injections of cultured autologous, collagen-producing, nonbulbar dermal sheath cells into the injury site to stimulate tendon regeneration

From the scientific and manufacturing perspective, RepliCel is using the hair follicle as the cell source because the cells are simple to collect, grow well in culture, and are both relatively naive and highly functional. On a clinical level, the company is simply addressing a deficit of active cells in the patient by local delivery of cells shown to function in ways needed to solve a human condition such as tendinosis or pattern baldness.

“The cells are injected in ways and places that largely eliminate any concerns around in vivo cell migration,” explains Hall. “[This approach ensures] enough cells stay in situ and viable to affect a sustained effect.”

Indications

For tendinosis—a disrupted healing cycle of the tendon—nonbulbar dermal sheath (NBDS) fibroblast cells are isolated from a biopsy of hair follicles taken from the back of the scalp. After these cells are replicated, creating populations of millions of cells, they are injected into the wound site to jump-start the disrupted wound repair.

In early-stage trials, clinical advisory board member David Connell, M.D., used a similar approach with tendinosis patients who had been failed by other therapies. The NBDS approach returned these patients to painless, near-normal function.

In the next 18 months, Hall says he expects to conclude a Phase I/II study at the University of British Columbia involving 28 participants. As yet, there is no approved therapy that treats the underlying cause of this chronic condition.

This same NBDS platform technology also may be used to repair damaged and aging skin. RepliCel filed a clinical trial application for Germany in February.

Phase II trials to treat baldness—specifically, androgenetic alopecia—will begin this year. For this therapy, dermal sheath cup (DSC) cells are isolated from the base of the hair follicle, replicated into the millions, and injected to the area of thinning hair.

“DSC cells are responsible for maintaining the number of dermal papillae cells, which directly corresponds to the hair thickness,” Hall explains. “We are simply delivering a volume of androgen-insensitive DSC cells into an area where androgen-sensitive DSC cells have disappeared … to restore the normal hair follicle cycle.”

RepliCel’s autologous cell therapy utilizes dermal sheath cup (DSC) cells to treat androgenetic alopecia. DSC cells are responsible for the regulation of the volume of dermal papillae (DP) cells, which are responsible for the thickness and growth of a hair fiber. Another RepliCel technology uses nonbulbar dermal sheath (NBDS) fibroblast cells to treat tendinosis.

In animal studies, this approach grew hair on the feet of mice (which have no hair follicles there). When these cells were injected into their ears, the healthy cells migrated into resident hair follicles, making that hair thicker.

In humans, this approach could address existing hair follicle damage. “This is our longer-term program,” Hall stresses. RepliCel will begin a clinical trial in Germany this year involving 160 patients. Hall says results from RepliCel’s Phase I and Phase II clinical trials for chronic tendinosis and UV-damaged/aged skin are expected in 2016.

Manufacturing and Delivery

RepliCel currently uses industry-standard fetal calf serum in its manufacturing process, but is validating a serum-free process. “This is a distinguishing commercial step,” Hall asserts. “[It] adds value to our therapeutics program.” Hall notes that RepliCel anticipates licensing the process.

RepliCel is also investigating the potential of using its cells in an allogeneic setting. Hall says that a successful licensing effort could enhance both the business model and the value of company assets.
RepliCel also is developing a dermal injector to ensure controlled, consistent delivery of the cells to the skin and scalp. RepliCel expects that this device will control cell volume and delivery depth while minimizing shear force to the cells.

“We have also incorporated a Pelletier element into the tip, which reduces or removes the need for pre-injection anesthetics,” Hall informs. This second-generation injector is available for licensure. RepliCel plans to file for the CE mark in the latter half of 2015.

Partnerships

RepliCel already has a partnership with Shiseido in Japan to co-develop and commercialize RepliCel’s RCH-01 technology as a therapy for thinning hair in China, South Korea, and the ASEAN nations. RepliCel is actively pursuing similar geographically focused licensing and co-development partnerships for its other products.

It also is commercially active in Japan, where recent changes to Japanese regulations for regenerative medicine “have dramatically changed the pathway toward revenue generation,” Hall remarks. Those changes allow products that have demonstrated safety and potential efficacy in early-stage trials to gain conditional marketing approval. That lets them be sold and reimbursed up to seven years before being subjected to a final marketing approval review.

“In the current Japanese environment, we can generate data while simultaneously generating revenue and continuing to develop the same technology in the West,” Hall confides. He suggests that as a result of these regulatory changes, Japan will become important as a test bed for regenerative medicine.

RepliCel’s business model seems well-suited to Japan’s new regulatory stance for regenerative medicine. “We’re built to discover, validate, and license,” Hall states. “Commercialization is done with partners.”

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To read the article on The Life Sciences Report, click here:

It makes no sense to look at stem cell companies differently from drug or biologics companies. The technology may be different, but the diseases they seek to treat are the same. In fact, cell therapies may ultimately be more useful and more curative than drugs, and hence more valuable. That’s the way Alain Vertès of NxR Biotechnologies sees it. In this interview with The Life Sciences Report, Vertès talks about some of the stem cell names he knows well, and draws comparisons investors can bank on.

The Life Sciences Report: Alain, you have compared the current stage in the development of the stem cell and regenerative medicine industry to the beginning of the monoclonal antibody revolution. Companies formed to leverage stem cell technology have been around now for three decades. When are we going to start to see the approval, marketing and reimbursement of some of these technologies?

Alain Vertès: I am quite optimistic we’ll see these things soon, I have to say.

It’s true that there is a very nice parallel between the technology of stem cell therapeutics and the technology of monoclonals. A historic look at monoclonals is a very insightful way to understand the stem cell industry, in the sense that it took about 25 years for monoclonal antibodies to emerge as a mainstream product category. As recently as 2007, there were only a handful of companies with double-digit sales derived from monoclonal antibody-based therapies. The transition and penetration of this new technology class started quite slowly. I think we are witnessing something similar with stem cells and regenerative medicine.

“Athersys Inc.’s MultiStem could very well be among the first few products approved in Japan.“

Considering only mesenchymal stem cells, I would say that by 2017 we should have good clarity regarding deployment in major markets. First of all, we have Prochymal (allogeneic human mesenchymal stem cells; [remestemcel-L]), a product developed by Osiris Therapeutics Inc. (OSIR:NASDAQ) and acquired by Mesoblast Ltd. (MSB:ASE; MBLTY:OTCPK) in October 2013. Mesoblast is continuing the development of Prochymal in refractory Crohn’s disease. It has been conditionally approved in 2012 in Canada and New Zealand for the treatment of acute graft-versus-host disease in steroid-refractory pediatric patients, and should be deployed in major markets relatively soon, including in Japan, where it is developed by Mesoblast’s partner there. I think Prochymal, for this particular indication and for this particular patient population, will be one of the first stem cell therapies to hit the market. Having said that, let’s not forget that South Korea has already approved some of these therapies.

It is interesting also to look more closely at what is happening in Japan. That country has a new law that essentially enables companies to more quickly develop and deploy stem cell technologies into the market, as long as safety is demonstrated. This is particularly in response to an aging society, and the observation that conventional pharmaceutical approaches have not satisfactorily addressed a range of indications—for example, stroke as a leading cause of death and disability—that impose high social and financial burdens. Regenerative medicine products could change this. The Japanese parliament enacted the new law in November 2013, revising the Pharmaceutical Affairs law to define new regenerative medicine products. Companies can now get conditional approval for stem cell products after they show safety, like they would in a Phase 2 trial.

“Right now, RepliCel Life Sciences Inc. is positioned with very good potential.”

On March 2, Chugai Pharmaceutical Co. Ltd. (4519:TSE) and Athersys Inc. (ATHX:NASDAQ) announced a deal using Athersys’ MultiStem (allogeneic multipotent adult progenitor cells) product for the treatment of ischemic stroke. MultiStem could very well be among the first few products approved in Japan. But then again, the law will be beneficial for all stem cell companies, which is very exciting.

TLSR: We are just starting to see oligonucleotides come to the market as approved therapies. It appears to take a quarter of a century for a new technology to move from lab bench to treating patients. Would you agree?

AV: It does appear that way. Hopefully, with the accelerated pathway we’re seeing in Japan, novel therapeutics will take a lot less time to get to patients. And even outside Japan, given the number of trials in Phase 2 and Phase 3 that will be reading out this year or next year, we should see some cell therapy products begin to emerge.

TLSR: Unlike cell technologies, the monoclonal antibody industry is relatively straightforward. Monoclonal antibodies act pretty much the same way as small molecules do: They engage or inhibit a protein on a cell membrane to alter signal transduction into and within the cell. With stem cells, aren’t we talking about a much more complex system? Cells perform most all metabolic activities, including reproduction. Importantly, they also express multiple genes. Are we talking about apples and oranges here?

AV: I think we can have both perspectives. We can say that stem cells and monoclonals are very much similar in terms of the S-curve of development. Speaking retrospectively, it’s quite easy to identify the S-curve that made monoclonal antibody products a reality. When we started with murine (mouse) antibodies, those didn’t work because of immune reactions. We had to progress upward on the S-curve from murine to chimeric (combining genetic elements from nonhuman and human) to humanized, and to fully human antibodies. When we reached the last level, the technology became mature enough to penetrate the market. It was only a question of allowing innovation to take over. If we look at stem cells, we see very similar lower stages of S-curve development. The safety of mesenchymal stem cells is now clear. It’s a little bit less clear for induced pluripotent stem cells or embryonic stem cell products.

“The market is still not valuing stem cell programs and companies fairly; this is a very exciting time for proposed stem cell therapies.”

But there is a difference. For the first time, we have pharmaceutical-like products—these cells—that are able to be implanted and enrich a target microenvironment. Cell therapies represent a critical development in healthcare because we now have a therapy that is going to understand, for lack of a better term—or rather sense, through a complex network of signal transduction relay molecules—the specifics of the microenvironment it encounters when it is implanted or infused. These cells will then respond as well as possible based on the area of the body targeted and, of course, based on the specific disease. We thus have the machinery to develop a fresh salvo and create arrays of cytokine growth factors and beneficial effects. That’s what makes cells better at targeting disease.

TLSR: I know you have some thoughts about the failed Athersys/Pfizer Inc. (PFE:NYSE) Phase 2 trial with MultiStem, which was reported at the end of April 2014. This study, randomized and double-blind with 126 patients, failed to meet its primary endpoint of reducing the incidence and severity of adverse events in ulcerative colitis. Did that have a chilling effect on big pharma companies, which saw Pfizer fail in this trial?

AV: I don’t think it scared companies away because, regarding stem cell therapies, big pharma is really in the monitoring mode at the moment. Everybody in large pharma understands that emerging technologies will lead to some failures, so that’s not a surprise. Going back to monoclonal antibodies, the first 15 clinical trials were failures. That’s important to keep in mind, because emerging technologies are very challenging.

“Hopefully, with the accelerated pathway we’re seeing in Japan, novel therapeutics will take a lot less time to get to patients.”

I don’t think the Athersys/Pfizer failure was a dramatic problem. Understand that if we look at the fundamentals and properties of Athersys’ cell technology, they are still rock solid. Looking at the details of that Phase 2 trial with MultiStem, Athersys and Pfizer set a very, very high bar for success in terms of trial design. One reason this was so challenging was that they were essentially attempting to treat patients who were very sick, and who had already failed several types of therapy. I don’t think this was a major failure for the field of stem cell technology. It’s clearly a setback, but it’s not a fundamentally worrying setback. I don’t think it scared away people.

TLSR: You said the bar was set very high. Do you think the single-infusion design was a problem? That single infusion of cells was intended to treat or alleviate a disease some patients had been suffering with for a decade, and in some cases for half their lives. I don’t think a small molecule or even an antibody would be expected to work with a single administration.

AV: That definitely was the case. These patients had chronic moderate to severe disease for an average of ten years, and a single injection may not have been sufficient. Also, maybe the company would need to treat patients earlier in their disease progression. It was a very high bar.

TLSR: Athersys’ share price has more than doubled over the last three months. My understanding is that short covering was a contributor to that share-price appreciation, but it’s clearly a good sign. Would you summarize your thoughts on Athersys?

AV: The stock price has been recovering from the trial failure. As far as MultiStem goes, it has been found to be safe. I do like this company, and its prospects are quite positive.

TLSR: Can you speak to another company working in the cell therapy space?

AV: Yes. I’ve looked at RepliCel Life Sciences Inc. (RP:TSX.V; REPCF:OTCQB), and I think it’s an interesting company, especially when considering its business model. It has an autologous cell therapy model for hair transplant and Achilles tendinosis. In addition, the company has developed a very clever way to deliver its autologous cells for both of its indications—a dermal injector device. Its business model offers investors a reasonable cost of goods sold (COGS). RepliCel has also established a strategic partnership with Shiseido Company Ltd. (4911:TSE) in Japan. This is a partnership with a very good company. Right now, RepliCel is positioned with very good potential. I do not see any fundamental flaw or problem with this company.

TLSR: It has been a rough year for stem cell companies in general. Many companies working in the space have seen double-digit declines in their stock prices. But there’s one company that stands out because of its valuation. Mesoblast had more than a $2 billion ($2B) market cap two years ago. Now it’s just $1B. What is going on with Mesoblast?

AV: There has definitely been a group effect with regard to the share prices of all these companies. But the case of Mesoblast is very interesting. The company was at the height of its valuation a couple of years ago, and there was a correction in the stock price, following these systemic trends that you just mentioned. The key question here is whether there is a major, fundamental issue in the company.

The answer is no. There is no flaw in terms of the company’s fundamental technology; that technology is rock solid. In terms of practical application, the company is solid as well. If we look at the portfolio of Mesoblast indications, there are several disease areas. The company has immunology, oncology, orthopedics and cardiovascular, and in each one of these indications—all of which are major—you have Phase 2 and Phase 3 programs in progress. The essential question we have to ask is, “What is the real valuation for a company with a portfolio like this?” If we were talking about monoclonal antibodies, the valuation of this company would be significantly more than $10B. If we were looking at comparable pharmas, it would be even bigger.

What I’m trying to say is that the market is still not valuing stem cell programs and companies fairly. I think this is a very exciting time for proposed stem cell therapies. If you look at companies with products on the market for similar disease indications, and compare those valuations to the low valuations of stem cell companies, you can see real value here.

TLSR: Alain, it was a pleasure meeting you.

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To read the article on the Financial Post website click here.\\n

\\n

Canada and Japan are taking distinctly different but complementary paths in the development of a regenerative medicine industry within their borders. While\\n their paths may differ, their activities are having a profound impact on the future of a global industry that is poised for exponential growth.\\n
Dr. Lesley Chan, Cell Manufacturing Development Scientist at CCRM, culturing cells\\n

\\n

Japan’s commitment to regenerative medicine leadership has been fuelled by Prime Minister Shinzo Abe’s vision for revitalizing the country’s economy. That\\n economic revival includes policies to support the development of a robust, world-leading regenerative medicine industry in Japan, including US$1-billion\\n in funding for stem cell research over 10 years.

\\n

While the Japanese initiatives are in part driven by national economic interests, they are fundamentally about bringing new medicines to a significantly\\n and rapidly aging Japanese demographic.

\\n

“Japan is looking to establish leadership in the regenerative medicine industry by encouraging domestic innovation and enticing foreign companies to develop\\n products in Japan by bringing foreign therapeutics to the Japanese market”, states Shinichi Muto, Chief Japan Representative for Euro Pacific Canada,\\n Inc. “The mission of our nation’s leadership is to pave the way for real, practical, breakthroughs in regenerative medicine. My firm is actively working\\n with companies outside Japan, like RepliCel Life Sciences and others, to build three-way partnerships between Japanese investors, strategic partners,\\n and therapeutic developers.”

\\n

“The regenerative medicine and cell therapy field is changing rapidly around the world,” says Michael May, Chief Executive Officer of the Centre for Commercialization\\n of Regenerative Medicine (CCRM) in downtown Toronto. “What is happening in Japan is one example of how momentum is building in this industry. Corporate,\\n technological, financial and clinical developments are happening very, very quickly.”

\\n

Regenerative medicine aims to harness the power of cells, biomaterials and molecules to repair, regenerate or replace diseased cells, tissues and organs.\\n It has the promise to treat, manage and perhaps cure some of the most devastating and costly diseases or chronic conditions in the world today.

\\n

A key component of Japan’s strategy is changing the regulatory policy around the oversight, approval, clinical development and manufacturing processes\\n related to cell-based therapies. “For those in the industry, this is a leading initiative that promises to dramatically change the regenerative medicine\\n landscape,” May says. “Japan is revolutionizing regulatory approval in order to become a ‘stem cell nation’.”

\\n

Canada has its own leadership role to play in terms of its strength in regenerative medicine science, he adds, “Canada has some very novel and valuable\\n strategies in play around regenerative medicine that will benefit immensely in light of Japan’s movement.”

\\n

CCRM is playing a key role in commercializing the wealth of regenerative medicine science and intellectual property available in Canada. This is being\\n achieved either by establishing new companies or finding partners to develop technologies on their behalf. Since its inception in 2011, CCRM has established\\n ties with academia, created a formal industry consortium of more than 40 companies from around the world, and gained six core Canadian institutional\\n partners.

\\n

Consortium members representing key sectors of the regenerative industry include the McEwen Centre for Regenerative Medicine,\\n a world-renowned centre for stem cell biology and regenerative medicine to treat conditions such as heart disease, diabetes, respiratory disease and\\n spinal cord injury. Canada is also home to the Canadian Stem Cell Network,\\n one of the most prodigious producers of preclinical stem cell research and publications.

\\n

CCRM to-date has performed due diligence on 200 cell therapy technologies from Canada and around the world. These include work by Canadian leaders such\\n as Induce Biologics, Sernova, TRT, RepliCel Life Sciences, Insception Lifebank, Octane, Northern Therapeutics, Interface Biologics, Stemcell Technologies,\\n Actium Research, Hemostemix and more.

\\n

Now the focus is on building a third network which is one of investors, May says. “The plan is to launch investment vehicles specifically focused on regenerative\\n medicine to finance commercial opportunities in Canada. This final piece is really important in supporting commercialization and creating manufacturing\\n capability in Ontario. When this happens, Canada will hold a unique leadership position in the world.”

\\n

CCRM is a world-class example of the efforts to create pathways for regenerative medicine commercialization, says Lee Buckler, Vice President, Business\\n and Corporate Development, for RepliCel Life Sciences (TSXV: RP) in Vancouver. “They are really bringing the whole industry to Canada by creating an\\n infrastructure for great research, development, production, and commercialization.”

\\n

RepliCel is a regenerative medicine innovator that has been among the first in the world to create formal ties with Japanese industry to leverage this\\n rapidly emerging opportunity. In 2013, it signed a major deal with Shiseido Company for commercialization of its autologous cell therapy (produced\\n using cells harvested from the patient’s own hair follicles) for treating pattern baldness. The agreement granted an exclusive license for RepliCel’s\\n most advanced product, RCH-01, to Shiseido for certain Asian countries.

\\n

Mr. Youichi Shimatani, Shiseido’s Chief Corporate Officer for Research and Development commented, “Creating beauty in everyday life is the mission of Shiseido.\\n To alleviate suffering of people with alopecia, we have dedicated many years to hair research. Using the knowledge and technologies acquired from our\\n research activities, Shiseido is currently preparing to launch an RCH-01 clinical research study for the treatment of pattern baldness under the supervision\\n of key clinical opinion leaders of hair research in Japan.” In his opinion, “Japan’s new Regenerative Medicine Law allows industry partners like Shiseido\\n to take part in clinical research under clinical guidance to develop new regenerative therapies. We hope that our efforts will lead to further promotion\\n and advancement of regenerative medicine in Japan.”

\\n

RepliCel holds a unique and strong competitive position in Japan, Buckler notes, because the deal with Shiseido was signed shortly before Japan’s new regulations\\n were finalized in November 2014.

\\n

He says RepliCel ranks as one of the few foreign cell therapy companies with a Japanese partner, and one of an even smaller group with an active manufacturing\\n footprint in Japan. “We believe we are also one of the first foreign cell therapy companies poised to initiate a clinical trial with its Japanese partner\\n under the new regulations.”

\\n

The company is also actively engaged with investors and potential partners to establish similar partnerships for other products in its pipeline for orthopedic\\n (tendon repair) and dermatological (skin rejuvenation) applications.

\\n

Buckler believes Canada’s deep roots in regenerative medicine, combined with the collaborative efforts on the part of CCRM, bode well for the prospects\\n of companies such as RepliCel that are pursuing global commercialization opportunities.

\\n

While Japan is not the sole focus of CCRM’s global collaboration efforts, May says it is a cornerstone to Canada’s future as a leader in regenerative medicine.\\n “One of the most revolutionary things Japan has done is create new pathways for regenerative medicine that allow cell therapy companies to get conditional\\n approval and bring their product to market more quickly. Expediting market access has created a tremendous motivation for companies to bring technologies\\n into Japan for development and commercialization. Investors for their part see the same opportunity and are looking for ways to build on this momentum.”

\\n

This momentum is indicative of the interest being generated in investment in cell therapy research globally, May says. “CCRM’s networking efforts with\\n other global centres of excellence, and new regulatory pathways in countries such as Japan, are wonderful examples of how firms are working in multiple\\n jurisdictions to bring potentially life-saving products to market.”

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By: Eric Chiu, Biotech, Healthcare Contributor
Published October 10, 2014

To read the entire article as it appears on Seeking Alpha click here.

Summary

RepliCel’s partnership with Shiseido shows validation from a major third-party player and potentially advanced access to revenues.
The results from Phase I trials show compelling data of up to 19.6% increase in hair density for RCH-01.
For a $23M market cap, I believe RepliCel is an under researched firm that possesses a diverse drug pipeline.

RepliCel Life Sciences, Inc. (OTCQB:REPCF) is a company focused on the development of autologous cell therapies currently targeting pattern baldness, tendonosis and aging skin. The technology is based upon two different cell types derived from the hair follicle. One product is comprised of dermal sheath cup cells which are believed to be responsible for generation of hair follicles. The other product is a platform technology comprised of fibroblast cells responsible for the synthesis of Type I collagen. In both instances the cells are derived from a small (single-suture) biopsy taken from the back of a patient’s head.

Hair-derived fibroblast cells such as those under development by RepliCel, have been shown to produce five times more Type I collagen than fibroblast cells derived from skin. RepliCel’s products are administered to the target site in need of repair using a proprietary purpose-designed injector, also under development by RepliCel. This has been optimized for the administration of cell suspensions and other cellular injections.

According to the company, its cell-based products enjoy several beneficial attributes due to their autologous use:

No risk of a patient rejecting the cells, their minimal invasiveness to obtain the starting material (a single-suture biopsy from the back of the head).
Lack of cell manipulation aside from mere replication.
Cost of production capable of supporting commercially attractive margins at a reasonable price point for payers
Employ cell populations purpose-designed for their intended therapeutic effect unlike many of the stem cell therapies in development.

The goal of RepliCel is to generate compelling Phase I and II data for potential licensing or sale to larger life science companies with experience, expertise, and capacity for commercializing product to market. The intent is to de-risk technologies for late-stage partners which delivers nearer-term return on investment to shareholders than would exist for those investing in a company aiming to take a product through commercial approval and distribution.

Deal With Shiseido

In July 2013, RepliCel announced it had completed a collaboration and Technology Development agreement with Shiseido Company Limited, the world’s fourth largest cosmetics firm. This gave Shiseido exclusive market rights for the hair regenerative technology, RCH-01, in the ASEAN countries including, Japan, China, Taiwan and South Korea. The deal included a $4M upfront payment and sales milestones of up to $31.5M plus other sales royalties. Furthermore, the agreement established a joint steering committee to ensure continued research and development of the product was done collaboratively and the results of any such efforts would be shared. Shiseido is expected to launch their own clinical trial of RCH-01 imminently and will share this data with RepliCel for their own use in development and further licensing discussions pertaining to markets outside of Shiseido’s. Recently Shiseido announced they’ve already opened their constructed manufacturing facility to support clinical testing starting later this year.

The implications behind this partnership are huge. For one, Japan has taken initiative to be the global leader in regenerative cell therapies. In 2013 they revised the Pharmaceutical Affairs Law which allows regenerative medicines to be marketed before full authorization by the government. Data from the first consumers will be collected and used in the full market authorization approval.

Figure 1. Diagram of Japanese authorization process with revised Pharmaceutical Affairs Law.

For RepliCel this means:

Potentially faster access to sales royalty and milestone revenues if Shiseido gets the product through conditional approval in Japan

More clinical data points since Shiseido is funding their own trial

Validation from a major life science firm, that has done extensive due diligence on the hair regenerative market, company and technology

Current Research Data and Forthcoming Trials

Figure 2. RepliCel’s product pipeline and current development phase.

Hair

RepliCel’s Phase I trial of RCT-01 for treatment of pattern baldness resulted in firmly establishing the product’s safety. The study designed for safety, met its endpoint with no reported adverse side effects aside from a temporary, mild burning sensation at the injection site reported by some patients.

Efficacy was only measured up to the six-month point even though efficacy doesn’t typically peak until the 12-month post-treatment for other products or treatments. At six months, 63% of the “responders” (patients achieving over 5% density increase) experienced an average density increase of 11.8%.

Figure 3. RCH-01 Phase I results at the six-month mark.

Current Treatments for Hair Loss

The gold standard for hair loss treatment is micro-transplant surgery, which is a costly and extremely time consuming treatment. This would be for patients that are looking for dramatic change and have the means to do so. Rogaine is a topical solution available for men and women that increase hair density by 8%-16% at the 12-month mark, which needs to constantly reapplied. Propecia is an oral pill, for men only, that increases hair density by 7%-14% at the 12-month mark, which again needs to constantly be reapplied.

While the results were varied, a single injection of RCH-01 saw results, at the six-month mark, of up to 19.6% increase in hair density in a sample size of 16 people. Overall these are very impressive results and it was this data package that compelled Shiseido to seek out a deal for the technology. RepliCel’s pending Phase II trial of RCH-01 will study single vs. double injections and also investigate different doses.

RCH-01 fits into the market between surgery and drugs offering potentially stronger results through the means of a less invasive clinical treatment. This would be between the micro-transplant surgy which is expensive, and the drugs Propecia and Rogaine, which carry the risk of side effects and must be consistently reapplied for effectiveness.

Things to look for in the Phase two trials will be the percent change from baseline and the effectiveness of increased dosage and/or multiple injections). Even in the event that RCH-01 does not show a significant increase in both effectiveness and responders, RCH-01 can position itself in two ways for consumers; if the number of responders is increased, this can be potentially used as a combination treatment with hair regenerative drugs. Secondly, if the percent change from baseline shows a dramatic increase in a limited set of responders, it would be worth a clinical visit even if response percentages are low. In such case, it may justify doing a subset analysis or other preclinical work to identify patient biomarkers capable of predicting responders.

The upcoming trial will initiate in late 2014 or early 2015 costing $2-$2.5M over two years with data expected to be released in 2016.

Tendonosis

A study by Dr. David Connell showed significant changes in pain and function scores in patients with Achilles tendinosis through the introduction of dermal fibroblast cells. It has been shown that these cells are not as strong as fibroblast cells from the dermal sheath (RepliCel’s technology) at synthesizing Type I collagen. As a result, Connell licensed his intellectual property, data, and technology to RepliCel and joined as an advisor.

RepliCel’s anticipate Phase I/II study, titled “A randomized, double-blind, multi-centre dose-finding study to evaluate the efficacy and safety of RCT-01 in men and women with unilateral, chronic Achilles tendinosis,” addresses the inherent deficit of active fibroblasts required to regenerate healthy functioning tendon after injury. The trial, to be conducted at the University of British Columbia (Canada), will measure several safety and efficacy endpoints following a single injection of RCT-01. The study will be performed over 12 months costing under $1M and will initiate later this year. Six-month efficacy data is expected in second half of 2015.

Chronic Achilles tendinosis is a degenerative disease of the tendon caused by a cycle of injury, improper healing and re-injury resulting in ongoing pain and loss of function. Healthy functioning tendon is comprised of highly structured Type 1 collagen which resident fibroblasts play a significant role in producing and maintaining. RCT-01 is a fibroblast platform using cells derived from the patient’s hair follicle. These particular fibroblasts are highly expressive of Type 1 collagen, which is needed to support the regeneration of tendon for patients suffering from chronic tendinosis.

A recent study published in the British Journal of Sports Medicine estimated the incidence rates of Achilles tendinopathy to be .235% of the general adult population (21-60 years). If applied to the U.S. population this would translate into approximately 750,000 people in the U.S. suffering from this chronic condition at any given time.

Skin

Younger healthy skin is typically found to have high density of Type I collagen which decreases as time progresses and UV damage sets in. In a Phase I study of healthy volunteers RepliCel’s fibroblast technology (RCS-01) will be tested for its potential to reverse this and treat the appearance of aged skin. The primary end point will be safety but biopsies will be taken at various follow-up intervals to measure (by histology and FACS analysis) the product’s effectiveness on a number of biomarkers associated with aging skin. This Phase I study will enroll 28 patients costing approximately $500,000 with data available in 2015.

Financials

The company’s cash position as of Q2 results was $4.3M in cash and equivalents. Sporting a current burn rate of $350,000/month which is expected to increase late 2014/early 2015 as clinical trials ramp up, RepliCel will likely be looking at raising cash in 2015. In addition to equity financing the company reports actively exploring funding from other potential partnerships, warrants in the money and other sources of non-dilutive funding. Current shares outstanding of 54.9M and 67.4M fully diluted may raise concerns as returns are dispersed through a large volume of shares. Ownership is 43.5% by founders, officers and insiders, which indicate belief in the product that can be developed and licensed out.

Comparables

Risks

With all micro-cap stocks, especially biotechs, one should be wary of the risks. The valuation of the company is currently based on its potential future returns that carry the uncertainty of being unrealized due to failed clinical trials. RepliCel currently does not generate revenue from operations and faces significant business failure risk. Due to the nature of the product, the success of RepliCel post-approval will rely on the acceptance from the medical community and general public, which may be a hurdle.

Conclusion

This is a company with one Phase I trial, one Phase I/II trial, one Phase II trial, and late-stage prototype development of a new injectable device for $23M market cap. On top of this, there is support from Shiseido, which is funding an additional Phase II trial that could lead to conditional market approval in Japan. That, in turn, would trigger early access to revenue streams for RepliCel. I believe RepliCel is a heavily under-researched stock that has a lot of potential to be a disruptive player in the regenerative medicine sector.

Editor’s Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.

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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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