Japan, China, and Dermal Injector Programs Progress to Milestones
VANCOUVER, British Columbia, Sept. 14, 2020 (GLOBE NEWSWIRE) -- 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 provide an update to shareholders from its Board and Management represented by President and CEO, Mr. R. Lee Buckler.
As industry reestablishes global supply chains and business patterns from the lasting impact of pandemic slow-downs, I am pleased to provide this much-anticipated update on RepliCel’s programs from the Board of Directors and management.
As announced earlier, RepliCel is in discussion with investors regarding a financing of ~$3.5M CAD to finance those Company programs intended to create the greatest potential near-term value for RepliCel’s shareholders including the launch of the Replicel Dermal Injector Product Line in multiple markets and production of multiple sets of clinical data across its platform of cell-based regenerative products. This summer, the Company settled over $900,000 by issuing shares for debt as well as new equity investment by new and existing shareholders including major insider participation. Current insiders now own over 30% of the Company’s shares both on an issued and fully diluted basis and one non-insider shareholder owns another 7% of issued common shares.
While specific timelines for milestones are dependent on when the associated capital is raised, we are confident that we will complete a financing and, assuming this is completed in the near future, we anticipate meeting the milestones outlined in the full version of this release on our website at https://replicel.com/news. Over the next months we expect to deliver consistent, regular value creation with a steady stream of very meaningful announcements – all largely driven by partnership funding, dermal injector product line revenue, grant funds, and milestone payments.
All the pieces are in place to deliver on these milestones once the financing is completed. We have a great team on the ground in Japan, a great partner actively engaged in China, and outstanding partners in Europe providing manufacturing of both the device product line and cell therapies.
As previously announced, RepliCel’s Directors have committed the Company to a three-part strategy prioritizing the following programs:
Initial market launch of the RepliCel Dermal Injector (RCI-02) Product Line (i.e., the injector handheld wand, the injector desktop control unit, and single use consumables including needle heads, syringe, plunger, and injector footpad lining) in countries accepting CE mark regulatory designation for commercialization;
Clinical development of the skin and tendon products in China with YOFOTO; and
Regulatory review by Japan’s PMDA (Pharmaceuticals and Medical Devices Agency) targeting approvals for RepliCel to launch the next-phase clinical trials of our tendon product (RCT-01) and skin product (RCS-01) in Japan potentially leading to commercial launch upon completion.
Secondary emphasis was placed on the following initiatives:
Partnership discussions in Japan focused on our skin, tendon, and dermal injector products;
Distributor discussions in Europe focused on the RepliCel Dermal Injector Product Line;
Clarifying Shiseido’s plans for RCH-01 in Japan and Asia;
Continued cell marker research at the University of British Columbia (as funding permits);
Support of the cell culture biomaterials study at the University of Victoria (grant funded); and
Preparing for phase 2 studies of products outside Asia (as funding permits).
While we are not as far along in some of our programs as we had anticipated we would be at this point in 2020 given the unanticipated impacts of the global pandemic, over the past 12 months we've announced:
the completion, validation, an opening of our partner YOFOTO’s facility;
positive clinical data from the Japanese hair-regrowth study which was published in the esteemed JAAD, Journal of the American Academy of Dermatology. To have a paper accepted by such a publication highlights the unique efficacy and potential of RCH-01 as well as Shiseido’s ongoing commitment to the product;
publication of positive data from our phase 1 skin rejuvenation study;
production launch of the RepliCel Dermal Injector Product Line which was then temporarily halted due to COVID;
new patents issued in Japan;
the second of three clearances in Japan needed to launch clinical studies of skin and tendon; and
the launch and initial partial closing of a private placement.
For greater detail on the status and next steps for each of RepliCel's programs, see the full version of this press release posted on our website at https://replicel.com/news.
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on developing cell therapies for aesthetic and orthopedic conditions affecting what the Company believes is approximately one in three people in industrialized nations, including aging/sun-damaged skin, pattern baldness, and chronic tendon degeneration. These conditions, often associated with aging, are caused by a deficit of healthy cells required for normal tissue healing and function. These cell therapy product candidates are based on RepliCel’s innovative technology, utilizing cell populations isolated from a patient’s healthy hair follicles.
The Company’s product pipeline is comprised of RCT-01 for tendon repair, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration. RCH-01 is exclusively licensed in Asia to Shiseido Company. RepliCel and Shiseido are currently co-developing the product in Japan. RepliCel maintains the rights to RCH-01 for the rest of the world. RCT-01 and RCS-01 are exclusively licensed in Greater China to YOFOTO (China) Health Company. RepliCel and YOFOTO are currently co-developing these products in China. RepliCel maintains the rights to these products outside of Greater China.
RepliCel has also developed a proprietary injection device, RCI-02, and related consumables, which is expected to improve the administration of its cell therapy products and certain other injectables. YOFOTO has exclusively licensed the commercial rights for the RCI-02 device and consumables in Greater China for dermatology applications and is expected to first launch the product in Hong Kong upon it being CE marked. Please visit www.replicel.com for additional information.
For more information, please contact:
Lee Buckler, CEO and President
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This press release and the website content linked in it contains forward-looking statements and information that involve various risks and uncertainties regarding future events, including, but not limited to, statements regarding:
that the Company will complete a financing; that the Company will meet the milestones outlined in the full version of this release on our website at https://replicel.com/news; that the Company will complete an initial market launch of the RepliCel Dermal Injector (RCI-02) Product Line (i.e., the injector handheld wand, the injector desktop control unit, and single use consumables including needle heads, syringe, plunger, and injector footpad lining) in countries accepting CE mark regulatory designation for commercialization; that the Company will complete clinical development of the skin and tendon products in China with YOFOTO; and that the Company will get approval from Japan’s PMDA (Pharmaceuticals and Medical Devices Agency) to launch the next-phase clinical trials of its tendon product (RCT-01) and skin product (RCS-01) in Japan potentially leading to commercial launch upon completion; that the Company will continue its cell marker research at UBC; that the Company will enter into partnership discussions (outside of greater China) for its RCI-02 device and cell therapy products; that the Company will clarify Shiseido’s plans for RCH-01 in Japan; that commercial grade prototypes of its dermal injector and related consumables will pass testing and be available for commercial launch; that the Company will obtain CE mark approval for all components of the RepliCel Dermal Injector Product Line; that the Company will launch its next-phase clinical trials of RCS-01 in Japan as soon as the RCI-02 device and consumables are available in Japan; that the Company will receive clinical data from Shiseido; that the Company will transition from being a pre-revenue development company to generating commercial revenue; and that the Company will be able to minimize dilution and maximize shareholder value.
These statements are only predictions and involve known and unknown risks which may cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking statements, including: risks that the Company will not complete a financing or raise sufficient funds to complete all of its planned activities; risks related YOFOTO spending the required amounts on RepliCel’s programs and related infrastructure over the next 5 years in Greater China; risk related to YOFOTO paying $4.5M CDN in milestone payments and sales royalties; risks that the Company’s products may not perform as, or have the benefits, expected; risks that the Company’s products may not be accepted and adopted by the public; the risk that the Company will not obtain CE mark clearance for its injector device as anticipated or at all; the risk that there will be delays enrolling clinical trial participants or commencing any clinical or research programs as anticipated or at all; the risk that the Company will receive negative results from the Company’s clinical trials; the effects of government regulation on the Company’s business; risk that the Company may not obtain any further data from Shiseido; risks associated with the Company obtaining all necessary regulatory approvals for its various programs; risks associated with the Company’s ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company’s ability to raise additional capital; and other factors beyond the Company’s control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statement speaks only as of the date on which such statement is made and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2019 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.