RepliCel Q3 2020 Management Update
Japan, China, and Dermal Injector Programs Progress to Milestones
VANCOUVER, BC, CANADA – 14 September 2020 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA:P6P2) (“RepliCel” or the “Company”), a company developing next-generation technologies in aesthetics and orthopedics, 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 below:
Within 6-12 months:
- Obtain CE mark approval for commercial launch our dermal injector and consumables in Europe and other markets which accept a CE mark approval (e.g., Hong Kong and Singapore)
- Receive a $.5M milestone from our Chinese partner upon CE mark registration in Hong Kong
- Announce distributorships for the dermal injector product line in Europe
- Obtain Chinese regulatory approval to launch a clinical trial for tendon regeneration in China financed by our partner, YOFOTO)
- Obtain Chinese regulatory approval to launch a clinical trial for skin rejuvenation in China financed by our partner, YOFOTO)
- Obtain Japanese regulatory approval to launch a clinical trial for tendon regeneration in Japan financed by a partner yet to be announced – 2 of 3 required approvals have already been obtained
- Obtain Japanese regulatory approval to launch a clinical trial for skin rejuvenation in Japan financed by a partner yet to be announced – 2 of 3 required approvals have already been obtained
- Announce a Japanese partner (or syndicate and/or grant funding) to fund the tendon program in Japan (discussion already underway)
- Announce a Japanese partner (or syndicate) to fund the skin program in Japan (discussions already underway)
- Announce data from a clinical study of the dermal injector (though this will likely not be required for regulatory approval, it will be valuable for marketing purposes)
- Announce clinical data from a skin rejuvenation clinical study in Japan
- Announce plans for the commercial launch of the skin rejuvenation treatment in Japan
- Obtain Japanese regulatory approval to market launch the dermal injector product line in Japan
- Announce a Japanese partnership for commercial distribution of the dermal injector product line in Japan
- Announce a partnership to fund a next-phase hair regeneration study in a select market
- Announce data from the skin rejuvenation clinical trial in China
- Receive a $1M milestone payment from our Chinese partner upon completion of the skin program clinical trial and an additional $1M CAD upon the first regulatory approval for market launch in Greater China
- Announce data from the tendon regeneration clinical trial in China
- Receive a $.5M milestone payment from our Chinese partner upon completion of the tendon program clinical trial and an additional $.5M CAD upon the first regulatory approval for market launch in Greater China
- Announce data from the tendon regeneration clinical trial in Japan
- Commercially launch the skin rejuvenation product in Japan
- Announce conditional approval for the market launch of the tendon regeneration product in Japan
- Commercially launch the tendon regeneration product in Japan
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.
- 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.
RepliCel Dermal Injector (RCI-02) Product Line – The manufacturing of RepliCel’s initial batch of commercial-grade dermal injectors and related consumables was materially impacted by pandemic-related shutdowns and supply-chain disruptions. Production is still recovering and we await delivery of the first units to commence the functional testing needed to produce the data required as part of the CE mark approval application.
New European regulations have impacted the testing and commercialization requirements. We continue to work with regulators to determine precisely how this will affect the timing of our commercial launch timelines but a launch is now expected to slip into early 2021.
Discussions with potential regional distributors and global partners (outside of Greater China which is licensed to YOFOTO) are currently underway.
Tendon Regeneration RCT-01 – RepliCel’s cell therapy for the treatment of chronic tendon damage (Tendinopathy) has been the subject of a successful phase 1 human clinical trial in the repair of Achilles tendinopathy (chronic tendon degeneration/pain). RepliCel is now planning to execute next-phase clinical trials of RCT-01 in Japan as doing so could lead to the launch of the product in Japan after a single, successful trial. The Company is currently seeking regulatory (PMDA) approval to launch such a trial. This is a three-step process and earlier this year RepliCel successfully passed the second stage and is now preparing for the third and final approval step.
Skin Rejuvenation RCS-01 – RepliCel’s cell therapy for the treatment of skin aging and sun damage has been the subject of a successful phase 1 human clinical trial. RepliCel is now planning to execute next-phase clinical trials of RCS-01 in Japan as soon as the Company can ensure the RCI-02 device and consumables are available in Japan for use in such a trial. Once commercial-grade units and consumables are available, management expects to obtain regulatory certainty on when that requirement will be met and a skin rejuvenation clinical study can be launched in Japan.
Hair Regrowth RCH-01 – RepliCel’s cell therapy for the treatment of Androgenic Alopecia has been the subject of a successful phase 1 human clinical trial in Europe and a successful dose-finding human clinical study in Japan. Shiseido has announced its intent to conduct further development and clinical testing of the product in Asia examining, in particular, the impact of a series of injections in the area of thinning hair. Once the RCI-02 injectors and consumables are available for clinical studies, RepliCel will begin preparations for phase 2 human clinical trial of this product outside of Asia (Shiseido’s licensed territory) examining both dose and injection frequency for the treatment of hair loss. Early stage discussions with potential partners outside of Asia are currently underway.
Partnership with Shiseido – The disagreement regarding the status of the agreement between Shiseido and RepliCel remains unresolved but is not the subject of any litigation or arbitration. RepliCel maintains the Agreement remains intact and is communicating with Shiseido its expectation that (a) they deliver to RepliCel the full clinical data set from the recently completed study of RCH-01 in Japan and (b) confirm that their license agreement remains intact without breach. RepliCel reserves the right to take the position that Shiseido’s failure to deliver the clinical data from the recently completed clinical study in Shiseido’s Territory constitutes a material breach of contract which, failing a cure, will warrant RepliCel’s termination of the agreement and revocation of Shiseido’s license resulting in RepliCel’s freedom to license the RCH-01 technology to competitors in Asia.
Partnership with YOFOTO – Since closing the license and co-development agreement with YOFOTO, they have designed, developed, validated, certified a stand-alone manufacturing facility and clinical site purpose built for regenerative medicine and nearly completed the technology transfer required for the non-bulbar dermal sheath cell products, RCS-01 and RCT-01. After experiencing pandemic-related shutdowns and delays, YOFOTO has now been able to resume preparations for regulatory submissions seeking approvals to launch phase 2 clinical trials of the tendon and skin products in China.
Research and Development – The grant-funded research project aimed at manufacturing optimization being conducted at the University of Victoria has resumed (with grant extensions) after experiencing pandemic-related shutdowns and delays. The first stage of the research being conducted at the University of British Columbia has successfully completed and plans are now in place for the second stage pending funding. Further product and process development, aimed at manufacturing improvements, will be prioritized as funding permits.
Business Development – Management is currently engaged in several early-stage partnership discussions including:
- a collaboration involving 3rd party funding for a next-phase RCT-01 clinical study in Japan in exchange for a right-of-first-refusal on pre-negotiated commercial terms for a Japanese license;
- a collaboration involving 3rd party funding for a next-phase RCS-01 clinical study in Japan in exchange for a right-of-first-refusal on pre-negotiated commercial terms for a Japanese license;
- a global commercial partnership for the RepliCel (RCI-02) Dermal Injector and Consumables with a company which has a dermal filler product;
- regional distributors for the RepliCel (RCI-02) Dermal Injector and Consumables;
- a collaboration to secure funding for a next-phase RCH-01 clinical study outside of Asia; and
- a license for RCH-01 in Japan and/or China in the event Shiseido’s license is revoked.
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.
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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Please note that any opinion, estimates or forecasts made by the authors of these statements are theirs alone and do not represent opinions, forecasts or predictions of RepliCel Life Sciences Inc. or its management. RepliCel Life Sciences Inc. does not, by its reference or distribution of these links imply its endorsement of, or concurrence with, such information, conclusions or recommendations.