Dear Shareholders,
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
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
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) inJapan 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 andAsia ; - 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.
Respectfully yours,
CEO
About
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
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
For more information, please contact:
604-248-8693
info@replicel.com
Neither
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
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
Source:
2020 GlobeNewswire, Inc., source