RepliCel CEO Provides Company Outlook
A data-rich 2017 positions RepliCel for maturity through the next phase of its product development, research programs, and revenue generatio
VANCOUVER, BC – May 25, 2017 – RepliCel Life Sciences Inc. (OTCQB: REPCF) (TSXV: RP) (FRA6P2) (“RepliCel” or the “Company”), a regenerative medicine company addressing large-market opportunities with innovative technologies in aesthetics and sports injury/orthopedics, today unveiled its go-forward strategy.
In the first few months of 2017, the Company made pivotal announcements based on data collected from all three of its cell therapy programs. Furthermore, RepliCel continues to make significant progress on its nearest-term commercial asset, the dermal injector (RCI-02).
Building on a decade of the Company’s discovery, pre-clinical work, and successful first-in-human clinical data, RepliCel has formulated a strategic plan for 2017 through 2019 focused on maturing its assets through three distinct pillars:
- Commercializing the Company’s dermal injector;
- Research and development to enhance clinical efficacy, optimize manufacturing, and strengthen the Company's intellectual property portfolio; and
- Preparing and launching phase II clinical trials.
The plan includes several key milestones anticipated to be part of the Company's next 30 months including:
- Building and testing the commercial-grade prototypes of RepliCel's next-generation dermal injector;
- Preparing the RCI-02 device for marketing approval in Europe (CE-mark);
- Executing an application-focused commercialization agreement for RCI-02 with a multi-national partner, including the payment of non-dilutive licensing/milestone fees and ongoing sales royalties;
- Launching and executing a molecular marker study anticipated to add significant value to the Company's intellectual property, manufacturing technologies, and the enhancement of clinical efficacy;
- Completing ongoing research related to the manufacture of dermal sheath cup cells as a precursor to phase II clinical trials of RCH-01; and
- Preparing for phase II clinical studies of the RCT-01 (tendinopathy) and RCS-01 (skin aging) clinical programs.
Further details on each of the programs are expected to be released in the coming few weeks.
"The first decade of RepliCel's growth was focused on moving our initial discoveries through pre-clinical research, diversification, and achieving proof-of-concept data in first-in-human clinical trials. Now we are presented with the exciting opportunity to mature the Company and its assets through device commercialization, next-phase clinical trials, and partnerships," stated RepliCel's President & CEO, R. Lee Buckler.
"Given the near-term commercial status of our dermal injector development and the nature of the discussions underway, we remain confident we will secure a revenue-generating, commercialization partnership for this asset next year," continued Buckler. "Additionally, we are currently engaged in a number of early-stage partnership and collaboration discussions for each of our cell therapy programs. While we have already commenced planning preparation for our next-phase clinical trials, these discussions may influence how we prioritize and finance these studies. Shareholders should expect a series of releases over the next few weeks providing more clarity on each of these programs."
About RepliCel Life Sciences
RepliCel is a regenerative medicine company focused on aesthetics and sports injury applications.
As its nearest-term commercial asset, RepliCel is developing a next-generation dermal injection device (RCI-02) designed to optimize aesthetic injections. The Company’s cell therapy product pipeline is comprised of three clinical-stage products: RCT-01 for tendon regeneration, RCS-01 for skin rejuvenation, and RCH-01 for hair restoration which is being co-developed 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.