With a new strategic plan, RepliCel
prioritizes focus on commercial revenue
VANCOUVER, March 5, 2019 /CNW/ - 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 President and CEO, Mr. R. Lee
Buckler.
Dear Shareholders,
I am pleased to be providing this much-anticipated 2019
update.
First, a quick recap of our Annual General Meeting held
December 14, 2018 at which the
shareholders elected a new slate of directors to RepliCel's Board -
some re-elected, some new. The Board now has higher shareholder
representation as well as a duly-elected nominee of our new
investor/partner in Greater
China.
Strategic Planning
Management and the Board have spent the past 60 days conducting
an end-to-end analysis of the Company and its programs followed by
comprehensive strategic planning to establish the Company's
direction and priorities for the next 24-36 months.
A recent Board meeting solidified the analysis and strategic
plan. We have emerged from this process with clarity around our
strategy that we are eager to communicate with shareholders and the
broader marketplace.
Our core message is this: RepliCel's strategy drives the
Company toward revenue and the Board's objective of minimizing the
need for capital and dilution until the Company is revenue
generating.
Transition to Commercial Revenue
RepliCel's focus on its transition to commercial revenue leads
the Company to prioritize commercialization of the Company's dermal
injector (and consumables) as well as clinical development of the
tendon and skin programs in Japan
where the pathway to commercial launch is the shortest due to its
unique regulatory framework for cell therapies.
RepliCel will also continue to support its partnership
commitments to YOFOTO and Shiseido. With the progress YOFOTO has
made in the past three months, RepliCel is encouraged YOFOTO will
meet milestones in China in a
timely way. With the clinical study of RCH-01 now successfully
completed in Japan, RepliCel
expects Shiseido to declare its near-term plans for RCH-01.
Three-Part Strategic Focus
RepliCel's Board has endorsed a three-part strategy prioritizing
the following programs:
- Initial market launch of the RCI-02 device and consumables in
countries accepting CE mark regulatory designation for
commercialization by mid-2020
- Clinical development of the skin and tendon products in
China with YOFOTO launching
2019/2020
- 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 in 2020 potentially leading
to commercial launch upon completion
"The objective of our strategic planning process," stated
RepliCel's Board Chairman, David
Hall, "was to review the Company's programs and identify
ways to maximize shareholder value in a way which was minimally
dilutive. We believe this will best be done by setting the Company
on a path which prioritizes the pursuit of commercial revenue,
allowing the Company to pursue its longer-term development projects
when they can be financed through some combination of revenue,
debt, and equity."
Secondary emphasis will be placed on the following
initiatives:
- Continued cell marker research at UBC (as funding permits)
- Support of the UVic cell culture biomaterials study (grant
funded)
- Preparing for phase 2 studies of NBDS products in Europe (as funding permits)
- Partnership discussions in Japan focused on our skin, tendon and dermal
injector products
- Distributor discussions in Europe focused on the dermal injector and
consumables
- Clarifying Shiseido's plans for RCH-01 in Japan and Asia
Below is a brief synopsis of how the new strategic plan impacts
RepliCel's programs:
RCI-02 and consumables – RepliCel's dermal injector and related
consumables are now in the final stages of development and
prototype manufacture. New European regulations have impacted the
commercialization timelines. The Company anticipates
commercial-grade prototypes will be available in late Q3/early Q4
with the timeline dependent on final part sourcing and design
changes currently being finalized. This put us on track for an
anticipated CE mark approval and product launch next year. More
details will be shared in another announcement shortly.
RCT-01 – RepliCel's cell therapy for the treatment of chronic
tendon damage (Tendinopathy) has been the subject of a successful
phase 1 trial. RepliCel is now planning to execute next-phase
clinical trials of RCT-01 in Japan
where, subject to PMDA approvals, such a trial could launch early
next year and be commercialized in Japan by late 2021/early 2022.
RCS-01 – RepliCel's cell therapy for the treatment of skin aging
and sun damage has been the subject of a successful phase 1 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.
Management is currently seeking clarity on this timeline and
expects to announce it shortly.
RCH-01 – RepliCel's cell therapy for the treatment of Androgenic
Alopecia has been the subject of a successful phase 1 trial in
Europe and a clinical study now
complete in Japan. Shiseido is
expected to announce soon whether it will commercially launch the
product in Japan or conduct
further development and clinical testing. RepliCel will not plan
for a phase 2 clinical trial of this product until it has the
RCI-02 injector commercially available to use in such a trial and
it has clarity from Shiseido regarding its plans for the product in
Japan.
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 regarding its expectation of a release
of data from the recently completed study of RCH-01 in Japan and clarity around Shiseido's commercial
plans for the product in Asia (the
territory for the Shiseido license).
Partnership with YOFOTO – In the four months since completing
the transaction with YOFOTO, good progress has been made in
China in preparing for
manufacture, technology transfer, and the regulatory review in
China needed to launch 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 continues
on-track. The first stage of the research being conducted at the
University of British Columbia has
successfully completed (details to be announced shortly) and plans
are being laid for the second stage. Further product and process
development, aimed at manufacturing improvements, will be
prioritized as funding permits.
A series of announcements are planned to provide more detailed
updates on each of our programs over the coming weeks.
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.
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 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 launch its dermal injector (RCI-02) and
the consumables in countries accepting the CE mark regulatory
designation for commercialization by mid-2020; that the Company
will launch clinical development of its NBDS products in
China with YOFOTO in 2019/2020;
that the Company will obtain approval to launch the next-phase
clinical trials of its tendon product (RCI-01) and skin product
(RCS-01) in Japan in 2020 and
launch YOFOTO-sponsored trials in China; that the Company will continue its cell
marker research at UBC; that the Company will prepare for phase 2
studies of NBDS products in Europe; that the Company will enter into
partnership discussions (outside of greater China) for its RCI-01 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 be
available in late Q3 or early Q4; that the Company will obtain CE
mark approval next year; 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 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, 2017 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 http://www.sedar.com/.
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SOURCE RepliCel Life Sciences Inc.