With a new Asian partnership and 2017
deliverables met, RepliCel is primed and ready for
expansion
VANCOUVER, Jan. 25, 2018
/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 very pleased to be providing this 2018 update. The Company
had a very successful 2017, which has only paved the way for a
successful year as we enter into 2018. We are ramping up for
expansion of all our programs and are actively focused on
additional partnership discussions to drive the Company towards
maturation. These are exciting times and we look forward to sharing
more news as RepliCel continues to gain momentum taking its place
as a biotech industry leader.
Looking back over the past 24 months, 2016 was about
restructuring and refinancing the Company, 2017 was about
delivering promised clinical and injector milestones, and now 2018
is about expansion.
With the rebuilding that the Company has accomplished in the
past 24 months, RepliCel has now set the stage to execute across
multiple fronts over the next 24 months. Armed with clinical data,
functioning device prototypes, a new partner committed to financing
our programs in Greater China, and
significant capital to execute our programs elsewhere through 2019,
we have now positioned RepliCel to deliver on its next phase across
several platforms at a faster pace.
We have ongoing research programs at the University of British Columbia in Vancouver, the Shiseido-funded clinical
research in Japan, and our dermal
injector development taking place in Europe. Expanding from there, we are laying
plans for development programs with lead experts in North America and Europe, phase 2 clinical trials in
Europe, new clinical trials in
Hong Kong and mainland
China, regulatory clarity with the
United States FDA, and exploring other deals currently under
discussion.
In 2018, shareholders should expect to see:
- The launch of a European multi-centre, phase 2 clinical trial
measuring the impact of RCS-01 injections on aging skin.
- Completion of commercial-grade prototypes for the RCI-02 dermal
injector.
- Filing of a CE-mark application for our dermal injector seeking
the regulatory marketing approval needed to commercially launch the
device in Europe and Hong Kong.
- Preparations for launching the device in Hong Kong by licensing partner, YOFOTO
(China) Health Industry Co.
Ltd.
- Data from the clinical research being funded by Shiseido in
Japan measuring the benefit of
RCH-01 injections in men and women suffering from hair loss due to
androgenic alopecia.
- Data from the research program at UBC identifying different
genetic marker expression profiles of various cell populations in
the hair follicle with an aim of potentially improving cell
selection, manufacturing, and clinical outcomes.
- The launch of tendon repair (RCT-01) and skin rejuvenation
(RCS-01) clinical trial activity in Hong
Kong and/or Mainland China funded by YOFOTO.
- The launch of planned product development projects with various
partners intended to add significant value to our programs.
- A meeting with the FDA reviewing one or more of our
programs.
- Business development activity which may well lead to the
execution of other commercial partnerships.
Unlike previous years, not only are we are financed to move
through these milestones, we have new, significant non-dilutive
funding commitments for much of this expansion, subject to
successful closing of the deal with YOFOTO.
The pending investment from and partnership with YOFOTO,
announced earlier this month, brings to RepliCel a new major
shareholder committed not only to finance the programs licensed for
Greater China but also to the
overall success of the Company. The dilutive investment upfront
will be used to fund our programs outside of Asia. This will be counterbalanced with
YOFOTO's funding of our programs in Greater China which will bring significant
value to the Company as they generate clinical data and
commercialize products. RepliCel shareholders can also look forward
to the Company receiving further non-dilutive milestone and royalty
payments as part of the YOFOTO partnership.
With the YOFOTO partnership including the dermal injector, we
now have a commercial partner able to launch the device
commercially in Hong Kong once we
have obtained CE-mark approval. This means we now have commercial
partnerships in place not only with the potential for near-term
commercial launch of RCH-01 in Japan but also a near-term launch of the
injector of the device in Hong
Kong.
As I outlined in our September press release, we have leveraged
our progress in 2017 into a very exciting pipeline of ongoing
partnership discussions. While we have now announced the YOFOTO
partnership focused on product development and commercialization in
Greater China, we have other deals
we are in a position to consider in the months ahead. These
potential partnerships offer unique opportunities to position and
capitalize the Company on its path to increasing maturity.
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. 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
currently being co-developed with, and under exclusive license by,
Shiseido 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.
RepliCel has also developed a proprietary injection device, RCI-02,
optimized for the administration of its products and licensable for
use with other dermatology applications. 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.
Disclaimer for Forward-Looking Statements
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:
the completion of the transaction with YOFOTO for financing the
Company's programs in Greater
China, and providing significant capital to execute the
Company's programs elsewhere through 2019; the Company conducting
development programs with lead experts in North America and Europe, phase 2 clinical trials in
Europe and new clinical trials in
Hong Kong and mainland
China; the Company obtaining
regulatory clarity with the United States FDA; the launch of a
European multi-centre, phase 2 clinical trial measuring the impact
of RCS-01 injections on aging skin; completion of commercial-grade
prototypes for the RCI-02 dermal injector; the filing of a CE-mark
application for our dermal injector seeking the regulatory
marketing approval needed to commercially launch the device in
Europe and Hong Kong; obtaining clinical data from the
clinical research being funded by Shiseido in Japan and data from the research program at
UBC identifying different genetic marker expression profiles of
various cell populations in the hair follicle; the launch of tendon
repair (RCT-01) and skin rejuvenation (RCS-01) clinical trial
activity in Hong Kong and/or
Mainland China funded by YOFOTO; the launch of planned product
development projects with various partners; the execution of other
commercial partnerships; that YOFOTO will fund the Company's
programs in Greater China
resulting in the generation of clinical data and commercialized
products; the Company receiving further non-dilutive milestone and
royalty payments as part of the YOFOTO transaction; that YOFOTO
will become a commercial partner for the injector device; and the
near-term commercial launch of RCH-01 in Japan.
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 to the
Company and YOFOTO being able to negotiate and enter
into the definitive agreements required for the
transaction with YOFOTO, risks related to the Company obtaining the
approval of the TSX-V and its shareholders for the transaction with
YOFOTO, risks related to YOFOTO obtaining consent for the
transaction from the required parties and applicable regulatory
authorities; 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; the risk that there will be
delays enrolling clinical trial participants or commencing any
clinical or research programs; 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; 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, 2016 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/.
SOURCE RepliCel Life Sciences Inc.
