Partnership and Investment Fuel Plans for
Upcoming Advancements
VANCOUVER, Oct. 15, 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,
Now that we have closed our deal with YOFOTO, I am very pleased
to provide this updated outlook.
In January, I outlined our progress over the past 24 months and
included our goals for 2018 which, I said, would be focused on
"...leveraging partnerships to drive the Company towards
maturation." Last week, we announced we had closed an investment
with YOFOTO (China) Health
Industry Co. Ltd ("YOFOTO"), which is now a significant shareholder
and business partner.
This update is intended to provide shareholders with a sense of
what this strategic transaction means for RepliCel and an update on
our next steps.
Firstly, let's recap the recent news:
For the past eleven months, we
have been working toward securing and closing this partnership in
Greater China. The valuation at
which the upfront investment was made clearly indicates that YOFOTO
believes they will help us create considerably more value in the
company over the coming months.
YOFOTO has committed to spending a minimum of $7M CDN on RepliCel's programs and related
infrastructure over the next 5 years in Greater China. This includes them funding
technology transfer, manufacturing, regulatory submissions and
clinical trials in Greater China
as well as the commercial launch of our dermal injector in
Greater China. YOFOTO has told us
it expects to spend much more than this minimum. YOFOTO has also
committed to over $4.5M CDN in
milestone payments, some of which are pre-commercial, and sales
royalties.
In addition to funding clinical development and commercialization
in Greater China as a licensee,
YOFOTO is now a significant investor in RepliCel having invested
just over $5M CDN at $0.95 per common share. RepliCel will use the
proceeds from this investment to fund its programs in Europe and North America. Additionally,
YOFOTO has financing participation rights for two years to maintain
their pro-rata ownership position which translates into a likely
lead order in any private placement that may be needed in the
future.
Near-term Commercial Opportunity
There are two near-term commercial opportunities for RepliCel
programs. Firstly, with sufficiently positive data from the RCH-01
clinical study in Japan, Shiseido
may be in a position to launch the product in Japan for the treatment of patients with
androgenic alopecia. Secondly, YOFOTO is committed to launching the
RCI-02 dermal injector in Hong
Kong as soon as it is CE-marked. The CE mark also presents a
significant new partnering opportunity to secure a commercial
partnership for the launch of the device in Europe and other countries recognizing the CE
mark approval.
Either or both of these potential commercial launches would
transition RepliCel from being a pre-revenue development company to
generating revenue as a commercial entity. This is a material
transition in the minds of many retail and institutional investors
and is expected to help offset our future development costs for
other products.
Development Next Steps
RepliCel will focus resources and capacities on three priorities
in the near-term:
- Finalizing the dermal injector to build the commercial-grade
prototypes, test and validate its function, and submit an
application for a CE mark to enable its commercial launch;
- Engaging in the technology transfer work needed from
Europe and Canada to set YOFOTO up in China to prepare for clinical trials there as
quickly as possible; and
- Preparing for next-stage clinical trials.
Partnership and Business Development Update
Many shareholders have been asking about the status of our
relationship with Shiseido. This remains unchanged from the
information provided in September
2016. This may or may not change if positive clinical data
is announced in the coming weeks from the Japanese clinical study
and/or if Shiseido announces an intention to commercially launch
the product in Japan. We continue
to press for a commercial solution with Shiseido that is mutually
beneficial.
With the YOFOTO partnership now in place to begin executing our
collaboration, I will be turning attention to other strategic
corporate opportunities. I firmly believe we are not done on the
deal-making front even in the near-term. We are in active and
promising discussions with other potential partners which I look
forward to providing more insights on in the coming months.
The next 18 months
RepliCel shareholders should expect to see an exciting stream of
activity and updates coming out of China (funded by YOFOTO) in addition to
RepliCel activity with particular focus on its device
commercialization (funded by this recent transaction).
In January, I laid out an ambitious plan for what shareholders
should watch for in 2018. We are, without question, behind
schedule on many of these items because of how long it took us to
get to an executed agreement with YOFOTO and to close the
associated financing transaction. Some of these milestones will
clearly slip into 2019; others we will double our efforts on to
catch up and deliver yet this year.
Near-term catalysts to watch for over the next 15-18 months
include:
- Anticipated announcement of clinical results from the
Shiseido-funded pattern baldness study in Japan
- Commercial-grade prototypes of the dermal injector built and
available for clinical and functional testing
- Launch of clinical testing of the injector at select clinical
sites for limited clinical applications
- CE-mark of the dermal injector to be followed by a new level of
commercial partnership discussions
- Registration of the RCI-02 CE mark in Hong Kong for a commercial launch of the
dermal injector by YOFOTO
- A decision from Shiseido on if and when it intends to launch of
the RCH-01 in Japan
- Data from the gene marker identification study ongoing at
University of British Columbia
- Receipt of grant funding to fund further product
development
- Completion of YOFOTO's manufacturing facility in Ningbo, China
- Completion of technology transfer of the two licensed cell
therapy programs to YOFOTO
- Guidance from Chinese regulators on approvals for clinical
trials of RCS-01 (skin rejuvenation) and RCT-01 (tendon
regeneration) in China
- A designation from Chinese regulators for the RCI-02 (dermal
injector) in mainland China
As resources permit, we will continue planning with leading
experts in North America,
Europe, and Asia on:
- establishing a regulatory dialogue with the United States
FDA;
- finalizing plans for phase 2 clinical trials; and
- additional manufacturing optimization projects as we plan for
profitable commercialization.
In summary, we have leveraged our accomplishments in 2017 into a
new partnership which brings tremendous value to RepliCel
shareholders and puts us on a trajectory for great things to come
in the coming year. We have a pipeline of activity and news which I
believe will demonstrate significant momentum throughout the
remainder of the year as we work to deliver on near-term milestones
and catalysts including transitioning into a revenue-generating,
commercial-stage Company with the launch of our first products.
I look forward to getting back on the road, as time permits, to
meet with many of you. As always, I warmly welcome your emails,
phone calls, or meeting requests.
Sincerely,
R. Lee Buckler
RepliCel President and CEO
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:
YOFOTO spending a minimum of $7M
CDN on RepliCel's programs and related infrastructure over
the next 5 years in Greater China;
YOFOTO spending much more than this minimum of $7M CDN; YOFOTO paying $4.5M CDN in milestone payments and sales
royalties; YOFOTO being a lead order in any future private
placements; Shiseido may be in a position to launch the product in
Japan for the treatment of
patients with androgenic alopecia; YOFOTO launching the RCI-02
dermal injector in Hong Kong as
soon as it is CE-marked; the Company identifying and closing on
significant new partnering opportunities to secure a commercial
partnership for the launch of the device in Europe and other countries recognizing the CE
mark approval; RepliCel will transition from being a pre-revenue
development company to generating revenue as a commercial entity;
the Company will finalize the dermal injector and build
commercial-grade prototypes, test and validate its function, and
submit an application for a CE mark to enable its commercial
launch; the Company resolving its issues with Shiseido in a
mutually beneficial manner; the Company identifying other
potential partners and completing other strategic partnerships; the
Company achieving any of the near-term catalysts set out in this
news release in the next 15 to 18 months or at all; and the Company
achieving significant momentum throughout the remainder of the year
and completing the near-term milestones and catalysts set out in
this news release, including transitioning into a
revenue-generating, commercial-stage Company; 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; 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
YOFOTO spending the $7M CDN
on RepliCel's programs and related infrastructure over the next 5
years in Greater China; risks
related to YOFOTO spending much more than this minimum of
$7M CDN; risk related to YOFOTO
paying $4.5M CDN in milestone
payments and sales royalties; risks related to YOFOTO being a lead
order in any future private placements; 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, 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 www.sedar.com.
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SOURCE RepliCel Life Sciences Inc.
