RepliCel Reports Third Quarter 2013 Financial Results and Provides Corporate Update

RepliCel Reports Third Quarter 2013 Financial Results and Provides Corporate 
Update 
VANCOUVER, BRITISH COLUMBIA -- (Marketwired) -- 11/20/13 -- RepliCel
Life Sciences Inc. (OTCQB:REPCF)(CNSX:RP), a clinical stage
regenerative medicine company focused on the development of
autologous cell therapies, today reported financial results for the
third quarter and nine months ended September 30, 2013.  
"We continue to make solid progress on our development plans for
RCT-01 for treating chronic tendinosis and RCH-01 for treating
pattern baldness and expect to have our Phase 2 clinical trials for
both programs underway during the first half of 2014," stated David
Hall, CEO of RepliCel. "The third quarter brought incremental funding
and validation of our platform with the establishment of a
collaboration and technology transfer agreement with Shiseido
covering our potential baldness product, RCH-01, on an exclusive
basis in Japan and additional Asian countries."  
Recent Business Accomplishments  


 
--  In July, RepliCel finalized a Collaboration and Technology Development
    Transfer Agreement with Shiseido Company, Limited. RepliCel received an
    upfront fee of yen 400,000,000 (approx. CDN $4,120,000). Under terms of
    the agreement, Shiseido will pay RepliCel sales milestones up to an
    additional yen 3,000,000,000 (approx. CDN $31,500,000) based on the
    achievement of specified sales milestones and royalties. The agreement
    grants Shiseido an exclusive geographic license to use RepliCel's RCH-01
    hair regeneration technology in Japan, China, South Korea, Taiwan and
    the ASEAN countries. 
    
--  In July, RepliCel completed a private placement financing that resulted
    in gross proceeds of CDN $525,000 and the issuance of 1,050,000 shares
    of common stock at a price of CDN $0.50 per share. 
    
--  In October, RepliCel announced the formation of a Clinical Advisory
    Board to support the clinical development of RCT-01, the company's
    autologous cell therapy for the treatment of a variety of chronic tendon
    injuries including Achilles, patellar and elbow tendinosis. The board,
    chaired by Ross G. Davidson, MBChB, will provide its expertise and
    guidance on all aspects of the clinical trial program. Additional
    members include David A. Connell, MBBS, and Jack E. Taunton, M.D. 

 
Research and Development Update  
RCT-01: RepliCel is currently finalizing its standard operating
procedures (SOPs,) for the manufacturing of cells for its Phase 2
clinical trial for the treatment of chronic Achilles tendinosis which
the company plans to conduct in Canada. The preliminary clinical
trial design has been completed, and negotiations are underway for
the contract manufacturing of the cells required for the study. Upon
the finalization of the manufacturing SOPs, the company will initiate
its pre-clinical trial application meeting with Health Canada to
discuss the trial design and manufacturing protocols and make any
necessary changes before filing the final Clinical Trial Application
planned for the first half of 2014.  
RCH-01: The company has completed its Phase 2 pre-filing meetings
with the German Competent Authority responsible for the authorization
of cellular therapies (the Paul Ehrlich Institute) and is in the
process of completing cell stability studies required for the
Investigational Medical Product Dossier. Submission is planned for
early 2014 with the initiation of the trial anticipated in the first
half of 2014. The company is also in the final stages of RCH-01
technology transfer to its licensed partner, Shiseido, for Japan,
China and the ASEAN countries. Shiseido is developing its own program
for RCH-01 in Japan. Any new improvements made to the technology by
either party will be shared. In addition, the government of Japan has
announced its intention to accelerate cell-based therapies through a
revised regulatory process which is expected to be made public in
January 2014. The new process should facilitate the initiation of
Shiseido's clinical program and, as a result, RepliCel expects to
have two concurrent RCH-01 human clinical trials which will
significantly increase the available human clinical data on RCH-01. 
RCI-02: RepliCel has designed and is developing a new cell injector
device to be used in conjunction with the RCH-01 treatment. The
company believes that the device will also have applications in
certain other dermatological procedures requiring injections of
specific volumes of material at specific depths. In addition to the
programmable variables of volume and depth, the device will have
interchangeable heads for different injection procedures (single and
multi-needle) as well as a built-in cooling capability to remove the
requirement for an anesthetic during an injection process.
Development is expected to be completed in the second half of 2014. 
2013 Third Quarter and Nine Months Financial Results (CDN $)  
Net earnings for the third quarter of 2013 was $2,613,456 or $0.06
per share compared to a net loss of $36,393 or $nil per share for the
third quarter of 2012. Net earnings for the nine months ended
September 30, 2013 was $1,013,154 or $0.02 per share compared to a
net loss of $2,655,554 and $0.06 per share for the comparable period
in 2012.  
Revenue for the third quarter and nine months ended September 30,
2013, was $4,120,400, attributed to completion of a Collaboration and
Technology Development Transfer Agreement with Shiseido Company,
Limited.  
Research and development (R&D) expense for the third quarter of 2013
was $301,996 compared to $182,073 in the prior year period. For the
nine months ended September 30, 2013 R&D expense was $805,637
compared to $752,067 in the prior year period. The increase was the
result of advancing the pre-clinical work for RCT-01, development of
the RCI-02 injector device prototype, improvements in the cell
replication process for RCH-01 in preparation for our submission to
regulatory authorities and incremental expenditure on IP. 
General and administrative (G&A) expenses totaled $585,021 for the
third quarter of 2013 compared to $644,534 for the third quarter of
2012. For the nine months ended September 30, 2013 G&A expense was
$1,788,507 compared to $2,791,555 in the comparable period during
2012. The decrease is primarily attributable to a decline in
marketing and investor relations activities, and a reduction in stock
based compensation which resulted from the forfeiture of options held
by certain employees and consultants during the quarter.  
RepliCel exited the third quarter of 2013 with $3.2 million of cash
and cash equivalents. This compares to cash and cash equivalents of
$0.4 million on December 31, 2012 and $74,745 on June 30, 2013. The
company anticipates that its minimum operating expenses for the next
12 months will be approximately $2.2 million. Furthermore, the
company believes that its current working capital and financial
resources are sufficient to sustain its minimum operations for the
next 18 months. 
Notice Regarding Forward Looking Statements 
This press release contains projections and forward-looking
statements, as that term is defined under applicable securities laws.
Statements in this press release, which are not purely historical,
are forward-looking statements that relate to the approval and
commercialization of the Company's hair restoration process, the
Company's development of its Achilles tendon technology and the
expected commencement of the Company's Phase 2 clinical trial for its
tendon technology. 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 information, including: negative
results from the Company's clinical trials; the effects of government
regulation on the Company's business; 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, 2012 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. 


 
                        REPLICEL LIFE SCIENCES INC.                         
           CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS          
                   =========================================================
                          Three months ended           Nine months ended    
                                                                            
                     September 30,     September     September     September
                              2013      30, 2012      30, 2013      30, 2012
                   ---------------------------------------------------------
                             (unaudited)                  (unaudited)       
                                                                            
Revenue             $    4,120,400 $           - $   4,120,400 $           -
                                                                            
Expenses                                                                    
 Research and                                                               
  development              301,996       182,073       805,637       752,067
 General and                                                                
  administrative           585,021       644,534     1,788,507     2,791,555
                   ---------------------------------------------------------
Income (loss) from                                                          
 operations              3,233,383     (826,607)     1,526,256   (3,543,622)
                   ---------------------------------------------------------
Other items:                                                                
 Change in fair                                                             
  value of warrants                                                         
  denominated in a                                                          
  foreign currency       (209,811)       830,371     (245,168)       896,798
 Foreign exchange                                                           
  gain (loss)                1,924      (40,157)       (6,677)       (8,730)
 Scientific                                                                 
  research and                                                              
  development                                                               
  credit                         -             -       150,783             -
 Withholding tax         (412,040)             -     (412,040)             -
                   ---------------------------------------------------------
Total comprehensive                                                         
 income (loss)      $    2,613,456 $    (36,393) $   1,013,154 $ (2,655,554)
                   =========================================================
Basic and diluted                                                           
 earnings (loss)                                                            
 per share          $         0.06 $      (0.00) $        0.02 $      (0.06)
                   =========================================================
                                                                            
Weighted average                                                            
 shares outstanding     46,213,174    43,325,054    44,852,082    42,463,441
                   =========================================================
                                                                            
                  SELECTED CONSOLIDATED BALANCE SHEET DATA                  
                                  ==========================================
                                          September 30,         December 31,
                                                   2013                 2012
                                  ------------------------------------------
                                            (unaudited)                     
Cash and cash equivalents          $          3,162,293 $            384,286
Total current assets                          3,249,644              483,893
Working capital                               2,865,346               67,768
Total assets                                  3,267,406              505,488
Total shareholders' equity                    2,569,735               21,158
                                  ==========================================

Contacts:
CORPORATE CONTACT:
RepliCel Life Sciences
Tammey George
Director of Communications
604-248-8696
tg@replicel.com 
INVESTOR CONTACTS:
Westwicke Partners, LLC
Stefan Loren, Ph.D.
Managing Director
(443) 213-0507
sloren@westwicke.com 
Westwicke Partners, LLC
Robert H. Uhl
Managing Director
(858) 356-5932
robert.uhl@westwicke.com
 
 
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