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Trimel Provides Corporate Update and First Quarter 2014 Financial Results

TORONTO, ONTARIO -- (Marketwired) -- 05/08/14 -- Trimel Pharmaceuticals Corporation (TSX:TRL) today provided an overview of its corporate accomplishments and reported financial results for the three month period ended March 31, 2014.

2014 Corporate Developments

As previously communicated, the Food and Drug Administration's ("FDA") review of CompleoTRT(TM) is progressing and is in its final stages. Barring any unforeseen circumstances, the Company expects to obtain a final decision regarding marketing approval in late May 2014.

With respect to the ongoing Phase II clinical trial for Tefina(TM), a product being developed for the treatment of Female Orgasmic Disorder, the last patient enrolled in the study has now completed the applicable treatment protocol. Full database lock is scheduled to occur on May 9, 2014. The Company anticipates receiving top-line results from the study by the end of May 2014.

During the 2014 first quarter, the Company successfully raised net proceeds of CAD $10.5 million (US$9.5 million) from a private placement which closed on February 21, 2014. In connection with the private placement, the Company issued 14,829,676 common shares at a price of CAD$0.711 per share.

Shareholder Meeting and Earnings Call

Shareholders are advised that an annual general and special meeting of shareholders will occur on June 12, 2014 at 11:00 a.m. (Toronto time) at The Toronto Region Board of Trade, First Canadian Place, 77 Adelaide Street West, Toronto, Ontario. Shareholders of record as of May 6, 2014 shall be entitled to vote on all matters at the meeting, and a detailed management information circular and voting materials will be mailed to shareholders shortly. If shareholders have not received their materials by June 1, 2014, they are encouraged to follow up directly with their brokers at such time.

Additionally, shareholders are reminded of the conference call to discuss the Company's first quarter results to be held on May 9, 2014 at 8:30 a.m. (Toronto time). To access the call live, please dial 416-340-2216 or 1-866-223-7781. Listeners are encouraged to dial in 10 minutes before the call begins to avoid delays. A replay of the conference call will be available until 7:00 p.m. (Toronto time) on Friday, May 16, 2014 by dialing 905-694-9451 or 1-800-408-3053, using access code: 6382379#.

Financial Results for the Three Months Ended March 31, 2014

For the three month period ended March 31, 2014, Trimel incurred Research and Development ("R&D") expenses of US$2.7 million, as compared to US$4.9 million for the comparable 2013 period. Higher R&D expenses for the 2013 first quarter reflected CompleoTRT(TM) expenses associated with the NDA submission in April 2013, a $2.0 million time-based milestone payment which became due on March 31, 2013, and development materials and mould prototypes for CompleoTRT(TM). First quarter 2014 R&D expenses were impacted by higher Tefina(TM) clinical trial costs as this study progressed to its completion in April 2014.

Trimel incurred General and Administrative expenses of US$1.3 million for the three month period ended March 31, 2014, as compared to US$3.4 million for the comparable 2013 period. The decrease in spending was primarily attributable to lower legal fees related to arbitration, corporate and intellectual property matters. The arbitration matters were settled pursuant to a December 21, 2013 agreement.

For the three month period ended March 31, 2014, the Company incurred a net loss of US$0.02 per share, as compared to a net loss of US$0.09 per share for the comparable 2013 period.

At March 31, 2014, the Company had total assets of US$27.2 million, as compared to US$28.1 million at December 31, 2013 and total liabilities of US$8.4 million at March 31, 2014, as compared to US$14.6 million at December 31, 2013. The US$6.2 million decrease in total liabilities was primarily impacted by a US$4.25 million milestone obligation paid to M&P Patent AG, payments related to the Company's debt facility and payments related to the purchase of CompleoTRT(TM) inventory.

The Company had a net cash outflow of US$0.6 million for the three months ended March 31, 2014. After adjusting this net cash outflow for the US$9.5 million private placement and the US$4.25 million milestone payment to M&P Patent AG which was accrued at the end of fiscal 2013 and paid on January 2, 2014, the Company's burn rate during the 2014 first quarter was approximately US$5.85 million, or an average of US$1.95 million per month. The Company believes it has sufficient resources to fund its ongoing activities through 2014, depending on the timing of further clinical activities and barring unforeseen events.

The information set out above is in summary form. Readers are encouraged to review the Company's annual information form, financial statements (and accompanying notes), together with management's discussion and analysis available on SEDAR at www.sedar.com and on the Company's website at www.trimelpharmaceuticals.com.

About Trimel

Trimel is a specialty pharmaceutical company developing medications for male hypogonadism, female sexual dysfunction and various respiratory disorders. An NDA for CompleoTRT(TM), a product utilizing Trimel's licensed bioadhesive intranasal gel technology, has been accepted for review by the FDA for regulatory approval in the United States. For more information, please visit www.trimelpharmaceuticals.com.

Notice regarding forward-looking statements:

Information in this press release that is not current or historical factual information may constitute forward looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the company is subject to a number of risks and uncertainties, including that CompleoTRT(TM) may not be approved by the FDA or that any approval may be delayed, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our annual information form dated March 5, 2014 which is available at www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.

                                                                            
                     TRIMEL PHARMACEUTICALS CORPORATION                     
       CONDENSED INTERIM CONSOLIDATED STATEMENT OF FINANCIAL POSITION       
                            AS AT MARCH 31, 2014                            
                                 UNAUDITED                                  
                        (expressed in U.S. Dollars)                         
                                                                            
                                   ASSETS                                   
                                                  March 31,    December 31, 
                                                       2014            2013 
                                            --------------------------------
                                                                            
CURRENT                                                                     
  Cash                                         $ 17,507,518    $ 18,111,145 
  Restricted cash                                    22,614          23,505 
  Inventory                                       2,179,094       1,913,772 
  Prepaids and other assets                       1,716,208       1,582,924 
                                            --------------------------------
                                                 21,425,434      21,631,346 
                                                                            
NON-CURRENT ASSETS                                                          
  Property and equipment, net                     2,582,675       3,273,196 
  Intangible assets                               3,142,850       3,216,800 
                                            --------------------------------
TOTAL ASSETS                                   $ 27,150,959    $ 28,121,342 
                                            --------------------------------
                                                                            
                                                                            
                                LIABILITIES                                 
                                                                            
CURRENT                                                                     
  Accounts payable and accrued liabilities      $ 4,438,903     $ 9,864,079 
  Current portion of long-term debt, net of                                 
   issuance costs                                 2,846,946       2,834,639 
                                            --------------------------------
                                                  7,285,849      12,698,718 
                                                                            
LONG-TERM                                                                   
  Long-term debt, net of issuance costs           1,092,120       1,827,082 
  Derivative financial instrument                    41,676          20,977 
                                            --------------------------------
TOTAL LIABILITIES                               $ 8,419,645    $ 14,546,777 
                                            --------------------------------
                                                                            
                                                                            
                            SHAREHOLDERS' EQUITY                            
                                                                            
Share capital                                   129,211,443     119,741,040 
Warrants                                          1,039,705       1,039,705 
Contributed surplus                               8,058,386       7,987,237 
Accumulated other comprehensive income                                      
 (loss)                                          (3,445,938)     (1,639,862)
Deficit                                        (116,132,282)   (113,553,555)
                                            --------------------------------
TOTAL SHAREHOLDERS' EQUITY                       18,731,314      13,574,565 
                                            --------------------------------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY     $ 27,150,959    $ 28,121,342 
                                            --------------------------------
                                                                            
                     TRIMEL PHARMACEUTICALS CORPORATION                     
  CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS  
             FOR THE THREE MONTHS ENDED MARCH 31, 2014 AND 2013             
                                 UNAUDITED                                  
                        (expressed in U.S. Dollars)                         
                                                                            
                                                        2014           2013 
                                              ------------------------------
EXPENSES                                                                    
  Research and development                       $ 2,709,961    $ 4,874,417 
  General and administrative                       1,275,065      3,402,311 
                                              ------------------------------
  Total operating expenses                         3,985,026      8,276,728 
                                              ------------------------------
                                                                            
FINANCE COSTS, NET                                                          
  Interest on long-term debt and other                                      
   financing costs                                   176,712        288,655 
  Interest income                                    (19,643)        (4,143)
  Foreign exchange (gain)/ loss                   (1,584,067)         3,370 
  Change in fair value of derivative financial                              
   instrument                                         20,699       (135,967)
                                              ------------------------------
                                                  (1,406,299)       151,915 
                                              ------------------------------
TOTAL EXPENSES                                     2,578,727      8,428,643 
                                              ------------------------------
LOSS BEFORE INCOME TAXES                          (2,578,727)    (8,428,643)
                                                                            
INCOME TAXES                                               -              - 
                                              ------------------------------
NET LOSS                                        $ (2,578,727)  $ (8,428,643)
                                              ------------------------------
                                              ------------------------------
                                                                            
OTHER COMPREHENSIVE LOSS, NET OF INCOME TAX                                 
Items that may be reclassified subsequently to                              
 profit or loss:                                                            
  Foreign currency translation adjustment         (1,806,076)      (126,487)
                                              ------------------------------
TOTAL COMPREHENSIVE LOSS FOR THE PERIOD         $ (4,384,803)  $ (8,555,130)
                                              ------------------------------
                                              ------------------------------
Basic and diluted weighted average shares                                   
 outstanding                                     154,722,955     90,796,762 
                                                                            
Basic and diluted net loss per common share          $ (0.02)       $ (0.09)
                                                                            
                     TRIMEL PHARMACEUTICALS CORPORATION                     
 CONDENSED INTERIM CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
                                 (DEFICIENCY)                               
             FOR THE THREE MONTHS ENDED MARCH 31, 2014 AND 2013             
                                  UNAUDITED                                 
                         (expressed in U.S. Dollars)                        
                                                                            
                                                                 Contributed
                               Share capital        Warrants         surplus
                            ------------------------------------------------
                                                                            
Balance, January 1, 2013        $ 78,214,661     $ 3,452,607     $ 4,318,927
                                                                            
Net loss for the period                    -               -               -
                                                                            
Cumulative translation                                                      
 adjustment                                -               -               -
                                                                            
----------------------------------------------------------------------------
                                                                            
Total comprehensive loss for                                                
 the period                                -               -               -
                                                                            
Share based compensation                   -               -         477,545
----------------------------------------------------------------------------
Balance as at March 31, 2013    $ 78,214,661     $ 3,452,607     $ 4,796,472
----------------------------------------------------------------------------
----------------------------------------------------------------------------
                                                                            
Balance, January 1, 2014       $ 119,741,040     $ 1,039,705     $ 7,987,237
                                                                            
Net loss for the period                    -               -               -
                                                                            
Cumulative translation                                                      
 adjustment                                -               -               -
                                                                            
----------------------------------------------------------------------------
                                                                            
Total comprehensive loss for                                                
 the period                                -               -               -
                                                                            
Common shares, net of share                                                 
 issuance costs                    9,470,403               -               -
                                                                            
Share based compensation                   -               -          71,149
----------------------------------------------------------------------------
Balance as at March 31, 2014   $ 129,211,443     $ 1,039,705     $ 8,058,386
----------------------------------------------------------------------------

                                                                            
                     TRIMEL PHARMACEUTICALS CORPORATION                     
CONDENSED INTERIM CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY 
                                (DEFICIENCY)                                
             FOR THE THREE MONTHS ENDED MARCH 31, 2014 AND 2013             
                                 UNAUDITED                                  
                        (expressed in U.S. Dollars)                         
                                                                            
                                Accumulated                                 
                                      other                                 
                              comprehensive                                 
                                     income                                 
                                     (loss)         Deficit           Total 
                            ------------------------------------------------
                                                                            
Balance, January 1, 2013          $ 362,920   $ (81,598,627)    $ 4,750,488 
                                                                            
Net loss for the period                   -      (8,428,643)     (8,428,643)
                                                                            
Cumulative translation                                                      
 adjustment                        (126,487)              -        (126,487)
                                                                            
----------------------------------------------------------------------------
                                                                            
Total comprehensive loss for                                                
 the period                        (126,487)     (8,428,643)     (8,555,130)
                                                                            
Share based compensation                  -               -         477,545 
----------------------------------------------------------------------------
Balance as at March 31, 2013      $ 236,433   $ (90,027,270)   $ (3,327,097)
----------------------------------------------------------------------------
----------------------------------------------------------------------------
                                                                            
Balance, January 1, 2014       $ (1,639,862) $ (113,553,555)   $ 13,574,565 
                                                                            
Net loss for the period                   -      (2,578,727)     (2,578,727)
                                                                            
Cumulative translation                                                      
 adjustment                      (1,806,076)              -      (1,806,076)
                                                                            
----------------------------------------------------------------------------
                                                                            
Total comprehensive loss for                                                
 the period                      (1,806,076)     (2,578,727)     (4,384,803)
                                                                            
Common shares, net of share                                                 
 issuance costs                           -               -       9,470,403 
                                                                            
Share based compensation                  -               -          71,149 
----------------------------------------------------------------------------
Balance as at March 31, 2014   $ (3,445,938) $ (116,132,282)   $ 18,731,314 
----------------------------------------------------------------------------
                                                                            
                     TRIMEL PHARMACEUTICALS CORPORATION                     
           CONDENSED INTERIM CONSOLIDATED STATEMENT OF CASH FLOWS           
             FOR THE THREE MONTHS ENDED MARCH 31, 2014 AND 2013             
                                 UNAUDITED                                  
                        (expressed in U.S. Dollars)                         
                                                                            
                                                        2014           2013 
                                              ------------------------------
                                                                            
CASH FLOWS FROM OPERATING ACTIVITIES                                        
----------------------------------------------                              
  Net loss for the period                       $ (2,578,727)  $ (8,428,643)
  Items not requiring an outlay of cash:                                    
    Adjustment for foreign exchange                                         
     (gain)/loss                                  (1,250,269)        63,742 
    Amortization of intangible assets                 73,950         73,950 
    Depreciation of property and equipment           635,799        170,414 
    Interest on long-term debt and other                                    
     financing costs                                 176,712        288,655 
    Change in fair value of derivative                                      
     financial instrument                             20,699       (135,967)
    Share based compensation                          71,149        477,545 
  Net changes in non-cash working capital                                   
   items related to operating activities:                                   
    Inventory                                       (265,322)             - 
    Prepaids and other assets                       (137,696)      (158,947)
    Accounts payable and accrued liabilities      (5,404,597)     3,561,219 
  Provisions                                               -         (7,784)
                                              ------------------------------
                                                  (8,658,302)    (4,095,816)
                                              ------------------------------
                                                                            
CASH FLOWS FROM FINANCING ACTIVITIES                                        
----------------------------------------------                              
  Proceeds from issuance of common shares, net                              
   of financing costs                              9,470,403              - 
  Financing costs, long-term debt                    (35,757)             - 
  Payment of long-term debt obligations             (750,000)      (500,000)
  Payment of capital lease obligations                     -       (103,705)
  Interest paid                                      (78,836)      (130,311)
                                              ------------------------------
                                                   8,605,810       (734,016)
                                              ------------------------------
                                                                            
CASH FLOWS FROM INVESTING ACTIVITIES                                        
----------------------------------------------                              
  Acquisition of property and equipment              (27,103)       (34,796)
  Proceeds from sale of property and equipment             -          1,015 
                                              ------------------------------
                                                     (27,103)       (33,781)
                                              ------------------------------
                                                                            
                                                                            
NET DECREASE IN CASH FOR THE PERIOD                  (79,595)    (4,863,613)
                                                                            
Exchange (loss) on cash                             (524,032)      (144,542)
                                                                            
CASH BEGINNING OF PERIOD                          18,111,145      9,216,999 
                                              ------------------------------
                                                                            
CASH END OF PERIOD                              $ 17,507,518    $ 4,208,844 
                                              ------------------------------

Contacts:
Trimel Pharmaceuticals Corporation
Kenneth G. Howling
Chief Financial Officer
416 679 0536
[email protected]

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