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Trimel Reports Fourth Quarter and Full Year 2013 Financial Results

TORONTO, ONTARIO -- (Marketwired) -- 03/05/14 -- Trimel Pharmaceuticals Corporation (TSX: TRL) today provided an overview of its corporate accomplishments and reported financial results for the three and twelve month periods ended December 31, 2013.

2013 Corporate Accomplishments

During 2013, numerous accomplishments were achieved in the advancement of Trimel's business. The Company successfully raised gross proceeds of $46 million in connection with its April 2013 offering which also allowed for an expansion of its shareholder base. The Company's first New Drug Application, for the novel male testosterone replacement therapy CompleoTRT™, was filed with the U.S. Food and Drug Administration in April 2013. The independence and expertise of the Board of Directors was strengthened with the addition of Dr. Lorne Tyrrell, Mr. Matthew Pfeffer, and Mr. Ian Ihnatowycz as directors. The Company re-negotiated its agreement with M&P Patent AG which resolved certain matters in dispute, strengthened the relationship, and provided non-exclusive rights in important commercial markets Trimel previously did not have access to. Lastly, Trimel also saw the completion of the enrolment phase for the Phase II clinical trial for Tefina™, a product being developed for the treatment of Female Orgasmic Disorder which is estimated to effect up to one in five women worldwide.

Financial Results for the Three and Twelve Months Ended December 31, 2013

For the three and twelve month periods ended December 31, 2013, Trimel incurred Research and Development ("R&D") expenses of US$8.9 million and US$22.7 million respectively as compared to US$4.1 million and US$17.2 million for the comparable 2012 periods. The increase in R&D expenses for the three and twelve month periods ended December 31, 2013 versus the comparable 2012 periods reflects the favourable settlement of arbitration matters with a technology partner during the fourth quarter or 2013 for $4.25 million.

Trimel incurred General and Administrative expenses of US$2.3 million and US$9.9 million for the three and twelve month periods ended December 31, 2013 respectively as compared to US$3.0 million and US$10.1 million for the comparable 2012 periods. The decrease in expense for the three month period ended December 31, 2013, as compared to the same 2012 period, is primarily attributable to lower share based compensation. The decrease in expense for the twelve month period ended December 31, 2013, as compared to the equivalent 2012 period, is primarily attributable to lower share based compensation expense offset partially by higher professional fees associated with arbitration matters that were resolved during 2013.

For the three and twelve month periods ended December 31, 2013, the Company incurred a net loss of US$0.07 and US$0.25 per share respectively, as compared to US$0.09 and US$0.32 per share for the comparable 2012 periods.

As at December 31, 2013, the Company had total assets of US$28.1 million as compared to US$16.9 million at December 31, 2012 and total liabilities of US$14.5 million at December 31, 2013 as compared to US$12.2 million at December 31, 2012. The Company's average monthly burn rate during the 2013 fourth quarter was approximately $2.0 million.

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™, 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™ 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
                CONSOLIDATED STATEMENT OF FINANCIAL POSITION
                      AS AT DECEMBER 31, 2013 AND 2012
                        (expressed in U.S. Dollars)

                                   ASSETS

                                                     2013              2012
                                         ----------------- -----------------

CURRENT
 Cash                                    $     18,111,145  $      9,216,999
 Restricted cash                                   23,505            25,128
 Inventory                                      1,913,772                 -
 Prepaids and other assets                      1,582,924         1,095,256
                                         ----------------- -----------------
                                               21,631,346        10,337,383

NON-CURRENT ASSETS
 Property and equipment, net                    3,273,196         3,026,160
 Intangible assets                              3,216,800         3,562,600
                                         ----------------- -----------------
TOTAL ASSETS                             $     28,121,342  $     16,926,143
                                         ----------------- -----------------


                                LIABILITIES

CURRENT
 Accounts payable and accrued
  liabilities                            $      9,864,079  $      4,844,608
 Current portion of capital lease
  obligation                                            -           140,551
 Current portion of long-term debt, net
  of issuance costs                             2,834,639         2,425,562
                                         ----------------- -----------------
                                               12,698,718         7,410,721

LONG-TERM
 Long-term debt, net of issuance costs          1,827,082         4,561,686
 Derivative financial instrument                   20,977           203,248
                                         ----------------- -----------------
TOTAL LIABILITIES                        $     14,546,777  $     12,175,655
                                         ----------------- -----------------


                            SHAREHOLDERS' EQUITY

Share capital                                 119,741,040        78,214,661
Warrants                                        1,039,705         3,452,607
Contributed surplus                             7,987,237         4,318,927
Accumulated other comprehensive income
 (loss)                                        (1,639,862)          362,920
Deficit                                      (113,553,555)      (81,598,627)
                                         ----------------- -----------------
TOTAL SHAREHOLDERS' EQUITY                     13,574,565         4,750,488
                                         ----------------- -----------------
TOTAL LIABILITIES AND SHAREHOLDERS'
 EQUITY                                  $     28,121,342  $     16,926,143
                                         ----------------- -----------------


                     TRIMEL PHARMACEUTICALS CORPORATION
           CONSOLIDATED STATEMENT OF LOSS AND COMPREHENSIVE LOSS
               FOR THE YEARS ENDED DECEMBER 31, 2013 AND 2012
                        (expressed in U.S. Dollars)

                                            For the year ended December 31,
                                                     2013              2012
                                         ----------------- -----------------
EXPENSES
 Research and development                $     22,680,609  $     17,240,969
 General and administrative                     9,896,688        10,147,650
                                         ----------------- -----------------
 Total operating expenses                      32,577,297        27,388,619

FINANCE COSTS, NET
 Interest on long-term debt and other
  financing costs                               1,112,912           635,247
 Interest income                                 (116,289)          (14,060)
 Foreign exchange loss/(gain)                  (1,116,721)           30,730
 Change in fair value of derivative
  financial instrument                           (182,271)           94,158
                                         ----------------- -----------------
                                                 (302,369)          746,075
                                         ----------------- -----------------
TOTAL EXPENSES                                 32,274,928        28,134,694
                                         ----------------- -----------------
LOSS BEFORE INCOME TAXES                      (32,274,928)      (28,134,694)

(RECOVERY OF) INCOME TAXES
 Current                                                -           (53,036)
 Deferred                                        (320,000)          (57,945)
                                         ----------------- -----------------
                                                 (320,000)         (110,981)
                                         ----------------- -----------------
NET LOSS                                 $    (31,954,928) $    (28,023,713)
                                         ----------------- -----------------
                                         ----------------- -----------------

OTHER COMPREHENSIVE LOSS, NET OF INCOME
 TAX
Items that may be reclassified
 subsequently to profit or loss:
 Foreign currency translation adjustment       (2,002,782)          284,238
                                         ----------------- -----------------
TOTAL COMPREHENSIVE LOSS                 $    (33,957,710) $    (27,739,475)
                                         ----------------- -----------------
                                         ----------------- -----------------
Basic and Diluted Weighted Average
 Shares Outstanding                           130,351,557        86,663,082

Basic and Diluted Net Loss per Common
 Share                                   $          (0.25) $          (0.32)


                     TRIMEL PHARMACEUTICALS CORPORATION
          CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
               FOR THE YEARS ENDED DECEMBER 31, 2013 AND 2012
                         (expressed in U.S. Dollars)
                                                                 Contributed
                              Share capital        Warrants          surplus
                            --------------- ---------------- ---------------
                            --------------- ---------------- ---------------

Balance, January 1, 2012     $   67,430,241  $    2,413,367   $    1,610,972

Net loss for the year                     -               -                -

Cumulative translation
 adjustment                               -               -                -

----------------------------------------------------------------------------

Total comprehensive loss
 for the year                             -               -                -

Units, net of issuance
 costs                           10,728,722       1,002,882                -

Broker warrants issued as
 part of long-term debt                   -          36,823                -

Conversion of warrants                5,698            (465)               -

Conversion of options                50,000               -                -

Share based compensation                  -               -        2,707,955
----------------------------------------------------------------------------
Balance as at December 31,
 2012                        $   78,214,661  $    3,452,607   $    4,318,927
----------------------------------------------------------------------------
----------------------------------------------------------------------------

Balance, January 1, 2013     $   78,214,661  $    3,452,607   $    4,318,927

Net loss for the year                     -               -                -

Cumulative translation
 adjustment                               -               -                -

----------------------------------------------------------------------------

Total comprehensive loss
 for the year                             -               -                -

Common shares, net of share
 issuance costs                  41,526,379               -                -

Warrant expiry, net of tax                -      (2,412,902)       2,092,902

Share based compensation                  -               -        1,575,408
----------------------------------------------------------------------------
Balance as at December 31,
 2013                        $  119,741,040  $    1,039,705   $    7,987,237
----------------------------------------------------------------------------
----------------------------------------------------------------------------


                               Accumulated
                                     other
                             comprehensive
                             income (loss)         Deficit            Total
                            --------------- --------------- ----------------
                            --------------- --------------- ----------------

Balance, January 1, 2012     $      78,682  $  (53,574,914)  $   17,958,348

Net loss for the year                    -     (28,023,713)     (28,023,713)

Cumulative translation
 adjustment                        284,238               -          284,238

----------------------------------------------------------------------------

Total comprehensive loss
 for the year                      284,238     (28,023,713)     (27,739,475)

Units, net of issuance
 costs                                   -               -       11,731,604

Broker warrants issued as
 part of long-term debt                  -               -           36,823

Conversion of warrants                   -               -            5,233

Conversion of options                    -               -           50,000

Share based compensation                 -               -        2,707,955
----------------------------------------------------------------------------
Balance as at December 31,
 2012                        $     362,920  $  (81,598,627)  $    4,750,488
----------------------------------------------------------------------------
----------------------------------------------------------------------------

Balance, January 1, 2013     $     362,920  $  (81,598,627)  $    4,750,488

Net loss for the year                    -     (31,954,928)     (31,954,928)

Cumulative translation
 adjustment                     (2,002,782)              -       (2,002,782)

----------------------------------------------------------------------------

Total comprehensive loss
 for the year                   (2,002,782)    (31,954,928)     (33,957,710)

Common shares, net of share
 issuance costs                          -               -       41,526,379

Warrant expiry, net of tax               -               -         (320,000)

Share based compensation                 -               -        1,575,408
----------------------------------------------------------------------------
Balance as at December 31,
 2013                        $  (1,639,862) $ (113,553,555)  $   13,574,565
----------------------------------------------------------------------------
----------------------------------------------------------------------------


                     TRIMEL PHARMACEUTICALS CORPORATION
                    CONSOLIDATED STATEMENT OF CASH FLOWS
               FOR THE YEARS ENDED DECEMBER 31, 2013 AND 2012
                        (expressed in U.S. Dollars)

                                                       2013            2012
                                             --------------- ---------------

CASH FLOWS FROM OPERATING ACTIVITIES
--------------------------------------------
Net loss for the year                        $  (31,954,928) $  (28,023,713)
Items not requiring an outlay of cash:
 Adjustment for foreign exchange (gain)/loss     (1,148,602)        210,078
 Amortization of intangible assets                  295,800         295,800
 Depreciation of property and equipment             870,705         687,889
 Interest on long-term debt and other
  financing costs                                 1,112,912         635,247
 Change in fair value of derivative
  financial instrument                             (182,271)         94,158
 Share based compensation                         1,575,408       2,707,955
 Intangible asset write-off                          50,000               -
 Loss on disposal of property and equipment          49,331               -
 Deferred income tax liability                            -         (57,898)
 Recovery of deferred income tax                   (320,000)              -
 Income tax provision                                     -         (53,036)
Net changes in non-cash working capital
 items related to operating activities:
 Inventory                                       (1,913,772)              -
 Prepaids and other assets                         (977,790)       (734,228)
 Accounts payable and accrued liabilities         5,069,637       1,108,512
Income taxes received (paid)                              -         (22,876)
                                             --------------- ---------------
                                                (27,473,570)    (23,152,112)
                                             --------------- ---------------

CASH FLOWS FROM FINANCING ACTIVITIES
--------------------------------------------
Proceeds from issuance of common shares and
 warrants, net of financing costs                41,526,379      11,731,604
Proceeds from long-term debt financing, net
 of financing costs                                       -       6,914,379
Proceeds from exercise of warrants                        -           5,233
Proceeds from exercise of options                         -          50,000
Payment of long-term debt obligations            (2,750,000)              -
Payment of capital lease obligations               (136,451)       (400,669)
Interest paid                                      (643,025)       (346,419)
                                             --------------- ---------------
                                                 37,996,903      17,954,128
                                             --------------- ---------------

CASH FLOWS FROM INVESTING ACTIVITIES
--------------------------------------------
Acquisition of property and equipment              (891,575)       (136,941)
Proceeds from sale of property and equipment          3,219           2,833
Restricted cash                                           -         (25,128)
                                             --------------- ---------------
                                                   (888,356)       (159,236)
                                             --------------- ---------------


NET INCREASE/(DECREASE) IN CASH FOR THE YEAR     10,783,580      (5,567,298)

Exchange (loss)/gain on cash                       (740,831)         45,594

CASH BEGINNING OF YEAR                            9,216,999      14,528,625
                                             --------------- ---------------

CASH END OF YEAR                             $   18,111,145  $    9,216,999
                                             --------------- ---------------

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