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Marketwired
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Trimel Pharmaceuticals Corporation Announces Second Quarter Highlights and Financial Results / FDA Confirms CompleoTRT PDUFA Date of February 28, 2014 - Tefina Phase II Trial Achieves 50% Enrolment

TORONTO, ONTARIO -- (Marketwired) -- 07/31/13 -- Trimel Pharmaceuticals Corporation (TSX: TRL) today reported its financial results for the three and six month periods ended June 30, 2013.

Management of the Company will host a conference call to discuss these results and update investors on the status of its business on Thursday, August 1, 2013, at 8:30 a.m. Eastern Daylight Time. The conference call details can be found at the end of the press release.

Financial Results for the Three and Six Months Ended June 30, 2013 (All values in U.S. dollars)

For the three and six month period ended June 30, 2013, Trimel incurred Research and Development ("R&D") expenses of $6.8 million and $11.8 million respectively, as compared to $5.0 million and $9.4 million for the same periods in 2012. The increase in R&D spending for the six month period ended June 30, 2013 relates primarily to the costs incurred for the preparation and filing of the CompleoTRT™ New Drug Application ("NDA") with the United States Food and Drug Administration ("FDA"), milestones paid related to CompleoTRT™ and Tefina™, as well as the costs associated with the Company's ongoing Tefina™ Phase II clinical trial.

Trimel incurred General and Administrative expenses of $2.4 million and $5.8 million for the three and six month periods ended June 30, 2013, as compared to $2.5 million and $4.5 million for the comparable 2012 periods. The increase in spending for the first six months of 2013 as compared to spending levels for the same 2012 period was largely attributable to legal and professional fees related to arbitration matters, intellectual property and public company costs partially offset by the decrease in general and administrative share based compensation.

For the three and six month periods ended June 30, 2013, the Company incurred a net loss of $0.07 and $0.16 per share respectively, as compared to a net loss of $0.09 and $0.17 per share for the comparable 2012 periods.

As at June 30, 2013, the Company had total assets of $39.4 million, as compared to $11.8 million at March 31, 2013 and total liabilities of $11.2 million at June 30, 2013, as compared to $15.1 million at March 31, 2013.

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

Recent Developments

FDA Acceptance of CompleoTRT™ New Drug Application

On July 9, 2013, the Company announced that the FDA had formally accepted the Company's NDA for review. The FDA confirmed that under the United States Prescription Drug User Fee Act, the NDA will be subject to a standard review and that the target action date for the NDA is February 28, 2014.

Tefina™ - Phase II Ambulatory Study Enrolment Update

In an effort to further the enrolment in the ongoing Tefina™ phase II ambulatory trial, the Company recently expanded the cohort of active clinical sites in the United States, Canada and Australia to a total of 40. In total, 120 patients have been randomized to a treatment or placebo arm and 53 patients have now completed the study.

The Tefina™ phase II study is being conducted as an ambulatory trial and has an expected enrolment of 240 women experiencing orgasmic disorder. As part of this double-blinded, placebo-controlled study, patients will administer Tefina™ or placebo at their homes instead of a hospital setting. The primary efficacy endpoint of this ambulatory trial is the number of orgasms following administration of the three different dosage strengths of Tefina™ compared to placebo over the treatment period. Trial completion is expected in the first half of 2014, however the Company may, in accordance with the study protocol, elect to conduct an interim analysis when approximately 50% of patients have completed the study, which is expected to be reached in late 2013.

Conference Call Details

To access the call live, please dial 416-340-2216 (Toronto), 1-866-226-1792 (Canada and U.S.) or 00-800-9559-6849 (International). 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. Eastern Daylight Time on Thursday, August 8, 2013 by dialing 905-694-9451 (Toronto), 1-800-408-3053 (Canada and U.S.) or 00-800-3366-3052 (International), using access code: 3086288#.

About Trimel

Trimel is a specialty pharmaceutical company actively developing medications for male hypogonadism, female sexual dysfunction and various respiratory disorders. A New Drug Application for CompleoTRT™, a product using Trimel's licensed bioadhesive intranasal 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 whether the Company will be successful in obtaining FDA approval of CompleoTRT™, 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 24, 2013 and prospectus dated April 18, 2013 which are 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 JUNE 30, 2013
                                 UNAUDITED
                        (expressed in U.S. Dollars)



                                     ASSETS
                                                    June 30,   December 31,
                                                        2013           2012
                                               -------------- --------------

CURRENT
 Cash                                          $  30,314,399  $   9,216,999
 Other receivables                                    35,547         72,209
 Prepaids and other assets                         2,938,659      1,023,047
                                               -------------- --------------
                                                  33,288,605     10,312,255

NON-CURRENT ASSETS
 Restricted cash                                      23,769         25,128
 Property and equipment, net                       2,693,427      3,026,160
 Intangible assets                                 3,414,700      3,562,600
                                               -------------- --------------
TOTAL ASSETS                                   $  39,420,501  $  16,926,143
                                               -------------- --------------


                                  LIABILITIES

CURRENT
 Accounts payable and accrued
  liabilities                                  $   5,157,941  $   4,802,114
 Provisions                                                -         42,494
 Current portion of capital
  lease obligation                                         -        140,551
 Current portion of long-term
  debt, net of issuance costs                      2,754,447      2,425,562
                                               -------------- --------------
                                                   7,912,388      7,410,721

LONG-TERM
 Long-term debt, net of issuance
  costs                                            3,263,525      4,561,686
 Derivative financial instrument                      56,334        203,248
                                               -------------- --------------
TOTAL LIABILITIES                              $  11,232,247  $  12,175,655
                                               -------------- --------------


                                 SHAREHOLDERS'
                                     EQUITY

Share capital                                    119,741,040     78,214,661
Warrants                                           3,452,607      3,452,607
Contributed surplus                                5,319,483      4,318,927
Accumulated other comprehensive
 income (loss)                                    (1,167,354)       362,920
Deficit                                          (99,157,522)   (81,598,627)
                                               -------------- --------------
TOTAL SHAREHOLDERS' EQUITY                        28,188,254      4,750,488
                                               -------------- --------------
TOTAL LIABILITIES AND
 SHAREHOLDERS' EQUITY                          $  39,420,501  $  16,926,143
                                               -------------- --------------


                     TRIMEL PHARMACEUTICALS CORPORATION
  CONDENSED INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
         FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2013 AND 2012
                                 UNAUDITED
                        (expressed in U.S. Dollars)

                     For the three months ended   For the six months ended
                              June 30,                    June 30,
                             2013          2012          2013          2012
                     ------------- ------------- ------------- -------------
EXPENSES
 Research and
  development        $  6,843,728  $  5,003,412  $ 11,792,337  $  9,401,986
 General and
  administrative        2,436,094     2,465,292     5,764,213    4,502,6161
                     ------------- ------------- ------------- -------------
 Total operating
  expenses              9,279,822     7,468,704    17,556,550    13,904,602
                     ------------- ------------- ------------- -------------

FINANCE COSTS, NET
 Interest on long-
  term debt and
  other financing
  costs                   369,723         8,510       658,378        18,194
 Interest income          (36,940)       (3,352)      (41,083)       (5,743)
 Foreign exchange
  gain                   (471,406)      (25,404)     (468,036)      (44,134)
 Change in fair
  value of
  derivative
  financial
  instrument              (10,947)            -      (146,914)            -
                     ------------- ------------- ------------- -------------
                         (149,570)      (20,246)        2,345       (31,683)
                     ------------- ------------- ------------- -------------

TOTAL EXPENSES          9,130,252     7,448,458    17,558,895    13,872,919
                     ------------- ------------- ------------- -------------
LOSS BEFORE INCOME
 TAXES                 (9,130,252)   (7,448,458)  (17,558,895)  (13,872,919)

PROVISION FOR
 (RECOVERY OF)
 INCOME TAXES
 Current                        -       (52,714)            -       (52,714)
 Deferred                       -           258             -       (57,593)
                     ------------- ------------- ------------- -------------
                                -       (52,456)            -      (110,307)
                     ------------- ------------- ------------- -------------

NET LOSS             $ (9,130,252) $ (7,396,002) $(17,558,895) $(13,762,612)
                     ------------- ------------- ------------- -------------
                     ------------- ------------- ------------- -------------

OTHER COMPREHENSIVE
 LOSS, NET OF INCOME
 TAX
Items that may be
 reclassified
 subsequently to
 profit or loss:
 Foreign currency
  translation
  adjustment           (1,403,787)      (70,352)   (1,530,274)      (39,461)
                     ------------- ------------- ------------- -------------

TOTAL COMPREHENSIVE
 LOSS FOR THE PERIOD $(10,534,039) $ (7,466,354) $(19,089,169) $(13,802,073)
                     ------------- ------------- ------------- -------------
                     ------------- ------------- ------------- -------------

Basic and Diluted
 Weighted Average
 Shares Outstanding   132,555,004    83,151,680   112,108,917    83,141,926

Basic and Diluted
 Net Loss per Common
 Share               $      (0.07) $      (0.09) $      (0.16) $      (0.17)


                     TRIMEL PHARMACEUTICALS CORPORATION
CONDENSED INTERIM CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
              FOR THE SIX MONTHS ENDED JUNE 30, 2013 AND 2012
                                 UNAUDITED
                        (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 period                     -             -              -

Cumulative translation
 adjustment                                 -             -              -

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

Total comprehensive loss for
 the period                                 -             -              -

Conversion of warrants                  5,698          (465)             -

Conversion of options                  50,000             -              -

Share based compensation                    -             -      1,186,874

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

Balance as at June 30, 2012     $  67,485,939 $   2,412,902  $   2,797,846
--------------------------------------------------------------------------
--------------------------------------------------------------------------

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                                 -             -              -

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

Share based compensation                    -             -      1,000,556

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

Balance as at June 30, 2013     $ 119,741,040 $   3,452,607  $   5,319,483
--------------------------------------------------------------------------
--------------------------------------------------------------------------


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

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

Net loss for the period                     -    (13,762,612)   (13,762,612)

Cumulative translation
 adjustment                           (39,461)             -        (39,461)

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

Total comprehensive loss for
 the period                           (39,461)   (13,762,612)   (13,802,073)

Conversion of warrants                      -              -          5,233

Conversion of options                       -              -         50,000

Share based compensation                    -              -      1,186,874

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

Balance as at June 30, 2012     $      39,221  $ (67,337,526) $   5,398,382
----------------------------------------------------------------------------
----------------------------------------------------------------------------

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

Net loss for the period                     -    (17,558,895)   (17,558,895)

Cumulative translation
 adjustment                        (1,530,274)             -     (1,530,274)

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

Total comprehensive loss for
 the period                        (1,530,274)   (17,558,895)   (19,089,169)

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

Share based compensation                    -              -      1,000,556

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

Balance as at June 30, 2013     $  (1,167,354) $ (99,157,522) $  28,188,254
----------------------------------------------------------------------------
----------------------------------------------------------------------------


                     TRIMEL PHARMACEUTICALS CORPORATION
           CONDENSED INTERIM CONSOLIDATED STATEMENT OF CASH FLOWS
              FOR THE SIX MONTHS ENDED JUNE 30, 2013 AND 2012
                                 UNAUDITED
                        (expressed in U.S. Dollars)



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

CASH FLOWS FROM OPERATING ACTIVITIES
-------------------------------------------
Net loss for the period                        $ (17,558,895) $ (13,762,612)
Items not requiring an outlay of cash:
 Amortization of intangible assets                   147,900        147,900
 Depreciation of property and equipment              412,561        351,262
 Interest on long-term debt and other
  financing costs                                    658,378         18,194
 Change in fair value of derivative
  financial instrument                              (146,914)             -
 Share based compensation                          1,000,556      1,186,874
 Loss on property and equipment                        9,338              -
 Deferred income tax liability                             -        (56,301)
 Income tax provision                                      -        (52,851)
 Other                                                     -         29,917
Net changes in non-cash working capital
 items related to operating activities:
 Other receivables                                    35,275       (122,312)
 Accounts payable and accrued liabilities            383,458      2,997,466
 Prepaids and other assets                        (1,961,275)      (439,650)
Provisions                                           (41,620)      (352,149)
                                               -------------- --------------
                                                 (17,061,238)   (10,054,262)
                                               -------------- --------------

CASH FLOWS FROM FINANCING ACTIVITIES
-------------------------------------------
Proceeds from issuance of common shares,
 net of financing costs                           41,526,379         55,233
Payment of long-term debt obligations             (1,250,000)             -
Payment of capital lease obligations                (140,551)      (189,821)
Interest paid                                       (319,602)       (18,194)
                                               -------------- --------------
                                                  39,816,226       (152,782)
                                               -------------- --------------

CASH FLOWS FROM INVESTING ACTIVITIES
-------------------------------------------
Acquisition of property and equipment               (245,611)      (119,497)
Proceeds from sale of fixed assets                     2,812              -
                                               -------------- --------------
                                                    (242,799)      (119,497)
                                               -------------- --------------


NET INCREASE (DECREASE) IN CASH FOR THE
 PERIOD                                           22,512,189    (10,326,541)

Exchange loss on cash                             (1,414,789)        (2,947)

CASH, BEGINNING OF THE PERIOD                      9,216,999     14,528,625
                                               -------------- --------------

CASH, END OF THE PERIOD                        $  30,314,399  $   4,199,137
                                               -------------- --------------

Contacts:
Trimel Pharmaceuticals Corporation
Kenneth G. Howling
Chief Financial Officer
416 679 0536
ir@trimelpharmaceuticals.com

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