SYS-CON MEDIA Authors: Elizabeth White, Pat Romanski, Carmen Gonzalez, Liz McMillan, Kevin Jackson

News Feed Item

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™ 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™, 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™ 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™. First quarter 2014 R&D expenses were impacted by higher Tefina™ 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™ 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™, 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
       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
                                              ------------------------------

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
“DevOps is really about the business. The business is under pressure today, competitively in the marketplace to respond to the expectations of the customer. The business is driving IT and the problem is that IT isn't responding fast enough," explained Mark Levy, Senior Product Marketing Manager at Serena Software, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
15th Cloud Expo, which took place Nov. 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA, expanded the conference content of @ThingsExpo, Big Data Expo, and DevOps Summit to include two developer events. IBM held a Bluemix Developer Playground on November 5 and ElasticBox held a Hackathon on November 6. Both events took place on the expo floor. The Bluemix Developer Playground, for developers of all levels, highlighted the ease of use of Bluemix, its services and functionalit...
In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect at GE, and Ibrahim Gokcen, who leads GE's advanced IoT analytics, focused on the Internet of Things / Industrial Internet and how to make it operational for business end-users. Learn about the challenges posed by machine and sensor data and how to marry it with enterprise data. They also discussed the tips and tricks to provide the Industrial Internet as an end-user consumable service using Big Data Analytics and Industrial C...
SYS-CON Media announced that Splunk, a provider of the leading software platform for real-time Operational Intelligence, has launched an ad campaign on Big Data Journal. Splunk software and cloud services enable organizations to search, monitor, analyze and visualize machine-generated big data coming from websites, applications, servers, networks, sensors and mobile devices. The ads focus on delivering ROI - how improved uptime delivered $6M in annual ROI, improving customer operations by minin...
"SOASTA built the concept of cloud testing in 2008. It's grown from rather meager beginnings to where now we are provisioning hundreds of thousands of servers on a daily basis on behalf of customers around the world to test their applications," explained Tom Lounibos, CEO of SOASTA, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
IBM has announced a new strategic technology services agreement with Anthem, Inc., a health benefits company in the U.S. IBM has been selected to provide operational services for Anthem's mainframe and data center server and storage infrastructure for the next five years. Among the benefits of the relationship, Anthem has the ability to leverage IBM Cloud solutions that will help increase the ease, availability and speed of adding infrastructure to support new business requirements.
Things are being built upon cloud foundations to transform organizations. This CEO Power Panel at 15th Cloud Expo, moderated by Roger Strukhoff, Cloud Expo and @ThingsExpo conference chair, addressed the big issues involving these technologies and, more important, the results they will achieve. Rodney Rogers, chairman and CEO of Virtustream; Brendan O'Brien, co-founder of Aria Systems, Bart Copeland, president and CEO of ActiveState Software; Jim Cowie, chief scientist at Dyn; Dave Wagstaff, VP ...
SYS-CON Media announced today that PagerDuty has launched a popular blog feed on DevOps Journal. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. DevOps Journal brings valuable information to DevOps professionals who are transforming the way enterprise IT is done.
SYS-CON Media announced that Cisco, a worldwide leader in IT that helps companies seize the opportunities of tomorrow, has launched a new ad campaign in Cloud Computing Journal. The ad campaign, a webcast titled 'Is Your Data Center Ready for the Application Economy?', focuses on the latest data center networking technologies, including SDN or ACI, and how customers are using SDN and ACI in their organizations to achieve business agility. The Cisco webcast is available on-demand.
“The year of the cloud – we have no idea when it's really happening but we think it's happening now. For those technology providers like Zentera that are helping enterprises move to the cloud - it's been fun to watch," noted Mike Loftus, VP Product Management and Marketing at Zentera Systems, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Today’s enterprise is being driven by disruptive competitive and human capital requirements to provide enterprise application access through not only desktops, but also mobile devices. To retrofit existing programs across all these devices using traditional programming methods is very costly and time consuming – often prohibitively so. In his session at @ThingsExpo, Jesse Shiah, CEO, President, and Co-Founder of AgilePoint Inc., discussed how you can create applications that run on all mobile ...
The Industrial Internet revolution is now underway, enabled by connected machines and billions of devices that communicate and collaborate. The massive amounts of Big Data requiring real-time analysis is flooding legacy IT systems and giving way to cloud environments that can handle the unpredictable workloads. Yet many barriers remain until we can fully realize the opportunities and benefits from the convergence of machines and devices with Big Data and the cloud, including interoperability, ...
Companies today struggle to manage the types and volume of data their customers and employees generate and use every day. With billions of requests daily, operational consistency can be elusive. In his session at Big Data Expo, Dave McCrory, CTO at Basho Technologies, will explore how a distributed systems solution, such as NoSQL, can give organizations the consistency and availability necessary to succeed with on-demand data, offering high availability at massive scale.
IoT is still a vague buzzword for many people. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed the business value of IoT that goes far beyond the general public's perception that IoT is all about wearables and home consumer services. He also discussed how IoT is perceived by investors and how venture capitalist access this space. Other topics discussed were barriers to success, what is new, what is old, and what th...
The Internet of Things (IoT) is rapidly in the process of breaking from its heretofore relatively obscure enterprise applications (such as plant floor control and supply chain management) and going mainstream into the consumer space. More and more creative folks are interconnecting everyday products such as household items, mobile devices, appliances and cars, and unleashing new and imaginative scenarios. We are seeing a lot of excitement around applications in home automation, personal fitness,...