Trimel Pharmaceuticals Corporation Announces Second Quarter Highlights and Financial Results
- FDA Confirms CompleoTRT(TM) PDUFA Date of February 28, 2014 - Tefina(TM) Phase II Trial Achieves 50% Enrolment
(firmenpresse) - 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 .
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
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 . 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.
Contacts:
Trimel Pharmaceuticals Corporation
Kenneth G. Howling
Chief Financial Officer
416 679 0536
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Datum: 31.07.2013 - 21:32 Uhr
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News-ID 283658
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