Trimel Pharmaceuticals Corporation Provides Third Quarter Financial Results and Update
- Ending Cash Balance at September 30, 2013 Totalled $24 Million - Third Quarter 2013 Average Monthly Burn Rate Totalled $2.1 Million - Tefina(TM) Phase II Enrollment Level Surpasses 75%
(firmenpresse) - TORONTO, CANADA -- (Marketwired) -- 11/03/13 -- Trimel Pharmaceuticals Corporation (TSX: TRL) today reported its financial results for the three and nine month periods ended September 30, 2013.
Management of the Company will host a conference on Monday November 4, 2013 at 8:30 a.m. Eastern Standard Time call to discuss these results and update investors on the status of its business. The conference call details can be found at the end of the press release.
Financial Results for the Three and Nine Months Ended September 30, 2013 (all values in U.S. dollars)
For the three and nine month period ended September 30, 2013, Trimel incurred Research and Development ("R&D") expenses of $2.0 million and $13.8 million respectively, as compared to $3.7 million and $13.1 million for the same periods in 2012. During the first nine months of 2013, the Company incurred the following significant R&D expense items: $2.0 million NDA application fee for CompleoTRT™ (Q2), $2.0 million milestone payment related to the filing of the CompleoTRT™ NDA (Q2), and a $2.25 million expense pertaining to the settlement of a Tefina™ arbitration matter (Q2). The increase in R&D spending for the nine month period ended September 30, 2013 as compared to the same period in 2012 relates primarily to the items mentioned above partially offset by a lower level of ongoing R&D spending largely attributable to the completion of the CompleoTRT™ Phase III clinical trial at the end of 2012.
Trimel incurred General and Administrative expenses of $1.9 million and $7.6 million for the three and nine month periods ended September 30, 2013, respectively, as compared to $2.6 million and $7.1 million for the comparable 2012 periods. The increase in spending for the first nine months of 2013 as compared to spending levels for the same 2012 period was largely attributable to increased legal, professional services and administrative costs for activities resulting from arbitration and intellectual property matters.
For the three and nine month periods ended September 30, 2013, the Company incurred a net loss of $0.03 and $0.18 per share, respectively, as compared to a net loss of $0.07 and $0.24 per share for the comparable 2012 periods.
As at September 30, 2013, the Company had total assets of $33.1 million, including $24.0 million in cash, as compared to total assets of $39.4 million at June 30, 2013 and total liabilities of $8.3 million at September 30, 2013, as compared to $11.2 million at June 30, 2013.
Trimel's 2013 third quarter cash requirements totalled $6.3 million, reflecting an average monthly cash burn rate of $2.1 million per month. Excluding a $2.25 million milestone payment expensed in the second quarter and made during the third quarter to a technology partner, Trimel's 2013 third quarter cash requirement was $4.05 million, reflecting an average monthly cash burn rate of $1.4 million per month. During the nine month period ended September 30, 2013, the Company had negative cash flow from operations of $23.4 million. Excluding the $2.0 million NDA application fee for CompleoTRT™, a $2.0 million milestone payment related to the filing of the CompleoTRT™ NDA and the $2.25 million payment pertaining to the settlement of a Tefina™ arbitration matter, Trimel's negative cash flow from operations for the nine months ended September 30, 2013 was $17.2 million, reflecting a nine month cash burn rate average of $1.9 million per month.
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 to be available on SEDAR at .
Recent Developments
Tefina™ - Phase II Ambulatory (AMB) Study Enrollment Update
The currently ongoing Tefina™ Phase II study has an expected enrollment of 240 adult women experiencing acquired orgasmic disorder, defined as absence of orgasm during the past six months and according to the Diagnostic and Statistical Manual of Mental Disorders IV criteria. As part of this randomized, placebo-controlled, double-blind, parallel-group, dose-finding trial, patients will be randomized to either one of three strengths of Tefina™ or placebo, and instructed to administer the intranasal gel two to eight hours prior to a planned sexual event.
The primary efficacy endpoint of this trial is to compare the number of orgasms following administration of the three different dosage strengths of Tefina™ compared to placebo over the entire treatment period. Secondary objectives involve the assessment of the three dose strengths of Tefina™ compared to placebo for changes in sexual event satisfaction, sexual function and distress level due to orgasmic disorder over a 28-day period compared to baseline.
Over the past few months, Trimel has expanded the cohort of active clinical sites from 32 to 48 and implemented a number of patient recruitment initiatives. The impact of these activities has been an increase in patient enrollment. As of October 28, 2013, the Tefina™ study had 183 patients randomized, which is over 75% of the anticipated study sample of 240 patients. 98 patients have now completed the study.
The Company included the option for an interim data analysis in the Tefina™ Phase II study protocol. This analysis could be conducted for futility purposes when 50% of subjects (120) had completed the study. The objective of this analysis is to determine if any of the active treatment arms outperformed the placebo arm for the primary efficacy variable. Based on this assessment, the Company could then determine whether it was advisable to continue to enroll patients in the study.
Given the current recruitment levels for the Tefina™ Phase II trial, Trimel anticipates enrolling the full study cohort in December 2013, which is approximately the same time as the aforementioned futility analysis results would otherwise be available. Therefore, under these circumstances, Trimel does not intend to conduct such analysis given the limited value it would provide. Trimel expects to receive top-line data from the full patient cohort following completion of the study in the first half of 2014.
CompleoTRT™ NDA Review Update
On October 24, 2013, Trimel provided an update on the progress of the CompleoTRT™ NDA. As part of the FDA's review of the NDA, Trimel received a mid-cycle review information request from the FDA asking for clarification of several points relating to the dosing arms in the CompleoTRT™ Phase III study and the utilization of certain data from such dosing arms to support the proposed product label. In particular, the FDA requested an explanation regarding the relative performance of those patients that commenced treatment using a twice-a-day dose and were titrated to a three-times-a-day dose in accordance with the proposed titration scheme.
Trimel will pursue the NDA in its current form, and following consultation with its external experts, submitted a response to the FDA on November 1, 2013. The Company remains committed to the commercialization of CompleoTRT™ and will continue to work with the FDA towards obtaining approval.
For further information, please refer to the press release issued by the Company on October 24, 2013 titled "Trimel Announces Update Regarding CompleoTRT™ FDA Review" available on SEDAR at .
Conference Call Details
To access the call live, please dial 416-340-2216 (Toronto), 1-866-223-7781 (Canada and U.S.) or 00-800-6578-9898 (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 Standard Time on Monday November 11, 2013 by dialing 905-694-9451 (Toronto), 1-800-408-3053 (Canada and U.S.) or 00-800-3366-3052 (International), using access code: 5944011#.
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 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 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: 04.11.2013 - 01:00 Uhr
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