Marketwire - Canada
TORONTO, ONTARIO--(Marketwire - Aug. 7, 2012) - Trimel Pharmaceuticals Corporation (TSX:TRL) ("Trimel or "the Company") today reported its financial results for the three and six month periods ended June 30, 2012. The Company also provided investors today with an update on the status of its product development programs.
Management of the Company will host a conference call to discuss these results and update investors on the status of its business on Wednesday, August 8, 2012, at 8:30 a.m. Eastern Daylight Time. Presenting from Trimel will be Bruce Brydon, Chairman of the Board and Chief Executive Officer, Tom Rossi, President and Chief Operating Officer and Kenneth Howling, Chief Financial Officer. 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, 2012
For the three and six month periods ended June 30, 2012, Trimel incurred Research and Development expenses ("R&D") of US$4.8 million and US$9.1 million respectively as compared to US$2.9 million and US$4.7 million for the comparable 2011 periods. The increase in R&D spending for the 2012 period relates primarily to the costs associated with the advancement of the CompleoTRT(TM) Phase III clinical trial.
Trimel incurred General and Administrative expenses of US$2.6 million and US$4.8 million for the three and six month periods ended June 30, 2012 respectively as compared to US$1.3 million and US$3.2 million for the comparable 2011 periods. The increase in spending for the 2012 period as compared to spending levels for the same 2011 period was primarily attributable to employment related expenses, professional fees and public company costs following the Company's successful 'go public' transaction in July 2011.
For the three and six month periods ended June 30, 2012, the Company incurred a net loss of US$0.09 and US$0.17 per share respectively, as compared to US$0.10 and US$0.19 per share for the comparable 2011 periods.
As at June 30, 2012, the Company had total assets of US$12.1 million as compared to US$17.6 million at March 31, 2012 and total liabilities of US$6.7 million at June 30, 2012 as compared to US$5.6 million at March 31, 2012. Subsequent to June 30, 2012the Company completed two financing transactions raising total gross proceeds of US$20.6 Million (see "Corporate Update" section below).
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.
Product Development Update
CompleoTRT(TM) (Testosterone - Hypogonadism ("Low T"))
Phase III Enrolment Completed
On July 23, 2012, the Company announced the completion of enrolment and randomization of 304 patients in the Phase III clinical trial evaluating CompleoTRT(TM). The pivotal Phase III clinical trial, which was initiated in October 2011, is a randomized study in which patients are administered CompleoTRT(TM) and evaluated for efficacy after 90 days of treatment using the pharmacokinetic endpoint established for Low T therapies. The Phase III study in its entirety represents the final stage of product development prior to the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for marketing approval in the United States.
Efficacy results from the Phase III clinical trial are expected to be available in the fourth quarter of 2012. As previously announced on May 29, 2012, the preliminary review of early data from the Phase III trial demonstrated that patients treated with CompleoTRT(TM) achieved an average serum testosterone level that exceeds the threshold required by the FDA to confirm the efficacy of a testosterone replacement product.
Testosterone Market Dynamics - Second Quarter 2012
According to IMS Health, nearly 1.7 million testosterone prescriptions were written in the second quarter of 2012, reflecting growth of 37% versus the same period in 2011. This represents an acceleration of prescription growth rates as physicians and patient awareness of this medical condition increases.
Tefina(TM) (Testosterone - Female Orgasmic Disorder)
Enrolment initiated for 240 Patient Ambulatory Study
On May 17th, 2012, the Company announced the initiation of patient enrolment into one of the largest clinical studies to ever explore a "use-as-required" treatment for women experiencing Female Orgasmic Disorder ("FOD"), or more commonly referred to as Anorgasmia. FOD is defined as the persistent or recurrent delay in, or absence of, orgasm following a normal sexual excitement phase which can result in marked personal distress or interpersonal difficulties. FOD affects 1 in 5 women worldwide. Currently there are no approved treatments for FOD and therefore this condition represents a significant unmet need for women suffering distress from this condition.
The Company intends to enrol 240 patients in this Phase II study being initiated in the United States, with additional sites in Canada and Australia expected to join the study in the second half of 2012. The Tefina(TM) Phase II study design will involve pre-menopausal women experiencing FOD and will be conducted as an ambulatory trial. As part of this double-blinded placebo-controlled study, patients will receive Tefina(TM) or placebo at home instead of in a hospital setting. The primary efficacy endpoint of the ambulatory trial will be the increase in the occurrence of orgasm over the treatment period compared against baseline levels.
Corporate Update Equity Financing
On July 17th, 2012 the Company announced that it had closed a public offering for aggregate gross proceeds of C$13.2 Million. In connection with the offering the Company issued 7,569,000 units ("Units") at a price of C$1.75 per Unit. Each Unit consists of one common share of the Company ("Common Share") and one-half of one common share purchase warrant (each whole warrant, a "Warrant"). Each whole Warrant entitles the holder to purchase one Common Share at an exercise price of C$2.50 until January 17, 2015.
The Offering was completed by a syndicate of underwriters led by RBC Dominion Securities Inc. and including GMP Securities L.P. On July 31, 2012, RBC Dominion Securities Inc. and GMP Securities L.P. exercised in part their over-allotment option to purchase an additional 60,400 Trimel Common Shares and 74,700 Trimel Warrants for aggregate gross proceeds of C$111,040. The closing of the over-allotment took place on August 3, 2012.
Debt Financing
On July 18, 2012, the Company had entered into a loan and security agreement with GE Capital, Healthcare Financial Services ("GE Capital"), as agent for the lenders party thereto, pursuant to which GE Capital advanced U.S. $7,500,000 (the "Loan") to the Company. According to the Loan Agreement, the Loan accrues interest at 10.75% per year and is repayable in scheduled instalments through to July 1, 2015 (subject to repayment on demand at any time should certain customary events of default occur). As is customary, the Company has granted security over the assets of the Company and its subsidiaries. In connection with the transaction, the lenders under the Loan Agreement (or certain of their affiliates) have been issued warrants exercisable for an aggregate of 154,916 Common Shares of the Company and certain brokers have been issued warrants exercisable for an aggregate of 51,639 common shares of the Company. The warrants are exercisable for five years at an exercise price calculated using the volume weighted average trading price of the Common Shares on the Toronto Stock Exchange for the period of five days ending immediately prior to the completion of the Loan.
Conference Call Details
To access the call live, please dial 416-340-2216 (Toronto), 1-866-226-1792 (Canada and U.S.), and 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 Tuesday, August 14, 2012 by dialing 905-694-9451 (Toronto), 1-800-408-3053 (Canada and U.S.) or 00-800-3366-3052 (International), using access code: 2484026#.
About CompleoTRT(TM)
CompleoTRT(TM) is designed to represent a significant advancement in the treatment of male hypogonadism, or low testosterone - commonly known as "Low T". CompleoTRT(TM)'s unique delivery technology is designed to provide patients with the therapeutic effect of supplementing testosterone levels while doing so with a small amount of drug in the form of a bio-adhesive intranasal gel.
CompleoTRT(TM)'s intranasal no-touch delivery system is designed to avoid the risk of accidental transfer (primary or secondary transference) of testosterone to spouses or other family members, thus offering unique patient benefits and improved safety as compared to other currently marketed products indicated to treat "Low T".
Since Trimel took over development of the product in the second half of 2009, CompleoTRT(TM) has been optimized to meet FDA regulatory requirements, including the development of a product dispenser that is designed to ensure that CompleoTRT(TM) is dosed accurately and discretely. Trimel has now successfully manufactured over 60,000 multi-dose dispensers. Trimel's CompleoTRT(TM) clinical program, having previously demonstrated that CompleoTRT(TM) is safe and effective in a Phase II trial, has recorded over 10,000 drug exposures in the studies conducted thus far in the United States.
About Hypogonadism ("Low T")
Subject to FDA approval, Trimel's lead product candidate, CompleoTRT(TM) would be indicated for the treatment of male hypogonadism or low testosterone - commonly known as "Low T". Hypogonadism is a biochemical syndrome characterized by a deficiency in serum testosterone levels that can be either acquired or inherited, and seriously affects the quality of life for those affected with the syndrome. Low testosterone is estimated to affect 13 million men in the United States, of which an estimated 90% go untreated. According to IMS Health, sales of marketed treatments for low testosterone in the United States grew 24% in 2011 versus 2010 to now exceed $1.6 billion in annual sales volume.
About Tefina(TM)
Trimel's product candidate Tefina(TM) is a bioadhesive 'no touch' intranasal low-dose gel formulation of testosterone. Tefina(TM) is being developed to offer women with anorgasmia, a "use as required" treatment option. Tefina(TM) is expected to present an attractive safety profile, with virtually no androgen-related side effects such as acne, facial and body hair growth or deepening of the voice. Moreover, there is no expected risk of skin-to-skin transfer of testosterone to third parties with the multi-dose dispenser.
About Female Orgasmic Disorder
Female Orgasmic Disorder ("FOD") is defined as the persistent or recurrent delay in, or absence of, orgasm following normal sexual excitement phase that causes marked personal distress or interpersonal difficulties. The etiology of FOD is often characterized by whether the dysfunction has been lifelong (primary) or acquired (secondary). This condition affects 1 in 5 pre and post menopausal women worldwide. Currently there are no approved treatments for FOD and therefore represents an unmet need for women suffering distress from this condition.
About Trimel
Trimel Pharmaceuticals Corporation (TSX:TRL) - Developing medications for Female Sexual Health and conditions related to Aging, and Well Being. Trimel is developing multiple product opportunities, including CompleoTRT(TM), a bio-adhesive intranasal Testosterone gel currently in Phase III clinical testing in the United States. CompleoTRT(TM) is under investigation for the treatment of male hypogonadism, a condition commonly referred to as "Low T". For more information, please visit www.trimelpharmaceuticals.com.
For further information regarding Trimel Pharmaceuticals Corporation, please contact either Bruce Brydon, Chairman of the Board and Chief Executive Officer at (416) 679-0711 or Kenneth Howling, Chief Financial Officer at (416) 679-0536 or via email at ir@trimelpharmaceuticals.com.
