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Trevena Reports Full Year 2014 Financial ResultsTrevena, Inc. (NASDAQ: TRVN), a clinical stage biopharmaceutical company focused on the discovery and development of G protein coupled receptor (GPCR) biased ligands, today announced financial results for the fourth quarter and year ended December 31, 2014. "In 2014, Trevena made outstanding progress across all areas of our business and we are now well positioned to advance our clinical pipeline this year as we look to initiate the Company's first Phase 3 study in 2016," said Maxine Gowen, Ph.D., chief executive officer. "The results of our Phase 2a/b study of TRV130 in postoperative pain support its potential to provide more powerful pain relief than may be achievable with currently used opioids, with an encouraging safety and tolerability profile. We are on track to complete our ongoing Phase 2b soft-tissue surgery trial and are continuing to plan for the Phase 3 program. For TRV027, we launched a large-scale, well-designed Phase 2b study in acute heart failure at the beginning of 2014. We have completed the pre-specified interim analysis and recently announced additional funding of $10 million from Actavis to expand the number of patients in this study. Finally, we rapidly advanced oral TRV734 through two Phase 1 studies, and recently added a preclinical delta receptor compound, TRV250, to our pipeline." Recent Corporate Highlights CNS Programs (TRV130, TRV734, and TRV250)
Acute Heart Failure Program (TRV027)
Corporate Developments
Financial Results For the fourth quarter of 2014, Trevena reported a net loss attributable to common stockholders of $13.3 million, or $0.45 per share, compared with a net loss attributable to common stockholders for the fourth quarter of 2013 of $7.0 million, or $7.48 per share. For the year ended December 31, 2014, the Company incurred a net loss attributable to common stockholders of $49.7 million, or $2.02 per share, compared with a net loss attributable to common stockholders of $23.6 million, or $29.71 per share, for the comparable period in 2013. Cash, cash equivalents and marketable securities were $106.9 million as of December 31, 2014. The increase in net loss attributable to common stockholders for the year ended December 31, 2014, compared to the net loss attributable to common stockholders for the same period in 2013, was primarily due to higher clinical research expenses in 2014 associated with the Company's advancement into a Phase 2b clinical trial of TRV027 and the initiation and completion of a Phase 2a/b clinical trial of TRV130, as well as increased operating costs in support of the Company's expanded development activities. Conference Call Information Trevena will host a conference call today, March 18th at 8:30 a.m. Eastern Daylight Savings Time. The call can be accessed by dialing (855) 465-0180 (U.S. and Canada) or (484) 756-4313 (international), and entering passcode 98326456. To access the live audio webcast, or the subsequent archived recording, visit the "Investors" section at trevenainc.com. The webcast will be recorded and will be available for replay on the company's website for 30 days. A replay of the call will be available for 30 days and can be accessed by dialing (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international), and entering passcode 98326456. About Trevena Trevena, Inc. is a clinical stage biopharmaceutical company that discovers, develops and intends to commercialize therapeutics that use a novel approach to target G protein coupled receptors, or GPCRs. Using its proprietary product platform, Trevena is developing four biased ligand product candidates it has identified - TRV027 to treat acute heart failure (Phase 2b), TRV130 to treat moderate to severe acute pain intravenously (Phase 2b), TRV734 to treat moderate to severe acute and chronic pain orally (Phase 1), and TRV250 for treatment-refractory migraine (preclinical). Cautionary Note on Forward Looking Statements Any statements in this press release about future expectations, plans and prospects for the company, including statements about the company's strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the company's clinical trials, including when top-line Phase 2 data will be reported for TRV027 and TRV130; the uncertainties inherent in conducting clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical trials will be indicative of the results of future trials, including whether (i) the interim results from the TRV027 Phase 2 will be consistent with the final results from the study, (ii) the results from and trends seen in the Phase 2a/b bunionectomy study of TRV130 will be consistent with the results from the ongoing Phase 2b study and (iii) the Phase 1 data for TRV734 support further study in Phase 2; expectations for regulatory approvals; availability of funding sufficient for the company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of the company's therapeutic candidates; the inherent uncertainties associated with intellectual property; and other factors discussed in the Risk Factors set forth in the company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC (News - Alert)) and in other filings the company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the company's views only as of the date hereof. The company anticipates that subsequent events and developments may cause the company's views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.
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