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Trevena Reports Second Quarter 2016 Financial Results and Provides Corporate UpdateTrevena, Inc. (NASDAQ: TRVN), a clinical stage pharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors (GPCRs), today announced financial results for the quarter ended June 30, 2016 and provided an update regarding its ongoing clinical programs. "This quarter marked an important milestone for the company's oliceridine program with the initiation of our two Phase 3 pivotal efficacy trials," said Maxine Gowen, Ph.D., chief executive officer. "Following our successful End-of-Phase-2 and Breakthrough Therapy designation meeting with the FDA in the first quarter, we were able to rapidly initiate the pivotal efficacy trials, which are enrolling well." Second Quarter and Recent Highlights
At the Society for Ambulatory Anesthesia (SAMBA) 31st Annual Meeting, the company was awarded a First Place in Excellence and Innovation Award for its presentation of data from the oliceridine Phase 2 program. Further presentations of oliceridine data at additional pain medicine conferences are expected in the second half of 2016, including at the American Society of Anesthesiology 2016 annual meeting in October.
Financial Results Net loss attributable to common stockholders for the quarter ended June 30, 2016 was $19.2 million, or $0.37 per share, compared to $11.5 million, or $0.28 per share for the quarter ended June 30, 2015. Research and development expenses were $17.2 million in the second quarter of 2016 compared to $10.3 million for the same period in 2015, primarily due to increased clinical trial expenses associated with the oliceridine Phase 3 program. For the remainder of 2016, the company anticipates that research and development expenses will increase as compared to the first half of 2016, primarily as a result of the initiation of the APOLLO efficacy studies in June and the expected acceleration of the ATHENA safety study recruitment. General and administrative expenses were $3.7 million, compared to $3.1 million for the second quarter of 2015. Cash, cash equivalents, and marketable securities totaled $144.5 million as of June 30, 2016, which Trevena expects will be sufficient to fund its operations into 2018. 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. Oliceridine (TRV130), Trevena's lead product candidate, is the first pain program granted Breakthrough Therapy designation by the U.S. Food & Drug Administration and is in Phase 3 development for intravenous treatment of moderate to severe post-operative acute pain. In Phase 2b, intravenous oliceridine demonstrated rapid and powerful analgesic efficacy with reduced frequency of opioid-related adverse events including nausea, vomiting, and hypoventilation compared to intravenous morphine, thus offering a promising safety and tolerability profile compared to conventional opioid analgesics while providing powerful pain relief to patients. 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 the expected timing of the release of top-line data from the APOLLO studies and the timing of the NDA filing for oliceridine; the uncertainties inherent in conducting clinical trials, including whether the Phase 3 studies will support the approval of oliceridine and any potential differentiation of oliceridine from conventional opioids; 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; expectations for regulatory approvals, including for oliceridine; availability of funding sufficient for the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; uncertainties related to the Company's intellectual property; other matters that could affect the availability or commercial potential of the Company's therapeutic candidates; 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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