On Wednesday, Shares of Trevena Inc (NASDAQ:TRVN), lost -8.44% to $3.65. The 52-week range of the share price is from $3.52 – $9.65. The beta value for this stock stands at -0.57points, while its earnings per share (EPS) was $-1.59. The company has total market capitalization of $188.83M and a total of 52.33M outstanding shares.
Trevena, Inc. (TRVN) today declared financial results for the fourth quarter and full year ended December 31, 2016 and offered an update on its ongoing clinical programs, counting additional data from the recently accomplished Phase 3 APOLLO-1 and APOLLO-2 pivotal efficacy studies of OLINVO in moderate-to-severe acute pain.
“The recent successful completion of the pivotal efficacy studies for OLINVO puts us in a strong position to bring this innovative analgesic to physicians and patients in need of a new option for managing moderate-to-severe acute pain in the hospital,” said Maxine Gowen, Ph.D., chief executive officer. “We believe the data from these studies highlight the potential for OLINVO to reduce the burden of opioid-related adverse effects, particularly for those patients who are at elevated risk for serious consequences from post-operative nausea and vomiting or opioid-induced respiratory depression.”
2016 and recent corporate highlights:
Obtained Breakthrough Therapy Designation for OLINVO. In February 2016, the Company declared that the U.S. Food and Drug Administration (FDA) had awarded OLINVO Breakthrough Therapy status, a designation granted to new therapies intended to treat serious conditions and for which preliminary clinical evidence indicates that the drug may demonstrate substantial clinical improvement over presently available therapies.
Successful End-of-Phase 2 meeting with FDA. In May 2016, the Company declared that it had reached general agreement with the FDA on key elements of the Phase 3 OLINVO program to support a New Drug Application (NDA), counting that the APOLLO-1 and APOLLO-2 pivotal efficacy trials in bunionectomy and abdominoplasty included appropriate patient populations to support an indication for moderate-to-severe acute pain.
In February 2017, declared positive top-line results from two Phase 3 pivotal efficacy studies of OLINVO in moderate-to-severe acute pain. OLINVO demonstrated fast onset and strong opioid efficacy in hard tissue and soft tissue pain models, supporting the Company’s planned NDA submission and a potential indication for the administration of moderate-to-severe acute pain. Numerous measures of respiratory safety and gastrointestinal tolerability all showed trends of meaningful improvements for OLINVO contrast to a commonly used IV morphine regimen.
Initiated Phase 3 ATHENA open label safety study of OLINVO. In January 2016, the Company declared the launch of the OLINVO Phase 3 clinical program with the enrollment of patients in the open label Phase 3 ATHENA study. This study is evaluating the safety and tolerability of OLINVO in patients with acute moderate-to-severe pain in various surgical settings. As of February 15, 2017, more than 400 patients have been treated with OLINVO, with no apparent off-target or unpredictable drug-related adverse effects to date. The Company remains on track to submit an NDA for OLINVO in the fourth quarter of 2017.
Accomplished clinical pharmacology and pharmacokinetics studies suggesting that OLINVO may offer potentially safer dosing in hard-to-treat patients. In February 2017, the Company declared the completion of a number of additional studies of OLINVO.
– A renal impairment study found no evidence of altered pharmacokinetics or accumulation in patients with renal failure, both of which occur with morphine and hydromorphone.
– Preclinical and clinical studies have found no evidence of active metabolites, which for other opioids can cause variable and delayed adverse events.
Continued engagement with academic and medical communities. The Company presented peer-reviewed data from its Phase 2 studies of OLINVO at a number of academic and medical conferences, counting the 41st Annual Regional Anesthesiology and Acute Pain Medicine Meeting, the 35th Annual Scientific Meeting of the American Pain Society, and the 2016 Annual Meeting of the American Society of Anesthesiologists.
Accomplished preclinical development of TRV250 for migraine. The Company declared recently that it anticipates initiating first-time-in-human studies of TRV250 for the treatment of migraine in the second quarter of this year. TRV250 is a G protein biased ligand targeting the δ-receptor with potential for a first-in-class, non-narcotic mechanism for the treatment of migraine. TRV250 also may have utility in a range of other central nervous system indications. Because TRV250 selectively targets the δ-receptor, the Company believes it will not have the addiction liability or other adverse effects associated with compounds targeting the mu-opioid receptor.
For the fourth quarter of 2016, Trevena stated a net loss attributable to common stockholders of $36.10M, or $0.67 per share, contrast with a net loss attributable to common stockholders for the fourth quarter of 2015 of $15.50M, or $0.30 per share.
For the year ended December 31, 2016, the Company incurred a net loss attributable to common stockholders of $103.0M, or $1.97 per share, contrast with a net loss attributable to common stockholders of $50.50M, or $1.15 per share, for the comparable period in 2015.
Cash, cash equivalents, and marketable securities were $110.60M as of December 31, 2016. The Company anticipates that expenses will decrease in 2017 contrast to 2016, mainly attributable to lower R&D expense following the recent completion of the Phase 3 APOLLO trials. As such, the Company anticipates presently available cash, cash equivalents, and marketable securities to fund operations into the second quarter of 2018, which should be sufficient to complete the OLINVO Phase 3 ATHEHA study, submit the NDA in 4Q 2017, continue OLINVO commercial launch preparations, complete the TRV250 first-time-in-human study, and continue the progression of Trevena’s pipeline.
The average true range of the stock is recorded at 0.41 and the relative strength index of the stock stands 21.24. The stock price is going below to its 52-week low with -1.35% and up from its 52-week high with -62.18%.
The stock has shown weekly performance of -1.72% and monthly performance stands at -48.32%. The stock price is trading downbeat from its 200 days moving average with -42.46% and down from 50 days moving average with -40.58%.
Analyst recommendation for this stock stands at 1.60.