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Trevena Reports Fourth Quarter and Full Year 2018 Results
Company announces submission of oliceridine healthy volunteer study protocol and analysis plan to FDA
Successful fundraising extends cash runway into 3Q 2020
Company to host conference call today, March 13, 2019 at 8:00 am ET
CHESTERBROOK, PA, March 13, 2019 Trevena, Inc. (NASDAQ: TRVN), a biopharmaceutical company focused on the development and commercialization of innovative treatment options that target and treat diseases affecting the central nervous system, or CNS, today reported its financial results for the fourth quarter and full year ended December 31, 2018, and provided an overview of its 2018 and 2019 year-to-date operational highlights.
Following our successful Type A meeting with FDA, we have continued to rapidly move the oliceridine program forward, said Carrie L. Bourdow, President and Chief Executive Officer. We have submitted the protocol for the previously announced healthy volunteer study of oliceridine and anticipate commencing this study in the first half of 2019. In addition, we have achieved meaningful milestones with our early-stage pipeline assets and, in 2019, expect to continue the development of these assets to build long-term stockholder value.
2018 and recent corporate highlights:
· Gained clarity on path forward to address CRL. In January 2019, the Company announced receipt of the Type A meeting minutes from FDA related to the oliceridine complete response letter (CRL). FDA agreed that the Companys current safety database will support labeling at a maximum daily dose of 27 mg and indicated that the Company can conduct a study in healthy volunteers to collect the additional QT interval data requested as part of the CRL. The Company has submitted a detailed protocol and analysis plan for this study to FDA and anticipates study initiation in first half of 2019, following receipt of feedback from FDA.
· Announced publication of APOLLO 1 Phase 3 results for oliceridine. The Company announced the publication of the Phase 3 results in The Journal of Pain Research on the effects of oliceridine versus IV morphine for the management of moderate-to-severe acute pain following bunionectomy.
· Completed successful capital raise. In January 2019, the Company completed a $10 million registered direct offering of common stock that yielded $9.2 million of net proceeds and enabled the Company to extend its cash runway into the third quarter of 2020.
· Continued progress with pipeline assets. In 2018, the Company completed a Phase 1 trial for TRV250, a potential new mechanism of action for the treatment of acute migraine and commenced a partnership with the National Institute on Drug Abuse (NIDA) for TRV734 in the management of opioid use disorder. In its S1P receptor program, the Company is today announcing its identification of a lead candidate for this program, designated as TRV045. This candidate holds promise as a new mechanism of action for a novel, non-opioid treatment of chronic pain and other CNS conditions.
· Strengthened the Board of Directors. Effective October 1, 2018, Scott Braunstein, M.D., was appointed to the Board of Directors bringing over twenty-five years of industry experience to the Trevena Board.
· Executed two ex-US licensing agreements. In the second quarter of 2018, the Company entered into exclusive licensing agreements for the development and commercialization of oliceridine in South Korea with PharmBio Korea Inc. and in China with Jiangsu Nhwa Pharmaceutical Co. Ltd.
Financial Results for Fourth Quarter and Full Year 2018
For the fourth quarter of 2018, the Company reported a net loss attributable to common stockholders of $8.0 million, or $0.10 per share, compared to $14.7 million, or $0.24 per share, for the fourth quarter of 2017. For the full year ended December 31, 2018, net loss attributable to common stockholders was $30.8 million, or $0.42 per share, compared to $71.9 million, or $1.21 per share, for the year ended December 31, 2017. This decrease is primarily due to the recognition in 2018 of collaboration revenue associated with the licensing agreements for oliceridine, and to substantially lower research and development expenses.
The following information was filed by Trevena Inc (TRVN) on Wednesday, March 13, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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