CHESTERBROOK, Pa., May 10, 2019 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients affected by Central Nervous System (CNS) conditions, today announced receipt of comments from the U.S Food and Drug Administration (FDA) on the proposed healthy volunteer study protocol, and reported its financial results for the quarter ended March 31, 2019.
“We are very pleased with the feedback from FDA, which provides us with the necessary information to move forward and initiate the healthy volunteer study by the end of June,” said Carrie Bourdow, President and Chief Executive Officer. “This marks a critical step on the path towards resubmission of the new drug application for oliceridine, and I am proud of our team for their considerable efforts in preparing for this important upcoming work.”
First Quarter and Recent Corporate Highlights:
- Received feedback from FDA on key design elements for the healthy volunteer study. The FDA confirmed that the study can be conducted in healthy volunteers over a 24-hour period. The study will be performed at a single site as a three-period crossover design that includes oliceridine, placebo, and moxifloxacin as a positive control.
The Company plans to submit data on approximately 60 participants. Among this study population, a minimum of 20 participants will receive a cumulative dose of 27 mg of oliceridine, the proposed maximum daily dose, through the 24-hour study period.
The study remains on track to initiate by the end of June. The Company will provide additional details on a conference call scheduled for Monday, May 13th at 8:00 a.m. Eastern Time.
- Completed successful capital raise. In January, the Company completed a $10 million registered direct offering of common stock that yielded $9.2 million of net proceeds.
Financial Results for First Quarter 2019
For the first quarter of 2019, the Company reported a net loss attributable to common stockholders of $5.2 million, or $0.06 per share, compared to $9.0 million, or $0.14 per share, for the first quarter of 2018. This decrease is primarily due to lower personnel related costs associated with the 2018 restructuring and reduction in force, and lower research and development expenses.
Cash, cash equivalents, and marketable securities were $60.1 million at March 31, 2019. The Company believes its cash, cash equivalents, and marketable securities as of March 31, 2019, together with interest thereon, to be sufficient to fund the Company’s operating expenses and capital expenditure requirements into the third quarter of 2020.
About Trevena
Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients affected by Central Nervous System (CNS) conditions. The Company has three novel and differentiated investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250 for the treatment of acute migraine, and TRV734 for the management of pain and/or management of opioid use disorder. In its preclinical programs, the Company has identified TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to managing chronic pain.
