- Company announces receipt of FDA feedback on healthy volunteer study protocol and analysis plan for oliceridine -
- Study on track to initiate by end of June -
-- Company to host conference call Monday, May 13, 2019 at 8:00 a.m. ET --
CHESTERBROOK, PA, May 10, 2019 – 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.
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.
The Company will host a conference call and webcast with the investment community on Monday, May 13th at 8:00 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and CEO, and Mark Demitrack, SVP and Chief Medical Officer.
Toll-Free: (855) 465-0180
International: (484) 756-4313
Toll-Free: (855) 859-2056
International: (404) 537-3406
Conference ID: 7698684
(Available approximately one hour after the completion of the live call until 11:59 p.m. ET on May 22, 2019)
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.
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 or any future trials, including with respect to any future clinical study of oliceridine; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of the discussions with FDA, whether there is a path to resubmit the oliceridine NDA, and the timing of any FDA review of the protocol for a future oliceridine study; availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and whether cash, cash equivalents, and marketable securities as of March 31, 2019 will be sufficient to fund operating expenses and capital expenditure requirements into the third quarter of 2020; 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) 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.
For more information, please contact:
Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: 212-896-1254 / 212-896-1267
Bob Yoder, SVP and Chief Business Officer
|Condensed Statements of Operations|
|(Unaudited, in thousands except share and per share data)|
|Three Months Ended March 31,|
|General and administrative||3,060||5,072|
|Research and development||2,154||4,598|
|Total operating expenses||5,214||9,693|
|Loss from operations||(5,214||)||(9,693||)|
|Other income (expense)||45||672|
|Loss before income tax expense||(5,169||)||(9,021||)|
|Foreign income tax expense||-||-|
|Per share information:|
|Net loss per share of common stock, basic and diluted||($0.06||)||($0.14||)|
|Weighted average shares outstanding, basic and diluted||88,897,292||64,562,236|
|Condensed Balance Sheets|
|(Unaudited, in thousands)|
|March 31, 2019||December 31, 2018|
|Cash and cash equivalents||$||20,261||$||32,892|
|Prepaid expenses and other current assets||1,581||607|
|Total current assets||61,644||62,089|
|Property and equipment, net||3,238||3,387|
|Right-of-use lease assets||5,702||-|
|Liabilities and stockholders’ equity|
|Accrued expenses and other current liabilities||1,956||3,305|
|Current portion of loans payable, net||14,330||12,562|
|Current portion of lease liabilities||563|
|Total current liabilities||17,207||17,490|
|Loans payable, net||-||4,811|
|Leases, net of current portion||8,281||20|
|Deferred rent, net of current portion||-||2,931|
|Additional paid-in capital||439,735||429,727|
|Accumulated other comprehensive income (loss)||3||(9||)|
|Total stockholders’ equity||46,387||41,526|
|Total liabilities and stockholders’ equity||$||71,889||$||66,779|
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