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Trevena Reports First Quarter 2021 Results-- Company reaffirms YE target of 100 formulary approvals for OLINVYK® Announces new OLINVYK clinical outcomes study to further examine potential benefit on respiratory, GI, and cognitive function TRV027 selected for two large, multi-site COVID-19 studies led by NIH / Vanderbilt University Medical Center and REMAP-CAP TRV045 IND filing remains on track for 1H 2021 with a lead target indication of diabetic neuropathic pain $97.7M cash at Q1 funds operations through YE 2022 -- Company to host conference call today, May 6th, 2021, at 8:00 a.m. ET -- CHESTERBROOK, Pa., May 06, 2021 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the first quarter ended March 31, 2021, and provided an overview of its recent operational highlights. “In the first quarter, we made significant progress across our business. We continued to expand awareness of OLINVYK with key customers and announced an exciting outcomes study to further enhance the value proposition,” said Carrie Bourdow, President and Chief Executive Officer of Trevena, Inc. “In parallel, we advanced our pipeline with major new studies for TRV027 in COVID-19 patients, in collaboration with two of the most prominent platform trial networks in the world, and we selected diabetic neuropathic pain as the initial indication for TRV045.” First Quarter 2021 and Recent Corporate Highlights: OLINVYK (oliceridine) injection Milestones
Pipeline Milestones
Financial Results for First Quarter 2021 For the first quarter of 2021, the Company reported a net loss attributable to common stockholders of $9.8 million, or $0.06 per share, compared to $5.7 million, or $0.06 per share, for the first quarter of 2020. This increase is primarily related to increases in commercialization activities for OLINVYK. Cash and cash equivalents were $97.7 million as of March 31, 2021, which the Company believes will be sufficient to fund the Company’s operating expenses and capital expenditure requirements through the fourth quarter of 2022. Conference Call and Webcast Information The Company will host a conference call and webcast with the investment community on May 6, 2021, at 8:00 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive Officer, Bob Yoder, Senior Vice President and Chief Commercial Officer, Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer, and Barry Shin, Senior Vice President and Chief Financial Officer.
About OLINVYK® (oliceridine) injection OLINVYK is a new chemical entity approved by the FDA in August 2020. OLINVYK contains oliceridine, a Schedule II controlled substance with a high potential for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials, and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses greater than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information, including the BOXED WARNING, and full prescribing information at www.OLINVYK.com. About Trevena Trevena, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one approved product in the United States, OLINVYK® (oliceridine) injection, indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate. The Company’s novel pipeline is based on Nobel Prize winning research and includes four differentiated investigational drug candidates: TRV250 for the acute treatment of migraine, TRV734 for maintenance treatment of opioid use disorder, TRV045 for epilepsy and chronic neuropathic pain, and TRV027 for acute respiratory distress syndrome and abnormal blood clotting in COVID-19 patients. For more information, please visit www.Trevena.com 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 and trials of its therapeutic candidates, plans for potential future product candidates, commercialization of approved drug products and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “objective,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” “ongoing,” or the negative of these terms or 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 commercialization of any approved drug product, the status, timing, costs, results and interpretation of the Company’s clinical trials or any future trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations for regulatory interactions, submissions and approvals, including the Company’s assessment of the discussions with the FDA or other regulatory agencies about any and all of its programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to the Company’s intellectual property; uncertainties related to the ongoing COVID-19 pandemic, 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: Investor Contact: Dan Ferry PR & Media Contact: Sasha Bennett
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