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Trevena Reports Fourth Quarter and Full Year 2019 Results -- PDUFA date of

Key Takeaway: Trevena Reports Fourth Quarter and Full PDUFA date of August 7, 2020 for IV oliceridine; FDA considers NDA resubmission complete Initiated proof-of-concept studies for acute migraine (TRV250) and opioid use disorder (TRV734) Announces NIH collaboration to evaluate Updated g

Full Press Release Details

Trevena Reports Fourth Quarter and Full
PDUFA date of August 7, 2020 for IV
oliceridine; FDA considers NDA resubmission complete
Initiated proof-of-concept studies
for acute migraine (TRV250) and opioid use disorder (TRV734)
Announces NIH collaboration to evaluate
Updated guidance on extended cash
runway, funding operations into Q1 2021
Company to host conference call today,
March 12, 2020, at 8:00 a.m. ET
CHESTERBROOK, Pa., [Mar. 12], 2020 (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 fourth quarter and full year ended December
31, 2019, and provided an overview of its 2019 and 2020 year-to-date operational highlights.
"In 2019, we delivered on our plan to establish Trevena
as a leading innovator in the treatment of CNS disorders. We completed a significant amount of work to thoroughly address the FDA
complete response letter for oliceridine, which positioned us to successfully resubmit the NDA earlier this year. Additionally,
we advanced our pipeline, initiating two proof-of-concept studies for acute migraine and opioid use disorder, as well as a collaboration
with NIH to evaluate TRV045 for epilepsy," said Carrie Bourdow, President and Chief Executive Officer of Trevena. "We
enter 2020 with the same focus and commitment, preparing for the expected approval of oliceridine in the second half of the year,
as well as advancing our pipeline assets."
2019 and 2020 YTD Corporate Highlights:
IV Oliceridine Milestones
In March 2020, the Company announced that FDA had
acknowledged receipt of the resubmitted NDA. In their acknowledgement letter, FDA stated that the Company's resubmission
was a complete, Class 2 response to the Agency's action letter. A PDUFA goal date has been set for August 7, 2020.
CNS Pipeline Milestones
The primary endpoint of the study is reduction of
sustained NTG-induced headaches; secondary outcomes include overall safety measures and reduction of symptomatic anxiety. The Company
continues to expect reporting topline data in 2H 2020.
The primary endpoint of the study is reduction of
acute opioid craving symptoms. The study will also evaluate suppression of withdrawal signs, neurocognitive changes, and overall
The Company today announced it entered into a collaboration
with the U.S. National Institutes of Health (NIH) to evaluate the potential of TRV045 as a treatment for epilepsy. NIH is assessing
TRV045 within its Epilepsy Therapy Screening Program.
Financial and Corporate Milestones
In July 2019, the Company announced the appointment
of Barry Shin as Senior Vice President and Chief Financial Officer. Mr. Shin brings over 17 years of investment banking and corporate
advisory experience, focused on the biopharmaceutical sector.
Financial Results for Fourth Quarter and Full Year 2019
For the fourth quarter of 2019, the Company reported a net loss
attributable to common stockholders of $6.4 million, or $0.07 per share, compared to $8.0 million, or $0.10 per share, for the
fourth quarter of 2018. For the full year ended December 31, 2019, net loss attributable to common stockholders was $24.9 million,
or $0.27 per share, compared to $30.8 million, or $0.42 per share, for the year ended December 31, 2018. This decrease is primarily
due to a reduction in headcount associated with the 2018 restructuring and reduction in force, as well as a decrease in research
and development expenses from the completion of the Phase 1 clinical trial for TRV250.
Cash, cash equivalents, and marketable securities were $35.8
million at December 31, 2019. The Company believes that its cash and cash equivalents and marketable securities as of December
31, 2019, together with interest thereon, to be sufficient to fund the Company's operating expenses and capital expenditure
requirements into the first quarter of 2021.
Conference Call and Webcast Information
The Company will host a conference call and webcast with the
investment community on March 12, 2020, at 8:00 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive
Officer, Mark Demitrack, SVP and Chief Medical Officer, Barry Shin, SVP and Chief Financial Officer, and Timothy Beard, M.D., Chair
of the Department of Surgery at Summit Medical Group.
Title: Trevena Fourth Quarter 2019 & Full Year 2019 Financial Results Conference Call and Webcast
Date: Thursday, March 12, 2020
Time: 8:00 a.m. ET
Conference Call Details: Toll-Free: 877-451-6152 International: 201-389-0879 Conference ID: 13699727
Webcast: https://www.trevena.com/investors/events-presentations/ir-calendar http://public.viavid.com/index.php?id=138309
Oliceridine is a G protein-selective mu-opioid receptor agonist
in development for the management of moderate-to-severe acute pain in hospitals or other controlled clinical settings where intravenous
therapy is warranted. It is a new chemical entity with a novel mechanism of action that enables more selective targeting of newly
discovered pathways with the potential for fewer side effects. Oliceridine is an investigational product and has not been approved
by FDA or any other regulatory agency. If approved, the Company expects that oliceridine will be classified as a Schedule II controlled
Trevena, Inc. is a biopharmaceutical company focused on the
development and commercialization of novel medicines for patients with CNS disorders. The Company has four novel and differentiated
investigational drug candidates, including IV oliceridine, for the management of moderate to severe acute pain in hospitals, TRV250
for the acute treatment of migraine, and TRV734 for maintenance treatment of opioid use disorder. The Company has also identified
TRV045, a novel S1P receptor modulator that may offer a new, non-opioid approach to treating a variety of CNS disorders.
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 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 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 FDA, the timing of FDA's
decision on the oliceridine NDA; available funding ; 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:
LifeSci Advisors, LLC
SVP and Chief Business Officer
Last updated: Mar 13, 2020