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Trevena Reports First Quarter 2020 Results -- FDA review of oliceridine NDA ongoing; PDUFA date

Key Takeaway: Reports First Quarter 2020 Results review of oliceridine NDA ongoing; PDUFA date August 7, 2020 filing for novel S1P modulator (TRV045) in 1H 2021; ongoing collaboration with NIH to evaluate for epilepsy and pain to host conference call today, May 7, 2020, at 8:00 a.m. ET CHE

Full Press Release Details

Reports First Quarter 2020 Results
review of oliceridine NDA ongoing; PDUFA date August 7, 2020
filing for novel S1P modulator (TRV045) in 1H 2021; ongoing collaboration with NIH to evaluate for epilepsy and pain
to host conference call today, May 7, 2020, at 8:00 a.m. ET
CHESTERBROOK, Pa., [May 7], 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 first
quarter ended March 31, 2020, and provided an overview of its recent operational highlights.
"In the first quarter, we reached a significant milestone
for the oliceridine program, with our resubmission and FDA's acceptance of the NDA. I am very pleased with FDA's engagement
in the review process, and we look forward to receiving their decision in August," said Carrie Bourdow, President and Chief
Executive Officer of Trevena, Inc.
First Quarter 2020 and Recent Corporate Highlights:
FDA's review of the NDA resubmission is ongoing,
and the Company continues to expect a decision from the Agency by August 7.
The Company today announced that NIH is also investigating
TRV045 as a potential non-addictive treatment for various acute and chronic pain conditions, including inflammatory and neuropathic
pain, within its Preclinical Screening Platform for Pain.
Financial Results for First Quarter 2020
For the first quarter of 2020, the Company reported a net loss
attributable to common stockholders of $5.7 million, or $0.06 per share, compared to $5.2 million, or $0.06 per share, for the
first quarter of 2019. This increase in net loss is primarily due to higher research and development expenses associated with the
TRV250 acute migraine proof-of-concept study and activities to support the NDA resubmission for oliceridine.
Cash and cash equivalents were $28.1 million at March 31, 2020,
which the Company believes 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 May 7, 2020, at 8:00 a.m. Eastern Time featuring remarks by Carrie Bourdow, President and Chief Executive
Officer, Robert Yoder, Chief Business Officer, Mark Demitrack, M.D., Chief Medical Officer, and Barry Shin, Chief Financial Officer.
Title: Trevena First Quarter 2020 Conference Call and Webcast
Date: Thursday, May 7, 2020
Time: 8:00 a.m. ET
Conference Call Details: Toll-Free: 855-465-0180 International: 484-756-4313 Conference ID: 5469527
Webcast: https://www.trevena.com/investors/events-presentations/ir-calendar
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; 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:
LifeSci Advisors, LLC
SVP and Chief Business Officer
Condensed Statements of Operations
(Unaudited, in thousands except share and per share data)
Three Months Ended March 31,
2020 2019
Revenue $ - $ -
Operating expenses:
General and administrative 3,632 3,060
Research and development 2,191 2,154
Total operating expenses 5,823 5,214
Loss from operations (5,823 ) (5,214 )
Other income 98 45
Loss before income tax expense (5,725 ) (5,169 )
Income tax expense - -
Net loss $ (5,725 ) $ (5,169 )
Per share information:
Net loss per share of common stock, basic and diluted $ ( 0.06 ) $ ( 0.06 )
Weighted average shares outstanding, basic and diluted 96,332,324 88,897,292
Condensed Balance Sheets
(Unaudited, in thousands)
March 31, 2020 December 31, 2019
Assets
Current assets:
Cash and cash equivalents $ 28,090 $ 32,305
Marketable securities - 3,500
Prepaid expenses and other current assets 1,666 1,683
Total current assets 29,756 37,488
Restricted cash 1,310 1,309
Property and equipment, net 2,577 2,705
Right-of-use lease assets 5,389 5,472
Other assets 18 20.00
Total assets $ 39,050 $ 46,994
Liabilities and stockholders' equity
Current liabilities:
Accounts payable $ 698 $ 1,047
Accrued expenses and other current liabilities 1,277 2,403
Current portion of loans payable, net - 5,037
Current portion of lease liabilities 642 620
Total current liabilities 2,617 9,107
Leases, net of current portion 7,636 7,804
Warrant liability 2 5
Total liabilities 10,255 16,916
Common stock 99 94
Additional paid-in capital 447,566 443,129
Accumulated deficit (418,870 ) (413,145 )
Total stockholders' equity 28,795 30,078
Total liabilities and stockholders' equity $ 39,050 $ 46,994
Last updated: May 7, 2020