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Trevena Reports Third Quarter 2021 Results -- Advanced OLINVYK commercial launch with expanded field medical team and additional target markets Announced new OLINVYK cognitive function study vs. IV morphine, enrollment e

Key Takeaway: Reports Third Quarter 2021 Results Advanced OLINVYK commercial launch with expanded field medical team and additional target markets Announced new OLINVYK cognitive function study vs. IV morphine, enrollment expected to start in Q1 2022 Initiated enrollment for Cleveland Cli

Full Press Release Details

Reports Third Quarter 2021 Results
Advanced OLINVYK commercial launch with expanded
field medical team and additional target markets
Announced new OLINVYK cognitive function study
vs. IV morphine, enrollment expected to start in Q1 2022
Initiated enrollment for Cleveland Clinic-led
OLINVYK outcomes study, topline data expected in mid-2022
Progressed TRV027 with NIH / ACTIV-4 trial
for COVID-19 on track for topline data in mid-2022
$78.6M cash at Q3 funds operations through
Company to host conference call today, November
15th, 2021, at 8:00 a.m. ET
CHESTERBROOK, PA, November 15, 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 third quarter ended September 30,
2021 and provided an overview of its recent operational highlights.
"As we advance the OLINVYK commercial launch,
we have continued to hear positive feedback on its performance in the post-operative setting. This feedback has helped us refine our launch
strategy and post-approval plan, which we believe will help position us for success as hospitals begin to reopen and in-person engagement
resumes," said Carrie Bourdow, President and CEO of Trevena. "We have also continued to make progress on our pipeline, with
the recent announcement of positive TRV027 proof-of-concept data, and other exciting developments."
Third Quarter 2021 and Recent Corporate Highlights:
OLINVYK (oliceridine) injection Milestones
Financial Results for Third Quarter 2021
For the third quarter
of 2021, the Company reported a net loss attributable to common stockholders of $13.9 million, or $0.08 per share, compared to $5.6 million,
or $0.04 per share, for the third quarter of 2020. This increase is primarily related to increases in commercialization activities for
Cash and cash equivalents
were $78.6 million as of September 30, 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.
The Company will host
a conference call and webcast with the investment community on November 15, 2021, at 8:00 a.m. Eastern Time featuring remarks by Carrie
Bourdow, President and CEO; Bob Yoder, Senior Vice President, Chief Business Officer & Head of Commercial Operations; Patricia Drake,
Senior Vice President and Chief Commercial Officer; Mark Demitrack, M.D., Senior Vice President and Chief Medical Officer; Barry Shin,
Senior Vice President and Chief Financial Officer; and Paul F. Rider, M.D. FACS, FASCRS, Professor of Surgery, Division Chief, Colon &
Rectal Surgery, University of South Alabama College of Medicine.
Title: Trevena Third Quarter 2021 Financial Results Conference Call and Webcast
Date: Monday, November 15, 2021
Time: 8:00 a.m. ET
Conference Call Details: Toll-Free: (855) 465-0180 International: (484) 756-4313 Conference ID: 2279839
Webcast: https://www.trevena.com/investors/events-presentations/ir-calendar
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.
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 diabetic neuropathic pain and epilepsy, 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:
LifeSci Advisors, LLC
Associate Vice President
Condensed Statements of Operations
(Unaudited, in thousands except share and per share data)
Product revenue 112 $ - $ 499 $ - $ License revenue 69
3,000 69 3,000 Total revenue 181 3,000 568 3,000 Operating expenses: Cost of goods
sold 199 - 620 - Selling, general and administrative 10,438 4,089 28,351 11,021 Research and development 3,404 4,301 9,489 9,450 Total
operating expenses 14,041 8,390 38,460 20,471 Loss from operations (13,860) (5,390) (37,892) (17,471) Other income 89 139 257 273 Loss
before income tax expense (13,771) (5,251) (37,635) (17,198) Foreign income tax expense - (300) - (300) Net loss (13,771) $ (5,551) $
(37,635) $ (17,498) $ Per share information: Net loss per share of common stock, basic and diluted ($0.08) ($0.04) ($0.23) ($0.15) Weighted
average shares outstanding, basic and diluted 164,510,570 144,335,143 162,811,136 117,420,221 Three Months Ended Sept 30, Nine Months
Ended Sept 30, TREVENA, INC. Condensed Statements of Operations (Unaudited, in thousands except share and per share data)
Condensed Balance Sheets
(Unaudited, in thousands)
September 30, 2021 December 31, 2020 Assets Current assets: Cash
and cash equivalents 78,646 $ 109,403 $ Accounts receivable, net 103 71 Inventories 1,310 - Insurance recovery - 9,000 Prepaid expenses
and other current assets 2,345 570 Total current assets 82,404 119,044 Restricted cash 1,311 1,310 Property and equipment, net 1,947
2,253 Right-of-use lease assets 4,815 5,119 Other assets 1,171 13 Total assets 91,648 $ 127,739 $ Liabilities and stockholders'
equity Current liabilities: Accounts payable, net 2,969 $ 1,693 $ Accrued expenses and other current liabilities 3,678 5,168 Estimated
settlement liability - 9,000 Current portion of lease liabilities 770 703 Total current liabilities 7,417 16,564 Leases, net of current
portion 6,516 7,101 Warrant liability - 6 Total liabilities 13,933 23,671 Common stock 165 160 Additional paid-in capital 557,707 546,422
Subscription receivable (8) - Accumulated deficit (480,149) (442,514) Total stockholders' equity 77,715 104,068 Total liabilities
and stockholders' equity 91,648 $ 127,739 $ TREVENA, INC. Condensed Balance Sheets (Unaudited, in thousands)
Last updated: Nov 15, 2021