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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

Key Takeaway: Reports First Quarter 2021 Results reaffirms YE target of 100 formulary approvals for OLINVYK new OLINVYK clinical outcomes study to further examine potential benefit on respiratory, GI, and cognitive function selected for two large, multi-site COVID-19 studies led by NIH / Va

Full Press Release Details

Reports First Quarter 2021 Results
reaffirms YE target of 100 formulary approvals for OLINVYK
new OLINVYK clinical outcomes study to further examine potential benefit on respiratory, GI, and cognitive function
selected for two large, multi-site COVID-19 studies led by NIH / Vanderbilt University Medical Center and REMAP-CAP
IND filing remains on track for 1H 2021 with a lead target indication of diabetic neuropathic pain
cash at Q1 funds operations through YE 2022
to host conference call today, May 6th, 2021, at 8:00 a.m. ET
PA, May 6, 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.
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
Quarter 2021 and Recent Corporate Highlights:
(oliceridine) injection Milestones
April 2021, the Company announced that TRV027 had been selected for an international, multi-arm, multi-site Phase 2/3 trial in COVID-19
patients. TRV027 will be administered in conjunction with an ACE inhibitor in 200-300 patients. The trial is being conducted and funded
as part of REMAP-CAP, a global clinical trial network led by experts in pandemic response and financially supported by an array of governments
and research organizations worldwide.
Results for First Quarter 2021
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.
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.
Call and Webcast Information
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.
Title: Trevena First Quarter 2021 Financial Results Conference Call and Webcast
Date: Thursday, May 6, 2021
Time: 8:00 a.m. ET
Conference Call Details: Toll-Free: 855-465-0180 International: 484-756-4313 Conference ID: 3884579
Webcast: https://www.trevena.com/investors/events-presentations/ir-calendar
OLINVYK (oliceridine) injection
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.
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.
more information, please visit www.Trevena.com
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.
more information, please contact:
Thr ee Months E nded M ar ch 31,
2021 2020
P r o du c t r e v e nu e $ 209 $ -
To t a l r e v e nu e 209 -
Op e r a t in g ex p e n ses :
Cos t of goo d s so ld 1 63 -
Ge n e r a l a nd a dmini s t r a t iv e 7,368 3,632
Resea r c h a nd d e v e l o pm e n t 2,636 2,191
To t a l o p e r a t in g ex p e n ses 10,167 5,823
L oss f r o m o p e r a t i o n s (9,958 ) (5,823 )
O t h e r in co m e 116 98
N e t l oss $ (9,842 ) $ (5,725 )
Pe r s h a r e in fo rm a ti o n :
N e t l oss p e r s h a r e of co mm o n s t oc k, b as i c a nd dilut e d $ (0.06 ) $ (0.06 )
W e i g ht e d a v e r age s h a r es o u t s t a ndin g , b as i c a nd dilut e d 160,508,373 96,332,324
March 31, 2021 D ece mb e r 31, 2020
Assets
Curr e n t assets :
C as h a nd cas h e quiv a l e n ts $ 97,720 $ 109,403
A cco un ts r ece iv a bl e , n et 296 71
In s ur a n ce r eco v e ry 9,000 9,000
P r e p a id e xp e n ses a nd ot h e r c urr e n t assets 2,575 570
Tota l c urr e n t assets 109,591 119,044
Rest ri cte d cas h 1,310 1,310
P r o p e rty a nd e quipm e n t , n et 2,145 2,253
R i g h t-of- u se l ease assets 5,022 5,119
O t h e r assets 428 1 3
Tota l assets $ 118,496 $ 127,739
Liabili t i es a nd stoc kh o l de r s ' eq ui ty
C urr e n t li a bili t i es :
A cco un ts p a y a bl e , n et $ 2,220 $ 1,693
A cc ru e d e xp e n ses a nd ot h e r c urr e n t li a bili t i es 1,568 5,168
E st im ate d sett l e m e n t li a bili t y 9,000 9,000
C urr e n t p o rti o n of l ease li a bili t i es 725 703
Tota l c urr e n t li a bili t i es 13,513 16,564
Leases , n et of c urr e n t p o rti o n 6,911 7,101
W a rr a n t li a bili t y 3 6
Tota l li a bili t i es 20,427 23,671
C o mm o n stoc k 161 160
Addi t i o n a l p a id - in ca pi ta l 550,264 546,422
A cc umul ate d d e fi c i t ( 452 , 356 ) ( 442 , 5 1 4 )
Tota l stoc kh o ld e r s ' e qui t y 98,069 104,068
Tota l li a bili t i es a nd stoc kh o ld e r s ' e qui t y $ 118,496 $ 127,739
Last updated: May 6, 2021