Trevena Reports First Quarter 2017 Financial Results and Provides Corporate Update
May 04 2017 - 7:00AM
– Successfully completed two positive Phase 3
pivotal efficacy studies of OLINVO™ (oliceridine injection) –
Trevena, Inc. (NASDAQ:TRVN) today announced financial results for
the quarter ended March 31, 2017 and provided an update on its
ongoing clinical programs.
“This quarter marked a key milestone for our OLINVO program,
with the delivery of robust data that we believe will support our
new drug application and demonstrates the potential value of OLINVO
for the management of moderate-to-severe acute pain in the
hospital,” said Maxine Gowen, Ph.D., chief executive officer.
“There remains a critical unmet need for patients who require IV
opioids to manage pain but are at risk for poor outcomes from
opioid-related adverse effects. Our successful Phase 3 data
showed not only significant efficacy of OLINVO versus placebo to
support approval, but also showed the potential for fewer
gastrointestinal and respiratory adverse effects while providing
comparable pain relief to a commonly used morphine regimen.”
First quarter and recent corporate
highlights
- Announced positive top-line results from two Phase 3
pivotal efficacy studies of OLINVOTM (oliceridine injection) for
moderate-to-severe pain. In February, the Company
announced positive data from the APOLLO-1 and APOLLO-2 studies of
OLINVO in moderate-to severe-acute pain following hard tissue and
soft tissue surgeries, respectively. OLINVO demonstrated
significant analgesic efficacy compared to placebo in both studies
for all three tested dosing regimens. Consistent with Phase 2b
results, a 0.35 mg dose regimen provided comparable pain relief to
a common IV morphine regimen and showed potential to reduce
opioid-related adverse effects on multiple measures of respiratory
safety and gastrointestinal tolerability.
- OLINVO program remains on track for a new drug
application (NDA) submission in 4Q 2017. As of March 31,
2017, approximately 600 patients have been treated with OLINVO in
the ongoing open-label, multi-procedure ATHENA safety study. In
addition, the Company has successfully completed a chemistry,
manufacturing, and controls Type B pre-NDA meeting with the U.S.
Food and Drug Administration (FDA), and all pre-NDA activities
remain on track to support an NDA submission to the FDA in the
fourth quarter of 2017.
- Presentation of Phase 3 OLINVO data at medical
conferences. In April, the Company announced two
presentations of results from the APOLLO-1 and APOLLO-2 pivotal
efficacy studies of OLINVO at the 42nd Annual Regional
Anesthesiology and Acute Pain Medicine Meeting, representing the
first scientific presentations of the Phase 3 OLINVO data.The
Company also today announced a poster presentation highlighting the
APOLLO-1 data at the Society for Ambulatory Anesthesia (SAMBA) 32nd
Annual Meeting taking place May 4 - 6 in Scottsdale, Arizona. David
Soergel, M.D., chief medical officer, also will highlight APOLLO-1
and APOLLO-2 data at a sponsored symposium on May 5th entitled
“Consequences of Poorly Controlled Acute Pain and New Frontiers in
Opioid Pharmacotherapy.” Later this month, the Company will be
making multiple presentations during the 36th Annual Scientific
Meeting of the American Pain Society (APS). Mike Lark, Ph.D., chief
scientific officer, and David Soergel, M.D., chief medical officer,
will present pre-clinical and clinical data, respectively, from the
OLINVO program as part of a panel entitled “Biased ligands: is
basic science finally starting to pay off?” at the Spring Pain 2017
conference running in partnership with APS. The Company will also
be making two poster presentations at the APS meeting.
- Initiated clinical development of TRV250 for treatment
of episodic migraine. In April, the Company initiated the
dosing of healthy volunteers for the first-time-in human study of
TRV250. This study aims to evaluate the safety, tolerability, and
pharmacokinetics of TRV250 dosed subcutaneously and orally. TRV250
is a new chemical entity targeting a novel mechanism of action for
treating migraine.
Financial results
For the first quarter of 2017, Trevena reported a net loss
attributable to common stockholders of $20.7 million, or $0.36 per
share, compared with a net loss attributable to common stockholders
for the first quarter of 2016 of $17.8 million, or $0.35 per share.
Research and development expenses were $16.1 million in the first
quarter of 2017 compared to $15.8 million for the same period in
2016; general and administrative expenses were $4.9 million,
compared to $3.9 million for the first quarter of 2016.
Cash, cash equivalents, and marketable securities were $97.9
million as of March 31, 2017, which the Company expects will fund
operations into the third quarter of 2018, including funding
enrollment in the Phase 3 ATHENA study by mid-year sufficient to
support the submission of the NDA for OLINVO, submitting the NDA to
the FDA in the fourth quarter of 2017, advancing TRV250 through a
first-time-in-human study, and the continued progression of the
Company’s pipeline.
About Trevena
Trevena, Inc. is a biopharmaceutical company developing
innovative therapies based on breakthrough science to benefit
patients and healthcare providers confronting serious medical
conditions. The Company has discovered four novel and
differentiated drug candidates, including OLINVO™ (oliceridine
injection). Trevena also has discovered TRV250, in Phase 1
development for the treatment of migraine, and TRV734 for pain. The
Company maintains an early stage portfolio of drug discovery
programs.
Cautionary note on 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 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, including the interpretation of the top-line
results from the APOLLO trials, whether such data will support the
Company’s new drug application and demonstrate the value of OLINVO,
whether OLINVO has the potential for fewer gastrointestinal and
respiratory adverse effects while providing comparable pain relief
to morphine, and the expected timing of the NDA submission for
oliceridine; the uncertainties inherent in conducting clinical
trials; expectations for regulatory approvals, including whether
the Phase 3 data will support FDA approval of oliceridine for the
management of moderate-to-severe pain; availability of funding
sufficient for the Company’s foreseeable and unforeseeable
operating expenses and capital expenditure requirements;
uncertainties related to the Company’s intellectual property; other
matters that could affect the availability or commercial potential
of the Company’s therapeutic candidates, including whether
physicians, patients, and payers will conclude that the oliceridine
development program has shown consistent differentiation from
morphine across multiple clinical trials; 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.
|
TREVENA, INC. |
Condensed Statements of
Operations |
(Unaudited, in thousands except share and per
share data) |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
Collaboration revenue |
|
$ |
- |
|
|
$ |
1,875 |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
General
and administrative |
|
|
4,879 |
|
|
|
3,918 |
|
Research
and development |
|
|
16,096 |
|
|
|
15,753 |
|
Total
operating expenses |
|
|
20,975 |
|
|
|
19,671 |
|
Loss
from operations |
|
|
(20,975 |
) |
|
|
(17,796 |
) |
Other
income |
|
|
261 |
|
|
|
17 |
|
Net
loss |
|
$ |
(20,714 |
) |
|
$ |
(17,779 |
) |
|
|
|
|
|
Per
share information: |
|
|
|
|
Net loss
per share of common stock, basic and diluted |
|
($0.36 |
) |
|
($0.35 |
) |
Weighted
average shares outstanding, basic and diluted |
|
|
56,894,672 |
|
|
|
51,350,365 |
|
|
|
|
|
|
TREVENA, INC. |
|
Condensed Balance Sheets |
|
(Unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
March 31, 2017 |
|
December 31, 2016 |
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
18,655 |
|
|
$ |
24,266 |
|
|
Marketable securities |
|
|
79,253 |
|
|
|
86,335 |
|
|
Prepaid
expenses and other current assets |
|
|
2,930 |
|
|
|
1,788 |
|
|
Total
current assets |
|
|
100,838 |
|
|
|
112,389 |
|
|
Property
and equipment, net |
|
|
1,096 |
|
|
|
1,059 |
|
|
Intangible asset, net |
|
|
13 |
|
|
|
13 |
|
|
Restricted cash |
|
|
1,193 |
|
|
|
1,193 |
|
|
Total
assets |
|
$ |
103,140 |
|
|
$ |
114,654 |
|
|
|
|
|
|
|
|
Liabilities and stockholders’
equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
|
$ |
4,712 |
|
|
$ |
8,749 |
|
|
Accrued
expenses and other current liabilities |
|
|
2,367 |
|
|
|
8,208 |
|
|
Current
portion of loans payable, net |
|
|
3,912 |
|
|
|
5,039 |
|
|
Deferred
rent |
|
|
54 |
|
|
|
52 |
|
|
Total
current liabilities |
|
|
11,045 |
|
|
|
22,048 |
|
|
Loans
payable, net |
|
|
23,999 |
|
|
|
13,270 |
|
|
Capital
leases, net of current portion |
|
|
16 |
|
|
|
18 |
|
|
Deferred
rent, net of current portion |
|
|
173 |
|
|
|
187 |
|
|
Warrant
liability |
|
|
40 |
|
|
|
75 |
|
|
Other
long term liabilities |
|
|
567 |
|
|
|
475 |
|
|
Total
liabilities |
|
|
35,840 |
|
|
|
36,073 |
|
|
|
|
|
|
|
|
Common
stock |
|
|
57 |
|
|
|
56 |
|
|
Additional paid-in capital |
|
|
373,631 |
|
|
|
364,148 |
|
|
Accumulated deficit |
|
|
(306,339 |
) |
|
|
(285,625 |
) |
|
Accumulated other comprehensive income (loss) |
|
|
(49 |
) |
|
|
2 |
|
|
Total
stockholders’ equity |
|
|
67,300 |
|
|
|
78,581 |
|
|
Total
liabilities and stockholders’ equity |
|
$ |
103,140 |
|
|
$ |
114,654 |
|
|
|
|
|
|
|
|
Contacts
Trevena, Inc.
Investors:
Jonathan Violin, Ph.D.
Vice president, corporate strategy & investor relations
610-354-8840 x231
jviolin@trevena.com
or
Media:
Public Relations
PR@trevena.com
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