– Two positive Phase 3 pivotal efficacy studies
of OLINVO™ (oliceridine injection) completed –
Trevena, Inc. (NASDAQ:TRVN) today announced financial results for
the fourth quarter and full year ended December 31, 2016 and
provided an update on its ongoing clinical programs, including
additional data from the recently completed Phase 3 APOLLO-1 and
APOLLO-2 pivotal efficacy studies of OLINVO in moderate-to-severe
acute pain.
“The recent successful completion of the pivotal
efficacy studies for OLINVO puts us in a strong position to bring
this innovative analgesic to physicians and patients in need of a
new option for managing moderate-to-severe acute pain in the
hospital,” said Maxine Gowen, Ph.D., chief executive officer. “We
believe the data from these studies highlight the potential for
OLINVO to reduce the burden of opioid-related adverse effects,
particularly for those patients who are at elevated risk for
serious consequences from post-operative nausea and vomiting or
opioid-induced respiratory depression.”
2016 and recent corporate
highlights
- Obtained Breakthrough Therapy Designation for
OLINVO. In February 2016, the Company announced that the
U.S. Food and Drug Administration (FDA) had awarded OLINVO
Breakthrough Therapy status, a designation granted to new therapies
intended to treat serious conditions and for which preliminary
clinical evidence indicates that the drug may demonstrate
substantial clinical improvement over currently available
therapies.
- Successful End-of-Phase 2 meeting with FDA. In
May 2016, the Company announced that it had reached general
agreement with the FDA on key elements of the Phase 3 OLINVO
program to support a New Drug Application (NDA), including that the
APOLLO-1 and APOLLO-2 pivotal efficacy trials in bunionectomy and
abdominoplasty included appropriate patient populations to support
an indication for moderate-to-severe acute pain.
- In February 2017, announced positive top-line results
from two Phase 3 pivotal efficacy studies of OLINVO in
moderate-to-severe acute pain. OLINVO demonstrated fast
onset and strong opioid efficacy in hard tissue and soft tissue
pain models, supporting the Company’s planned NDA submission and a
potential indication for the management of moderate-to-severe acute
pain. Numerous measures of respiratory safety and
gastrointestinal tolerability all showed trends of meaningful
improvements for OLINVO compared to a commonly used IV morphine
regimen.
- Initiated Phase 3 ATHENA open label safety study of
OLINVO. In January 2016, the Company announced the launch
of the OLINVO Phase 3 clinical program with the enrollment of
patients in the open label Phase 3 ATHENA study. This study is
evaluating the safety and tolerability of OLINVO in patients with
acute moderate-to-severe pain in a variety of surgical settings. As
of February 15, 2017, more than 400 patients have been treated with
OLINVO, with no apparent off-target or unexpected drug-related
adverse effects to date. The Company remains on track to
submit an NDA for OLINVO in the fourth quarter of 2017.
- Completed clinical pharmacology and pharmacokinetics
studies suggesting that OLINVO may offer potentially safer dosing
in hard-to-treat patients. In February 2017, the Company
announced the completion of a number of additional studies of
OLINVO. - A renal impairment study found no evidence of altered
pharmacokinetics or accumulation in patients with renal failure,
both of which occur with morphine and hydromorphone.- Preclinical
and clinical studies have found no evidence of active metabolites,
which for other opioids can cause variable and delayed adverse
events.
- Continued engagement with academic and medical
communities. The Company presented peer-reviewed data from
its Phase 2 studies of OLINVO at a number of academic and medical
conferences, including the 41st Annual Regional Anesthesiology and
Acute Pain Medicine Meeting, the 35th Annual Scientific Meeting of
the American Pain Society, and the 2016 Annual Meeting of the
American Society of Anesthesiologists.
- Completed preclinical development of TRV250 for
migraine. The Company announced today that it expects
to initiate first-time-in-human studies of TRV250 for the treatment
of migraine in the second quarter of this year. TRV250 is a G
protein biased ligand targeting the δ-receptor with potential for a
first-in-class, non-narcotic mechanism for the treatment of
migraine. TRV250 also may have utility in a range of other central
nervous system indications. Because TRV250 selectively targets the
δ-receptor, the Company believes it will not have the addiction
liability or other adverse effects associated with compounds
targeting the mu-opioid receptor.
Financial results
For the fourth quarter of 2016, Trevena reported a
net loss attributable to common stockholders of $36.1 million, or
$0.67 per share, compared with a net loss attributable to common
stockholders for the fourth quarter of 2015 of $15.5 million, or
$0.30 per share.
For the year ended December 31, 2016, the Company
incurred a net loss attributable to common stockholders of $103.0
million, or $1.97 per share, compared with a net loss attributable
to common stockholders of $50.5 million, or $1.15 per share, for
the comparable period in 2015.
Cash, cash equivalents, and marketable securities
were $110.6 million as of December 31, 2016. The Company expects
that expenses will decrease in 2017 compared to 2016, primarily
attributable to lower R&D expense following the recent
completion of the Phase 3 APOLLO trials. As such, the Company
expects currently available cash, cash equivalents, and marketable
securities to fund operations into the second quarter of 2018,
which should be sufficient to complete the OLINVO Phase 3
ATHEHA study, submit the NDA in 4Q 2017, continue OLINVO commercial
launch preparations, complete the TRV250 first-time-in-human study,
and continue the progression of Trevena’s pipeline.
Conference call and webcast
Date: March 8, 2017
Time: 8:00 a.m. EST
Telephone Access: (855) 465-0180
International: (484) 756-4313
Conference ID: 81728820
To access the live audio webcast of the
presentation, please visit the Investor section of the Company's
website. The webcast will be available for replay for 30 days.
About OLINVO™ (oliceridine
injection)
OLINVO™ (oliceridine injection), Trevena’s lead
product candidate, is a next generation IV analgesic in Phase 3
development for the management of moderate-to-severe acute pain in
the hospital and similar settings and has been granted Breakthrough
Therapy designation by the U.S. Food and Drug Administration (FDA).
OLINVO was specifically designed to improve conventional opioid
pharmacology to deliver the pain-reducing potential of an opioid
but with fewer associated adverse effects. In Phase 2 and Phase 3
clinical trials, OLINVO provided rapid and powerful analgesic
efficacy while demonstrating a wider therapeutic window compared to
morphine, suggesting it may be highly effective and well-tolerated
for patients in need of strong analgesia. OLINVO is an
investigational product and has not been approved by the FDA or any
other regulatory agency. The Company expects OLINVO to be a
Schedule II controlled substance.
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 preclinical
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 results put the Company in a strong position to file
the OLINVO NDA and bring this product to market, whether OLINVO
will provide safer dosing for hard-to-treat patients or reduce the
burden of opioid-related adverse effects, whether TRV250 may have
utility in other central nervous system indications and not have
the addiction liability or other adverse effects seen with
mu-opioid receptors, and the expected timing of the NDA submission
for oliceridine; the uncertainties inherent in conducting clinical
trials, including whether top-line results from the APOLLO trials
will be consistent with the full results of the trials, once
available, or adverse events seen to date in the ATHENA safety
study will be consistent with any future adverse events;
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 per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
- |
|
|
$ |
1,875 |
|
|
$ |
3,750 |
|
|
$ |
6,250 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
General
and administrative |
|
|
4,384 |
|
|
|
3,820 |
|
|
|
16,077 |
|
|
|
12,797 |
|
|
Research
and development |
|
|
31,451 |
|
|
|
13,549 |
|
|
|
89,956 |
|
|
|
44,074 |
|
|
Total
operating expenses |
|
|
35,835 |
|
|
|
17,369 |
|
|
|
106,033 |
|
|
|
56,871 |
|
|
Loss
from operations |
|
|
(35,835 |
) |
|
|
(15,494 |
) |
|
|
(102,283 |
) |
|
|
(50,621 |
) |
|
Other
income (expense) |
|
|
(265 |
) |
|
|
30 |
|
|
|
(711 |
) |
|
|
93 |
|
|
Net
loss |
|
$ |
(36,100 |
) |
|
$ |
(15,464 |
) |
|
$ |
(102,994 |
) |
|
$ |
(50,528 |
) |
|
|
|
|
|
|
|
|
|
|
|
Per
share information: |
|
|
|
|
|
|
|
|
|
Net loss
per share of common stock, basic and diluted |
|
$ |
(0.67 |
) |
|
$ |
(0.30 |
) |
|
$ |
(1.97 |
) |
|
$ |
(1.15 |
) |
|
Weighted
average shares outstanding, basic and diluted |
|
|
53,850 |
|
|
|
50,770 |
|
|
|
52,399 |
|
|
|
43,794 |
|
|
|
|
|
|
|
|
|
|
|
|
TREVENA, INC. |
|
Condensed Balance Sheets |
|
(Unaudited, in thousands) |
|
|
|
|
|
|
|
|
|
December 31, 2016 |
|
December 31, 2015 |
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
24,266 |
|
|
$ |
46,774 |
|
|
Marketable securities |
|
|
86,335 |
|
|
|
125,864 |
|
|
Prepaid
expenses and other current assets |
|
|
1,788 |
|
|
|
1,893 |
|
|
Total
current assets |
|
|
112,389 |
|
|
|
174,531 |
|
|
Property
and equipment, net |
|
|
1,059 |
|
|
|
696 |
|
|
Intangible asset, net |
|
|
13 |
|
|
|
15 |
|
|
Restricted cash |
|
|
1,193 |
|
|
|
112 |
|
|
Total
assets |
|
$ |
114,654 |
|
|
$ |
175,354 |
|
|
|
|
|
|
|
|
Liabilities and stockholders’
equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts
payable |
|
$ |
8,749 |
|
|
$ |
6,750 |
|
|
Accrued
expenses and other current liabilities |
|
|
8,208 |
|
|
|
3,030 |
|
|
Current
portion of loans payable, net |
|
|
5,039 |
|
|
|
- |
|
|
Deferred
revenue |
|
|
- |
|
|
|
3,750 |
|
|
Deferred
rent |
|
|
52 |
|
|
|
44 |
|
|
Total
current liabilities |
|
|
22,048 |
|
|
|
13,574 |
|
|
Loans
payable, net |
|
|
13,270 |
|
|
|
18,186 |
|
|
Capital
leases, net of current portion |
|
|
18 |
|
|
|
8 |
|
|
Deferred
rent, net of current portion |
|
|
187 |
|
|
|
239 |
|
|
Warrant
liability |
|
|
75 |
|
|
|
153 |
|
|
Other
long term liabilities |
|
|
475 |
|
|
|
63 |
|
|
Total
liabilities |
|
|
36,073 |
|
|
|
32,223 |
|
|
|
|
|
|
|
|
Common
stock |
|
|
56 |
|
|
|
51 |
|
|
Additional paid-in capital |
|
|
364,148 |
|
|
|
325,784 |
|
|
Accumulated deficit |
|
|
(285,625 |
) |
|
|
(182,498 |
) |
|
Accumulated other comprehensive income (loss) |
|
|
2 |
|
|
|
(206 |
) |
|
Total
stockholders’ equity |
|
|
78,581 |
|
|
|
143,131 |
|
|
Total
liabilities and stockholders’ equity |
|
$ |
114,654 |
|
|
$ |
175,354 |
|
|
|
|
|
|
|
|
Contacts
Trevena, Inc.
Investors:
Jonathan Violin, Ph.D.
Sr. Director, Investor Relations
610-354-8840 x231
jviolin@trevena.com
or
Media:
Public Relations
PR@trevena.com
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