Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical
company focused on the development and commercialization of novel
medicines for patients with Central Nervous System (CNS)
conditions, today reported its financial results for the second
quarter ended June 30, 2019, and provided an overview of its recent
operational highlights.
“We made substantive progress in the second quarter on the key
activities to support resubmission of the NDA for oliceridine and
advancement of our pipeline,” said Carrie Bourdow, President and
Chief Executive Officer. “Subject enrollment in our healthy
volunteer study for oliceridine is progressing well, and we remain
focused on delivering topline data next quarter. We’re also
excited to continue development efforts for our other pipeline
assets, including the acute migraine study for TRV250, which is
slated to start next quarter.”
Second Quarter and Recent Corporate
Highlights:
- Strengthened leadership team. The
Company recently announced the appointment of Barry Shin as Senior
Vice President and Chief Financial Officer. Mr. Shin brings
over 17 years of investment banking and corporate advisory
experience focused in the biopharmaceuticals sector, including in
the Healthcare Investment Banking groups of Mizuho Securities,
Guggenheim Securities, and Piper Jaffray.
- Initiated healthy volunteer QT interval study for
oliceridine. In June, the Company announced
initiation of its single-site, three-period crossover, healthy
volunteer study for oliceridine. The primary objective of the
study is to collect the additional QT interval data requested by
the U.S. Food and Drug Administration (FDA) for the resubmission of
the NDA for oliceridine.Study enrollment is on track to support
topline data readout in the fourth quarter of 2019. As of
today, over half of study subjects have begun dosing, with more
than 20 subjects receiving the maximum daily dose of 27 mg of
oliceridine, a key FDA requirement of the study design. The
Company continues to expect to resubmit the NDA for oliceridine as
early as possible in the first quarter of 2020.
- Advanced acute migraine proof-of-concept study protocol
for TRV250. This double-blind, placebo-controlled
clinical study will enroll approximately 120 migraineurs in a
validated nitroglycerin (NTG) provocation migraine model.
Migraineurs will receive a 20 mg subcutaneous dose of TRV250
or placebo. Target engagement will be determined by the
reduction in the number of subjects who experience a sustained
NTG-induced headache. The Company continues to expect to
initiate this study in the fourth quarter of 2019.
- Submitted four oliceridine abstracts, all of which were
accepted for presentation at the 2019 Annual Meeting of the
American Society of Anesthesiologists (ASA). The
Company today announced that all abstracts submitted to the 2019
ASA meeting have been accepted for presentation, including one that
will be featured in the Best of Clinical Science session.
The meeting will take place October 19-23, 2019, at the
Orange County Convention Center in Orlando, Florida. The
presentations will feature data highlighting the safety profile of
oliceridine compared to IV morphine.
Presentation details:
- Improved safety of opioid analgesic Oliceridine compared to
Morphine assessed by utility function analysis (oral presentation,
Best of Abstracts: Clinical Science featured
session)• Saturday, October 19, 2019 from 1:00 p.m. – 3:00
p.m. EST• Sunday, October 20, 2019 from 8:00 a.m. – 9:30 a.m.
EST
- Low Incidence Of Opioid-induced Respiratory Depression Observed
With Oliceridine Regardless Of Age Or Body Mass Index (e-poster,
abstract #2228)• Sunday, October 20, 2019 from 1:30 p.m. – 2:00
p.m. EST
- Lower Incidence Of Postoperative Opioid-induced Respiratory
Depression With Oliceridine Compared To Morphine: A Retrospective
Analysis (e-poster, abstract #2232)• Sunday, October 20, 2019 from
2:00 p.m. – 2.30 p.m. EST
- Oliceridine (TRV130) Demonstrates Less Opioid-induced
Respiratory Depression Than Morphine (M) As Measured By The Average
Cumulative Duration Of Dosing Interruption In Patients Being
Treated For Acute Post-surgical Pain (e-poster, abstract #3069)•
Monday, October 21, 2019 from 10:00 a.m. – 10:30 a.m. EST
All abstracts will be made available on
https://www.asahq.org/annualmeeting/education/sessions.
- Published clinical data for oliceridine. In
June, the Company announced the publication of pivotal Phase 3
results in the journal Pain Practice on the effects of oliceridine
for the management of moderate to severe acute pain following soft
tissue surgery.
Financial Results for Second Quarter 2019
For the second quarter of 2019, the Company reported a net loss
attributable to common stockholders of $4.7 million, or $0.05 per
share, compared to $9.3 million, or $0.13 per share, for the second
quarter of 2018. This decrease is primarily due to a decrease
in expenditures resulting from the 2018 restructuring and reduction
in force and associated cost-saving initiatives.
Cash, cash equivalents, and marketable securities were $54.0
million as of June 30, 2019. The Company believes its cash,
cash equivalents, and marketable securities as of June 30, 2019,
together with interest thereon, to be sufficient to fund the
Company’s operating expenses, debt service, and capital expenditure
requirements for at least twelve months following the date of this
filing, into the third quarter of 2020.
Conference Call and Webcast Information
The Company will host a conference call and webcast with the
investment community on Wednesday, August 7, 2019 at 8:00 a.m.
Eastern Time featuring remarks by Carrie Bourdow, President and
CEO, Barry Shin, SVP and Chief Financial Officer, and Mark
Demitrack, SVP and Chief Medical Officer.
Live
Call: |
Toll-Free: (855)
465-0180International: (484) 756-4313 |
Webcast: |
investors.trevena.com |
Replay: |
Toll-Free: (855)
859-2056International: (404) 537-3406Conference ID: 3799758
(Available approximately one hour after the completion of the live
call until 11:59 p.m. ET on August 14, 2019) |
|
|
About TrevenaTrevena, Inc. is a
biopharmaceutical company focused on the development and
commercialization of novel medicines for patients with Central
Nervous System conditions. 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 managing chronic pain.
Forward-Looking StatementsAny 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 or any future trials, including with respect to any future
clinical study of oliceridine; the uncertainties inherent in
conducting clinical trials; expectations for regulatory
interactions, submissions and approvals, including the Company’s
assessment of the discussions with FDA, and whether there is a path
to resubmit the oliceridine NDA; availability of funding sufficient
for the Company’s foreseeable and unforeseeable operating expenses
and capital expenditure requirements and whether cash, cash
equivalents, and marketable securities as of June 30, 2019 will be
sufficient to fund operating expenses and capital expenditure
requirements into the third quarter of 2020; uncertainties related
to the Company’s intellectual property; 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:
Investor Contact:Valter Pinto / Allison
SossKCSA Strategic CommunicationsPhone: 212-896-1254 /
212-896-1267Email: IR@trevena.com
Company Contact:Bob Yoder, SVP and Chief
Business OfficerTrevena, Inc.Phone: 610-354-8840
TREVENA, INC. |
Condensed Statements of
Operations |
(Unaudited, in thousands except share and per share
data) |
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
Revenue |
$ |
- |
|
|
$ |
2,500 |
|
|
$ |
- |
|
|
$ |
2,500 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
General and administrative |
|
3,311 |
|
|
|
5,926 |
|
|
|
6,371 |
|
|
|
10,998 |
|
Research and development |
|
2,722 |
|
|
|
5,128 |
|
|
|
4,876 |
|
|
|
9,726 |
|
Restructuring charges |
|
- |
|
|
|
41 |
|
|
|
- |
|
|
|
64 |
|
Impairment of property and equipment |
|
108 |
|
|
|
- |
|
|
|
108 |
|
|
|
- |
|
Total operating expenses |
|
6,141 |
|
|
|
11,095 |
|
|
|
11,355 |
|
|
|
20,788 |
|
Loss from operations |
|
(6,141 |
) |
|
|
(8,595 |
) |
|
|
(11,355 |
) |
|
|
(18,288 |
) |
Other income |
|
1,450 |
|
|
|
36 |
|
|
|
1,495 |
|
|
|
708 |
|
Loss before income tax expense |
|
(4,691 |
) |
|
|
(8,559 |
) |
|
|
(9,860 |
) |
|
|
(17,580 |
) |
Foreign income tax expense |
|
- |
|
|
|
(745 |
) |
|
|
- |
|
|
|
(745 |
) |
Net loss |
$ |
(4,691 |
) |
|
$ |
(9,304 |
) |
|
$ |
(9,860 |
) |
|
$ |
(18,325 |
) |
|
|
|
|
|
|
|
|
Per share information: |
|
|
|
|
|
|
|
Net loss per share of common stock, basic and diluted |
$ |
(0.05 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.27 |
) |
Weighted average shares outstanding, basic and diluted |
|
92,414,644 |
|
|
|
69,664,994 |
|
|
|
90,665,684 |
|
|
|
67,127,711 |
|
|
|
|
|
|
|
|
|
TREVENA, INC. |
Condensed Balance Sheets |
(Unaudited, in thousands) |
|
|
|
|
|
June 30, 2019 |
|
December 31, 2018 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
23,826 |
|
|
$ |
32,892 |
|
Marketable securities |
|
30,140 |
|
|
|
28,590 |
|
Prepaid expenses and other current assets |
|
1,301 |
|
|
|
607 |
|
Total current assets |
|
55,267 |
|
|
|
62,089 |
|
Restricted cash |
|
1,306 |
|
|
|
1,303 |
|
Property and equipment, net |
|
2,982 |
|
|
|
3,387 |
|
Right-of-use lease assets |
|
5,629 |
|
|
|
- |
|
Total assets |
$ |
65,184 |
|
|
$ |
66,779 |
|
|
|
|
|
Liabilities and stockholders’
equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
403 |
|
|
$ |
1,416 |
|
Accrued expenses and other current liabilities |
|
2,416 |
|
|
|
3,295 |
|
Current portion of loans payable, net |
|
11,258 |
|
|
|
12,562 |
|
Current portion of lease liabilities |
|
581 |
|
|
|
10 |
|
Deferred rent |
|
- |
|
|
|
207 |
|
Total current liabilities |
|
14,658 |
|
|
|
17,490 |
|
Loans payable, net |
|
- |
|
|
|
4,811 |
|
Leases, net of current portion |
|
8,127 |
|
|
|
20 |
|
Deferred rent, net of current portion |
|
- |
|
|
|
2,931 |
|
Warrant liability |
|
7 |
|
|
|
1 |
|
Total liabilities |
|
22,792 |
|
|
|
25,253 |
|
|
|
|
|
Common stock |
|
92 |
|
|
|
82 |
|
Additional paid-in capital |
|
440,424 |
|
|
|
429,727 |
|
Accumulated deficit |
|
(398,134 |
) |
|
|
(388,274 |
) |
Accumulated other comprehensive income (loss) |
|
10 |
|
|
|
(9 |
) |
Total stockholders’ equity |
|
42,392 |
|
|
|
41,526 |
|
Total liabilities and stockholders’ equity |
$ |
65,184 |
|
|
$ |
66,779 |
|
|
|
|
|
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