— Company announces
submission of oliceridine healthy volunteer study protocol and
analysis plan to FDA —
Trevena, Inc. (NASDAQ: TRVN), a biopharmaceutical
company focused on the development and commercialization of
innovative treatment options that target and treat diseases
affecting the central nervous system, or CNS, today reported its
financial results for the fourth quarter and full year ended
December 31, 2018, and provided an overview of its 2018 and 2019
year-to-date operational highlights.
“Following our successful Type A meeting with FDA, we have
continued to rapidly move the oliceridine program forward,” said
Carrie L. Bourdow, President and Chief Executive Officer. “We
have submitted the protocol for the previously announced healthy
volunteer study of oliceridine and anticipate commencing this study
in the first half of 2019. In addition, we have achieved
meaningful milestones with our early-stage pipeline assets and, in
2019, expect to continue the development of these assets to build
long-term stockholder value.”
2018 and recent corporate highlights:
- Gained clarity on path forward to address CRL.
In January 2019, the Company announced receipt of the Type A
meeting minutes from FDA related to the oliceridine complete
response letter (CRL). FDA agreed that the Company’s current
safety database will support labeling at a maximum daily dose of 27
mg and indicated that the Company can conduct a study in healthy
volunteers to collect the additional QT interval data requested as
part of the CRL. The Company has submitted a detailed
protocol and analysis plan for this study to FDA and anticipates
study initiation in first half of 2019, following receipt of
feedback from FDA.
- Announced publication of APOLLO 1 Phase 3 results for
oliceridine. The Company announced the publication
of the Phase 3 results in The Journal of Pain Research on the
effects of oliceridine versus IV morphine for the management of
moderate-to-severe acute pain following bunionectomy.
- Completed successful capital raise. In
January 2019, the Company completed a $10 million registered direct
offering of common stock that yielded $9.2 million of net proceeds
and enabled the Company to extend its cash runway into the third
quarter of 2020.
- Continued progress with pipeline assets.
In 2018, the Company completed a Phase 1 trial for TRV250, a
potential new mechanism of action for the treatment of acute
migraine and commenced a partnership with the National Institute on
Drug Abuse (NIDA) for TRV734 in the management of opioid use
disorder. In its S1P receptor program, the Company is today
announcing its identification of a lead candidate for this program,
designated as TRV045. This candidate holds promise as a new
mechanism of action for a novel, non-opioid treatment of chronic
pain and other CNS conditions.
- Strengthened the Board of Directors.
Effective October 1, 2018, Scott Braunstein, M.D., was appointed to
the Board of Directors bringing over twenty-five years of industry
experience to the Trevena Board.
- Executed two ex-US licensing agreements.
In the second quarter of 2018, the Company entered into exclusive
licensing agreements for the development and commercialization of
oliceridine in South Korea with PharmBio Korea Inc. and in China
with Jiangsu Nhwa Pharmaceutical Co. Ltd.
Financial Results for Fourth Quarter and Full Year
2018
For the fourth quarter of 2018, the Company reported a net loss
attributable to common stockholders of $8.0 million, or $0.10 per
share, compared to $14.7 million, or $0.24 per share, for the
fourth quarter of 2017. For the full year ended December 31,
2018, net loss attributable to common stockholders was $30.8
million, or $0.42 per share, compared to $71.9 million, or $1.21
per share, for the year ended December 31, 2017. This
decrease is primarily due to the recognition in 2018 of
collaboration revenue associated with the licensing agreements for
oliceridine, and to substantially lower research and development
expenses.
Cash, cash equivalents, and marketable securities were $61.5
million at December 31, 2018. On January 29, 2018, the
Company completed a registered direct offering of 10.0 million
shares of common stock, which yielded net proceeds to the Company
of approximately $9.2 million. The Company believes that its
cash and cash equivalents and marketable securities as of December
31, 2018, together with interest thereon, and the approximately
$9.2 million of net proceeds from the registered direct offering,
to be sufficient to fund the Company’s operating expenses and
capital expenditure requirements into the third quarter of
2020.
Conference Call and Webcast InformationThe
Company will host a conference call and webcast with the investment
community on Wednesday, March 13th at 8:00 a.m. Eastern Time
featuring remarks by Carrie L. Bourdow, President and CEO, Mark A.
Demitrack, M.D., SVP and Chief Medical Officer, and John P. Hamill,
VP, Finance.
Live Call: |
Toll-Free: (855) 465-0180International: (484) 756-4313 |
Webcast: |
investors.trevena.com |
Replay: |
Toll-Free: (855) 859-2056 International: (404) 537-3406
Conference ID: 3496246(Available approximately one hour after the
completion of the live call until 11:59 p.m. ET on March 27,
2019) |
About TrevenaTrevena, Inc. is a
biopharmaceutical company focused on the development and
commercialization of innovative treatment options that target and
treat diseases affecting the central nervous system, or CNS.
The Company has three novel and differentiated investigational drug
candidates, including IV oliceridine, for the management of
moderate to severe acute pain in hospitals, TRV250 for the
treatment of acute migraine, and TRV734 for the management of pain
and/or management of opioid dependence. In its preclinical
programs, we have 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, whether there is a path to
resubmit the oliceridine NDA, and the timing of any FDA review of
the protocol for a future oliceridine study; 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 December
31, 2018 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 December 31, |
|
Year Ended December 31, |
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
232 |
|
|
$ |
- |
|
|
$ |
5,732 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
General
and administrative |
|
|
4,073 |
|
|
|
5,143 |
|
|
|
18,979 |
|
|
|
19,639 |
|
|
Research
and development |
|
|
2,747 |
|
|
|
7,198 |
|
|
|
15,824 |
|
|
|
48,974 |
|
|
Restructuring charges |
|
|
1,363 |
|
|
|
1,774 |
|
|
|
1,427 |
|
|
|
1,774 |
|
|
Total
operating expenses |
|
|
8,183 |
|
|
|
14,115 |
|
|
|
36,230 |
|
|
|
70,387 |
|
|
Loss
from operations |
|
|
(7,951 |
) |
|
|
(14,115 |
) |
|
|
(30,498 |
) |
|
|
(70,387 |
) |
|
Other
income (expense) |
|
|
(25 |
) |
|
|
(605 |
) |
|
|
459 |
|
|
|
(1,478 |
) |
|
Loss
before income tax expense |
|
|
(7,976 |
) |
|
|
(14,720 |
) |
|
|
(30,039 |
) |
|
|
(71,865 |
) |
|
Foreign
income tax expense |
|
|
- |
|
|
|
- |
|
|
|
(745 |
) |
|
|
- |
|
|
Net
loss |
|
$ |
(7,976 |
) |
|
$ |
(14,720 |
) |
|
$ |
(30,784 |
) |
|
$ |
(71,865 |
) |
|
|
|
|
|
|
|
|
|
|
|
Per
share information: |
|
|
|
|
|
|
|
|
|
Net loss
per share of common stock, basic and diluted |
|
($0.10 |
) |
|
($0.24 |
) |
|
($0.42 |
) |
|
($1.21 |
) |
|
Weighted
average shares outstanding, basic and diluted |
|
|
82,323,393 |
|
|
|
62,290,002 |
|
|
|
73,558,548 |
|
|
|
59,436,649 |
|
|
|
|
|
|
|
|
|
|
|
|
|
TREVENA, INC. |
Condensed Balance Sheets |
(Unaudited, in thousands) |
|
|
|
|
|
|
|
December 31, 2018 |
|
December 31, 2017 |
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash
equivalents |
|
$ |
32,892 |
|
|
$ |
16,557 |
|
Marketable securities |
|
|
28,590 |
|
|
|
49,543 |
|
Prepaid
expenses and other current assets |
|
|
607 |
|
|
|
1,393 |
|
Total
current assets |
|
|
62,089 |
|
|
|
67,493 |
|
Restricted cash |
|
|
1,303 |
|
|
|
1,413 |
|
Property
and equipment, net |
|
|
3,387 |
|
|
|
3,805 |
|
Intangible asset, net |
|
|
- |
|
|
|
11 |
|
Total
assets |
|
$ |
66,779 |
|
|
$ |
72,722 |
|
|
|
|
|
|
Liabilities and stockholders’
equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts
payable |
|
$ |
1,416 |
|
|
$ |
1,424 |
|
Accrued
expenses and other current liabilities |
|
|
3,305 |
|
|
|
4,303 |
|
Current
portion of loans payable, net |
|
|
12,562 |
|
|
|
12,425 |
|
Deferred
rent |
|
|
207 |
|
|
|
61 |
|
Total
current liabilities |
|
|
17,490 |
|
|
|
18,213 |
|
Loans
payable, net |
|
|
4,811 |
|
|
|
15,725 |
|
Capital
leases, net of current portion |
|
|
20 |
|
|
|
31 |
|
Deferred
rent, net of current portion |
|
|
2,931 |
|
|
|
3,006 |
|
Warrant
liability |
|
|
1 |
|
|
|
10 |
|
Other
long term liabilities |
|
|
- |
|
|
|
1,104 |
|
Total
liabilities |
|
|
25,253 |
|
|
|
38,089 |
|
|
|
|
|
|
Common
stock |
|
|
82 |
|
|
|
62 |
|
Additional paid-in capital |
|
|
429,727 |
|
|
|
392,103 |
|
Accumulated deficit |
|
|
(388,274 |
) |
|
|
(357,490 |
) |
Accumulated other comprehensive income (loss) |
|
|
(9 |
) |
|
|
(42 |
) |
Total
stockholders’ equity |
|
|
41,526 |
|
|
|
34,633 |
|
Total
liabilities and stockholders’ equity |
|
$ |
66,779 |
|
|
$ |
72,722 |
|
|
|
|
|
|
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