Trevena Reports First Quarter 2019 Results
May 10 2019 - 7:00AM
Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical
company focused on the development and commercialization of novel
medicines for patients affected by Central Nervous System (CNS)
conditions, today announced receipt of comments from the U.S Food
and Drug Administration (FDA) on the proposed healthy volunteer
study protocol, and reported its financial results for the quarter
ended March 31, 2019.
“We are very pleased with the feedback from FDA, which provides
us with the necessary information to move forward and initiate the
healthy volunteer study by the end of June,” said Carrie Bourdow,
President and Chief Executive Officer. “This marks a critical
step on the path towards resubmission of the new drug application
for oliceridine, and I am proud of our team for their considerable
efforts in preparing for this important upcoming work.”
First Quarter and Recent Corporate
Highlights:
- Received feedback from FDA on key design elements for
the healthy volunteer study. The FDA confirmed that
the study can be conducted in healthy volunteers over a 24-hour
period. The study will be performed at a single site as
a three-period crossover design that includes oliceridine, placebo,
and moxifloxacin as a positive control.The Company plans to submit
data on approximately 60 participants. Among this study
population, a minimum of 20 participants will receive a cumulative
dose of 27 mg of oliceridine, the proposed maximum daily dose,
through the 24-hour study period.The study remains on track to
initiate by the end of June. The Company will provide
additional details on a conference call scheduled for Monday, May
13th at 8:00 a.m. Eastern Time.
- Completed successful capital raise. In
January, the Company completed a $10 million registered direct
offering of common stock that yielded $9.2 million of net
proceeds.
Financial Results for First Quarter 2019
For the first quarter of 2019, the Company reported a net loss
attributable to common stockholders of $5.2 million, or $0.06 per
share, compared to $9.0 million, or $0.14 per share, for the first
quarter of 2018. This decrease is primarily due to lower
personnel related costs associated with the 2018 restructuring and
reduction in force, and lower research and development
expenses.
Cash, cash equivalents, and marketable securities were $60.1
million at March 31, 2019. The Company believes its cash,
cash equivalents, and marketable securities as of March 31, 2019,
together with interest thereon, 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 Monday, May 13th at 8:00 a.m. Eastern Time featuring
remarks by Carrie Bourdow, President and CEO, 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)
859-2056 International: (404) 537-3406 Conference ID:
7698684(Available approximately one hour after the completion of
the live call until 11:59 p.m. ET on May 22, 2019) |
About TrevenaTrevena, Inc. is a
biopharmaceutical company focused on the development and
commercialization of novel medicines for patients affected by
Central Nervous System (CNS) conditions. 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 use disorder. In its preclinical programs, the
Company has 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 March 31,
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 March 31, |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
Revenue |
|
$ |
- |
|
|
$ |
- |
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
General and administrative |
|
|
3,060 |
|
|
|
5,072 |
|
Research and development |
|
|
2,154 |
|
|
|
4,598 |
|
Restructuring charges |
|
|
- |
|
|
|
23 |
|
Total operating expenses |
|
|
5,214 |
|
|
|
9,693 |
|
Loss from operations |
|
|
(5,214 |
) |
|
|
(9,693 |
) |
Other income (expense) |
|
|
45 |
|
|
|
672 |
|
Loss before income tax expense |
|
|
(5,169 |
) |
|
|
(9,021 |
) |
Foreign income tax expense |
|
|
- |
|
|
|
- |
|
Net loss |
|
$ |
(5,169 |
) |
|
$ |
(9,021 |
) |
|
|
|
|
|
Per share information: |
|
|
|
|
Net loss per share of common stock, basic and diluted |
|
|
($0.06 |
) |
|
|
($0.14 |
) |
Weighted average shares outstanding, basic and diluted |
|
|
88,897,292 |
|
|
|
64,562,236 |
|
|
|
|
|
|
TREVENA, INC. |
Condensed Balance Sheets |
(Unaudited, in thousands) |
|
|
|
|
|
|
|
March 31, 2019 |
|
December 31, 2018 |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
20,261 |
|
|
$ |
32,892 |
|
Marketable securities |
|
|
39,802 |
|
|
|
28,590 |
|
Prepaid expenses and other current assets |
|
|
1,581 |
|
|
|
607 |
|
Total current assets |
|
|
61,644 |
|
|
|
62,089 |
|
Restricted cash |
|
|
1,305 |
|
|
|
1,303 |
|
Property and equipment, net |
|
|
3,238 |
|
|
|
3,387 |
|
Right-of-use lease assets |
|
|
5,702 |
|
|
|
- |
|
Total assets |
|
$ |
71,889 |
|
|
$ |
66,779 |
|
|
|
|
|
|
Liabilities and stockholders’
equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
|
$ |
358 |
|
|
$ |
1,416 |
|
Accrued expenses and other current liabilities |
|
|
1,956 |
|
|
|
3,305 |
|
Current portion of loans payable, net |
|
|
14,330 |
|
|
|
12,562 |
|
Current portion of lease liabilities |
|
|
563 |
|
|
|
Deferred rent |
|
|
- |
|
|
|
207 |
|
Total current liabilities |
|
|
17,207 |
|
|
|
17,490 |
|
Loans payable, net |
|
|
- |
|
|
|
4,811 |
|
Leases, net of current portion |
|
|
8,281 |
|
|
|
20 |
|
Deferred rent, net of current portion |
|
|
- |
|
|
|
2,931 |
|
Warrant liability |
|
|
14 |
|
|
|
1 |
|
Total liabilities |
|
|
25,502 |
|
|
|
25,253 |
|
|
|
|
|
|
Common stock |
|
|
92 |
|
|
|
82 |
|
Additional paid-in capital |
|
|
439,735 |
|
|
|
429,727 |
|
Accumulated deficit |
|
|
(393,443 |
) |
|
|
(388,274 |
) |
Accumulated other comprehensive income (loss) |
|
|
3 |
|
|
|
(9 |
) |
Total stockholders’ equity |
|
|
46,387 |
|
|
|
41,526 |
|
Total liabilities and stockholders’ equity |
|
$ |
71,889 |
|
|
$ |
66,779 |
|
|
|
|
|
|
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