Trevena Reports Third Quarter 2017 Financial Results and Announces New Positive Clinical Trial Data
November 07 2017 - 07:00AM
– New ATHENA data show OLINVO effectiveness with
promising safety/tolerability in key target procedures –
Trevena, Inc. (NASDAQ:TRVN) today announced financial results for
the quarter ended September 30, 2017, and announced positive new
data from both its OLINVOTM (oliceridine injection) and TRV250
programs.
“The recent submission of the OLINVO NDA capped a transformative
period for our Company,” said Maxine Gowen, Ph.D., chief executive
officer. “We are now focused on preparing for the approval and
commercialization of OLINVO, while continuing to advance our
development pipeline following our recent strategic decision to
halt our discovery research efforts. To this end, new results
continue to highlight the potential value of OLINVO for patients in
a real world setting who require IV opioids but are at risk of
opioid-related adverse events. Positive interim Phase 1 data
for TRV250 bode well for future clinical development of this
exciting potential migraine therapy.”
Third quarter and recent corporate
highlights
- OLINVO New Drug Application submitted. The
Company recently submitted its New Drug Application (NDA) for
OLINVO to the U.S. Food and Drug Administration (FDA). OLINVO
is the first G protein biased ligand of the mu opioid receptor, a
new class of opioid receptor modulator, and the first pain program
to receive Breakthrough Therapy designation from the FDA. The
submission includes data showing that intravenous OLINVO
demonstrated analgesic efficacy in all three dosing regimens tested
in the two Phase 3 APOLLO pivotal efficacy studies. These
trials were designed to support an indication for the management of
moderate-to-severe acute pain in adult patients for whom an
intravenous opioid is warranted. The filing also includes safety
and tolerability data for over 1,100 patients administered OLINVO
across Phase 2 and Phase 3 studies, including the ATHENA open label
safety study. Additional pharmacokinetic data, clinical
pharmacology data, and results from five randomized controlled
trials with head to head comparisons to morphine, support potential
differentiation of OLINVO.
- New data from Phase 3 ATHENA open label safety
study. In July, the Company announced top-line
results from the first 418 patients administered OLINVO to manage
medical or postoperative pain in the ATHENA study, which was
designed to model real-world use including multimodal analgesia
regimens incorporating OLINVO. Data for all 768 patients
administered OLINVO are now final, and highlight the effectiveness
and utility of OLINVO in treating patients who require an IV opioid
to manage pain. Across the ATHENA study:
- The most common procedures were orthopedic, colorectal,
gynecologic, and general surgeries. Patients at elevated risk
of opioid-related adverse events were well represented; more than
30% of patients were 65 years or older, and more than 50% of
patients were obese, with body mass index (BMI) >30
kg/m2.
- Only 2% of patients discontinued for adverse events, and 4% of
patients discontinued for lack of efficacy. The most common
adverse events were nausea, constipation, and vomiting, with
prevalence lower than in the APOLLO studies. Adverse event
rates associated with OLINVO administered by patient controlled
analgesia (PCA) and as-needed bolus dosing were similar, supporting
potential use of OLINVO in both administration paradigms.
- Hosted an Analyst Day featuring four leading experts in
acute pain management in the hospital. In July, the
Company hosted an Analyst Day where it outlined its commercial
strategy for OLINVO, including plans to focus on patients who
require IV opioids and are at greater risk of opioid-related
adverse effects (ORAEs). These patients comprise approximately 7 to
9 million annual hospital inpatients in the United States.
Among other data presented, investigator-reported observations from
the ATHENA study included a retrospective chart review at one site
that found that colorectal surgery patients who received OLINVO
showed return of bowel function 28 hours faster than similar
patients treated with conventional opioids (p=0.0001 vs.
historical control at the same site).
- Continued publication and medical conference
presentation of OLINVO data. The Company has continued to
present OLINVO clinical data and analyses of unmet needs in acute
pain in peer-reviewed journals and at medical meetings. OLINVO has
also been featured in independent peer-reviewed publications.
Select presentations and publications included:
- Peer-reviewed publication of full Phase 2b
results, by Singla et al:
https://www.dovepress.com/getfile.php?fileID=38764
- Prevalence and costs of opioid-related adverse
events presented at PainWeek and the American Society of
Anesthesiologist annual meetings
- Unmet needs and potential new options in acute pain
management, by Gan et al:
https://www.dovepress.com/getfile.php?fileID=38563
- Structural basis for the novel OLINVO mechanism of
action, by Kappor et al:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5595830/pdf/41598_2017_Article_11483.pdf
- Joined a Department of Health and Human Services
Secretarial Round Table on Opioids, held October 5, 2017
in Washington, D.C. The round table invited industry leaders,
including Dr. Gowen, to discuss novel drugs and delivery systems
that have the potential to improve pain management or reduce opioid
addiction. At the meeting, Dr. Gowen emphasized that because IV
opioids will remain necessary for millions of hospital patients,
there is an urgent need for new options that may offer improved
safety while helping to avoid unnecessarily prolonged exposure to
opioids.
- Positive interim results of Phase 1 study of TRV250 for
acute migraine. TRV250 is under investigation as a
potential new mechanism of action for the acute treatment of
migraine. The ongoing first-time-in-human Phase 1 trial is a single
ascending dose study of safety, tolerability, and pharmacokinetics
of both subcutaneous and oral TRV250 in healthy volunteers.
The Company has completed dosing of the initially planned cohorts.
- In the doses studied to date, TRV250 demonstrated
dose-proportional exposure after s.c. administration.
TRV250 was well tolerated at all doses tested. Because no
dose-limiting adverse events were identified in the initial cohorts
of healthy subjects, the company has expanded the study to evaluate
higher doses to support future Phase 2 planning.
- Preliminary data from oral administration of TRV250 to healthy
volunteers suggest TRV250 has adequate oral bioavailability to
support further clinical development.
- Discovery of novel S1P modulators, a new non-narcotic
approach to managing chronic pain. In July, the Company
disclosed a new preclinical lead optimization program targeting S1P
receptors. The Company’s compounds are all new chemical entities,
expected to be non-addictive, and use a new mechanism of action
that in preclinical models avoids the immune suppression associated
with approved and investigational S1P receptor targeted
drugs. These molecules have demonstrated activity in
preclinical models of chemotherapy-induced peripheral neuropathy,
neuropathic pain, and inflammatory pain.
Financial results
For the third quarter of 2017, Trevena reported a net loss
attributable to common stockholders of $16.0 million, or $0.27 per
share, compared with a net loss attributable to common stockholders
for the third quarter of 2016 of $29.9 million, or $0.57 per share.
Research and development expenses were $10.2 million in the third
quarter of 2017 compared to $25.5 million for the same period in
2016; general and administrative expenses were $5.2 million,
compared to $4.1 million for the third quarter of 2016.Cash, cash
equivalents, and marketable securities were $76.6 million as of
September 30, 2017, which the Company expects to be sufficient to
fund its operating expenses and capital expenditure requirements
for at least twelve months from today’s date.
For additional details, please see the Company’s Form 10-Q,
which will be filed with the SEC today.
Conference Call and Webcast
Date: November 7, 2017 Time: 8:00 a.m. EST Telephone Access:
(855) 465-0180 International: (484) 756-4313Webcast:
http://investors.trevena.com/index.cfmConference ID: 9796968
About Trevena
Trevena, Inc. is a biopharmaceutical company focused on
providing better, safer therapies to patients in pain. The
Company has leveraged breakthrough science to discover and develop
its investigational product OLINVO™ (oliceridine injection) for the
management of moderate-to-severe acute pain. OLINVO has been
granted Breakthrough Therapy designation by the U.S. Food and Drug
Administration and was designed to provide healthcare providers an
innovative new option for patients who would otherwise require
conventional intravenous opioids. The Company has an early
stage pipeline of new chemical entities targeting novel mechanisms
of action, including for acute migraine, neuropathic pain, and
other indications.
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 or any future trials, including whether the
positive interim data from the Phase 1 study of TRV250 bode well
for the future clinical development of this therapy; the
uncertainties inherent in conducting clinical trials;
interpretations of regulatory interactions and expectations for
regulatory submissions and approvals; 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 the
ATHENA data highlights the potential value of OLINVO for patients
who require IV opioids but are at risk of opioid-related adverse
events; 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.
ContactsTrevena, Inc.
Investors:Jonathan Violin, Ph.D.Vice president,
corporate strategy & investor relations610-354-8840
x231jviolin@trevena.com
or
Media:Public RelationsPR@trevena.com
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TREVENA, INC. |
|
Condensed Statements of
Operations |
|
(Unaudited, in thousands except share and per
share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
|
|
2017 |
|
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
3,750 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
General
and administrative |
|
|
5,232 |
|
|
|
4,078 |
|
|
|
14,496 |
|
|
|
11,693 |
|
|
Research
and development |
|
|
10,181 |
|
|
|
25,549 |
|
|
|
41,776 |
|
|
|
58,505 |
|
|
Total
operating expenses |
|
|
15,413 |
|
|
|
29,627 |
|
|
|
56,272 |
|
|
|
70,198 |
|
|
Loss
from operations |
|
|
(15,413 |
) |
|
|
(29,627 |
) |
|
|
(56,272 |
) |
|
|
(66,448 |
) |
|
Other
income (expense) |
|
|
(586 |
) |
|
|
(272 |
) |
|
|
(873 |
) |
|
|
(446 |
) |
|
Net
loss |
|
$ |
(15,999 |
) |
|
$ |
(29,899 |
) |
|
$ |
(57,145 |
) |
|
$ |
(66,894 |
) |
|
|
|
|
|
|
|
|
|
|
|
Per
share information: |
|
|
|
|
|
|
|
|
|
Net loss
per share of common stock, basic and diluted |
|
|
($0.27 |
) |
|
|
($0.57 |
) |
|
|
($0.98 |
) |
|
|
($1.29 |
) |
|
Weighted
average shares outstanding, basic and diluted |
|
|
60,113,327 |
|
|
|
52,205,156 |
|
|
|
58,475,079 |
|
|
|
51,911,017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
TREVENA, INC. |
Condensed Balance Sheets |
(Unaudited, in thousands) |
|
|
|
|
|
|
|
September 30, 2017 |
|
December 31, 2016 |
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and
cash equivalents |
|
$ |
18,068 |
|
|
$ |
24,266 |
|
Marketable securities |
|
|
58,505 |
|
|
|
86,335 |
|
Prepaid
expenses and other current assets |
|
|
2,111 |
|
|
|
1,788 |
|
Total
current assets |
|
|
78,684 |
|
|
|
112,389 |
|
Property
and equipment, net |
|
|
4,132 |
|
|
|
1,059 |
|
Restricted cash |
|
|
1,413 |
|
|
|
1,193 |
|
Intangible asset, net |
|
|
12 |
|
|
|
13 |
|
Total
assets |
|
$ |
84,241 |
|
|
$ |
114,654 |
|
|
|
|
|
|
Liabilities and stockholders’
equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts
payable |
|
$ |
1,783 |
|
|
$ |
8,749 |
|
Accrued
expenses and other current liabilities |
|
|
3,868 |
|
|
|
8,208 |
|
Current
portion of loans payable, net |
|
|
10,283 |
|
|
|
5,039 |
|
Deferred
rent |
|
|
58 |
|
|
|
52 |
|
Total
current liabilities |
|
|
15,992 |
|
|
|
22,048 |
|
Loans
payable, net |
|
|
17,783 |
|
|
|
13,270 |
|
Capital
leases, net of current portion |
|
|
34 |
|
|
|
18 |
|
Deferred
rent, net of current portion |
|
|
2,675 |
|
|
|
187 |
|
Warrant
liability |
|
|
22 |
|
|
|
75 |
|
Other
long term liabilities |
|
|
925 |
|
|
|
475 |
|
Total
liabilities |
|
|
37,431 |
|
|
|
36,073 |
|
|
|
|
|
|
Common
stock |
|
|
62 |
|
|
|
56 |
|
Additional paid-in capital |
|
|
389,539 |
|
|
|
364,148 |
|
Accumulated deficit |
|
|
(342,770 |
) |
|
|
(285,625 |
) |
Accumulated other comprehensive income (loss) |
|
|
(21 |
) |
|
|
2 |
|
Total
stockholders’ equity |
|
|
46,810 |
|
|
|
78,581 |
|
Total
liabilities and stockholders’ equity |
|
$ |
84,241 |
|
|
$ |
114,654 |
|
|
|
|
|
|
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