[May 09, 2014] |
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Trevena Reports First Quarter 2014 Financial Results
KING OF PRUSSIA, Pa. --(Business Wire)--
Trevena, Inc. (NASDAQ:TRVN), a clinical stage pharmaceutical company
focused on the discovery and development of G protein coupled receptor
(GPCR) biased ligands, today announced financial results for the quarter
ended March 31, 2014.
"We have had a strong start to 2014, reflecting continued investment in
our novel pipeline of biased ligands targeting validated GPCRs," stated
Maxine Gowen, Ph.D., chief executive officer of Trevena. "Since the
beginning of the year, we have advanced each of our clinical candidates
into a new stage of development, initiating a Phase 2b trial for TRV027
in acute heart failure, initiating a Phase 2 trial for TRV130 for the
treatment of moderate to severe postoperative pain, successfully
completing the first part of a multiple ascending dose study of TRV130,
and successfully completing dosing in our first clinical study of TRV734
for acute and chronic pain. Each of these candidates has the potential
to offer a superior therapeutic profile compared to current treatment
options, and we look forward to learning more about their clinical
utility as these programs progress."
The Company also announced today the successful completion of the first
part of a randomized, double-blind, placebo-controlled multiple
ascending dose study of TRV130, which Trevena is developing as a
first-line intravenous treatment for patients experiencing moderate to
severe acute pain. This study evaluated the maximum tolerated dose and
pharmacokinetics of TRV130 when multiple doses were given, and is an
important step in furthering the development of TRV130. This study also
measured pharmacodynamic effects of TRV130, including pupil constriction
and cold pain test analgesia. The results of this trial were consistent
with earlier studies, showing reproducible pharmacokinetics and
pharmacodynamic effects of TRV130. Safety and tolerability of TRV130
were also consistent with earlier trials, and no unexpected adverse
effects were observed. The second part of the study, which tests the
effects of subjects' metabolic capacity on TRV130 potential duration of
action, is in progress.
"The encouraging results from the TRV130 multiple ascending dose trial
were consistent with our expectations, demonstrating reproducible
pharmacokinetics and analgesia, and an encouraging tolerability profile,
upon repeat dosing," stated David Soergel, M.D., senior vice president
of clinical development at Trevena. "These results are an important step
in progressing TRV130 into Phase 2 studies, which we have now initiated."
In addition, Trevena reported the completion of dosing in its first
Phase 1 trial TRV734, a novel drug candidate in development as an orally
administered treatment for moderate to severe acute and chronic
pain. The objectives of this trial were to evaluate the safety,
tolerability, pharmacokinetics, and pharmacodynamics of single ascending
doses of TRV734 in healthy subjects. Top-line data for this trial are
expected mid-year.
Other Recent Corporate and Clinical Highlights
CNS programs
Initiated Phase 2a/b Trial for TRV130 in Acute Postoperative Pain. In
May, Trevena initiated a Phase 2a/b trial of TRV130, which is in
development as a first-line intravenous treatment for patients
experiencing moderate to severe acute pain where intravenous
administration is preferred. The study is a 400-patient, multicenter,
randomized, double-blind, placebo- and active-controlled, multiple dose,
adaptive trial that is designed to evaluate TRV130's efficacy and
tolerability in the management of postoperative pain following
bunionectomy surgery, using the gold-standard morphine as a benchmark.
Top-line data from the trial are expected in the first quarter of 2015.
Presented Phase 1b Data for TRV130 at American Society of Pain
Meeting. In May, Trevena presented results of its Phase 1b trial of
TRV130 at the American Pain Society Annual Meeting. In the study, TRV130
was generally well tolerated and produced greater analgesia compared to
morphine, with less reduction in respiratory drive, less vomiting, and
less severe nausea in healthy subjects.
Acute heart failure program
Initiated Phase 2b BLAST Trial for TRV027 in Acute Heart Failure
(AHF). In January, the Company reported dosing of the first patient
in a randomized, double-blind, standard of care controlled, Phase 2b
trial of TRV027 in AHF. The primary objective of this 500-patient trial
is to evaluate the effects of three dose levels of TRV027, 1.0 mg/hr,
5.0 mg/hr and 25 mg/hr, on a composite of clinically important outcomes:
mortality, worsening heart failure, hospital readmission rate, dyspnea,
and length of hospital stay. Results from the study are expected in the
second half of 2015. Trevena has granted Forest Laboratories an
exclusive option to license TRV027 under the companies' May 2013 Option
and Licensing Agreements.
Corporate update
Appointed Robert Prachar as SVP, Commercial and Corporate Strategy. In
April, Trevena appointed Robert Prachar to the newly created position of
Senior Vice President, Commercial and Corporate Strategy. Mr. Prachar,
who had served as a full-time consultant for the Company since August
2013, brings over 20 years of commercial leadership experience in the
life sciences industry to Trevena.
Financial Results
Cash and cash equivalents totaled $91.3 million as of March 31, 2014,
compared to $38.0 million as of December 31, 2013. The increase reflects
the net proceeds of $59.6 million received from the Company's initial
public offering in January 2014, offset by operating expenses. Trevena
expects that its existing cash and cash equivalents will be sufficient
to fund operations through the end of 2015.
Research and development expenses were $7.6 million in the first quarter
of 2014 versus $2.1 million in the first quarter of 2013. The increase
was primarily driven by clinical research expenses for TRV130, expenses
associated with the Phase 2b study for TRV027, and expenses associated
with the progression of TRV734 from preclinical to clinical studies.
General and administrative expenses were $2.0 million for the quarter
ended March 31, 2014, as compared to $0.8 million in the prior year. The
increase is primarily the result of headcount and salary costs,
increased compensation expense associated with stock options granted and
increased insurance, professional fees and other operating costs as a
result of becoming a public company. Net loss attributable to common
shareholders for the quarter ended March 31, 2014 was $9.4 million, or
$0.59 per share, as compared with a net loss of $3.0 million, or $4.30
per share, for the first quarter of 2013. Included in the net loss to
common shareholders were non-cash charges of $28,521 and $79,161 for the
accretion of preferred stock in 2014 and 2013, respectively.
Conference Call and Webcast
Trevena will host a conference call today, Friday, May 9, 2014, at 11:00
a.m. Eastern Time to discuss corporate updates and financial results for
the first quarter ended March 31, 2014. The call can be accessed by
dialing (855) 465-0180 (U.S. and Canada) or (484) 756-4313
(international), and entering passcode 36961657. To access a live audio
webcast of the presentation, please visit the "Investors" section at
trevenainc.com. The webcast will be recorded and available for replay on
the company's website for two weeks.
About TRV027
TRV027 is an investigational peptide drug in Phase 2b trials for the
treatment of heart failure (AHF). It targets the Angiotensin II type 1
receptor, a key driver of AHF, with an innovative "biased ligand"
mechanism which simultaneously vasodilates while increasing cardiac
performance. This profile has the potential to become an important new
therapy for AHF patients.
About TRV130
TRV130 is in investigational small molecule drug in Phase 2 trials for
the treatment of pain via intravenous administration. It binds and
activates the mu opioid receptor with a biased ligand mechanism unlike
other opioid drugs, and is intended to provide increased pain relief
with fewer adverse effects than currently used opioid analgesics.
About TRV734
TRV734 is an oral follow-on to TRV130, in Phase 1 for the treatment of
acute and chronic pain. It has a preclinical profile highly similar to
TRV130, and is intended to provide the benefits of TRV130 in an oral
form.
About Trevena
Trevena, Inc. is a clinical stage biopharmaceutical company that
discovers, develops and intends to commercialize therapeutics that use a
novel approach to target G protein coupled receptors, or GPCRs. Using
its proprietary product platform, Trevena has identified and advanced
three differentiated biased ligand product candidates into the clinic -
TRV027 to treat acute heart failure, TRV130 to treat moderate to severe
acute pain intravenously, and TRV734 to treat moderate to severe acute
and chronic pain orally. Trevena also plans to advance additional
product candidates in its portfolio, including a preclinical program
focused on central nervous system 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, its future operations, clinical development of its therapeutic
candidates, potential therapeutic utility for its product candidates,
market opportunities for its product candidates, its plans for potential
future product candidates and other statements containing the words
"anticipate," "believe," "estimate," "expect," "intend," "may," "plan,"
"predict," "project," "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: availability and timing of data
from ongoing clinical trials, the uncertainties inherent in the
initiation of future clinical trials, whether interim results from a
clinical trial will be predictive of the final results of the trial or
results of early clinical trials will be indicative of the results of
future trials, expectations for regulatory approvals, availability of
funding sufficient for the Company's foreseeable and unforeseeable
operating expenses and capital expenditure requirements, other matters
that could affect the availability or commercial potential of the
Company's therapeutic candidates and other factors discussed in the
"Risk Factors" section of the Company's Annual Report on Form 10-K for
the year ended December 31, 2013 filed with the Securities and Exchange
Commission on March 20, 2014 and other filings the Company makes with
the Securities and Exchange Commission from time to time. In addition,
the forward-looking statements included in this press release represent
the Company's views 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, the Company
specifically disclaims any obligation to do so. These forward-looking
statements should not be relied upon as representing the Company's views
as of any date subsequent to the date hereof.
Trevena Inc.
Statement of Operations
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Three Months Ended March 31,
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2013
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2014
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Revenue:
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Grant revenue
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$
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41,201
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$
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-
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Collaboration revenue
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-
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-
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Total revenue
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41,201
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-
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Operating expenses:
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General and administrative
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761,437
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2,020,865
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Research and development
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2,115,066
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7,633,509
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Total operating expenses
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2,876,503
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9,654,374
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Loss from operations
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(2,835,302)
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(9,654,374)
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Other income (expense):
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Change in fair value of warrant liability
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10,255
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98,922
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Miscellaneous income
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-
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176,015
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Interest income
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-
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6,023
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Interest expense
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(58,241)
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-
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Total other income (expense)
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(47,986)
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280,960
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Net loss and comprehensive loss
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(2,883,288)
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(9,373,414)
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Accretion of redeemable convertible preferred stock
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(79,161)
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(28,521)
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Net loss attributable to common stockholders
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$
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(2,962,449)
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$
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(9,401,935)
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Per share information:
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Net loss per share of common stock, basic and diluted
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$
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(4.30)
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$
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(0.59)
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Weighted average shares outstanding, basic and diluted
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689,266
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16,023,497
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Trevena Inc.
Balance Sheet Information
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December 31, 2013
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March 31, 2014
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Assets
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Current assets:
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Cash and cash equivalents
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$
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37,965,198
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$
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91,344,666
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Prepaid expenses and other current assets
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1,957,765
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3,395,364
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Offering costs
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1,999,279
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-
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Total current assets
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41,922,242
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94,740,030
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Property and equipment, net
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343,059
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257,864
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Restricted cash
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112,000
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112,000
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Other assets
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15,625
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45,300
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Total assets
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$
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42,392,926
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$
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95,155,194
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Liabilities, redeemable convertible preferred stock
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and stockholders' (deficit) equity
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Current liabilities:
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Accounts payable
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$
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545,053
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$
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3,084,016
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Accrued expenses and other current liabilities
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2,158,792
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1,775,505
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Deferred rent
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33,114
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34,707
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Total current liabilities
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2,736,959
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4,894,228
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|
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Deferred rent, net of current portion
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|
313,919
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|
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307,374
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|
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Warrant liability
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350,519
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|
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106,341
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Total liabilities
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|
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|
3,401,397
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5,307,943
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Commitments and contingencies
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Redeemable convertible preferred stock:
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Series A convertible preferred stock, $0.001 par value; 25,074,999 and
0 shares authorized, 25,074,999 and 0 shares issued and outstanding
at December 31, 2013 and March 31, 2014 respectively,
(liquidation preference of $25,074,999 at December 31,
2013)
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25,024,373
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-
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Series B convertible preferred stock, $0.001 par value; 35,500,000 and
0 shares authorized, 30,800,000 and 0 shares issued and outstanding
at December 31, 2013 and March 31, 2014, respectively
(liquidation preference of $30,800,000 at December 31,
2013)
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30,778,700
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-
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Series B 1 convertible preferred stock, $0.001 par value; 6,000,000 and
0 shares authorized, 4,750,000 and 0 shares issued and outstanding
at December 31, 2013 and 2014, respectively (liquidation
preference of $4,200,000 at December 31, 2013)
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4,823,079
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-
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Series C convertible preferred stock, $0.001 par value; 37,000,000 and
0 shares authorized, 36,764,704 and 0 shares issued and outstanding
at December 31, 2013 and March 31, 2014, respectively
(liquidation preference of $59,999,997 at December 31,
2013)
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59,935,986
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-
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Total redeemable convertible preferred stock
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120,562,138
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-
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Stockholders' (deficit) equity:
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Common stock-$0.001 par value; 132,000,000 shares authorized,
957,756 and 26,232,941 shares issued and outstanding at
December 31, 2013 and March 31, 2014, respectively
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|
958
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26,233
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|
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|
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|
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|
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Additional paid-in capital
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|
|
697,283
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|
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|
181,463,282
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|
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|
|
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|
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Deficit accumulated during the development stage
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(82,268,850)
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(91,642,264)
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Total stockholders' (deficit) equity
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(81,570,609)
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89,847,251
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Total liabilities, redeemable convertible preferred stock and stockholders'
(deficit) equity
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$
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42,392,926
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$
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95,155,194
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