Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a
biopharmaceutical company discovering and developing protein
therapeutics to treat diseases of the eye, today reported financial
results for the first quarter ended March 31, 2016 and provided a
review of recent business highlights.
“We remain on target to make our planned submission of an
investigational new drug application for EBI-031 for the treatment
of diabetic macular edema this quarter,” said Abbie Celniker,
Ph.D., President and Chief Executive Officer of Eleven
Biotherapeutics. “In addition, we were pleased to have several
opportunities to showcase our data at this week’s ARVO Annual
Meeting. We also continue to evaluate strategic alternatives, as
previously communicated, with a goal to maximize shareholder
value.”
Recent Business Highlights:
- Presenting one oral presentation on
EBI-031 today and three posters on isunakinra at the Association
for Research in Vision and Ophthalmology (ARVO) 2016 Annual Meeting
taking place May 1 to 5, 2016 in Seattle.
- The EBI-031 presentation will discuss
the findings from a non-human primate study, including intravitreal
half-life of 5 days, systemic half-life of 0.85 days, immune
response, in vitro potency, and the appropriate species to use in
IND-enabling, non-human primate toxicology studies.
- Isunakinra posters showed results in an
environmental study in patients with moderate to severe allergic
conjunctivitis as well as efficacy and safety data from a study
with patients with moderate to severe dry eye disease. Top-line
results from these two Phase 3 clinical trials had been previously
reported in January 2016 and May 2015, respectively. A post-hoc
analysis identified a subset of subjects known to be high
interleukin-1 (IL-1) producers identified by genotyping that showed
an increased response to treatment with isunakinra compared with
vehicle in both allergic conjunctivitis and dry eye disease.
Interleukin-1 is a cytokine known to play a central role in the
regulation of immune and inflammatory responses. As previously
reported, Eleven does not plan to pursue further development of
isunakinra.
First Quarter 2016 Financial Results:
- Revenue: Revenue
was $0.2 million for the three months ended March
31, 2016, compared to $0.2 million for the same period in
2015.
- R&D Expenses: Research
and development expenses were $4.6 million for the three
months ended March 31, 2016, compared to $5.2 million for
the same period in 2015. This decrease was primarily due to lower
isunakinra related development expenses partially offset by higher
EBI-031 related development expenses.
- G&A Expenses: General
and administrative expenses were $2.1 million for the
three months ended March 31, 2016, compared to $2.6
million for the same period in 2015.
- Net Loss: Net loss
applicable to common stockholders was $7.6 million,
or $0.39 per share, for the three months ended March 31,
2016, compared to net loss applicable to common stockholders
of $6.5 million, or $0.36 per share, for the same
period in 2015. Net loss applicable to common stockholders for the
three months ended March 31, 2016 includes $0.9 million associated
with the extinguishment of debt.
- Cash and Cash
Equivalents: Cash and cash equivalents were $13.4
million as of March 31, 2016. On March 1, 2016, we
prepaid all outstanding amounts owed to Silicon Valley Bank with
existing cash on hand and terminated our loan agreement. We believe
that our current cash and cash equivalents will be sufficient to
fund our operating expenses into the fourth quarter of 2016.
About EBI-031
Eleven Biotherapeutics' most advanced preclinical product
candidate is EBI-031 for treatment of diabetic macular edema, or
DME, and uveitis. EBI-031 was designed and engineered for
intravitreal delivery using Eleven’s AMP-Rx platform. EBI-031 is a
potent blocker of both free IL-6 and IL-6 complexed to the soluble
IL-6 receptor (IL-6R) and has demonstrated a longer vitreal
retention time in preclinical models than antibodies and antibody
like molecules approved for intravitreal injection. Eleven is
undertaking the necessary manufacturing development work and
nonclinical safety studies to support the submission of an
investigational new drug application, or IND, to the FDA in the
first half of 2016 for the purpose of conducting clinical trials of
EBI-031 in DME and uveitis.
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is a preclinical-stage
biopharmaceutical company with a proprietary protein engineering
platform, called AMP-Rx, that it applies to the discovery and
development of protein therapeutics to treat diseases of the eye.
Eleven’s therapeutic approach is based on the role of cytokines in
diseases of the eye, the Company’s understanding of the structural
biology of cytokines and the Company’s ability to rationally design
and engineer proteins to modulate the effects of cytokines.
Cytokines are cell signaling molecules found in the body that can
have important inflammatory effects. For more information please
refer to the Company's website www.elevenbio.com.
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,
advancement or maturation of its product candidates and product
pipeline, clinical development of the Company's product candidates,
including expectations regarding timing of regulatory submissions
and initiation of clinical trials, regulatory requirements for
initiation of clinical trials and registration of product
candidates, the review of its strategic alternatives and the
outcome of such review, the sufficiency of its cash resources 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: the
uncertainties inherent in the initiation and conduct of clinical
trials, availability and timing of data from clinical trials,
whether results of early clinical trials or preclinical studies
will be indicative of the results of future trials, the adequacy of
any clinical models, uncertainties associated with regulatory
review of clinical trials and applications for marketing approvals
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, 2015 as filed with the Securities and Exchange Commission and
other reports on file with the Securities and Exchange Commission.
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 will
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.
ELEVEN BIOTHRAPEUTICS, INC.CONDENSED BALANCE
SHEETS(unaudited)(in thousands)
March 31,2016 December
31,2015 Assets Current assets: Cash and
cash equivalents $ 13,419 $ 36,079 Prepaid expenses and other
current assets 387 232 Total current
assets 13,806 36,311 Property and equipment, net 353 407 Restricted
cash 174 94 Other assets - 13
Total assets $ 14,333 $ 36,825
Liabilities
and stockholders' equity Current liabilities: Accounts payable
$ 1,588 $ 1,246 Accrued expenses 491 1,794 Notes payable, current
portion - 4,134 Deferred revenue 203 406
Total current liabilities 2,282 7,580 Other liabilities 81
423 Notes payable, net of current portion - 9,763 Warrant liability
- 115 Stockholders' equity: Common stock 20 20 Additional
paid-in capital 144,726 144,126 Accumulated deficit (132,776
) (125,202 ) Total stockholders' equity 11,970
18,944 Total liabilities and stockholders'
equity $ 14,333 $ 36,825
ELEVEN
BIOTHERAPEUTICS, INC.CONDENSED STATEMENTS OF
OPERATIONS(unaudited)(in thousands, except per share
data) Three Months Ended
March 31,
2016
2015
Total revenue $ 229 $ 244 Operating expenses: Research and
development 4,632 5,238 General and administrative 2,147
2,603
Total operating expenses
6,779 7,841 Loss from operations (6,550
) (7,597 ) Other (expense) income, net (1,024 ) 1,073
Net loss $ (7,574 ) $ (6,524 )
Net loss per share applicable to common
stockholders—basic and diluted
$ (0.39 ) $ (0.36 )
Weighted-average number of common shares
used in net loss per shareapplicable to common stockholders—basic
and diluted
19,639 17,971
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version on businesswire.com: http://www.businesswire.com/news/home/20160505005168/en/
Eleven BiotherapeuticsLeah Monteiro,
617-714-0619Leah.Monteiro@elevenbio.com
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