Clinical Programs Advance with Patient Enrollment Finalized in Three
Clinical Trials: Phase 3 Allergic Conjunctivitis Trial, Phase 2b
Glaucoma Trial and Phase 2 Inflammatory Dry Eye Trial
Follow-on Public Offering of 4 Million Shares Completed
Conference Call Today at 5:00 pm Eastern Time
Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company
focused on the development and commercialization of innovative therapies
for diseases and conditions of the eye, today announced financial
results for the second quarter ended June 30, 2015.
“We continued to make strong progress in our development programs this
quarter and look forward to several significant clinical milestones
expected during the second half of 2015. For our lead product candidate,
DEXTENZA™ (sustained release dexamethasone, 0.4mg), we remain on track
to submit an NDA to the FDA for a post-surgical ocular pain indication
and initiate a third Phase 3 clinical trial for the treatment of
post-surgical ocular inflammation and pain in the fourth quarter of
2015. In addition, we have completed patient enrollment in a Phase 3
clinical trial with DEXTENZA for the treatment of allergic
conjunctivitis and for our exploratory Phase 2 clinical trial for the
treatment of inflammatory dry eye, as part of our strategy to expand
clinical indications for DEXTENZA,” said Amar Sawhney, Ph.D., President
and Chief Executive Officer. “We have also closed patient enrollment in
our Phase 2b clinical trial of OTX-TP (sustained release travoprost) for
the treatment of glaucoma and ocular hypertension and expect topline
efficacy data in the fourth quarter.”
Dr. Sawhney further commented, “On the corporate development front, we
also made important progress during this quarter, highlighted by the
closing of a $101 million follow-on public offering, which resulted in
approximately $66 million in net proceeds to the Company. These proceeds
will be used to further the clinical development of DEXTENZA for
post-operative pain and inflammation, expanded indications for DEXTENZA
and OTX-TP for the treatment of glaucoma and ocular hypertension, as
well as preclinical development of our sustained release hydrogel depot
for the intravitreal delivery of anti-VEGF drugs for the treatment of
wet AMD. We believe we are well-positioned to further execute on our
vision of leading the development of sustained ophthalmic therapies with
proprietary tailored hydrogels to improve patient experience and
outcomes.”
Recent Highlights and Anticipated Near-Term Milestones for Key
Development Programs
DEXTENZA for the treatment of post-surgical ocular inflammation
and pain
-
Submission of an NDA for DEXTENZA for a post-surgical ocular pain
indication expected in the fourth quarter of 2015.
-
Initiation of a third Phase 3 clinical trial for DEXTENZA for
post-surgical ocular inflammation and pain expected in the fourth
quarter of 2015 with modifications to the trial design based on
learnings from the previously completed Phase 3 trials, made
subsequent to a pre-NDA meeting with the Food and Drug Administration
in April 2015.
-
Submission of an NDA supplement for DEXTENZA expected in the second
half of 2016 to broaden the indication to include treatment of
post-surgical ocular inflammation, subject to favorable results from
the third Phase 3 clinical trial and the approval of the NDA for
DEXTENZA for the pain indication.
DEXTENZA for the treatment of allergic conjunctivitis and
inflammatory dry eye disease
-
DEXTENZA is being investigated for the treatment of allergic
conjunctivitis, and has completed enrollment in a Phase 3 clinical
trial. Topline efficacy data from the Phase 3 trial is expected in the
fourth quarter of 2015, for which the primary endpoints are ocular
itching and conjunctival redness. Ocular itching is the labeling for
many currently marketed prescription eye drops for allergic
conjunctivitis.
-
DEXTENZA is also being investigated for the treatment of inflammatory
dry eye disease and is in an exploratory Phase 2 clinical trial which
is now fully enrolled, with topline efficacy data expected in the
fourth quarter of 2015.
OTX-TP (sustained release travoprost) product candidate for the
treatment of glaucoma
-
The Company’s OTX-TP product candidate for the treatment of glaucoma
and ocular hypertension is being evaluated in a Phase 2b clinical
trial at multiple sites in the United States. Enrollment is now closed
and the company expects to report topline efficacy data in the fourth
quarter of 2015. This trial has been designed to further assist in the
Phase 3 clinical design and to estimate treatment effect relative to
timolol, determine the duration of effect up to 3 months and to assess
patients’ ability to self-assess the presence of the drug product.
Second Quarter 2015 Financial Results
-
Ocular Therapeutix reported a net loss of approximately $10.0 million,
or $(0.45) per share, for the quarter ended June 30, 2015, compared to
a net loss of $6.4 million, or $(2.10) per share, for the quarter
ended June 30, 2014. The second quarter 2015 results include $1.2
million in non-cash charges for stock-based compensation compared to
$0.6 million in non-cash charges for stock-based compensation.
-
Total operating expenses for the quarter ended June 30, 2015 were
$10.1 million as compared to $6.0 million for the quarter ended June
30, 2014. Research and development (R&D) expenses for the quarter
ended June 30, 2015 were $6.7 million, compared to $4.3 million for
the quarter ended June 30, 2014. The increase is primarily related to
personnel costs and clinical trials of DEXTENZA and OTX-TP product
candidates.
-
Ocular Therapeutix generated $0.5 million in revenue during the three
months ended June 30, 2015 from product sales of ReSure® Sealant and
from collaborations with corporate partners.
-
As of June 30, 2015, cash and cash equivalents and marketable
securities totaled $123.7 million. Cash used in operating activities
was $15.4 million for the six months ended June 30, 2015.
-
There was $15.0 million in outstanding debt as of June 30, 2015, with
an interest only period through September 30, 2015.
-
As of August 7, 2015, there were approximately 24.7 million shares
issued and outstanding.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a live
conference call and webcast today at 5:00 pm Eastern Time to
discuss the Company's financial results and provide a general business
update.
The live webcast can be accessed by visiting the investor section of the
Company’s website at investors.ocutx.com.
Please connect at least 15 minutes prior to the live webcast to ensure
adequate time for any software download that may be needed to access the
webcast. Alternatively, please call 844-464-3934 (U.S.) or 765-507-2620
(International) to listen to the conference call. The conference ID
number for the live call will be 98596258. An archive of the webcast
will be available until August 24, 2015 on the company’s website.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a biopharmaceutical company
focused on the development and commercialization of innovative therapies
for diseases and conditions of the eye using its proprietary hydrogel
platform technology. Ocular Therapeutix's lead product candidates are in
Phase 3 clinical development for post-surgical ocular inflammation and
pain and allergic conjunctivitis, and Phase 2 clinical development for
glaucoma, and inflammatory dry eye disease. The Company is also
evaluating sustained-release injectable anti-VEGF drug depots for
back-of-the-eye diseases. Ocular Therapeutix's first product, ReSure®
Sealant, is FDA-approved to seal corneal incisions following cataract
surgery.
Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about the
development of the Company’s product candidates, such as the Company’s
plans for regulatory submissions and the design, initiation and conduct
of a third clinical trial of DEXTENZA™ for post-surgical inflammation
and pain, the ongoing development of the Company’s sustained release
hydrogel depot technology, the timing and conduct of the Company’s Phase
2b clinical trial of OTX-TP for the treatment of glaucoma and ocular
hypertension, the Company’s Phase 3 clinical trials of DEXTENZA for
allergic conjunctivitis and the Company’s Phase 2 clinical trial of
OTX-DP for the treatment of inflammatory dry eye disease, the
advancement of the Company's other product candidates and other
statements containing the words "anticipate," "believe," "estimate,"
"expect," "intend", "goal," "may", "might," "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. Such forward-looking statements involve substantial
risks and uncertainties that could cause the Company’s clinical
development programs, future results, performance or achievements to
differ significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include, among
others, those related to the timing and costs involved in
commercializing ReSure® Sealant, the initiation
and conduct of clinical trials, availability of data from clinical
trials and expectations for regulatory submissions and approvals, the
Company’s scientific approach and general development progress, the
availability or commercial potential of the Company’s product
candidates, the sufficiency of cash resources and need for additional
financing or other actions and other factors discussed in the “Risk
Factors” section contained in the Company’s quarterly and annual 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 of this release. 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 of this release.
Ocular Therapeutix, Inc.
|
Statements of Operations and Comprehensive Loss
|
(In thousands, except share and per share data)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
2015
|
|
|
|
2014
|
|
|
|
|
|
|
|
|
|
|
Revenue:
|
|
|
|
|
|
|
|
|
Product revenue
|
|
$
|
334
|
|
|
$
|
97
|
|
|
$
|
572
|
|
|
$
|
124
|
|
Collaboration revenue
|
|
|
125
|
|
|
|
—
|
|
|
|
313
|
|
|
|
—
|
|
Total revenue:
|
|
|
459
|
|
|
|
97
|
|
|
|
885
|
|
|
|
124
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Cost of product revenue
|
|
|
80
|
|
|
|
20
|
|
|
|
136
|
|
|
|
29
|
|
Research and development
|
|
|
6,743
|
|
|
|
4,292
|
|
|
|
11,462
|
|
|
|
9,250
|
|
Selling and marketing
|
|
|
1,041
|
|
|
|
535
|
|
|
|
1,911
|
|
|
|
845
|
|
General and administrative
|
|
|
2,230
|
|
|
|
1,196
|
|
|
|
4,124
|
|
|
|
2,771
|
|
Total operating expenses
|
|
|
10,094
|
|
|
|
6,043
|
|
|
|
17,633
|
|
|
|
12,895
|
|
Loss from operations
|
|
|
(9,635
|
)
|
|
|
(5,946
|
)
|
|
|
(16,748
|
)
|
|
|
(12,771
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
28
|
|
|
|
1
|
|
|
|
68
|
|
|
|
2
|
|
Interest expense
|
|
|
(405
|
)
|
|
|
(257
|
)
|
|
|
(910
|
)
|
|
|
(300
|
)
|
Other income (expense), net
|
|
|
3
|
|
|
|
(190
|
)
|
|
|
3
|
|
|
|
(331
|
)
|
Total other expense, net
|
|
|
(374
|
)
|
|
|
(446
|
)
|
|
|
(840
|
)
|
|
|
(629
|
)
|
Net loss
|
|
|
(10,009
|
)
|
|
|
(6,392
|
)
|
|
|
(17,587
|
)
|
|
|
(13,400
|
)
|
Accretion of redeemable convertible preferred stock to redemption
value
|
|
|
—
|
|
|
|
(5
|
)
|
|
|
—
|
|
|
|
(11
|
)
|
Net loss attributable to common stockholders
|
|
$
|
(10,009
|
)
|
|
$
|
(6,397
|
)
|
|
$
|
(17,587
|
)
|
|
$
|
(13,411
|
)
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to common stockholders, basic and
diluted
|
|
$
|
(0.45
|
)
|
|
$
|
(2.10
|
)
|
|
$
|
(0.81
|
)
|
|
$
|
(4.54
|
)
|
Weighted average common shares outstanding, basic and diluted
|
|
|
22,167,274
|
|
|
|
3,044,605
|
|
|
|
21,765,087
|
|
|
|
2,952,689
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(10,009
|
)
|
|
$
|
(6,392
|
)
|
|
$
|
(17,587
|
)
|
|
$
|
(13,411
|
)
|
Other comprehensive loss:
|
|
|
|
|
|
|
|
|
Unrealized loss on marketable securities
|
|
|
(8
|
)
|
|
|
—
|
|
|
|
(8
|
)
|
|
|
—
|
|
Total other comprehensive loss
|
|
|
(8
|
)
|
|
|
—
|
|
|
|
(8
|
)
|
|
|
—
|
|
Total comprehensive loss
|
|
$
|
(10,017
|
)
|
|
$
|
(6,392
|
)
|
|
$
|
(17,595
|
)
|
|
$
|
(13,411
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OCULAR THERAPEUTIX, INC.
|
|
BALANCE SHEETS
|
(In thousands, except share and per share data)
|
(Unaudited)
|
|
|
|
|
|
|
|
|
June 30, 2015
|
|
December 31, 2014
|
|
|
|
|
|
Assets
|
|
|
|
|
Current assets:
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
78,686
|
|
|
$
|
37,393
|
|
Marketable securities
|
|
|
45,036
|
|
|
|
37,435
|
|
Accounts receivable
|
|
|
164
|
|
|
|
329
|
|
Inventory
|
|
|
145
|
|
|
|
133
|
|
Prepaid expenses and other current assets
|
|
|
2,608
|
|
|
|
893
|
|
Total current assets
|
|
|
126,639
|
|
|
|
76,183
|
|
Property and equipment, net
|
|
|
2,603
|
|
|
|
1,782
|
|
Restricted cash
|
|
|
228
|
|
|
|
228
|
|
Total assets
|
|
$
|
129,470
|
|
|
$
|
78,193
|
|
|
|
|
|
|
Liabilities and Stockholders’ Equity
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
Accounts payable
|
|
$
|
2,812
|
|
|
$
|
1,316
|
|
Accrued expenses
|
|
|
2,284
|
|
|
|
3,016
|
|
Deferred revenue
|
|
|
125
|
|
|
|
188
|
|
Notes payable, net of discount, current
|
|
|
4,370
|
|
|
|
1,354
|
|
Total current liabilities
|
|
|
9,591
|
|
|
|
5,874
|
|
Deferred rent, long-term
|
|
|
94
|
|
|
|
112
|
|
Notes payable, net of discount, long-term
|
|
|
10,673
|
|
|
|
13,511
|
|
Total liabilities
|
|
|
20,358
|
|
|
|
19,497
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity:
|
|
|
|
|
Preferred stock, $0.0001 par value; 5,000,000 authorized at June 30,
2015 and December 31, 2014; no shares issued or outstanding at June
30, 2015 and December 31, 2014
|
|
|
—
|
|
|
|
—
|
|
Common stock, $0.0001 par value; 100,000,000 shares authorized at
June 30, 2015 and December 31, 2014; 24,719,225 and 21,333,507
shares issued and outstanding at June 30, 2015 and December 31,
2014, respectively
|
|
|
2
|
|
|
|
2
|
|
Additional paid-in capital
|
|
|
216,133
|
|
|
|
148,122
|
|
Accumulated deficit
|
|
|
(107,015
|
)
|
|
|
(89,428
|
)
|
Accumulated other comprehensive loss
|
|
|
(8
|
)
|
|
|
—
|
|
Total stockholders’ equity
|
|
|
109,112
|
|
|
|
58,696
|
|
Total liabilities and stockholders’ equity
|
|
$
|
129,470
|
|
|
$
|
78,193
|
|
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