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 first quarter ended March 31, 2015 and provided an
update on its clinical and preclinical programs for its proprietary
hydrogel platform technology. Following a meeting with the Food and Drug
Administration (FDA) in April 2015, the Company now plans to submit a
New Drug Application (NDA) for OTX-DP for the treatment of post-surgical
ocular pain. The Company also received conditional acceptance of the
name DEXTENZA™ from the FDA for its OTX-DP product candidate. A request
for a proprietary name review is planned as part of the NDA submission.
“We are pleased with the overall progress of our pipeline of sustained
release drug delivery products in clinical and preclinical development.
We continue to advance our clinical programs for the treatment of
post-surgical ocular inflammation and pain, allergic conjunctivitis,
inflammatory dry eye disease and glaucoma, with several anticipated
milestones in the near-term. Furthermore, last week we presented
preclinical data on our sustained release hydrogel depot for the
delivery of anti-vascular endothelial growth factors (anti-VEGF) for the
treatment of wet age-related macular degeneration at the recent annual
ARVO meeting in Denver. This is a promising platform for a condition
that is one of the leading causes of blindness,” said Amar Sawhney,
Ph.D., President and Chief Executive Officer.
Dr. Sawhney further commented, “We remain confident about our program
for post-surgical ocular inflammation and pain, and our plans for the
regulatory and clinical pathway for this product candidate. We intend to
submit an NDA for a post-surgical ocular pain indication and conduct an
additional Phase 3 clinical trial. Our goal is to subsequently submit an
NDA supplement to expand the labeling for the inflammation indication,
subject to favorable results from the additional trial and the initial
approval of the NDA for the pain indication.”
Clinical Update for DEXTENZA for the Treatment of Post-Surgical
Ocular Inflammation and Pain
Following a Pre-NDA Clinical meeting held with FDA in April 2015, Ocular
Therapeutix is charting a path forward for DEXTENZA for the treatment of
post-surgical ocular inflammation and pain. The Company’s plan now
includes:
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Submission of an NDA for DEXTENZA for a post-surgical ocular pain
indication in the second half of 2015.
-
Initiation of an additional Phase 3 clinical trial for DEXTENZA for
post-operative ocular inflammation and pain with modifications to the
trial design based on learnings from the previously completed second
Phase 3 trial, including the exclusion of patients on high-dose
nonsteroidal anti-inflammatory drugs (NSAIDs), randomizing patients in
a 1:1 ratio into treatment and placebo groups and providing more
protocol specificity regarding the administration of rescue
medications.
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Submission of an NDA supplement for DEXTENZA to broaden the indication
to include treatment of post-operative ocular inflammation, subject to
favorable results from the additional Phase 3 clinical trial and the
approval of the NDA for DEXTENZA for the pain indication.
Recent Highlights for Other Key Development Programs
Sustained release depots for treatment of retinal diseases
At the recent Association for Research in Vision and Ophthalmology
(ARVO) annual meeting in Denver, Ocular Therapeutix presented a total of
eight posters, three of which highlighted the company’s sustained
release hydrogel depot platform technology.
The data presented on back-of-the-eye depots focused on demonstrating
the viability of the platform for treating retinal diseases using
bevacizumab and other anti-VEGF agents as model proteins. In preclinical
studies, data showed in-situ formed bioresorbable anti-VEGF
hydrogel depots maintain their structure and bioactivity within the
company’s hydrogel. Data further showed tolerability and drug release of
clinically meaningful concentration and duration.
Decreasing the frequency of intravitreal injections with a sustained
release modality remains a major clinical challenge in treating chronic
diseases such as age-related macular degeneration (AMD) and diabetic
macular edema (DME).
A multi-pronged strategy is being pursued to seek to maximize the
potential of this technology for back-of-the-eye diseases. The Company
is pursuing ongoing collaborations with several different pharmaceutical
companies using protein based anti-VEGF agents and internal development
efforts using bevacizumab. Additionally, the delivery of small molecule
drugs, such as tyrosine-kinase inhibitors, or TKIs, in the Company’s
hydrogel depot are being evaluated. The Company believes this class of
drugs is well suited to the Company’s hydrogel depot platform given its
high potency, multiple targeting capability, and low water solubility.
The Company plans to continue evaluating these multiple pathways as
additional preclinical milestones are achieved.
OTX-TP product candidate for the treatment of glaucoma
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The Company’s OTX-TP product candidate for the treatment of glaucoma
and ocular hypertension is now in a Phase 2b clinical trial at
multiple sites in the United States, which is more than 80% enrolled
and remains on track to report topline efficacy data in the fourth
quarter of 2015.
DEXTENZA product candidate for the treatment of allergic
conjunctivitis and inflammatory dry eye disease
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The DEXTENZA product candidate is being investigated for the treatment
of allergic conjunctivitis, for which two Phase 3 trials are to be
conducted beginning in the middle of 2015.
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DEXTENZA is also being investigated for the treatment of inflammatory
dry eye disease and is currently nearing enrollment completion in an
exploratory Phase 2 clinical trial, with topline efficacy data to be
released in the fourth quarter of 2015.
First Quarter 2015 Financial Results
-
Ocular Therapeutix reported a net loss of approximately $7.6 million,
or $(0.35) per share, for the quarter ended March 31, 2015, compared
to a net loss of $7.0 million, or $(2.45) per share, for the quarter
ended March 31, 2014. The first quarter 2015 results include $0.9
million in non-cash charges for stock-based compensation compared to
$2.9 million in non-cash charges for stock-based compensation and
licensing and consultant fees paid in common stock in the first
quarter of 2014.
-
Total operating expenses for the quarter ended March 31, 2015 were
$7.5 million as compared to $6.9 million for the quarter ended March
31, 2014. Research and development (R&D) expenses for the quarter
ended March 31, 2015 were $4.7 million, compared to $4.9 million for
the quarter ended March 31, 2014. In the quarter ended March 31, 2014,
there was $1.7 million in non-cash licensing fees paid in common stock
relating to the Company’s intellectual property rights. This was
partially offset by increases in personnel costs and clinical trials
of DEXTENZA and OTX-TP product candidates.
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Ocular Therapeutix generated $0.4 million in revenue during the three
months ended March 31, 2015 from product sales of ReSure®
Sealant and from collaborations with corporate partners.
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As of March 31, 2015, cash and cash equivalents and marketable
securities totaled $67.4 million. Cash used in operating activities
was $6.9 million for the three months ended March 31, 2015.
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There was $15.0 million in outstanding debt as of March 31, 2015, with
an interest only period through September 30, 2015.
-
As of May 3, 2015, there were approximately 21.4 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 8:00 am 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 34331440. An archive of the webcast
will be available until May 29, 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 Phase 2 clinical development for glaucoma, allergic
conjunctivitis 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 OTX-DP 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 OTX-DP 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 Annual Report on Form 10-K
for the year ended December 31, 2014 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.
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OCULAR THERAPEUTIX, INC.
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STATEMENTS OF OPERATIONS (In thousands, except
share and per share data) (Unaudited)
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Three Months ended March 31,
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2015
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2014
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Product revenue
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$
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238
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$
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27
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Collaboration revenue
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188
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-
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Total revenue
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426
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27
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Operating Expenses:
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Cost of product revenue
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56
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9
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Research and development
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4,719
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4,958
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Selling and marketing
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870
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310
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General and administrative
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1,894
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1,575
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Total operating expenses
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7,539
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6,852
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Loss from operations
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(7,113)
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(6,825)
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Other income (expense):
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Interest income
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40
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1
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Interest expense
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(505)
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(43)
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Other (expense) income, net
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-
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(141)
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Total other expense, net
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(465)
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(183)
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Net loss and comprehensive loss
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(7,578)
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(7,008)
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Accretion of redeemable convertible preferred stock to redemption
value
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-
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(6)
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Net loss attributable to common stockholders
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$
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(7,578)
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$
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(7,014)
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Net loss per share attributable to common stockholders per share,
basic and diluted
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$
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(0.35)
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$
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(2.45)
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Weighted average shares outstanding, basic and diluted
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21,362,731
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2,859,752
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OCULAR THERAPEUTIX, INC.
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BALANCE SHEETS (In thousands, except share and per
share data) (Unaudited)
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March 31, 2015
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December 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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12,523
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$
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37,393
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Marketable securities
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54,900
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37,435
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Accounts receivable
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352
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329
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Inventory
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158
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133
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Prepaid expenses and other current assets
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1,537
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893
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Total current assets
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69,470
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76,183
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Property and equipment, net
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1,799
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1,782
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Restricted cash
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228
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228
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Total assets
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$
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71,497
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$
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78,193
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Liabilities and Stockholders’ Equity
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Current liabilities:
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Accounts payable
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$
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2,195
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$
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1,316
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Accrued expenses
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1,922
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3,016
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Deferred revenue
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250
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188
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Notes payable, net of discount, current
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2,860
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1,354
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Total current liabilities
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7,227
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5,874
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Deferred rent, long-term
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103
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112
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Notes payable, net of discount, long-term
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12,094
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13,511
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Total liabilities
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19,424
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19,497
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Commitments and contingencies
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Stockholders’ equity:
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Preferred stock, $0.0001 par value; 5,000,000 authorized at March
31, 2015 and December 31, 2014; no shares issued or outstanding at
March 31, 2015 and December 31, 2014
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—
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—
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Common stock, $0.0001 par value; 100,000,000 shares authorized at
March 31, 2015 and December 31, 2014; 21,428,571 and 21,333,507
shares issued and outstanding at March 31, 2015 and December 31,
2014, respectively
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2
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|
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2
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Additional paid-in capital
|
|
|
|
|
|
|
149,077
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|
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148,122
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Accumulated deficit
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|
|
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(97,006)
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|
|
(89,428)
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|
|
|
|
|
|
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Total stockholders’ equity
|
|
|
|
|
|
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52,073
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|
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58,696
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|
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|
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Total liabilities and stockholders’ equity
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|
|
|
|
|
$
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71,497
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$
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78,193
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Copyright Business Wire 2015