Conference Call Today at 5:00pm Eastern
Time
Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical
company focused on the development, manufacturing and
commercialization of innovative therapies for diseases and
conditions of the eye, today announced financial results for the
second quarter ended June 30, 2017, and provided a corporate
update.
“This is an important time for Ocular Therapeutix as we focus
our efforts on the resubmission of our NDA for DEXTENZA™ for the
treatment of post-surgical ocular pain while continuing to advance
our pipeline programs,” said Antony Mattessich, Chief Executive
Officer. “My goal as CEO is to fully realize the opportunities for
Ocular Therapeutix by deepening the Company’s expertise in
biopharmaceuticals. I believe our hydrogel technology represents an
important innovation in the field of ophthalmology and has great
potential to improve outcomes across a wide range of diseases of
the eye by improving the performance of both small and large
molecules. We are focused on execution and working as diligently as
possible to achieve our vision.”
Recent Updates and Anticipated
Near-Term Milestones Across Key Development Programs
DEXTENZA™ for the treatment of post-surgical ocular inflammation
and pain
- In July 2017, Ocular Therapeutix
received a Complete Response Letter (CRL) from the U.S. Food and
Drug Administration (FDA), regarding resubmission of a New Drug
Application (NDA) for DEXTENZA™ (dexamethasone insert) 0.4mg for
the treatment of ocular pain following ophthalmic surgery. The CRL
did not identify any efficacy or safety concerns with respect to
the clinical data for DEXTENZA provided in the NDA, nor any need
for additional clinical trials for the NDA approval.
- The CRL from the FDA referred to
deficiencies in manufacturing processes and analytical testing
related to manufacture of drug product for commercial production
identified in an outstanding Form FDA-483. The Form FDA-483 was
received following an FDA pre-NDA approval re-inspection of the
Ocular Therapeutix manufacturing facility that was completed in May
2017. Ocular Therapeutix plans to produce additional commercial
batches of DEXTENZA and submit data from these batches to the FDA
with the resubmission of its NDA.
OTX-TP (travoprost insert) for the treatment of glaucoma and
ocular hypertension
- Ocular Therapeutix continues to enroll
patients in its first Phase 3 clinical trial for OTX-TP (travoprost
insert) for the treatment of glaucoma and ocular hypertension.
Topline efficacy data from the trial is expected in the second half
of 2018.
- The primary efficacy endpoint is
statistically superior reduction of intraocular pressure (IOP) from
baseline with OTX-TP compared to placebo at three diurnal time
points of 8am, 10am, and 4pm, at intervals of 2, 6 and 12 weeks
following insertion.
- The Phase 3 study design does not
include a timolol comparator or validation arm, and does not have
active or placebo eye drops administered in either arm.
- The Company plans to initiate its
second Phase 3 clinical trial with OTX-TP for the treatment of
glaucoma and ocular hypertension in 2017.
OTX-TIC (travoprost intracameral injection) for the treatment of
moderate to severe glaucoma and ocular hypertension
- Ocular Therapeutix is developing an
intracameral product candidate, OTX-TIC, which is a bioresorbable
travoprost-containing hydrogel depot delivered via a fine-gauge
needle injection. The Company is developing OTX-TIC to potentially
address the need for a higher level of IOP reduction for patients
who have moderate to severe glaucoma.
- The Company plans to initiate a pilot
human clinical trial in 2017 to assess safety and obtain initial
efficacy data.
Sustained release intravitreal depots for the treatment of
serious retinal diseases
- Ocular Therapeutix is engaged in the
preclinical development of its extended release intravitreal
tyrosine kinase inhibitor (TKI) depot (OTX-TKI) using the Company’s
proprietary bioresorbable hydrogel fiber technology.
- At the ARVO Annual Meeting in May 2017,
Ocular Therapeutix presented preclinical data, demonstrating for
the first time the ability to deliver an efficacious dose of TKI to
the posterior segment of the eye for the treatment of VEGF-induced
retinal leakage for an extended duration of up to six months.
- The Company expects to enter Phase 1
clinical testing with OTX-TKI by the end of 2017.
- In partnership with Regeneron
Pharmaceuticals, Ocular Therapeutix also continues to advance the
development of an extended release hydrogel-based formulation of
Regeneron’s protein-based anti-vascular endothelial growth factor
(VEGF) trap, aflibercept, for the treatment of wet age-related
macular degeneration (wet AMD) and other serious retinal
diseases.
Second Quarter 2017 Financial Results
- As of June 30, 2017, cash, cash
equivalents and marketable securities totaled $66.0 million. Cash
used in operating activities was $11.3 million in the second
quarter of 2017, compared to $9.8 million for the second quarter of
2016. The Company expects that cash, cash equivalents and
marketable securities will be sufficient to fund operating
expenses, debt service obligations and capital expenditures through
the third quarter of 2018.
- Ocular Therapeutix reported a net loss
of approximately $(18.7) million, or $(0.64) per share, for the
quarter ended June 30, 2017, compared to a net loss of $(11.4)
million, or $(0.46) per share, for the quarter ended June 30, 2016.
The second quarter 2017 results include $2.1 million in non-cash
charges for stock-based compensation and depreciation compared to
$1.7 million in such non-cash charges in the second quarter of
2016.
- Total costs and operating expenses for
the quarter ended June 30, 2017 were $18.8 million, as compared to
$11.5 million for the quarter ended June 30, 2016. Research and
development expenses for the quarter ended June 30, 2017 were $8.1
million, compared to $7.0 million for the quarter ended June 30,
2016. The Company continues to advance the clinical and preclinical
development of its hydrogel platform technology and its portfolio
of drug product candidates.
- Ocular Therapeutix generated $0.4
million in revenue during the three-month period ended June 30,
2017 from product sales of ReSure® Sealant.
- As of June 30, 2017, there were
approximately 29.1 million shares issued and outstanding.
Conference Call & Webcast InformationMembers of the
Ocular Therapeutix management team will host a live conference call
and webcast today at 5:00pm Eastern Time to review the Company's
financial results and provide a general business update.
The live webcast can be accessed by visiting the Investors
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 live conference
call. The conference ID number for the live call will be 59980638.
An archive of the webcast will be available until August 22, 2017
on the Company’s website.
About Ocular Therapeutix, Inc.Ocular Therapeutix,
Inc. is a biopharmaceutical company focused on the development,
manufacturing and commercialization of innovative therapies for
diseases and conditions of the eye using its proprietary hydrogel
platform technology. Ocular Therapeutix’s lead product candidate,
DEXTENZA™ (dexamethasone insert) 0.4 mg for intracanalicular use
has completed Phase 3 clinical development for the treatment of
ocular pain and inflammation following ophthalmic surgery. OTX-TP
(travoprost insert) is in Phase 3 clinical development for glaucoma
and ocular hypertension. Ocular Therapeutix is also evaluating
injectable drug delivery 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 StatementsAny statements in this press
release about future expectations, plans and prospects for the
Company including the development and regulatory status of the
Company’s product candidates, such as the Company’s expectations
and plans regarding product development efforts and regulatory
submissions for and the timing and conduct of clinical trials of
DEXTENZA for the treatment of post-surgical ocular inflammation and
pain, including with respect to the manufacturing deficiencies
identified by the FDA and the prospects for approvability of
DEXTENZA for these indications, DEXTENZA for the treatment of
allergic conjunctivitis, DEXTENZA for the treatment of dry eye
disease and OTX-TP for the treatment of glaucoma and ocular
hypertension, the ongoing development of the Company’s sustained
release intravitreal depot, the potential utility of any of the
Company’s product candidates, potential commercialization of the
Company’s product candidates, the sufficiency of the Company’s cash
resources, 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 or any product candidate that
receives regulatory approval, the initiation and conduct of
clinical trials, availability of data from clinical trials and
expectations for regulatory submissions and approvals, the
Company’s manufacturing operations, the Company’s scientific
approach and general development progress, the availability or
commercial potential of the Company’s product candidates, the
availability 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 Six Months Ended June
30, June 30, 2017 2016
2017 2016 Revenue: Product revenue $
438 $ 441 $ 913 $ 857 Collaboration revenue —
— — 42 Total revenue 438
441 913 899 Costs
and operating expenses: Cost of product revenue 104 105 219 204
Research and development 8,117 6,978 14,846 14,051 Selling and
marketing 6,832 1,492 12,859 2,881 General and administrative
3,724 2,973 7,000
5,379 Total costs and operating expenses 18,777
11,548 34,924 22,515
Loss from operations (18,339 ) (11,107 )
(34,011 ) (21,616 ) Other income (expense): Interest
income 113 80 205 167 Interest expense (468 ) (418 )
(911 ) (836 ) Total other expense, net (355 )
(338 ) (706 ) (669 ) Net loss (18,694 )
(11,445 ) $ (34,717 ) $ (22,285 ) Net loss per share, basic
and diluted $ (0.64 ) $ (0.46 ) $ (1.22 ) $ (0.90 ) Weighted
average common shares outstanding, basic and diluted
29,026,259 24,770,059 28,352,348
24,761,498 Comprehensive loss: Net loss $ (18,694 ) $
(11,445 ) $ (34,717 ) $ (22,285 ) Other comprehensive income
(loss): Unrealized gain on marketable securities 9
10 5 78 Total other
comprehensive income 9 10 5
78 Total comprehensive loss $ (18,685 ) $
(11,435 ) $ (34,712 ) $ (22,207 )
Balance Sheets
(In thousands, except share and per
share data)
(Unaudited)
June 30, December 31, 2017
2016 Assets Current assets: Cash and cash
equivalents $ 63,049 $ 32,936 Marketable securities 3,000 35,209
Accounts receivable 211 250 Inventory 90 113 Prepaid expenses and
other current assets 1,978 1,390 Total
current assets 68,328 69,898 Property and equipment, net 9,619
3,313 Restricted cash 1,728 1,728 Total
assets $ 79,675 $ 74,939
Liabilities and
Stockholders’ Equity Current liabilities: Accounts payable $
6,307 $ 2,116 Accrued expenses and deferred rent 4,379 4,635 Notes
payable, net of discount, current 2,444 1,549
Total current liabilities 13,130 8,300 Deferred rent,
long-term 3,146 537 Notes payable, net of discount, long-term
15,374 14,094 Total liabilities
31,650 22,931 Commitments and contingencies
(Note 11) Stockholders’ equity: Preferred stock, $0.0001 par value;
5,000,000 shares authorized at June 30, 2017 and December 31, 2016;
no shares issued or outstanding at June 30, 2017 and December 31,
2016 — — Common stock, $0.0001 par value; 100,000,000 shares
authorized at June 30, 2017 and December 31, 2016; 29,055,460 and
25,024,100 shares issued and outstanding at June 30, 2017 and
December 31, 2016, respectively 3 3 Additional paid-in capital
256,618 225,889 Accumulated deficit (208,596 ) (173,879 )
Accumulated other comprehensive loss — (5 )
Total stockholders’ equity 48,025 52,008
Total liabilities and stockholders’ equity $ 79,675 $
74,939
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version on businesswire.com: http://www.businesswire.com/news/home/20170808006386/en/
InvestorsBurns McClellanSteve Klass,
212-213-0006sklass@burnsmc.comorOcular TherapeutixGeorge
MigauskyInterim Chief Financial
Officergmigausky@ocutx.comorMediaOcular TherapeutixScott
CorningVice President of Marketing & Commercial
Operationsscorning@ocutx.com
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