Conference Call Today at 5:00pm Eastern Time
BEDFORD, Mass.--(BUSINESS WIRE)--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 Information
Members 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 Statements
Any 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.
