EyeGate Pharmaceuticals Reports Full-year 2016 Financial Results and Provides Business Update
February 23 2017 - 4:08PM
EyeGate Pharmaceuticals, Inc. (NASDAQ:EYEG) (“EyeGate” or the
“Company”), a clinical-stage specialty pharmaceutical company that
focuses on developing and commercializing products for treating
diseases and disorders of the eye, today announced financial
results for the twelve-month period ended December 31, 2016, and
provided an update on recent corporate and operational
achievements.
2016 and Recent Business
Highlights:
- Entered into exclusive, worldwide licensing agreement with
Valeant Pharmaceuticals International, Inc. (“Valeant”) for EGP-437
combination product to treat post-operative pain and inflammation
in ocular surgery patients. Under the agreement, the Company
received an upfront cash payment and is eligible to receive
development and commercial milestone payments as well as royalties
on the sale of the product;
- Reported positive top-line data from Phase 1b/2a clinical trial
of the EGP-437 combination product for treatment of post-operative
inflammation and pain in cataract surgery patients;
- Received additional milestone payments from Valeant under
licensing agreement for EGP-437 combination product in
uveitis;
- Continued enrolling patients in confirmatory Phase 3 clinical
trial of the EGP-437 combination product targeting non-infectious
anterior uveitis;
- Reported positive top-line data from first-in-human pilot study
of EyeGate Ocular Bandage Gel (“EyeGate OBG”) in the treatment of
corneal epithelial defects;
- FDA Pre-Submission meeting confirmed 510(k) De Novo regulatory
path for EyeGate OBG
“We made remarkable progress throughout 2016,
setting the stage for 2017 to be a potentially transformational
year for EyeGate. Following the positive top-line data from our
cataract surgery trial reported in the fourth quarter, we recently
signed our second licensing agreement with Valeant through which
they will commercialize our EGP-437 combination product in this
highly prevalent indication. We remain on-track to initiate a
placebo-controlled Phase 2b study in cataract surgery patients in
the first half of 2017 and continue to target the filing of a
supplemental NDA in the second half of 2018,” said Stephen From,
Chief Executive Officer of EyeGate. “Our pivotal study of EGP-437
in anterior uveitis, the first indication licensed to Valeant,
continues to progress as well. We expect to complete enrollment in
Q3 2017 and to report top-line data in Q4 2017, leading to an NDA
submission by the end of the year.
“In addition to the success of the EGP-437
program, 2016 was notable for the expansion of our clinical
portfolio through the acquisition of Jade Therapeutics and its
novel Cross-linked, Thiolated Carboxymethyl Hyaluronic Acid
(CMHA-S) platform. Since completing the acquisition nearly a year
ago, we generated positive data from a first-in-human pilot study
of our lead CMHA-S product, EyeGate OBG, for the acceleration of
re-epithelialization of large corneal epithelial defects in
patients having undergone photorefractive keratectomy (“PRK”) and
are currently planning to initiate a double-masked, controlled
trial evaluating EyeGate OBG monotherapy against the current
standard of care, bandage contact lens, in Q2 2017. Importantly,
our fourth quarter pre-submission meeting with the FDA confirmed
that EyeGate OBG will pursue regulatory clearance in the U.S. via
the 510(k) De Novo path. Based on the encouraging data from the
pilot study as well as continued discussions with the FDA, we are
targeting submission of the 510(k) De Novo application by the end
of this year. This is truly an exciting time for EyeGate and we
believe our outlook has never been more positive. We are grateful
to our shareholders for their ongoing support and look forward to
sharing details of our future success.”
Full-year 2016 Financial
Review
Net loss for 2016 was $13.3 million, compared
with $8.4 million in 2015.
Research and development expenses for the year
totaled $8.4 million compared with $2.7 million in 2015. The
increase of $5.7 million in costs was primarily due to an increase
in clinical and other activity, which we were able to undertake
after our August 2015 follow-on offering and is also related to the
initiation of our Phase 3 clinical trial for the treatment of
anterior uveitis, the Phase 1b/2a trial for post-cataract surgery
inflammation and pain, the development of and clinical trial for
the EyeGate OBG, as well as research expenses attributable to the
Company’s EGP-437-based and CMHA-S-based product pipelines.
General and administrative expenses were $5.6
million, compared with $4.0 million in 2015. The increase of $1.6
million was primarily due to increases in payroll, office and other
expenses as company operations have expanded with the increase in
clinical activity related to the EGP-437 Phase 3 trials for the
treatment of anterior uveitis, the Phase 1b/2a trial for
post-cataract surgery inflammation and pain, and the clinical trial
for the EyeGate OBG, as well as the expansion of operations
following the Jade Acquisition.
Cash and cash equivalents as of December 31,
2016 totaled $3.6 million, compared with $8.4 million as of
December 31, 2015. Cash and cash equivalents as of December 31,
2016 does not include the upfront payment received in conjunction
with the recently announced Valeant licensing agreement.
About EyeGate:
EyeGate is a clinical-stage specialty
pharmaceutical company that is focused on developing and
commercializing products for treating diseases and disorders of the
eye. EGP-437, EyeGate’s first product in clinical trials,
incorporates a reformulated topically active corticosteroid,
Dexamethasone Phosphate that is delivered into the ocular tissues
through EyeGate’s proprietary innovative drug delivery system, the
EyeGate II Delivery System. In addition, EyeGate is developing,
through its wholly-owned Jade subsidiary, products using
cross-linked thiolated carboxymethyl hyaluronic acid (“CMHA-S”), a
modified form of the natural polymer hyaluronic acid (HA), which
possesses unique physical and chemical properties such as hydration
and healing properties. The ability of CMHA-S to adhere longer to
the ocular surface, resist degradation and protect the ocular
surface makes it well-suited for treating various ocular surface
injuries. For more information, please visit
www.EyeGatePharma.com.
Forward-looking Statements
Some of the statements in this press release are
“forward-looking” and are made pursuant to the safe harbor
provision of the Private Securities Litigation Reform Act of 1995.
These “forward-looking” statements include statements relating to,
among other things, the commercialization efforts and other
regulatory or marketing approval efforts pertaining to EyeGate’s
products, including EyeGate’s EGP-437 combination product and those
of Jade, a wholly owned subsidiary of EyeGate, as well as the
success thereof, with such approvals or success may not be obtained
or achieved on a timely basis or at all. These statements involve
risks and uncertainties that may cause results to differ materially
from the statements set forth in this press release, including,
among other things, certain risk factors described under the
heading “Risk Factors” contained in our Annual Report on Form 10-K
filed with the SEC on February 23, 2017 or described in our other
public filings. Our results may also be affected by factors of
which we are not currently aware. The forward-looking statements in
this press release speak only as of the date of this press release.
EyeGate expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to such statements to
reflect any change in its expectations with regard thereto or any
changes in the events, conditions or circumstances on which any
such statement is based.
Lee Roth / Janhavi Mohite
The Ruth Group for EyeGate Pharmaceuticals
646-536-7012 / 7026
lroth@theruthgroup.com / jmohite@theruthgroup.com
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