EyeGate Pharmaceuticals Reports Third Quarter 2016 Financial Results and Provides Business Update
November 02 2016 - 9:20AM
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 three-month period ended September 30, 2016, and
provided an update on recent corporate and operational activities.
Third Quarter 2016 and Recent Business
Highlights:
- 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 payment from Valeant
Pharmaceuticals International, Inc. (“Valeant”) for EGP-437 in
uveitis;
- Continued enrolling patients in confirmatory Phase 3 clinical
trial of the EGP-437 combination product targeting non-infectious
anterior uveitis;
- Awarded $448,185 for second year of funding of Phase II SBIR
Grant from U.S. Department of Defense to continue development of
cross-linked thiolated hyaluronic acid (“CMHA-S”) for use as an
ocular bandage film;
“We made continued, significant progress in the
third quarter as we further advanced both the EGP-437 combination
product and the EyeGate OBG programs, and positioned the Company to
achieve key milestones over the next 12 months,” said Stephen From,
President and Chief Executive Officer of EyeGate. “The three new
cohorts in our Phase 1b/2a trial of the EGP-437 combination product
in cataract surgery patients have progressed according to plan and
we remain on track to report top-line data from these cohorts in
the fourth quarter of 2016. We believe that these additional
cohorts, which are evaluating additional doses and dosing regimens
of EGP-437, will allow us to build upon the positive top-line data
we reported in August and to initiate a randomized,
placebo-controlled trial of EGP-437 in cataract surgery patients in
the first quarter of 2017.
“In addition, patient enrollment in the
confirmatory Phase 3 trial of the EGP-437 combination product in
uveitis progressed, and the Company earned another milestone
payment under our worldwide licensing agreement with Valeant for
this indication. We continue to target an NDA submission for the
EGP-437 combination product in uveitis in late 2017.”
Mr. From continued, “We are extremely pleased with
the progress we have made on the EGP-437 combination product, and
have also taken important steps forward in the development of our
CHMA-S platform and its lead product, the EyeGate OBG. We are on
track for a meeting with the FDA and expect to initiate our first
CMHA-S clinical trial, in corneal repair, by the end of the year.
Additionally, we received the second year of funding of our Phase
II SBIR grant from the U.S. Department of Defense to continue
studying the use of CMHA-S as an ocular bandage film, which
represents a large potential market. We are extremely excited about
what the future holds for EyeGate and look forward to the
opportunities that lie ahead.”
Third Quarter 2016 Financial
Review
EyeGate’s revenue for the third quarter of 2016
totaled $0.274 million, compared with no revenue in the third
quarter of 2015. Third quarter 2016 revenue was attributable to
U.S. government grants to fund the Company’s CMHA-S product. Net
loss for the quarter was $(3.377) million, compared with $(1.356)
million in the third quarter of 2015. The increase in net loss was
attributable to expenses relating to the Company’s confirmatory
Phase 3 trial of EGP-437 in anterior uveitis, its Phase 1b/2a trial
for post-cataract surgery inflammation and pain and the continued
development of the EyeGate OBG, as well as increased R&D,
general and administrative and other expenses in support of these
activities.
Research and Development Expenses. Research and
development expenses were $2.449 million for the three months ended
September 30, 2016, compared to $0.408 million for the three months
ended September 30, 2015. The increase of $2.041 million is
primarily due to an increase in clinical and other activity related
to the acceleration of Phase 3 clinical trials for the treatment of
anterior uveitis, the Phase 1b/2a trial for post-cataract surgery
inflammation and pain, and 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. General and
administrative expenses were $1.202 million for the three months
ended September 30, 2016, compared to $0.946 million for the three
months ended September 30, 2015. The increase of $0.256 million was
due primarily to increases in payroll, office and other expenses as
company operations have expanded with the acceleration 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.
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. The EGP-437 combination product, EyeGate’s first and only
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. EyeGate intends to initiate a clinical study for
Jade’s lead product candidate for corneal epithelial defects by
year-end 2016. For more information, please visit
www.EyeGatePharma.com.
Safe Harbor Statement: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 March 30, 2016, and our Quarterly Report on Form 10-Q, as
filed with the SEC on November 1, 2016 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.
Contact:
Lee Roth / Joseph Green
The Ruth Group for EyeGate Pharmaceuticals
646-536-7012 / 7013
lroth@theruthgroup.com / jgreen@theruthgroup.com
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