EyeGate Pharmaceuticals Reports Third Quarter 2018 Financial Results and Provides Business Update
14 11월 2018 - 6:05AM
EyeGate Pharmaceuticals, Inc. (NASDAQ: EYEG) (“EyeGate” or “the
Company”) today announced financial results for the three-month
period ended September 30, 2018 and provided an update on recent
corporate and operational activities.
Stephen From, EyeGate’s Chief Executive Officer, said, “The
third quarter of 2018 was a transformative quarter for EyeGate,
with the Company receiving FDA approval for two IDE submissions for
our Ocular Bandage Gel ('OBG') product, as well as focusing our
efforts toward the key clinical trials that support this innovative
product.” Mr. From continued, “We are extremely pleased to have
announced positive top-line data in each of our OBG studies for
photorefractive keratectomy ('PRK') surgery and punctate
epitheliopathies ('PE'). We are very happy with the data and
believe that all of our data is sufficient and robust enough to
create a path toward regulatory filings for approval and
commercialization.”
Recent Business Highlights:
- Positive Top-Line Data in Two OBG Studies
- The Company announced top-line data from its study evaluating
the potential of EyeGate’s OBG to help clinicians better manage
corneal epithelial defects in patients following PRK surgery,
compared to current standard of care. Both of the OBG dosing
regimens outperformed the standard of care in the number of eyes
healed at day 3 and day 4 post-surgery.
- The Company announced top-line data from its study evaluating
the potential of EyeGate’s OBG to help clinicians better manage
patients with PE due to pathologies such as dry eye. OBG eye drops
achieved a statistically significant improvement (p-value <
0.05) in symptoms as quickly as day 7, as well as at day
28.
- Technology Transfer and License Agreement with SentrX Animal
Care
- The Company executed a license agreement with SentrX Animal
Care, Inc. that in-licenses the rights to trade secrets and
expertise related to the manufacturing of EyeGate’s OBG. The
agreement will enable the Company to pursue a different vendor with
a larger capacity for manufacturing and an FDA-approved facility
for commercialization of the OBG product for human use.
- Additional 180 Days Granted to Comply with Nasdaq Listing Rules
- The Company was granted an additional 180 days, or until March
18, 2019, to comply with Nasdaq Listing Rule 5550(a)(2) by
maintaining a closing bid price of at least $1 per share for ten
consecutive business days during this additional time period.
Third Quarter 2018 Financial Review:
EyeGate’s revenue was $0.315 million in the third quarter of
2018, compared to $0.075 million in the third quarter of 2017. The
revenue generated in the third quarter of 2018 was related to
milestone payments earned from Bausch Health Companies (“BHC”),
while the revenue generated in the third quarter of 2017 was
related to governmental grants.
EyeGate’s net loss in the third quarter of 2018 was $3.124
million, compared with $4.140 million in the third quarter of 2017
and $2.780 million in the second quarter of 2018.
Research and development expenses were $2.260 million in the
third quarter of 2018, compared to $3.176 million in the third
quarter of 2017. The decrease of $0.916 million was primarily due
to decreases in clinical activity for the EGP-437 trials for
anterior uveitis and the treatment of post cataract surgery
inflammation and pain, and chemistry, manufacturing and controls
(“CMC”) work related to EyeGate OBG. These decreases were partially
offset by increases in clinical activity for the OBG trials for PRK
surgery and PE, as well as CMC work related to EGP-437.
General and administrative expenses were $1.233 million in the
third quarter of 2018, compared to $1.039 million in the third
quarter of 2017. The increase of $0.194 million was primarily due
to increases in personnel related costs and professional fees for
legal and corporate communications, partially offset by decreases
in corporate costs, including the forgiveness of a promissory note
in the third quarter of 2017.
Cash and cash equivalents as of September 30, 2018 totaled
$9.900 million, compared with $7.806 million as of December 31,
2017. The increase in cash and cash equivalents was primarily due
net proceeds of $10.109 million from the completion of a public
offering, as well as cash receipts from BHC and warrant exercises;
offset by cash outflows to fund the Company’s operations.
About EyeGate
EyeGate is a clinical-stage specialty pharmaceutical company
focused on developing and commercializing products using its two
proprietary platform technologies for treating diseases and
disorders of the eye.
EyeGate’s CMHA-S platform, EyeGate OBG, is based on a modified
form of the natural polymer hyaluronic acid, which is a gel that
possesses unique physical and chemical properties such as hydrating
and healing when applied to the ocular surface. 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 including surgical trauma.
EGP-437, EyeGate’s other 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. For more information, please visit
www.EyeGatePharma.com.
EyeGate Social Media
EyeGate uses its website (www.EyeGatePharma.com), Facebook page
(https://www.facebook.com/ EyeGatePharma/), corporate Twitter
account (https://twitter.com/EyeGatePharma), and LinkedIn page
(https://www.linkedin.com/company/135892/) as channels of
distribution of information about EyeGate and its product
candidates. Such information may be deemed material information,
and EyeGate may use these channels to comply with its disclosure
obligations under Regulation FD. Therefore, investors should
monitor EyeGate’s website and its social media accounts in addition
to following its press releases, SEC filings, public conference
calls, and webcasts. The social media channels that EyeGate intends
to use as a means of disclosing the information described above may
be updated from time to time as listed on EyeGate’s investor
relations website.
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 the
EyeGate OBG product, 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 EyeGate’s Annual Report on Form 10-K filed with the SEC on March
2, 2018 or described in EyeGate’s other public filings. EyeGate’s
results may also be affected by factors of which EyeGate is 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
Joseph Green / Andrew GibsonEdison Advisors for EyeGate
Pharmaceuticals646-653-7030 / 7719jgreen@edisongroup.com /
agibson@edisongroup.com
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