- Novel Retinal Treatment Demonstrates Potential
of Proprietary Therapeutic Platform -- XIPERE™ NDA Accepted and On
Track for October 19, 2019 PDUFA Date -- Management to Host Webcast
and Conference Call Today at 5:00 PM ET -
Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical
company dedicated to developing treatments that restore and
preserve vision for people with serious eye diseases, today
reported financial results for the fourth quarter and year ended
December 31, 2018 and provided a corporate update.
“Clearside is focused on treating blinding
diseases by combining our innovative technology with a proprietary
drug formulation to deliver pharmacotherapy to the part of the eye
that requires treatment,” said Daniel H. White, President and Chief
Executive Officer. “The recent acceptance of our New Drug
Application (NDA) for XIPERE™ (triamcinolone acetonide ophthalmic
suspension) for Suprachoroidal Injection for the treatment of
macular edema associated with uveitis marks a significant milestone
for Clearside and our unique, therapeutic platform. We believe this
targeted drug delivery approach has broad applicability utilizing
proven compounds, like triamcinolone, novel small molecules, and
gene therapy.”
“As we look forward, our plan is to expand our
expertise in macular edema associated with uveitis to broader
indications, prudently build our ophthalmic pipeline, and work with
potential partners to leverage our platform and provide
international reach. We are looking forward to our October 19, 2019
PDUFA (Prescription Drug User Fee Act) goal date to receive a
response from the U.S. Food and Drug Administration (FDA). Our team
is working diligently on launch preparations to make XIPERE
available to uveitis patients with macular edema, the most common
cause of uveitis-related blindness and where there is no approved
therapy. Given the timing of our October 19th PDUFA date, if
approved, we expect to formally launch XIPERE in the first quarter
of 2020,” Mr. White concluded.
Charlie Deignan, Chief Financial Officer,
commented, “We are prudently allocating funds to our near-term
priorities and have reduced research & development (R&D)
expenses by closing down the two large Phase 3 studies in retinal
vein occlusion (RVO). Based on our current plans for
commercializing XIPERE, R&D activities, and anticipated
available funding facilities, we believe we will have sufficient
resources to fund our planned operations into the first quarter of
2020, including the potential launch of XIPERE for the treatment of
macular edema associated with uveitis.”
Key Highlights and Upcoming
Milestones
- Clearside’s NDA for XIPERE for the
treatment of macular edema associated with uveitis was accepted for
review by the FDA and assigned a PDUFA goal date of October 19,
2019.
- Clearside’s suprachoroidal
injection platform was featured at the 42nd Annual Meeting of The
Macula Society in multiple oral presentations, including release of
new, nonclinical data on suprachoroidal administration of
gene-based therapies.
- Data was presented at the American
Uveitis Society’s Winter Symposium based on Clearside’s Phase 3
extension study (MAGNOLIA) demonstrating that XIPERE maintained
efficacy outcomes through 48-weeks in uveitic macular edema
patients.
- Clearside discontinued development
of combination therapy in retinal vein occlusion based on results
of its Phase 3 study (SAPPHIRE).
- Additional data from Clearside’s
pivotal Phase 3 study of XIPERE (PEACHTREE) were presented at the
American Academy of Ophthalmology 2018 Annual Meeting, highlighting
efficacy data resolving non-infectious uveitic inflammation and
clinically significant vitreous haze in patients with
non-infectious uveitic macular edema.
Fourth Quarter 2018 Financial
Results
Clearside’s research and development expenses
for the fourth quarter of 2018 were $17.5 million, compared to
$13.9 million for the fourth quarter of 2017. The $3.6 million
increase was primarily attributable to increased costs related to
Clearside’s clinical development programs, including costs related
to closing down the two Phase 3 clinical trials in RVO.
General and administrative expenses for the
fourth quarter of 2018 were $4.2 million, compared to $2.4 million
for the fourth quarter of 2017. The $1.8 million increase was
primarily attributable to increased employee-related costs and
marketing expenses related to the potential commercialization of
XIPERE.
Net loss for the fourth quarter of 2018 was
$21.6 million, or $0.68 per share of common stock, compared to
$16.5 million, or $0.65 per share of common stock, for the fourth
quarter of 2017. The increase in net loss was primarily
attributable to higher research and development expenses in
2018.
Full Year 2018 Financial
Results
Clearside’s research and development expenses
for the year ended December 31, 2018 were $68.3 million, compared
to $49.1 million for the year ended December 31, 2017. The $19.2
million increase was primarily attributable to increased costs
related to Clearside’s clinical development programs.
General and administrative expenses were $14.7
million for the year ended December 31, 2018, compared to $9.7
million for the year ended December 31, 2017. The $5.0 million
increase was primarily attributable to increased employee-related
costs and marketing expenses related to the potential
commercialization of XIPERE.
Net loss for the year ended December 31, 2018
was $82.8 million, or $2.69 per share of common stock, compared to
$59.0 million for the year ended December 31, 2017, or $2.33 per
share of common stock. The increase in net loss was primarily
attributable to higher research and development expenses in
2018.
Cash, cash equivalents and short-term
investments totaled $40.9 million as of December 31, 2018. Since
then, Clearside has augmented its year-end 2018 cash balance with
$5.6 million of net proceeds from sales of common stock under its
at-the-market facility.
Conference Call & Webcast
Details
Clearside’s management will host a webcast and
conference call today at 5:00 p.m. Eastern Time to discuss the
financial results and provide a corporate update. The live and
archived webcast may be accessed on the Clearside website under the
Investors section: Events and Presentations. The live call
can be accessed by dialing (844) 263-8310 (domestic) or (213)
358-0959 (international) and entering conference code:
1855758. An archive of the webcast will be available for
three months.
About Suprachoroidal Injection
Platform
Clearside’s proprietary suprachoroidal injection
treatment approach offers unprecedented access to the back of the
eye where sight-threatening disease often occurs. The company’s
unique platform is inherently flexible and intended to work with
established medications, new formulations of medicines, as well as
future innovations such as gene therapy.
About XIPERE
XIPERETM (triamcinolone acetonide ophthalmic
suspension) for Suprachoroidal Injection, formerly known as CLS-TA,
is a proprietary suspension of the corticosteroid triamcinolone
acetonide formulated for administration to the back of the eye via
suprachoroidal injection for the treatment of macular edema
associated with uveitis. Clearside’s patented technology is
designed to deliver drug to the suprachoroidal space located
between the choroid and the outer protective layer of the eye,
known as the sclera. Suprachoroidal injection enables the rapid and
adequate dispersion of medicine to the back of the eye, offering
the potential for the medicine to act longer and minimize harm to
the surrounding healthy parts of the eye, thus potentially
providing advantageous and sustained efficacy with a favorable
safety profile.
About Clearside Biomedical
Clearside Biomedical, Inc. is a
biopharmaceutical company dedicated to developing treatments that
restore and preserve vision for people with serious eye diseases.
Clearside’s proprietary suprachoroidal treatment approach offers
unprecedented access to the back of the eye where sight-threatening
disease often occurs. The Company’s unique platform for eye disease
treatments is inherently flexible and intended to work with
established medications, new formulations of medicines, as well as
future innovations such as gene therapy. Clearside is headquartered
in Alpharetta, GA. For more information, please visit
http://www.clearsidebio.com.
Cautionary Note Regarding
Forward-Looking Statements
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as “believe”, “expect”, “may”, “plan”,
“potential”, “will”, and similar expressions, and are based on
Clearside’s current beliefs and expectations. These forward-looking
statements include expectations regarding the clinical development
of Clearside’s product candidates, the potential attributes and
benefits of Clearside’s product candidates, and the potential
approval and commercialization of XIPERE in the United States.
These statements involve risks and uncertainties that could cause
actual results to differ materially from those reflected in such
statements. Risks and uncertainties that may cause actual results
to differ materially include uncertainties inherent in the conduct
of clinical trials, Clearside’s reliance on third parties over
which it may not always have full control, and other risks and
uncertainties that are described in Clearside’s Annual Report on
Form 10-K for the year ended December 31, 2017, filed with
the U.S. Securities and Exchange Commission
(“SEC”) on March 16, 2018, Clearside’s Quarterly Report
on Form 10-Q for the quarter ended September 30, 2018, filed with
the SEC on November 8, 2018, and Clearside’s other Periodic Reports
filed with the SEC. Any forward-looking statements speak only
as of the date of this press release and are based on information
available to Clearside as of the date of this release, and
Clearside assumes no obligation to, and does not intend to, update
any forward-looking statements, whether as a result of new
information, future events or otherwise.
Investor and Media Contacts: Jenny Kobin (919)
423-4799Remy Bernarda (415) 203-6386ir@clearsidebio.com
-Financial Tables Follow-
CLEARSIDE BIOMEDICAL, INC.Selected
Financial Data (in thousands, except share and per share
data)(unaudited)
Statements of
Operations Data |
|
Three Months EndedDecember
31, |
|
|
Year EndedDecember
31, |
|
|
|
2018 |
|
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
License and
collaboration revenue |
|
$ |
30 |
|
|
|
$ |
55 |
|
|
$ |
30 |
|
|
$ |
345 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
17,486 |
|
|
|
|
13,935 |
|
|
|
68,291 |
|
|
|
49,053 |
|
General
and administrative |
|
|
4,176 |
|
|
|
|
2,441 |
|
|
|
14,684 |
|
|
|
9,700 |
|
Total
operating expenses |
|
|
21,662 |
|
|
|
|
16,376 |
|
|
|
82,975 |
|
|
|
58,753 |
|
Loss from
operations |
|
|
(21,632 |
) |
|
|
|
(16,321 |
) |
|
|
(82,945 |
) |
|
|
(58,408 |
) |
Other (expense) income,
net |
|
|
(6 |
) |
|
|
|
(172 |
) |
|
|
127 |
|
|
|
(567 |
) |
Net loss |
|
$ |
(21,638 |
) |
|
|
$ |
(16,493 |
) |
|
$ |
(82,818 |
) |
|
$ |
(58,975 |
) |
Net loss per share of
common stock — basic and diluted |
|
$ |
(0.68 |
) |
|
|
$ |
(0.65 |
) |
|
$ |
(2.69 |
) |
|
$ |
(2.33 |
) |
Weighted average shares
outstanding — basic and diluted |
|
|
32,041,305 |
|
|
|
|
25,346,345 |
|
|
|
30,733,600 |
|
|
|
25,311,614 |
|
Balance Sheet
Data |
December 31, |
|
|
December 31, |
|
|
2018 |
|
|
2017 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents
and short-term investments |
$ |
40,878 |
|
|
$ |
37,640 |
|
Restricted cash |
|
360 |
|
|
|
360 |
|
Total assets |
|
44,120 |
|
|
|
40,493 |
|
Long-term debt
(including current portion) |
|
9,975 |
|
|
|
8,009 |
|
Total liabilities |
|
20,500 |
|
|
|
19,078 |
|
Total stockholders’
equity |
|
23,620 |
|
|
|
21,415 |
|
Source: Clearside Biomedical, Inc.
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