Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical
company dedicated to developing and delivering treatments that
restore and preserve vision for people with serious back of the eye
diseases, today reported financial results for the second quarter
of 2019 and provided a corporate update.
“We continue to make progress in leveraging
Clearside’s proprietary suprachoroidal space (SCS) injection
platform,” said George Lasezkay, Pharm.D., J.D., Clearside’s Chief
Executive Officer. “We recently announced an agreement with Aura
Biosciences, which broadens the potential use of our SCS
Microinjector™ technology into ocular oncology, where there is a
significant unmet medical need. With ongoing exposure at medical
conferences and in ophthalmic publications highlighting our
targeted drug delivery approach, we are exploring various
opportunities to prudently build our internal pipeline and we are
also attracting significant interest from other companies to
partner our technology like we did with Aura Biosciences.”
Dr. Lasezkay continued, “I have been working
with our team and Board of Directors to re-evaluate the Company’s
overall strategy. We have concluded that the optimal path to
maximize the value of XIPERE™ (triamcinolone acetonide
suprachoroidal injectable suspension) is to out-license rights to
XIPERE rather than commercialize it on our own. The XIPERE New Drug
Application is currently under review with the U.S. FDA. We believe
that a partner, or partners, will be better positioned to bring
XIPERE to market more effectively and to more markets than would be
possible for Clearside, and we are currently in ongoing discussions
with multiple interested parties. This change in strategy benefits
Clearside in a number of ways in the near term: it lowers expenses
and eliminates the inherent risks and investment related to
creating and maintaining a commercial infrastructure; it also has
the potential to provide access to non-dilutive funding via
potential upfront and milestone-based payments, and future
royalties, which could be used to fund our internal research and
development (R&D) pipeline.”
“We are excited about this new strategic
direction for the Company. We can now dedicate additional
resources to advancing our two-prong development strategy centered
on the use of our proprietary SCS injection platform. This includes
(1) building an internal R&D pipeline in areas such as gene
therapy and novel small molecules, and (2) creating external
collaborations with other companies, allowing them access to the
SCS so their therapies can be delivered in a targeted, non-surgical
manner. As a result of this strategic change, we believe we
will now have sufficient resources to fund our planned operations
into the third quarter of 2020, without relying on any
partnership-related payments that we might gain through XIPERE
out-licensing or external R&D collaboration agreements,”
concluded Dr. Lasezkay.
Key Highlights
- Worldwide licensing agreement with Aura Biosciences for the use
of Clearside’s SCS Microinjector to deliver Aura’s proprietary drug
candidates into the suprachoroidal space for the potential
treatment of certain ocular cancers, including choroidal
melanoma.
- Positive meeting with the Austrian Medicines and Medical
Devices Agency supporting a path forward for XIPERE registration
for uveitic macular edema in the European Union.
- Multiple oral presentations on Clearside’s pipeline and
proprietary SCS Microinjector were given by leading ophthalmology
experts at the American Society of Retinal Specialists (ASRS)
Annual Meeting.
- Thomas A. Ciulla, M.D., MBA, Chief Medical Officer of
Clearside, served on a panel entitled, “Advancements in Genetic and
Regenerative Therapies” at the Ophthalmology Innovation Summit
event at ASRS.
- Opportunities for suprachoroidal delivery were recently
featured in several professional journals including two articles in
the official journal of the ASRS, Retina Times: “Suprachoroidal
Drug Delivery for Uveitic Macular Edema”; “Gene Therapy: Predicting
the Impact on Treating Rare and Chronic Diseases”; and a feature
article in Ophthalmology Management titled “Introduction to Gene
Therapy.”
Second Quarter 2019 Financial
Results
Clearside’s research and development expenses
for the quarter ended June 30, 2019 were $0.7 million, compared to
$17.3 million for the quarter ended June 30, 2018. The $16.6
million decrease was primarily attributable to a $14.1 million
decrease due to closing down two late-stage clinical trials, which
included a one-time credit of $2.6 million upon reconciliation of
final costs.
General and administrative expenses were $5.0
million for the quarter ended June 30, 2019, compared to $3.6
million for the quarter ended June 30, 2018. The $1.4 million
increase was primarily attributable to an increase in
employee-related costs, including expenses related to the
resignation of Clearside’s former CEO, and marketing-related
expenses for XIPERE.
Net loss for the quarter ended June 30, 2019 was
$5.7 million, or $0.15 per share of common stock, compared to $20.7
million for the quarter ended June 30, 2018, or $0.65 per share of
common stock. The decrease in net loss was primarily related to
lower clinical development costs.
Cash and cash equivalents totaled $26.2 million
as of June 30, 2019.
Conference Call & Webcast
Details
Clearside’s management will host a webcast and
conference call today at 4:30 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:
7657547. An archive of the webcast will be available for
three months.
About XIPERE™
XIPERETM (triamcinolone acetonide suprachoroidal
injectable suspension), formerly known as CLS-TA, is a proprietary
suspension of the corticosteroid triamcinolone acetonide formulated
for administration to the back of the eye 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. A New Drug Application was submitted to the U.S.
Food and Drug Administration in December 2018 for XIPERE, and, if
approved, XIPERE will be the first therapy indicated for macular
edema associated with uveitis.
About Uveitis and Macular
Edema
Uveitis is a set of ocular inflammatory
conditions and is one of the leading causes of vision loss,
affecting approximately 350,000 patients in the United
States and more than one million worldwide. Approximately
one-third of these patients develop uveitic macular edema, a
build-up of fluid in the macula, the area of the retina responsible
for sharp, straight-ahead vision. Macular edema is the leading
cause of vision loss and blindness in uveitis patients and can
occur from uveitis affecting any anatomic location - anterior,
intermediate, posterior or pan. The uveitis market is expected to
grow by 2024 to nearly $550 million in the United
States and over $1 billion globally.
About Clearside Biomedical
Clearside Biomedical, Inc. is a
biopharmaceutical company dedicated to developing and delivering
treatments that restore and preserve vision for people with serious
back of the eye diseases. Clearside’s proprietary SCS
Microinjector™ targeting the suprachoroidal space (SCS) offers
unique access to the macula, retina and choroid where
sight-threatening disease often occurs. The Company’s SCS injection
platform is an inherently flexible, in-office, non-surgical
procedure, intended to provide targeted delivery to the site of
disease and to work with both established and new formulations of
medications, as well as future therapeutic innovations such as gene
therapy. For more information, please visit
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 statements regarding the potential out-licensing
of XIPERE and the economic terms such a license might include,
opportunities for expanding Clearside’s internal pipeline and
entering into other licensing arrangements, the potential benefits
of XIPERE and the SCS injection platform, the potential approval of
XIPERE for the treatment of macular edema associated with uveitis
in the United States and Europe and the period of time over which
Clearside expects its current financial resources to be sufficient
to fund its planned operations. 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, 2018, filed with the U.S. Securities and
Exchange Commission (“SEC”) on March 15, 2019, 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 Remy
Bernarda ir@clearsidebio.com(678) 430-8206
-Financial Tables Follow-
CLEARSIDE BIOMEDICAL, INC.Selected
Financial Data (in thousands, except share and per share
data)(unaudited)
Statements of
Operations Data |
|
Three Months EndedJune 30, |
|
|
Six Months EndedJune 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Collaboration revenue |
|
$ |
45 |
|
|
$ |
— |
|
|
$ |
90 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
658 |
|
|
|
17,343 |
|
|
|
11,625 |
|
|
|
30,722 |
|
General and administrative |
|
|
5,004 |
|
|
|
3,561 |
|
|
|
9,388 |
|
|
|
6,635 |
|
Total operating expenses |
|
|
5,662 |
|
|
|
20,904 |
|
|
|
21,013 |
|
|
|
37,357 |
|
Loss from operations |
|
|
(5,617 |
) |
|
|
(20,904 |
) |
|
|
(21,923 |
) |
|
|
(37,357 |
) |
Other (expense) income, net |
|
|
(117 |
) |
|
|
203 |
|
|
|
(215 |
) |
|
|
49 |
|
Net loss |
|
$ |
(5,734 |
) |
|
$ |
(20,701 |
) |
|
$ |
(21,138 |
) |
|
$ |
(37,308 |
) |
Net loss per share of common
stock — basic and diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.65 |
) |
|
$ |
(0.59 |
) |
|
$ |
(1.27 |
) |
Weighted average shares
outstanding — basic and diluted |
|
|
37,636,053 |
|
|
|
31,979,158 |
|
|
|
35,899,777 |
|
|
|
29,412,904 |
|
Balance Sheet
Data |
June 30, |
|
December 31, |
|
2019 |
|
2018 |
|
|
|
|
|
|
Cash, cash equivalents and
short-term investments |
$ |
26,174 |
|
$ |
40,878 |
Restricted cash |
|
360 |
|
|
360 |
Total assets |
|
29,854 |
|
|
44,120 |
Long-term debt (including current
portion) |
|
10,099 |
|
|
9,975 |
Total liabilities |
|
16,953 |
|
|
20,500 |
Total stockholders’ equity |
|
12,901 |
|
|
23,620 |
Source: Clearside Biomedical, Inc.
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