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 third quarter of
2019 and provided a corporate update.
“With three recent partnerships and plans to
expand our internal development pipeline, we have made meaningful
progress on our overall strategy to broaden the reach of our
suprachoroidal space injection platform,” said George Lasezkay,
Pharm.D., J.D., Clearside’s Chief Executive Officer. “Last quarter,
we announced our plans to out-license rights to XIPERE™
(triamcinolone acetonide suprachoroidal injectable suspension)
rather than commercialize it on our own, to create external
collaborations with other companies enabling access to our
platform, and to build an internal pipeline in areas such as gene
therapy and small molecules.”
“We have now signed deals with Bausch Health,
REGENXBIO and Aura Biosciences that will benefit Clearside in a
number of ways: 1) we have eliminated the inherent risks and
investment related to building and maintaining a commercial
infrastructure for XIPERE ourselves; 2) we are entitled to receive
$7 million of non-dilutive capital in upfront payments and are
eligible to receive over $200 million in potential future
development and sales milestones and royalty payments; and 3) we
have expanded the use of our platform to other indications
including choroidal melanoma, wet age-related macular degeneration
(AMD), and diabetic retinopathy. We look forward to completing the
next steps on XIPERE and continuing to expand our pipeline through
partner collaborations and planned internal research and
development efforts,” concluded Dr. Lasezkay.
Thomas A. Ciulla, M.D., MBA, Chief Medical
Officer of Clearside, commented, “With a renewed focus on research
and development, our team has spent the last several months
performing additional analysis on our proprietary suspension of
axitinib (CLS-AX) for suprachoroidal injection and we are now
planning to advance this as our next internal development program.
Axitinib directly inhibits receptor tyrosine kinases, including
vascular endothelial growth factor (VEGF) receptors-1, -2, and -3
with high potency and specificity, and pan-VEGF inhibition may
benefit patients who sub-optimally respond to current anti-VEGF
therapy. Further, our preclinical testing of CLS-AX using our
proprietary microinjector demonstrated reduced growth of
experimental neovascularization with decreased fluorescein leakage,
and delivered the compound directly to affected tissues with
durable drug levels, suggesting the potential to maintain visual
gains and reduce clinical treatment burden in patients with
angiogenic retinal diseases. Based on our current and planned
non-clinical research, we are targeting submission of an
Investigational New Drug (IND) application for CLS-AX in
mid-2020.”
Clearside is working to address the issues
raised by the U.S. Food and Drug Administration (FDA) in the
complete response letter received last month regarding XIPERE. The
Company currently expects to resubmit its New Drug Application
(NDA) in the first quarter of 2020 and believes the FDA will review
the NDA within six months of receipt of the resubmission.
Key Highlights
- Bausch Health acquired an exclusive license for the
commercialization and development of XIPERE in the United States
and Canada.
- REGENXBIO Inc. exercised its option to license Clearside’s
proprietary, in-office SCS Microinjector for the delivery of
adeno-associated virus (AAV)-based therapeutics to the
suprachoroidal space to potentially treat wet AMD, diabetic
retinopathy, and other conditions for which chronic anti-VEGF
treatment is currently the standard of care.
- Aura Biosciences entered a worldwide licensing agreement 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.
- Multiple oral presentations at the American Academy of
Ophthalmology (AAO) 2019 Annual Meeting featured Clearside’s
suprachoroidal injection platform and potential value of XIPERE in
uveitis patients.
- Presentations were made related to Clearside on gene therapy
delivery, additional analysis of XIPERE clinical programs, and the
unmet need in diabetic macular edema at global conferences
including The Retina Society 52nd Scientific Program in London, UK,
the Ophthalmology Futures Forum in Paris, France and the European
Society of Retina Specialists EURETINA 2019 Congress in Paris,
France.
Third Quarter 2019 Financial
Results
Clearside’s research and development expenses
for the quarter ended September 30, 2019 were $2.7 million,
compared to $20.1 million for the quarter ended September 30, 2018.
The $17.4 million decrease was primarily attributable to closing
down two late-stage clinical trials in early 2019. General and
administrative expenses were $3.8 million for the quarter ended
September 30, 2019, compared to $3.9 million for the quarter ended
September 30, 2018.
Net loss for the quarter ended September 30,
2019 was $6.5 million, or $0.17 per share of common stock, compared
to $23.9 million for the quarter ended September 30, 2018, or $0.75
per share of common stock. The decrease in net loss was primarily
related to lower clinical development costs.
Cash and cash equivalents totaled $22.6 million
as of September 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: 1137365. An
archive of the webcast will be available for three months.
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 timing for resubmitting
the XIPERE NDA and submitting the IND for CLS-AX, plans to expand
Clearside’s internal pipeline and enter into other licensing
arrangements, the potential benefits of CLS-AX and the SCS
injection platform and the potential approval of XIPERE for the
treatment of macular edema associated with uveitis. 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,
Clearside’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2019, filed with the SEC on August 8, 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 EndedSeptember
30, |
|
|
Nine Months EndedSeptember
30, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Collaboration revenue |
$ |
141 |
|
|
$ |
— |
|
|
$ |
231 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
2,728 |
|
|
|
20,083 |
|
|
|
14,353 |
|
|
|
50,805 |
|
General and administrative |
|
3,781 |
|
|
|
3,873 |
|
|
|
13,169 |
|
|
|
10,508 |
|
Total operating expenses |
|
6,509 |
|
|
|
23,956 |
|
|
|
27,522 |
|
|
|
61,313 |
|
Loss from operations |
|
(6,368 |
) |
|
|
(23,956 |
) |
|
|
(27,291 |
) |
|
|
(61,313 |
) |
Other (expense) income, net |
|
(168 |
) |
|
|
84 |
|
|
|
(383 |
) |
|
|
133 |
|
Net loss |
$ |
(6,536 |
) |
|
$ |
(23,872 |
) |
|
$ |
(27,674 |
) |
|
$ |
(61,180 |
) |
Net loss per share of common
stock — basic and diluted |
$ |
(0.17 |
) |
|
$ |
(0.75 |
) |
|
$ |
(0.75 |
) |
|
$ |
(2.02 |
) |
Weighted average shares
outstanding — basic and diluted |
|
38,414,751 |
|
|
|
32,024,223 |
|
|
|
36,747,314 |
|
|
|
30,292,909 |
|
|
|
|
|
|
|
Balance Sheet
Data |
September 30, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and
short-term investments |
$ |
22,551 |
|
|
$ |
40,878 |
|
Restricted cash |
|
360 |
|
|
|
360 |
|
Total assets |
|
25,867 |
|
|
|
44,120 |
|
Long-term debt (including current
portion) |
|
10,162 |
|
|
|
9,975 |
|
Total liabilities |
|
16,108 |
|
|
|
20,500 |
|
Total stockholders’ equity |
|
9,759 |
|
|
|
23,620 |
|
Source: Clearside Biomedical, Inc.
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