Clearside Biomedical Announces First Quarter 2020 Financial Results
May 08 2020 - 7:05AM
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 first quarter
ended March 31, 2020.
“Our team remains focused on progressing our
programs as we navigate the evolving business and regulatory
environment,” said George Lasezkay, Pharm.D., J.D., President and
Chief Executive Officer. “We are committed to advancing our first
product candidate, XIPERE™, to the U.S. regulatory finish line as
quickly as possible to maximize its commercial potential. Our
Investigational New Drug application remains on track for
submission in mid-2020 for CLS-AX (axitinib injectable suspension)
in wet age-related macular degeneration, which would potentially
enable us to initiate a Phase 1/2a clinical trial before the end of
this year. Additionally, we continue to support our clinical
development partners in gene therapy and ocular cancer as they move
their programs forward using our SCS Microinjector®.”
Key Highlights
- Clearside and Bausch Health Companies Inc. and its leading
global eye health business, Bausch + Lomb, amended their licensing
agreement for the commercialization and development of XIPERE in
the U.S. and Canada. Clearside granted Bausch + Lomb an exclusive
option for the right to commercialize and develop XIPERE in (i)
Europe and the United Kingdom, (ii) Australia and New Zealand,
and/or (iii) South America and Mexico; and Bausch + Lomb extended
the time allowed for Clearside to obtain regulatory approval for
XIPERE in the U.S.
- NDA resubmission timeline for XIPERE (triamcinolone acetonide
suprachoroidal injectable suspension) is currently targeted for the
fourth quarter of 2020 based on recent manufacturing updates.
- Clearside received an upfront payment of $4.0 million from
Arctic Vision pursuant to a license agreement for the
commercialization and development of XIPERE in China, Hong Kong,
Macau, Taiwan and South Korea.
- Experienced research and development executive, Nancy J.
Hutson, Ph.D., was appointed to Clearside’s Board of
Directors.
- Clearside established a Scientific Advisory Board with highly
experienced retinal physicians who will provide input on program
and clinical development.
- Multiple presentations featuring Clearside’s suprachoroidal
injection platform in a range of indications, including wet AMD,
uveitis, diabetic macular edema and ocular gene therapy, were
highlighted at global conferences, including the Annual Meeting of
the Macula Society, the Annual Angiogenesis Meeting, and the Annual
American Uveitis Society Winter Symposium.
- Ophthalmology, the peer-reviewed journal of the American
Academy of Ophthalmology, published results from the Phase 3
clinical trial of XIPERE (the PEACHTREE trial).
First Quarter 2020 Financial
Results
Clearside’s license revenue for the first
quarter of 2020 was $4.1 million, compared to $45,000 for the first
quarter of 2019. The $4.0 million increase was related to the
receipt of the upfront payment from Arctic Vision.
Research and development expenses for the first
quarter of 2020 were $3.8 million, compared to $11.0 million for
the first quarter of 2019. The $7.2 million decrease was primarily
attributable to reduced expenses from two closed late-stage
clinical trials.
General and administrative expenses for the
first quarter of 2020 were $3.1 million, compared to $4.4 million
for the first quarter of 2019. The $1.3 million decrease was
primarily attributable to lower marketing and employee-related
expenses due to Clearside’s out-licensing of the commercialization
of XIPERE.
Net loss for the first quarter of 2020 was $2.9
million, or $0.07 per share of common stock, compared to a net loss
of $15.4 million, or $0.45 per share of common stock, for the first
quarter of 2019. The decrease in net loss was primarily
attributable to lower research and development expenses in
2020.
As of March 31, 2020, Clearside’s cash and cash
equivalents totaled $20.9 million. Based on Clearside’s current
research and development plans and expected near-term partnership
milestone payments, Clearside believes it will have sufficient
resources to fund its planned operations into the second quarter of
2021.
Clearside will not be hosting a conference call
in conjunction with this release. The Company conducted a corporate
update call on April 28, 2020, which is accessible on the Clearside
website under the Investors section: Events and Presentations.
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 timelines for
resubmitting the NDA for XIPERE and submitting the IND for CLS-AX,
as well as Clearside’s ability to fund its operations into the
second quarter of 2021, including the receipt of potential
milestone payments. 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, uncertainties regarding the COVID-19 pandemic
and other risks and uncertainties that are described in Clearside’s
Annual Report on Form 10-K for the year ended December 31, 2019,
filed with the U.S. Securities and Exchange Commission (“SEC”) on
March 13, 2020, 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 EndedMarch 31, |
|
|
|
2020 |
|
|
2019 |
|
License and other revenue |
|
$ |
4,097 |
|
|
$ |
45 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
3,811 |
|
|
|
10,967 |
|
General and administrative |
|
|
3,122 |
|
|
|
4,384 |
|
Total operating expenses |
|
|
6,933 |
|
|
|
15,351 |
|
Loss from operations |
|
|
(2,836 |
) |
|
|
(15,306 |
) |
Other expense |
|
|
(75 |
) |
|
|
(98 |
) |
Net loss |
|
$ |
(2,911 |
) |
|
$ |
(15,404 |
) |
Net loss per share of common
stock — basic and diluted |
|
$ |
(0.07 |
) |
|
$ |
(0.45 |
) |
Weighted average shares
outstanding — basic and diluted |
|
|
44,753,510 |
|
|
|
34,144,209 |
|
Balance Sheet
Data |
March 31, |
|
|
December 31, |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
20,930 |
|
|
$ |
22,595 |
|
Restricted cash |
|
360 |
|
|
|
360 |
|
Total assets |
|
25,043 |
|
|
|
26,776 |
|
Deferred revenue |
|
5,100 |
|
|
|
5,000 |
|
Debt (including current
portion) |
|
5,183 |
|
|
|
5,152 |
|
Total liabilities |
|
14,603 |
|
|
|
15,619 |
|
Total stockholders’ equity |
|
10,440 |
|
|
|
11,157 |
|
Source: Clearside Biomedical, Inc.
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