Clearside Biomedical Announces Third Quarter 2020 Financial Results and Provides Corporate Update
November 10 2020 - 4:05PM
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
ended September 30, 2020 and provided a corporate update on key
initiatives.
“Over the last 15 months, we have been focused
on implementing our strategy of building an internal research and
development pipeline and establishing targeted external clinical
development and commercial collaborations in the suprachoroidal
space,” said George Lasezkay, Pharm.D., J.D., President and Chief
Executive Officer. “We are making excellent progress on our
internal and external programs and expect to have three novel
therapeutic assets delivered via our SCS Microinjector® in four
clinical trials by the end of this year. We expect this momentum to
continue into 2021 with key catalyst events including the potential
U.S. Food and Drug Administration approval of XIPERE™
(triamcinolone acetonide suprachoroidal injectable
suspension) and initial data from our Phase 1/2a CLS-AX
clinical trial in wet age-related macular degeneration (wet AMD).
We also plan to advance our preclinical programs and look forward
to initial clinical data readouts from our collaboration
partners.”
Recent Key
Highlights
- Clearside’s adeno-associated virus
(AAV)-based gene therapy partner, REGENXBIO, dosed the first
patient in its Phase 2 clinical trial, entitled AAVIATE, to
evaluate the suprachoroidal delivery of RGX-314, an AAV gene
therapy, using Clearside’s SCS Microinjector for the treatment of
wet AMD. REGENXBIO expects to complete enrollment of the first
cohort by the end of 2020, and report initial safety data from the
first cohort in early 2021.
- REGENXBIO recently announced that
its Phase 2 trial, ALTITUDE, to evaluate the targeted, in-office
suprachoroidal delivery of RGX-314 in patients with diabetic
retinopathy (DR), is active. REGENXBIO expects to begin enrolling
patients by the end of 2020 and plans to report interim data from
this trial in 2021.
- Clearside’s ophthalmic oncology
partner, Aura Biosciences, dosed the first patient in its Phase 2
clinical trial evaluating the safety and efficacy of suprachoroidal
administration of AU-011 as a potential first-line treatment for
patients with primary choroidal melanoma. Aura is using Clearside’s
SCS Microinjector to deliver AU-011 into the suprachoroidal space
(SCS®).
- Three new Clearside patents were
issued in the United States and Europe, including a U.S. patent
that covers Clearside’s SCS Microinjector for the suprachoroidal
administration of axitinib (CLS-AX), and two European patents
related to suprachoroidal administration of any therapeutic agent
and suprachoroidal administration of triamcinolone.
- Multiple posters and oral
presentations on Clearside’s pipeline targeting the suprachoroidal
space and its proprietary SCS Microinjector were delivered at the
virtual 53rd Annual Scientific Meeting of The Retina Society.
- Data from the Clearside’s Phase 2
clinical trial in diabetic macular edema (DME) was published in
Ophthalmology Retina. The trial, entitled TYBEE, evaluated the
investigational suprachoroidally injected drug XIPERE when used
with intravitreally administered aflibercept in patients with DME
over a 6-month evaluation period. This early data suggest a
potential role for XIPERE in reducing treatment burden for DME
patients.
- Data was published on the clinical
characterization of the suprachoroidal injection procedure across
three retinal disorders in Translational Vision Science and
Technology, a journal of the Association for Research in Vision and
Ophthalmology. The data suggest that suprachoroidal injection could
be readily adopted in clinical practice for targeted,
compartmentalized delivery of ocular therapeutics.
Upcoming Events and Projected
Milestones
- Initiation of a Phase 1/2a clinical
trial by the end of 2020 to assess safety and tolerability of
CLS-AX administered via suprachoroidal injection in wet AMD with
initial safety data from the first cohort expected in
mid-2021.
- AAV gene therapy partner,
REGENXBIO, expects to report initial safety data from the first
suprachoroidal cohort of its AAVIATE trial in wet AMD in early 2021
and interim data from its ALTITUDE trial in DR in 2021.
- Data presentations on Clearside’s
programs will be made at the American Academy of Ophthalmology 2020
Annual Meeting which will be held virtually from Friday, November
13, 2020 through Sunday, November 15, 2020.
- Clearside’s management team will
present at two virtual investor events: Stifel 2020 Virtual
Healthcare Conference on Tuesday, November 17, 2020, and the JMP
Securities Wet AMD Call on Friday, November 20, 2020.
- XIPERE New Drug Application (NDA)
resubmission is targeted for no later than the first half of
2021.
Third
Quarter
2020 Financial
Results
Clearside’s license revenue for the third
quarter of 2020 was $3.4 million, compared to $141,000 for the
third quarter of 2019. The $3.3 million increase was primarily
attributable to the receipt of a partner milestone payment upon the
initiation of a Phase 2 clinical trial using Clearside’s SCS
Microinjector.
Research and development expenses for the third
quarter of 2020 were $3.5 million, compared to $2.7 million for the
third quarter of 2019. The $0.8 million increase was primarily
attributable to increased expenses related to preparation for
initiation of the CLS-AX Phase 1/2a clinical trial and costs
related to drug manufacturing for XIPERE.
General and administrative expenses for the
third quarter of 2020 were $2.4 million, compared to $3.8 million
for the third quarter of 2019. The $1.4 million decrease was
primarily attributable to reduced marketing-related expenses
resulting from the out-licensing of XIPERE commercialization.
Net loss for the third quarter of 2020 was $2.4
million, or $0.05 per share of common stock, compared to a net loss
of $6.5 million, or $0.17 per share of common stock, for the third
quarter of 2019.
As of September 30, 2020, Clearside’s cash and
cash equivalents totaled $14.8 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 third
quarter of 2021.
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: 3169417.
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® targets the suprachoroidal space (SCS®) and 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 and the potential approval of XIPERE, the
timing of initiation of future clinical trials, the timing of
receipt of data from clinical trials, future management and data
presentations and Clearside’s ability to fund its operations into
the third 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, Clearside’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2020 filed with the SEC on November 10,
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 EndedSeptember
30, |
|
|
Nine Months EndedSeptember
30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
License and other revenue |
|
$ |
3,432 |
|
|
$ |
141 |
|
|
$ |
7,883 |
|
|
$ |
231 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
3,490 |
|
|
|
2,728 |
|
|
|
10,601 |
|
|
|
14,353 |
|
General and administrative |
|
|
2,374 |
|
|
|
3,781 |
|
|
|
8,107 |
|
|
|
13,169 |
|
Total operating expenses |
|
|
5,864 |
|
|
|
6,509 |
|
|
|
18,708 |
|
|
|
27,522 |
|
Loss from operations |
|
|
(2,432 |
) |
|
|
(6,368 |
) |
|
|
(10,825 |
) |
|
|
(27,291 |
) |
Other expense |
|
|
(1 |
) |
|
|
(168 |
) |
|
|
(273 |
) |
|
|
(383 |
) |
Net loss |
|
$ |
(2,433 |
) |
|
$ |
(6,536 |
) |
|
$ |
(11,098 |
) |
|
$ |
(27,674 |
) |
Net loss per share of common stock — basic and diluted |
|
$ |
(0.05 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.75 |
) |
Weighted average shares outstanding — basic and diluted |
|
|
46,976,649 |
|
|
|
38,414,751 |
|
|
|
45,653,068 |
|
|
|
36,747,314 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheet
Data |
September 30, |
|
|
December 31, |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
14,839 |
|
|
$ |
22,595 |
|
Restricted cash |
|
360 |
|
|
|
360 |
|
Total assets |
|
17,405 |
|
|
|
26,776 |
|
Deferred revenue |
|
5,000 |
|
|
|
5,000 |
|
Long-term debt (including current
portion) |
|
991 |
|
|
|
5,152 |
|
Total liabilities |
|
9,281 |
|
|
|
15,619 |
|
Total stockholders’ equity |
|
8,124 |
|
|
|
11,157 |
|
Source: Clearside Biomedical, Inc.
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