Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical
company revolutionizing the delivery of therapies to the back of
the eye through the suprachoroidal space (SCS®), today reported
financial results for the third quarter ended September 30, 2021.
“The approval of XIPERE™ marks a significant
milestone for Clearside as we enter a new era in delivering
therapies to the back of the eye via the suprachoroidal space using
our proprietary platform,” said George Lasezkay, Pharm.D., J.D.,
President and Chief Executive Officer. “It is always an exciting
moment when you are able to develop a truly innovative
pharmaceutical treatment option for patients that addresses an
important unmet medical need. XIPERE is now the first product
approved for injection into the suprachoroidal space, and the first
therapy approved for macular edema associated with uveitis. By
utilizing our SCS Microinjector®, retina physicians will now have a
differentiated route of administration that provides a targeted
treatment for their patients suffering from this sight-threatening
disease.”
Dr. Lasezkay continued, “I am proud of the work
completed by our team to advance our first clinical product,
XIPERE, to final FDA approval, validating our ability to
successfully develop ophthalmic therapies for suprachoroidal
administration. We also continue to work closely and cooperatively
with Bausch + Lomb as they prepare to launch XIPERE in the U.S. in
the first quarter of 2022.”
“With the approval of XIPERE, we expect to
receive a total of $19 million in non-dilutive funding for approval
and pre-launch milestones from our commercialization partners. This
additional capital will be utilized to advance our clinical
development pipeline led by CLS-AX (axitinib injectable suspension)
for suprachoroidal administration. In September 2021, we completed
dosing in Cohort 2 of OASIS, our ongoing Phase 1/2a clinical trial
of CLS-AX in patients with neovascular age-related macular
degeneration (wet AMD). We look forward to reporting the safety and
tolerability results from Cohort 2 by the end of this year,”
concluded Dr. Lasezkay.
Key Highlights
- XIPERE
(triamcinolone acetonide injectable suspension) for suprachoroidal
use for the treatment of macular edema associated with uveitis was
approved by the U.S. Food and Drug Administration in October
2021.
- Enrollment and
dosing were completed in Cohort 2 of OASIS, Clearside’s U.S. based,
open-label, dose-escalation Phase 1/2a trial in patients with wet
AMD, to assess the safety and tolerability of a 0.1 mg dose of
CLS-AX (axitinib injectable suspension) administered by
suprachoroidal injection via Clearside’s SCS Microinjector.
- Exclusive XIPERE
license agreement with Arctic Vision, a China-based biotechnology
company focused on innovative ophthalmic therapies, was expanded
from Greater China and South Korea to also include Australia, New
Zealand, India and the ASEAN Countries (Brunei, Cambodia,
Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore,
Thailand, and Vietnam).
- REGENXBIO presented
positive initial data from two Phase 2 clinical trials testing
RGX-314 using suprachoroidal delivery. In the AAVIATE® trial for
the treatment of wet AMD, RGX-314 was well tolerated in 50 patients
in Cohorts 1-3, with no drug-related serious adverse events, and a
treatment effect observed in Cohort 1 patients at six months after
one-time treatment. In the ALTITUDE™ trial for the treatment of
diabetic retinopathy, RGX-314 was well tolerated in 15 patients in
Cohort 1, with no drug-related serious adverse events, no
intraocular inflammation observed, and positive interim data from
Cohort 1 at three months after one-time treatment.
- Aura Biosciences
presented interim Phase 2 safety data evaluating suprachoroidal
administration of AU-011 in patients with choroidal melanoma,
reporting that there have been no related serious adverse events,
dose limiting toxicities, or grade 3 adverse events observed during
the trial and that suprachoroidal administration may improve the
therapeutic index and optimize treatment parameters.
- Multiple
presentations featuring the use of Clearside’s proprietary
suprachoroidal space injection platform were highlighted at global
conferences, including the American Society of Retina Specialists
Annual Meeting, the Retina Society 54th Annual Scientific Meeting,
the OIS Retina Summit and the Ophthalmology Futures European 2021
Virtual Retina Forum.
- A data manuscript
entitled, “Suprachoroidal CLS-TA with and without Systemic
Corticosteroid and/or Steroid-Sparing Therapy: A Post-Hoc Analysis
of the Phase 3 PEACHTREE Clinical Trial”, was published in Ocular
Immunology & Inflammation in August 2021.
Third Quarter 2021 Financial
Results
Clearside’s license and other revenue for the
third quarter of 2021 was $3.1 million, compared to $3.4 million
for the third quarter of 2020. This decrease was primarily
attributable to higher revenue from partner licensing agreements in
the third quarter of 2020.
Research and development expenses for the third
quarter of 2021 were $5.1 million, compared to $3.5 million for the
third quarter of 2020. This increase was primarily attributable to
increased costs for continued development of CLS-AX and other
pipeline programs and employee-related expenses.
General and administrative expenses for the
third quarter of 2021 were $2.8 million, compared to $2.4 million
for the third quarter of 2020. This increase was primarily
attributable to an increase in employee-related expenses.
Net loss for the third quarter of 2021 was $4.9
million, or $0.08 per share of common stock, compared to a net loss
of $2.4 million, or $0.05 per share of common stock, for the third
quarter of 2020. This increase in net loss was primarily
attributable to higher research and development expenses in the
third quarter of 2021.
As of September 30, 2021, Clearside’s cash and
cash equivalents totaled $25.2 million. With the anticipated XIPERE
approval related milestone payments of $19 million from Clearside’s
commercialization partners, the Company believes it will have
sufficient resources to fund its planned operations into 2023.
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: 1698586. An
archive of the webcast will be available for three months.
Important Safety Information about
XIPERE™
Indication XIPERE™ (triamcinolone
acetonide injectable suspension) for suprachoroidal use is a
corticosteroid indicated for the treatment of macular edema
associated with uveitis.
IMPORTANT SAFETY
INFORMATIONPatients should be monitored following
injection for elevated intraocular pressure. See Dosage and
Administration instructions in full Prescribing Information.
-
XIPERE is contraindicated in patients with active
or suspected ocular or periocular
infections including most viral diseases of the
cornea and conjunctiva, including active epithelial herpes simplex
keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial
infections, and fungal diseases.
-
XIPERE™ is contraindicated in patients with
known hypersensitivity to triamcinolone
acetonide or any other components of this
product.
-
Use of corticosteroids may produce cataracts, increased intraocular
pressure, and glaucoma. Use of corticosteroids may enhance the
establishment of secondary ocular infections due to bacteria,
fungi, or viruses, and should be used cautiously in patients with a
history of ocular herpes simplex.
-
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's
syndrome, and hyperglycemia can occur following administration of a
corticosteroid. Monitor patients for these conditions with chronic
use.
-
In controlled studies, the most common ocular adverse reactions
were increased ocular pressure, non-acute (14%), eye pain,
non-acute (12%), cataract (7%); increased intraocular pressure,
acute (6%), cataract (7%), vitreous detachment (5%), injection site
pain (4%) conjunctival hemorrhage (4%), visual acuity reduced (4%),
dry eye (3%), eye pain, acute (3%), photophobia (3%), and vitreous
floaters (3%), and in 2% of patients: uveitis, conjunctival
hyperaemia, punctate keratitis, conjunctival oedema, meibomianitis,
anterior capsule contraction, chalazion, eye irritation, eye
pruritus, eyelid ptosis, photopsia, and vision blurred.The most
common non-ocular adverse event was headache (5%).
-
Corticosteroids should be used during pregnancy or nursing only if
the potential benefit justifies the potential risk to the fetus or
nursing infant.
You are encouraged to report negative
side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.
Please click here for full Prescribing
Information.
About Clearside Biomedical
Clearside Biomedical, Inc. is a
biopharmaceutical company revolutionizing the delivery of therapies
to the back of the eye through the suprachoroidal space (SCS®).
Clearside’s SCS injection platform, utilizing the Company’s
proprietary SCS Microinjector®, enables an in-office, repeatable,
non-surgical procedure for the targeted and compartmentalized
delivery of a wide variety of therapies to the macula, retina or
choroid to potentially preserve and improve vision in patients with
sight-threatening eye diseases. Clearside is developing its own
pipeline of small molecule product candidates for administration
via its SCS Microinjector and strategically partners its SCS
injection platform with companies utilizing other ophthalmic
therapeutic innovations. Clearside’s first product, XIPERE™
(triamcinolone acetonide injectable suspension) for suprachoroidal
use, was approved by the U.S. Food and Drug Administration in
October 2021. 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 clinical development,
including the timing of data from the OASIS clinical trial, the
potential benefits of XIPERE, CLS-AX and therapies using
Clearside’s SCS Microinjector®, the timing of commercial launch of
XIPERE by Bausch + Lomb and Clearside’s ability to fund its
operations into 2023. 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, 2020,
filed with the U.S. Securities and Exchange Commission (“SEC”) on
March 15, 2021, 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
XIPERE™, suprachoroidal space (SCS®), and SCS Microinjector® are
trademarks of Clearside Biomedical. AAVIATE® and ALTITUDE™ are
trademarks of REGENXBIO Inc.
-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, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
License and other revenue |
|
$ |
3,074 |
|
|
$ |
3,432 |
|
|
$ |
3,888 |
|
|
$ |
7,883 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
5,147 |
|
|
|
3,490 |
|
|
|
14,697 |
|
|
|
10,601 |
|
General and administrative |
|
|
2,816 |
|
|
|
2,374 |
|
|
|
8,525 |
|
|
|
8,107 |
|
Total operating expenses |
|
|
7,963 |
|
|
|
5,864 |
|
|
|
23,222 |
|
|
|
18,708 |
|
Loss from operations |
|
|
(4,889 |
) |
|
|
(2,432 |
) |
|
|
(19,334 |
) |
|
|
(10,825 |
) |
Other income |
|
|
2 |
|
|
|
— |
|
|
|
1,001 |
|
|
|
— |
|
Other expense |
|
|
— |
|
|
|
(1 |
) |
|
|
— |
|
|
|
(273 |
) |
Net loss |
|
$ |
(4,887 |
) |
|
$ |
(2,433 |
) |
|
$ |
(18,333 |
) |
|
$ |
(11,098 |
) |
Net loss per share of common stock — basic and diluted |
|
$ |
(0.08 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.24 |
) |
Weighted average shares outstanding — basic and diluted |
|
|
59,474,346 |
|
|
|
46,976,649 |
|
|
|
58,095,080 |
|
|
|
45,653,068 |
|
Balance Sheet
Data |
September 30, |
|
|
December 31, |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
25,217 |
|
|
$ |
17,287 |
|
Total assets |
|
27,378 |
|
|
|
19,322 |
|
Deferred revenue |
|
5,000 |
|
|
|
5,000 |
|
Long-term debt (including current
portion) |
|
— |
|
|
|
991 |
|
Total liabilities |
|
9,530 |
|
|
|
10,559 |
|
Total stockholders’ equity |
|
17,848 |
|
|
|
8,763 |
|
Source: Clearside Biomedical, Inc.
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