Clearside Biomedical Announces Second Quarter 2023 Financial Results and Provides Corporate Update
14 Agosto 2023 - 10:05PM
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 second quarter ended June 30, 2023 and
provided a corporate update.
“The last several months have been very
productive for Clearside with the initiation of ODYSSEY, our Phase
2b clinical trial with CLS-AX, which we believe has the potential
to be up to a twice-a-year treatment for wet AMD,” said George
Lasezkay, Pharm.D., J.D., Clearside’s President and Chief Executive
Officer. “We are enrolling patients through a broad network of U.S.
clinical sites, and we now have nearly all of our planned 30 sites
currently open to enroll participants in the trial. We expect to
report topline data in the third quarter of 2024. Our
differentiated treatment approach utilizes our SCS Microinjector®,
a proven, non-surgical, non-implant way to deliver our proprietary
formulation of axitinib, the most potent tyrosine kinase inhibitor
in development for patients with wet AMD.”
“We continue to be encouraged by the acceptance
of suprachoroidal administration as an innovative and safe form of
ophthalmic drug delivery. With an approved product in the U.S., our
Asia-Pacific partner’s recent NDA submission in Australia, the
continued clinical progress by REGENXBIO/AbbVie and Aura
Biosciences using our SCS Microinjector, and multiple presentations
at prominent medical meetings, including ARVO and ASRS, Clearside
is the leader in suprachoroidal delivery of therapeutic agents to
the back of the eye,” concluded Dr. Lasezkay.
Key Highlights
- Enrollment and
dosing of participants is underway in ODYSSEY, Clearside’s
randomized, multi-center Phase 2b clinical trial of CLS-AX
(axitinib injectable suspension) using suprachoroidal delivery in
neovascular age-related macular degeneration (wet AMD).
- Clearside’s
Asia-Pacific partner, Arctic Vision, announced the acceptance in
Australia of its New Drug Application for suprachoroidal use of
Arcatus® (known as XIPERE® in the U.S.) for the treatment of
uveitic macular edema.
- Clearside’s SCS
Microinjector technology was featured in the peer-reviewed Nature
portfolio journal, Experimental & Molecular Medicine, in an
article titled Genome editing in the treatment of ocular diseases
(Choi, E.H., et al., August 2023). The article highlighted
suprachoroidal injection as a novel modality for delivering
genome-editing tools to the retinal pigment epithelium and retina
and concluded that it is reasonable that therapeutics for
neovascular and non-neovascular AMD delivered to the SCS might
reach the retinal-RPE interface more readily than those delivered
via intravitreal injection. The full article is available on
Clearside’s website.
- Safety and
tolerability data from Clearside’s OASIS Phase 1/2a clinical trial
of CLS-AX in wet AMD were presented at the American Society of
Retina Specialists (ASRS) 41st Annual Scientific Meeting by Rahul
N. Khurana, MD, FACRS, highlighting the excellent safety profile
and potential benefits of CLS-AX, a proprietary suspension
formulation of the tyrosine kinase inhibitor (TKI) axitinib,
delivered via Clearside’s proprietary SCS Microinjector® to provide
high potency pan-VEGF inhibition.
- Clinical data was
presented at The Association for Research in Vision and
Ophthalmology (ARVO) 2023 Annual Meeting, which highlighted that
SCS delivery of small molecule suspensions offered targeted,
compartmentalized, and durable drug delivery to the chorioretina.
In addition, a poster presentation based on the OASIS Phase 1/2a
trial data showed that CLS-AX had an excellent safety profile and
that Extension Study participants with wet AMD maintained visual
acuity while experiencing a meaningful reduction in treatment
burden over 6 months.
- Partner
presentations featuring clinical data from programs using
Clearside’s proprietary SCS Microinjector technology were
highlighted at the ASRS and ARVO meetings. In addition, Clearside’s
commercial partner presented data on the adoption of XIPERE®
(triamcinolone acetonide injectable suspension) for suprachoroidal
use, which continues to garner broad acceptance by the retinal
community.
- Clearside received
the International Organization for Standardization (ISO)
Certification EN ISO 13485:2016 for “The design, development, and
manufacture of sterile piston syringes, needles, and associated
accessories for the area of ophthalmology”.
- In June 2023, Clay
B. Thorp, General Partner, Hatteras Venture Partners, was named
Chair of Clearside’s Board of Directors. Mr. Thorp has served as a
director of Clearside since 2012. He succeeds William D. Humphries,
CEO, Alcami Corporation, who continues to serve as a director. Mr.
Humphries has served as a director of Clearside since 2012 and
served as Board Chair from 2018 to 2023.
- Clearside’s
Scientific Advisory Board (SAB) was enhanced with the additions of
Thomas A. Ciulla, M.D., M.B.A. as Chair, Arshad M. Khanani, M.D.,
M.A. and Lejla Vajzovic, M.D. The SAB is comprised of industry
leading retinal physicians who provide medical and scientific
expertise and input on the Company’s research and development
programs.
Second Quarter 2023 Financial
Results
- License Revenue: License and other
revenue for the second quarter of 2023 was $1.0 million, compared
to $0.4 million for the second quarter of 2022.
- Cost of Goods Sold: Cost of Goods
Sold for the second quarter of 2023 was $0.2 million, compared to
$0 for the second quarter of 2022. The increase was related to
sales of Clearside’s SCS Microinjector to licensees.
- Research and Development (R&D)
Expenses: R&D expenses for the second quarter
of 2023 were $4.9 million, compared to $5.4 million for the second
quarter of 2022.
- General and Administrative
(G&A) Expenses: G&A expenses for the
second quarter of 2023 were $3.1 million, compared to $2.8 million
for the second quarter of 2022.
- Other Income: Other income for the
second quarter of 2023 was $0.5 million, compared to $24,000 for
the second quarter of 2022. The increase was due to higher interest
rates earned on cash and cash equivalents.
- Other Expense:
Non-cash interest expense for the second quarter of 2023 was $2.3
million, compared to $0 in the second quarter of 2022. Non-cash
interest expense was comprised of imputed interest on the liability
related to the sales of future royalties and the amortization of
the associated issuance costs.
- Net Loss: Net loss for the second
quarter of 2023 was $9.1 million, or $0.15 per share of common
stock, compared to net loss of $7.8 million, or $0.13 per share of
common stock, for the second quarter of 2022.
- Cash Position: As
of June 30, 2023, Clearside’s cash and cash equivalents totaled
$35.0 million. The Company believes it will have sufficient
resources to fund its planned operations into the third quarter of
2024.
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 (877) 545-0320 (U.S.) or 973-528-0002
(international) and entering conference code: 895559. The Company
suggests participants join 15 minutes in advance of the event.
About Clearside Biomedical,
Inc.
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. The Company’s lead program, CLS-AX
(axitinib injectable suspension), for the treatment of neovascular
age-related macular degeneration (wet AMD), is in Phase 2 clinical
testing. Clearside developed and gained approval for its first
product, XIPERE® (triamcinolone acetonide injectable suspension)
for suprachoroidal use, which is available in the U.S. through a
commercial partner. Clearside also strategically partners its SCS
injection platform with companies utilizing other ophthalmic
therapeutic innovations. 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 of
CLS-AX, the expected timing of topline results from the ODYSSEY
clinical trial, the potential for CLS-AX to be a twice-a-year
treatment for wet AMD and other potential benefits of CLS-AX and
other product candidates using Clearside’s SCS Microinjector® and
Clearside’s ability to fund its operations into the third quarter
of 2024. 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, 2022,
filed with the U.S. Securities and Exchange Commission (SEC) on
March 14, 2023 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 Ended June
30, |
|
|
Six Months Ended June
30, |
|
2023 |
|
|
2022 |
|
|
|
2023 |
|
|
2022 |
|
License and other revenue |
$ |
1,018 |
|
|
$ |
384 |
|
|
|
$ |
1,022 |
|
|
$ |
731 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
213 |
|
|
|
— |
|
|
|
|
213 |
|
|
|
— |
|
Research and development |
|
4,948 |
|
|
|
5,430 |
|
|
|
|
9,399 |
|
|
|
9,966 |
|
General and administrative |
|
3,127 |
|
|
|
2,791 |
|
|
|
|
6,285 |
|
|
|
6,248 |
|
Total operating expenses |
|
8,288 |
|
|
|
8,221 |
|
|
|
|
15,897 |
|
|
|
16,214 |
|
Loss from operations |
|
(7,270 |
) |
|
|
(7,837 |
) |
|
|
|
(14,875 |
) |
|
|
(15,483 |
) |
Other income |
|
458 |
|
|
|
24 |
|
|
|
|
950 |
|
|
|
26 |
|
Non-cash interest expense on
liability related to the sales of future royalties |
|
(2,294 |
) |
|
|
— |
|
|
|
|
(4,461 |
) |
|
|
— |
|
Net loss |
$ |
(9,106 |
) |
|
$ |
(7,813 |
) |
|
|
$ |
(18,386 |
) |
|
$ |
(15,457 |
) |
Net loss per share of common
stock — basic and diluted |
$ |
(0.15 |
) |
|
$ |
(0.13 |
) |
|
|
$ |
(0.30 |
) |
|
$ |
(0.26 |
) |
Weighted average shares
outstanding — basic and diluted |
|
61,654,520 |
|
|
|
60,150,348 |
|
|
|
|
61,413,343 |
|
|
|
60,107,517 |
|
Balance Sheet
Data |
June 30, |
|
|
December 31, |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
35,005 |
|
|
$ |
48,258 |
|
Accounts receivable |
|
255 |
|
|
|
— |
|
Total assets |
|
39,185 |
|
|
|
51,303 |
|
Liabilities related to the sales
of future royalties, net |
|
38,088 |
|
|
|
33,977 |
|
Total liabilities |
|
44,158 |
|
|
|
40,696 |
|
Total stockholders’ (deficit)
equity |
|
(4,973 |
) |
|
|
10,607 |
|
Source: Clearside Biomedical, Inc.
Grafico Azioni Clearside Biomedical (NASDAQ:CLSD)
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Grafico Azioni Clearside Biomedical (NASDAQ:CLSD)
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