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, 2022 and
provided a corporate update.
“We are building significant momentum through
our internal and partnered programs leveraging our proprietary SCS
platform technology,” said George Lasezkay, Pharm.D., J.D.,
Clearside’s President and Chief Executive Officer. “We have created
a new paradigm in retinal drug delivery with XIPERE® for
suprachoroidal use. It is the first product approved by the U.S.
FDA for suprachoroidal injection and is now being used by
physicians across the U.S. to treat patients with macular edema
associated with uveitis.”
Dr. Lasezkay continued, “There are multiple
upcoming anticipated catalysts related to our internal CLS-AX
program and from our development and commercialization partners. We
successfully completed dosing in Cohorts 3 and 4 of OASIS, our
Phase 1/2a clinical trial of CLS-AX in patients with neovascular
age-related macular degeneration (wet AMD). We expect to report the
OASIS data for all four cohorts in November of this year, which we
believe will provide more insight into the potential benefits of
combining pan-VEGF inhibition from the highly potent tyrosine
kinase inhibitor, axitinib, with targeted delivery to affected
chorioretinal tissues utilizing our proprietary SCS
Microinjector.”
Key Highlights
- Completed dosing in
Cohorts 3 and 4 of OASIS, Clearside’s U.S. based, open-label,
dose-escalation Phase 1/2a clinical trial of CLS-AX in patients
with wet AMD.
- Entered into a
Royalty Interest Purchase and Sale Agreement with HealthCare
Royalty Partners, which may provide Clearside up to $65 million in
non-dilutive funding to support ongoing clinical development of
Clearside’s pipeline, and pursuant to which HealthCare Royalty
Partners will receive all royalties and milestone payments due to
Clearside from XIPERE and certain SCS Microinjector license
agreements, subject to a cap of 2.5 times the total purchase price
paid by HealthCare Royalty under the agreement; the cap may be
increased under certain circumstances.
- Clearside’s
commercialization partner, Bausch + Lomb, received XIPERE’s
permanent J-code, a reimbursement code used in the US by commercial
insurers and government payers, which became effective for provider
billing on July 1, 2022.
- Appointed Susan L.
Coultas, Ph.D., as Chief Clinical Officer.
- Clearside’s
proprietary suprachoroidal space injection platform was highlighted
in the July 2022 special edition of Retinal Physician and in
multiple presentations and panels at global conferences, including
the American Society of Retina Specialists (ASRS) Annual Meeting,
the Ophthalmology Innovation Source (OIS) Retina Innovation Summit,
and the Association for Research in Vision and Ophthalmology (ARVO)
2022 Annual Meeting.
- A data manuscript
entitled, “Suprachoroidal CLS-TA for non-infectious uveitis: an
open-label, safety trial (AZALEA)” was published in the British
Journal of Ophthalmology in June 2022.
- A data manuscript
entitled, “Optical Coherence Tomography Anatomic and Temporal
Biomarkers in Uveitic Macular Edema” was published in the American
Journal of Ophthalmology in May 2022.
- A data manuscript
entitled, “Suprachoroidal Injection of Triamcinolone Acetonide
Suspension: Ocular Pharmacokinetics and Distribution in Rabbits
Demonstrates High and Durable Levels in the Chorioretina” was
published in the Journal of Ocular Pharmacology in April 2022.
Second Quarter 2022 Financial
Results
Clearside’s license and other revenue for the
second quarter of 2022 was $384,000, compared to $780,000 for the
second quarter of 2021.
Research and development expenses for the second
quarter of 2022 were $5.4 million, compared to $4.1 million for the
second quarter of 2021. The $1.3 million increase was primarily
attributable to CLS-AX Phase 1/2a clinical trial costs.
General and administrative expenses for the
second quarter of 2022 were $2.8 million, compared to $2.8 million
for the second quarter of 2021.
Net loss for the second quarter of 2022 was $7.8
million, or $0.13 per share of common stock, compared to a net loss
of $6.1 million, or $0.11 per share of common stock, for the second
quarter of 2021.
On August 8, 2022 (Closing Date), Clearside
entered into a non-dilutive financing agreement with HealthCare
Royalty Partners for up to $65 million. Under the terms of the
agreement, Clearside will receive an initial payment of $32.5
million, less certain expenses, within 15 business days of the
Closing Date. At the same time, an additional $12.5 million will be
deposited in an escrow account to be released to Clearside upon
attainment of a pre-specified sales milestone for XIPERE. The terms
of the agreement also provide for an additional milestone payment
of $20 million to Clearside upon attainment of a second
pre-specified 2024 sales milestone for XIPERE.
As of June 30, 2022, Clearside’s cash and cash
equivalents totaled $29.0 million. The initial royalty agreement
payment of $32.5 million combined with the second quarter-end cash
balance is expected to provide financial runway into 2024.
Conference Call & Webcast
Details
Clearside’s management will host a webcast and
conference call today at 8:30 a.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 Company suggests
participants log in 15 minutes in advance of the event.
About XIPERE®
(triamcinolone acetonide injectable suspension) for
suprachoroidal use
XIPERE® (triamcinolone
acetonide injectable suspension) for suprachoroidal use, formerly
known as CLS-TA, is a proprietary suspension of the corticosteroid
triamcinolone acetonide for administration to the suprachoroidal
space for the treatment of macular edema associated with uveitis.
Bausch + Lomb, a leading global eye health company dedicated to
helping people see better to live better, has the exclusive license
for the commercialization and development of XIPERE in the United
States and Canada. Arctic Vision, a specialty ophthalmology company
based in China, has the exclusive license for the commercialization
and development of XIPERE, which they refer to as Arcatus™, in
Greater China, South Korea, Australia, New Zealand, India and the
ASEAN Countries. XIPERE was approved by the U.S. Food and Drug
Administration in October 2021 and is commercially available in the
U.S.
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, is commercially available in the U.S. 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, including the expected timing of data from the OASIS
clinical trial, the potential benefits of CLS-AX and product
candidates using Clearside’s SCS Microinjector®, the anticipated
use of proceeds from the agreement with HealthCare Royalty
Partners, potential future payments under the agreement with
HealthCare Royalty Partners and Clearside’s ability to fund its
operations into 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, 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, 2021,
filed with the U.S. Securities and Exchange Commission (SEC) on
March 11, 2022, 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 EndedJune 30, |
|
|
Six Months EndedJune 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
License and other revenue |
|
$ |
384 |
|
|
$ |
780 |
|
|
$ |
731 |
|
|
$ |
814 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
5,430 |
|
|
|
4,060 |
|
|
|
9,966 |
|
|
|
9,550 |
|
General and administrative |
|
|
2,791 |
|
|
|
2,816 |
|
|
|
6,248 |
|
|
|
5,709 |
|
Total operating expenses |
|
|
8,221 |
|
|
|
6,876 |
|
|
|
16,214 |
|
|
|
15,259 |
|
Loss from operations |
|
|
(7,837 |
) |
|
|
(6,096 |
) |
|
|
(15,483 |
) |
|
|
(14,445 |
) |
Other income |
|
|
24 |
|
|
|
1 |
|
|
|
26 |
|
|
|
999 |
|
Net loss |
|
$ |
(7,813 |
) |
|
$ |
(6,095 |
) |
|
$ |
(15,457 |
) |
|
$ |
(13,446 |
) |
Net loss per share of common
stock — basic |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
and diluted |
|
$ |
(0.13 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.23 |
) |
Weighted average shares
outstanding — basic |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
and diluted |
|
|
60,150,348 |
|
|
|
57,745,465 |
|
|
|
60,107,517 |
|
|
|
57,394,017 |
|
Balance Sheet Data |
June 30, |
|
|
December 31, |
|
|
2022 |
|
|
2021 |
|
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
29,033 |
|
|
$ |
30,436 |
|
Accounts
receivable |
|
123 |
|
|
|
10,000 |
|
Total
assets |
|
30,746 |
|
|
|
42,903 |
|
Total
liabilities |
|
5,498 |
|
|
|
4,928 |
|
Total
stockholders’ equity |
|
25,248 |
|
|
|
37,975 |
|
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