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 second quarter
ended June 30, 2020 and provided a corporate update on key
initiatives.
Key Highlights
- The Investigational New Drug (IND) application for
suprachoroidal CLS-AX (axitinib injectable suspension) was
submitted as planned and accepted by the U.S. Food and Drug
Administration (FDA).
- Expanded the suprachoroidal development pipeline by initiating
two new programs:
- A non-viral vector gene therapy program (“therapeutic
biofactory”) designed to express and secrete anti-VEGF therapeutic
protein after suprachoroidal administration of DNA nanoparticles
containing the corresponding gene.
- A preclinical development program utilizing suprachoroidal
administration of an integrin inhibitor small molecule
suspension.
- Engaged a new contract manufacturing partner for XIPERE™
(triamcinolone acetonide suprachoroidal injectable suspension) to
allow for a more efficient and predictable process for New Drug
Application (NDA) resubmission and review.
- Clearside’s ophthalmic oncology partner, Aura Biosciences,
presented preclinical research at the Association for Research in
Vision and Ophthalmology (ARVO) Annual Meeting regarding the ocular
distribution and efficacy in a rabbit model of AU-011 utilizing
Clearside’s SCS Microinjector®. According to Aura, the data showed
distribution of AU-011 in the suprachoroidal space (SCS®) and
complete necrosis of tumors following laser activation of choroidal
melanoma. Preclinical studies have been completed, and Aura
expects to initiate a Phase 2 clinical trial evaluating
suprachoroidal delivery of AU-011 during the third quarter of
2020.
- Clearside’s adeno-associated virus (AAV)-based gene therapy
partner, REGENXBIO, announced that their Phase 2 clinical trial
(AAVIATE) for RGX-314 for the treatment of wet AMD using
suprachoroidal delivery is active, with enrollment expected to
begin in the third quarter of 2020 and an interim data update from
the first cohort expected by the end of 2020. REGENXBIO also
expects to initiate a Phase 2 clinical trial for RGX-314 using
suprachoroidal delivery in diabetic retinopathy in the second half
of 2020.
- In April 2020, 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.
- Experienced research and development executive, Nancy J.
Hutson, Ph.D., was appointed to Clearside’s Board of
Directors.
- A Scientific Advisory Board was established with highly
respected and experienced retinal physicians who will provide input
on new technology, preclinical programs and clinical
development.
- Multiple posters and oral presentations on Clearside’s pipeline
targeting the suprachoroidal space and its proprietary SCS
Microinjector were delivered at the 2020 Virtual Annual Meetings of
ARVO and the American Society of Retina Specialists (ASRS).
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 in neovascular age-related
macular degeneration (wet AMD) with initial safety data from the
first cohort expected in mid-2021.
- XIPERE NDA resubmission targeted in the first half of
2021.
- Data presentations on Clearside’s programs will be made at the
Retina Society 2020 Annual Meeting which will be held
virtually.
- Clearside’s management team will present at two virtual
investor conferences: 2020 Wedbush PacGrow Healthcare Conference
and the H.C. Wainwright 22nd Annual Global Investment
Conference.
George Lasezkay, Pharm.D., J.D., President and
Chief Executive Officer, commented, “Over the past year, we have
worked purposefully and diligently to reorient Clearside from a
single product company to one that has multiple relevant and
promising opportunities targeting the suprachoroidal space. We have
made important progress in our key clinical and preclinical
programs and we are positioning ourselves to have a strong year in
2021 with potential approval of XIPERE and initial patient data
from our CLS-AX program.”
Dr. Lasezkay continued, “Our IND application for
CLS-AX was accepted and we are preparing to initiate a Phase 1/2a
trial in wet AMD later this year to assess the safety and
tolerability of our proprietary suspension of axitinib delivered
via our SCS Microinjector. We also continue to expand our internal
suprachoroidal pipeline with two new preclinical programs: a
‘therapeutic biofactory’ program which is our second, non-viral
vector, suprachoroidal gene therapy preclinical program; and a
small molecule preclinical program utilizing a suprachoroidal
integrin inhibitor suspension. We look forward to advancing our
expanded internal development pipeline over the next year.”
“We have also engaged a new, U.S.-based contract
manufacturing organization (CMO) for XIPERE, which we believe will
allow for a more efficient and predictable process for NDA
resubmission and review. We were recently notified by our previous
CMO that it is no longer willing to serve as our commercial
supplier for XIPERE. While this news was unexpected, we had
proactively begun evaluating alternative manufacturers given
previously disclosed delays due to manufacturing and facility
issues. Therefore, we were able to quickly engage a new CMO and
rapidly initiate manufacturing technology transfer activities,”
said Dr. Lasezkay.
“This transition is a positive step forward to
achieving XIPERE approval as the new CMO provides Clearside and our
licensees with an experienced and reliable partner for the
manufacture of registration batches and future commercial supplies
of XIPERE, if approved. The new CMO has an established track record
with respect to FDA inspections, has extensive experience with
production of small molecule suspensions, steroids and ophthalmic
products, and is prepared to move quickly to produce the necessary
batches of XIPERE to support our NDA resubmission. We expect to
resubmit the XIPERE NDA as quickly as possible after the transfer
of the manufacturing process has been completed and the required
three-month stability data is generated. Although we are still in
the process of finalizing the timelines with the new CMO, our
current expectation is that resubmission will occur no later than
the first half of 2021,” Dr. Lasezkay concluded.
Second Quarter 2020 Financial
Results
Clearside’s license revenue for the second
quarter of 2020 was $0.4 million, compared to $45,000 for the
second quarter of 2019.
Research and development expenses for the second
quarter of 2020 were $3.3 million, compared to $0.7 million for the
second quarter of 2019. The $2.6 million increase was attributable
to vendor credits of $2.6 million received in the second quarter of
2019 upon reconciliation of final costs from the closure of two
late-stage clinical trials.
General and administrative expenses for the
second quarter of 2020 were $2.6 million, compared to $5.0 million
for the second quarter of 2019. The $2.4 million decrease was
primarily attributable to reduced employee and marketing expenses
resulting from executive management changes and the out-licensing
of XIPERE commercialization.
Net loss for the second quarter of 2020 was $5.8
million, or $0.13 per share of common stock, compared to a net loss
of $5.7 million, or $0.15 per share of common stock, for the second
quarter of 2019.
As of June 30, 2020, Clearside’s cash and cash
equivalents totaled $15.1 million. During the second quarter of
2020, due to various restrictions and other limiting covenants, the
Company elected to make an early payoff of its outstanding $5.0
million principal balance under its bank loan, plus $0.3 million
reflecting the final payment fee and accrued interest. 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.
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: 2290836. An
archive of the webcast will be available for three months.
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 XIPERE, initiation of future clinical
trials, future management and data presentations, manufacturing
expectations with respect to XIPERE and 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, Clearside’s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2020 to be filed with the SEC on August 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) |
|
Statement of
Operations Data |
Three Months EndedJune 30, |
|
|
Six Months EndedJune 30, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
License and other revenue |
$ |
354 |
|
|
$ |
45 |
|
|
$ |
4,451 |
|
|
$ |
90 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
3,300 |
|
|
|
658 |
|
|
|
7,111 |
|
|
|
11,625 |
|
General and administrative |
|
2,611 |
|
|
|
5,004 |
|
|
|
5,733 |
|
|
|
9,388 |
|
Total operating expenses |
|
5,911 |
|
|
|
5,662 |
|
|
|
12,844 |
|
|
|
21,013 |
|
Loss from operations |
|
(5,557 |
) |
|
|
(5,617 |
) |
|
|
(8,393 |
) |
|
|
(20,923 |
) |
Other expense |
|
(197 |
) |
|
|
(117 |
) |
|
|
(272 |
) |
|
|
(215 |
) |
Net loss |
$ |
(5,754 |
) |
|
$ |
(5,734 |
) |
|
$ |
(8,665 |
) |
|
$ |
(21,138 |
) |
Net loss per share of common
stock — basic and diluted |
$ |
(0.13 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.19 |
) |
|
$ |
(0.59 |
) |
Weighted average shares
outstanding — basic and diluted |
|
45,214,500 |
|
|
|
37,636,053 |
|
|
|
44,984,005 |
|
|
|
35,899,777 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheet
Data |
June 30, |
|
December 31, |
|
2020 |
|
2019 |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
15,071 |
|
$ |
22,595 |
Restricted cash |
|
360 |
|
|
360 |
Total assets |
|
17,738 |
|
|
26,776 |
Deferred revenue |
|
5,000 |
|
|
5,000 |
Long-term debt (including current
portion) |
|
991 |
|
|
5,152 |
Total liabilities |
|
10,451 |
|
|
15,619 |
Total stockholders’ equity |
|
7,287 |
|
|
11,157 |
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