“We continue to make progress in leveraging Clearside’s proprietary suprachoroidal space (SCS) injection platform,” said George Lasezkay, Pharm.D., J.D., Clearside’s Chief Executive Officer. “We recently announced an agreement with Aura Biosciences, which broadens the potential use of our SCS Microinjector™ technology into ocular oncology, where there is a significant unmet medical need. With ongoing exposure at medical conferences and in ophthalmic publications highlighting our targeted drug delivery approach, we are exploring various opportunities to prudently build our internal pipeline and we are also attracting significant interest from other companies to partner our technology like we did with Aura Biosciences.”
Dr. Lasezkay continued, “I have been working with our team and Board of Directors to re-evaluate the Company’s overall strategy. We have concluded that the optimal path to maximize the value of XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) is to out-license rights to XIPERE rather than commercialize it on our own. The XIPERE New Drug Application is currently under review with the U.S.
“We are excited about this new strategic direction for the Company. We can now dedicate additional resources to advancing our two-prong development strategy centered on the use of our proprietary SCS injection platform. This includes (1) building an internal R&D pipeline in areas such as gene therapy and novel small molecules, and (2) creating external collaborations with other companies, allowing them access to the SCS so their therapies can be delivered in a targeted, non-surgical manner. As a result of this strategic change, we believe we will now have sufficient resources to fund our planned operations into the third quarter of 2020, without relying on any partnership-related payments that we might gain through XIPERE out-licensing or external R&D collaboration agreements,” concluded Dr. Lasezkay.
- Worldwide licensing agreement with Aura Biosciences for the use of Clearside’s SCS Microinjector to deliver Aura’s proprietary drug candidates into the suprachoroidal space for the potential treatment of certain ocular cancers, including choroidal melanoma.
- Positive meeting with the
Austrian Medicines and Medical Devices Agencysupporting a path forward for XIPERE registration for uveitic macular edema in the European Union.
- Multiple oral presentations on Clearside’s pipeline and proprietary SCS Microinjector were given by leading ophthalmology experts at the
American Society of Retinal Specialists(ASRS) Annual Meeting. Thomas A. Ciulla, M.D., MBA, Chief Medical Officer of Clearside, served on a panel entitled, “Advancements in Genetic and Regenerative Therapies” at the Ophthalmology Innovation Summit event at ASRS.
- Opportunities for suprachoroidal delivery were recently featured in several professional journals including two articles in the official journal of the ASRS, Retina Times: “Suprachoroidal Drug Delivery for Uveitic Macular Edema”; “Gene Therapy: Predicting the Impact on Treating Rare and Chronic Diseases”; and a feature article in Ophthalmology Management titled “Introduction to Gene Therapy.”
Second Quarter 2019 Financial Results
Clearside’s research and development expenses for the quarter ended
General and administrative expenses were
Net loss for the quarter ended
Cash and cash equivalents totaled
Conference Call & Webcast Details
Clearside’s management will host a webcast and conference call today at
XIPERETM (triamcinolone acetonide suprachoroidal injectable suspension), formerly known as CLS-TA, is a proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye for the treatment of macular edema associated with uveitis. Clearside’s patented technology is designed to deliver drug to the suprachoroidal space located between the choroid and the outer protective layer of the eye, known as the sclera. Suprachoroidal injection enables the rapid and adequate dispersion of medicine to the back of the eye, offering the potential for the medicine to act longer and minimize harm to the surrounding healthy parts of the eye, thus potentially providing advantageous and sustained efficacy with a favorable safety profile. A New Drug Application was submitted to the
About Uveitis and Macular Edema
Uveitis is a set of ocular inflammatory conditions and is one of the leading causes of vision loss, affecting approximately 350,000 patients in the United States and more than one million worldwide. Approximately one-third of these patients develop uveitic macular edema, a build-up of fluid in the macula, the area of the retina responsible for sharp, straight-ahead vision. Macular edema is the leading cause of vision loss and blindness in uveitis patients and can occur from uveitis affecting any anatomic location - anterior, intermediate, posterior or pan. The uveitis market is expected to grow by 2024 to nearly $550 million in the United States and over $1 billion globally.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the potential out-licensing of XIPERE and the economic terms such a license might include, opportunities for expanding Clearside’s internal pipeline and entering into other licensing arrangements, the potential benefits of XIPERE and the SCS injection platform, the potential approval of XIPERE for the treatment of macular edema associated with uveitis in
-Financial Tables Follow-
CLEARSIDE BIOMEDICAL, INC.
Selected Financial Data
(in thousands, except share and per share data)
|Statements of Operations Data||Three Months Ended
|Six Months Ended
|Research and development||658||17,343||11,625||30,722|
|General and administrative||5,004||3,561||9,388||6,635|
|Total operating expenses||5,662||20,904||21,013||37,357|
|Loss from operations||(5,617||)||(20,904||)||(21,923||)||(37,357||)|
|Other (expense) income, net||(117||)||203||(215||)||49|
|Net loss per share of common stock — basic and diluted||$||(0.15||)||$||(0.65||)||$||(0.59||)||$||(1.27||)|
|Weighted average shares outstanding — basic and diluted||37,636,053||31,979,158||35,899,777||29,412,904|
|Balance Sheet Data||June 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||26,174||$||40,878|
|Long-term debt (including current portion)||10,099||9,975|
|Total stockholders’ equity||12,901||23,620|