Clearside Biomedical, Inc. Announces Third Quarter 2017 Financial Results and Provides Corporate Update
“More than 300 patients suffering from sight-threatening diseases have received suprachoroidal injections of CLS-TA in Clearside’s clinical development programs designed to support our pursuit of transformative, elegant, precise solutions to restore and preserve vision,” said
Update on Key Development Programs
CLS-TA, Clearside’s proprietary suspension formulation of the corticosteroid triamcinolone acetonide for suprachoroidal administration (“suprachoroidal CLS-TA”), is part of Clearside’s pipeline of potential treatments for unmet or underserved blinding eye diseases where the pathologies manifest in the choroid and retina. Suprachoroidal CLS-TA is being studied for potential administration both alone and together with an intravitreal anti-VEGF agent.
Macular Edema Associated with Non-Infectious Uveitis
Macular Edema Associated with Retinal Vein Occlusion (“RVO”)
Clearside continues to enroll patients in SAPPHIRE, a multicenter, multi-country, randomized, masked, controlled Phase 3 clinical trial designed to assess the safety and efficacy of suprachoroidal CLS-TA used in combination with intravitreally administered EYLEA® (aflibercept) (“intravitreal Eylea”) in patients with RVO. The primary objective of this trial is to determine the proportion of patients in the combination treatment arm, compared to the intravitreal Eylea alone control arm, with best corrected visual acuity improvement of at least 15 letters from baseline at eight weeks after initial treatment. Several secondary efficacy and safety endpoints will also be evaluated. Patient enrollment is proceeding as planned, and Clearside currently expects to report preliminary data from this trial in the first quarter of 2019.
Clearside is also making preparations to initiate TOPAZ, a second multicenter, randomized, masked, controlled Phase 3 clinical trial of suprachoroidal CLS-TA in combination with an anti-VEGF agent for the treatment of patients with RVO. While Clearside plans to announce detailed information about TOPAZ at a later date, this trial is expected to have a similar design to the SAPPHIRE trial. Clearside anticipates enrollment of the first patient in the TOPAZ Phase 3 trial in the first quarter of 2018.
Diabetic Macular Edema (“DME”)
Clearside expects to report preliminary results from the HULK trial on
Pipeline and Collaborations
Clearside continues nonclinical efforts both internally and with multiple collaborations in development areas such as gene therapy for inherited retinal disorders, wet age-related macular degeneration (“wet AMD”), and other ocular diseases that may benefit from a suprachoroidal administration of treatment approach.
Third Quarter 2017 Financial Results
Clearside’s research and development expenses for the three months ended
General and administrative expenses were
Cash, cash equivalents and short-term investments totaled
Net loss for the third quarter of 2017 was
Conference Call & Webcast Details
Clearside is pleased to invite all interested parties to participate in a conference call today at
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 expectations regarding the clinical development of Clearside’s product candidates and the availability of data from Clearside’s clinical trials. 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
Selected Financial Data
(in thousands, except share and per share data)
|Statements of Operations Data||Three Months Ended
|Nine Months Ended
|License and collaboration revenue||$||155||$||5||$||290||$||515|
|Research and development||16,050||3,682||35,118||12,484|
|General and administrative||2,298||1,629||7,259||3,872|
|Total operating expenses||18,348||5,311||42,377||16,356|
|Loss from operations||(18,193||)||(5,306||)||(42,087||)||(15,841||)|
|Other expense, net||(143||)||(339||)||(395||)||(355||)|
|Net loss per share of common stock — basic and diluted||$||(0.72||)||$||(0.28||)||$||(1.68||)||$||(1.54||)|
|Weighted average shares outstanding — basic and diluted||25,338,462||20,493,377||25,299,910||10,502,459|
|Balance Sheet Data||September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||52,627||$||83,631|
|Long-term debt (including current portion)||7,903||7,586|
|Total stockholders’ equity||36,895||71,659|
Chief Financial Officer
Source: Clearside Biomedical, Inc.