“With three recent partnerships and plans to expand our internal development pipeline, we have made meaningful progress on our overall strategy to broaden the reach of our suprachoroidal space injection platform,” said George Lasezkay, Pharm.D., J.D., Clearside’s Chief Executive Officer. “Last quarter, we announced our plans to out-license rights to XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) rather than commercialize it on our own, to create external collaborations with other companies enabling access to our platform, and to build an internal pipeline in areas such as gene therapy and small molecules.”
“We have now signed deals with
Clearside is working to address the issues raised by the
Bausch Healthacquired an exclusive license for the commercialization and development of XIPERE in the United Statesand Canada. REGENXBIO Inc.exercised its option to license Clearside’s proprietary, in-office SCS Microinjector for the delivery of adeno-associated virus (AAV)-based therapeutics to the suprachoroidal space to potentially treat wet AMD, diabetic retinopathy, and other conditions for which chronic anti-VEGF treatment is currently the standard of care.
- Aura Biosciences entered a worldwide licensing agreement 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.
- Multiple oral presentations at the
American Academy of Ophthalmology(AAO) 2019 Annual Meeting featured Clearside’s suprachoroidal injection platform and potential value of XIPERE in uveitis patients.
- Presentations were made related to Clearside on gene therapy delivery, additional analysis of XIPERE clinical programs, and the unmet need in diabetic macular edema at global conferences including
The Retina Society52nd Scientific Program in London, UK, the Ophthalmology Futures Forumin Paris, Franceand the European Society of Retina Specialists EURETINA2019 Congressin Paris, France.
Third Quarter 2019 Financial Results
Clearside’s research and development expenses for the quarter ended
Net loss for the quarter ended
Cash and cash equivalents totaled
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 timing for resubmitting the XIPERE NDA and submitting the IND for CLS-AX, plans to expand Clearside’s internal pipeline and enter into other licensing arrangements, the potential benefits of CLS-AX and the SCS injection platform and the potential approval of XIPERE for the treatment of macular edema associated with uveitis. 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
-Financial Tables Follow-
CLEARSIDE BIOMEDICAL, INC.
Selected Financial Data
(in thousands, except share and per share data)
|Statements of Operations Data||Three Months Ended
|Nine Months Ended
|Research and development||2,728||20,083||14,353||50,805|
|General and administrative||3,781||3,873||13,169||10,508|
|Total operating expenses||6,509||23,956||27,522||61,313|
|Loss from operations||(6,368||)||(23,956||)||(27,291||)||(61,313||)|
|Other (expense) income, net||(168||)||84||(383||)||133|
|Net loss per share of common stock — basic and diluted||$||(0.17||)||$||(0.75||)||$||(0.75||)||$||(2.02||)|
|Weighted average shares outstanding — basic and diluted||38,414,751||32,024,223||36,747,314||30,292,909|
|Balance Sheet Data||September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||22,551||$||40,878|
|Long-term debt (including current portion)||10,162||9,975|
|Total stockholders’ equity||9,759||23,620|