Clearside Biomedical Announces First Quarter 2020 Financial Results
“Our team remains focused on progressing our programs as we navigate the evolving business and regulatory environment,” said George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer. “We are committed to advancing our first product candidate, XIPERE™, to the
Clearsideand Bausch Health Companies Inc. and its leading global eye health business, Bausch + Lomb, amended their licensing agreement for the commercialization and development of XIPERE in the U.S.and Canada. Clearside granted Bausch + Lomb an exclusive option for the right to commercialize and develop XIPERE in (i) Europeand the United Kingdom, (ii) Australia and New Zealand, and/or (iii) South Americaand Mexico; and Bausch + Lomb extended the time allowed for Clearside to obtain regulatory approval for XIPERE in the U.S.
- NDA resubmission timeline for XIPERE (triamcinolone acetonide suprachoroidal injectable suspension) is currently targeted for the fourth quarter of 2020 based on recent manufacturing updates.
- Clearside received an upfront payment of
$4.0 millionfrom Arctic Vision pursuant to a license agreement for the commercialization and development of XIPERE in China, Hong Kong, Macau, Taiwanand South Korea.
- Experienced research and development executive,
Nancy J. Hutson, Ph.D., was appointed to Clearside’s Board of Directors.
- Clearside established a
Scientific Advisory Boardwith highly experienced retinal physicians who will provide input on program and clinical development.
- Multiple presentations featuring Clearside’s suprachoroidal injection platform in a range of indications, including wet AMD, uveitis, diabetic macular edema and ocular gene therapy, were highlighted at global conferences, including the Annual Meeting of the
Macula Society, the Annual Angiogenesis Meeting, and the Annual American Uveitis SocietyWinter Symposium.
- Ophthalmology, the peer-reviewed journal of the
American Academy of Ophthalmology, published results from the Phase 3 clinical trial of XIPERE (the PEACHTREE trial).
First Quarter 2020 Financial Results
Clearside’s license revenue for the first quarter of 2020 was
Research and development expenses for the first quarter of 2020 were
General and administrative expenses for the first quarter of 2020 were
Net loss for the first quarter of 2020 was
Clearside will not be hosting a conference call in conjunction with this release. The Company conducted a corporate update call on
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 and submitting the IND for CLS-AX, as well as 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
Investor and Media Contacts:
-Financial Tables Follow-
Selected Financial Data
(in thousands, except share and per share data)
|Statements of Operations Data||Three Months Ended
|License and other revenue||$||4,097||$||45|
|Research and development||3,811||10,967|
|General and administrative||3,122||4,384|
|Total operating expenses||6,933||15,351|
|Loss from operations||(2,836||)||(15,306||)|
|Net loss per share of common stock — basic and diluted||$||(0.07||)||$||(0.45||)|
|Weighted average shares outstanding — basic and diluted||44,753,510||34,144,209|
|Balance Sheet Data|
|Cash and cash equivalents||$||20,930||$||22,595|
|Debt (including current portion)||5,183||5,152|
|Total stockholders’ equity||10,440||11,157|
Source: Clearside Biomedical, Inc.