“The momentum for Clearside is building as we increase awareness of our suprachoroidal space injection platform, develop our internal pipeline and work with our partners to advance multiple clinical programs,” said George Lasezkay, Pharm.D., J.D., Clearside’s President and Chief Executive Officer. “We have been encouraged by the medical community’s interest in our preclinical data on CLS-AX (axitinib injectable suspension), which we believe could support the potential for long-acting pan-VEGF inhibition in wet age-related macular degeneration. We expect to submit an Investigational New Drug (IND) application to the
Dr. Lasezkay continued, “As we continue to progress our XIPERE program and partnerships, we are working together with Bausch + Lomb and our commercial manufacturer to ensure the most thorough and highest quality New Drug Application (NDA) resubmission. We currently expect to resubmit our NDA for XIPERE by the end of
Key Highlights and Upcoming Milestones
- License agreement with upfront and milestone payments and royalties on product sales from Arctic Vision for the commercialization and development of XIPERE in
Greater Chinaand South Korea.
- George Lasezkay, Pharm.D., J.D. was appointed President and Chief Executive Officer, transitioning from the Interim CEO position.
- Adeno-associated virus (AAV) gene therapy partner, REGENXBIO, plans to initiate its Phase 2 clinical trial for suprachoroidal delivery of RGX-314 using the SCS Microinjector for treatment of wet age-related macular degeneration (wet AMD) in the first half of 2020, with interim data from the first cohort expected by the end of 2020.
- REGENXBIO expects to submit an IND application for a Phase 2 trial for treatment of diabetic retinopathy in the first half of 2020 using the SCS Microinjector to deliver RGX-314 to the suprachoroidal space. The trial is expected to begin in the second half of 2020 and enrollment of the first cohort is expected to be complete by the end of 2020, with interim data expected in 2021.
- Ocular oncology partner, Aura Biosciences, expects to initiate clinical testing during the second half of 2020 using suprachoroidal delivery for AU-011 for the potential treatment of certain ocular cancers, including choroidal melanoma.
- Preclinical data on Clearside’s lead development asset, CLS-AX was presented at the 43rd Annual Meeting of
The Macula Society.
- Multiple oral 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, the Annual American Uveitis SocietyWinter Symposium and the American Academy of OphthalmologyAnnual Meeting.
- Ophthalmology, the peer-reviewed journal of the
American Academy of Ophthalmology, published results from the Phase 3 clinical trial of XIPERE (the PEACHTREE trial).
Fourth Quarter 2019 Financial Results
Clearside’s license revenue for the fourth quarter of 2019 was
Research and development expenses for the fourth quarter of 2019 were
General and administrative expenses for the fourth quarter of 2019 were
Net loss for the fourth quarter of 2019 was
Full Year 2019 Financial Results
Clearside’s license and collaboration revenue for the year ended
Research and development expenses for the year ended
General and administrative expenses were
Net loss for the year 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 opportunities for expanding Clearside’s internal pipeline, the potential benefits of XIPERE and the SCS injection platform, the potential receipt of milestone payments, the timing for resubmitting the XIPERE NDA and the anticipated outcome of interactions with the FDA and the development and potential benefits of CLS-AX, including the timing for the IND submission for CLS-AX. 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
|Research and development||1,305||17,486||15,658||68,291|
|General and administrative||3,650||4,176||16,819||14,684|
|Total operating expenses||4,955||21,662||32,477||82,975|
|Loss from operations||(3,013||)||(21,632||)||(30,304||)||(82,945||)|
|Other (expense) income, net||(83||)||(6||)||(466||)||127|
|Net loss per share of common stock — basic and diluted||$||(0.07||)||$||(0.68||)||$||(0.81||)||$||(2.69||)|
|Weighted average shares outstanding — basic and diluted||42,394,959||32,041,305||38,170,830||30,733,600|
|Balance Sheet Data|
|Cash, cash equivalents and short-term investments||$||22,595||$||40,878|
|Long-term debt (including current portion)||5,152||9,975|
|Total stockholders’ equity||11,157||23,620|