Clearside Biomedical, Inc. is a biopharmaceutical company that has revolutionized the delivery of therapies to the back of the eye through its innovative suprachoroidal space (SCS) injection platform. With a strong focus on addressing unmet needs in ophthalmology, Clearside has developed a compelling pipeline of product candidates and strategic partnerships that have the potential to transform the treatment landscape for various retinal diseases.
Business Overview and Company History
Clearside Biomedical was incorporated in the State of Delaware on May 26, 2011, with the goal of developing and commercializing therapies for the treatment of sight-threatening diseases of the eye using its proprietary suprachoroidal space (SCS) injection platform. In its early years, the company’s operations primarily consisted of conducting preclinical studies, raising capital, and undertaking other research and development initiatives to advance its pipeline of product candidates. During this period, Clearside faced challenges in securing funding to support its research and development activities as it had not yet generated any revenue from product sales.
A significant milestone in Clearside’s history was the development of its proprietary SCS Microinjector, a device designed to precisely and safely deliver therapeutics into the suprachoroidal space. This innovative approach allows for targeted and compartmentalized delivery of a wide range of therapies, potentially enhancing their efficacy while minimizing systemic exposure and side effects.
In October 2021, Clearside achieved a major breakthrough with the FDA approval of its first product, XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use, for the treatment of macular edema associated with uveitis. This milestone marked a significant achievement for the company, as XIPERE became the first and only FDA-approved therapy delivered via the suprachoroidal route, validating Clearside’s innovative suprachoroidal delivery platform.
To expand the global reach of its suprachoroidal injection platform, Clearside has strategically partnered some of its assets for development and/or commercialization. The company has entered into collaboration agreements with companies such as Bausch + Lomb, Arctic Vision, REGENXBIO, Aura Biosciences, and BioCryst Pharmaceuticals. These partnerships have allowed Clearside to leverage its proprietary technology while generating revenue through upfront payments, milestone payments, and potential future royalties.
Despite the early challenges, Clearside has emerged as the proven leader in suprachoroidal drug delivery. The company has solidified its formulation expertise, established commercial-scale microinjector manufacturing capabilities, and obtained key industry certifications. With the approval of XIPERE and the progress made with its collaborations, Clearside has demonstrated the versatility and potential of its innovative suprachoroidal delivery platform to address various sight-threatening eye diseases.
Financial Performance and Liquidity
As of September 30, 2024, Clearside Biomedical reported cash, cash equivalents, and short-term investments of $23.6 million. The company’s financial performance has been primarily driven by revenue from its licensing agreements and collaborations, as it has not yet generated any product sales from its own commercial operations.
For the nine months ended September 30, 2024, Clearside reported total revenue of $1.36 million, compared to $1.88 million in the same period of the previous year. The company’s net loss for the nine-month period was $27.05 million, compared to a net loss of $27.65 million in the prior-year period.
In the most recent fiscal year (2023), Clearside reported revenue of $8.23 million, with a net loss of $32.49 million. The company’s operating cash flow (OCF) for 2023 was negative $18.14 million, and its free cash flow (FCF) was negative $19.91 million.
For the most recent quarter (Q3 2024), Clearside reported revenue of $1.04 million, representing a 21% increase compared to Q3 2023. This increase was primarily due to higher license and other revenue from the company’s licensing agreements. The net loss for Q3 2024 was $7.69 million, with an operating cash flow of negative $5.93 million and a free cash flow of negative $5.97 million.
Clearside’s ongoing research and development efforts, as well as its general and administrative expenses, have been the primary drivers of its net losses. The company has been actively managing its cash resources and has raised additional capital through various financing activities, including a registered direct offering in February 2024 that generated net proceeds of $13.9 million.
As of September 30, 2024, Clearside had a debt-to-equity ratio of 0.012, with cash and cash equivalents of $13.89 million. The company’s current ratio and quick ratio both stand at 4.49, indicating a strong short-term liquidity position. Clearside has a sales agreement with Cantor Fitzgerald that allows it to offer and sell up to $50 million in shares of common stock. As of September 30, 2024, the company has sold $0.5 million in shares under this agreement.
Based on its current plans and forecasted expenses, Clearside believes its existing cash, cash equivalents, and short-term investments will enable it to fund its planned operations into the third quarter of 2025. However, the company will likely need to raise additional capital in the future to support the continued development of its pipeline and to maintain its operations.
Operational Highlights and Pipeline Progress
Clearside’s key operational highlight in 2024 was the positive topline results from the ODYSSEY Phase 2b clinical trial of its lead product candidate, CLS-AX, for the treatment of wet AMD. The trial achieved all of its primary and secondary endpoints, demonstrating stable visual acuity and anatomical control over 9 months, as well as a favorable safety profile with no serious adverse events.
The ODYSSEY trial results were particularly noteworthy for Clearside, as CLS-AX is the only tyrosine kinase inhibitor (TKI) wet AMD program with repeat dosing data. This differentiated profile positions CLS-AX as a potential maintenance therapy that could provide extended duration of effect while offering flexible dosing similar to a biologic, potentially addressing a significant unmet need in the wet AMD treatment landscape.
Key takeaways from the ODYSSEY trial include:
Clearside is now preparing to advance CLS-AX into Phase 3 development, with plans to conduct two pivotal trials using aflibercept 2 mg as a comparator. These trials will likely be conducted in treatment-naive patients with a flexible dosing component. The company expects to have an end-of-Phase 2 meeting with the FDA in early 2025 to finalize the essential components of the Phase 3 program.
Beyond CLS-AX, Clearside’s pipeline includes several other promising candidates leveraging its SCS delivery platform. The company’s research team is currently evaluating small molecule therapies for the potential treatment of geographic atrophy, a debilitating form of dry age-related macular degeneration. Clearside believes that its ability to deliver these molecules directly to the choroid, the vascular layer of the eye, may provide a more comprehensive approach to addressing this disease.
Clearside’s SCS delivery platform has also been widely recognized and adopted by its strategic partners. Arctic Vision, the company’s Asia-Pacific licensee for XIPERE, recently announced a commercial collaboration with Santen Pharmaceutical, a global ophthalmic leader, to bring the suprachoroidal therapy to patients in China. This partnership provides further validation of Clearside’s innovative technology and its potential to address unmet needs in posterior segment eye diseases.
Product Segments and Commercial Strategy
Clearside Biomedical’s product portfolio and commercial strategy are centered around its innovative suprachoroidal space (SCS) injection platform. The company’s key product segments include:
Internal Pipeline: CLS-AX CLS-AX (axitinib injectable suspension) is Clearside’s most advanced internal product candidate, being developed as a long-acting therapy for the treatment of neovascular age-related macular degeneration (wet AMD). The positive results from the ODYSSEY Phase 2b trial have positioned CLS-AX as a promising candidate for further development.
Preclinical Programs Clearside’s research team is evaluating various small molecule compounds through in vivo models for the potential treatment of geographic atrophy. The company believes that delivering small molecules via suprachoroidal injection can enable comprehensive drug coverage of both the retina and choroid.
External Collaborations To expand the reach of its suprachoroidal injection platform, Clearside has strategic partnerships with several companies, including Bausch + Lomb, Arctic Vision, REGENXBIO, Aura Biosciences, and BioCryst Pharmaceuticals. These collaborations allow Clearside’s technology to be utilized for the development and delivery of partner companies’ therapeutic candidates across different ophthalmic indications and geographies.
Risks and Challenges
As a clinical-stage biopharmaceutical company, Clearside Biomedical faces several risks and challenges that investors should be aware of:
Regulatory and clinical development risks: The company’s product candidates, including CLS-AX, are subject to the inherent risks of clinical development and the regulatory approval process, which can be lengthy, costly, and unpredictable.
Commercialization and market acceptance: Even if Clearside’s product candidates receive regulatory approval, there is no guarantee that they will be widely adopted and accepted by healthcare providers and patients.
Intellectual property protection: Clearside’s ability to protect its proprietary technologies and intellectual property is crucial to its long-term success and may be challenged by competitors.
Funding and capital requirements: As a pre-revenue company, Clearside will likely need to raise additional capital to support its ongoing operations and the development of its pipeline, which could be dilutive to existing shareholders.
Geographic concentration: Currently, XIPERE is only approved in the US and licensed for commercialization in the US, Canada, and parts of Asia Pacific. This limited geographic footprint exposes the company to regional market risks.
Competition: The ophthalmic drug delivery market is highly competitive, with several established players and emerging technologies vying for market share.
Despite these risks, Clearside’s innovative approach to ophthalmic drug delivery, its promising pipeline, and its strategic partnerships have positioned the company as a leader in the field of posterior segment eye diseases. Investors should closely monitor the company’s progress as it continues to advance its programs and navigate the challenges of the biopharmaceutical industry.
Conclusion
Clearside Biomedical is a pioneering biopharmaceutical company that has revolutionized the delivery of therapies to the back of the eye through its innovative SCS injection platform. With its first commercial product, XIPERE, already approved and a robust pipeline of product candidates in development, Clearside is well-positioned to address significant unmet needs in ophthalmology.
The positive topline results from the ODYSSEY Phase 2b trial of CLS-AX in wet AMD, coupled with the company’s strategic partnerships and ongoing research efforts, suggest that Clearside Biomedical is poised to play a transformative role in the future of retinal disease treatment. As the company continues to navigate the challenges of the industry, investors will undoubtedly keep a close eye on its progress and the potential impact of its groundbreaking approach to ocular drug delivery.
With a strong liquidity position and a clear strategy for advancing its pipeline, Clearside Biomedical appears to be well-positioned to capitalize on the growing market for innovative ophthalmic treatments. However, investors should remain mindful of the inherent risks associated with clinical-stage biopharmaceutical companies and the competitive landscape of the ophthalmology market.
Disclaimer: This article is for informational purposes only. It does not constitute financial, legal, or other types of advice. While every effort has been made to ensure the accuracy of the information presented here, the author and the publisher do not make any guarantees about the completeness, reliability, and accuracy of this information.