Clearside Biomedical, Inc. (NASDAQ:CLSD) is a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®). The company's novel SCS injection platform, utilizing its proprietary SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases.

Clearside's financial performance in recent years has been marked by significant investments in research and development to advance its pipeline. In 2023, the company reported annual revenue of $8.2 million, annual net loss of $32.5 million, annual operating cash outflow of $18.1 million, and annual free cash outflow of $19.9 million. These financial results reflect Clearside's focus on developing its proprietary technology and product candidates rather than generating near-term profitability.

During the first quarter of 2024, Clearside reported revenue of $0.2 million, a net loss of $11.8 million, and used $7.9 million in operating cash flow. The company ended the quarter with $35.4 million in cash and cash equivalents, which it believes will fund its planned operations into the third quarter of 2025.

Business Overview

Clearside's primary focus is on developing its SCS injection platform to enable the targeted delivery of therapies to the back of the eye. The company's first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, was approved by the U.S. Food and Drug Administration (FDA) in October 2021 for the treatment of macular edema associated with uveitis. XIPERE's commercialization rights are licensed to Bausch + Lomb in the United States and Canada, and to Arctic Vision in Asia, excluding Japan.

In addition to XIPERE, Clearside has built a pipeline of internal product candidates and external collaborations leveraging its SCS injection platform. The company's most advanced internal program is CLS-AX (axitinib injectable suspension), which is being developed for the treatment of neovascular age-related macular degeneration (wet AMD). Clearside is currently conducting a Phase 2b clinical trial, called ODYSSEY, to evaluate CLS-AX versus aflibercept intravitreal injection. The company expects to report topline data from the ODYSSEY trial in the third quarter of 2024.

Clearside has also established strategic partnerships with several companies to expand the use of its suprachoroidal injection platform. These collaborations include agreements with Bausch Health, Arctic Vision, REGENXBIO, Inc., Aura Biosciences, and BioCryst Pharmaceuticals, Inc. Through these partnerships, Clearside has been able to generate revenue from upfront payments, milestone payments, and potential future royalties, while also broadening the reach of its technology.

Financial Condition and Liquidity

As of March 31, 2024, Clearside had $35.4 million in cash and cash equivalents, which the company believes will fund its planned operations into the third quarter of 2025. This cash runway provides the company with the financial flexibility to continue advancing its pipeline, including the completion of the ODYSSEY trial for CLS-AX and the planning of a potential Phase 3 program.

Clearside's financial performance has been characterized by significant research and development expenses, which totaled $5.6 million in the first quarter of 2024, compared to $4.5 million in the same period of the prior year. This increase was primarily driven by costs related to the ODYSSEY trial for CLS-AX. The company's general and administrative expenses decreased slightly to $2.8 million in the first quarter of 2024, from $3.2 million in the first quarter of 2023, due to a decrease in professional fees.

In February 2024, Clearside raised $13.9 million in net proceeds from a registered direct offering of common stock and warrants. This additional capital strengthens the company's balance sheet and supports its ongoing development activities.

Risks and Challenges

Clearside faces several risks and challenges that could impact its future performance. As a clinical-stage biopharmaceutical company, the company is subject to the inherent risks associated with drug development, including the uncertainty of regulatory approvals, the potential for clinical trial failures, and the ability to successfully commercialize its product candidates.

The company's reliance on its SCS injection platform and the successful development and commercialization of its product candidates, including CLS-AX, is a significant risk. Any setbacks or delays in the development or regulatory approval of these assets could have a material adverse effect on Clearside's financial condition and future prospects.

Additionally, Clearside's ability to generate revenue and achieve profitability is dependent on the successful commercialization of XIPERE by its licensees, Bausch + Lomb and Arctic Vision, as well as the potential future commercialization of its other product candidates. The company's financial performance may be impacted by the commercial success, or lack thereof, of these products.

Outlook

Clearside is poised for a transformative year in 2024, with several key milestones on the horizon. The company's primary focus is on the upcoming data readout from the ODYSSEY trial for CLS-AX, which is expected in the third quarter of 2024. This data will be crucial in informing the design of a potential Phase 3 program for CLS-AX, which the company is already planning.

In addition to the ODYSSEY data, Clearside is also working to expand the reach of its SCS injection platform through its existing partnerships and potential new collaborations. The company's recent additions of Dr. Victor Chong as Chief Medical Officer and Anthony S. Gibney to its Board of Directors are expected to strengthen Clearside's clinical and strategic capabilities, respectively, as it navigates these important milestones.

Clearside's financial position, with $35.4 million in cash and cash equivalents as of March 31, 2024, provides the company with the resources to execute on its development plans and explore new opportunities. The company's ability to continue advancing its pipeline and leveraging its SCS injection platform will be key drivers of its long-term success.

Conclusion

Clearside Biomedical is a promising biopharmaceutical company that is pioneering the use of suprachoroidal drug delivery to address serious eye diseases. With its approved product XIPERE and a robust pipeline of internal and partnered programs, the company is well-positioned to potentially transform the treatment paradigm for retinal diseases.

The upcoming data readout from the ODYSSEY trial for CLS-AX, as well as the company's strategic partnerships and recent leadership additions, make 2024 a pivotal year for Clearside. Investors will want to closely monitor the company's progress as it continues to advance its innovative SCS injection platform and drive value for shareholders.