Clearside Biomedical, Inc. reported a net loss of $34.4 million for the fiscal year ending December 31, 2024, compared to a net loss of $32.5 million in 2023. The company's revenue significantly decreased to $1.7 million from $8.2 million in the previous year, primarily due to a lack of substantial milestone payments and a shift in revenue sources. The 2024 revenue was mainly derived from training materials and clinical trial products provided to licensees, while the previous year included a $5 million upfront payment from BioCryst and other milestone payments. Operating expenses also declined to $30.5 million from $33.1 million, reflecting reduced research and development costs, particularly related to the ODYSSEY clinical trial for CLS-AX.

In terms of strategic developments, Clearside continues to leverage its proprietary SCS Microinjector technology, which allows for targeted drug delivery to the back of the eye. The company has entered into several licensing agreements, including a recent deal with BioCryst Pharmaceuticals for the delivery of avoralstat, which could yield up to $47.5 million in milestone payments and royalties. Additionally, the company has received a permanent Category 1 Current Procedural Terminology (CPT) code for the suprachoroidal injection procedure, which is expected to enhance access and adoption of this method.

Operationally, Clearside's employee count remained stable at 32 full-time employees as of December 31, 2024. The company has trained over 1,200 retinal physicians on the use of its SCS Microinjector since the launch of its first product, XIPERE, in early 2022. However, the company faces significant competition in the ocular drug market, particularly from established anti-VEGF therapies and other emerging treatments. The market for anti-VEGF therapies was valued at approximately $14.3 billion globally in 2020, highlighting the competitive landscape Clearside must navigate.

Looking ahead, Clearside anticipates needing additional funding to support its ongoing operations and clinical trials, particularly for the Phase 3 trial of CLS-AX, which is expected to begin in the second half of 2025. The company has indicated that its current cash reserves will sustain operations into the fourth quarter of 2025, but substantial doubt exists regarding its ability to continue as a going concern without securing further financing. The company plans to explore various funding options, including equity offerings and potential collaborations, to ensure it can meet its financial obligations and continue its development efforts.

About Clearside Biomedical, Inc.

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