BEDFORD, Mass.—Ocular Therapeutix, Inc. (NASDAQ: OCUL), a biopharmaceutical company developing therapies for retinal diseases and other eye conditions, yesterday reported financial results for the third quarter ended September 30, 2024. The company reported total net revenue of $15.4 million for the third quarter of 2024, a slight increase from $15.1 million in the same period last year. The company also reported a net loss of $36.5 million in the third quarter of 2024, compared with a net loss of $0.5 million in the prior-year period.

“2024 has been a year of significant change and tremendous execution at Ocular, but this is all in anticipation of what’s ahead,” said Pravin U. Dugel, MD, executive chairman, president and chief executive officer of Ocular Therapeutix. “We are making outstanding progress on enrollment in the two complementary studies in our registrational program for AXPAXLI in wet AMD, SOL-1 and SOL-R. I’m thrilled to share that SOL-1 has reached a key enrollment milestone, as we have now ‘flipped the switch’ to allow direct enrollment of subjects into SOL-R. We expect to complete SOL-1 randomization by year-end, with topline data to follow in the fourth quarter of 2025. As SOL-1 quickly approaches complete randomization, eligible subjects who are not ultimately randomized can seamlessly enroll in SOL-R, creating a streamlined and efficient pathway that capitalizes on recruitment momentum at our clinical sites.” 

In the third quarter of 2024, the company reported total net revenue of $15.4 million, a 2.3 percent increase over total net revenue of $15.1 million in the comparable period in 2023. This increase was driven by increased gross revenues from Dextenza sales offset by higher gross-to-net provisions in the 2024 period compared with the prior comparable period, the company noted, adding that it expects full-year 2024 total net revenues for Dextenza to be between $62.0 million and $67.0 million, compared with $57.9 million reported for 2023.

Total cash and cash equivalents were reported at $427.2 million as of September 30, 2024. Based on current plans and related estimates of anticipated cash inflows from Dextenza, the company stated it believes that its current cash balance is sufficient to support its planned expenses, obligations and capital expenditure requirements into 2028.

Research and development expenses for the third quarter of 2024 were reported at $37.1 million, compared with $15.0 million for the same period in 2023, reflecting an increase in overall clinical expenses associated with product development programs, specifically the SOL-1 and SOL-R Phase 3 clinical trials.

General and administrative expenses were reported at $12.2 million for the third quarter of 2024 versus $8.6 million for the comparable quarter of 2023, primarily due to an increase in professional fees and personnel-related costs, including stock-based compensation, the company noted.

“SOL-1 and SOL-R were strategically designed with the goals of de-risking clinical outcomes, aligning with regulatory standards, enhancing each other’s enrollment, and providing a broad evaluation of AXPAXLI’s durability, repeatability and flexibility,” said Dr. Dugel. “Thanks to the team’s strong execution, attention to patient care, and long-standing relationships in the retina community, we have enrolled SOL-1 faster than we expected and continue to build enthusiasm for SOL-R. Supported by our dedicated team and strong financial resources, Ocular is on solid footing as we head toward what we expect will be an important milestone year in 2025.”