Opus Genetics Reports $57.5 Million Net Loss for Fiscal Year 2024 Amid Rising Expenses

Opus Genetics, Inc. reported a significant increase in its net loss for the fiscal year ending December 31, 2024, amounting to $57.5 million, compared to a net loss of $10.0 million in the previous year. This increase is attributed to higher operating expenses, which rose to $73.1 million from $29.6 million in 2023. The surge in expenses was primarily driven by a $28 million charge related to acquired in-process research and development (IPR&D) following the company's acquisition of Private Opus, as well as increased research and development costs associated with ongoing clinical trials for its gene therapy products.

The company’s revenue from licenses and collaborations decreased to $11.0 million in 2024 from $19.0 million in 2023. The decline was largely due to the absence of a significant milestone payment that had been received in the prior year following the FDA approval of Phentolamine Ophthalmic Solution 0.75%, marketed as RYZUMVI. The company has not yet generated substantial revenue from product sales, relying instead on milestone payments and reimbursements from its collaboration with Viatris, which is responsible for the commercialization of RYZUMVI.

Strategically, Opus Genetics has expanded its product pipeline through the acquisition of Private Opus, which added gene therapy programs targeting inherited retinal diseases (IRDs) such as Leber congenital amaurosis and bestrophinopathy. The company is currently conducting a Phase 1/2 clinical trial for its lead gene therapy candidate, OPGx-LCA5, which has shown promising results in early-stage trials. The company has also received Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA for this candidate, which may facilitate a faster regulatory review process.

Operationally, Opus Genetics has a workforce of 18 employees, with plans to expand as it advances its clinical development efforts. The company is also seeking to establish partnerships to further develop its pipeline, particularly for its APX3330 program, which is currently in need of a strategic partner to continue its clinical development. The company’s financial position remains precarious, with an accumulated deficit of approximately $139 million as of December 31, 2024, and it anticipates needing additional capital to fund its ongoing operations and development activities.

Looking ahead, Opus Genetics aims to continue advancing its gene therapy programs while exploring opportunities for additional collaborations and licensing agreements. The company expects to face challenges in achieving profitability, particularly given the high costs associated with clinical trials and the uncertainty surrounding regulatory approvals. The management remains focused on executing its strategy to develop innovative therapies for IRDs and other ophthalmic disorders, while navigating the complexities of the biotechnology landscape.