ADDED
As of March 5, 2026, there were 71,149,045 shares of the registrant s common stock outstanding.
Our planned clinical trials may face substantial delays, result in failure, or provide inconclusive or adverse results that may not satisfy U.S.
Food and Drug Administration ( FDA ) requirements to further develop our therapeutic products.
Our ability to utilize our common stock to finance future capital needs, or for other purposes, is limited by our authorized shares available for issuance.
Risks Related to Government Regulation Instability and operational disruptions at government agencies, such as the FDA, may adversely impact our development and commercialization plans by causing delays and requiring the use of additional, unforeseen resources to obtain regulatory approval for trials or products in our pipeline.
We operate in a highly regulated industry and face many challenges adapting to sudden changes in legislative reform or the regulatory environment, including due to government shutdowns and disruptions at government agencies, which cause delays, requires the use of additional, unforeseen resources, affects our pipeline stability, and could impair our ability to compete in international markets.
Risks Related to Ownership of Our Common Stock The market price of our common stock is expected to be volatile and if we fail to comply with the continued listing standards of Nasdaq, our common stock may be delisted.
(the Company, Opus, we, us, or our ) is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases ( IRDs ), and other types of therapies for additional ophthalmic disorders.
Pipeline Our pipeline is composed of a portfolio of gene therapies being developed as durable, one-time treatments designed to address the underlying genetic causes of severe retinal disorders.
The pipeline includes seven adeno-associated virus ( AAV )-based programs, led by OPGx-LCA5 for LCA5-related mutations and OPGx-BEST1 for BEST1-related retinal degeneration, with additional candidates targeting RHO, CNGB1, RDH12, NMNAT1, and MERTK.
REMOVED
As of March 27, 2025, there were 45,483,823 shares of the registrant s common stock outstanding.
Risks Related to the Opus Acquisition Failure to successfully integrate our businesses with Former Opus (as defined below) could have a material adverse effect on our business, financial condition and results of operations.
The Opus Acquisition (as defined below) significantly expanded our product pipeline and business operations and shifted our business strategies, which may not improve the value of our common stock.
Our planned clinical trials may face substantial delays, result in failure, or provide inconclusive or adverse results that may not satisfy FDA requirements to further develop our therapeutic products.
Risks Related to Government Regulation We operate in a highly regulated industry and face many challenges adapting to sudden changes in legislative reform or the regulatory environment, which affects our pipeline stability and could impair our ability to compete in international markets.
Our current focus on the cash-pay utilization for future sales of RYZUMVI may limit our ability to increase sales or achieve profitability with this product.
Risks Related to Ownership of Our Common Stock The market price of our common stock is expected to be volatile and subject to certain dilutive risks associated with our Equity Line of Credit arrangement.
(the Company, Opus, we, us, or our ) is a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases ( IRDs ) and other types of therapies for additional ophthalmic disorders.
Our expanded pipeline following the Opus Acquisition includes assets from the adeno-associated virus ( AAV ) based gene therapy portfolio of Private Opus that address mutations in genes that cause different forms of Leber congenital amaurosis ( LCA ), bestrophinopathy, and retinitis pigmentosa.
Our most advanced gene therapy program is designed to address mutations in the LCA5 gene ( LCA5 ), which encodes the lebercilin protein.