ADDED
As of December 16, 2025, the registrant had outstanding 64,114,399 shares of common stock, par value $0.01 per share.
Currency translations between Swiss Francs, or CHF, and United States dollars provided herein are based on the noon buying rate in New York City for cable transfers in foreign currencies as certified for customs purposes by the Federal Reserve Bank of New York on September 30, 2025, or CHF 0.80 = $1.00.
We do not represent that CHF were, could have been, or could be, converted into United States dollars at such rate or at any other rate.
In September 2025, we conducted a Type A meeting with the FDA at which we received feedback on resubmitting the BLA.
We subsequently resubmitted the ONS-5010/LYTENAVA BLA and have received a Prescription Drug User Fee Act, or PDUFA, goal date of December 31, 2025 for a decision by the FDA; We may need to enter into alliances with other companies that can provide capabilities and funds for the development and commercialization of product candidates.
If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for ONS-5010/LYTENAVA outside the EU and UK, or for any other of our product candidates, or commercialize ONS-5010/LYTENAVA or any other of our product candidates and our business could be harmed; We currently engage single source suppliers for clinical trial services, drug substance manufacturing, and fill-finish manufacturing of ONS-5010/LYTENAVA.
Business Overview We are a biopharmaceutical company that has developed ONS-5010/LYTENAVA TM as the first ophthalmic formulation of bevacizumab approved by the European Commission in the European Union, or EU, and the Medicines and Healthcare products Regulatory Agency, or MHRA, in the United Kingdom, or UK, for use in adults for the treatment of wet age-related macular degeneration, or wet AMD.
In June 2025, we launched directly into the initial markets of Germany and the UK.
Additionally, our Biologics License Application, or BLA, is currently under review at the U.S.
Food and Drug Administration, or FDA, for the use of ONS-5010/LYTENAVA as a treatment for wet AMD in the United States.
REMOVED
As of December 24, 2024, the registrant had outstanding 24,905,635 shares of common stock, par value $0.01 per share.
dollars provided herein are based on the noon buying rate in New York City for cable transfers in foreign currencies as certified for customs purposes by the Federal Reserve Bank of New York on September 30, 2024, or CHF 0.9015 = $1.00.
We do not represent that CHF were, could have been, or could be, converted into U.S.
Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations; Raising additional capital, including modifications to our existing convertible securities, may cause dilution to our securityholders, restrict our operations or require us to relinquish rights to our technologies or product candidates; We are highly dependent on the success of ONS-5010/LYTENAVA, our only product that has been approved in the EU and UK.
If ONS-5010/LYTENAVA does not receive regulatory approval outside the EU and UK, or is not successfully commercialized, our business may be harmed; We may need to enter into alliances with other companies that can provide capabilities and funds for the development and commercialization of product candidates.
If we are unable to establish and maintain sales and marketing capabilities in jurisdictions for which we choose to retain commercialization rights, we may be unable to generate any revenue and will depend on the efforts of our licensing partners, if any; We rely on third parties to manufacture and test ONS-5010/LYTENAVA, conduct our preclinical and clinical trials and perform other tasks for us.
Business Overview We are a biopharmaceutical company that is the first to receive marketing authorization for an ophthalmic formulation of ONS-5010/LYTENAVA ( bevacizumab-gamma) for use in treating wet age-related macular degeneration, or wet AMD, in the European Union, or EU, and United Kingdom, or UK.
We are developing ONS-5010/LYTENAVA to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases.
We are also working to receive approval and launch ONS-0510/LYTENAVA in the United States.
Our initial goal is to launch directly in the EU and the UK, and in the United States, if approved, as the first and only approved ophthalmic bevacizumab for the treatment of retina conditions, including wet age-related macular degeneration, or wet AMD.