OTLK — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-15

• 5010/LYTENAVA has potential to mitigate risks associated with off-label use of unapproved bevacizumab. We believe there is significant opportunity in Europe with a total anti-VEGF retina market estimated to be approximately $3.6 billion, including approximately 1.52 million treated patients and appr…

• Global uncertainty due to tariffs and global macroeconomic conditions may have a material adverse effect on our commercialization efforts. The global financial markets recently have experienced significant disruptions due to various macroeconomic factors, including, among other things, the impacts o…

• Through March 31, 2026, we have funded substantially all of our operations with $650.3 million in net proceeds from the sale and issuance of our equity and debt securities. We have also received $29.0 million pursuant to our collaboration and licensing agreements through such date. Our net loss for …

• We evaluated whether there are conditions or events considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern. We do not believe that the existing cash and cash equivalents as of March 31, 2026 are sufficient to fund our operations through one year fr…

• costs associated with manufacturing of LYTENAVA as a component of research and development expense that would have been included in cost of revenues.

Text removed vs the prior filing · source: 10-Q · 2026-02-17

• first-line product. It is estimated that 34% of the total anti-VEGF market is off-label bevacizumab (new and maintenance therapy) (Citeline (2023); Global Data (2023); Market Scope (2022); ASRS 2024 Membership Survey; Market Scope 2024 US Retina Quarterly Updates; GlobalData: Age-Related Macular Deg…

• Global uncertainty due to tariffs and global macroeconomic conditions may have a material adverse effect on our commercialization efforts. The global financial markets recently have experienced significant disruptions due to various macroeconomic factors, including, among other things, the impacts o…

• countries in which we conduct our business, that political, diplomatic, and national security factors can lead to global trade restrictions and changes in trade policies and export regulations that may adversely affect our business and operations. The current international trade and regulatory envir…

• Through December 31, 2025, we have funded substantially all of our operations with $627.5 million in net proceeds from the sale and issuance of our equity and debt securities. We have also received $29.0 million pursuant to our collaboration and licensing agreements through such date. Our net loss f…

• On December 31, 2025, we did not meet the required $3.0 million Quarterly Debt Reduction Obligation, as defined below. The failure to make this required payment constituted a Major Trigger Event, as defined below, under the terms of the March 2025 Note, as defined below. Subsequent to December 31, 2…

Text added vs the prior filing · source: 10-Q · 2026-05-15

• The following risk factors supplement and, to the extent inconsistent therewith, supersede the risk factors previously disclosed in Item 1A of the Company’s Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 19, 2025 (the “Annual Report”). You should car…

• There is substantial doubt about our ability to continue as a going concern. We will continue to need to raise substantial additional funding to complete the development of ONS-5010/LYTENAVA outside the EU and UK and support our operations until we are able to generate sufficient revenue from the sa…

• necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.

• Developing product candidates is an expensive, risky and lengthy process. We have received a marketing authorization from the European Commission and the MHRA for ONS-5010/LYTENAVA for the treatment of wet AMD in the EU and UK, respectively. We are currently advancing ONS-5010/LYTENAVA through the r…

• As of March 31, 2026, our cash and cash equivalents balance was $7.7 million. We do not believe that our cash and cash equivalents as of March 31, 2026, together with the $4.5 million of net proceeds of the Registered Direct Offering and concurrent private placement in April 2026 are sufficient to f…

Text removed vs the prior filing · source: 10-Q · 2026-02-17

• As of the date of this Quarterly Report on Form 10-Q, there have been no material changes to the risk factors that were previously disclosed in Item 1A in the Company’s Form 10-K for the year ended September 30, 2025 filed with the SEC on December 19, 2025.