OTLK — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-18

• Bevacizumab is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody, or mAb, that inhibits VEGF and associated angiogenic activity. Prior to the approval of LYTENAVA in the US,

• EU and UK, bevacizumab had only been approved for use in the treatment of various forms of cancer and had not been optimized for use in the treatment of retina diseases. Because there previously were no approved bevacizumab products for the treatment of retinal diseases in the United States and othe…

• 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…

• manufacture LYTENAVA in the United States, which helps mitigate exposure to global tariff volatility. However, this concentration of manufacturing may adversely affect our pricing and competitiveness in the United Kingdom and European Union.

• On August 12, 2026, we entered into an underwriting agreement with Piper Sandler & Co. and BTIG, LLC, as representatives of the several underwriters named therein, relating to the public offering, or the August 2026 Offering, by the Company of (i) 55,555,556 shares of common stock and (ii) accompany…

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

• Bevacizumab is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody, or mAb, that inhibits VEGF and associated angiogenic activity. Prior to the approval of ONS-5010/LYTENAVA in the EU and UK, bevacizumab had only been approved for use in the treatm…

• 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…

• Separately, in March 2022, we submitted a BLA to the FDA for ONS-5010/LYTENAVA for the treatment of wet AMD. In May 2022, we voluntarily withdrew our BLA to provide additional information requested by the FDA. We re-submitted the BLA to the FDA for ONS-5010/LYTENAVA in August 2022, and in October 20…

• We agreed to conduct an additional adequate and well-controlled clinical trial following discussions with the FDA in support of our BLA for ONS-5010/LYTENAVA. In December 2023, we submitted a Special Protocol Assessment, or SPA, to the FDA for this study (NORSE EIGHT) seeking confirmation that, if s…

• 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…

Text added vs the prior filing · source: 10-Q · 2026-08-18

• The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is re…

• executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Because there are inherent limitations in all control systems, a control system, no matter how well conceived and operated, can provide only re…

• There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(d) and 15d-15(d) under the Exchange Act) that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting during our fiscal quarter ended…

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

• The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is re…

• There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(d) and 15d-15(d) under the Exchange Act) that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting during our first fiscal quarter…

Text added vs the prior filing · source: 10-Q · 2026-08-18

• Developing and commercializing pharmaceutical products are expensive, risky and lengthy processes. LYTENAVA has been approved for marketing for the treatment of wet AMD in adults in the US, EU and UK, however we have not generated material revenue from sales of LYTENAVA. We expect to incur increased…

• As of June 30, 2026, our cash and cash equivalents balance was $11.2 million. We estimate that our cash and cash equivalents as of June 30, 2026, together with $51.1 million in net proceeds from our August 2026 Offering, will only be sufficient to fund our operations into the second quarter of calen…

• Because our cash and cash equivalents, together with $51.1 million of net proceeds from our August 2026 Offering, will not be adequate to fund our currently planned operations through at least the 12 months from the date of this Quarterly Report, there is substantial doubt about our ability to conti…

• Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms accept…

• our ability to launch and commercialize LYTENAVA and develop our technology and product candidates. Moreover, the terms of any financing may negatively impact the holdings or the rights of our stockholders, and the issuance of additional securities, whether equity or debt, by us or the possibility o…

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

• 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…

• We do not believe our cash and cash equivalents, together with net proceeds of $[__] million from the April 2026 Offering, will be adequate to fund our currently planned operations through at least the next 12 months from the date of our Quarterly Report on Form 10-Q for the quarter ended March 31, …

• Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms accept…