Legal & controls
Item 3 and Item 9A as filed · every verdict is the registrant’s own sentence, printed below it · a filing that fails an extraction gate reads “not extracted”
| Fiscal year | Filed | Item 3 | ICFR | disclosure controls | material weakness | Filing |
|---|---|---|---|---|---|---|
| 2025-09-30 | 2025-12-19 | described here | effective | not extracted | none in Item 9A | EDGAR |
Item 3 · On November 3, 2023, a securities class action lawsuit was filed against us and certain of our officers in the United States District Court for the District of New Jersey. The class action complaint alleges violations of the Exchange Act in connection with allegedly false and misleading statements made by us related to our BLA during the period from August 3, 2021 through August 29, 2023. The complaint alleges, among other things, that we violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 by failing to disclose that there was an alleged lack of evidence supporting ONS-5010/LYTENAVA as a treatment for wet AMD and that we and/or our manufacturing partner had deficient CMC controls for ONS-5010/LYTENAVA, which remained unresolved at the time our BLA was re-submitted to the FDA and, as a result, the FDA was unlikely to approve our BLA, and that our stock price dropped when such information was disclosed. The plaintiffs in the class action complaint seek damages and interest, and an award of reasonable costs, including attorneys’ fees. The defendants’ motion to dismiss the second amended complaint is currently pending before the court. On October 10, 2024, certain… Item 9A · ICFR · Based on our evaluation, we concluded that our internal control over financial reporting was effective as of September 30, 2025. | ||||||
| 2024-09-30 | 2024-12-27 | described here | effective | not extracted | none in Item 9A | EDGAR |
Item 3 · On November 3, 2023, a securities class action lawsuit was filed against us and certain of our officers in the United States District Court for the District of New Jersey. The class action complaint alleges violations of the Exchange Act in connection with allegedly false and misleading statements made by us related to our BLA during the period from August 3, 2021 through August 29, 2023. The complaint alleges, among other things, that we violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 by failing to disclose that there was an alleged lack of evidence supporting ONS-5010/LYTENAVA as a treatment for wet AMD and that we and/or our manufacturing partner had deficient CMC controls for ONS-5010/LYTENAVA, which remained unresolved at the time our BLA was re-submitted to the FDA and, as a result, the FDA was unlikely to approve our BLA, and that our stock price dropped when such information was disclosed. The plaintiffs in the class action complaint seek damages and interest, and an award of reasonable costs, including attorneys’ fees. Defendants’ motion to dismiss is currently pending before the court. On October 10, 2024, certain of the company’s officers and dir… Item 9A · ICFR · Based on our evaluation, we concluded that our internal control over financial reporting was effective as of September 30, 2024. | ||||||
| 2023-09-30 | 2023-12-22 | described here | effective | not extracted | none in Item 9A | EDGAR |
Item 3 · On November 3, 2023, a securities class action lawsuit was filed against us and certain of our officers in the United States District Court for the District of New Jersey. The class action complaint alleges violations of the Exchange Act in connection with allegedly false and misleading statements made by us related to our BLA during the period from December 29, 2022 through August 29, 2023. The complaint alleges, among other things, that we violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 by failing to disclose that there was an alleged lack of evidence supporting ONS-5010 as a treatment for wet AMD and that we and/or our manufacturing partner had deficient CMC controls for ONS-5010, which remained unresolved at the time our BLA was re-submitted to the FDA and, as a result, the FDA was unlikely to approve our BLA, and that our stock price dropped when such information was disclosed. The plaintiffs in the class action complaint seek damages and interest, and an award of reasonable costs, including attorneys’ fees. The pending lawsuit and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend… Item 9A · ICFR · Based on our evaluation, we concluded that our internal control over financial reporting was effective as of September 30, 2023. | ||||||
| 2022-09-30 | 2022-12-29 | described here | effective | not extracted | none in Item 9A | EDGAR |
Item 3 · From time to time, we may become involved in litigation relating to claims arising from the ordinary course of business. Our management believes that there are currently no claims or actions pending against us, the ultimate disposition of which would have a material adverse effect on our results of operations, financial condition or cash flows. On July 20, 2020, Liomont filed a complaint against us in the U.S. District Court of the Southern District of New York alleging certain breach of contract claims under our June 25, 2014 strategic development, license and supply agreement relating to the biosimilar development program for ONS-3010 and ONS-1045 claiming $3,000,000 in damages. On March 30, 2021, we entered into a confidential settlement agreement with Liomont and the complaint was dismissed on April 11, 2021. We agreed to make an initial settlement payment of $625,000 that was paid in April 2021; and an additional payment of $750,000, which was paid in April 2022. There are no remaining future financial obligations. Item 9A · ICFR · Based on our evaluation, we concluded that our internal control over financial reporting was effective as of September 30, 2022. | ||||||
| 2021-09-30 | 2021-12-23 | described here | effective | not extracted | none in Item 9A | EDGAR |
Item 3 · From time to time, we may become involved in litigation relating to claims arising from the ordinary course of business. Our management believes that there are currently no claims or actions pending against us, the ultimate disposition of which would have a material adverse effect on our results of operations, financial condition or cash flows. On July 20, 2020, Laboratorios Liomont S.A. de C.V., or Liomont, filed a complaint against us in the U.S. District Court of the Southern District of New York alleging certain breach of contract claims under our June 25, 2014 strategic development, license and supply agreement relating to the biosimilar development program for ONS-3010 and ONS-1045 claiming $3,000,000 in damages. On March 30, 2021, we entered into a confidential settlement agreement with Liomont and the complaint was dismissed on April 11, 2021. We agreed to make an initial settlement payment of $625,000 that was paid in April 2021; and an additional payment of $750,000, which is contingent upon the occurrence of certain future events. Item 9A · ICFR · Based on our evaluation, we concluded that our internal control over financial reporting was effective as of September 30, 2021. | ||||||
5 of 5 annual reports on record have their filing text cached on this host; the rest are listed with their EDGAR link and no extraction, because this surface never fetches from SEC on a page load.
- Item 3 and Item 9A are located in the filing HTML already cached on this host and read with the same line-anchored item matcher and largest-gap body disambiguation the filing-narrative pass uses for Item 1A and Item 7 — no fetch, no model, no summarization.
- A heading is accepted as a section only when it is not a table-of-contents row (a trailing page number), not a quoted reference in prose, and names its own section; the span must then clear a per-item length band and carry readable text after the heading. Anything that fails a gate is served as 'not extracted' with the reason — never as a default value.
- An effectiveness conclusion is read only from a sentence that names its own control set (disclosure controls and procedures, or internal control over financial reporting) and states an outcome. Conditional sentences — the standard limitations paragraph and forward-looking remediation language — are excluded, because they are hypotheses rather than conclusions.
- When a filing's own sentences disagree — an effective conclusion beside an unremediated material-weakness disclosure, or two conclusions of opposite sign — no verdict is asserted. A wrong 'controls were effective' reading is worse than no reading.
- Every verdict is shown beside the verbatim sentence it was read from. The excerpt is the filing's own words, capped at 1,200 characters; the filing itself is one link away.