OCGN — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-06

• We are developing a modifier gene therapy platform designed to fulfill unmet medical needs related to retinal diseases, including inherited retinal degenerations ("IRDs"), such as retinitis pigmentosa ("RP"), Stargardt disease ("ST"), and multifactorial diseases such as dry age-related macular degen…

• OCU400- our first modifier gene therapy product is based on the use of NHRs, and we believe our novel modifier gene therapy platform has the potential to address major blindness diseases, including rare genetic diseases such as RP, with a gene-agnostic approach. OCU400 is intended for early to advan…

• ▪Visual function benefits were consistently observed over 3 years, with 88% (7/8) of evaluable treated subjects showing improvement or preservation versus untreated fellow eyes; and,

• ▪Approximately 2-line gain (N=8) observed across multiple mutation types in treated eyes compared to untreated eyes at 3 years.

• We have completed enrollment in the Phase 3 liMeliGhT clinical trial for OCU400 (N=140 subjects), reflecting strong interest from investigators and patients. Topline Phase 3 data is expected in the first quarter of 2027, advancing OCU400 towards potential approval in the fourth quarter of 2027 as a …

Text removed vs the prior filing · source: 10-Q · 2026-05-08

• OCU400- Based on the use of nuclear hormone receptors ("NHRs"), we believe our novel modifier gene therapy platform has the potential to address major blindness diseases, including rare genetic diseases such as RP (OCU400), with a gene-agnostic approach. OCU400 is intended for early to advanced case…

• ◦Visual function benefits were consistently observed over 3 years, with 88% (7/8) of evaluable treated subjects showing improvement or preservation versus untreated fellow eyes.

• ◦Approximately 2-line gain (N=8) observed across multiple mutation types in treated eyes compared to untreated eyes at 3 years.

• We expect to begin a rolling BLA submission in the third quarter of 2026 and plan to complete the BLA submission by the second quarter of 2027. We announced OCU400 Phase 3 liMeliGhT enrollment completion (N=140 subjects), reflecting strong interest from investigators and patients.

• Topline Phase 3 data is expected in the first quarter of 2027, advancing OCU400 towards potential approval in the fourth quarter of 2027 as a treatment option for early- to late-stage RP.

Text added vs the prior filing · source: 10-Q · 2026-08-06

• We have carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) …

• evaluation, our principal executive officer and principal financial officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures are effective in ensuring that (a) the information required to be disclosed by us in the reports that we file or subm…

• There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months ended June 30, 2026, that have materially affected, or are reasonably likely to materially affect, our internal control ov…

Text removed vs the prior filing · source: 10-Q · 2026-05-08

• We have carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) …

• There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over f…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• On June 5, 2026, Shankar Musunuri, the Chairman of the Board of Directors and Chief Executive Officer of the Company, adopted a Rule 10b5-1 Sales Plan (the "Plan") intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Securities Exchange Act of 1934, as amended (the "Exc…

• The Plan provides, during the term commencing on September 9, 2026 and ending on September 9, 2027, for the potential periodic sale of up to 2,188,783 shares of common stock owned by Dr. Musunuri, directly or indirectly, and for the potential sale from time to time of up to 2,802,208 shares of commo…

• No other director or officer, as such term is defined in Rule 16a-1(f) promulgated under the Exchange Act, adopted, and no directors or officers of the Company terminated, any Rule 10b5-1 trading arrangement or any non-Rule 10b5-1 trading arrangement, as such terms are defined in Item 408(a) of Regu…

Text removed vs the prior filing · source: 10-Q · 2026-05-08

• During the three months ended March 31, 2026, none of our directors or "officers," as defined in Rule 16a-1(f) under the Securities Exchange Act of 1934, as amended, adopted or terminated a Rule 10b5-1 trading plan or arrangement or a non-Rule 10b5-1 trading plan or arrangement, as defined in Item 4…