IRD 最新10-Q变化
将 IRD 最新的定期申报(10-K/10-Q)与上一份同类型申报逐章节对比:每个章节新增/删除的段落数与原文摘录。全部为确定性文本对比——无相似度评分、无方向判断、非投资建议。
对比:10-Q · 2026-08-06 与上一份 10-Q · 2026-05-12
| 章节 | 结果 | 新增 | 删除 | 微调 | 未变 |
|---|---|---|---|---|---|
| 管理层讨论与分析 | 文字有新增/删除 | +50 | −32 | ~41 | 93 |
| 控制与程序 | 文字有新增/删除 | +3 | −2 | ~1 | 1 |
| 法律诉讼 | 无段落级文字变化 | 0 | 0 | 0 | 1 |
| 风险因素 | 公司称无重大变化(指向 10-K) | — | — | — | — |
| 其他信息 | 文字有新增/删除 | +2 | 0 | ~1 | 0 |
计数单位为段落;"新增/删除"指相对上一份文件新增/删除的文字,不含方向或好坏判断。
未列出(无法可靠提取或缺失):市场风险(第3项)
代表性摘录
每个章节最多 5 条、每条约 300 字符的原文摘录,直接来自两份 SEC 文件。
管理层讨论与分析
相对上期新增的文字 · 来源:10-Q · 2026-08-06
In September 2025, we reported positive data from six participants. The three pediatric participants treated over three months demonstrated large gains in cone-mediated vision with improvements across multiple measures of visual function. In the three adult participants, responses were observed out …
In November 2025, we announced the successful completion of a Type B RMAT meeting with the FDA regarding OPGx-LCA5. The meeting provided constructive feedback from the FDA on key elements of the Company’s registration strategy, including Chemistry, Manufacturing and Controls (CMC), and the pivotal t…
In July 2026, we announced alignment with the FDA in a Type B RDEP meeting on the design of our registrational Phase 3 clinical trial evaluating OPGx-LCA5 in eight participants with a six-month run-in period, allowing each participant to serve as their own control, prior to receiving treatment in bo…
In August 2026, enrollment in the trial was completed, with dosing of OPGx-LCA5 expected to begin in the fourth quarter of 2026 using clinical drug supply manufactured with the intended commercial processes.
The study’s primary efficacy endpoint is a mean improvement of at least seven decibels (dB) in retinal sensitivity across 16 test loci, a clinically meaningful measure of visual function. The study is designed with greater than 90% statistical power to detect a treatment effect of at least seven dB.
相对上期删除的文字 · 来源:10-Q · 2026-05-12
OPGx-LCA5 is currently being evaluated in an open-label, adaptive Phase 1/2/3 clinical trial. To date, six late-stage participants have been treated with OPGx-LCA5, all of whom have experienced improvements in vision, providing evidence of biological activity with the potential for functional restor…
In September 2025, we reported positive data from the six participants. The three pediatric participants treated over three months demonstrated large gains in cone-mediated vision with improvements across multiple measures of visual function. In the three adult participants, responses have been obse…
In November 2025, we announced the successful completion of a Type B RMAT meeting with the FDA regarding OPGx-LCA5. The meeting provided constructive feedback from the FDA on key elements of the Company’s registration strategy, including Chemistry, Manufacturing and Controls (“CMC”), and the pivotal…
We will incorporate the FDA’s feedback into our clinical development and CMC plans for the Phase 3 portion of the study to include enrolling as few as 8 participants in a single arm, 12-month study utilizing an adaptive design, which provides flexibility on endpoints and number of participants, refl…
We expect the Phase 3 portion of the trial will include a run-in period prior to dosing to evaluate the natural history of each participant to serve as their own control in the study. We are actively identifying patients for this segment and have enrolled multiple participants for ongoing disease mo…
控制与程序
相对上期新增的文字 · 来源:10-Q · 2026-08-06
that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. The design of any system of controls is based, in part, upon …
Under the supervision of and with the participation of our management, including our principal executive officer and principal financial officer, we evaluated the effectiveness of our disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15(d)- 15(e) promulgated under th…
There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) during the quarter ended June 30, 2026, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
相对上期删除的文字 · 来源:10-Q · 2026-05-12
Under the supervision of and with the participation of our management, including our principal executive officer and principal financial officer, we evaluated the effectiveness of our disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15(d)- 15(e) promulgated under th…
There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) during the quarter ended March 31, 2026, that have materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.
其他信息
相对上期新增的文字 · 来源:10-Q · 2026-08-06
On April 30, 2026, Rob Gagnon, the Company’s Chief Financial Officer, adopted a Rule 10b5‑1 trading plan (as defined in Rule 10b5‑1(c) under the Securities Exchange Act of 1934) providing for the potential sale of up to 536,589 shares of the Company’s common stock. Pursuant to the trading plan, sale…
On May 1, 2026, Dr. Sally Tucker, the Company’s Chief Medical Officer, adopted a Rule 10b5‑1 trading plan (as defined in Rule 10b5‑1(c) under the Securities Exchange Act of 1934) providing for the potential sale of up to 232,869 shares of the Company’s common stock. Pursuant to the trading plan, sal…
如何读 10-Q 的风险因素(第 1A 项)
10-Q 的风险因素章节有三种常见形态,本页按其一分类展示:
- 指向(pointer) — 公司仅声明"无重大变化"并指向年度 10-K 的完整风险因素;本季没有自己的风险文本可对比。
- 部分更新(partial) — 公司写明"除下述外无重大变化",只更新部分风险;摘录展示的正是本季新增的内容。
- 全文重述(restated) — 本季重新给出完整风险因素。若上一季只是"指向",则无法逐段对比,本页会将其标为"本季全文重述"。
这只是对文件结构的客观描述,不构成对风险高低的判断。
数据来自 SEC EDGAR 两份申报文件的文本级对比 · 确定性计算(无 AI 生成内容)· 仅供参考 · 非投资建议