Opus Genetics Files 8-K with Regulatory Updates

Ticker: IRD · Form: 8-K · Filed: Sep 30, 2025 · CIK: 1228627

Sentiment: neutral

Topics: regulatory-disclosure, corporate-events, financial-reporting

TL;DR

Opus Genetics filed an 8-K on 9/30/25 covering Reg FD, other events, and financials.

AI Summary

Opus Genetics, Inc. filed an 8-K on September 30, 2025, reporting on events that occurred on the same date. The filing includes information related to Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits. The company, formerly known as Ocuphire Pharma, Inc., Rexahn Pharmaceuticals, Inc., and Corporate Road Show Dot Com Inc., is incorporated in Delaware and headquartered in Durham, NC.

Why It Matters

This 8-K filing provides crucial updates on Opus Genetics' regulatory compliance and financial reporting, which are important for investors to monitor the company's status.

Risk Assessment

Risk Level: low — This filing is a routine disclosure of corporate events and financial information, not indicating any immediate operational or financial distress.

Key Players & Entities

FAQ

What specific events are disclosed under 'Other Events' in this 8-K filing?

The filing indicates 'Other Events' are reported, but the specific details of these events are not provided in the excerpt.

What is the primary business sector for Opus Genetics, Inc.?

Opus Genetics, Inc. is in the 'PHARMACEUTICAL PREPARATIONS' sector, with SIC code 2834.

When did Opus Genetics, Inc. change its name from Ocuphire Pharma, Inc.?

The filing states the date of name change from Ocuphire Pharma, Inc. was November 9, 2020.

What is the principal executive office address for Opus Genetics, Inc.?

The principal executive offices are located at 8 Davis Drive, Suite 220, Durham, NC 27713.

What is the SEC file number for Opus Genetics, Inc.?

The SEC file number for Opus Genetics, Inc. is 001-34079.

Filing Stats: 1,115 words · 4 min read · ~4 pages · Grade level 11.4 · Accepted 2025-09-30 07:24:16

Key Financial Figures

Filing Documents

01

Item 7.01 Regulation FD Disclosure. On September 30, 2025, Opus Genetics, Inc., a Delaware corporation (the " Company "), issued a press release announcing three-month data from the pediatric cohort and 18-month data from the adult cohort of its ongoing Phase 1/2 clinical trial (the " OPGx-LCA5-1001 Trial ") evaluating OPGx-LCA5, an investigational gene augmentation therapy for Leber congenital amaurosis type 5 (" OPGx-LCA5 "). A copy of the press release is furnished herewith as Exhibit 99.1. In connection with the foregoing, the Company announced that it would be discussing the OPGx-LCA5-1001 Trial, among other things, on a webcast and conference call on September 30, 2025. A presentation prepared for the purposes of the webcast and conference call is furnished herewith as Exhibit 99.2. The Company has also made the presentation available to investors on the "Events" section of the Company's website at https://ir.opusgtx.com. The information in this Item 7.01 of this Current Report on Form 8-K, and Exhibits 99.1 and 99.2, are furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the " Exchange Act "), nor shall each be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such a filing. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibits 99.1 and 99.2.

01

Item 8.01 Other Events. The Company reported positive data from the OPGx-LCA5-1001 Trial evaluating OPGx-LCA5. OPGx-LCA5 has been well tolerated in all six participants treated to date (three adults and three pediatric participants), with no ocular serious adverse events or dose-limiting toxicities observed. All ocular adverse events were mild in severity and anticipated, with no events related to the study drug. One pediatric participant had a pre-existing cataract that worsened at three months, attributed to the surgical procedure, which did not obscure improvements in retinal sensitivity. Three pediatric participants with severe baseline vision impairment received a single subretinal injection of OPGx-LCA5. All three pediatric participants provided evidence of improvements across multiple measures of visual function, including a group average of a 0.3 logMAR improvement in visual acuity and a >1 log unit improvement in cone sensitivity to both red and blue light on full-field stimulus testing, with additional evidence of functional benefit on mobility testing and microperimetry. Additionally, the combined adult data from the three adult participants supports that improvements in visual acuity were sustained through 18 months. The Company expects to meet with the U.S. Food and Drug Administration in the fourth quarter of 2025 to discuss the OPGx-LCA5-1001 Trial results and next steps for the program.

Forward Looking Statements

Forward Looking Statements This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are that could cause or contribute to such differences include, but are not limited to, those described under the heading "Risk Factors" included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, in Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025 and June 30, 2025, and in the Company's other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "aim," "may," "ongoing," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The Company undertakes no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise.

Financial Statements and Exhibits

Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release, dated September 30, 2025. 99.2 Presentation, dated September 30, 2025. 104.1 Cover Page Interactive Data File (embedded within Inline XBRL document). SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. OPUS GENETICS, INC. Date: September 30, 2025 By: /s/ Dr. George Magrath Name: Dr. George Magrath Title: Chief Executive Officer

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