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Opus Genetics, Inc. furnished a current report to share a new corporate update with investors. The company submitted an 8-K that includes a press release titled “Opus Genetics Highlights 2025 Progress and Upcoming 2026 Catalysts,” indicating it has summarized recent achievements from 2025 and outlined important expected milestones for 2026. The information is provided under a disclosure item that is treated as “furnished” rather than “filed,” meaning it is not automatically subject to certain Exchange Act liabilities or incorporated into other securities law filings unless specifically referenced.
Opus Genetics (IRD) filed its Q3 2025 10‑Q, reporting license and collaboration revenue of $3.079 million and a net loss of $17.454 million (basic and diluted loss per share $0.25). For the first nine months of 2025, revenue was $10.331 million with a net loss of $33.068 million.
Cash and cash equivalents were $30.815 million with total assets of $36.122 million. Warrant liabilities stood at $21.325 million, reflecting the March 2025 financings. Stockholders’ equity was $5.967 million. The company stated its cash is expected to fund operations for at least the next 12 months from the financial statement issuance date.
During 2025, Opus raised capital via an underwritten offering and private placement in March, an ATM program, and a related‑party funding agreement for the MERTK program. The Series A preferred stock converted into 14,145,374 common shares on May 5, 2025. Common shares outstanding were 64,544,096 at September 30, 2025, and 68,964,208 as of November 10, 2025.
Opus Genetics, Inc. reported that it has released its financial results for the third quarter ended September 30, 2025, and has shared these details through a press release.
The company furnished this press release as Exhibit 99.1 to a current report, allowing investors to review the full quarterly results and commentary there. The information in this report and the exhibit is treated as furnished rather than filed under the securities laws, which affects how it is incorporated into other regulatory filings.
Opus Genetics entered a securities purchase agreement for a registered direct offering, selling 3,827,751 shares of common stock and issuing pre-funded warrants for 7,177,033 shares. Shares are priced at $2.09 and the pre-funded warrants at $2.0899 (with a $0.0001 exercise price). Gross proceeds are expected to be approximately $23.0 million, with closing expected on or about November 7, 2025, subject to customary conditions.
The company plans to use net proceeds to advance its LCA5 and BEST-1 gene therapy clinical programs and for working capital and general corporate purposes. The transaction was conducted without a placement agent or underwriter, so no underwriting discounts or commissions are being paid. The pre-funded warrants are immediately exercisable and include a beneficial ownership cap of 4.99% (or 9.99% at holder election). The securities were offered under the company’s effective Form S-3 (File No. 333-276462).
Opus Genetics (IRD) filed an 8‑K announcing a $23 million registered direct offering and the successful completion of a Type B RMAT meeting with the FDA for OPGx‑LCA5, its gene therapy for LCA5‑related blindness. The FDA provided constructive feedback on Chemistry, Manufacturing and Controls and pivotal trial design and acknowledged the significant unmet medical need, noting regulatory flexibility for rare genetic diseases.
In Phase 1/2, six late‑stage participants treated with OPGx‑LCA5 experienced clinically meaningful vision improvements. The Phase 3 portion is planned as a single‑arm, 12‑month, adaptive study enrolling as few as eight participants, with a run‑in to establish each participant’s natural history as their own control. Dosing is anticipated in the second half of 2026 after validated commercial‑process supply, with topline data expected about one year later. Including expected offering proceeds, the company projects cash resources funding operations into the second half of 2027.
Opus Genetics (IRD) launched a primary offering of 3,827,751 shares of common stock and 7,177,033 pre‑funded warrants at $2.09 and $2.0899, respectively, for gross proceeds of approximately $23.0 million, before ~$0.3 million of expenses. The pre‑funded warrants are immediately exercisable at $0.0001 per share and this prospectus also covers 7,177,033 shares issuable upon their exercise. There is no underwriter or placement agent.
The company estimates net proceeds of about $22.7 million, assuming full warrant exercise, to advance its LCA5 and BEST1 gene therapy programs and for working capital and general corporate purposes. Shares outstanding were 65,002,665 as of October 31, 2025; the company states 76,007,449 would be outstanding assuming full exercise of the pre‑funded warrants.
Recent updates note constructive FDA RMAT feedback on OPGx‑LCA5 and a planned Phase 3 design, with dosing anticipated in the second half of 2026 and topline data about a year later. Including expected proceeds, management projects cash resources funding operations into the second half of 2027.
Opus Genetics, Inc. (IRD) reported an insider transaction amendment. The Chief Executive Officer and Director filed a Form 4/A clarifying that 30,350 shares of common stock were withheld by the issuer on 11/01/2025 to satisfy tax obligations from an RSU vesting event, coded F (tax withholding). This was not an open‑market sale.
Following the transaction, the reporting person beneficially owned 1,291,654 shares directly. The amendment was filed solely to add a footnote explaining the nature of the transaction.
Opus Genetics (IRD) disclosed an insider transaction by its Chief Executive Officer and Director. On 11/01/2025, a Form 4 reports a transaction coded “F” involving 30,350 shares of common stock at $2.30 per share. After this transaction, the reporting person beneficially owned 1,291,654 shares, held directly.
Opus Genetics (IRD) reported an insider transaction on a Form 4. On 10/22/2025, a transaction in Common Stock with code F involved 23,795 shares at $1.95. After this activity, the reporting person beneficially owns 319,005 shares, held directly.
The reporting person is listed as a Director and Officer (President), and the filing was made by one reporting person.
Opus Genetics reported encouraging early results from its Phase 1/2 OPGx-LCA5-1001 trial of OPGx-LCA5, a gene therapy for Leber congenital amaurosis type 5. The treatment has been well tolerated in all six participants (three adults and three pediatric), with no ocular serious adverse events or dose-limiting toxicities and only mild, expected eye-related side effects not attributed to the study drug.
All three pediatric participants with severe baseline vision impairment showed improvements across several vision measures after a single subretinal injection, including an average 0.3 logMAR gain in visual acuity and more than a 1 log unit increase in cone sensitivity to red and blue light, alongside mobility and microperimetry benefits. In adults, improvements in visual acuity were sustained through 18 months. The company plans to meet with the U.S. Food and Drug Administration in the fourth quarter of 2025 to discuss these results and potential next steps for the program.