Form 8-K

8-K — Opus Genetics, Inc.

Accession: 0001628280-26-053824

Filed: 2026-08-06

Period: 2026-08-06

CIK: 0001228627

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ird-20260806.htm (Primary)

EX-99.1 (ird-202686xex991.htm)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K

8-K (Primary)

Filename: ird-20260806.htm · Sequence: 1

ird-20260806

0001228627FALSE00012286272026-08-062026-08-06

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 6, 2026

Opus Genetics, Inc.

(Exact name of registrant as specified in its charter)

Delaware 001-34079 11-3516358

(State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.)

8 Davis Drive

Durham, NC

27713

(Address of principal executive offices) (Zip Code)

(984) 884-6030

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading Symbol(s) Name of each exchange on which registered

Common Stock, $0.0001 par value per share IRD The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 2.02 Results of Operations and Financial Condition.

On August 6, 2026, Opus Genetics, Inc., a Delaware corporation (the “Company”), issued a press release announcing its financial results for the second quarter ended June 30, 2026. A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.

The information in this Item 2.02 of this Current Report on Form 8-K, and Exhibit 99.1, is 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 it 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.

Item 9.01 Financial Statements and Exhibits.

(d)Exhibits

Exhibit No. Description

99.1

Press Release, dated August 6, 2026.

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.

Dated: August 6, 2026

OPUS GENETICS, INC.

By: /s/ Dr. George Magrath

Name: Dr. George Magrath

Title: Chief Executive Officer

EX-99.1

Filename: ird-202686xex991.htm · Sequence: 2

Document

Exhibit 99.1

Opus Genetics Announces Financial Results for

Second Quarter 2026 and Provides Corporate Update

OPGx-BEST1 Cohort 1 Topline Data Expected in Second Week of September 2026

Enrollment Completed in LCA5 Registrational Trial with Dosing Planned for Q4 2026

RDH12, MERTK and RHO Programs Advancing with Upcoming Initiation of Clinical Testing

Cash Runway into 2029 Expected to Support Multiple Clinical Inflection Points

and Opportunities for Priority Review Vouchers

RESEARCH TRIANGLE PARK, N.C. – August 6, 2026 - Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced financial results for the second quarter ended June 30, 2026, and provided a corporate update.

“With a focus on execution, we are rapidly advancing five gene therapy programs that address significant unmet need in inherited retinal diseases, with OPGx-BEST1 Cohort 1 clinical data targeted for the second week of September and four additional clinical readouts expected in 2027,” said George Magrath, M.D., Chief Executive Officer of Opus Genetics. “Based on recent FDA interactions, we finalized the OPGx-LCA5 registrational trial design. We have completed enrollment and expect to initiate participant dosing in the fourth quarter of this year. Our recent R&D Science Forum highlighted the significant progress we have made in advancing our pipeline. Our strong cash runway into 2029 positions us to initiate new clinical studies, deliver multiple data inflection points, pursue potential product approvals, and unlock opportunities for Priority Review Vouchers.”

Pipeline Updates

OPGx-BEST1

•Enrollment was completed in Cohort 1 of the Phase 1/2 trial (BIRD-1), with 3-month topline data from Cohort 1 expected during the second week of September 2026, assuming all participants complete their assessments as scheduled.

•Baseline demographics were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting with the related poster presentation available on the Publications & Presentations page of the Opus Genetics website. Additionally, a slide presentation and video summary recording titled “OPGx-BEST1 Cohort 1 Baseline Demographics and Key Endpoints for IRDs” are provided on the OPGx-BEST1 Program section of the Opus Genetics website.

OPGx-LCA5

•Alignment was achieved with the U.S. Food and Drug Administration (FDA) on the 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 both eyes.

•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. Topline data from the study is expected by the end of 2027.

OPGx-RDH12

•The OPGx-RDH12 program is expected to enter the clinic in the fourth quarter of 2026 and is partially funded through a partnership with the RDH12 Alliance.

OPGx-MERTK

•The OPGx-MERTK program is expected to initiate clinical testing at the Cleveland Clinic Abu Dhabi in the first quarter of 2027.

OPGx-RHO

•Preclinical data presented at ARVO 2026 and the Foundation Fighting Blindness Retinal Therapeutics Innovation Summit 2026 provided safety and efficacy data on the use of OPGx-RHO in two large animal models of autosomal-dominant retinitis pigmentosa (adRP).

•The OPGx-RHO program is expected to initiate clinical testing globally in the second half of 2027.

Recent Medical Presentations

Opus Genetics delivered numerous data presentations at prominent medical meetings during the period including at the Association for Research in Vision and Ophthalmology (ARVO), Retina World Congress, and the American Society of Gene & Cell Therapy. In addition, in July 2026, Human Gene Therapy published “Evaluation of the Toxicity and Efficacy of an Adeno‑Associated Viral Vector Expressing BEST1 Delivered by Subretinal Injection in a Canine Model of Human Bestrophinopathy”. All materials can be found on the Publications & Presentations page of the Company website.

Financial Results for the Second Quarter Ended June 30, 2026

Cash Position: As of June 30, 2026, Opus Genetics had cash and cash equivalents of $88.8 million. With the current cash and cash equivalents, and potential future fundings under the note purchase agreement with Oberland Capital Management, the Company believes its aggregate cash resources will fund operations into 2029. This estimate excludes any potential proceeds from callable warrants or future milestone payments.

Revenue: License and collaborations revenue totaled $0.8 million for the quarter ended June 30, 2026, compared to $2.9 million for the same period in 2025. Revenue in both periods came primarily from reimbursement of research and development (R&D) services based on the Company’s collaboration with Viatris, Inc.

Research and Development (R&D) Expenses: R&D expenses were $11.2 million for the quarter ended June 30, 2026, compared to $6.0 million for the same period in 2025. The increase was primarily attributable to higher manufacturing and clinical costs associated with the Company's IRD programs, partially offset by lower clinical costs associated with the Phentolamine Ophthalmic Solution 0.75% programs. Research and development expenses included $0.4 million and $0.3 million in stock-based compensation expense for the three months ended June 30, 2026 and 2025, respectively.

General and Administrative (G&A) Expenses: G&A expenses were $6.0 million for the quarter ended June 30, 2026, compared to $5.8 million for the same period in 2025. The increase was primarily attributable to higher employee compensation costs, partially offset by lower public company related costs. General and administrative expenses included $1.0 million and $0.6 million in stock-based compensation expense during the three months ended June 30, 2026 and 2025, respectively.

Net Loss: Net loss for the quarter ended June 30, 2026 was $8.1 million, or ($0.08) per basic and ($0.14) per diluted share, compared to a net loss of $7.4 million, or ($0.12) per basic and diluted share, for the same period in 2025. The increase in net loss was primarily due to higher R&D expense, lower license and collaborations revenue, and higher financing costs period over period. These changes were partially offset by higher income period over period of $6.3 million from the fair value change in instruments measured at fair value.

About Opus Genetics

Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs). The Company is developing durable, one-time treatments designed to address the underlying genetic causes of severe retinal disorders. The Company’s pipeline includes seven AAV-based programs, led by OPGx-LCA5 for LCA5-related mutations and OPGx-BEST1 for BEST1-related retinal degeneration, with additional candidates targeting RDH12, MERTK, RHO, CNGB1 and NMNAT1. The Company is based in Research Triangle Park, NC. For more information, visit www.opusgtx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements related to cash runway and future financing availability, potential future funding under the Oberland facility, potential product approvals, and Priority Review Voucher opportunities, the clinical development, clinical results, preclinical data and future plans for Phentolamine Ophthalmic

Solution 0.75%, OPGx-LCA5, OPGx-BEST1, OPGx-MERTK, OPGx-RDH12, OPGx-RHO and earlier stage programs, and expectations regarding us, our business prospects and our results of operations, and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in our most recent Annual Report on Form 10-K and in our other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the 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. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise.

Contacts:

Investors

Jenny Kobin

Remy Bernarda

IR Advisory Solutions

ir@opusgtx.com

Media

Kimberly Ha

KKH Advisors

917-291-5744

kimberly.ha@kkhadvisors.com

-Financial Tables Follow-

Opus Genetics, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share amounts and par value)

As of

June 30,

2026 December 31,

2025

Assets (Unaudited)

Current assets:

Cash and cash equivalents $ 88,812 $ 45,091

Accounts receivable 1,041 1,995

Contract assets and unbilled receivables (Note 12) 415 1,170

Prepaids and other current assets 2,428 1,788

Total current assets 92,696 50,044

Property and equipment, net 172 199

Restricted cash 100 —

Total assets $ 92,968 $ 50,243

Liabilities, convertible preferred stock and stockholders’ (deficit) equity

Current liabilities:

Accounts payable $ 1,881 $ 3,293

Accrued expenses 5,724 4,488

Total current liabilities 7,605 7,781

Long-term debt 34,932 —

Warrant liabilities

62,145 25,985

Funding agreement, related party

1,272 1,129

Total liabilities 105,954 34,895

Commitments and contingencies (Note 4 and Note 11)

Stockholders’ (deficit) equity:

Preferred stock, par value $0.0001; 10,000,000 shares authorized as of June 30, 2026 and December 31, 2025; no shares issued and outstanding at June 30, 2026 and December 31, 2025. — —

Common stock, par value $0.0001; 250,000,000 and 125,000,000 shares authorized as of June 30, 2026 and December 31, 2025, respectively; 82,647,946 and 69,894,507 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively. 8 7

Additional paid-in capital 249,228 203,930

Accumulated deficit (262,222) (188,589)

Total stockholders’ (deficit) equity

(12,986) 15,348

Total liabilities, convertible preferred stock and stockholders’ (deficit) equity

$ 92,968 $ 50,243

Opus Genetics, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(in thousands, except share and per share amounts)

(Unaudited)

For the Three Months Ended

June 30, For the Six Months Ended

June 30,

2026 2025 2026 2025

License and collaborations revenue

$ 755 $ 2,882 $ 2,912 $ 7,252

Operating expenses:

Research and development 11,207 6,022 21,784 13,975

General and administrative 6,028 5,766 11,972 12,112

Total operating expenses 17,235 11,788 33,756 26,087

Loss from operations (16,480) (8,906) (30,844) (18,835)

Fair value change in instruments measured at fair value 7,174 917 (44,190) 3,722

Financing costs (531) 35 (1,113) (1,337)

Other income, net 1,739 534 2,514 836

Loss before income taxes (8,098) (7,420) (73,633) (15,614)

Benefit (provision) for income taxes — — — —

Net loss

(8,098) (7,420) (73,633) (15,614)

Other comprehensive loss, net of tax — — — —

Comprehensive loss

$ (8,098) $ (7,420) $ (73,633) $ (15,614)

Net loss per share:

Net loss per share - basic $ (0.08) $ (0.12) $ (0.81) $ (0.32)

Net loss per share - diluted

$ (0.14) $ (0.12) $ (0.81) $ (0.32)

Number of shares used in per share calculations:

Weighted average shares outstanding - basic 95,483,280 63,376,392 91,211,050 48,712,124

Weighted average shares outstanding - diluted

111,384,011 63,376,392 91,211,050 48,712,124

Source: Opus Genetics, Inc.

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