Opus Genetics Announces Financial Results for Third Quarter 2026 and Provides Corporate Update

FDA approval for adult presbyopia triggered a Viatris milestone payment, while quarterly research and development spending increased.

Rhea-AI Summary

Opus Genetics (IRD) reported a third-quarter 2026 net loss of $46.495 million while advancing its inherited retinal disease programs. Revenue fell to $1.137 million from $3.079 million a year earlier; net loss widened from $17.454 million. Cash was $88.974 million at September 30, 2026. The company expects funding into 2029, including potential future Oberland funding.

OPGx-BEST1 completed high-dose Cohort 2 dosing in 11 participants, with data expected in Q1 2027. The OPGx-LCA5 registrational Phase 3 trial fully enrolled eight participants. Following FDA clearance of its application to begin human testing, OPGx-RDH12 is also advancing; Opus expects dosing in both programs in Q4 2026. FDA approval of RYZUMVI for adult presbyopia triggered a milestone payment from Viatris. BEST1 low-dose results showed visual-function improvements in all five participants, with no serious adverse events or dose-limiting toxicities.

15 points · 0 major

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2 major · 15 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointBEST1 potential pivotal endpoint gained FDA alignment: ≥3 dB microperimetry improvement in ≥5 prespecified loci, alongside patient-reported outcomes.
• Moderate point. Forward-looking: it has not happened yet and may not happen.OPGx-LCA5 Phase 3 fully enrolled eight participants; dosing is expected to begin in Q4 2026.
• Moderate pointCash and cash equivalents rose to $88.974 million at September 30, 2026, from $45.091 million at December 31, 2025.
• Minor pointRYZUMVI approval for adult presbyopia triggered a regulatory milestone payment from commercial partner Viatris.
• Minor pointOPGx-BEST1 Cohort 1 showed clinically meaningful visual-function improvement in all five participants at reported 3- and 6-month assessments.

10 minor points

• Minor pointBEST1 retinal sensitivity improved in 75% of evaluable participants (3/4); four of five showed structural improvements.
• Minor pointBEST1 Cohort 1 safety showed no serious adverse events or dose-limiting toxicities.
• Minor point. Forward-looking: it has not happened yet and may not happen.BEST1 high-dose Cohort 2 completed enrollment and dosing of 11 participants; topline data are expected in Q1 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.BEST1 potential pivotal Phase 3 dosing is anticipated to begin in the second half of 2027.
• Minor pointLCA5 Phase 1/2 data showed sustained adult visual-acuity and light-sensitivity improvements through 24 months.
• Minor pointLCA5 pediatric results through six months were characterized by Opus as encouraging.
• Minor point. Forward-looking: it has not happened yet and may not happen.OPGx-RDH12 received FDA clearance to enter human testing; Phase 1/2 dosing is expected in Q4 2026.
• Minor pointOther income, net rose to $1.362 million in Q3 2026 from $0.382 million a year earlier.
• Minor pointNine-month other income, net rose to $3.876 million in 2026 from $1.218 million in 2025.
• Minor pointNine-month financing costs fell to $1.113 million in 2026 from $1.337 million in 2025.

Negative

• Major pointNine-month net loss widened to $120.128 million, or $1.27 per share, from $33.068 million, or $0.59.
• Major pointCommon shares outstanding increased to 95,799,574 at September 30, 2026, from 69,894,507 at December 31, 2025.
• Moderate pointQ3 net loss widened to $46.495 million, or $0.46 per share, from $17.454 million, or $0.25.
• Moderate pointQ3 operating loss widened to $19.247 million from $8.311 million a year earlier.
• Moderate pointNine-month operating loss widened to $50.091 million in 2026 from $27.146 million in 2025.
• Moderate pointLong-term debt reached $34.530 million at September 30, 2026, versus none at December 31, 2025.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Expected runway into 2029 includes potential future funding under the Oberland Capital Management note purchase agreement.

8 minor points

• Minor pointQ3 revenue declined to $1.137 million in 2026 from $3.079 million in 2025.
• Minor pointQ3 research and development expense increased to $14.494 million from $6.409 million a year earlier.
• Minor pointQ3 general and administrative expense increased to $5.890 million from $4.981 million a year earlier.
• Minor pointQ3 fair-value expense increased to $28.610 million from $9.525 million a year earlier.
• Minor pointNine-month revenue declined to $4.049 million in 2026 from $10.331 million in 2025.
• Minor pointNine-month research and development expense increased to $36.278 million in 2026 from $20.384 million in 2025.
• Minor pointNine-month general and administrative expense increased to $17.862 million in 2026 from $17.093 million in 2025.
• Minor pointNine-month fair-value expense increased to $72.800 million in 2026 from $5.803 million in 2025.

News Explained

At September 30, 2026, Opus reported $34,530 thousand of long-term debt, versus none at December 31, 2025.

Opus Genetics reported its completed third-quarter results with 95,799,574 common shares outstanding at September 30, 2026, versus 69,894,507 at December 31, 2025; for a holder whose share count did not change, the larger share count means a smaller ownership percentage.

Key Figures

Cash and equivalents: $89.0 million Cash runway: Into 2029 License and collaborations revenue: $1.1 million vs. $3.1 million +5 more

Cash and equivalents

$89.0 million

As of September 30, 2026

Cash runway

Into 2029

Company expectation based on current cash and potential future note funding

License and collaborations revenue

$1.1 million vs. $3.1 million

Third quarter 2026 vs. third quarter 2025

Net loss

$46.5 million vs. $17.5 million

Third quarter 2026 vs. third quarter 2025

BEST1 Cohort 1 participants with clinically meaningful improvement

5 participants

Phase 1/2 BIRD-1 trial

Retinal sensitivity improvement by microperimetry

75% (3 of 4 evaluable participants)

OPGx-BEST1 Cohort 1

Cohort 2 participants dosed

11 participants

OPGx-BEST1 high-dose Cohort 2

LCA5 Phase 3 participants enrolled

8 participants

Registrational Phase 3 trial

Previous Earnings Reports

1 past event · Latest: Nov 12

Same Type 1 event

1. Nov 12

   Q3 earnings

   24h Move

   -2.5%

   Prior-year Q3 revenue and net loss provide the comparison baseline cited in this release.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

dose-limiting toxicities, microperimetry, patient-reported outcome, investigational new drug, +1 more

5 terms

dose-limiting toxicities medical

"no serious adverse events or dose-limiting toxicities"

Dose-limiting toxicities are the harmful side effects seen in early clinical trials that are severe enough to stop researchers from raising a drug’s dose. Like a car’s speed limiter marking the safe top speed, DLTs define the maximum tolerable dose, and they matter to investors because they determine whether a medicine can reach effective levels, influence development timelines, costs, and regulatory chances, and thus affect a drug’s commercial prospects.

microperimetry medical

"retinal sensitivity improvement by microperimetry in 75% of evaluable participants"

Microperimetry is a clinical eye test that maps how well specific spots on the retina detect light while tracking their exact location on an image of the back of the eye. For investors, it matters because it provides precise, location-specific evidence of vision improvement or decline in drug and device trials, affecting regulatory decisions, market potential and reimbursement—think of it as a high-resolution measuring stick for retinal function.

patient-reported outcome medical

"in conjunction with a patient-reported outcome"

Patient-reported outcome is information gathered directly from patients about their symptoms, quality of life, or ability to perform everyday activities, without interpretation by clinicians. Investors care because these measures can determine whether a treatment wins regulatory approval, gains reimbursement, and attracts customers — similar to how product reviews influence buyer demand and a company’s sales prospects.

investigational new drug regulatory

"Received FDA clearance of the Investigational New Drug (IND) application"

An investigational new drug is a medication that is still being tested in clinical trials to determine if it is safe and effective for treating a specific condition. For investors, it represents a potential breakthrough that could lead to a new treatment and significant financial gains if successful, but also carries risks since it has not yet been approved for widespread use.

supplemental new drug application regulatory

"Received FDA approval of the supplemental New Drug Application (sNDA)"

A supplemental new drug application is a request submitted to regulatory authorities to make changes to an existing approved medication, such as adding new uses, strengths, or formulations. For investors, it signals that a pharmaceutical company is seeking approval for new product developments or expanded applications, which can impact the company's future sales, market potential, and stock value.

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OPGx-BEST1 Cohort 2 Dosing Complete and Data Expected in Q1 2027

OPGx-LCA5 Registrational Phase 3 Trial Fully Enrolled with Initiation of Dosing Expected in Q4 2026

FDA Clearance of IND for OPGx-RDH12, with Phase 1/2 Trial Dosing Planned for Q4 2026

FDA Approval of Phentolamine Ophthalmic Solution 0.75% for Presbyopia Triggers Milestone Payment

Cash Runway into 2029 Expected to Support Multiple Clinical Inflection Points and Opportunities for Priority Review Vouchers

RESEARCH TRIANGLE PARK, N.C., Nov. 10, 2026 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2026, and provided a corporate update.

“The last several months have marked a period of tremendous advancement for our leading gene therapy programs,” said George Magrath, M.D., Chief Executive Officer of Opus Genetics. “Positive Cohort 1 data from our Phase 1/2 trial of OPGx-BEST1 provide important evidence of its potential to improve both visual function and retinal structure in patients with BEST1-related retinal disease. With U.S. Food & Drug Administration (FDA) alignment on a potential pivotal endpoint and Cohort 2 over-enrolled with 11 participants, we expect to have data in Q1 2027, followed by dosing in a potential pivotal Phase 3 trial anticipated to begin in the second half of 2027. For OPGx-LCA5, we have fully enrolled our registrational Phase 3 trial and expect to begin dosing participants this quarter. We are also advancing our third gene therapy program into the clinic following IND clearance for OPGx-RDH12.”

“The FDA approval of phentolamine ophthalmic solution 0.75% for presbyopia marks the second FDA-approved indication for RYZUMVI®, demonstrating the capabilities of our clinical and regulatory teams. With our cash runway into 2029, we remain focused on bringing potentially transformative gene therapies to patients with rare inherited retinal diseases,” concluded Dr. Magrath.

Pipeline Updates

OPGx-BEST1

• Announced positive 3- and 6-month results from the low-dose Cohort 1 of the Phase 1/2 BIRD-1 trial, with a favorable safety profile and no serious adverse events or dose-limiting toxicities.
• All five participants demonstrated clinically meaningful improvement in visual function, including retinal sensitivity improvement by microperimetry in 75% of evaluable participants (3/4), and four of five showed structural improvements.
• Aligned with the FDA on a potential pivotal endpoint of ≥3 dB microperimetry improvement in ≥5 prespecified loci, in conjunction with a patient-reported outcome.
• Completed enrollment and dosing of 11 participants in the high-dose Cohort 2, with topline data, including 3-month data from Cohort 2 and 6-month data for the three Cohort 1 participants with Best vitelliform macular dystrophy, expected in Q1 2027.

OPGx-LCA5

• The registrational Phase 3 trial is fully enrolled with 8 participants, and initiation of dosing is expected in Q4 2026.
• Phase 1/2 data presented at Retina in Rio 2026 showed sustained improvements in visual acuity and light sensitivity in adults through 24 months and encouraging results in pediatric participants through six months.

OPGx-RDH12

• Received FDA clearance of the Investigational New Drug (IND) application for OPGx-RDH12 for RDH12-associated Leber congenital amaurosis (RDH12-LCA), with initiation of dosing in a Phase 1/2 trial expected in Q4 2026.
  

Phentolamine Ophthalmic Solution 0.75%

• Received FDA approval of the supplemental New Drug Application (sNDA) for phentolamine ophthalmic solution 0.75% (RYZUMVI^®) for the treatment of presbyopia in adults, triggering a regulatory milestone payment to Opus Genetics from commercial partner, Viatris Inc.
  

Recent Medical Presentations

Opus Genetics delivered numerous data presentations at prominent medical meetings, including the Euretina Innovation Spotlight, Euretina 2026, and Retina in Rio 2026, where OPGx-BEST1 Cohort 1 data and OPGx-LCA5 Phase 1/2 data were presented. All materials can be found on the Publications & Presentations page of the Company website.

Management Team

Opus Genetics recently added Andrew Murphy, Ph.D., as Chief Scientific Officer, and Jamie Lynne Hart, M.S., M.P.H., as Executive Director, Executive Operations, strengthening its scientific and operational leadership.

Financial Results for the Third Quarter Ended September 30, 2026

Cash Position: As of September 30, 2026, Opus Genetics had cash and cash equivalents of $89.0 million. With the current cash and cash equivalents, and potential future funding under the note purchase agreement with Oberland Capital Management, the Company believes its aggregate cash resources will fund operations into 2029.

Revenue: License and collaborations revenue totaled $1.1 million for the quarter ended September 30, 2026, compared to $3.1 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 $14.5 million for the quarter ended September 30, 2026, compared to $6.4 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 $0.6 million and $0.2 million in stock-based compensation expense for the three months ended September 30, 2026 and 2025, respectively.

General and Administrative (G&A) Expenses: G&A expenses were $5.9 million for the quarter ended September 30, 2026, compared to $5.0 million for the same period in 2025. The increase was primarily attributable to higher employee compensation costs on a period-over-period basis. General and administrative expenses included $1.0 million and $0.6 million in stock-based compensation expense for the three months ended September 30, 2026 and 2025, respectively.

Net Loss: Net loss for the quarter ended September 30, 2026 was $46.5 million, or ($0.46) per basic and diluted share, compared to a net loss of $17.5 million, or ($0.25) per basic and diluted share, for the same period in 2025. The increase in net loss was primarily due to higher expense period over period of $19.1 million from the fair value change in instruments measured at fair value, increased R&D expense period over period of $8.1 million, and lower license and collaborations revenue of $2.0 million period over period.

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 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 OPGx-RDH12 cleared to enter the clinic, and additional candidates targeting 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. 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. Such statements include, but are not limited to, statements related to the Company’s continued clinical development, clinical results, preclinical data, and future plans for its product candidates, including the anticipated timing of initiation of clinical trials, dosing completion, data results;  the Company’s development strategy for its product candidates;  the outcome of the Company’s ongoing regulatory interactions with the FDA and its expectations regarding the design of, and potential endpoints for, its planned clinical trials of its product candidates; the therapeutic potential of the Company’s product candidates; the Company’s expectations regarding its cash runway, future financing availability and potential future funding under the Oberland facility, and the anticipated sufficiency of the Company’s cash runway to enable it to achieve multiple clinical inflection points and opportunities for priority review vouchers; and the Company’s expectations regarding its business prospects and results of operations. The forward-looking statements contained herein are subject to certain risks and uncertainties posed by many factors and events that could cause the Company’s 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 the Company’s most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2025, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, 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 statements, which speak only as of the date of this press release. These forward-looking statements are based upon the Company’s 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. The Company undertakes 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
	September 30, 2026				December 31, 2025
Assets	(Unaudited)
Current assets:
Cash and cash equivalents	$	88,974			$	45,091
Accounts receivable		1,005				1,995
Contract assets and unbilled receivables		628				1,170
Prepaids and other current assets		4,249				1,788
Total current assets		94,856				50,044
Property and equipment, net		339				199
Restricted cash		100				—
Total assets	$	95,295			$	50,243
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	3,727			$	3,293
Accrued expenses		6,105				4,488
Total current liabilities		9,832				7,781
Long-term debt		34,530				—
Warrant liabilities		11,151				25,985
Funding agreement, related party		1,351				1,129
Total liabilities		56,864				34,895
Commitments and contingencies
Stockholders’ equity:
Preferred stock, par value $0.0001; 10,000,000 shares authorized as of September 30, 2026 and December 31, 2025; no shares issued and outstanding at September 30, 2026 and December 31, 2025.		—				—
Common stock, par value $0.0001; 250,000,000 and 125,000,000 shares authorized as of September 30, 2026 and December 31, 2025, respectively; 95,799,574 and 69,894,507 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively.		10				7
Additional paid-in capital		346,032				203,930
Accumulated other comprehensive income		1,106				—
Accumulated deficit		(308,717	)			(188,589	)
Total stockholders’ equity		38,431				15,348
Total liabilities and stockholders’ equity	$	95,295			$	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 September 30,								For the Nine Months Ended September 30,
		2026				2025				2026				2025
License and collaborations revenue	$	1,137			$	3,079			$	4,049			$	10,331
Operating expenses:
Research and development		14,494				6,409				36,278				20,384
General and administrative		5,890				4,981				17,862				17,093
Total operating expenses		20,384				11,390				54,140				37,477
Loss from operations		(19,247	)			(8,311	)			(50,091	)			(27,146	)
Fair value change in instruments measured at fair value		(28,610	)			(9,525	)			(72,800	)			(5,803	)
Financing costs		—				—				(1,113	)			(1,337	)
Other income, net		1,362				382				3,876				1,218
Loss before income taxes		(46,495	)			(17,454	)			(120,128	)			(33,068	)
Benefit (provision) for income taxes		—				—				—				—
Net loss		(46,495	)			(17,454	)			(120,128	)			(33,068	)
Change in fair value of the Notes attributable to instrument specific credit risk		1,106				—				1,106				—
Comprehensive loss	$	(45,389	)		$	(17,454	)		$	(119,022	)		$	(33,068	)
Net loss per share:
Basic and diluted	$	(0.46	)		$	(0.25	)		$	(1.27	)		$	(0.59	)
Number of shares used in per share calculations:
Basic and diluted		101,841,608				70,636,887				94,793,509				56,100,689

Source: Opus Genetics, Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were Opus Genetics’ third-quarter 2026 financial results?

Opus Genetics reported $1.137 million in revenue and a $46.495 million net loss, or $0.46 per basic and diluted share. In the same quarter of 2025, revenue was $3.079 million and net loss was $17.454 million, or $0.25 per basic and diluted share.

When does Opus Genetics expect its next BEST1 trial results?

Opus expects Q1 2027 topline data covering 3-month results from high-dose Cohort 2 and 6-month results for the three Cohort 1 participants with Best vitelliform macular dystrophy. Enrollment and dosing of all 11 Cohort 2 participants are complete.

What potential pivotal endpoint has Opus Genetics aligned with the FDA on for BEST1?

The potential pivotal endpoint is ≥3 dB improvement in microperimetry at ≥5 prespecified loci, together with a patient-reported outcome. Microperimetry measures retinal light sensitivity at selected locations. Opus anticipates dosing in a potential pivotal Phase 3 trial beginning in the second half of 2027.