What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-06 compared with 2026-05-12 · 223 added, 133 removed, 353 unchanged (50% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion of our financial condition and results of operations should be read in conjunction with the unaudited financial statements and notes included in Part I “Financial Information”, Item I “Financial Statements” of this Quarterly Report on Form 10-Q (the “Report”) and the audited financial statements and related footnotes included in our Annual Report on Form 10-K for the year ended December 31, 2025.

The following discussion of our financial condition and results of operations should be read in conjunction with the unaudited financial statements and notes included in Part I “Financial Information”, Item I “Financial Statements” of this Quarterly Report on Form 10-Q (this “Report”) and the audited financial statements and related footnotes included in our Annual Report on Form 10-K for the year ended December 31, 2025.

Forward-Looking Statements

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Such statements include, but are not limited to, statements concerning our strategic business plans, the applications of our product candidates, ongoing discussions with the U.S.

Federal Drug Administration (the “FDA”) regarding various of our drug products, and continued drug development and commercialization under our agreement with Viatris, Inc.

Food and Drug Administration (the “FDA”) regarding various of our drug products, and continued drug development and commercialization under our agreement with Viatris, Inc.

In some cases, you can identify forward-looking statements by the following words:

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• Our gene therapy product candidates are based on a novel technology that is difficult to develop and manufacture, which may result in delays and difficulties in obtaining regulatory approval ;

• Our planned clinical trials may face substantial delays, result in failure, or provide inconclusive or adverse results that may not satisfy U.S.

Food and Drug Administration (“FDA”) requirements to further develop our therapeutic products ;

• Our planned clinical trials may face substantial delays, result in failure, or provide inconclusive or adverse results that may not satisfy FDA requirements to further develop our therapeutic products ;

• Delays or difficulties associated with patient enrollment in clinical trials may affect our ability to conduct and complete those clinical trials and obtain necessary regulatory approvals ;

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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 restoration of vision in individuals with advanced disease.

In September 2025, we reported positive data from the six participants.

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 have been observed out to 18 months, underscoring the potential durability of the treatment response.

In the three adult participants, responses were observed out to 18 months, underscoring the potential durability of the treatment response.

OPGx-LCA5 has been well tolerated with no ocular serious adverse events or dose-limiting toxicities.

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The FDA acknowledged the significant unmet medical need for individuals with LCA5-related blindness and reaffirmed its commitment to regulatory flexibility for rare genetic diseases.

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, reflective of LCA5 as a rare condition with an urgent medical need.

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 monitoring.

Following availability of validated clinical drug supply manufactured with the intended commercial processes, Phase 3 dosing with OPGx-LCA5 is anticipated in the fourth quarter of 2026 with topline clinical data expected approximately one year later.

In May 2026, OPGx-LCA5 was accepted into the FDA's RDEP program.

The FDA introduced this RDEP review process in September 2025 to provide greater speed and predictability in the review of therapies intended to treat ultra-rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect that is the major driver of the pathophy siology.

Opus Genetics, Inc.

On May 7, 2026, six-month pediatric clinical data from the ongoing OPGx-LCA5 Phase 1/2 study was reported at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

Also, in May 2026, six-month pediatric clinical data from the ongoing OPGx-LCA5 Phase 1/2 study was reported at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

The data demonstrated restoration of cone-mediated vision in pediatric LCA5 patients, with sensitivity improvements reaching normal ranges.

In June 2026, data out to 24 months in the adult participants was reported, demonstrating a maintained response in visual acuity improvement.

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 both eyes.

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.

Opus Genetics, Inc.

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.

The intent is that data from this study will be used to submit a Biologics License Application (BLA).

In addition, OPGx-LCA5 may qualify to receive a Priority Review Voucher if approved, which we believe would represent a potentially significant strategic asset.

OPGx-BEST1 is being developed for the treatment of IRDs associated with mutations in the BEST1 gene.

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In August 2025, we announced FDA clearance of an Investigational New Drug (IND) application to initiate a clinical trial.

An adaptive, open-label, dose-exploring Phase 1/2 trial, known as BIRD1, is currently recruiting participants to study the safety and tolerability of subretinally injected OPGx-BEST1 in participants with Best Vitelliform Macular Dystrophy (BVMD) or Autosomal-Recessive Bestrophinopathy (ARB).

In November 2025, we dosed our first participant in our OPGx-BEST1 Phase 1/2 clinical trial, known as BIRD-1.

The trial is an adaptive, open-label, dose-exploring, safety and tolerability study in patients with BVMD or ARB.

Treatment is administered via a single subretinal injection in one eye of each participant with two dosing cohorts.

In November 2025, we dosed our first (sentinel) participant in an adaptive, open-label, dose-exploring Phase 1/2 trial, known as BIRD-1, to evaluate the safety and efficacy of single-eye subretinal administration of OPGx-BEST1 in adult participants with Best Vitelliform Macular Dystrophy (BVMD) or Autosomal-Recessive Bestrophinopathy (ARB).

The trial is designed as a dose escalation trial to evaluate two doses of OPGx-BEST1:

1.5E9 vg/eye (Cohort 1) and 4.5E9 vg/eye (Cohort 2).

The trial will also explore biological activity through functional and anatomical endpoints, including changes in visual function and retinal structure.

In December 2025, we announced that the Independent Data Monitoring Committee (IDMC) overseeing the trial completed its pre-specified safety review of the one-month data from the sentinel participant and recommended advancing enrollment and dosing of additional participants in the trial, without modification.

Results from the first sentinel patient were presented at the Macula Society in February 2026 by the principal investigator, Dr Mark Pennesi.

In February 2026, results from the sentinel patient were presented at the Macula Society by the principal investigator, Dr Mark Pennesi.

The data demonstrated that OPGx-BEST1 was well tolerated with no ocular inflammation, no ocular or treatment-related adverse events, and no dose limiting toxicities.

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In addition, structural improvement in central subfield thickness (CST) was observed with a 23% decrease in the study eye.

Resolution of intraretinal fluid was also seen as early as 1-month in areas with less atrophy.

In May 2026, enrollment in Cohort 1 was completed.

Five participants have been enrolled in the study, three with BVMD and two with ARB.

The first four participants have been dosed, and the fifth participant is scheduled for dosing in May 2026.

We expect to announce 3-month topline data from Cohort 1 in September 2026, followed by the presentation of data at an ophthalmology medical conference later this year.

Data is expected to be provided on both structural and functional outcome measures.

We are planning to discuss with the FDA an adaptive Phase 1/2/3 trial design, similar to the design of the OPGx-LCA5 trial, and acceleration to a pivotal study if the majority of patients show a treatment-related fluid resolution on optical coherence tomography.

Resolution of intraretinal fluid was also seen as early as one month in areas with less atrophy.

In May 2026, enrollment in Cohort 1 was completed with five participants in the study, three with BVMD and two with ARB.

In the BVMD participants, we completed the added step of using an in vitro platform to confirm that each participant’s disease mutation is amenable to gene augmentation.

In July 2026, we provided a program update and timeline for BIRD-1.

In Cohort 1, the primary endpoint for evaluation is the safety and tolerability of OPGx-BEST1.

In addition to safety measures, Opus will also be assessing a number of structural and functional parameters.

We expect to announce three-month topline data from Cohort 1 during the second week of September 2026, assuming all participants complete their assessments as scheduled.

In addition, we plan to present the data at the annual EURETINA Congress taking place in Vienna, Austria in October 2026.

We also expect to present the three-month data to the FDA and meet with them as needed to align on the next steps for clinical development.

OPGx-RDH12 is being developed for retinal dystrophy caused by mutations in the RDH12 gene, which is a severe, early-onset IRD marked by visual acuity loss in early childhood and rapid progression during adolescence.

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We are advancing OPGx-RDH12 to deliver a functional RDH12 gene to photoreceptors using an AAV vector.

Preclinical studies in cellular and mouse models have demonstrated restoration of RDH12 activity and functional improvement.

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

Preclinical studies in cellular and mouse models have demonstrated restoration of RDH12 activity and functional

Opus Genetics, Inc.

This 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 is being developed for retinal degeneration caused by mutations in the MERTK gene, which plays a critical role in phagocytosis of photoreceptor outer segments by RPE cells.

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MERTK affects an estimated 2,600 patients in the U.S., 14,300 in the MENA region and 21,960 globally.

We are advancing OPGx-MERTK using a modern AAV vector design, building on prior preclinical proof of concept and earlier clinical experience, with the aim of improving durability and efficacy.

OPGx-MERTK is designed to restore critical retinal pigment epithelium metabolic functions;

therefore, we are advancing OPGx-MERTK using a modern AAV vector design, building on prior preclinical proof of concept and earlier clinical experience, with the aim of improving durability and efficacy.

In preclinical studies, OPGx-MERTK provided evidence of retinal preservation of structure/function and preserved outer nuclear layer thickness in a small animal model of retinal degeneration.

Preclinical work was funded by the Retinal Degeneration Fund (“RDF”) of the Foundation Fighting Blindness ("FFB").

This program is expected to initiate clinical testing at the Cleveland Clinic Abu Dhabi in the first quarter of 2027.

The initial clinical study is being funded through Abu Dhabi’s Healthcare Research and Innovation Fund, in collaboration with the Department of Health – Abu Dhabi (DoH), Cleveland Clinic Abu Dhabi, the Innovative Research Oversight and Support (IROS) division of the M42 group, and the Authority of Social Contribution – Ma’an.

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We are advancing OPGx-RHO to preserve rod photoreceptors by replacing the mutant RHO gene with a functional copy, addressing the underlying genetic cause of disease.

OPGx-RHO is being co-funded by the FFB and the National Institutes of Health (“NIH”) .

This program is expected to enter the clinic in 2027.

Patient prevalence estimates are from an analysis completed in February 2026 by Triangle Insights Group.

In preclinical studies, OPGx-RHO maintained rod morphology in the retinas in two large animal models.

Preclinical work was co-funded by the FFB and the National Institutes of Health .

This program is expected to initiate clinical testing globally in the second half of 2027.

Disease Prevalence

Global patient prevalence estimates are from an analysis of key markets including the United States, EU4 (France, Spain, Germany, & Italy), United Kingdom, Middle East/North Africa, and China, which was completed in February 2026 by Triangle Insights Group.

Earlier Stage Programs

Preclinical work is ongoing for other programs, including targeting genetic mutations in CNGB1 and NMNAT1.

Preclinical work is ongoing for other programs, including targeting genetic mutations in CNGB1, NMNAT1 and other undisclosed retinal diseases.

Phentolamine Ophthalmic Solution 0.75% (PS)

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For more information on the Viatris License Agreement, please refer to Note 12 – License and Collaboration Agreements and Other Funding Agreements included in Part I, Item 1– Financial Statements and Supplementary Data of this Report.

Opus Genetics, Inc.

RYZUMVI ® (phentolamine ophthalmic solution) 0.75%:

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The trial also met key secondary efficacy endpoints, reinforcing the benefit observed.

Based on positive results from both Phase 3

Opus Genetics, Inc.

studies, Viatris, the Company’s global commercialization partner for PS, filed a supplemental New Drug Application (sNDA) with the FDA in December 2025.

Based on positive results from both Phase 3 studies, Viatris, the Company’s global commercialization partner for PS, filed a supplemental New Drug Application (sNDA) with the FDA in December 2025.

In February 2026, the FDA accepted the sNDA and set a Prescription Drug User Fee Act (PDUFA) action date of October 17, 2026.

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Recent Developments

Note Purchase and Stock Purchase and Conversion Agreements

On April 2, 2026 , we entered into a strategic financing agreement with Oberland Capital Management LLC ( “ Oberland Capital ” ).

Note Purchase and Purchase and Conversion Agreements

On April 2, 2026 , we entered into a senior secured note purchase agreement (as amended from time to time, the "Note Purchase Agreement") with affiliates of Oberland Capital Management LLC (collectively, “ Oberland Capital ” ).

The proceeds of the financing may be used for general corporate purposes of the Company, which includes uses to accelerate the clinical development, manufacturing, and potential commercialization of our broad IRD gene therapy pipeline.

The new senior secured notes facility provides us with access to future non-dilutive funding of up to $155.0 million to support our future strategic initiatives and growth, with an initial tranche of $35.0 million, which was funded on April 21, 2026, the initial closing, a second $35.0 million tranche available at our option (subject to satisfaction of customary funding conditions) within the next 12 months, along with additional tranches up to $35.0 million available to us upon the occurrence of certain milestones and satisfaction of customary funding conditions.

The facility also provides for up to $50.0 million in additional tranches at the mutual agreement of the parties.

See further details in Note 14 – Subsequent Events and the Liquidity and Capital Resources section below under Historical Capital Resources .

Concurrently with the Note Purchase Agreement, we entered into a stock purchase and conversion agreement with Oberland Capital, providing for the issuance of an aggregate of 1,116,070 shares of our common stock at a price per share equal to $4.48, for an aggregate purchase price of $5.0 million.

See further details in Note 14 – Subsequent Events and the Liquidity and Capital Resources section below under Historical Capital Resources .

The Purchase and Conversion Agreement was amended on April 13, 2026, updating the expected closing of the issuance of the Purchase Shares to be on or about May 22, 2026, subject to the satisfaction of customary closing conditions.

March 2025 Warrant Exercises

At various dates subsequent to March 31, 2026, holders of the Company's March 2025 Warrants (as defined and described further below in the Liquidity and Capital Resources section under Historical Capital Resources ) exercised an aggregate of 1,750,126 warrants with an exercise price of $0.95 for cash proceeds of approximately $1.7 million.

The Note Purchase Agreement provides us with access to future non-dilutive funding of up to $155.0 million to support our future strategic initiatives and growth, with an initial tranche of $35.0 million, which was funded on April 21, 2026, the First Purchase Date, a second $35.0 million tranche available at our option (subject to satisfaction of customary funding conditions) until April 2, 2027, along with additional tranches up to $35.0 million available to us upon the occurrence of certain milestones and satisfaction of customary funding conditions.

The Note Purchase Agreement also provides for up to $50.0 million in additional tranches at the mutual agreement of the parties.

See further details in Note 7 – Debt and the Liquidity and Capital Resources section below under Historical Capital Resources .

Concurrently with the Note Purchase Agreement, we entered into a Purchase and Conversion Agreement with the Purchasers, providing for the issuance of an aggregate of 1,116,070 shares of our common stock at a price per share equal to $4.48, for an aggregate purchase price of $5.0 million.

See further details in Note 9 – Financings and the Liquidity and Capital Resources section below under Historical Capital Resources .

The Note Purchase Agreement and Purchase and Conversion Agreement were amended on April 13, 2026.

The amendment revised the Per Share Purchase Price to the lower of $4.48 per share or a 30 day volume weighted average price of the Company's common stock ending on the issuance date of the Purchase Shares, revised the Notes conversion price to the lower of $6.72 or 150% of the Per Share Purchase Price, and updated the expected issuance of the Purchase Shares to be on or about May 22, 2026, subject to the satisfaction of customary closing conditions.

February 2026 Private Placement and Conversion of Series B Preferred Stock

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At-The-Market Program

During the three months ended March 31, 2026, we sold 1,000,000 shares of common stock under the Leerink ATM program (as defined and described further below in the Liquidity and Capital Resources section under Historical Capital Resources) for gross proceeds of $2.3 million, before deducting issuance expenses.

Total issuance expenses, including sales agent fees and legal and accounting expenses, were $0.1 million for the three months ended March 31, 2026.

During the three and six months ended June 30, 2026, we sold 1,000,000 shares of common stock under the Leerink ATM program (as defined and described further below in the Liquidity and Capital Resources section under Historical Capital Resources) for gross proceeds of $2.3 million, before deducting issuance expenses.

Total issuance expenses, including sales agent fees and legal and accounting expenses, were $0.1 million for the three and six months ended June 30, 2026.

Opus Genetics, Inc.

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Until such time, if ever, as we can consistently generate substantial product revenue, we expect to finance our cash needs through a combination of equity, debt and alternative financings as well as through collaborations, strategic alliances and licensing arrangements.

Through March 31, 2026, we have funded our operations primarily through equity financings, the issuance of convertible notes in private placements, and license fee and milestone payments in connection with the Viatris License Agreement.

O ur net loss was $65.5 million for the three months ended March 31, 2026, as compared to a net loss of $8.2 million for the three months ended March 31, 2025.

As of March 31, 2026, we had an accumulated deficit of $254.1 million.

Through June 30, 2026 , we have funded our operations primarily through equity financings, the issuance of senior secured notes, and license fee and milestone payments in connection with the Viatris License Agreement.

O ur net loss was $8.1 million and $73.6 million for the three and six months ended June 30, 2026, as compared to a net loss of $7.4 million and $15.6 million for the three and six months ended June 30, 2025.

As of June 30, 2026, we had an accumulated deficit of $262.2 million.

We anticipate that our expenses will continue to increase as we:

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(“Processa”).

We anticipate that we will recognize revenue as we earn reimbursement for research and development services in connection with the Viatris License Agreement, up to a cap of $50.0 million , and we may earn additional revenues from potential milestone and royalty payments from the agreements with Viatris or from other license

however, the attainment of milestones or level of sales required to earn significant

Opus Genetics, Inc.

agreements entered into the future;

however, the attainment of milestones or level of sales required to earn significant royalty payments is highly uncertain for the reasons explained below.

royalty payments is highly uncertain for the reasons explained below.

Until further notice, we will report earned RYZUMVI® royalties as a component of license and collaboration revenue listed in the consolidated statements of comprehensive loss.

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Other significant costs include insurance coverage for directors and officers and other property and liability exposures, legal fees relating to intellectual property and corporate matters, business development costs, professional fees for accounting and tax services, other services provided by business consultants and legal settlements.

Fair value change in warrant liabilities

The fair value change in warrant liabilities consists of the fair value changes associated with the March 2025 Warrants and March 2025 Private Placement Warrants described further below in the Liquidity and Capital Resources section under Historical Capital Resources .

Fair value change in instruments measured at fair value

The fair value change in instruments measured at fair value consists of the fair value changes associated with the March 2025 Warrants, March 2025 Private Placement Warrants, and the Notes from the Note Purchase Agreement described further below in the Liquidity and Capital Resources section under Historical Capital Resources .

Financing costs

Financing costs consist of issuance costs attributed to our March 2025 Warrants and March 2025 Private Placement Warrants as well as in connection with the April 2, 2026 Note Purchase Agreement described further in Note 14 – Subsequent Events and below in the Liquidity and Capital Resources section under Historical Capital Resources .

Opus Genetics, Inc.

Interest Expense

Interest expense consists of non-cash interest cost during the three-month period ended March 31, 2026 incurred under the Company ’ s RDF Agreement, which is accounted for as debt under ASC 470, Debt .

There was no non-cash interest expense for the three-month period ended March 31, 2025.

Financing costs consist of issuance costs attributed to our March 2025 Warrants and March 2025 Private Placement Warrants as well as in connection with the April 2, 2026 Note Purchase Agreement described further in Note 7 – Debt and below in the Liquidity and Capital Resources section under Historical Capital Resources .

Other income, net

Other income, net includes interest earned from cash and cash equivalent investments and reimbursements in connection with grants and other sources when they occur.

Other income, net includes interest earned from cash and cash equivalent investments, reimbursements in connection with grants and other sources when they occur, and non-cash interest expense under the Company's RDF Agreement, which is accounted for as debt under ASC 470, Debt .

Opus Genetics, Inc.

Provision for income taxes

Provision for income taxes consists of federal and state income taxes in the United States, as well as deferred income taxes and changes in related valuation allowance reflecting the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes.

Currently, a full valuation allowance has been provided on the net deferred tax assets as of March 31, 2026 and December 31, 2025 given the uncertainty of future taxable income and other related factors impacting the realizability or our remaining net deferred tax assets.

Currently, a full valuation allowance has been provided on the net deferred tax assets as of June 30, 2026 and December 31, 2025 given the uncertainty of future taxable income and other related factors impacting the realizability or our remaining net deferred tax assets.

Results of Operations

Comparison of Three Months Ended March 31, 2026 and 2025

Comparison of Three Months Ended June 30, 2026 and 2025

The following table summarizes our operating results for the periods indicated (in thousands):

For the Three Months Ended

Three Months Ended

2026 2025 Change

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Loss from operations (16,480) (8,906) (7,574)

Fair value change in warrant liabilities (51,364) 2,805 (54,169)

Fair value change in instruments measured at fair value

7,174 917 6,257

Financing costs (531) 35 (566)

Interest expense (69) — (69)

Other income, net 1,739 534 1,205

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License and collaborations revenue

License and collaborations revenue was $2.2 million and $4.4 million for the three months ended March 31, 2026 and 2025, respectively.

License and collaborations revenue was $0.8 million and $2.9 million for the three months ended June 30, 2026 and 2025, respectively.

Revenue during both quarterly periods was derived from the Viatris License Agreement, primarily for the reimbursement of research and development services, and to a much lesser extent, earned royalties from sales of RYZUMVI, indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents by our commercial partner.

The $2.2 million decrease in license and collaborations revenue during the current three month period ended March 31, 2026 compared to the corresponding prior year period was due to a decrease in PS research and development services.

The $2.1 million decrease in license and collaborations revenue during the current three month period ended June 30, 2026 compared to the corresponding prior year period was due to a decrease in PS research and development services.

Opus Genetics, Inc.

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The following table illustrates the components of our research and development expenses for the periods presented (in thousands):

For the Three Months Ended

Three Months Ended

2026 2025 Change

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Total research and development expense $ 11,207 $ 6,022 $ 5,185

A greater percentage of our research and development expense incurred has been allocated to IRD programs for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025 as we continue to focus on developing our broad IRD gene therapy pipeline.

Conversely, a lesser percentage of research and development expense incurred has been allocated to PS and APX 3330 for the three months ended March 31, 2026 as compared to the three months ended March 31, 2025.

Research and development expenses for the three months ended March 31, 2026 were $10.6 million compared to $8.0 million for the three months ended March 31, 2025.

The $2.6 million increase was primar ily attributable to higher manufacturing costs associated with the Company's IRD programs of $4.4 million as development progresses, partially offset by lower clinical costs associated with the PS related programs of $1.7 million as clinical trials near completion.

Research and development expenses included $0.4 million and $0.3 million in stock-based compensation expense for the three months ended March 31, 2026 and 2025, respectively.

A greater percentage of our research and development expense incurred has been allocated to IRD programs for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025 as we continue to focus on developing our broad IRD gene therapy pipeline.

Conversely, a lesser percentage of research and development expense incurred has been allocated to PS for the three months ended June 30, 2026 as compared to the three months ended June 30, 2025.

Research and development expenses for the three months ended June 30, 2026 were $11.2 million compared to $6.0 million for the three months ended June 30, 2025.

The $5.2 million increase was primar ily attributable to higher manufacturing and clinical costs associated with the Company's IRD programs of $3.6 million and $1.4 million, respectively, as development progresses, partially offset by lower clinical costs associated with the PS related programs of $1.8 million as clinical trials near completion.

Additionally contributing to the change period over period was an increase of $1.1 million in discovery costs related to IRD programs, an increase of $0.7 million in employee compensation costs, and an increase of $0.2 million in miscellaneous research and development costs.

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

General and administrative expenses for the three months ended March 31, 2026 were $5.9 million compared to $6.3 million for the three months ended March 31, 2025.

The decrease of $0.4 million was primarily attributable to lower legal costs of $1.5 million, partially offset by higher employee compensation related costs of $1.1 million, inclusive of stock-based compensation expense, period over period.

General and administrative expenses included $1.1 million and $0.6 million in stock-based compensation expense during the three months ended March 31, 2026 and 2025, respectively.

Fair value change in warrant liabilities

The fair value change in warrant liabilities was attributed to the March 2025 Warrants and March 2025 Private Placement Warrants, and was an expense of $51.4 million and income of $2.8 million for the three months ended March 31, 2026 and 2025, respectively.

The fair value changes are attributed to the fluctuations in our common stock fair value and underlying changes in volatility, expected term and interest rates.

General and administrative expenses for the three months ended June 30, 2026 were $6.0 million compared to $5.8 million for the three months ended June 30, 2025.

The increase of $0.2 million was primarily attributable to higher employee compensation costs of $0.7 million, partially offset by lower public company related costs of $0.5 million.

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.

Fair value change in instruments measured at fair value

The fair value change in instruments measured at fair value was attributed to the March 2025 Warrants and March 2025 Private Placement Warrants, and to a lesser extent, the Notes remeasured at fair value on a recurring basis.

The income of $7.2 million for the three months ended June 30, 2026 is due to income of $7.4 million from the warrant fair value remeasurement, partially offset by a $0.2 million charge for the fair value remeasurement of the Notes.

The income of $0.9 million for the three months ended June 30, 2025 is due exclusively to the warrant fair value remeasurement.

The fair value changes are attributed to the fluctuations in our common stock fair value and underlying changes in volatility, expected term and interest rates, as well as discount rate for the Notes.

Opus Genetics, Inc.

Financing costs

Financing costs of $0.6 million for the three months ended March 31, 2026 were comprised of issuance costs attributed to the April 2, 2026 Note Purchase Agreement described further in Note 14 – Subsequent Events and below in the Liquidity and Capital Resources section under Historical Capital Resources .

Financing costs for the three months ended March 31, 2025 of $1.4 million were comprised of issuance costs attributed to the March 2025 Warrants and March 2025 Private Placement Warrants.

Interest expense

During the three months ended March 31, 2026, we incurred interest expense in connection with the RDF Agreement in the amount of $0.1 million .

There was no interest expense during the comparable prior year period.

Financing costs of $0.5 million for the three months ended June 30, 2026 were comprised of issuance costs attributed to the April 2, 2026 Note Purchase Agreement described further in Note 7 – Debt and below in the Liquidity and Capital Resources section under Historical Capital Resources .

Financing costs for the three months ended June 30, 2025 were comprised of issuance costs attributed to the March 2025 Warrants and March 2025 Private Placement Warrants.

Other Income, net

During the three months ended March 31, 2026, we had other income, net of $0.8 million which primarily consisted of interest income in the amount of $0.4 million in connection with our cash and cash equivalents on-hand and grant income in the amount of $0.4 million.

During the three months ended March 31, 2025, we had other income, net of $0.3 million related primarily to interest income in connection with our cash and cash equivalents on-hand.

During the three months ended June 30, 2026, we had other income, net of $1.7 million which primarily consisted of interest income in the amount of $0.7 million in connection with our cash and cash equivalents on-hand and grant income in the amount of $1.1 million, partially offset by non-cash interest expense in the amount of $0.1 million.

During the three months ended June 30, 2025, we had other income, net of $0.5 million related primarily to interest income in connection with our cash and cash equivalents on-hand of $0.4 million and grant income in the amount of $0.1 million.

Comparison of Six Months Ended June 30, 2026 and 2025

The following table summarizes our operating results for the periods indicated (in thousands):

For the Six Months Ended

2026 2025 Change

License and collaborations revenue

$ 2,912 $ 7,252 $ (4,340)

Operating expenses:

Research and development 21,784 13,975 7,809

General and administrative 11,972 12,112 (140)

Total operating expenses 33,756 26,087 7,669

Loss from operations (30,844) (18,835) (12,009)

Fair value change in instruments measured at fair value

(44,190) 3,722 (47,912)

Financing costs (1,113) (1,337) 224

Other income, net 2,514 836 1,678

Loss before income taxes (73,633) (15,614) (58,019)

Benefit (provision) for income taxes — — —

$ (73,633) $ (15,614) $ (58,019)

License and collaborations revenue

License and collaborations revenue was $2.9 million and $7.3 million for the six months ended June 30, 2026 and 2025, respectively.

Revenue during the six month periods was derived from the Viatris License Agreement, primarily for the reimbursement of research and development services, and to a much lesser extent, earned royalties from sales of RYZUMVI, indicated for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents by our commercial partner.

The $4.4 million decrease in license and collaborations revenue during the current six month period ended June 30, 2026 compared to the corresponding prior year period was due to a decrease in PS research and development services.

Research and development

Opus Genetics, Inc.

The following table illustrates the components of our research and development expenses for the periods presented (in thousands):

Six Months Ended

2026 2025 Change

External costs:

IRD Programs $ 14,842 $ 4,111 $ 10,731

Phentolamine Ophthalmic Solution 0.75% (“PS”) 2,615 6,493 (3,878)

APX 3330 18 147 (129)

Unallocated 31 238 (207)

Total external cost 17,506 10,989 6,517

Internal costs:

Employee related expenses 3,850 2,858 992

Facilities, supplies and other 428 128 300

Total internal costs 4,278 2,986 1,292

Total research and development expense $ 21,784 $ 13,975 7,809

A greater percentage of our research and development expense incurred has been allocated to IRD programs for the six months ended June 30, 2026 as compared to the six months ended June 30, 2025 as we continue to focus on developing our broad IRD gene therapy pipeline.

Conversely, a lesser percentage of research and development expense incurred has been allocated to PS for the six months ended June 30, 2026 as compared to the six months ended June 30, 2025.

Research and development expenses for the six months ended June 30, 2026 were $21.8 million compared to $14.0 million for the six months ended June 30, 2025.

The $7.8 million increase was primar ily attributable to higher manufacturing and clinical costs associated with the Company's IRD programs of $7.9 million and $1.5 million, respectively, as development progresses, partially offset by lower clinical costs associated with the PS related programs of $3.7 million as clinical trials near completion.

Additionally contributing to the change period over period was an increase of $1.4 million in discovery costs related to IRD programs and an increase of $0.7 million in employee compensation costs.

Research and development expenses included $0.8 million and $0.6 million in stock-based compensation expense for the six months ended June 30, 2026 and 2025, respectively.

General and administrative

General and administrative expenses for the six months ended June 30, 2026 were $12.0 million compared to $12.1 million for the six months ended June 30, 2025.

The decrease of $0.1 million was primarily attributable to lower public company related costs and legal costs of approximately $2.0 million, partially offset by higher employee compensation related costs of $1.9 million.

General and administrative expenses included $2.1 million and $1.2 million in stock-based compensation expense during the six months ended June 30, 2026 and 2025, respectively.

Fair value change in instruments measured at fair value

The expense of $44.2 million for the six months ended June 30, 2026 is due to expense of $44.0 million from the warrant fair value remeasurement, and expense of $0.2 million from the fair value remeasurement of the Notes.

The income of $3.7 million for the six months ended June 30, 2025 is due exclusively to the warrant fair value remeasurement.

Opus Genetics, Inc.

Financing costs

Financing costs of $1.1 million for the six months ended June 30, 2026 were comprised of issuance costs attributed to the April 2, 2026 Note Purchase Agreement described further in Note 7 – Debt and below in the Liquidity and Capital Resources section under Historical Capital Resources .

Financing costs of $1.3 million for the six months ended June 30, 2025 were comprised of issuance costs attributed to the March 2025 Warrants and March 2025 Private Placement Warrants.

Other Income, net

During the six months ended June 30, 2026, we had other income, net of $2.5 million which primarily consisted of interest income in the amount of $1.1 million in connection with our cash and cash equivalents on-hand and grant income in the amount of $1.5 million, partially offset by non-cash interest expense in the amount of $0.1 million.

During the six months ended June 30, 2025, we had other income, net of $0.8 million related primarily to interest income in connection with our cash and cash equivalents on-hand of $0.6 million and grant income in the amount of $0.2 million.

Liquidity and Capital Resources

Capital Resources

As of March 31, 2026, our principal sources of liquidity consisted of cash and cash equivalents of $60.0 million .

Subsequently in April 2026, we received net proceeds of approximately $34.5 million from the funding of the first tranche of our senior secured notes facility with Oberland Capital on April 21, 2026 .

We believe our current available cash and cash equivalents, including the April 2026 proceeds from the Oberland Capital senior secured notes facility will be sufficient to fund our operations for at least the next 12 months from the date of issuance of these financial statements.

As of March 31, 2026, our cash and cash equivalents were invested primarily in cash deposits and cash equivalent investments at four large financial institutions.

As of June 30, 2026, our principal sources of liquidity consisted of cash and cash equivalents of $88.8 million .

We believe our current available cash and cash equivalents will be sufficient to fund our operations for at least the next 12 months from the date of issuance of these financial statements.

As of June 30, 2026, our cash and cash equivalents were invested primarily in cash deposits and cash equivalent investments at four large financial institutions.

Historical Capital Resources

Our primary source of cash to fund our operations has been various equity offerings in the amount of $145.3 million, the senior secured notes facility with Oberland Capital, referenced above and described further below, and the issuance of convertible notes in the amount of $8.5 million.

In addition, we received a one-time non-refundable cash payment of $35.0 million during the fourth quarter of 2022, a $10.0 million milestone payment during the fourth quarter of 2023, and have received reimbursement for costs related to development since the fourth quarter of 2022 totaling $40.1 million through March 31, 2026, all in connection with the Viatris License Agreement.

Our primary source of cash to fund our operations has been various equity offerings in the amount of $145.3 million, the Notes from the First Purchase Date of Note Purchase Agreement with Oberland Capital totaling $35.0 million, described further below, and the issuance of convertible notes in the amount of $8.5 million.

In addition, we received a one-time non-refundable cash payment of $35.0 million during the fourth quarter of 2022, a $10.0 million milestone payment during the fourth quarter of 2023, and have received reimbursement for costs related to development since the fourth quarter of 2022 totaling $41.2 million through June 30, 2026, all in connection with the Viatris License Agreement.

Lastly, we have received funding in the amount of $3.2 million from the RDF Agreement and various research and development grants.

April 2026 Note Purchase Agreement

On April 2, 2026, we entered into a strategic financing agreement with Oberland Capital.

On April 2, 2026, we entered into the senior secured Note Purchase Agreement with Oberland Capital.

The new senior secured notes facility with Oberland Capital provides us with access to future non-dilutive funding of up to $155.0 million to support our future strategic initiatives and growth, with an initial tranche of $35.0 million, which was funded on April 21, 2026, the initial closing, a second $35.0 million tranche available at the Company’s option (subject to satisfaction of customary funding conditions) within the next 12 months, along with additional tranches of up to $35.0 million available to us upon the occurrence of certain milestones and satisfaction of customary financing conditions.

The facility also provides for up to $50.0 million in additional tranches upon the mutual agreement of the parties.

Opus Genetics, Inc.

Capitalized terms used in this section but not defined herein have the meanings given to such terms in the Note Purchase Agreement.

The Note Purchase Agreement with Oberland Capital provides us with access to future non-dilutive funding of up to $155.0 million to support our future strategic initiatives and growth, with an initial tranche of $35.0 million, which was funded on April 21, 2026, the First Purchase Date, a second $35.0 million tranche available at the Company’s option (subject to satisfaction of customary funding conditions) until April 2, 2027, along with additional tranches of up to $35.0 million available to us upon the occurrence of certain milestones and satisfaction of customary financing conditions.

The Note Purchase Agreement also provides for up to $50.0 million in additional tranches upon the mutual agreement of the parties.

The Notes mature on April 21, 2033 (the “Maturity Date”) and bear interest at a rate per annum equal to Term SOFR for the three-month interest period (subject to a 3.68% floor) plus the Applicable Margin, payable quarterly.

Interest payable on the first eight interest payment dates following the effective date of the Note Purchase Agreement shall be payable as follows:

50% of the interest owed for each applicable period shall be paid in kind and the remaining 50% of interest owed for such applicable period shall be paid in cash.

50% of the interest owed for each applicable period shall be paid in kind and the remaining 50% of

Opus Genetics, Inc.

interest owed for such applicable period shall be paid in cash.

Thereafter, 100% of the interest owed for each applicable period shall be paid in cash.

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We are required to make mandatory prepayments of the Notes with net cash proceeds from insurance proceeds or condemnation awards, in each case, subject to certain exceptions and reinvestment rights.

Stock Purchase and Conversion Agreement

Concurrently with the Note Purchase Agreement, on April 2, 2026, we entered into a stock purchase and conversion agreement (the “Purchase and Conversion Agreement”) with the Purchasers providing for the issuance of an aggregate of 1,116,070 shares (the “Purchase Shares”) of our common stock at a price per share equal to $4.48 (the “Per Share Purchase Price”), for an aggregate purchase price of $5.0 million.

The Purchase and Conversion Agreement also provides the Purchasers with an option to acquire additional Purchase Shares (the “Option Shares”) at a price per share equal to $0.0001 (subject to adjustment as set forth in the Purchase and Conversion Agreement, the “Per Share Exercise Price”) in the event that prior to October 2, 2026, we issue shares of common stock (or instruments exercisable for or convertible into shares of common stock) at an effective sale price per share below the Per Share Purchase Price, subject to certain exceptions (a “Dilutive Equity Round”).

The number of Option Shares issuable upon exercise of such option will be such that, accounting for the sale and issuance of the Option Shares, the weighted average of the Per Share Purchase Price and Per Share Exercise Price for all Purchase Shares (including Option Shares) issued pursuant to the Purchase and Conversion Agreement, taken together, shall equal the lowest effective sale price per share paid in cash by third party investors to us for the common stock we issued in such Dilutive Equity Round.

Purchase and Conversion Agreement

Concurrently with the Note Purchase Agreement, on April 2, 2026, we entered into the Purchase and Conversion Agreement with the Purchasers providing for the issuance of an aggregate of 1,116,070 shares of our common stock at a price per share equal to $4.48, for an aggregate purchase price of $5.0 million.

The Purchase and Conversion Agreement also provides the Purchasers with an option to acquire Option Shares at a price per share equal to $0.0001 (subject to adjustment as set forth in the Purchase and Conversion Agreement) in the event that prior to October 2, 2026, we issue shares of our common stock (or instruments exercisable for or convertible into shares of its common stock) in a Dilutive Equity Round.

The number of Option Shares issuable upon exercise of such option will be such that, accounting for the sale and issuance of the Option Shares, the weighted average of the Per Share Purchase Price and Per Share Exercise Price for all Purchase Shares (including Option Shares) issued pursuant to the Purchase and Conversion Agreement, taken together, shall equal the lowest effective sale price per share paid in cash by third party investors to us for its common stock issued by us in such Dilutive Equity Round.

The Purchase and Conversion Agreement was amended on April 13, 2026 to revise the Per Share Purchase Price to the lower of $4.48 per share or a 30 day volume weighted average price of our common stock ending on the issuance date of the Purchase Shares and updated the expected issuance of the Purchase Shares to be on or about May 22, 2026, subject to the satisfaction of customary closing conditions.

The issuance of the Purchase Shares contemplated by the Purchase and Conversion Agreement closed on May 26, 2026, resulting in the issuance of 1,116,070 shares of common stock for aggregate gross proceeds of $5.0 million

February 2026 Private Placement

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August 2025 Private Placement

On August 25, 2025 , we entered into subscription agreements pursuant to which we agreed to issue and sell in the August 2025 Private Placement to certain investors an aggregate of 3,138,338 shares of our common stock.

On August 25, 2025 , we entered into subscription agreements pursuant to which we agreed to issue and sell to certain investors an aggregate of 3,138,338 shares of our common stock (the “August 2025 Private Placement”).

The aggregate gross proceeds from the August 2025 Private Placement were approximately $3.5 million .

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Opus Genetics, Inc.

As of March 31, 2026 , we had sold an aggregate of 10,573,250 shares of common stock under the ATM Programs since their inception, resulting in gross proceeds of $31.0 million and total issuance costs of $1.5 million .

As of June 30, 2026 , we had sold an aggregate of 10,573,250 shares of common stock under the ATM Programs since their inception, resulting in gross proceeds of $31.0 million and total issuance costs of $1.5 million .

Registered Direct Offering

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The RDO was made pursuant to the Company’s 2021 shelf registration.

The RDO Warrants have an exercise price of $6.09 per share, are exercisable from the initial issuance date of June 8, 2021, and will expire five years following the initial issuance date.

As of March 31, 2026, 1,538,461 RDO Warrants were outstanding and none have been exercised since issuance.

The RDO Warrants had an exercise price of $6.09 per share, and were exercisable from the initial issuance date of June 8, 2021 for five years through June 8, 2026 .

As of June 30, 2026, no RDO Warrants were outstanding and none were exercised prior to their expiration on June 8, 2026 .

Subject to limited exceptions, a holder of a RDO Warrant will not have the right to exercise any portion of its RDO Warrants if the holder, together with its affiliates, would beneficially own in excess of 4.99% (or, at the election of a holder prior to the date of issuance, 9.99%) of the number of shares of the Company ’ s common stock outstanding immediately after giving effect to such exercise;

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The following table summarizes our cash flows for the periods indicated (in thousands):

For the Three Months Ended

For the Six Months Ended

Net cash (used in) operating activities

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Net cash provided by financing activities 68,498 21,371

Net increase in cash and cash equivalents $ 14,868 $ 11,471

Net increase in cash, cash equivalents and restricted cash $ 43,821 $ 2,108

Cash Flow from Operating Activities

For the three months ended March 31, 2026 , cash used in operating activities of $12.7 million was attributable to a net loss of $65.5 million , partially offset by non-cash expense of $52.9 million which was primarily driven by the change in fair value attributable to the warrant liabilities resulting in a non-cash expense of $51.4 million and non-cash stock-based compensation expense of $1.5 million.

The net change in our operating assets and liabilities used cash of $0.1 million and resulted primarily from an increase in prepaids and other current assets of $2.1 million driven by increased prepaid manufacturing costs associated with our IRD pipeline, partially offset by an increase in accounts payable and accrued expenses of $1.6 million and a decrease in accounts receivable of $0.3 million due to a lower receivable balance from Viatris in connection with the Viatris license agreement.

For the three months ended March 31, 2025 , cash used in operating activities of $9.0 million was attributable to a net loss of $8.2 million , adjusted by a reclassification to financing activities related to the March 2025 financings and by non-cash net operating income of $0.5 million in the aggregate, and attributed to a net change cash use of $0.3 million in Opus’s net operating assets and liabilities.

The non-cash expenses consisted principally of a fair value change in warrant liabilities benefit of $2.8 million , partially offset by stock-based compensation of $0.9 million.

For the six months ended June 30, 2026 , cash used in operating activities of $24.7 million was attributable to a net loss of $73.6 million , partially offset by non-cash expense of $48.1 million which was primarily driven by the change in fair value attributable to the warrant liabilities and Notes resulting in a non-cash expense of $43.9 million, non-cash stock-based compensation expense of $2.9 million, and the reclass of $1.1 million of debt issuance costs associated with the Note Purchase Agreement to financing activities.

The net change in our operating assets and liabilities provided cash of $0.9 million and resulted primarily from a decrease in accounts receivable of $1.0 million due to a lower receivable balance from Viatris in connection with the Viatris license agreement.

For the six months ended June 30, 2025 , cash used in operating activities of $19.3 million was attributable to a net loss of $15.6 million , adjusted by a reclassification to financing activities related to the March 2025 financings and by non-cash net operating income of approximately $0.6 million in the aggregate, and attributed to a net change cash use of $3.1 million in net operating assets and liabilities.

The non-cash expenses consisted principally of a fair value change in warrant and other derivative liabilities benefit of $3.7 million , partially offset by stock-based compensation of $1.8 million .

The reclassification to financing activities for issuance costs attributed to our liability classified warrants was $1.3 million .

The change in operating assets and liabilities was primarily attributable to a net decrease in our aggregate accounts payable and accrued expenses and by an increase in our prepaid expenses and other assets, offset in part by a decrease in our accounts receivable and contract assets.

All of the changes were attributed to fluctuations in our operating expenses and collections in the normal course of business.

All of the changes were attributed to fluctuations in Opus’s operating expenses and collections under the normal course of business.

Opus Genetics, Inc.

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Cash Flow from Financing Activities

Net cash provided by financing activities during the three months ended March 31, 2026 was $27.6 million that consisted principally of gross proceeds received from the issuance of Series B preferred stock in the February 2026 private placement of $25.0 million, gross proceeds from the ATM in the amount of $2.3 million, and proceeds from the exercise of stock options totaling $0.7 million .

These financing activities were offset by issuance costs of $0.4 million in the aggregate.

Net cash provided by financing activities during three months ended March 31, 2025 was $20.5 million that consisted principally of gross proceeds received from the March 2025 Offering and March 2025 Private Placement of $21.5 million in the aggregate, and from gross proceeds received from the ATM of $0.4 million .

Net cash provided by financing activities during the six months ended June 30, 2026 was $68.5 million that consisted principally of gross proceeds received from the Note Purchase Agreement of $35.0 million, gross proceeds received from the Purchase and Conversion Agreement of $5.0 million, gross proceeds received from the issuance of Series B preferred stock in the February 2026 private placement of $25.0 million, gross proceeds from the ATM in the amount of $2.3 million, proceeds from the exercise of warrants of $1.7 million, and proceeds from the exercise of stock options totaling $1.2 million .

These financing activities were offset by issuance costs of $1.1 million related to the Note Purchase Agreement and issuance costs of $0.5 million related to equity instruments.

Net cash provided by financing activities during six months ended June 30, 2025 was $21.4 million that consisted principally of gross proceeds received from the March 2025 Offering and March 2025 Private Placement of $21.5 million in the aggregate, and from gross proceeds received from the ATM of $0.4 million .

Both financings were offset by issuance costs of $1.5 million in the aggregate.

Lastly, we received funding of $1.0 million in connection with the RDF Agreement.

Liquidity and Capital Resource Requirements

As of March 31, 2026 we had cash and cash equivalents of $60.0 million .

License and collaborations revenue inception to date was derived from a one-time non-refundable payment of $35.0 million , a milestone payment of $10.0 million , and we have received reimbursement for costs related to development since the fourth quarter of 2022 totaling $40.1 million through March 31, 2026, all in connection with the Viatris License Agreement.

As of June 30, 2026 we had cash and cash equivalents of $88.8 million .

Our primary source of cash to fund our operations has been various equity offerings in the amount of $145.3 million, the Note Purchase Agreement with Oberland Capital, referenced above and described further below, and the issuance of convertible notes in the amount of $8.5 million.

License and collaborations revenue inception to date was derived from a one-time non-refundable payment of $35.0 million , a milestone payment of $10.0 million , and we have received reimbursement for costs related to development since the fourth quarter of 2022 totaling $41.2 million through June 30, 2026, all in connection with the Viatris License Agreement.

We anticipate that we will recognize revenue as we earn reimbursement for research and development services in connection with the Viatris License Agreement and we may earn additional revenues from future potential milestone and royalty payments from the agreement with Viatris, or from other license agreements entered into in the future;

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Through the ATM program with Leerink, we may offer and sell, from time to time at our sole discretion, to or through Leerink, acting as agent and/or principal, shares of our common stock having an aggregate offering price of up to $40.0 million .

As of March 31, 2026 , we had sold an aggregate of 10,573,250 shares of our common stock under the ATM Programs since their inception, resulting in gross proceeds of $31.0 million and total issuance costs of $1.5 million .

As of June 30, 2026 , we had sold an aggregate of 10,573,250 shares of our common stock under the ATM Programs since their inception, resulting in gross proceeds of $31.0 million and total issuance costs of $1.5 million .

To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation, warrants or other preferences that adversely affect your rights as a common stockholder.

Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

If we raise additional funds through future collaborations, strategic alliances or licensing arrangements with pharmaceutical partners, we may have to relinquish valuable rights to our technologies, future revenue streams or grant licenses on terms that may not be favorable to us.

If we are unable to raise

Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional

Opus Genetics, Inc.

additional funds through equity or debt financings or through collaborations, strategic alliances or licensing arrangements when needed, we may be required to delay, limit, reduce or terminate our product development, future commercialization efforts, or grant rights to develop and market our product candidates that we would otherwise prefer to develop and market ourselves.

debt, making capital expenditures or declaring dividends.

If we are unable to raise additional funds through equity or debt financings or through collaborations, strategic alliances or licensing arrangements when needed, we may be required to delay, limit, reduce or terminate our product development, future commercialization efforts, or grant rights to develop and market our product candidates that we would otherwise prefer to develop and market ourselves.

Future Capital Requirements

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See “Part I, Item 1— Business— Pipeline— Sales and Marketing—Manufacturing— Review and Approval of Drugs and Biologics in the United States— Review and Approval of Drug Products in the European Union” in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 12, 2026, for a discussion of design, development, pre-clinical and clinical activities that we may conduct in the future, including expected cash expenditures required for some of those activities, to the extent we are able to estimate such costs.

Our other cash requirements within the next 12 months include accounts payable, accrued expenses, purchase commitments, quarterly cash interest obligations associated with the Oberland Capital Notes Purchase Agreement and other current liabilities.

Our other cash requirements greater than 12 months from various contractual obligations and commitments may include future principal repayments and additional obligations under the Oberland Capital Note Purchase Agreement, operating leases and contractual agreements with third-party service providers for clinical research, product development, manufacturing, commercialization, supplies, payroll, equipment maintenance, and audits for periods into calendar year 2027.

Refer to Note 3 – Commitments and Contingencies and Note 14 – Subsequent Events included in Part 1, Item 1 – “Financial Statements” of this Report for further detail of our lease obligation and license agreements with regard to the timing of expected future payments.

Our other cash requirements within the next 12 months include accounts payable, accrued expenses, purchase commitments, quarterly cash interest obligations associated with the Note Purchase Agreement and other current liabilities.

Our other cash requirements greater than 12 months from various contractual obligations and commitments may include future principal repayments and additional obligations under the Note Purchase Agreement, operating leases and contractual agreements with third-party service providers for clinical research, product development, manufacturing, commercialization, supplies, payroll, equipment maintenance, and audits for periods into calendar year 2027.

Refer to Note 4 – Commitments and Contingencies in Part 1, Item 1 – “Financial Statements” of this Report for further detail of our license agreements with regard to the timing of expected future payments.

We expect to satisfy our short-term and long-term obligations through cash on hand, from future equity and debt financings, and from reimbursement payments, potential milestone and royalty payments under the Viatris License Agreement and any future collaborations and license agreements, until we generate an adequate level of revenue from commercial sales to cover expenses, if ever.

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generally accepted accounting principles (GAAP).

These accounting principles require us to make estimates and judgments that can affect the reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of revenue and expense during the periods presented.

We believe that the estimates and judgments upon which we rely are reasonably based upon information available to us at the time that we make these estimates and judgments.

To the extent that there are material differences

Opus Genetics, Inc.

between these estimates and actual results, our financial results will be affected.

periods presented.

We believe that the estimates and judgments upon which we rely are reasonably based upon information available to us at the time that we make these estimates and judgments.

To the extent that there are material differences between these estimates and actual results, our financial results will be affected.

The accounting policies that reflect our more significant estimates and judgments and which we believe are the most critical to aid in fully understanding and evaluating our reported financial results are described below.

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For discussion about the determination of license and collaborations revenue, see Note 12 — License and Collaboration Revenue and Other Funding Agreements included in Part 1, Item 1 – “Financial Statements” of this Report.

Accrued research and development expense

As part of the process of preparing our condensed consolidated financial statements, we are required to estimate certain accrued research and development expenses.

This process involves estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual costs.

We make estimates of our accrued expenses as of each balance sheet date in our condensed consolidated financial statements based on facts and circumstances known to us at that time.

We periodically confirm the accuracy of the estimates with the service providers and make adjustments if necessary.

Examples of estimated accrued research and development expenses include those related to fees paid to:

• vendors in connection with discovery and preclinical development activities;

• Contract research organizations ( “ CROs ”) in connection with clinical trials, preclinical studies and testing;

• Contract manufacturing organizations ( “ CMOs ”) in connection with the process development and scale up activities and the production of materials

We base the expense recorded related to contract research and manufacturing on our estimates of the services received and efforts expended pursuant to quotes and contracts with multiple CROs and CMOs that conduct services and supply materials.

The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows.

In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period.

If the actual timing of the performance of services or the level of effort varies from the estimate, we adjust the accrual accordingly.

Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in reporting amounts that are too high or too low in any particular period.

While the majority of our service providers invoice us in arrears for services performed, on a pre-determined schedule or when contractual milestones are met;

some require advance payments.

There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the expense.

Payments we make for research and development services prior to the services being rendered are recorded as prepaid assets in our condensed consolidated balance sheets and are expensed as the services are provided

Opus Genetics, Inc.

Warrant Liabilities

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For further discussion about the determination of the warrant liabilities, see Note 9 – Financings included in “Part 1, Item 1 – Financial Statements" of this Report.

Fair Value of Notes

The fair value of the Notes pursuant to the Note Purchase Agreement represents the present value of estimated future payments, including interest, principal, and Repayment Amount (each as defined in the Note Purchase Agreement).

The fair value measurement is based on significant Level 3 unobservable inputs such as the Repayment Amount and the discount rate.

We determined the fair value of the Notes utilizing a discounted cash flow model of estimated future payments including interest, principal, and Repayment Amount utilizing a discount rate calculated as the term matched risk-free rate plus credit spread.

Significant increases or decreases in any of these inputs in isolation could result in a significantly lower or higher fair value measurement.

While the assumptions used to calculate and account for the fair value of Notes represent management’s best estimates, these estimates involve inherent uncertainties and the application of management’s judgment.

As a result, if revisions are made to our underlying assumptions and estimates, the fair value of Notes and consequently the change in fair value of Notes could vary significantly from period to period.

Income Tax Assets and Liabilities

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Not applicable for smaller reporting companies.

Opus Genetics, Inc.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis