Opus Genetics, Inc. 10-Q

Item 2. 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 (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 Certain statements contained in this Report are not statements of historical fact and are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements give current expectations or forecasts of future events or our future financial or operating performance. 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. Food and Drug Administration (the “FDA”) regarding various of our drug products, and continued drug development and commercialization under our agreement with Viatris, Inc. (“Viatris”). In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “could,” “continue,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. These forward-looking statements reflect our management’s beliefs and views with respect to future events, are based on estimates and assumptions as of the date of this Report and are subject to risks and uncertainties, many of which are beyond our control, that could cause our actual results to differ materially from those in these forward-looking statements, including, without limitation: • 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 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 ; • Changes in regulatory requirements could result in increased costs or delays in development timelines ; • We depend heavily on the success of our product pipeline; if we fail to find strategic partners or fail to adequately develop or commercialize our pipeline products, our business will be materially harmed ; • Others may discover, develop, or commercialize products similar to those in our pipeline before or more successfully than we do or develop generic variants of our products even while our product patents remain active, thereby reducing our market share and potential revenue from product sales ; • We do not currently have any sales or marketing infrastructure in place and we have limited drug research and discovery capabilities ; • The future commercial success of our products could significantly depend upon several uncertain factors, including third-party reimbursement practices and the existence of competitors with similar products ; • Product liability lawsuits against us or our suppliers or manufacturers could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop ; • Failure to comply with health and safety laws and regulations could lead to material fines ; • We have not generated significant revenue from sales of any products and expect to incur losses for the foreseeable future ; 27 Table of Contents Opus Genetics, Inc. Form 10-Q • Our future viability is difficult to assess due to our short operating history and our future need for substantial additional capital, access to which could be limited by any adverse developments that affect the financial markets ; • Raising additional capital may cause our stockholders to be diluted, among other adverse effects ; • Instability and operational disruptions at government agencies, such as the FDA, may adversely impact our development and commercialization plans by causing delays and requiring the use of additional, unforeseen resources to obtain regulatory approval for trials or products in our pipeline ; • We operate in a highly regulated industry and face many challenges adapting to sudden changes in legislative reform or the regulatory environment, including due to government shutdowns and disruptions at government agencies, which cause delays, requires the use of additional, unforeseen resources, affects our pipeline stability, and could impair our ability to compete in international markets ; • We may not receive regulatory approval to market our developed product candidates within or outside of the U.S. ; • With respect to any of our product candidates that receive marketing approval, we may be subject to substantial penalties if we fail to comply with applicable regulatory requirements ; • Our potential relationships with healthcare providers and third-party payors will be subject to certain healthcare laws and regulations, which could expose us to extensive potential liabilities ; • We rely on third parties for material aspects of our business, such as conducting our nonclinical and clinical trials and supplying and manufacturing bulk drug substances, which exposes us to certain risks ; • We may be unsuccessful in entering into or maintaining licensing arrangements or establishing strategic alliances on favorable terms, which could harm our business ; • Inadequate patent protection for our product candidates may result in our competitors developing similar or identical products or technology, which would adversely affect our ability to successfully commercialize; • We may be unable to obtain full protection for our intellectual property rights under U.S. or foreign laws; • We may become involved in lawsuits for a variety of reasons associated with our intellectual property rights, including alleged infringement suits initiated by third parties; • We are dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy; • As we grow, we may not be able to operate internationally or adequately develop and expand our sales, marketing, distribution, and other corporate functions, which could disrupt our operations; • The market price of our common stock is expected to be volatile and if we fail to comply with the continued listing standards of Nasdaq, our common stock may be delisted ; and • Factors out of our control related to our securities, such as securities litigation or actions of activist stockholders, could adversely affect our business and stock price and cause us to incur significant expenses. We discuss many of these risks in greater detail under Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025 and below under the heading “Risk Factors,” and in subsequent reports filed with or furnished to the Securities and Exchange Commission (the “SEC”). Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. Given these uncertainties, you should not place undue reliance on these forward-looking statements. 28 Table of Contents Opus Genetics, Inc. Form 10-Q Any forward-looking statement made by us in this Report speaks only as of the date hereof or as of the date specified herein. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by applicable laws or regulations. Overview Opus Genetics, Inc. (the “Company,” “Opus,” “we,” “us,” or “our”) is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with IRDs. We also have a small molecule therapy for other ophthalmic disorders. Gene Therapy Programs Our pipeline features a portfolio of seven adeno-associated virus (“AAV”) based gene therapies that address mutations in genes that cause different forms of Leber congenital amaurosis (“LCA”), bestrophinopathy, and retinitis pigmentosa. OPGx-LCA5 OPGx-LCA5 is being developed to address a form of LCA due to biallelic mutations in the LCA5 gene, which encodes the lebercilin protein. LCA5-associated IRD is an early-onset severe inherited retinal dystrophy. Studies in patients with this mutation have reported evidence for the dissociation of retinal architecture and visual function in this disease, suggesting an opportunity for therapeutic intervention through gene augmentation. OPGx-LCA5 uses an adeno-associated virus 8 (AAV8) vector to precisely deliver a functional LCA5 gene to the outer retina via a single subretinal injection. OPGx-LCA5 has been accepted into the FDA's Rare Disease Evidence Principles (RDEP) program, and has also been granted Rare Pediatric Disease, Regenerative Medicine Advanced Therapy (RMAT), and Orphan Drug designations from the FDA. LCA5 affects an estimated 170 patients in the U.S. and 3,240 globally. OPGx-LCA5 is currently being evaluated in an open-label, adaptive Phase 1/2/3 clinical trial. 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 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. In November 2025, we announced the successful completion of a Type B RMAT meeting with the FDA regarding OPGx-LCA5. The meeting provided constructive feedback from the FDA on key elements of the Company’s registration strategy, including Chemistry, Manufacturing and Controls (CMC), and the pivotal trial design. 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. 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. 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. 29 Table of Contents Opus Genetics, Inc. Form 10-Q 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 OPGx-BEST1 is being developed for the treatment of IRDs associated with mutations in the BEST1 gene. BEST1 disease, or vitelliform macular dystrophy, is a rare, inherited retinal condition causing macular degeneration by mutations in the BEST1 gene, leading to progressive vision loss and, in some cases, blindness. In preclinical studies conducted in a naturally occurring canine model of BEST1 disease, OPGx-BEST1 demonstrated restoration of the retinal pigment epithelium-photoreceptor interface using AAV-mediated gene delivery, providing evidence in support of a first-in-man clinical trial. BEST1 affects an estimated 8,400 patients in the U.S. and 21,800 globally. In August 2025, we announced FDA clearance of an Investigational New Drug (IND) application to initiate a clinical trial. 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. 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. Early signals of functional vision improvement were observed, including an equivalent 12-letter gain in Best Corrected Visual Acuity (BCVA) in the treated study eye. 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 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 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. RDH12 encodes a retinol dehydrogenase enzyme involved in the visual cycle, protecting photoreceptors from toxic metabolite accumulation. RDH12 affects an estimated 2,500 patients in the U.S., 17,500 in the MENA (Middle East/North Africa) region, and 30,900 globally. 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 30 Table of Contents Opus Genetics, Inc. Form 10-Q 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. OPGx-MERTK 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. Loss of this function leads to rod-cone dystrophy, progressive vision loss and eventual blindness. MERTK affects an estimated 2,600 patients in the U.S., 14,300 in the MENA region and 21,960 globally. 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. OPGx-RHO OPGx-RHO is being developed for retinitis pigmentosa caused by autosomal dominant mutations in the rhodopsin protein utilizing a knock-down of the mutant rhodopsin and replacement with wild type rhodopsin protein. RHO affects an estimated 8,800 patients in the U.S., 14,600 in China and 30,200 globally. 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. 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, NMNAT1 and other undisclosed retinal diseases. Phentolamine Ophthalmic Solution 0.75% (PS) Our pipeline also includes Phentolamine Ophthalmic Solution 0.75% (PS), a relatively non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size, administered as an eye drop. It aims to work by uniquely blocking the alpha-1 receptors found on the radial iris dilator muscles, which are activated by the alpha-1 adrenergic receptors. PS is designed to reduce pupil diameter through a sympatholytic mechanism of action that avoids engaging the ciliary muscle, potentially reducing risks such as retinal tears or detachment associated with older parasympathomimetic agents. PS is targeting three different indications. In November 2022, we entered into a license and collaboration agreement (as amended, the “Viatris License Agreement”) with Viatris, Inc. (“Viatris”), pursuant to which we granted Viatris an exclusive license to develop, manufacture, import, export and commercialize PS for treating (a) reversal of pharmacologically-induced mydriasis, (b) decreased vision under mesopic (low) light conditions after keratorefractive surgery, and (c) presbyopia; and (ii) PS and low dose pilocarpine for treating presbyopia (together, the “PS Products”) worldwide except for certain countries and jurisdictions in Asia. 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. 31 Table of Contents Opus Genetics, Inc. Form 10-Q RYZUMVI ® (phentolamine ophthalmic solution) 0.75%: PS was approved by the FDA for the treatment for pharmacologically-induced mydriasis under the brand name RYZUMVI ® in September 2023, which triggered a $10 million milestone payment under the Viatris License Agreement. RYZUMVI was commercialized by Viatris in April 2024. Presbyopia: In June 2025, we announced positive results from VEGA-3, our second pivotal Phase 3 trial evaluating PS for the treatment of presbyopia, an ophthalmic disorder that involves the progressive loss of ability to focus on close objects that results in blurred near vision, difficulty seeing in dim light, and eye strain. VEGA-3 met its primary endpoint, with a statistically significant 27.2% of participants treated with PS achieving a ≥15-letter improvement in binocular distance-corrected near visual acuity (DCNVA), with less than a 5-letter loss in binocular best-corrected distance visual acuity (BCDVA) at 12 hours post-dose on Day 8, compared to 11.5% of patients on placebo (p<0.0001). The trial also met key secondary efficacy endpoints, reinforcing the benefit observed. 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. Mesopic, Low-Contrast Conditions: We are conducting our second Phase 3 trial, known as LYNX-3, to treat significant, chronic night driving impairment in keratorefractive patients with reduced mesopic vision. The program is being conducted under a Special Protocol Assessment and has received Fast Track Designation from the FDA. The first Phase 3 trial, LYNX-2, met its primary endpoint of a gain of three lines (or 15 letters) or more of distance vision improvement on a low contrast chart in low light conditions after 15 days of dosing. In the study, 17.3% of participants treated with PS achieved a ≥15-letter Early Tr eatment Diabetic Retinopathy Study (ETDRS) (≥ 3-line) improvement in Mesopic Low Contrast Distance Visual Acuity (mLCVA) at Day 15, compared to 9.2% in the placebo group (p<0.05). We are currently enrolling participants in LYNX-3. 32 Table of Contents Opus Genetics, Inc. Form 10-Q Recent Developments 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 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 On February 13, 2026 , we entered into a securities purchase agreement with certain investors for a private placement of 7,374,632 shares of Series B preferred stock at a purchase price of $3.39 per share. The private placement closed on February 18, 2026 , resulting in gross proceeds of approximately $25.0 million . The Series B preferred stock was convertible into shares of our common stock on a one‑for‑one basis, subject to stockholder approval of an increase in the Company’s authorized common stock and certain beneficial ownership limitations. On April 20, 2026, we held our 2026 Annual Meeting. During the 2026 Annual Meeting, our stockholders voted to approve an amendment to our restated certificate of incorporation to increase the number of authorized shares of our common stock from 125 million shares to 250 million shares. Following the vote and filing of the associated amendment to our Certificate of Incorporation with the Delaware Secretary of State, all 7,374,632 outstanding shares of Series B preferred stock were converted on a one-for-one basis into 7,374,632 shares of common stock. At-The-Market Program 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. 33 Table of Contents Opus Genetics, Inc. Form 10-Q Strategic Outlook We intend to advance our current active pipeline and may explore opportunities to out-license from our portfolio or in-license other drug candidates. To date, our primary activities have been conducting research and development activities, performing business and financial planning, recruiting personnel and raising capital. We have one product, RYZUMVI®, approved for sale that is generating royalties based on sales by Viatris, and we do not expect to consistently generate significant revenues, other than license and collaborations revenue, unless and until the FDA or other regulatory authorities approve, and we successfully commercialize, LCA5, BEST1, other internally-developed gene therapy assets or PS for other indications. 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 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: • continue clinical trials for LCA5, BEST1, PS and for any other product candidate in our future pipeline; • continue nonclinical studies for our pipeline of gene therapies; • develop additional product candidates that we identify, in-license or acquire; • seek regulatory approvals for any product candidates that successfully complete clinical trials; • contract to manufacture our product candidates; • maintain, expand and protect our intellectual property portfolio; • hire additional staff, including clinical, scientific, operational and financial personnel, to execute our business plan; • add operational, financial and management information systems and personnel to support our product development and potential future commercialization efforts; • continue to operate as a public company; and • establish on our own or with partners, a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain regulatory approval. Our net loss will likely continue to fluctuate significantly from quarter to quarter and year to year, depending on fair value adjustments related to our liability classified warrants, the timing of our nonclinical studies, clinical trials, expenditures on other research and development activities (and reimbursement thereof), and from potential milestone payments received from and revenue earned under the Viatris License Agreement or any other license and collaboration agreements that we enter into. Financial Operations Overview License and collaborations revenue License and collaborations revenue to date was derived from a one-time, non-refundable payment related to a license transfer, an additional milestone payment and reimbursement of expenses earned under the Viatris License Agreement, and to a much lesser degree, from license agreements with BioSense Global LLC (“BioSense”) and Processa Pharmaceuticals, Inc. (“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 agreements entered into the future; however, the attainment of milestones or level of sales required to earn significant 34 Table of Contents Opus Genetics, Inc. Form 10-Q 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. To date, outside of the license and collaborations revenue referenced above, we do not expect to generate significant revenue unless or until RYZUMVI® sales become material, or regulatory approval is obtained, and commercialization begins for LCA5, BEST1, other internally-developed assets or PS for additional indications. If we fail to complete the development of LCA5, BEST1, PS, or any other product candidate we may pursue or fail to obtain regulatory approval, our ability to generate significant revenue will be compromised. Operating expenses Our operating expenses are classified into two categories: research and development and general and administrative. Research and development expenses To date, our research and development expenses have related primarily to the clinical stage development of our IRD programs, including LCA5 and BEST1, and PS. Research and development expenses consist of costs incurred in performing research and development activities, including compensation, benefits and stock-based compensation costs for research and development employees and costs for consultants, costs associated with nonclinical studies and clinical trials, regulatory activities, manufacturing activities to support clinical activities, license fees, nonlegal patent costs, fees paid to external service providers that conduct certain research and development, and an allocation of overhead expenses. Pursuant to the Viatris License Agreement, our research and development expenses related to the development of PS to date have been fully reimbursed by Viatris. We expect that LCA5, BEST1, PS and other internally-developed assets will have higher development costs during the later stages of clinical development, as compared to costs incurred during their earlier stages of development, primarily due to the increased size and duration of the later-stage clinical trials and associated nonclinical studies. We expect our research and development expenses to increase over the next several years. However, it is difficult for us to determine with certainty the duration, costs and timing to complete our current or future nonclinical programs and clinical trials of LCA5, BEST1, PS and other internally-developed assets. General and administrative expenses General and administrative expenses consist primarily of personnel-related costs, including salaries, benefits and stock-based compensation costs, for personnel in functions not directly associated with research and development activities. 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 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 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, 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 . 35 Table of Contents Opus Genetics, Inc. Form 10-Q 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 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 June 30, 2026 and 2025 The following table summarizes our operating results for the periods indicated (in thousands): Three Months Ended June 30, 2026 2025 Change License and collaborations revenue $ 755 $ 2,882 $ (2,127) Operating expenses: Research and development 11,207 6,022 5,185 General and administrative 6,028 5,766 262 Total operating expenses 17,235 11,788 5,447 Loss from operations (16,480) (8,906) (7,574) Fair value change in instruments measured at fair value 7,174 917 6,257 Financing costs (531) 35 (566) Other income, net 1,739 534 1,205 Loss before income taxes (8,098) (7,420) (678) Benefit (provision) for income taxes — — — Net loss $ (8,098) $ (7,420) $ (678) License and collaborations revenue 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 $2.1 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. 36 Table of Contents Opus Genetics, Inc. Form 10-Q Research and development The following table illustrates the components of our research and development expenses for the periods presented (in thousands): Three Months Ended June 30, 2026 2025 Change External costs: IRD Programs $ 8,207 $ 2,188 $ 6,019 Phentolamine Ophthalmic Solution 0.75% (“PS”) 592 2,458 (1,866) APX 3330 5 (246) 251 Unallocated 3 102 (99) Total external cost 8,807 4,502 4,305 Internal costs: Employee related expenses 2,150 1,449 701 Facilities, supplies and other 250 71 179 Total internal costs 2,400 1,520 880 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 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 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. 37 Table of Contents Opus Genetics, Inc. Form 10-Q Financing costs 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 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 — — — Net loss $ (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 38 Table of Contents Opus Genetics, Inc. Form 10-Q The following table illustrates the components of our research and development expenses for the periods presented (in thousands): Six Months Ended June 30, 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 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 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. 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. 39 Table of Contents Opus Genetics, Inc. Form 10-Q 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 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 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 the senior secured Note Purchase Agreement with 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. 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 40 Table of Contents Opus Genetics, Inc. Form 10-Q 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. We shall make a payment of principal on each outstanding Note on the sixth anniversary of the First Purchase Date in an amount equal to half of the aggregate principal amount of such Notes outstanding on such date, with the remaining balance payable on the Maturity Date. Pursuant to the Note Purchase Agreement, any Purchaser may, at any time and from time to time prior to the date that is 18 months after the effective date of the Note Purchase Agreement, elect to convert up to 10% in the aggregate of the principal amount of such Purchaser’s Notes then outstanding (the “Conversion Amount”) into shares (the “Conversion Shares”) of the Company’s common stock. The number of Conversion Shares issuable upon such conversion shall be equal to the Conversion Amount divided by $6.72. Upon any such conversion, an aggregate principal amount of Notes equal to the Conversion Amount shall be deemed paid and satisfied in full and shall cease to accrue interest. Any interest accrued and unpaid through and including the date of such conversion shall remain outstanding and shall be payable in cash on the next interest payment date (or, if we and the Purchasers so elect in writing, shall be convertible into Conversion Shares). We may voluntarily prepay the Notes in full at any time subject to a prepayment premium. Moreover, a prepayment premium may also be payable by us upon the occurrence of, (i) at any time prior to the first anniversary of the First Purchase Date, an acceleration of the obligations under the Note Purchase Agreement following an event of default (other than a change of control) or, (ii) at any time prior to the date that is 18 months after the First Purchase Date, a change of control of the Company that is not otherwise consented to by the Purchasers holding a majority of the outstanding Notes. 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. 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 On February 13, 2026 , we entered into a securities purchase agreement with certain investors for a private placement of an aggregate of 7,374,632 shares of Series B preferred stock at a purchase price of $3.39 per share. The private placement closed on February 18, 2026 , resulting in gross proceeds of approximately $25.0 million . As a result of the approval by stockholders of the Authorized Stock Proposal at the 2026 Annual Meeting, all 7,374,632 outstanding shares of Series B preferred stock were converted on a one-for-one basis into 7,374,632 shares of common stock . November 2025 Registered Direct Offering On November 5, 2025 , we entered into a securities purchase agreement to sell securities in a registered direct offering for gross proceeds of approximately $23.0 million , before deducting offering expenses. The financing was led by Perceptive Advisors and Balyasny Asset Management, with participation by new and existing institutional investors, including Nantahala Capital. 41 Table of Contents Opus Genetics, Inc. Form 10-Q In the offering, we sold an aggregate of 3,827,751 shares of common stock at a price of $2.09 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 7,177,033 shares of common stock at a purchase price of $2.0899 per pre-funded warrant. Each pre-funded warrant has an exercise price of $0.0001 per share of common stock, will be immediately exercisable subject to certain conditions set forth in each pre-funded warrant, and will not expire. The offering closed on November 10, 2025 . August 2025 Private Placement 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 . The August 2025 Private Placement closed on August 25, 2025 . The August 2025 Private Placement was led by Cam Gallagher, Chair of our board of directors (the “Board”), with an investment of $1.0 million , along with participation by Sean Ainsworth, the lead independent director of the Board, and other investors. March 2025 Financings On March 21, 2025, we entered into an underwriting agreement with Craig-Hallum Capital Group, LLC, as the sole underwriter. Pursuant to the underwriting agreement, we agreed to issue and sell, in an underwritten public offering, 12,219,736 shares of common stock and warrants to purchase up to 21,052,631 shares of common stock (the “March 2025 Warrants”). Each share of common stock was sold together with one March 2025 Warrant to purchase one share of common stock, at a price to the public of $0.95 per share and related March 2025 Warrant. We also issued 8,832,895 pre-funded warrants (“Pre-Funded Warrants”) at a price to the public of $0.9499 per Pre-Funded Warrant. Also on March 21, 2025, we entered into a subscription agreement (the “Subscription Agreement”) with each of Dr. George Magrath, the Company’s Chief Executive Officer, and Cam Gallagher, the chairman of our Board. Pursuant to the Subscription Agreement, the Company agreed to issue and sell, in a private offering (the “March 2025 Private Placement”), a total of 392,157 shares of common stock to Mr. Magrath and 784,314 shares of common stock to Mr. Gallagher, as well as 392,157 warrants to purchase shares of common stock to Mr. Magrath and 784,314 warrants to purchase shares of common stock to Mr. Gallagher (“March 2025 Private Placement Warrants”). Each March 2025 Private Placement Warrant has an initial exercise price of $1.15 , expires on the five-year anniversary of the original issuance date and may be called by the Company 30 days following the release of the Company’s OPGx-BEST1 DUO-1001 Cohort 1 data upon achievement of a volume weighted average price of our common stock for 30 consecutive trading days of over $1.725 per share and the trading average daily volume for such 30 day period exceeds $150,000 per trading day. The combined gross proceeds from the March 2025 Offering and the March 2025 Private Placement, which both closed on March 24, 2025 , were approximately $21.5 million , before deducting underwriting discounts and commissions and offering expenses payable by us. March 2025 Warrants The March 2025 Warrants have an initial exercise price equal to $0.95 per share of common stock and are exercisable for five years from the date of issuance. The exercise prices and numbers of shares of common stock issuable upon exercise are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the common stock and also upon any distributions of assets, including cash, stock or other property to our stockholders. A holder may not exercise the March 2025 Warrant if, after giving effect to such exercise, the holder (together with its affiliates) would beneficially own (as determined in accordance with the terms of the March 2025 Warrants) more than 4.99% (or, at the election of the holder, 9.99% ) of the outstanding common stock immediately after giving effect to the exercise. The March 2025 Warrants are callable by us in certain circumstances. Subject to certain exceptions, in the event that the March 2025 Warrants are outstanding, if, after the closing date, March 24, 2025 (the “Closing Date”), (i) we have announced OPGx-BEST1 DUO-1001 Cohort 1 data, (ii) the volume weighted average price of the common stock for 30 consecutive trading days (“Warrant Measurement Period”), which 30 consecutive trading day period shall not have commenced until after the initial exercise date exceeds $1.425 (subject to adjustment), (iii) the trading average daily volume for such Warrant Measurement Period exceeds $150,000 per trading day and (iv) the March 2025 Warrant holder is not in possession of any information that constitutes or might constitute material non-public information which was 42 Table of Contents Opus Genetics, Inc. Form 10-Q provided by the Company, its subsidiaries or any of its officers, directors, employees, agents or affiliates, then the Company may, within one trading day of the end of such Warrant Measurement Period, upon notice, call for cancellation of all or any portion of the March 2025 Warrants for which a notice of exercise has not yet been delivered for consideration equal to $0.001 per March 2025 Warrant share. In the event of a fundamental transaction, as defined in the Form of Warrant, the holders of the March 2025 Warrants will be entitled to receive upon exercise the kind and amount of securities, cash or other property that the holders would have received had they exercised immediately prior to such fundamental transaction. Additionally, as more fully described in the Form of Warrant, in the event of certain fundamental transactions, the holders of the March 2025 Warrants will be entitled to receive consideration in an amount equal to the Black Scholes Value of the remaining unexercised portion of the March 2025 Warrants on the date of consummation of such fundamental transaction. March 2025 Private Placement Warrants The March 2025 Private Placement Warrants have an initial exercise price equal to $1.15 per share of common stock and are exercisable for five years from the date of issuance. The March 2025 Private Placement Warrants are callable by us in certain circumstances. Subject to certain exceptions, in the event that the March 2025 Private Placement Warrants are outstanding, if, after the Closing Date, (i) the Company announced OPGx-BEST1 DUO-1001 Cohort 1 data, (ii) the volume weighted average price of the common stock for 30 consecutive trading days (“Private Placement Measurement Period”), which 30 consecutive trading day period shall not have commenced until after the initial exercise date exceeds $1.725 (subject to adjustment), (iii) the trading average daily volume for such Private Placement Measurement Period exceeds $150,000 per trading day and (iv) the March 2025 Private Placement Warrant holder is not in possession of any information that constitutes or might constitute material non-public information which was provided by the Company, its subsidiaries or any of its officers, directors, employees, agents or affiliates, then the Company may, within one trading day of the end of such Private Placement Measurement Period, upon notice, call for cancellation of all or any portion of the March 2025 Private Placement Warrants for which a notice of exercise has not yet been delivered for consideration equal to $0.001 per March 2025 Private Placement Warrant share. Other terms under the March 2025 Private Placement Warrants are generally identical to the terms of the March 2025 Warrants discussed above. Pre-Funded Warrants The Pre-Funded Warrants have an exercise price of $0.0001 per share of common stock and are immediately exercisable and are exercisable at any time until exercised in full. The exercise prices and numbers of shares of common stock issuable upon exercise are subject to appropriate adjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting the common stock. A holder may not exercise the Pre-Funded Warrant if, after giving effect to such exercise, the holder (together with its affiliates) would beneficially own (as determined in accordance with the terms of the Pre-Funded Warrants) more than 4.99% (or, at the election of the holder, 9.99% ) of the outstanding common stock immediately after giving effect to the exercise. In the event of a fundamental transaction, as defined in the form of Pre-Funded Warrant, the holders of the Pre-Funded Warrants will be entitled to receive upon exercise of the Pre-Funded Warrants the kind and amount of securities, cash or other property that the holders would have received had they exercised the Pre-Funded Warrants immediately prior to such fundamental transaction. At-The-Market Program Since 2021, we have maintained at‑the‑market equity offering programs (collectively, the “ATM Programs”) pursuant to sales agreements with JonesTrading Institutional Services LLC (“JonesTrading”) and, more recently, Leerink Partners LLC (“Leerink”). Under the ATM Programs, shares of our common stock may be offered and sold from time to time at prevailing market prices. References in this Report to proceeds from “the ATM” or “ATM offerings” refer collectively to sales of our common stock under one or more of the ATM Programs. On March 11, 2021 , we entered into a sales agreement with JonesTrading under which we may offer and sell, from time to time at our sole discretion, to or through JonesTrading, acting as agent and/or principal, shares of our common stock having an aggregate offering price of up to $40.0 million . On January 13, 2025 , we entered into a new sales agreement with Leerink under which 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 . Upon entry into the new sales agreement, the Company terminated its prior ATM program pursuant to the Capital on DemandTM Sales Agreement dated March 11, 2021 , by and between the Company and JonesTrading. 43 Table of Contents Opus Genetics, Inc. Form 10-Q 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 On June 4, 2021 , we entered into a placement agency agreement for a registered direct offering (“RDO”) with A.G.P./Alliance Global Partners (“AGP”). Pursuant to the terms of the placement agency agreement, AGP on June 8, 2021 sold an aggregate of 3,076,923 shares of our common stock and warrants to purchase 1,538,461 shares of our common stock (the “RDO Warrants”) at an offering price of $4.875 per one share and per one-half of each RDO Warrant. The RDO was made pursuant to the Company’s 2021 shelf registration. 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; provided that upon prior notice to the Company, the holder may increase or decrease the beneficial ownership limitation, provided further that in no event shall the beneficial ownership limitation exceed 9.99%. Cash Flows The following table summarizes our cash flows for the periods indicated (in thousands): For the Six Months Ended 2026 2025 Net cash (used in) operating activities $ (24,677) $ (19,263) Net cash provided by (used in) investing activities — — Net cash provided by financing activities 68,498 21,371 Net increase in cash, cash equivalents and restricted cash $ 43,821 $ 2,108 Cash Flow from Operating Activities 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 Opus’s operating expenses and collections under the normal course of business. 44 Table of Contents Opus Genetics, Inc. Form 10-Q Cash Flow from Investing Activities There were no sources or uses of cash from investing activities during the periods presented. Cash Flow from Financing Activities 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 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; however, the attainment of milestones or level of sales required to earn royalty payments is highly uncertain for the reasons explained below. To date, outside of the license and collaborations revenue referenced above, we do not expect to generate significant revenue unless or until RYZUMVI sales become material, or regulatory approval is obtained and commercialization begins for LCA5, BEST1, other internally-developed assets or PS for additional indications. If we fail to complete the development of LCA5, BEST1, other internally-developed assets, PS or any other product candidate we may pursue in the future in a timely manner or fail to obtain regulatory approval for any of such product candidates, our ability to generate significant revenue would be compromised. The April 2026 Note Purchase Agreement provides for, among other things, the issuance of up to $155.0 million of senior secured notes, of which the Purchasers have committed, subject to the satisfaction of customary funding conditions and, in certain cases, achievement of certain milestones, to purchase $105.0 million (the first tranche of $35.0 million has been purchased), and the remaining $50.0 million is uncommitted. The April 2026 Purchase and Conversion Agreement provides 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 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. 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 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 45 Table of Contents Opus Genetics, Inc. Form 10-Q 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 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 Pursuant to the Viatris License Agreement, our budgeted research and development expenses related to the development of PS are fully reimbursed by Viatris. The development of LCA5, BEST1 and other internally-developed assets is subject to numerous uncertainties, and we have based these estimates on assumptions that may prove to be substantially different than what we currently anticipate and could result in cash resources being used sooner than what we currently expect. Additionally, the process of advancing early-stage product candidates and testing product candidates in clinical trials is costly, and the timing of progress in these clinical trials is uncertain. Our ability to successfully transition to profitability will be dependent upon achieving a level of product sales adequate to support our cost structure. We cannot give any assurance that we will ever be profitable or generate positive cash flow from operating activities. Contractual Obligations and Commitments Our contractual obligations in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 12, 2026, have not materially changed since we filed that report, except as discussed below. Other Commitments In the course of normal operations, we enter into cancelable purchase commitments from time to time with our suppliers for various key research, clinical and manufacturing services. The purchase commitments covered by these arrangements are subject to change based on our research and development efforts. Other Funding Requirements As noted above, certain of our cash requirements relate to the funding of our ongoing research and development of our gene therapy product candidates, inclusive of any potential milestone and royalty obligations under our intellectual property licenses. 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 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. Critical Accounting Policies and Estimates Our financial statements are prepared in accordance with U.S. 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 46 Table of Contents Opus Genetics, Inc. Form 10-Q 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. Our significant accounting policies are discussed in Note 1 — Company Description and Summary of Significant Accounting Policies, included in “Part I, Item 1 – Financial Statements” of this Report. We believe that the following accounting policies and estimates are the most critical to aid in fully understanding and evaluating our reported financial results. These estimates require our most difficult, subjective, or complex judgments because they relate to matters that are inherently uncertain. We have reviewed these critical accounting policies and estimates and related disclosures with the Audit Committee of our Board. We have not made any material changes to date, nor do we believe there is a reasonable likelihood of a material future change to the accounting methodologies for the areas described below. License and Collaborations Revenue We account for license and collaborations revenue in accordance with the provisions of the Financial Accounting Standards Board Accounting Standards Codification 606, Revenue from Contracts with Customers . The guidance provides a unified model to determine how revenue is recognized. We have entered into license and collaboration agreements which have revenue recognition implications. We recognize license and collaborations revenue by first allocating the transaction price of a contract to each performance obligation under the contract based on its stand-alone price. The stand-alone price of each performance obligation is based on its fair value utilizing a discounted cash flow approach, taking into consideration assumptions, including projected worldwide net profit for each of the respective programs based on probability assessments, projections based on internal forecasts, industry data, and information from other guideline companies within the same industry and other relevant factors. We do not expect to have in the future significant variable consideration adjustments related to our existing license and collaborations revenue recognized. 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; and • 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 47 Table of Contents Opus Genetics, Inc. Form 10-Q Warrant Liabilities The Company issued warrants to purchase equity securities in connection with the March 2025 financings that are recorded under the warrant liabilities line item in the accompanying condensed consolidated balance sheets. The Company accounts for these warrants as a liability at fair value when the valuation inputs are not fixed and determinable. The Company adjusts the liability for changes in fair value until the earlier of the exercise or expiration of the warrants. Any future change in fair value of the warrant liabilities, when outstanding, is recognized in the condensed consolidated statements of comprehensive loss under the fair value change in warrant liabilities line item. 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 A full valuation allowance has been provided on our net deferred tax assets given the uncertainty of future taxable income and other related factors impacting the realizability of our remaining net deferred tax assets. For additional information, see Note 12 — Income Taxes included in “Part II, Item 8 – Financial Statements and Supplementary Data” in our Annual Report filed on Form 10-K for the year ended December 31, 2025, and see Note 14 — Income Taxes included in “Part 1, Item 1 – Financial Statements” of this Report. Recent Accounting Pronouncements Refer to Note 1— “Company Description and Summary of Significant Accounting Policies” to our condensed consolidated financial statements included in “Part 1, Item 1 – Financial Statements” in this Report for a discussion of recently issued accounting pronouncements. Item 3. Quantitative and Qualitative Disclosures About Market Risk Not applicable for smaller reporting companies.