IRD

OPGx-BEST1 Cohort 1 Topline Data Expected in Second Week of September 2026 Enrollment Completed in LCA5 Registrational Trial with Dosing Planned for Q4 2026 RDH12, MERTK and RHO Programs Advancing with Upcoming Initiation of Clinical Testing Cash Runway into 2029 Expected to Support Multiple Clinical Inflection Points and Opportunities for Priority Review Vouchers RESEARCH TRIANGLE PARK, N.C., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced financial results for the second quarter ended June 30, 2026, and provided a corporate update. “With a focus on execution, we are rapidly advancing five gene therapy programs that address significant unmet need in inherited retinal diseases, with OPGx-BEST1 Cohort 1 clinical data targeted for the second week of September and four additional clinical readouts expected in 2027,” said George Magrath, M.D., Chief Executive Officer of Opus Genetics. “Based on recent FDA interactions, we finalized the OPGx-LCA5 registrational trial design. We have completed enrollment and expect to initiate participant dosing in the fourth quarter of this year. Our recent R&D Science Forum highlighted the significant progress we have made in advancing our pipeline. Our strong cash runway into 2029 positions us to initiate new clinical studies, deliver multiple data inflection points, pursue potential product approvals, and unlock opportunities for Priority Review Vouchers.” Pipeline Updates OPGx-BEST1 Enrollment was completed in Cohort 1 of the Phase 1/2 trial (BIRD-1), with 3-month topline data from Cohort 1 expected during the second week of September 2026, assuming all participants complete their assessments as scheduled. Baseline demographics were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting with the related poster presentation available on the Publications & Presentations page of the Opus Genetics website. Additionally, a slide presentation and video summary recording titled “OPGx-BEST1 Cohort 1 Baseline Demographics and Key Endpoints for IRDs” are provided on the OPGx-BEST1 Program section of the Opus Genetics website. OPGx-LCA5 Alignment was achieved with the U.S. Food and Drug Administration (FDA) on the registrational Phase 3 clinical trial evaluating OPGx-LCA5 in eight participants with a six-month run-in period, allowing each participant to serve as their own control, prior to receiving treatment in both eyes. Enrollment in the trial was completed, with dosing of OPGx-LCA5 expected to begin in the fourth quarter of 2026 using clinical drug supply manufactured with the intended commercial processes. Topline data from the study is expected by the end of 2027. OPGx-RDH12 The OPGx-RDH12 program is expected to enter the clinic in the fourth quarter of 2026 and is partially funded through a partnership with the RDH12 Alliance. OPGx-MERTK The OPGx-MERTK program is expected to initiate clinical testing at the Cleveland Clinic Abu Dhabi in the first quarter of 2027. OPGx-RHO Preclinical data presented at ARVO 2026 and the Foundation Fighting Blindness Retinal Therapeutics Innovation Summit 2026 provided safety and efficacy data on the use of OPGx-RHO in two large animal models of autosomal-dominant retinitis pigmentosa (adRP). The OPGx-RHO program is expected to initiate clinical testing globally in the second half of 2027. Recent Medical Presentations Opus Genetics delivered numerous data presentations at prominent medical meetings during the period including at the Association for Research in Vision and Ophthalmology (ARVO), Retina World Congress, and the American Society of Gene & Cell Therapy. In addition, in July 2026, Human Gene Therapy published “Evaluation of the Toxicity and Efficacy of an Adeno‑Associated Viral Vector Expressing BEST1 Delivered by Subretinal Injection in a Canine Model of Human Bestrophinopathy”. All materials can be found on the Publications & Presentations page of the Company website. Financial Results for the Second Quarter Ended June 30, 2026 Cash Position: As of June 30, 2026, Opus Genetics had cash and cash equivalents of $88.8 million. With the current cash and cash equivalents, and potential future fundings under the note purchase agreement with Oberland Capital Management, the Company believes its aggregate cash resources will fund operations into 2029. This estimate excludes any potential proceeds from callable warrants or future milestone payments. Revenue: License and collaborations revenue totaled $0.8 million for the quarter ended June 30, 2026, compared to $2.9 million for the same period in 2025. Revenue in both periods came primarily from reimbursement of research and development (R&D) services based on the Company’s collaboration with Viatris, Inc. Research and Development (R&D) Expenses: R&D expenses were $11.2 million for the quarter ended June 30, 2026, compared to $6.0 million for the same period in 2025. The increase was primarily attributable to higher manufacturing and clinical costs associated with the Company's IRD programs, partially offset by lower clinical costs associated with the Phentolamine Ophthalmic Solution 0.75% programs. Research and development expenses included $0.4 million and $0.3 million in stock-based compensation expense for the three months ended June 30, 2026 and 2025, respectively. General and Administrative (G&A) Expenses: G&A expenses were $6.0 million for the quarter ended June 30, 2026, compared to $5.8 million for the same period in 2025. The increase was primarily attributable to higher employee compensation costs, partially offset by lower public company related costs. General and administrative expenses included $1.0 million and $0.6 million in stock-based compensation expense during the three months ended June 30, 2026 and 2025, respectively. Net Loss: Net loss for the quarter ended June 30, 2026 was $8.1 million, or ($0.08) per basic and ($0.14) per diluted share, compared to a net loss of $7.4 million, or ($0.12) per basic and diluted share, for the same period in 2025. The increase in net loss was primarily due to higher R&D expense, lower license and collaborations revenue, and higher financing costs period over period. These changes were partially offset by higher income period over period of $6.3 million from the fair value change in instruments measured at fair value. About Opus Genetics Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs). The Company is developing durable, one-time treatments designed to address the underlying genetic causes of severe retinal disorders. The Company’s pipeline includes seven AAV-based programs, led by OPGx-LCA5 for LCA5-related mutations and OPGx-BEST1 for BEST1-related retinal degeneration, with additional candidates targeting RDH12, MERTK, RHO, CNGB1 and NMNAT1. The Company is based in Research Triangle Park, NC. For more information, visit www.opusgtx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements related to cash runway and future financing availability, potential future funding under the Oberland facility, potential product approvals, and Priority Review Voucher opportunities, the clinical development, clinical results, preclinical data and future plans for Phentolamine Ophthalmic Solution 0.75%, OPGx-LCA5, OPGx-BEST1, OPGx-MERTK, OPGx-RDH12, OPGx-RHO and earlier stage programs, and expectations regarding us, our business prospects and our results of operations, and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in our most recent Annual Report on Form 10-K and in our other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. Contacts: InvestorsJenny KobinRemy BernardaIR Advisory [email protected] Media Kimberly HaKKH [email protected] Source: Opus Genetics, Inc.

Cohort 1 Topline Data Expected in the Second Week of September 2026 RESEARCH TRIANGLE PARK, N.C., July 09, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company”, “Opus Genetics” or “Opus”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today provided updates on its ongoing OPGx-BEST1 Phase 1/2 clinical trial (BIRD-1) targeting BEST-1 associated IRDs. Opus expects to announce three-month topline data from Cohort 1 of the Phase 1/2 trial during the second week of September 2026, assuming all participants complete their assessments as scheduled. In addition, the Company plans to present the data at the annual EURETINA Congress taking place in Vienna, Austria from October 1 - 4, 2026. BIRD-1 is an adaptive, open-label, Phase 1/2 study evaluating 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). Enrollment in Cohort 1 was completed in May 2026 with five participants in the study, three with BVMD and two with ARB, who were carefully selected to meet the defined entry criteria. In the BVMD participants, the Company completed the added step of using an in vitro platform to confirm that each participant’s disease mutation is amenable to gene augmentation. After the last participant has completed the Month 3 visit, the Independent Data Monitoring Committee (IDMC) will review all Cohort 1 data and determine next steps. In Cohort 1, the primary endpoint for evaluation is the safety and tolerability of OPGx-BEST1. In addition to safety measures, Opus will be also assessing a number of structural parameters including subretinal fluid as measured by Optical Coherence Tomography (OCT) scans. A reduction in subretinal fluid on OCT would suggest that OPGx-BEST1 has a biological effect demonstrating target engagement. A reduction trending towards 20% may be considered clinically meaningful, and these results, in addition to those on safety, are expected to be used to provide the rationale to advance the trial into Cohort 2 to optimize dose selection, per the trial protocol. Given the high level of patient interest in the trial, potential participants have already been identified to enroll in Cohort 2 if necessary. In the event that OPGx-BEST1 demonstrates a 100% reduction in fluid in the majority of patients in Cohort 1, the trial may be expanded into a potential pivotal trial. Opus expects to present the Month 3 data to the U.S. Food and Drug Administration (FDA) to align on the next steps for clinical development. In addition to OCT structural assessments, functional endpoints will also be evaluated including microperimetry, best corrected visual acuity (BCVA), low luminance visual acuity (LLVA) and contrast sensitivity. Correlation between functional improvements and structural changes would suggest clinically meaningful target engagement by of functional improvements with structural changes would be suggestive of clinically meaningful target engagement of OPGx-BEST1. Due to the open-label nature of the trial, the Company plans to enter an investor relations quiet period beginning July 15, 2026, and continuing until the public announcement of these data. “We continue to work closely with our study sites and investigators to support this trial. We are deeply grateful to the participants and encouraged by the significant interest in this trial from the patient community,” said George Magrath, M.D., Chief Executive Officer of Opus Genetics. “For the significant number of BEST1 patients in the U.S. and globally, there is a substantial need for treatment options, with no therapies currently available today.” Additional OPGx-BEST1 resources can be found on the Opus Genetics website: Overview, presentations and webcasts can be found here, including: Publications and medical conference presentations can be found here, including the baseline demographics poster presentation from the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting (May 2026). About OPGx-BEST1 OPGx-BEST1 leverages Opus Genetics’ proprietary AAV-based gene therapy platform, designed to deliver a functional copy of the BEST1 gene directly to the retinal pigment epithelium (RPE) cells where the defective gene resides. The program builds on extensive preclinical work demonstrating restoration of BEST1 protein expression and improved retinal function in relevant disease models. By restoring BEST1 function, the therapy aims to address the underlying genetic cause of retinal degeneration and support preservation of photoreceptor health and visual function. Estimated global prevalence in BEST1-associated IRDs is approximately 21,800 patients, including roughly 8,400 patients in the U.S. comprised of approximately 8,000 best vitelliform macular dystrophy (BVMD) and approximately 400 autosomal recessive bestrophinopathy (ARB) patients. OPGx-BEST1 is currently being evaluated in an open-label, Phase 1/2 clinical trial. Additional information on the trial can be found by ClinicalTrials.gov Identifier: NCT07185256. There are currently no approved treatments for the disease. About Opus Genetics Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs). The Company is developing durable, one-time treatments designed to address the underlying genetic causes of severe retinal disorders. The Company’s pipeline includes seven AAV-based programs, led by OPGx-LCA5 for LCA5-related mutations and OPGx-BEST1 for BEST1-related retinal degeneration, with additional candidates targeting RDH12, MERTK, RHO, CNGB1 and NMNAT1. The Company is based in Research Triangle Park, NC. For more information, visit www.opusgtx.com. Forward-Looking Statements This press release contains certain statements that 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, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements related to the anticipated timing of topline data from the OPGx-BEST1 Phase 1/2 clinical trial, clinical development, clinical results, preclinical data, and future plans for OPGx-BEST1 and expectations regarding us, our business prospects, and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2025, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, and in our other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. Contacts: InvestorsJenny KobinRemy BernardaIR Advisory [email protected] MediaKimberly HaKKH [email protected] Source: Opus Genetics, Inc.

Opus Genetics Virtual R&D Science Forum Scheduled for Tuesday, June 16, 2026, at 10:00 am ET Upcoming Data Readout for Cohort 1 of OPGx-BEST1 Gene Therapy Study Expected in September 2026 LCA5 Accepted to FDA’s Rare Disease Evidence Principles (RDEP) Program and Enrolling Pivotal Trial RDH12, MERTK and RHO Programs Expected to Advance to Clinical Testing in the Next 12 Months Cash Runway into 2029 Expected to Support Multiple Clinical Inflection Points, Potential Product Approvals and Opportunities for Priority Review Vouchers RESEARCH TRIANGLE PARK, N.C., May 12, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced financial results for the first quarter ended March 31, 2026, and provided a corporate update. “With encouraging momentum across both our LCA5 and BEST1 gene therapy programs, Opus Genetics is entering a defining stretch where we believe our precision targeted approach can reshape what’s possible for patients with inherited retinal diseases,” said George Magrath, M.D., Chief Executive Officer of Opus Genetics. “Our upcoming BEST1 Cohort 1 clinical data and June R&D Science Forum will provide key opportunities to showcase the depth and maturity of our science and pipeline. Backed by a strong balance sheet and disciplined capital strategy, we are well-positioned to advance our lead programs toward pivotal trials, and accelerate our earlier‑stage RDH12, MERTK, and RHO programs into the clinic.” Pipeline Updates Research & Development (R&D) Science Forum Opus Genetics plans to host an R&D Science Forum on Tuesday, June 16, 2026, from 10:00 am – 12:00 pm ET, with management and key opinion leaders (KOLs) highlighting earlier-stage gene therapy programs entering clinical testing and IRD global market opportunities. Registration for the event will be available on the Events page of the Opus Genetics website. OPGx-BEST1 Enrollment completed in Cohort 1 of the Phase 1/2 trial (BIRD-1) including participants with both dominant and recessive forms of BEST disease, with the final participant scheduled for dosing this month. Baseline demographics were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2026 Annual Meeting with the related poster presentation available on the Publications & Presentations page of the Opus Genetics website. Additionally, a slide presentation and video summary recording titled “OPGx-BEST1 Cohort 1 Baseline Demographics and Key Endpoints for IRDs” are provided on the IR Presentations page of the Opus Genetics website. Opus Genetics expects to announce three-month topline data from Cohort 1 of the Phase 1/2 trial in September 2026. OPGx-LCA5 Positive six-month pediatric cohort data was presented at ARVO 2026; robust and consistent improvements were observed in cone-mediated function with average gains of approximately 1.5 log unit in cone sensitivity, reaching normal ranges after a single dose. Improvements were also observed in objective measures, visual acuity, and functional vision. The therapy was well tolerated, with most adverse events anticipated, mild, and not related to OPGx-LCA5. The U.S. Food and Drug Administration (FDA) granted acceptance of the LCA5 program into the Rare Disease Evidence Principles (RDEP) program, which is designed to provide guidance on the types of evidence that can be used to demonstrate substantial evidence of effectiveness, including the potential use of a single adequate and well-controlled study supported by confirmatory evidence. Recruitment is ongoing in the run-in period for the pivotal Phase 3 trial. In parallel, the clinical and commercial batch of drug product is being manufactured. Dosing with OPGx-LCA5 is expected to start in the fourth quarter of 2026. OPGx-RDH12 OPGx-RDH12 is being developed to deliver a functional RDH12 gene to photoreceptors using an AAV vector. This program is expected to enter the clinic in the fourth quarter of 2026. Funding is supported by 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. Clinical development activities are underway. Funding is supported by a consortium led by Abu Dhabi’s Healthcare Research and Innovation Fund. OPGx-RHO Preclinical data presented at ARVO 2026 and the Foundation Fighting Blindness Retinal Therapeutics Innovation Summit 2026 provided safety and efficacy data on the use of OPGx-RHO in two large animal models of autosomal-dominant retinitis pigmentosa (adRP). This preclinical work was co-funded by the Foundation Fighting Blindness and the National Institutes of Health. This program is expected to enter the clinic in 2027. Recent Medical Presentations ARVO 2026 Annual Meeting: “Restoration of Cone-Mediated Vision After Gene Augmentation in Children with LCA5” “Preliminary Results from Adult Participant in a Phase 1b/2a Clinical Study of OPGx-BEST1 Gene Therapy for ARB and BVMD Due to BEST1 Mutations” “Development of Cell-Based Expression and Functional Potency Assays for OPGx-BEST1 Gene Therapy” “Nonclinical Efficacy and Toxicity Study of GMP-Grade Vector OPGx-RHO (Scaav2/5-RHO820-Shrna820) Delivered by Subretinal Injection in a Canine Model of RHO-adRP” “Therapeutic Efficacy of a Mutation-Independent AAV Knockdown and Replacement Approach in a Swine Animal Model of Autosomal-Dominant Retinitis Pigmentosa (adRP)” Foundation Fighting Blindness Retinal Therapeutics Innovation Summit 2026: “Safety and Efficacy of OPGx-RHO Silence-and-Replace Gene Therapy for RHO-adRP: Evidence Across Two Large Animal Models” The Macula Society Annual Meeting: “Preliminary Results from Sentinel Patient in a Phase 1b/2a Clinical Study of OPGx-BEST1 Gene Therapy for the Treatment of BVMD and ARB Due to BEST1 Mutations” Asia-Pacific Academy of Ophthalmology Congress (APAO): “Gene Therapy for BEST1 Inherited Retinal Disease” Advanced Therapies Week: “Building Scalable Viral Vector Manufacturing Models” Financial Results for the First Quarter Ended March 31, 2026 Cash Position: As of March 31, 2026, Opus Genetics had cash and cash equivalents of $60 million. Subsequent to the end of the period, the Company entered into a strategic financing agreement with Oberland Capital Management, which included funding of a principal amount of $35 million of senior secured notes and a commitment to a $5 million equity investment, which is expected to close on or about May 22, 2026, subject to the satisfaction of customary closing conditions. With approximately $90 million in current cash, and potential future fundings under the facility with Oberland Capital Management, the Company believes its aggregate cash resources will fund operations into 2029. This estimate excludes any potential proceeds from callable warrants or future milestone payments. Revenue: License and collaborations revenue totaled $2.2 million for the quarter ended March 31, 2026, compared to $4.4 million for the same period in 2025. Revenue in both periods came primarily from reimbursement of research and development (R&D) services based on the Company’s collaboration with Viatris, Inc. Research and Development (R&D) Expenses: R&D expenses were $10.6 million for the quarter ended March 31, 2026, compared to $8.0 million for the same period in 2025. The increase was primarily attributable to higher manufacturing costs associated with the Company’s IRD programs, partially offset by lower clinical costs associated with the Company’s phentolamine-related programs. R&D 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. General and Administrative (G&A) Expenses: G&A expenses were $5.9 million for the quarter ended March 31, 2026, compared to $6.3 million for the same period in 2025. The decrease was primarily attributable to lower legal costs, partially offset by higher employee compensation-related costs. G&A expenses included $1.1 million and $0.6 million in stock-based compensation expense for the three months ended March 31, 2026 and 2025, respectively. Net Loss: Net loss for the quarter ended March 31, 2026 was $65.5 million, or ($0.75) per basic and diluted share, compared to a net loss of $8.2 million, or ($0.24) per basic and diluted share, for the same period in 2025. The increase in net loss was primarily due to a non-cash expense, driven by the increase in the fair value change in warrant liabilities associated with the Company’s March 2025 warrants, and higher R&D expenses as discussed above. About Opus Genetics Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs). The Company is developing durable, one-time treatments designed to address the underlying genetic causes of severe retinal disorders. The Company’s pipeline includes seven AAV-based programs, led by OPGx-LCA5 for LCA5-related mutations and OPGx-BEST1 for BEST1-related retinal degeneration, with additional candidates targeting RDH12, MERTK, RHO, CNGB1 and NMNAT1. The Company is based in Research Triangle Park, NC. For more information, visit www.opusgtx.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements related to cash runway and future financing availability, potential future funding under the Oberland facility, potential product approvals, and Priority Review Voucher opportunities, the clinical development, clinical results, preclinical data and future plans for Phentolamine Ophthalmic Solution 0.75%, OPGx-LCA5, OPGx-BEST1, OPGx-MERTK, OPGx-RDH12, OPGx-RHO and earlier stage programs, and expectations regarding us, our business prospects and our results of operations, and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in our most recent Annual Report on Form 10-K and in our other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. Contacts: Investors Jenny Kobin Remy Bernarda IR Advisory Solutions [email protected] Media Kimberly Ha KKH Advisors 917-291-5744 [email protected] Source: Opus Genetics, Inc.

Certara, Inc. (CERT) came out with quarterly earnings of $0.09 per share, missing the Zacks Consensus Estimate of $0.11 per share. This compares to earnings of $0.14 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -20.57%. A quarter ago, it was expected that this company would post earnings of $0.11 per share when it actually produced earnings of $0.09, delivering a surprise of -18.18%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Certara, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $106.92 million for the quarter ended March 2026, surpassing the Zacks Consensus Estimate by 1.22%. This compares to year-ago revenues of $106 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Certara shares have lost about 28.4% since the beginning of the year versus the S&P 500's gain of 8.1%. While Certara has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Certara was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.12 on $106.24 million in revenues for the coming quarter and $0.45 on $427.74 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Opus Genetics, Inc. (IRD), has yet to report results for the quarter ended March 2026. This company is expected to post quarterly loss of $0.16 per share in its upcoming report, which represents a year-over-year change of +50%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Opus Genetics, Inc.'s revenues are expected to be $2.81 million, down 35.7% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Certara, Inc. (CERT) : Free Stock Analysis Report Opus Genetics, Inc. (IRD) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

- Favorable early safety and initial efficacy data from BEST1 program highlighted at premier gathering of global retinal experts with additional data expected mid-year 2026 - - Reauthorization of FDA’s Rare Pediatric Disease Priority Review Voucher (PRV) program provides opportunity for Opus’ deep pipeline in rare inherited retinal diseases - - FDA Prescription Drug User Fee Act (PDUFA) date in October 2026 for Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia - - Funding from prominent healthcare investors expected to extend cash runway into 2028 - RESEARCH TRIANGLE PARK, N.C., March 10, 2026 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced financial results for the year ended December 31, 2025, and provided a corporate update. “We are delivering a steady cadence of data and milestones across our pipeline,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “With positive clinical results from both our BEST1 and LCA5 gene therapy programs, new funding for our MERTK program and an upcoming FDA PDUFA date for Phentolamine Ophthalmic Solution 0.75% in presbyopia, we are advancing therapies with both scientific promise and compelling commercial potential. The reauthorization of the U.S. Rare Pediatric Disease Priority Review Voucher program further strengthens our work, reinforcing long‑term incentives that support sustainable investment in rare gene therapy development. With multiple catalysts ahead and a capital‑efficient operating model, we believe Opus is positioned to create significant long‑term value for shareholders.” Pipeline Updates OPGx-BEST1 – Gene Therapy for BEST1-Related IRD Recruitment is ongoing at multiple U.S. sites with two participants treated to date in the Phase 1/2 trial (BIRD-1) that includes patients with both dominant and recessive forms of BEST disease. Positive initial three-month data from the first (sentinel) participant presented at Macula Society 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 observed to date. 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. 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. Three-month results from the full Cohort 1 are expected in mid-year 2026. OPGx-LCA5 – Gene Therapy for Leber Congenital Amaurosis (LCA5) Recruitment ongoing with multiple participants enrolled to date in a run-in period for the pivotal Phase 3 trial, which is targeted to enroll as few as eight participants in a single arm, 12-month study utilizing an adaptive design. Dosing with OPGx-LCA5 expected in the second half of 2026. Application expected to be submitted in Q1 2026 for Rare Disease Evidence Principles (RDEP) review process from the U.S. Food and Drug Administration (FDA), designed to provide greater speed and predictability in the review of therapies intended to treat rare diseases with very small patient populations with significant unmet medical need and that are driven by a known genetic defect. Presentation of Phase 1/2 six-month pediatric cohort data expected at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) conference in May 2026. Preclinical Gene Therapy Pipeline Funding secured from Abu Dhabi’s Healthcare Research and Innovation Fund to conduct a clinical trial evaluating OPGx-MERTK for MERTK-related retinitis pigmentosa (RP), a rare IRD that causes progressive vision loss and eventual blindness. Clinical development activities are underway. Preclinical work ongoing for Opus’ broad IRD pipeline related to genetic mutations in RHO, CNGB1, RDH12-LCA, and NMNAT1, with one to two programs targeted to enter clinical testing this year. Phentolamine Ophthalmic Solution 0.75% (PS) The FDA accepted the Company’s supplemental New Drug Application (sNDA) for Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia and set a PDUFA action date of October 17, 2026. LYNX-3, the second pivotal Phase 3 trial in keratorefractive participants with visual disturbances under mesopic, low-contrast conditions (dim light disturbances), is ongoing with topline results expected in the first half of 2026. Recent Medical Publications and Presentations Presentation at The Macula Society Annual Meeting titled “Preliminary Results from Sentinel Patient in a Phase 1b/2a Clinical Study of OPGx-BEST1 Gene Therapy for the Treatment of BVMD and ARB Due to BEST1 Mutations.” Presentation at the Asia-Pacific Academy of Ophthalmology Congress (APAO) titled “Gene Therapy for BEST1 Inherited Retinal Disease.” Presentation at the Advanced Therapies Week Conference titled “Building Scalable Viral Vector Manufacturing Models.” Presentation at the Cell and Gene Meeting on the Mesa titled “Transformative Gene Therapies for the Treatment of Rare Inherited Retinal Diseases.” Poster presentation at the American Academy of Optometry Annual Meeting 2025 titled “LYNX-2: A Pivotal Phase 3 Trial of Phentolamine Ophthalmic Solution in Post-Keratorefractive Surgery Subjects with Decreased Mesopic Visual Acuity.” Presentation at Eyecelerator at the American Academy of Ophthalmology (AAO) Annual Meeting titled “Transformative Gene Therapies for the Treatment of Rare Inherited Retinal Diseases.” Financial Results for the Year Ended December 31, 2025 Cash Position: As of December 31, 2025, Opus Genetics had cash and cash equivalents of $45.1 million. Subsequent to the end of the fourth quarter, the Company raised approximately $25.0 million in gross proceeds through a private placement of equity securities. Based on current operating plans, the Company believes its aggregate cash resources of $70.1 million will fund operations into the first half of 2028, excluding any potential proceeds from callable warrants or future milestone payments. Revenue: License and collaborations revenue totaled $14.2 million for the year ended December 31, 2025, compared to $11.0 million for the same period in 2024. Revenue in both periods was driven by the Company’s collaboration with Viatris, Inc. from reimbursement of research and development (R&D) services. Research and Development (R&D) Expenses: R&D expenses were $30.8 million for the year ended December 31, 2025, compared to $26.9 million for the same period in 2024. The increase was primarily attributable to higher costs related to clinical research, toxicology, payroll, professional services and other operating expenses, partially offset by lower manufacturing and regulatory costs. R&D expenses included $1.0 million in stock-based compensation expense during each of the years ended December 31, 2025 and 2024. General and Administrative (G&A) Expenses: G&A expenses were $22.0 million for the year ended December 31, 2025, compared to $18.2 million for the same period in 2024. The increase was primarily attributable to higher legal and patent-related costs, payroll and public company-related costs, and professional service fees. G&A expenses included $2.4 million in stock-based compensation expense during each of the years ended December 31, 2025 and 2024. Net Loss: Net loss for the year ended December 31, 2025 was $49.6 million, or ($0.80) per basic and diluted share, compared to a net loss of $57.5 million, or ($2.15) per basic and diluted share, for the same period in 2024. The year‑over‑year decrease in net loss was primarily driven by the absence of the $28.0 million acquired in‑process research and development charge recognized in 2024, partially offset by an $11.5 million increase in the fair value of warrant and other derivative liabilities associated with the Company’s March 2025 financings and increases to R&D and G&A expense as noted above. About Opus Genetics Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs). The Company is developing durable, one-time treatments designed to address the underlying genetic causes of severe retinal disorders. The Company’s pipeline includes seven AAV-based programs, led by OPGx-LCA5 for LCA5-related mutations and OPGx-BEST1 for BEST1-related retinal degeneration, with additional candidates targeting RHO, CNGB1, RDH12, NMNAT1, and MERTK. Opus Genetics is also advancing a small-molecule therapy, Phentolamine Ophthalmic Solution 0.75%, beyond its approved use for pharmacologically induced mydriasis, with a supplemental new drug application under review for presbyopia and an ongoing Phase 3 pivotal trial for mesopic, low contrast conditions after keratorefractive surgery (dim light disturbances). The Company is based in Research Triangle Park, NC. For more information, visit www.opusgtx.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements related to cash runway, the clinical development, clinical results, preclinical data and future plans for Phentolamine Ophthalmic Solution 0.75%, OPGx-LCA5, OPGx-BEST1, RDH12 and earlier stage programs, and expectations regarding us, our business prospects and our results of operations, and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in our most recent Annual Report on Form 10-K and in our other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. Contacts: Investors Jenny Kobin Remy Bernarda IR Advisory Solutions [email protected] Media Kimberly Ha KKH Advisors 917-291-5744 [email protected] -Financial Tables Follow- Source: Opus Genetics, Inc.

- Positive 3-month pediatric and 18-month adult clinical data from OPGx-LCA5 Phase 1/2 trial support the potential for restoring cone-mediated vision - - Successful FDA RMAT meeting provides the potential for an accelerated regulatory pathway to approval for OPGx-LCA5 - - OPGx-BEST1 gene therapy program underway with recruitment ongoing in Phase 1/2 trial for the treatment of BEST1 disease - - Supplemental New Drug Application submission planned by year-end 2025 for Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia - - Strengthened capital position from recent equity offering and non-dilutive funding from patient advocacy groups - RESEARCH TRIANGLE PARK, N.C., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs), today announced financial results for the third quarter ended September 30, 2025, and provided a corporate update. “We have taken critical steps in advancing our pipeline, including the positive data and successful outcome of our recent FDA meeting regarding our LCA5 program and the opening of recruitment in our BEST1 Phase 1/2 clinical trial,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “We look forward to continuing this momentum into next year, when we expect multiple data readouts across several programs. The financing we recently completed reinforces the strong support from existing shareholders and new prominent healthcare investors and provides us with financial resources to expedite the path toward multiple approvals.” Pipeline Updates OPGx-LCA5 – Gene Therapy for Leber Congenital Amaurosis (LCA) In September 2025, positive data was reported from the six participants treated to date in an open-label, Phase 1/2 clinical trial. Large gains in cone-mediated vision with improvements across multiple measures of visual function were observed in the three pediatric participants treated over three months. In the three adult participants, responses have been 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 to date. Successful completion of a Type B Regenerative Medicine Advanced Therapy (RMAT) meeting with the U.S. Food and Drug Administration (FDA) provides the potential for an accelerated regulatory pathway to approval of OPGx-LCA5. The Company plans to advance its ongoing trial into a Phase 3 portion which is expected to enroll 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. The first participant was enrolled in the planned run-in period of the Phase 3 portion of the study to evaluate the natural history of each participant to serve as their own control. Dosing with OPGx-LCA5 is anticipated in the second half of 2026 following availability of validated clinical drug supply manufactured with the intended commercial processes, with topline clinical data expected approximately one year later. LCA5 program featured on Good Morning America in honor of World Blindness Awareness Month. OPGx-BEST1 – Gene Therapy for BEST1-Related IRD In August 2025, the FDA accepted the Company’s Investigational New Drug (IND) application for OPGx-BEST1 to initiate a clinical trial. The Company is currently recruiting participants in an adaptive, open-label, dose-exploring Phase 1/2 trial known as BIRD1 to evaluate the safety and tolerability of subretinally injected OPGx-BEST1 in participants with Best Vitelliform Macular Dystrophy (BVMD) or Autosomal-Recessive Bestrophinopathy (ARB). Initial data is expected in the first quarter of 2026. OPGx-RDH12 and OPGx-MERTK – Advancing with Non-Dilutive Support Partnership with the Global RDH12 Alliance provides up to $1.6 million in non-dilutive funding to accelerate development of OPGx-RDH12 for Leber congenital amaurosis (RDH12-LCA). Non-dilutive funding of up to $2 million received from the Retinal Degeneration Fund to advance OPGx-MERTK, targeting retinitis pigmentosa caused by pathogenic variants in the Mer proto-oncogene tyrosine kinase (MERTK) gene. Phentolamine Ophthalmic Solution 0.75% (PS) – Advancing Toward Supplemental New Drug Application (sNDA) Submissions Based on positive clinical data from the VEGA-3 Phase 3 trial to treat presbyopia, Opus Genetics plans to submit an sNDA to the FDA by year-end 2025. Full recruitment has been completed in LYNX-3, the second pivotal Phase 3 trial in keratorefractive participants with visual disturbances under mesopic, low-contrast conditions, with topline results expected in the first half of 2026. The program is being conducted under a Special Protocol Assessment (SPA) and has received Fast Track Designation from the FDA. Medical Publications and Presentations Peer-reviewed publication of LCA5 Phase 1/2 trial data in Molecular Therapy: “Recovery of Cone-Mediated Vision in a Severe Ciliopathy after Gene Augmentation: One-Year Results of a Phase I/II Trial for LCA5-LCA,” authored by Tomas S. Aleman, M.D., et al. Presentation at Eyecelerator at the American Academy of Ophthalmology (AAO) Annual Meeting titled “Transformative Gene Therapies for the Treatment of Rare Inherited Retinal Diseases.” Presentation at the Cell and Gene Meeting on the Mesa titled: “Transformative Gene Therapies for the Treatment of Rare Inherited Retinal Diseases.” Poster presentation at the American Academy of Optometry Annual Meeting titled: “LYNX-2: A Pivotal Phase 3 Trial of Phentolamine Ophthalmic Solution in Post-Keratorefractive Surgery Subjects with Decreased Mesopic Visual Acuity.” Financial Results for the Third Quarter Ended September 30, 2025 Cash Position: As of September 30, 2025, Opus Genetics had cash and cash equivalents of $30.8 million. Subsequent to the end of the quarter, the Company raised approximately $23.0 million in gross proceeds through a registered direct offering of equity securities. Based on current operating plans, the Company expects its existing cash resources will fund operations into the second half of 2027, excluding any potential proceeds from callable warrants or future milestone payments. The existing cash position of over $50 million is expected to support progress through key milestones including initial data from the BEST1 program and running the pivotal LCA5 trial. Revenue: License and collaborations revenue totaled $3.1 million for the third quarter of 2025, compared to $3.9 million in the same period in 2024. Revenue in both periods was driven by the Company’s collaboration with Viatris, Inc. (“Viatris”), primarily from reimbursement of research and development (R&D) services. The decrease was due to lower PS R&D services. General and Administrative (G&A) Expenses: G&A expenses were $5.0 million for the third quarter of 2025, compared to $2.9 million for the same period in 2024. The increase was primarily attributable to higher legal and patent-related costs, payroll and public company-related costs, and professional service fees. G&A expenses included $0.6 million and $0.5 million in stock-based compensation in the third quarters of 2025 and 2024, respectively. Research and Development (R&D) Expenses: R&D expenses were $6.4 million for the third quarter of 2025, compared to $9.0 million for the same period in 2024. The decrease was primarily attributable to lower clinical research, manufacturing and toxicology costs for APX 3330 and PS, partially offset by increased IRD program expense. R&D expenses related to PS were fully reimbursed under the license and collaboration agreement with Viatris. R&D expenses included $0.2 million in stock-based compensation in both of the third quarters of 2025 and 2024. Net Loss: Net loss for the third quarter of 2025 was $17.5 million, or $(0.25) per basic and diluted share, compared to a net loss of $7.5 million, or $(0.29) per basic and diluted share, for the third quarter of 2024. The increased net loss was primarily due to the fair value change in warrant and other derivative liabilities related to the warrants issued in the March 2025 public offering and the March 2025 private placement, based on fluctuations in common stock fair value and underlying changes in volatility, expected term and interest rates. About Opus Genetics Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with inherited retinal diseases (IRDs). The Company is developing durable, one-time treatments designed to address the underlying genetic causes of severe retinal disorders. The Company’s pipeline includes seven AAV-based programs, led by OPGx-LCA5 for LCA5-related mutations and OPGx-BEST1 for BEST1-related retinal degeneration, with additional candidates targeting RHO, RDH12, and MERTK. Opus Genetics is also advancing Phentolamine Ophthalmic Solution 0.75%, an approved small-molecule therapy for pharmacologically induced mydriasis, with additional indications in late-stage development for presbyopia and low-light visual disturbances following keratorefractive surgery. The Company is based in Research Triangle Park, NC. For more information, visit www.opusgtx.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements related to cash runway, the clinical development, clinical results, preclinical data, and future plans for Phentolamine Ophthalmic Solution 0.75%, OPGx-LCA5, OPGx-BEST1, RDH12, and earlier stage programs, and expectations regarding us, our business prospects, and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, our subsequent Quarterly Report on Form 10-Q, and our other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. Contacts: Investors Jenny Kobin Remy Bernarda IR Advisory Solutions [email protected] Media Kimberly Ha KKH Advisors 917-291-5744 [email protected] -Financial Tables Follow- Source: Opus Genetics, Inc.

The market expects Opus Genetics, Inc. (IRD) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended September 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.14 per share in its upcoming report, which represents a year-over-year change of +51.7%. Revenues are expected to be $2.77 million, down 28.4% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 4.55% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Opus Genetics, Inc., the Most Accurate Estimate is the same as the Zacks Consensus Estimate, suggesting that there are no recent analyst views which differ from what have been considered to derive the consensus estimate. This has resulted in an Earnings ESP of 0%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that Opus Genetics, Inc. will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Opus Genetics, Inc. would post a loss of$0.25 per share when it actually produced a loss of -$0.12, delivering a surprise of +52.00%. Over the last four quarters, the company has beaten consensus EPS estimates three times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Opus Genetics, Inc. doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Certara, Inc. (CERT), is soon expected to post earnings of $0.11 per share for the quarter ended September 2025. This estimate indicates a year-over-year change of -15.4%. This quarter's revenue is expected to be $105.22 million, up 11% from the year-ago quarter. The consensus EPS estimate for Certara has been revised 77.3% higher over the last 30 days to the current level. However, a lower Most Accurate Estimate has resulted in an Earnings ESP of -4.76%. When combined with a Zacks Rank of #3 (Hold), this Earnings ESP makes it difficult to conclusively predict that Certara will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Opus Genetics, Inc. (IRD) : Free Stock Analysis Report Certara, Inc. (CERT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

It's been a pretty great week for Opus Genetics, Inc. (NASDAQ:IRD) shareholders, with its shares surging 12% to US$1.20 in the week since its latest second-quarter results. Revenues came in at US$2.9m, a whole 32% below what the analysts were forecasting. Losses were a (relative) bright spot by comparison, with a per-share (statutory) loss of US$0.12 substantially smaller than what was expected. The analysts typically update their forecasts at each earnings report, and we can judge from their estimates whether their view of the company has changed or if there are any new concerns to be aware of. Readers will be glad to know we've aggregated the latest statutory forecasts to see whether the analysts have changed their mind on Opus Genetics after the latest results. Trump has pledged to "unleash" American oil and gas and these 15 US stocks have developments that are poised to benefit. Taking into account the latest results, the current consensus, from the four analysts covering Opus Genetics, is for revenues of US$14.3m in 2025. This implies a measurable 7.4% reduction in Opus Genetics' revenue over the past 12 months. Losses are predicted to fall substantially, shrinking 50% to US$0.49. Yet prior to the latest earnings, the analysts had been forecasting revenues of US$17.3m and losses of US$0.84 per share in 2025. So there's been quite a change-up of views after the recent consensus updates, withthe analysts making a serious cut to their revenue forecasts while also reducing the estimated losses the business will incur. See our latest analysis for Opus Genetics The analysts have cut their price target 11% to US$6.00per share, suggesting that the declining revenue was a more crucial indicator than the forecast reduction in losses. The consensus price target is just an average of individual analyst targets, so - it could be handy to see how wide the range of underlying estimates is. Currently, the most bullish analyst values Opus Genetics at US$8.00 per share, while the most bearish prices it at US$5.00. Analysts definitely have varying views on the business, but the spread of estimates is not wide enough in our view to suggest that extreme outcomes could await Opus Genetics shareholders. One way to get more context on these forecasts is to look at how they compare to both past performance, and how other companies in the same industry are performing. We would highlight that revenue is expected to reverse, with a forecast 14% annualised decline to the end of 2025. That is a notable change from historical growth of 37% over the last five years. By contrast, our data suggests that other companies (with analyst coverage) in the same industry are forecast to see their revenue grow 20% annually for the foreseeable future. It's pretty clear that Opus Genetics' revenues are expected to perform substantially worse than the wider industry. The most obvious conclusion is that the analysts made no changes to their forecasts for a loss next year. Unfortunately, they also downgraded their revenue estimates, and our data indicates underperformance compared to the wider industry. Even so, earnings per share are more important to the intrinsic value of the business. Still, earnings are more important to the intrinsic value of the business. The consensus price target fell measurably, with the analysts seemingly not reassured by the latest results, leading to a lower estimate of Opus Genetics' future valuation. Keeping that in mind, we still think that the longer term trajectory of the business is much more important for investors to consider. We have forecasts for Opus Genetics going out to 2027, and you can see them free on our platform here. Plus, you should also learn about the 4 warning signs we've spotted with Opus Genetics (including 2 which make us uncomfortable) . Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

- Positive 12-month Phase 1/2 clinical data in adult cohort and early pediatric clinical data support potential for meaningful vision restoration with OPGx-LCA5 - - FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation for OPGx-LCA5 - - Positive topline results reported from VEGA-3 and LYNX-2 Phase 3 trials with Phentolamine Ophthalmic Solution 0.75% - - OPGx-BEST1 on track to enter Phase 1/2 trial in H2 2025 for the treatment of bestrophin-1 related inherited retinal disease - - Non-dilutive funding from patient advocacy groups secured to advance multiple early-stage gene therapy programs - RESEARCH TRIANGLE PARK, N.C., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the “Company” or “Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders, today announced financial results for the second quarter ended June 30, 2025, and provided a corporate update. “We’ve made significant progress across our pipeline, with multiple clinical and regulatory milestones achieved this quarter,” said George Magrath, M.D., Chief Executive Officer, Opus Genetics. “Receiving RMAT designation for our OPGx-LCA5 program underscores the strength of our clinical data and the urgent need for effective gene therapies to treat inherited retinal diseases. We are encouraged by the sustained functional vision improvements observed in adult patients in our clinical trial to date and the early signs of efficacy in the pediatric cohort. In parallel, our advancement of OPGx-BEST1 toward the clinic and the nomination of two additional development candidates in partnership with the Retinal Degeneration Fund and the Global RDH12 Alliance highlight the breadth of our IRD pipeline.” “Beyond gene therapy, the positive readouts from our two Phase 3 Phentolamine trials represent a major step toward our goal of bringing a new treatment option to millions of patients living with vision challenges. With several upcoming key milestones, including new clinical data, a supplemental New Drug Application (sNDA) submission, and the launch of a pivotal study, we remain focused on execution to deliver transformative treatments to patients with significant unmet needs,” Dr. Magrath concluded. Pipeline Updates OPGx-LCA5 – Gene Therapy for Leber Congenital Amaurosis (LCA) The U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation for OPGx-LCA5, for the treatment of Leber Congenital Amaurosis (LCA) due to genetic variations in the LCA5 gene, signifying the program’s potential to address a serious condition and providing a pathway for accelerated development and review. Twelve-month clinical data from adult participants in the Phase 1/2 trial demonstrated sustained improvements in visual function, including visual acuity gains and improved mobility testing scores. This data was presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in May. Initial pediatric data at one-month post-treatment showed vision improvement with no drug-related adverse events; three-month pediatric data is expected to be reported in Q3 2025. OPGx-BEST1 – Gene Therapy for BEST1-Related IRD Preclinical data presented at the American Ophthalmological Society (AOS) in May demonstrated restoration of the retinal pigment epithelium-photoreceptor interface in a canine model of BEST1 using AAV-mediated gene delivery. Investigational New Drug (IND) submission and Phase 1/2 trial initiation remain on track for the second half of 2025. OPGx-RDH12 and OPGx-MERTK – Advancing with Non-Dilutive Support Partnership with the Global RDH12 Alliance provides up to $1.6 million in non-dilutive funding to accelerate development of OPGx-RDH12 for Leber congenital amaurosis (RDH12-LCA). Non-dilutive funding up to $2 million received from the Retinal Degeneration Fund to advance OPGx-MERTK, targeting retinitis pigmentosa caused by MERTK mutations. Preclinical OPGx-MERTK data presented at the American Society of Gene & Cell Therapy (ASGCT) in May showed preservation of retinal function in animal models. Phentolamine Ophthalmic Solution 0.75% – Advancing Toward sNDA Submissions VEGA-3 Phase 3 trial met its primary and multiple secondary endpoints in presbyopia, with 27.2% of treated patients achieving a ≥15-letter gain in near visual acuity (vs. 11.5% on placebo, p<0.0001) and favorable participant reported outcomes and safety profile. LYNX-2 Phase 3 trial met its primary and multiple secondary endpoints in keratorefractive patients with night vision disturbances. Patients showed statistically significant gains in mesopic low contrast vision and improvements in night-driving related symptoms. sNDA submission for presbyopia indication planned for the second half of 2025. LYNX-3 Phase 3 trial expected to initiate enrollment in the second half of 2025 targeting reduced low light vision and nighttime visual disturbances. Additional Medical Meeting Presentations Virtual reality-guided functional testing to support meaningful clinical endpoints in IRD trials was presented at the Retinal Imaging Biomarkers Summit. Upcoming Expected Data Readouts and Program Advancements Report three-month pediatric data from OPGx-LCA5 Phase 1/2 trial in Q3 2025. Initiate enrollment in Phase 1/2 trial for OPGx-BEST1 in H2 2025. Submit Phentolamine sNDA for presbyopia in H2 2025. Initiate enrollment in Phentolamine LYNX-3 Phase 3 trial in H2 2025. Financial Results for the Second Quarter Ended June 30, 2025 Cash Position: As of June 30, 2025, Opus Genetics had cash and cash equivalents of $32.4 million. Based on current operating plans, the Company expects its existing cash resources will fund operations into the second half of 2026. Revenue: License and collaboration revenue totaled $2.9 million for the second quarter of 2025, compared to $1.1 million in the same period in 2024. Revenue in both periods was driven by the Company’s collaboration with Viatris, Inc., primarily from reimbursement of R&D services. General and Administrative (G&A) Expenses: G&A expenses were $5.8 million for the second quarter of 2025, compared to $3.4 million for the same period in 2024. The increase was mainly due to higher costs associated with legal and patent-related expenses, payroll, and business development activities. G&A expenses included $0.6 million and $0.5 million in stock-based compensation in the second quarters of 2025 and 2024, respectively. Research and Development (R&D) Expenses: R&D expenses were $6.0 million for the second quarter of 2025, compared to $6.1 million in the prior-year period. The slight decrease was primarily due to lower manufacturing and consulting costs, partially offset by increased clinical trial, toxicology, and payroll-related expenses. R&D expenses related to Phentolamine Ophthalmic Solution 0.75% were fully reimbursed under the Viatris License Agreement. Stock-based compensation within R&D expenses was $0.3 million in both periods. Net Loss: Net loss for the second quarter of 2025 was $7.4 million, or $(0.12) per basic and diluted share, compared to a net loss of $7.8 million, or $(0.30) per basic and diluted share, for the second quarter of 2024. SEC Filing: Additional details on the Company’s financial results will be available in its Quarterly Report on Form 10-Q for the period ended June 30, 2025, to be filed with the U.S. Securities and Exchange Commission (SEC). About Opus Genetics Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders. The Company’s pipeline features AAV-based gene therapies targeting inherited retinal diseases including Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa. Its lead gene therapy candidates are OPGx-LCA5, which is in an ongoing Phase 1/2 trial for LCA5-related mutations, and OPGx-BEST1, a gene therapy targeting BEST1-related retinal degeneration. Opus is also advancing Phentolamine Ophthalmic Solution 0.75%, a partnered therapy currently approved in one indication and being studied in two Phase 3 programs for presbyopia and reduced low light vision and nighttime visual disturbances. The Company is based in Research Triangle Park, NC. For more information, visit www.opusgtx.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements related to cash runway, the clinical development, clinical results, preclinical data, and future plans for Phentolamine Ophthalmic Solution 0.75%, OPGx-LCA5, OPGx-BEST1, RDH12, and earlier stage programs, and expectations regarding us, our business prospects, and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. Contacts: Investors Jenny Kobin Remy Bernarda IR Advisory Solutions [email protected] Media Kimberly Ha KKH Advisors 917-291-5744 [email protected] Source: Opus Genetics, Inc.

It's been a good week for Opus Genetics, Inc. (NASDAQ:IRD) shareholders, because the company has just released its latest quarterly results, and the shares gained 7.7% to US$1.02. Revenues of US$4.4m crushed expectations, although expenses increased commensurately, with statutory losses hitting US$0.24 per share, -17% above what the analysts expected. The analysts typically update their forecasts at each earnings report, and we can judge from their estimates whether their view of the company has changed or if there are any new concerns to be aware of. So we collected the latest post-earnings statutory consensus estimates to see what could be in store for next year. We've discovered 4 warning signs about Opus Genetics. View them for free. Taking into account the latest results, the current consensus from Opus Genetics' three analysts is for revenues of US$15.4m in 2025. This would reflect a decent 13% increase on its revenue over the past 12 months. The loss per share is expected to greatly reduce in the near future, narrowing 39% to US$0.78. Before this latest report, the consensus had been expecting revenues of US$13.3m and US$0.81 per share in losses. So there's been quite a change-up of views after the recent consensus updates, with the analysts making a sizeable increase to their revenue forecasts while also reducing the estimated loss as the business grows towards breakeven. Check out our latest analysis for Opus Genetics Yet despite these upgrades, the analysts cut their price target 31% to US$7.33, implicitly signalling that the ongoing losses are likely to weigh negatively on Opus Genetics' valuation. Fixating on a single price target can be unwise though, since the consensus target is effectively the average of analyst price targets. As a result, some investors like to look at the range of estimates to see if there are any diverging opinions on the company's valuation. Currently, the most bullish analyst values Opus Genetics at US$8.00 per share, while the most bearish prices it at US$6.00. With such a narrow range of valuations, the analysts apparently share similar views on what they think the business is worth. Another way we can view these estimates is in the context of the bigger picture, such as how the forecasts stack up against past performance, and whether forecasts are more or less bullish relative to other companies in the industry. We would highlight that Opus Genetics' revenue growth is expected to slow, with the forecast 17% annualised growth rate until the end of 2025 being well below the historical 44% p.a. growth over the last five years. Juxtapose this against the other companies in the industry with analyst coverage, which are forecast to grow their revenues (in aggregate) 17% annually. Factoring in the forecast slowdown in growth, it looks like Opus Genetics is forecast to grow at about the same rate as the wider industry. The most obvious conclusion is that the analysts made no changes to their forecasts for a loss next year. They also upgraded their revenue forecasts, although the latest estimates suggest that Opus Genetics will grow in line with the overall industry. Furthermore, the analysts also cut their price targets, suggesting that the latest news has led to greater pessimism about the intrinsic value of the business. With that in mind, we wouldn't be too quick to come to a conclusion on Opus Genetics. Long-term earnings power is much more important than next year's profits. We have estimates - from multiple Opus Genetics analysts - going out to 2027, and you can see them free on our platform here. It is also worth noting that we have found 4 warning signs for Opus Genetics (1 is potentially serious!) that you need to take into consideration. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

ARVO presentation highlights 12-month results from Phase 1/2 study that support potential of OPGx-LCA5 gene therapy to restore meaningful vision Pediatric cohort of LCA5 study ongoing with initial multi-patient data anticipated in Q3 2025 OPGx-BEST1 on track for IND filing and initiation of Phase 1/2 trial with early data expected in Q1 2026 Leading healthcare investors provide funding to deliver on key milestones RESEARCH TRIANGLE PARK, N.C., May 15, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biopharmaceutical company developing important new therapies for the treatment of inherited retinal diseases (IRDs) and other ophthalmic disorders (“Opus” or the “Company”), today announced financial results for the first quarter ended March 31, 2025, and provided a corporate update. “Opus is off to a strong start in 2025, with progress across our two product portfolios – the inherited retinal disease platform and the phentolamine eye drop franchise,” said George Magrath, M.D., Chief Executive Officer. “We reported positive 12-month data from the Phase 1/2 trial of OPGx-LCA5 for the treatment of Leber congenital amaurosis 5 (LCA5), an inherited disease which leads to severe vision loss from infancy. The evidence of durable efficacy in adult patients is very encouraging, with the treatment benefits previously seen at 6 months now sustained out to one year. We are now enrolling pediatric patients and are encouraged by the meaningful improvement in visual function and early safety profile observed in the first of these patients at one month.” Dr. Magrath continued, “We believe that the initial success with our lead IRD program, OPGx-LCA5, has the potential to translate to the rest of our pipeline, which includes gene therapy candidates for six additional IRDs. We plan to initiate a Phase 1/2 study with our BEST-1 program later this year with early data expected in the first quarter of 2026. “In the phentolamine eye drop pipeline, we look forward to near-term clinical data readouts from the Phase 3 data trials in dim light vision disturbances and in presbyopia. We ended the first quarter with a strong cash position, having completed a successful financing with leading institutional healthcare investors who share our confidence in the Company’s strategic direction,” concluded Dr. Magrath. Strategic Highlights Opus’s pipeline includes a portfolio of seven adeno-associated virus (AAV)-based gene therapy assets, each targeting a specific IRD, as well as Phentolamine Ophthalmic Solution 0.75%, which is currently being evaluated in presbyopia and mesopic (dim) light vision disturbances (DLD) after keratorefractive surgery. Emerging clinical data on OPGx-LCA5 provide evidence of clinical proof of concept and support the potential of this novel gene therapy to restore meaningful vision for individuals with mutations in the LCA5 gene. Another gene therapy candidate, OPGx-BEST1, which Opus is developing for treatment of bestrophin-1 (BEST1)-related IRD, is on track to enter the clinic by the fourth quarter of 2025, with preliminary data expected in the first quarter of 2026. In March 2025, Opus completed a successful underwritten public offering and concurrent private placement anchored by leading healthcare investors, Perceptive Advisors and Nantahala Capital. The transaction raised approximately $21.5 million in gross proceeds with the potential for up to $21.4 million in additional proceeds upon exercise of warrants that are tied to data release from the BEST1 program. Recent Business Highlights and Corporate Updates Gene Therapy Programs OPGx-LCA5 Opus’ most advanced investigational gene therapy candidate, OPGx-LCA5, is being developed to treat patients with inherited retinal degeneration due to biallelic mutations in the LCA5 gene, an early-onset, severe hereditary retinal degeneration. One-year open-label data on adult patients being treated in the ongoing Phase 1/2 clinical trial of OPGx-LCA5 were featured in an oral presentation by Dr. Tomas Aleman of the Scheie Eye Institute, University of Pennsylvania, at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, in Salt Lake City. All treated patients had late-stage disease. Improvements in subjective and objective measures of efficacy that had been observed at six months persisted for one year. Enrollment in a cohort of three pediatric patients in the Phase 1/2 trial began in February 2025. Preliminary data on the first patient showed an encouraging early safety profile and meaningful improvement in visual function at one month. The pediatric cohort is expected to complete enrollment in the second quarter of 2025, with initial data from all three patients anticipated in the third quarter of 2025. The U.S. Food and Drug Administration (the “FDA”) granted a Regenerative Medicine Advanced Therapy (“RMAT”) designation to OPGx-LCA5 based on the early data from the first three patients treated. The RMAT designation program offers the potential for expedited development and review of regenerative medicine therapies that demonstrate the potential to address serious or life-threatening diseases based on preliminary clinical evidence. The designation provides sponsors with early interactions with the FDA, guidance on efficient development and manufacturing, and the opportunity to discuss surrogate endpoints to support accelerated approval. A Type D meeting was held with the FDA in March 2025 to discuss the potential regulatory path for OPGx-LCA5, including the design of a potential registrational study. Opus will continue to work with the FDA on the most appropriate design, including the primary endpoint. OPGx-BEST1 OPGx-BEST1 is an investigational Phase 1/2-ready asset in development for IRDs associated with mutations in the BEST1 gene (sometimes referred to as “Best Disease”), which can lead to legal blindness. In IND-enabling studies of OPGx-BEST1 provided safety and efficacy data in support of a first-in-human clinical trial. Opus plans to file an IND and begin a Phase 1/2 trial by the fourth quarter of 2025, with preliminary data expected in the first quarter of 2026. Phentolamine Ophthalmic Solution 0.75% The LYNX-2 pivotal Phase 3 trial evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of visual loss in low light conditions associated with keratorefractive surgery completed enrollment in the first quarter of 2025 with topline data expected mid-year 2025. The LYNX-2 trial is covered by a Special Protocol Assessment (“SPA”) agreement with the FDA, which ensures agreement with the FDA on the trial design, endpoints, and study size (power). The FDA granted Fast Track designation for Phentolamine Ophthalmic Solution 0.75% for treatment of significant chronic night driving impairment with concomitant increased risk of motor vehicle accidents and debilitating loss of best spectacle corrected mesopic vision in keratorefractive patients with photic phenomena (i.e., glare, halos, starburst). The VEGA-3 pivotal Phase 3 trial evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia completed enrollment in the first quarter of 2025, with topline data expected in the first half of 2025. The development portfolio related to Phentolamine Ophthalmic Solution 0.75% is being funded by the Company’s partner, Viatris Inc., in both indications (presbyopia and dim light vision disturbances). Expected Growth Drivers in 2025 and Beyond Initial data from three pediatric patients treated with OPGx-LCA5 anticipated in Q3 2025. IND filing and initiation of a Phase 1/2 clinical trial for OPGx-BEST1 is planned for 2025, with preliminary data expected in Q1 2026. Topline data from the LYNX-2 pivotal Phase 3 trial evaluating Phentolamine Ophthalmic Solution 0.75% for visual loss in low light conditions associated with keratorefractive surgery are expected mid-year 2025. Topline data from the VEGA-3 pivotal Phase 3 clinical trial evaluating Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia are expected in the first half of 2025. Financial Highlights for the First Quarter Ended March 31, 2025 As of March 31, 2025, Opus had cash and cash equivalents of $41.8 million. Based on current projections, management believes that the cash on hand will be sufficient to fund operations into the second quarter of 2026. License and collaborations revenue was $4.4 million and $1.7 million during the three months ended March 31, 2025 and 2024, respectively. Revenue during both quarterly periods was derived from the Company’s license and collaboration agreement (the “Viatris License Agreement”) with Viatris, Inc. (“Viatris”) largely from the reimbursement of research and development services and to a much lesser degree from royalty payments stemming from the sales of RYZUMVI™ by Viatris. General and administrative (“G&A”) expenses for the three months ended March 31, 2025 were $6.3 million compared to $4.7 million for the three months ended March 31, 2024. The increase was primarily attributable to professional services fees, corporate legal support, legal fees associated with intellectual property and public company costs, including filing fees and investor relations and governance costs, offset in part by decreases in general operating and other costs on a net basis. G&A expenses included $0.6 million and $0.8 million in stock-based compensation expense during the three months ended March 31, 2025 and 2024, respectively. Research and development (“R&D”) expenses for the three months ended March 31, 2025 were $8.0 million compared to $4.7 million for the three months ended March 31, 2024. The increase was primarily attributable to higher clinical costs and payroll related costs, offset partially by lower manufacturing expenses attributed to an activity reduction in the VEGA-2 trial and by lower regulatory and other costs on a net basis. Pursuant to the Viatris License Agreement, budgeted R&D expenses related to the development of the Phentolamine Ophthalmic Solution 0.75% products have been fully reimbursed by Viatris to date. R&D expenses included $0.3 million and $0.2 million in stock-based compensation expense during the three months ended March 31, 2025 and 2024, respectively. Net loss for the quarter ended March 31, 2025, was $8.2 million or $(0.24) per basic and diluted share, as compared to net loss of $7.1 million, or $(0.29) per basic and diluted share, for the quarter ended March 31, 2024. For further details on financial results, refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 to be filed with the Securities and Exchange Commission (the “SEC”). About Opus Genetics Opus Genetics is a clinical-stage ophthalmic biopharmaceutical company developing therapies to treat patients with IRDs and other treatments for ophthalmic disorders. Our pipeline includes adeno-associated virus (AAV)-based investigational gene therapies that address gene mutations responsible for different forms of Leber congenital amaurosis (“LCA”), bestrophinopathy and retinitis pigmentosa. Our most advanced investigational gene therapy program is designed to address mutations in the LCA5 gene, which encodes the lebercilin protein and is currently being evaluated in a Phase 1/2 open-label, dose-escalation trial, with encouraging early data. Our pipeline also includes BEST1 investigational gene therapy, designed to address mutations in the BEST1 gene, which is associated with retinal degeneration. The pipeline also includes Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist being investigated to reduce pupil size that is currently being evaluated in Phase 3 trials for presbyopia and mesopic (dim) light vision disturbances. For additional information, please visit www.opusgtx.com. University of Pennsylvania (“Penn”) Financial Disclosure: The laboratory of Dr. Tomas Aleman has received clinical trial research funding from Opus Genetics. Penn and Dr. Aleman have either received, or may receive in the future, financial consideration related to the licensing of certain Penn intellectual property to Opus Genetics. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, expectations regarding our cash runway, expectations of potential growth, and statements concerning data from and future enrollment for our clinical trials and our pipeline of additional indications. These forward-looking statements relate to us, our business prospects and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, and in our other filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: Our clinical data related to gene therapies for the treatment of IRDs are preliminary and related to a relatively small group of patients, and, as a result, data that initially appear promising may be revised, updated, or invalidated at a later data readout and/or may ultimately not be capable of duplication in additional patients; Failure to successfully integrate our businesses following our acquisition of former Opus Genetics Inc. (the “Opus Acquisition”) could have a material adverse effect on our business, financial condition and results of operations; The Opus Acquisition significantly expanded our product pipeline and business operations and shifted our business strategies, which may not improve the value of our common stock; 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; 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 services market; Raising additional capital may cause our stockholders to be diluted, among other adverse effects; We operate in a highly regulated industry and face many challenges adapting to sudden changes in legislative reform or the regulatory environment, which 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 (such as the Viatris License Agreement) or establishing strategic alliances on favorable terms, which could harm our business; Our current focus on the cash-pay utilization for future sales of RYZUMVI™ may limit our ability to increase sales or achieve profitability with this product; 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; Our common stock may be subject to delisting from the Nasdaq Capital Market and delisting could adversely affect our ability to access capital markets; 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; and Impact from current or proposed tariffs on imported goods we purchase. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive. Readers are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the SEC that advise interested parties of the risks and factors that may affect our business. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Contacts