RESEARCH TRIANGLE PARK, N.C., March 21, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies for other ophthalmic disorders, today announced that a presentation featuring the LYNX-1 Phase 3 study of Phentolamine Ophthalmic Solution 0.75% in patients with dim light disturbances will be delivered this week at World Cornea Congress IX, taking place March 20-22, ...

Additional approximately $21 million tied to data release for the Company’s BEST1 programRESEARCH TRIANGLE PARK, N.C., March 21, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (“Opus” or the “Company”) (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies for other ophthalmic disorders, today announced the pricing of an underwritten public offering with gross proceeds of $20 million and concurrent private ...

Core Insights - Opus Genetics, Inc. has approved equity awards for two new employees as part of its 2021 Inducement Plan, effective March 13, 2025 [1] - The equity awards consist of options to purchase a total of 205,742 shares at an exercise price of $0.93 per share, with a four-year vesting schedule [2] - Opus Genetics is focused on developing therapies for inherited retinal diseases (IRDs) and other ophthalmic disorders, with a pipeline that includes gene therapies and other investigational treatments [3] Group 1 - The independent Board of Directors approved equity awards as a material inducement for new hires [1] - The options granted will vest over four years, with 25% vesting after one year and the remainder in monthly or quarterly installments [2] - The company is developing AAV-based gene therapies targeting specific genetic mutations associated with various retinal diseases [3] Group 2 - The most advanced program targets mutations in the LCA5 gene, currently in a Phase 1/2 trial with promising early results [3] - Other investigational products include BEST1 gene therapy and Phentolamine Ophthalmic Solution 0.75%, which is in Phase 3 trials for presbyopia [3] - The company has reached an agreement with the FDA for a Phase 3 trial of oral APX3330 for diabetic retinopathy treatment [3]

Core Insights - Opus Genetics, Inc. announced that three abstracts on its investigational gene therapy candidates have been accepted for presentation at the ARVO 2025 Meeting, showcasing advancements in gene therapies for inherited retinal diseases [1][3] - The company is focusing on its lead candidate OPGx-LCA5, which is currently in a Phase 1/2 trial, with promising 12-month data indicating visual improvement in adult patients [4][3] - Additional presentations will cover pre-clinical results for OPGx-MERTK and OPGx-RDH12, expanding the company's pipeline in treating various retinal disorders [5][7] Company Overview - Opus Genetics is a clinical-stage ophthalmic biotechnology company developing gene therapies for inherited retinal diseases and other ophthalmic disorders [9] - The company's pipeline includes AAV-based investigational gene therapies targeting mutations in genes associated with bestrophinopathy, Leber congenital amaurosis (LCA), and retinitis pigmentosa [9] - The most advanced program, OPGx-LCA5, is designed to address mutations in the LCA5 gene and is currently undergoing a Phase 1/2 open-label, dose-escalation trial [9] Upcoming Presentations - The presentation titled "Recovery of cone mediated vision in severe ciliopathy after gene augmentation; One year results from a Phase I/II trial of LCA5-LCA (OPGx-LCA5)" will take place on May 4, 2025, highlighting the efficacy of OPGx-LCA5 [4] - Another presentation on OPGx-MERTK will discuss its evaluation in a rat model of retinitis pigmentosa, scheduled for May 8, 2025 [5] - A study on the ocular tolerability of OPGx-RDH12 will be presented on May 5, 2025, focusing on its delivery in cynomolgus primates [6][7] Clinical Trials and Regulatory Status - The ongoing Phase 1/2 trial of OPGx-LCA5 has shown that all three adult patients experienced visual improvement at six months, with new data indicating sustained efficacy for a year [4][3] - The company plans to advance OPGx-LCA5 into a pivotal Phase 3 trial, contingent on continued safety and efficacy [3] - Phentolamine Ophthalmic Solution 0.75% is currently in Phase 3 trials for treating presbyopia and reduced dim light vision, with FDA Fast Track Designation granted for chronic night driving impairment [9]

New Data from First Three Adult Patients in Phase 1/2 Trial with OPGx-LCA5 Showed that Subjective and Objective Signs of Efficacy Persisted for One YearDurham, NC., March 05, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and other ophthalmologic disorders, today announced that three abstracts on its investigational gene therapy candidates have been accepted for pre ...

Core Insights - The FDA has granted Fast Track designation for Phentolamine Ophthalmic Solution 0.75% to treat significant chronic night driving impairment in keratorefractive patients with reduced mesopic vision [1][7] - Enrollment in the VEGA-3 Phase 3 trial for presbyopia is complete, while the LYNX-2 trial is expected to complete enrollment in the first half of 2025 [1][2] - Phentolamine Ophthalmic Solution 0.75% aims to provide a non-invasive treatment option for presbyopia and low light vision disturbances post-keratorefractive surgery [2][10] VEGA-3 Phase 3 Program - The VEGA-3 trial involves 545 participants and is designed to assess the improvement in near visual acuity after treatment with Phentolamine Ophthalmic Solution 0.75% [3] - The primary endpoint is a 15-letter improvement in distance-corrected near visual acuity on day eight post-treatment [3] LYNX-2 Phase 3 Program - The LYNX-2 trial targets 200 subjects who have experienced decreased visual acuity in low light conditions after keratorefractive surgery, with over 95% enrollment achieved [5] - The primary endpoint is a gain of 3 lines (or 15 letters) in distance vision improvement on a low contrast chart after 15 days of dosing [5] About Phentolamine Ophthalmic Solution 0.75% - This solution is a non-selective alpha-1 and alpha-2 adrenergic antagonist that reduces pupil size, potentially improving vision in low light conditions [10] - It is being developed as a treatment for both presbyopia and visual disturbances following keratorefractive surgery [10] Company Overview - Opus Genetics is a clinical-stage ophthalmic biotechnology company focused on gene therapies for inherited retinal diseases and other ophthalmic disorders [11] - The company is advancing multiple programs, including Phentolamine Ophthalmic Solution 0.75% and gene therapies targeting specific genetic mutations associated with retinal diseases [11]

First patient dosed in the pediatric cohort of the Phase 1/2 trial of OPGx-LCA5; initial data on the cohort anticipated by Q3 2025New 12-month data on the first three adult OPGx-LCA5 patients to be presented at a major medical conference in Q2 2025FDA meeting scheduled in March 2025 to discuss Phase 3 trial design and registrational endpoints for OPGx-LCA5 DURHAM, N.C., Feb. 18, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene ther ...

Core Viewpoint - The current Board's strategic, management, and capital allocation failures have led to an 80% decline in stock price over the past 22 months, necessitating new leadership to restore accountability and shareholder value [1][6][10] Governance and Leadership - The Restore Value Slate has nominated seven candidates for the Board of Directors, collectively owning approximately 4.1% of the Company's outstanding shares [1][2] - If elected, the Nominees aim to enhance leadership, accountability, and transparency to restore long-term shareholder value without further dilution [2][10] Company Performance and Challenges - The Company has experienced a dramatic stock price decline from over $6 to the $1 range since April 2023, significantly underperforming compared to the Nasdaq Biotech Small Cap Index, which gained over 15% during the same period [6][7] - The market capitalization has fallen below reported cash levels, indicating severe financial distress [6] Capital Allocation and Strategy - The current Board has been criticized for undisciplined capital allocation and a poorly conceived strategy pivot that undervalues the legacy portfolio [3][4] - The Board's expansion from three to seven executive officers and from seven to nine Board members has been deemed inappropriate given the Company's financial challenges [6][7] Cash Flow and Financial Viability - The Restore Value Slate warns of a potential cash shortfall, with less than a year of runway at the current burn rate [6] - The strategic pivot towards rare disease gene therapy is viewed as high-risk and capital-intensive, potentially leading to significant shareholder dilution [6][7] Asset Management - The Board has deprioritized Ryzumvi™, the Company's most advanced asset, despite its potential for significant long-term value and revenue generation [7][8] - Ryzumvi™ offers double-digit royalties and milestone payments through 2040, with future sales potential in the hundreds of millions across various markets [7] Nominee Expertise - The Restore Value Slate comprises individuals with extensive experience in life sciences, biotechnology, and healthcare, aiming to improve operational efficiencies and reduce unnecessary costs [8][9] - The Nominees collectively bring over 30 years of leadership experience, with backgrounds in strategic transactions, clinical development, and public and private company board leadership [8][9]

Core Insights - Opus Genetics has reached an agreement with the FDA on a Special Protocol Assessment (SPA) for a Phase 3 clinical trial of oral APX3330 targeting moderate to severe nonproliferative diabetic retinopathy (NPDR) [1][2][3] - The primary endpoint of the trial is a reduction in 3-step or greater worsening on the binocular diabetic retinopathy severity scale (DRSS) compared to placebo [2] - APX3330 has shown potential in previous trials to slow or prevent the progression of diabetic retinopathy and has a favorable safety profile [2][4] Company Overview - Opus Genetics is a clinical-stage ophthalmic biotechnology company focused on developing gene therapies for inherited retinal diseases (IRDs) and other ophthalmologic disorders [5] - The company’s pipeline includes AAV-based gene therapies for various retinal diseases and small-molecule drugs like APX3330 [5] - APX3330 is a first-in-class oral inhibitor of the transcription factor regulator Ref-1, targeting pathways involved in angiogenesis, oxidative stress, and inflammation [4] Market Context - Diabetic retinopathy is a leading cause of blindness among working-age adults, affecting approximately 10 million patients in the U.S. [3] - The successful development and approval of APX3330 could provide a transformative treatment option for NPDR patients [3]

Group 1 - Opus Genetics, Inc. reported a quarterly loss of $0.29 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.30, and a decline from earnings of $0.25 per share a year ago, representing an earnings surprise of 3.33% [1] - The company posted revenues of $3.87 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 230.51%, but down from $11.94 million in the same quarter last year [2] - Opus Genetics shares have declined approximately 61.1% since the beginning of the year, contrasting with the S&P 500's gain of 25.8% [3] Group 2 - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The estimate revisions trend for Opus Genetics is mixed, resulting in a Zacks Rank 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] - The current consensus EPS estimate for the upcoming quarter is -$0.22 on revenues of $3.35 million, and for the current fiscal year, it is -$1.11 on revenues of $7.34 million [7] Group 3 - The Medical - Biomedical and Genetics industry, to which Opus Genetics belongs, is currently ranked in the top 29% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Equillium, Inc., another company in the same industry, is expected to report quarterly earnings of $0.07 per share, reflecting a year-over-year increase of 163.6%, with revenues anticipated to be $37.2 million, up 319.4% from the previous year [9]