RESEARCH TRIANGLE PARK, N.C., May 12, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and other treatments for ophthalmic disorders, today announced presentations related to its IRD gene therapy programs at these upcoming scientific conferences in May. Presentation Details American Society of Gene & Cell Therapy (ASGCT) 28th Annual Meeting Title:Evaluation of MERTK gene therapy ...

Core Viewpoint - Opus Genetics, Inc. is anticipated to report a year-over-year decline in earnings despite an increase in revenues for the quarter ending March 2025, with the consensus outlook indicating a significant impact on the stock price based on actual results compared to estimates [1][3]. Financial Performance Expectations - The company is expected to post a quarterly loss of $0.34 per share, reflecting a year-over-year change of -17.2% [3]. - Revenues are projected to be $2.8 million, which represents a 63.7% increase from the same quarter last year [3]. Estimate Revisions and Predictions - The consensus EPS estimate has remained unchanged over the last 30 days, indicating stability in analyst expectations [4]. - The Most Accurate Estimate aligns with the Zacks Consensus Estimate, resulting in an Earnings ESP of 0%, suggesting no recent differing analyst views [10]. Earnings Surprise History - In the last reported quarter, the company was expected to post a loss of $0.34 per share but instead reported a loss of $1.27, resulting in a surprise of -273.53% [12]. - Over the past four quarters, Opus Genetics has only beaten consensus EPS estimates once [13]. Industry Comparison - Cue Biopharma, another player in the Zacks Medical - Biomedical and Genetics industry, is expected to report a loss of $0.14 per share for the same quarter, indicating a year-over-year change of +44% [17]. - Cue Biopharma's revenues are expected to be $2 million, up 16.3% from the previous year, with an unchanged consensus EPS estimate over the last 30 days [17][18].

NEW YORK, April 15, 2025 (GLOBE NEWSWIRE) -- PRISM MarketView today published a Q&A feature with Dr. George Magrath, Chief Executive Officer of Opus Genetics, Inc. ("Opus Genetics" or the "Company") (NASDAQ:IRD), a clinical-stage gene therapy company developing treatments for inherited retinal diseases (IRDs) and broader ophthalmic conditions. Dr. George Magrath, Chief Executive Officer of Opus Genetics, Inc. In the interview, Dr. Magrath outlines Opus Genetics' recent milestones, including: Completion of ...

Board Timed Highly Dilutive Financing to Close on the Record Date for the Annual Meeting, Tilting the Vote and Forcing the Withdrawal of the Restore Value Slate Second Major Transaction in Six Months Undertaken Without Stockholder Input with Significant Equity Dilution Company's Shifting Narrative on APX3330 in Disclosures Raises Questions of Omissions, Consistency, and Integrity of Strategic Communications FDA-Approved RYZUMVI™ Received Minimal Valuation in Both the Merger and Financing Transactions Desp ...

Core Insights - The first pediatric patient treated with OPGx-LCA5 showed an encouraging early safety profile and significant improvement in visual function one month post-treatment [1][3] - A second pediatric patient has been dosed, with the pediatric cohort expected to complete enrollment by Q2 2025, and initial data from all three patients anticipated in Q3 2025 [1][2] - The FDA Type D meeting clarified next steps for a registrational trial design to support BLA submission, with potential trial initiation in 2026 [1][5] Company Overview - Opus Genetics, Inc. is a clinical-stage ophthalmic biotechnology company focused on developing gene therapies for inherited retinal diseases (IRDs) [1][8] - The company is currently evaluating OPGx-LCA5 in a Phase 1/2 trial for LCA5-related IRD, which began enrolling pediatric patients in February 2025 [2][6] - OPGx-LCA5 targets a rare genetic disorder leading to early-onset vision loss due to mutations in the LCA5 gene, with no approved therapies available to date [2][7] Clinical Trial Details - The ongoing Phase 1/2 trial is designed to evaluate the safety and preliminary efficacy of OPGx-LCA5 in patients with inherited retinal degeneration due to biallelic mutations in the LCA5 gene [6][7] - Efficacy endpoints include functional vision measurements using the Multi-Luminance Orientation and Mobility Test (MLoMT), Full-Field Stimulus Testing (FST), and microperimetry [6] - Preliminary results from adult patients in the same trial showed visual improvement at six months, with one-year data to be presented at the ARVO 2025 Meeting [4][6] Regulatory Pathway - Following the FDA meeting, Opus proposed a single-arm, adaptive pivotal study to enroll as few as 19 patients, with the primary endpoint being the MLoMT [5] - The FDA provided constructive feedback on the proposed statistical analysis plan and requested additional information, with plans for further discussions [5] - The pivotal trial is anticipated to initiate in Q1 2026, contingent on the completion of regulatory requirements [5]

Board Comments on Misguided Campaign from Mina Sooch to Replace a Majority of Opus’ Directors and Promote a Flawed Strategy Urges Stockholders to Vote on the BLUE Proxy Card FOR All Nine of the Company’s Nominees RESEARCH TRIANGLE PARK, N.C., April 07, 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 disorde ...

Board Comments on Misguided Campaign from Mina Sooch to Replace a Majority of Opus' Directors and Promote a Flawed Strategy Urges Stockholders to Vote on the BLUE Proxy Card FOR All Nine of the Company's Nominees RESEARCH TRIANGLE PARK, N.C., April 07, 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 disorder ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the Fiscal Year Ended December 31, 2024 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. For the transition period from _____ to _____ Commission File No. 001-34079 Securities registered pursuant to Section 12(b) of the Act: Opus Genetics, Inc. (Exact name of registrant as specified in its c ...

Financial Performance - The company reported a net loss of approximately $56.8 million for the year ended December 31, 2024[6] - Net cash used in operating activities for the year ended December 31, 2024 was approximately $25.6 million[6] Cash Position - The cash and cash equivalents balance as of December 31, 2024 was approximately $30.3 million[6]

Provides update on the Company's transformation and promising portfolio of innovative gene therapy treatments for inherited retinal diseases Strong cash position with $21.5 million financing to supplement $30.3 million year-end balance New capital supports delivery on key milestones for two lead gene therapy candidates OPGx-LCA5 and OPGx- BEST1 RESEARCH TRIANGLE PARK, N.C., March 31, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. ("Opus" or the "Company") (NASDAQ:IRD), a clinical-stage ophthalmic biopharmaceu ...