Core Viewpoint - Opus Genetics, Inc. is advancing its gene therapy programs for inherited retinal diseases (IRDs) and will present findings at several scientific conferences in May 2025 [1] Presentation Details - The company will present at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting on May 13, 2025, focusing on MERTK gene therapy in RCS rats [2] - At the American Ophthalmological Society (AOS) Annual Meeting from May 15-17, 2025, the company will discuss endpoints for the first interventional gene therapy clinical study in BEST Disease [3] - An oral presentation on utilizing VR guided testing for visual function assessment is scheduled for May 29, 2025 [7] Research Highlights - Retinitis pigmentosa (RP) affects 1 in 3,000 to 1 in 7,000 people, with 3% of cases linked to mutations in the MERTK gene [5] - OPGx-MERTK, an investigational gene therapy, showed effective preservation of photoreceptors and retinal function in a rat model after a single bilateral subretinal injection [5] - OPGx-BEST1 is being developed for BEST1-related inherited retinal diseases, with preclinical studies showing restoration of the RPE-photoreceptor interface in treated canines [6] Company Overview - Opus Genetics is a clinical-stage biopharmaceutical company focused on gene therapies for IRDs and other ophthalmic disorders [8] - The pipeline includes AAV-based investigational gene therapies targeting mutations in LCA, BEST1, and retinitis pigmentosa [8] - The company plans to initiate a Phase 1/2 trial of OPGx-BEST1 in 2025, aiming for preliminary data by Q1 2026 [6]

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].

Core Insights - Opus Genetics is a clinical-stage gene therapy company focused on developing treatments for inherited retinal diseases and other ophthalmic conditions [1][7] - The company has achieved significant milestones and aims to establish a repeatable gene therapy platform with anticipated clinical milestones throughout 2025 [2][5] Company Developments - Completion of enrollment in two Phase 3 clinical trials: VEGA-3 for presbyopia and LYNX-2 for post-LASIK night vision disturbances [3] - Received FDA Fast Track designation for phentolamine ophthalmic solution to treat chronic night driving impairment [3] - Upcoming data presentations for OPGx-LCA5, an AAV-based gene therapy targeting Leber congenital amaurosis 5 [3] Future Outlook - 2025 is projected to be a pivotal year for Opus Genetics due to multiple regulatory milestones and clinical readouts [5] - The company is developing a pipeline that includes AAV-based investigational gene therapies for various genetic mutations causing retinal diseases [7]

Core Viewpoint - The recent actions of the Board of Opus Genetics, including a highly dilutive financing and a shift in strategic focus, have raised significant concerns regarding governance, stockholder interests, and the overall direction of the company [1][4][31]. Group 1: Board Actions and Governance - The Board executed a highly dilutive financing that added over 13 million new shares just before the record date for the Annual Meeting, effectively sidelining stockholders from decision-making [1][5][11]. - The timing of the financing, which coincided with the record date for the Annual Meeting, raises serious governance concerns as it appears designed to influence the election outcome [12][13][18]. - The Board has previously undertaken major transactions, such as a merger, without stockholder input, leading to questions about transparency and accountability [15][27]. Group 2: Financial Impact and Stockholder Value - The company's outstanding share count nearly doubled from 25 million to 45 million, with expectations of reaching 60 million after the Annual Meeting, resulting in significant dilution for existing stockholders [5][11]. - The stock price has fallen below $1 per share, down from over $6 per share in April 2023, indicating a destruction of value that is uncorrelated with the Nasdaq Biotech Small Cap Index [5][31]. - The recent financing and merger transactions have been criticized for providing minimal valuation to the FDA-approved product RYZUMVI™, despite its long-term potential [1][26]. Group 3: Strategic Direction and Legacy Assets - The company has shifted its focus towards high-risk, early-stage gene therapy programs while sidelining legacy assets like RYZUMVI™, which could generate significant revenue without the same development risks [25][26][28]. - The narrative around legacy asset APX3330 has changed dramatically, raising concerns about the integrity of the company's communications and its commitment to maximizing shareholder value [20][23]. - The strategic pivot towards gene therapy has not been adequately explained, and there is a lack of transparency regarding the rationale behind abandoning de-risked assets [28][29]. Group 4: Future Considerations - The company is urged to consider strategic partnerships and risk-sharing collaborations for its early-stage gene therapy programs to mitigate high-risk development and further dilution [30]. - Stockholders are encouraged to scrutinize the company's governance and capital allocation decisions, as the recent actions have raised important questions about the Board's oversight and commitment to transparency [31][32].

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 ...

Core Insights - Opus Genetics is focused on developing innovative gene therapy treatments for inherited retinal diseases (IRDs) and has made significant progress in its transformation and pipeline [1][2] - The company raised $21.5 million through a public offering and private placement, enhancing its cash position to approximately $50.7 million, which supports key milestones for its gene therapy candidates [2][9] - The acquisition of Opus Genetics has strengthened the company's pipeline, which now includes seven adeno-associated virus (AAV)-based gene therapy assets targeting specific IRDs [4][17] Financial Performance - For the year ended December 31, 2024, Opus reported a net loss of $57.5 million, or $2.15 per share, compared to a net loss of $10.0 million, or $0.46 per share, in 2023 [15][25] - License and collaborations revenue decreased to $11.0 million in 2024 from $19.0 million in 2023, primarily due to the absence of a milestone payment received in 2023 [12][25] - General and administrative expenses increased to $18.2 million in 2024 from $12.0 million in 2023, attributed to transaction costs related to the acquisition and other operational expenses [13][25] Pipeline and Clinical Trials - The lead gene therapy candidate, OPGx-LCA5, is in a Phase 1/2 trial and has shown positive results, with visual improvement observed in all adult patients after one year [9][18] - OPGx-BEST1 is expected to enter clinical trials in 2025, targeting IRDs associated with mutations in the BEST1 gene [9][18] - The LYNX-2 Phase 3 trial for Phentolamine Ophthalmic Solution 0.75% has completed enrollment, with topline data expected in mid-2025 [9][18] Strategic Direction - The company aims to achieve several key milestones in 2025, including up to four clinical trial data readouts and the initiation of new trials for its gene therapy candidates [2][10] - A Type D meeting with the FDA was held to discuss the regulatory path for OPGx-LCA5, indicating proactive engagement with regulatory authorities [9][18] - The company is also seeking a strategic partner to advance the late-stage development of APX3330, a novel oral REF-1 inhibitor for diabetic retinopathy [9][18]

Core Insights - Opus Genetics, Inc. is presenting results from the LYNX-1 Phase 3 study of Phentolamine Ophthalmic Solution 0.75% at the World Cornea Congress IX, focusing on its potential to treat dim light disturbances in patients, particularly those who have undergone keratorefractive surgery [1][3][4] Study Results - The LYNX-1 Phase 3 study met its primary endpoint, showing that 13% of participants treated with Phentolamine gained 15 or more letters of mesopic low contrast distance visual acuity (mLCVA) at Day 8 compared to 3% in the placebo group (p<0.05) [5] - At Day 15, 21% of Phentolamine-treated participants gained 15 or more letters of mLCVA compared to 3% in the placebo group (p<0.01) [5] - Patient-reported outcomes for glare, halos, and starbursts were significantly lower in the Phentolamine group at Day 15 (p<0.01) [5] - In a subset analysis of post-LASIK participants, 29% of those treated with Phentolamine gained 15 or more letters of mLCVA at Day 8 compared to 9% in the placebo group [5] - The positive results from the LYNX-1 study support the ongoing Phase 3 LYNX-2 trial, with topline results expected in mid-2025 [5] Company Overview - Opus Genetics is a clinical-stage ophthalmic biotechnology company focused on developing gene therapies for inherited retinal diseases and other ophthalmic disorders [4] - The company's pipeline includes AAV-based investigational gene therapies targeting mutations in genes associated with various retinal diseases, with the most advanced program addressing mutations in the LCA5 gene [4] - Phentolamine Ophthalmic Solution 0.75% is being investigated for its ability to reduce pupil size and improve vision in patients with reduced mesopic vision following keratorefractive surgery [6]