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]

Core Viewpoint - Opus Genetics, Inc. is urging stockholders to vote for its nine nominated directors on the BLUE proxy card, emphasizing the importance of the upcoming Annual Meeting on April 30, 2025, as a pivotal moment for the company's transformation and future success [2][3][15] Company Strategy and Transformation - The company has undergone significant changes over the past two years, including a strategic repositioning after facing challenges with its previous assets [4][5] - In April 2023, the board terminated the former CEO, Mina Sooch, and appointed Dr. George Magrath as the new CEO to lead the company towards long-term growth [5][6] - The new management team, supported by an independent consulting firm, evaluated over 50 potential assets and identified a compelling pipeline of gene therapies for inherited retinal diseases from Legacy Opus [6][7][8] Recent Developments - In October 2024, Ocuphire announced the acquisition of Legacy Opus, adopting the name Opus Genetics to reflect its new strategy [9] - The company is seeking stockholder approval for the conversion of preferred shares into common shares to align interests and advance its new plan [9] Board of Directors and Leadership - The board has strengthened its composition by appointing three new directors with significant experience in biotechnology and clinical development, alongside six other nominees who have contributed to the company's transformation [10][11] - The board emphasizes the qualifications and dedication of its nominees, who possess expertise in critical areas for the company's success [11] Financial Support and Investor Confidence - The company recently completed a public offering and private placement, raising $21.5 million from prominent healthcare investors, indicating strong support for its new strategy and leadership [12] Opposition and Challenges - Former CEO Mina Sooch has nominated herself and five associates to replace a majority of the board, which the current board believes would not serve the best interests of stockholders [13][14] - The board argues that Sooch's proposed strategy is flawed and would hinder the company's progress, advocating instead for the continuation of the current gene therapy-focused strategy [14][15]

Core Viewpoint - Opus Genetics, Inc. is urging stockholders to vote for its nine nominated directors on the BLUE proxy card, emphasizing the importance of the upcoming Annual Meeting on April 30, 2025, as a pivotal moment for the company's transformation and future success [2][3][15] Company Strategy and Transformation - The company has undergone significant changes over the past two years, including a strategic repositioning after facing challenges with its previous assets [4][5] - In 2023, the board terminated the former CEO and appointed Dr. George Magrath as the new CEO, who has since built a strong executive team [5][11] - A review of the company's assets led to the acquisition of Legacy Opus, which has a promising pipeline of gene therapies for inherited retinal diseases [6][9] Board of Directors and Governance - The board is nominating nine candidates for election, including three new directors with extensive experience in biotechnology and clinical development [10][11] - The board believes that the election of the former CEO's nominees would not serve the best interests of stockholders and could reverse the company's progress [13][14] Financial Support and Market Confidence - The company recently raised $21.5 million from top-tier healthcare investors, indicating strong market confidence in its new strategy and leadership [12]

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]

Core Viewpoint - Opus Genetics, Inc. has announced a public offering and private placement to raise approximately $21 million for its gene therapy programs targeting inherited retinal diseases [1][3][4]. Group 1: Offering Details - The public offering consists of 21,052,631 shares of common stock and warrants at a price of $0.95, potentially generating gross proceeds of $20 million [5]. - The concurrent private placement includes 1,176,471 shares of common stock and warrants at an offering price of $1.275, with gross proceeds of $1.5 million [6]. - The total potential gross proceeds from both offerings, including warrants, could reach approximately $43 million [4]. Group 2: Use of Proceeds - The net proceeds from the offerings will be utilized to fund clinical development of the lead gene therapy programs, OPGx-LCA5 and OPGx-BEST1, as well as for general corporate purposes and working capital [3]. Group 3: Warrants and Conditions - Warrants issued in the public offering could provide up to $21.4 million in additional capital upon the release of OPGx-BEST1 DUO-1001 Cohort 1 data [4]. - The warrants from the public offering will be exercisable immediately and have an initial exercise price of $0.95, expiring five years from issuance [5]. - The private placement warrants will also be exercisable immediately, with an initial exercise price of $1.15, and similar expiration terms [6]. Group 4: Company Background - Opus Genetics is focused on developing gene therapies for inherited retinal diseases and other ophthalmic disorders, with a pipeline that includes investigational therapies for various genetic mutations [11]. - The company is currently evaluating its most advanced gene therapy program in a Phase 1/2 trial, with plans to initiate a Phase 1/2 study for BEST1 in 2025 [11].

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]

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]