UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2025 OR (State or other jurisdiction of incorporation or organization) 8 Davis Drive, Suite 220 Durham, NC 27713 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (984) 884-6030 N/A ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...

Exhibit 99.1 Opus Genetics Announces Financial Results for Second Quarter 2025 and Provides Corporate Update - 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 Ph ...

Core Insights - Opus Genetics has achieved significant progress in its clinical pipeline, including positive clinical data for OPGx-LCA5 and FDA's RMAT designation, indicating strong potential for vision restoration therapies [1][2][5] - The company reported positive topline results from Phase 3 trials for Phentolamine Ophthalmic Solution 0.75%, which could provide new treatment options for patients with vision challenges [1][2][13] - Financial results for Q2 2025 show an increase in collaboration revenue and a net loss reduction compared to the same period in 2024, indicating improved financial performance [9][12][22] Pipeline Updates - OPGx-LCA5, a gene therapy for Leber Congenital Amaurosis, has shown sustained visual function improvements in adult patients, with initial pediatric data indicating positive outcomes [1][5] - OPGx-BEST1 is on track to enter Phase 1/2 trials in H2 2025, targeting bestrophin-1 related inherited retinal disease [1][4][14] - Non-dilutive funding has been secured to support the advancement of multiple early-stage gene therapy programs, including OPGx-RDH12 and OPGx-MERTK [1][13] Financial Performance - As of June 30, 2025, Opus Genetics reported cash and cash equivalents of $32.4 million, expected to fund operations into the second half of 2026 [8] - License and collaboration revenue for Q2 2025 totaled $2.9 million, up from $1.1 million in Q2 2024, driven by collaboration with Viatris, Inc. [9] - General and administrative expenses increased to $5.8 million in Q2 2025 from $3.4 million in Q2 2024, primarily due to higher legal and patent-related costs [10] Upcoming Milestones - The company plans to report three-month pediatric data from the OPGx-LCA5 trial in Q3 2025 and initiate enrollment for OPGx-BEST1 in H2 2025 [14] - A supplemental New Drug Application (sNDA) for Phentolamine is expected to be submitted in the second half of 2025 [14] - Enrollment for the LYNX-3 Phase 3 trial targeting nighttime visual disturbances is anticipated to begin in H2 2025 [14]

Core Insights - Opus Genetics, Inc. is a clinical-stage biopharmaceutical company focused on developing gene therapies for inherited retinal diseases and small molecule therapies for other ophthalmic disorders [1][3] - The company granted equity awards to two new non-executive employees as an inducement for employment, consisting of stock options and restricted stock units (RSUs) [1][2] Equity Awards Details - The equity awards include stock options for 240,000 shares and 150,000 RSUs, with the stock options having an exercise price of $0.94, equal to the closing price on the grant date [2] - Stock options vest over four years, with 25% vesting on the one-year anniversary and the remaining 75% vesting quarterly thereafter; RSUs vest in four equal installments on each anniversary of the grant date [2] Company Pipeline - Opus Genetics is developing AAV-based gene therapies targeting inherited retinal diseases such as Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa [3] - The lead candidate, OPGx-LCA5, is in a Phase 1/2 trial for LCA5-related mutations and has shown promising early results [3] - Additional programs include OPGx-BEST1 for BEST1-related retinal degeneration and a Phase 3-ready small molecule therapy for diabetic retinopathy, developed under a Special Protocol Assessment with the FDA [3] - The company is also advancing Phentolamine Ophthalmic Solution 0.75%, which is approved for one indication and is being studied in two Phase 3 programs for presbyopia and dim light vision disturbances [3]

Core Insights - Opus Genetics announced positive topline results from the VEGA-3 trial, which evaluated Phentolamine Ophthalmic Solution 0.75% for treating presbyopia, showing significant improvement in near vision for participants [1][2][3] Group 1: Trial Results - The VEGA-3 trial met its primary endpoint, with 27.2% of participants achieving a ≥15-letter improvement in binocular distance-corrected near visual acuity (DCNVA) compared to 11.5% in the placebo group (p<0.0001) [2][7] - Key secondary efficacy endpoints were also met, indicating rapid and sustained improvement in near visual acuity [6] - Significant patient-reported functional benefits were observed, with satisfaction in near vision reported upon awakening (p<0.0001) [7] Group 2: Study Design - VEGA-3 is a multicenter, randomized, double-masked, placebo-controlled Phase 3 study that enrolled 545 participants across 40 sites in the United States [4] - Participants were randomized in a 3:2 ratio to receive either Phentolamine Ophthalmic Solution 0.75% or placebo, administered once daily in the evening [4] Group 3: Safety Profile - The safety profile of Phentolamine Ophthalmic Solution 0.75% was consistent with previous clinical trials, with no treatment-related serious adverse events reported [6][15] - Common treatment-emergent adverse events included conjunctival hyperemia, instillation site irritation, and dysgeusia, all predominantly mild [15] Group 4: Future Plans - The positive results from the VEGA-3 trial support the submission of an application to the U.S. Food and Drug Administration (FDA), planned for the second half of 2025 [3] - Opus Genetics is also advancing Phentolamine Ophthalmic Solution 0.75% in two Phase 3 programs for presbyopia and dim light vision disturbances [11][13]

Core Insights - Opus Genetics announced positive topline results from the LYNX-2 Phase 3 clinical trial for Phentolamine Ophthalmic Solution 0.75%, targeting chronic night driving impairment in keratorefractive patients with reduced mesopic vision [1][4][6] Group 1: Clinical Trial Results - The LYNX-2 study met its primary endpoint, showing that 17.3% of patients treated with Phentolamine achieved a ≥15-letter improvement in mesopic low contrast distance visual acuity (mLCVA) at Day 15, compared to 9.2% in the placebo group (p<0.05) [3][12] - Patient-reported outcomes indicated significant improvements in night-driving vision, particularly in difficulties seeing the road due to oncoming headlights and glare during dawn or dusk [4][12] - The study involved 199 patients who had undergone keratorefractive surgery and reported decreased visual acuity under low-light conditions, treated over a 6-week period [5][6] Group 2: Mechanism and Safety Profile - Phentolamine Ophthalmic Solution 0.75% works by reducing pupil diameter through a sympatholytic mechanism, avoiding risks associated with older agents [2][10] - The safety profile of Phentolamine was consistent with previous studies, with no new safety signals identified and no evidence of tachyphylaxis observed over the 6-week period [6][7] Group 3: Market Potential and Partnerships - The therapy addresses a significant unmet need, as there are currently no FDA-approved treatments for this condition, potentially offering meaningful benefits to keratorefractive patients [4][10] - Opus Genetics has a global licensing agreement with Viatris for the commercialization of Phentolamine Ophthalmic Solution 0.75% in the U.S. [8]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ________ Commission File Number: 001-34079 Opus Genetics, Inc. (Exact name of Registrant as specified in its charter) | Delaware | 11-3516358 | | --- | --- | | ( ...

Opus Genetics, Inc. (IRD) came out with a quarterly loss of $0.32 per share versus the Zacks Consensus Estimate of a loss of $0.34. This compares to loss of $0.29 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 5.88%. A quarter ago, it was expected that this company would post a loss of $0.34 per share when it actually produced a loss of $1.27, delivering a surprise of -273.53%.Over the last four quarters, the company has surp ...

Pediatric cohort of LCA5 study ongoing with initial multi-patient data anticipated in Q3 2025 Exhibit 99.1 Opus Genetics Announces Financial Results for First Quarter 2025 and Provides Corporate Update ARVO presentation highlights 12-month results from Phase 1/2 study that support potential of OPGx-LCA5 gene therapy to restore meaningful vision 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 k ...

Core Insights - Opus Genetics reported positive 12-month results from the Phase 1/2 trial of OPGx-LCA5, showing sustained treatment benefits for adult patients with Leber congenital amaurosis 5 (LCA5) [2][10] - The company is enrolling pediatric patients in the LCA5 study, with initial data expected in Q3 2025 [1][10] - Opus is on track to file an IND for OPGx-BEST1 and initiate a Phase 1/2 trial by Q4 2025, with preliminary data anticipated in Q1 2026 [1][6] Gene Therapy Programs - OPGx-LCA5 is the most advanced investigational gene therapy candidate targeting inherited retinal degeneration due to mutations in the LCA5 gene [5][6] - The pipeline includes seven AAV-based gene therapy assets for various inherited retinal diseases (IRDs) and the OPGx-BEST1 program for BEST1-related IRDs [6][16] - The FDA granted RMAT designation to OPGx-LCA5, allowing for expedited development and review [10] Financial Highlights - Opus reported a net loss of $8.2 million for Q1 2025, compared to a net loss of $7.1 million in Q1 2024, with a loss per share of $(0.24) [15][28] - License and collaborations revenue increased to $4.4 million in Q1 2025 from $1.7 million in Q1 2024, primarily from the Viatris License Agreement [12][27] - As of March 31, 2025, the company had cash and cash equivalents of $41.8 million, expected to fund operations into Q2 2026 [11][24] Clinical Trials and Development - The LYNX-2 pivotal Phase 3 trial for Phentolamine Ophthalmic Solution 0.75% completed enrollment in Q1 2025, with topline data expected mid-2025 [10][14] - The VEGA-3 pivotal Phase 3 trial for the same solution in presbyopia also completed enrollment in Q1 2025, with topline data expected in the first half of 2025 [10][14] - Initial data from three pediatric patients treated with OPGx-LCA5 is anticipated in Q3 2025 [10][14]