Core Insights - Opus Genetics, Inc. is set to present positive clinical results from its gene therapy and Phentolamine Ophthalmic Solution programs at various medical and industry conferences in October 2025 [1][2] Company Overview - Opus Genetics is a clinical-stage biopharmaceutical company focused on developing gene therapies for inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders [5] - The company's pipeline includes AAV-based gene therapies targeting conditions such as Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa [5] - Lead gene therapy candidates include OPGx-LCA5, currently in a Phase 1/2 trial for LCA5-related mutations, and OPGx-BEST1 for BEST1-related retinal degeneration [5] - 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 visual disturbances [5] Conference Participation - The company will participate in several key conferences, including: - Cell and Gene Meeting on the Mesa - Fierce Biotech Week - American Academy of Optometry Annual Meeting 2025 - Eyecelerator @ American Academy of Ophthalmology (AAO) [3][4] Presentation Details - Presentation on OPGx-LCA5 will include three-month pediatric and 18-month adult clinical data from the Phase 1/2 trial for Leber congenital amaurosis type 5 [6] - A fireside chat titled "Investing with Intention – How Early Vision and Partnership Shaped Opus Genetics" will feature key executives from the company [6] - A poster presentation on the pivotal Phase 3 trial of Phentolamine Ophthalmic Solution will also take place [6]

Momentum investing is all about the idea of following a stock's recent trend, which can be in either direction. In the "long context," investors will essentially be "buying high, but hoping to sell even higher." And for investors following this methodology, taking advantage of trends in a stock's price is key; once a stock establishes a course, it is more than likely to continue moving in that direction. The goal is that once a stock heads down a fixed path, it will lead to timely and profitable trades.Whil ...

PresentationOperator Greetings, and welcome to the Opus Genetics LCA5 Data Conference Call. [Operator Instructions] Please note that the webcast participants will be able to see and hear the video. However, teleconference participants dialed-in by phone will need to view the video in the Event Replay in the Investors section of the company's website. As a reminder, this conference call is being recorded. I will now turn the conference over to your host, Jenny Kobin, Opus Investor Relations. Ma'am, please go ...

Pediatric participants demonstrated large gains in cone-mediated vision; therapy remains well tolerated with no ocular serious adverse events or dose-limiting toxicitiesLasting, durable responses observed out to 18 months in adult participantsExpected FDA Meeting in Q4 2025Management to Host Webcast and Conference Call Today at 8:30 A.M. ET RESEARCH TRIANGLE PARK, N.C., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage biopharmaceutical company developing gene therapies ...

Core Viewpoint - Opus Genetics has initiated the first patient dosing in LYNX-3, a pivotal Phase 3 clinical trial for Phentolamine Ophthalmic Solution 0.75%, aimed at treating chronic night driving impairment in keratorefractive patients with reduced mesopic vision [1][2]. Group 1: Clinical Trial Details - LYNX-3 is the second Phase 3 trial for this indication, designated as Fast Track by the FDA, and follows a Special Protocol Assessment [2]. - The trial will enroll approximately 200 adults with decreased visual acuity in low-light conditions post-keratorefractive surgery, including LASIK and PRK [5]. - Participants will be randomized to receive either Phentolamine Ophthalmic Solution 0.75% or placebo for about two weeks [5]. Group 2: Treatment Mechanism and Benefits - Phentolamine Ophthalmic Solution 0.75% is a non-selective α1/α2 adrenergic antagonist designed to reduce pupil size in low-light conditions, potentially improving visual quality by decreasing the impact of peripheral light rays [3][7]. - The primary endpoint of the trial is the percentage of participants achieving a ≥15-letter improvement in mesopic low-contrast visual acuity at Day 15 [6]. - Key secondary endpoints include patient-reported outcomes related to night driving and visual disturbances such as glare and halos [6]. Group 3: Company Overview - Opus Genetics is a clinical-stage biopharmaceutical company focused on gene therapies for inherited retinal diseases and small-molecule therapies for ophthalmic disorders [9]. - The company is advancing Phentolamine Ophthalmic Solution 0.75% in two Phase 3 programs, with one approved indication for drug-induced mydriasis and positive data for presbyopia [4][9].

Company Overview - Opus Genetics, Inc. is a clinical-stage biopharmaceutical company focused on developing gene therapies for inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders [3] - The company's pipeline includes AAV-based gene therapies targeting conditions such as Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa [3] - Lead gene therapy candidates include OPGx-LCA5, currently in a Phase 1/2 trial for LCA5-related mutations, and OPGx-BEST1, targeting BEST1-related retinal degeneration [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 reduced low light vision [3] Corporate Update - George Magrath, MD, CEO, and Ash Jayagopal, Ph.D., MBA, Chief Scientific and Development Officer, will present a corporate update at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025 [1] - The presentation will be available on demand starting September 8, 2025, at 7:00 a.m. ET [1] Investor Relations - Recent investor event replays are accessible on the Opus Genetics website under the Investors section [2]

Core Insights - Opus Genetics, Inc. has appointed Rob Gagnon as Chief Financial Officer, bringing over two decades of financial and operational leadership experience in the biotech sector [1][2][3] Company Overview - Opus Genetics is a clinical-stage biopharmaceutical company focused on developing gene therapies for inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders [5] - The company's pipeline includes AAV-based gene therapies targeting conditions such as Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa [5] - Lead gene therapy candidates include OPGx-LCA5, currently in a Phase 1/2 trial for LCA5-related mutations, and OPGx-BEST1, targeting BEST1-related retinal degeneration [5] - Opus is also advancing Phentolamine Ophthalmic Solution 0.75%, which is approved for one indication and being studied in two Phase 3 programs for presbyopia and visual disturbances [5] Leadership Experience - Rob Gagnon has raised over $2 billion in capital and has experience in guiding companies through IPOs, late-stage clinical development, and M&A [2][3] - Prior to joining Opus, Gagnon served as CFO at Remix Therapeutics and held senior roles at Verastem Oncology, Harvard Bioscience, Clean Harbors, and Biogen [2][3][4] - Gagnon holds an MBA from MIT Sloan School of Management and a BA in Accounting from Bentley College, and is a Certified Public Accountant [4]

Company Overview - Opus Genetics, Inc. is a clinical-stage biopharmaceutical company focused on developing gene therapies for inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders [3] - The company's pipeline includes AAV-based gene therapies targeting conditions such as Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa [3] - Lead gene therapy candidates include OPGx-LCA5, currently in a Phase 1/2 trial for LCA5-related mutations, and OPGx-BEST1 for BEST1-related retinal degeneration [3] - Additionally, the company is advancing Phentolamine Ophthalmic Solution 0.75%, which is approved for one indication and is being studied in two Phase 3 programs for presbyopia and low light vision disturbances [3] Upcoming Presentations - Opus Genetics will present its IRD gene therapy programs at several scientific conferences in September 2025 [1] - Presentation at the Ophthalmology Futures Forum will focus on "Gene & Cell Therapies for Rare & Common Retinal Diseases: Hype Vs Progress" on September 3, 2025 [2] - At the RD 2025 International Symposium, the company will share one-year results from a Phase I/II study of OPGx-LCA5 for inherited retinal degeneration due to biallelic mutations in the LCA5 gene [2] - The LSX World Congress will feature a presentation titled "The Equation for Maturation: Biotech Requirements to Achieve Scale" [2] Key Personnel - Sally Tucker, Ph.D., Senior Vice President Clinical Development, will present at the Ophthalmology Futures Forum and participate in a panel discussion in Paris, France on September 3, 2025 [4] - Ash Jayagopal, Ph.D., Chief Scientific & Development Officer, will present in Prague, Czech Republic on September 15, 2025 [4] - Ben Yerxa, Ph.D., President, will also participate in a panel discussion in Boston, MA on September 17, 2025 [4]

Core Insights - Opus Genetics has received FDA acceptance for its Investigational New Drug (IND) application for OPGx-BEST1, a gene therapy targeting BEST1-related inherited retinal disease (IRD) [1][4] - The Phase 1/2 clinical trial is set to begin in the second half of 2025, focusing on safety, tolerability, and preliminary efficacy of a single subretinal injection [3][4] - BEST1-related IRDs currently lack approved treatments, highlighting the urgency for effective therapies in this area [4] Company Overview - Opus Genetics is a clinical-stage biopharmaceutical company specializing in gene therapies for inherited retinal diseases and small molecule therapies for other ophthalmic disorders [5] - The company's pipeline includes AAV-based gene therapies for conditions such as Leber congenital amaurosis (LCA) and retinitis pigmentosa, with OPGx-LCA5 also in an ongoing Phase 1/2 trial [5] - The company is based in Research Triangle Park, NC, and is committed to advancing multiple therapies for patients with unmet needs [5]

Company Performance - Opus Genetics, Inc. reported a quarterly loss of $0.12 per share, which was better than the Zacks Consensus Estimate of a loss of $0.25, representing an earnings surprise of +52.00% [1] - The company posted revenues of $2.88 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 12.13%, compared to revenues of $1.11 million a year ago [2] - Over the last four quarters, Opus Genetics has surpassed consensus EPS estimates three times and topped consensus revenue estimates three times [2] Stock Movement and Outlook - Opus Genetics shares have declined approximately 6.7% since the beginning of the year, while the S&P 500 has gained 9.6% [3] - 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 current consensus EPS estimate for the upcoming quarter is -$0.25 on revenues of $3.44 million, and for the current fiscal year, it is -$0.99 on revenues of $15.66 million [7] Industry Context - The Medical - Biomedical and Genetics industry, to which Opus Genetics belongs, is currently ranked in the bottom 41% of over 250 Zacks industries, indicating potential challenges for stock performance [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Opus Genetics' stock performance [5][6]