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Yahoo
15-04-2025
- Business
- Yahoo
PRISM MarketView Spotlights Opus Genetics in New Q&A with CEO George Magrath
Feature Details Company Milestones and 2025 Catalysts Across Gene Therapy and Ophthalmic Programs 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 George Magrath, Chief Executive Officer of Opus Genetics, Inc. In the interview, Dr. Magrath outlines Opus Genetics' recent milestones, including: Completion of enrollment in two Phase 3 clinical trials: VEGA-3 for presbyopia and LYNX-2 for post-LASIK night vision disturbances; FDA Fast Track designation for phentolamine ophthalmic solution to treat chronic night driving impairment; and Upcoming data presentations for OPGx-LCA5, an AAV-based gene therapy targeting Leber congenital amaurosis 5. The feature also explores Opus Genetics' strategy to seek to build a repeatable gene therapy platform and anticipated clinical milestones throughout 2025.'With multiple regulatory milestones and clinical readouts, as well as an expanding pipeline, 2025 has the potential to be a pivotal year for Opus Genetics,' said Dr. Magrath. The full Q&A, published by PRISM MarketView, is available here: Opus GeneticsOpus Genetics is a clinical-stage ophthalmic biopharmaceutical company developing therapies to treat patients with IRDs and other treatments for ophthalmic disorders. Our pipeline includes adeno-associated virus (AAV)-based investigational gene therapies that address mutations in genes that cause different forms of bestrophinopathy, Leber congenital amaurosis (LCA) and retinitis pigmentosa. Our most advanced investigational gene therapy program is designed to address mutations in the LCA5 gene, which encodes the lebercilin protein and is currently being evaluated in a Phase 1/2 open-label, dose-escalation trial, with encouraging early data. Our pipeline also includes BEST1 investigational gene therapy, designed to address mutations in the BEST1 gene, which is associated with retinal degeneration. The pipeline also includes Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist being investigated to reduce pupil size, and APX3330, a novel small-molecule inhibitor of Ref-1 being investigated to slow the progression of non-proliferative diabetic retinopathy. Phentolamine Ophthalmic Solution 0.75% is currently being evaluated in Phase 3 trials for presbyopia and dim (mesopic) light vision disturbances. We have reached agreement with the FDA under SPA for a Phase 3 trial to evaluate oral APX3330 for the treatment of DR more information, please visit Forward-Looking Statements This article contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning data from and future enrollment for the Company's clinical trials, the results of the Company's ongoing Phase 1/2 trial with respect to OPGx LCA5, and the Company's pipeline of additional indications. These forward-looking statements relate to the Company, its business prospects and its results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause its actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under Part II, Item 1A, 'Risk Factors', in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in the Company's other filings with the U.S. Securities and Exchange Commission (the 'SEC'). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this article. In some cases, you can identify forward-looking statements by the following words: 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'aim,' 'may,' 'ongoing,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'will,' 'would' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The Company undertakes no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise, except as may be required by applicable law. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: Failure to successfully integrate our businesses with former Opus Genetics Inc. could have a material adverse effect on our business, financial condition and results of operations; The acquisition of former Opus Genetics Inc. significantly expanded our product pipeline and business operations and shifted our business strategies, which may not improve the value of our common stock; Our gene therapy product candidates are based on a novel technology that is difficult to develop and manufacture, which may result in delays and difficulties in obtaining regulatory approval; Our planned clinical trials may face substantial delays, result in failure, or provide inconclusive or adverse results that may not satisfy FDA requirements to further develop our therapeutic products; Changes in regulatory requirements could result in increased costs or delays in development timelines; We depend heavily on the success of our product pipeline; if we fail to find strategic partners or fail to adequately develop or commercialize our pipeline products, our business will be materially harmed; Others may discover, develop, or commercialize products similar to those in our pipeline before or more successfully than we do or develop generic variants of our products even while our product patents remain active, thereby reducing our market share and potential revenue from product sales; We do not currently have any sales or marketing infrastructure in place and we have limited drug research and discovery capabilities; The future commercial success of our products could significantly depend upon several uncertain factors, including third-party reimbursement practices and the existence of competitors with similar products; Product liability lawsuits against us or our suppliers or manufacturers could cause us to incur substantial liabilities and could limit commercialization of any product candidate that we may develop; Failure to comply with health and safety laws and regulations could lead to material fines ; We have not generated significant revenue from sales of any products and expect to incur losses for the foreseeable future; Our future viability is difficult to assess due to our short operating history and our future need for substantial additional capital, which could be limited by any adverse developments that affect the financial services industry; Raising additional capital may cause our stockholders to be diluted, among other adverse effects; We operate in a highly regulated industry and face many challenges complying to sudden changes in legislative reform or the regulatory environment, which affects our pipeline stability and could impair our ability to compete in international markets; We may not receive regulatory approval to market our developed product candidates within or outside of the U.S.; With respect to any of our product candidates that receive marketing approval, we may be subject to substantial penalties if we fail to comply with applicable regulatory requirements; Our potential relationships with healthcare providers and third-party payors will be subject to certain healthcare laws and regulations, which could expose us to extensive potential liabilities; We rely on third parties for material aspects of our business, such as conducting our nonclinical and clinical trials and supplying and manufacturing bulk drug substances, which exposes us to certain risks; We may be unsuccessful in entering into or maintaining licensing arrangements (such as the Viatris License Agreement) or establishing strategic alliances on favorable terms, which could harm our business; Our current focus on the cash-pay utilization for future sales of RYZUMVI may limit our ability to increase sales or achieve profitability with this product; Inadequate patent protection for our product candidates may result in our competitors developing similar or identical products or technology, which would adversely affect our ability to successfully commercialize; We may be unable to obtain full protection for our intellectual property rights under U.S. or foreign laws; We may become involved in lawsuits for a variety of reasons associated with our intellectual property rights, including alleged infringement suits initiated by third parties; We are dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy; As we grow, we may not be able to operate internationally or adequately develop and expand our sales, marketing, distribution, and other corporate functions, which could disrupt our operations; The market price of our common stock is expected to be volatile and subject to certain dilutive risks associated with our Equity Line of Credit arrangement; and Factors out of our control related to our securities, such as securities litigation or actions of activist stockholders, could adversely affect our business and stock price and cause us to incur significant expenses. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive. Readers are urged to carefully review and consider the various disclosures made by the Company in this statement and in the Company's other reports filed with the SEC that advise interested parties of the risks and factors that may affect the Company's business. All forward-looking statements contained in this article speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by applicable law. About PRISM MarketViewPRISM MarketView is a financial media platform focused on highlighting emerging growth companies and breakthrough innovation across public markets. Through original editorial, video features, and executive Q&A content, PRISM delivers timely insights and elevates visibility for high-potential companies. PRISM also maintains a suite of proprietary indexes tracking momentum across sectors including biotech, AI, and consumer tech. Learn more at PRISM MarketView does not provide investment advice. DisclaimerThis communication was produced by PRISM MarketView, an affiliate of PCG Advisory Inc., (together "PCG"). PCG is not a registered or licensed broker-dealer nor investment adviser. No information contained in this communication constitutes an offer to sell, a solicitation of an offer to buy, or a recommendation of any security. PCG may be compensated by respective clients for publicizing information relating to its clients' securities. See Contact:PRISM MarketViewinfo@ Photos accompanying this announcement are available at:
Yahoo
21-03-2025
- Business
- Yahoo
Opus Genetics Announces Presentation on Phentolamine Ophthalmic Solution 0.75% in Dim Light Disturbances at World Cornea Congress IX
RESEARCH TRIANGLE PARK, N.C., March 21, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies for other ophthalmic disorders, today announced that a presentation featuring the LYNX-1 Phase 3 study of Phentolamine Ophthalmic Solution 0.75% in patients with dim light disturbances will be delivered this week at World Cornea Congress IX, taking place March 20-22, 2025 in Washington, D.C. Key highlights from the presentation As previously reported, the LYNX-1 Phase 3 study met its primary endpoint, with a statistically significant greater percentage of Phentolamine Ophthalmic Solution 0.75%-treated participants gaining 15 or more letters of mesopic low contrast distance visual acuity (mLCVA) at Day 8, compared to placebo (13% vs. 3%; p<0.05). The effect of Phentolamine Ophthalmic Solution 0.75% increased at Day 15, with 21% of participants gaining 15 or more letters of mLCVA compared to 3% of participants given the placebo (p<0.01). Patient reported outcomes for glare, halos, and starbursts were significantly lower for the Phentolamine Ophthalmic Solution 0.75% group compared to placebo at Day 15 (p<0.01). A subset analysis of post-LASIK participants demonstrated clinically meaningful results at Day 8, with 29% of Phentolamine Ophthalmic Solution 0.75% participants gaining 15 or more letters of mLCVA compared to 9% of participants given the placebo. The effect of Phentolamine Ophthalmic Solution 0.75% was sustained at Day 15 in post-LASIK participants, with 21% of participants gaining 15 or more letters of mLCVA compared to 0% of participants given the placebo. The positive LYNX-1 Phase 3 data support the rational of the ongoing Phase 3 LYNX-2 trial of Phentolamine Ophthalmic Solution 0.75% for keratorefractive patients with reduced mLCVA with photic phenomena. LYNX-2 is fully enrolled, with topline results expected mid 2025. The full abstract can be accessed at the World Cornea Congress IX website here. 'We are pleased to present the results from the LYNX-1 Phase 3 trial of Phentolamine Ophthalmic Solution 0.75%, including a subset analysis highlighting results from participants who underwent some form of keratorefractive surgery, including LASIK,' said Jay Pepose, M.D., PhD., Chief Medical Advisor at Opus Genetics. 'Some patients who underwent keratorefractive surgery have experienced debilitating reduced mesopic vision and are more likely to be involved in motor vehicle collisions. Phentolamine Ophthalmic Solution 0.75% has the potential to be the first treatment for keratorefractive patients suffering from these debilitating symptoms.' Presentation details Title: Randomized, Placebo-Controlled, Double-Masked Phase 3 Studies of Phentolamine Solution in Keratorefractive Patients with Dim Light Disturbances and Decreased Mesopic Vision Presenter: Jay Pepose, M.D., Ph.D. (Chief Medical Advisor, Opus Genetics) Session: Paper Session 2 Date/time: Friday, March 21, 2025 at 2:10 – 2:16 PM ET Location: Rock Creek C, Ballroom Level, Westin Washington DC Downtown About Opus Genetics Opus Genetics is a clinical-stage ophthalmic biotechnology company developing gene therapies to treat patients with inherited retinal diseases (IRDs) and other treatments for ophthalmic disorders. The pipeline includes adeno-associated virus (AAV)-based investigational gene therapies that address mutations in genes that cause different forms of bestrophinopathy, Leber congenital amaurosis (LCA) and retinitis pigmentosa. Our most advanced investigational gene therapy program is designed to address mutations in the LCA5 gene, which encodes the lebercilin protein and is currently being evaluated in a Phase 1/2 open-label, dose-escalation trial, with encouraging early data. BEST1 investigational gene therapy is designed to address mutations in the BEST1 gene, which is associated with retinal degeneration; we expect that a Phase 1/2 study will be initiated in 2025. The pipeline also includes Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist being investigated to reduce pupil size, and APX3330, a novel small-molecule inhibitor of Ref-1, being investigated to slow the progression of non-proliferative diabetic retinopathy. Phentolamine Ophthalmic Solution 0.75% is currently being evaluated in Phase 3 trials for treatment of presbyopia and reduced dim (mesopic) light low contrast vision following keratorefractive surgery. We have reached agreement with the FDA on a SPA for a Phase 3 trial to evaluate oral APX3330 for the treatment of DR. For more information, please visit Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning data from and future enrollment for our clinical trials and our pipeline of additional indications. These forward-looking statements relate to us, our business prospects and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading 'Risk Factors' included in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and in our other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. In some cases, you can identify forward-looking statements by the following words: 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'aim,' 'may,' 'ongoing,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'will,' 'would' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: Our ability to successfully integrate the business of former Opus Genetics Inc. and manage our expanded combined product pipeline; Our ability to develop and obtain regulatory approval for newly acquired gene therapies to treat inherited retinal diseases; Our ability to obtain and maintain orphan drug designation or rare pediatric disease designation for our current and future product candidates; The success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts; Regulatory requirements or developments; Changes to or unanticipated events in connection with clinical trial designs and regulatory pathways; Delays or difficulties in the enrollment of patients in clinical trials; Substantial competition, including from generic versions of our product candidates; Rapid technological change; Our development of sales and marketing infrastructure; Future revenue losses and profitability; Changes in capital resource requirements; Risks related to our inability to obtain sufficient additional capital to continue to advance our product candidates and our preclinical programs; Domestic and worldwide legislative, regulatory, political and economic developments; Our dependency on key personnel; Changes in market opportunities and acceptance; Reliance on third parties to conduct our clinical trials and supply and manufacture drug supplies; Future, potential product liability and securities litigation; System failures, unplanned events, or cyber incidents; The substantial number of shares subject to potential issuance associated with our equity line of credit arrangement; Risks that our licensing or partnership arrangements may not facilitate the commercialization or market acceptance of our product candidates; Future fluctuations in the market price of our common stock; Actions by activist stockholders; The success and timing of commercialization of any of our product candidates; Obtaining and maintaining our intellectual property rights; and The success of mergers and acquisitions. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive. Readers are urged to carefully review and consider the various disclosures made by us in this report and in our other reports filed with the Securities and Exchange Commission that advise interested parties of the risks and factors that may affect our business. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Contacts Corporate Investor Relations Nirav JhaveriCFOir@ Corey Davis, Advisorscdavis@ in to access your portfolio
Yahoo
19-03-2025
- Business
- Yahoo
Opus Genetics Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)
RESEARCH TRIANGLE PARK, N.C., March 19, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biopharmaceutical company developing important new therapies for the treatment of inherited retinal diseases (IRDs) and other ophthalmic disorders ('Opus' or the 'Company'), today announced that the independent members of its Board of Directors approved equity awards under the Company's 2021 Inducement Plan, as amended, as a material inducement to two new employees in connection with the commencement of their employment with the Company effective March 13, 2025. The equity awards were approved in accordance with Nasdaq Listing rule 635(c)(4), which also requires a public announcement of equity awards that are not made under a stockholder approved equity plan. The equity awards were granted in the form of options to purchase an aggregate of 205,742 shares of the Company's common stock. The option awards each have an exercise price of $0.93 per share, the closing price of the Company's common stock on the grant date of March 13, 2025. The options vest over a period of four years, with 25% vesting on the one-year anniversary of the grant date and the remaining 75% vesting either in equal monthly or quarterly installments thereafter, and subject to acceleration or forfeiture upon the occurrence of certain events as set forth in each new hire's award agreements. About Opus Genetics Opus Genetics is a clinical-stage ophthalmic biopharmaceutical company developing therapies to treat patients with inherited retinal diseases (IRDs) and other treatments for ophthalmic disorders. Our pipeline includes adeno-associated virus (AAV)-based investigational gene therapies that address mutations in genes that cause different forms of bestrophinopathy, Leber congenital amaurosis (LCA) and retinitis pigmentosa. Our most advanced investigational gene therapy program is designed to address mutations in the LCA5 gene, which encodes the lebercilin protein and is currently being evaluated in a Phase 1/2 open-label, dose-escalation trial, with encouraging early data. Our pipeline also includes BEST1 investigational gene therapy, designed to address mutations in the BEST1 gene, which is associated with retinal degeneration. The pipeline also includes Phentolamine Ophthalmic Solution 0.75%, a non-selective alpha-1 and alpha-2 adrenergic antagonist being investigated to reduce pupil size, and APX3330, a novel small-molecule inhibitor of Ref-1 being investigated to slow the progression of non-proliferative diabetic retinopathy. Phentolamine Ophthalmic Solution 0.75% is currently being evaluated in Phase 3 trials for presbyopia and dim (mesopic) light vision disturbances. We have reached agreement with the FDA under SPA for a Phase 3 trial to evaluate oral APX3330 for the treatment of DR. For more information, please visit Contacts Corporate Investor Relations Nirav JhaveriCFOir@ Corey Davis, Advisorscdavis@ in to access your portfolio
