Opus Genetics, Inc.

The resulting company will operate under the name Opus Genetics and the Nasdaq ticker symbol (IRD) RALEIGH, N.C., Oct. 25, 2024 /PRNewswire/ -- The RD Fund (Retinal Degeneration Fund) – the venture arm of the Foundation Fighting Blindness – announces the all-stock acquisition of Opus Genetics, Inc. "Opus" (private) by Ocuphire Pharma, Inc., (Nasdaq: OCUP) a clinical-stage ophthalmic biopharmaceutical company. The companies have combined under the name of Opus Genetics to create a transformative biotech company committed to being a leader in the development of gene therapies for the treatment of inherited retinal diseases (IRDs). The combined company is trading on the Nasdaq under the ticker symbol "IRD." The RD Fund launched Opus in the fall of 2021 to develop gene therapies for the treatment of inherited retinal diseases (IRDs). The RD Fund led the seed financing for Opus as the first internally conceived spinout of the Fund to further the Foundation's mission. With the full support of the Foundation's and Fund's Board of Directors, the company was co-founded and initially managed by Ben Yerxa, PhD, Rusty Kelley, PhD, Peter Ginsberg, and Jason Menzo along with its scientific founders, Jean Bennett, MD, PhD and Junwei Sun from the University of Pennsylvania and Eric Pierce, MD, PhD, from Harvard and Massachusetts Eye and Ear. "The initial seed funding allowed Opus to build a pipeline of early-stage preclinical assets, including advancing OPGx-LCA5 into a Phase 1/2 trial where 6-month data demonstrated safety and visual improvement in early onset retinal degeneration," said Rusty Kelley, managing director of the RD fund and a founding director of the company. "We thank our major donors, including those that enabled project-based funding from the Foundation Fighting Blindness, for helping us advance Opus's pipeline while weathering a significant biotech downturn," added Jason Menzo, Opus co-founder and CEO of the Foundation Fighting Blindness. The acquisition of Opus by Ocuphire is a key milestone as it represents the first RD Fund portfolio company to enter the public markets. The milestone further validates the venture philanthropy model of derisking assets - making them more attractive to institutional investors and the public markets. "That a highly skilled and experienced team - including former Opus executives and directors Ben Yerxa, Jean Bennett, and Adrienne Graves - will advance the Opus portfolio with a commitment to being a leader in developing genetic medicines for the treatment of IRDs accelerated our approval of the transaction," said Kelley. About the RD Fund The RD Fund (Retinal Degeneration Fund), the venture investment arm of the Foundation Fighting Blindness, has a dual mission: accelerate the approval of therapies for retinal diseases and provide alternative revenue sources to further the Foundation's mission. Established in 2018, the RD Fund prioritizes investments in companies around the globe developing therapies that are close to clinical testing. For more information, visit RDFund.org. About the Foundation Fighting Blindness Established in 1971, the Foundation Fighting Blindness is the world's leading private funding source for retinal degenerative disease research. The Foundation has raised more than $915 million toward its mission of accelerating research for preventing, treating, and curing blindness caused by the spectrum of blinding retinal diseases including: retinitis pigmentosa, macular degeneration, and Usher syndrome. Visit FightingBlindness.org for more information. Media Contact: Chris Adams 410-423-0585 [email protected] SOURCE Foundation Fighting Blindness WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Pfizer’s Abryso is designed to stimulate an immune response against RSV prefusion conformation (pre-F), thereby providing protection against lower respiratory tract disease caused by RSV. Image credit: Jonathan Weiss / Shutterstock. The US Food and Drug Administration (FDA) has expanded the indication for Pfizer ’s respiratory syncytial virus (RSV) vaccine Abrysvo to include adults aged 18–59 years who have chronic conditions that place them at increased risk of lower respiratory tract disease caused by the virus. The label expansion adds to the existing label for Abrysvo that allows for vaccine use in adults over 60 years of age and pregnant women (between 32 and 36 weeks of gestation). The approval comes just in time for the current RSV season in the US, which typically runs from October to April. Abrysvo generated $515m in sales in the fourth quarter of last year, as per Pfizer’s financials. While these are nowhere close to the profits Pfizer saw with products such as its Covid-19 vaccine developed with BioNTech , and the antiviral treatment Paxlovid, at their peak, with weakening demand for the Covid-19 products , Pfizer has touted Abrysvo as one of the primary revenue driver. Abrysvo’s main competitor is GSK ’s Arexvy, which is approved in the same indication . However, its use is limited to adults over 50 years of age. Arexvy raked in $1.2bn in sales last year, as per GSK’s financials. GlobalData expects Arexvy to have higher sales of $3.3bn in 2030, compared to $2.2bn of Abrysvo over the same period. GlobalData is the parent company of Pharmaceutical Technology . See Also: Ocuphire and Opus Genetics merge to develop IRD gene therapy FDA approves Alvotech and Teva’s SELARSDI for new indications The FDA approval of the indication was based on the positive data from the Phase III MONeT study (NCT05842967). The trial was divided into two substudies; substudy A, which evaluated Abrysvo in patients with chronic medical conditions, including asthma and diabetes; and substudy B , which investigated the vaccine in immunocompromised patients. Pfizer has not disclosed detailed results from the trial, stating its intention to publish these in a peer-reviewed scientific journal and present the same at a scientific conference. In August, the company reported that a single 120µg dose of the vaccine led to “strong neutralising” responses against RSV-A and RSV-B. The commonly reported treatment-associated side effects were pain at the injection site, muscle pain, joint pain and nausea. Pfizer is also evaluating Abrysvo in children aged between two and 17 years in an open-label Phase I PICASSO trial (NCT05900154). The trial enrolled 128 participants across the US, according to ClinicalTrials.gov .

The merger is set to create a company dedicated to gene therapy development for inherited retinal diseases. Credit: elenavolf/Shutterstock. Ocuphire Pharma has announced the acquisition of Opus Genetics to create a biotech company dedicated to gene therapy development for inherited retinal diseases (IRDs). The combined entity will be named Opus Genetics. Ocuphire has issued 5.2m common stock shares and 14,100 shares of its convertible preferred stock to Opus Genetics’ stockholders. The preferred shares will be convertible into common stock, pending approval at the annual meeting in April 2025. Post-merger, Ocuphire’s pre-acquisition stockholders will hold 58% of the fully diluted capitalisation of the combined company, while Opus Genetics’ stockholders will own almost 42%. See Also: FDA approves Alvotech and Teva’s SELARSDI for new indications AAO 2024: NMA reveals Vabysmo’s superior CST improvement over Eylea HD Newly combined company president Ben Yerxa stated: “With the Ocuphire team’s late-stage ophthalmic drug development and regulatory approval experience and resources, we believe we are well-positioned to accelerate our pipeline of potentially transformative gene therapies for inherited retinal diseases. “We see this transaction as a win for patients with IRDs around the world, and we look forward to efficiently progressing our combined pipeline.” The expanded pipeline of the new company includes adeno-associated virus (AAV)-based gene therapy assets for IRDs and Ocuphire’s late-stage product candidate RYZUMVI (phentolamine ophthalmic solution 0.75%), which is being assessed for presbyopia and dim light vision disturbances following keratorefractive surgery. RYZUMVI is designed to reduce pupil size by blocking alpha-1 receptors on the radial iris dilator muscles. The combined company’s expected cash runway is extended into 2026, anticipating clinical data readouts for several trials. Leerink Partners is the exclusive financial advisor to Ocuphire. Sidley Austin and Smith Anderson are serving as legal counsels to Ocuphire and Opus Genetics, respectively. In 2022, Opus Genetics signed an agreement with National Resilience for developing and manufacturing AAV vector-based gene therapies for IRD. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva . Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content. Free Whitepaper Cell and gene therapies: Pipe dream to pipeline The cell and gene industry is gaining momentum, with a new wave of therapies promising to transform the way doctors treat, and even cure, disease. In this report, Cytiva and GlobalData have collaborated to explore the rise of the cell and gene therapy industries, the current state of the market, present and future opportunities for advancement, and the challenges that lie ahead. Thank you. You will receive an email shortly. Please check your inbox to download the Whitepaper. By Cytiva Thematic By downloading this Whitepaper, you acknowledge that GlobalData may share your information with Cytiva Thematic and that your personal data will be used as described in their Privacy Policy