Opus Genetics acquired, becomes public company based in NC
Date: Oct 30, 2024
Author: Barry Teater
Source: www.ncbiotech.org ( click here to go to the source)
Research Triangle Park-based Opus Genetics, a clinical-stage gene therapy company devoted to treating inherited retinal diseases, has been acquired by a small ophthalmic biopharmaceutical firm with Durham operations, becoming North Carolina's newest publicly traded life sciences company.
Opus was acquired by Ocuphire Pharma of Farmington Hills, Mich., in an all-stock transaction announced on Oct. 22. The combined company will operate under the Opus Genetics name, and its shares have begun trading on the Nasdaq stock market under the ticker symbol IRD, shorthand for inherited retinal diseases, the company's focus.
"Opus Genetics has created a compelling pipeline of transformative therapies for patients with inherited retinal diseases, with promising early data," said George Magrath, M.D., Ocuphire's chief executive officer, who will continue in that role with the combined company. "This is an opportunity to advance these treatments quickly, with four major clinical milestones on the horizon in 2025 for the combined company.Opus logo
"We are excited to bring together a leadership team with deep expertise in the development of potentially groundbreaking gene therapies. We look forward to continuing our progress, creating value, and improving patient outcomes together."
Ben Yerxa, Ph.D., former president and CEO of Opus, is president of the newly combined company, to be based in the Research Triangle.
"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," Yerxa said. "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 includes multiple assets from Opus's adeno-associated virus (AAV)-based gene therapy portfolio for IRDs, as well as Ocuphire's phentolamine ophthalmic solution, an eye drop that is being evaluated in presbyopia and dim light vision disturbances after keratorefractive surgery. Ocuphire partnered with Viatris Inc. to commercialize the eye drop solution, branded as Ryzumvi, for reversing drug-induced eye dilations.
Ocuphire was also developing an oral pill for the treatment of non-proliferative diabetic retinopathy, but Opus will seek a strategic partner for that work so the company can focus its resources on seven gene therapy programs.
Promising early results
The most advanced gene therapy candidate, OPGx-LCA5, is being developed to treat LCA5, an early-onset retinal degeneration that causes vision loss. An ongoing Phase 1/2 clinical trial has shown early clinical proof-of-concept, with new six-month data demonstrating visual improvement in all three adult patients participating in the trial, each of whom has late-stage disease and is legally blind.
Jean Bennett, M.D., Ph.D., scientific co-founder of Opus, said, "This level of efficacy in patients with late-stage disease is exciting and supportive of the potential for a one-time treatment with OPGx-LCA5, which could have a transformative impact on individuals who have experienced devastating vision loss and for whom no alternative treatment options exist."
Enrollment of the first pediatric patients in the Phase 1/2 trial is expected in the first quarter of 2025, with the first data anticipated in the third quarter of 2025.
OPGx-LCA5 has received Rare Pediatric Disease Designation and Orphan Drug Designation from the U.S. Food and Drug Administration, so the therapy will be eligible to receive a priority review voucher upon biologics license application approval.
The expected cash runway of the combined company has been extended into 2026, the year when the company anticipates clinical data readouts for pediatric patients in the OPGx-LCA5 Phase 1/2 trial and readouts for three other clinical trials.
The company reported an approximate cash balance of $37 million on Sept. 30.
Terms of acquisition
Ocuphire issued 5.2 million shares of its common stock and 14,100 shares of its convertible preferred stock to existing stockholders of Opus.
Following the issuances, stockholders of Ocuphire now own about 58% of the combined company's fully diluted capitalization, and prior stockholders of Opus now own about 42%.
Bennett, Yerxa and Adrienne Graves, Ph.D., each of whom served on the board of directors of Opus prior to the transaction, are now on the expanded board for the combined company.
Bennett is the scientific co-founder of Opus and former scientific founder of Spark Therapeutics. She was one of the first investigators to use viral vectors to deliver transgenes to specific cells in the retina and led the first team to demonstrate proof-of-principle of ocular gene therapy.
Yerxa co-founded Opus in 2021 and was the former CEO of the Foundation Fighting Blindness, where he oversaw the establishment of the Foundation Fighting Blindness' Retinal Degeneration (RD) Fund. He has more than 30 years of experience in biotechnology and ophthalmic drug development, translating promising research discoveries into clinical milestones and treatments. Yerxa also serves on the North Carolina Biotechnology Center's board of directors.
Graves is the former CEO of Santen Inc. and former chair of Iveric Bio. She currently serves as board chair for the RD Fund.
Magrath, the CEO, previously led Durham-based Lexitas Pharma Services, a contract research organization specializing in ophthalmology.
Earlier this year, he established a small research lab for Ocuphire at BioLabs North Carolina, a biotech co-working facility in downtown Durham.
Author: Barry Teater
Source: www.ncbiotech.org ( click here to go to the source)
Featured firm in this article: Opus Genetics Inc of Durham, NC
Research Triangle Park-based Opus Genetics, a clinical-stage gene therapy company devoted to treating inherited retinal diseases, has been acquired by a small ophthalmic biopharmaceutical firm with Durham operations, becoming North Carolina's newest publicly traded life sciences company.
Opus was acquired by Ocuphire Pharma of Farmington Hills, Mich., in an all-stock transaction announced on Oct. 22. The combined company will operate under the Opus Genetics name, and its shares have begun trading on the Nasdaq stock market under the ticker symbol IRD, shorthand for inherited retinal diseases, the company's focus.
"Opus Genetics has created a compelling pipeline of transformative therapies for patients with inherited retinal diseases, with promising early data," said George Magrath, M.D., Ocuphire's chief executive officer, who will continue in that role with the combined company. "This is an opportunity to advance these treatments quickly, with four major clinical milestones on the horizon in 2025 for the combined company.Opus logo
"We are excited to bring together a leadership team with deep expertise in the development of potentially groundbreaking gene therapies. We look forward to continuing our progress, creating value, and improving patient outcomes together."
Ben Yerxa, Ph.D., former president and CEO of Opus, is president of the newly combined company, to be based in the Research Triangle.
"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," Yerxa said. "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 includes multiple assets from Opus's adeno-associated virus (AAV)-based gene therapy portfolio for IRDs, as well as Ocuphire's phentolamine ophthalmic solution, an eye drop that is being evaluated in presbyopia and dim light vision disturbances after keratorefractive surgery. Ocuphire partnered with Viatris Inc. to commercialize the eye drop solution, branded as Ryzumvi, for reversing drug-induced eye dilations.
Ocuphire was also developing an oral pill for the treatment of non-proliferative diabetic retinopathy, but Opus will seek a strategic partner for that work so the company can focus its resources on seven gene therapy programs.
Promising early results
The most advanced gene therapy candidate, OPGx-LCA5, is being developed to treat LCA5, an early-onset retinal degeneration that causes vision loss. An ongoing Phase 1/2 clinical trial has shown early clinical proof-of-concept, with new six-month data demonstrating visual improvement in all three adult patients participating in the trial, each of whom has late-stage disease and is legally blind.
Jean Bennett, M.D., Ph.D., scientific co-founder of Opus, said, "This level of efficacy in patients with late-stage disease is exciting and supportive of the potential for a one-time treatment with OPGx-LCA5, which could have a transformative impact on individuals who have experienced devastating vision loss and for whom no alternative treatment options exist."
Enrollment of the first pediatric patients in the Phase 1/2 trial is expected in the first quarter of 2025, with the first data anticipated in the third quarter of 2025.
OPGx-LCA5 has received Rare Pediatric Disease Designation and Orphan Drug Designation from the U.S. Food and Drug Administration, so the therapy will be eligible to receive a priority review voucher upon biologics license application approval.
The expected cash runway of the combined company has been extended into 2026, the year when the company anticipates clinical data readouts for pediatric patients in the OPGx-LCA5 Phase 1/2 trial and readouts for three other clinical trials.
The company reported an approximate cash balance of $37 million on Sept. 30.
Terms of acquisition
Ocuphire issued 5.2 million shares of its common stock and 14,100 shares of its convertible preferred stock to existing stockholders of Opus.
Following the issuances, stockholders of Ocuphire now own about 58% of the combined company's fully diluted capitalization, and prior stockholders of Opus now own about 42%.
Bennett, Yerxa and Adrienne Graves, Ph.D., each of whom served on the board of directors of Opus prior to the transaction, are now on the expanded board for the combined company.
Bennett is the scientific co-founder of Opus and former scientific founder of Spark Therapeutics. She was one of the first investigators to use viral vectors to deliver transgenes to specific cells in the retina and led the first team to demonstrate proof-of-principle of ocular gene therapy.
Yerxa co-founded Opus in 2021 and was the former CEO of the Foundation Fighting Blindness, where he oversaw the establishment of the Foundation Fighting Blindness' Retinal Degeneration (RD) Fund. He has more than 30 years of experience in biotechnology and ophthalmic drug development, translating promising research discoveries into clinical milestones and treatments. Yerxa also serves on the North Carolina Biotechnology Center's board of directors.
Graves is the former CEO of Santen Inc. and former chair of Iveric Bio. She currently serves as board chair for the RD Fund.
Magrath, the CEO, previously led Durham-based Lexitas Pharma Services, a contract research organization specializing in ophthalmology.
Earlier this year, he established a small research lab for Ocuphire at BioLabs North Carolina, a biotech co-working facility in downtown Durham.
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