Ophthalmic Biopharmaceutical Ocuphire Pharma Shifts Focus To Gene Therapy Through Opus Genetics Stock Deal

On Wednesday, Ocuphire Pharma, Inc. OCUP announced the all-stock acquisition of Opus Genetics, Inc., a clinical-stage gene therapy company for inherited retinal diseases (IRDs).

The merger creates a biotech company focused on developing gene therapies for IRDs.

The combined company will be renamed Opus Genetics, effective October 23, 2024, and trade on the Nasdaq under the “IRD” ticker, effective October 24, 2024.

The combined company now has an expanded pipeline that includes multiple assets from its adeno-associated virus (AAV)-based gene therapy portfolio, which is currently being developed for IRDs, as well as Phentolamine Ophthalmic Solution 0.75%, which is currently being evaluated in presbyopia and dim (mesopic) light vision disturbances (sometimes referred to as DLD) after keratorefractive surgery.

Due to the capital requirements and developmental timelines of APX3330 for non-proliferative diabetic retinopathy, the company will seek a partner to advance the clinical development of the late-stage diabetic retinopathy program. It will redirect its existing resources toward the acquired gene therapy programs.

The most advanced gene therapy candidate, OPGx-LCA5, is being developed for LCA5, an early-onset retinal degeneration, and an open-label, dose-escalation Phase 1/2 trial is ongoing.

The trial has shown early clinical proof-of-concept, with new six-month data demonstrating visual improvement in three out of three adult patients participating in the trial.

The first pediatric patients in the Phase 1/2 trial are expected to be enrolled in the first quarter of 2025, and the first data are anticipated in the first quarter of 2025.

The expected cash runway of the combined company has been extended into 2026.

Ocuphire issued 5.2 million shares and 14.1 thousand shares of its convertible preferred stock.

Following the issuances, Ocuphire will own approximately 58% of the combined company, and Opus Genetics will own approximately 42%.

Price Action: OCUP stock is down 13.5% at $1.15 at last check Wednesday.

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