Ocuphire Pharma Reports Q1 2024 Financials and Corporate Update

Ocuphire Pharma, Inc., a clinical-stage ophthalmic biopharmaceutical company, has reported significant advancements in its pipeline for the first quarter ending March 31, 2024. The company's focus remains on developing small molecule therapies for retinal and refractive eye disorders. CEO George Magrath highlighted progress on key projects including APX3330 and RYZUMVI™.

In early 2024, Ocuphire submitted a Special Protocol Assessment (SPA) to the FDA for a Phase 2/3 registration study for APX3330 in diabetic retinopathy (DR). This move followed an End-of-Phase 2 meeting with the FDA in late 2023. The trial's primary endpoint will be a 3-step or more worsening on a binocular Diabetic Retinopathy Severity Scale (DRSS). The FDA is currently reviewing the SPA, with further updates on the study design and timing expected once the agency reaches a decision.

APX3330 has shown promise in slowing DR progression. Earlier this month, findings from the ZETA-1 trial were shared at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting. The results indicated that APX3330 effectively targets the primary endpoint agreed upon with the FDA, marking a significant step forward in its development.

In a notable commercial move, Ocuphire's partner Viatris launched RYZUMVI™ (phentolamine ophthalmic solution) in April 2024. This product, aimed at treating pharmacologically-induced mydriasis in both adults and children aged three and above, is expected to provide Ocuphire with royalties from sales. Moreover, Ocuphire and Viatris are also exploring additional indications for the solution, such as treating decreased visual acuity under low light conditions and presbyopia. The LYNX-2 Phase 3 registration study, which commenced in April 2024, will evaluate these new applications of the solution.

On the corporate front, Ocuphire appointed Nirav Jhaveri as Chief Financial Officer and Ashwath Jayagopal as Chief Scientific and Development Officer, both joining in February 2024. These leadership changes are expected to bolster the company's strategic and financial operations.

Financially, Ocuphire reported cash and cash equivalents of $47.2 million as of March 31, 2024. This is projected to be sufficient to support operations through mid-2025. The company’s revenue from licenses and collaborations remained steady at $1.7 million for Q1 2024, consistent with the same period in 2023. This income primarily stems from the Viatris license agreement. Additionally, Ocuphire received its first royalty payment of $3,000 from Viatris following the commercial launch of RYZUMVI in late March 2024.

General and administrative expenses for Q1 2024 were $4.7 million, up from $2.3 million in Q1 2023, attributed mainly to increased payroll, stock-based compensation, professional services, and other operational costs. Research and development expenses saw a decrease, totaling $4.7 million in Q1 2024 compared to $5.6 million in the same quarter the previous year. This reduction was due to lower clinical, regulatory, and manufacturing costs, despite increased spending on toxicology, payroll, and consulting.

Ocuphire reported a net loss of $7.1 million for Q1 2024, an increase from the $5.8 million net loss in Q1 2023. This translates to a loss of $0.29 per share, compared to $0.28 per share in the previous year.

Ocuphire Pharma continues to advance its clinical programs, particularly for APX3330 and RYZUMVI™, aiming to bring new treatments to market and improve outcomes for patients with retinal and refractive eye disorders. The ongoing discussions with the FDA and the successful launch of RYZUMVI™ underscore the company’s commitment to innovation and patient care in the ophthalmic field.