Ocuphire Pharma Reports Q2 2024 Financials and Corporate Update

Ocuphire Pharma, Inc., a clinical-stage ophthalmic biopharmaceutical company, announced its financial results for the second quarter ending June 30, 2024, and provided an update on its corporate activities. The company is dedicated to developing small-molecule therapies for retinal and refractive eye disorders.

The CEO of Ocuphire, Dr. George Magrath, highlighted the progress of their lead product candidate, APX3330. This non-invasive treatment aims to delay complications in patients with non-proliferative diabetic retinopathy (DR) who currently have limited treatment options. The company is preparing for the next clinical study and continues to work closely with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for a Phase 2/3 trial and the overall clinical development plan for APX3330.

In addition, Ocuphire is advancing the development of phentolamine ophthalmic solution 0.75% for other indications. Notably, the VEGA-3 Phase 3 trial for presbyopia is now recruiting participants. This treatment has shown promise in previous studies and could offer a convenient option for people with presbyopia. The LYNX-2 Phase 3 study, which focuses on dim light disturbances (DLD) following keratorefractive surgery, is also seeing strong enrollment.

Clinical and regulatory updates reveal that data from APX3330 studies in DR were presented at several medical meetings, including the Association for Research in Vision and Ophthalmology, the American Society of Retina Specialists, the Clinical Trials at the Summit meeting, and the Retinal Imaging Biomarkers & Endpoints Summit meeting. These presentations included a subset analysis that evaluated the efficacy of APX3330 in slowing DR progression among high-risk patients.

The VEGA-3 Phase 3 trial for presbyopia is a randomized, double-masked, placebo-controlled, multi-center study expected to enroll up to 545 subjects at 40 U.S. sites. Participants will be randomized in a 3:2 ratio to receive either phentolamine ophthalmic solution 0.75% or a placebo. The primary endpoint is a 15-letter improvement in photopic binocular distance-corrected near visual acuity (DCNVA) on the eighth day following the first visit, with topline results expected in 2025. Likewise, the LYNX-2 Phase 3 registration study for dim light vision disturbances following keratorefractive surgery is under SPA with the FDA. An additional Phase 3 study, LYNX-3, is planned for 2024.

Financial highlights for the second quarter reveal that Ocuphire had cash and cash equivalents of $41.4 million as of June 30, 2024. This amount is anticipated to fund operations through mid-2025. License and collaborations revenue were $1.1 million for the quarter, compared to $3.7 million in the same period of 2023. The revenue during both periods was primarily from the commercial partner License Agreement for the reimbursement of research and development services. The second quarter also included a $19,000 royalty payment from sales of RYZUMVI™, indicated for treating pharmacologically-induced mydriasis.

General and administrative expenses for the three months ending June 30, 2024, were $3.4 million, a decrease from $4.3 million in the same period of 2023. This reduction was primarily due to lower payroll-related costs and operating expenses. However, there were increased costs in business development, legal support, and other operating expenses. Research and development expenses rose to $6.1 million from $4.7 million, mainly due to increased manufacturing and toxicology costs for APX3330 and payroll-related expenses.

The net loss for the quarter was $7.8 million, or $(0.30) per share, compared to a net loss of $5.0 million, or $(0.24) per share, in the second quarter of 2023. Further details on Ocuphire’s financial results for the six-month period ending June 30, 2024, can be found in the company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission.

Ocuphire Pharma is committed to developing groundbreaking treatments for retinal and refractive eye disorders, and their ongoing trials and financial stability position them to make significant advancements in this field.

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