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Sep 30, 2023
Ocuphire Q3 2023 Earnings Report
Ocuphire achieved regulatory and clinical milestones and reported positive financial results.
Key Takeaways
Ocuphire Pharma reported a successful third quarter of 2023, marked by FDA approval of RYZUMVI™, a $10 million milestone payment from Viatris, and positive clinical trial results for APX3330 and phentolamine ophthalmic solution. The company's cash reserves are expected to fund operations into 2025.
FDA approved RYZUMVI™ for reversal of pharmacologically induced mydriasis, triggering a $10 million milestone payment.
VEGA-2 Phase 3 trial in presbyopia met its primary endpoint, with Viatris expected to continue Phase 3 development.
Successful End-of-Phase 2 meeting with FDA for oral APX3330, reaching agreement on Phase 3 registration endpoint.
Cash and cash equivalents totaled $42.4 million, sufficient to fund operations into 2025.
Ocuphire
Ocuphire
Forward Guidance
Ocuphire anticipates continued progress with APX3330, aiming for SPA agreement with the FDA. Viatris is expected to continue Phase 3 development of phentolamine ophthalmic solution.
Positive Outlook
- Advancing APX3330 towards Phase 3 program in diabetic retinopathy.
- Potential for APX3330 to be a non-invasive treatment for diabetic retinopathy.
- Commercial launch of RYZUMVI™ expected in the first half of 2024.
- Viatris expected to continue Phase 3 development for presbyopia.
- SPA submission planned for night vision disturbances.
Challenges Ahead
- Success and timing of regulatory submissions and clinical trials are uncertain.
- Regulatory requirements or developments could impact progress.
- Changes to clinical trial designs and regulatory pathways are possible.
- Inability to obtain sufficient additional capital could hinder product development.
- Commercialization of product candidates is not guaranteed.