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Jun 30, 2023
Ocuphire Q2 2023 Earnings Report
Ocuphire Pharma reported financial results for the second quarter of 2023 and provided a corporate update.
Key Takeaways
Ocuphire Pharma reported license and collaborations revenue of $3.7 million for the second quarter of 2023. The company's cash and cash equivalents were approximately $40.0 million as of June 30, 2023, which is expected to fund operations into 2025. The net loss for the quarter was $5.0 million, or ($0.24) per share.
End-of-Phase 2 meeting with FDA scheduled for Q4 2023 for oral APX3330 in Diabetic Retinopathy (DR).
Cash balance of $40 million is expected to fund operations into 2025.
Nyxol RM PDUFA date is September 28, 2023; Approval would trigger $10 million milestone payment.
Common Share Purchase Agreement with Lincoln Park Capital Fund, LLC provides up to $50 million in committed financing over 30 months.
Ocuphire
Ocuphire
Forward Guidance
Ocuphire expects to present at prominent medical forums the results from the ZETA-1 Phase 2 trial of APX3330 and topline results from VEGA-2 Phase 3 pivotal trial of Nyxol in Presbyopia in Q4 2023.
Positive Outlook
- APX3330: End-of-Phase 2 (EOP2) meeting scheduled with FDA to confirm Phase 3 regulatory path for oral APX3330 in DR (Q4 2023).
- Nyxol: PDUFA date for Nyxol in RM (September 28, 2023).
- FDA approval in RM would trigger a $10 million milestone payment to Ocuphire
- Nyxol: Topline results from VEGA-2 Phase 3 pivotal trial of Nyxol in Presbyopia (Q4 2023)
- Common Share Purchase Agreement with Lincoln Park Capital Fund, LLC providing up to $50 million in committed financing over 30 months
Challenges Ahead
- Success of regulatory submissions and clinical trials is uncertain.
- Regulatory requirements or developments could change.
- Changes to clinical trial designs and regulatory pathways may occur.
- There are risks related to the inability of Ocuphire to obtain sufficient additional capital.
- The Nyxol partnership may not facilitate the commercialization or market acceptance of Ocuphire’s product candidates