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Mar 31, 2023
Ocuphire Q1 2023 Earnings Report
Ocuphire reported financial results for the first quarter of 2023 and provided a corporate update.
Key Takeaways
Ocuphire Pharma reported license and collaborations revenue of $1.7 million for Q1 2023, derived from reimbursement of research and development services under the Nyxol License Agreement. The company's cash and cash equivalents were approximately $39 million, sufficient to fund operations into 2025. Net loss for the quarter was $5.8 million, or ($0.28) per share.
License and collaborations revenue was $1.7 million for the three months ended March 31, 2023.
Cash and cash equivalents of approximately $39.0 million as of March 31, 2023.
Net loss for the quarter ended March 31, 2023 was $5.8 million or ($0.28) per share.
Company anticipates an End-of-Phase 2 meeting with the FDA to confirm Phase 3 regulatory path for Oral APX3330 in DR in the second half of 2023.
Ocuphire
Ocuphire
Forward Guidance
Ocuphire anticipates several milestones, including an End-of-Phase 2 meeting with the FDA for APX3330 in the second half of 2023 and a PDUFA date for Nyxol in Reversal of Mydriasis (RM) on September 28, 2023.
Positive Outlook
- Potential FDA approval of Nyxol in RM, triggering a $10 million milestone payment.
- Topline results from the VEGA-2 Phase 3 pivotal trial of Nyxol in Presbyopia expected in late 2023.
- APX3330 achieved statistical significance on a key pre-specified secondary endpoint in the ZETA-1 Phase 2 trial.
- Oral APX3330 has potential as a non-invasive, early intervention treatment for DR patients.
- Cash balance of $39 million expected to fund operations into 2025.
Challenges Ahead
- Success and timing of regulatory submissions and clinical trials are subject to risks and uncertainties.
- Changes to clinical trial designs and regulatory pathways could affect outcomes.
- The company's ability to obtain sufficient additional capital to continue to advance its product candidates is a risk.
- Legislative, regulatory, political, and economic developments could impact results.
- The Nyxol partnership may not facilitate commercialization or market acceptance of Ocuphire’s product candidates.