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Jun 30, 2022
Ocuphire Q2 2022 Earnings Report
Ocuphire reported financial results for the second quarter of 2022 and provided a corporate update.
Key Takeaways
Ocuphire Pharma reported a net loss of $4.9 million for Q2 2022, with cash and cash equivalents totaling $17.0 million as of June 30, 2022. The company is focused on a late 2022 NDA filing for Nyxol in reversal of mydriasis and anticipates potential approval in 2023.
Completed final clinical trials for Nyxol in reversal of mydriasis (RM) and held a pre-NDA meeting with the FDA.
On track for a late 2022 NDA submission for Nyxol in RM, with potential approval in 2023.
Reported positive results from the Phase 3 LYNX-1 trial of Nyxol in Night Vision Disturbances (NVD).
Plans to initiate the VEGA Phase 3 FDA registration program for Nyxol in presbyopia in 2H 2022.
Ocuphire
Ocuphire
Forward Guidance
Ocuphire anticipates several key milestones in the near future, including the planned NDA submission for Nyxol in RM, the initiation of VEGA-2 trial for Nyxol in presbyopia, and the report of top-line results from the APX3330 Phase 2b ZETA-1 trial in diabetic retinopathy.
Positive Outlook
- Planned NDA with the FDA for Nyxol in RM indication in late 2022, with potential launch in 2H 2023.
- Plan to initiate VEGA-2 trial for Nyxol alone and with low dose pilocarpine in presbyopia in 2H 2022.
- Expects to file a supplemental NDA for Nyxol as a single-agent for presbyopia and a new NDA for the combination thereafter.
- Report top-line results from the APX3330 Phase 2b ZETA-1 trial in 2H 2022.
- Current cash sufficient to fund operations through Q3 2023.
Challenges Ahead
- Success of regulatory filings and clinical trials are subject to risks and uncertainties.
- Capital resource requirements may change.
- Inability to obtain sufficient additional capital to advance product candidates.
- Legislative, regulatory, political, and economic developments may affect results.
- COVID-19 effects on clinical programs and business operations.