Ocuphire Q3 2022 Earnings Report
Key Takeaways
Ocuphire Pharma reported a net loss of $4.5 million for Q3 2022. The company's cash and cash equivalents totaled $13.9 million as of September 30, 2022, which is expected to fund operations into Q4 2023. The company is on track for NDA submission for Nyxol for reversal of mydriasis in Q4 2022 and topline data from ZETA-1 Phase 2b trial of oral APX3330 is expected in early 2023.
NDA submission for Nyxol for reversal of mydriasis is on track for Q4 2022.
Initiation of VEGA-2 is on track for Q4 2022.
Topline data from ZETA-1 Phase 2b trial of oral APX3330 is expected in early 2023.
Cash and cash equivalents totaled $13.9 million as of September 30, 2022, sufficient to fund operations into Q4 2023.
Ocuphire
Ocuphire
Forward Guidance
Ocuphire anticipates several key milestones, including the submission of an NDA for Nyxol in Q4 2022, the reporting of topline results from the ZETA-1 Phase 2b trial of APX3330 in early 2023, and the initiation of the VEGA-2 Phase 3 trial in Q4 2022.
Positive Outlook
- Plan to submit New Drug Application (NDA) with the FDA for Nyxol in RM indication in Q4 2022, with potential approval and commercial launch as first dilation reversal drop in 2023.
- Plan to report top-line results from the ZETA-1 Phase 2b trial of APX3330 in early 2023.
- Plan to initiate VEGA-2 Phase 3 trial in Q4 2022 investigating Nyxol alone and Nyxol with 0.4% low-dose pilocarpine (LDP) as adjunctive therapy.
- VEGA-3 (2nd Phase 3) and LYRA-1 (1-year safety) trials are planned to begin in 2023.
- Current cash on hand will be sufficient to fund operations into the fourth quarter of 2023.