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Mar 31, 2022
Ocuphire Q1 2022 Earnings Report
Ocuphire Pharma reported financial results for the first quarter of 2022 and provided a corporate update.
Key Takeaways
Ocuphire Pharma reported a net loss of $6.6 million, or $0.35 per share, for Q1 2022. As of March 31, 2022, the company's cash and cash equivalents totaled $19.2 million, expected to fund operations into Q2 2023.
Nyxol posted 5 positive clinical data readouts including presbyopia in the last 12 months.
Successfully enrolled 4 late-stage trials for Nyxol and APX3330 in the first quarter.
NDA filing is on track for late 2022 for potential 2023 approval of Nyxol as the only dilation reversal drop.
Data is expected in 2H22 from Phase 2b trial of oral APX3330 for Diabetic Retinopathy
Ocuphire
Ocuphire
Forward Guidance
Ocuphire is planning for an NDA filing with the FDA for Nyxol in RM indication in late 2022, with potential launch in 2H 2023. They plan to initiate VEGA Phase 3 program in mid-2022, and report top-line results from the Nyxol Phase 3 LYNX-1 trial in Q2 2022 and APX3330 Phase 2b ZETA-1 trial in 2H 2022.
Positive Outlook
- Planned New Drug Application (NDA) with the FDA for Nyxol in RM indication in late 2022
- Potential launch as first dilation reversal drop in 2H 2023
- Initiate VEGA Phase 3 program in mid-2022 investigating Nyxol alone and Nyxol with 0.4% low-dose pilocarpine (LDP) as adjunctive therapy
- File an NDA in 2023 if VEGA Phase 3 program is successful
- Report top-line results from the Nyxol Phase 3 LYNX-1 trial in 2Q 2022
Challenges Ahead
- Success and timing of planned regulatory filings (including NDA filings)
- Potential increase in the identification of DR patients
- Future clinical trials
- Commercialization of Ocuphire’s product candidates
- Reliance on current expectations and assumptions that may never materialize or may prove to be incorrect