Ocuphire Q4 2021 Earnings Report
Key Takeaways
Ocuphire Pharma reported its Q4 and full year 2021 financial results, highlighting the completion of patient enrollment in four late-stage trials and anticipating multiple late-stage clinical trial data catalysts in 2022. The company's cash and cash equivalents were approximately $24.5 million as of December 31, 2021, which is expected to fund operations into the second quarter of 2023.
Completed enrollment in MIRA-3, MIRA-4, and LYNX-1 Phase 3 trials, and ZETA-1 Phase 2b trial.
Anticipates topline results from MIRA-3, MIRA-4, and LYNX-1 trials in the first half of 2022.
Expects to report topline results from the APX3330 Phase 2b ZETA-1 trial in the second half of 2022.
Plans to initiate VEGA Phase 3 program in mid-2022 for Nyxol in presbyopia.
Ocuphire
Ocuphire
Forward Guidance
Ocuphire is focused on advancing its clinical programs for Nyxol and APX3330, with multiple data readouts expected in 2022 and a planned NDA filing for Nyxol in reversal of mydriasis.
Positive Outlook
- MIRA-3: Report topline results from the Phase 3 MIRA-3 registration trial at the end of 1Q 2022
- MIRA-4: Report topline results from pediatric safety trial in 2Q 2022
- New Drug Application (NDA): If the results are positive from the ongoing MIRA trials, expect to file an NDA with the FDA for Nyxol in RM indication in late 2022 with potential launch as first dilation reversal drop in 2H 2023
- Presbyopia: Initiate VEGA Phase 3 program in mid-2022 investigating Nyxol alone and Nyxol with 0.4% LDP as adjunctive treatment; and, if successful, expect to file an NDA in 2023
- Night Vision Disturbances (NVD): Report top-line results in 2Q 2022 from the Nyxol Phase 3 LYNX-1 trial
Challenges Ahead
- The success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts
- Regulatory requirements or developments
- Changes to clinical trial designs and regulatory pathways
- Changes in capital resource requirements
- Risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs