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Dec 31, 2022
Ocuphire Q4 2022 Earnings Report
Ocuphire's financial profile improved markedly with global license agreement to develop and commercialize Nyxol, and cash runway into 2025.
Key Takeaways
Ocuphire Pharma reported a net income of $33.9 million for the fourth quarter ended December 31, 2022, compared to a net loss of $6.3 million for the same period in 2021. The company's cash and cash equivalents totaled $42.6 million as of December 31, 2022, and they anticipate this will fund operations into 2025. License and collaborations revenue was $39.9 million for the quarter.
Entered into an exclusive license agreement with Viatris for Nyxol development and commercialization.
Received an upfront payment of $35 million from Viatris.
NDA for Nyxol in reversal of mydriasis has a PDUFA date of September 28, 2023.
ZETA-1 Phase 2 trial of oral APX3330 achieved statistical significance on a potential registration endpoint.
Ocuphire
Ocuphire
Forward Guidance
Ocuphire anticipates several milestones in 2023, including the potential FDA approval of Nyxol for reversal of mydriasis, the advancement of APX3330 for diabetic retinopathy, and the initiation of Phase 3 trials for Nyxol in presbyopia and night vision disturbances.
Positive Outlook
- Potential FDA approval of Nyxol for reversal of mydriasis by September 28, 2023.
- Advancement of APX3330 with an End-of-Phase 2 FDA meeting planned.
- Initiation of VEGA-3, a second Phase 3 trial in presbyopia.
- Initiation of LYNX-2, a second Phase 3 trial in night vision disturbances.
- Initiation of LYRA-1, a long-term safety trial for presbyopia and night vision disturbances.
Challenges Ahead
- Risks related to regulatory submissions and clinical trials.
- Potential changes to clinical trial designs and regulatory pathways.
- Risks related to obtaining sufficient additional capital.
- Potential effects of macroeconomic conditions on business operations.
- Risks that the Nyxol partnership may not facilitate commercialization.