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Sep 30, 2021
Ocuphire Q3 2021 Earnings Report
Ocuphire reported financial results and provided a corporate update.
Key Takeaways
Ocuphire Pharma reported third-quarter results, highlighting the progress of its late-stage clinical programs, including upcoming Phase 3 trials for Nyxol® Eye Drops and data readouts expected in early 2022. The company's cash runway extends into late 2022.
On track to initiate additional Phase 3 FDA registration trials for Nyxol® Eye Drops in Reversal of Mydriasis (RM) in 4Q21 and Presbyopia in 1H22
Three Clinical Trial Data Readouts Expected in Early 2022 for Nyxol in Night Vision Disturbance, RM, and RM for Pediatric Patients
Planning to file NDA submission with FDA for Nyxol in RM indication in late 2022
Currently Recruiting for Phase 2 Trial Evaluating APX3330 for the Treatment of Diabetic Retinopathy with Data Expected in 2H22
Forward Guidance
Ocuphire is focused on advancing its clinical programs and achieving key milestones in 2022, which are expected to build significant value for the company and its shareholders.
Positive Outlook
- Initiate second Phase 3 (MIRA-3) registration trial in subjects 12 and older and a small pediatric trial in subjects ages 3 to 11 (MIRA-4) in the fourth quarter of 2021 investigating Nyxol with results expected in early 2022
- Planning to file NDA submission with FDA for Nyxol in RM indication in late 2022
- Initiate Phase 3 program (VEGA-2) in first half of 2022 investigating Nyxol and Low-Dose Pilocarpine (LDP)
- Top-line data expected in early 2022 from Phase 3 (LYNX-1) registration trial investigating Nyxol
- Top-line data expected in the second half of 2022 for the randomized, well-controlled Phase 2 (ZETA-1) trial investigating APX3330
Historical Earnings Impact
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Avg. Return Before/After Earnings
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