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Jun 30, 2021
Ocuphire Q2 2021 Earnings Report
Ocuphire announced financial results for the second quarter of 2021 and provided a corporate update.
Key Takeaways
Ocuphire Pharma reported a productive second quarter of 2021, marked by clinical trial successes, key data presentations, and strengthened IP protection for Nyxol. The company's cash balance reached $24.2 million, expected to provide runway into late 2022.
Announced positive top-line results from VEGA-1 Phase 2 trial of Nyxol plus low-dose pilocarpine (LDP) for presbyopia.
Initiated the ZETA-1 Phase 2 clinical trial to evaluate oral APX3330 in non-proliferative diabetic retinopathy (NPDR) and mild proliferative diabetic retinopathy (mild PDR).
Closed a $15 million registered direct offering and just over $4 million from ATM, extending cash runway into late 2022.
Received two new U.S. patent grants covering Nyxol® including Nyxol plus LDP claims for the treatment of presbyopia through 2039.
Ocuphire
Ocuphire
Ocuphire Revenue by Segment
Revenue by Segment
License and Collaborations Revenue
CapyFin.com Forward Guidance
Ocuphire anticipates several key milestones in 2022, including initiating Phase 3 programs for Presbyopia (VEGA-2/3) and completing enrollment in the Phase 3 trial for Night Vision Disturbances (LYNX-1). They also plan to file NDA submission with FDA for Nyxol in RM indication in late 2022.
Positive Outlook
- Initiate second Phase 3 (MIRA-3) registration trial and a small pediatric trial (MIRA-4) in the second half of 2021 investigating Nyxol with results expected in early 2022 for Reversal of Mydriasis (RM).
- Planning to file NDA submission with FDA for Nyxol in RM indication in late 2022.
- Initiate Phase 3 program (VEGA-2/3) in first half of 2022 investigating Nyxol and LDP for Presbyopia.
- Completion of enrollment expected by year-end 2021 and top-line data expected in early 2022 from Phase 3 (LYNX-1) registration trial investigating Nyxol for Night Vision Disturbances.
- Completion of enrollment in Phase 2 (ZETA-1) trial investigating APX3330 and top-line data expected in 2022 for Diabetic Retinopathy and Diabetic Macular Edema.
Challenges Ahead
- Success of clinical trials is subject to regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts.
- Clinical trials are subject to regulatory requirements or developments.
- Clinical trials are subject to changes to clinical trial designs and regulatory pathways.
- The company's cash runway is dependent on changes in capital resource requirements and the inability of Ocuphire to obtain sufficient additional capital.
- Commercialization of any of Ocuphire’s product candidates is subject to legislative, regulatory, political and economic developments, changes in market opportunities, and the effects of COVID-19.