Ocuphire Q2 2021 Earnings Report
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
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.