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Sep 30, 2023
Ocugen Q3 2023 Earnings Report
Ocugen reported its Q3 2023 financial results, highlighting pipeline progress and advancements in gene and cell therapies.
Key Takeaways
Ocugen reported a net loss of $14.162 million, or $0.06 per share, for the third quarter of 2023. The company's cash, cash equivalents, and investments totaled $53.5 million as of September 30, 2023. Ocugen is advancing its pipeline, with OCU400 showing promising data and OCU500 being selected by NIAID for clinical trials.
OCU400 demonstrated a favorable safety and tolerability profile in RP and LCA subjects.
83% of subjects in the OCU400 Phase 1/2 study showed stabilization or improvement in BCVA, MLMT, or LLVA in treated eyes.
OCU500, Ocugen’s inhaled mucosal vaccine candidate for COVID-19, was selected by NIH/NIAID’s Project NextGen for inclusion in clinical trials.
Ocugen is preparing to start Phase 3 for OCU400, begin dosing patients for OCU410 and OCU410ST, and initiate the Phase 1 trial for OCU500 in collaboration with NIAID.
Ocugen
Ocugen
Forward Guidance
Ocugen is focused on advancing its pipeline of gene and cell therapies, biologics, and vaccines. Key priorities include initiating Phase 3 for OCU400, dosing patients for OCU410 and OCU410ST, and starting the Phase 1 trial for OCU500 in collaboration with NIAID.
Positive Outlook
- Initiating Phase 3 clinical trial for OCU400 in early 2024.
- Expanding OCU400 Phase 3 clinical trial for LCA patients in the second half of 2024.
- Dosing patients in Phase 1/2 trials for both OCU410 and OCU410ST by the end of 2023.
- Initiating Phase 1 clinical trial for OCU200 in the first half of 2024, contingent on the lift of the FDA hold and adequate availability of funding.
- Beginning Phase 3 clinical trial for NeoCart® in the second half of 2024.
Challenges Ahead
- Phase 1 clinical trial for OCU200 is contingent on the lift of the FDA hold and adequate availability of funding.
- Clinical development activities are subject to risks and uncertainties.
- Success and data announcements of current ongoing preclinical and clinical trials are not guaranteed.
- Ability to initiate new clinical programs is subject to various factors.
- Financial condition may impact the progress of clinical programs.