Ocugen provides FY2023 update: FDA alignment for OCU400 Phase 3, RMAT designation, cash $39.5M, restatement planned

Ocugen, Inc.

FDA alignment for broad retinitis pigmentosa indication in Phase 3 trial of OCU400; RMAT designation granted.
Completed cohort 1 dosing for OCU410 (GA) and OCU410ST (Stargardt) in Phase 1/2 trials.
Cash, cash equivalents, and investments $39.5M as of Dec 31, 2023, vs. $90.9M a year earlier; runway into Q4 2024.
Intends to restate FY2022 and first three quarters of 2023 financials due to non-cash accounting error; no cash impact.
OCU500 mucosal vaccine selected for NIAID Project NextGen; clinical trials expected mid-2024.

item 2.02 item 9.01

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Earnings Releases SEC 8-K Item 2.02 confidence 0.8

Ocugen, Inc. reported financial results for the fourth quarter and the fiscal year ended December 31, 2023.

Period: the fourth quarter and the fiscal year ended December 31, 2023
Result: reported results

Exact text from the filing

On April 2, 2024, Ocugen, Inc. (the "Company") issued a press release announcing certain financial data for the fourth quarter and the fiscal year ended December 31, 2023.

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Source: SEC EDGAR

accession 0001628280-24-014236

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