The earnings call highlighted significant progress in clinical development and strategic partnerships, including FDA and EMA approvals, and successful clinical trial data. However, there are concerns about declining cash reserves and operating expenses.
Company Guidance -
Q3 2025
During the call, Ocugen provided guidance on its gene therapy platform and associated clinical trials. The company is advancing three candidates, with two in late-stage trials, and aims to file three biological licensing applications (BLAs) and market authorization applications (MAAs) within the next three years. Specifically, the OCU400 Phase III liMeliGhT trial for retinitis pigmentosa is recruiting patients in the U.S. and Canada, targeting BLA and MAA filings in 2026. The OCU410ST trial for Stargardt disease, following the Rare Pediatric Disease Designation, has commenced dosing with plans for a BLA filing in 2027. The OCU410 trial for geographic atrophy demonstrated a 27% reduction in lesion growth at six months and plans to provide full 12-month data by Q1 2026. Financially, the company reported cash and equivalents of $27.3 million as of June 30, 2025, with total operating expenses of $15.2 million for the quarter. Ocugen is actively pursuing strategic partnerships, including a regional licensing agreement in Korea for OCU400, to bolster its financial position and expand its global reach.
Progress in Gene Therapy Platform
All three candidates are advancing through the clinic, with two in late-stage development. Aiming for three biological licensing applications and market authorization application filings in the next three years.
FDA and EMA Approvals
FDA agreed to proceed with the Phase II/III GARDian3 trial for OCU410ST for Stargardt disease following Rare Pediatric Disease Designation. EMA granted eligibility to submit the OCU400 Market Authorization Application (MAA) through the centralized procedure.
Strategic Partnerships and Spin-Off
Signed a binding term sheet for the first regional partnership for OCU400 in Korea and announced the spin-off of NeoCart into OrthoCellix to create a NASDAQ-listed company focused on orthopedic diseases.
Positive Clinical Data
Phase I 12-month preliminary data for OCU410ST and OCU410 showed improved structural and functional outcomes. OCU400 Phase III trial targeting multiple genetic mutations with a single therapy.
Ocugen (OCGN) Earnings, Revenues Date & History
The upcoming earnings date is based on a company’s previous reporting, and may be updated when the actual date is announced
The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.
Beat
Missed
OCGN Earnings-Related Price Changes
Report Date
Price 1 Day Before
Price 1 Day After
Percentage Change
Aug 01, 2025
$1.03
$0.99
-3.88%
May 09, 2025
$0.69
$0.67
-2.90%
Mar 05, 2025
$0.59
$0.57
-3.39%
Nov 08, 2024
$1.08
$0.99
-8.33%
Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.
FAQ
When does Ocugen Inc (OCGN) report earnings?
Ocugen Inc (OCGN) is schdueled to report earning on Nov 07, 2025, Before Open (Confirmed).
What is Ocugen Inc (OCGN) earnings time?
Ocugen Inc (OCGN) earnings time is at Nov 07, 2025, Before Open (Confirmed).
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