Ocugen's earnings call highlighted significant progress in advancing their gene therapy platform with positive clinical trial results and strategic partnerships. However, financial challenges due to a decreased cash position and the need to secure additional funding were also noted. Overall, the positive advancements in their clinical programs and strategic partnerships outweigh the financial concerns.

Company Guidance -

Q3 2025

During the call, Ocugen provided comprehensive guidance on its clinical and operational progress, highlighting several key metrics. The company is advancing three novel modified gene therapy candidates, with two in late-stage development, and aims to file three Biological License Applications (BLAs) and Market Authorization Applications (MAAs) within the next three years. For the OCU400 Phase III liMeliGhT clinical trial targeting retinitis pigmentosa (RP), Ocugen is on track for BLA and MAA filings in 2026, and the trial has received multiple regulatory designations to assist its review. The company reported that preliminary 12-month Phase I data for OCU410ST and OCU410 demonstrated positive safety and efficacy outcomes. Moreover, Ocugen plans to provide full 12-month data from the Phase II study of OCU410 in the first quarter of 2026 and initiate Phase III trials the same year. Financially, Ocugen's cash, cash equivalents, and restricted cash totaled $27.3 million as of June 30, 2025, with total operating expenses of $15.2 million for the quarter. Additionally, the company announced strategic moves such as a binding term sheet for a regional partnership for OCU400 in Korea and the spin-off of NeoCart into OrthoCellix, which are expected to impact Ocugen's financial position positively.

Advancement of Gene Therapy Candidates

Ocugen's three gene therapy candidates are advancing through clinical trials, with two in late stages. The company is on track to file three biological licensing applications and market authorization applications in the next three years.

Regulatory Designations and Trial Approvals

OCU400 has received multiple regulatory designations, including Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation from the FDA, and has been granted eligibility for a Market Authorization Application through the EMA.

Successful Strategic Partnerships

Ocugen signed a binding term sheet for a regional partnership for OCU400 in Korea, with expectations to close the definitive agreement by September.

Positive Clinical Trial Results

Phase I data for OCU410 showed a 48% slower lesion growth and significant improvements in visual acuity at 12 months compared to untreated eyes. OCU410 for geographic atrophy showed a 27% lesion growth reduction at 6 months, surpassing currently approved therapies.

Leadership Strengthening

New Board appointments and leadership changes include experienced individuals from the pharmaceutical and biotechnology industries, aiming to bolster Ocugen's strategic and operational capabilities.

Ocugen (OCGN) Earnings, Revenues Date & History

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OCGN Earnings History

Report Date	Fiscal Quarter	Forecast / EPS	Last Year's EPS	EPS YoY Change	Slides	Play Transcript
Nov 07, 2025	2025 (Q3)	-0.06 / -	-0.05	―	―	―
Aug 01, 2025	2025 (Q2)	-0.06 / -0.05	-0.04	-25.00% (-0.01)	―
May 09, 2025	2025 (Q1)	-0.06 / -0.05	-0.05	0.00% (0.00)	―
Mar 05, 2025	2024 (Q4)	-0.05 / -0.05	-0.03	-66.67% (-0.02)	―
Nov 08, 2024	2024 (Q3)	-0.06 / -0.05	-0.06	16.67% (<+0.01)
Aug 08, 2024	2024 (Q2)	-0.05 / -0.04	-0.1	60.00% (+0.06)	―
May 14, 2024	2024 (Q1)	- / -0.07	-0.07	7.14% (<+0.01)	―
Apr 02, 2024	2023 (Q4)	-0.06 / -0.05	-0.07	28.57% (+0.02)	―	―
Nov 09, 2023	2023 (Q3)	-0.07 / -0.06	-0.1	40.00% (+0.04)	―
Aug 21, 2023	2023 (Q2)	-0.07 / -0.10	-0.09	-11.11% (-0.01)	―

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.