Table of Contents
Corporate Overview
Ocugen, Inc.
Media Contact
Tiffany Hamilton
Head of Communications, Ocugen, Inc.
11 Great Valley Parkway, Malvern, PA 19355
Phone: 484.328.4701
11 Great Valley Parkway, Malvern, PA 19355
Phone: 484.328.4701
Disclaimer
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the pre-clinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing pre-clinical and clinical trials, including the timing of enrollment and data readouts, the ability to initiate new clinical programs, Ocugen’s financial condition and expected cash runway into the fourth quarter of 2026, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, statements regarding potential market size and commercial possibilities of Ocugen’s product candidates, and Ocugen’s projections under its license agreement with Kwangdong Pharmaceutical Co., Ltd., which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and topline clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing may not be predictive of the results or success of later clinical trials; and that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities. These and other risks and uncertainties are more fully described in our annual and periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
March 4, 2026
Conference Call and Webcast Today at 8:30 a.m. ET
- Enrollment for the OCU400 Phase 3 liMeliGhT clinical trial—the first and largest gene therapy registrational trial for broad retinitis pigmentosa patients—is completed. Topline Phase 3 data expected in the first quarter 2027, advancing OCU400 towards potential approval in 2027.
- OCU410ST Phase 2/3 pivotal confirmatory trial nearing enrollment completion. Interim data expected in the third quarter 2026, followed by topline Phase 2/3 data in the second quarter 2027 in advance of the BLA submission.
- OCU410 positive preliminary Phase 2 data announced in January. Full Phase 2 data expected in March 2026.
- First regional licensing agreement for OCU400 in 2025 initiates strategic partnership strategy ahead of commercialization.
- Rounded out executive leadership team with top talent in business development, commercial, finance, and operations to encompass all required expertise for upcoming growth.
MALVERN, PA, March 04, 2026 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported fourth quarter and full year 2025 financial results along with a general business update.
“Considerable development across all our modifier gene therapy programs, notable licensing and financing agreements to strengthen our financial position, and meaningful appointments to our leadership team made 2025 a transformative year for Ocugen,” said Dr. Shankar Musunuri, Chairman, CEO, Co‑founder of Ocugen. “We are poised to leverage upcoming catalysts and advance the business as we near the first of our three BLA filings.”
Business Updates
Novel Modifier Gene Therapy Platform—Targeting Three BLA Filings in the Next Three Years
- OCU400 – Completed enrollment in the Phase 3 liMeliGhT clinical trial and are on track to file the rolling BLA in the third quarter of 2026.
- OCU410ST – The Phase 2/3 GARDian3 pivotal confirmatory trial is progressing ahead of schedule with anticipated enrollment completion in the first quarter of 2026. Interim data is expected in the third quarter of 2026.
- OCU410 – In January 2026, Ocugen announced positive preliminary 12‑month data for Phase 2 subjects from the ArMaDa clinical trial for GA secondary to dry age‑related macular degeneration. The complete data set is expected in March 2026.
Other Programs
- OCU200 – No serious adverse events reported to date; enrollment expected to complete by Q1 2026.
- OCU500 – NIAID intends to initiate the OCU500 Phase 1 clinical trial in Q2 2026.
- NeoCart – Created OrthoCellix as a wholly‑owned subsidiary for regenerative cell therapy assets.
Financial Results
Fourth quarter – R&D expenses were $10.7 million (vs. $8.3 million YoY). G&A expenses were $6.1 million (vs. $6.3 million YoY). Net loss per share: $0.06 (vs. $0.05 YoY).
Full year – R&D expenses were $39.8 million (vs. $32.1 million YoY). G&A expenses were $27.6 million (vs. $26.7 million YoY). Net loss per share: $0.23 (vs. $0.20 YoY).
Cash and restricted cash totaled $18.9 million as of December 31, 2025, compared with $58.8 million as of December 31, 2024. The $22.5 million financing in January 2026 is expected to fund operations into Q4 2026.
Conference Call and Webcast Details
Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights.
Dial‑in Numbers: (800) 715‑9871 (U.S.) or (646) 307‑1963 (International)
Conference ID: 3029428
Webcast: Available on the events page
OCUGEN, INC. – Consolidated Balance Sheets (in thousands) – Unaudited
| As of December 31, | 2025 | 2024 | ||
|---|---|---|---|---|
| Assets | ||||
| Current assets | ||||
| Cash | $ | 18,571 | $ | 58,514 |
| Prepaid expenses and other current assets | 5,769 | 3,168 | ||
| Total current assets | 24,340 | 61,682 | ||
| Property and equipment, net | 14,392 | 16,554 | ||
| Restricted cash | 316 | 307 | ||
| Other assets | 4,468 | 3,899 | ||
| Total assets | $ | 43,516 | $ | 82,442 |
| Liabilities and stockholders' equity | ||||
| Current liabilities | ||||
| Accounts payable | $ | 6,202 | $ | 4,243 |
| Accrued expenses and other current liabilities | 14,733 | 15,500 | ||
| Operating lease obligations | 858 | 519 | ||
| Current portion of long term debt | 1,250 | 1,326 | ||
| Total current liabilities | 23,043 | 21,588 | ||
| Non‑current liabilities | ||||
| Operating lease obligations, less current portion | 3,494 | 3,313 | ||
| Long term debt, net | 27,542 | 27,345 | ||
| Other non‑current liabilities | 1,603 | 564 | ||
| Total non‑current liabilities | 32,639 | 31,222 | ||
| Total liabilities | 55,682 | 52,810 | ||
| Stockholders' equity | ||||
| Common stock | 3,125 | 2,915 | ||
| Treasury stock | (48) | (48) | ||
| Additional paid‑in capital | 392,763 | 366,938 | ||
| Accumulated other comprehensive income | 61 | 48 | ||
| Accumulated deficit | (408,067) | |||
Consolidated Statements of Operations (in thousands, except share and per share amounts) – Unaudited
| Total stockholders' equity | (12,166) | 29,632 | |||
| Total liabilities and stockholders' equity | $ | 43,516 | $ | 82,442 |
Three months ended December 31, 2025 vs. Year ended December 31, 2024
| Collaborative arrangement revenue | $ (193) | $ 764 | $ 4,413 | $ 4,055 |
| Total revenue | (193) | 764 | 4,413 | 4,055 |
| Research and development | 10,670 | 8,290 | 39,750 | 32,126 |
| General and administrative | 6,132 | 6,314 | 27,579 | 26,686 |
| Total operating expenses | 16,802 | 14,604 | 67,329 | 58,812 |
| Loss from operations | (16,995) | (13,840) | (62,916) | (54,757) |
| Interest income | 144 | 408 | 922 | 1,251 |
| Interest expense | (1,331) | (601) | (5,188) | (688) |
| Other income (expense) | 476 | 153 | (664) | 140 |
| Net loss | $(17,706) | $(13,880) | $(67,846) | $(54,054) |
Net loss attributable to common shareholders— basic and diluted: $(17,706) for Q4 2025, $(13,880) for FY 2024, $(67,846) for Q4 2025, $(54,054) for FY 2024.
Weighted shares used in calculating net loss per common share — basic and diluted: 312,339,265 (Q4 2025), 290,924,531 (FY 2024), 300,167,989 (Q4 2025), 270,995,121 (FY 2024).
Net loss per share attributable to common shareholders — basic and diluted: $(0.06) (Q4 2025), $(0.05) (FY 2024), $(0.23) (Q4 2025), $(0.20) (FY 2024).
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