Ocugen (NASDAQ: OCGN) reports positive 12-month OCU410 data in GA

Rhea-AI Filing Summary

Ocugen, Inc. filed a report describing new clinical progress for its eye disease pipeline. The company announced positive preliminary 12‑month data from both its Phase 1 and Phase 2 ArMaDa trials of OCU410 (AAV5‑RORA), a modifier gene therapy candidate being studied for geographic atrophy caused by dry age‑related macular degeneration, a severe form of vision loss.

Ocugen also furnished a press release and an investor presentation as exhibits, which elaborate on the OCU410 results and program. The company cautions that these findings are preliminary and that clinical trial data, including from OCU400 and OCU410ST, may differ as studies progress and as regulators review results. It highlights the possibility that new or reanalyzed data could be interpreted differently and refers readers to its prior annual and other reports for a fuller discussion of risks.

Insights

Biotech clinical-stage analyst

Ocugen reports encouraging early OCU410 data but stresses it is preliminary.

The company highlights positive preliminary 12‑month data from Phase 1 and Phase 2 ArMaDa trials of OCU410, a modifier gene therapy for geographic atrophy secondary to dry age‑related macular degeneration. Reaching a 12‑month readout across two trials suggests the program is advancing and that management views the results as supportive enough to feature in a press release and corporate presentation.

At the same time, the disclosure emphasizes typical biotech development risks. It notes that preliminary, interim and top‑line results may not match final data, that earlier non‑clinical and clinical findings may not predict later outcomes, and that regulators and other stakeholders may interpret data differently. Future updates in annual and other reports will be important for understanding how OCU410, OCU400 and OCU410ST progress through additional clinical stages and regulatory review.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15 (d)

of the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): January 15, 2026

OCUGEN, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware		001-36751		04-3522315
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(I.R.S. Employer Identification Number)

11 Great Valley Parkway

Malvern, Pennsylvania 19355

(484) 328-4701

(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.01 par value per share		OCGN		The Nasdaq Stock Market LLC (The Nasdaq Capital Market)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01. Other Events.

On January 15, 2026, Ocugen, Inc. (the “Company”) issued a press release announcing positive preliminary 12-month data from both its Phase 1 and Phase 2 ArMaDa trials evaluating OCU410 (AAV5-RORA), its novel modifier gene therapy for geographic atrophy secondary to dry age-related macular degeneration. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference, other than the seventh, eighth, and ninth paragraphs thereof.

Attached as Exhibit 99.2 hereto and incorporated herein by reference is a presentation that the Company will post on its website on January 15, 2026 and may use from time to time in presentations or discussions with investors, analysts, other parties.

Cautionary Note Regarding Forward Looking Statements

This Current Report on Form 8-K contains forward-looking statements that involve estimates, assumptions, risks and uncertainties. Forward-looking statements include, but are not limited to, statements related to the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; the ability of OCU400 or OCU410ST to perform in humans in a manner consistent with nonclinical, preclinical or previous clinical study 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 of may not be predictive of the results or success of later clinical trials; and that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities as well as other risks detailed from time to time in the Company’s filings with the U.S. Securities and Exchange Commission, including in its Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings. These documents contain important factors that could cause actual results to differ from current expectations and from the forward-looking statements contained in this Current Report on Form 8-K. These forward-looking statements speak only as of the date of this Current Report on Form 8-K and the Company undertakes no obligation to publicly update any forward-looking statements to reflect new information, events or circumstances after the date of this Current Report on Form 8-K.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

The following exhibits are being filed herewith:

Exhibit No.		Document
99.1		Press Release, dated January 15, 2026.
99.2		Corporate Presentation, dated January 15, 2026.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 15, 2026

OCUGEN, INC.
By:	/s/ Shankar Musunuri
	Name: Shankar Musunuri
	Title:   Chairman, Chief Executive Officer, & Co-Founder

FAQ

What did Ocugen (OCGN) report about its OCU410 clinical trials?

Ocugen reported positive preliminary 12‑month data from both its Phase 1 and Phase 2 ArMaDa trials evaluating OCU410 (AAV5‑RORA) for geographic atrophy secondary to dry age‑related macular degeneration.

What is OCU410 and what condition is Ocugen targeting?

OCU410 (AAV5‑RORA) is described as a novel modifier gene therapy being developed to treat geographic atrophy secondary to dry age‑related macular degeneration, a serious eye disease that can cause progressive vision loss.

How did Ocugen share the OCU410 trial results with investors?

Ocugen issued a press release and posted an investor presentation on its website, which are filed as Exhibits 99.1 and 99.2 and may be used in discussions with investors, analysts, and other parties.

What cautions did Ocugen include about the OCU410 and related trial data?

Ocugen cautioned that preliminary, interim and top‑line clinical results may not be indicative of final data, that new or further analyses may yield unfavorable results, and that clinical data for OCU400, OCU410, and OCU410ST may be interpreted differently by regulators and other stakeholders.

Where can investors find more information on Ocugens risks and assumptions?

The company refers to its filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10‑K for the year ended December 31, 2024 and subsequent filings, for a detailed discussion of risks and factors that could cause actual results to differ from forward‑looking statements.