OCUGEN, INC. Form 8-K (Dec. 15, 2022)

Summary

Current report on Form 8-K of Ocugen, Inc., signed December 16, 2022, filed under Items 8.01 and 9.01. The report states that on December 15, 2022 the company issued a press release announcing that the U.S. Food and Drug Administration granted orphan drug designations to OCU400 for the treatment of retinitis pigmentosa and Leber congenital amaurosis (Exhibit 99.1). It further states that on December 16, 2022 the company issued a press release announcing that it has reached agreement with the FDA on the Phase 3 clinical trial protocol for its product candidate NeoCart (Exhibit 99.2).

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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): December 15, 2022

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

(Address, including zip code, and telephone
number, including area code, of principal executive office)

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 December 15, 2022, Ocugen, Inc. (the “Company”)
issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) granted orphan drug designations to OCU400—human
nuclear hormone receptor subfamily 2 group E member 3 (h NR2E3 )—for the treatment of retinitis pigmentosa and Leber congenital
amaurosis. A copy of this press release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and incorporated
herein by reference.

On December 16, 2022, the Company issued a press release announcing
that it has reached agreement with the FDA on the Phase 3 clinical trial protocol for its product candidate NeoCart ® . A
copy of this press release is filed herewith as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.

Item 9.01 | Financial Statements and Exhibits.

The following exhibits are being filed herewith:

(d) Exhibits

Exhibit No. | Document
99.1 | Press Release of Ocugen, Inc. dated December 15, 2022.
99.2 | Press Release of Ocugen, Inc. dated December 16, 2022.
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document).

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SIGNATURE

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

Date: December 16, 2022

OCUGEN, INC.
By: | /s/ Shankar Musunuri
Name: Shankar Musunuri
Title: Chief Executive Officer and Chairman

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