OCUGEN, INC. Form 8-K (Nov. 8, 2021)
Summary
Current report on Form 8-K of Ocugen, Inc., dated November 8, 2021, filed under Items 8.01 and 9.01. It states that on November 8, 2021 the company issued a press release announcing that it has submitted an Investigational New Drug application with the U.S. Food and Drug Administration to initiate a Phase 1/2 clinical trial of OCU400, a modifier gene therapy candidate for the treatment of retinitis pigmentosa resulting from genetic mutations found in NR2E3 and RHO. The press release is Exhibit 99.1. The signature block shows /s/ Shankar Musunuri, Chief Executive Officer and Chairman.
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Cite this document
“OCUGEN, INC. Form 8-K (Nov. 8, 2021).”
Original at www.sec.gov. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/sec-ocgn-8-k-filed2021-11-08-0001104659-21-135419-85c6ed5ae9/
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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): November 8, 2021 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) 263 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 November 8, 2021, Ocugen, Inc. issued a press release announcing that it has submitted an Investigational New Drug application with the U.S. Food and Drug Administration to initiate a Phase 1/2 clinical trial of OCU400 (AAV- NR2E3 ), a modifier gene therapy candidate for the treatment of retinitis pigmentosa resulting from genetic mutations found in NR2E3 and RHO . A copy of this press release is filed herewith as Exhibit 99.1 to this Current Report on Form 8-K and is 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 November 8, 2021. 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). 1 SIGNATURE 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: November 8, 2021 OCUGEN, INC. By: | /s/ Shankar Musunuri Name: Shankar Musunuri Title: Chief Executive Officer and Chairman 2
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