UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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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 12, 2024
___________________________________________________________
(Exact Name of Registrant as Specified in its Charter)
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| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) | ||||||||||||
(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):
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
(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 7.01 Regulation FD Disclosure.
Attached as Exhibit 99.1 hereto and incorporated herein by reference is a presentation that Ocugen, Inc. will present at an in-person Clinical Showcase at the Nasdaq Market Site in Times Square, New York City on November 12, 2024, and may use from time to time in presentations or discussions with investors, analysts, and other parties. The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
The following exhibits are being furnished herewith:
(d) Exhibits
| Exhibit No. | Document | |||||||
| 99.1 | ||||||||
| 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: November 12, 2024
| OCUGEN, INC. | ||||||||
| By: | /s/ Shankar Musunuri | |||||||
| Name: Shankar Musunuri | ||||||||
| Title: Chairman, Chief Executive Officer, & Co-Founder | ||||||||
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• • • •
• • • • • • • • • • •
Multifactorial Aging A B C
o o o o o o o o o • • • •
• •
• • • • OCU400 (AAV encoding NR2E3) Rho-/- RhoP23H+/- Rd7 (NR2E3) Rd1 (PDE6B) Rd16 (CEP290) Adapted from: § Li et al., Nature Gene Therapy, 2021 § McNamee et al., Nature Gene Therapy, 2024 Fundus Imaging Improvement in Retinal Structure OCU400 Untreated Treated Histology Slow/Stop Retina Degeneration OCU400 Untreated Treated Biomarkers: Molecular reset Restoration of Expression of Key Transcription Factors Immunofluorescence (IF) Restoration of Phototransduction Gene Expression OCU400 Untreated Treated RP LCA Preclinical Animal Models: Electroretinography (ERG) Improvement in Photoreceptor Function
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• • • • • •
• • •
• •
2 • •
• • • • • • • • • • •
• • • • • • • • •
27 • •
• • • • • • • • • •
-10 -8 -6 -4 -2 0 2 4 6 8 Screening M3 M6 M9 M12 002-007 (treated) 002-007 (untreated) 010-001 (treated) 010-001 (untreated) 003-010 (treated) 003-010 (untreated) ∆ ∆ • • • •
• • • • • • • • •
• • • • • • • • • • • •
0.96 ± 0.25 0.76 ± 0.53 Inset • • •
-55 -50 -45 -40 -35 -30 -25 -20 -15 -10 -5 0 5 10 SCREENING 3 MONTHS 6 MONTHS LL VA c ha ng e (∆ )f ro m b as el in e Study Duration (Months) 006-001 Treated 006-001 Untreated 007-001 Treated 007-001 Untreated 006-004 Treated 006-004 Untreated ±
• • • • •
• • • • • • • • • •
• • • • • • • •
M e a n C h a n g e in T o ta l A tr o p h y A re a f ro m B a s el in e (m m 2 ) 84% 0.12 ± 0.36 0.73 ± 0.26
• • • • • • ± µm,
• • •
Severe RP only ( blind) 85%
% C3 *
2023
