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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 18, 2025
OCULAR
THERAPEUTIX, INC.
(Exact Name of Company as Specified in Charter)
| Delaware |
|
001-36554 |
|
20-5560161 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
15
Crosby Drive
Bedford,
MA 01730
(Address of Principal Executive Offices) (Zip
Code)
Company’s telephone number, including area
code: (781) 357-4000
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:
| ¨ |
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, $0.0001 par value per share |
|
OCUL |
|
The
Nasdaq Global 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. ¨
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements
of Ocular Therapeutix, Inc. (the “Company”) regarding future expectations, plans, and prospects for the Company; statements
regarding the timing of the availability of data from the Company’s SOL-1 Phase 3 clinical trial of AXPAXLI (also known as OTX-TKI)
for the treatment of wet age-related macular degeneration; statements regarding the timing of the availability of audited financial results;
and other statements containing the words “anticipate”, “believe”, “estimate”, “expect”,
“intend”, “designed”, “goal”, “may”, “might”, “plan”, “predict”,
“project”, “target”, “potential”, “will”, “would”, “could”, “should”,
“continue”, and similar expressions, all of which constitute forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements
as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause
the Company’s development programs, future results, performance, or achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties regarding the timing, conduct
and availability of data from ongoing clinical trials, including the Company’s SOL-1 trial; risks associated with reliance
on clinical trial sites and other third parties; uncertainties as to the timing of the completion of the Company’s financial
statement close and audit process and other factors discussed in the “Risk Factors” section contained in the Company’s
quarterly and annual reports on file with the Securities and Exchange Commission. In addition, the forward-looking statements included
in this Current Report on Form 8-K represent the Company’s views as of the date of this Current Report on Form 8-K. The Company
anticipates that subsequent events and developments may cause the Company’s views to change. However, while the Company may elect
to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, whether
as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be
relied upon as representing the Company’s views as of any date subsequent to the date of this Current Report on Form 8-K.
As the Company prepares for database lock for its SOL-1 Phase 3 clinical
trial of AXPAXLI (also known as OTX-TKI) for the treatment of wet age-related macular degeneration, the Company is entering a quiet period
beginning December 20, 2025. The Company's next planned investor communication is expected early February 2026, with the release
of its financial results for the fourth quarter and fiscal year ending December 31, 2025. At such time, the Company expects
to provide an update on the timing of SOL-1 data, which remain on track for the first quarter of 2026.
SIGNATURES
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.
| |
OCULAR THERAPEUTIX, INC. |
| |
|
|
| Date: December 18, 2025 |
By: |
/s/ Donald Notman |
| |
|
Donald Notman |
| |
|
Chief Financial Officer and Chief Operating Officer |
