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): May 10, 2022
OVID THERAPEUTICS INC.
(Exact name of Registrant as Specified in Its Charter)
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Delaware | 001-38085 | 46-5270895 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
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1460 Broadway, Suite 15044 New York, New York | | 10036 |
(Address of Principal Executive Offices) | | (Zip Code) |
Registrant’s Telephone Number, Including Area Code: 646-661-7661
Not Applicable
(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 Instructions 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:
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Title of each class | | Trading Symbol(s) | | Name of each exchange on which registered |
Common Stock par value $0.001 per share | | OVID | | The Nasdaq Stock Market LLC |
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 the afternoon of May 10, 2022, Takeda Pharmaceutical Company Limited (“Takeda”) notified Ovid Therapeutics Inc. (the “Company”) that Takeda planned to announce that two pivotal Phase 3 programs evaluating soticlestat for the potential treatment of Dravet and Lennox-Gastaut syndromes are likely to be delayed due to enrollment challenges specifically related to the geopolitical situation in Ukraine and Russia and Covid-19 lockdowns in China. Takeda disclosed it is working on multiple approaches to minimize delays, accelerate recruitment and optimize regulatory timelines for the soticlestat programs. Takeda stated that the studies are actively recruiting patients and remain one of Takeda's highest priority, late-stage, programs. Takeda estimated on its annual earnings call, held on May 11, 2022, that the primary completion date for the soticlestat studies will be March 2024 and anticipates regulatory filings in its fiscal 2024.
The Company maintains a significant financial interest in the future regulatory development and potential commercialization of soticlestat, which Takeda is responsible for advancing globally. Soticlestat is a cholesterol 24 hydroxylase inhibitor, which is currently in Phase 3 trials for Dravet and Lennox-Gastaut syndromes.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibit
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Exhibit No. | | Description |
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104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
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OVID THERAPEUTICS INC. |
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By: | /s/ Thomas M. Perone |
| Thomas M. Perone |
| General Counsel & Corporate Secretary |
Dated: May 11, 2022
