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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): March 19, 2021

 

Odonate Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

001-38318

82-2493065

(State or other jurisdiction of

incorporation or organization)

(Commission File Number)

(I.R.S. Employer

Identification No.)

3 East 28th Street, 10th Floor

New York, New York 10016

(332) 206-0935

(Address, including zip code, and telephone number, including area code, of registrant’s 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:

 

☐

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 Exchange Act:

 

Title of Each Class

Trading Symbol

Name of Each Exchange on Which Registered

Common Stock, $0.01 par value per share

ODT

Nasdaq Global Select 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 2.05 Costs Associated with Exit or Disposal Activities

On March 19, 2021, Odonate Therapeutics, Inc. (“Odonate” or the “Company”) committed to a plan of termination involving the termination of certain employees previously supporting the development of tesetaxel (the “Restructuring”). As previously announced on March 22, 2021, following feedback from the U.S. Food and Drug Administration (“FDA”) in a pre-New Drug Application meeting, Odonate concluded that its clinical data package for tesetaxel is unlikely to support FDA approval. Therefore, Odonate is discontinuing the development of tesetaxel and will wind down the operations of the Company. Odonate estimates that the Restructuring will be substantially complete by June 30, 2021 and that costs incurred in connection with the Restructuring will be approximately $14 million.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

 

Exhibit

No.

  

Description

 

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 


 

 

 

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.

 

 

Odonate Therapeutics, Inc.

 

 

 

 

Date: March 25, 2021

By:

 

/s/    Michael Hearne

 

 

 

Michael Hearne

 

 

 

Chief Financial Officer

 

 

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