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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

 

September 11, 2023

Date of Report (Date of earliest event reported)

 

Bicycle Therapeutics plc

(Exact name of registrant as specified in its charter)

 

England and Wales   001-38916   Not applicable

(State or other jurisdiction
of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

Blocks A & B, Portway Building,
Granta Park Great Abington
, Cambridge
United Kingdom

CB21 6GS
(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: +44 1223 261503

  

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
Ordinary shares, nominal value £0.01 per share n/a The Nasdaq Stock Market LLC*
American Depositary Shares, each representing one ordinary share, nominal value £0.01 per share BCYC The Nasdaq Stock Market LLC

 

* Not for trading, but only in connection with the listing of the American Depositary Shares on 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 8.01Other Events.

 

On September 11, 2023, Bicycle Therapeutics plc (the “Company”) issued a press release announcing that it will proceed with its development plan for BT8009 for advanced bladder cancer following recent discussions with the U.S. Food and Drug Administration. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 8.01 by reference.

 

Also on September 11, 2023, the Company hosted a conference call to discuss the above-mentioned development plan for BT8009. A copy of the presentation used in the conference call can be accessed by visiting the “Presentation + Events” section at investors.bicycletherapeutics.com. 

 

Item 9.01Financial Statements and Exhibits

 

(a)Exhibits

 

99.1Press Release dated September 11, 2023
104Cover 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.

 

Date: September 11, 2023 BICYCLE THERAPEUTICS PLC
   
  By: /s/ Alethia Young
  Name: Alethia Young
  Title: Chief Financial Officer