UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION 

WASHINGTON, DC 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): February 6, 2023

Aceragen, Inc.

(Exact name of registrant as specified in its charter)

Registrant’s telephone number, including area code: (484) 348-1600

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:

Indicate by check mark whether the registrant is an emerging growth company as defined in 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. ¨

As previously disclosed in the Current Report on Form 8-K/A filed by Aceragen, Inc. (formerly known as Idera Pharmaceuticals, Inc.) (the “Company”) with the Securities and Exchange Commission on December 9, 2022, the Company is conducting the TERRA study (NCT05105035), a phase 2 randomized, double-blind, placebo-controlled study for the treatment of melioidosis in hospitalized patients with melioidosis (the “TERRA Study”). The Company previously disclosed that the independent data monitoring committee (“iDMC”), which has responsibility for overseeing safety and efficacy data from the TERRA Study, was expected to convene in the first quarter of 2023 to provide recommendations for potential changes in eligibility criteria based on its assessment of safety and aggregate clinical event rates observed in the TERRA Study. On February 6, 2023, the Company issued a press release announcing that the iDMC for the TERRA Study met and recommended that the TERRA Study continue without modification. A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

(d) Exhibits.

See the Exhibit Index below, which is incorporated by reference herein.

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.