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)
Delaware (State or Other Jurisdiction of Incorporation) | 001-31918 (Commission File Number) | 04-3072298 (I.R.S. Employer Identification No.) |
505 Eagleview Blvd., Suite 212 | ||
Exton, Pennsylvania | 19341 | |
(Address of Principal Executive Offices) | (Zip Code) |
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):
¨ | 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, par value $0.001 per share | ACGN | Nasdaq Capital Market |
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. ¨
Item 8.01. | Other Events. |
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.
Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
See the Exhibit Index below, which is incorporated by reference herein.
Exhibit No. | Description | |
99.1 | Press Release, dated February 6, 2023. | |
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.
ACERAGEN, INC. | ||
By: | /s/ Bryant D. Lim | |
Bryant D. Lim | ||
Chief Business Officer and General Counsel | ||
Dated: February 6, 2023 |