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): November 23, 2021
SELECTA BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-37798 | 26-1622110 | ||
(State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
65 Grove Street, Watertown, MA 02472
(Address of principal executive offices)(Zip Code)
(617) 923-1400
Registrant’s telephone number, including area code
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 Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Common Stock (Par Value $0.0001) | SELB | 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 November 23, 2021, Selecta Biosciences, Inc. (the “Company”) was notified by letter from the U.S. Food & Drug Administration (“FDA”) that the FDA has placed a clinical hold on the Company’s Phase 1/2 clinical trial of SEL-302 (which consists of MMA-101 plus ImmTOR) for the treatment of patients with methylmalonic acidemia (MMA). The FDA issued the clinical hold in order to obtain additional information on the chemistry, manufacturing and controls (CMC) related to the MMA-101 product candidate. There were no outstanding clinical or pre-clinical questions in the letter. This clinical trial had not yet been initiated, and no human patients will be dosed with MMA-101 until all of the FDA’s questions are resolved. The Company intends to work closely with the FDA to address the requests for additional information.
On November 24, 2021, the Company issued a press release announcing the clinical hold. A copy of this press release is filed herewith as Exhibit 99.1 to this Current Report.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
EXHIBIT NUMBER | EXHIBIT DESCRIPTION | |
99.1 | Press Release of Selecta Biosciences, Inc. dated November 24, 2021 | |
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.
SELECTA BIOSCIENCES, INC. | ||||||
Date: November 24, 2021 | By: | /s/ Carsten Brunn, Ph.D. | ||||
Carsten Brunn, Ph.D. | ||||||
President and Chief Executive Officer |