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): February 9, 2024
Biofrontera Inc.
(Exact name of registrant as specified in its charter)
| Delaware | | 001-40943 | | 47-3765675 |
(State or other jurisdiction of incorporation) | | (Commission File Number) | | (IRS Employer Identification No.) |
120 Presidential Way, Suite 330 Woburn, Massachusetts | | 01801 |
| (Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including area code: (781) 245-1325
Not Applicable
(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)) |
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| ☐ | 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(s) | | Name of each exchange on which registered |
| Common stock, par value $0.001 per share | | BFRI | | The Nasdaq Stock Market LLC |
| Preferred Stock Purchase Rights | | | | The Nasdaq Stock Market LLC |
| Warrants to purchase common stock | | BFRIW | | 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 (the “Exchange Act”) (§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 February 9, 2024, Biofrontera, Inc. (the “Company”) was notified that its licensor for Ameluz®, Biofrontera AG (the “Licensor”), had initiated a voluntary recall of a limited number of lots of Ameluz®, the Company’s licensed product, due to a manufacturing defect in the impacted product’s packaging, which is provided by an unaffiliated supplier. In its communication, the Licensor confirmed that the recalled product is not likely to cause adverse health consequences. The Company is in the process of notifying all impacted physician customers of this recall and arranging for the prompt replacement of the recalled products.
Pursuant to the Company’s License and Supply Agreement with the Licensor, the Company will not bear any financial responsibility for the costs associated with this recall. As such, the Company does not anticipate a material financial impact on its business as a result of the recall.
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.
February 13, 2024 (Date) | | Biofrontera Inc. (Registrant) |
| | | |
| | By: | /s/ E. Fred Leffler III |
| | | E. Fred Leffler III |
| | | Chief Financial Officer |
