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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-K/A
(Amendment
No. 1)
(Mark
One)
| ☒ |
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR
THE FISCAL YEAR ENDED DECEMBER 31, 2025
OR
| ☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR
THE TRANSITION PERIOD FROM _________TO__________
COMMISSION
FILE NUMBER 001-40943
BIOFRONTERA
INC.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
47-3765675 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.R.S.
Employer
Identification
No.) |
| |
|
|
| 660
Main Street, 1st Floor |
|
|
| Woburn,
Massachusetts |
|
01801 |
| (Address
of principal executive offices) |
|
(Zip
code) |
(781)
245-1325
(Registrant’s
telephone number, including area code)
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 |
|
BFRI |
|
The
Nasdaq Stock Market LLC |
| Warrants
for common stock |
|
BFRIW |
|
The
Nasdaq Stock Market LLC |
Securities
registered pursuant to Section 12(g) of the Act:
None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
| |
|
|
|
| Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
| |
|
|
|
| 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.
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐ No ☒
As
of June 30, 2025, the last day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of
the common stock held by non-affiliates of the registrant was $6.9 million, based on the closing price of the registrant’s common
stock.
As
of March 16, 2026, there were 11,648,323 shares outstanding of the registrant’s common stock, par value $0.001 per share.
DOCUMENTS
INCORPORATED BY REFERENCE:
Portions of the Proxy Statement for the 2026 Annual Meeting of Stockholders of Biofrontera Inc. (the “Company”) are incorporated by
reference into Part III of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”)
on March 19, 2026 (the “Original 10-K”). This Amendment No. 1 to Annual Report on Form 10-K (this “Form 10-K/A”) does not amend Part III of the Original 10-K.
EXPLANATORY
NOTE
The
Company is filing this Form 10-K/A to amend the Original 10-K solely to include Exhibit 3.3 in the exhibit index and to make other minor
changes to the exhibit index. Pursuant to Rule 12b-15 under the Securities Exchange Act of 1934, as amended, this Form 10-K/A also contains
new certifications by the Company’s principal executive officer and principal financial officer as required by Section 302 of the
Sarbanes-Oxley Act of 2002. Because no financial statements have been included in this Form 10-K/A and this Form 10-K/A does not contain
or amend any disclosure with respect to Items 307 and 308 of Regulation S-K, paragraphs 3, 4 and 5 of the certifications have been omitted.
Accordingly, this Form 10-K/A consists solely of the cover page, this explanatory note, the exhibit index, and the exhibits filed herewith
or incorporated by reference herein.
The
Company has made no attempt in this Form 10-K/A to modify or update the Original 10-K other than as noted in the previous paragraph.
Except as noted above, this Form 10-K/A does not reflect events occurring after the filing of the Original 10-K. Accordingly, this Form
10-K/A should be read in conjunction with the Original 10-K and the Company’s other filings with the SEC subsequent to the filing
of the Original 10-K, including any amendments thereto.
PART
IV
Item
15. Exhibit and Financial Statement Schedules
(a)
The
following documents are filed as part of this report:
| (1) |
No
financial statements are filed with this Form 10-K/A. These items were included in Part II, “Item 8. Financial Statements
and Supplementary Data” of the Original 10-K. |
| (2) |
Financial
Statement Schedules: |
Financial
statement schedules have been omitted because either they are not applicable or the required information is included in the financial
statements or the notes thereto.
The
following exhibits are filed herewith or are incorporated by reference to exhibits previously filed with the SEC.
| Exhibit
No. |
|
|
| |
|
| 2.1# |
|
Share and Purchase Agreement dated March 25, 2019 between Biofrontera Newderm LLC, Biofrontera AG, Maruho Co. Ltd. And Cutanea Life Sciences, Inc. (incorporated by reference to Exhibit 4.13 to Biofrontera AG’s Form 20-F filed with the SEC on April 29, 2019). |
| |
|
|
| 2.2 |
|
Asset and Purchase Agreement dated November 6, 2025 between Biofrontera Inc. and Pelthos Therapeutics Inc. (incorporated by reference to the Company’s Form 8-K filed with the SEC on November 7, 2025) |
| |
|
|
| 3.1 |
|
Amended and Restated Certificate of Incorporation of the Company (incorporated by reference to Exhibit 3.1 to the Company’s Form 8-K filed with the SEC on November 3, 2021) |
| |
|
|
| 3.2 |
|
Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Biofrontera Inc. (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 3, 2023) |
| |
|
|
| 3.3 |
|
Amended and Restated Bylaws of the Company (incorporated by reference to Exhibit 3.2 to the Company’s Current Report on Form 8-K filed with the SEC on November 3, 2021). |
| |
|
|
| 3.4 |
|
Certificate of Second Amendment to the Amended and Restated Certificate of Incorporation of Biofrontera Inc. filed April 25, 2024 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on April 30, 2024) |
| |
|
|
| 3.5 |
|
Certificate of Third Amendment to the Amended and Restated Certificate of Incorporation of Biofrontera Inc., filed June 16, 2025 (incorporated by reference to Exhibit 3.3 to the Company’s Quarterly Report on Form 10-Q filed with the SEC on August 13, 2025) |
| |
|
|
| 3.6 |
|
Certificate of Designation of Preferences, Rights and Limitations of the Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K filed with the SEC on February 23, 2024) |
| 4.5 |
|
Form of Unit Purchase Option (incorporated by reference to Exhibit 4.3 to the Company’s Form 8-K filed with the SEC on December 3, 2021) |
| |
|
|
| 4.6 |
|
Form of 2022 Purchaser Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 20, 2022) |
| |
|
|
| 4.7 |
|
Form of Inducement Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Form 8-K filed with the SEC on July 28, 2022) |
| |
|
|
| 4.8 |
|
Stockholder Rights Agreement, dated as of October 13, 2022, between Biofrontera Inc. and Computershare Trust Company, N.A., as Rights Agent (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form 8-A filed with the SEC on October 14, 2022) |
| |
|
|
| 4.9 |
|
Amendment No. 1 to the Stockholder Rights Agreement, dated as of April 26, 2023, between Biofrontera Inc. and Computershare Trust Company, N.A., as Rights Agent (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed on April 28, 2023) |
| |
|
|
| 4.10 |
|
Form of Common Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on November 2, 2023) |
| |
|
|
| 4.11 |
|
Form of Senior Secured Convertible Note dated November 22, 2024 (incorporated by reference to Exhibit 4.1 of the Company’s Current Report on Form 8-K filed with the SEC on November 27, 2024) |
| |
|
|
| 10.1 |
|
Amended and Restated Master Contract Services Agreement, by and among the Company, Biofrontera AG, Biofrontera Pharma GmbH and Biofrontera Bioscience GmbH (incorporated by reference to Exhibit 10.8 to the Company’s Form S-1 filed with the SEC on July 6, 2021) |
| |
|
|
| 10.2 |
|
Quality Agreement dated November 1, 2016, between the Company and Biofrontera Pharma GmbH (incorporated by reference to Exhibit 10.9 to Amendment No. 1 to the Company’s Form S-1 filed with the SEC on July 26, 2021). |
| |
|
|
| 10.3 |
|
Intercompany Services Agreement dated January 1, 2016, between the Company, Biofrontera AG, Biofrontera Pharma GmbH and Biofrontera Bioscience GmbH (incorporated by reference to Exhibit 10.10 to Amendment No. 4 to the Company’s Form S-1 filed with the SEC on September 16, 2021) |
| 10.4† |
|
Amended Employment Agreement dated October 1, 2021 – Hermann Lübbert (incorporated by reference to Exhibit 10.11 to Amendment No. 5 to the Company’s Form S-1 filed with the SEC on October 1, 2021) |
| |
|
|
| 10.5† |
|
2021 Omnibus Incentive Plan (as amended and restated on December 12, 2022) (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on December 16, 2022) |
| |
|
|
| 10.6† |
|
Form of Restricted Stock Unit Executive Award Agreement under 2021 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.13 to Amendment No. 6 to the Company’s Form S-1 filed with the SEC on October 12, 2021) |
| |
|
|
| 10.7† |
|
Form of Nonqualified Stock Option Executive Award Agreement under 2021 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.14 to Amendment No. 6 to the Company’s Form S-1 filed with the SEC on October 12, 2021) |
| |
|
|
| 10.8† |
|
Form of Nonqualified Stock Option Award Agreement under 2021 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.15 to Amendment No. 6 to the Company’s Form S-1 filed with the SEC on October 12, 2021) |
| |
|
|
| 10.9† |
|
Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.16 filed with the SEC on October 12, 2021) |
| |
|
|
| 10.10 |
|
Form of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on December 3, 2021) |
| |
|
|
| 10.11 |
|
Form of Registration Rights Agreement (incorporated by reference to Exhibit 10.2 to the Company’s Form 8-K filed with the SEC on December 3, 2021) |
| |
|
|
| 10.12†
|
|
Amendment to Amended Employment Agreement effective as December 15, 2021 and dated March 2, 2022 — Herman Lübbert (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on March 8, 2022) |
| |
|
|
| 10.13 |
|
Form of Securities Purchase Agreement for 2022 Private Placement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 20, 2022) |
| |
|
|
| 10.14 |
|
Form of Registration Rights Agreement for 2022 Private Placement (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed with the SEC on May 20, 2022) |
| 10.15 |
|
Form of Inducement Letter (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on July 28, 2022) |
| |
|
|
| 10.16† |
|
Employment Agreement —Fred Leffler (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on October 24, 2022) |
| |
|
|
| 10.17 |
|
Form of Exchange Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on October 31, 2022) |
| |
|
|
| 10.18# |
|
Settlement Agreement dated April 11, 2023 between Biofrontera Inc., Hermann Luebbert, John J. Borer, Loretta M. Wedge, Beth J. Hoffman, Kevin D. Weber and Biofrontera AG (incorporated by reference to Exhibit 10.1 to the Company’s Form 10-Q filed with the SEC on May 12, 2023) |
| |
|
|
| 10.19 |
|
Securities Purchase Agreement, dated October 30, 2023, by and between Biofrontera Inc. and an institutional investor (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on November 2, 2023) |
| 10.20 |
|
Placement Agency Agreement, dated October 30, 2023, by and between Biofrontera Inc. and Roth Capital Partners, LLC (incorporated by reference to Exhibit 10.2 to the Company’s Form 8-K filed with the SEC on November 2, 2023) |
| |
|
|
| 10.21 |
|
Amendment to Common Stock Purchase Warrants, dated October 30, 2023, by and between Biofrontera Inc. and institutional investor (incorporated by reference to Exhibit 10.3 to the Company’s Form 8-K filed with the SEC on November 2, 2023) |
| |
|
|
| 10.22 |
|
Amendment No. 1 to Settlement Agreement dated as of October 12, 2023, between Biofrontera Inc., Hermann Luebbert, John J. Borer, Loretta M. Wedge, Beth J. Hoffman, Kevin D. Weber and Biofrontera AG (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on October 13, 2023) |
| 10.23 |
|
Form of Securities Purchase Agreement, dated February 19, 2024, by and among Biofrontera Inc. and the purchasers named therein (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on February 23, 2024) |
| |
|
|
| 10.24 |
|
Placement Agency Agreement, dated February 19, 2024, by and between Biofrontera Inc. and Roth Capital Partners, LLC (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on February 23, 2024) |
| |
|
|
| 10.25 |
|
Form of Securities Purchase Agreement dated November 21, 2024 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on November 27, 2024) |
| |
|
|
| 10.26 |
|
Security Agreement dated as of November 21, 2024 between the Company and the Collateral Agent (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on November 27, 2024) |
| |
|
|
| 10.27† |
|
2021 Omnibus Incentive Plan (as amended and restated on June 12, 2024) (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on June 14, 2024) |
| |
|
|
| 10.28 |
|
Form of Securities Purchase Agreement, dated June 27, 2025, by and among Biofrontera Inc. and the purchasers named therein (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on July 1, 2025) |
| |
|
|
| 10.29 |
|
Form of Agreement, dated June 30, 2025, by and among Biofrontera Inc. and Biofrontera AG (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K/A filed with the SEC on July 16, 2025) |
| |
|
|
| 10.30 |
|
Form of Asset Purchase Agreement, dated October 20, 2025, by and among Biofrontera Inc. and the purchasers named therein (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on October 24, 2025) |
| |
|
|
| 10.31 |
|
Form of Earnout Agreement, dated October 20, 2025, by and among Biofrontera Inc. and the purchasers named therein (incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on October 24, 2025) |
| |
|
|
| 10.32† |
|
Employment Agreement dated July 18, 2025—George P. Jones (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on August 11, 2025) |
| |
|
|
| 10.33 |
|
Supply Agreement, dated December 12, 2025, by and among Biofrontera Discovery GmbH and Midas Pharma GmbH (filed as Exhibit 10.33 to the Original 10-K and incorporated herein by reference) |
| * |
Filed
herewith. |
| † |
Indicates
a management contract or compensatory plan or arrangement. |
| # |
Certain
confidential portions of this Exhibit were omitted by means of marking such portions with brackets (“[***]”) because
the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed. |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its
behalf by the undersigned, thereunto duly authorized in the City of Woburn, Commonwealth of Massachusetts, on July 22, 2026.
| |
BIOFRONTERA
INC. |
| |
|
|
| |
By: |
/s/
Hermann Lübbert |
| |
Name:
|
Hermann
Lübbert |
| |
Title: |
Chief
Executive Officer and Chairman |
| Signature |
|
Title |
|
Date |
| |
|
|
|
|
| /s/
Hermann Lübbert |
|
Chief
Executive Officer and Chairman |
|
July
22, 2026 |
| Hermann
Lübbert |
|
(Principal
Executive Officer) |
|
|
| |
|
|
|
|
| /s/
E. Fred Leffler, III |
|
Chief
Financial Officer |
|
July
22, 2026 |
| E.
Fred Leffler, III |
|
(Principal
Financial Officer)
(Principal
Accounting Officer) |
|
|
| |
|
|
|
|
| /s/
John J. Borer |
|
Director |
|
July
22, 2026 |
| John
J. Borer |
|
|
|
|
| |
|
|
|
|
| /s/
Beth J. Hoffman |
|
Director |
|
July
22, 2026 |
| Beth
J. Hoffman |
|
|
|
|
| |
|
|
|
|
| /s/
Heikki Lanckriet |
|
Director |
|
July
22, 2026 |
| Heikki
Lanckriet |
|
|
|
|
| |
|
|
|
|
| /s/
Kevin D. Weber |
|
Director |
|
July
22, 2026 |
| Kevin
D. Weber |
|
|
|
|
ATTACHMENTS / EXHIBITS
EX-31.3
EX-31.4
XBRL SCHEMA FILE
XBRL DEFINITION FILE
XBRL LABEL FILE
XBRL PRESENTATION FILE
IDEA: R1.htm
IDEA: FilingSummary.xml
IDEA: MetaLinks.json
IDEA: form10-ka_htm.xml
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