What changed in this filing

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Item 9A. Controls and Procedures

2026-03-19 compared with 2025-03-20 · 48 added, 49 removed, 151 unchanged (39% of the section changed)

20 unchanged sentences

in Internal Control Over Financial Reporting

were no changes in our internal control over financial reporting during the most recent fiscal quarter ended December 31, 2024 that materially

were no changes in our internal control over financial reporting during the quarter ended December 31, 2025 that materially

affected, or is reasonably likely to materially affect, our internal control over financial reporting (as defined in Rule 13a-15(f) under

1 unchanged sentence

Other Information

December 12, 2025, Discovery entered into a Supply Agreement (“Supply Agreement”) with Midas Pharma GmbH (“Midas”).

Among other things, the Supply Agreement provides that Midas will supply to Discovery or its contract manufacturers 5-Aminolevulinic

Acid Hydrochloride, the active pharmaceutical ingredient used in the manufacture of Ameluz, in amounts as specified therein.

Under the terms of the Supply Agreement, Discovery will provide Midas with a twenty-four (24) months non-binding

rolling forecast, which shall 1) indicate the anticipated quantity of API required by the company and 2) be updated every twelve (12)

months during the term of the agreement.

Agreement has an initial term ending on December 31, 2030, and automatically renews for successive two-year periods unless either party

provides at least 12 months’ notice of termination prior to expiration of the then-current term.

The Supply Agreement is governed

by the laws of Germany.

This description of the Supply Agreement does no t purport to be complete and is qualified in its entirety by reference

to the full text of the Supply Agreement, a copy of which is attached as Exhibits 10.33, respectively, to this Form 10-K and incorporated

herein by reference.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Directors, Executive Officers and Corporate Governance

required by this Item is incorporated by reference to our Proxy Statement for our Annual Meeting of Stockholders for the fiscal year

ended December 31, 2024, which will be filed with the Securities and Exchange Commission, pursuant to Regulation 14A, no later than 120

days after the end of the 2024 fiscal year covered by this Form 10-K,or alternatively, by amendment to this Form 10-K under cover of

Form 10-K/A no later than the end of such 120 day period.

Information required by this Item is incorporated by reference to our Proxy

Statement for our Annual Meeting of Stockholders for the fiscal year ended December 31, 2025, which will be filed with the Securities

and Exchange Commission, pursuant to Regulation 14A, no later than 120 days after the end of the 2025 fiscal year covered by this Form

10-K,or alternatively, by amendment to this Form 10-K under cover of Form 10-K/A no later than the end of such 120 day period.

Executive Compensation

9 unchanged sentences

Certain Relationships and Related Transactions, and Director Independence

required by this Item is incorporated by reference to our Proxy Statement for our Annual Meeting of Stockholders for the fiscal year

ended December 31, 2024, which will be filed with the Securities and Exchange Commission, pursuant to Regulation 14A, no later than 120

days after the end of the 2024 fiscal year covered by this Form 10-K,or alternatively, by amendment to this Form 10-K under cover of

Form 10-K/A no later than the end of such 120 day period.

Information required by this Item is incorporated by reference to our Proxy

Statement for our Annual Meeting of Stockholders for the fiscal year ended December 31, 2025, which will be filed with the Securities

and Exchange Commission, pursuant to Regulation 14A, no later than 120 days after the end of the 2025 fiscal year covered by this Form

10-K,or alternatively, by amendment to this Form 10-K under cover of Form 10-K/A no later than the end of such 120 day period.

Principal Accountant Fees and Services

7 unchanged sentences

Financial Statements and Supplementary Data ”:

Report of Independent Registered Public Accounting Firm

of Independent Registered Public Accounting Firm (PCAOB ID No.

Consolidated Balance Sheets as of December 31, 2025 and 2024

10 unchanged sentences

(incorporated by reference to Exhibit 4.13 to Biofrontera AG’s Form 20-F filed with the SEC on April 29, 2019).

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)

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)

Certificate of Designations of Series A Junior Participating Cumulative Preferred Stock of Biofrontera Inc.

(incorporated by reference to Exhibit 3.1 to the Company’s Registration Statement on Form 8-A filed with the SEC on October 14, 2022)

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).

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)

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).

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)

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)

Certificate of Designation of Preferences, Rights and Limitations of the Series C Convertible Preferred Stock (incorporated by reference to Exhibit 3.2 of the Company’s Current Report on Form 8-K filed with the SEC on July 1, 2025)

Certificate of Designation of Preferences, Rights and Limitations of the Series D Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 of the Company’s Current Report on Form 8-K filed with the SEC on July 1, 2025)

Description of Securities

1 unchanged sentence

Warrant Agent Agreement (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed with the SEC on November 3, 2021)

Form of Purchaser Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Form 8-K filed with the SEC on December 3, 2021).

of Purchaser Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Form 8-K filed with the SEC on December 3, 2021)

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)

7 unchanged sentences

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)

Form of Series B-3 Convertible Preferred Stock Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed with the SEC on February 23, 2024)

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)

Amended and Restated License and Supply Agreement dated June 16, 2021 by and among Biofrontera Pharma GmbH, Biofrontera Bioscience GmbH and Biofrontera Inc.

(incorporated by reference to Exhibit 10.1 to Company’s Form S-1 filed with the SEC on July 6, 2021).

License and Supply Agreement dated March 10, 2014 by and between Ferrer Internacional, S.A.

and Medimetriks Pharmaceuticals, Inc., as amended by Amendment No.

1 and Consent and Acknowledgment Agreement with respect thereto (incorporated by reference to Exhibit 4.14 to Biofrontera AG’s Form 20-F filed with the SEC on April 29, 2019).

Amendment No.

1 to License and Supply Agreement dated March 5, 2018 by and between Medimetriks Pharmaceuticals, Inc.

and Ferrer Internacional, S.A.

(incorporated by reference to Exhibit 4.15 to Biofrontera AG’s Form 20-F filed with the SEC on April 29, 2019).

Consent and Acknowledgement Agreement dated March 5, 2018 by and between Medimetriks Pharmaceuticals, Inc.

and Ferrer Internacional, S.A.

(incorporated by reference to Exhibit 4.16 to Biofrontera AG’s Form 20-F filed with the SEC on April 29, 2019).

Agreement dated March 2018 by and between Ferrer Internacional, S.A.

and Cutanea Life Sciences, Inc.

(incorporated by reference to

Exhibit 4.17 to Biofrontera AG’s Form 20-F filed with the SEC on April 29, 2019).

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)

13 unchanged sentences

Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.16 filed with the SEC on October 12, 2021)

Corrected Amendment to Amended and Restated License and Supply Agreement dated October 8, 2021 by and among Biofrontera Pharma GmbH, Biofrontera Bioscience GmbH and Biofrontera Inc.

(incorporated by reference to Exhibit 10.17 to Amendment No.

7 to the Company’s Form S-1 filed with the SEC on October 13, 2021).

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)

1 unchanged sentence

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)

Amended Settlement Allocation Agreement dated March 31,2022 between the Company and Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, Biofrontera Development GmbH, Biofrontera Neuroscience GmbH, (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on April 5, 2022).

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)

20 unchanged sentences

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)

Addendum to Amended and Restated License and Supply Agreement, dated as of December 12, 2023 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on December 15, 2023)

Amended and Restated Business Loan and Security Agreement between Biofrontera Inc.

and Agile Capital Funding, LLC and Agile Lending, LLC, dated as of December 21, 2023 (incorporated by reference to Exhibit 10.34 of the Company’s Form 10-K filed with the SEC on March 15, 2024)

Business Loan and Security Agreement between Biofrontera Inc.

and Cedar Advance, LLC, dated as of December 21, 2023 (incorporated by reference to Exhibit 10.35 of the Company’s Form 10-k filed with the SEC on March 15, 2024)

Confidential Settlement Agreement and Mutual Release, dated as of December 27, 2023 and effective as of December 22, 2023, by and between the Company and Maruho (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on January 3, 2024)

Amended and Restated Addendum to Amended and Restated License and Supply Agreement, dated January 29, 2024 (incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on February 2, 2024)

Second Amended and Restated License and Supply Agreement, dated February 19, 2024, between the Company, Pharma and Bioscience.

(incorporated by reference to Exhibit 10.1 of the Company’s Current Report on Form 8-K filed with the SEC on February 20, 2024)

Release of Claims, dated February 13, 2024, between the Company, Pharma and Bioscience.

(incorporated by reference to Exhibit 10.2 of the Company’s Current Report on Form 8-K filed with the SEC on February 20, 2024)

Form of Securities Purchase Agreement, dated February 19, 2024, by and among Biofrontera Inc.

5 unchanged sentences

2021 Omnibus Incentive Plan (as amended and restated (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)

Insider Trading Policy

List of Subsidiaries of the Company

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)

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)

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)

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)

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)

Supply Agreement, dated December 12, 2025, by and among Biofrontera Discovery GmbH and Midas Pharma GmbH

Insider Trading Policy (incorporated by reference to Exhibit 19.1 to the Company’s Form 10-K filed with the SEC on March 20, 2025)

List of Subsidiaries of the Company (incorporated by reference to Exhibit 21.1 to the Company’s Form 10-K filed with the SEC on March 20, 2025)

Consent of CBIZ CPAs P.C., independent registered public accounting firm

Consent of Marcum LLP, independent registered public accounting firm

21 unchanged sentences

Executive Officer and Chairman

March 19, 2026

Executive Officer)

Financial Officer

March 19, 2026

Financial Officer)

2 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures