Form 8-K

8-K — Biofrontera Inc.

Accession: 0001493152-26-042508

Filed: 2026-09-14

Period: 2026-09-14

CIK: 0001858685

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

EX-99.1 (ex99-1.htm)

GRAPHIC (ex99-1_001.jpg)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K

8-K (Primary)

Filename: form8-k.htm · Sequence: 1

false

0001858685

2026-09-14

0001858685

BFRI:CommonStockParValue0.001PerShareMember

2026-09-14

0001858685

BFRI:WarrantsToPurchaseCommonStockMember

2026-09-14

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

8-K

CURRENT

REPORT

PURSUANT

TO SECTION 13 OR 15(D)

THE SECURITIES EXCHANGE ACT OF 1934

Date

of Report (Date of earliest event reported): September 14, 2026

Biofrontera

Inc.

(Exact

name of registrant as specified in its charter)

Delaware

001-40943

47-3765675

(State

or other jurisdiction

incorporation)

(Commission

File

Number)

(IRS

Employer

Identification

No.)

660

Main Street, First Floor, 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))

☐

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

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 ☒

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.

September 14, 2026, Biofrontera Inc. (the “Company”) issued a press release announcing that it has received notification

from the U.S. Food and Drug Administration (the “FDA”) that the FDA had approved the Company’s supplemental New Drug

Application for Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10%, in combination with photodynamic therapy

using the BF-RhodoLED® lamp series, for the treatment of superficial basal cell carcinoma in adults. A copy of the press

release is being furnished as Exhibit 99.1 attached to this Current Report on Form 8-K.

The

information contained in Item 8.01 of this Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed”

for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liabilities

of that section, nor shall it be deemed incorporated by reference in any filing by the company under the Securities Act of 1933 or the

Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item

9.01 Financial Statements and Exhibits.

99.1

Press release of Biofrontera Inc. dated September 14, 2026

104

Cover

Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document)

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.

September

14, 2026

Biofrontera

Inc.

(Date)

(Registrant)

/s/

E. Fred Leffler III

Fred Leffler, III

Chief

Financial Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

Biofrontera

Announces FDA Approval of Ameluz® Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma

Ameluz

used in conjunction with the RhodoLED lamp becomes the first and only photodynamic therapy approved in the United States to treat a skin

cancer, creating an additional growth opportunity for Biofrontera’s photodynamic therapy platform

WOBURN,

Mass., September 14, 2026 — Biofrontera Inc. (NASDAQ: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical

company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today announced that the

U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for Ameluz®

(aminolevulinic acid hydrochloride) topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED®

lamp series, for the treatment of superficial Basal Cell Carcinoma (sBCC) in adults1.

With

this approval, Ameluz becomes the first and only PDT drug approved by the FDA for the treatment of a skin cancer, and the only topical

PDT in the United States indicated to treat both a pre-cancerous skin condition, actinic keratosis (AK), and a skin cancer. The sBCC

indication expands the addressable market for Ameluz and strengthens its position in medical dermatology. This label expansion also furthers

Biofrontera’s strategy of broadening the clinical utility of its Red-Light PDT platform. Hermann Luebbert, Chief Executive Officer

and Chairman of Biofrontera, stated: “FDA approval of Ameluz for superficial basal cell carcinoma is a defining milestone for Biofrontera.

Ameluz is now the first and only photodynamic therapy approved in the United States to treat a skin cancer, which sets our platform apart

in medical dermatology and gives dermatologists an effective, non-surgical option for a very common tumor. This approval reflects years

of disciplined investment in the clinical development of Ameluz, and the latest stage in the ongoing expansion of our PDT platform.”

He added “We are planning an official launch of the sBCC indication late in the fourth quarter of 2026 through the first quarter

of 2027 with our existing commercial organization and installed lamp base. We believe the approval represents a further driver of long-term

growth for our existing customers. It also gives new Dermatology practices a reason to purchase a RhodoLED lamp and begin to use Ameluz

PDT, expanding our overall installed base.” This new indication utilizes the same topical product (Ameluz) and the same red-light

device as the Company’s AK indication, so our existing customers will be able to rapidly adopt this new treatment option.

Basal

cell carcinoma (BCC) is the most common skin cancer in the United States, with approximately 3.6 million cases diagnosed annually, according

to the Skin Cancer Foundation. Published estimates suggest that the superficial subtype accounts for approximately 15%-20% of BCC cases,

or an estimated 540,000 to 720,000 sBCC cases annually in the U.S.2. Superficial BCC lesions can be up to several cm in diameter

and are frequently located on the trunk and extremities and often present as multiple lesions, for which non-surgical, tissue-sparing

treatment options are limited.

The

approval is supported by a multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial in 187 adults with histologically

confirmed sBCC. The primary endpoint was a composite of both clinical and histological complete response of a main target lesion 12 weeks

after the start of the last PDT cycle. This rigorous target was achieved in 66% of subjects treated with Ameluz PDT (95/145) compared

with 5% of subjects treated with placebo-PDT (2/42). Histological clearance of the main target lesion was seen in 76% of Ameluz PDT treated

patients versus 19% with Placebo-PDT, and 83% of Ameluz-treated subjects achieved complete clinical clearance of all target lesions

compared with 21% for Placebo-PDT. The most common adverse reactions were application-site reactions consistent with the known safety

profile of Ameluz PDT.

Dr.

M. Shane Chapman, MBA, board certified dermatologist, Professor and Founding Chair, Department of Dermatology, Dartmouth Hitchcock Medical

Center and the Dartmouth Geisel School of Medicine, and a key contributor to the Phase 3 study added “For many patients with superficial

basal cell carcinoma — those with multiple lesions, lesions in cosmetically sensitive locations, or for whom surgery would not

be preferred — treatment options have been limited. This FDA approval for Ameluz® and the RhodoLED gives us a rigorously studied,

non-surgical option that we can deliver in our office. As someone who has worked with PDT for many years, I see this as a meaningful

expansion in the use of this treatment.”

Ameluz Prescribing information (https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208081s040lbl.pdf)

Scrivener Y, Grosshans E, Cribier B. Variations of basal cell carcinomas according to gender, age, location and histopathological subtype.

Br J Dermatol. 2002;147(1):41–47

About

Biofrontera Inc.

Biofrontera

Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological

conditions with photodynamic therapy (PDT). The Company’s products are used for the treatment of actinic keratoses, which are pre-cancerous

skin lesions, and superficial basal cell carcinoma, and are in development for additional indications. For more information, visit www.biofrontera-us.com

and follow Biofrontera on LinkedIn and X.

Investor

Contact

Ben

Shamsian

Lytham

Partners

646-829-9701

shamsian@lythampartners.com

Forward-Looking

Statements

Certain

statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private

Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, in this press release, including

statements regarding our strategy, future operations, regulatory process, future financial position, future revenue, projected costs,

prospects, plans, objectives of management and expected market growth, are forward-looking statements. The words “believe”,

“anticipate”, “intend”, “expect”, “target”, “goal”, “estimate”,

“plan”, “assume”, “may”, “will”, “predict”, “project”, “would”,

“could” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements

contain these identifying words. You should read this press release and any documents referenced herein completely and with the understanding

that our actual future results may be materially different from what we expect. While we have based these forward-looking statements

on our current expectations and projections about future events, we may not actually achieve the plans, intentions or expectations disclosed

in or implied by our forward-looking statements, and you should not place undue reliance on our forward-looking statements.

These

forward-looking statements are subject to risks, uncertainties and assumptions about us and accordingly, actual results or events could

differ materially from the plans, intentions and expectations disclosed in or implied by the forward-looking statements we make. These

risks and uncertainties, many of which are beyond our control, include, but are not limited to: our ability to achieve and sustain profitability;

our ability to compete effectively in selling our products; our ability to expand, manage and maintain our direct sales and marketing

efforts, including our ability to obtain the financing to develop our marketing strategy, if needed; changes in our relationship with

our manufacturing partners and the possible impact of tariffs; our ability to manufacture our products; our ability to adequately protect

our intellectual property and operate the business without infringing upon the intellectual property rights of others; our actual financial

results may vary significantly from forecasts and from period to period; our estimates regarding anticipated operating losses, future

revenues, capital requirements and our needs for additional financing; market risks regarding consolidation and group purchasing organizations

(“GPOs”) in the healthcare industry; the willingness of healthcare providers to purchase our products if coverage, reimbursement

and pricing from third-party payors for our products, or procedures using our products significantly declines; our ability to market,

commercialize, achieve market acceptance for and sell our products; the fact that product quality issues or product defects may harm

our business; any claims brought against the Company, including but not limited to product liability claims, claims of patent infringement,

or claims challenging the validity of our intellectual property; our ability to maintain compliance with The Nasdaq Stock Market, LLC

continued listing standards; our ability to comply with the requirements of being a public company; the progress, timing and completion

of research, development and preclinical studies and clinical trials for our products; our ability to obtain and maintain the regulatory

approvals necessary for the marketing of our products in the United States; and other factors that may be disclosed in the Company’s

filings with the Securities and Exchange Commission (“SEC”), which can be obtained on the SEC website at www.sec.gov.

Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures

or investments that we may make. We do not assume any obligation to update any forward-looking statements, whether as a result of new

information, future events or otherwise, except as required by law. Any forward-looking statements speak only as of the date on which

they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances

that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made

by us in light of these important factors.

GRAPHIC

Filename: ex99-1_001.jpg · Sequence: 3

Binary file (15790 bytes)

Download ex99-1_001.jpg

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 20

v3.26.3

Cover

Sep. 14, 2026

Document Type

8-K

Amendment Flag

false

Document Period End Date

Sep. 14, 2026

Entity File Number

001-40943

Entity Registrant Name

Biofrontera

Inc.

Entity Central Index Key

0001858685

Entity Tax Identification Number

47-3765675

Entity Incorporation, State or Country Code

Entity Address, Address Line One

660

Main Street

Entity Address, Address Line Two

First Floor

Entity Address, City or Town

Woburn

Entity Address, State or Province

Entity Address, Postal Zip Code

01801

City Area Code

(781)

Local Phone Number

245-1325

Written Communications

false

Soliciting Material

false

Pre-commencement Tender Offer

false

Pre-commencement Issuer Tender Offer

false

Entity Emerging Growth Company

true

Elected Not To Use the Extended Transition Period

false

Common stock, par value $0.001 per share

Title of 12(b) Security

Common

stock, par value $0.001 per share

Trading Symbol

BFRI

Security Exchange Name

NASDAQ

Warrants to purchase common stock

Title of 12(b) Security

Warrants

to purchase common stock

Trading Symbol

BFRIW

Security Exchange Name

NASDAQ

- Definition

Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

+ References

No definition available.

+ Details

Name:

dei_AmendmentFlag

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Area code of city

+ References

No definition available.

+ Details

Name:

dei_CityAreaCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

+ References

No definition available.

+ Details

Name:

dei_DocumentPeriodEndDate

Namespace Prefix:

dei_

Data Type:

xbrli:dateItemType

Balance Type:

Period Type:

duration

- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

+ References

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

dei_

Data Type:

dei:submissionTypeItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 1 such as Attn, Building Name, Street Name

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 2 such as Street or Suite number

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine2

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the City or Town

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCityOrTown

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Code for the postal or zip code

+ References

No definition available.

+ Details

Name:

dei_EntityAddressPostalZipCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the state or province.

+ References

No definition available.

+ Details

Name:

dei_EntityAddressStateOrProvince

Namespace Prefix:

dei_

Data Type:

dei:stateOrProvinceItemType

Balance Type:

Period Type:

duration

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

Namespace Prefix:

dei_

Data Type:

dei:centralIndexKeyItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if an emerging growth company has elected not to use the extended transition period for complying with any new or revised financial accounting standards.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 7A

-Section B

-Subsection 2

+ Details

Name:

dei_EntityExTransitionPeriod

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Details

Name:

us-gaap_StatementClassOfStockAxis=BFRI_CommonStockParValue0.001PerShareMember

Namespace Prefix:

Data Type:

Balance Type:

Period Type:

- Details

Name:

us-gaap_StatementClassOfStockAxis=BFRI_WarrantsToPurchaseCommonStockMember

Namespace Prefix:

Data Type:

Balance Type:

Period Type: