UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2026

☐	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)		(IRS Employer Identification No.)

660 Main Street, 1^st Floor, Woburn, Massachusetts		01801
(Address of principal executive offices)		(Zip Code)

(781) 245-1325

(Registrant’s telephone number, including area code)

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)

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 to purchase common stock	BFRIW	The Nasdaq Stock Market LLC

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 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 is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of August 11, 2026, there were 14,852,359 shares outstanding of the registrant’s common stock, par value $0.001 per share.

TABLE OF CONTENTS

	PART I. FINANCIAL INFORMATION

ITEM 1.	Financial Statements	3
	Condensed Consolidated Balance Sheets as of June 30, 2026 (unaudited) and December 31, 2025	3
	Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2026 (unaudited) and 2025 (unaudited)	4
	Condensed Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2026 (unaudited) and 2025 (unaudited)	5
	Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2026 (unaudited) and 2025 (unaudited)	6
	Notes to Condensed Consolidated Financial Statements	7
ITEM 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	23
ITEM 3.	Quantitative and Qualitative Disclosures About Market Risk	35
ITEM 4.	Controls and Procedures	35

	PART II. OTHER INFORMATION

ITEM 1.	Legal Proceedings	36
ITEM 1A.	Risk Factors	36
ITEM 2.	Unregistered Sales of Equity Securities and Use of Proceeds	36
ITEM 3.	Defaults Upon Senior Securities	36
ITEM 4.	Mine Safety Disclosures	36
ITEM 5.	Other Information	36
ITEM 6.	Exhibits	36
Signatures		37

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

BIOFRONTERA INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except par value and share amounts)

	June 30, 2026			December 31, 2025
	(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents	$	4,659		$	6,392
Investment, related party		8			9
Accounts receivable, net		5,545			7,291
Inventories		1,097			1,426
Prepaid expenses and other current assets		892			2,279
Other assets, related party		234			686

Total current assets		12,435			18,083

Inventories, long term		3,658			3,729
Property and equipment, net		2,139			2,158
Operating lease right-of-use assets		2,813			1,584
Intangible assets, net		2,568			2,650
Other assets		451			360

Total assets	$	24,064		$	28,564

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		4,315			1,855
Accounts payable, related parties, net		1,044			4,811
Accounts payable		1,044			4,811
Operating lease liabilities		472			332
Accrued expenses and other current liabilities		4,710			4,897

Total current liabilities		10,541			11,895

Long-term liabilities:
Convertible notes payable, net		4,620			4,589
Warrant liabilities		526			351
Operating lease liabilities, non-current		2,412			1,240
Other liabilities		9			9

Total liabilities		18,108			18,084

Commitments and contingencies (see Note 17)		-			-

Stockholders’ equity:
Convertible Preferred Stock, $0.001 par value, 20,000,000 shares authorized; no Series B-1; 1,850 and 2,050 Series B-2; 6,498 and 6,593 Series B-3; 9,707 and 10,719 Series C; and 3,019 Series D shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively		-			-
Common stock, $0.001 par value, 70,000,000 shares authorized; 14,206,126 and 11,648,323 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively		14			12
Additional paid-in capital		139,243			138,413
Accumulated deficit		(133,301	)		(127,945	)

Total stockholders’ equity		5,956			10,480

Total liabilities and stockholders’ equity	$	24,064		$	28,564

The accompanying notes are an integral part of these condensed consolidated financial statements.

BIOFRONTERA INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share amounts and number of shares)

(Unaudited)

	2026			2025			2026			2025
	Three Months Ended June 30,						Six Months Ended June 30,
	2026			2025			2026			2025

Product revenues, net	$	12,003		$	9,030		$	22,087		$	17,617

Operating expenses
Cost of revenues, related party		2,185			2,380			4,016			5,455
Cost of revenues, other		225			262			510			455
Cost of revenues		225			262			510			455
Selling, general and administrative		9,628			10,528			20,623			19,183
Selling, general and administrative, related party		41			69			42			76
Patent remediation expense		-			-			392			-
Research and development		448			870			1,348			2,077

Total operating expenses		12,527			14,109			26,931			27,246

Loss from operations		(524	)		(5,079	)		(4,844	)		(9,629	)

Other income (expense)
Change in fair value of warrant liabilities		44			153			(175	)		702
Change in fair value of investment, related party		(1	)		2			(1	)		2
Interest expense, net		(126	)		(115	)		(251	)		(220	)
Other income (expense), net		26			(264	)		(62	)		(363	)

Total other income (expense)		(57	)		(224	)		(489	)		121

Loss before income taxes		(581	)		(5,303	)		(5,333	)		(9,508	)
Income tax expense		23			21			23			19

Net loss	$	(604	)	$	(5,324	)	$	(5,356	)	$	(9,527	)

Loss per common share:
Basic and diluted	$	(0.05	)	$	(0.57	)	$	(0.44	)	$	(1.05	)

Weighted-average common shares outstanding:
Basic and diluted		12,923,710			9,351,557			12,306,944			9,108,091

The accompanying notes are an integral part of these condensed consolidated financial statements.

BIOFRONTERA INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands, except number of shares)

(Unaudited)

	Shares			Amount		Shares		Amount		Capital			Deficit			Total
	Three and Six Months Ended June 30, 2026
	Preferred Stock					Common Stock				Additional Paid-in			Accumulated
	Shares			Amount		Shares		Amount		Capital			Deficit			Total
Balance, April 1, 2026		22,381		$	-		11,873,323	$	12	$	138,755		$	(132,697	)	$	6,070
Conversion of Series B-2 Preferred into Common		(200	)		-		282,600		-		-			-			-
Conversion of Series B-3 Preferred into Common		(95	)		-		134,235		-		-			-			-
Conversion of Series C Preferred into Common		(1,012	)		-		1,619,463		2		(2	)		-			-
Conversion of convertible notes into Common		-			-		296,505		-		227			-			227
Stock-based compensation		-			-		-		-		263			-			263
Net loss		-			-		-		-		-			(604	)		(604	)
Balance, June 30, 2026		21,074			-		14,206,126		14		139,243			(133,301	)		5,956

Balance, January 1, 2026		22,381		$	-		11,648,323	$	12	$	138,413		$	(127,945	)	$	10,480
Conversion of Series B-2 Preferred into Common		(200	)		-		282,600		-		-			-			-
Conversion of Series B-3 Preferred into Common		(95	)		-		134,235		-		-			-			-
Conversion of Series C Preferred into Common		(1,012	)		-		1,619,463		2		(2	)		-			-
Conversion of convertible notes into Common		-			-		296,505		-		227			-			227
Issuance of shares for restricted stock units		-			-		225,000		-		-			-			-
Stock-based compensation		-			-		-		-		605			-			605
Net loss		-			-		-		-		-			(5,356	)		(5,356	)
Balance, June 30, 2026		21,074		$	-		14,206,126	$	14	$	139,243		$	(133,301	)	$	5,956

	Three and Six Months Ended June 30, 2025
	Preferred Stock					Common Stock				Additional Paid-in		Accumulated
	Shares			Amount		Shares		Amount		Capital		Deficit			Total
Balance, April 1, 2025		10,129			-		8,873,932		9		122,072		(121,612	)		469
Conversion of Series B-2 Preferred into Common		(725	)		-		1,024,425		-		-					-
Conversion of Series B-3 Preferred into Common		(170	)		-		240,210		-		-					-
Stock based compensation							-				187					187
Net loss					-				-		-		(5,324	)		(5,324	)
Balance, June 30, 2025		9,234			-		10,138,567		9		122,259		(126,936	)		(4,668	)

Balance, January 1, 2025		10,129			-		8,873,932		9		121,833		(117,409	)		4,433
Balance		10,129			-		8,873,932		9		121,833		(117,409	)		4,433
Conversion of Series B-2 Preferred into Common		(725	)		-		1,024,425		-		-		-			-
Conversion of Series B-3 Preferred into Common		(170	)		-		240,210		-		-		-			-
Stock based compensation					-		-		-		426		-			426
Net loss					-		-		-		-		(9,527	)		(9,527	)
Balance, June 30, 2025		9,234			-		10,138,567		9		122,259		(126,936	)		(4,668	)
Balance		9,234			-		10,138,567		9		122,259		(126,936	)		(4,668	)

The accompanying notes are an integral part of these condensed consolidated financial statements.

BIOFRONTERA INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

	2026			2025
	Six Months Ended June 30,
	2026			2025
Cash flows from operating activities:

Net loss	$	(5,356	)	$	(9,527	)

Adjustments to reconcile net loss to cash flows used in operations:

Depreciation and amortization		120			55
Reduction in the carrying amount of right-of-use assets		263			386
Stock-based compensation		605			426
Non-cash interest expense		259			240
Allowance for credit losses		40			(57	)
Change in fair value of warrant liabilities		175			(702	)
Realized/unrealized (gain)/ loss in investment, related party		1			(2	)
Loss from termination of operating leases		4			-

Changes in operating assets and liabilities:
Accounts receivable		1,706			1,418
Other receivables, related party		(54	)		-
Prepaid expenses and other assets		1,296			45
Other assets, related party		452			(953	)
Inventories		386			2,618
Accounts payable		2,461			2,412
Accounts payable, related parties, net		(3,714	)		(4,674	)
Operating lease liabilities		(184	)		(371	)
Accrued expenses and other liabilities		(188	)		1,524

Cash flows used in operating activities		(1,728	)		(7,162	)

Cash flows from investing activities
Purchases of property and equipment		(5	)		(4	)

Cash flows used in investing activities		(5	)		(4	)

Cash flows from financing activities
Proceeds from stockholder advances		-			8,500

Cash flows provided by financing activities		-			8,500

Net change in cash, cash equivalents		(1,733	)		1,334
Cash, cash equivalents and restricted cash, at the beginning of the period		6,592			6,105

Cash, cash equivalents and restricted cash, at the end of the period	$	4,859		$	7,439

Supplemental disclosure of cash flow information
Interest paid		-			3
Income taxes paid, net		21			21

Supplemental non-cash financing activities
Addition of right-of-use assets in exchange for operating lease liabilities	$	1,529		$	98
Conversion of convertible note payable and PIK interest into common stock	$	227			-

The accompanying notes are an integral part of these condensed consolidated financial statements.

Biofrontera Inc.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

1. Organization and Business Overview

Biofrontera Inc., a Delaware corporation (the “Company,” “we,” “us,” “our,” or “Biofrontera”), is a United States-based biopharmaceutical company engaging in the development, manufacturing, and commercialization of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (“PDT”). The Company’s products, which include Ameluz^® as well as the BF-RhodoLED^® and RhodoLED^® XL lamp series (together, the “RhodoLED^® Lamps”), are used for the treatment of actinic keratosis (“AK”), a common skin condition characterized by the growth of pre-cancerous skin lesions (or “AKs”). With our national commercial team, we generate revenue by selling our products directly to dermatology offices and groups.

We conduct all clinical trials relating to Ameluz^® in the United States through Biofrontera Discovery GmbH (“Discovery”), our wholly owned subsidiary organized under the laws of Germany and formed in February 2022. Our research and development (“R&D”) programs are focused on label expansion for Ameluz^® as well as supporting PDT growth by improving the capabilities of the RhodoLED^® Lamps to better fulfill the needs of dermatologists.

On October 20, 2025, the Company entered into (i) an Asset Purchase Agreement (the “Transfer Agreement”) and (ii) an Earnout Agreement (together with the Transfer Agreement, the “Agreements”) with Biofrontera AG and its consolidated subsidiaries (the “Biofrontera Group”), pursuant to which the Company acquired all rights in the United States (the “U.S. Rights”) to Ameluz^® and RhodoLED^® (the “Strategic Transaction”). In exchange for the U.S. Rights, and in addition to a monthly earnout payable to the Biofrontera Group and the Company’s assumption of all costs associated with the U.S. business, Biofrontera AG received 3,019 shares of Series D Convertible Preferred Stock, par value $0.001 per share (the “Series D Preferred Stock”). The Strategic Transaction was funded through an $11.0 million investment by existing investors. See Note 13. Related Party Transactions for additional information.

On November 6, 2025, the Company completed the sale of the long-lived intangible asset relating to its Xepi product line. The Company received fixed consideration in the amount of $3.0 million and may receive up to $7.0 million of variable consideration contingent upon the buyer’s future activities. See Note 10. Asset Held for Sale, to our consolidated financial statements included in Item 8. Financial Statements and Supplementary Data in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 (the “2025 Form 10-K”) for additional information.

On May 6, 2026, the U.S. International Trade Commission (the “Commission”) issued a Limited Exclusion Order (“LEO”) and cease and desist order (“CDO”) prohibiting the Company from importing and/or selling the RhodoLED^® XL in the United States and restricting the Company from selling Ameluz^® for use with the RhodoLED^® XL (the “ITC Matter”). See Note 17. Commitments and Contingencies for additional information.

Liquidity and Going Concern

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. Since we commenced operations in 2015, we have generated significant losses. The Company incurred net cash outflows from operations of $1.7 million and $7.2 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, the Company’s accumulated deficit was $133.3 million. The Company’s primary sources of liquidity are its cash collected from the sales of its products and cash flows from financing transactions. As of June 30, 2026, we had cash and cash equivalents of $4.7 million, compared to $6.4 million as of December 31, 2025.

As discussed above and in Note 17. Commitments and Contingencies, in connection with the ITC Matter, the Company has recorded an estimated remediation cost of $0.5 million and expects related cash disbursements to occur over the twelve months following July 6, 2026; these disbursements are reflected in the Company's cash flow forecasts used in this assessment. Based on currently available information, management does not expect this matter to materially impair the Company's core Ameluz^® revenue base.

The Company cannot provide assurance that it will ultimately achieve profitable operations and become operating cash flow positive or raise additional debt or equity capital. Additionally, the current capital resources are not adequate to continue operating and maintaining the business strategy for a period of twelve months from the issuance date of this report. Management believes that these conditions raise substantial doubt about the Company’s ability to continue as a going concern for at least twelve months from the issuance date of this Quarterly Report on Form 10-Q.

The Company plans to address the conditions that raise substantial doubt regarding its ability to continue as a going concern by, among other things, continuing to expand the commercialization of Ameluz^® in the United States while controlling expenses; drawing on a working capital line of credit; pursuing the realization of an additional $1.0 million in milestone payments from the sale of the Xepi intangible asset expected in December 2026; and, if necessary, securing additional capital through equity or debt financings to support commercial expansion and R&D programs. However, there can be no assurance that the Company will be successful in obtaining sufficient funding on acceptable terms, if at all. If the Company is unable to raise additional capital when needed, it will not have sufficient cash resources and liquidity to fund its business operations and may be forced to delay or reduce continued commercialization efforts or R&D programs which could have a material adverse effect on the Company and its financial statements.

The condensed consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern.

2. Summary of Significant Accounting Policies