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Biofrontera Inc. (BFRI) reports that the U.S. Food and Drug Administration has approved its supplemental New Drug Application for Ameluz topical gel, 10%, used with the BF‑RhodoLED lamp series for treatment of superficial basal cell carcinoma (sBCC) in adults. Ameluz is now the first and only photodynamic therapy approved in the United States to treat a skin cancer and the only topical PDT indicated for both actinic keratosis and a skin cancer.
The company states that this new sBCC indication broadens Ameluz’s addressable market and supports its strategy to expand its red‑light PDT platform. In a Phase 3 trial of 187 adults with sBCC, complete clinical and histological response of the main target lesion at 12 weeks was achieved in 66% of Ameluz PDT patients versus 5% with placebo PDT. Biofrontera plans an official launch of the sBCC indication in late fourth quarter 2026 through first quarter 2027 using its existing commercial organization and installed lamp base.
Biofrontera Inc. reported strong top-line growth but continued losses for the quarter and six months ended June 30, 2026. Net product revenue rose to $12.0 million for the quarter and $22.1 million year-to-date, up from $9.0 million and $17.6 million in 2025, driven by Ameluz sales. Loss from operations narrowed to $0.5 million for the quarter and $4.8 million for six months, with net loss of $0.6 million and $5.4 million, respectively.
Cash used in operations improved to $1.7 million in the first half versus $7.2 million a year earlier, but cash and equivalents declined to $4.7 million, and accumulated deficit reached $133.3 million. Management states that current capital resources are not adequate for 12 months and explicitly discloses substantial doubt about the company’s ability to continue as a going concern, absent new financing or milestone receipts.
Leverage includes $4.6 million of senior secured convertible notes and $0.5 million of warrant liabilities, with significant potential dilution from preferred stock, warrants, options and notes. The October 2025 strategic acquisition of U.S. rights to Ameluz and RhodoLED shifted costs from transfer pricing to a sales-based earnout, resulting in $2.6 million earnout expense in the first half. In May 2026, a U.S. International Trade Commission order prohibited import and sale of RhodoLED XL and Ameluz for use with that device; Biofrontera recorded $0.5 million of remediation cost and a related $0.1 million inventory write-down.
Biofrontera Inc. reported a strong improvement in operating performance for the quarter and six months ended June 30, 2026. Second-quarter net product revenue was $12.0 million, up 32.9% from $9.0 million, with gross margin rising to 80% from 71% as a new Ameluz® cost structure took hold. Quarterly net loss narrowed sharply to $0.6 million ($(0.05) per share) from $5.3 million ($(0.57) per share), and Adjusted EBITDA improved to $(0.2) million from $(5.1) million.
For the first half of 2026, net product revenue grew 25.4% to $22.1 million, with gross margin at 80% versus 67%. Net loss decreased to $5.4 million ($(0.44) per share) from $9.5 million, while Adjusted EBITDA improved to $(3.7) million from $(9.5) million. Cash used in operating activities fell to $1.7 million from $7.2 million, including a $3.7 million related-party paydown. Cash and equivalents were $4.7 million and stockholders’ equity was $6.0 million as of June 30, 2026. The company noted an International Trade Commission exclusion order affecting its RhodoLED XL lamp from July 7, 2026 but does not expect it to change full-year 2026 revenue goals.
Biofrontera Inc. received an amended Schedule 13G/A from Rosalind Advisors, Inc., Rosalind Master Fund L.P., and portfolio managers Steven Salamon and Gilad Aharon reporting a significant ownership position in the company’s common shares.
The reporting group may be deemed to beneficially own 1,275,609 common shares, representing approximately 9.96% of Biofrontera’s 12,803,344 common shares outstanding as of May 13, 2026. They also hold preferred shares and convertible debt that would be convertible into an additional 15,526,020 common shares; however, a 9.99% ownership “blocker” provision prevents exercising these instruments to the extent such exercise would push ownership above that threshold, so they state they cannot currently exercise them.
The reporting persons have shared voting and dispositive power over 1,275,609 shares and no sole voting or dispositive power. Rosalind Advisors acts as investment advisor to the fund, and Salamon and Aharon as portfolio managers, but they each disclaim beneficial ownership of shares held by the fund.
Biofrontera Inc. CEO and Chairman Hermann Luebbert converted 62,500 restricted stock units (RSUs) into 62,500 shares of common stock on July 28, 2026. These RSUs are part of a 125,000-unit award granted on July 22, 2025, vesting in two equal yearly installments beginning July 22, 2026. After the conversion, he directly held 352,711 shares of common stock and 62,500 RSUs from this grant, with RSUs having different terms expressly excluded.
Biofrontera Inc. Chief Financial Officer Eugene Frederick Leffler converted 31,250 restricted stock units into 31,250 shares of common stock on July 28, 2026 through an exercise of derivative securities. After this settlement, he directly holds 206,250 shares of Biofrontera common stock.
Biofrontera Inc., a Delaware corporation listed on Nasdaq under the symbol BFRI, has filed Amendment No. 1 to its Original 10-K for the year ended December 31, 2025. The amendment is narrowly focused on updating the exhibit index.
The changes primarily add the company’s Amended and Restated Bylaws as Exhibit 3.3 and make other minor exhibit-index adjustments. It also includes new principal executive officer and principal financial officer certifications under Section 302 of the Sarbanes-Oxley Act, with certain paragraphs omitted because no financial statements are included.
No financial statements or internal control disclosures are revised, and events after the Original 10-K filing date are not reflected. As of June 30, 2025, the aggregate market value of common stock held by non-affiliates was $6.9 million, and 11,648,323 common shares were outstanding as of March 16, 2026.
Biofrontera Inc. reported the results of its Annual Meeting of Stockholders held on June 11, 2026. Stockholders elected Beth J. Hoffman, Ph.D. and Kevin D. Weber as Class II directors, with each receiving over 8.0 million votes in favor and more than 3.3 million broker non-votes recorded.
Investors also approved an amendment and restatement of the 2021 Omnibus Incentive Plan, increasing the total number of common shares authorized under the plan from 3,750,000 to 8,750,000, with about 7.9 million votes cast in favor. In addition, stockholders ratified CBIZ CPAs P.C. as the independent registered public accounting firm for the fiscal year ending December 31, 2026, with approximately 10.9 million votes for the proposal.
Biofrontera Inc. reported first‑quarter 2026 net product revenue of $10.1M, up 17.4% from the prior year, driven mainly by higher Ameluz unit volumes and a late‑2025 price increase. Despite this growth, the company recorded a net loss of $4.8M, slightly larger than in 2025.
Cash and cash equivalents were $6.3M as of March 31, 2026, with operating cash outflows of about $0.1M in the quarter. Management states that existing capital resources are not adequate for twelve months and discloses substantial doubt about continuing as a going concern without additional financing or improved profitability.
The quarter also reflects a new cost structure from the 2025 strategic transaction with the Biofrontera Group, which replaced a 25% transfer‑pricing model with a lower earnout tied to Ameluz sales. Separately, an International Trade Commission final determination on RhodoLED XL led to a $0.5M remediation charge and restrictions on importing and selling certain lamp components, though the company has appealed elements of the patent dispute and the orders are under Presidential Review.
Biofrontera Inc. reported solid Q1 2026 progress, with revenue of $10.1 million, up about 17% from $8.6 million a year earlier, driven by higher Ameluz unit volumes and a price increase. Gross margin improved sharply to roughly 80% from 62%, reflecting a new earnout structure after its 2025 strategic transaction.
Operating loss narrowed slightly to $4.3 million, while net loss was $4.8 million, or $0.41 per share, compared with $4.2 million, or $0.47 per share. Adjusted EBITDA improved to a loss of $3.6 million, and operating cash usage was only $70 thousand, leaving $6.3 million in cash as of March 31, 2026.
The company highlighted key pipeline and regulatory milestones, including FDA filing acceptance of an sNDA for Ameluz PDT in superficial basal cell carcinoma with a PDUFA target action date of September 28, 2026, positive Phase 3 data in actinic keratoses on additional body sites, positive Phase 2b acne results, and regaining compliance with the Nasdaq Minimum Bid Price Requirement.