Biofrontera Inc. SEC Filings

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.

Biofrontera Inc. has called a fully virtual 2026 annual stockholder meeting for June 11, 2026. Investors will vote on electing two Class II directors, amending and restating the 2021 Omnibus Incentive Plan, and ratifying CBIZ CPAs P.C. as independent auditor for 2026.

The equity plan proposal would lift the share limit from 3,750,000 to 8,750,000, supporting future stock-based awards. As of the April 21, 2026 record date, 12,007,558 common shares and 22,286 preferred shares were outstanding, together entitled to 16,750,083 votes voting as a single class.

Biofrontera Inc. reported positive Phase 2b clinical results for its Ameluz® photodynamic therapy in moderate to severe acne vulgaris. In the 3-hour incubation per-protocol group, Ameluz achieved a 57.97% reduction in inflammatory lesions versus 36.51% with vehicle, and 25% of Ameluz patients met the mIGA co-primary endpoint compared with 21.4% on vehicle.

The 3-hour regimen also showed larger absolute reductions in inflammatory, non-inflammatory and total lesion counts and a safety profile consistent with prior PDT experience, with mainly mild to moderate burning and itching. Patient satisfaction was high, and the company plans to present these Phase 2b data to the FDA in Q3 2026 to discuss potential next development steps.

Biofrontera Inc. director Kevin Daniel Weber reported receiving an employee stock option grant to acquire 20,000 shares of the company’s stock. The option carries an exercise price of $0.00 per share and represents a new award, bringing his total directly held derivative securities from this grant to 20,000 options.

According to the disclosure, the option vests in twelve equal monthly installments beginning on April 4, 2026, meaning the right to exercise will phase in over one year. The filing notes that other options with different terms are not included in this reported transaction.

Biofrontera Inc. CEO and Chairman Hermann Luebbert reported several equity awards and an option-related share conversion. On March 4, 2026, he received 125,000 restricted stock units and an employee stock option for 125,000 shares, both at a price of $0.00 per unit or option. The restricted stock units vest in two equal yearly installments beginning on March 4, 2027, and may be settled in shares, cash, or a combination within 60 days of each vesting date. The option vests in two equal installments on September 4, 2026 and March 4, 2027. On March 5, 2026, 137,500 restricted stock units were exercised or converted into 137,500 shares of common stock at $0.00 per share, bringing his directly held common stock to 290,211 shares after the transaction.