Welcome to our dedicated page for Biofrontera SEC filings (Ticker: BFRI), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Biofrontera Inc. (NASDAQ: BFRI) SEC filings page provides access to the company’s official disclosures as filed with the U.S. Securities and Exchange Commission. Biofrontera is a U.S.-based biopharmaceutical company focused on dermatology and photodynamic therapy (PDT), commercializing Ameluz® and the RhodoLED® lamp series for actinic keratoses and developing additional indications such as superficial basal cell carcinoma and acne vulgaris.
Through its current and periodic reports, investors can review how Biofrontera describes its business, risk factors and financial condition. Form 8-K filings document material events, including quarterly financial results, strategic transactions with Biofrontera AG to acquire all U.S. rights to Ameluz® and RhodoLED®, private placements of Series C and Series D convertible preferred stock, and the divestiture of the Xepi® antibiotic cream license. Other 8-Ks detail Nasdaq listing compliance notices and stockholder meeting outcomes.
Annual reports on Form 10-K and quarterly reports on Form 10-Q (when available) typically include information on revenues from dermatology products, operating expenses, liquidity, and discussions of clinical and regulatory progress for Ameluz®-PDT. These filings also outline the company’s reliance on product sales, competition in dermatology, intellectual property matters, and other risks relevant to its PDT-focused business model.
Stock Titan enhances these filings with AI-powered summaries that highlight key points from lengthy documents, helping users quickly understand topics such as revenue trends, changes in earnout structures, capital raises, and outcomes of clinical and regulatory milestones. Investors can also use this page to monitor Form 4 insider transaction reports, as well as proxy and registration statements that discuss governance, capital structure and preferred stock offerings.
By combining real-time EDGAR updates with AI-generated insights, this page offers a structured view of Biofrontera’s regulatory history, financial reporting, and material corporate events tied to its dermatology and photodynamic therapy strategy.
Biofrontera Inc. reports a significant development in its patent dispute with Sun Pharmaceutical Industries. On February 23, 2026, the U.S. Patent Trial and Appeal Board issued a Final Written Decision finding all challenged claims of Sun’s U.S. Patent No. 11,697,028 unpatentable.
Sun may still request rehearing, seek review by the Director of the U.S. Patent and Trademark Office, or appeal to the U.S. Court of Appeals for the Federal Circuit, so the outcome is not yet final. The company notes that the impact of this decision on ongoing proceedings in the U.S. District Court for the District of Massachusetts and the International Trade Commission cannot be determined at this time.
Rosalind Master Fund L.P. and related parties report beneficial ownership of approximately 9.9% of Biofrontera Inc. common shares. The stake is reported on a passive basis and is calculated using 11,648,323 common shares outstanding as of November 10, 2025.
Rosalind Master Fund L.P. may be deemed to beneficially own 1,140,764 common shares, with additional 15,048,017 shares issuable from preferred shares and convertible debt that are subject to a 9.99% ownership blocker and therefore not currently exercisable. Rosalind Advisors, Inc. acts as investment adviser, and portfolio managers Steven Salamon and Gilad Aharon may be deemed beneficial owners but disclaim beneficial ownership.
Biofrontera Inc. reported positive, statistically significant Phase 3 results for Ameluz® photodynamic therapy (PDT) to treat mild to moderate actinic keratoses on the extremities, neck, and trunk using its RhodoLED® platform.
Ameluz® PDT achieved complete clearance in 45.6% of patients in the Full Analysis Set, versus 16.7% with vehicle PDT (p < 0.0003), and 53.2% versus 22.2% in the Per Protocol Set (p < 0.001). Lesion clearance reached 73.1% in the Full Analysis Set and 80.3% in the Per Protocol Set. Investigators rated cosmetic outcomes as good or very good in 75.2% of patients, and 86.3% indicated they would choose PDT again. Based on these data, Biofrontera plans to submit a supplemental New Drug Application to the FDA in the third quarter of 2026 for a potential label expansion beyond the face and scalp.
Biofrontera Inc. received an updated ownership disclosure from AIGH-related entities and Orin Hirschman. The reporting persons state beneficial ownership of 915,210 shares of common stock, representing 7.9% of the class. These securities are held with sole voting and dispositive power.
The filing notes an additional 14,642,510 common shares are issuable upon conversion of preferred shares and convertible notes but are not currently convertible or exercisable because of beneficial ownership limitations on conversion. The securities are described as acquired and held in the ordinary course of business and not for the purpose of changing or influencing control of Biofrontera.
Biofrontera Inc. filed a current report to let investors know it has released a press release with preliminary, unaudited revenue figures for the fourth quarter and full year ended December 31, 2025. The press release, dated January 13, 2026, is included as Exhibit 99.1 and incorporated by reference.
The company notes that these revenue numbers are preliminary estimates and remain subject to its normal review processes, meaning the final fourth quarter results could differ materially. The disclosure is furnished rather than filed under the Exchange Act, limiting certain legal liabilities, and Biofrontera includes standard cautionary language that these forward‑looking statements reflect management’s views only as of the date of the report.
Biofrontera Inc. reported that it received a notice from Nasdaq stating its common stock is not in compliance with the Nasdaq Capital Market’s minimum bid price rule, which requires a closing bid of at least $1.00 per share. The stock’s closing bid was below $1.00 for 34 consecutive business days, triggering the deficiency notice.
The company has 180 calendar days, until June 30, 2026, to regain compliance by having its closing bid price at or above $1.00 per share for at least 10 consecutive business days. If it fails to do so, Biofrontera may seek an additional compliance period, potentially including a reverse stock split, but its securities could ultimately face delisting if requirements are not met. The company plans to monitor its share price and consider available options, while noting there is no assurance it will regain or maintain compliance.
Biofrontera Inc. (BFRI) reported that it furnished a press release announcing financial and operational results for the three and nine months ended September 30, 2025. The release is attached as Exhibit 99.1.
The company noted the press release includes non-GAAP measures with reconciliations to comparable GAAP metrics pursuant to Regulation G. The information is being furnished, not filed, and is not subject to Section 18 liability or incorporated by reference unless expressly stated.
Biofrontera Inc. (BFRI) reported Q3 2025 results and closed a strategic deal for U.S. rights to Ameluz and RhodoLED. Q3 revenue was $6.988 million versus $9.012 million a year ago, reflecting softer seasonality and lower volumes. For the nine months, revenue was $24.605 million versus $24.762 million. The company posted a Q3 net loss of $6.649 million and a nine‑month net loss of $16.176 million.
Liquidity remains tight. Cash and cash equivalents were $3.417 million at September 30, 2025, and management disclosed substantial doubt about continuing as a going concern. Stockholders’ equity moved to a deficit of $2.581 million from $4.433 million at year‑end 2024.
Strategic actions: on October 20, 2025, Biofrontera completed the acquisition of U.S. rights to Ameluz and RhodoLED with a monthly earnout of 12% of U.S. Ameluz revenue (15% above $65.0 million). Financing included $11.0 million of Series C preferred in two tranches ($8.5 million in July and $2.5 million in October). The company finalized the sale of the Xepi product line on November 6, 2025 and reported regaining Nasdaq compliance in November. Convertible notes outstanding were $4.5 million at quarter‑end with a 10% PIK rate and a $0.78 conversion price.
Biofrontera Inc. reported it has regained Nasdaq listing compliance. The company received notices on November 4 and November 6 confirming compliance with Nasdaq Rules 5550(b)(1) (stockholders’ equity test) and 5550(a)(2) (minimum bid price), respectively.
Nasdaq cited company disclosures indicating compliance with Rule 5550(b)(1), while warning the company may be subject to delisting if it fails to evidence compliance upon filing its next periodic report. Compliance with Rule 5550(a)(2) was restored after the company’s common stock maintained a closing bid of at least $1.00 per share for 11 consecutive business days.
Earlier in May, Nasdaq had notified the company that it was out of compliance with both rules, based on its reported stockholders’ equity and a sub-$1.00 bid price over an extended period.
Biofrontera Inc. completed the sale of all assets related to its Xepi (ozenoxacin) cream to Pelthos Therapeutics. The purchase price is up to $10,000,000, including $3,000,000 in cash paid at closing on November 6, 2025.
An additional $1,000,000 is payable within 30 days after commercial quantities become available, subject to conditions in the asset purchase agreement. Earnouts provide $3,000,000 upon initial achievement of $10,000,000 in annual net sales and another $3,000,000 upon $15,000,000 in annual net sales. At closing, the buyer is to enter a consulting agreement with a consultant experienced with Xepi; part of the second payment depends on the consultant’s performance. Biofrontera agreed to customary representations, indemnities, and restrictive covenants, and will indemnify the buyer for any material breach of the consultant’s obligations during the defined period.