BFRI News & Events

Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc., stated: "2025 was a transformational year for Biofrontera. We delivered record annual and fourth quarter revenues, clear evidence that our refined commercial strategy is gaining traction and that the Ameluz PDT platform continues to resonate with dermatologists and their patients. The completion of our strategic transaction with Biofrontera AG marks a fundamental inflection point for the Company. With full ownership and control of our U.S. assets-including intellectual property, regulatory approvals, and manufacturing rights-combined with a more favorable earnout structure, we have materially strengthened our cost profile. We saw this already in Q4 and expect the full annualized benefits of this transformation to be realized in 2026. At the same time, our clinical pipeline is advancing with strong momentum, highlighted by a PDUFA date for sBCC in September 2026, positive Phase 3 results in AK on the extremities, and encouraging Phase 2b data in acne. With additional planned studies and patent protection extending through 2043, we believe we are uniquely positioned as the only company in the U.S. actively advancing FDA-controlled PDT clinical programs in dermatology. Importantly, the combination of accelerating revenue growth, structurally lower cost of goods, and disciplined expense management drove profitability in the fourth quarter-the first full quarter reflecting our new cost structure. We believe this marks the beginning of a meaningful shift in our financial trajectory as we move toward sustained profitability and cash flow breakeven in 2026."

Biofrontera announced results of its Phase 2b clinical trial evaluating Ameluz topical gel, 10% PDT for the treatment of moderate to severe acne vulgaris. The multicenter, randomized, double-blind study compared Ameluz and vehicle gel using two incubation times prior to illumination with the BF-RhodoLED lamp. Participants received one tube of Ameluz or vehicle gel applied to the entire face, followed by incubation and illumination with the red light. Up to three PDT treatments were administered at one-month intervals, and patients were followed up for two months after receiving the final PDT treatment. The study had co-primary endpoints, one of which looked at the relative reduction in inflammatory lesion counts. The other required an improvement of at least two grades on a 5-point modified Investigator Global Assessment scale and that the patient was rated "clear" or "almost clear". Greater improvements in both inflammatory lesion counts and mIGA scores were observed with Ameluz vs. vehicle with the 3-hour incubation regimen, identifying this as the most promising protocol for further clinical investigation in acne vulgaris. In the 3-hour per-protocol population, the Ameluz group achieved a 57.97% reduction in inflammatory lesions, compared with 36.51% in the corresponding vehicle group. For the mIGA analysis, 25% of the Ameluz treated patients met this co-primary endpoint with 21.4% of the vehicle patients achieving the same outcome. Reductions in absolute lesion counts further supported the efficacy of the 3-hour regimen. The values for inflammatory, non-inflammatory and total lesion reductions were 19.7, 23.1 and 42.7 with Ameluz vs. 15.4, 16.5 and 31.9 with vehicle. Ameluz PDT demonstrated a favorable safety profile consistent with previously reported photodynamic therapy experience. The most frequently reported treatment-related adverse events were burning sensation and pruritus, both of which were generally mild to moderate in severity. In addition, the average pain scores during the 3-hour incubation PDT treatments were modest, with the values in the Ameluz group ranging from 3.4 to 3.8, and from 2.0 to 2.1 with vehicle on an 11-point scale. Participants reported high overall satisfaction with PDT treatment. Of the patients who underwent the 3-hour Ameluz incubation, 85.7% said they would choose PDT again and 71.4% of them rated their esthetic outcome as "good" or "very good".

Biofrontera announced that on February 23, 2026, the U.S. Patent Trial and Appeal Board issued a Final Written Decision finding all challenged claims of Sun Pharmaceutical Industries, Inc.'s U.S. Patent No. 11,697,028 to be unpatentable. As previously disclosed in Biofrontera's filings with the Securities and Exchange Commission, in June 2024, Sun Pharma initiated proceedings against Biofrontera and certain of its affiliates in the U.S. District Court for the District of Massachusetts and the International Trade Commission alleging infringement of the '028 Patent and a related patent, U.S. Patent No. 11,446,512. In response to these proceedings, Biofrontera challenged the validity of Sun Pharma's asserted claims by filing petitions for Inter Partes Review with the Board. The Board has now agreed with Biofrontera on all challenged claims of the '028 Patent. Sun Pharma has the right to request a review of the decision or appeal it to the United States Court of Appeals for the Federal Circuit. The decision does not affect the petition filed by the Company relating to the '512 patent, which was denied review by the Patent Office on administrative, rather than substantive, grounds. "Biofrontera is pleased with the Board's Final Written Decision.," commented Hermann Luebbert, CEO and Chairman of Biofrontera. "We remain focused on clinical research and development in the PDT space to better serve clinicians and improve their patients' lives."