Biofrontera reports Q2 2026 results, cites pending sBCC decision and pipeline data

Biofrontera Inc. reported second quarter 2026 results on August 13, 2026, tied to its Ameluz photodynamic therapy business. Chief Executive Officer Hermann Luebbert said the company continues to be encouraged by new indications advancing in its development pipeline, including superficial basal cell carcinoma, for which it has a PDUFA date in late September of this year and expects to launch in Q1 of 2027.¹ Luebbert added that if approved for sBCC, Ameluz would be the first PDT in the United States approved for the treatment of cancerous tumors.¹

Luebbert also pointed to recent positive Phase III results in actinic keratosis on the extremities, neck and trunk and encouraging Phase 2B data in acne¹ as areas the company believes could expand its PDT platform.

On operations, the company noted an ongoing regulatory issue affecting its lamp hardware. Order timing from certain customers was affected in anticipation of potential supply restrictions tied to an International Trade Commission exclusion order on the RhodoLED XL lamp that took effect July 7, 2026, though the company said this affected order timing rather than total demand.¹ Biofrontera said it is pursuing a remediation plan to allow it to begin selling a modified version of the XL lamp.¹ The company said because the substantial majority of its installed lamp base is unaffected by the ITC order, any shift in orders is not expected to impact its full-year 2026 revenue goals.¹

On cash, Biofrontera reported cash and cash equivalents of $4.7 million as of June 30, 2026, compared to $6.4 million as of December 31, 2025¹, with cash used in operating activities for the six months ended June 30, 2026 of $1.7 million, compared to $7.2 million in the prior-year period.¹ CFO Fred Leffler said the company continues to make progress towards cash flow breakeven in 2026.¹