Biofrontera Inc. reports news on the commercialization and development of photodynamic therapy in dermatology. The company’s core product platform includes Ameluz, an aminolevulinic acid hydrochloride topical gel used with the RhodoLED red-light lamp series, with an established focus on actinic keratoses and clinical programs addressing additional dermatologic conditions.
Recurring updates include financial results, U.S. commercial performance, clinical data for Ameluz PDT, FDA-related label-expansion activity, patent proceedings, and business updates tied to the company’s U.S. product rights, regulatory approvals, intellectual property, and manufacturing rights.
Biofrontera (NASDAQ:BFRI), a biopharmaceutical company focused on dermatological products commercialization, has scheduled its Second Quarter 2025 Financial Results announcement for August 13, 2025 after market close.
The company will host a conference call and webcast to discuss the results on Thursday, August 14, 2025, at 10:00 AM ET. Investors can access the call via U.S. toll-free number (1-877-877-1275) or international number (1-412-858-5202).
Biofrontera Inc. (NASDAQ: BFRI) has announced a major restructuring agreement with Biofrontera AG, backed by an $11 million investment from Rosalind Advisors and AIGH Capital Management LLC. The company will acquire all US assets related to Ameluz® and RhodoLED®, including the New Drug Application (NDA) and associated patents.
Under the new agreement, Biofrontera Inc. will pay a significantly reduced royalty rate of 12% of net sales (increasing to 15% for revenue above $65 million), down from the previous 25-35% transfer pricing model. Biofrontera AG will receive a 10% post-money equity stake in Biofrontera Inc.
The $11 million investment will be funded in two tranches: $8.5 million with the signing of the royalty agreement and $2.5 million upon finalizing the asset transfer agreement by September 30, 2025. The capital will be provided as preferred shares convertible to common shares at $0.6249 per share.
Biofrontera Inc. (BFRI) has achieved two significant milestones: patent approval for Ameluz® extending protection until December 2043, and completion of patient enrollment in a Phase 2b study for acne treatment. The study evaluates Ameluz® photodynamic therapy (PDT) for moderate to severe acne vulgaris, enrolling 120 patients with treatments involving 1-hour and 3-hour incubation periods.
The U.S. acne treatment market, valued at $5.7 billion in 2024, is growing at a 5.3% CAGR. Over 55% of market spending goes to oral antibiotics and isotretinoin, which often have systemic side effects. With approximately 50 million Americans suffering from acne vulgaris, Ameluz® PDT could provide an alternative treatment option without the side effects associated with current systemic therapies.
The Phase 2b trial's last-patient-out is expected in Q3 2025, marking a crucial step in expanding Ameluz®'s indications beyond its current approval for mild to moderate actinic keratosis.Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company focused on dermatological products commercialization, has scheduled its first quarter 2025 financial results announcement for May 15, 2025, after market close. The company will hold a conference call and webcast to discuss the results and provide a business update on Friday, May 16, 2025, at 10:00 AM ET. Interested parties can access the conference call via U.S. toll-free number 1-877-877-1275 or international number 1-412-858-5202.
Biofrontera Inc. (NASDAQ:BFRI) and Almirall have launched the Hats On Challenge, a social media initiative to raise awareness about Actinic Keratosis (AK) ahead of Global AK Awareness Day on May 24, 2025. The campaign aims to support The Skin Cancer Foundation and Euromelanoma through a social media challenge where participants wear hats and post videos using specific hashtags.
AK is a common precancerous skin condition affecting an estimated 58 million Americans, with a global prevalence of 14%. The condition, characterized by rough, scaly patches on sun-exposed areas, can develop into squamous cell carcinoma if left untreated. The campaign will run throughout May 2025, with both companies making monetary donations to The Skin Cancer Foundation on behalf of participants.
Biofrontera Inc. (NASDAQ:BFRI) reported record financial results for fiscal year 2024, achieving total revenues of $37.3 million, a 9.5% increase from 2023. Q4 2024 revenue grew 18.5% to $12.6 million.
Key highlights include: reduced operating expenses to $54.5 million (down 3.9%), improved cash position to $5.9 million, and restructured agreements resulting in Ameluz® transfer price reduction from 50% to 25%. The company successfully placed 100 RhodoLED® XL lamps since June 2024 launch.
Notable achievements include FDA approval for using up to three Ameluz® tubes per treatment, significant Phase 3 study results for Superficial Basal Cell Carcinoma treatment, and accelerated patient recruitment in clinical trials. However, the company reported a net loss of $(17.8) million for 2024, though improved from $(20.1) million in 2023.
Biofrontera (Nasdaq: BFRI) has completed patient enrollment in its Phase 3 clinical trial evaluating Ameluz® for treating mild to moderate actinic keratoses (AKs) on extremities, neck and trunk. The study enrolled 172 patients in a 4:1 ratio receiving either Ameluz® or vehicle gel.
This multicenter, randomized, double-blind study will assess the safety and efficacy of Ameluz® PDT using 1-3 tubes over surface areas of 80-240cm². Patients receive one PDT treatment, with a second treatment at 12 weeks if AK lesions remain, followed by a one-year monitoring period.
The treatment phase is expected to complete by September 2025, with follow-up concluding in Q2 2026. Upon positive outcomes, Biofrontera plans to submit a supplemental New Drug Application to the FDA in second half of 2026.