Biofrontera Inc. Engages Lytham Partners for Strategic Investor Relations and Shareholder Communication.

Biofrontera Inc. has engaged Lytham Partners to lead a strategic investor relations and shareholder communication program. The firm will help broaden Biofrontera's investor base and ensure its value proposition is recognized by the market. The engagement comes as the company has strengthened its foundation and momentum is building for meaningful profitability in the quarters ahead.

Biofrontera Inc. (Nasdaq: BFRI) has announced the completion of the active treatment phase of its Phase 3 clinical trial evaluating Ameluz® (10% 5-aminolevulinic acid hydrochloride gel) photodynamic therapy (PDT) for mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk. All 172 enrolled patients have now entered the 12-month follow-up phase, expected to conclude in Q2 2026 Biofrontera Inc. Announces Last Patient Out in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Photodynamic Therapy (PDT) for the Treatment of Actinic Keratoses (AK) on the Extremities, Neck and Trunk^[1].

Actinic keratosis is a common precancerous skin condition that affects 58 million US adults, with a significant risk of progressing to cutaneous squamous cell carcinomas if left untreated Biofrontera Inc. Announces Last Patient Out in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Photodynamic Therapy (PDT) for the Treatment of Actinic Keratoses (AK) on the Extremities, Neck and Trunk^[1]. This Phase 3 study, a multicenter, randomized, double-blind trial, evaluated the safety and efficacy of Ameluz® PDT versus vehicle gel. The trial involved larger surface areas, building on the recent FDA approval for the use of up to 3 tubes of Ameluz® per treatment Biofrontera Inc. Announces Last Patient Out in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Photodynamic Therapy (PDT) for the Treatment of Actinic Keratoses (AK) on the Extremities, Neck and Trunk^[1].

The 12-month follow-up phase will assess recurrence and new lesion development. Positive outcomes from this phase could lead to a supplemental New Drug Application (sNDA) submission in Q2 2026, expanding the use of Ameluz® PDT to treat AKs beyond the face and scalp Biofrontera Inc. Announces Last Patient Out in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Photodynamic Therapy (PDT) for the Treatment of Actinic Keratoses (AK) on the Extremities, Neck and Trunk^[1].

Biofrontera, specializing in PDT for dermatological conditions, has engaged Lytham Partners to lead a strategic investor relations and shareholder communication program. The firm aims to broaden Biofrontera's investor base and ensure its value proposition is recognized by the market .

References
Biofrontera Inc. Announces Last Patient Out in Phase 3 Study of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10% Photodynamic Therapy (PDT) for the Treatment of Actinic Keratoses (AK) on the Extremities, Neck and Trunk^[1] https://www.globenewswire.com/news-release/2025/09/16/3150998/0/en/Biofrontera-Inc-Announces-Last-Patient-Out-in-Phase-3-Study-of-Ameluz-aminolevulinic-acid-HCI-Topical-Gel-10-Photodynamic-Therapy-PDT-for-the-Treatment-of-Actinic-Keratoses-AK-on-t.html
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