Biofrontera Stock Price, News & Analysis

Biofrontera reported Q3 2024 revenues of $9.0 million, up 1.5% from Q3 2023, with potential 19% growth impacted by Hurricane Milton delays. Nine-month revenues reached $24.8 million, showing 5.6% growth. Ameluz achieved record volume in September 2024, while SG&A expenses decreased 14% year-over-year. The company successfully launched RhodoLED XL with 39 installations since June 2024. Notable developments include FDA approval to increase Ameluz dosage to three tubes per treatment and highly significant Phase 3 sBCC study results showing 75.9% histological clearance versus 19% with placebo.

Biofrontera announced significant results from its Phase 3 study of Ameluz®-PDT for treating superficial basal cell carcinoma (sBCC). The study involved 187 patients and showed 65.5% success rate with Ameluz®-PDT compared to 4.8% with placebo in achieving complete clinical and histological clearance. Secondary endpoints were also highly significant (p<0.0001), with 64.1% of Ameluz®-PDT patients achieving total clearance of all sBCC lesions versus 4.8% for placebo. Patient satisfaction was notable, with 64.3% rating the treatment as very good and 22.2% as good. The company plans to submit FDA documentation in Q2/Q3 2025 after completing the one-year follow-up phase in December.

Biofrontera Inc. (Nasdaq: BFRI) has announced the database lock for its Phase 3 study ALA-BCC-CT013, evaluating Ameluz®-Photodynamic Therapy (PDT) for treating superficial Basal Cell Carcinoma (sBCC). This marks the end of data collection for the treatment phase, with analysis now underway. The study, involving 186 patients, is the first Phase 3 PDT trial for sBCC in the United States.

Key points:

• Double-blind, randomized, placebo-controlled multi-center study
• Primary endpoint: complete clinical and histological clearance of target BCC lesion
• Interim results expected November 2024
• FDA submission targeted for Q1 2025, including 1-year follow-up data

If approved, this would expand Biofrontera's label from premalignant applications to treating cutaneous malignancy, advancing their goal of becoming market leaders in PDT.

The FDA has approved Biofrontera’s sNDA to increase the maximum dosage of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10%, from one to three tubes per treatment. This approval enhances the treatment of actinic keratosis (AK) on the face and scalp using Ameluz®-PDT with the BF-RhodoLED or RhodoLED XL lamp. The decision is based on two Phase 1 safety studies involving 116 patients, which confirmed that the increased dosage maintains safety and efficacy levels. This approval allows healthcare providers to treat larger or multiple areas more effectively, improving convenience for both providers and patients. Biofrontera is working with Medicare and commercial payers to secure reimbursement for this update.

Biofrontera Inc. (NASDAQ:BFRI) reported financial results for Q2 2024, showing significant growth. Total revenues increased 34% to $7.8 million compared to Q2 2023. The company's cash position improved to $4.4 million as of June 30, 2024. Biofrontera launched the FDA-approved RhodoLED® XL lamp in June and took control of all U.S. clinical trials for Ameluz®.

Despite revenue growth, the company reported a net loss of $257,000 for Q2 2024, a substantial improvement from the $9.8 million loss in Q2 2023. Adjusted EBITDA was negative $4.7 million, compared to negative $7.9 million in the prior-year quarter. The company raised an additional $8.0 million in May 2024 from warrant exercises and has paid down all outstanding debt.

Biofrontera has launched its FDA-approved RhodoLED XL lamp, a red light emitting LED device for photodynamic therapy (PDT) of actinic keratoses. Used with the Ameluz topical gel, also FDA-approved, the RhodoLED XL is designed to treat mild-to-moderate actinic keratoses on the face and scalp. The device features an expanded treatment area and advanced positioning sensors to optimize energy delivery. It was first shipped on June 10, 2024, and has received positive feedback from dermatology practices, including Cleaver Dermatology. This launch aligns with Biofrontera's commitment to innovation in dermatologic care.

Biofrontera Inc. (Nasdaq: BFRI) announced the results from its 2022 Annual Meeting of Stockholders held on December 12, 2022. Stockholders re-elected Loretta M. Wedge as a Class I director until the 2025 Annual Meeting. They approved an amendment to the 2021 Omnibus Incentive Plan, increasing share issuance by 2,589,800 shares. Additionally, Grant Thornton LLP was ratified as the independent accounting firm for the 2022 fiscal year. Detailed voting results are available in a Current Report on Form 8-K filed with the SEC.

Biofrontera (Nasdaq: BFRI) announced its participation in Benchmark’s 11th Annual Discovery One-on-One Investor Conference on December 1, 2022, in New York, NY. CEO Erica Monaco and Executive Chairman Hermann Lübbert will engage with registered investors through one-on-one meetings and small-group sessions. The company specializes in dermatological products, focusing on treatments for actinic keratoses and impetigo.

For more details, please visit Biofrontera's website.

Biofrontera Inc. (NASDAQ: BFRI) will engage in a Virtual Non-Deal Roadshow Series hosted by Renmark Financial Communications. The live events are scheduled for November 30, December 5, December 9, and December 19, 2022, aimed at discussing the latest investor presentation and company updates. Key speakers include Prof. Hermann Luebbert, Erica Monaco, and Fred Leffler, who will also participate in a live Q&A. Investors can register for each session and access replays through the company’s investor page post-event.