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WOBURN, Mass. - Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company, announced the completion of data collection for its phase 3 clinical trial evaluating the safety and efficacy of its photodynamic therapy (PDT) in treating superficial basal cell carcinoma (sBCC), a common form of skin cancer. The study, known as ALA-BCC-CT013, has reached an important milestone with the database lock, signaling the end of changes to the trial data and the start of final analysis.
The trial involved 186 patients who underwent a double-blind, randomized, placebo-controlled multicenter study. Participants received one cycle of two PDT treatments with either Ameluz®-PDT or a placebo, repeated after three months if necessary. The primary endpoint of the study is the complete clinical and histological clearance of the target BCC lesion 12 weeks post-treatment.
Secondary efficacy parameters and drug safety were also evaluated. The Food and Drug Administration (FDA) requires a final study report, including follow-up data obtained one year after the first PDT, for submission. The last patient follow-up is anticipated by December 2024, with a submission target set for the first quarter of 2025.
Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc., stated that if the FDA grants the indication, it would mark an expansion of their label from premalignant applications for Actinic Keratoses to the treatment of cutaneous malignancy. This would represent a significant step in the company's mission to become market leaders in PDT.
The company specializes in the development and commercialization of PDT and currently markets Ameluz® with the RhodoLED® lamp series for the treatment of Actinic Keratoses, pre-cancerous skin lesions that can progress to invasive skin cancers.
Interim results from the study are expected in November 2024. This announcement is based on a press release statement from Biofrontera Inc.
In other recent news, Biofrontera has seen several significant developments. The U.S. Food and Drug Administration (FDA) approved an increased dosage of the company's product Ameluz®, a treatment for actinic keratosis (AK). This approval allows for the use of up to three tubes of Ameluz® per treatment, an increase from the previous maximum of one tube. This expanded use is expected to enhance the product's sales and provide a competitive edge over rival therapies.
In terms of financial performance, Biofrontera reported a substantial 34% sales growth in its second-quarter financial results, with total revenues reaching $7.8 million. The company also successfully navigated reimbursement challenges, reduced total operating expenses, and cleared all outstanding debt, thereby strengthening its financial position.
Roth/MKM maintained a positive stance on Biofrontera, reiterating a Buy rating and a $16.00 price target. The firm's decision follows these recent developments, signaling confidence in Biofrontera's growth trajectory and its ability to capitalize on the expanded treatment capabilities of Ameluz. However, despite these positive developments, Biofrontera reported a negative adjusted EBITDA of $4.7 million for Q2 2024 and a net loss of $10.7 million for the first half of 2024.
InvestingPro Insights
As Biofrontera Inc. (NASDAQ:BFRI) advances its clinical trials for photodynamic therapy in treating skin cancer, investors should consider some key financial metrics and insights from InvestingPro.
According to InvestingPro data, Biofrontera's market capitalization stands at $4.43 million, reflecting its current position as a small-cap biopharmaceutical company. Despite the potential breakthrough in skin cancer treatment, the company faces financial challenges. An InvestingPro Tip indicates that Biofrontera is "quickly burning through cash," which is a critical factor for investors to consider given the ongoing clinical trials and the timeline for potential FDA approval.
On a positive note, the company's revenue growth shows promise. InvestingPro data reveals that Biofrontera's revenue for the last twelve months as of Q2 2024 was $35.24 million, with a revenue growth of 21.33% over the same period. This growth aligns with the company's efforts to expand its market presence in photodynamic therapy treatments.
However, profitability remains a concern. An InvestingPro Tip notes that "Analysts do not anticipate the company will be profitable this year," which is consistent with the reported operating income margin of -53.42% for the last twelve months as of Q2 2024.
For investors interested in a deeper analysis, InvestingPro offers 12 additional tips for Biofrontera, providing a more comprehensive view of the company's financial health and market position.
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