WOBURN, Mass. - Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company, has announced significant findings from its Phase 3 study of photodynamic therapy (PDT) using Ameluz® and the BF-RhodoLED® lamp for treating superficial basal cell carcinoma (sBCC). The study revealed a markedly higher success rate in treating sBCC with Ameluz®-PDT compared to a placebo.
The double-blind, randomized, placebo-controlled, multi-center study involved 187 patients with confirmed sBCCs. Participants received two PDT treatments with either Ameluz®-PDT or a placebo, with a possible repeat after three months. The primary endpoint was the complete clinical and histological clearance of a targeted lesion 12 weeks after treatment. The Ameluz®-PDT group achieved a 65.5% success rate, significantly outperforming the placebo group's 4.8%.
Secondary efficacy parameters also showed highly significant results, with 64.1% of patients treated with Ameluz®-PDT experiencing total clearance of all sBCC lesions, in contrast to 4.8% for placebo-PDT. Patient satisfaction with the treatment and aesthetic outcomes were rated as very good or good by a majority of those treated with Ameluz®.
Dr. Hermann Luebbert, CEO and Chairman of Biofrontera, expressed satisfaction with the results, which align with previous European studies. Following a one-year follow-up phase ending in December, the company plans to submit documentation to the FDA around late Q2 or early Q3 of 2025.
Basal cell carcinoma is the most common form of skin cancer in the U.S., with over 3 million cases diagnosed annually. Biofrontera specializes in PDT treatments for dermatological conditions and aims to expand the use of its products for non-melanoma skin cancers and severe acne.
This report is based on a press release statement from Biofrontera Inc. and does not constitute an endorsement of the company or its products.
In other recent news, Biofrontera Inc. has made significant strides in its clinical trials and product development. The biopharmaceutical company recently completed data collection for its phase 3 clinical trial on photodynamic therapy (PDT) for treating superficial basal cell carcinoma (sBCC). The FDA's approval of an increased dosage of Biofrontera's product Ameluz® for actinic keratosis (AK) treatment was also a notable development.
Furthermore, Biofrontera reported a substantial 34% sales growth in its second quarter, with total revenues reaching $7.8 million. The company successfully navigated reimbursement challenges and reduced total operating expenses, strengthening its financial position. Despite 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, Biofrontera remains optimistic about its future.
In terms of analyst outlook, Roth/MKM maintained a positive stance on Biofrontera, reiterating a Buy rating. This decision follows the recent developments and reflects confidence in Biofrontera's growth trajectory. However, it's important to note that these are the analysts' projections and the actual results could vary.
InvestingPro Insights
While Biofrontera Inc. (NASDAQ:BFRI) has reported promising results from its Phase 3 study, a look at the company's financial metrics from InvestingPro reveals a more complex picture. The company's market capitalization stands at a modest $5.18 million, reflecting its current position as a small-cap biopharmaceutical player.
Despite the positive clinical outcomes, Biofrontera faces financial challenges. An InvestingPro Tip indicates that the company is "quickly burning through cash," which is a common concern for biopharmaceutical firms in the research and development phase. This cash burn rate is particularly relevant given the company's plans to submit documentation to the FDA in late Q2 or early Q3 of 2025, as mentioned in the article.
On a more positive note, another InvestingPro Tip suggests that Biofrontera "holds more cash than debt on its balance sheet," which could provide some financial flexibility as it moves towards potential FDA submission and commercialization of its Ameluz®-PDT treatment.
The company's revenue for the last twelve months as of Q2 2024 was $35.24 million, with a notable revenue growth of 21.33% over the same period. This growth aligns with the company's focus on expanding its product applications in the dermatological market.
For investors seeking a deeper understanding of Biofrontera's financial position and growth prospects, InvestingPro offers 10 additional tips, providing a comprehensive view of the company's potential in the competitive biopharmaceutical landscape.
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