WOBURN, Mass. - Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company, has received approval from the U.S. Food and Drug Administration (FDA) for a supplemental New Drug Application (sNDA) that permits an increased dosage of Ameluz®, a photodynamic therapy (PDT) for actinic keratosis (AK) on the face and scalp. The FDA's nod allows for the use of up to three tubes of Ameluz® per treatment, up from the previous maximum of one tube, offering greater flexibility in treating larger or multiple affected areas.
The sNDA was backed by two Phase 1 safety studies involving 116 patients, which demonstrated that the increased dosage did not raise the blood concentration of the active ingredient to levels known to cause side effects. The systemic and application site adverse events observed with the triple-tube dosage were comparable to those seen with one tube.
Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc., expressed the company's satisfaction with the FDA's decision and mentioned that efforts are underway to secure reimbursement for the updated labeling. The approval is expected to enhance the convenience of treatment for healthcare providers and patients.
Ameluz® is recognized by the FDA for both lesion-directed and field-directed treatment of AKs, a common pre-cancerous skin lesion that may progress into squamous cell carcinoma if left untreated. The condition affects approximately 58 million people in the U.S., with around 13 million treatments performed annually.
Dr. Jonathan Weiss, an investigator and co-managing partner at Georgia Dermatology Partners, noted the importance of being able to treat the entire affected field, given that up to 60% of squamous cell carcinomas originate from untreated AK lesions. He anticipates using the increased dosage for patients with extensive AK.
Biofrontera Inc. focuses on the commercialization of dermatologic products, particularly in the treatment of non-melanoma skin cancers and moderate to severe acne, through clinical trials aimed at extending the use of their products.
This news article is based on a press release statement from Biofrontera Inc.
In other recent news, Biofrontera reported a substantial 34% sales growth in its second-quarter financial results, with total revenues hitting the $7.8 million mark. The company has successfully navigated reimbursement challenges, reduced total operating expenses, and cleared all outstanding debt, thereby fortifying its financial position. In terms of product development, the FDA-approved RhodoLED XL lamp has been launched and 57 BF-RhodoLED lamps have been placed in various physician offices, marking significant progress in Biofrontera's commercial efforts.
The company is expecting FDA approvals and the release of clinical trial data in the near future. In particular, FDA approval is anticipated for the use of up to three tubes of Ameluz per treatment in Q4 2024. Clinical trials are currently underway, with results expected in the coming months. Biofrontera's cash and cash equivalents stood at $4.4 million as of June 30, 2024.
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. However, the company remains optimistic about its future, with strategic investments in its commercial and support teams, coupled with clinical advancements, expected to contribute to its long-term success.
InvestingPro Insights
While Biofrontera Inc. (NASDAQ:BFRI) celebrates this regulatory milestone, a closer look at the company's financial health reveals some interesting insights. According to InvestingPro data, Biofrontera's market capitalization stands at a modest $5.32 million, reflecting its current position in the biopharmaceutical landscape.
Despite the positive news on the regulatory front, InvestingPro Tips highlight that the company is "quickly burning through cash" and is "not profitable over the last twelve months." This suggests that while the FDA approval for increased Ameluz® dosage is a step forward, Biofrontera still faces financial challenges that investors should consider.
On a more positive note, the company's revenue growth shows promise, with a 21.33% increase over the last twelve months as of Q2 2024, and a more impressive 34.05% growth in quarterly revenue. This aligns with the potential for increased sales following the FDA's approval of higher Ameluz® dosages.
It's worth noting that Biofrontera is "trading at a low revenue valuation multiple," which could be of interest to value-oriented investors. However, this should be weighed against the fact that the "stock has taken a big hit over the last six months," with a -46.96% price return during that period.
For those interested in a more comprehensive analysis, InvestingPro offers additional tips and insights on Biofrontera Inc. In fact, there are 11 more InvestingPro Tips available for BFRI, providing a deeper understanding of the company's financial position and market performance.
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