Core Viewpoint - Biofrontera Inc. has received FDA acceptance for its supplemental New Drug Application for Ameluz, which could expand its use to treat superficial basal cell carcinoma (sBCC) if approved, addressing a significant unmet medical need in dermatology [1][4][6]. Group 1: FDA Approval and Market Potential - The FDA has completed its review and accepted the filing of Biofrontera's sNDA for Ameluz, with a PDUFA target action date set for September 28, 2026 [1][6]. - If approved, this indication would significantly expand the Ameluz PDT platform beyond its current use for actinic keratosis, validating Biofrontera's photodynamic therapy approach [2][4]. - The potential approval would make Ameluz the first PDT photosensitizer indicated for the treatment of sBCC in the U.S., which is the most common skin cancer with approximately 3.6 million cases diagnosed annually [6][8]. Group 2: Clinical Significance and Treatment Options - Basal cell carcinoma (BCC) is prevalent in the U.S., with estimates suggesting that 10-25% of cases are of the superficial subtype, highlighting the need for effective treatment options [3][6]. - Current treatment methods often involve surgical or destructive approaches, which may not be suitable for all patients, indicating a demand for non-invasive alternatives like Ameluz PDT [3][4]. Group 3: Company Strategy and Leadership - The CEO of Biofrontera emphasized the importance of this milestone in expanding the clinical utility of Ameluz and reinforcing photodynamic therapy as a versatile platform in dermatology [4]. - The company believes that the new indication for Ameluz has the potential to significantly expand its addressable market and strengthen its position in medical dermatology [4].

Core Insights - Biofrontera Inc. announced positive Phase 3 clinical trial results for Ameluz PDT, demonstrating significant efficacy in treating actinic keratoses (AKs) on various body areas [1][5][9] Study Design and Results - The Phase 3 study was a multicenter, randomized, double-blind, vehicle-controlled trial involving 172 patients, with a 4:1 randomization to receive Ameluz gel or vehicle gel [2] - The primary endpoint was the "subject complete clearance rate," defined as the percentage of patients achieving complete clearance of all treated AK lesions 12 weeks post-treatment [4] - Ameluz PDT showed a complete clearance rate of 45.6% in the Full Analysis Set (FAS) compared to 16.7% for vehicle PDT (p < 0.0003) [5] - In the Per Protocol Set (PPS), complete clearance rates were 53.2% for Ameluz PDT versus 22.2% for vehicle PDT (p < 0.001) [5] Secondary Outcomes - Key secondary outcomes indicated a 73.1% clearance rate of AK lesions in the FAS and 80.3% in the PPS 12 weeks after treatment [6] - Clearance rates by anatomical location showed 38.5% (FAS) and 46.5% (PPS) on extremities, and 74.1% (FAS) and 78.3% (PPS) on neck and trunk [6] Patient Satisfaction and Cosmetic Outcomes - Ameluz PDT demonstrated favorable cosmetic outcomes, with 75.2% of investigators rating treated skin as "good" or "very good" [7] - 70.9% of patients reported similar assessments, and 86.3% indicated they would choose PDT again for future treatment [7] Future Plans - Based on the positive results, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the U.S. FDA in Q3 2026 [8]

Biofrontera (NasdaqCM:BFRI) FY Conference January 15, 2026 08:30 AM ET Company ParticipantsBen Shamsian - VPRobert Blum - Managing PartnerFred Leffler - CFOHermann Lübbert - Founder and Executive ChairmanFrançois Roberge - CEORobert BlumHello, everyone. Welcome to the Lytham Partners 2026 Investor Healthcare Summit. I'm Robert Blum, Managing Partner here at Lytham and your host for today's event. We're excited to introduce this group of companies driving innovation across the healthcare landscape today. Thr ...

• Ameluz® and RhodoLED® New Drug Application (NDA) and Investigational New Drug Application (IND) have successfully been transferred to Biofrontera Inc.• Assignment to Biofrontera Inc. of 11 granted US patents, 10 pending US patent applications and various trademarks associated with Ameluz® and the RhodoLED® Lamp Series has been applied for registration with the relevant authorities, including the US Patent Office (USPTO)• In addition, 19 international patent applications and/or registered designs for Rhodo ...

Registration No. 333- As filed with the Securities and Exchange Commission on December 5, 2025. UNITED STATES SECURITIES AND EXCHANGE COMMISSION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 47-3765675 (Primary Standard Industrial Classification Code Number) Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 BIOFRONTERA INC. (I.R.S. Employer Identification No.) 660 Main Street Woburn, M ...

Phase 1 Maximal-use Phase 1 study evaluated pharmacokinetic (PK) profile following application of 3 tubes of Ameluz® over treatment area of 240 cm2Completion of this study marks a key milestone towards a planned summer 2026 FDA submission for FDA approval for the use of Ameluz® on all non-face and scalp areas WOBURN, Mass., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of p ...

Company Performance - Biofrontera Inc. experienced a price drop to $0.05, marking a decrease of approximately 36.07%, potentially due to market dynamics or operational challenges [2][8] - IAC Inc. saw its stock decline to $0.60, a 33.31% drop, attributed to the recent spin-off of its subsidiary, Angi Inc., and subsequent market adjustments [3][8] - OmniAb, Inc. had its stock price fall to $0.08, a decrease of 44.83%, indicating investor concerns over growth prospects or market competition [4][8] - S&W Seed Company experienced a price drop to $0.11, reflecting a 48.59% decrease, possibly due to its decision to voluntarily delist from The Nasdaq Capital Market [5] - MingZhu Logistics Holdings Limited saw a significant decline to $0.17, an 83.53% drop, related to operational challenges and market competition in the logistics sector [6] Market Trends - The price movements of these companies reflect a combination of company-specific developments, sectoral challenges, and broader market trends [7]

Core Viewpoint - Biofrontera Inc. reported stable revenues for the first nine months of 2025, with expectations for substantial growth in the fourth quarter due to increased demand for its Ameluz-PDT treatment and a new royalty structure that enhances profitability [4][9][7]. Financial Highlights - Total revenues for the first nine months of 2025 were $24.6 million, slightly down from $24.8 million in the same period of 2024 [16]. - Third quarter revenues were $7.0 million, a 22% decline from $9.0 million in Q3 2024, attributed to advanced purchases ahead of a price increase [10][9]. - Operating expenses decreased by 5% year-over-year in Q3 2025, totaling $13.3 million compared to $14.0 million in Q3 2024 [11]. - The net loss for Q3 2025 was $6.6 million, compared to a net loss of $5.7 million in Q3 2024 [13]. - Adjusted EBITDA for Q3 2025 was negative $6.0 million, worsening from negative $4.6 million in Q3 2024 [14]. Recent Operational Highlights - The company is on track to meet its full-year sales objectives, supported by growing demand for Ameluz-PDT treatment [4]. - A new agreement with Biofrontera AG allows the company to acquire all U.S. rights, approvals, and patents for Ameluz and RhodoLED lamps, expected to enhance gross margins and long-term profitability [7]. - The company secured an $11 million investment from institutional investors, with $2.5 million received post-reporting period [8]. - Clinical studies for Ameluz are nearing completion, aiming for FDA approval to treat actinic keratoses on the entire body and potentially for superficial basal cell carcinoma and acne vulgaris [6]. Cash Position and Financing - Cash balance as of September 30, 2025, was $3.4 million [9]. - The company announced the divestiture of its Xepi antibiotic cream for $3 million at closing, with additional milestone payments tied to revenue thresholds [9].

Core Viewpoint - Biofrontera Inc. has successfully completed a restructuring and asset purchase agreement with its former parent company, Biofrontera AG, acquiring full U.S. rights to Ameluz and RhodoLED, which is expected to enhance its financial and operational profile [1][5][8] Group 1: Transaction Details - Biofrontera Inc. has acquired all U.S. assets and rights related to Ameluz and RhodoLED, including the New Drug Application (NDA), Investigational New Drug Application (IND), manufacturing rights, intellectual property, and personnel [1][3] - The transaction includes a new earnout structure where Biofrontera Inc. will pay 12% of U.S. net sales of Ameluz up to $65 million and 15% for sales above that threshold, replacing the previous model of 25%-35% [2][8] - The transaction was funded through an $11 million investment led by Rosalind Advisors and AIGH Capital Management, with Biofrontera AG receiving a 10% post-money equity stake in Biofrontera Inc. [4][8] Group 2: Operational Implications - Following the agreement, Biofrontera Inc. will take full responsibility for the manufacturing, regulatory, quality management, pharmacovigilance, and commercialization of Ameluz and RhodoLED in the U.S. [3] - The company anticipates completing the full transfer of assets and personnel by late Q4 2025 or early Q1 2026 [3] - The new earnout structure is expected to drive significant gross margin expansion starting in Q4 2025, positioning the company for accelerated growth of Ameluz and potential label expansion [5]

Summary of Biofrontera Inc. Conference Call Company Overview - **Company Name**: Biofrontera Inc. (NasdaqCM: BFRI) - **Industry**: Dermatology and Oncology - **Specialization**: Photodynamic therapy (PDT) for treating actinic keratosis (AK) and other dermatologic conditions - **Key Products**: Ameluz and BF-RhodoLED lamps - **Market Position**: Focused on expanding treatment indications and vertical integration in the U.S. pharmaceutical market [2][4] Financial Performance - **2024 Revenue**: $37.3 million - **Year-to-Date Revenue (Q2 2025)**: $17.6 million, up from $15.8 million in Q2 2024 - **Long-term Gross Margin**: Expected to be 80-85%, with current year-to-date gross margin at 71% for Q2 2025, compared to 45% in 2024 [3][17] - **Adjusted EBITDA**: Year-over-year adjusted EBITDA for 2025 is flat due to one-time legal expenses [18] Market Opportunity - **Actinic Keratosis Market**: Estimated market opportunity of $500 million - **Total Addressable Market**: Approximately $4 billion, focusing on a $520 million market suited for field therapy [3][10] - **Reimbursement**: Ameluz priced at $363, with an average reimbursement of $262 per treatment for healthcare professionals [11] Product Efficacy and Technology - **Efficacy**: 91% clearance rate after one to two treatments, significantly better than competitors [9] - **Technology**: Utilizes nanoemulsion technology for better absorption and penetration compared to traditional treatments [10][21] Competitive Landscape - **Competitors**: Main competitor is Levulan, which is limited to spot treatment; Biofrontera is the only PDT drug formulated for field treatment [21][22] - **Advantages**: Superior penetration and efficacy of Ameluz compared to cryotherapy and topical treatments [21] Growth Strategy - **Label Expansion**: Ongoing clinical trials for non-melanoma skin cancers and acne, with expected FDA submissions for basal cell carcinoma and trunk/extremities indications by mid-2027 [16][24] - **Customer Conversion**: Strategy to convert patients from other therapies to Ameluz, optimizing salesforce productivity [14][15] - **Inorganic Growth**: Actively seeking late-stage or commercial products that complement PDT [17] Leadership and Management - **CEO**: Professor Hermann Luebbert, founder of Biofrontera - **Key Executives**: Includes George Jones (Chief Commercial Officer) and Sam Whitcomb (VP of Corporate Strategy) [19] Financial Outlook - **Break-even Expectation**: Anticipated break-even in 2026, with modest growth and new indications contributing to revenue [24] - **Cash Position**: $3.5 million cash on hand, with long-term convertible debt of $4.3 million [19] Additional Insights - **Cyclical Revenue Pattern**: Revenue typically peaks in Q4 and Q1, with a decline in summer months due to patient behavior [25] - **Intellectual Property**: Strong patent protection for nanoemulsion technology until 2028, with an extension for a new formulation until 2043 [12] This summary encapsulates the key points discussed during the Biofrontera Inc. conference call, highlighting the company's market position, financial performance, growth strategies, and competitive advantages.