Database locks for studies on actinic keratosis (AK) and acne vulgaris achieved on January 5, 2026Data generated will support key regulatory milestones for Ameluz PDT in both indicationsAK and acne are the two most commonly diagnosed skin disorders in the US1 WOBURN, Mass., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced the succ ...

• 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 ...

Core Viewpoint - Biofrontera Inc. has submitted a supplemental New Drug Application (sNDA) to the FDA for Ameluz-PDT, seeking approval for the treatment of superficial basal cell carcinoma (sBCC) [1][9]. Submission Details - The submission includes comprehensive efficacy data from a Phase 3 study and a one-year follow-up, along with an integrated safety assessment from U.S. and European clinical studies [2]. - The filing aims to expand the Ameluz label to include sBCC treatment using BF-RhodoLED or RhodoLED XL red light lamps [2]. Study Overview - A double-blind, randomized, placebo-controlled Phase 3 study evaluated Ameluz-PDT in 187 patients with confirmed sBCC [3]. - Participants received one or two cycles of PDT treatments, with a second cycle possible at three months if needed [3]. Efficacy Results - The primary endpoint showed a 65.5% clearance rate in the Ameluz-PDT group compared to 4.8% in the placebo group, with a highly significant statistical difference (p<0.0001) [4]. - Key secondary endpoints indicated even higher efficacy: - Complete histological clearance in 75.9% of Ameluz patients vs. 19.0% in placebo [5]. - Complete clinical clearance in 83.4% of Ameluz patients vs. 21.4% in placebo [5]. - Total clearance of all sBCC lesions in 64.1% of Ameluz patients vs. 4.8% in placebo [5]. Patient Outcomes - Patient-reported outcomes showed 85.5% rated their treatment satisfaction and aesthetic outcome with Ameluz-PDT as very good or good [6]. - One-year follow-up data indicated low recurrence rates and excellent long-term cosmetic outcomes [6]. Industry Context - BCC is the most common skin cancer in the U.S., with over 3 million cases diagnosed annually [9]. - Actinic keratosis (AK), a precursor to skin cancer, affects approximately 58 million people in the U.S., with 13 million AK treatments performed in 2020 [8]. Company Perspective - The CEO of Biofrontera expressed optimism about the submission aligning with European study results and the potential market leadership in PDT for cutaneous oncology [7]. - A board-certified dermatologist highlighted the study's findings as reinforcing the value of Ameluz-PDT for treating sBCC [7].

Financial Data and Key Metrics Changes - Year-to-date revenues until September 30, 2025, were approximately flat compared to the same period in 2024, with Q3 revenues at $7.0 million, a 22% decline from $9.0 million in Q3 2024 [5][14] - Total operating expenses for Q3 2025 were $13.3 million, down from $14 million in Q3 2024, while net loss increased to $6.6 million from $5.7 million year-over-year [14][15] - Adjusted EBITDA for Q3 2025 was negative $6.0 million compared to negative $4.6 million in Q3 2024 [16] Business Line Data and Key Metrics Changes - The installed base of RhodoLED lamps reached approximately 750, supporting recurring high-margin sales of Ameluz gel [6][7] - Cost of revenues decreased by $2.8 million, or 58%, due to a reduced cost agreement with Biofrontera AG [14][15] - Selling, general, and administrative expenses increased to $10.4 million in Q3 2025 from $8.4 million in Q3 2024, primarily due to increased legal costs [15] Market Data and Key Metrics Changes - The company anticipates strong revenue growth in Q4 2025, driven by a normalization of sales following a transient effect in Q3 [5] - The new royalty structure for Ameluz is expected to enhance gross margins significantly, with a royalty of 12% when U.S. revenue is below $65 million and 15% above that threshold [11] Company Strategy and Development Direction - The company is focused on expanding the clinical and commercial potential of Ameluz across multiple high-value dermatologic indications, including upcoming FDA submissions for new indications [8][10] - A transformational agreement with Biofrontera AG has granted the company full control over U.S. rights, approvals, and patents for Ameluz and RhodoLED, enhancing long-term profitability [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving full-year sales objectives despite a challenging Q3, citing a strong pipeline and upcoming catalysts for growth [5][6] - The company aims to reach cash flow breakeven by fiscal year 2026, supported by recent financing and divestments [12][19] Other Important Information - The company completed the sale of the Xepi license for $3 million, with potential additional milestones of $7 million, which will not impact current sales due to the product's inactivity [12] - As of September 30, 2025, the company had cash and cash equivalents of $3.4 million, bolstered by recent financing and divestment proceeds [18][19] Q&A Session Summary Question: Are you contemplating any price increases in the future and if so, when? - Management confirmed plans for a price increase before year-end [26] Question: When do you expect data from the trial for AK of the extremities and the plan for FDA submission? - Data is expected in January, with FDA submission planned for Q2 [27] Question: When will data be available for the acne trial and what are the next steps? - Data will be available early next year, followed by an end of phase 2 meeting with the FDA [30] Question: Should the plan for breaking even be modeled similarly to the seasonality seen in the income statement? - Management confirmed that individual quarters in 2026 might fluctuate between losses and gains, with the fourth quarter expected to be significant for achieving breakeven [33]

Revenue Performance - Revenues for the first nine months of 2025 were stable at $24.6 million, compared to $24.8 million for the same period in 2024[5] - In Q3 2025, revenues were $7.0 million, a 22% decline from $9.0 million in Q3 2024, primarily due to advanced purchases ahead of a price increase[11] - Total revenues for Q3 2025 were $6,988 million, a decrease of 22.5% compared to $9,012 million in Q3 2024[29] Operating Expenses - Operating expenses decreased by 5% year-over-year in Q3 2025, totaling $13.3 million compared to $14.0 million in Q3 2024[12] - Operating expenses for Q3 2025 totaled $13,266 million, slightly down from $13,972 million in Q3 2024[29] - Total operating expenses for the nine months ended September 30, 2025, were $40,512 million, slightly up from $40,260 million in 2024[29] Net Loss - The net loss for Q3 2025 was $6.6 million, compared to a net loss of $5.7 million in the prior-year quarter[14] - Net loss for Q3 2025 was $6,649 million, compared to a net loss of $5,669 million in Q3 2024, representing an increase in loss of 17.3%[31] - Loss from operations for the nine months ended September 30, 2025, was $(15,907) million, compared to $(15,498) million for the same period in 2024[29] Adjusted EBITDA - Adjusted EBITDA for Q3 2025 was negative $6.0 million, compared to negative $4.6 million for Q3 2024[15] - Adjusted EBITDA for Q3 2025 was $(5,987) million, with an adjusted EBITDA margin of -85.7%, compared to $(4,575) million and -50.8% in Q3 2024[31] Financing and Assets - The company closed the purchase of all Ameluz and RhodoLED US assets from Biofrontera AG, with a new earnout structure reducing payment rates to 12%-15% of U.S. net sales[5] - The company received the final $2.5 million of an $11 million financing led by existing investors in October 2025[10] - The divestiture of the Xepi antibiotic cream to Pelthos Pharmaceuticals was announced for $3 million at closing, with potential milestone payments of up to $6 million[5] Cash and Liabilities - The cash balance as of September 30, 2025, was $3.4 million, down from $5.9 million at the end of 2024[26] - Total liabilities as of September 30, 2025, were $17.996 million, compared to $17.668 million at the end of 2024[26] Research and Development - Research and development expenses increased to $854 million in Q3 2025 from $669 million in Q3 2024, reflecting a growth of 27.7%[29] Earnings Per Share - Basic and diluted loss per common share for Q3 2025 was $(0.62), compared to $(0.98) in Q3 2024[29] Interest Expense and Fair Value Changes - Interest expense, net for Q3 2025 was $(111) million, compared to $8 million in Q3 2024[31] - The company reported a change in fair value of warrants resulting in a loss of $(285) million in Q3 2025, compared to a loss of $(680) million in Q3 2024[31]

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].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission file number 001-40943 Biofrontera Inc. (Exact name of registrant as specified in its charter) Delaware 47-37 ...

Core Viewpoint - Biofrontera Inc. has divested its US license for Xepi (ozenoxacin) Cream, 1% to Pelthos Therapeutics Inc., receiving a total of up to $10 million, which is expected to strengthen its balance sheet and support its path to profitability [1][2][5]. Financial Summary - The divestiture includes an initial payment of $3 million at closing, an additional $1 million upon availability of the commercial product, and up to $6 million in milestone payments tied to achieving $10 million and $15 million in annual net revenues for Xepi [1][5]. - The transaction is anticipated to bolster Biofrontera's cash position, aiding in funding its operations towards profitability [5]. Business Focus - Biofrontera specializes in photodynamic therapy (PDT) and is focused on expanding the indications for its product Ameluz® for the treatment of actinic keratosis (AK) and potentially other conditions [2][3]. - The company is also involved in clinical trials to extend the use of its products for treating non-melanoma skin cancers and moderate to severe acne [3]. Product Information - Xepi (ozenoxacin) Cream, 1% is a topical non-fluorinated quinolone that is FDA-approved for treating impetigo, a common skin infection caused by Staphylococcus aureus or Streptococcus pyogenes, with no known antibiotic resistance [2].