Biofrontera

BFRI

Market cap $9.56M

Phase 1 Maximal-use Phase 1 study evaluated pharmacokinetic (PK) profile following application of 3 tubes of Ameluz® over treatment area of 240 cm2 Completion 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 photodynamic therapy (PDT), today announced the completion of the final patient visit in its Phase 1 pharmacokinetic (PK) study of Ameluz® (aminolevulinic acid hydrochloride) gel, 10%, for the treatment of mild to moderate actinic keratoses (AKs) on the neck, trunk and extremities (peripheral body areas).

WOBURN, Mass., Dec. 02, 2025 (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 submission of an sNDA to the FDA, seeking approval of Ameluz®-PDT for the treatment of sBCC.

Biofrontera Inc. ( BFRI ) Q3 2025 Earnings Call November 13, 2025 10:00 AM EST Company Participants Hermann Lubbert - CEO, President & Chairman Eugene Leffler - Chief Financial Officer Conference Call Participants Ben Shamsian Bruce Jackson - The Benchmark Company, LLC, Research Division Presentation Operator Welcome to the Biofrontera Inc. Third Quarter 2025 Financial Results and Business Update Conference Call. [Operator Instructions].

Conference call will be held today, Thursday, November 13 at 10:00 am ET Woburn, MA, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the three and nine months ended September 30, 2025 and provided a business update. Financial highlights Revenues for the first nine months of 2025 were stable with $24.6 million compared to $24.8 million for the same period in 2024 The 2025 result was achieved without the buy-in effects from a price increase In 3Q25 revenues were $7.0 million, lagging behind the $9.0 million in 3Q24 due to advanced purchases ahead of the Company's October 2024 price increase 4Q25 revenues are expected to compensate for this effect and result in substantial annual year-over-year growth Operating expenses decreased 5% year over year in 3Q25 compared to 3Q24 Cash balance was $3.4 million as of September 30, 2025 Recent Operational Highlights Closed the purchase of all Ameluz and RhodoLED US Assets from Biofrontera AG.

WOBURN, Mass., Nov. 07, 2025 (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 that it has divested its US license for Xepi® (ozenoxacin) Cream, 1% to Pelthos Therapeutics Inc. Biofrontera received $3 million at closing, and is to receive an additional $1 million upon availability of commercial product, and up to $6 million in milestone payments, with $3 million each tied to achieving $10 million and $15 million in annual net revenues for Xepi®, respectively, within the U.S., Puerto Rico and the U.S. Virgin Islands.

WOBURN, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, announces it will report financial results for the three and nine months ended September 30, 2025 after the close of the U.S. financial markets on Wednesday, November 12, 2025. The company will host a conference call on Thursday, November 13 at 10:00am Eastern Time to discuss those results, provide a business update and answer questions.

WOBURN, Mass., Oct. 23, 2025 (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 closing of its restructuring and asset purchase agreement with its former parent company, Biofrontera AG. Under the transaction, 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 and contracts, all intellectual property, and related personnel.

Woburn, MA, Sept. 26, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc., (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, today announced that it will participate in a webcast presentation and host one-on-one meetings with investors at the Lytham Partners Fall 2025 Investor Conference, taking place virtually on Tuesday, September 30, 2025.

WOBURN, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), has engaged Lytham Partners to lead a strategic investor relations and shareholder communication program.

WOBURN, Mass., Sept. 16, 2025 (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 that the final patient completed the active treatment phase of its Phase 3 clinical trial evaluating Ameluz® (10% 5-aminolevulinic acid hydrochloride gel) PDT for mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk on September 3, 2025. All 172 enrolled patients have now entered the 12-month follow-up phase, expected to conclude in Q2 2026.