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Biofrontera Inc., a biopharmaceutical company, engages in the commercialization of pharmaceutical products for the treatment of dermatological conditions in the United States. The company offers Ameluz, which is a prescription drug approved for use in combination with the company's licensor's medical device; and the RhodoLED lamp series for photodynamic therapy for the lesion-directed and field-directed treatment of actinic keratosis of mild-to-moderate severity on the face and scalp. It also Xepi, a prescription cream for the treatment of impetigo. The company was incorporated in 2015 and is headquartered in Woburn, Massachusetts.

Biofrontera Inc.

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 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 RHODOLED  LAMPS OUTSIDE OF THE US WERE ACQUIRED AND REGISTRATION OF THE TRANSFER HAS BEEN INITIATED

BIOFRONTERA INC. COMPLETES TRANSFER OF AMELUZ AND RHODOLED FDA APPROVAL AND ASSOCIATED INTELLECTUAL PROPERTY PORTFOLIO

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).

LAST PATIENT COMPLETES BIOFRONTERA'S PHASE 1 PHARMACOKINETICS STUDY OF AMELUZ FOR TREATMENT OF ACTINIC KERATOSES ON THE TRUNK AND EXTREMITIES

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. ANNOUNCES FILING OF SUPPLEMENTAL NEW DRUG APPLICATION (SNDA) FOR THE TREATMENT OF SUPERFICIAL BASAL CELL CARCINOMA (SBCC) WITH AMELUZ-PDT

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.

BIOFRONTERA INC. REPORTS THIRD QUARTER 2025 FINANCIAL RESULTS AND PROVIDES A BUSINESS UPDATE

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.

BIOFRONTERA INC. ANNOUNCES SALE OF LICENSE TO XEPI ANTIBIOTIC CREAM TO PELTHOS THERAPEUTICS INC. FOR UP TO $10M

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.

BIOFRONTERA INC. TO REPORT THIRD QUARTER 2025 FINANCIAL RESULTS ON NOVEMBER 12, 2025 AND HOST A CONFERENCE CALL ON NOVEMBER 13, 2025

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.

BIOFRONTERA INC. CLOSES PURCHASE OF ALL AMELUZ AND RHODOLED US ASSETS FROM BIOFRONTERA AG

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.

BIOFRONTERA INC. TO PARTICIPATE IN THE LYTHAM PARTNERS FALL 2025 INVESTOR CONFERENCE ON 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.

BIOFRONTERA INC. ENGAGES LYTHAM PARTNERS TO LEAD 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.

BIOFRONTERA INC. ANNOUNCES LAST PATIENT OUT IN PHASE 3 STUDY OF AMELUZ (AMINOLEVULINIC ACID HCI) TOPICAL GEL, 10% PHOTODYNAMIC THERAPY (PDT) FOR THE TREATMENT OF ACTINIC KERATOSES (AK) ON THE EXTREMITIES, NECK AND TRUNK

Biofrontera Inc.

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