Superficial basal cell carcinoma

Last patient completed 1 year follow-up of study ALA-BCC-CT013 in December 2024.Data from follow-up will be included in FDA submission, expected in Q3 2025.Biofrontera announced highly statistically significant results for all primary and secondary endpoints (p <0.0001) in October 2024.BCC, of which sBCC is a subgroup, is the most common skin cancer in the US with more than 3 million cases each year1. WOBURN, Mass., Jan. 08, 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 a key milestone in its Phase 3 study of the use of Ameluz and RhodoLED PDT in the treatment of sBCC (ALA-BCC-CT013) was met with the last patient completing the 1 year follow-up visit in December of 2024. The double-blind, randomized, placebo-controlled, multi-center study evaluated safety and efficacy in 187 patients with one or more clinically and histologically confirmed superficial BCCs. They each received one cycle of two PDT treatments (either Ameluz® -PDT or placebo-PDT) 1-2 weeks apart. Lesions that were not completely resolved after 3 months were retreated. The FDA has advised Biofrontera to submit the sNDA with one-year follow-up data. While 1-year data will support the FDA submission, the superficial BCC lesions will in total be followed up for five years. Long-term follow-up studies are often required by the FDA for dermatology product submissions, in particular for skin cancers, and they are important in trials enrolling sBCC patients due to the risk of local recurrence, or subsequent additional skin cancer development. “We were delighted with the highly statistically significant results for the primary and secondary endpoints that we communicated last year”, stated Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “The completion of the 1-year follow-up is a crucial milestone in our path to an FDA submission in 2025 and potentially expanding our label to the treatment of a cutaneous malignancy. It demonstrates our continued investment in PDT and supports our vision of partnering with the dermatology community to improve patient care” he concluded. “We routinely use PDT in our institution for the treatment of actinic keratoses” commented Dr Shane Chapman, Chair of the Department of Dermatology at Dartmouth Hitchcock Medical Center and the Geisel School of Medicine at Dartmouth, and an investigator for ALA-BCC-CT013. “We were impressed with the results of the 12-week data and I look forward to being able to offer Ameluz-PDT as a treatment option for my patients with sBCC”. About Basal Cell Carcinoma BCC is the most common form of skin cancer and the most frequently occurring form of all cancers. In the U.S. alone, an estimated 3.6 million cases are diagnosed each year, a subset of which is superficial basal cell carcinoma. BCCs arise from abnormal, uncontrolled growth of basal cells at the bottom of the epidermis. They rarely spread beyond the original tumor site but, if untreated, can become locally invasive, grow wide and deep into the skin, and destroy skin, tissue and bone. 1 https://www.skincancer.org/skin-cancer-information/basal-cell-carcinoma/ About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate to severe acne. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and Twitter. Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to the clinical development strategy for Ameluz®, ongoing clinical trials and the future impact of such trials on the market for Ameluz®, Biofrontera's commercial opportunities and the commercial success of its licensed products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of any extraordinary external events; any changes in the Company’s relationship with its licensors; the ability of the Company’s licensors to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company’s ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s licensed products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz ® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company’s expectations; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), which can be obtained on the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Contact:Investor RelationsAndrew Barwicki1-516-662-9461ir@bfri.com

AIV001 is currently in development for evaluation in Superficial and Nodular Superficial Basal Cell Carcinoma (sBCC and nBCC) COSA MESA, Calif., Dec. 09, 2024 (GLOBE NEWSWIRE) -- AiViva Biopharma Inc., a clinical-stage biotechnology company, announced the receipt of FDA clearance for testing AIV001 (axitinib) by intradermal injection with their formulation in facial skin. AIV001 is a pan-tyrosine kinase inhibitor in a proprietary formulation, designed for prolonged drug release. This FDA clearance was supported by AiViva’s submission of safety data on non-facial skin tolerability and efficacy, and systemic exposure from 67 subjects treated with AIV001 in BCC and in scar management. “This agreement allows a clear path forward to develop AIV001 in cosmetically sensitive skin that includes the face, neck, and scalp, and sets it on track to be the first therapeutic developed for facial skin areas having sBCC or nBCC lesions,” said Diane Tang-Liu, PhD, President and CEO of AiViva. “We are excited about the product prospect of AIV001 using a focal delivery method that is supported by our strong intellectual property position,” continued Diane Tang-Liu. To date, AiViva has completed three clinical studies using intradermal injection of AIV001. Subjects received one to three treatments, three weeks apart. The potency of AIV001 and prolonged drug release in the skin provided clinical and histological clearance of biopsied-confirmed BCC lesions in 26 patients. In addition, a total of 41 subjects were treated in two trials using scar models. Reduced fibrosis formation was observed after a single intradermal injection over the surgical incisional wounds and indicated AIV001’s potential use in scar management. “This was an important achievement for the clinical development of AIV001 allowing us to expand our ability to evaluate AIV001’s utility in dermatological conditions,” concluded Darlene Deecher, AiViva’s Vice President of Clinical Development. About AiViva Biopharma, Inc. AiViva is a clinical stage biotech company led by a team of seasoned industry experts with proven track record in drug development and commercialization. AiViva has developed innovative approaches to address high unmet medical needs by transforming treatment paradigms through focal therapies that target diseases of neovascularization, abnormal cell proliferation, and fibrosis. Core competencies include development of novel drugs using proprietary technologies, including JEL®, in specialty therapeutic areas of dermatology, ophthalmology, urology and oncology. AIV001 is an investigational product candidate in clinical development. The efficacy and safety profiles have not been established, and they have not been approved for marketing by the Food and Drug Administration. Follow the Company on its website and LinkedIn for updates. Investors & Media AiViva Biopharma, Inc Shane Cerrato Vice President, Business Development Shane@aiviva.com

WOBURN, Mass., Nov. 21, 2022 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today the launch of a randomized, double-blind, vehicle-controlled, multicenter Phase 3 clinical study to evaluate the safety and efficacy of Ameluz® and BF-RhodoLED® XL in the field-directed treatment of actinic keratosis (AK) on the extremities, neck and trunk. The study is being managed by Biofrontera Bioscience GmbH. This past weekend Biofrontera held an Investigator Meeting to train clinical investigators on the protocol for this photodynamic therapy (PDT) study and prepare for site initiation. Initially 11 clinical trial sites in the U.S. will participate, enrolling approximately 165 patients stratified by body region. This study will utilize Biofrontera’s new RhodoLED® XL, a red-light lamp approved by the U.S. Food and Drug Administration (FDA) for use in PDT in combination with Ameluz® (Ameluz®-PDT) for the treatment of mild-to-moderate actinic keratosis. This lamp allows for the illumination of a larger surface area, thereby enabling simultaneous treatment of AK lesions that are distant from one another. “This Phase 3 clinical study supports our strategy to gain market share by expanding the label for Ameluz®-PDT beyond the treatment of AK on the face and scalp. Additionally, by employing the larger RhodoLED® XL lamp investigators can target more lesions and reinforce the lamp’s utility ahead of commercial launch,” said Erica Monaco, Chief Executive Officer of Biofrontera Inc. Patients enrolled in this study will have 4-15 mild-to-moderate AK lesions in the treatment field. Each will be treated once with Ameluz®-PDT and upon a three-month evaluation, will be treated a second time if any lesions remain. Investigators will continue to follow patients for 12 months after their most recent treatment to monitor for any recurrences or new lesions, as well as for any adverse events. The primary endpoint is total clearance of all lesions three months after the most recent treatment. Secondary endpoints are total clearance of all lesions three months after the last treatment by body region, percentage of all lesions cleared overall and percentage cleared by body region and severity. Ameluz® and the BF-RhodoLED® lamps, through Biofrontera Inc.’s license and supply agreement with Biofrontera AG, are also undergoing clinical testing in three additional indications: A Phase 3 clinical study in the U.S. evaluating Ameluz®-PDT utilizing the BF-RhodoLED® lamp for the treatment of superficial basal cell carcinoma. A multicenter, randomized, double-blind Phase 2 clinical study evaluating the efficacy of Ameluz®-PDT for the treatment of moderate-to-severe acne. An open-label, multicenter Phase 1 clinical study evaluating the safety and tolerability of Ameluz-PDT for the treatment of AK located on the face and scalp utilizing the BF-RhodoLED® XL lamp and three tubes of Ameluz®. About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (PDT) and topical antibiotics. The Company’s licensed products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection. For more information, visit . Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Biofrontera Inc.’s (the “Company”) revenue guidance for 2022, the Company’s relationship with Biofrontera AG (including beneficial ownership of Biofrontera AG’s shares and future collaboration between the Company and Biofrontera AG), business and marketing strategy, hiring strategy, development of medical affairs initiatives, growth of the Company’s profile, future operations and business, increased patent protection for our licensed products, potential to expand the label of Ameluz® , market presence and position of Ameluz® and ongoing clinical trials conducted by our licensing partners and the future impact of such trials on the market for Ameluz®. We have based these forward-looking statements on our current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, including, but not limited to, the impact of extraordinary external events, such as the current COVID-19 pandemic; any changes in the Company’s relationship with its licensors; the ability of the Company’s licensors to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company’s ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s licensed products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz® in combination with BF-RhodoLED® in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz® in combination with BF-RhodoLED® is consistent with the Company’s expectations; the Company’s ability to complete the transition to a public company; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing and other factors that may be disclosed in the Company’s filings with the SEC, which can be obtained on the SEC website at . Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Contacts Biofrontera Inc. Anke zur Mühlen +1 781 486 1539 us-ir@biofrontera.com LHA Investor Relations Tirth T. Patel +1 212 201 6614 tpatel@lhai.com # # #