Biofrontera Bioscience GmbH

Trial Results Expected in Mid-2024 WOBURN, MA / ACCESSWIRE / August 10, 2023 / Biofrontera AG Inc. (NASDAQ:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatological products, announces that patient enrollment is now complete in the Phase 3 clinical study evaluating Ameluz®-PDT in combination with the BF-RhodoLED® lamp for the treatment of basal cell carcinoma (BCC). This study is being conducted by Biofrontera Bioscience GmbH. "Completing patient enrollment in this Phase 3 clinical study is an important milestone in our strategy to expand the Ameluz® label beyond actinic keratosis (AK). As awareness about skin cancer increases, so does demand for non-surgical BCC treatments without ionizing radiation. According to the Skin Cancer Foundation, of the 5.4 million annual cases of non-melanoma skin cancer in the U.S., approximately 3.6 million, or 67%, are BCC. There is a significant unmet medical need for more effective, less invasive and cost-efficient therapies that treat BCC as well as underlying premalignancies. We look forward to sharing results from this Phase 3 study in mid-2024," said Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc. "In addition to treating individual lesions, Ameluz® is indicated by its prescribing information* for the lesion-directed and field-directed treatment of skin areas with multiple AKs. Superficial BCC is another, more severe form of neoplastic damage that such a field may carry, and inclusion into the label broadens the use of Ameluz® in field-directed treatment, starting a new chapter of PDT for non-melanoma skin cancer", he continued. This randomized, double-blind, placebo-controlled study aimed at enrolling 186 patients at 19 U.S. sites. With 183 patients now treated, and four more patients screened and awaiting histological results and treatment, the clinical sites have been informed that the enrollment is complete. Each patient had one or more clinically and histologically confirmed superficial BCC. Patients receive one cycle of two PDTs (either Ameluz®-PDT or placebo-PDT) 1-2 weeks apart, which may be repeated after three months if required. The last assessment of the patient will take place three months after the final PDT cycle. The primary endpoint is the composite complete clinical and histological clearance of a main BCC lesion, which was selected at the beginning of the study. In addition, data on drug safety as well as secondary efficacy parameters of all BCCs will be evaluated. After completion of the trial, patients will be followed for an additional five years. *For full prescribing information for Ameluz®, please see About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of products for the treatment of dermatologic 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 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 to date. These statements include, but are not limited to, statements relating to Biofrontera Inc.'s (the "Company") preliminary revenues for the three and six months ended June 30, 2023, expectations for revenue growth in 2023, the adoption of PDT and sBCC for the treatment of actinic keratoses by dermatologists, the achievements of our salesforce and the performance of the Company's new hires. 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 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 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 comply with public company requirements; the Company's ability to regain compliance with Nasdaq continued listing standards, 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. Contact: LHA Investor Relations Tirth T. Patel 212-201-6614 tpatel@lhai.com SOURCE: Biofrontera Inc. View source version on accesswire.com:

WOBURN, MA / ACCESSWIRE / May 30, 2023 / Biofrontera Inc. (Nasdaq:BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, announces that its Board of Directors has named Hermann Luebbert as Chief Executive Officer. Mr. Luebbert is a founder of the Company and currently serves as Executive Chairman. He will continue to serve as Chairman of the Board of Directors. Mr. Luebbert founded Biofrontera's former parent company, Biofrontera AG, in 1997 and served as CEO and Managing Director while completing an initial public offering for Biofrontera AG in Germany and later in the U.S. He served as CEO and Chairman of the Company during the process of establishing Biofrontera AG's U.S. operations as Biofrontera Inc. The U.S. business subsequently completed its own initial public offering on Nasdaq in 2021, at which time Mr. Luebbert was named Executive Chairman and shortly thereafter resigned from his position at Biofrontera AG. Prior to founding Biofrontera AG, Mr. Luebbert spent 10 years in Neuroscience Research at Novartis and was Chair of the Animal Physiology Department at Ruhr-University Bochum. Mr. Luebbert received a Ph.D. in Biology from the University of Cologne and completed post-doctoral research at the California Institute of Technology. "I look forward to taking a more active, day-to-day role in driving a focused path to profitability, executing tightly against our forecasts and, in turn, building shareholder value. As CEO, I am committed to transparency regarding our strategic vision and our progress as we grow Biofrontera more broadly and integrate other value-creating initiatives to support our commercial team," said Mr. Luebbert. "By establishing in-house R&D we expect to expand Biofrontera beyond our core strength in sales and marketing, gain greater control over our future and be better equipped to accelerate ongoing efforts to broaden the market for photodynamic therapy (PDT)," he added. Among other strategic initiatives to transform Biofrontera into an integrated pharmaceutical company, Mr. Luebbert is evaluating plans to establish Biofrontera's own research and development capability. Currently R&D is managed by Biofrontera Bioscience GmbH and funded by Biofrontera Inc. via a royalty on sales of licensed products, and is limited to predefined clinical trials. The Company will evaluate R&D costs and relative return as it considers building the infrastructure to manage its own clinical studies, which could support the expansion of the Ameluz-PDT label into new indications and potentially the development of new products. "We also will strengthen our established medical affairs function by our continued support of investigator-initiated research. All of this will be pursued by starting small and carefully balancing expenses against our growing revenue," continued Mr. Luebbert. The Company's plans include an enhanced focus on pursuing new products and new technologies through acquisitions and licensing transactions, while maintaining the Company's focus on dermatology and leveraging its commercial expertise. About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of products for the treatment of dermatologic 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 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 to date. These statements include, but are not limited to, statements relating to the growth strategy for Biofrontera Inc. (the "Company"), the transition of responsibilities at the Company, 2023 forecasts, the establishment of and benefits from in-house research and development, efforts to broaden the market for PDT, the expansion of the Ameluz® label, new products, and potential acquisition and licensing transactions. 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 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® 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 comply with public company requirements; the Company's ability to regain compliance with Nasdaq continued listing standards, 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. Contact: LHA Investor Relations Tirth T. Patel 212-201-6614 tpatel@lhai.com SOURCE: Biofrontera Inc. View source version on accesswire.com:

Novel Protocol is Expected to be Less Painful with Efficacy Similar to Conventional PDT WOBURN, MA / ACCESSWIRE / May 15, 2023 / Biofrontera Inc. (Nasdaq:BFRI) (the "Company"), a biopharmaceutical company specializing in the commercialization of dermatologic products, announces that the U.S. Patent and Trademark Office (USPTO) has granted a new patent to Biofrontera Bioscience GmbH related to a photodynamic therapy (PDT) protocol that is expected to be less painful but similarly effective to conventional PDT. This new patent is exclusively licensed to Biofrontera Inc. and expires in April 2039, including a patent term adjustment (PTA) approved by the USPTO. Titled "Photodynamic therapy comprising two light exposures at different wavelengths" (U.S. Patent No. 11,642,411 B2), the patent covers the use of a composition comprising a photosensitizer, a light-sensitive molecule activated by the absorption of light, that is used in PDT performed with illumination by two different photo-activating wavelengths of light. "This is the fourth US patent recently issued to Biofrontera Bioscience GmbH and licensed exclusively to Biofrontera Inc. At the start of 2022 we had no protection for our intellectual property in the U.S., and since then we were granted protection for our product combination of Ameluz and the RhodoLED lamp series until 2040. Our growing licensed patent portfolio further establishes Biofrontera not only as a leader in PDT, but also in dermatologic innovation," said Hermann Lübbert, Executive Chairman of Biofrontera Inc. and the sole inventor on the patent. "This latest patent covers a protocol that supports further adoption of PDT. With an incubation between application of the gel with exposure to light with a wavelength spectrum similar to sunlight followed by 10 minutes of red-light illumination, this novel protocol is far more patient-friendly yet similarly effective to conventional PDT. It adds additional patient friendliness to another patent granted early in 2022, protecting red light application in defined ramps and pulses, expected to reduce PDT pain even further. Both patents add substance to our goal of providing doctors with data on patient-friendly PDT protocols to help them select the optimal risk-benefit ratio for their patients." One of the four patents granted in 2022 is already listed in FDA's Orange Book, taking Ameluz/RhodoLED out of the list of products threatened by generic competition until 2040. To demonstrate proof-of-concept with the goal of expanding the FDA label for pain-reduced Ameluz®-PDT, a Phase 3 study for almost pain-free PDT for the treatment of actinic keratoses on the face and scalp is currently designed, combining the new protocols for illumination with two wavelengths and light pro Light profiles are already applied in the ongoing Phase 3 trial investigating the treatment of actinic keratosis in the periphery with Ameluz and the RhodoLED® XL lamp. The studies are performed in clinical centers throughout the U.S. and organized by Biofrontera Bioscience GmbH as part of the obligations financed by Biofrontera Inc. through the license and supply agreement for Ameluz and RhodoLED lamps. About Biofrontera Inc. Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatologic 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 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 to date. These statements include, but are not limited to, statements relating to the growth strategy for Biofrontera Inc.'s (the "Company") strategic plan, 2023 commercial goals and potential for growth, and the transition of responsibilities at the Company. 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 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® 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 comply with public company requirements; the Company's ability to regain compliance with Nasdaq continued listing standards, 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. Contact: LHA Investor Relations Tirth T. Patel 212-201-6614 tpatel@lhai.com SOURCE: Biofrontera Inc. View source version on accesswire.com: