Biofrontera AG

First Phase 3 PDT study in patients with sBCC in the United States. Rigorous dual endpoints requiring complete clinical and cytological clearance of malignant lesions. Data now being analyzed, interim results expected November 2024. BCC is the most common skin cancer in the US with more than 3 million cases each year 1 . WOBURN, Mass., Oct. 14, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”) , a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), announced today that the database for the treatment phase of study ALA-BCC-CT013 has been locked. The database lock is an important milestone in the lifecycle of a clinical trial, marking the end of data collection and the point at which no further changes can be made to the trial database. The clinical data are now ready for final analysis. This Phase 3 trial is to evaluate the safety and efficacy of Ameluz ® -PDT in combination with the BF-RhodoLED ® lamp for the treatment of sBCC. It is a double-blind, randomized, placebo-controlled multi-center study involving 186 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, repeated after three months if required. The primary endpoint is the composite complete clinical and histological clearance of the target BCC lesion 12 weeks after the start of the last PDT cycle. Secondary efficacy parameters and drug safety were evaluated. In addition to the final study report, the FDA requires the inclusion in the submission of follow-up data obtained 1 year after the first PDT. The last patient is expected to complete this follow up by December of this year, and submission is targeted for Q1 2025. “If this indication is granted by the FDA this would expand our label from premalignant application for Actinic Keratoses to the treatment of cutaneous malignancy. It would be the next stage in our continued development of PDT and part of our vision to become the market leaders in this field” stated Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. About Actinic Keratosis AK is the most common pre-cancerous skin lesion caused by chronic sun exposure that may, if left untreated, develop into life-threatening skin cancer called squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face, bald scalp, arms or the back of the hands. In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed. 2 1. 2. 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 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 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 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 Relations Andrew Barwicki 1-516-662-9461 ir@bfri.com

Approval allows for larger field treatment of actinic keratosis (AK) on face and scalp with Ameluz®-PDT using the BF-RhodoLED or the RhodoLED XL lampSupplemental New Drug Application (sNDA) supported by two Phase 1 safety studiesAK is the second most common diagnosis made by dermatologists in the United States1An estimated 13 million treatments given each year for AK in the US2 WOBURN, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s sNDA to increase the maximally approved dosage from one to three tubes of Ameluz® per treatment. This approval allows healthcare professionals greater flexibility in addressing larger or multiple treatment areas for patients undergoing photodynamic therapy (PDT) for AK on the face and scalp, leading to greater convenience for both healthcare providers and their patients. “We are delighted with the FDA’s decision to approve the use of up to three tubes of Ameluz® per treatment,” stated Dr. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc. “We are now working with Medicare and commercial payers to obtain reimbursement for this label update and will notify our customers accordingly.” The sNDA was supported by two clinical Phase I safety studies in which three tubes of Ameluz® were applied to 116 patients. The studies showed that the blood concentrations of the active ingredient and the metabolite were several magnitudes below those at which side effects are known to occur, and that the systemic and application site adverse events were equivalent to those observed with one tube of Ameluz®. “Ameluz® is the only PDT photosensitizer indicated by the FDA for both lesion-directed and field-directed treatment of AKs. This approval will allow dermatologists to offer the more comprehensive option they desired for their patients, while maintaining the proven efficacy and safety profile of Ameluz®. It is another important milestone for Biofrontera as we continue to demonstrate our commitment to PDT and our dedication to the development of this important treatment modality,” commented Dr. Luebbert. “Up to 60% of squamous cell carcinomas begin as untreated AK lesions, so it’s important for us to be able to treat the entire affected field. I have used Ameluz® now for more than 7 years for the management of AK because of the demonstrated efficacy and safety it delivers. With the approval of the sNDA, I look forward to being able to use up to three tubes for those patients that need them,” said Dr. Jonathan Weiss, investigator and co-managing partner at Georgia Dermatology Partners in Atlanta. About Actinic Keratosis AK is the most common pre-cancerous skin lesion caused by chronic sun exposure that may, if left untreated, develop into life-threatening skin cancer called squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face, bald scalp, arms or the back of the hands. In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed.3 Landis ET. et al. Dermatol Online J. 2014 Apr 16;20(4):22368.Market data accessible from CMS and IQVIA, 2021www.skincancer.org/skin-cancer-information/actinic-keratosis/ 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 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

Taylor Tieden for BioSpace One upcoming decision—on a perioperative PD-1 regimen for lung cancer—comes as the FDA considers an overhaul of trial designs in this treatment setting. The FDA is kicking off October with a trio of decisions on new drug candidates, including a rare disease medicine and a lung cancer treatment. Read below for more. Biofrontera Seeks Greater Maximum Dose for Actinic Keratosis Cream By October 4, the FDA is set to release its decision on Biofrontera’s supplemental New Drug Application (sNDA) seeking to increase the maximum dose of its actinic keratosis gel Ameluz (aminolevulinic acid HCI) to up to three tubes per treatment. Affecting more than 58 million people across the U.S., actinic keratosis is the most common precancerous skin lesion, according to Biofrontera. It is typically caused by prolonged exposure to the sun and manifests as rough bumps on the skin, especially on the face and arms. If left unchecked, actinic keratosis can develop into a potentially deadly type of skin cancer called squamous cell carcinoma. Ameluz is a topical treatment that is administered by a healthcare provider alongside photodynamic therapy with a BF-RhodoLED lamp, which targets lesions with red light to activate Ameluz’s main therapeutic ingredient. People whose lesions have not completely resolved within three months after the initial treatment can undergo retreatment, according to the drug’s label . Biofrontera’s sNDA proposes to use up to three tubes of Ameluz for the field treatment of actinic keratosis. If approved, this dosing adjustment could allow doctors to address large surface areas in one visit, making treatment more convenient for patients, according to the company. The application is backed by data from two Phase I trials demonstrating the safety of three Ameluz tubes. Results showed that blood levels of Ameluz’s active ingredient and subsequent metabolites are transiently higher after the administration but were still far below the thresholds at which side effects occur. Systemic toxicities were comparable to one tube of Ameluz. BMS Proposes Perioperative Opdivo Regimen in NSCLC Bristol Myers Squibb is advancing Opdivo (nivolumab) for the perioperative treatment of resectable non-small cell lung cancer (NSCLC), including neoadjuvant PD-1 treatment plus chemotherapy followed by postoperative adjuvant Opdivo. The FDA’s decision is due by October 8. The application is backed by data from the Phase III CheckMate -77T study, which showed significantly better event-free survival in patients treated with the perioperative Opdivo regimen. BMS published data from the study in October 2023, touting a 42% drop in the risk of disease recurrence, progression or death. Participants in the Opdivo arm also achieved superior pathologic complete response and major pathologic response rates. BMS’ application comes as the FDA rethinks its position on perioperative PD-1 treatment in lung cancer. In July 2024, the regulator’s Oncologic Drugs Advisory Committee unanimously backed the need for changes in perioperative trial designs, particularly to better differentiate the therapeutic contributions of different phases of treatment. David Mitchell, president of the nonprofit Patients for Affordable Drugs, said during the adcomm meeting that patients and doctors need to know “which phase of treatment is contributing what.” Exposing patients to a year or so of adjuvant therapy without being sure of its therapeutic benefit “is not acceptable,” Mitchell said. Zealand Awaits Verdict for Rare Disease Therapy Also on or before October 8, the FDA is expected to release its decision on Zealand Pharma’s NDA for dasiglucagon, which the Danish biotech is proposing as a treatment for congenital hyperinsulinism (CHI). Afflicting one out of 50,000 children, CHI is an ultrarare genetic disease characterized by dysfunctional pancreatic beta cells, which pump out too much insulin into the bloodstream. People with this condition suffer from frequent, recurrent and severe hypoglycemic episodes, which, if left unchecked, can lead to seizures, brain damage and even death. Dasiglucagon is an investigational glucagon receptor agonist that promotes the secretion of stored sugar from the liver, helping counteract the glucose-lowering action of insulin. Zealand is developing the drug candidate as a subcutaneous continuous infusion delivered via a wearable pump system. Phase III data for dasiglucagon, released in May 2022, showed that the drug can significantly cut the need for intravenous glucose by 55% versus placebo. Dasiglucagon previously won the FDA’s approval in May 2021 for the treatment of severe hypoglycemia in people with diabetes. The drug is marketed under the brand name Zegalogue for this indication. Zealand’s CHI NDA for dasiglucagon will be reviewed by the FDA in two parts “to ensure the most efficient regulatory process,” the biotech noted in an August 2023 press release . The target action date on October 8 is for the first part, which covers dosing for up to three weeks. The second part of dasiglucagon’s NDA is for use beyond three weeks. The company expects to submit an application for this part by the end of 2024.