Annuncio • Feb 27
U.S. Patent Board Rules Sun Pharmaceutical Industries, Inc’s Patent Is Unpatentable After Biofrontera Challenge Biofrontera Inc. announced that on February 23, 2026, the U.S. Patent Trial and Appeal Board issued a Final Written Decision finding all challenged claims of Sun Pharmaceutical Industries Inc.’s U.S. Patent No. 11,697,028 to be unpatentable. As previously disclosed in Biofrontera’s filings with the Securities and Exchange Commission, in June 2024, Sun Pharma initiated proceedings against Biofrontera and certain of its affiliates in the U.S. District Court for the District of Massachusetts and the International Trade Commission alleging infringement of the ‘028 Patent and a related patent, U.S. Patent No. 11,446,512 (the “’512 Patent”). In response to these proceedings, Biofrontera challenged the validity of Sun Pharma’s asserted claims by filing petitions for Inter Partes Review with the Board. The Board has now agreed with Biofrontera on all challenged claims of the ‘028 Patent. Sun Pharma has the right to request a review of the decision or appeal it to the United States Court of Appeals for the Federal Circuit. The decision does not affect the petition filed by the Company relating to the ‘512 patent, which was denied review by the Patent Office on administrative, rather than substantive, grounds. Annuncio • Feb 18
Biofrontera Inc. Announces Database Lock of Phase 1 Pharmacokinetics Study of Ameluz®? for Actinic Keratoses on Trunk and Extendedities Biofrontera Inc. announced that the database of its Phase 1 PK study evaluating Ameluz®? (aminolevulinic acid hydrochloride) topical gel for the treatment of mild to moderate actinic keratoses (AKs) on neck, trunk and trunk and trunk was locked on February 11, 2026. The Phase 1, non-randomized, open-label study assessed systemic exposure to 5-aminolevulinic acid (ALA) and its metabolite protoporphyrin IX (PpIX) during photodynamic therapy (PDT) with Ameluz®? in combination with the red-light BF-RhodoLED®? XL lamp. The study was designed to investigate the pharmacokinetics of 5-aminolevulinIC acid (ALA) and protoporphyrin IX ("PpIX") under maximal use conditions during and after treatment with 3 entire tubes of Ameluz®? applied to an approximately 240 cm2 treatment field. Seventeen patients received a single PDT treatment with Ameluz®?. Plasma concentrations of ALA and PpIX were then measured for a 10-hour period following application. Together with the Company's previously announced positive Phase 3 clinical results evaluating Ameluz®? PDT for mild to moderate AKs on the extremities, neck and trunk, the PK data are intended to support a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for expansion of the current label. This submission is expected in the third quarter of 2026 and aims at extending the label from the currently approved indication of an up to 60 cm2 treatment field with AK on the face and scalp to an AK treatment field of up to 240 cm2 on other body parts. Annuncio • Feb 11
Biofrontera Inc. Announces U.S. Food and Drug Administration Filing Acceptance of Supplemental New Drug Application for Ameluz PDT in Superficial Basal Cell Carcinoma Biofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and accepted filing of the Company's supplemental New Drug Application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel used in combination with the RhodoLED®? red-light lamp series for the treatment of sBCC. The FDA identified no filing deficiencies and assigned a PDUFA target action date of September 28, 2026. If approved, this new indication would represent a significant clinical expansion of the Ameluz®? PDT platform beyond its existing FDA approval for treatment of actinic keratosis. It would also further validate Biofrontera's PDT approach, which combines Ameluz®?'s nanoemulsion technology with red-light illumination designed to penetrate deeper into tissue compared with shorter wavelengths of light such as green and blue, enabling treatment of lesions extending into deeper skin layers. Basal cell carcinoma is the most common cancer in the U.S., with approximately 3.6 million cases diagnosed annually, and published estimates suggest that 10-25% of these cases are of the superficial subtype2,3,4. If approved, Ameluz®? PDT for the treatment of SBCC would offer dermatology providers and their patients a non-invasive treatment option aligned with real-world practice needs. The Company commercializes the drug-device combination Ameluz®? with the RhodoLED®®? lamp series for PDT of Actinic Keratosis, pre-cancerous skin lesions which may progress to invasive skin cancers5. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate-to-severe acne. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements make. These risks and uncertainties, many of which are beyond the control, include, but are not limited to: 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; the impact of any extraordinary external events; the Company's ability to achieve and sustainability; whether global disruptions in supply chains will impact the Company's ability to obtain and distribute its products; changes in the practices of healthcare providers, including any changes to coverage, reimbursement and pricing for procedures using the Company's products; whether the market opportunity for Ameluz®? in addition with BF-Rhodo LED®? 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 will be available for the Company's financial resources and need for additional financing. Annuncio • Feb 10
Biofrontera Announces Positive Results in Phase 3 Study of Ameluz PDT for Actinic Keratoses on the Extremities, Neck, and Trunk, Meeting Primary Endpoint Biofrontera Inc. announced positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz®? PDT with the red-light LED (RhodoLED) platform for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk. The multicenter, randomized, double-blind, vehicle-controlled Phase 3 study evaluated the efficacy and tolerability of field-directed Ameluz PDT compared with vehicle PDT in patients with AKs located on the extremities, neck., and trunk. The study enrolled 172 patients, randomized 4:1 to receive Ameluz gel or vehicle gel, respectively. Based on these positive Phase 3 results, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration in the third quarter of 2026. Annuncio • Jan 13
Biofrontera Inc. Provides Earnings Guidance for the Fourth Quarter and Full Year Ended December 31, 2025 Biofrontera Inc. provided earnings guidance for the fourth quarter and full year ended December 31, 2025. For the quarter,
revenues are expected to be between $17.0 million and $17.5 million, representing the highest quarterly revenue in the Company’s history.
For the full year 2025, revenues are expected to be in the range of $41.5 million to $42.0 million, reflecting year-over-year growth of approximately 11% to 13%. The Company expects to report complete fourth quarter and full year 2025 financial results in March 2026. Annuncio • Dec 18
Biofrontera Inc. Completes Transfer of Ameluz®? and RhodoLED®? FDA Approval and Associated Intellectual Property Portfolio Biofrontera Inc. announced the completion of the transfer of the FDA approvals for Ameluz and the RhodoLED Lamp Series, including the NDA and the Investigational New Drug Application (IND), to Biofrontera. In addition, the Company has completed all necessary filings to transfer all US and some international intellectual property associated with Ameluz and the RhodiLED Lamp Series, including 11 granted US patents, 10 US patent applications, and 19 patent filings or registered designs outside of the US. The registration of the assignment to Biofrontera of all associated trademarks has also been initiated. These asset transfers were secured, in part, by an $11.0 million investment recently reported by the Company. Annuncio • Dec 04
Last Patient Completes Biofrontera's Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and Extremities Biofrontera Inc. 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). The last patient visit took place on 24 November 2025. Data from this study, together with results from Biofrontera's recently completed Phase 3 clinical trial, will form the basis of a planned supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the Ameluz® label to include the treatment of AKs on all peripheral body areas. Actinic Keratoses commonly occur on sun-exposed areas across the body and may progress to squamous cell carcinoma if left untreated. Expanding Ameluz®'s current FDA approval for use beyond the face and scalp would address a critical unmet need in dermatology. This open-label Phase 1 study assessed the PK profile of 5-aminolevulinic acid (ALA) and its metabolite protoporphyrin IX (PpIX) during Ameluz®-PDT of the upper extremities, neck or trunk using the BF-RhodoLED® XL lamp. Pending positive outcomes of this trial and the corresponding Phase III study, the company plans to submit a supplemental New Drug Application (s NDA) to the Food and Drug Administration ("FDA") in the Summer of 2026. Annuncio • Dec 02
Biofrontera Inc. Announces Filing of Supplemental New Drug Application (Snda) for the Treatment of Superficial Basal Cell Carcinoma with Ameluz®?-Pdt Biofrontera Inc. announced the submission of an sNDA to the FDA, seeking approval of Ameluz-PDT for the treatment of sBCC. The submission includes the full efficacy data sets from the Phase 3 treatment phase and the one-year follow-up, together with an integrated safety assessment combining data from Biofrontera's U.S. and European Basal Cell Carcinoma clinical studies. The filing seeks to expand the Ameluz label to include treatment of sBCC treatment with PDT using its BF-RhodoLED or RhodoLED XL red light lamps. Participants received one cycle of two PDT treatments (either Ameluz-PDT or placebo-PDT) 1-2 weeks apart. If required, a second treatment cycle was repeated at three months. The study's primary endpoint was a composite measure of complete clinical and histological clearance of one preselected "main target lesion" (MTL) at 12 weeks after the start of the last PDT cycle. This rigorous target was achieved with a 65.5% clearance rate in the Ameluz-PDT arm (95/145 subjects) compared to 4.8% in the placebo-PDT arm (2/42 subjects), a highly significant statistical difference (p(JAAD) summarized "The efficacy, tolerability, and aesthetic outcomes demonstrated in the Phase 3 study and highlighted in the publication reinforce the value of Ameluz-PD T for the treatment of sBC C. In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed. Annuncio • Nov 07
Biofrontera Inc. to Report Q3, 2025 Results on Nov 12, 2025 Biofrontera Inc. announced that they will report Q3, 2025 results at 4:00 PM, US Eastern Standard Time on Nov 12, 2025 Annuncio • Sep 17
Biofrontera Inc. Announces Last Patient Out in Phase 3 Study of Ameluz Topical Gel Biofrontera Inc. 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 Second Quarter 2026. Actinic keratosis is a common precancerous skin condition found on sun-exposed areas of the body: 58 million US adults have at least one AK lesion1. In total, 172 subjects were enrolled in the study. The 12-month follow-up Phase 3 study is expected to be completed by Second Quarter 2026. Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) that same quarter. Annuncio • Aug 26
Biofrontera Inc. Announces Last-Patient-Out in Phase 2b Study of Ameluz®? Topical Gel, 10% for the Treatment of Moderate to Severe Acne Vulgaris Biofrontera Inc. announced that the final patient in its Phase 2b clinical trial evaluating Ameluz®? (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris (AV) completed participation on August 22, 2025. Acne vulgaris is a common skin condition characterized by inflammatory and non-inflammatory lesions that frequently lead to permanent scarring. Beyond the physical burden, AV often has a significant psychological impact, including reduced self-esteem and depression. Many of these patients continue to rely on regimens that carry significant treatment burdens including cost, adverse effects and the necessity for prolonged treatments. Expanding the use of Ameluz®? to treat acne would be a valuable advancement for both physicians and patients. The company look forward to the study results with great anticipation. Pending positive results, the Company intends to present the findings to the U.S. Food Drug Administration (FDA) in early Third Quarter 2026 as the basis for a future Phase III program, with the goal of achieving approval for Ameluz®? PDT for the treatment of acne vulgaris. Annuncio • Aug 12
Biofrontera Inc. Appoints George Jones as Chief Commercial Officer, Effective August 25, 2025 Biofrontera Inc. announced the appointment of George Jones as Chief Commercial Officer (CCO), starting August 25, 2025. In this role, Mr. Jones will oversee the Company’s commercial functions, including sales, marketing, and market access. He will report directly to CEO Dr. Hermann Luebbert. Hiring a CCO in this transformational situation will further strengthen the Company’s unparalleled commercial and clinical efforts in the PDT field. Mr. Jones brings over 25 years of extensive commercial leadership experience within the specialty pharmaceutical and biotech sectors. Mr. Jones' career is marked by a demonstrated ability to build and lead commercial organizations. At Currax Pharmaceuticals, as Vice President Global Marketing and Commercial Operations and one of the earliest employees following the company's restructuring, he was instrumental in the build out of the commercial organization, including supporting the establishment of the marketing department, sales force and training functions. He guided the young company through a period of rapid growth while simultaneously navigating the early stages of the global pandemic. While at Currax Mr. Jones also led the development of a first-in-market digital ecosystem, driving direct patient demand via social media linked to telemedicine. Prior to Currax, at Pernix Therapeutics, Mr. Jones was promoted to Vice President of Sales and Marketing and implemented an efficient and focused sales strategy that supported rapid growth while lowering the cost structure. Earlier in his career, at Depomed Inc. while a Senior Director of Marketing, his efforts supported the company’s inorganic growth strategy successfully leading the marketing integration and re-launch of five product acquisitions. Most recently, Mr. Jones served as Chief Operating Officer at UpScriptHealth. He was appointed to drive change and support the evolution of the leading telehealth technology platform. Under his guidance, UpScriptHealth achieved substantial growth, including a more than threefold increase in partnership revenues. This experience underscores his expertise in leveraging innovative channels to enhance patient access to therapies. Annuncio • Aug 05
Biofrontera Inc. to Report Q2, 2025 Results on Aug 13, 2025 Biofrontera Inc. announced that they will report Q2, 2025 results After-Market on Aug 13, 2025 Annuncio • Jul 01
Biofrontera Inc. announced that it expects to receive $11 million in funding from Aigh Capital Management, LLC, Rosalind Advisors, Inc. Biofrontera Inc. announced a private placement of preferred shares for gross proceeds of $11,000,000 on June 30, 2025. The preferred shares are convertible to common shares at the price of $0.6249 per share. The transaction will include participation from new investors Aigh Capital Management, LLC, Rosalind Advisors, Inc.
On the same day, the company raised $8,500,000 in its first tranche. The second tranche of $2,500,000 will be funded upon finalization of a detailed asset transfer agreement, which is expected by September 30, 2025. Annuncio • Jun 04
Biofrontera Inc. Announces Patent for Propylene Glycol-Free Formula of Ameluz® (aminolevulinic Acid HCI) Biofrontera Inc. announced the inclusion of the patent for its propylene glycol-free formulation of Ameluz® nanoemulsion gel in the US Food and Drug Administration's (FDA's) publication "Approved Drug Products with Therapeutic Equivalence Evaluations" (commonly known as the Orange Book). The Orange Book is a key reference for healthcare providers, pharmacists, and payers and is the definitive source for identifying FDA-approved drug products. Inclusion of a drug in the Orange Book confirms that the FDA recognizes that the drug meets their rigorous standards for safety, efficacy, and quality. In addition, patents listed confer intellectual property protections which may include the drug's composition, formulation, or specific uses. Listing of the patent for the propylene glycol-free formulations of Ameluz® prevents generic competition as long as the patent is valid, which currently is December 2043. It offers a significant improvement for individuals who are sensitive to this excipient without compromising the treatment's effectiveness. The patent for the revised formulation of Ameluz®® was issued on April 22, 2025, and lasts until December 8, 2043. The formulation itself was accepted by the FDA and has been in use since 2024. 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. Annuncio • May 24
Biofrontera Receives A Non-Compliance Letter from the Nasdaq Stock Market On May 21, 2025, Biofrontera Inc. received a letter from The Nasdaq Stock Market (“Nasdaq”) notifying the Company that, because the Company’s stockholders’ equity as reported in its Quarterly Report on Form 10-Q for the period ended March 31, 2025 was $469,000, the Company is no longer in compliance with the continued listing requirement under Nasdaq Listing Rule 5550(b)(1), which requires that a listed company’s stockholders’ equity be at least $2,500,000. Additionally, as of the date of the Notice, the Company did not meet either of the alternative requirements of maintaining a market value of listed securities of $35 million or achieving a net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years. As a result, as of the date of this Report, the Company does not satisfy Nasdaq Marketplace Rule 5550(b). The Notice has no immediate effect on the listing or trading of the Company’s securities on the Nasdaq Capital Market. In accordance with Nasdaq rules, the Company has 45 calendar days from the date of the Notice to submit a plan to regain compliance with the Nasdaq Listing Rules. The Company intends to evaluate available options to regain compliance and timely submit a compliance plan to Nasdaq. If the Company’s compliance plan is accepted, the Company may be granted up to 180 calendar days from May 21, 2025 to evidence compliance. If the plan is not accepted, then the Company will have the opportunity to appeal that decision to a Nasdaq Hearings Panel. Annuncio • May 16
Biofrontera Inc. Announces New Patent Protection on Ameluz®? until 2043 and the Completion of Patient Enrollment in Phase 2b Study of Ameluz®? Topical Gel, 10% for the Treatment of Moderate to Severe Acne Vulgaris Biofrontera Inc. received confirmation that the updated formulation of the Ameluz nanoemulsion gel without propylene glycol received patent approval through to December 2043. The formulation was earlier accepted for use in Ameluz by the US Food and Drug Administration (FDA) and is in use since 2024. In addition to this long-lasting protection of Ameluz against generic competition, Biofrontera announced the successful enrollment of the final patient in its Phase 2b clinical trial evaluating Ameluz (aminolevulinic acid hydrochloride) for the treatment of moderate to severe acne vulgaris. The multicenter, randomized, double-blind study is designed to assess the safety and efficacy of PDT with the BF-RhodoLED® lamp and Ameluz® or vehicle gel after two different incubation periods --1 hour and 3 hours. The U.S. acne treatment market was valued at approximately $5.7 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 5.3%, driven by rising adult prevalence of acne and demand for advanced therapies5. These therapies, while effective, are often associated with systemic side effects, underscoring the need for alternative treatment options. It marks a significant step in expanding the indications for Ameluz®?PD over and above the currently approved treatment of mild to moderate actinic keratosis on the face and scalp. Annuncio • May 15
Biofrontera Receives a Letter from the Listing Qualifications Department of the Nasdaq Stock Market On May 8, 2025, Biofrontera Inc. received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that the listing of its common stock was not in compliance with Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market, as the closing bid price of the Company’s common stock was less than $1.00 per share for the previous 33 consecutive business days. The notice has no present impact on the listing or trading of the Company’s securities on The Nasdaq Capital Market. Under Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until November 5, 2025, to regain compliance with the rule referred to in this paragraph. To regain compliance, during this 180-day compliance period, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of 10 consecutive business days. In the event that the Company does not regain compliance with the Nasdaq Listing Rules prior to the expiration of the 180-day compliance period ending on November 5, 2025, the Company may be eligible for additional time to regain compliance pursuant to Nasdaq Listing Rule 5810(c)(3)(A)(ii) by meeting the continued listing requirement for market value of publicly held shares and all other applicable standards for initial listing on The Nasdaq Capital Market, with the exception of the minimum bid price requirement, and providing written notice to Nasdaq of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. Should the Nasdaq staff conclude that the Company will not be able to cure the deficiency, or if the Company does not meet other listing standards, Nasdaq could provide notice that the Company’s securities will be subject to delisting. At such time, the Company may appeal the delisting determination to a Hearings Panel. The Company intends to actively monitor the closing bid price of its common stock and, as appropriate, will consider available options to resolve the deficiency and regain compliance with the Nasdaq Listing Rules. There can be no assurance that the Company will be able to regain compliance with Rule 5550(a)(2) or maintain compliance with the other listing requirements of the Nasdaq Capital Market. Annuncio • May 07
Biofrontera Inc. to Report Q1, 2025 Results on May 15, 2025 Biofrontera Inc. announced that they will report Q1, 2025 results After-Market on May 15, 2025 Annuncio • Apr 21
Biofrontera Inc., Annual General Meeting, Jun 12, 2025 Biofrontera Inc., Annual General Meeting, Jun 12, 2025. Location: meetnow.global/m4t9rh6, United States Annuncio • Mar 18
Biofrontera Inc. Announces Completion of Patient Enrollment in Phase 3 Study of Ameluz®? Topical Gel, 10% for the Treatment of Actinic Keratoses on the Extremities, Neck and Trunk Biofrontera Inc. announced the enrollment of the final patient in its Phase 3 clinical trial evaluating Ameluz®? (aminolevulinic acid hydrochloride) for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck and trunk. Actinic keratosis is a common skin condition found on sun-exposed areas of the body, and if left untreated, may progress to squamous cell carcinoma. This trial is a multicenter, randomized, double-blind study comparing Ameluz®? with vehicle in the field-directed treatment of actinic keratosing (AK) located on the extremities, neck & trunk with PDT using a RhodoLED lamp (BF-RhodoLED®? XL or BF-RhodoLED™?). It is designed to assess the safety and efficacy of Ameluz®? PDT following the application of 1-3 tubes of product over a surface area (continuous or in patches) of approximately 80, 160 or 240cm2. Patients receive one PDT treatment with either Ameluz®? or vehicle gel, and a second one at 12 weeks if at least one AK lesion remains. With enrollment complete, Biofrontera anticipates finishing the treatment phase of the study by September, 2025 and the follow-up phase by second quarter 2026. Pending positive outcomes, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) in the second half of 2026. Annuncio • Mar 11
Biofrontera Inc. to Report Q4, 2024 Results on Mar 21, 2025 Biofrontera Inc. announced that they will report Q4, 2024 results Pre-Market on Mar 21, 2025 Annuncio • Jan 08
Biofrontera Inc. Announces Achievement of Key Milestone In Phase 3 Study Of Ameluz®-Photodynamic Therapy (PDT) In The Treatment Of Superficial Basal Cell Carcinoma (sBCC) Biofrontera Inc. 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. Annuncio • Nov 23
Biofrontera Inc. announced that it has received $4.2 million in funding Biofrontera Inc. announced that it has completed private placement of a $4.2 million senior secured convertible note on November 22, 2024. The Note matures on November 22, 2027, bears a paid in kind interest of 10% per annum and is secured by the Company’s assets Annuncio • Nov 01
Biofrontera Inc. to Report Nine Months, 2024 Results on Nov 13, 2024 Biofrontera Inc. announced that they will report nine months, 2024 results on Nov 13, 2024 Annuncio • Oct 31
Biofrontera Inc. Announces Highly Significant Results In Phase 3 Study Of Ameluz-Photodynamic Therapy (PDT) Regarding The Treatment Of Superficial Basal Cell Carcinoma (sBCC) Biofrontera Inc. announced top-line results in its Phase 3 study of the use of Ameluz with the BF-RhodoLED lamp in the treatment of sBCC (study ALA-BCC-CT013). 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, repeated after three months, if required. The primary endpoint was a composite of complete clinical and histological clearance of one preselected “main target” BCC lesion per patient 12 weeks after the start of the last PDT cycle. Ameluz-PDT achieved 65.5% success (95/145 subjects) in this rigorous target, compared to 4.8% success (2/42 subjects) achieved with placebo-PDT (p<0.0001). Complete histological clearance was seen in 75.9% (110/145) of these lesions in the Ameluz arm, compared to 19.0% (8/42) with placebo. Complete clinical clearance was achieved in 83.4% (121/145) of patients treated with Ameluz compared to 21.4% (8/42) with placebo. The results for all other secondary efficacy parameters were equally highly significant (p<0.0001) with, for instance, 64.1% of Ameluz-PDT patients achieving total clearance of all sBCC lesions compared to only 4.8% of those treated with placebo-PDT. Most patients who received Ameluz-PDT rated the overall treatment satisfaction and esthetic outcome as very good (64.3%) or good (22.2%). Annuncio • Oct 14
Biofrontera Inc. Announces Database Lock of Phase 3 Study of Ameluz-Photodynamic Therapy in Treatment of Superficial Basal Cell Carcinoma Biofrontera Inc. announced 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 First Quarter 2025. Annuncio • Oct 07
FDA Approves Use of Up To Three Tubes of Biofrontera Inc.’s Ameluz (aminolevulinic acid HCI) Topical Gel, 10% In One Treatment Biofrontera Inc. 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. 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®. Annuncio • Aug 09
Biofrontera Inc. to Report Q2, 2024 Results on Aug 14, 2024 Biofrontera Inc. announced that they will report Q2, 2024 results at 4:00 PM, US Eastern Standard Time on Aug 14, 2024 Annuncio • Jun 24
Biofrontera Announces the Launch of A New, FDA-Approved Red Light Source, the RhodoLED® XL Lamp Biofrontera Inc. announced the launch of its FDA-approved RhodoLED XL, a red light emitting LED lamp. Biofrontera RhodoLED XL®?: This innovative device represents a significant advancement in the treatment of PDT with engineering, robust but sleek construction and an intuitive user interface. It is designed to be simple to manage and able to accommodate various patient treatment positions in order to optimize ease of use. Biofrontera's PDT drug, Ameluz®?, is approved by the FDA in combination with either member of the RhodoLED lamp family. The introduction of the RhodoLED XL provides the option to illuminate a larger area in a single on-label Ameluz PDT treatment. In comparison to Biofrontera's existing lamp, the RhodoLED XL offers a larger illumination area with five panels compared to one, and additional features such as positioning sensors to ensure the patient receives the optimal energy delivery from the LED array. Cleaver Dermatology, a renowned practice with offices in Missouri and Georgia, was the first to have the RhodoLED XL lamp installed. Annuncio • May 08
Biofrontera Inc. to Report Q1, 2024 Results on May 15, 2024 Biofrontera Inc. announced that they will report Q1, 2024 results After-Market on May 15, 2024 Annuncio • Mar 27
Biofrontera Inc., Annual General Meeting, Jun 12, 2024 Biofrontera Inc., Annual General Meeting, Jun 12, 2024. Annuncio • Mar 09
Biofrontera Inc. to Report Q4, 2023 Results on Mar 15, 2024 Biofrontera Inc. announced that they will report Q4, 2023 results After-Market on Mar 15, 2024 Annuncio • Feb 23
Biofrontera Inc. announced that it has received $8 million in funding On February 22, 2024, Biofrontera Inc., closed the transaction. Annuncio • Feb 06
Biofrontera Inc. Announces FDA Filing of Supplemental New Drug Application for Ameluz(R) to Permit Up to Three Tubes Per Use Biofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a "no filing review issues identified" letter regarding the sNDA (supplementary New Drug Application) submitted by its licensor Biofrontera Bioscience GmbH to increase the maximally approved dosage from one to three tubes of Ameluz® per treatment. FDA has completed its filing review and will begin its substantive review of Biofrontera's communication. The sNDA is supported by two clinical phase I studies investigating the safety of the application of three tubes of Ameluz®. The first study investigated the blood levels of 5-aminolevulinic acid, the active ingredient in Ameluz®, and its active metabolite protoporphyrine IX (PpIX), in 32 patients. Blood concentrations of these compounds were determined at 14 time points before and up to 10 hours after treatment in two groups of patients: 16 receiving photodynamic therapy (PDT) and three tubes of Ameluz on the face or scalp, and 16 receiving PDT and 3 tubes of Ameluz on other parts of the body. Further to a Type A meeting with the FDA in 2021, an additional safety trial with 100 patients receiving PDT with three tubes of Ameluz® was conducted. This data also formed part of the sNDA. The studies showed that after application of three tubes the blood concentrations of the active ingredient and the metabolite are transiently increased but they were several magnitudes below those at which side effects are known to occur. The systemic and application site adverse events were similar to those observed with one tube of Ameluz®, with patients frequently experiencing a transient inflammatory response at the application site and pain during illumination that was managed by a cooling air stream. Annuncio • Jan 26
Nasdaq Determines to Grant Biofrontera Inc. an Extension of 180 Calendar Days from November 22, 2023 to Regain Compliance Reference is made to the Current Report on Form 8-K filed by Biofrontera Inc. (the “Company”) with the Securities and Exchange Commission on November 29, 2023 regarding the notice received by the Company from The Nasdaq Stock Market (“Nasdaq”) on November 22, 2023 that the Company was no longer in compliance with certain of Nasdaq’s continued listing requirements. On January 8, 2024, the Company submitted to Nasdaq a plan to regain compliance with those requirements. On January 19, 2024, Nasdaq notified the Company that, based on the Company’s compliance plan, Nasdaq has determined to grant the Company an extension of 180 calendar days from November 22, 2023 (i.e., by May 20, 2024) to regain compliance. Annuncio • Jan 17
Biofrontera Inc. has filed a Follow-on Equity Offering in the amount of $4.5 million. Biofrontera Inc. has filed a Follow-on Equity Offering in the amount of $4.5 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Warrants
Security Type: Equity Warrant
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Annuncio • Nov 30
Biofrontera Receives Non-Compliance Notice from Nasdaq Regarding Non-Compliance with the Continued Listing Requirement Under Nasdaq Listing Rule 5550(b)(1) On November 22, 2023, Biofrontera Inc. (the ‘Company’) received a notice (the ‘Notice’) from the Listing Qualifications staff of The Nasdaq Stock Market (‘Nasdaq’) notifying the Company that, because the Company’s stockholders’ equity as reported in its Quarterly Report on Form 10-Q for the period ended September 30, 2023 was $1,038,000, the Company is no longer in compliance with the continued listing requirement under Nasdaq Listing Rule 5550(b)(1), which requires that a listed company’s stockholders’ equity be at least $2,500,000. Additionally, as of the date of the Notice, the Company did not meet either of the alternative requirements of maintaining a market value of listed securities of $35 million or achieving a net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years. As a result, as of the date of this Report, the Company does not satisfy Nasdaq Marketplace Rule 5550(b). The Notice has no immediate effect on the listing or trading of the Company’s securities on the Nasdaq Capital Market. In accordance with Nasdaq rules, the Company has 45 calendar days from the date of the Notice to submit a plan to regain compliance with the Nasdaq Listing Rules. The Company intends to evaluate available options to regain compliance and timely submit a compliance plan to Nasdaq. If the Company’s compliance plan is accepted, the Company may be granted up to 180 calendar days from November 22, 2023 to evidence compliance. If the plan is not accepted, then the Company will have the opportunity to appeal that decision to a Nasdaq Hearings Panel. Annuncio • Nov 18
Biofrontera Inc., Annual General Meeting, Dec 20, 2023 Biofrontera Inc., Annual General Meeting, Dec 20, 2023, at 10:00 US Eastern Standard Time. Agenda: To elect two Class II directors to company's Board of Directors, to serve until the 2026 annual meeting of stockholders and until their successor has been duly elected and qualified, or until their earlier death, resignation or removal; to ratify the appointment of Marcum LLP as company's independent registered public accounting firm for the fiscal year ending December 31, 2023; and to transact such other business as may properly come before the 2023 Annual Meeting or any adjournment or postponement thereof. Annuncio • Nov 12
Biofrontera Inc. Reaffirms Revenue Guidance for the Full Year 2023 Biofrontera Inc. reaffirmed revenue guidance for the full year 2023. The company affirms expectations for full-year 2023 growth in revenue to be at least 25% compared with 2022. Annuncio • Nov 04
Biofrontera Inc. to Report Q3, 2023 Results on Nov 09, 2023 Biofrontera Inc. announced that they will report Q3, 2023 results After-Market on Nov 09, 2023 Annuncio • Oct 11
Biofrontera Inc. Receives FDA Approval for New Formulation of Ameluz(R) Biofrontera Inc. announced that its licensor Biofrontera Bioscience GmbH has received approval from the U.S. Food and Drug Administration (FDA) for a new formulation of Ameluz (aminolevulinic acid hydrochloride) for the treatment of actinic keratosis (AK). The new formulation is covered by the License and Supply Agreement between the two companies. The company anticip that the new formulation, which will be implemented in all U.S. Ameluz production beginning in 2024, will improve the safety profile of the topical gelby replacing propylene glycol, an ingredient common in semi-solid formulations, with ingredients already existing in Ameluz. The improved Ameluz formulation eliminates potential risks of propylene glycol due to the ingredient exhibiting allergic potential and reacting with other components, giving rise to contaminants accumulating over time. Biofrontera Biosci has filed a patent application to protect the new formulation given that the nanoemulsion without propylene glycol constitutes a novel invention. If granted, patent protection for Ameluz could be extended until at least 2043. The use of PDT with Ameluz (Ameluz-PDT) and RhodoLED lamps could be protected until 2040 by patents granted on the RhodoLED lamps and the associated procedure. Patent protection for Ameluz® itself currently expires in28, after which protection in the U.S. would rely on the lamp and procedure patents in the combination approval. These statements include, but are not limited to, statements relating to the effects and efficacy of the new formulation of Biofrontera Inc.'s (the "Company") licensed product Ameluz, the reduced risk of contaminants, the potential extension of patent protection for ameluz and the benefits of a new patent for Ameluz. Annuncio • Aug 29
Biofrontera Inc. Announces Positive Results from Phase 1 Safety Study Evaluating Photodynamic Therapy with Three Tubes of Ameluz(R) Biofrontera Inc. announced positive topline results from its non-randomized, open-label, multicenter Phase 1 study evaluating the safety and tolerability of 3 entire tubes of BF-200 ALA (Ameluz®) in the treatment of actinic keratosis (AK) on the face and scalp with photodynamic therapy using the RhodoLED® XL lamp. Of the 100 patients treated in 9 participating clinical centers, the incidences of Treatment Emergent Adverse Events (TEAEs) were consistent with the TEAEs listed in the US prescribing information (US PI) that are based on studies with 1 tube. The treatment was generally well tolerated and TEAEs were as expected due to the therapeutic principle of photodynamic therapy. All TEAEs were transient. In most cases, they resolved within 1 to 4 days after PDT, but occasionally persisted for 1 to 2 weeks or in a few cases even longer, similar to the TEAEs observed after single-tube PDT. No Serious Adverse Events (SAEs), deaths or other clinically relevant AEs were reported during the study and no subject discontinued the study due to a TEAE. With results demonstrating no additional safety or tolerability issues with 3 tubes, Biofrontera Inc. intends to present these findings to the U.S. Food and Drug Administration during the fourth quarter of this year. This Phase 1 study, conducted by Biofrontera Bioscience GmbH, follows a maximal-usage pharmacokinetics study presented to the FDA in 2021, upon which the FDA requested another safety study focusing on transient side effects before amending the product information, which currently limits use to one tube of Ameluz® per treatment. Additionally, following Biofrontera Inc.'s recent announcement of completed patient enrollment in the Phase 3 clinical study evaluating Ameluz®-PDT in combination with the BF-RhodoLED® lamp for the treatment of basal cell carcinoma, all patients in screening at the time have now been randomized. The study is now treating 187 patients, which is one patient more than agreed upon with the FDA. The last patient to complete the final assessment, which occurs three months after their final PDT, is expected in the first quarter of 2024. Annuncio • Aug 12
Biofrontera Inc. Affirms Guidance for 2023 Biofrontera Inc. affirms guidance for 2023 revenue growth of at least 25% compared with 2022. Annuncio • Aug 11
Biofrontera Inc. Announces Last Patient Enrolled in Phase 3 Clinical Study Evaluating Ameluz(R)-Pdt for the Treatment of Basal Cell Carcinoma Biofrontera Inc. 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. 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. Annuncio • Aug 05
Biofrontera Inc. to Report Q2, 2023 Results on Aug 11, 2023 Biofrontera Inc. announced that they will report Q2, 2023 results Pre-Market on Aug 11, 2023 New Risk • Jul 15
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 3 years. Trailing 12-month net loss: US$14m Forecast net loss in 3 years: US$9.1m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (21% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$9.1m net loss in 3 years). Shareholders have been diluted in the past year (41% increase in shares outstanding). Market cap is less than US$100m (€11.0m market cap, or US$12.4m). Annuncio • Jul 14
Biofrontera Inc. Provides Preliminary Revenue Guidance for the Second Quarter, First Half and Full-Year of 2023 Biofrontera Inc. provided preliminary revenue guidance for the second quarter, first half and full-year of 2023. For the second quarter, the company anticipated Revenues to be in the range of approximately $5.7 million to $5.9 million, an increase of approximately 26% to 31% compared with the second quarter of 2022.For the first half, the company anticipated revenue to be in the range of approximately $14.4 million to $14.6 million, representing growth of approximately 1% to 3% compared with the first half of 2022.For the full year, the company affirms its previously announced expectations for full-year 2023 growth in revenue to be at least 25% compared with 2022. Annuncio • Jul 13
Biofrontera Inc. Appoints Heikki Lanckriet to Its Board of Directors Biofrontera Inc. announced the appointment of Heikki Lanckriet, Ph.D. to its board of directors. Dr. Lanckriet brings to the company more than 20 years of commercial and scientific experience in the life sciences industry, along with proven success in developing high-growth technology companies. Dr. Lanckriet was nominated to the company's board of directors by Biofrontera AG under the terms of the April 2023 settlement agreement between the two companies previously disclosed in the company's Current Report on Form 8-K filed with the Securities and Exchange Commission on April 17, 2023. Dr. Lanckriet currently serves as a member of Biofrontera AG's Supervisory Board. Dr. Lanckriet currently serves as chief executive officer and chief scientific officer of 4basebio PLC, UK. In 2020 Heikki led the sale of Expedeon's proteomics and immunology business to Abcam PLC. Earlier, Dr. Lanckriet was Founder and Chief Scientific Officer of Novexin, later transitioning to Chief Operating Officer. Dr. Lanckriet also held roles as Chief Executive Officer and Chief Scientific Officer at 2invest AG and Sygnis AG. Dr. Lanckriet holds a Ph.D. in Chemical Engineering from the University of Cambridge in the U.K. and a M.Eng. in Chemical Engineering from the University of Ghent in Belgium. He has authored several scientific papers that have been published in peer-reviewed medical and scientific journals, and is a named inventor on a multitude of patents. Annuncio • Jul 04
Biofrontera Announces 1-For-20 Reverse Stock Split to Bring the Company into Compliance with Nasdaq's Minimum Bid Price Requirement for Continued Listing Biofrontera Inc. ("Biofrontera" or the "Company"), announced that it will effect a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-20 that will become effective after the close of trading at 11:59 p.m. July 03, 2023. Biofrontera Inc. common stock will begin trading on Nasdaq on a split-adjusted basis when the market opens on July 5, 2023 under the existing symbol, BFRI, and under a new CUSIP number, 09077D 209. Upon effectiveness of the reverse stock split, every 20 shares of Biofrontera Inc. common stock issued and outstanding will be automatically combined into one share of common stock. Outstanding equity-based awards and other equity rights will be proportionately adjusted. No fractional shares will be issued as a result of the reverse stock split. Stockholders otherwise entitled to receive a fractional share as a result of the reverse stock split will automatically receive an additional fraction of a share of common stock to round up to the next whole share. The Company's publicly traded warrants will continue to be traded on Nasdaq under the symbol "BFRIW" and the CUSIP number for the warrants will remain unchanged. However, under the terms of the applicable warrant agreement, the number of shares of common stock issuable on exercise of each warrant will be proportionately decreased. Specifically, on a split-adjusted basis, every 20 shares of common stock that may be purchased pursuant to the exercise of public warrants now represents one share of common stock that may be purchased pursuant to such warrants. Accordingly, for the Company's warrants trading under the symbol "BFRIW", every 20 warrants will be exercisable for one share of common stock at an exercise price of $100.00 per share. This reverse stock split is primarily intended to bring the Company into compliance with Nasdaq's minimum bid price requirement for continued listing. "This reverse stock split, which was approved by our shareholders and authorized by our Board of Directors, should allow Biofrontera to regain compliance with Nasdaq's continued-listing requirements. Additionally, we believe the post-split stock price may make an investment in Biofrontera more attractive to a broader group of investors," commented Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc. Annuncio • May 29
Biofrontera Notifies Nasdaq Regarding its No Longer in Compliance with Nasdaq Listing Rule 5605(c)(2)(A) On May 23, 2023, Biofrontera Inc. notified Nasdaq that, as a result of the resignation of Loretta Wedge as a member of the Board of Directors (the ‘Board’) of the Company and as chairperson of the Audit Committee, the company was no longer in compliance with Nasdaq Listing Rule 5605(c)(2)(A), which requires that the audit committee of a listed company be composed of at least three independent directors and that at least one member of the audit committee is a financial expert. On May 25, 2023, John Borer, a member of the Board, was appointed to the audit committee. The Board has determined that Mr. Borer is an ‘audit committee financial expert’ as defined in Item 407(d)(5)(ii) of Regulation S-K promulgated under the Securities Act of 1933, as amended, and that, as of January 1, 2023, Mr. Borer is deemed ‘independent’ under the additional, more stringent requirements under the Nasdaq rules for purposes of audit committee membership. Reported Earnings • May 14
First quarter 2023 earnings released: US$0.28 loss per share (vs US$0.33 profit in 1Q 2022) First quarter 2023 results: US$0.28 loss per share (down from US$0.33 profit in 1Q 2022). Revenue: US$8.73m (down 10% from 1Q 2022). Net loss: US$7.48m (down 235% from profit in 1Q 2022). Revenue is forecast to grow 32% p.a. on average during the next 3 years, compared to a 3.8% growth forecast for the Pharmaceuticals industry in Germany. Annuncio • May 13
Biofrontera Inc. Announces Resignation of Erica Monaco, Chief Executive Officer Biofrontera Inc. announced that on May 8, 2023, Erica Monaco, Chief Executive Officer of the Company notified the Company’s Board of Directors that she intends to resign from the Company to pursue other opportunities. The Company and Ms. Monaco have agreed to discuss an appropriate transition period, including the effective date of her resignation. Board Change • May 10
Less than half of directors are independent There are 4 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 4 new directors. No experienced directors. 1 highly experienced director. 2 independent directors (3 non-independent directors). Executive Chairman & President Hermann Lubbert is the most experienced director on the board, commencing their role in 2015. Independent Director Beth Hoffman was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of experienced directors. Board Change • Apr 21
Less than half of directors are independent There are 4 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 4 new directors. No experienced directors. 1 highly experienced director. 2 independent directors (3 non-independent directors). Executive Chairman & President Hermann Lubbert is the most experienced director on the board, commencing their role in 2015. Independent Director Beth Hoffman was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of experienced directors. Reported Earnings • Mar 10
Full year 2022 earnings released: US$0.024 loss per share (vs US$4.28 loss in FY 2021) Full year 2022 results: US$0.024 loss per share (improved from US$4.28 loss in FY 2021). Revenue: US$28.7m (up 19% from FY 2021). Net loss: US$640.0k (loss narrowed 98% from FY 2021). Revenue is forecast to grow 28% p.a. on average during the next 2 years, compared to a 3.3% growth forecast for the Pharmaceuticals industry in Germany. Board Change • Feb 23
Less than half of directors are independent There are 4 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 4 new directors. 1 experienced director. No highly experienced directors. 2 independent directors (3 non-independent directors). Executive Chairman & President Hermann Lubbert is the most experienced director on the board, commencing their role in 2015. Independent Director Beth Hoffman was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of experienced directors. Breakeven Date Change • Jan 13
Forecast breakeven date pushed back to 2024 The 2 analysts covering Biofrontera previously expected the company to break even in 2022. New consensus forecast suggests losses will reduce by 40% per year to 2023. The company is expected to make a profit of US$17.9m in 2024. Average annual earnings growth of 61% is required to achieve expected profit on schedule. Annuncio • Nov 22
Biofrontera Inc. to Launch Phase 3 Clinical Study Evaluating Ameluz(R)-PDT for the Treatment of Actinic Keratosis on the Extremities, Neck and Trunk Biofrontera Inc. announced the launch of a randomized, double- blind, vehicle-controlled, multicenter Phase 3 clinical study to evaluate the safety and efficacy of Ameluz(R) and BF- RhodoLED(R) 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(R) XL, a red-light lamp approved by the U.S. Food and Drug Administration (FDA) for use in PDT in combination with Ameluz(R) (Ameluz(R) -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 strategy to gain market share by expanding the label for Ameluz(R) -PDT beyond the treatment of AK on the face and scalp. Ameluz(R) and the BF-RhodoLED(R) lamps, through Biofrontera Inc.'s license and supply agreement with Biofrontera AG, are also undergoing clinical testing in three additional indications: Phase 3 3 clinical study in the U.S. evaluating Ameluz(R)-PDT utilizing the BF-RhodoLED(R) lamp for the treatment of superficial basal cell carcinoma. A multicenter, randomized, double-blind Phase 2 clinical study evaluating the efficacy of Ameluz(R)-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(R) XL lamp and three tubes of Ameluz(R). Breakeven Date Change • Nov 21
Forecast breakeven date moved forward to 2022 The 2 analysts covering Biofrontera previously expected the company to break even in 2024. New consensus forecast suggests the company will make a profit of US$860.0k in 2022. Earnings growth of 62% is required to achieve expected profit on schedule. Board Change • Nov 21
Less than half of directors are independent There are 4 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 4 new directors. 1 experienced director. No highly experienced directors. 2 independent directors (3 non-independent directors). Executive Chairman & President Hermann Lubbert is the most experienced director on the board, commencing their role in 2015. Independent Director Beth Hoffman was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of experienced directors. Annuncio • Nov 15
Biofrontera Inc. Revises Revenue Guidance for the Year 2022 Biofrontera Inc. revised revenue guidance for the year 2022. The company is revising its previously announced financial guidance for 2022, as follows: Total revenues for 2022 are expected to increase between 24% and 31% compared with 2021, including typical seasonal strength in the first and fourth quarters. Annuncio • Nov 11
Biofrontera Inc. to Report Q3, 2022 Results on Nov 14, 2022 Biofrontera Inc. announced that they will report Q3, 2022 results at 9:30 AM, US Eastern Standard Time on Nov 14, 2022 Annuncio • Nov 09
Biofrontera Inc., Annual General Meeting, Dec 12, 2022 Biofrontera Inc., Annual General Meeting, Dec 12, 2022, at 09:00 US Eastern Standard Time. Agenda: To elect one Class I director to our board of directors, to serve until the 2025 annual meeting of stockholders and until their successor has been duly elected and qualified, or until their earlier death, resignation or removal; to approve the amendment to our 2021 Omnibus Incentive Plan to increase the total number of shares of common stock authorized for issuance thereunder by 2,589,800 shares; to ratify the appointment of Grant Thornton LLP as our independent registered public accounting firm for the fiscal year ending December 31, 2022; and to transact such other business as may properly come before the 2022 Annual Meeting or any adjournment or postponement thereof. Annuncio • Oct 25
Biofrontera Inc. Names Fred Leffler as Chief Financial Officer Biofrontera Inc. announced the appointment of Fred Leffler as Chief Financial Officer, effective immediately. Mr. Leffler is an experienced financial executive with 15 years of leadership, financial management, consultancy and operations experience across a range of private and public organizations, including growth-stage, private equity and Fortune 100 companies. Most recently, Mr. Leffler was a Senior Manager at McKinsey & Company in Boston, having served in a similar capacity in their Washington, D.C. office earlier in his career. Previously, he was a Senior Director at FTI Consulting in their Corporate Finance and Restructuring group, a Vice President at the boutique global investment firm RockCreek, and held various financial positions at General Electric and Sun Edison. Mr. Leffler received a BSBA in finance and economics from The Ohio State University Fisher School of Business, and an MBA from Duke University's Fuqua School of Business. Annuncio • Oct 06
Biofrontera Inc. Reports Preliminary Product Revenues for the Third Quarter and Nine Months Ended September 30, 2022 Biofrontera Inc. reported preliminary product revenues for the third quarter and nine months ended September 30, 2022. Product revenues for the third quarter of 2022 are anticipated to be approximately $4.3 million, consistent with the third quarter of 2021.These projections result in product revenues for the first nine months of 2022 expected to be approximately $18.5 million up approximately 24% compared with the first nine months of 2021. Year-to-date 2022 product revenues are at a record high, and are up approximately 26% over the comparable period in the pre-Covid year 2019. Annuncio • Sep 14
Biofrontera Inc. Appoints Gerard Digirolamo as National Sales Director Biofrontera Inc. announced the appointment of Gerard DiGirolamo as National Sales Director. In this newly created position, Mr. DiGirolamo will report to Mark Baldyga, Biofrontera's Head of Sales & Marketing, and will help execute the Company's U.S. sales division and objectives including the strategic design, expansion and leadership of its sales team. Gerard will oversee recruiting and staffing to support Ameluz(R), BF- RhodoLED(R) and Xepi(R) commercial efforts, as well as spearhead planning for the launch of BF-RhodoLED XL(R) .Mr. DiGirolamo brings to Biofrontera more than 25 years of experience in building pharmaceutical sales and commercial teams with a particular expertise in dermatology. Most recently he served as Vice President of Sales at Verrica Pharmaceuticals, a medical dermatology company where he built their U.S. sales infrastructure in preparation for a commercial launch of its drug-device combination product for the treatment of molluscum contagiosum. This provides valuable experience for working with Biofrontera's combination of Ameluz(R) and the RhodoLED(R) lamps. "Gerard's insight and understanding of the dermatology market, along with the many relationships he's cultivated within industry will be extremely valuable in working with Mark Baldyga on the successful implementation of commercial strategy. His approach involving collaborating with medical affairs, marketing, key opinion leaders and national influencers through advisory boards and conferences fully aligns with mission. Gerard is passionate about building cohesive and collaborative teams that have led to successful product launches and market-share gains. Mr. DiGirolamo was a Field Vice President at GlaxoSmithKline (GSK) and previously spent 16 years with Stiefel, now part of GSK. At GSK he worked with multiple dermatology brands and exceeded sales forecasts including for the launch of Fabior Foam(R), a treatment for psoriasis and acne. As Executive National Account Manager at Stiefel he led negotiations with national managed care organizations, securing unrestricted access to the acne therapy Duac CS(TM) and coverage of the seborrheic dermatitis therapies Extina(TM) and Xologel(TM) . Prior to Stiefel, Gerard was an Area and District Sales Manager at Novartis. Mr. DiGirolamo holds a B.A. from Rutgers University. Reported Earnings • Aug 13
Second quarter 2022 earnings released: US$0.045 loss per share (vs US$0.46 loss in 2Q 2021) Second quarter 2022 results: US$0.045 loss per share (up from US$0.46 loss in 2Q 2021). Revenue: US$4.46m (down 24% from 2Q 2021). Net loss: US$850.0k (loss narrowed 77% from 2Q 2021). Over the next year, revenue is forecast to grow 58%, compared to a 6.3% growth forecast for the industry in Germany. Annuncio • Aug 13
Biofrontera Inc. Provides Earnings Guidance for the Fiscal Year of 2022 Biofrontera Inc. provided earnings guidance for the fiscal year of 2022. For the period, the company expects total revenues to increase by at least 30% compared with 2021, including typical seasonal strength in the first and fourth quarters. Annuncio • Aug 05
Biofrontera Inc. to Report Q2, 2022 Results on Aug 12, 2022 Biofrontera Inc. announced that they will report Q2, 2022 results Pre-Market on Aug 12, 2022 Annuncio • Jul 13
Biofrontera Inc. Provides Revenue Guidance for the Second Quarter and Six Months Ended June 30, 2022 Biofrontera Inc. provided revenue guidance for the second quarter and six months ended June 30, 2022. As anticipated because of the effect of a price increase, product revenues for the second quarter of 2022 are expected to be in the range of approximately $4.4 million to $4.6 million, representing a decrease of approximately 21% to 25% compared with the second quarter of 2021.For the first half of 2022, product revenues are anticipated to be in the range of approximately $14.1 million to $14.3 million, representing an increase of approximately 34% to 36% compared with the first half of 2021. This represents the strongest first six-month revenues of a year Biofrontera ever had, 102-105% higher than in 2020 and 22-24% higher than the pre-Covid year 2019. Annuncio • Jun 26
Biofrontera Inc.(NasdaqCM:BFRI) dropped from Russell Microcap Value Index Biofrontera Inc.(NasdaqCM:BFRI) dropped from Russell Microcap Value Index Annuncio • May 26
Biofrontera Inc. Appoints Kevin D. Weber to the Nominating and Corporate Governance, Audit and Compensation Committees On May 18, 2022, the board of directors of the Biofrontera Inc. appointed Kevin D. Weber to the Nominating and Corporate Governance, Audit and Compensation committees of the board of directors, effective as of May 18, 2022. Annuncio • May 24
Biofrontera Inc. announced that it has received $9.40068 million in funding On May 23, 2022, Biofrontera Inc. closed the transaction. The round included participation from one investor. The company raised $9,400,681 in the transaction. Annuncio • May 18
Biofrontera Inc. announced that it expects to receive $9.40225 million in funding Biofrontera Inc. announced that it has entered into a securities purchase agreement with a single institutional investor for a private placement of 3,419,000 shares and warrants to purchase up to an aggregate of 3,419,000 shares at a price of $2.75 per share for gross proceeds of $9,402,250 on May 16, 2022. The warrants have an exercise price of $2.77 per share, will be immediately exercisable, and will expire six years, and will expire five and one-half years from the issuance date. from the issuance date. The transaction is expected to close on or about May 17, 2022, subject to the satisfaction of customary closing conditions. The securities are being issued under Section 4(a)(2) of the Securities Act of 1933, as amended and Regulation D promulgated thereunder. Reported Earnings • May 15
First quarter 2022 earnings released: EPS: US$0.33 (vs US$0.44 loss in 1Q 2021) First quarter 2022 results: EPS: US$0.33 (up from US$0.44 loss in 1Q 2021). Revenue: US$9.75m (up 106% from 1Q 2021). Net income: US$5.56m (up US$9.10m from 1Q 2021). Profit margin: 57% (up from net loss in 1Q 2021). Over the next year, revenue is forecast to grow 60%, compared to a 6.2% growth forecast for the industry in Germany. Annuncio • May 14
Biofrontera Inc. Re-Affirms Earnings Guidance for 2022 Biofrontera Inc. re-affirmed earnings guidance for 2022. The company maintains its previously announced financial guidance for 2022, as total revenues are expected to increase by at least 30% compared with 2021, including typical seasonal strength in the first and fourth quarters. The commercial focus throughout 2022 will be on achieving deeper sales penetration among current customer accounts, with additions to the Biofrontera sales force expected to begin in 2023. Annuncio • May 07
Biofrontera Inc. to Report Q1, 2022 Results on May 13, 2022 Biofrontera Inc. announced that they will report Q1, 2022 results Pre-Market on May 13, 2022 Board Change • Apr 28
Less than half of directors are independent There are 4 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 4 new directors. 1 experienced director. No highly experienced directors. 2 independent directors (3 non-independent directors). Executive Chairman & President Hermann Lubbert is the most experienced director on the board, commencing their role in 2015. Independent Director Beth Hoffman was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of experienced directors. Reported Earnings • Apr 09
Full year 2021 earnings released: US$4.28 loss per share (vs US$479 loss in FY 2020) Full year 2021 results: US$4.28 loss per share. Revenue: US$24.1m (up 28% from FY 2020). Net loss: US$37.7m (loss widened 243% from FY 2020). Over the next year, revenue is forecast to grow 76%, compared to a 7.9% growth forecast for the pharmaceuticals industry in Germany. Breakeven Date Change • Apr 08
Forecast to breakeven in 2023 The 2 analysts covering Biofrontera expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$447.0k in 2023. Average annual earnings growth of 82% is required to achieve expected profit on schedule. Board Change • Apr 08
High number of new and inexperienced directors There are 4 new directors who have joined the board in the last 3 years. The company's board is composed of: 4 new directors. 1 experienced director. No highly experienced directors. Executive Chairman & President Hermann Lubbert is the most experienced director on the board, commencing their role in 2015. The company’s lack of experienced directors is considered a risk according to the Simply Wall St Risk Model.