Last Patient Completes Biofrontera’s Phase 1 Pharmacokinetics Study of Ameluz® for Treatment of Actinic Keratoses on the Trunk and Extremities

Rhea-AI Summary

Biofrontera (Nasdaq: BFRI) completed the final patient visit in a Phase 1 pharmacokinetic study of Ameluz gel 10% for treatment of mild-to-moderate actinic keratoses on the neck, trunk and extremities; the last visit occurred on 24 November 2025.

Under maximal-use conditions three tubes were applied to ~240 cm2; 17 patients received one PDT treatment and blood samples were collected over 10 hours to assess systemic ALA and PpIX exposure. Data plus a completed Phase 3 will form the basis for a planned sNDA submission in Summer 2026 to expand Ameluz labeling to peripheral body areas.

Positive

• Phase 1 last patient visit on 24 November 2025
• Study used maximal-use conditions: 3 tubes on ~240 cm2
• 17 patients dosed with PK sampling over 10 hours
• Data to support planned sNDA submission Summer 2026

Negative

• sNDA submission is conditional on positive outcomes from this trial and Phase 3
• Phase 1 cohort size was 17 patients, a limited sample for systemic PK assessment

Key Figures

Ameluz usage 3 tubes Maximal-use Phase 1 PK study application per treatment

Treatment area 240 cm² Surface area treated under maximal-use conditions in Phase 1

Patients treated 17 patients Phase 1 PK study of Ameluz® on peripheral body areas

PK sampling window 10 hours Blood sampling duration after Ameluz® application

Planned sNDA timing Summer 2026 Target timing for sNDA to expand Ameluz® peripheral AK label

Current price $0.8129 Price before this news, <b>56.53%</b> below 52-week high

52-week range $0.536–$1.87 Pre-news 52-week low and high for BFRI

Market cap $9,466,592 Equity value prior to the Phase 1 PK milestone release

Market Reality Check

$0.0900 Last Close

Volume Volume 16,377 is at 0.12x the 20-day average of 136,114, indicating muted trading interest ahead of this milestone news. low

Technical Shares trade below the 200-day MA of 0.85 with the stock at 0.8129, remaining well under the 1.87 52-week high.

Peers on Argus 1 Up

Peer moves are mixed: names like EVOK, IMCC, SNOA and YCBD show small gains (up to 1.21%), while SBFM is down 0.68%. Only one peer (FLGC) appears in momentum scanners, up 5.18% without news, suggesting BFRI’s move around this trial update is stock-specific rather than a broad sector rotation.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 04	Phase 1 completion	Positive	+3.2%	Last patient visit completed in Phase 1 PK study for peripheral AKs.
Dec 02	sNDA filing	Positive	-0.1%	sNDA filed for Ameluz-PDT in superficial basal cell carcinoma with strong Phase 3 data.
Nov 13	Earnings update	Negative	-8.6%	Q3 2025 revenues declined and liquidity concerns raised with going-concern language.
Nov 07	Asset sale	Positive	-6.9%	Sale of Xepi license for up to $10M to support PDT platform growth.
Nov 06	Earnings date set	Neutral	+6.4%	Announcement of Q3 2025 reporting date and related conference call details.

Pattern Detected

News tied directly to core Ameluz clinical progress often saw modest positive reactions, while strategic or asset-sale news produced sharper negative moves, indicating sensitivity to financing and portfolio changes.

Recent Company History

Over the last months, Biofrontera has focused on expanding Ameluz® across indications and body areas. Clinical milestones included Phase 3 progress in actinic keratoses on extremities, neck and trunk and strong Phase 3 data in superficial basal cell carcinoma, alongside acne development work. Financially, Q3 2025 results showed revenue softness and liquidity pressure, partially offset by the Xepi® asset sale and acquisition of U.S. Ameluz/RhodoLED rights. Today’s Phase 1 PK completion on peripheral AKs continues this label-expansion trajectory toward a planned Summer 2026 sNDA.

Market Pulse Summary

This announcement marks completion of the final patient visit in a Phase 1 pharmacokinetic study of Ameluz® for actinic keratoses on peripheral body areas, supporting a planned Summer 2026 sNDA. It builds on prior Phase 3 progress in the same indication and strong data in superficial basal cell carcinoma, reinforcing Biofrontera’s strategy to broaden Ameluz®’s label. Investors may watch for full PK results, Phase 3 readouts, and upcoming regulatory interactions as key validation points for this expansion path.

Key Terms

pharmacokinetic medical

"Phase 1 pharmacokinetic (PK) study of Ameluz® (aminolevulinic acid..."

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

photodynamic therapy medical

"a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT)"

Photodynamic therapy is a medical treatment that uses a special light-sensitive substance and a specific type of light to target and destroy abnormal or diseased cells, often in cancer treatment. It is important to investors because advances in this technology can lead to new, minimally invasive treatment options, potentially expanding healthcare markets and driving growth for biotech companies involved in developing such therapies.

actinic keratoses medical

"for the treatment of mild to moderate actinic keratoses (AKs) on the neck, trunk and extremities"

Actinic keratoses are rough, scaly patches or spots that develop on the skin after long-term exposure to sunlight. Although they are usually harmless, they can sometimes progress into skin cancer if left untreated. For investors, understanding health-related issues like this is important because they can impact companies involved in healthcare, pharmaceuticals, and aging-related products and services.

supplemental New Drug Application regulatory

"will form the basis of a planned supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration"

A supplemental new drug application is a request submitted to regulatory authorities to make changes to an existing approved medication, such as adding new uses, strengths, or formulations. For investors, it signals that a pharmaceutical company is seeking approval for new product developments or expanded applications, which can impact the company's future sales, market potential, and stock value.

protoporphyrin IX medical

"ALA and its metabolite protoporphyrin IX (PpIX) during Ameluz®-PDT of the upper extremities"

Protoporphyrin IX is a naturally occurring molecule that acts as the final building block before iron is added to form heme, the iron-containing core of hemoglobin and many cellular enzymes — imagine the last puzzle piece waiting for the metal centerpiece. Abnormal levels can indicate blood disorders or mitochondrial dysfunction and the molecule is used as a diagnostic marker and a light-activated agent in some therapies, so changes in its measurement or drugs affecting its pathway can influence diagnostics, therapeutics and related company value.

photodynamic therapy (PDT) medical

"Ameluz®-PDT has already proven to be a valuable option for the treatment of AKs"

Photodynamic therapy (PDT) is a medical treatment that uses special light-sensitive drugs and a light source to target and destroy abnormal or cancerous cells. It works like a precise spotlight, activating the drug only in the affected area to minimize damage to surrounding tissue. While primarily a health care method, its development and adoption can influence biotech and pharmaceutical markets, making it relevant for investors tracking advancements in medical technology.

AI-generated analysis. Not financial advice.

• Phase 1 Maximal-use Phase 1 study evaluated pharmacokinetic (PK) profile following application of 3 tubes of Ameluz^® over treatment area of 240 cm²
• Completion of this study marks a key milestone towards a planned summer 2026 FDA submission for FDA approval for the use of Ameluz^® on all non-face and scalp areas

WOBURN, Mass., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced the completion of the final patient visit in its Phase 1 pharmacokinetic (PK) study of Ameluz^® (aminolevulinic acid hydrochloride) gel, 10%, for the treatment of mild to moderate actinic keratoses (AKs) on the neck, trunk and extremities (peripheral body areas). 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. Under maximal use conditions, three tubes of Ameluz^® were applied to a treatment area of approximately 240 cm². Seventeen patients received one PDT treatment and blood samples were taken over the 10 hours following the application of Ameluz^® to assess the systemic exposure to ALA and PpIX.

“We are delighted to reach this important clinical milestone” said Dr. Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “Completion of this Phase 1 study is a key step toward expanding the use of Ameluz^® to treat Actinic Keratoses on the extremities, neck and trunk. If approved this label extension would not only provide meaningful benefits for patients but would be an immense step forward toward our vision to become market leaders in the field of PDT in dermatology.”

Dr. Ted Lain, board-certified dermatologist, Chief Medical Officer of Sanova Dermatology, Executive Director for the Austin Institute for Clinical Research (AICR) and a key contributor to the Phase 1 study stated “Ameluz^® PDT has already proven to be a valuable option for the treatment of AKs on the face and scalp. We see many patients who have these lesions on other areas of the body, and I look forward to potentially having this as an approved option for my patients.”

Pending positive outcomes of this trial and the corresponding Phase III study, the company plans to submit a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) in the Summer of 2026.

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.¹

1. https://www.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 X.

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 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; the ability of the Company’s manufacturing partners to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether any 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 the coverage, reimbursement and pricing for procedures using the Company’s 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. 

Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com

FAQ

What did Biofrontera (BFRI) announce on December 4, 2025 about Ameluz?

Biofrontera announced completion of the final patient visit in a Phase 1 PK study for Ameluz on peripheral body areas, with the last visit on 24 Nov 2025.

How many patients were enrolled in Biofrontera's Phase 1 Ameluz PK study (BFRI)?

Seventeen patients received one PDT treatment and had blood samples taken over 10 hours.

What were the dosing and maximal-use conditions in the Ameluz Phase 1 study (BFRI)?

Under maximal-use conditions three tubes of Ameluz were applied to a treatment area of approximately 240 cm2.

When does Biofrontera plan to submit the sNDA to the FDA for Ameluz (BFRI)?

The company plans to submit a supplemental New Drug Application to the FDA in Summer 2026, pending positive study outcomes.

What measurements did the Phase 1 Ameluz study collect for Biofrontera?

The study assessed systemic exposure to ALA and its metabolite PpIX via blood sampling over a 10-hour post-application period.