Biofrontera Inc. Announces Data Base Locks for Two Clinical Studies Supporting Key Data and Regulatory Milestones

Rhea-AI Summary

Biofrontera (Nasdaq: BFRI) announced that the databases for its Phase 3 actinic keratosis (AK) study and Phase 2 acne vulgaris study of Ameluz PDT were locked on January 5, 2026, enabling unblinding and statistical analysis. The company expects topline data for both studies in February 2026. Pending positive AK results, Biofrontera plans an sNDA submission in Summer 2026 to expand Ameluz PDT use beyond face and scalp. Phase 2 acne results are planned for FDA discussion in early Q3 2026 to inform a future Phase 3 program.

Positive

• Databases for Phase 3 AK and Phase 2 acne studies locked on Jan 5, 2026
• Topline data expected for both studies in February 2026
• Planned sNDA submission in Summer 2026 if Phase 3 AK results are positive

Negative

• Acne program currently at Phase 2; a Phase 3 program is required for approval
• One-year follow-up of the Phase 3 AK study is ongoing and not yet complete

Key Figures

Database lock date January 5, 2026 Treatment-phase databases locked for Phase 3 AK and Phase 2 acne studies

Phase 3 AK study Phase 3 Ameluz PDT for actinic keratosis on extremities, neck and trunk

Phase 2 acne study Phase 2 Ameluz PDT for moderate to severe acne vulgaris

Data timing February 2026 Company expects data for both AK and acne studies

Planned AK sNDA Summer 2026 Target timing to submit sNDA for AK beyond face and scalp

Acne FDA interaction Early Q3 2026 Planned FDA meeting to discuss Phase 2 acne results and Phase 3 program

sBCC sNDA submission December 2025 sNDA for superficial basal cell carcinoma with Ameluz PDT submitted

AK follow-up duration 1-year follow-up Ongoing Phase 3 AK study follow-up, not required for FDA approval

Market Reality Check

$0.8245 Last Close

Volume Volume 29,265 is far below 20-day average 403,399 (relative volume 0.07). low

Technical Price 0.798 trades below 200-day MA at 0.84, sitting between 52-week low 0.536 and high 1.87.

Peers on Argus

Peers show mixed moves: EVOK and SBFM up, IMCC flat, SNOA and YCBD down. No momentum scanner flags or same-day peer news, suggesting today’s clinical milestone for BFRI is stock-specific rather than a coordinated sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 18	Regulatory transfer	Positive	+5.6%	Completed transfer of Ameluz and RhodoLED FDA approvals and IP portfolio.
Dec 04	Clinical milestone	Positive	+3.2%	Last patient completed Phase 1 PK study for Ameluz in AK on trunk and extremities.
Dec 02	sNDA submission	Positive	-0.1%	Filed sNDA with FDA for Ameluz-PDT in superficial basal cell carcinoma.
Nov 13	Earnings update	Negative	-8.6%	Reported Q3 2025 revenue decline, losses, tight liquidity and going-concern doubt.
Nov 07	Asset divestiture	Positive	-6.9%	Sold Xepi U.S. license for up to $10M to refocus on PDT platform growth.

Pattern Detected

Recent positive strategic and clinical updates often saw supportive price reactions, but some constructive milestones (sNDA filing, asset sale) coincided with short-term downside, indicating occasional divergence between news quality and near-term trading.

Recent Company History

Over the past few months, Biofrontera has advanced Ameluz® clinically and strategically. In November–December 2025 it filed an sNDA for superficial BCC with strong Phase 3 data, completed a Phase 1 PK study for AK expansion, and finished transferring Ameluz and RhodoLED FDA approvals alongside IP backed by an $11.0M investment. Financially, Q3 2025 results showed revenue pressure and a going‑concern warning. Today’s database locks for Phase 3 AK and Phase 2 acne trials extend this pattern of execution on the PDT pipeline despite a challenged balance sheet.

Market Pulse Summary

This announcement marks database locks for Biofrontera’s Phase 3 AK and Phase 2 acne studies, setting up key data and FDA interactions in 2026. Historically, clinical‑trial milestones for Ameluz® have been frequent catalysts, while financial filings have underscored liquidity constraints. Investors may watch upcoming readouts, timing of the planned AK sNDA, and design of any acne Phase 3 program, alongside progress on profitability and capital structure, to gauge how effectively the PDT franchise is being expanded.

Key Terms

database lock technical

"today announced the successful database lock of two clinical studies"

A database lock is the point in a clinical trial when the collected study data are finalized and no further changes or corrections are allowed, so analysts can run the official statistical tests. For investors this matters because it usually precedes public results or regulatory filings—think of it like sealing and signing off an exam before grading: once locked, the timing and content of the readout become clearer and uncertainty about last-minute data edits is reduced.

photodynamic therapy (PDT) medical

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

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.

actinic keratosis medical

"Phase 3 clinical study evaluating Ameluz PDT for the treatment of actinic keratosis (AK)"

Actinic keratosis is a rough, scaly patch on the skin caused by long-term sun exposure that is considered a precancerous lesion because it can sometimes progress to skin cancer. For investors, its importance lies in the size of the patient pool, clinical trial outcomes, and regulatory approvals for drugs or devices—think of it as a frayed area in fabric that may need repair to prevent a much larger tear, driving demand for treatments and diagnostics.

acne vulgaris medical

"Phase 2 clinical study evaluating the treatment of moderate to severe acne vulgaris"

A common inflammatory skin condition that causes pimples, blackheads, whiteheads and sometimes deeper cysts, usually where oil glands are abundant such as the face, chest and back. It matters to investors because the large and recurring patient need drives demand for prescription drugs, over‑the‑counter treatments, dermatology devices and cosmetic procedures; treatment advances, clinical trial results or regulatory approvals can meaningfully affect sales, market share and valuation of healthcare and consumer companies.

supplemental New Drug Application (sNDA) regulatory

"plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food"

A supplemental new drug application (snda) is a formal request made to regulatory authorities to make changes to an already approved medication, such as adding new uses, adjusting dosages, or improving manufacturing processes. It’s similar to updating a product’s packaging or instructions after it has been approved for sale. For investors, an snda signals ongoing development or improvements that could impact a company’s future sales or regulatory approval prospects.

U.S. Food and Drug Administration (FDA) regulatory

"submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA)"

The U.S. Food and Drug Administration (FDA) is a government agency responsible for protecting public health by ensuring the safety and effectiveness of food, medicines, vaccines, and other health-related products. For investors, the FDA’s decisions can significantly impact companies in the healthcare and food industries, as approval or rejection of products can influence a company's success and stock performance.

superficial Basal Cell Carcinoma (sBCC) medical

"sNDA for the treatment of superficial Basal Cell Carcinoma (sBCC) with Ameluz PDT"

A superficial basal cell carcinoma (sBCC) is a common, slow-growing form of skin cancer that stays near the surface of the skin, often appearing as a scaly or reddish patch rather than a deep lump. Investors care because its high prevalence and tendency to be treated with topical drugs, minor procedures or recurring therapy creates steady demand, clinical trial opportunities and regulatory milestones that can materially affect companies focused on dermatology treatments.

AI-generated analysis. Not financial advice.

• Database locks for studies on actinic keratosis (AK) and acne vulgaris achieved on January 5, 2026
• Data generated will support key regulatory milestones for Ameluz PDT in both indications
• AK and acne are the two most commonly diagnosed skin disorders in the US¹
  

WOBURN, Mass., Jan. 08, 2026 (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 successful database lock of two clinical studies evaluating Ameluz^® PDT, marking an important milestone ahead of several anticipated data and regulatory events in 2026.

The databases for the treatment phase of the Company’s Phase 3 clinical study evaluating Ameluz^® PDT for the treatment of actinic keratosis (AK) on the extremities, neck and trunk as well as its Phase 2 clinical study evaluating the treatment of moderate to severe acne vulgaris were successfully locked on January 5, 2026.

All data from participants that is collected throughout each study is captured in a specific database. Locking the database enables unblinding and statistical analysis of the study results in accordance with the pre-specified study endpoints. Biofrontera expects data for both studies to be available in February of this year.

Actinic keratosis and acne vulgaris are the two skin disorders most commonly diagnosed by dermatologists in the US¹, with tens of millions of patients impacted.

“Despite the prevalence of AK and acne vulgaris, a large unmet need still exists for the treatment of these common skin conditions. An in-office treatment could significantly improve the compliance rate compared to other therapies for each of these disorders. Growing concerns about antibiotic resistance, systemic safety, and treatment burden have led dermatologists to look at different approaches to prolonged oral antibiotic and isotretinoin use for the treatment of acne². Together with the large number of AKs appearing on areas of the body other than the face and scalp we believe these two indications have the potential to increase the use of Ameluz PDT substantially if approved,” commented Prof. Hermann Luebbert, Biofrontera’s CEO.

Pending positive outcomes of the Phase 3 AK study, the company plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in Summer of 2026 to expand the approved use of Ameluz^® PDT for AK beyond the face and scalp. Results from the Phase 2 acne vulgaris study are expected to be presented to the FDA in early Q3 2026 and are intended to provide the basis of a future Phase 3 program, with the goal of achieving approval for Ameluz^® PDT in this indication.

Together with the submission in December 2025 of the Company’s sNDA for the treatment of superficial Basal Cell Carcinoma (sBCC) with Ameluz^® PDT, these milestones support Biofrontera’s strategy to expand the clinical utility of its PDT platform and advance additional growth opportunities.

For further information on the two studies, please see Biofrontera’s press releases^3,4 from September 16, 2025, and August 25, 2025. The 1-year follow-up phase of the phase III study on AK is still ongoing, but not required for FDA approval of the indication.

References

1. Peck et al., J Invest Dermatol; Vol 142; (8), S60
2. Del Rosso JQ et al., J Clin & Aesthet Dermatol. 2019; 12(6):30-41; Habeshian KA, Cohen BA. Current Issues in the Treatment of Acne Vulgaris. Pediatrics. 2020 May;145(Suppl 2):S225-S230; Leyden JJ, J Eur Acad Dermatol Venereol. 2001;15 Suppl 3:51-5.
3. https://investors.biofrontera-us.com/full-news/?qm-storyId=7016033192978791
4. https://investors.biofrontera-us.com/full-news/?qm-storyId=7994141858240250).

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.⁵

5. https://www.skincancer.org/skin-cancer-information/actinic-keratosis/

About Acne Vulgaris

Acne vulgaris is the most common skin condition in the United States, affecting an estimated 50 million people each year¹. Although often associated with adolescence, it persists into adulthood, impacting approximately 40% of adults². The condition ranges from mild blackheads and whiteheads to severe inflammatory forms such as nodules and cysts, which can cause permanent scarring and have profound effects on mental health and self-esteem³. Current U.S. guidelines recommend topical therapies, oral antibiotics, and isotretinoin for moderate to severe acne⁴. However, these treatments are frequently limited by significant systemic side effects, driving demand for safer and more effective alternatives. The U.S. acne treatment market, valued at $5.7 billion in 2024 and projected to grow at a 5.3% CAGR, reflects this unmet need⁵. More than 55% of spending is currently directed to oral antibiotics and isotretinoin⁶, underscoring the reliance on systemic therapies and the opportunity for novel treatment approaches.

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 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 Company’s ability to achieve and sustain profitability; whether any 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. 

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

FAQ

What does the BFRI database lock on January 5, 2026 mean for Ameluz PDT?

Database lock enables unblinding and statistical analysis of the Phase 3 AK and Phase 2 acne study results.

When will Biofrontera report topline results for the Jan 2026 database-locked studies?

The company expects topline data for both studies in February 2026.

Will Biofrontera file an sNDA for Ameluz PDT for actinic keratosis (BFRI)?

Pending positive Phase 3 AK results, Biofrontera plans an sNDA submission in Summer 2026 to expand the indication beyond face and scalp.

What are the next regulatory steps for Ameluz PDT in acne vulgaris (BFRI)?

Phase 2 acne results are expected to be presented to the FDA in early Q3 2026 to support a future Phase 3 program.

Does the ongoing 1-year follow-up affect FDA approval timing for AK (BFRI)?

The 1-year follow-up is ongoing but is not required for FDA approval of the AK indication.