Biofrontera Inc.
BFRI evidence brief
What we can confirm
- BioSniper Score:
- 4.8 / 10
- Market Cap:
- $23.0M
- Lead Asset:
- ameluz (Phase 3)
What it means
What to watch
Prepared research question
What matters most for BFRI—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · BFRI
Biofrontera Inc. (BFRI) is a biopharmaceutical company focused on developing and commercializing photodynamic therapy (PDT) products, primarily Ameluz® gel and RhodoLED® lamps, for skin conditions such as actinic keratosis, acne vulgaris, and basal cell carcinoma.
Key risk: Cash runway concern
BioSniper Score
Based on 4 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 2 clinical trials · 1 catalyst · 1 FDA decision for Biofrontera Inc..
Biofrontera Inc. (BFRI) is a biopharmaceutical company focused on developing and commercializing photodynamic therapy (PDT) products, primarily Ameluz® gel and RhodoLED® lamps, for skin conditions such as actinic keratosis, acne vulgaris, and basal cell carcinoma.
- Cash & equivalents of $4.7M as of 2026-06-30 [sec].
- Total revenue of $12.0M and net income of -$0.6M as of 2026-06-30 [sec].
- Shareholders' equity of $6.0M as of 2026-06-30 [sec].
- Positive Phase 3 results for Ameluz® PDT in treating actinic keratoses on extremities, neck, and trunk, meeting primary endpoint with p<0.0003 [news · published 2026-02-09].
- Supplemental NDA for superficial basal cell carcinoma (sBCC) submitted to FDA on November 28, 2025 [news · published 2025-12-02].
What works
- Positive Phase 3 results for Ameluz® PDT in actinic keratosis on extremities, neck, and trunk, with highly statistically significant superiority vs. vehicle gel (p<0.0003) [news · published 2026-02-09].
- Supplemental NDA for sBCC submitted to FDA, with primary and key secondary endpoints met (p<0.0001) and favorable recurrence outcomes [news · published 2025-12-02].
- Database locks achieved for two clinical studies (AK and acne) in January 2026, supporting key regulatory milestones [news · published 2026-01-08].
What to weigh
- Cash & equivalents of $4.7M as of 2026-06-30 [sec] may be insufficient; management expressed substantial doubt about ability to continue as a going concern for at least twelve months from the date of the 2025 annual report [sec_mda · as of 2026-03-19].
- Net income of -$0.6M as of 2026-06-30 [sec] indicates ongoing losses.
- The company cannot assure it will achieve profitable operations or raise additional capital [sec_mda · as of 2026-03-19].
From the filings
Quoted directly from source documents.
Positive Phase 3 results for Ameluz PDT in actinic keratosis on extremities, neck, and trunk
“Study findings met its primary endpoint and showed highly statistically significant superiority for Ameluz® vs. vehicle gel (p<0.0003)”
News · February 9, 2026
Supplemental NDA for sBCC submitted to FDA
“sNDA for treatment of sBCC with Ameluz®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025”
News · December 2, 2025
Management expressed substantial doubt about going concern
“Management believes that these conditions raise substantial doubt about the Company's ability to continue as a going concern for at least twelve months from the date of this Annual Report on Form 10-K.”
SEC MD&A · March 19, 2026
Cash position as of December 31, 2025
“As of December 31, 2025, we had cash and cash equivalents of $6.4 million.”
SEC MD&A · March 19, 2026
Catalyst timeline
- 2043-12-08 · Patent_Expiry · AMINOLEVULINIC ACID HYDROCHLORIDE — Patent_Expiry: NDA208081 — Patent expiry for the active ingredient in Ameluz; may affect market exclusivity.
Risks & what to watch (3)›
Key risks
- Cash runway concern — Cash & equivalents $4.7M as of 2026-06-30 [sec]; management doubts ability to continue as going concern for 12 months [sec_mda · as of 2026-03-19].
- Ongoing net losses — Net income -$0.6M as of 2026-06-30 [sec] indicates continued unprofitability.
- Dependence on regulatory approvals — Future revenue depends on FDA approvals for label expansions (sBCC, acne, AK extremities) [news].
What to watch
- FDA decision on sNDA for sBCC (submitted Nov 28, 2025) [news · published 2025-12-02].
- Supplemental NDA submission for extremities, neck, and trunk indication expected Q3 2026 [news · published 2026-02-17].
- FDA discussion for Phase 3 acne program planned Q3 2026 [news · published 2025-08-25].
- Patent expiry for AMINOLEVULINIC ACID HYDROCHLORIDE on 2043-12-08 [catalyst].
Sources: Catalysts · News · SEC MD&A · Generated October 8, 2026 · How we verify sources →
Run Biofrontera Inc. through your own thesis
Use the pipeline, catalyst, financial, FDA, and market facts on this page as inputs to a protocol you control.
Your protocol can:
- Turn available Biofrontera Inc. facts into screen rules or deeper checks
- Show cited findings, blockers, and unresolved evidence together
- Save the logic and rerun it as the company evidence changes
Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
D/E 3.04 · 0% dilution
Lead: Phase 3
1 candidate
1 upcoming, next in ~6265d
No insider transactions in the last 180 days
Catalysts
Pipeline
Regulatory
Financials
Short Interest
as of May 20, 2026- % of float
- 0.7%
- Days to cover
- 0.6
- Shares short
- 76,357
- Daily short volume (Apr 30, 2026)
- 35.8%
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
BFRI short interestGovernance
Frequently asked questions
What is the AI investment thesis for Biofrontera Inc.?
Biofrontera Inc. (BFRI) is a biopharmaceutical company focused on developing and commercializing photodynamic therapy (PDT) products, primarily Ameluz® gel and RhodoLED® lamps, for skin conditions such as actinic keratosis, acne vulgaris, and basal cell carcinoma.
What is Biofrontera Inc.'s lead drug candidate?
Biofrontera Inc.'s most advanced tracked candidate is ameluz (Phase 3) for Actinic Keratosis (Trunk & extremities).
What is Biofrontera Inc.'s next catalyst?
Biofrontera Inc.'s next tracked catalyst is a Patent_Expiry event — "Patent_Expiry: NDA208081" — expected December 8, 2043.
Who is the CEO of Biofrontera Inc.?
Dr. Hermann Luebbert Ph.D. is the chief executive officer of Biofrontera Inc. (BFRI).
Where is Biofrontera Inc. headquartered?
Biofrontera Inc. (BFRI) is headquartered in Woburn, MA, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.