false
0001858685
0001858685
2026-03-09
2026-03-09
0001858685
BFRI:CommonStockParValue0.001PerShareMember
2026-03-09
2026-03-09
0001858685
BFRI:WarrantsToPurchaseCommonStockMember
2026-03-09
2026-03-09
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(D)
OF
THE SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): March 9, 2026
Biofrontera
Inc.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-40943 |
|
47-3765675 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
660
Main Street
Woburn,
Massachusetts |
|
01801 |
| (Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (781) 245-1325
Not
Applicable
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ☐ |
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Exchange Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Common stock, par value
$0.001 per share |
|
BFRI |
|
The Nasdaq Stock Market
LLC |
| Warrants to purchase
common stock |
|
BFRIW |
|
The Nasdaq Stock Market
LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (the “Exchange Act”) (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item
7.01 Regulation FD Disclosure
On
March 9, 2026, Biofrontera Inc. issued a press release announcing the results in its Phase 2b study of Ameluz® PDT for the treatment
moderate to severe Acne Vulgaris. The full text of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein
by reference.
The
information contained in Item 7.01 of this Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liabilities
of that section, nor shall it be deemed incorporated by reference in any filing by the company under the Securities Act of 1933 or the
Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item
9.01 Financial Statements and Exhibits.
| 99.1 |
|
Press Release dated March 9, 2026 |
| 104 |
|
Cover Page Interactive
Data File (the cover page XBRL tags are embedded within the inline XBRL document) |
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
March
9, 2026
(Date) |
Biofrontera
Inc.
(Registrant) |
| |
|
| |
/s/
E. Fred Leffler III |
| |
E. Fred Leffler III |
| |
Chief Financial Officer |
Exhibit
99.1
Biofrontera
Inc. Reports Positive Phase 2b Results Supporting Further Development of Ameluz® Photodynamic Therapy for moderate to severe Acne
Vulgaris
●
Phase 2b study demonstrated greater reductions in inflammatory acne lesions with Ameluz® PDT versus vehicle
●
3-hour incubation regimen identified as the most promising protocol for further clinical development
●
Acne vulgaris represents a promising potential future indication for Ameluz®, significantly broadening the Company’s dermatology
pipeline
WOBURN,
Mass. (March 9, 2026) – Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical
company specializing in the development and commercialization of photodynamic therapy (PDT), today announced results of its Phase 2b
clinical trial evaluating Ameluz® (aminolevulinic acid HCL) topical gel, 10% PDT for the treatment of moderate to severe acne vulgaris
(AV).
The
multicenter, randomized, double-blind study compared Ameluz® and vehicle gel using two incubation times (1 hour and 3 hours) prior
to illumination with the BF-RhodoLED® lamp. Participants received one tube of Ameluz® or vehicle gel applied to the entire face,
followed by incubation and illumination with the red light. Up to three PDT treatments were administered at one-month intervals, and
patients were followed up for two months after receiving the final PDT treatment.
The
study had co-primary endpoints, one of which looked at the relative reduction in inflammatory lesion counts. The other required an improvement
of at least two grades on a 5-point modified Investigator Global Assessment (mIGA) scale and that the patient was rated “clear”
or “almost clear” (score 0 or 1).
Clinical
results
Greater
improvements in both inflammatory lesion counts and mIGA scores were observed with Ameluz® vs. vehicle with the 3-hour incubation
regimen, identifying this as the most promising protocol for further clinical investigation in acne vulgaris.
In
the 3-hour per-protocol population, the Ameluz group achieved a 57.97% reduction in inflammatory lesions (n=20), compared with 36.51%
(n=14) in the corresponding vehicle group. For the mIGA analysis, 25% of the Ameluz treated patients met this co-primary endpoint with
21.4% of the vehicle patients achieving the same outcome.
Reductions
in absolute lesion counts further supported the efficacy of the 3-hour regimen. The values for inflammatory, non-inflammatory and total
lesion reductions were 19.7, 23.1 and 42.7 with Ameluz vs. 15.4, 16.5 and 31.9 with vehicle.
Safety,
Tolerability and Patient Satisfaction
Ameluz®
PDT demonstrated a favorable safety profile consistent with previously reported photodynamic therapy experience. The most frequently
reported treatment-related adverse events were burning sensation and pruritus, both of which were generally mild to moderate in severity.
In
addition, the average pain scores during the 3-hour incubation PDT treatments were modest, with the values in the Ameluz group ranging
from 3.4 to 3.8, and from 2.0 to 2.1 with vehicle on an 11-point scale.
Participants
reported high overall satisfaction with PDT treatment. Of the patients who underwent the 3-hour Ameluz incubation, 85.7% said they would
choose PDT again and 71.4% of them rated their esthetic outcome as “good” or “very good”.
Medical
Need for Moderate to Severe Acne
Acne
vulgaris is one of the most common dermatologic conditions in the US, affecting millions of patients and representing a large treatment
market. It may lead to permanent scarring and can carry a significant psychosocial burden, including reduced self-esteem and depression.
Current
treatment options include topical therapies requiring long-term daily treatment, and systemic antibiotic and oral isotretinoin which
may have significant safety considerations. Additionally, increasing antibiotic resistance continues to drive interest in alternative
treatment approaches.
As
an in-office physician-administered procedure, photodynamic therapy may offer dermatologists an alternative treatment option with a high
rate of compliance and that avoids patients having to undergo chronic systemic exposure.
“We
are thrilled to reach this crucial milestone in our clinical program”, said Dr. Hermann Luebbert, CEO and Chairman of Biofrontera
Inc. “The results of this Phase 2b study show promising reductions of inflammatory, non-inflammatory and total lesions with Ameluz®
PDT after 3-hour incubation, as well as an improvement in the mIGA.
The
successful completion of this study brings us a step closer to potentially offering an effective and well tolerated treatment option
for patients with moderate to severe acne vulgaris. Expanding the potential indications for Ameluz® demonstrates our commitment to
the development of PDT and would further strengthen our dermatology franchise.”
Mitchel
P. Goldman, MD, FAAD, Medical Director of Cosmetic Laser Dermatology, Board Member of Platinum Dermatology Partners and the coordinating
investigator of the study, expressed enthusiasm about its’ potential impact for the treatment of acne vulgaris. “Ameluz®
PDT has shown encouraging potential for the treatment of moderate to severe acne vulgaris. We see many patients who suffer from this
condition, still relying on treatment regimens that often come with a high burden for the patients. The possibility of expanding the
use of Ameluz® to treat those patients with PDT is promising for physicians and our patients.”
The
Company plans to present these Phase 2b data to the U.S. Food and Drug Administration (FDA) in Q3 2026 to discuss potential next steps
to develop Ameluz® PDT for the treatment of acne vulgaris.
About
Biofrontera Inc.
Biofrontera
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 Actinic Keratosis,
pre-cancerous skin lesions which may progress to invasive skin cancers1. 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 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; 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
Ben
Shamsian
646-829-9701
shamsian@lythampartners.com
