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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): February 5, 2024
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.) |
120
Presidential Way, Suite 330
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 |
Preferred
Stock Purchase Rights |
|
|
|
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
February 5, 2024, Biofrontera Inc. (the “Company”) issued a press release announcing the U.S. Food and Drug Administration
(FDA) has completed its filing review and has determined that Biofrontera’s application to increase the maximally approved dosage
from one to three tubes of Ameluz® per treatment is sufficiently complete to permit a substantive review, a copy of which is attached
here as Exhibit 99.1.
The
information in Item 7.01 of this Current Report is being furnished and shall not be deemed “filed” for the purpose of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in this
Current Report shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act
of 1933, as amended.
Item
9.01 |
Financial
Statements and Exhibits. |
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.
February
5, 2024
(Date) |
|
Biofrontera
Inc.
(Registrant) |
|
|
|
|
By: |
/s/
E. Fred Leffler III |
|
|
E.
Fred Leffler III |
|
|
Chief
Financial Officer |
Exhibit
99.1
Biofrontera
Inc. Announces FDA Filing of Supplemental New Drug Application for Ameluz® to Permit Up to Three Tubes per Use
FDA
has set a target action date of October 4, 2024
sNDA
supported by two Phase 1 safety studies1
Aims
at actinic keratosis (AK) field treatment with up to 3 tubes
An
estimated 13 million treatments given each year for AK in the US2
WOBURN,
Mass. (February 5, 2024) – Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical
company specializing in the commercialization of dermatologic products, today 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
studies supporting this application showed robust safety parameters for the simultaneous use of three tubes, with systemic and application
site adverse events equivalent to those with one tube,” stated Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera
Inc. “Many patients have actinic keratoses over large surface areas and the ability to treat these pre-cancerous lesions in one
office visit is more convenient for patients and more efficient for their dermatologists. Therefore, we believe this approval, if granted,
will lead to increased use of Ameluz in the US” he continued.
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.
About
Actinic Keratosis
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.3
About
Biofrontera Inc.
Biofrontera
Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of products for the treatment of dermatologic conditions with
a focus on photodynamic therapy (PDT) and topical antibiotics. The Company’s licensed products are used for the treatment of actinic
keratoses, which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection. 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 to date. These statements include, but are not limited to, statements relating to
the clinical development strategy for Ameluz®, the potential to expand the label of Ameluz®, ongoing clinical trials
conducted in collaboration with our licensing partner, and the future impact of such trials on the market for Ameluz®.
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, including, but not limited to, the impact of
any extraordinary external events; any changes in the Company’s relationship with its licensors; the ability of the Company’s
licensors to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability;
whether the current global disruptions in supply chains will impact the Company’s ability to obtain and distribute its licensed
products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures
using the Company’s licensed 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® 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® is consistent with the Company’s
expectations; the Company’s ability to comply with public company requirements; 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 SEC, which can be obtained on the SEC 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:
Barwicki
Investor Relations
Andrew
Barwicki
1-516-662-9461
ir@bfri.com
#
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