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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): October 10, 2023
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
October 10, 2023 Biofrontera Inc. issued a press release announcing the FDA approval of an improved formulation of its licensed product
Ameluz® and the filing of a patent application based on the improved formulation. 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. |
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.
October
10, 2023
(Date) |
Biofrontera
Inc.
(Registrant) |
|
|
|
/s/
E. Fred Leffler III |
|
E.
Fred Leffler III |
|
Chief
Financial Officer |
Exhibit
99.1
Biofrontera
Inc. Receives FDA Approval for New Formulation of Ameluz®
Patent Application Filed with Potential to Extend Ameluz® Protection to 2043
WOBURN,
Mass. (October 10, 2023) – Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”),
a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced that its licensor Biofrontera
Bioscience GmbH has received approval from the U.S. Food and Drug Administration (FDA) for a new formulation of Ameluz®
(aminolevulinic acid hydrochloride) for the treatment of actinic keratosis (AK). The new formulation is covered by the License
and Supply Agreement between the two companies.
We
anticipate that the new formulation, which will
be implemented in all U.S. Ameluz® production beginning in 2024, will improve the safety profile of the topical
gel by replacing propylene glycol, an ingredient common in semi-solid formulations, with ingredients already existing in Ameluz®.
The improved Ameluz® formulation eliminates potential risks of propylene glycol due to the ingredient exhibiting allergic potential
and reacting with other components, giving rise to contaminants accumulating over time.
“Receipt
of FDA approval reflects Biofrontera’s commitment to continued innovation and improving patient outcomes and experiences with photodynamic
therapy (PDT) to treat AK. With a reengineered formulation of Ameluz®, Biofrontera is not only able to deliver a superior
product with reduced risk of contaminants, but also potentially benefit from extended patent protection,” stated Hermann Luebbert,
Chief Executive Officer and Chairman of Biofrontera Inc.
Biofrontera
Bioscience has filed a patent application to protect the new formulation given that the nanoemulsion without propylene glycol
constitutes a novel invention. If granted, patent protection for Ameluz® could be extended until at least 2043.
“The
use of PDT with Ameluz® (Ameluz®-PDT) and RhodoLED® lamps could be protected until
2040 by patents granted on the RhodoLED® lamps and the associated procedure. Patent protection for Ameluz®
itself currently expires in 2028, after which protection in the U.S. would rely on the lamp and procedure patents in the combination
approval. In addition to extending the overall patent life, a potential new patent on Ameluz® itself would provide considerably
stronger protection,” added Dr. Luebbert.
The
license agreement between Biofrontera Bioscience GmbH and Biofrontera Inc. covers all new developments and patents on Ameluz®,
including the new formulation.
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. According to the Skin Cancer Foundation, in the U.S. AK affected approximately 58 million people in 2020
and an estimated 13 million AK treatments were performed.
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 effects and efficacy of the new formulation of Biofrontera Inc.’s (the “Company”) licensed product Ameluz®,
the reduced risk of contaminants, the potential extension of patent protection for Ameluz® and the benefits of a new patent
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:
LHA
Investor Relations
Tirth
T. Patel
212-201-6614
tpatel@lhai.com
#
# #
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