Form 8-K - Current report

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.

99.1	Press release dated October 10, 2023
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.

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

# # #

Cover	Oct. 10, 2023
Document Type	8-K
Amendment Flag	false
Document Period End Date	Oct. 10, 2023
Entity File Number	001-40943
Entity Registrant Name	Biofrontera Inc.
Entity Central Index Key	0001858685
Entity Tax Identification Number	47-3765675
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	120 Presidential Way
Entity Address, Address Line Two	Suite 330
Entity Address, City or Town	Woburn
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	01801
City Area Code	(781)
Local Phone Number	245-1325
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	true
Elected Not To Use the Extended Transition Period	false
Common stock, par value $0.001 per share
Title of 12(b) Security	Common stock, par value $0.001 per share
Trading Symbol	BFRI
Security Exchange Name	NASDAQ
Preferred Stock Purchase Rights
Title of 12(b) Security	Preferred Stock Purchase Rights
Security Exchange Name	NASDAQ
Warrants to purchase common stock
Title of 12(b) Security	Warrants to purchase common stock
Trading Symbol	BFRIW
Security Exchange Name	NASDAQ