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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): May 30, 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, each warrant exercisable for one share of common stock, each at an exercise price of $5.00 per share   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 May 30, 2023, Biofrontera Inc. (the “Company”) issued a press release announcing the appointment of Hermann Luebbert as its chief executive officer, 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.

 

99.1 Press release dated May 30, 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.

 

May 30, 2023

(Date)

 

Biofrontera Inc.

(Registrant)

     
   

/s/ E. Fred Leffer, III

   

E. Fred Leffler, III

Chief Financial Officer

 

 

 

EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

 

Biofrontera Inc. Names Founder and Executive Chairman Hermann

Luebbert as Chief Executive Officer

 

WOBURN, Mass. (May 30, 2023) – Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the commercialization of dermatologic products, announces that its Board of Directors has named Hermann Luebbert as Chief Executive Officer. Mr. Luebbert is a founder of the Company and currently serves as Executive Chairman. He will continue to serve as Chairman of the Board of Directors.

 

Mr. Luebbert founded Biofrontera’s former parent company, Biofrontera AG, in 1997 and served as CEO and Managing Director while completing an initial public offering for Biofrontera AG in Germany and later in the U.S. He served as CEO and Chairman of the Company during the process of establishing Biofrontera AG’s U.S. operations as Biofrontera Inc. The U.S. business subsequently completed its own initial public offering on Nasdaq in 2021, at which time Mr. Luebbert was named Executive Chairman and shortly thereafter resigned from his position at Biofrontera AG. Prior to founding Biofrontera AG, Mr. Luebbert spent 10 years in Neuroscience Research at Novartis and was Chair of the Animal Physiology Department at Ruhr-University Bochum. Mr. Luebbert received a Ph.D. in Biology from the University of Cologne and completed post-doctoral research at the California Institute of Technology.

 

“I look forward to taking a more active, day-to-day role in driving a focused path to profitability, executing tightly against our forecasts and, in turn, building shareholder value. As CEO, I am committed to transparency regarding our strategic vision and our progress as we grow Biofrontera more broadly and integrate other value-creating initiatives to support our commercial team,” said Mr. Luebbert.

 

“By establishing in-house R&D we expect to expand Biofrontera beyond our core strength in sales and marketing, gain greater control over our future and be better equipped to accelerate ongoing efforts to broaden the market for photodynamic therapy (PDT),” he added.

 

Among other strategic initiatives to transform Biofrontera into an integrated pharmaceutical company, Mr. Luebbert is evaluating plans to establish Biofrontera’s own research and development capability. Currently R&D is managed by Biofrontera Bioscience GmbH and funded by Biofrontera Inc. via a royalty on sales of licensed products, and is limited to predefined clinical trials. The Company will evaluate R&D costs and relative return as it considers building the infrastructure to manage its own clinical studies, which could support the expansion of the Ameluz-PDT label into new indications and potentially the development of new products.

 

“We also will strengthen our established medical affairs function by our continued support of investigator-initiated research. All of this will be pursued by starting small and carefully balancing expenses against our growing revenue,” continued Mr. Luebbert.

 

The Company’s plans include an enhanced focus on pursuing new products and new technologies through acquisitions and licensing transactions, while maintaining the Company’s focus on dermatology and leveraging its commercial expertise.

 

 

 

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 growth strategy for Biofrontera Inc. (the “Company”), the transition of responsibilities at the Company, 2023 forecasts, the establishment of and benefits from in-house research and development, efforts to broaden the market for PDT, the expansion of the Ameluz® label, new products, and potential acquisition and licensing transactions. 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 regain compliance with Nasdaq continued listing standards, 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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