8-K
Biofrontera Inc. (BFRI)
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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
Dateof Report (Date of earliest event reported): October 23, 2025
BiofronteraInc.
(Exactname 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<br><br> <br>Woburn, Massachusetts | 01801 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’stelephone number, including area code: (781) 245-1325
NotApplicable
(Formername 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<br> pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant<br> to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications<br> pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications<br> 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 | No | 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. ☐
Item7.01 Regulation FD Disclosure.
On October 23, 2025, Biofrontera Inc. issued a press release announcing the closing of its restructuring and asset purchase agreement with Biofrontera AG, backed by an investment of $11 million led by existing investors. The full text of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.
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.
Item9.01 Financial Statements and Exhibits.
| 99.1 | Press release dated October 23, 2025 |
|---|---|
| 104 | Cover Page Interactive<br> 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 23, 2025<br><br> <br>(Date) | Biofrontera Inc.<br><br> <br>(Registrant) |
|---|---|
| /s/ E Fred Leffler, III | |
| E<br> Fred Leffler, III<br><br> <br>Chief Financial Officer |
Exhibit99.1
BiofronteraInc. Closes Purchase of All Ameluz^®^ and RhodoLED^®^ US Assets from Biofrontera AG
| ● | Biofrontera<br> Inc. acquires full U.S. rights to Ameluz^®^ and RhodoLED^®^, including New Drug Application and associated<br> patents, from former parent Biofrontera AG. |
|---|---|
| ● | New<br> earnout structure reduces payment rate to 12%–15% of U.S. net sales from 25%–35%. |
| ● | Closing<br> releases final $2.5 million of $11 million financing<br> led by existing investors Rosalind Advisors and AIGH Capital Management, which is expected to fund Biofrontera Inc. to profitability. |
WOBURN,Mass., October 23, 2025 – Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced the closing of its restructuring and asset purchase agreement with its former parent company, Biofrontera AG. Under the transaction, Biofrontera Inc. has acquired all U.S. assets and rights related to Ameluz^®^ and RhodoLED^®^, including the New Drug Application (NDA), Investigational New Drug Application (IND), manufacturing rights and contracts, all intellectual property, and related personnel.
As a result of the transaction, Biofrontera Inc. will now pay a monthly earnout of 12% in years where annual U.S. net sales of Ameluz^®^ are up to $65 million, and 15% in years where U.S. net sales are above that threshold. These payments will cease upon patent expiry. This replaces the prior transfer-pricing model under which the Company paid perpetual 25%–35% of net sales per tube, depending on timing and indication. The new structure reduces overall cost for Biofrontera Inc. and is expected to accelerate the Company’s timeframe to reach break-even.
With the completion of this agreement, Biofrontera Inc. now assumes full responsibility for manufacturing, regulatory, quality management, pharmacovigilance, and commercialization of Ameluz^®^ and the RhodoLED^®^ portfolio in the U.S. The Company expects the full transfer of assets and personnel to be completed by late Q4 2025 or early Q1 2026.
The transaction was funded through an $11 million investment led by existing investors Rosalind Advisors, Inc. and AIGH Capital Management LLC, $8.5 million of which was funded at the time of term-sheet execution. Biofrontera AG will also receive a 10% post-money equity stake in Biofrontera Inc., aligning long-term interests between the two entities.
“This is a transformative transaction that strengthens Biofrontera’s financial and operational profile,” said Dr. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera Inc. “The significantly reduced earnout structure is expected to drive meaningful gross margin expansion starting in the fourth quarter of 2025. Coupled with the new capital infusion, this positions us to accelerate Ameluz^®^ growth and advance label expansion into additional indications.”
About Biofrontera Inc.
Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the development and 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 cancers. 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; 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 products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s products; whether the market opportunity for Ameluz^®^ in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company’s expectations; 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 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 Contact
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com