Biofrontera Inc 8-K Filings

Biofrontera Inc. reported the results of its Annual Meeting of Stockholders held on June 11, 2026. Stockholders elected Beth J. Hoffman, Ph.D. and Kevin D. Weber as Class II directors, with each receiving over 8.0 million votes in favor and more than 3.3 million broker non-votes recorded.

Investors also approved an amendment and restatement of the 2021 Omnibus Incentive Plan, increasing the total number of common shares authorized under the plan from 3,750,000 to 8,750,000, with about 7.9 million votes cast in favor. In addition, stockholders ratified CBIZ CPAs P.C. as the independent registered public accounting firm for the fiscal year ending December 31, 2026, with approximately 10.9 million votes for the proposal.

Biofrontera Inc. reported solid Q1 2026 progress, with revenue of $10.1 million, up about 17% from $8.6 million a year earlier, driven by higher Ameluz unit volumes and a price increase. Gross margin improved sharply to roughly 80% from 62%, reflecting a new earnout structure after its 2025 strategic transaction.

Operating loss narrowed slightly to $4.3 million, while net loss was $4.8 million, or $0.41 per share, compared with $4.2 million, or $0.47 per share. Adjusted EBITDA improved to a loss of $3.6 million, and operating cash usage was only $70 thousand, leaving $6.3 million in cash as of March 31, 2026.

The company highlighted key pipeline and regulatory milestones, including FDA filing acceptance of an sNDA for Ameluz PDT in superficial basal cell carcinoma with a PDUFA target action date of September 28, 2026, positive Phase 3 data in actinic keratoses on additional body sites, positive Phase 2b acne results, and regaining compliance with the Nasdaq Minimum Bid Price Requirement.

Biofrontera Inc. reported record fourth quarter 2025 results, highlighted by strong growth and a swing to profitability. Q4 revenues rose 36% to $17.1 million from $12.6 million, with gross margin expanding to 82.4% from 58.0%. Operating income reached $4.6 million and net income was $5.6 million, both reversing prior-year losses.

For full year 2025, revenue increased 12% to $41.7 million, while the net loss narrowed to $10.5 million from $17.7 million. Adjusted EBITDA improved to $4.9 million in Q4 versus a $(1.4) million loss a year earlier, though it remained negative at $(10.6) million for the year. Cash and cash equivalents were $6.4 million as of December 31, 2025.

The company completed the purchase of all U.S. Ameluz and RhodoLED assets, reducing the earnout rate on U.S. net sales from 25%–35% to 12%–15%, and advanced its PDT pipeline with positive Phase 2b and Phase 3 data and an FDA-accepted sBCC sNDA with a PDUFA date in September 2026.

Biofrontera Inc. reported positive Phase 2b clinical results for its Ameluz® photodynamic therapy in moderate to severe acne vulgaris. In the 3-hour incubation per-protocol group, Ameluz achieved a 57.97% reduction in inflammatory lesions versus 36.51% with vehicle, and 25% of Ameluz patients met the mIGA co-primary endpoint compared with 21.4% on vehicle.

The 3-hour regimen also showed larger absolute reductions in inflammatory, non-inflammatory and total lesion counts and a safety profile consistent with prior PDT experience, with mainly mild to moderate burning and itching. Patient satisfaction was high, and the company plans to present these Phase 2b data to the FDA in Q3 2026 to discuss potential next development steps.

Biofrontera Inc. reports a significant development in its patent dispute with Sun Pharmaceutical Industries. On February 23, 2026, the U.S. Patent Trial and Appeal Board issued a Final Written Decision finding all challenged claims of Sun’s U.S. Patent No. 11,697,028 unpatentable.

Sun may still request rehearing, seek review by the Director of the U.S. Patent and Trademark Office, or appeal to the U.S. Court of Appeals for the Federal Circuit, so the outcome is not yet final. The company notes that the impact of this decision on ongoing proceedings in the U.S. District Court for the District of Massachusetts and the International Trade Commission cannot be determined at this time.

Biofrontera Inc. reported positive, statistically significant Phase 3 results for Ameluz® photodynamic therapy (PDT) to treat mild to moderate actinic keratoses on the extremities, neck, and trunk using its RhodoLED® platform.

Ameluz® PDT achieved complete clearance in 45.6% of patients in the Full Analysis Set, versus 16.7% with vehicle PDT (p < 0.0003), and 53.2% versus 22.2% in the Per Protocol Set (p < 0.001). Lesion clearance reached 73.1% in the Full Analysis Set and 80.3% in the Per Protocol Set. Investigators rated cosmetic outcomes as good or very good in 75.2% of patients, and 86.3% indicated they would choose PDT again. Based on these data, Biofrontera plans to submit a supplemental New Drug Application to the FDA in the third quarter of 2026 for a potential label expansion beyond the face and scalp.

Biofrontera Inc. filed a current report to let investors know it has released a press release with preliminary, unaudited revenue figures for the fourth quarter and full year ended December 31, 2025. The press release, dated January 13, 2026, is included as Exhibit 99.1 and incorporated by reference.

The company notes that these revenue numbers are preliminary estimates and remain subject to its normal review processes, meaning the final fourth quarter results could differ materially. The disclosure is furnished rather than filed under the Exchange Act, limiting certain legal liabilities, and Biofrontera includes standard cautionary language that these forward‑looking statements reflect management’s views only as of the date of the report.

Biofrontera Inc. reported that it received a notice from Nasdaq stating its common stock is not in compliance with the Nasdaq Capital Market’s minimum bid price rule, which requires a closing bid of at least $1.00 per share. The stock’s closing bid was below $1.00 for 34 consecutive business days, triggering the deficiency notice.

The company has 180 calendar days, until June 30, 2026, to regain compliance by having its closing bid price at or above $1.00 per share for at least 10 consecutive business days. If it fails to do so, Biofrontera may seek an additional compliance period, potentially including a reverse stock split, but its securities could ultimately face delisting if requirements are not met. The company plans to monitor its share price and consider available options, while noting there is no assurance it will regain or maintain compliance.

Biofrontera Inc. (BFRI) reported that it furnished a press release announcing financial and operational results for the three and nine months ended September 30, 2025. The release is attached as Exhibit 99.1.

The company noted the press release includes non-GAAP measures with reconciliations to comparable GAAP metrics pursuant to Regulation G. The information is being furnished, not filed, and is not subject to Section 18 liability or incorporated by reference unless expressly stated.

Biofrontera Inc. reported it has regained Nasdaq listing compliance. The company received notices on November 4 and November 6 confirming compliance with Nasdaq Rules 5550(b)(1) (stockholders’ equity test) and 5550(a)(2) (minimum bid price), respectively.

Nasdaq cited company disclosures indicating compliance with Rule 5550(b)(1), while warning the company may be subject to delisting if it fails to evidence compliance upon filing its next periodic report. Compliance with Rule 5550(a)(2) was restored after the company’s common stock maintained a closing bid of at least $1.00 per share for 11 consecutive business days.

Earlier in May, Nasdaq had notified the company that it was out of compliance with both rules, based on its reported stockholders’ equity and a sub-$1.00 bid price over an extended period.

Biofrontera Inc. completed the sale of all assets related to its Xepi (ozenoxacin) cream to Pelthos Therapeutics. The purchase price is up to $10,000,000, including $3,000,000 in cash paid at closing on November 6, 2025.

An additional $1,000,000 is payable within 30 days after commercial quantities become available, subject to conditions in the asset purchase agreement. Earnouts provide $3,000,000 upon initial achievement of $10,000,000 in annual net sales and another $3,000,000 upon $15,000,000 in annual net sales. At closing, the buyer is to enter a consulting agreement with a consultant experienced with Xepi; part of the second payment depends on the consultant’s performance. Biofrontera agreed to customary representations, indemnities, and restrictive covenants, and will indemnify the buyer for any material breach of the consultant’s obligations during the defined period.

Biofrontera Inc. finalized agreements with Biofrontera AG to acquire all U.S. rights to Ameluz and RhodoLED. As part of the deal, the company will pay an earnout of 12% of U.S. Ameluz revenues in years when U.S. net sales are $65.0 million or less and 15% in years when they exceed $65.0 million. This replaces the prior transfer-pricing model under the now-terminated license and supply agreement.

The company also closed the second tranche of its private placement, issuing 2,500 Series C Convertible Preferred shares at $1,000 each for $2.5 million in gross proceeds to help fund the transaction and for general purposes. Each preferred share is immediately convertible, at the holder’s option and subject to stated limits, into common stock based on the formula: Original Share Price divided by 0.6249.

Biofrontera plans to file a resale registration statement for the common stock underlying the newly issued preferred shares within three days of closing and to seek effectiveness within stated SEC review timelines. The company believes its stockholders’ equity now exceeds $5 million, aligning with Nasdaq Listing Rule 5550(b)(1), with Nasdaq continuing to monitor compliance.

Biofrontera Inc. announced the closing of its restructuring and asset purchase agreement with Biofrontera AG, supported by an investment of $11 million led by existing investors. The company disclosed this update under Regulation FD, indicating it is being furnished rather than filed.

The closing marks completion of the transaction described, with the new capital noted alongside the deal. The press release providing details was issued on October 23, 2025 and is included as Exhibit 99.1.

Biofrontera, Inc. reported results from a special shareholder meeting where shareholders holding 8,403,861 votes were present for proposals one, three, and four, and shareholders holding 6,820,211 votes were present for proposal two, constituting a quorum for all proposals. The filing states that the meeting was solicited under Regulation 14A and that there was no solicitation in opposition. The proxy statement filed on August 5, 2025 is cited as the source for the detailed descriptions of the proposals. The document indicates that the meeting "summarizes all matters voted on," but it does not include the vote tallies or explicit outcomes for each proposal within the provided text.