The foregoing description of the Omnibus Amendment is not complete and is qualified in its entirety by reference to the complete text of the Omnibus Amendment, which is filed as Exhibit 10.1 to this Current Report on Form 8-K (this “Report”) and is incorporated herein by reference.
Item 2.02. | Results of Operations and Financial Condition. |
As previously disclosed, the Company filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation (the “Charter Amendment”) with the Secretary of State of the State of Delaware to effect a 1-for-25 reverse stock split (the “Reverse Stock Split”) of the Company’s Common Stock, effective as of 12:01 a.m. Eastern Time on January 3, 2025.
On January 8, 2025, the Company filed Amendment No. 1 to its registration statement on Form S-1 (“Amendment No. 1”) relating to a proposed public offering. Such Amendment No. 1 included (i) audited consolidated financial statements of the Company for the years ended December 31, 2023 and December 31, 2022 (the “audited financial statements”), (ii) interim unaudited financial statements of the Company for the quarter ended September 30, 2024 (the “unaudited financial statements”), and (iii) management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2023 and the quarter ended September 30, 2024, each as retroactively adjusted to reflect the Reverse Stock Split (the “MD&A” and, together with the audited financial statements and the unaudited financial statements, the “financial information”). The information in this Report is not an amendment to, or restatement of, the financial information and does not modify or update the disclosures therein in any way, other than to reflect the Reverse Stock Split, as described above.
Copies of the audited financial statements, the unaudited financial statements, and the MD&A are filed as Exhibits 99.1, 99.2 and 99.3, respectively, to this Report and are incorporated herein by reference.
This Report, including Exhibits 99.1, 99.2 and 99.3, does not reflect events (other than the Reverse Stock Split) occurring after the filing of Amendment No. 1 and does not modify or update the disclosures in such filing, other than as required to reflect the Reverse Stock Split.
Item 7.01 | Regulation FD Disclosure. |
The information set forth under Item 2.02 is incorporated by reference into this Item 7.01.
On January 8, 2025, the Company issued a press release announcing topline results from its AUDACITY clinical trial. The full text of such press release is attached to this Report as Exhibit 99.4.
The information in this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
The disclosures in this Report shall not constitute an offer to sell or the solicitation of an offer to buy the Company’s securities, nor shall there be any sale of its securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Cautionary Note Regarding Forward-Looking Statements
This Report, including its exhibits, contains forward-looking statements within the meaning of the U.S. federal and state securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions and include statements regarding the Company’s proposed public offering; the Company’s strategy, business plans and focus; the progress and timing of the clinical development of its products and offerings, including the results of the AUDACITY trial evaluating the safety and efficacy of the Allurion Balloon and the timing of, and plan to submit, a premarket approval (PMA)