UNITED STATES
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FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
On May 3, 2024, AEON Biopharma, Inc. (the “Company”) issued a press release announcing the preliminary top-line results from its Phase 2 interim analysis of ABP-450 in the preventative treatment of chronic migraine, a copy of which is furnished as Exhibit 99.1 to this Form 8-K and incorporated herein by reference.
The information furnished under this Item 7.01 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01. Other Events.
On May 3, 2024, the Company announced the preliminary top-line results from its Phase 2 interim analysis of ABP-450 in the preventative treatment of chronic migraine. In a total of 325 analyzed patients randomized to three arms, the primary endpoint of mean reduction in monthly migraine days (MMD) over the period 13-24 weeks, showed a reduction of 8.5 days in the 150 U arm, a reduction of 7.7 days in the 195 U arm, and a reduction of 8.4 days in the placebo arm. These differences did not achieve statistical significance (p=0.9132 in 150 U arm; p=0.3611 in 195 U arm). The numerical reduction in MMDs were in the expected range for the two active arms, but the reduction in the placebo arm was much higher than expected. None of the secondary endpoints met statistical significance.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release, dated May 3, 2024 | |
| 104 | Cover Page Interactive Data File (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.
| AEON Biopharma, Inc. | ||
| Date: May 3, 2024 | By: | /s/ Marc Forth |
| Name: | Marc Forth | |
| Title: | Chief Executive Officer | |