AEON Biopharma Reports First Quarter 2024 Financial Results
– Ongoing analysis of interim data from the Phase 2 study of ABP-450 in chronic migraine, which did not achieve its primary or secondary endpoints –
– Evaluating next-steps across the Company’s late-stage clinical pipeline for ABP-450 that targets multiple indications –
IRVINE, Calif., May 14, 2024 – AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, announced financial results for the first quarter ended March 31, 2024, and provided a business update.
“We continue to believe in our development pipeline for ABP-450, which targets a number of indications that have well-founded scientific rationale to pursue in early- and late-stage clinical trials. Several of the late-stage clinical programs are candidates to advance into the next phase of clinical development,” commented Marc Forth, AEON’s President and Chief Executive Officer. “We look forward to keeping you apprised of our progress and updated timelines across the development strategy for our pipeline.”
Recent Clinical and Corporate Highlights
●Phase 2 study of ABP-450 in episodic and chronic migraine:
oChronic Migraine - Interim Analysis: The topline interim analysis did not achieve its primary or secondary endpoints. The Company is continuing its analysis of interim data from the study. The Phase 2 randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of ABP-450 for the prevention of chronic migraine in adults who suffer from 15 or more headache days per month and at least 8 migraine days per month. The study has enrolled a total of 492 patients across approximately 50 sites in the United States, Canada and Australia.
oEpisodic Migraine End-of-Phase 2 Meeting with U.S. FDA: In the first quarter of 2024, the Company held a productive end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration to present the Company’s Phase 2 episodic migraine study results, which demonstrated a favorable safety profile for patients with episodic migraine and achieved key prespecified secondary endpoints, although it did not statistically separate from placebo with respect to the primary endpoint. The meeting resulted in a preliminary alignment on the design and endpoints for the proposed pivotal Phase 3 trial.
●Completed $15 Million Private Placement Agreements
oIn April 2024, the Company received the second and final installment from its definitive agreements relating to a private placement of $15 million aggregate principal amount of senior secured convertible notes (the “Notes”) with its strategic partner, Daewoong Pharmaceutical Co., LTD (“Daewoong”). Proceeds from the private placement are being used for general working capital purposes.
oIn connection with the receipt of the final installment of the Notes, Seongsoo (Shawn) Park was appointed to the Company’s Board of Directors as Daewoong’s representative.