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AEON Biopharma Inc. Class A (AEON0.00%) has submitted its annual report on Form 10-K filing for the fiscal year ended December 31, 2024.
The filing details AEON's strategic focus on developing its botulinum toxin complex, ABP-450, as a biosimilar to Botox for therapeutic uses. The company plans to pursue a Biologics License Application under Section 351(k) of the Public Health Service Act, targeting the global therapeutic botulinum toxin market.
AEON has completed a Phase 2 study of ABP-450 for cervical dystonia and has discontinued its Phase 2 clinical trials for episodic and chronic migraine due to cash preservation measures. The company aims to align with the FDA on developing a Botox biosimilar through planned analytical studies and a potential Biosimilar Biological Product Development meeting in 2025.
The filing outlines AEON's exclusive license agreement with Daewoong Pharmaceutical Co., Ltd. for the development and commercialization of ABP-450 in specified territories. AEON relies solely on Daewoong for the manufacturing of ABP-450.
AEON reported a net income of $42.0 million for the year ended December 31, 2024, primarily due to a gain on the fair value of contingent consideration. The company acknowledges substantial doubt about its ability to continue as a going concern and highlights the need for additional capital to fund operations.
The report includes risk factors such as potential delays in regulatory approvals, competition from existing botulinum toxin products, and reliance on third-party manufacturers. AEON also faces challenges related to intellectual property protection and compliance with healthcare laws and regulations.
AEON is subject to extensive government regulation and must comply with various healthcare laws, including the Anti-Kickback Statute and the False Claims Act. The company also addresses cybersecurity risks and data privacy regulations.
The filing discusses AEON's plans to expand its therapeutic applications for botulinum toxins and enhance the economics of botulinum toxin treatments. The company aims to leverage its management team's expertise in drug development and commercialization.
AEON's principal executive office is located in Irvine, California. The company had five employees as of December 31, 2024.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the AEON Biopharma Inc. Class A annual 10-K report dated March 24, 2025. To report an error, please email earnings@qz.com.