Irvine, California — November 20, 2025 — Leads & Copy — AEON Biopharma, Inc. (NYSE American: AEON) announced the first closing of its private placement (PIPE) resulting in approximately $1.79 million in proceeds. Additionally, the U.S. Food and Drug Administration (FDA) has proposed a new date of January 21, 2026, for AEON’s Biosimilar Biological product Development (BPD) Type 2a meeting.
The first closing of the PIPE occurred on November 18, 2025. The second closing is subject to stockholder approval and other closing conditions required under the securities purchase agreement. The proceeds will enable the uninterrupted execution of AEON’s analytical program and are expected to accelerate ABP-450’s biosimilar development by up to six months.
On November 18, 2025, the FDA informed AEON that the BPD Type 2a meeting would be rescheduled and proposed January 21, 2026, as the new meeting date. The Type 2a meeting will review AEON’s analytical development plan and initial data supporting biosimilarity. The FDA did not cite any scientific or program-related issues regarding the scheduling change.
Rob Bancroft, President & Chief Executive Officer of AEON said securing funds from the first closing of the PIPE allows the company to maintain full program momentum. He added that the company looks forward to its Type 2a meeting with the FDA.
The FDA regulates biosimilars under the Public Health Service Act’s 351(k) pathway. This requires developers to demonstrate that a proposed product is highly similar to an approved reference biologic with no clinically meaningful differences in safety, purity, or potency. Analytical similarity is the scientific foundation of this process.
AEON Biopharma is seeking accelerated and full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX. The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually. The Company’s lead asset is ABP-450 for debilitating medical conditions. ABP-450 is the same botulinum toxin complex currently approved and marketed for cosmetic indications by Evolus, Inc. under the name Jeuveau®. ABP-450 is manufactured by Daewoong Pharmaceutical in compliance with current Good Manufacturing Practice (cGMP) in a facility approved by the FDA, Health Canada, and European Medicines Agency. The product is approved as a biosimilar in India, Mexico, and the Philippines. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories.
Certain statements in this press release may be considered forward-looking statements and are subject to risks, uncertainties, and other factors which could cause actual results to differ. These forward-looking statements are based upon estimates and assumptions that are inherently uncertain.
Factors that may cause actual results to differ materially from current expectations include, but are not limited to the ability of the Company to obtain stockholder approval for the PIPE transaction and the ability of the Company to satisfy other closing conditions. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements.
Investor Contact:
Laurence Watts
New Street Investor Relations
+1 619 916 7620
laurence@newstreetir.com
Source: AEON Biopharma
