Aeon Biopharma Inc (AEON) News & EventsAEONAeon Biopharma Inc

AEON Biopharma Receives FDA Meeting Minutes

AEON Biopharma announced receipt of the official minutes from its Biosimilar Biological Product Development Type 2b meeting held with the U.S. Food and Drug Administration regarding ABP-450's development pathway. "The Type 2b meeting feedback provides greater clarity on the development pathway for ABP-450 and, consistent with FDA's recent biosimilar guidance, supports a potentially more efficient clinical development program," said Rob Bancroft, President and Chief Executive Officer of AEON. "Our strategy is to bring together the most sensitive, complementary and relevant evidence available, including our analytical program, comparative human pharmacodynamic data and the substantial comparative human experience already generated with ABP-450."

Aeon Biopharma Appoints Paul Lee as Acting Chief Regulatory Officer

Aeon Biopharma announced the designation of Paul Lee as the company's acting chief regulatory officer, through Clintrex. Lee and Clintrex currently advise Aeon on the regulatory and clinical development strategy for ABP-450, providing strategic guidance as the company advances its biosimilar development program. In his acting chief regulatory officer role, Lee will lead Aeon's regulatory strategy, help guide the company's interactions with the FDA and work closely with Aeon's analytical, CMC and clinical teams as it advances ABP-450 under the 351 biosimilar pathway.

Aeon Biopharma Prices Public Offering to Raise Up to $43.3M

Aeon Biopharma announced the pricing of its underwritten public offering to raise up to approximately $43.3M in gross proceeds based on the approximately $13.75M in expected gross proceeds from the offering and up to an additional $29.6M in potential gross proceeds upon the cash exercise in full of the milestone warrants issued in the offering. The offering consists of 42.69M shares of common stock of the company, with each share of common of the company, with each share of common stock or pre-funded warrant accompanied by one two-year milestone warrant to purchase one share of common stock and one five-year milestone warrant to purchase one share of common stock. The combined public offering price is 32.21c per share of common stock and accompanying two-year milestone warrant and five-year milestone warrant. The proceeds from this offering are expected to be used for working capital and general corporate purposes, including conducting comparative analytical testing on ABP-450 to support biosimilarity to Botox. The offering is expected to close on or about July 15, subject to satisfaction or waiver of customary closing conditions. Lake Street Capital Markets is acting as the sole bookrunner for this offering. Laidlaw & Company is acting as lead manager for the offering.