AEON Biopharma(AEON) - 2025 Q3 - Quarterly Report

Financial Performance - As of September 30, 2025, the company reported an accumulated deficit of $433.7 million and cash and cash equivalents of $5.9 million, raising substantial doubt about its ability to continue as a going concern [166][170]. - The company expects to incur significant operating losses and does not anticipate revenue from ABP-450 until regulatory approval and commercialization are achieved [167]. - The Company reported a net loss of $4.5 million for the three months ended September 30, 2025, compared to a net loss of $6.2 million for the same period in 2024 [196]. - The company has incurred recurring losses from operations and expects to continue incurring significant operating losses for the foreseeable future [219]. - The company reported a net loss of $2.1 million for the nine months ended September 30, 2025, compared to a net income of $39.9 million for the same period in 2024 [225][226]. - The total operating costs and expenses for the nine months ended September 30, 2025, were $7.3 million, compared to a significant loss of $75.3 million in the same period in 2024 [196]. Research and Development - The company aims to develop ABP-450 as a biosimilar to Botox, targeting a global therapeutic botulinum toxin market estimated at $3.3 billion based on AbbVie's reported revenues for the fiscal year ended 2024 [156]. - The initial results from analytical studies show a 100% amino acid sequence match between ABP-450 and Botox, supporting the biosimilar development [161]. - The company expects R&D expenses to increase as it develops and seeks regulatory approval for ABP-450, with significant costs anticipated for clinical studies [189]. - The company has discontinued Phase 2 clinical trials for episodic and chronic migraine due to not meeting primary endpoints, implementing cash preservation measures instead [157]. - The company has scheduled a BPD Type 2a meeting with the FDA on November 19, 2025, to review analytical study results for ABP-450 [160]. - The company announced a strategic reprioritization to pursue a 351(k) biosimilar regulatory pathway for ABP-450, using Botox as a reference product [213]. Financing Activities - The Company completed an underwritten public offering on January 7, 2025, selling 555,571 Common Units, resulting in net proceeds of approximately $18.3 million after expenses [182]. - The company entered into a PIPE financing agreement on November 12, 2025, for the sale of 6,581,829 shares at a price of $0.9116 per share, generating gross proceeds of $6 million [183]. - The company entered into a Subscription Agreement with Daewoong for the sale of Convertible Notes totaling up to $15 million to support the late-stage clinical development of ABP-450 [175]. - The Company announced a binding term sheet with Daewoong for the exchange of $15.0 million in 2024 Convertible Notes for approximately 23,103,694 shares of Class A common stock and a new $1.5 million convertible note due 2030 with an interest rate of 15.79% [179]. - The company plans to use net proceeds from the PIPE financing to advance its ABP-450 biosimilar program and for general corporate purposes [217]. Compliance and Regulatory Issues - The company received a notice of non-compliance from NYSE American due to a stockholders' deficit of $32.1 million as of September 30, 2024, and is working on a plan to regain compliance [171]. - The company has substantial doubt about its ability to continue as a going concern, indicating potential challenges in meeting obligations within one year [224]. - The exercise price of the Private Placement Warrants is $828.00 per warrant, while the last reported sales price of common stock was $0.935, suggesting low likelihood of warrant exercise [221]. - The company may need to raise additional funds through equity or debt financing, which could lead to dilution for stockholders [223]. - The company is classified as a smaller reporting company, with a market value of common stock held by non-affiliates below $700 million [233]. - The company intends to rely on exemptions from various public company reporting requirements as an emerging growth company [231]. Operating Expenses - For the three months ended September 30, 2025, SG&A expenses decreased by $1.1 million, or 36%, to $1.9 million compared to $3.0 million for the same period in 2024 [197]. - SG&A expenses decreased by $2.7 million, or 25%, to $8.3 million for the nine months ended September 30, 2025, compared to $11.0 million for the same period in 2024 [198]. - Research and development expenses for the nine months ended September 30, 2025, were $2.5 million, a significant decrease from $11.1 million in the same period in 2024 [196]. - R&D expenses for the nine months ended September 30, 2025, were $2.5 million, a decrease of $8.7 million, or 80%, from $11.1 million for the same period in 2024 [200]. - The change in fair value of convertible notes resulted in a loss of $1.9 million for the three months ended September 30, 2025 [196]. - The company recorded a loss on issuance of warrants of $75.6 million due to the fair value of warrants exceeding proceeds received [202].