AEON Biopharma(AEON) - 2025 Q1 - Quarterly Results

Corporate Update and Clinical Highlights AEON Biopharma appointed a new CEO, progressed its ABP-450 biosimilar program towards an H2 2025 FDA meeting, and reported $10.4 million cash, securing NYSE compliance extension - Appointed Rob Bancroft as President and Chief Executive Officer, who also joined the Board of Directors, effective April 29, 2025[2][8] - Advancing the development of ABP-450 as a biosimilar to BOTOX under the 351(k) regulatory pathway, which could allow for approval across all of BOTOX's therapeutic indications[3][5][6] - A Biosimilar Biological Product Development (BPD) Type 2a meeting with the FDA is planned for the second half of 2025 to discuss analytical study outcomes and define next steps[3][8] - As of March 31, 2025, the company had $10.4 million in cash and cash equivalents, expected to fund operations through Q4 2025[8] - The NYSE American has granted the company an extension until August 3, 2026, to regain compliance with continued listing standards[8] First Quarter 2025 Financial Results AEON reported a significant Q1 2025 financial improvement, moving from a net loss to a net income, primarily due to warrant fair value changes, and ended the quarter with $10.4 million cash Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended March 31, | | | :--- | :--- | :--- | | | 2025 | 2024 | | Total operating costs and expenses | $462 | $74,150 | | Loss from operations | $(462) | $(74,150) | | Total other income (loss), net | $9,557 | $(43,868) | | Net income (loss) | $9,095 | $(118,018) | | Basic and diluted net income (loss) per share | $2.28 | $(227.87) | Condensed Consolidated Balance Sheet Highlights (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $10,446 | $13 | | Total assets | $13,799 | $3,142 | | Total liabilities | $25,122 | $31,711 | | Total stockholders' deficit | $(11,323) | $(28,569) | About AEON Biopharma AEON is a clinical-stage biopharmaceutical company developing ABP-450 for therapeutic indications, holding exclusive rights in key global markets - AEON is a clinical-stage biopharmaceutical company developing ABP-450 (prabotulinumtoxinA) for therapeutic indications[7] - ABP-450 is the same botulinum toxin complex marketed by Evolus for cosmetic indications as Jeuveau and is manufactured by Daewoong[7] - The company holds exclusive development and distribution rights for therapeutic uses of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and other territories[7] Forward-Looking Statements This report contains forward-looking statements concerning future events and ABP-450's potential, subject to substantial risks and uncertainties, advising against undue reliance - Forward-looking statements relate to future events, such as meetings with the FDA and the potential determination of ABP-450 as a biosimilar to BOTOX[8][9] - These statements are subject to risks and uncertainties that could cause actual results to differ materially, including legal proceedings, capital requirements, financing ability, and regulatory outcomes[12] - The company does not undertake any duty to update these forward-looking statements[13]