Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40021 AEON Biopharma, Inc. (Exact name of registrant as specified in its charter) Delaware 85-3940478 (I.R.S. ...

– Cash runway expected to support operations through FDA meeting and regulatory feedback – IRVINE, Calif., August 12, 2025 – AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE: AEON), a biopharmaceutical company seeking an accelerated and full-label U.S. market entry by developing ABP-450 (prabotulinumtoxinA) as a BOTOXÒ (onabotulinumtoxinA) biosimilar, announced its financial results for the second quarter ended June 30, 2025, and provided a business update. "We have made strong progress this quarter tow ...

Core Insights - AEON Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for various therapeutic indications [1][3] - The company will present a corporate overview at the Aegis Capital Corp. 2025 Virtual Conference on May 21, 2025 [1] Company Overview - AEON is developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, for debilitating medical conditions [3] - ABP-450 is the same botulinum toxin complex marketed for cosmetic uses under the name Jeuveau by Evolus [3] - The product is manufactured by Daewoong in compliance with current Good Manufacturing Practice (cGMP) and is approved by the U.S. FDA, Health Canada, and the European Medicines Agency [3] - ABP-450 is approved as a biosimilar in Mexico and India [3] - AEON holds exclusive development and distribution rights for therapeutic indications of ABP-450 in the U.S., Canada, EU, UK, and other international territories [3] - The company has a highly experienced management team with expertise in biopharmaceutical and botulinum toxin development and commercialization [3]

[Part I: Financial Information](index=6&type=section&id=Part%20I%20Financial%20Information) [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) AEON Biopharma reported a **$9.1 million net income** for Q1 2025, driven by non-cash gains, despite ongoing going concern doubts and a strategic shift [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, cash increased to **$10.4 million**, total assets to **$13.8 million**, and stockholders' deficit improved to **$(11.3) million** Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $10,446 | $13 | | Total current assets | $12,321 | $1,590 | | Total assets | $13,799 | $3,142 | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $8,640 | $14,149 | | Total liabilities | $25,122 | $31,711 | | Total stockholders' deficit | $(11,323) | $(28,569) | | Total liabilities and stockholders' deficit | $13,799 | $3,142 | [Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20%28Loss%29) The company reported a **$9.1 million net income** for Q1 2025, a significant turnaround from a **$118.0 million net loss** in Q1 2024, driven by non-cash gains Q1 2025 vs. Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Selling, general and administrative | $3,125 | $4,649 | | Research and development | $825 | $5,732 | | Loss from operations | $(462) | $(74,150) | | Change in fair value of warrants | $86,729 | $(20,903) | | Loss on issuance of warrants | $(75,644) | — | | Net income (loss) | $9,095 | $(118,018) | | Basic and diluted net income (loss) per share | $2.28 | $(227.87) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$7.9 million**, offset by **$18.3 million** from financing, resulting in a **$10.4 million** net cash increase Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,909) | $(8,600) | | Net cash used in investing activities | $(4) | — | | Net cash provided by financing activities | $18,346 | $5,000 | | **Net increase (decrease) in cash** | **$10,433** | **$(3,600)** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Key notes include a reverse stock split, substantial doubt about going concern, a strategic shift to a biosimilar pathway for ABP-450, and details on financing and complex liabilities - The company has experienced recurring losses and negative cash flows, leading management to conclude there is **substantial doubt** about its ability to continue as a going concern within one year[24](index=24&type=chunk)[27](index=27&type=chunk) - In July 2024, the company announced a strategic reprioritization to pursue a Section 351(k) biosimilar regulatory pathway for ABP-450, using Botox as a reference product, after discontinuing its Phase 2 migraine trials[25](index=25&type=chunk) - On January 7, 2025, the company closed a public offering, receiving net proceeds of approximately **$18.3 million**[68](index=68&type=chunk) - In March 2024, the company entered into an agreement for up to **$15.0 million** in senior secured convertible notes with its supplier, Daewoong[61](index=61&type=chunk) - The issuance of Series A and B Warrants in January 2025 resulted in a recognized loss on issuance of **$75.6 million**, as the fair value of the warrants exceeded the proceeds received[76](index=76&type=chunk)[101](index=101&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=40&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic pivot to developing ABP-450 as a biosimilar, significant cost reductions, and the need for additional funding to address going concern doubts - The company has pivoted its strategy to develop ABP-450 as a biosimilar product under a Section 351(k) BLA pathway, using AbbVie's Botox as a reference product, after discontinuing its Phase 2 trials for migraine[133](index=133&type=chunk)[134](index=134&type=chunk) - As of the report date, the company has sufficient cash to fund its operating plan only into the **fourth quarter of 2025**, and additional funding is required for further development of ABP-450[145](index=145&type=chunk)[187](index=187&type=chunk) Operating Expense Comparison (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Selling, General & Administrative | $3,125 | $4,649 | -33% | | Research & Development | $825 | $5,732 | -86% | - The decrease in R&D expenses was primarily due to the wind-down of Phase 2 clinical trials for migraine and cervical dystonia, while SG&A decreased mainly due to lower legal and professional fees[174](index=174&type=chunk)[175](index=175&type=chunk) - The company received a notice of non-compliance from NYSE American in February 2025 for failing to meet the minimum stockholders' equity requirement, but the exchange accepted its compliance plan, granting it until **August 2026** to regain compliance[150](index=150&type=chunk)[151](index=151&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=58&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, AEON Biopharma is not required to provide information under this item - The Company is a smaller reporting company and is not required to provide information under this item[207](index=207&type=chunk) [Controls and Procedures](index=60&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were not effective as of March 31, 2025, due to material weaknesses in risk assessment and segregation of duties, with remediation efforts underway - The company's certifying officers concluded that disclosure controls and procedures were **not effective** as of March 31, 2025[212](index=212&type=chunk) - Material weaknesses were identified related to ineffective risk assessment over complex transactions and a lack of segregation of duties in financial reporting[213](index=213&type=chunk) - Remediation efforts are in progress, including engaging additional resources and implementing enhanced controls and processes[216](index=216&type=chunk)[217](index=217&type=chunk) [Part II: Other Information](index=62&type=section&id=Part%20II%20Other%20Information) [Legal Proceedings](index=62&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in a lawsuit with Odeon Capital Group LLC over an alleged **$1.25 million** unpaid deferred underwriting fee from the 2023 merger, with the breach of contract claim proceeding - Odeon Capital Group LLC filed a lawsuit against the Company for an alleged unpaid deferred underwriting fee of **$1.25 million** from the 2023 merger[113](index=113&type=chunk)[221](index=221&type=chunk) - The company successfully had non-breach of contract claims dismissed in April 2024, but the breach of contract claim is still proceeding[113](index=113&type=chunk)[221](index=221&type=chunk) [Risk Factors](index=62&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors previously disclosed in the Annual Report on Form 10-K filed on March 24, 2025 - There have been no material changes to the risk factors disclosed in the Annual Report on Form 10-K filed on March 24, 2025[222](index=222&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=62&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - No unregistered sales of equity securities occurred during the period[223](index=223&type=chunk) [Defaults Upon Senior Securities](index=62&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - No defaults upon senior securities occurred during the period[224](index=224&type=chunk) [Mine Safety Disclosures](index=64&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's business - This item is not applicable to the company[225](index=225&type=chunk) [Other Information](index=64&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the quarter[226](index=226&type=chunk) [Exhibits](index=64&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed with the quarterly report, including agreements, corporate governance documents, and certifications - The report includes an index listing all exhibits filed, such as the Business Combination Agreement, Certificate of Incorporation, Warrant Agreements, and officer certifications[227](index=227&type=chunk)[229](index=229&type=chunk)

[Corporate Update and Clinical Highlights](index=1&type=section&id=Corporate%20Update%20and%20Clinical%20Highlights) 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](index=2&type=chunk)[8](index=8&type=chunk) - 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](index=3&type=chunk)[5](index=5&type=chunk)[6](index=6&type=chunk) - 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](index=3&type=chunk)[8](index=8&type=chunk) - As of **March 31, 2025**, the company had **$10.4 million** in **cash and cash equivalents**, expected to fund operations through **Q4 2025**[8](index=8&type=chunk) - The **NYSE American** has granted the company an extension until **August 3, 2026**, to regain compliance with continued listing standards[8](index=8&type=chunk) [First Quarter 2025 Financial Results](index=6&type=section&id=First%20Quarter%202025%20Financial%20Results) 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](index=3&type=section&id=About%20AEON%20Biopharma) 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](index=7&type=chunk) - **ABP-450** is the same **botulinum toxin complex** marketed by **Evolus** for cosmetic indications as **Jeuveau** and is manufactured by **Daewoong**[7](index=7&type=chunk) - 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](index=7&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) 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](index=8&type=chunk)[9](index=9&type=chunk) - 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](index=12&type=chunk) - The company **does not undertake any duty to update** these forward-looking statements[13](index=13&type=chunk)

Core Insights - AEON Biopharma is advancing its biosimilar development program for ABP-450, aiming for FDA approval under the 351(k) regulatory pathway, which could cover all current and future indications of BOTOX [2][5] - The global therapeutic toxin market is estimated to be at least $3.3 billion, predominantly controlled by a single toxin, indicating significant market potential for AEON's ABP-450 [2][5] - The company reported cash and cash equivalents of $10.4 million as of March 31, 2025, which is expected to fund operations through the fourth quarter of 2025 [6] Recent Developments - AEON is conducting primary analytical studies in preparation for a potential Biosimilar Biological Product Development (BPD) Type 2a meeting with the FDA in the second half of 2025 [4][5] - Rob Bancroft has been appointed as President and CEO, bringing over 25 years of experience in the life sciences industry [4][5] - The company has received an extension until August 3, 2026, to regain compliance with NYSE American listing standards [6] Financial Performance - For the first quarter ended March 31, 2025, AEON reported a net income of $9.1 million, a significant improvement compared to a net loss of $118 million in the same period of 2024 [14][15] - Operating expenses decreased to $4.0 million from $10.4 million year-over-year, reflecting a reduction in selling, general, and administrative costs [15] - The total assets of the company increased to $13.8 million as of March 31, 2025, compared to $3.1 million at the end of 2024 [13]

Core Viewpoint - AEON Biopharma has received acceptance from NYSE American for its plan to regain compliance with listing standards, allowing until August 3, 2026, to meet requirements related to market capitalization and stockholders' equity [1][2]. Group 1: Compliance and Listing Standards - NYSE American has granted AEON a Plan Period until August 3, 2026, to regain compliance with continued listing standards [2]. - The company will undergo periodic reviews by NYSE American during the Plan Period to assess progress [2]. - Failure to regain compliance or make sufficient progress may lead to delisting proceedings by NYSE American [2]. Group 2: Company Overview - AEON Biopharma is focused on developing its proprietary botulinum toxin complex, ABP-450, for various therapeutic indications, initially targeting the neurosciences market [3]. - ABP-450 is the same botulinum toxin complex marketed for cosmetic use as Jeuveau by Evolus and is manufactured in compliance with cGMP [3]. - The product has received biosimilar approval in Mexico and India, with exclusive development and distribution rights in the U.S., Canada, EU, UK, and other territories [3]. Group 3: Management and Expertise - The company has assembled a highly experienced management team with specific expertise in biopharmaceutical and botulinum toxin development and commercialization [3].

Group 1 - AEON Biopharma has appointed Rob Bancroft as President and CEO, and the Compensation Committee has approved inducement awards for him [1] - Mr. Bancroft will receive a non-qualified stock option to purchase 59,034 shares of AEON Class A common stock and 177,103 restricted stock units (RSUs) under the 2025 Employment Inducement Incentive Award Plan [2][3] - The stock option and RSUs will vest over four years, with 25% vesting on each annual anniversary of the vesting commencement date [3] Group 2 - AEON Biopharma is focused on developing its proprietary botulinum toxin complex, ABP-450, for various therapeutic indications, initially targeting the neurosciences market [4] - ABP-450 is the same botulinum toxin complex marketed for cosmetic use by Evolus under the name Jeuveau and is manufactured in compliance with cGMP [4] - The company holds exclusive development and distribution rights for therapeutic indications of ABP-450 in the U.S., Canada, EU, UK, and other territories [4]

Core Points - AEON Biopharma has appointed Rob Bancroft as President and CEO, effective April 29, 2025, with Bancroft also joining the Board of Directors [1][2] - Bancroft has over 25 years of experience in the life sciences industry, including leadership roles at Revance Therapeutics and Allergan, where he was involved in the commercialization of BOTOX [2][3] - The company is focused on advancing its ABP-450 program along the 351(k) biosimilar regulatory pathway, aiming to bring ABP-450 to the U.S. market for all current and future BOTOX indications under a single FDA approval [2][3] Company Overview - AEON Biopharma is a clinical-stage biopharmaceutical company developing ABP-450 (prabotulinumtoxinA) for various therapeutic indications, initially targeting the neurosciences market [3] - ABP-450 is the same botulinum toxin complex currently marketed for cosmetic use as Jeuveau by Evolus and is manufactured in compliance with cGMP [3] - The product has been approved as a biosimilar in Mexico and India, with AEON holding exclusive rights for therapeutic indications in the U.S., Canada, EU, UK, and other territories [3]

Leadership Transition - Marc Forth is stepping down as President and CEO of AEON Biopharma, effective April 4, 2025, to pursue another opportunity, but will remain on the Board of Directors [1] - Jost Fischer, the current Chairman of the Board, will serve as Interim CEO while the Board searches for a permanent replacement [1][2] Company Progress and Strategy - AEON is making progress along a 351(k) biosimilar regulatory pathway to potentially bring ABP-450 to the U.S. market for all of BOTOX's approved and future therapeutic indications under a single FDA approval [2] - The company anticipates a Biosimilar BPD Type 2a meeting with the FDA in the second half of 2025, with current cash balance expected to support this process [2] Product Development - AEON is focused on developing its proprietary botulinum toxin complex, ABP-450, for debilitating medical conditions, initially targeting the neurosciences market [3] - ABP-450 is the same botulinum toxin complex marketed for cosmetic use as Jeuveau by Evolus and is approved as a biosimilar in Mexico and India [3]