- Meeting date aligns with prior guidance - - FDA to review AEON’s analytical development plan and initial data - IRVINE, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a biopharmaceutical company developing ABP-450 (prabotulinumtoxinA) as a BOTOX® (onabotulinumtoxinA) biosimilar, today announced that the U.S. Food and Drug Administration (FDA) has scheduled a Biosimilar Biological Product Development (BPD) Type 2a meeting for ABP-450 on November 19, 2 ...

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. ...

[Corporate Update and Business Overview](index=1&type=section&id=Corporate%20Update%20and%20Business%20Overview) AEON Biopharma reported Q2 2025 results, detailing ABP-450 biosimilar development and liquidity supporting operations through Q4 2025 - AEON Biopharma is developing ABP-450 (prabotulinumtoxinA) as a BOTOX (onabotulinumtoxinA) biosimilar, seeking accelerated and full-label U.S. market entry[1](index=1&type=chunk) - The U.S. therapeutic neurotoxin market exceeds **$3.0 billion annually**, presenting a major opportunity for biosimilar entry[2](index=2&type=chunk)[7](index=7&type=chunk) [Initial Announcement and CEO Commentary](index=1&type=section&id=Initial%20Announcement%20and%20CEO%20Commentary) CEO Rob Bancroft highlighted strong progress for ABP-450 biosimilar development milestones in H2 2025 - CEO Rob Bancroft highlighted strong progress towards major biosimilar development milestones for ABP-450 in the second half of 2025[2](index=2&type=chunk) - Anticipated completion of primary structure analysis and select functional analyses in **3Q'25**, critical for the planned Type 2a meeting with the FDA in **4Q'25**[1](index=1&type=chunk)[2](index=2&type=chunk) - AEON aims to bring ABP-450 to the U.S. market via the **351(k) pathway**, potentially covering all BOTOX therapeutic indications and offering a more cost-effective solution[2](index=2&type=chunk) [Recent Clinical and Corporate Highlights](index=1&type=section&id=Recent%20Clinical%20and%20Corporate%20Highlights) The company is advancing ABP-450 biosimilar development through comparative analytical assessment for FDA alignment - Advancing ABP-450's biosimilar development through the comparative analytical assessment (CAA) via a **351(k) regulatory pathway**, using BOTOX as the reference product[3](index=3&type=chunk) - Expects to complete primary structure and select functional analyses for ABP-450 in **3Q'25**[3](index=3&type=chunk) - Anticipates a **Type 2a meeting with the FDA in 4Q'25** to discuss study results and align on next development steps[3](index=3&type=chunk) [Liquidity and Capital Resources](index=3&type=section&id=Liquidity%20and%20Capital%20Resources) AEON Biopharma's cash and cash equivalents are expected to fund operations through Q4 2025 Liquidity and Capital Resources (June 30, 2025) | Metric | Amount | | :----- | :--------------------- | | Cash and cash equivalents | $8.4 million | - Cash runway expected to support operations through the **fourth quarter of 2025** and the planned Type 2a meeting with the FDA[1](index=1&type=chunk)[5](index=5&type=chunk) [Expected Upcoming Milestones](index=3&type=section&id=Expected%20Upcoming%20Milestones) Key milestones include primary structure and functional analyses in Q3 2025, and an FDA meeting in Q4 2025 - **3Q'25**: Expected completion of primary structure analysis by the Company[10](index=10&type=chunk) - **3Q'25**: Expected completion of select functional analyses by Daewoong Pharmaceutical, the Company's licensing partner[10](index=10&type=chunk) - **4Q'25**: Expected results and path forward from Biosimilar Biological Product Development (BPD) Type 2a FDA meeting[10](index=10&type=chunk) [About AEON Biopharma](index=3&type=section&id=About%20AEON%20Biopharma) AEON Biopharma develops ABP-450 as a BOTOX biosimilar for the U.S. market, manufactured by Daewoong - AEON Biopharma seeks accelerated and full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX[7](index=7&type=chunk) - ABP-450 is manufactured by Daewoong Pharmaceutical in compliance with current Good Manufacturing Practice (cGMP) in an FDA-approved facility[7](index=7&type=chunk) - 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 U.S., Canada, EU, UK, and other territories[7](index=7&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines forward-looking statements, subject to risks and uncertainties, with no obligation to update - Forward-looking statements generally relate to future events or AEON's future financial or operating performance, including meetings with the FDA and the timing/outcome of primary comparative analytical studies[8](index=8&type=chunk) - Such statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially, including the completion of analyses, FDA meeting outcomes, future capital requirements, and regulatory factors[8](index=8&type=chunk)[9](index=9&type=chunk)[11](index=11&type=chunk) - Readers 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 statements[14](index=14&type=chunk) [Contacts](index=5&type=section&id=Contacts) This section provides contact information for investor relations inquiries - Investor Contact: Laurence Watts, New Street Investor Relations, **+1 619 916 7620**, laurence@newstreetir.com[15](index=15&type=chunk) [Condensed Consolidated Financial Statements](index=6&type=section&id=Condensed%20Consolidated%20Financial%20Statements) Condensed consolidated financial statements detail AEON Biopharma's financial position and operating results for Q2 2025 and 2024 [Condensed Consolidated Balance Sheets](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) The balance sheets highlight significant increases in cash and total assets, alongside an improved stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Item | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Cash and cash equivalents | $8,439 | $13 | +$8,426 | | Prepaid expenses and other current assets | $1,823 | $1,577 | +$246 | | Total current assets | $10,262 | $1,590 | +$8,672 | | Total assets | $11,662 | $3,142 | +$8,520 | | Total current liabilities | $9,129 | $14,149 | -$5,020 | | Convertible notes at fair value | $15,174 | $11,689 | +$3,485 | | Warrant liability | $2,122 | $1,187 | +$935 | | Contingent consideration liability | $69 | $3,541 | -$3,472 | | Total liabilities | $27,514 | $31,711 | -$4,197 | | Total stockholders' deficit | $(15,852) | $(28,569) | +$12,717 | - Cash and cash equivalents increased significantly from **$13 thousand** at December 31, 2024, to **$8,439 thousand** at June 30, 2025[17](index=17&type=chunk) - Total stockholders' deficit improved by **$12,717 thousand**, from **$(28,569) thousand** at December 31, 2024, to **$(15,852) thousand** at June 30, 2025[17](index=17&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20(LOSS)%20INCOME) Statements of operations show a shift to net loss in Q2 2025, driven by fair value adjustments and reduced R&D expenses Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Selling, general and administrative | $3,258 | $3,321 | $6,383 | $7,970 | | Research and development | $1,064 | $4,439 | $1,889 | $10,172 | | Change in fair value of contingent consideration | $16 | $(161,233) | $(3,472) | $(97,464) | | Total operating costs and expenses | $4,338 | $(153,473) | $4,800 | $(79,322) | | (Loss) income from operations | $(4,338) | $153,473 | $(4,800) | $79,322 | | Change in fair value of convertible notes | $(1,854) | $1,795 | $(3,485) | $1,708 | | Change in fair value of warrants | $(542) | $5,905 | $86,187 | $(14,999) | | Loss on issuance of warrants | — | — | $(75,644) | — | | Net (loss) income | $(6,642) | $164,112 | $2,453 | $46,094 | | Basic net (loss) income per share | $(0.60) | $304.00 | $0.32 | $87.15 | | Diluted net (loss) income per share | $(0.60) | $304.00 | $0.31 | $87.15 | - Net loss of **$(6,642) thousand** for the three months ended June 30, 2025, compared to net income of **$164,112 thousand** for the same period in 2024[20](index=20&type=chunk) - Research and development expenses decreased significantly from **$4,439 thousand** in Q2 2024 to **$1,064 thousand** in Q2 2025[20](index=20&type=chunk) - The change in fair value of contingent consideration significantly impacted operating costs, moving from a **$(161,233) thousand** gain in Q2 2024 to a **$16 thousand** expense in Q2 2025[20](index=20&type=chunk)

Core Insights - AEON Biopharma is progressing towards significant biosimilar development milestones for ABP-450, aiming for a Type 2a meeting with the FDA in 4Q'25 [2][5] - The U.S. therapeutic neurotoxin market exceeds $3.0 billion, presenting a substantial opportunity for AEON's entry with ABP-450 as a cost-effective alternative to BOTOX [4][5] Financial Overview - As of June 30, 2025, AEON reported cash and cash equivalents of $8.4 million, expected to fund operations through the planned FDA meeting in 4Q'25 [5] - The company incurred a net loss of $6.6 million for the three months ended June 30, 2025, compared to a net income of $164.1 million for the same period in 2024 [12][13] - Total current assets amounted to $10.3 million, while total liabilities were reported at $27.5 million, resulting in a stockholders' deficit of $15.9 million [11] Upcoming Milestones - Completion of primary structure analysis and select functional analyses for ABP-450 is expected in 3Q'25 [5] - The anticipated Type 2a meeting with the FDA in 4Q'25 will discuss the results of these studies and outline the next steps for ABP-450's development [5][6] Product Development - ABP-450 is being developed as a biosimilar to BOTOX, utilizing the 351(k) regulatory pathway to potentially cover all therapeutic indications of BOTOX [2][5] - The product is already approved as a biosimilar in India, Mexico, and the Philippines, with exclusive development rights in the U.S., Canada, EU, and UK [6]

永旺梦乐城（湘江新区店）正有序推进装修工程。 湘江早报全媒体记者 罗钟杰 摄 通过融合生态、阳光和城市文化元素，该项目缔造了与自然共生的特色空间，诠释可持续发展的购物场景，并全 力打造女性友好、家庭友好、宠物友好三大主题空间，以及屋顶公园等满足顾客社交、情绪需求的场所。 永旺梦乐城（湘江新区店）室内效果图。 永旺梦乐城（湘江新区店）又有新进展！近日，记者从永旺梦乐城（湖南）湘江新区商业管理有限公司了解到， 优衣库、无印良品、鲁比猴儿童乐园正式入驻该购物中心。据悉，永旺梦乐城（湘江新区店）规划引入近260家品 牌，目前，正持续推进内部装修工程，预计今年年底开门迎客。 永旺梦乐城（湘江新区店）是永旺梦乐城在湖南开设的第二家店，位于雷锋大道与金圆路交会处，项目紧邻长沙 高铁西站，交通网络发达，辐射区域广泛，覆盖了较为庞大的消费客群。项目总建筑面积约23万平方米，包括1栋 4层购物中心、1栋6层停车楼以及整体一层地下室，共计约3300个停车位，规划有近260家品牌入驻，集电影院、 潮流服饰、大型餐饮、家居杂货、特色休闲娱乐等多种业态于一体。 目前，该项目已引入了河西首家永旺超市、中影国际影城、湖南首家具有高抛滑梯的城 ...

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].