IRVINE, Calif., May 19, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, today announced that Rob Bancroft, AEON’s President and Chief Executive Officer, will present a corporate overview at the Aegis Capital Corp. 2025 Virtual Conference on Wednesday, May 21st at 7:00 a.m. PT / 10:00 am ET. Please register here to attend the c ...

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 March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES Commission File Number: 001-40021 AEON Biopharma, Inc. (Exact name of registrant as specified in its charter) Delaware 85-3940478 (State or other jurisdiction of incorporation or organization) ...

AEON Biopharma Reports First Quarter 2025 Financial Results and Provides Corporate Update – Appointed Rob Bancroft as the Company's President and Chief Executive Officer; Mr. Bancroft also joined AEON's Board of Directors – IRVINE, Calif., May 14, 2025 – AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced its financial results for the first quar ...

– Continue to conduct analytical studies to prepare for a potential Biosimilar Biological Product Development (“BPD”) Type 2a meeting with the FDA in the second half of 2025 – – Pursuing a 351(k) regulatory pathway for ABP-450, which offers potential access to the U.S. market under a single approval for all of BOTOX’s currently approved and future therapeutic indications – – Appointed Rob Bancroft as the Company’s President and Chief Executive Officer; Mr. Bancroft also joined AEON’s Board of Directors – IR ...

IRVINE, Calif., April 25, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced today it has received notification (the “Acceptance Letter”) from the NYSE American LLC (“NYSE American”) that NYSE American has accepted the Company's previously submitted plan (the “Plan”) to regain compliance with NYSE American's continued l ...

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]

Financial Performance - Net income for 2024 was $42,005,000, compared to a net loss of $323,954,000 in 2023, representing a turnaround of approximately $365,959,000[578]. - Basic net income per share improved from a loss of $627.33 in 2023 to a profit of $77.74 in 2024[578]. - The company reported a segment net income of $42,005 thousand for the year ended December 31, 2024, compared to a net loss of $323,954 thousand for the year ended December 31, 2023[601]. - The company experienced recurring losses from operations, raising substantial doubt about its ability to continue as a going concern[569]. - The company has substantial doubt about its ability to continue as a going concern due to recurring losses and negative cash flows from operations[592]. - The company reported an accumulated deficit of $431.6 million as of December 31, 2024[588]. - The total stockholders' deficit improved from $(153,044,000) in 2023 to $(28,569,000) in 2024, a positive change of approximately 81.3%[575]. - Total operating costs and expenses for the year ended December 31, 2024, were $72,985 thousand, significantly lower than $318,442 thousand for the previous year[601]. - The company incurred professional and legal fees of $6,233 thousand in 2024, up from $5,499 thousand in 2023, indicating a rise of about 13%[601]. - The company experienced a net cash used in operating activities of $20,292, an improvement from $26,080 in the previous year[582]. Clinical Development - The Phase 2 clinical study of ABP-450 for cervical dystonia enrolled 59 patients across approximately 20 sites in the U.S., with a treatment cycle consisting of one treatment cycle tailored to individual patient needs[57]. - ABP-450 met the primary endpoint of safety and tolerability, with zero discontinuations due to treatment-emergent adverse events (TEAEs) and a low rate of treatment-related TEAEs[59]. - TWSTRS scores improved by 14.01 points in the 150 unit arm, 11.28 points in the 250 unit arm, and 9.92 points in the 350 unit arm, compared to a 3.57 point improvement in the placebo group, indicating statistically significant changes[60]. - The median duration of treatment effect for all three treatment arms was at least 20 weeks[61]. - The company acknowledges the need for additional funding to continue the development of ABP-450 for cervical dystonia, including Phase 3 clinical trials[61]. - AEON Biopharma announced the discontinuation of its Phase 2 clinical trials for episodic and chronic migraine in May 2024 due to not meeting primary or secondary endpoints[589]. Market and Competitive Landscape - The global therapeutic botulinum toxin market is projected to grow, with the current market leader holding approximately 95% market share in the US therapeutic market as of 2019[79]. - The estimated market for episodic migraine treatments is $18.5 billion, with ABP-450 aiming to enhance safety and tolerability for patients[82]. - The pharmaceutical industry is highly competitive, with many competitors having greater resources for R&D, marketing, and promotion[99]. - ABP-450 will compete directly with other injectable botulinum toxins, including Botox, Dysport, Xeomin, Myobloc, and Daxxify, which are already approved for various therapeutic uses[102]. - The company faces competition from CGRP agonists for the preventative treatment of chronic migraine, including Aimovig, Ajovy, and Emgality, which are self-administered[106]. Regulatory and Compliance - The FDA requires a comprehensive process for marketing approval of biological products, including nonclinical tests, clinical studies, and submission of a Biologics License Application (BLA)[109]. - The company plans to submit an original Biologics License Application (BLA) for its product candidate ABP-450 after developing necessary safety and efficacy data[119]. - The FDA's goal is to review standard BLA applications within ten months and priority review applications within six months after acceptance for filing[124]. - The FDA may require substantial post-approval testing and surveillance to monitor the product's safety and efficacy, which could affect market potential[130]. - The company must comply with ongoing FDA regulations, including record-keeping and reporting of adverse experiences, after product approval[139]. - The FDA may condition approval of a BLA on the requirement for post-marketing studies to further assess safety and effectiveness[130]. - The BPCIA allows for a biosimilar application to be submitted only four years after the reference product's first licensure, with a twelve-year exclusivity period for the reference product[146]. - In the EEA, new products receive eight years of data exclusivity and an additional two years of market exclusivity upon marketing authorization[152]. - The market exclusivity period in the EEA prevents generic or biosimilar applicants from commercializing their products for ten years from the initial authorization of the reference product[154]. - The approval process for products varies significantly across countries, impacting the timeline for clinical studies and marketing[160]. Financial Position and Funding - The company expects to have sufficient cash to fund its operating plan into Q4 2025, including $18.3 million in net proceeds from a public offering in January 2025[53]. - The company raised $197 million for investment in AEON since 2019, including $20 million in gross proceeds from a public offering in January 2025[82]. - The company is preparing for a potential Biosimilar Biological Product Development Type 2a meeting with the FDA in the second half of 2025[75]. - The company entered into an at-the-market sales agreement with Leerink Partners, allowing for gross proceeds of up to $50 million, with $49.8 million remaining available as of December 31, 2024[591]. - The company relies exclusively on Daewoong Pharmaceutical Co., Ltd. for the manufacturing of its source material, which poses a risk if the agreement is terminated[604]. Intellectual Property - A patent for a treatment paradigm involving fewer injections for migraine was issued in November 2023, enhancing the company's intellectual property portfolio[94]. - The company currently owns one issued patent and has six pending Patent Cooperation Treaty international patent applications related to ABP-450, which could expire in 2040 if issued[95]. - The company relies on trade secrets, know-how, and confidentiality agreements to protect proprietary information, although these may be breached[98]. Operational Challenges - The company is subject to significant federal, state, and local regulations, which govern various aspects of product development and marketing[108]. - Non-compliance with healthcare regulations can lead to severe penalties, including exclusion from federal healthcare programs[162]. - Coverage and reimbursement for products in the U.S. depend on third-party payors, which may challenge pricing and medical necessity[163]. - Third-party payors may require additional studies to demonstrate cost-effectiveness, increasing the financial burden on the company[164]. - The cost of preparing and submitting a BLA is substantial, and the submission is subject to a significant application fee and annual program fees[123].

Financial Performance - AEON Biopharma reported a net income of $2.083 million for Q4 2024, compared to a net loss of $26.241 million in Q4 2023[17]. - Research and development expenses for the year 2024 were $14.181 million, compared to $13.243 million in 2023, reflecting an increase of about 7.1%[17]. - The company’s accumulated deficit improved from $(473.602) million in 2023 to $(431.597) million in 2024, a reduction of approximately 8.9%[15]. Capital and Funding - The company closed a public offering on January 7, 2025, raising gross proceeds of $20.0 million, which will fund operations through 2025[5][6]. - Approximately 89% of the Series B warrants from the public offering have been exercised as of March 21, 2025[6]. Assets and Liabilities - Total current assets decreased from $6.222 million in 2023 to $1.590 million in 2024, a decline of approximately 74.5%[15]. - Current liabilities increased from $13.049 million in 2023 to $14.149 million in 2024, an increase of about 8.4%[15]. - The total liabilities decreased significantly from $159.889 million in 2023 to $31.711 million in 2024, a reduction of approximately 80.2%[15]. Regulatory and Development Activities - AEON is pursuing a 351(k) regulatory pathway for ABP-450, with primary analytical studies initiated in Q4 2024[4][2]. - The company plans to hold a Biosimilar Biological Product Development Type 2a meeting with the FDA in the second half of 2025[4]. Corporate Changes - The merger resulted in the historical financial statements of AEON Biopharma Sub, Inc. becoming the historical financial statements of the combined Company[19]. - The financial statements reflect the Successor periods for the three months ended December 31, 2024, and December 31, 2023, as well as the year ended December 31, 2024[21]. - A reverse stock split at a ratio of 1-for-72 was effectuated on February 24, 2025, combining 72 pre-split shares into one new share of Common Stock[22].