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].

Core Insights - AEON Biopharma, Inc. is advancing its biosimilar development program for ABP-450, utilizing BOTOX as the reference product under the 351(k) regulatory pathway [2][3] - The company initiated primary analytical studies in Q4 2024 to support its regulatory efforts and plans to hold a BPD Type 2a meeting with the FDA in the second half of 2025 [6][7] - AEON closed a public offering in January 2025, raising gross proceeds of $20 million, which will fund its operational plans through 2025 [7] Financial Performance - As of December 31, 2024, AEON reported total current assets of $1.59 million, a decrease from $6.22 million in 2023 [13] - Total liabilities amounted to $31.71 million, down from $159.89 million in the previous year, indicating a significant reduction in financial obligations [14] - The company reported a net income of $2.08 million for Q4 2024, a recovery from a net loss of $26.24 million in Q4 2023 [16] Business Development - AEON is focused on developing its proprietary botulinum toxin complex, ABP-450, for various therapeutic indications, with an initial emphasis on the neurosciences market [5] - The product is already approved as a biosimilar in Mexico and India, and AEON holds exclusive rights for therapeutic indications in the U.S., Canada, and the EU [5][8] - The management team has extensive experience in biopharmaceutical and botulinum toxin development, positioning the company for future growth [8]

Company Overview - AEON Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway [1][3] - The company is developing its proprietary product, ABP-450 (prabotulinumtoxinA) injection, targeting debilitating medical conditions, with an initial focus on the neurosciences market [3] - ABP-450 is the same botulinum toxin complex currently marketed for cosmetic use by Evolus under the name Jeuveau [3] - The product is manufactured by Daewoong in compliance with current Good Manufacturing Practice (cGMP) and has been 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, and AEON holds exclusive development and distribution rights for therapeutic indications in the U.S., Canada, EU, UK, and other territories [3] Upcoming Events - Marc Forth, AEON's President and CEO, will present a corporate overview at the Leerink Global Healthcare Conference from March 10 to 12, 2025, in Miami, FL [1] - The corporate presentation is scheduled for March 10 at 1:00-1:30 PM ET [2]

Core Points - AEON Biopharma, Inc. announced a 1-for-72 reverse stock split to comply with NYSE American requirements [1][2] - The reverse stock split will take effect on February 26, 2025, with trading resuming under the existing ticker symbol "AEON" [2] - The ownership percentage of each stockholder will remain unchanged, except for fractional shares, which will be rounded up [3] Company Overview - AEON is a clinical-stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450, for medical conditions, particularly in the neurosciences market [5] - ABP-450 is the same botulinum toxin complex marketed for cosmetic use by Evolus under the name Jeuveau and is approved as a biosimilar in Mexico and India [5] - The company has exclusive rights for therapeutic indications of ABP-450 in the U.S., Canada, EU, UK, and other territories, and has a management team experienced in biopharmaceutical development [5]

Core Viewpoint - AEON Biopharma, Inc. is facing non-compliance with NYSE American listing standards due to a stockholders' deficit of $32.1 million and reported losses in two of the last three fiscal years [1][2] Group 1: Compliance and Regulatory Actions - AEON must submit a plan to regain compliance by March 5, 2025, with a deadline to meet listing standards by August 3, 2026 [2] - If the plan is accepted, AEON will undergo periodic reviews; failure to comply may lead to delisting proceedings [2] - The notice does not immediately affect the trading status of AEON's common stock, which will continue to trade under the symbol "AEON" with a ".BC" designation indicating non-compliance [3] Group 2: Company Overview - AEON is a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex, ABP-450, for medical conditions, particularly in the neurosciences market [5] - ABP-450 is the same product marketed for cosmetic use as Jeuveau and is approved as a biosimilar in Mexico and India [5] - The company has exclusive rights for therapeutic indications of ABP-450 in several regions, including the U.S., Canada, and the EU [5]

Core Points - AEON Biopharma, Inc. has successfully closed a public offering, raising approximately $20.0 million in gross proceeds [1][4] - The offering included 40,000,000 Common Units, each comprising one share of Common Stock and two types of warrants (Series A and Series B) with an exercise price of $0.625 [2][3] - Aegis Capital Corp. acted as the sole book-running manager for the offering and has a 45-day option to purchase additional shares and warrants to cover over-allotments [3][5] Financial Details - The public offering price per Common Unit was set at $0.50, and the total gross proceeds were approximately $20.0 million before expenses [1][4] - The Series A and Series B Warrants are exercisable following stockholder approval and have different expiration periods of 60 months and 30 months, respectively [2][3] Company Overview - AEON Biopharma is focused on developing a proprietary botulinum toxin complex, ABP-450, for medical conditions, with an initial emphasis on the neurosciences market [7][8] - ABP-450 is the same botulinum toxin complex marketed for cosmetic use under the name Jeuveau and is approved as a biosimilar in Mexico and India [8] - The company holds exclusive development and distribution rights for therapeutic indications of ABP-450 in several regions, including the U.S., Canada, and the EU [8]

Core Viewpoint - AEON Biopharma, Inc. has announced a public offering expected to raise approximately $20.0 million to support the development of its botulinum toxin complex, ABP-450, as a biosimilar to BOTOX® for therapeutic uses [1][4]. Offering Details - The offering consists of 40,000,000 Common Units, each including one share of Common Stock or one Pre-Funded Warrant, along with Series A and Series B Registered Common Warrants, both with an exercise price of $0.625 [2]. - The public offering price per Common Unit is set at $0.50, with Pre-Funded Units priced at $0.4999 [2]. - Aegis Capital Corp. has been granted a 45-day option to purchase additional shares and warrants to cover over-allotments, up to 15% of the number of shares and warrants sold in the offering [3]. Use of Proceeds - The capital raised is intended to fund operations through 2025 and facilitate comparative analytical studies required under the 351(k) regulatory pathway [4]. - The net proceeds will be used for general corporate purposes and working capital [4]. Company Background - AEON Biopharma is focused on developing its proprietary botulinum toxin complex, ABP-450, for debilitating medical conditions, initially targeting the neurosciences market [8]. - ABP-450 is manufactured in compliance with cGMP and is approved as a biosimilar in Mexico and India, with exclusive development rights in several regions including the U.S. and EU [8].

IRVINE, Calif., Jan. 03, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE:AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, today announced that it has commenced a public offering (the "Offering") to offer and sell units, consisting of (i) shares of Common Stock (or pre-funded warrants in lieu thereof) and (ii) warrants to purchase shares of Common Stock. In addition, the Company expects to grant ...

Financial Performance - As of September 30, 2024, AEON reported an accumulated deficit of $433.7 million and cash and cash equivalents of $0.5 million, raising substantial doubt about its ability to continue as a going concern [165][170]. - Losses from operations for the three months ended September 30, 2024, were $4.0 million, while consolidated net loss for the same period was $(6.2) million [165][166]. - SG&A expenses for the three months ended September 30, 2024, were $3.0 million, a decrease of $3.3 million, or 52%, compared to $5.3 million for the prior period [197]. - R&D expenses for the three months ended September 30, 2024, were $1.0 million, a decrease of $7.0 million, or 88%, compared to $6.4 million for the prior period [199]. - The company recognized a gain of $75.9 million related to the change in the fair value of contingent consideration for the nine months ended September 30, 2024 [201]. - Other loss, net was $2.2 million for the three months ended September 30, 2024, compared to a loss of $25.0 million for the prior period [202]. - Other loss, net for the nine months ended September 30, 2024, was $35.4 million, mainly due to a loss of $19.9 million on forward purchase agreements and derivative liabilities [204]. - SG&A expenses for the nine months ended September 30, 2024, were $11.0 million, a decrease of $4.1 million, or 27%, compared to $15.1 million for the prior period [198]. - R&D expenses for the nine months ended September 30, 2024, were $11.1 million, a decrease of $15.0 million, or 57%, compared to $19.8 million for the prior period [200]. - Net cash used in operating activities for the nine months ended September 30, 2024 was $19.7 million, primarily due to a net income of $39.9 million and non-cash charges of $(57.0) million [221]. - The company incurred net cash used in operating activities of $21.7 million and $15.1 million for the periods from January 1, 2023 to July 21, 2023 and July 22, 2023 to September 30, 2023 respectively [222]. - Net cash provided by financing activities for the nine months ended September 30, 2024 was $15.1 million, primarily from the issuance of convertible notes [225]. Research and Development - R&D expenses are primarily focused on the development of ABP-450 for migraine, cervical dystonia, and gastroparesis, with expected increases as the company advances clinical studies [185]. - The company expects significant R&D expenses over the next several years as it prepares for regulatory approval of ABP-450 [186]. - The Phase 2 clinical trials for episodic and chronic migraine were discontinued in May 2024 due to not meeting primary endpoints, leading to a strategic shift towards a 351(k) biosimilar regulatory pathway [159]. - AEON has completed a Phase 2 study for cervical dystonia, with plans to potentially commence a Phase 3 study pending capital resources and FDA discussions [164]. - The company plans to pursue a 351(k) biosimilar regulatory pathway for ABP-450, using AbbVie Inc.'s product Botox as a proposed reference product [206]. - The company has recorded acquired in-process research and development (IPR&D) costs, which were written off due to the technology not reaching feasibility [187]. Capital and Financing - The company entered into a Subscription Agreement with Daewoong for the sale of Convertible Notes totaling up to $15.0 million, with an annual interest rate of 15.79% and a maturity date three years from the funding date [177]. - The company issued a Convertible Note of $5.0 million on March 24, 2024, and an additional $10.0 million Convertible Note on April 12, 2024, to Daewoong [177]. - The Forward Purchase Agreements with ACM and Polar involved a total cash amount of $66.7 million, which was not accessible post-merger, potentially affecting liquidity [172][175]. - The company may need to raise additional capital through equity or debt financing, which could dilute existing shareholders [216]. - The company expects to have sufficient cash to fund operations into Q4 2024 but is actively seeking additional capital [214]. - Significant operating losses are expected to continue, with cash primarily used for R&D and SG&A expenditures [215]. Company Structure and Regulatory Status - The merger with Priveterra Acquisition Corp. was completed on July 21, 2023, with Old AEON's historical financial statements becoming those of the combined company [157]. - AEON has exclusive development and distribution rights for ABP-450 in the U.S., Canada, EU, UK, and other territories [158]. - The company is classified as an emerging growth company and intends to rely on exemptions from various public company reporting requirements [227]. - The company will remain an emerging growth company until the earliest of December 31, 2026, or achieving total annual gross revenue of at least $1.235 billion [227]. - The market value of the company's common stock held by non-affiliates must exceed $700 million to cease being an emerging growth company [227]. - The company is also a smaller reporting company, with a market value of common stock held by non-affiliates and annual revenue both below specified thresholds [227]. - The company may present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K [227]. - Reduced disclosure obligations regarding executive compensation apply to the company as a smaller reporting company [227]. - If the company remains a smaller reporting company, it may continue to rely on certain disclosure exemptions [227]. - Investors may find the company's common stock less attractive due to reliance on these exemptions, potentially leading to a less active trading market [227]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its smaller reporting company status [230]. Management and Future Outlook - Management has expressed substantial doubt about the company's ability to continue as a going concern within one year of the financial statements issuance [220]. - The company anticipates increased SG&A expenses to support R&D activities and compliance with public company requirements, with significant costs expected if ABP-450 receives regulatory approval [184]. - A strategic reprioritization to pursue a Section 351(k) biosimilar regulatory pathway for ABP-450 was announced, with comparative studies anticipated to start in Q4 2024 [213].