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]

IRVINE, Calif., Feb. 24, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (NYSE: AEON) (the “Company”), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, today announced that the Company’s Board of Directors approved a 1-for-72 reverse stock split (the “Reverse Stock Split”) of the Company’s common stock, par value $0.0001 (the “Common Stock”), to increase the selling price of the Company’s Common Stock in order to maintain compliance ...

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]

IRVINE, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (NYSE:AEON) (the "Company"), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, today announced the pricing of a firm commitment underwritten public offering with gross proceeds to the Company expected to be approximately $20.0 million, before deducting underwriting fees and other estimated offering expenses payable by the Company. The offering consists of 40,000, ...

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 ...

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 September 30, 2024 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 (St ...

Financial Performance - AEON Biopharma reported total assets of $4,004,000 as of September 30, 2024, down from $6,845,000 at the end of 2023, indicating a decrease of approximately 41%[8] - Cash and cash equivalents decreased significantly to $537,000 from $5,158,000, representing a decline of about 90%[8] - Total current liabilities were reported at $10,726,000, a decrease from $13,049,000, reflecting a reduction of approximately 18%[8] - The company has a stockholders' deficit of $32,090,000 as of September 30, 2024, compared to a deficit of $153,044,000 at the end of 2023, showing an improvement of about 79%[8] - AEON's accumulated deficit decreased to $433,679,000 from $473,602,000, indicating a reduction of approximately 8%[8] - For the three months ended September 30, 2024, total operating expenses were $4,016,000, compared to $283,714,000 for the same period in 2023, reflecting a significant decrease[9] - The net loss for the three months ended September 30, 2024, was $6,171,000, or $0.16 per share, compared to a net loss of $297,711,000, or $8.01 per share, for the same period in 2023[9] - The company reported a change in the fair value of contingent consideration amounting to $348,000 for the three months ended September 30, 2024, compared to a loss of $75,939,000 in 2023[9] - Total operating costs and expenses for the nine months ended September 30, 2024, were $283,714,000, compared to $29,644,000 for the same period in 2023[9] - The company experienced a loss from operations of $4,016,000 for the three months ended September 30, 2024, compared to a loss of $283,714,000 in 2023[9] - The change in fair value of convertible notes resulted in a loss of $1,878,000 for the three months ended September 30, 2024[9] Regulatory and Development Plans - AEON plans to initiate primary comparative analytical studies for ABP-450 in Q4 2024, contingent on securing capital resources[2] - The company aims to hold a Biosimilar Biological Product Development Type 2 meeting with the FDA in 2025 to discuss outcomes from the planned studies[4] - AEON is aligned with the FDA on the initial key requirements for the 351(k) regulatory pathway for ABP-450, which utilizes BOTOX as the reference product[3] - The company is evaluating all available options to secure capital resources necessary for executing its regulatory strategy for ABP-450[2] Merger Impact - AEON completed a merger with AEON Biopharma Sub, Inc. on July 21, 2023, which has impacted the comparability of financial results between periods[11] - The company’s financial statements reflect the historical operating results of AEON Biopharma Sub, Inc. prior to the merger and the combined results following the merger[11] Development Rights - The company has exclusive development and distribution rights for ABP-450 in the U.S., Canada, the EU, the UK, and other territories[6] Research and Development - Research and development expenses for the nine months ended September 30, 2024, were $11,144,000, down from $19,803,000 in 2023, indicating a reduction in R&D spending[9] - The weighted average shares of common stock outstanding for the three months ended September 30, 2024, were 39,515,292, compared to 37,159,600 for the same period in 2023[10]

– Held biosimilar advisory meeting with FDA in Q3 2024, and aligned on next steps for a 351(k) regulatory pathway to approval for ABP-450 (prabotulinumtoxinA) as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product – – Plan to initiate comparative analytical studies anticipated in Q4 2024 subject to available resources – – 351(k) regulatory pathway offers potential to bring ABP-450 to the U.S. market under a single approval for all of BOTOX’s currently approved and future therapeutic ...