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].

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]

Core Insights - AEON Biopharma is advancing its biosimilar development program for ABP-450 under the 351(k) regulatory pathway, utilizing BOTOX as the reference product [2][3] - The company plans to initiate primary comparative analytical studies in Q4 2024, contingent on securing capital resources [2][3] - AEON aims to hold a Biosimilar Biological Product Development Type 2 meeting with the FDA in 2025 to discuss study outcomes and next steps [3] Financial Performance - As of September 30, 2024, AEON reported current assets of $2.371 million, a decrease from $6.222 million at the end of 2023 [8] - Total liabilities stood at $36.094 million, significantly down from $159.889 million at the end of 2023 [9] - The company reported a net loss of $6.171 million for the third quarter of 2024, compared to a net loss of $297.711 million for the same period in 2023 [11] Corporate Developments - AEON completed a merger with AEON Biopharma Sub, Inc. on July 21, 2023, with the latter becoming a wholly-owned subsidiary [12] - The merger has been accounted for as a forward merger asset acquisition, affecting the comparability of financial results pre- and post-merger [13] - AEON has exclusive development and distribution rights for ABP-450 in the U.S., Canada, EU, UK, and other territories [4]

Core Viewpoint - AEON Biopharma, Inc. has experienced a significant downtrend, losing 61% of its stock value over the past four weeks, but a hammer chart pattern suggests a potential trend reversal due to increased buying interest and positive earnings estimates from analysts [1]. Group 1: Technical Analysis - The formation of a hammer chart pattern indicates a possible bottoming out of the stock, suggesting that selling pressure may be exhausting [1]. - A hammer pattern occurs when a stock opens lower, makes a new low, but then closes near or above its opening price, signaling a potential loss of control by bears [2]. Group 2: Fundamental Analysis - There has been a positive trend in earnings estimate revisions for AEON, with the consensus EPS estimate increasing by 15.4% over the last 30 days, indicating bullish sentiment among analysts [3]. - AEON holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [3]. - The Zacks Rank serves as a timing indicator, suggesting that AEON's prospects are beginning to improve, reinforcing the potential for a turnaround [3].

Company Overview - AEON Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex, ABP-450, for various therapeutic indications, initially targeting the neurosciences market [2] - ABP-450 is the same botulinum toxin complex marketed for cosmetic use under the name Jeuveau by Evolus [2] - 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 [2] - AEON holds exclusive development and distribution rights for therapeutic indications of ABP-450 in the U.S., Canada, the EU, the UK, and other international territories [2] Upcoming Events - Marc Forth, AEON's President and CEO, will present a corporate overview at the H.C. Wainwright 26th Annual Global Investment Conference on September 11, 2024, at 1:30 PM ET in New York [1] - Mr. Forth will also engage in one-on-one meetings with institutional investors during the conference [1]

Financial Performance - AEON Biopharma reported a net income of $164.1 million for Q2 2024, compared to a net loss of $15.4 million in Q2 2023, reflecting a significant turnaround in financial performance[10]. - Total operating expenses for Q2 2024 were $153.5 million, a substantial increase from $14.0 million in Q2 2023, primarily due to a change in the fair value of contingent consideration[10]. - The total liabilities of AEON Biopharma as of June 30, 2024, were $33.7 million, a decrease from $159.9 million at the end of 2023[8]. - AEON's additional paid-in capital increased to $399.6 million as of June 30, 2024, from $381.3 million at the end of 2023[8]. - The financial results of AEON Biopharma Sub, Inc. prior to the Merger are not directly comparable to the results following the Merger[11]. - Historical financial statements of AEON Biopharma Sub, Inc. became the historical financial statements of the combined Company after the Merger[11]. - The financial statements reflect both Predecessor periods for the three and six months ended June 30, 2023, and Successor periods for the three and six months ended June 30, 2024[11]. - A black line in the financial statements highlights the lack of comparability between Predecessor and Successor periods[11]. Cash Position - The company has $3.4 million in cash and cash equivalents as of June 30, 2024, down from $5.2 million at the end of 2023[8]. Clinical Development - AEON plans to initiate a Phase 3 clinical study in approximately 400 patients to compare ABP-450 to BOTOX, aiming to demonstrate non-inferiority[3]. - The company submitted a briefing package to the FDA, providing extensive data that could support a Biologics License Application (BLA) filing for ABP-450[3]. - AEON is scheduled to hold an initial advisory meeting with the FDA in Q3 2024 regarding the biosimilar development of ABP-450[3]. - The company aims to leverage the 351(k) regulatory pathway to bring ABP-450 to the U.S. market under a single approval for all of BOTOX's therapeutic indications[2]. Development Rights - The company has exclusive development and distribution rights for ABP-450 in the U.S., Canada, EU, UK, and other territories[4].

Financial Performance - AEON Biopharma has an accumulated deficit of $427.5 million as of June 30, 2024, and has never generated revenue from ABP-450[159]. - Losses from operations for the three months ended June 30, 2024, were $7.8 million, compared to $18.1 million for the same period in 2023[159]. - Consolidated net income for the three months ended June 30, 2024, was $164.1 million, while the loss for the same period in 2023 was $15.4 million[159]. - The company reported a net income of $164.1 million for the three months ended June 30, 2024, compared to a net loss of $(15.4) million for the same period in 2023[188]. - Basic and diluted net income per share for the three months ended June 30, 2024, was $4.22, compared to a loss of $(0.11) per share for the same period in 2023[188]. - Other income was $10.6 million for the three months ended June 30, 2024, compared to a loss of $1.4 million for the same period in 2023[194]. - A loss of $33.2 million was recorded for other income (loss), net for the six months ended June 30, 2024, compared to a loss of $6.0 million for the same period in 2023[195]. - The net cash used in operating activities for the six months ended June 30, 2024, was $16.7 million, with a net income of $46.1 million and non-cash charges totaling $60.8 million[213]. - Net cash used in operating activities for the six months ended June 30, 2023, was $21.1 million, primarily due to a net loss of $33.0 million and non-cash items of $8.7 million[214]. - Net cash provided by financing activities for the six months ended June 30, 2024, and June 30, 2023, were $15.0 million and $14.0 million, respectively, mainly related to the issuance of convertible notes[216]. Research and Development - A Phase 2 study of ABP-450 for cervical dystonia met all primary endpoints, supporting further development[158]. - The company has completed enrollment for a Phase 2 study of ABP-450 for chronic and episodic migraine, but these trials did not meet their primary endpoints[153]. - The company expects R&D expenses to continue to increase as it develops and initiates a Phase 3 study of ABP-450 in cervical dystonia and a Phase 2 study for gastroparesis[178]. - R&D expenses for the three months ended June 30, 2024, were $4.4 million, a decrease of $4.6 million, or 51%, compared to $9.0 million for the same period in 2023[192]. - R&D expenses decreased by $8.1 million, or 44%, to $10.2 million for the six months ended June 30, 2024, compared to $18.2 million for the same period in 2023[193]. Cash Position and Financing - AEON Biopharma has $3.4 million in cash and cash equivalents as of June 30, 2024, and substantial doubt exists about its ability to continue as a going concern without additional financing[159]. - The company expects to have sufficient cash to fund operations into the fourth quarter of 2024 but is actively seeking additional capital[205]. - AEON Biopharma entered into a Subscription Agreement for Convertible Notes totaling up to $15.0 million to support late-stage clinical development of ABP-450[168]. Market and Regulatory Pathway - The global therapeutic botulinum toxin market is estimated at $3.0 billion and projected to grow to $4.4 billion by 2027[152]. - AEON Biopharma plans to pursue a 351(k) biosimilar regulatory pathway for ABP-450, using AbbVie Inc.'s Botox as a reference product[153]. - The company has entered into a License Agreement Amendment with Daewoong, which includes a Termination Purchase Right for $1.00 if certain conditions are met[171]. Operating Expenses - SG&A expenses for the three months ended June 30, 2024, were $3.3 million, a decrease of $1.6 million, or 33%, compared to $4.9 million for the same period in 2023[189]. - The company anticipates increased SG&A expenses in the future to support ongoing R&D activities and compliance with public company requirements[177]. - The company expects to incur significant expenses related to building its commercialization infrastructure for ABP-450[160]. - The company expects to incur additional annual expenses related to being a public company, including liability insurance and compliance costs[174]. Company Status and Reporting - The company remains an emerging growth company and intends to rely on certain exemptions from public company reporting requirements until at least December 31, 2026, or until specific revenue or market value thresholds are met[218]. - The company qualifies as a smaller reporting company, with the market value of its common stock held by non-affiliates being less than $700 million and annual revenue below $100 million[220]. - The company has reduced disclosure obligations regarding executive compensation due to its status as an emerging growth company and smaller reporting company[220]. - The company may continue to rely on exemptions from certain disclosure requirements if it remains a smaller reporting company after ceasing to be an emerging growth company[220]. - The company has not included all executive compensation-related information that would be required if it were not an emerging growth company[218]. - There have been no changes to the company's critical accounting policies as of June 30, 2024, compared to those reported in the Annual Report Form 10-K[217]. - Actual results may differ materially from estimates and assumptions made in the financial statements, which could be material to the financial position and results of operations[217].

Core Insights - AEON Biopharma is advancing the development of ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA) with plans to hold an initial advisory meeting with the FDA in the third quarter of 2024 [1][2][3] - The 351(k) regulatory pathway may allow AEON to bring ABP-450 to the U.S. market under a single approval for all current and future therapeutic indications of BOTOX [1][2] Company Overview - AEON Biopharma is a clinical-stage biopharmaceutical company focused on developing ABP-450 for various therapeutic indications, initially targeting the neurosciences market [4] - ABP-450 is the same botulinum toxin complex currently marketed for cosmetic uses under the name Jeuveau by Evolus [4] - 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, EU, UK, and other territories [4] Financial Highlights - For the second quarter ended June 30, 2024, AEON reported a significant loss from operations amounting to $153.5 million, compared to a loss of $14 million in the same period of the previous year [11][12] - Operating expenses included $3.3 million for selling, general, and administrative costs, and $4.4 million for research and development [11] - The net income for the second quarter of 2024 was reported at $164.1 million, a substantial increase from a net loss of $15.4 million in the same quarter of 2023 [12] Development Plans - AEON plans to initiate a pivotal clinical study comparing ABP-450 to BOTOX in treating cervical dystonia (CD), pending funding [3] - The company has submitted a briefing package to the FDA containing extensive data from various studies to support a Biologics License Application (BLA) filing [3] - A successful Phase 3 study could provide the necessary data to demonstrate that ABP-450 is highly similar to BOTOX for all approved and future indications [3]

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on July 23, 2024 Registration No. 333-274094 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 5 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 AEON Biopharma, Inc. (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of incorporation or organization) 2834 (Primary Standard Industrial Classification Code Number) 5 Park Plaza, Suite 1750 Irvin ...