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AEON Biopharma(AEON) - 2023 Q4 - Annual Report
2024-03-29 19:49
Product Development - The company has three existing product candidates in its pipeline: migraine, cervical dystonia, and gastroparesis, with financing needs being highly variable and difficult to project [53]. - The company plans to enroll 765 patients in the Phase 2 clinical study across approximately 60 study sites in the U.S., Canada, and Australia [64]. - The company plans to initiate a Phase 2a clinical study for gastroparesis in 2024, focusing on safety and efficacy with a 12-week treatment period [83]. - The company is focusing clinical efforts on treating migraine, cervical dystonia, and gastroparesis, with plans to explore additional therapeutic indications [122]. - The company believes that ABP-450 has the potential to demonstrate a similar efficacy and safety profile as Botox for the prophylactic treatment of migraine [61]. - The expected cost of the Phase 2 clinical study for migraine is between $45 million and $55 million, while the open-label extension study is expected to cost between $30 million and $40 million [69]. - The primary endpoints for the clinical study include the change in mean monthly migraine days from the baseline period to weeks 21 to 24 of the treatment period [66]. - The Phase 2 clinical trial for episodic migraine did not meet the primary endpoint but showed statistical significance on multiple secondary endpoints, including a reduction of at least 50% in monthly migraine days [68]. - 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 [75]. - The median duration of treatment effect was at least 20 weeks for all three treatment arms [77]. Financial Overview - The company has raised $177 million for investment in AEON since 2019, including $15 million related to convertible notes with Daewoong [105]. - The company reported a total cash used in operating activities of $21.7 million for the first half of 2023 and $26.1 million for the second half, reflecting significant cash outflows [641]. - The company had cash reserves of $5,158,000 as of December 31, 2023, down from $9,746,000 in the previous year [635]. - The accumulated deficit as of December 31, 2023, was $473,602,000, slightly improved from $474,839,000 in 2022 [635]. - The total stockholders' deficit was reported at $153,044,000 in 2023, compared to $270,413,000 in 2022, indicating a reduction in deficit [635]. - For the year ended December 31, 2023, AEON Biopharma reported a net loss of $60.7 million compared to a net income of $24.0 million for the second half of the year [636]. - Total operating expenses for 2023 were $29.6 million, with research and development costs amounting to $19.8 million, representing a significant investment in product development [636]. - The company experienced a basic and diluted net loss per share of $0.44 for 2023, compared to a net income per share of $0.65 in the latter half of the year [636]. - The company's current liabilities increased to $13,049,000 in 2023 from $82,574,000 in 2022, primarily due to a significant reduction in convertible notes [635]. Regulatory Environment - The company operates in a highly regulated industry, subject to various federal and state laws, including the Federal Food, Drug and Cosmetic Act and the Public Health Service Act [129]. - The biological product development process requires completion of nonclinical tests, submission of an Investigational New Drug (IND) application, and performance of controlled human clinical studies [130]. - The FDA requires satisfactory completion of pre-licensure inspections of manufacturing facilities to ensure compliance with current Good Manufacturing Practices (cGMP) [148]. - Clinical studies for ABP-450 will be conducted under an IND and must comply with state and federal regulations and Good Clinical Practices (GCPs) [133]. - The FDA may withdraw approval if compliance with regulatory standards is not maintained, leading to potential marketing restrictions or product recalls [160]. - The FDA closely regulates marketing and promotion of biologics, allowing only claims approved in the product's labeling [162]. - The company must navigate varying international regulations for product approval, which can significantly differ from those in the United States and Europe, affecting market entry timelines [179]. Market Potential - Approximately 15% of adults in the U.S. experience migraine or severe headache, representing around 40 million people, with an estimated 1 billion people worldwide suffering from migraines [56]. - Botox sales for chronic migraine were estimated at $691 million in 2019, with claims ranging from 118,000 to 147,000 quarterly from 2018 to Q1 2021 [58]. - The global therapeutic botulinum toxin market is expected to grow, with the current market leader holding approximately 95% market share in the U.S. as of 2019 [100]. - ABP-450 has potential applications across a broad range of indications, including an estimated $18.5 billion market for episodic migraine [101]. - The company has identified over 230 potential therapeutic uses for botulinum toxins and continues to evaluate these opportunities [98]. Legal and Compliance Issues - The company is currently involved in a legal proceeding regarding a deferred underwriting fee of $1.25 million claimed by Odeon Capital Group LLC [202]. - The company has agreed to indemnify Daewoong for losses arising from its own misconduct, while Daewoong will indemnify the company for losses due to its willful misconduct [113]. - The company is subject to stringent data privacy and security regulations, which may complicate compliance efforts [198]. - The company faces significant risks related to the clinical and commercial success of its product candidates and the need for substantial additional financing [658]. Strategic Partnerships - Daewoong has completed a Phase 2/3 clinical study for blepharospasm, which was the basis for Nabota's registration and approval in South Korea [96]. - The Daewoong Agreement grants the company an exclusive license to commercialize ABP-450 in multiple territories, including the U.S., EU, and Canada, with no milestone or royalty payments required [108]. - Daewoong is responsible for all manufacturing costs of ABP-450, while the company bears the costs for regulatory approvals and commercialization [108]. - The initial term of the Daewoong Agreement lasts until at least December 20, 2029, with automatic three-year renewals unless terminated [110]. Employee and Operational Information - As of December 31, 2023, the company had ten employees, with no representation by labor unions [200]. - The company has a lease agreement for 8,000 square feet of office space, with a lease term ending in December 2024 [201]. - Stock-based compensation expenses for 2023 totaled $7.0 million, indicating a commitment to incentivizing employees and aligning their interests with shareholders [640].
AEON Biopharma(AEON) - 2023 Q4 - Annual Results
2024-03-29 19:46
Exhibit 99.1 PRESS RELEASE AEON Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results – Recent end-of-Phase 2 meeting with FDA resulted in alignment on the design and endpoints for the proposed pivotal Phase 3 trials for the preventive treatment of both episodic and chronic migraine – – Topline data from planned interim analysis of ongoing Phase 2 study in chronic migraine are expected to be announced in Q2 2024; On track to announce top-line data from the full study in Q3 2024 – – Announced ...
AEON Biopharma Announces Clinical Update and Productive End-of-Phase 2 Meeting with FDA on ABP-450 (prabotulinumtoxinA) for the Preventive Treatment of Migraine
Newsfilter· 2024-03-19 20:30
– FDA and AEON align on the design and endpoints for the proposed pivotal Phase 3 trials for the preventive treatment of both episodic and chronic migraine – – An interim analysis from the ongoing Phase 2 study in chronic migraine will now be conducted and data are expected in Q2 2024; previously stated timeline for top-line data on the complete cohort remains on track for Q3 2024 – IRVINE, Calif., March 19, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE:AEON, AEON WS))), a cl ...
AEON Biopharma Presents Positive Clinical and Pre-clinical Data for ABP-450 (prabotulinumtoxinA) in Treating Cervical Dystonia and PTSD, Respectively, at a Leading Neurotoxin Conference
Newsfilter· 2024-01-18 21:05
– Open label extension (OLE) Phase 2 data show peak efficacy for all ABP-450 doses and cycles in treating cervical dystonia (CD) occurred early, within 4 weeks; durability of effect was demonstrated 12 to 16 weeks post treatment – – Early-phase, original research illustrated successful implementation of image-guided Stellate Ganglion Block (SGB) using ABP-450 both as monotherapy and in conjunction with lidocaine as a preclinical model for treating PTSD – IRVINE, Calif., Jan. 18, 2024 (GLOBE NEWSWIRE) -- AEO ...
AEON Biopharma(AEON) - Prospectus(update)
2023-11-23 02:48
Table of Contents As filed with the Securities and Exchange Commission on November 22, 2023 Registration No. 333-274094 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 2 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 2834 85-3940478 (Primary Standard Industrial (I.R.S. Employer Identification No.) Classification Code Number) 5 Park Plaza, Suite 1750 Irvine, Californ ...
AEON Biopharma(AEON) - 2023 Q3 - Quarterly Report
2023-11-12 16:00
Financial Performance - The company reported an accumulated deficit of $423.1 million as of September 30, 2023, with no revenue generated from ABP-450[154]. - Losses from operations were $29.6 million for the Predecessor period and $57.9 million for the Successor period from July 22, 2023, to September 30, 2023[154]. - The total operating expenses for the period from July 22, 2023 to September 30, 2023 (Successor) were $(57.9) million, compared to $29.6 million for the nine months ended September 30, 2022 (Predecessor)[164]. - The company incurred a loss from operations of $(2.6) million for the period from July 1, 2023 to July 21, 2023 (Predecessor) and a gain of $57.9 million for the period from July 22, 2023 to September 30, 2023 (Successor)[164]. - The company recorded a net loss of $(5.0) million for the period from July 1, 2023 to July 21, 2023 (Predecessor) and a net income of $43.9 million for the period from July 22, 2023 to September 30, 2023 (Successor)[164]. - Other income (loss), net was a loss of $14.0 million for the period from July 22, 2023 to September 30, 2023 (Successor), compared to a loss of $0.5 million during the same period in 2022 (Predecessor)[166]. Research and Development - The Phase 2 clinical trial for episodic migraine did not meet its primary endpoint but showed statistical significance on multiple secondary endpoints, including a 50% reduction in monthly migraine days[154]. - The Phase 2 study for cervical dystonia confirmed that ABP-450 met all primary endpoints, demonstrating safety and efficacy comparable to other botulinum toxin products[154]. - The company expects R&D expenses to continue to increase as it advances clinical studies for ABP-450 and prepares for regulatory approval[163]. Cash and Financing - As of September 30, 2023, the company had $16.2 million in cash, which is insufficient to fund operations for the next 12 months without additional financing[154]. - The company has entered into Forward Purchase Agreements totaling $66.7 million, which may affect its liquidity and capital needs[156]. - The company closed a merger on July 21, 2023, with approximately $30 million of committed financing from existing and new investors available at closing[169]. - The company has sufficient cash to fund its operating plan through mid-December 2023 but is actively seeking additional capital to fund operations[169]. - The company may seek to raise additional capital through the sale of equity or convertible debt securities, which could lead to substantial dilution for existing stockholders[171]. - Net cash used in operating activities from January 1, 2023, to September 30, 2023, was $36.8 million, consisting of a net loss of $38.0 million and non-cash charges of $53.2 million[172]. Expenses and Costs - The company anticipates increased SG&A expenses due to the costs associated with being a public company and establishing sales and marketing functions[158]. - R&D expenses for the period from July 22, 2023 to September 30, 2023 (Successor) were $6.3 million, a decrease of 4% compared to $25.2 million during the nine months ended September 30, 2022 (Predecessor)[164]. - SG&A expenses increased by $4.2 million, or 175%, to $5.5 million for the period from July 22, 2023 to September 30, 2023 (Successor) compared to $2.4 million during the same period in 2022 (Predecessor)[166]. Contingent Consideration and Stock - The company has a contingent consideration liability of $72.1 million as of September 30, 2023, with an income of $69.7 million recognized related to the change in fair value of contingent consideration for the period from July 22, 2023, to September 30, 2023[193]. - The company plans to issue up to 4,000,000 shares of common stock contingent upon FDA acceptance for the BLA for episodic migraine treatment, which could increase to 11,000,000 shares under certain conditions[193]. - The company may issue up to 16,000,000 additional shares of common stock as contingent consideration based on specific milestones related to clinical studies and FDA submissions[191]. - The company has recorded a total of 45,272 ABP Sub options, converting into options to purchase 3,515,218 shares of common stock, and 15,059 RSU awards converting into 1,169,366 shares[204]. Company Classification and Reporting - The company is classified as an emerging growth company under the JOBS Act, allowing it to rely on certain exemptions from public company reporting requirements[207]. - The company remains an emerging growth company until the earliest of December 31, 2026, or achieving total annual gross revenue of at least $1.235 billion[209]. - The company qualifies as a smaller reporting company, with a market value of common stock held by non-affiliates less than $700 million and annual revenue below $100 million[209]. - As a smaller reporting company, the company may present only the two most recent fiscal years of audited financial statements in its Annual Report[209]. - Reduced disclosure obligations regarding executive compensation apply to the company as both an emerging growth and smaller reporting company[209].
AEON Biopharma(AEON) - Prospectus(update)
2023-10-21 01:46
Table of Contents As filed with the Securities and Exchange Commission on October 20, 2023 Registration No. 333-274094 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 1 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) 85-3940478 (I.R.S. Employer ...
AEON Biopharma(AEON) - Prospectus
2023-08-18 21:27
Table of Contents As filed with the Securities and Exchange Commission on August 18, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT (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) Alex Wilson, Chief Legal Officer c/o AEON Biopharma, Inc. 5 Park Plaza, Suite 1750 Irvine, California 92614 ...
AEON Biopharma(AEON) - 2023 Q2 - Quarterly Report
2023-07-20 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to. Priveterra Acquisition Corp. (Exact name of registrant as specified in its charter) Delaware 001-39945 85-3940478 (State or other jurisdiction of (Commission File Num ...
AEON Biopharma(AEON) - 2023 Q1 - Quarterly Report
2023-05-16 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to. Priveterra Acquisition Corp. (Exact name of registrant as specified in its charter) Delaware 001-39945 85-3940478 (State or other jurisdiction of (Commission File Nu ...