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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) - 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) - 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 ...
AEON Biopharma(AEON) - 2022 Q4 - Annual Report
2023-02-21 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 for the fiscal year ended December 31, 2022 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 Priveterra Acquisition Corp (Exact Name of Registrant as Specified in Its Charter) Delaware 85-3940478 (State or Other Jurisd ...
AEON Biopharma(AEON) - 2021 Q4 - Annual Report
2022-03-27 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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 Priveterra Acquisition Corp. (Exact Name of Registrant as Specified in Its Charter) | Delaware | | 85-394047 ...