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AEON Biopharma Announces Strategic Reprioritization to Pursue a Biosimilar Pathway for ABP-450
Newsfilter· 2024-07-09 12:00
Core Insights - AEON Biopharma plans to conduct a pivotal Phase 3 study comparing its lead candidate ABP-450 to BOTOX® for cervical dystonia, utilizing the 351(k) biosimilar pathway following an FDA meeting in Q3 2024 [1][2] - The company aims to demonstrate that ABP-450 is highly similar to BOTOX® across all currently approved and future therapeutic indications through a single comparative study [2] Company Overview - AEON Biopharma is a clinical-stage biopharmaceutical company focused on developing ABP-450 (prabotulinumtoxinA) for various therapeutic indications, initially targeting the neurosciences market [4] - ABP-450 shares the same molecular weight as BOTOX® at 900kDa and has undergone extensive analytical and preclinical testing, much of which is already completed [2] - The company has exclusive development and distribution rights for ABP-450 in the U.S., Canada, EU, UK, and other territories, and the product is already approved as a biosimilar in Mexico and India [4] Clinical Trial Details - The Phase 2 clinical trial of ABP-450 for cervical dystonia involved 57 patients across 20 sites in the U.S., with results presented at the IP-MDS Congress in August 2023 [3] - The trial demonstrated statistically significant improvements in the Toronto Western Spasmodic Torticollis rating scale (TWSTRS) total score for the lower doses of ABP-450, with improvements of 14.01 points (p=0.007) for 150 units and 11.28 points (p=0.0406) for 250 units [3] - All dosing arms showed sustained benefits, with a median duration of effect of at least 20 weeks [3]
AEON Biopharma(AEON) - Prospectus(update)
2024-05-31 20:03
As filed with the Securities and Exchange Commission on May 31, 2024 Registration No. 333-274094 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 4 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 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) 5 Park Plaza, Suite ...
Down -64.16% in 4 Weeks, Here's Why AEON Biopharma, Inc. (AEON) Looks Ripe for a Turnaround
zacks.com· 2024-05-29 14:35
Core Viewpoint - AEON Biopharma, Inc. has experienced significant selling pressure, resulting in a 64.2% decline in stock price over the past four weeks, but analysts anticipate improved earnings in the near future [1] Group 1: Stock Performance - AEON's stock is currently in oversold territory, indicated by an RSI reading of 24.09, suggesting that the heavy selling may be exhausting itself [4] - The stock has lost 64.2% in value over the last month, highlighting the extent of the selling pressure [1] Group 2: Earnings Estimates - There has been a strong consensus among sell-side analysts to raise AEON's earnings estimates, with a 22.9% increase in the consensus EPS estimate over the last 30 days [4] - An upward trend in earnings estimate revisions typically correlates with price appreciation in the near term [4] Group 3: Analyst Ratings - AEON currently holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises [5] - This ranking serves as a strong indicator of the stock's potential for a turnaround in the near term [5]
AEON Biopharma(AEON) - 2024 Q1 - Quarterly Report
2024-05-14 20:09
Part I - Financial Information [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company reported a significantly increased net loss of $118.0 million for Q1 2024 and faces substantial doubt about its ability to continue as a going concern Condensed Consolidated Balance Sheet Highlights (Successor) | Balance Sheet Item | March 31, 2024 (Unaudited) | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $1.6 million | $5.2 million | | Total assets | $3.0 million | $6.8 million | | Total liabilities | $201.4 million | $159.9 million | | Total stockholders' deficit | ($198.4 million) | ($153.0 million) | Condensed Consolidated Statement of Operations Highlights | Income Statement Item | Three Months Ended Mar 31, 2024 (Successor) | Three Months Ended Mar 31, 2023 (Predecessor) | | :--- | :--- | :--- | | Research and development | $5.7 million | $9.2 million | | Selling, general and administrative | $4.6 million | $3.8 million | | Change in fair value of contingent consideration | $63.8 million | $0 | | Loss from operations | ($74.2 million) | ($13.0 million) | | Net loss | ($118.0 million) | ($17.6 million) | | Basic and diluted net loss per share | ($3.17) | ($0.13) | Condensed Consolidated Statement of Cash Flows Highlights | Cash Flow Item | Three Months Ended Mar 31, 2024 (Successor) | Three Months Ended Mar 31, 2023 (Predecessor) | | :--- | :--- | :--- | | Net cash used in operating activities | ($8.6 million) | ($11.1 million) | | Net cash provided by financing activities | $5.0 million | $6.0 million | | Net decrease in cash and cash equivalents | ($3.6 million) | ($5.1 million) | | Cash and cash equivalents at end of period | $1.6 million | $4.7 million | - The company has experienced recurring losses and negative cash flows since inception, leading management to conclude there is **substantial doubt about its ability to continue as a going concern** within one year[31](index=31&type=chunk)[32](index=32&type=chunk) - A key subsequent event was the announcement on May 3, 2024, that the **Phase 2 trial of ABP-450 for chronic migraine did not meet its primary or secondary endpoints**, prompting the company to implement cash preservation measures and review strategic options[32](index=32&type=chunk)[159](index=159&type=chunk) [Note 1. Organization](index=9&type=section&id=Note%201.%20Organization) The company is a clinical-stage biopharmaceutical firm that recently merged with a SPAC and faces going concern issues due to trial failures - AEON Biopharma is a clinical-stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450, for debilitating medical conditions[27](index=27&type=chunk) - On July 21, 2023, the company completed its merger with Priveterra Acquisition Corp, a special purpose acquisition company (SPAC), and began trading on the NYSE American under the symbol "AEON"[28](index=28&type=chunk)[30](index=30&type=chunk) - As of March 31, 2024, the company had cash of **$1.6 million** and an accumulated deficit of **$591.6 million**, with the recent failure of its chronic migraine trial raising **substantial doubt about its ability to continue as a going concern**[31](index=31&type=chunk)[32](index=32&type=chunk) [Note 3. Forward Merger](index=16&type=section&id=Note%203.%20Forward%20Merger) The merger with Priveterra was accounted for as a $342.1 million asset acquisition, with a subsequent $348.0 million write-off of IPR&D - The merger with Priveterra was consummated on July 21, 2023, and was accounted for as an asset acquisition, with Priveterra as the accounting acquirer[77](index=77&type=chunk)[81](index=81&type=chunk) - The total purchase price was calculated at **$342.1 million**, which included the fair value of shares issued, contingent consideration, and replacement share-based awards[84](index=84&type=chunk) - Acquired in-process research and development (IPR&D) was valued at **$348.0 million** at closing and was subsequently written off to the consolidated statement of operations for the year ended December 31, 2023[83](index=83&type=chunk) [Note 5. Daewoong Convertible Notes](index=18&type=section&id=Note%205.%20Daewoong%20Convertible%20Notes) The company secured up to $15.0 million in financing from its partner Daewoong through senior secured convertible notes - On March 19, 2024, the company entered into a subscription agreement with its manufacturing partner, Daewoong, for up to **$15.0 million** in senior secured convertible notes[92](index=92&type=chunk) - The company received **$5.0 million** from Daewoong on March 24, 2024, and an additional **$10.0 million** on April 12, 2024, to support clinical development and for working capital[92](index=92&type=chunk)[157](index=157&type=chunk) - The license agreement with Daewoong was amended to include a termination clause if AEON ceases commercialization and clinical advancement of ABP-450, granting Daewoong a right to purchase related know-how for $1.00[93](index=93&type=chunk) [Note 6. Fair Value Measurements](index=19&type=section&id=Note%206.%20Fair%20Value%20Measurements) Significant non-cash charges arose from terminating forward purchase agreements and fair value adjustments to contingent consideration and warrant liabilities - On March 18, 2024, the company terminated its Forward Purchase Agreements with ACM and Polar, resulting in a recorded charge of **$20.3 million** and a reversal of the related subscription receivable and derivative liability[106](index=106&type=chunk)[107](index=107&type=chunk)[108](index=108&type=chunk) - The contingent consideration liability, related to milestone-based share issuances, increased significantly to **$168.1 million** as of March 31, 2024, resulting in a **$63.8 million expense** for the quarter due to changes in fair value[117](index=117&type=chunk) - The warrant liability increased to **$12.0 million**, resulting in a **$20.9 million expense** for the quarter; during the period, 6.2 million warrants were exercised on a cashless basis for 960,688 shares of common stock[119](index=119&type=chunk)[120](index=120&type=chunk)[122](index=122&type=chunk) [Note 10. Subsequent Events](index=29&type=section&id=Note%2010.%20Subsequent%20Events) The company announced the failure of its Phase 2 chronic migraine trial and secured an additional $10.0 million in financing - On May 3, 2024, the company announced that its Phase 2 trial of ABP-450 for the preventative treatment of chronic migraine **did not meet its primary or secondary endpoints**[159](index=159&type=chunk) - Following the negative trial results, the company immediately began cash preservation measures and a review of all strategic options[159](index=159&type=chunk) - On April 12, 2024, the company received the remaining **$10.0 million** in financing from Daewoong under their convertible note agreement[157](index=157&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the unsuccessful migraine trials, a significantly increased net loss driven by non-cash charges, and severe liquidity concerns [Overview](index=30&type=section&id=Overview) The company's development of ABP-450 has been set back by the failure of its chronic migraine trial, shifting focus to other indications - AEON is a clinical-stage biopharmaceutical company developing its proprietary botulinum toxin, ABP-450, for therapeutic uses, with initial programs in migraine, cervical dystonia, and gastroparesis[164](index=164&type=chunk)[166](index=166&type=chunk) - The Phase 2 trial for episodic migraine, reported in October 2023, **did not meet its primary endpoint** but showed statistical significance on some secondary endpoints[168](index=168&type=chunk) - The interim analysis of the Phase 2 trial for chronic migraine, reported in May 2024, **did not meet its primary or secondary endpoints**, leading the company to re-evaluate its development strategy and implement cash preservation measures[164](index=164&type=chunk)[169](index=169&type=chunk) - The Phase 2 study for cervical dystonia, with data released in September 2022, **met all primary endpoints**, and the company is in discussions with the FDA regarding a Phase 3 study design, contingent on capital resources[170](index=170&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) The net loss widened dramatically due to non-cash fair value adjustments, while R&D expenses decreased as clinical trials wound down Comparison of Operating Results (in thousands) | Expense Category | Q1 2024 (Successor) | Q1 2023 (Predecessor) | Change | | :--- | :--- | :--- | :--- | | Selling, General & Administrative | $4,649 | $3,841 | +$808 | | Research & Development | $5,732 | $9,205 | -$3,473 | | Change in fair value of contingent consideration | $63,769 | $0 | +$63,769 | | **Loss from operations** | **($74,150)** | **($13,046)** | **(+$61,104)** | | **Net loss** | **($118,018)** | **($17,639)** | **(+$100,379)** | - R&D expenses **decreased by $3.5 million (38%)** in Q1 2024 compared to Q1 2023, primarily due to the wind-down of Phase 2 clinical trials for migraine and cervical dystonia[200](index=200&type=chunk) - SG&A expenses **increased by $0.8 million (21%)**, mainly due to higher legal/professional fees related to the merger and increased D&O insurance costs as a public company[199](index=199&type=chunk) - Other loss, net **increased by $39.3 million**, driven by a $22.9 million loss on the termination of forward purchase agreements and a $20.9 million loss on the change in fair value of warrants[203](index=203&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) With only $1.6 million in cash and an accumulated deficit of $591.6 million, the company's ability to continue as a going concern is in substantial doubt - As of March 31, 2024, the company had **$1.6 million in cash and cash equivalents** and an accumulated deficit of **$591.6 million**[204](index=204&type=chunk) - Management has concluded there is **substantial doubt about the company's ability to continue as a going concern**, expecting current cash (including recent financing) to fund operations only through June 2024[211](index=211&type=chunk)[218](index=218&type=chunk) - In March and April 2024, the company secured a total of **$15.0 million** in financing from Daewoong through the issuance of senior secured convertible notes[208](index=208&type=chunk)[209](index=209&type=chunk) - The Forward Purchase Agreements, which were expected to provide capital, were terminated in March 2024; the company **did not receive any proceeds** and may be liable for up to $3.0 million in liquidated damages[207](index=207&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, AEON Biopharma, Inc is not required to provide the information under this item - The Company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[253](index=253&type=chunk) [Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls were not effective due to a material weakness in internal control over financial reporting - The company's certifying officers concluded that **disclosure controls and procedures were not effective** as of March 31, 2024[258](index=258&type=chunk) - A **material weakness was identified** related to an ineffective risk assessment over complex transactions, stemming from a lack of sufficient and qualified resources[259](index=259&type=chunk) - The company is implementing remediation plans, which include designing new controls for reviewing valuations and estimates, and engaging additional qualified resources or hiring new staff[263](index=263&type=chunk)[264](index=264&type=chunk) Part II - Other Information [Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in a lawsuit with Odeon Capital Group over an alleged unpaid deferred underwriting fee of $1.25 million - Odeon Capital Group LLC filed a lawsuit against the company on September 18, 2023, alleging failure to pay a **$1.25 million** deferred underwriting fee from the SPAC merger[268](index=268&type=chunk) - Odeon is seeking monetary damages for the full fee, punitive damages, and attorneys' fees; the company filed a motion to dismiss certain claims in November 2023[268](index=268&type=chunk) [Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) No material changes have been made to the risk factors previously disclosed in the company's Annual Report on Form 10-K - There have been **no material changes** to the risk factors disclosed in the company's Annual Report on Form 10-K filed on May 14, 2024[269](index=269&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=45&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the quarter that were not previously disclosed - No unregistered issuances or sales of equity securities occurred during the quarter ended March 31, 2024, that were not already reported on a Form 8-K[270](index=270&type=chunk)
AEON Biopharma(AEON) - 2024 Q1 - Quarterly Results
2024-05-14 20:07
Exhibit 99.1 PRESS RELEASE AEON Biopharma Reports First Quarter 2024 Financial Results – Ongoing analysis of interim data from the Phase 2 study of ABP-450 in chronic migraine, which did not achieve its primary or secondary endpoints – – Evaluating next-steps across the Company’s late-stage clinical pipeline for ABP-450 that targets multiple indications – IRVINE, Calif., May 14, 2024 – AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developi ...
AEON Biopharma Provides Update on Development Pipeline
Newsfilter· 2024-05-09 12:00
Core Viewpoint - AEON Biopharma is advancing its late-stage clinical pipeline for ABP-450, a proprietary botulinum toxin complex, despite mixed results in its chronic migraine program [1][2]. Clinical Pipeline Overview - The company has multiple late-stage programs aimed at demonstrating the safety and efficacy of ABP-450 for various medical conditions [2]. - The episodic migraine program has shown a favorable safety profile and achieved key secondary endpoints, although it did not meet the primary endpoint [3]. - Ongoing analysis of the chronic migraine Phase 2 study indicates that it did not achieve its primary or secondary endpoints [3]. - AEON is ready to initiate a Phase 3 study for cervical dystonia, having met significant endpoints in the Phase 2 study [3]. - A Phase 2 study for gastroparesis is ready to commence, with the IND already cleared by the FDA [3]. - IND-enabling studies for post-traumatic stress disorder (PTSD) are planned, with pilot data supporting the potential of ABP-450 for this indication [3]. Company Background - AEON Biopharma focuses on developing ABP-450 for debilitating medical conditions, particularly in the neurosciences market [4]. - ABP-450 is the same botulinum toxin complex marketed for cosmetic use under the name Jeuveau by Evolus [4]. - 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 [4].
AEON Biopharma Announces Preliminary Top-Line Results from Phase 2 Interim Analysis of ABP-450 in the Preventive Treatment of Chronic Migraine
Newsfilter· 2024-05-03 11:00
Core Insights - AEON Biopharma announced that the preliminary top-line results from the interim analysis of its Phase 2 trial for ABP-450 in chronic migraine treatment did not meet the primary endpoint [1][2] - The primary endpoint was the mean reduction in monthly migraine days (MMD), which showed a reduction of 8.5 days in the 150 U arm and 7.7 days in the 195 U arm, compared to 8.4 days in the placebo arm, with none achieving statistical significance [2] - The company will continue to evaluate the complete dataset and has initiated cash preservation measures while reviewing strategic options [2][3] Company Overview - AEON Biopharma is a clinical-stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450, for various debilitating medical conditions, particularly in 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 company holds exclusive development and distribution rights for therapeutic indications of ABP-450 in the U.S., Canada, EU, UK, and other territories [4]
Here's Why AEON Biopharma, Inc. (AEON) Is a Great 'Buy the Bottom' Stock Now
Zacks Investment Research· 2024-04-19 14:56
Core Viewpoint - AEON Biopharma, Inc. (AEON) has experienced a bearish trend with a 23.2% loss over the past week, but the formation of a hammer chart pattern suggests a potential trend reversal as buying interest may be increasing [1] Technical Analysis - The hammer chart pattern indicates a possible bottom formation, suggesting that selling pressure may be subsiding [1][3] - A hammer pattern typically forms during a downtrend when the stock opens lower, makes a new low, but then closes near or above the opening price, indicating a shift in control from bears to bulls [2][3] Fundamental Analysis - There has been a notable upward trend in earnings estimate revisions for AEON, with the consensus EPS estimate increasing by 23.4% over the last 30 days, indicating strong agreement among analysts about improved earnings potential [4] - AEON holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which historically outperform the market [4] - The Zacks Rank serves as a timing indicator, suggesting that AEON's prospects are beginning to improve, reinforcing the bullish case for the stock [4]
AEON Biopharma(AEON) - Prospectus(update)
2024-04-02 10:07
Table of Contents As filed with the Securities and Exchange Commission on April 2, 2024 Registration No. 333-274094 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 3 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 AEON Biopharma, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 85-3940478 (Primary Standard Industrial Classification Code Number) 5 Park Plaza, Suite ...
AEON Biopharma Announces Redemption of Public Warrants
Newsfilter· 2024-03-29 20:15
Core Viewpoint - AEON Biopharma, Inc. announced the redemption of all outstanding Public Warrants for its Class A common stock at a price of $0.10 per warrant, effective March 29, 2024, following the terms of the Warrant Agreement [1][2]. Group 1: Redemption Details - The Company can redeem all outstanding Public Warrants if the last sales price of the Common Stock is at least $10.00 per share for twenty trading days within a thirty-day period prior to the redemption notice [2]. - A notice of redemption has been delivered to all registered holders of the outstanding Public Warrants [2]. - Upon notice of redemption, all Public Warrants must be exercised on a "cashless basis," meaning holders cannot pay cash to exercise the warrants [3]. Group 2: Cashless Exercise Mechanism - The number of shares received by warrant holders upon cashless exercise will be calculated based on the Fair Market Value of the Common Stock as defined in the Warrant Agreement [4]. - The Redemption Fair Market Value is determined by the volume weighted average price of the Common Stock for the ten trading days following the redemption notice [4]. - Any fractional shares resulting from the exercise will be rounded down to the nearest whole number [4]. Group 3: Company Overview - AEON is a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex, ABP-450, for various medical conditions, with an initial focus on the neurosciences market [7]. - The Company has completed a Phase 2 study for cervical dystonia and is conducting another Phase 2 study for chronic migraine prevention [7]. - ABP-450 is manufactured in compliance with cGMP and has been approved by regulatory bodies including the FDA and EMA [7][8].