• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Dashboard
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlerts
    Company
    AboutQuantisnow PlusContactJobs
    Legal
    Terms of usePrivacy policyCookie policy

    AEON Biopharma Reports Third Quarter 2024 Financial Results and Provides Corporate Update

    11/13/24 4:05:00 PM ET
    $AEON
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $AEON alert in real time by email

    – 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 indications –

    IRVINE, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE:AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced financial results for the third quarter ended September 30, 2024, and provided a business update.

    "We are making significant progress advancing our biosimilar development program for ABP-450 under the 351(K) regulatory pathway utilizing BOTOX as the reference product. The next key step in this program is the initiation of our planned primary comparative analytical studies, which are scheduled to start in the coming weeks. Once we have the data from these studies, we can complete the primary comparative analytical assessment, which the FDA will use to evaluate and determine the next steps for the program. This is an exciting time for the company as we work towards executing a regulatory pathway that could allow us to bring ABP-450 to the U.S. market for all of BOTOX's currently approved and future therapeutic indications under a single FDA approval," commented Marc Forth, AEON's President and Chief Executive Officer. "As we evaluate our path forward, the single biggest limitation for the Company remains our current capital resources. We are evaluating all available options that would allow the AEON team to execute the current regulatory strategy for ABP-450."

    Recent Clinical and Corporate Highlights

    • Development plan for ABP-450 utilizing 351(k) regulatory pathway for biosimilars - Based on the formal minutes received from a Biosimilar Initial Advisory (BIA) Meeting in the third quarter of 2024 with the U.S. Food and Drug Administration (FDA) for ABP-450 (prabotulinumtoxinA) injection as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product, the Company believes it is aligned with the FDA on the initial key requirements in the development 351(k) regulatory pathway and next steps.
      • Actively planning primary comparative analytical studies to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA), which are expected to commence in the fourth quarter of 2024, subject to securing capital resources.
      • Plan to hold a Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA in 2025 to discuss the outcome from these studies and determine the next steps in development.

    About AEON Biopharma

    AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions, with an initial focus on the neurosciences market. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada and European Medicines Agency. The product is approved as a biosimilar in Mexico and India. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. The Company has built a highly experienced management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. To learn more about AEON, visit www.aeonbiopharma.com.

    Forward-Looking Statements

    Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON's future financial or operating performance. For example, statements regarding meetings with the FDA, the timing of primary comparative analytical studies, and potential determination that ABP-450 is highly similar to the reference product for currently approved and future therapeutic indications are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements.

    These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON's future capital requirements; (iii) AEON's ability to raise financing in the future; (iv) AEON's ability to continue to meet continued stock exchange listing standards; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; and (vi) other risks and uncertainties set forth in the section entitled "Risk Factors" and "Cautionary Note Regarding Forward-Looking Statements" in the Company's filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC's website at www.sec.gov.

    Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements.

    Contacts

    Investor Contact:

    Corey Davis, Ph.D.

    LifeSci Advisors

    +1 212 915 2577

    [email protected]

    Source: AEON Biopharma

     
    AEON BIOPHARMA, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands, except share data and par value amounts)
     
            
      September 30,  December 31,  
      2024

     2023

     
      (Unaudited)   
    ASSETS       
    Current assets:       
    Cash and cash equivalents $537  $5,158  
    Prepaid expenses and other current assets  1,834   1,064  
    Total current assets  2,371   6,222  
    Property and equipment, net  258   332  
    Operating lease right-of-use asset  1,346   262  
    Other assets  29   29  
    Total assets $4,004  $6,845  
    LIABILITIES AND STOCKHOLDERS' DEFICIT       
    Current liabilities:       
    Accounts payable $4,630  $3,388  
    Accrued clinical trials expenses  1,373   5,128  
    Accrued compensation  1,563   943  
    Other accrued expenses  3,160   3,590  
    Total current liabilities  10,726   13,049  
    Convertible notes at fair value, including related party amount of $15,170 and $0, at September 30, 2024 and December 31, 2023, respectively  15,170   —  
    Operating lease liability  1,204   —  
    Warrant liability  1,844   1,447  
    Contingent consideration liability  6,886   104,350  
    Embedded forward purchase agreements and derivative liabilities  264   41,043  
    Total liabilities  36,094   159,889  
    Commitments and contingencies       
    Stockholders' Deficit:       
    Class A common stock, $0.0001 par value; 500,000,000 shares authorized at September 30, 2024 and December 31, 2023, and 39,587,630 and 37,159,600 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively  4   4  
    Additional paid-in capital  401,585   381,264  
    Subscription receivables  —   (60,710) 
    Accumulated deficit  (433,679)  (473,602) 
    Total stockholders' deficit  (32,090)  (153,044) 
    Total liabilities and stockholders' deficit $4,004  $6,845  
     



     
    AEON BIOPHARMA, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME

    (in thousands, except share and per share data)
     
                         
      Three Months Ended  Nine Months Ended
      September 30,  September 30, 
      2024 2023

     2024 2023
       Successor  Successor

    July 22 to

    September 30
       Predecessor

    July 1 to

    July 21
      Successor  Successor

    July 22 to

    September 30
       Predecessor

    January 1 to

    July 21
    Operating expenses:                    
    Selling, general and administrative $3,044  $5,265   $1,055  $11,014  $5,265   $9,841 
    Research and development  972   6,388    1,573   11,144   6,388    19,803 
    Acquired in-process research and development  —   348,000    —   —   348,000    — 
    Change in fair value of contingent consideration  —   (75,939)   —   (97,464)  (75,939)   — 
    Total operating costs and expenses  4,016   283,714    2,628   (75,306)  283,714    29,644 
    (Loss) income from operations  (4,016)  (283,714)   (2,628)  75,306   (283,714)   (29,644)
    Other (loss) income:                    
    Change in fair value of convertible notes  (1,878)  —    (13,249)  (170)  —    (19,359)
    Change in fair value of warrants  (377)  1,593    —   (15,376)  1,593    — 
    Income (loss) on embedded forward purchase agreements and derivative liabilities, net  81   (15,776)   (11,789)  (19,931)  (15,776)   (11,789)
    Other income, net  19   186    5   94   186    114 
    Total other loss, net  (2,155)  (13,997)   (25,033)  (35,383)  (13,997)   (31,034)
    (Loss) income before taxes  (6,171)  (297,711)   (27,661)  39,923   (297,711)   (60,678)
    Income taxes  —   —    —   —   —    — 
    Net (loss) income $(6,171) $(297,711)  $(27,661) $39,923  $(297,711)  $(60,678)
    Basic net (loss) income per share $(0.16) $(8.01)  $(0.20) $1.04  $(8.01)  $(0.44)
    Diluted net (loss) income per share $(0.16) $(8.01)  $(0.20) $0.97  $(8.01)  $(0.44)
    Weighted average shares of common stock outstanding used to compute basic net (loss) income per share  39,515,292   37,159,600    138,848,177   38,545,882   37,159,600    138,848,177 
    Weighted average shares of common stock outstanding used to compute diluted net (loss) income per share  39,515,292   37,159,600    138,848,177   41,318,831   37,159,600    138,848,177 
     

    The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP"). The condensed consolidated financial statements include the accounts of the Company and its controlled subsidiaries.

    On July 21, 2023, AEON completed the Merger with AEON Biopharma Sub, Inc. ("Old AEON"), with Old AEON surviving the merger as a wholly-owned subsidiary of the Company, the accounting acquirer. The transaction has been accounted for as a forward merger asset acquisition.

    Unless the context otherwise requires, the "Company," for periods prior to the close of the Merger, refers to Old AEON, currently AEON Biopharma Sub, Inc. ("Predecessor"), and for the periods after the close of the Merger, refers to AEON Biopharma, Inc., including AEON Biopharma Sub, Inc. ("Successor"). As a result of the Merger, the results of operations, financial position and cash flows of the Predecessor and Successor are not directly comparable. AEON Biopharma Sub, Inc. was deemed to be the Predecessor entity. Accordingly, the historical financial statements of AEON Biopharma Sub, Inc. became the historical financial statements of the combined Company, upon the consummation of the Merger. As a result, the financial statements included in this release reflect (i) the historical operating results of AEON Biopharma Sub, Inc. prior to the Merger and (ii) the combined results of the Company, including AEON Biopharma Sub, Inc., following the closing of the Merger. The accompanying financial statements include Predecessor periods for the period from January 1, 2023 to July 21, 2023 and July 1, 2023 to July 21, 2023, and Successor periods for the three and nine months ended September 30, 2024. A black line between the Successor and Predecessor periods has been placed in the condensed consolidated financial statements and in the tables to the notes to the condensed consolidated financial statements to highlight the lack of comparability between these periods.



    Primary Logo

    Get the next $AEON alert in real time by email

    Chat with this insight

    Save time and jump to the most important pieces.

    Recent Analyst Ratings for
    $AEON

    DatePrice TargetRatingAnalyst
    8/18/2023$18.00Buy
    H.C. Wainwright
    More analyst ratings

    $AEON
    Press Releases

    Fastest customizable press release news feed in the world

    See more
    • AEON Biopharma Announces NYSE American Acceptance of Plan to Regain Listing Compliance

      IRVINE, Calif., April 25, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE:AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced today it has received notification (the "Acceptance Letter") from the NYSE American LLC ("NYSE American") that NYSE American has accepted the Company's previously submitted plan (the "Plan") to regain compliance with NYSE American's continued listing standards set forth in Sections 1003(a)(i), (ii) and (iii) of the NYSE American Company Guide (the "Company Guide") relating to minimum market capitalization and stockholders' equi

      4/25/25 4:05:00 PM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • AEON Biopharma Reports Inducement Grants Under NYSE American LLC Company Guide Section 711

      IRVINE, Calif., April 21, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE:AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, today announced that, in connection with the appointment of Rob Bancroft as President and Chief Executive Officer, the Company's Compensation Committee of the Board of Directors has approved the grant of inducement awards. The Compensation Committee approved the grant to Mr. Bancroft of a non-qualified stock option to purchase 59,034 shares of AEON Class A common stock under AEON's 2025 Employment Inducement Incentive Award Plan (the "I

      4/21/25 4:10:00 PM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • AEON Biopharma Appoints Industry Veteran Rob Bancroft as Chief Executive Officer

      IRVINE, Calif., April 21, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE:AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced today the appointment of Rob Bancroft as President and Chief Executive Officer, effective April 29, 2025. Mr. Bancroft will also join AEON's Board of Directors. "We are excited to welcome Rob as the new President and Chief Executive Officer of AEON. He is an exceptional leader who brings a wealth of experience in the therapeutic toxin industry, and a strong track record of building value through the execution of well-defined s

      4/21/25 4:05:00 PM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $AEON
    Leadership Updates

    Live Leadership Updates

    See more
    • AEON Biopharma Reports Inducement Grants Under NYSE American LLC Company Guide Section 711

      IRVINE, Calif., April 21, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE:AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, today announced that, in connection with the appointment of Rob Bancroft as President and Chief Executive Officer, the Company's Compensation Committee of the Board of Directors has approved the grant of inducement awards. The Compensation Committee approved the grant to Mr. Bancroft of a non-qualified stock option to purchase 59,034 shares of AEON Class A common stock under AEON's 2025 Employment Inducement Incentive Award Plan (the "I

      4/21/25 4:10:00 PM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • AEON Biopharma Appoints Industry Veteran Rob Bancroft as Chief Executive Officer

      IRVINE, Calif., April 21, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE:AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced today the appointment of Rob Bancroft as President and Chief Executive Officer, effective April 29, 2025. Mr. Bancroft will also join AEON's Board of Directors. "We are excited to welcome Rob as the new President and Chief Executive Officer of AEON. He is an exceptional leader who brings a wealth of experience in the therapeutic toxin industry, and a strong track record of building value through the execution of well-defined s

      4/21/25 4:05:00 PM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • AEON Biopharma Announces CEO Transition

      – Marc Forth Steps Down as President and CEO to Pursue Another Opportunity; will remain on the Board of Directors – – Jost Fischer, Chairman of AEON, will assume the role of interim CEO – IRVINE, Calif., March 27, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE:AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced today a leadership transition under which Marc Forth is stepping down as President and Chief Executive Officer of the Company to pursue another opportunity, effective April 4, 2025. Mr. Forth will continue with the Company as a member of it

      3/27/25 4:05:00 PM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $AEON
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    See more
    • SEC Form 4 filed by President & CEO Bancroft Robert E.

      4 - AEON Biopharma, Inc. (0001837607) (Issuer)

      5/1/25 4:50:50 PM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 3 filed by new insider Bancroft Robert E.

      3 - AEON Biopharma, Inc. (0001837607) (Issuer)

      5/1/25 4:50:25 PM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Amendment: Director Palmisano Robert J was granted 36,021 shares (SEC Form 4)

      4/A - AEON Biopharma, Inc. (0001837607) (Issuer)

      9/10/24 9:04:24 PM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $AEON
    Financials

    Live finance-specific insights

    See more
    • AEON Biopharma Announces Topline Results from Phase 2 Trial of ABP-450 (prabotulinumtoxinA) for the Preventive Treatment of Episodic Migraine

      – ABP-450 doses of 150 units and 195 units showed treatment effect of 4.8 days and 5.0 days, respectively, in the mean change from baseline in monthly migraine days (MMD) at weeks 21-24 but did not meet statistical significance vs. placebo because of a much higher-than-expected placebo response of 4.2 days – – Study demonstrated statistical significance on multiple secondary and exploratory endpoints, including the responder analysis of both a >50% and >75% improvement from baseline in MMD – – Totality of the data showed evidence of a dose response favoring the higher 195 units arm, and supports the decision to advance into Phase 3, anticipated in 2H 2024 – – Ongoing Phase 2 trial for the

      10/19/23 4:05:00 PM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $AEON
    SEC Filings

    See more
    • SEC Form DEF 14A filed by AEON Biopharma Inc.

      DEF 14A - AEON Biopharma, Inc. (0001837607) (Filer)

      4/29/25 4:06:14 PM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • AEON Biopharma Inc. filed SEC Form 8-K: Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

      8-K - AEON Biopharma, Inc. (0001837607) (Filer)

      4/25/25 4:06:13 PM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • AEON Biopharma Inc. filed SEC Form 8-K: Leadership Update, Financial Statements and Exhibits

      8-K - AEON Biopharma, Inc. (0001837607) (Filer)

      4/21/25 4:11:36 PM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $AEON
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    See more
    • H.C. Wainwright initiated coverage on AEON Biopharma with a new price target

      H.C. Wainwright initiated coverage of AEON Biopharma with a rating of Buy and set a new price target of $18.00

      8/18/23 8:03:13 AM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $AEON
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    See more
    • SEC Form SC 13G filed by AEON Biopharma Inc.

      SC 13G - AEON Biopharma, Inc. (0001837607) (Subject)

      11/14/24 5:05:14 PM ET
      $AEON
      Biotechnology: Pharmaceutical Preparations
      Health Care