AEON Biopharma Reports Full Year 2025 Financial Results and Highlights Positive Comparative Analytical Results and FDA Feedback for ABP-450 Biosimilar Program
– Announced positive initial comparative analytical results, confirming identical amino-acid sequencing and highly similar functional characteristics to BOTOX ® –
– Reported positive FDA BPD Type 2a meeting, with FDA feedback providing a clear framework for advancing the comparative analytical plan for ABP-450 biosimilar program –
– Strengthened balance sheet through $6 million PIPE financing and Daewoong note exchange, reducing outstanding debt by more than 90% –
– Appointed John Bencich as Chief Financial Officer, adding significant capital markets and strategic leadership experience –
IRVINE, Calif., March 30, 2026 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX ® (onabotulinumtoxinA) to achieve full-label U.S. market entry, today announced its financial results for the full year ended December 31, 2025, and provided a business update.
“We’ve advanced the ABP-450 program with a positive FDA meeting and supportive initial comparative analytical results that reinforce our biosimilar development strategy,” said Robert Bancroft, President and Chief Executive Officer of AEON. “The Agency’s feedback supports AEON’s proposed framework for completing our analytical program and preparing for our next regulatory interaction. At the same time, we strengthened our balance sheet through our recent financing and note exchange, positioning the Company to execute this next stage of development. With strong foundational biosimilarity data in hand, we are entering the next development phase with greater scientific, regulatory, and financial clarity, and remain confident in our strategy to pursue full-label U.S. market entry for ABP-450.”
Recent Clinical and Corporate Highlights
Liquidity and Capital Resources
About the U.S. Biosimilar Pathway
Analytical similarity forms the scientific foundation of the 351(k) pathway and represents the most data-intensive phase of biosimilar development. When analytical comparability across critical quality attributes is robustly demonstrated, the FDA may reduce the scope of required clinical studies under its totality-of-the-evidence framework. Sponsors may also seek extrapolation to additional indications of the reference product when scientifically justified.
About AEON Biopharma
AEON Biopharma is a biopharmaceutical company seeking full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX ®. The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually, representing a major opportunity for biosimilar entry. ABP-450 is the same botulinum toxin complex currently approved and marketed for cosmetic indications by Evolus, Inc. under the name Jeuveau ®. ABP-450 is manufactured by Daewoong Pharmaceutical in a facility that has been authorized by the U.S. Food and Drug Administration, Health Canada, and European Medicines Agency for the manufacture of botulinum toxin products. The product is approved as a biosimilar in India, Mexico, and the Philippines. 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. 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 completion of, or outcome of results from, primary comparative analytical studies, or 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 completion of additional analytical testing of ABP-450; (ii) the completion of additional functional analyses of ABP-450; (iii) the expected Type 2b meeting with the FDA and potential path forward to biosimilarity designation; (iv) AEON’s ability to receive full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX ® on an accelerated timeline or at all; (v) the outcome of any legal proceedings that may be instituted against AEON or others; (vi) AEON’s future capital requirements; (vii) AEON’s ability to raise financing in the future; (viii) AEON’s ability to continue to meet continued stock exchange listing standards; (ix) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; (x) the outcomes from any meetings or discussions with regulatory authorities; (xi) the timing of, or results from, any testing performed on AEON’s product; and (xii) 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:
Laurence Watts
New Street Investor Relations
+1 619 916 7620
laurence@newstreetir.com
Source: AEON Biopharma
The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). The consolidated financial statements include the accounts of the Company and its controlled subsidiaries.