FDA provided constructive feedback on Company’s analytical similarity strategy under the 351(k) biosimilar pathway Company continues to execute its analytical program and plans to request a BPD Type 2b meeting with the FDA in 2026 to discuss next steps in the development of ABP-450 as a biosimilar to BOTOX® IRVINE, Calif., March 25, 2026 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 (prabotulinumtoxinA) as a biosimil ...

Veteran biotechnology leader with extensive capital markets experience joins AEON as Company advances lead asset through key regulatory milestonesIRVINE, Calif., March 09, 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 accelerated and full-label U.S. market entry, today announced the appointment of John Bencich as Chief Financial Officer ...

Core Insights - AEON Biopharma is advancing ABP-450 as a biosimilar to BOTOX, aiming for accelerated and full-label U.S. market entry [1] - The company will present data at the 2026 American Academy of Neurology Annual Meeting, highlighting the analytical similarity of ABP-450 to the reference product [2][3] Company Overview - AEON Biopharma focuses on the U.S. therapeutic neurotoxin market, which exceeds $3.0 billion annually, presenting significant opportunities for biosimilar competition [5] - ABP-450 is manufactured by Daewoong Pharmaceutical under cGMP and is already approved as a biosimilar in India, Mexico, and the Philippines [5] - The company holds exclusive development and distribution rights for ABP-450 in the U.S., Canada, the EU, the UK, and other territories [5] Presentation Details - The poster presentation titled "Establishing Primary Structure Comparability Between ABP-450 and OnabotulinumtoxinA (Botox) to Support Biosimilarity" will take place on April 22, 2026 [4] - The session will be presented by Chad K. Oh, M.D., Chief Medical Officer of AEON Biopharma [4]

Core Insights - Biotech shares experienced significant movements in after-hours trading, with Sarepta Therapeutics leading due to anticipated trial data and other companies benefiting from recent clinical and regulatory updates [1] Company Summaries - Sarepta Therapeutics Inc. (SRPT) saw a surge of 9.65% to $23.17, driven by anticipation for a webcast on January 26, 2026, where three-year topline results from its Phase 3 trial of ELEVIDYS for Duchenne muscular dystrophy will be presented, potentially pivotal for its gene therapy program [2] - Fractyl Health, Inc. (GUTS) increased by 7.66% to $2.25, indicating speculative interest despite no new company news, suggesting momentum-driven trading [3] - Greenwich LifeSciences, Inc. (GLSI) advanced 2.08% to $26.00 following FDA approval of the first commercial lot of GP2 vials for the FLAMINGO-01 trial, marking a significant step in its commercialization efforts with the potential to prepare approximately 200,000 doses [4] - Anebulo Pharmaceuticals, Inc. (ANEB) rose 8.41% to $1.16, attracting buyers despite no new updates, reflecting investor interest [5] - OmniAb, Inc. (OABI) gained 4.59% to $2.05, similar to Anebulo, indicating broader investor interest in the biotech sector without fresh news [6] - Trevi Therapeutics, Inc. (TRVI) added 3.40% to $10.33 after publishing results from its Phase 2b CORAL trial in a peer-reviewed journal, enhancing credibility and investor enthusiasm [7] - AEON Biopharma, Inc. (AEON) edged up 1.80% to $1.13, confirming a meeting with the FDA and securing shareholder approval for financing transactions, simplifying its capital structure ahead of a second PIPE financing closing expected around January 27, 2026 [8]

Core Insights - AEON Biopharma has successfully completed its BPD Type 2a meeting with the FDA, marking a significant procedural milestone in the development of its biosimilar product ABP-450, which aims to compete with BOTOX [1][2][6] - Shareholders have approved key transactions that will enhance the company's financial position, including PIPE financing and the exchange of convertible notes with Daewoong Pharmaceutical, which will simplify AEON's capital structure and reduce outstanding debt [1][6] Company Overview - AEON Biopharma is focused on gaining accelerated and full-label access to the U.S. therapeutic neurotoxin market, which exceeds $3.0 billion annually, through the development of ABP-450 as a biosimilar to BOTOX [4] - ABP-450 is manufactured by Daewoong Pharmaceutical under cGMP standards and is already approved as a biosimilar in India, Mexico, and the Philippines, with exclusive rights for therapeutic indications in the U.S., Canada, EU, UK, and other territories [4] Regulatory Context - The FDA regulates biosimilars under the Public Health Service Act's 351(k) pathway, requiring developers to demonstrate that their product is highly similar to an approved reference biologic without clinically meaningful differences in safety, purity, or potency [3]

Core Viewpoint - AEON Biopharma and Daewoong Pharmaceutical have finalized an agreement to exchange $15 million of convertible notes into new equity, new notes, and cash-exercise warrants, which is a significant step towards reducing AEON's debt and advancing its biosimilar strategy for ABP-450 [2][3][4] Group 1: Transaction Details - The agreement involves the exchange of $15 million in convertible notes plus accrued interest into new equity and $1.5 million in new notes due in 2030, along with cash-exercise warrants for 8 million shares of common stock [2][3] - The cash-exercise warrants, if exercised, could provide AEON with over $8 million in additional cash proceeds [2] - The transaction is subject to shareholder approval, which is a necessary step for its consummation [3][4] Group 2: Impact on Company Structure - The exchange will eliminate more than 90% of AEON's outstanding debt, significantly transforming the company's capital structure [4] - This move is expected to strengthen Daewoong's long-term strategic alignment with AEON and its stockholders [4] Group 3: Company Background - AEON Biopharma is focused on entering the U.S. therapeutic neurotoxin market, which exceeds $3 billion annually, through the development of ABP-450 as a biosimilar to BOTOX [6] - ABP-450 is manufactured by Daewoong Pharmaceutical and is already approved as a biosimilar in India, Mexico, and the Philippines, with exclusive rights for therapeutic indications in the U.S., Canada, and the EU [6]

Core Points - AEON Biopharma, Inc. has completed the first closing of its PIPE, generating approximately $1.79 million in proceeds [1][2] - The FDA has rescheduled AEON's BPD Type 2a meeting to January 21, 2026, to review the analytical development plan and initial data supporting biosimilarity [3] Financial Summary - The first closing of the PIPE occurred on November 18, 2025, resulting in $1.79 million in proceeds [2] - The anticipated proceeds from the second closing will support AEON's analytical program and may accelerate the development of ABP-450 by up to six months [2] Regulatory Update - The FDA's rescheduling of the BPD Type 2a meeting to January 21, 2026, indicates continued engagement with AEON's biosimilar program [3] - The meeting will focus on AEON's analytical development plan without citing any scientific or program-related issues [3] Company Overview - AEON Biopharma is focused on gaining accelerated and full-label access to the U.S. therapeutic neurotoxin market, which exceeds $3.0 billion annually [5] - The company's lead asset, ABP-450, is a biosimilar to BOTOX and is manufactured in compliance with cGMP standards [5] - ABP-450 is already approved as a biosimilar in India, Mexico, and the Philippines, with exclusive development rights in the U.S., Canada, EU, UK, and other territories [5]

Financial Performance - As of September 30, 2025, the company reported an accumulated deficit of $433.7 million and cash and cash equivalents of $5.9 million, raising substantial doubt about its ability to continue as a going concern [166][170]. - The company expects to incur significant operating losses and does not anticipate revenue from ABP-450 until regulatory approval and commercialization are achieved [167]. - The Company reported a net loss of $4.5 million for the three months ended September 30, 2025, compared to a net loss of $6.2 million for the same period in 2024 [196]. - The company has incurred recurring losses from operations and expects to continue incurring significant operating losses for the foreseeable future [219]. - The company reported a net loss of $2.1 million for the nine months ended September 30, 2025, compared to a net income of $39.9 million for the same period in 2024 [225][226]. - The total operating costs and expenses for the nine months ended September 30, 2025, were $7.3 million, compared to a significant loss of $75.3 million in the same period in 2024 [196]. Research and Development - The company aims to develop ABP-450 as a biosimilar to Botox, targeting a global therapeutic botulinum toxin market estimated at $3.3 billion based on AbbVie's reported revenues for the fiscal year ended 2024 [156]. - The initial results from analytical studies show a 100% amino acid sequence match between ABP-450 and Botox, supporting the biosimilar development [161]. - The company expects R&D expenses to increase as it develops and seeks regulatory approval for ABP-450, with significant costs anticipated for clinical studies [189]. - The company has discontinued Phase 2 clinical trials for episodic and chronic migraine due to not meeting primary endpoints, implementing cash preservation measures instead [157]. - The company has scheduled a BPD Type 2a meeting with the FDA on November 19, 2025, to review analytical study results for ABP-450 [160]. - The company announced a strategic reprioritization to pursue a 351(k) biosimilar regulatory pathway for ABP-450, using Botox as a reference product [213]. Financing Activities - The Company completed an underwritten public offering on January 7, 2025, selling 555,571 Common Units, resulting in net proceeds of approximately $18.3 million after expenses [182]. - The company entered into a PIPE financing agreement on November 12, 2025, for the sale of 6,581,829 shares at a price of $0.9116 per share, generating gross proceeds of $6 million [183]. - The company entered into a Subscription Agreement with Daewoong for the sale of Convertible Notes totaling up to $15 million to support the late-stage clinical development of ABP-450 [175]. - The Company announced a binding term sheet with Daewoong for the exchange of $15.0 million in 2024 Convertible Notes for approximately 23,103,694 shares of Class A common stock and a new $1.5 million convertible note due 2030 with an interest rate of 15.79% [179]. - The company plans to use net proceeds from the PIPE financing to advance its ABP-450 biosimilar program and for general corporate purposes [217]. Compliance and Regulatory Issues - The company received a notice of non-compliance from NYSE American due to a stockholders' deficit of $32.1 million as of September 30, 2024, and is working on a plan to regain compliance [171]. - The company has substantial doubt about its ability to continue as a going concern, indicating potential challenges in meeting obligations within one year [224]. - The exercise price of the Private Placement Warrants is $828.00 per warrant, while the last reported sales price of common stock was $0.935, suggesting low likelihood of warrant exercise [221]. - The company may need to raise additional funds through equity or debt financing, which could lead to dilution for stockholders [223]. - The company is classified as a smaller reporting company, with a market value of common stock held by non-affiliates below $700 million [233]. - The company intends to rely on exemptions from various public company reporting requirements as an emerging growth company [231]. Operating Expenses - For the three months ended September 30, 2025, SG&A expenses decreased by $1.1 million, or 36%, to $1.9 million compared to $3.0 million for the same period in 2024 [197]. - SG&A expenses decreased by $2.7 million, or 25%, to $8.3 million for the nine months ended September 30, 2025, compared to $11.0 million for the same period in 2024 [198]. - Research and development expenses for the nine months ended September 30, 2025, were $2.5 million, a significant decrease from $11.1 million in the same period in 2024 [196]. - R&D expenses for the nine months ended September 30, 2025, were $2.5 million, a decrease of $8.7 million, or 80%, from $11.1 million for the same period in 2024 [200]. - The change in fair value of convertible notes resulted in a loss of $1.9 million for the three months ended September 30, 2025 [196]. - The company recorded a loss on issuance of warrants of $75.6 million due to the fair value of warrants exceeding proceeds received [202].

Financial Performance - Total operating costs and expenses for the three months ended September 30, 2025, were $2,493 million, compared to $4,016 million for the same period in 2024, representing a decrease of 38.0%[26] - Net loss for the three months ended September 30, 2025, was $4,538 million, compared to a net loss of $6,171 million for the same period in 2024, indicating an improvement of 26.4%[26] - Basic net loss per share for the three months ended September 30, 2025, was $0.39, compared to a loss of $11.24 per share for the same period in 2024, reflecting a significant reduction in losses[26] - Research and development expenses for the nine months ended September 30, 2025, totaled $2,485 million, down from $11,144 million in the same period of 2024, a decrease of 77.7%[26] - Total other loss income for the three months ended September 30, 2025, was $(2,045) million, compared to $(2,155) million for the same period in 2024, showing a slight improvement[26] - Loss on issuance of warrants for the nine months ended September 30, 2025, was $(75,644) million, indicating significant financial impact[26] - Change in fair value of convertible notes for the three months ended September 30, 2025, resulted in a loss of $(1,877) million, consistent with the previous year's loss of $(1,878) million[26] - The company reported a total loss before taxes of $(4,538) million for the three months ended September 30, 2025, compared to $(6,171) million for the same period in 2024, reflecting a reduction of 26.4%[26] - The change in fair value of warrants resulted in a loss of $(236) million for the three months ended September 30, 2025, compared to a gain of $85,950 million in the same period of 2024, indicating volatility in financial instruments[26] Financing and Cash Position - The company announced two financing transactions totaling $6 million, expected to reduce outstanding debt by over 90% and extend cash runway into Q2 2026[5][6] - As of September 30, 2025, AEON had cash and cash equivalents of $5.9 million, which will be sufficient to fund operations through Q2 2026[6] - Total assets increased to $8.734 million as of September 30, 2025, compared to $3.142 million at the end of 2024[23] - Total liabilities decreased to $28.606 million as of September 30, 2025, down from $31.711 million at the end of 2024[23] - AEON's accumulated deficit stood at $433.682 million as of September 30, 2025, compared to $431.597 million at the end of 2024[23] Product Development and Regulatory Updates - AEON reported positive biosimilarity data for ABP-450, confirming a 100% amino-acid sequence match to BOTOX® with 93-99% sequence coverage across all five proteins[3][4] - The FDA Type 2a meeting is scheduled for November 19, 2025, to discuss the analytical development plan and initial data for ABP-450[1][7] - AEON has exclusive development and distribution rights for ABP-450 in the U.S., Canada, EU, UK, and other territories, targeting a market exceeding $3.0 billion annually[9] - The company aims to accelerate the ABP-450 biosimilar program by up to six months following the recent financing[2][5] - The company has a globally approved manufacturing platform for ABP-450, with approvals in 69 countries, validating its biosimilar strategy[2]

Core Insights - AEON Biopharma is advancing its ABP-450 biosimilar program, with a Type 2a FDA meeting scheduled for November 19, 2025, to review its analytical development plan and initial data [1][6] - Positive biosimilarity data for ABP-450 has been submitted to the FDA, confirming identical amino-acid sequencing and highly similar functional characteristics to BOTOX® [1][6] - The company announced two financing transactions in November 2025, including a $6 million PIPE financing and a proposed note exchange with Daewoong, aimed at strengthening its balance sheet and extending its cash runway into the second quarter of 2026 [1][6] Financial Performance - As of September 30, 2025, AEON reported cash and cash equivalents of $5.9 million, which does not include expected proceeds from the November 2025 PIPE financing [4] - The financing is anticipated to allow the company to fund its operating plan through into the second quarter of 2026, beyond the upcoming FDA meeting [4] Scientific Validation - The analytical results for ABP-450 demonstrated a 100% amino-acid sequence match to BOTOX®, with sequence coverage of 93–99% across all five proteins in the botulinum toxin type A complex [6] - AEON's manufacturing platform is globally approved in 69 countries, supporting the scientific foundation of its biosimilar strategy [2] Strategic Developments - The two financing transactions are expected to reduce AEON's outstanding debt by more than 90% and accelerate the ABP-450 biosimilar program by up to six months [1][6] - The company is positioned to enter the next phase of development with a strong scientific and financial foundation ahead of the FDA meeting [2] Market Opportunity - The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually, representing a significant opportunity for AEON's biosimilar entry [9] - AEON holds exclusive development and distribution rights for therapeutic indications of ABP-450 in the U.S., Canada, the EU, the UK, and other territories [9]