- First closing of PIPE resulted in ~$1.79M in proceeds - - FDA BPD Type 2a meeting now scheduled for January 21, 2026 - IRVINE, Calif., Nov. 20, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company seeking accelerated and full-label U.S. market entry by developing ABP-450 (prabotulinumtoxinA) as a BOTOX (onabotulinumtoxinA) biosimilar, today announced the first closing of its previously announced private placement (“PIPE”). Additionally, ...

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].

Exhibit 99.1 PRESS RELEASE – Two complementary financing transactions announced in November 2025 - $6 million PIPE financing and a proposed Daewoong note exchange - are expected to strengthen AEON's balance sheet, reduce outstanding debt by more than 90%, accelerate the ABP-450 biosimilar program by up to six months, and extend cash runway into the second quarter of 2026 – IRVINE, Calif., November 14, 2025 – AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE American: AEON), a biopharmaceutical company se ...

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]

Core Insights - AEON Biopharma has announced two transactions that could provide up to approximately $22 million in potential proceeds, significantly improving its balance sheet and reducing outstanding debt by over 90% [1][7] Financing Details - AEON has entered a $6 million PIPE financing agreement, with the potential to raise over $7 million in additional capital through cash-exercise warrants [1][3] - The PIPE involves the sale of 6,581,829 shares at a price of $0.9116 per share, along with five-year warrants to purchase the same number of shares at an exercise price of $1.094 [3][4] - The first closing of the PIPE is expected in November 2025, with an initial gross proceeds of $1.79 million [4] Debt Exchange - AEON and Daewoong Pharmaceutical have agreed to exchange $15 million of existing convertible notes for approximately 23,103,694 shares of AEON common stock, a new $1.5 million note due in 2030, and 8 million cash-exercise warrants [6][7] - This exchange is anticipated to eliminate more than 90% of AEON's outstanding debt, thereby strengthening its capital structure [7] Program Advancement - The proceeds from these transactions are expected to support the uninterrupted advancement of AEON's ABP-450 biosimilar program, following positive analytical data submitted to the FDA [1][5] - The financing is projected to accelerate the biosimilar development timeline by up to six months [5] Market Context - AEON 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 [10] - The company has exclusive rights for therapeutic indications of ABP-450 in the U.S., Canada, and the EU, among other regions [10]

Core Insights - The Yongwang Dream City project in Xiangjiang New District is set to officially open at the end of November, having generated significant anticipation among local residents since its inception [1][6] Project Overview - The project, constructed by China State Construction Engineering Corporation, covers a total area of 236,200 square meters and includes a four-story shopping center and a six-story parking garage [3] - It aims to create a green, three-star commercial complex that integrates dining, furniture, and leisure entertainment, providing a new recreational space for residents [3][6] Construction Achievements - The project was completed in 400 days, nearly four months faster than similar projects, despite facing challenges such as complex geological conditions [3] - Innovative construction methods, including BIM technology and parallel construction techniques, were employed to optimize efficiency and ensure high-quality outcomes [3][5] Sustainability Initiatives - The project targets "Green Building Three-Star + LEED Gold" certification, incorporating sustainable practices throughout the construction process [5] - Low-carbon mechanical and electrical equipment is used, expected to reduce carbon emissions by over 1,000 tons annually, alongside a rainwater recovery system for landscaping [5] Community Engagement - The project team actively engaged with the local community, signing a partnership agreement to minimize construction impact and conducting various public welfare activities [5] - Local residents have expressed positive sentiments about the project, highlighting its benefits for shopping and convenience once completed [5][6]

Core Insights - The FDA has scheduled a Biosimilar Biological Product Development (BPD) Type 2a meeting for AEON's ABP-450 on November 19, 2025, which aligns with prior guidance [1][4] - The meeting will focus on AEON's analytical development plan under the 351(k) biosimilar pathway, aiming to establish alignment with the FDA on the analytical framework [2][3] Company Overview - AEON Biopharma is developing ABP-450 as a biosimilar to BOTOX, targeting the U.S. therapeutic neurotoxin market, which exceeds $3.0 billion annually [5] - ABP-450 is manufactured by Daewoong Pharmaceutical and is already approved as a biosimilar in India, Mexico, and the Philippines [5] - The company holds exclusive development and distribution rights for therapeutic indications of ABP-450 in the U.S., Canada, the EU, the UK, and other territories [5]

Financial Performance - The company reported a net loss of $6.6 million for the three months ended June 30, 2025, compared to a net income of $164.1 million for the same period in 2024[187]. - The company recognized a loss on the issuance of warrants amounting to $75.6 million due to the fair value of warrants exceeding proceeds received[185]. - The company incurred net cash used in operating activities of $10.0 million for the six months ended June 30, 2025, compared to $16.7 million for the same period in 2024[212][213]. - The company recognized a gain of $3.5 million related to the change in fair value of contingent consideration for the six months ended June 30, 2025[193]. - Net cash provided by financing activities for the six months ended June 30, 2025, was $18.4 million, compared to $15.0 million for the same period in 2024, primarily due to a public offering in Q1 2025 and proceeds from convertible notes in 2024[216]. Market and Product Development - The global therapeutic botulinum toxin market is estimated to be at least $3.3 billion based on AbbVie's reported revenues for its therapeutic Botox segment for the fiscal year ended 2024[147]. - The company plans to pursue a 351(k) biosimilar regulatory pathway for ABP-450, using Botox as a proposed reference product for all approved indications except cosmetic uses[148][157]. - The company has exclusive development and distribution rights for ABP-450 in the U.S., Canada, the EU, the UK, and other territories[156]. - The company completed a Phase 2 study of ABP-450 for cervical dystonia, which met all primary endpoints, supporting further development[153]. - The company intends to explore additional therapeutic indications for ABP-450 based on a comprehensive product assessment screening process[158]. Regulatory and Compliance 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[164]. - The NYSE American accepted the company's plan to regain compliance, granting until August 3, 2026, to meet listing standards[165]. - Management has expressed substantial doubt about the company's ability to continue as a going concern due to recurring losses and negative cash flows[211]. - 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[219]. - The market value of the company's common stock held by non-affiliates is less than $700 million, qualifying it as a smaller reporting company[220]. Financial Strategy and Funding - The company entered into a Subscription Agreement with Daewoong for the sale of Convertible Notes totaling up to $15.0 million, with an annual interest rate of 15.79% and a maturity date three years from the funding date[168]. - The company issued a Convertible Note of $5.0 million on March 24, 2024, and an additional $10.0 million Convertible Note on April 12, 2024, to support late-stage clinical development of ABP-450[168]. - The company expects to have sufficient cash to fund operations into Q4 2025 but will actively seek additional capital[205]. - The company anticipates increased costs associated with being a public company, including compliance and investor relations expenses[176]. Research and Development - R&D expenses for the six months ended June 30, 2025, were $1.9 million, a decrease from $10.2 million in the same period in 2024, reflecting a shift in focus towards biosimilar strategy[188]. - The company expects R&D expenses to increase as it develops and seeks regulatory approval for ABP-450, with significant costs anticipated in later-stage clinical studies[178]. - R&D expenses decreased to $1.1 million for Q2 2025, down 75% from $4.4 million in Q2 2024, primarily due to the wind down of Phase 2 clinical trials[190]. - For the six months ended June 30, 2025, R&D expenses were $1.9 million, an 81% decrease from $10.2 million in the same period of 2024[192]. Accounting and Reporting - The company has not made any changes to its critical accounting policies as of June 30, 2025, compared to those reported in the Annual Report Form 10-K[217]. - The company is permitted to rely on certain exemptions from public company reporting requirements due to its status as an emerging growth company[218]. - The company may continue to rely on exemptions from certain disclosure requirements as a smaller reporting company if it meets specific criteria[222]. - The company has provided only two years of unaudited financial statements in this report due to its emerging growth company status[218]. - The company has not disclosed information under Item 3 regarding market risk as it is classified as a smaller reporting company[225].

[Corporate Update and Business Overview](index=1&type=section&id=Corporate%20Update%20and%20Business%20Overview) AEON Biopharma reported Q2 2025 results, detailing ABP-450 biosimilar development and liquidity supporting operations through Q4 2025 - AEON Biopharma is developing ABP-450 (prabotulinumtoxinA) as a BOTOX (onabotulinumtoxinA) biosimilar, seeking accelerated and full-label U.S. market entry[1](index=1&type=chunk) - The U.S. therapeutic neurotoxin market exceeds **$3.0 billion annually**, presenting a major opportunity for biosimilar entry[2](index=2&type=chunk)[7](index=7&type=chunk) [Initial Announcement and CEO Commentary](index=1&type=section&id=Initial%20Announcement%20and%20CEO%20Commentary) CEO Rob Bancroft highlighted strong progress for ABP-450 biosimilar development milestones in H2 2025 - CEO Rob Bancroft highlighted strong progress towards major biosimilar development milestones for ABP-450 in the second half of 2025[2](index=2&type=chunk) - Anticipated completion of primary structure analysis and select functional analyses in **3Q'25**, critical for the planned Type 2a meeting with the FDA in **4Q'25**[1](index=1&type=chunk)[2](index=2&type=chunk) - AEON aims to bring ABP-450 to the U.S. market via the **351(k) pathway**, potentially covering all BOTOX therapeutic indications and offering a more cost-effective solution[2](index=2&type=chunk) [Recent Clinical and Corporate Highlights](index=1&type=section&id=Recent%20Clinical%20and%20Corporate%20Highlights) The company is advancing ABP-450 biosimilar development through comparative analytical assessment for FDA alignment - Advancing ABP-450's biosimilar development through the comparative analytical assessment (CAA) via a **351(k) regulatory pathway**, using BOTOX as the reference product[3](index=3&type=chunk) - Expects to complete primary structure and select functional analyses for ABP-450 in **3Q'25**[3](index=3&type=chunk) - Anticipates a **Type 2a meeting with the FDA in 4Q'25** to discuss study results and align on next development steps[3](index=3&type=chunk) [Liquidity and Capital Resources](index=3&type=section&id=Liquidity%20and%20Capital%20Resources) AEON Biopharma's cash and cash equivalents are expected to fund operations through Q4 2025 Liquidity and Capital Resources (June 30, 2025) | Metric | Amount | | :----- | :--------------------- | | Cash and cash equivalents | $8.4 million | - Cash runway expected to support operations through the **fourth quarter of 2025** and the planned Type 2a meeting with the FDA[1](index=1&type=chunk)[5](index=5&type=chunk) [Expected Upcoming Milestones](index=3&type=section&id=Expected%20Upcoming%20Milestones) Key milestones include primary structure and functional analyses in Q3 2025, and an FDA meeting in Q4 2025 - **3Q'25**: Expected completion of primary structure analysis by the Company[10](index=10&type=chunk) - **3Q'25**: Expected completion of select functional analyses by Daewoong Pharmaceutical, the Company's licensing partner[10](index=10&type=chunk) - **4Q'25**: Expected results and path forward from Biosimilar Biological Product Development (BPD) Type 2a FDA meeting[10](index=10&type=chunk) [About AEON Biopharma](index=3&type=section&id=About%20AEON%20Biopharma) AEON Biopharma develops ABP-450 as a BOTOX biosimilar for the U.S. market, manufactured by Daewoong - AEON Biopharma seeks accelerated and full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX[7](index=7&type=chunk) - ABP-450 is manufactured by Daewoong Pharmaceutical in compliance with current Good Manufacturing Practice (cGMP) in an FDA-approved facility[7](index=7&type=chunk) - 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 U.S., Canada, EU, UK, and other territories[7](index=7&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines forward-looking statements, subject to risks and uncertainties, with no obligation to update - Forward-looking statements generally relate to future events or AEON's future financial or operating performance, including meetings with the FDA and the timing/outcome of primary comparative analytical studies[8](index=8&type=chunk) - Such statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially, including the completion of analyses, FDA meeting outcomes, future capital requirements, and regulatory factors[8](index=8&type=chunk)[9](index=9&type=chunk)[11](index=11&type=chunk) - Readers 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 statements[14](index=14&type=chunk) [Contacts](index=5&type=section&id=Contacts) This section provides contact information for investor relations inquiries - Investor Contact: Laurence Watts, New Street Investor Relations, **+1 619 916 7620**, laurence@newstreetir.com[15](index=15&type=chunk) [Condensed Consolidated Financial Statements](index=6&type=section&id=Condensed%20Consolidated%20Financial%20Statements) Condensed consolidated financial statements detail AEON Biopharma's financial position and operating results for Q2 2025 and 2024 [Condensed Consolidated Balance Sheets](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) The balance sheets highlight significant increases in cash and total assets, alongside an improved stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Item | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Cash and cash equivalents | $8,439 | $13 | +$8,426 | | Prepaid expenses and other current assets | $1,823 | $1,577 | +$246 | | Total current assets | $10,262 | $1,590 | +$8,672 | | Total assets | $11,662 | $3,142 | +$8,520 | | Total current liabilities | $9,129 | $14,149 | -$5,020 | | Convertible notes at fair value | $15,174 | $11,689 | +$3,485 | | Warrant liability | $2,122 | $1,187 | +$935 | | Contingent consideration liability | $69 | $3,541 | -$3,472 | | Total liabilities | $27,514 | $31,711 | -$4,197 | | Total stockholders' deficit | $(15,852) | $(28,569) | +$12,717 | - Cash and cash equivalents increased significantly from **$13 thousand** at December 31, 2024, to **$8,439 thousand** at June 30, 2025[17](index=17&type=chunk) - Total stockholders' deficit improved by **$12,717 thousand**, from **$(28,569) thousand** at December 31, 2024, to **$(15,852) thousand** at June 30, 2025[17](index=17&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20(LOSS)%20INCOME) Statements of operations show a shift to net loss in Q2 2025, driven by fair value adjustments and reduced R&D expenses Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Selling, general and administrative | $3,258 | $3,321 | $6,383 | $7,970 | | Research and development | $1,064 | $4,439 | $1,889 | $10,172 | | Change in fair value of contingent consideration | $16 | $(161,233) | $(3,472) | $(97,464) | | Total operating costs and expenses | $4,338 | $(153,473) | $4,800 | $(79,322) | | (Loss) income from operations | $(4,338) | $153,473 | $(4,800) | $79,322 | | Change in fair value of convertible notes | $(1,854) | $1,795 | $(3,485) | $1,708 | | Change in fair value of warrants | $(542) | $5,905 | $86,187 | $(14,999) | | Loss on issuance of warrants | — | — | $(75,644) | — | | Net (loss) income | $(6,642) | $164,112 | $2,453 | $46,094 | | Basic net (loss) income per share | $(0.60) | $304.00 | $0.32 | $87.15 | | Diluted net (loss) income per share | $(0.60) | $304.00 | $0.31 | $87.15 | - Net loss of **$(6,642) thousand** for the three months ended June 30, 2025, compared to net income of **$164,112 thousand** for the same period in 2024[20](index=20&type=chunk) - Research and development expenses decreased significantly from **$4,439 thousand** in Q2 2024 to **$1,064 thousand** in Q2 2025[20](index=20&type=chunk) - The change in fair value of contingent consideration significantly impacted operating costs, moving from a **$(161,233) thousand** gain in Q2 2024 to a **$16 thousand** expense in Q2 2025[20](index=20&type=chunk)

Core Insights - AEON Biopharma is progressing towards significant biosimilar development milestones for ABP-450, aiming for a Type 2a meeting with the FDA in 4Q'25 [2][5] - The U.S. therapeutic neurotoxin market exceeds $3.0 billion, presenting a substantial opportunity for AEON's entry with ABP-450 as a cost-effective alternative to BOTOX [4][5] Financial Overview - As of June 30, 2025, AEON reported cash and cash equivalents of $8.4 million, expected to fund operations through the planned FDA meeting in 4Q'25 [5] - The company incurred a net loss of $6.6 million for the three months ended June 30, 2025, compared to a net income of $164.1 million for the same period in 2024 [12][13] - Total current assets amounted to $10.3 million, while total liabilities were reported at $27.5 million, resulting in a stockholders' deficit of $15.9 million [11] Upcoming Milestones - Completion of primary structure analysis and select functional analyses for ABP-450 is expected in 3Q'25 [5] - The anticipated Type 2a meeting with the FDA in 4Q'25 will discuss the results of these studies and outline the next steps for ABP-450's development [5][6] Product Development - ABP-450 is being developed as a biosimilar to BOTOX, utilizing the 351(k) regulatory pathway to potentially cover all therapeutic indications of BOTOX [2][5] - The product is already approved as a biosimilar in India, Mexico, and the Philippines, with exclusive development rights in the U.S., Canada, EU, and UK [6]