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AEON Biopharma Inc is a biopharmaceutical company focused on the development of ABP-450 (prabotulinumtoxinA), a biosimilar to Botox (onabotulinumtoxinA), for therapeutic indications. The company is advancing ABP-450 through the biosimilar regulatory pathway and holds development and commercialization rights across multiple international markets.

Founded: N/A Country:
United States
United States
Employees: N/A City: ALISO VIEJO
Market Cap: 13.0M IPO Year: 2021
Target Price: $1.82 AVG Volume (30 days): 1.2M
Analyst Decision: Strong Buy Number of Analysts: 4
Dividend Yield:
N/A
Dividend Payout Frequency: N/A
EPS: -0.28 EPS Growth: -105.42
52 Week Low/High: $0.18 - $1.45 Next Earning Date: 11-13-2026
Revenue: N/A Revenue Growth: N/A
Revenue Growth (this year): N/A Revenue Growth (next year): N/A
P/E Ratio: -0.86 Index: N/A
Free Cash Flow: -17312000.0 FCF Growth: N/A

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Stock Insider Trading Activity of AEON Biopharma Inc. (AEON)

Buy
AEON Aug 19, 2026

Avg Cost/Share

$0.21

Shares

1,150,000

Total Value

$243,455.00

Owned After

6,500,000

SEC Form 4

Earnings Transcripts

SEC 8-K filings with transcript text

View All
2026
Q2

Q2 2026 Earnings

8-K BUY

Aug 12, 2026 · 100% conf.

AI Prediction BUY

1D

+5.95%

$0.29

Act: -1.60%

5D

+9.74%

$0.30

20D

+25.82%

$0.35

Price: $0.28 Prob +5D: 100% AUC: 1.000
0001837607-26-000061

EX-99.1

2 aeon-20260812xex99d1.htm

EX-99.1

Exhibit 99.1

PRESS RELEASE

AEON Biopharma Reports Second Quarter 2026 Financial Results and Provides Corporate Update

- Executed a $15.3 million financing with milestone warrants providing potential for an additional $34.0 million in gross proceeds, supporting continued advancement of ABP-450's development program -

- Upfront proceeds from financing provide cash runway into the first quarter of 2027 -

ALISO VIEJO, Calif., August 12, 2026 – AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 as a biosimilar to BOTOX® (onabotulinumtoxinA) for therapeutic use to achieve full-label U.S. market entry, today reported its financial results for the second quarter ended June 30, 2026, and provided a corporate update.

“The second quarter marked continued progress in advancing ABP-450 through the analytical phase of our biosimilar development program while also strengthening the Company's financial position," commented Rob Bancroft, President and Chief Executive Officer of AEON. "As we enter the second half of 2026, our primary focus is obtaining FDA feedback on the next phase of development, including the clinical pharmacology and comparative clinical study requirements for ABP-450. With the successful completion of our recently oversubscribed public offering, AEON is well positioned to execute on our near-term regulatory and corporate objectives as we continue advancing our goal of bringing a biosimilar to BOTOX® to the therapeutic market."”

Second Quarter 2026 Highlights and Recent Developments

●Continued Advancement Toward BPD Type 2b Regulatory Feedback

oAEON held a successful Biosimilar Biological Product Development (BPD) Type 2a meeting with the U.S. Food and Drug Administration (FDA) during the first quarter of 2026. During the meeting, the Agency reviewed the Company's proposed analytical similarity strategy under the 351(k) biosimilar pathway and provided feedback supporting AEON's planned analytical development approach for ABP-450. Collectively, the FDA's feedback provided AEON with well-defined direction and a framework for the remaining analytical components of its biosimilar development program. The Agency also acknowledged the unique scientific challenges associated with characterizing the 900 kDa botulinum neurotoxin complex due to its large size and exceptional potency, while providing constructive feedback on the Company's proposed analytical assessment plan. The Company looks forward to feedback from its planned BPD Type 2b interaction with the FDA in the second half of 2026, which is expected to help inform the next phase of development for ABP-450, including clinical pharmacology and comparative clinical study requirements.

●Strengthened Balance Sheet through a $15.3 Million Financing with Milestone Warrants Providing Potential for an Additional $34.0 Million in Gross Proceeds

oIn July 2026, the Company completed an underwritten public offering that included net upfront proceeds of approximately $13.6 million, and up to an additional $34.0 million in potential gross proceeds upon the cash exercise in full of the milestone warrants issued in the offering. Upfront proceeds from the offering are expected to provide cash runway into the first quarter of 2027.

●NYSE American Compliance Restored

oOn August 3, 2026, the Company regained full compliance with NYSE American continued listing requirements, resolving previously identified deficiencies and maintaining its listing on the exchange.

‌​

Exhibit 99.1

PRESS RELEASE

●Presented Data and Advanced Scientific Engagement Supporting Analytical Similarity to BOTOX®

oIn April 2026, the Company presented a poster at the 2026 American Academy of Neurology (AAN) Annual Meeting entitled “Establishing Primary Structure Comparability Between ABP-450 (prabotulinumtoxinA) and OnabotulinumtoxinA (Botox®) to Support Biosimilarity.” The poster expanded upon analytical data previously reported by the Company demonstrating identical primary amino acid sequence between ABP-450 and the reference product, based on 93.5%–99.3% peptide sequence coverage.

oIn June 2026, the Company presented an Abstract at the American Headache Society (AHS) Annual Meeting entitled “Establishing Structural and Functional Comparability Between ABP-450 and OnabotulinumtoxinA to Support Biosimilarity.”

Liquidity and Capital Resources

The Company reported cash and cash equivalents of $3.4 million as of June 30, 2026, which does not include approximately $13.6 million of net proceeds from the underwritten public offering that was completed in July 2026. Including those proceeds, cash and cash equivalents are expected to fund operations into the first quarter of 2027, supporting continued advancement of the ABP-450 program including ongoing analytical and regulatory activities.

ABP-450 Development Milestones & Scientific and/or Corporate Events

●Second half 2026: Recei

2026
Q1

Q1 2026 Earnings

8-K

May 14, 2026

0001837607-26-000041

EX-99.1

2 aeon-20260514xex99d1.htm

EX-99.1

Exhibit 99.1

PRESS RELEASE

AEON Biopharma Reports First Quarter 2026 Financial Results and Provides Corporate Update

- Reported positive FDA Type 2a meeting supporting ABP-450’s comparative analytical strategy under the 351(k) regulatory pathway -

- Strengthened balance sheet through financing transactions and Daewoong note exchange, reducing outstanding debt by more than 90% -

- Bolstered leadership team with appointment of John Bencich as Chief Financial Officer -

IRVINE, Calif., May 14, 2026 – AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 as a biosimilar to BOTOX® (onabotulinumtoxinA) for therapeutic use to achieve full-label U.S. market entry, reported today its financial results for the first quarter ended March 31, 2026, and provided a corporate update.

“During the first quarter, we made meaningful progress advancing the ABP-450 development program and strengthening the company’s financial position,” commented Rob Bancroft, President and Chief Executive Officer of AEON. “We believe feedback from our BPD Type 2a meeting with the FDA supports our analytical similarity strategy under the 351(k) pathway and provides greater clarity on the path forward. In addition, the completion of our recent financing transactions, including the exchange of Daewoong-held notes, significantly reduced our outstanding debt.”

“With this foundation in place, we are focused on executing our analytical program and preparing for our planned Type 2b interaction, where we will seek further feedback from the FDA on the full definition of program requirements. We believe this progress positions ABP-450 to advance efficiently toward potential full-label approval and our goal of introducing a new competitive dynamic in a large therapeutic category that has been long dominated by a single product.”

First Quarter 2026 Highlights and Recent Developments

●Reported Feedback from FDA BPD Type 2a Meeting Regarding ABP-450

oThe FDA reviewed AEON’s initial analytical comparability results and the proposed analytical similarity strategy for ABP-450 under the 351(k) biosimilar pathway and provided guidance that AEON’s analytical plan was considered reasonable by the Agency to support advancement of the program toward a comprehensive analytical similarity package. The Company believes the FDA’s feedback provides a clear framework for the remaining analytical components of its biosimilar development program and plans to complete the majority of its analytical comparability program in 2026.

oAEON currently plans to request a BPD Type 2b meeting in 2026 to discuss the next phase of the development program to support potential approval of ABP-450 as a biosimilar to BOTOX® across all approved therapeutic indications.

●Strengthened Balance Sheet Through Closing of Strategic PIPE Financing and Note Exchange

oAEON held a special meeting at which shareholders voted to approve the completion of the complementary transactions announced in November, including the remaining issuances related to the Company’s private investment in public equity (“PIPE”) financing and the related exchange of the Company’s convertible notes held by Daewoong Pharmaceutical Co., Ltd. (“Daewoong”). The $6 million PIPE financing and Daewoong note exchange, together, strengthened AEON’s balance sheet and reduced outstanding debt by more than 90%.

​

‌​

Exhibit 99.1

PRESS RELEASE

●Appointed John Bencich as Chief Financial Officer

oMr. Bencich joins AEON with more than 25 years of leadership experience spanning corporate strategy, capital market transactions, and business development across emerging growth and publicly traded companies.

●Presented Data and Advanced Scientific Engagement Supporting Analytical Similarity to BOTOX®

oChad Oh, M.D., AEON’s Chief Medical Officer, presented a poster at the 2026 American Academy of Neurology (AAN) Annual Meeting in April entitled “Establishing Primary Structure Comparability Between ABP-450 (prabotulinumtoxinA) and OnabotulinumtoxinA (Botox®) to Support Biosimilarity.” The poster expanded upon analytical data previously reported by the Company demonstrating identical primary amino acid sequence between ABP-450 and the reference product, based on 93.5%–99.3% peptide sequence coverage.

oAn abstract was accepted for presentation at the upcoming American Headache Society (AHS) Annual Meeting on June 4-7, 2026 in Orlando, Florida entitled “Establishing Structural and Functional Comparability Between ABP-450 and OnabotulinumtoxinA to Support Biosimilarity.” The abstract will be presented on June 4th between 2:00 pm and 5:00 pm ET.

Liquidity and Capital Resources

The Company reported cash and cash equivalents of $6.2 million as of March 31, 2026, which does not include the $0.9 million of proceeds received upon ATM financing in April 2026. Including those proceeds, cash and cash equivalents are expected to fund op

2025
Q4

Q4 2025 Earnings

8-K

Mar 30, 2026

0001837607-26-000018

EX-99.1

2 aeon-20260330xex99d1.htm

EX-99.1

Exhibit 99.1

PRESS RELEASE

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 – 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

●Positive Biosimilarity Results

oIn November 2025, AEON reported positive initial comparative data for ABP-450, its proposed biosimilar to BOTOX®. These initial analytical results confirmed identical amino-acid sequencing and highly similar functional characteristics to BOTOX®. These analytical results were included in the package submitted to the FDA ahead of AEON’s BPD Type 2a meeting.

◾Liquid chromatography/mass spectrometry (LC/MS) analysis of over 3,400 amino acids demonstrated that the primary structure of ABP-450 exhibited a 100% sequence match to BOTOX®, based on sequence coverage of 93–99% across all five proteins comprising the 900 kDa botulinum toxin type A complex.

◾Functional analyses demonstrated initial similarity in potency (using LD50 and cell-based potency assays), composition (vial-to-vial comparability analyzed with ELISA), and enzymatic activity (functional cleavage of SNAP-25 consistent with mechanism of action).

oThe Company continues to build on this analytical biosimilarity foundation and expects the majority of its analytical comparability program to be completed in 2026.

‌​

Exhibit 99.1

PRESS RELEASE

●Announced Constructive FDA Feedback Following January 2026 Biosimilar Biological Product Development (BPD) Type 2a Meeting

oAEON reported that the U.S. Food and Drug Administration (“FDA” or the “Agency”) reviewed the Company’s proposed analytical similarity strategy under the 351(k) biosimilar pathway and noted that AEON’s analytical methodologies appeared reasonable to support advancement of the program toward a comprehensive analytical similarity package. The Company believes the FDA’s feedback provides a clear framework for the remaining analytical components of its biosimilar development program and plans to complete the majority of its analytical comparability program in 2026.

oAEON currently plans to request a BPD Type 2b meeting in 2026 to discuss the next phase of the development program to support approval of ABP-450 as a biosimilar to BOTOXÒ across all approved therapeutic indications.

●Strategic PIPE Financing and Note Exchange

oAEON announced complementary transactions through a $6 million PIPE financing and a Daewoong Pharmaceutical note exchange - which, together, strengthens AEON’s balance sheet and reduces outstanding debt by more than 90%.

●Appointed John Bencich as Chief Financial Officer

oIn March 2026, the Company announced the appointment of John Bencich as Chief Financial Officer. Mr. Bencich joins AEON with more than 25 years of leadership experience spanning corporate strategy, capital market transactions, and business development across emerging growth and publicly traded companies.

●Abstract Accepted for Presentation at 2026 American Academy of Neurology (AAN) Annual Meeting

oAlso in March 2026, AEON announced a poster presentation at the 2026 American Academy of Neurology (AAN) Annual Meeting, taking place April 18-22, 2026, in Chicag

2025
Q3

Q3 2025 Earnings

8-K

Nov 14, 2025

0001837607-25-000084

EX-99.1

2 aeon-20251114xex99d1.htm

EX-99.1

Exhibit 99.1

‌PRESS RELEASE

AEON Biopharma Reports Third Quarter 2025 Results, Including Positive ABP-450 Biosimilarity Data and Strategic Positioning for Continued Growth

– FDA Type 2a meeting scheduled for November 19, 2025 to review AEON’s analytical development plan and initial data –

– Positive biosimilarity data for ABP-450 confirming identical amino-acid sequencing and highly similar functional characteristics submitted to FDA ahead of scheduled Type 2a meeting –

– 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 seeking an accelerated and full-label U.S. market entry by developing ABP-450 (prabotulinumtoxinA) as a BOTOXÒ (onabotulinumtoxinA) biosimilar, today announced its financial results for the quarter ended September 30, 2025, and provided a business update.

“The foundation of AEON’s progress lies in our science and is underscored by years of market validation”, said Rob Bancroft, AEON’s President and Chief Executive Officer. “Our recently released analytical results confirm both ABP-450’s identical amino-acid sequencing of all visible portions and highly similar functional characteristics to BOTOX®. These results are supported by a globally approved and fully scaled manufacturing platform with approvals in 69 countries. Together, these scientific and global data points validate our biosimilar strategy and instill confidence in AEON’s path forward.”

“On the strength of this foundation, we announced two complementary financing transactions with Daewoong Pharmaceutical and institutional investors that are expected to eliminate over 90% of our outstanding debt, strengthen our balance sheet, and extend our cash runway into the second quarter of 2026 while accelerating the ABP-450 program by up to six months. With our FDA Type 2a meeting scheduled later this month, we are entering the next phase of development from a position of scientific and financial strength.”

Recent Clinical and Corporate Highlights

●Positive Biosimilarity Results

oIn November 2025, AEON reported positive biosimilarity data for ABP-450, its proposed biosimilar to BOTOX®. Analytical results confirmed identical amino-acid sequencing and highly similar functional characteristics to BOTOX®. The analytical package has been submitted to the FDA ahead of AEON’s Type 2a meeting scheduled for November 19, 2025.

◾LC-MS analysis demonstrated that the primary structure of ABP-450 exhibited a 100% amino-acid sequence match to BOTOX®, with sequence coverage of 93–99% across all five proteins comprising the 900 kDa botulinum toxin type A complex.

‌​

Exhibit 99.1

‌PRESS RELEASE

●Strategic Financing and Note Exchange

oAlso in November 2025, AEON announced two complementary transactions - a $6 million PIPE financing and a proposed Daewoong Pharmaceutical note exchange - which, together, are expected to strengthen AEON’s balance sheet, reduce outstanding debt by more than 90% and extend cash runway into the second quarter of 2026 while accelerating the ABP-450 program by up to six months.

Liquidity and Capital Resources

●The Company reported cash and cash equivalents of $5.9 million as of September 30, 2025, which does not include expected proceeds from the November 2025 PIPE financing. Including the recent financing, the company’s cash and cash equivalents are expected to be sufficient to fund the Company’s operating plan through into the second quarter of 2026, well beyond its Type 2a meeting with the FDA scheduled for this month.

Expected Upcoming Milestones

●November 19, 2025 – Expected results and path forward from Biosimilar Biological Product Development (BPD) Type 2a FDA meeting.

About the U.S. Biosimilar Pathway

The U.S. Food and Drug Administration (“FDA”) regulates biosimilars under the Public Health Service Act’s 351(k) pathway, which require developers to demonstrate that a proposed product is highly similar to an approved reference biologic with no clinically meaningful differences in safety, purity, or potency. Analytical similarity is the scientific foundation of this process, representing the most critical and data-intensive phase of development. Once analytical comparability across key quality attributes is established, subsequent FDA interactions focus on confirming whether any residual uncertainty requires limited clinical evaluation.

About AEON Biopharma

AEON Biopharma is a biopharmaceutical company seeking accelerated and full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX. The U.S. therapeutic neur

2025
Q2

Q2 2025 Earnings

8-K

Aug 12, 2025

0001837607-25-000065

EX-99.1

2 aeon-20250812xex99d1.htm

EX-99.1

Exhibit 99.1

‌PRESS RELEASE

AEON Biopharma Reports Second Quarter 2025 Financial Results and Provides Corporate Update

– Multiple near-term potential milestones, including anticipated completion of primary structure analysis and select functional analyses in 3Q’25 –

– Type 2a meeting with the FDA anticipated in 4Q’25–

– Cash runway expected to support operations through FDA meeting and regulatory feedback –

IRVINE, Calif., August 12, 2025 – AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a biopharmaceutical company seeking an accelerated and full-label U.S. market entry by developing ABP-450 (prabotulinumtoxinA) as a BOTOXÒ (onabotulinumtoxinA) biosimilar, announced its financial results for the second quarter ended June 30, 2025, and provided a business update.

“We have made strong progress this quarter toward the major biosimilar development milestones laid out for the second half of 2025. We are poised to report the results from our primary structure analysis and select functional analyses for ABP-450, which will be critical components of our planned Type 2a meeting with the FDA, anticipated to take place in 4Q’25. We expect our FDA meeting to provide clarity regarding our development path moving forward, as we work to bring greater patient accessibility to therapeutic neurotoxins as quickly as possible,” said Rob Bancroft, AEON’s President and Chief Executive Officer. “With our workstreams advancing as planned, we are now in a position to refine our prior guidance and move confidently into this next phase of development.”

Mr. Bancroft continued, “By utilizing the 351(k) pathway, we aim to bring ABP-450 to the U.S. market under a single FDA approval that could cover all of BOTOX’s currently approved and future therapeutic indications. Further, subject to approval, we believe ABP-450 has the potential to offer a more cost-effective solution that would enhance patient access and improve economics for both payers and healthcare providers. The over $3.0 billion U.S. therapeutic market remains controlled by a single toxin, and we believe our entry into the market would be welcomed by stakeholders.”

Recent Clinical and Corporate Highlights

●Advancing ABP-450’s biosimilar development through the comparative analytical assessment (CAA) – AEON is pursuing a 351(k) biosimilar regulatory pathway for ABP-450, using BOTOX® as the reference product for potentially all therapeutic indications for which BOTOX is approved. The CAA forms the analytical framework required for biosimilar approval.  The Company believes it is aligned with the FDA on the initial key requirements of the CAA.

oAEON expects to complete primary structure and select functional analyses for ABP-450 in 3Q’25.

oThe Company anticipates a Type 2a meeting with the FDA in 4Q’25 to discuss results of these studies and align on the next steps in the development of ABP-450.

oSupportive preclinical toxicology, manufacturing, and other data, which are expected to support the CAA and the Type 2a meeting, have been previously generated by the Company and its licensing partner, Daewoong Pharmaceutical.

‌​

Exhibit 99.1

‌PRESS RELEASE

●Liquidity and Capital Resources – The Company reported cash and cash equivalents of $8.4 million as of June 30, 2025, which is expected to be sufficient to fund the Company’s operating plan through the fourth quarter of 2025 and its planned Type 2a meeting with the FDA targeted in the 4Q’25.

Expected Upcoming Milestones

●3Q’25 – Expected completion of primary structure analysis performed by the Company.

●3Q’25 – Expected completion of select functional analyses performed by Daewoong Pharmaceutical, the Company’s licensing partner.

●4Q’25 – Expected results and path forward from Biosimilar Biological Product Development (BPD) Type 2a FDA meeting.

About AEON Biopharma

AEON Biopharma is a biopharmaceutical company seeking accelerated and 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.  The Company’s lead asset is ABP-450 injection for debilitating medical conditions. 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 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 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

2025
Q1

Q1 2025 Earnings

8-K

May 14, 2025

0001837607-25-000049

EX-99

2 aeon-20250514xex99.htm

EX-99

Exhibit 99.1

‌PRESS RELEASE

AEON Biopharma Reports First Quarter 2025 Financial Results and Provides Corporate Update

– Continue to conduct analytical studies to prepare for a potential Biosimilar Biological Product Development (“BPD”) Type 2a meeting with the FDA in the second half of 2025 –

– Pursuing a 351(k) regulatory pathway for ABP-450, which offers potential access to the U.S. market under a single approval for all of BOTOX’s currently approved and future therapeutic indications–

– Appointed Rob Bancroft as the Company’s President and Chief Executive Officer; Mr. Bancroft also joined AEON’s Board of Directors –

IRVINE, Calif., May 14, 2025 – 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 its financial results for the first quarter ended March 31, 2025, and provided a business update.

“I am excited to report that our team is quickly advancing the biosimilar development program for ABP-450 under the 351(k) regulatory pathway utilizing BOTOX as the reference product. By utilizing this pathway, we plan to bring ABP-450 to the U.S. market under a single FDA approval that could cover all of BOTOX’s currently approved and future therapeutic indications,” commented Rob Bancroft, AEON’s President and Chief Executive Officer. “We are making progress in conducting the primary analytical studies. Once the initial analytical studies are completed, we will be able to conduct the primary comparative analytical assessment, which the FDA will evaluate at our Biosimilar BPD Type 2a meeting and determine the next steps for the program.”

“Once we successfully complete the FDA's rigorous approval process for ABP-450 as a biosimilar to Botox, we believe our therapeutic neurotoxin has the potential to offer a more economically viable solution that would enhance patient access and optimize cost-efficiency for payers and healthcare providers. These changes would likely be widely welcomed by these stakeholders, given the current dynamics of the therapeutic toxin market, which is estimated to be at least $3.3 billion worldwide and predominantly controlled by a single toxin,” concluded Mr. Bancroft.

Recent Clinical and Corporate Highlights

●Advancing its development plan for ABP-450 utilizing 351(k) regulatory pathway for biosimilars – The Company is pursuing a 351(k) biosimilar regulatory pathway for ABP-450 (prabotulinumtoxinA) injection, using BOTOX® (onabotulinumtoxinA) as a proposed reference product for all of the therapeutic indications for which BOTOX is approved. The Company believes it is aligned with the FDA on the initial key requirements to proceed with the 351(k) regulatory pathway.

oThe Company continues to conduct the primary analytical studies to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA).

oExtensive preclinical toxicology and other data have been previously generated by the Company’s licensing partner.

‌​

Exhibit 99.1

‌PRESS RELEASE

oThe Company plans to hold a Biosimilar Biological Product Development (BPD) Type 2a meeting with FDA in the second half of 2025 to discuss the outcome from these studies and determine the next steps in development.

●Management Changes – The Company appointed Rob Bancroft as President and Chief Executive Officer, effective April 29, 2025. He was also appointed to the Company’s Board of Directors. Mr. Bancroft has over 25 years of leadership experience in the life sciences industry, spanning biopharmaceuticals, medical devices, and healthcare technology. Prior to joining AEON, he served as General Manager of the Therapeutics business at Revance Therapeutics, where he led the launch of Daxxify® in cervical dystonia with a novel strategy that prioritized expert endorsement, payer coverage, and reimbursement infrastructure ahead of broader investment - driving strong early adoption and differentiated positioning in the $3.3 billion botulinum toxin therapeutics market.

oFormer CEO, Marc Forth, to remain as a member of the Company’s Board of Directors, through which he will continue to advise the Company’s management team and provide strategic guidance.

●Liquidity and Capital Resources – The Company reported cash and cash equivalents of $10.4 million as of March 31, 2025, which is expected to be sufficient to fund the Company’s operating plan through the fourth quarter of 2025 and its planned BPD Type 2a meeting with the FDA targeted in the second half of 2025.

●NYSE American Listing – AEON recently announced the NYSE American LLC (“NYSE American”) accepted the Company's previously submitted plan to regain compliance with continued listing standards relating to minimum market capitalization and stockholders' equity. The NYSE American granted the Company until August 3, 2026 to regain compliance with the continued li

2024
Q4

Q4 2024 Earnings

8-K

Mar 24, 2025

0001837607-25-000021

EX-99

2 aeon-20250324xex99.htm

EX-99

Exhibit 99.1

‌PRESS RELEASE

AEON Biopharma Reports Fourth Quarter 2024 and Full Year Financial Results and Provides Corporate Update

– Initiated analytical studies in Q4 2024 to prepare for a potential Biosimilar Biological Product Development (“BPD”) Type 2a meeting with the FDA in the second half of 2025 –

– Pursuing a 351(k) regulatory pathway for ABP-450, which offers potential access to the U.S. market under a single approval for all of BOTOX’s currently approved and future therapeutic indications –

IRVINE, Calif., March 24, 2025 – 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 fourth quarter and full year ended December 31, 2024, and provided a business update.

“We are excited to move ahead with our biosimilar development program for ABP-450 under the 351(k) regulatory pathway utilizing BOTOX as the reference product. As part of this program, we initiated the primary analytical studies in the fourth quarter of 2024. The data from these studies will be used to complete the primary comparative analytical assessment, which the FDA will use to evaluate and determine the next steps for the program,” commented Marc Forth, AEON’s President and Chief Executive Officer.

“We are excited by the progress our team is making along this regulatory pathway, which we believe 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. The financing we closed in January provided the critical funding that will allow us to work through our Biosimilar BPD Type 2a meeting with FDA. We look forward to announcing the results of that meeting and next steps in our development program, which we believe will offer a clear pathway for investors to see the opportunity AEON has to build significant shareholder value,” concluded Mr. Forth.

Recent Clinical and Corporate Highlights

●Pursuing the development plan for ABP-450 utilizing 351(k) regulatory pathway for biosimilars – The Company is pursuing a 351(k) biosimilar regulatory pathway for ABP-450 (prabotulinumtoxinA) injection, using BOTOX® (onabotulinumtoxinA) as a proposed reference product for all of the therapeutic indications for which BOTOX is approved. The Company believes it is aligned with the FDA on the initial key requirements to proceed with the 351(k) regulatory pathway.

oIn the fourth quarter of 2024, the Company commenced the primary analytical studies to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA).

oExtensive preclinical toxicology and other data has been previously generated by the Company’s licensing partner.

oThe Company plans to hold a Biosimilar Biological Product Development (BPD) Type 2a meeting with FDA in the second half of 2025 to discuss the outcome from these studies and determine the next steps in development.

●Strengthened the Company’s balance sheet – The Company closed an underwritten public offering on January 7, 2025, receiving gross proceeds of $20.0 million, before deducting underwriting fees and other estimated offering expenses. The Company expects the net proceeds from the offering,

‌​

Exhibit 99.1

‌PRESS RELEASE

together with its existing cash, to fund its operating plan and working capital through 2025. Investors in the offering received both Series A warrants and Series B warrants.  Approximately 89% of the Series B warrants, which can be exercised on a cashless three-shares-per-warrant basis, have been exercised as of March 21, 2025.

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.

2024
Q3

Q3 2024 Earnings

8-K

Nov 13, 2024

0001837607-24-000092

EX-99

2 aeon-20241113xex99.htm

EX-99

Exhibit 99.1

‌PRESS RELEASE

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

– 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., November 13, 2024 – 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.

oActively 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.

oPlan 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.

‌​

Exhibit 99.1

‌PRESS RELEASE

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 "con

2024
Q2

Q2 2024 Earnings

8-K

Aug 12, 2024

0001837607-24-000083

EX-99

2 aeon-20240812xex99.htm

EX-99

Exhibit 99.1

‌PRESS RELEASE

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

– Progressing plans to develop ABP-450 (prabotulinumtoxinA) injection as a biosimilar utilizing BOTOX® (onabotulinumtoxinA) as the reference product –

– Scheduled to hold a biosimilar initial advisory meeting with FDA in 3Q 2024 –

– 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., August 12, 2024 – 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 second quarter ended June 30, 2024, and provided a business update.

“We are excited by the significant opportunity to advance our development of ABP-450 under the planned biosimilar strategy. Once we host and receive the minutes from our FDA meeting, which is being held later this quarter, we expect to have a clear path forward to initiate a single pivotal study directly comparing ABP-450 to BOTOX in the treatment of CD,” commented Marc Forth, AEON’s President and Chief Executive Officer. “The biosimilar approach may offer a potential regulatory pathway for us to bring ABP-450 differentiated economic model to the U.S. market for all of BOTOX’s currently approved and future therapeutic indications under a single approval.”

Recent Clinical and Corporate Highlights

●Development plan for ABP-450 utilizing 351(k) regulatory pathway for biosimilars - announced plans to initiate, subject to securing funding, a single pivotal clinical development study in cervical dystonia (“CD”) for the Company’s lead candidate, ABP-450 (prabotulinumtoxinA), utilizing the 351(k) regulatory pathway for biosimilars with the market leader, BOTOX® (onabotulinumtoxinA), as the reference product.

oSubmitted a briefing package to the FDA that provided extensive data from analytical, pharmacological, and animal studies that could contribute to a Biologics License Application (“BLA”) filing.

oScheduled to hold a biosimilar initial advisory meeting with FDA in 3Q 2024.

oExpect to initiate a planned Phase 3 CD study in approximately 400 patients to compare ABP-450 to BOTOX with a goal to demonstrate non-inferiority to BOTOX.

oA successful Phase 3 comparative study in CD could potentially provide the necessary clinical data to support a determination that ABP-450 is highly similar to Botox for all currently approved and future therapeutic indications.

‌​

Exhibit 99.1

‌PRESS RELEASE

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 a potential Phase 3 comparative study in CD, the translation of clinical trial results into support for a BLA filing, 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 statement

2024
Q1

Q1 2024 Earnings

8-K

May 14, 2024

0001837607-24-000062

EX-99

2 aeon-20240514xex99.htm

EX-99

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 developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, announced financial results for the first quarter ended March 31, 2024, and provided a business update.

“We continue to believe in our development pipeline for ABP-450, which targets a number of indications that have well-founded scientific rationale to pursue in early- and late-stage clinical trials. Several of the late-stage clinical programs are candidates to advance into the next phase of clinical development,” commented Marc Forth, AEON’s President and Chief Executive Officer. “We look forward to keeping you apprised of our progress and updated timelines across the development strategy for our pipeline.”

Recent Clinical and Corporate Highlights

●Phase 2 study of ABP-450 in episodic and chronic migraine:

oChronic Migraine - Interim Analysis: The topline interim analysis did not achieve its primary or secondary endpoints. The Company is continuing its analysis of interim data from the study. The Phase 2 randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of ABP-450 for the prevention of chronic migraine in adults who suffer from 15 or more headache days per month and at least 8 migraine days per month. The study has enrolled a total of 492 patients across approximately 50 sites in the United States, Canada and Australia.

oEpisodic Migraine End-of-Phase 2 Meeting with U.S. FDA: In the first quarter of 2024, the Company held a productive end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration to present the Company’s Phase 2 episodic migraine study results, which demonstrated a favorable safety profile for patients with episodic migraine and achieved key prespecified secondary endpoints, although it did not statistically separate from placebo with respect to the primary endpoint. The meeting resulted in a preliminary alignment on the design and endpoints for the proposed pivotal Phase 3 trial.

●Completed $15 Million Private Placement Agreements

oIn April 2024, the Company received the second and final installment from its definitive agreements relating to a private placement of $15 million aggregate principal amount of senior secured convertible notes (the “Notes”) with its strategic partner, Daewoong Pharmaceutical Co., LTD (“Daewoong”). Proceeds from the private placement are being used for general working capital purposes.

oIn connection with the receipt of the final installment of the Notes, Seongsoo (Shawn) Park was appointed to the Company’s Board of Directors as Daewoong’s representative.

‌​

Exhibit 99.1

‌PRESS RELEASE

​

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. 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 the closing of each installment of the Private Placement, AEON’s expected capital resources and liquidity needs and the anticipated timing of AEON’s clinical results 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

2023
Q4

Q4 2023 Earnings

8-K

Mar 29, 2024

0001837607-24-000013

EX-99.1

2 aeon-20240329xex99d1.htm

EX-99.1

Exhibit 99.1

‌PRESS RELEASE

AEON Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results

– Recent end-of-Phase 2 meeting with FDA resulted in alignment on the design and endpoints for the proposed pivotal Phase 3 trials for the preventive treatment of both episodic and chronic migraine –

– Topline data from planned interim analysis of ongoing Phase 2 study in chronic migraine are expected to be announced in Q2 2024; On track to announce top-line data from the full study in Q3 2024 –

– Announced private placement agreements for $15 million in aggregate principal amount of senior secured convertible notes –

IRVINE, Calif., March 29, 2024 – AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON, AEON WS), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

“We are pleased to have achieved a number of key milestones for our ABP-450 episodic and chronic migraine programs over the past several months, including a positive end-of-Phase 2 meeting with the FDA. We are now well-positioned to plan for the initiation of our pivotal Phase 3 program,” commented Marc Forth, AEON’s President and Chief Executive Officer. “Recently, we announced plans to conduct an interim analysis of our ongoing Phase 2 study of ABP-450 as a preventive treatment for chronic migraine, which completed enrollment in December 2023. We expect to announce the topline data from the interim analysis in the second quarter of 2024 and we anticipate the interim analysis to be statistically powered to demonstrate efficacy.”

Recent Clinical and Corporate Highlights

●Episodic Migraine End-of-Phase 2 Meeting with U.S. FDA:

oAnnounced a productive end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) following the Phase 2 data in episodic migraine the Company released in October 2023. The meeting resulted in a preliminary alignment on the design and endpoints for the proposed pivotal Phase 3 trials for the preventive treatment of both episodic and chronic migraine.

●Chronic Migraine Phase 2 Study of ABP-450:

oAnnounced completion of enrollment with the last patient first visit in the Phase 2 study of ABP-450 for the preventive treatment of chronic migraine. The Phase 2 randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of ABP-450 for the prevention of chronic migraine in adults who suffer from 15 or more headache days per month and at least 8 migraine days per month. The study has enrolled a total of 492 patients across approximately 50 sites in the United States, Canada and Australia.

oThe Company introduced an updated development plan for ABP-450 that includes an interim analysis of the ongoing Phase 2 study of ABP-450 for the preventive treatment of chronic migraine in the second quarter of 2024. With data from over 300 participants that have completed the two 12-week treatment cycles, the Company anticipates the interim analysis to be statistically powered to show efficacy.

‌​

Exhibit 99.1

‌PRESS RELEASE

●$15 Million Private Placement Agreements

oIn March 2023, the Company entered definitive agreements relating to a private placement of $15 million aggregate principal amount of senior secured convertible notes with its strategic partner, Daewoong Pharmaceutical Co., LTD. The Company has closed the first installment of $5 million and anticipates closing the second installment of $10 million in April 2024, subject to the closing conditions set forth in the definitive agreements. Proceeds from the private placement will be used to support the late-stage clinical development of ABP-450 and for general working capital purposes. The Company believes its cash, cash equivalents and investments, including the $15 million of private placement proceeds, will be sufficient to fund its planned clinical studies, as well as support corporate operations through June 2024.

Key Upcoming Milestones

●Ongoing Chronic Migraine Phase 2 Study

oExpect to announce topline data from the planned interim analysis of the ongoing Phase 2 program for ABP-450 in chronic migraine in the second quarter of 2024.

oOn track to announce topline results from the Phase 2 study of ABP-450 as a preventive treatment for chronic migraine in the third quarter of 2024.

●Episodic Migraine Program Next Steps – The Company is continuing to plan for the initiation of its proposed pivotal Phase 3 program for ABP-450.

About Migraine

Migraine is a complex neurological disease characterized by recurrent episodes of headaches that affects approximately 40 million people in the United States and approximately a billion people worldwide, making migraine the third most prevalent illness in the world. Patients that live with migrain

2023
Q3

Q3 2023 Earnings

8-K

Nov 13, 2023

0001558370-23-018705

EX-99.1

2 aeon-20231113xex99d1.htm

EX-99.1

Exhibit 99.1

‌PRESS RELEASE

AEON Biopharma Reports Third Quarter 2023 Financial Results

– Announced topline results from Phase 2 Trial of ABP-450 (prabotulinumtoxinA) for the preventive treatment of episodic migraine that support advancing the program into a pivotal Phase 3 study –

– Ongoing Phase 2 trial for the preventive treatment of chronic migraine has enrolled over 430 subjects; anticipate completing enrollment in Q4 2023 and announcing topline data in 2H 2024 –

– Successfully completed business combination transaction and associated equity financings

IRVINE, Calif., November 13, 2023 – AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON, AEON WS), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, announced financial results for the third quarter ended September 30, 2023 and provided a business update.

“Over the past several months, we have successfully executed our strategy with the announcement of clinical data that support the advancement of our ABP-450 programs and position the Company to finance our ongoing and planned clinical trials,” commented Marc Forth, AEON’s President and Chief Executive Officer. “We remain on track to complete enrollment in our ongoing Phase 2 study of ABP-450 as a preventive treatment for chronic migraine in the fourth quarter of 2023 and announce the topline data in the second half of 2024. These data are expected to further support advancing our chronic and episodic migraine programs into pivotal clinical trials. In addition, we continue to evaluate multiple parameters for the planned Phase 3 trial of ABP-450 for the preventive treatment of episodic migraine. We look forward to providing updates on these two exciting programs.”

Recent Clinical and Corporate Highlights

●Topline data from Episodic Migraine Phase 2 Study:

oAnnounced topline results from the Phase 2 clinical trial of ABP-450 (prabotulinumtoxinA) for the preventive treatment of episodic migraine, which showed ABP-450 had a treatment effect with mean reductions in MMD of 4.8 days at the 150U dose and 5.0 days at the 195U dose, compared to only 4.2 days in placebo at weeks 21-24, but did not meet statistical significance. ABP-450 did achieve statistical significance and clinically meaningful separation from placebo across most of the study’s key prespecified secondary endpoints. Also, ABP-450 demonstrated a favorable safety profile for patients with episodic migraine.

oThe Company believes the totality of the Phase 2 data provides evidence of a dose response favoring the higher 195U dose and lends support to progress ABP-450 into Phase 3.

●Presentation of Full Data from Cervical Dystonia (CD) Phase 2 Study - Presented positive full results from the Phase 2 clinical study of ABP-450 for the treatment of CD at the International Parkinson and Movement Disorders Society Congress® (IP-MDS). These data, previously released by the Company in September 2022, include showing relatively sustained benefits across all doses of ABP-450 in Toronto Western Spasmodic Torticollis rating scale (TWSTRS) total score and safety data that further support the Company’s strategy to pursue ABP-450 as an approved therapy for CD.

●New U.S. Patent - Received a notice of allowance from the United States Patent and Trademark Office (“USPTO”) for U.S. Patent Application No. 17/006,685, titled “Neurotoxin Compositions for

‌​

Exhibit 99.1

‌PRESS RELEASE

Use in Treating Headache” (the “Application”), which will provide protection in the U.S. for the claimed methods of use of ABP-450 (prabotulinumtoxinA) injection into 2041.

●Common Stock (AEON) and Warrants (AEON WS) Listed on NYSE American - Completed the Company’s listing of its common stock and warrants on NYSE American following the closing of the business combination with Priveterra Acquisition Corp., a special purpose acquisition company (the “Merger”).

●Post-Merger Funding - Closed the Company’s funding arrangements, which included approximately $50 million of committed financing from existing and new AEON investors, as well as the cash remaining in Priveterra’s trust account after redemptions.

●Cash, Cash Equivalents and Investments – The Company reported cash, cash equivalents and investments were approximately $16.2 million as of September 30, 2023. The Company believes its cash, cash equivalents and investments will be sufficient to fund its planned clinical studies, as well as support corporate operations into mid-December 2023.

Key Upcoming Milestones

●Episodic Migraine Program Next Steps - The Company plans to request an end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the protocol and study design for Phase 3, and the meeting is expected to take place in the first half of 2024. The Company is evaluating multiple parameters for the Phase 3 trial that are expec

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