Form 8-K

8-K — AEON Biopharma, Inc.

Accession: 0001837607-26-000071

Filed: 2026-10-23

Period: 2026-10-23

CIK: 0001837607

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — aeon-20261023x8k.htm (Primary)

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8-K

8-K (Primary)

Filename: aeon-20261023x8k.htm · Sequence: 1

AEON Biopharma, Inc._October 23, 2026

0001837607false00018376072026-10-232026-10-23

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 23, 2026

AEON Biopharma, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-40021

85-3940478

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification Number)

130 Vantis Drive

Suite 170

Aliso Viejo, CA 92656

(Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (949) 354-6499

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol

Name of each exchange on which registered

Class A Common Stock, $0.0001 par value per share

AEON

NYSE American

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01. Regulation FD Disclosure.

On October 23, 2026, AEON Biopharma, Inc. (the “Company” or “AEON”) made available in the investor relations section of its website a presentation (the “Corporate Presentation”), a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

The information from the Corporate Presentation may also be used by the management of the Company in future meetings regarding the Company. For important information about forward-looking statements in the Corporate Presentation, see the slide titled “Forward-Looking Statements” in Exhibit 99.1 attached hereto.

The information furnished in this Item 7.01 of this Current Report (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing, unless expressly incorporated by specific reference in such a filing.

Item 9.01. Financial Statement and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Corporate Presentation, dated October 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

AEON Biopharma, Inc.

Date: October 23, 2026

By:

/s/ Robert Bancroft

Robert Bancroft

Chief Executive Officer

EX-99

Filename: aeon-ex99.htm · Sequence: 2

Exhibit 99

Disrupting a $3.5B neurotoxin

market dominated by a single brand

for >30 years

CORPORATE PRESENTATION / OCTOBER 2026

NYSEAMERICAN: AEON

This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange

Act of 1934, as amended, and AEON Biopharma, Inc. (“AEON”) intends such statements to be covered by the safe harbor provided by those provisions. All statements in this presentation other than statements of historical fact are forward-looking statements, including statements regarding AEON’s strategy, objectives, plans, timelines and milestones; market opportunities and growth; future capital requirements and financing; the development, analytical, pharmacodynamic

and clinical evaluation, regulatory pathway and potential approval of ABP-450, including the expected timing of the IND submission for, and initiation of, the planned comparative pharmacodynamic study using compound muscle action

potential ("CMAP") measurement; the potential for AEON's analytical, pharmacodynamic and existing comparative clinical evidence, including previously completed comparative studies, if appropriately bridged, to support a determination

of biosimilarity or reduce or eliminate the need for a standalone comparative efficacy study; potential indications, labeling, extrapolation, biosimilarity and clinical substitutability; the competitive position of ABP-450; potential pricing,

reimbursement, average sales price treatment, provider economics, payer coverage and utilization management, market acceptance and commercialization; and the potential achievement of milestones underlying, exercise of, and proceeds

from outstanding warrants. Forward-looking statements may be identified by words such as “believe,” “estimate,” “expect,” “project,” “forecast,” “may,” “will,” “should,” “achieve,” “seek,” “plan,” “schedule,” “anticipate,” “intend,”

“target,” “potential,” “continue” and similar expressions, or the negatives of those terms.

Forward-looking statements are based on AEON’s current expectations, assumptions, estimates and projections and are inherently subject to known and unknown risks, uncertainties and other factors, many of which are beyond AEON’s

control, that could cause actual results, performance or achievements to differ materially from those expressed or implied. Important factors include, but are not limited to: (i) the timing and outcome of interactions with regulatory

authorities, including Biosimilar Biological Product Development meetings with the U.S. Food and Drug Administration (“FDA”), the FDA’s review of AEON’s submissions and data, including AEON’s investigational new drug application for the

CMAP study, whether the FDA agrees with AEON’s proposed analytical, clinical pharmacology, comparative clinical study, extrapolation, labeling and substitution-related strategies, the nature, scope and timing of any additional analytical,

clinical pharmacology, comparative clinical, safety, immunogenicity or indication-specific studies or other data that FDA may require, and whether FDA permits extrapolation to some or all of the therapeutic indications for which AEON may

seek approval; (ii) the initiation, cost, timing, progress and results of analytical studies, preclinical studies and clinical trials, including the CMAP pharmacodynamic study; and AEON’s ability to submit, obtain and maintain approval of a

biologics license application under Section 351(k) of the Public Health Service Act for therapeutic uses of ABP-450; (iii) whether ABP-450 can achieve the anticipated product profile, including potential full-label approval, comparable

clinical outcomes, operational similarity and commercial adoption; (iv) the accuracy of AEON’s assumptions concerning market size and growth, competitive positioning, pricing, reimbursement, average sales price treatment, provider

economics, payer behavior, market share and sales; (v) AEON’s dependence on Daewoong Pharmaceutical Co., Ltd. and other third parties for manufacturing, supply, analytical testing, clinical development and regulatory support, their

performance under applicable agreements, and their ability to obtain or maintain any governmental or regulatory approvals or authorizations necessary to support manufacturing, testing, technology transfer, clinical development or

regulatory submissions; (vi) AEON’s future capital requirements, ability to raise additional capital and ability to continue as a going concern; (vii) AEON’s ability to achieve the regulatory and clinical milestones applicable to its outstanding

milestone warrants, whether such warrants will be exercised for cash, the amount and timing of any resulting proceeds, and the potential dilution from outstanding securities; (viii) AEON’s ability to maintain compliance with the continued

listing standards of the NYSE American and the liquidity and trading of AEON’s securities; and (ix) risks relating to intellectual property, competition, government regulation, litigation, internal controls, key personnel, supply-chain

disruptions and macroeconomic or geopolitical developments.

Additional information concerning these and other risks and uncertainties is contained in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in AEON’s Annual Report on Form 10-K for the year

ended December 31, 2025, AEON’s Quarterly Report on Form 10-Q for the quarters ended March 31, 2026 and June 30, 2026, and AEON’s subsequent filings with the Securities and Exchange Commission. This list is not exhaustive. Forward-looking statements speak only as of the date of this presentation. You should not place undue reliance on them, and AEON undertakes no obligation to update or revise any forward-looking statement, except as required by applicable law.

Any forward-looking statements made orally in connection with this presentation are also qualified by these cautionary statements.

ABP-450 has not been approved by the FDA for any therapeutic indication, and its safety and effectiveness for therapeutic uses have not been established. References in this presentation to potential biosimilarity, clinical substitutability,

full-label approval, indications, product profile, commercialization or market adoption reflect AEON’s current objectives and expectations only and are not guarantees of future results.

Certain information in this presentation is derived from third-party studies, publications, market research, surveys, interviews and other sources, as well as AEON’s internal estimates and research. Unless otherwise indicated, AEON has not

independently verified third-party information. Such information and estimates are inherently subject to assumptions and limitations and may be inaccurate or incomplete. Quotations and responses attributed to physicians, payers and

other market participants reflect the views of the individual respondents and should not be viewed as representative of all physicians, payers or other market participants. AEON’s internal estimates and research have not been verified by an

independent source.

This presentation is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy any securities. AEON Biopharma and the AEON Biopharma logo are trademarks of AEON Biopharma, Inc. All other

trademarks are the property of their respective owners.

Forward-Looking Statements

Aiming to Unlock a $3.5B Market with the First BOTOX® Substitute

Developing ABP-450 as the first clinically substitutable therapeutic alternative to BOTOX®

→ Licensed exclusive rights to commercialize all BOTOX® therapeutic indications in the U.S., Canada, EU, UK and select international territories

→ Advancing full-label Extrapolation Strategy under the FDA’s 351(k) biosimilar pathway for ABP-450 covering all BOTOX® therapeutic indications

BOTOX® has remained the dominant player despite branded competition and expiration of key patents

→ Lack of full label for branded BOTOX® competitors serves as a significant hurdle for market adoption

→ A true biosimilar that could be substituted for BOTOX® has remained elusive given manufacturing complexity associated with toxins

ABP-450 is a validated botulinum toxin supported by established analytical and clinical data and manufactured in an FDA-inspected cGMP facility

→ Manufactured by Daewoong Pharmaceuticals in compliance with cGMP

o Identical product profile as Jeuveau®, approved and marketed for cosmetic indications by Evolus, Inc.

→ AEON may be able to leverage existing comparative clinical evidence rather than conducting a new large comparative efficacy study

o FDA indicated studies can be submitted for consideration subject to appropriate scientific bridging

→ Composition and mechanism of action (MoA) supports similarity to BOTOX®

o Same 900kDa size, 100% amino acid sequence identity, genetic & formulation parity, and highly similar potency supports clinical dose predictability

Led by newly appointed seasoned management team with demonstrated experience in toxins and capital formation

→ Rob Bancroft (CEO) served as the former BOTOX® leader responsible for competitive strategy and long-range asset maximization

→ John Bencich (CFO) led Achieve Life Sciences (CEO & CFO) and Oncogenex Pharmaceuticals (CFO); brings growth and capital strategy experience

Recent highlights and upcoming catalyst

→ FDA Type 2b feedback provided greater clarity on the CMAP pharmacodynamic study and opened the opportunity to incorporate prior ABP-450 vs.

BOTOX® studies into the biosimilar evidence package

→ IND submission planned in Q4’26 for CMAP pharmacodynamic study; study initiation expected in Q1’27

Advancing the First Clinically Substitutable BOTOX® Alternative

Despite >30 years of growth, prior competitors failed to overcome the barriers to switching at scale

Full-Label Parity

Captures all 12 indications at approval

→ Competes for the entire therapeutic

market from day one

→ Avoids the restricted labels that have

constrained prior competitors

Clinical Equivalence

No change to physician workflow

→ Same dosing, preparation, and

administration as BOTOX®

→ Prior competitors required changes →

limited adoption

Switching is Rewarded

Aligned economics drive adoption

→ Improves physician margin per treatment

→ Payers incentivized to reinforce switching

behavior

W H A T D R I V E S A D O P T I O N A T S C A L E

Adoption at scale + structurally limited follow-on competition → durable share

Clarivate. Market Insights US Therapeutic Botulinum Toxin Market. 2025. 5

The U.S. market accounts for ~86% of global therapeutic neurotoxin sales

2026 2027 2028 2029 2030 2031

$3.5B $3.8B

$4.1B

$4.4B

$4.8B

$5.1B

Therapeutic Botulinum Market Value in the U.S.

7.7%

CAGR

Includes BOTOX®, Xeomin®, Daxxify®, Dysport® & Myobloc®

〉 Strong Market Growth

• Total therapeutic toxin market value in the U.S.

has grown by >75% since 2020

〉 Key Tailwinds:

• Durable demand across large, chronic

indications (esp. neurological)

• Expanding diagnosis and treatment rates

〉 Key Headwinds:

• Payer pressure and tightening utilization

controls

• Provider margin compression under buy-and-bill dynamics

A Large & Growing Therapeutic Neurotoxin Market

BOTOX® Maintains >90% Share Despite Competition

Restricted labels have limited competitor adoption and scale

Clarivate. Market Insights US Therapeutic Botulinum Toxin Market. 2025. 6

Other brands collectively captured ~8%

of market value in 2025

No competitor has meaningfully challenged

BOTOX’s® full therapeutic label

BOTOX® accounted for

~92% of

therapeutic neurotoxin

market value in 2025

“BOTOX is the only one that truly covers everything.”

– Neurologist, 200+ BOTOX® patients/yr

BOTOX® Dominance Persists Despite Physician Economic Friction

Responses received through qualitative interviews (N=6) conducted by Kx Advisors between November-December 2025.

The lack of viable alternatives reinforces provider dependence, which can result in financial losses

“Sometimes, if we’re lucky, we

can make $5 per vial, but often

we don’t. My coffee costs $6, how

could I be happy with $5?”

– Neurologist, 200+ BOTOX® patients/yr

“Every toxin has different units

and dilution. We try not to

maintain multiple workflows. It’s

a huge operational headache and

creates room for error.”

– Neurologist, 300+ BOTOX® patients/yr

“BOTOX is the only one that truly

covers everything. Dysport,

XEOMIN, DAXXIFY they’re all

missing some of the major

indications, so we use them less.”

– Neurologist, 200+ BOTOX® patients/yr

Financial Burden

〉 High-volume injectors can

experience significant financial

loss while using BOTOX®

Operational Complexity

〉 Risk of error and workflow

complexity increase when

managing multiple products

Clinical Limitation

〉 Non-BOTOX® neurotoxin labels

are significantly narrower

− BOTOX® remains the only

approved option for key

conditions (e.g., migraine)

Heavy spend

concentrated in

BOTOX®, with rising

utilization and no

ability to slow volume

The Payers

Dilemma

Unsatisfied Payers with Minimal Levers to Curb Rising Costs

Payers trapped in a cycle with no viable

levers to curb rising toxin costs

“For us, BOTOX represents well over 65% of the total neurotoxin

dollars and they’re all clinically appropriate, so there really isn’t

anything we can do to slow the use.”

– Medical Director, National Plan with 10M+ lives covered

“Non-BOTOX products really haven’t shown any superiority

over BOTOX. Clinically they don’t differentiate, and total-dollar-wise they’re sometimes even higher than BOTOX, so there isn’t

a reason for us to try to push providers toward them.”

– Medical Director, National Plan with 10M+ lives covered

Minimal price leverage to reduce overall toxin cost due to lack of viable BOTOX® alternatives

Lack of clinically

substitutable alternatives

eliminates traditional cost

levers

With no pricing

leverage, payers

increasingly rely

on PA enforcement

as the only

practical control

Responses received through qualitative interviews (N=6) conducted by Kx Advisors between November-December 2025.

AEON is taking a different approach

We are not trying to be different.

We are trying to be the same.

Equivalence to BOTOX® across every relevant dimension –

same label, same dosing, same dilution, same outcomes, same coverage, same workflow.

Differentiation forces competitors to fight

three decades of cumulative BOTOX® investment, experience, and habit.

Biosimilarity can allow AEON to leverage it.

Clinical Substitutability Designed to Unlock Switching at Scale

Share moves when switching happens - and switching becomes rational under specific conditions

〉 Lower cost for payers, improved provider economics

Economic Alignment

〉 No change to dosing, preparation, or workflow

Operational Simplicity

〉 Equivalent outcomes across all indications

Clinical Substitution Switching Becomes Rational When...

〉 FDA confirms clinical comparability

〉 workflow remains unchanged

〉 economics improve for both payers and

providers

“If a product has the full BOTOX®

indications, and it’s identical and cheaper,

I’d consider switching entirely.”

-Neurologist, >300 BOTOX® patients/year

Responses received through qualitative interviews (N=6) conducted by Kx Advisors on Aeon’s behalf between November-December 2025.

AbbVie Inc.

1989

Merz Pharma

2010

Ipsen Group

2009

Crown Laboratories

2023

Therapeutic

Label

(FDA Approved

Indications)

1. Chronic migraine

2. Overactive bladder

3. Detrusor overactivity

4. Pediatric detrusor overactivity

5. Adult upper limb spasticity

6. Adult lower limb spasticity

7. Pediatric upper limb spasticity

8. Pediatric lower limb spasticity

9. Cervical dystonia

10. Axillary hyperhidrosis

11. Blepharospasm

12. Strabismus

Full Label Parity (targeted**)

1. Chronic migraine

2. Overactive bladder

3. Detrusor overactivity

4. Pediatric detrusor overactivity

5. Adult upper limb spasticity

6. Adult lower limb spasticity

7. Pediatric upper limb spasticity

8. Pediatric lower limb spasticity

9. Cervical dystonia

10. Axillary hyperhidrosis

11. Blepharospasm

12. Strabismus

1. Blepharospasm

2. Cervical dystonia

3. Adult upper limb spasticity

4. Pediatric upper limb spasticity

5. Chronic sialorrhea

1. Cervical dystonia

2. Adult upper limb spasticity

3. Adult lower lower limb spasticity

4. Pediatric upper limb spasticity

5. Pediatric lower limb spasticity

1. Cervical dystonia

Full-Label Access Is the Gatekeeper to the Market

Current competitors are restricted to a subset of indications - limiting adoption and scale

Full-label access is required to compete at scale - and no competitor has it today

*Clarivate. Market Insights US Therapeutic Botulinum Toxin Market. 2025.

** This is not a projection or a guarantee of future indications, but rather is indicative of the indications that AEON is targeting, and the actual approved indications, if any, may vary significantly from what is included here.

91.9% share* 4.4% share* 3.1% share* <1% share*

Minimizing Switching Barriers

ABP-450 is designed to offer operational simplicity with the same vial size, dilution, and dosing

Switching Friction Index

Friction reduces physician confidence and drives workflow disruption

ABP-450 Xeomin® Daxxify® Dysport®

Label Dose Reconstitution

LEGEND – OPERATIONAL DIFFERENCES

Patient Ed

Biosimilarity lowers switching friction – by design

〉 Biosimilar designation signals equivalence across

clinical and operational domains

– Dose, dilution, safety, immunogenicity, outcomes, patient ed

“If it’s basically the same as BOTOX in how we use it, same

workflow, same mixing, same injection, then switching wouldn’t

be an issue, it’d be a no-brainer”

– Neurologist, 300+ BOTOX® patients/yr

Responses received through qualitative interviews (N=6) conducted by Kx Advisors between November-December 2025.

Buy-and-Bill Economics Structurally Incentivize Biosimilar Adoption

Reimbursement & ASP dynamics expected to favor biosimilar products and reward switching

Biosimilars structurally improve physician economics for buy-and-bill products

through improved add-on payment and lower acquisition costs

Therapeutic-Only ASP Can Help Restore Physician Economics

• Unlike BOTOX, ABP-450’s ASP is expected to reflect therapeutic-market

pricing only, thus avoiding exposure to aesthetic-market discounting

CMS Framework Designed To Enhance Biosimilar Add-On Payment

• Add-on payment calculated on BOTOX ASP, not ABP-450 ASP

Lower Acquisition Cost

• ABP-450 expected to price below BOTOX

BOTOX® Biosimilar

Acquisition cost Higher Lower

ASP Calculation Blended

(therapeutic +

aesthetic)

Therapeutics-only

Reimbursement ASP + 6% ASP + 6%

(+6% based on

Botox ASP1

)

Provider

Economics

Less

Favorable

Potentially More

Favorable

1- The Affordable Care Act of 2009, 42 C.F.R. §414.904(j), as modified by the Inflation Reduction Act of 2022, Section 11403

A Lower-Cost Toxin That Payers Can Actually Act On

Responses received through qualitative interviews (N=6) conducted by Kx Advisors between November-December 2025.

ABP-450 expected to unlock new payer leverage and meaningful cost savings

“If neurologists want to use BOTOX, we can’t steer

them away. But if FDA deems the biosimilar as

identical to BOTOX, we have something comparable

that we can point them to”

– Medical Director, National Plan with 10M+ lives covered

“If a biosimilar is cheaper and does the same thing as

BOTOX and providers can use it in the exact same way,

we’d absolutely move volume towards it.”

– Medical Director, National Plan with 10M+ lives covered

“If the ASP is at least 20% lower, I can move a lot of

share to the biosimilar.”

– Medical Director, Regional Plan with 3M+ lives covered

ABP-450 gives plans the

flexibility to apply brand-specific

policies, potentially introduce UM or

step edits in favor of ABP-450

unavailable to them today

A lower-cost,

comparable toxin

could enable payers

to apply additional

pricing levers

ABP-450 delivers immediate cost

savings, addressing a category that

has grown unchecked for years

Unlock

The Payers

Dilemma

Highly Concentrated Market Enables Efficient Commercialization

~3,000 neurologists treat the vast majority of neurologic BOTOX® patients in the U.S.

PurpleLab 2024 Claims Data as of Wednesday, 12/10/25, 11:00 am EST, DRG, Piper Sandler

Analysis includes BOTOX® for Migraine, Spasticity, Blepharospasm, Strabismus, Cervical dystonia (N = 602,785 patients, N= 14,128 neurologists) 15

Implications for Commercial Strategy

〉 Neurology represents >70% of the total

therapeutic toxin market

〉 ~3,000 neurologists treat ~90% of neurologic

BOTOX® patients

〉 ~75 payers cover the majority of treated

patients

→ A small number of physicians and payers

control the majority of the U.S. toxin market

Why ABP-450 Stands To Win: Value Can Drive Systemwide Adoption

Payers, physicians, patients each can gain from ABP-450’s advantage

Payers:

Restores cost control and formulary leverages

through full label biosimilar competition

Physicians:

Improves physician economics with minimal change

to clinical workflow

Patients:

Lowers out-of-pocket costs while maintaining

equivalent treatment effectiveness

Proven Science

Comparable Outcomes

Full Label Parity

Better Economics

Target Profile:

Core Product Characteristics Limit Credible Biosimilar Followers

Unlike other biosimilars, this molecule presents unique manufacturing and analytical challenges

A Molecular Paradox

Large. Complex. Vanishingly small.

o ~900 kDa multi-protein complex

o ~1:100,000 vs. excipients (trace API levels in DP)

o Same starting material → highly variable results

These constraints limit credible entrants –

AEON has already navigated many critical steps

Manufacturing at Scale

→ Very Few Can Do It

o Biosecure handling and

specialized infrastructure

required

o U.S. cGMP production requires

tightly controlled, consistently

reproducible processes

→ Few platforms can reliably

manufacture at scale in the U.S.

Analytical Validation

→ Hard to Prove

o API at trace levels must be

isolated from the finished

product

o Requires highly sensitive and

advanced analytical

techniques

→ Difficult to demonstrate

biosimilarity with precision

ABP-450 Biosimilar

Development Program

A Uniquely Advantaged Starting Point for Therapeutic Biosimilarity

〉 Exclusive aesthetic rights

〉 FDA approval in moderate to severe glabellar

(frown) lines; $272.3m sales in 20251

Jeuveau® ABP-450

Aesthetics Therapeutics

〉 Exclusive therapeutic rights2

〉 License agreement in place with Medytox

permitting supply from Daewoong

The Daewoong 900 kDa toxin powering Jeuveau® also anchors ABP-450’s therapeutic biosimilar strategy

This shared toxin heritage means AEON is building its biosimilar strategy on a known

molecule, known manufacturing, and known safety - not on a blank page

1Evolus, Inc. Form-10K for the year ended December 31, 2025, filed with the SEC on March 3, 2026

2US, EU, UK, CAN and other select international markets

Globally Validated Product and Platform

Approved worldwide, manufactured at scale – forming the backbone of ABP-450’s U.S. biosimilar entry

Approved by regulators in

North America, EU, APAC, LATAM, MENA

20 1Under the brand name Jeuveau® in the U.S., Nuceiva® in Europe, Canada, Australia and Nabota® in other international markets

regulatory approvals

70+ WW

FDA & EMA approved

manufacturing facility

FDA’s Biosimilar Pathway Uses a Totality-of-Evidence Approach

Evidence is generated to progressively address remaining uncertainty

Analytical Similarity

Foundation of the evidence package

〉Structure

〉Function

〉Purity

〉Potency

〉Other critical quality attributes

Clinical Pharmacology

Sensitive assessments in humans

〉PK and/or PD, as appropriate

〉Designed to detect potential

differences between products

Totality of

Evidence

351(k) BLA

FDA evaluates the totality

of evidence supporting

biosimilarity

EXTRAPOLATION

Biosimilarity may support

approval across reference-product indications through

scientific justification for

extrapolation

Safety & Immunogenicity

Assess safety and immunogenicity using relevant

existing and newly generated evidence, as appropriate

IF NEEDED

Comparative Efficacy Study

If residual uncertainty remains that can be

meaningfully addressed through a

comparative efficacy study

The evidence required for biosimilarity is determined by what uncertainty remains — not

by a fixed sequence of studies

FDA Feedback Informs AEON’s Integrated Biosimilar Development Strategy

Analytical, clinical pharmacology and supportive clinical evidence contribute to the totality-of-evidence assessment

FDA BPD Type 2a | Q1 2026

Analytical Similarity

Evidence Generation

〉 Structural characterization

〉 Functional and potency comparisons

〉 Stability and forced degradation assessments

FDA Feedback

〉 Reviewed initial similarity data and CQA

framework

〉 Provided feedback on analytical similarity

strategy

DEVELOPMENT OBJECTIVE

Establish a comprehensive analytical foundation for

biosimilarity

FDA BPD Type 2b | Q3 2026

Clinical Pharmacology

Evidence Generation

〉 Focus: comparative pharmacodynamics

〉 Cornerstone: CMAP1 study designed to

maximize sensitivity to differences in activity

at the neuromuscular junction

FDA Feedback

〉 Agreed in principle with the proposed CMAP

dose-finding approach

〉 Emphasized sensitivity in selecting clinical

endpoints

DEVELOPMENT OBJECTIVE

Generate sensitive comparative evidence of

biological activity in humans

FDA BPD Type 2b | Q3 2026

Supportive Clinical Evidence

Evidence Generation

〉 Previously completed ABP-450/BOTOX®

comparative studies

〉 Scientific bridging to establish relevance of

historical study data

FDA Feedback

〉 Historical comparative studies may be

submitted as supportive evidence with

appropriate scientific bridging

DEVELOPMENT OBJECTIVE

Leverage existing clinical evidence to support the

overall assessment of biosimilarity

TOTALITY-OF-EVIDENCE

ASSESSMENT

Integrate evidence with goal of progressively resolving uncertainty and strengthening the scientific foundation

for biosimilarity

1CMAP (Compound Muscle Action Potential): An objective electrophysiological measure of muscle response to nerve stimulation, used to sensitively assess and compare the neuromuscular effects of botulinum toxin products

Primary Structure: 100% Amino Acid Sequence Identity* to BOTOX®

Not a single amino acid difference across 3 lots of ABP-450 and 2 lots of BOTOX®

*Based on sequence coverage of 97% - 99% for the 5 proteins that comprise the 900kD botulinum toxin type A complex.

**Drug Product (DP) is the final formulation of the Drug Substance (DS), which is the active pharmaceutical ingredient in the product.

〉 Full sequence identity established through liquid chromatography/mass spectrometry (LC/MS) based analysis

〉 Analytical sensitivity sufficient to detect even minor sequence deviations - none observed

Protein

Sequence Coverage % Amino Acid Match for the Sequence Covered

ABP-450 DP**

(Z23001C)

ABP-450 DP

(X24034)

ABP-450 DP

(X24100)

BOTOX® DP

(D0593AC4)

BOTOX® DP

(D0518C4)

100 U

(10 vials)

100 U

(10 vials)

100 U

(10 vials)

200 U

(5 vials)

100 U

(10 vials)

BoNT (core toxin) 98% 100% 100% 100% 100% 100%

NTNH 97% 100% 100% 100% 100% 100%

HA 17 98% 100% 100% 100% 100% 100%

HA 34 99% 100% 100% 100% 100% 100%

HA 70 97% 100% 100% 100% 100% 100%

Primary Structure = Foundation of Biosimilarity

Built for Consistency: Genetic and Formulation Parity w/ BOTOX®

〉 *One nucleotide difference in BoNT → not associated with amino acid sequence/coding for structural protein

〉 Same ingredients, same proportions - identical final composition

Summary: The formulation content of ABP-450 DP precisely matches BOTOX® DP

Item ABP-450 DP BOTOX® DP

Toxin 100 units / vial 100 units / vial

Human serum albumin (HSA) 0.5 mg / vial 0.5 mg / vial

NaCl 0.9 mg/ vial 0.9 mg/ vial

Summary: The genetic sequence for all 5 complex proteins are highly similar between ABP-450 and BOTOX®

BoNT NTNH HA70 HA34 HA17

99%* 100% 100% 100% 100%

Potency: Highly Similar Activity Across Two Independent Assays

〉ABP-450 demonstrates highly similar

potency to BOTOX® across two distinct

assays

– LD50 (in vivo biological activity)

– CBPA (cell-based potency assay)

〉Dual potency similarity expected to support

clinical dose predictability → addresses

important physician switching barrier

ABP-450 BOTOX®

average 98.9 93.9

SD 9.4 8.3

3 lots each – more data pending

ABP-450 BOTOX®

average 95.3 90.4

SD 0.7 3.4

3 lots each – more data pending

LD50

CBPA

CMAP Study Designed for Sensitive Comparison of ABP-450 and BOTOX®

Objective human pharmacodynamic assessment of neuromuscular activity to complement comparative analytical evidence

S T A G E 1

Dose Finding

Identify an informative dose range

〉 Characterize CMAP dose-response

relationships for ABP-450 and

BOTOX®

〉 Identify a dose within the

informative portion of the response

curve

Proposed N = 18–48

healthy volunteers

S T A G E 2

Comparative Assessment

Compare biological activity in

humans

〉 Compare ABP-450 and BOTOX® at

the selected dose

〉 Within-participant design to help

control variability

〉 Quantitative endpoints include

CMAP reduction and AUC

Proposed N = 24

healthy volunteers

Informative

dose range

Most sensitive

part of the curve

Plateau

Response saturates:

differences harder to

detect

Botulinum toxin dose

CMAP reduction (%)

Selected dose

carried into Stage 2

Illustrative dose-response relationship; not actual clinical data

Dose optimization and within-participant comparisons designed to improve sensitivity and reduce variability in assessing biological activity

Study design and sample sizes are proposed and subject to applicable regulatory requirements.

Illustrative dose-response curve; not actual clinical data.

Existing Clinical Evidence May Support ABP-450 Biosimilarity

Historical comparative studies span multiple indications, with additional safety and immunogenicity experience

COMPARATIVE CLINICAL EVIDENCE

Randomized, Non-Inferiority Comparative Studies

Conducted by Daewoong across four indications

Glabellar lines Crow’s feet

Blepharospasm Upper-limb spasticity

Historical studies generally reported similar efficacy and safety between

products

Additional Comparative Studies

Additional human comparative studies potentially contributing to the

broader clinical evidence package

EXISTING CLINICAL EXPERIENCE

Safety & Immunogenicity

Existing clinical experience across multiple

indications and treatment settings

Safety

Clinical exposure and adverse-event experience

Immunogenicity

Antibody and immunogenicity assessments

Existing clinical evidence may reduce the need for new comparative studies while strengthening the biosimilarity assessment

Potential regulatory contribution of historical evidence is subject to scientific relevance, appropriate bridging, data availability and FDA review.

Source: Daewoong DWP-450 (prabotulinumtoxinA) vs. BOTOX® (onabotulinumtoxinA) comparative clinical studies and published comparative literature.

10+

Corporate Profile

Proven Operators in Toxins, Biosimilars, and Capital Formation

Collectively executed >$750M in equity, debt and hybrid financings, complemented by >$1B in M&A transactions

〉 20+ years in biotech and life

sciences capital markets

〉 Over $500M in capital raised

through a variety of equity,

debt, and hybrid structures

Alex Wilson

Chief Legal & Strategy Officer;

Corporate Secretary

〉 Former BOTOX® leader

responsible for competitive

strategy and long-range asset

maximization

〉 Deep expertise in physician-administered biologics, payer

strategy and commercial

scale-up

Rob Bancroft

Chief Executive Officer

〉 20+ years in clinical development

and regulatory strategy –

responsible for multiple IND, NDA,

and BLA submissions

Chad Oh, MD

Chief Medical Officer

〉 Former Deputy Director, FDA

Office of Neuroscience; previously

Director, Division of Neurology 2

〉 Board-certified neurologist;

former NIH staff clinician and

rare-disease clinical investigator

Paul Lee, MD, PhD

Chief Regulatory Officer

〉 25+ years of financial and

leadership experience in the

biotechnology and life sciences

sectors

John Bencich

Chief Financial Officer

Data, Capital, Alignment: Key Milestones Fuel Strategic Momentum

MILESTONE DATE STRATEGIC IMPACT

PIPE Financing Q4 2025* ➢ Secured $6M near-term funding to ensure uninterrupted analytical execution and program

acceleration by up to six months

Daewoong Note Conversion Q1 2026 ➢ $15M convertible note converted to equity and $1.5M note simplifying balance sheet and

deepening alignment with AEON’s key partner

FDA Type 2a Meeting Q1 2026 ➢ Received feedback from FDA on analytical similarity strategy, which provides a clear

framework to complete remaining analytical work

Underwritten Public Offering Q3 2026 ➢ Closed upsized public offering providing gross proceeds of approximately $15.3M

➢ Milestone accelerated warrants provide additional ~$34M capital opportunity

Positive Biosimilarity Data Q3 2026 ➢ Expanded structural data showing 100% amino acid identity across all regions analyzed

➢ Forced degradation results showing similar potency in thermal and oxidative stress models

FDA Type 2b Meeting Feedback Q3 2026 ➢ Feedback informed clinical pharmacology and comparative clinical study requirements

➢ Provided additional clarity on regulatory pathway to BLA submission

IND Filing for CMAP Study Q4 2026** ➢ Two-stage design for a comparative pharmacodynamic study

➢ Agreement in principle with FDA on dosing phase during Type 2b meeting

*Transaction announced in November 2025 and closed in Q1’26

**Anticipated timing

Capitalization Overview

1. As of August 12, 2026

2. Issued in connection with PIPE financing and conversion of Daewoong note as announced November 2025 and in July 2026 underwritten public offering

3. Weighted average exercise price of $4.97

4. Weighted average exercise price of $0.35. Includes ~49.1M 2-year warrants with acceleration following public announcement of FDA Type 2B meeting minutes that do not preclude advancement of ABP-450 towards BLA under the

biosimilar pathway set forth in Section 351(k) of the Public Health Service Act and ~49.1M 5-year warrants with acceleration upon announcement of initiation of P3 study vs BOTOX®

Outstanding Warrants:

~49.9M

Shares Outstanding1

~18.4M

Time Based

Warrants3

~98.2M

Milestone Based

Warrants4

Share Count:

~48.2M

Pre-Funded

Warrants2

Underwritten Public Offering:

$3.4M

As of June 30, 2026

Cash:

~$15.3M

Gross proceeds from July 2026 offering

Strong analytical data flowing

from a proven toxin platform

Completed non-inferiority studies

may de-risk biosimilar pathway

Positioned to drive broad

market adoption

Full-label biosimilarity designed to

unlock the BOTOX® monopoly

Positioned to Deliver the First Clinical Substitute to BOTOX®

Strong data, aligned partner, FDA engagement: ABP-450 advancing towards full-label biosimilarity

A rare combination of scale, structural barriers, and identified path

Thank you

NYSEAMERICAN: AEON

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