AEON

On July 9, 2024, we announced a strategic reprioritization to seek regulatory approval of ABP-450 as a biosimilar product in the United States through submission of a BLA under Section 351(k) of the Public Health Service Act, or a Section 351(k) BLA, using AbbVie Inc.’s product Botox® as the reference product, for all of the indications for which Botox® is approved, other than the cosmetic uses for which we do not hold development or commercialization rights.
We held an initial meeting with the FDA in the third quarter of 2024 during which we obtained feedback from the FDA on the next steps to develop a Botox® biosimilar.
We commenced analytical studies in the fourth quarter of 2024 to prepare for a BPD Type 2a meeting with the FDA that was held on January 21, 2026, to review the results from the studies.
Because we have not yet received regulatory approvals, we are not permitted to market ABP-450 for any use in the United States or in any other territory, and as such, we have not generated any revenue from sales of ABP-450 to date.
We have recorded a loss from operations of $12.8 million for the year ended December 31, 2025, mainly due to loss from operations of $16.3 million and gain on fair value of contingent consideration of $3.5 million.
We have recorded operating income of $73.0 million for the year ended December 31, 2024, mainly due to gain on fair value of contingent consideration of $100.8 million and operating expenses of $27.8 million.
As of December 31, 2025, we had $3.0 million in cash and cash equivalents.
As a result of our ongoing losses, as of December 31, 2025, we had an accumulated deficit of $470.8 million.
Our prior losses, combined with expected future losses, may adversely affect the market price of common stock and our ability to raise capital and continue operations.
Our management has concluded that uncertainties around our ability to raise additional capital raise substantial doubt about our ability to continue as a going concern.
If we cannot continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements, and it is likely that our stockholders may lose some or all of their investment in us.
We expect that we will continue to expend substantial resources for the foreseeable future in order to complete development of and seek regulatory approval for ABP-450 as a biosimilar to Botox®, identify future potential therapeutic applications for ABP-450 and establish sales and marketing capabilities to commercialize ABP-450 across any approved indications.
As of the date of this Report, we expect to have sufficient cash to fund our operating plan into the third quarter of 2026.
Our future capital requirements depend on many factors, including: ● the timing of, and the costs involved in, obtaining regulatory approvals for ABP-450; ● the scope, progress, results and costs of researching and developing ABP-450, and conducting preclinical and clinical studies, including any studies required by the FDA to support submission of a Section 351(k) BLA; ● the cost of commercialization activities if ABP-450 is approved for sale, including marketing, sales and distribution costs; ● costs under our third-party manufacturing and supply arrangements for ABP-450 and any products we commercialize; ● the degree and rate of market acceptance of ABP-450, if approved, or any future approved products; ● the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing products; ● costs associated with any acquisition or in-license of products and product candidates, technologies or businesses, and the terms and timing of any strategic collaboration or other arrangement; ● the terms of any conversion of the senior secured convertible note in the principal amount of $1.5 million, pursuant to an exchange agreement, dated as of January 21, 2026 with Daewoong into shares of common stock, subject to certain conditions and limitations set forth in the convertible note; ● costs of operating as a public company.
If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidate(s), technologies, future revenue streams or research programs or may have to grant licenses on terms that may not be favorable to us.
Debt financing, receivables financing and royalty financing may also be coupled with an equity component, such as warrants to purchase our capital stock, which could also result in dilution of our existing stockholders’ ownership, and such dilution may be material.
Furthermore, if we raise additional capital through debt financing, we will have increased fixed payment obligations and may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures to meet specified financial ratios, and other operational restrictions, any of which could restrict our ability to commercialize ABP-450 or to operate as a business and may result in liens being placed on our assets.
If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly or more dilutive. Our future success depends entirely on obtaining U.S. regulatory approval and successfully commercializing ABP-450 as a proposed biosimilar to Botox®, and the biosimilar licensure pathway for a botulinum toxin product is uncertain. Our future success currently depends entirely on the successful and timely development, licensure and commercialization of ABP-450, our only product candidate.
We do not have any products approved for sale and we may never be able to develop and commercialize a marketable product.
If we are unable to obtain regulatory approval for ABP-450, or if we experience material delays in doing so, our business, financial condition and results of operations would be materially and adversely affected.
The clinical development, manufacturing, labeling, storage, record-keeping, advertising, promotion, import, export, marketing and distribution of biological products are subject to extensive regulation by the U.S.
Food and Drug Administration (FDA) in the United States.
We currently plan to pursue licensure for ABP-450 in the United States under the abbreviated pathway for biosimilar biological products under section 351(k) of the Public Health Service Act.
Under this pathway, we must demonstrate that ABP-450 is biosimilar to a single FDA-licensed reference product under a stepwise approach, which typically relies on extensive comparative analytical and functional characterization, together with nonclinical testing and clinical investigations, to the extent warranted.
The FDA has substantial discretion to determine the nature and extent of data required to support a section 351(k) BLA, including whether and to what extent additional clinical studies are necessary.
The FDA has not licensed a biosimilar or interchangeable biological product referencing Botox® to date.
As a result, FDA’s expectations for demonstrating biosimilarity for a botulinum toxin product may be uncertain and may evolve during the course of development and review.
The process of preparing, submitting and obtaining approval of a section 351(k) BLA is expensive, time-consuming and inherently uncertain, and can be delayed, limited, or denied for many reasons, including the following: ● the FDA may disagree with the design, endpoints, statistical analysis plan or conduct of our clinical investigations or may identify issues during inspection of clinical sites; ● the FDA may determine that our comparative analytical similarity package is insufficient, that observed differences are clinically meaningful, or that our assays, specifications, or control strategy are inadequate; ● the FDA may require additional or different clinical pharmacology, immunogenicity, safety, or comparative clinical studies (including comparative clinical efficacy studies) to address residual uncertainty; ● the FDA may not accept certain data generated outside the United States or may require additional bridging or other justification for the use of any non-U.S.-licensed comparator product; ● the FDA may identify deficiencies in our chemistry, manufacturing, and controls (“CMC”) information or in the manufacturing processes, quality systems, or facilities of our third-party manufacturers (including through pre-licensure inspections), or may require remediation or additional process validation; ● the FDA may approve ABP-450 only for a more limited set of indications than those sought by us (including denying or limiting extrapolation), or may impose labeling restrictions, distribution restrictions, risk management measures, or post-approval requirements; or ● the FDA or other authorities may change applicable laws, regulations, guidance, policies, or enforcement practices.
In addition, the complexity of biological products and the scientific and technical challenges associated with demonstrating high similarity may require significant time and resources.
Comparative analytical assessment for a biosimilar product typically requires sensitive, orthogonal methods and sufficient lots of both the proposed product and the reference product.
Differences observed during analytical similarity assessment or functional characterization may require additional scientific justification, increased testing, manufacturing changes, new or revised specifications, additional comparability data, or other remediation, any of which could delay development, increase costs, or prevent submission or approval of a Section 351(k) BLA.
Clinical investigations are inherently uncertain and can be delayed, suspended or terminated.
Prior to our strategic reprioritization to pursue a biosimilar pathway, our Phase 2 clinical trials for episodic and chronic migraine did not meet their respective primary endpoints and were discontinued.
The FDA may consider our prior clinical experience in determining the clinical or other data it will require for ABP-450’s development and potential licensure, which could lead the FDA to require additional studies or other data to address residual uncertainty or other concerns.
Even if we believe our planned analytical and clinical program is appropriate, the FDA may require additional pre-approval or post-approval studies, may object to elements of our development program, or may require that our program be altered.
Even if we demonstrate biosimilarity for ABP-450 and obtain approval of ABP-450 in one indication, the FDA may not permit extrapolation to additional indications approved for the reference product and may require additional data to support licensure for one or more indications.
Any limitation on the indications for which ABP-450 is licensed (for example, exclusion of certain therapeutic indications or constraints on the patient populations eligible for treatment) could materially reduce the commercial opportunity for ABP-450.
In addition to nonclinical and clinical requirements, FDA licensure will depend on the adequacy of our manufacturing and quality systems and those of any third-party manufacturers.
We rely on third parties, including Daewoong Pharmaceutical Co., Ltd., for manufacturing ABP-450.
The FDA will evaluate whether manufacturing facilities, methods and controls comply with cGMP and are adequate to preserve identity, strength, quality, purity and potency.

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Gone since FY2024

On July 9, 2024, we announced a strategic reprioritization to seek regulatory approval of ABP-450 as a biosimilar product in the United States through submission of a Biologics License Application, or BLA, under Section 351(k) of the Public Health Service Act, or a Section 351(k) BLA, using AbbVie Inc.’s product Botox as the reference product, for all of the indications for which Botox is approved, other than the cosmetic uses (for which we do not hold development or commercialization rights).
We held an initial meeting with the FDA in the third quarter of 2024 during which we aligned with the FDA on the next steps to develop a Botox biosimilar.
We commenced analytical studies in the fourth quarter of 2024 to prepare for a potential Biosimilar Biological Product Development (“BPD”) Type 2a meeting with the FDA in the second half of 2025 to review the results from the studies. Because we have not yet received regulatory approvals, we are not permitted to market ABP-450 for any use in the United States or in any other territory, and as such, we have not generated any revenue from sales of ABP-450 to date.
We have recorded income from operations of $73.0 million for the year ended December 31, 2024, mainly due to gain on fair value of contingent consideration of $100.8 million, and losses from operations of $29.6 million and $318.4 million for the periods from January 1, 2023 to July 21, 2023 (Predecessor) and July 22, 2023 to December 31, 2023 (Successor), respectively.
We have recorded net income of $42.0 million for the year ended December 31, 2024, mainly due to gain on fair value of contingent consideration, and net losses of $60.7 million and $324.0 million for the periods from January 1, 2023 to July 21, 2023 (Predecessor) and July 22, 2023 to December 31, 2023 (Successor), respectively.
As of December 31, 2024, we had $13 thousand in cash and cash equivalents.
As a result of our ongoing losses, as of December 31, 2024 (Successor), we had an accumulated deficit of $431.6 million.
Our prior losses, combined with expected future losses, may adversely affect the market price of common stock and our ability to raise capital and continue operations. Our management has concluded that uncertainties around our ability to raise additional capital raise substantial doubt about our ability to continue as a going concern.
If we cannot continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements, and it is likely that our stockholders may lose some or all of their investment in us. We expect that we will continue to expend substantial resources for the foreseeable future in order to complete development of and seek regulatory approval for ABP-450 as a biosimilar to Botox, identify future potential therapeutic applications for ABP-450 and establish sales and marketing capabilities to commercialize ABP-450 across any approved indications. As of the date of this Report, we expect to have sufficient cash to fund our operating plan into the fourth quarter of 2025.
Our future capital requirements depend on many factors, including: ● the timing of, and the costs involved in, obtaining regulatory approvals for ABP-450; ● the scope, progress, results and costs of researching and developing ABP-450, and conducting preclinical and clinical studies, including any studies required by the FDA to support submission of a Section 351(k) BLA; ● the cost of commercialization activities if ABP-450 is approved for sale, including marketing, sales and distribution costs; ● costs under our third-party manufacturing and supply arrangements for ABP-450 and any products we commercialize; ● the degree and rate of market acceptance of ABP-450, if approved, or any future approved products; ● the emergence, approval, availability, perceived advantages, relative cost, relative safety and relative efficacy of alternative and competing products; ● costs associated with any acquisition or in-license of products and product candidates, technologies or businesses, and the terms and timing of any strategic collaboration or other arrangement; ● the terms of any conversion of the senior secured convertible notes in the principal amount of $15.0 million (each a “Convertible Note” and together, the “Convertible Notes”), pursuant to a subscription agreement (the “Subscription Agreement”), dated as of March 19, 2024, with Daewoong Pharmaceutical Co.
(“Daewoong”), into shares of common stock, subject to certain conditions and limitations set forth in each Convertible Note ● costs of operating as a public company. If we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish certain valuable rights to our product candidate(s), technologies, future revenue streams or research programs or may have to grant licenses on terms that may not be favorable to us.
Debt financing, receivables financing and royalty financing may also be coupled with an equity component, such as warrants to purchase our capital stock, which could also result in dilution of our existing stockholders’ ownership, and such dilution may be material. Furthermore, if we raise additional capital through debt financing, we will have increased fixed payment obligations and may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt or making capital expenditures to meet specified financial ratios, and other operational restrictions, any of which could restrict our ability to commercialize ABP-450 or to operate as a business and may result in liens being placed on our assets.
If the equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult, more costly or more dilutive. Our future success currently depends entirely on the successful and timely regulatory approval and commercialization of our only product candidate, ABP-450.
The development and commercialization of pharmaceutical products is subject to extensive regulation, and we may not obtain regulatory approvals for ABP-450 on a timely basis or at all. The clinical development, manufacturing, labeling, storage, record-keeping, advertising, promotion, import, export, marketing and distribution of biological products, including ABP-450, are subject to extensive regulation by the FDA in the U.S. and by comparable foreign regulatory authorities in foreign markets.
Regulatory approval of biologics in the United States requires the submission of a BLA to the FDA.
A BLA must be supported by extensive clinical and preclinical data, as well as extensive information regarding pharmacology, chemistry, manufacturing and controls demonstrating the safety, purity and potency of the biological product for its intended uses.
FDA approval of a BLA is not guaranteed, and the review and approval process is an expensive and uncertain process that may take several years.
The FDA also has substantial discretion in the approval process, including the ability to delay, limit or deny approval of a product candidate for many reasons.
Despite the time and expense invested in clinical development of product candidates, regulatory approval of a product candidate is never guaranteed.
Of the large number of drugs in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are commercialized. Prior to obtaining approval to commercialize any product candidate in the United States or abroad, we must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that our product candidate, ABP-450, is safe and effective for its intended uses and in the case of biological products in the U.S., such as ABP-450, that such product candidate is safe, pure and potent for its intended uses.
Results from preclinical studies and clinical trials can be interpreted in different ways.
Even if we believe that the preclinical or clinical data for our product candidates, including ABP-450, are promising, such data may not be sufficient to support approval for further development, manufacturing or commercialization of our product candidates by the FDA and other regulatory authorities.
The FDA or other regulatory authorities may also require us to conduct additional preclinical studies or clinical trials for our product candidates either prior to or post-approval, or it may object to elements of our clinical development program, requiring their alteration.
The number and types of preclinical studies and clinical studies that will be required for BLA approval varies depending on the product candidate, the disease or the condition that the product candidate is designed to treat and the regulations applicable to any particular product candidate. The FDA and other regulatory authorities can delay, limit or deny approval of a product candidate for many reasons, including the following: ● such authorities may disagree with the design or execution of our clinical trials; ● negative or ambiguous results from our clinical trials or results may not meet the level of statistical significance or persuasiveness required by the FDA or comparable foreign regulatory agencies for approval; ● serious and unexpected drug-related side effects may be experienced by participants in our clinical trials or by individuals using drugs similar to our product candidates; ● the population studied in the clinical trial may not be sufficiently broad or representative to assure safety in the full population for which we seek approval; ● serious and unexpected drug-related side effects may be experienced by participants in our clinical trials or by individuals using products similar to our product candidates; ● the populations we evaluate in our the clinical trials may not be sufficiently broad or representative to assure safety in the full population for which we seek approval; ● such authorities may not accept clinical data from trials that are conducted at clinical facilities or in countries where the standard of care is potentially different from that of their own country; ● such authorities may disagree with our interpretation of data from preclinical studies or clinical trials; ● we may be unable to demonstrate that a product candidate is safe, pure, potent, or effective for its intended uses, that such product candidate’s clinical and other benefits outweigh its safety risks, or that such product candidate is biosimilar to a reference product; ● such authorities may not agree that the data collected from clinical trials of our product candidates are acceptable or sufficient to support the submission of a Section 351(k) BLA or other submission or to obtain regulatory approval in the U.S. or elsewhere, and such authorities may impose requirements for additional preclinical studies or clinical trials; ● such authorities may disagree with us regarding the formulation, labeling and/or the product specifications of our product candidates; ● approval may be granted only for indications that are significantly more limited than those sought by us, and/or may include significant restrictions on distribution and use; ● such authorities may find deficiencies in the manufacturing processes or facilities of the third-party manufacturers with which we contract for clinical and commercial supplies; or ● the FDA and other regulatory agencies may change their approval policies or adopt new regulations. If ABP-450 fails to demonstrate the requisite safety, purity, potency or biosimilarity in our planned clinical studies or does not gain approval, our business and results of operations will be materially and adversely harmed. We are currently planning to pursue approval for ABP-450 in the United States as a biosimilar to Botox, and our business presently depends entirely on our ability to obtain regulatory approval for ABP-450 and to successfully commercialize it in a timely manner.
To date, as an organization, we have completed one clinical study evaluating ABP-450 for the treatment of cervical dystonia.
We originally intended to pursue submission of an Original BLA seeking one or more potential therapeutic indications for ABP-450.
However, our Phase 2 clinical trials for episodic and chronic migraine did not meet their respective primary endpoints.
In May 2024, we announced the discontinuation of our Phase 2 clinical trials for episodic and chronic migraine in order to implement certain cash preservation measures.
As a result, on July 9, 2024, we announced a strategic reprioritization to pursue a Section 351(k) BLA for ABP-450, using AbbVie Inc.’s product Botox as a proposed reference product, for which we would seek approval for all of the indications for which Botox is approved, other than the cosmetic uses.
We held an initial meeting with the FDA in the third quarter of 2024 during which we aligned with the FDA on next steps to develop a Botox biosimilar.
We commenced analytical studies in the fourth quarter of 2024 to prepare for a potential Biosimilar Biological Product Development (“BPD”) Type 2a meeting with the FDA in the second half of 2025 to review the results from the studies.
Although we believe ABP-450 represents a favorable candidate to develop as a biosimilar product, the FDA may indicate that a biosimilar pathway is not feasible, or prohibitively challenging, with a neurotoxin.
For example, the FDA could require us to perform analytical testing procedures for ABP-450 that are not technologically feasible, or could disagree that the results from a single pivotal study could support submission of a Section 351(k) BLA.
Even if the FDA acknowledges that ABP-450 has the potential to be developed as a biosimilar product, we may not be able to successfully complete our planned clinical study, or successfully prepare, submit, and obtain approval of a Section 351(k) BLA in a timely manner, or at all. We have no products currently approved for sale and we may never be able to develop marketable products.
We are not permitted to market ABP-450 in the United States unless we receive approval of a BLA from the FDA or approval of a similar application in any other countries permitted under the Daewoong Agreement.
We can provide no assurances that ABP-450 will be successful in clinical studies or will ultimately receive regulatory approval.
In addition, if we receive approval in one country, we may not receive a similar approval in any other jurisdiction. Even if we obtain regulatory approvals for ABP-450 we may never be able to successfully commercialize ABP-450.
We will need to transition at some point from a company with a development focus to a company capable of supporting commercial activities, including by obtaining approval for coverage and adequate reimbursement from third-party and government payors, but we may not be successful in such a transition.
Accordingly, we may not be able to generate sufficient revenue through the sale of ABP-450 to continue our business. Clinical product development involves a lengthy, expensive and uncertain process.
We may incur greater costs than we anticipate or encounter substantial delays or difficulties in our clinical studies. We may not commercialize, market, promote or sell any product candidate, including ABP-450, without obtaining regulatory approval from the FDA or other regulatory agencies, and we may never receive such approvals. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome.

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Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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