AEON Biopharma, Inc.

*We are subject to various risks and uncertainties in the course of our business. Youshould carefully consider the risks and uncertainties described below and the other information in this report before making an investment in our Class A common stock, par value $0.0001 per share (“common stock”).*Our business, financial condition, results of operations, or prospects could be materially and

*adversely affected if any of these risksoccurs,and as a result, the market price of our common stock could decline and you could lose all or part of your investment. This report also contains forward-looking statements thatinvolverisks and uncertainties. See “Cautionary StatementRegardingForward-Looking Statements.” Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certainfactors,including those setforth *below.

Risks Related to Our Business Operations and Financial Position

We have a limited operating history and have incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future. If we ever achieve profitability, we may not be able to sustain it.

We are a clinical stage biopharmaceutical company with a limited operating history. Pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. Old AEON was originally incorporated in 2012 but did not begin focusing its efforts and financial resources on the clinical development and regulatory approval of ABP-450 for therapeutic indications until 2019. The operating history upon which investors must evaluate our business and prospects is limited. Consequently, any predictions about our future success, performance or viability may not be as accurate as they could be if we had a longer operating history or a history of commercial operations. In addition, as an organization, we have limited experience and have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in the biopharmaceutical market. To date, we have not obtained any regulatory approvals for ABP-450 or generated any revenue from product sales relating to ABP-450. On May 16, 2024, we announced the discontinuation of our Phase 2 double blind study of ABP-450 in the treatment of episodic migraine and chronic migraine, which had previously completed enrollment and dosing of patients, and ceased enrollment and dosing of patients in our open label extension study related to such study, in order to implement certain cash preservation measures while the Company continues to evaluate its strategic options. 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. We expect to continue to incur losses for the foreseeable future, and we anticipate these losses will increase as we continue to seek regulatory approval for, and begin to commercialize, ABP- 450, if approved. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generate revenues. Our prior losses and expected future losses have had and will continue to have an adverse effect on our stockholders’ equity (deficit) and working capital. Because of the numerous risks and uncertainties associated with drug development, we are unable to accurately predict the timing or amount of increased expenses, or when, if at all, we will be able to achieve profitability. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. 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. We will require additional financing to fund our future operations. Any failure to obtain additional capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our operations.

We have concluded that we do not have sufficient cash to fund our operations and to meet our obligations as they become due within one year from the date that our consolidated financial statements are issued and as a result, there is substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern is an issue raised as a result of ongoing operating losses and a lack of financing commitments to meet cash requirements, and is subject to our ability to generate a profit or obtain appropriate financing from outside sources, including obtaining additional funding from the sale of our securities or obtaining loans

from third parties where possible. We will need to raise additional capital to fund our operations. We cannot assure you that we will be able to raise additional capital on commercially reasonable terms or at all. The perception that we may not be able to continue as a going concern may materially limit our ability to raise additional funds through the issuance of new debt or equity securities or otherwise and no assurance can be given that sufficient funding will be available when needed to allow us to continue as a going concern. This perception may also make it more difficult to operate our business due to concerns about our ability to meet our contractual obligations. 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. We have based these estimates, however, on assumptions that may prove to be wrong, and we could spend our available capital resources much faster than we currently expect or require more capital to fund our operations than we currently expect. Our future capital requirements depend on many factors, including:

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. If we raise additional capital through public or private equity offerings or offerings of securities convertible into our equity, the ownership interest of stockholders will be diluted and the terms of any such securities may have a preference over our common stock. 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 we were to default on any of our indebtedness, we could lose such assets. Additional funding may not be available on acceptable terms, or at all. The global credit and financial markets have experienced volatility and disruptions recently, including diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates, and uncertainty about economic

stability. 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:

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. If the FDA identifies deficiencies during inspections or in our CMC information, it may delay, limit, or deny licensure, require additional remediation or validation work, or require other changes that could materially delay development and commercialization.

Even if we obtain regulatory approval, we may never be able to successfully commercialize ABP-450. Commercial success will depend on, among other things, physician and patient acceptance, payer coverage and reimbursement, contracting dynamics, formulary positioning, competitive responses by the reference product sponsor and other market participants, and our ability to build or access commercialization capabilities. Medicare Part B and other payor reimbursement methodologies (including those based on average sales price (ASP)) are complex and subject to change, and unfavorable coverage or reimbursement decisions, changes in reimbursement methodologies, or other policy developments could materially adversely affect the adoption, pricing, and commercial prospects for ABP-450.

If we are unable to develop and validate a robust comparative analytical similarity and CMC package for ABP-450 consistent with the FDA’s expectations for a 351(k) biosimilar BLA, we may be delayed or prevented from submitting or obtaining approval of a 351(k) BLA, and our business would be materially adversely affected.

Our ability to obtain U.S. licensure for ABP-450 under section 351(k) depends on demonstrating, that ABP-450 is highly similar to an FDA-licensed reference product notwithstanding minor differences in clinically inactive components and that there are no clinically meaningful differences in safety, purity and potency. Comparative analytical and functional characterization and a complete, robust CMC package are generally the foundation of a Section 351(k) BLA submission. If we cannot generate, interpret, or adequately justify the comparative analytical data the FDA expects, or if the FDA determines our control strategy does not assure consistent product quality, we may be required to conduct additional studies, modify our manufacturing process, delay submission of a Section 351(k) BLA, or may be unable to obtain approval.

Demonstrating analytical similarity may be particularly challenging for botulinum toxin products. The potency units of botulinum toxin products are specific to the preparation and assay method utilized and are not interchangeable across products, reflecting the importance and complexity of potency and functional assays and reference standards for this product class. Quantitating the active component and relevant impurities at very low concentrations and correlating those measurements to biological activity may require highly sensitive, validated analytical methods. Developing, qualifying, and validating a set of sensitive and specific assays, including orthogonal methods, to characterize the product and support similarity, may be technologically challenging, time-consuming and costly. The FDA may require additional method development or validation work, additional reference product lots, additional comparability analyses, alternative analytical approaches, or different acceptance criteria.

Our analytical program also depends on obtaining sufficient quantities and lots of the U.S.-licensed reference product for comparative testing, method qualification, and, if required, clinical investigations. Reference product supply constraints, controlled distribution channels, changes in list or net pricing, and other factors may limit our ability to obtain representative lots across time and within shelf life. If we cannot obtain adequate reference product supply, or if the lots we can obtain are not representative, our ability to characterize reference product variability or define appropriate similarity ranges may be compromised and the FDA may not accept our data package.

In certain circumstances, biosimilar sponsors may seek to use a comparator product approved outside the United States or non-U.S. clinical data to support aspects of development. If we pursue any such approach, the FDA may require additional scientific justification and “bridging” analyses, including three-way comparisons among ABP-450, the U.S.-licensed reference product, and any non-U.S.-licensed comparator product, and the FDA could reject the relevance of such data. Any additional bridging work may be time-consuming and expensive and could delay development and submission.

Even if we obtain adequate reference product supply, natural lot-to-lot variability, potential manufacturing changes over time by the reference product sponsor, and differences in storage, handling, or aging may contribute to variability in analytical results. We must account for such variability when establishing our comparative analytical assessment and setting specifications. If our analytical assessments identify differences that the FDA determines are clinically meaningful or otherwise raise residual uncertainty, the FDA may require additional nonclinical or clinical studies—including clinical pharmacology, immunogenicity, or comparative clinical efficacy studies—to support biosimilarity or to support extrapolation to additional indications.

Stability and comparability also present risk. Differences in stability profiles, aggregation, impurities, container closure performance, or degradation pathways—whether real or apparent based on method limitations—could require reformulation, additional stability work, new specifications, or changes to manufacturing controls. In addition, if we or our manufacturers make changes in manufacturing processes, quality systems, raw materials, sites, or equipment, we may need to generate additional comparability data to demonstrate that the product remains consistent with the material evaluated in our analytical program and any clinical investigations. These requirements could be heightened for a biosimilar program because the analytical similarity determination is a central basis for licensure.

We rely on third parties, including Daewoong Pharmaceutical Co., Ltd., for manufacturing ABP-450. Our ability to generate a consistent analytical comparability package and to support a Section 351(k) BLA also depends on the ability of our manufacturers to produce ABP-450 consistently and in compliance with cGMP, and the FDA may inspect manufacturing facilities in connection with a BLA. Manufacturing deviations, out-of-specification results, control strategy deficiencies, or inspection findings could require remediation, cause delays, result in batch failures or supply interruptions, or prevent submission or approval of a BLA.

If we cannot demonstrate satisfactory analytical similarity and CMC robustness, we may experience delays, incur substantial costs, be forced to narrow the indications or conditions of use we pursue, or be unable to obtain licensure under Section 351(k). Any such outcome could materially harm our commercialization plans and competitive position and could adversely affect coverage, reimbursement, and market adoption dynamics for ABP-450, particularly in settings where physician-administered biologics are sensitive to reimbursement and pricing methodologies.

Clinical development for a proposed biosimilar product involves a lengthy, expensive and uncertain process, including extensive comparative analytical work and potentially clinical investigations; we may incur greater costs than we anticipate or encounter substantial delays or difficulties in our studies.

We may not commercialize, market, promote or sell any product candidate, including ABP-450, in the United States unless and until we obtain regulatory approval from the FDA, and we may never receive such approval. Our current strategy is focused on pursuing a BLA for ABP-450 under the abbreviated pathway for biosimilar biological products under Section 351(k) of the Public Health Service Act. Although the biosimilar pathway differs from the stand-alone 351(a) pathway, it remains an expensive, time-consuming and uncertain process that may take several years and requires significant management attention and financial resources.

To obtain licensure under section 351(k), we must demonstrate that ABP-450 is biosimilar to a single FDA-licensed reference product. Clinical development is generally required to demonstrate biosimilarity.

Clinical investigations are expensive, difficult to design and implement, can take many years to complete, and are uncertain as to outcome. In addition, biosimilar development depends heavily on sophisticated analytical testing and method development, including establishing and validating assays and specifications that are sufficiently sensitive to detect potentially clinically meaningful differences. We cannot guarantee that our analytical studies or clinical investigations will be conducted as planned or completed on schedule, if at all. A failure can occur at any stage, and many companies that have believed their product candidates performed satisfactorily in testing have nonetheless failed to obtain regulatory approval.

The results from preclinical studies or early clinical investigations of a product candidate may not predict the results of later investigations, and interim results are not necessarily indicative of final results. Product candidates in later stages may fail to show the desired characteristics despite having progressed through earlier testing. In particular, while we have conducted clinical studies evaluating ABP-450 in patients with cervical dystonia and migraines, we do not know whether ABP-450 will perform as expected in future clinical investigations designed to support a biosimilar submission.

Moreover, data generated during a biosimilar program may be susceptible to varying interpretations and analyses. Differences observed during comparative analytical assessment or in clinical pharmacology, immunogenicity, safety or comparative clinical studies could result in the need for additional studies, additional manufacturing work, or changes to our development strategy, any of which could delay or prevent our ability to obtain regulatory approval. For example, our Phase 2 clinical trials for episodic and chronic migraine did not meet their respective primary endpoints. As a result, in May 2024, we announced the discontinuation of our Phase 2 clinical trials for episodic and chronic migraine, in part to implement cash preservation measures. The FDA may consider our prior clinical experience in determining the clinical or other data it will require for ABP-450’s development and licensure, which could lead the FDA to require additional studies or other data to address residual uncertainty or other concerns.

We do not know whether our planned clinical investigations will be completed on schedule, if at all. We may experience numerous unforeseen events prior to, during, or as a result of analytical studies and clinical investigations that could delay or prevent our ability to receive regulatory approval or to commercialize ABP-450 or any other product candidate, including the following:

Any inability to successfully complete our analytical and clinical development program could result in additional costs to us or impair our ability to generate revenue from future product sales or other sources. In addition, if we make manufacturing, formulation or process changes to ABP-450, change facilities, or modify our analytical methods or specifications, we may need to generate additional comparability, stability, analytical, and/or clinical data to bridge our modified product candidate to earlier versions or to demonstrate that such changes do not adversely affect the basis for biosimilarity.

Clinical and analytical delays could also allow competitors to bring competing products to market before we do, reduce the time available for us to execute a commercial launch strategy, and otherwise impair our ability to successfully commercialize ABP-450, which may harm our business, financial condition, results of operations and prospects.

Additionally, if results of our analytical studies or clinical investigations are inconclusive or if there are safety concerns or serious adverse events associated with ABP-450, we may be delayed in obtaining regulatory approval, not obtain regulatory approval at all, obtain approval only in narrower indications or patient populations than intended, obtain approval with labeling that includes significant restrictions or safety warnings, be subject to additional post-marketing testing requirements, have regulatory authorities withdraw or suspend approval, impose restrictions on distribution in the form of a risk evaluation and mitigation strategy (REMS), be sued, or experience damage to our reputation.

Our product development costs will increase if we experience delays in analytical testing, clinical investigations, manufacturing scale-up, or obtaining regulatory approvals. Further, we, the FDA, a foreign regulatory authority (if applicable), an ethics committee or an IRB may suspend our clinical investigations at any time if it appears that we are failing to conduct a study in accordance with regulatory requirements (including GCP), that we are exposing participants to unacceptable health risks, or if the FDA finds deficiencies in our current or planned investigational new drug applications (INDs) or the conduct of these studies. Therefore, we cannot predict with certainty the schedule for commencement and completion of future analytical studies or clinical investigations, including any planned pivotal study, and delays could negatively impact the commercial prospects of ABP-450 and delay our ability to generate revenue.

Additionally, certain of our scientific advisors or consultants who receive compensation from us are likely to be investigators for our future clinical investigations. Under certain circumstances, we may be required to report some of these relationships to the FDA. The FDA may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA may therefore question the integrity of the data generated at the applicable clinical study site and the utility of the clinical investigation itself may be jeopardized. This could result in a delay in approval or rejection of our marketing applications and may ultimately lead to denial of regulatory approval of ABP-450.

Enrollment and retention of patients in clinical studies is an expensive and time-consuming process and could be delayed, made more difficult or rendered impossible by multiple factors outside our control. If we experience delays or difficulties in enrolling patients in clinical studies, our clinical development activities could be delayed or otherwise adversely affected.

Identifying and qualifying patients to participate in our clinical studies is critical to our success. We may encounter difficulties in enrolling patients in our clinical studies and may compete against other clinical studies for the same pool of potential patients, thereby delaying or preventing development and potential regulatory approval of ABP-450. Patient enrollment in clinical trials may be affected by other factors, including:

We also rely on, and will continue to rely on, CROs and clinical trial sites to ensure proper and timely conduct of our clinical trials and preclinical studies. Though we have entered into agreements governing their services, we will have limited influence over their actual performance. Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs for ABP-450 and any other product candidate and jeopardize our ability to obtain regulatory approval. Furthermore, even if we are able to enroll a sufficient number of patients for our clinical trials, we may have difficulty maintaining enrollment of such patients in our clinical trials.

ABP-450 may cause undesirable side effects or have other properties that could delay or prevent its regulatory approval, limit its commercial potential or result in significant negative consequences following any potential regulatory approval.

During the conduct of clinical studies, patients report changes in their health, including illnesses, injuries and discomforts, to their doctor. Often, it is not possible to determine whether or not the product candidate being studied caused or contributed to these conditions and regulatory authorities may draw different conclusions from us and require additional testing to confirm these determinations, if they occur. Any adverse events or undesirable side effects caused by, or other unexpected properties of, ABP-450 could cause us, any future collaborators, IRB, or ethics committee or regulatory authorities to interrupt, delay or halt clinical studies of ABP-450 and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other regulatory authorities.

In addition, it is possible that as we test ABP-450 in further clinical studies, or as use of ABP-450 becomes more widespread if it receives regulatory approval, that illnesses, injuries, discomforts and other adverse events that were not observed in earlier studies conducted by us, or, in the case of ABP-450, by others using the same botulinum toxin, as well as conditions that did not occur or went undetected in previous studies, will be reported by subjects or patients. Many times, side effects are only detectable after investigational products are tested in large-scale pivotal studies or, in some cases, after they are made available to patients on a commercial scale after approval. If additional clinical experience indicates that ABP-450 has side effects or causes serious or life-threatening side effects, the development of ABP-450 may fail or be delayed. Additionally, there is the risk that as botulinum toxins other than ABP-450 are approved for and studied in connection with a broader range of diseases and conditions and across a more diverse population, additional safety signals and other adverse events may be identified. All botulinum toxin products are required to include a class labeling that contains a boxed warning related to safety and we could be required to include additional warnings on our product labeling, if approved.

Additionally, if ABP-450 or any other product candidate receives regulatory approval, and we or others later identify undesirable side effects caused by such product, a number of potentially significant negative consequences could result. For example, the FDA could require us to adopt a REMS to ensure that the benefits of treatment with such product candidate outweigh the risks for each potential patient, which may include, among other things, a communication plan to health care practitioners, patient education, extensive patient monitoring or distribution systems and processes that are highly controlled, restrictive and more costly than what is typical for the industry. We may also be required to engage in similar actions, such as patient education, certification of health care professionals or specific monitoring, if we or others later identify undesirable side effects caused by any product that we develop. Other potentially significant negative consequences associated with adverse events include:

Any of these events could diminish the usage or otherwise limit the commercial success of our product candidates and prevent us from achieving or maintaining market acceptance of ABP-450, if approved by the FDA or other regulatory authorities.

We announced a strategic pivot to pursue regulatory approval for ABP-450 utilizing a 351(k) biosimilar pathway. Obtaining regulatory approvals under this novel approach may prove difficult, or even impossible, for a variety of reasons.

On July 9, 2024, we announced a strategic reprioritization to pursue submission of 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. To obtain regulatory approval for the commercial sale of ABP-450 as biosimilar product, we will be required to demonstrate to the satisfaction of the FDA, among other things, that ABP-450 is highly similar to a biological reference product already licensed by the FDA pursuant to an approved BLA, notwithstanding minor differences in clinically inactive components, and that it has no clinically meaningful differences as compared to the reference product in terms of the safety, purity and potency of the product.

The potential to leverage the biosimilar pathway for a neurotoxin is untested, as no biosimilar has been approved utilizing Botox® as the reference product. Among other things, Section 351(k) BLAs must include an assessment of toxicity and a clinical study or studies sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and for which licensure is sought for the proposed biological product. The amount of toxin in a single vial of Botox® is miniscule and comparing toxicity vial-to-vial, which could be required by the FDA, may prove prohibitively difficult.

We plan to pursue the biosimilar pathway for ABP-450 because this pathway offers the potential to obtain FDA approvals for all FDA-approved indications for the reference product. If we are successful in demonstrating the biosimilarity of ABP-450 to Botox® and obtain regulatory approval with respect to one indication, we believe the FDA could also approve ABP-450 for one or more indications currently listed on Botox®’s FDA-approved labeling without our having to conduct additional clinical trials for ABP-450, provided that the FDA determines that ABP-450 relies on a similar mechanism of action to Botox® with respect to each such indication. However, even if we are able to demonstrate that ABP-450 is biosimilar to Botox® with respect to one indication, the FDA may nevertheless determine that certain of Botox® existing approved indications do not rely on a clearly established similar mechanism of action, which would limit our ability to seek approvals for ABP-450 without conducting additional trials. For example, pending FDA feedback, we plan to conduct a single pivotal clinical study in patients with cervical dystonia. And the FDA could determine that a clinical study in cervical dystonia, a muscular disorder, even if successful, will not support a Section 350(k) BLA seeking approval for ABP-450 as a biosimilar in patients with migraine, a neurological disorder, or any of the other therapeutic (non-cosmetic) indications for which Botox® is currently approved. Moreover, negative or ambiguous results from clinical trials of ABP-450 in certain patient populations, including the results from our Phase 2 trials, could adversely affect our ability to pursue certain indications in any Section 351(k) BLA. In addition, pursuant to our agreement with Daewoong, we do not have the rights to develop and commercialize ABP-450 for any of the cosmetic indications for which Botox® has been approved, which further limits the market potential for ABP-450, even if we are successful in pursuing a biosimilar pathway.

Additionally, even if the FDA allows us to pursue a biosimilar pathway for ABP-450, and even if we are successful in demonstrating biosimilarity for ABP-450 to the satisfaction of the FDA, many manufacturers of reference biological products have used legislative, regulatory and other means, such as litigation, to delay regulatory approval and to seek to restrict competition from manufacturers of biosimilars. These efforts may include or have included:

In addition, any of these factors could prevent us from obtaining market acceptance for or otherwise successfully commercializing ABP-450, if approved as a biosimilar product.

Even if ABP-450 receives regulatory approval as a biosimilar or otherwise, it may fail to achieve the broad degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

Even if ABP-450 receives regulatory approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. The commercial success of ABP-450, if approved, will depend significantly on the broad adoption and use of the resulting product by physicians. The degree of market acceptance of any product candidate, if approved for commercial sale, will depend on a number of factors, including but not limited to:

Our efforts to educate physicians, patients, third party payors and others in the medical community on the benefits of our product candidates, if approved, may require significant resources and may never be successful.

If ABP-450 fails to gain market acceptance, this will have a material adverse impact on our ability to generate revenues to provide a satisfactory, or any, return on our investments. Even if some therapeutic indications achieve market acceptance, the market may prove not to be large enough to allow us to generate significant revenues.

Due to our limited resources and access to capital, we must prioritize the regulatory approval for ABP-450 utilizing a 351(k) biosimilar pathway and evaluate the development of certain therapeutic uses of ABP-450; these decisions may prove to be wrong and may adversely affect our business.

While we have shifted our focus to the development and potential commercialization of ABP-450 as a biosimilar to Botox®, a key element of our future strategy is to identify additional conditions for which ABP-450 may warrant further development. However, there can be no assurances that we will be successful in identifying such conditions, such as gastroparesis and PTSD. Even if we are successful in identifying conditions that could potentially be treated with ABP-450, we may experience difficulties in identifying a proper treatment regimen, or we may fail to successfully develop ABP-450 or secure regulatory approval for such conditions.

Efforts to identify and pursue additional potential therapeutic uses of ABP-450 require substantial technical, financial and human resources, regardless of whether they are ultimately successful. Because we have limited financial and personnel resources, we may forgo or delay pursuit of opportunities with potential target indications that later prove to have greater commercial potential or a greater likelihood of success.

Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. We may focus our efforts and resources on potential therapeutic uses of ABP-450 that ultimately prove to be unsuccessful.

Even if we receive regulatory approval for ABP-450, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense, limit or prohibit commercial distribution, prevent continued investigation and research and subject us to penalties if we fail to comply with applicable regulatory requirements. Additionally, ABP-450, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.

For any regulatory approvals that we may receive for our ABP-450, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for our product candidates will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as ongoing compliance with cGMPs and GCPs for any clinical trials. In addition, manufacturers of biological products and their facilities are subject to continual review and periodic, unannounced inspections by the FDA and other regulatory authorities for compliance with cGMPs and other applicable regulations and standards. In addition, any regulatory approvals we may receive will require the submission of periodic reports to regulatory authorities and ongoing surveillance to monitor the safety and efficacy of the product. Such approvals may also contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements. For example, the FDA may require a Risk Evaluation Mitigation Strategy as a condition of approval of our product candidates, which could include requirements for a medication guide, physician training and communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilities where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. In addition, failure to comply with FDA and other comparable foreign regulatory requirements may subject our company to administrative or judicially imposed sanctions, including:

Regulatory policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of ABP-450. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow to or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may be subject to enforcement action and we may not achieve or sustain profitability, which would adversely affect our business, prospects, financial condition and results of operations.

In addition, given the similarity of ABP-450 to Jeuveau®, any adverse developments with respect to Jeuveau®, including adverse events or changes in regulatory status, may also directly impact the development, commercialization or regulation of ABP-450, if approved.

Even if we receive regulatory approval, coverage and adequate reimbursement may not be available for ABP-450, which could make it difficult for us to sell the product profitably.

Market acceptance and sales of ABP-450, if approved, will depend in part on the extent to which reimbursement for the product and related treatments will be available from third-party payors, including government health administration authorities, managed care organizations and other private health insurers.

Obtaining coverage and adequate reimbursement approval for a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products to the payor.

Third-party payors decide which therapies they will pay for and establish reimbursement levels. While no uniform policy for coverage and reimbursement exists in the United States, third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own coverage and reimbursement policies. However, decisions regarding the extent of coverage and amount of reimbursement to be provided for ABP-450 will be made on a payor-by-payor basis. Therefore, one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage, and adequate reimbursement, for the product or any related treatments. Additionally, a third-party payor’s decision to provide coverage for a therapy does not imply that an adequate reimbursement rate will be approved. Each payor determines whether or not it will provide coverage for a therapy, what amount it will pay the manufacturer for the therapy and on what tier of its formulary it will be placed. The position on a payor’s list of covered drugs and biological products, or formulary, generally determines the co-payment that a patient will need to make to obtain the therapy and can strongly influence the adoption of such therapy by patients and physicians. Patients who are prescribed treatments for their conditions and providers prescribing such services generally rely on third-party payors to reimburse all or part of the associated healthcare costs. Patients are unlikely to use our products unless coverage is provided and reimbursement is adequate to cover a significant portion of the cost of our products. In addition, because ABP-450 may be required to be physician-administered, separate reimbursement for the product itself may or may not be available. Instead, the administering physician may only be reimbursed for providing the treatment or procedure in which our product is used.

There may be significant delays in obtaining such coverage and reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product is approved by the FDA. Moreover, eligibility for coverage and reimbursement does not imply that a product will be paid for in all cases or at a rate that covers our costs, including research, development, intellectual property, manufacture, sale and distribution expenses. Interim reimbursement levels for new products, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement rates may vary according to the use of the product and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost products and may be incorporated into existing payments for other services. Net prices for products may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors, by any future laws limiting pharmaceutical prices and by any future relaxation of laws that presently restrict imports of product from countries where they may be sold at lower prices than in the United States.

Third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. We cannot be sure that coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement will be. Inadequate coverage and reimbursement may impact the demand for, or the price of, any product for which we obtain regulatory approval. If coverage and adequate reimbursement are not available, or are available only at limited levels, we may not be able to successfully commercialize ABP-450.

Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and we believe a continued emphasis on cost containment initiatives in Europe, Canada and other countries could continue to put pressure on the pricing and usage of our product candidates. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. Other countries allow companies to fix their own prices for medical products, but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the United States, the reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenue and profits.

Moreover, increasing efforts by governmental and third party payors in the United States and other jurisdictions to cap or reduce health care costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for our product candidates. We expect to experience pricing pressures in connection with the sale of any of our product candidates due to the trend toward managed health care, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on health care costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products.

Recently, CMS has commenced the third cycle of the Medicare Drug Price Negotiation Program established under the IRA, which is associated with the IPAY 2028 and, for the first time, may include drugs payable under Medicare Part B in addition to drugs covered under Medicare Part D. On January 27, 2026, CMS published the list of 15 selected drugs for IPAY 2028, which includes Botox®. CMS has stated that negotiations with participating manufacturers for this third cycle will occur during 2026 and that any negotiated MFPs will be effective beginning January 1, 2028, and CMS has issued program guidance describing the timing and milestones for the negotiation process, including the exchange of manufacturer-specific data, CMS offers and counteroffers, and publication of negotiated prices. Selection of Botox® for IPAY 2028 and any resulting MFP may affect reimbursement, utilization, contracting, pricing and access dynamics for botulinum toxin therapies, including therapies administered in physician offices and reimbursed under Medicare Part B, and could impact the size, attractiveness, and economics of the therapeutic Botox® market and related competitive markets, which could affect the pricing we may receive if approved. CMS’ Negotiation Program guidance indicates that, if CMS later determines that the statutory criteria for bona fide generic or biosimilar competition are met for a selected drug, the drug may be removed from the selected drug list and the MFP may cease to apply in subsequent years, subject to timing mechanics in CMS guidance.

Enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our products and may affect the prices we may set.

In the United States and other foreign jurisdictions, there have been, and we expect there will continue to be, a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or collectively the ACA, was enacted, which substantially changes the way healthcare is financed by both governmental and private insurers. Among the provisions of the ACA, those of greatest importance to the pharmaceutical and biotechnology industries include the following:

In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. For example, the Budget Control Act of 2011 has, among other things, led to aggregate reductions of Medicare payments to providers, which, due to subsequent legislative amendments to the statute, will remain in effect through 2032, with the exception of a temporary suspension from May 1, 2020 through March 31, 2022, unless additional action is taken by Congress. On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. In addition, the American Rescue Plan Act of 2021 was signed into law, which eliminated the statutory cap on drug manufacturers’ Medicaid drug rebate liability, beginning January 1, 2024. The rebate was previously capped at 100% of a drug’s average manufacturer price. These laws and any laws enacted in the future may result in additional reductions in Medicare and other health care funding, which could have a material adverse effect on our customers and accordingly, our financial operations.

Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS may develop new payment and delivery models, such as bundled payment models. In addition, recently there has been heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products. On August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare, with prices that can be negotiated subject to a cap; imposes rebates under Medicare Part B and Medicare Part D continue to penalize price increases that outpace inflation; and replaces the Part D coverage gap discount program with a new discounting program. The IRA permits the Secretary of the Department of Health and Human Services, or HHS, to implement many of these provisions through guidance, as opposed to regulation, for the initial years. HHS has and will continue to issue and update guidance as these programs are implemented. The full impact of the IRA on the pharmaceutical industry cannot yet be fully determined but is likely to be significant.

Under the Medicare Drug Price Negotiation Program established under the IRA, CMS published the negotiated prices for the initial ten drugs covered under Part D, which went into effect in January 2026, and for the subsequent 15 drugs, which will first be effective in 2027. CMS has also commenced the third cycle of the Medicare Drug Price Negotiation Program, which is associated with the IPAY 2028 and, for the first time, may include drugs payable under Medicare Part B in addition to drugs covered under Medicare Part D. On January 27, 2026, CMS published the list of 15 selected drugs for IPAY 2028, which includes Botox®. CMS has stated that negotiations with participating manufacturers for this third cycle will occur during 2026 and that any negotiated MFPs will be effective beginning January 1, 2028, and CMS has issued program guidance describing the timing and milestones for the negotiation process, including the exchange of manufacturer-specific data, CMS offers and counteroffers, and publication of negotiated prices. Selection of Botox® for IPAY 2028 and any resulting MFP may affect reimbursement, utilization, contracting, pricing and access dynamics for botulinum toxin therapies, including therapies administered in physician offices and reimbursed under Medicare Part B, and could impact the size, attractiveness, and economics of the therapeutic Botox® market and related competitive markets.

In 2026, the U.S. government also launched TrumpRx, a federal initiative to enable patients to gain access to certain prescription drugs at reduced costs based on pricing available in other countries (i.e., most-favored-nation pricing). In addition, the Trump administration is pursuing a two-fold strategy to reduce drug costs in the United States. While it is unclear whether and how the Trump proposals will be implemented, the Trump policies are likely to have a negative impact on the pharmaceutical industry and on our ability to receive adequate revenues for any product candidate that we commercialize. On the one hand, President Trump has threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the United States to the lowest price in a group of other countries. In response, multiple

manufacturers have entered into confidential pricing agreements with the federal government. On the other hand, the Trump administration is pursuing traditional regulatory pathways to impose drug pricing policies and published two proposed regulations in December 2025, referred to as Globe and Guard. If finalized, these regulations would implement mandatory payment models under which manufacturers of eligible drugs would be required to pay rebates to the federal government on a portion of the units of their drugs that are reimbursed by Medicare, with the rebate amount based on most favored nation pricing. While the impact of the Globe and Guard proposed regulations, if finalized, cannot yet be determined, it is likely to be significant. Even regulatory proposals or executive actions that are ultimately deemed unlawful could negatively impact the U.S. pharmaceutical sector and our business.

We expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. federal government will pay for healthcare products and services, which could result in reduced demand for ABP-450, if approved, or additional pricing pressures.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, marketing cost disclosure, drug price reporting and other transparency measures. Some states have enacted legislation creating so-called prescription drug affordability boards with the goal of imposing price limits on certain drugs in these states, and at least one state board is imposing an upper payment limit. States are also seeking to implement general, across the board price caps for pharmaceuticals, or are seeking to regulate drug distribution. Some measures are designed to encourage importation from other countries and bulk purchasing. Legally mandated price controls on payment amounts by third-party payors or other restrictions could harm our business, results of operations, financial condition and prospects. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs. This could reduce the ultimate demand for our products or put pressure on our product pricing.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we or our collaborators are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or our collaborators are not able to maintain regulatory compliance, our products may lose any regulatory approval that may have been obtained and we may not achieve or sustain profitability.

ABP-450, if approved, will face significant competition and our failure to effectively compete may prevent us from achieving significant market penetration and expansion.

The pharmaceutical industry is highly competitive and requires an ongoing, extensive search for technological innovation. It also requires, among other things, the ability to effectively discover, develop, test and obtain regulatory approvals for novel products, as well as the ability to effectively commercialize, market and promote approved products, including communicating the effectiveness, safety and value of products to actual and prospective customers and medical professionals. Numerous companies are engaged in the development, manufacture and marketing of products competitive with those that we are developing.

Our primary competitors for ABP-450 in the injectable botulinum toxin pharmaceutical market for therapeutic use are:

We are also aware of competing botulinum toxins currently being developed or commercialized in the United States, European Union, Asia, South America and other markets. While some of these products may not meet United States regulatory standards, the companies operating in these markets may be able to produce products at a lower cost than United States and European manufacturers. In addition to the injectable botulinum toxin dose forms, we are aware that other companies are developing topical botulinum toxins for therapeutic indications. We will also face competition in our target therapeutic markets from other pharmaceutical products.

As more companies develop new intellectual property in our markets, the possibility of a competitor acquiring patent or other rights that may limit our products or potential products increases, which could lead to litigation. In addition to product development, testing, approval and promotion, other competitive factors in the pharmaceutical industry include industry consolidation, product quality and price, product technology, reputation, customer service and access to technical information.

If we are unable to establish sales and marketing capabilities on our own or through third parties, we will be unable to successfully commercialize ABP-450, if approved, or generate product revenue.

We do not have a sales or marketing infrastructure and have little experience in the sale, marketing, or distribution of pharmaceutical products. To successfully commercialize ABP-450, if approved, in the United States and other jurisdictions we may seek to enter, we will need to build out our sales and marketing capabilities, either on our own or with others. The establishment and development of our own commercial team or the establishment of a contract sales force to market ABP-450 will be expensive and time-consuming and may divert significant management focus and resources, potentially delaying any product launch. Moreover, we cannot be certain that we will be able to successfully develop this capability, given that we have no experience as a company in commercializing products. We may seek to enter into collaborations with other entities to utilize their established marketing and distribution capabilities, but we may be unable to enter into or maintain such agreements on favorable terms or at all. We can provide no assurance that any future collaborators will provide effective sales forces or marketing and distribution capabilities. We compete with many companies that currently have extensive, experienced and well-funded marketing and sales operations to recruit, hire, train and retain marketing and sales personnel, and will have to compete with those companies to recruit, hire, train and retain any of our own marketing and sales personnel. We will likely also face competition if we seek third parties to assist us with the sales and marketing efforts of ABP-450. Without an internal team or the support of a third party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.

As of December 31, 2025, we had eight employees. If ABP-450 receives regulatory approval, we expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of research, development, regulatory affairs, sales, marketing and distribution. In addition, we also expect to hire additional personnel in order to operate as a public company. To manage our anticipated future growth, we must continue to implement and improve our managerial, operational and financial systems, expand our facilities, and continue to recruit and train additional qualified personnel. In addition, we must effectively integrate, develop and motivate a growing number of new employees, and maintain the beneficial aspects of our corporate culture. The expansion of our operations may lead to significant costs and may divert our management and business development resources. We may not be able to effectively manage the expansion of our operations or recruit and train additional qualified personnel. Any inability to manage growth could delay the execution of our development and strategic objectives or disrupt our operations.

We currently rely, and for the foreseeable future will continue to rely, in substantial part on third parties, including independent organizations, advisors and consultants, and CROs to provide certain services to support and perform our operations. There can be no assurance that the services of these third parties will continue to be available to us on a timely basis when needed, or that we can find qualified replacements. In addition, if we are unable to effectively manage our outsourced activities or if the quality, accuracy or quantity of the services provided, in particular the services provided by our CROs, is compromised for any reason, our clinical studies may be delayed or terminated, and we may not be able to obtain, or may be substantially delayed in obtaining, regulatory approval of ABP-450 or otherwise advance our business. There can be no assurance that we will be able to manage our existing consultants or find other suitable outside contractors and consultants on economically reasonable terms, or at all.

Our employees, independent contractors, consultants, commercial collaborators, principal investigators, vendors and other agents may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.

We are exposed to the risk that our employees, independent contractors, consultants, commercial collaborators, principal investigators, vendors and other agents may engage in fraudulent conduct or other illegal activity. Misconduct by these parties could include intentional, reckless or negligent conduct or disclosure of unauthorized activities to us that violates applicable regulations, including those laws requiring the reporting of true, complete and accurate information to regulatory agencies, manufacturing standards, and federal and state healthcare laws and regulations. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. We could face liability under the federal Anti-Kickback Statute and similar state laws. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, referrals, customer incentive programs and other business arrangements. Misconduct by these parties could also involve the improper use of individually identifiable information, including, without limitation, information obtained in the course of clinical studies, which could result in significant regulatory sanctions and serious harm to our reputation. Further, should violations include promotion of unapproved (off-label) uses of one or more of our products, we could face significant regulatory sanctions for unlawful promotion, as well as substantial penalties under the federal False Claims Act, or FCA, and similar state laws. Similar concerns could exist in jurisdictions outside of the United States as well. It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, imprisonment, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of noncompliance with these laws, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business, financial condition and results of operations.

Our potential international operations will expose us to risks, and failure to manage these risks may adversely affect our operating results and financial condition.

We expect to have operations both inside and outside the United States if ABP-450 is approved for commercial sale in multiple jurisdictions. International operations are subject to a number of inherent risks, and our future results could be adversely affected by a number of factors if we seek and obtain the necessary approvals, including:

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of ABP-450.

We face an inherent risk of product liability as a result of the clinical testing of ABP-450 and will face an even greater risk if we commercialize any products. For example, we may be sued if any product we develop allegedly causes injury or is found to be otherwise unsuitable during product testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability and a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our products. Even a successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

Although we maintain such insurance, any claim that may be brought against us could result in a court judgment or settlement in an amount that is not covered, in whole or in part, by our insurance or that is in excess of the limits of our insurance coverage. Our insurance policies also have various exclusions and deductibles, and we may be subject to a product liability claim for which we have no coverage. We will have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Moreover, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses. If and when we obtain approval for marketing ABP-450, we intend to expand our insurance coverage to include the sale of ABP-450; however, we may be unable to obtain this liability insurance on commercially reasonable terms.

If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop ABP-450, conduct our clinical studies and commercialize ABP-450.

Our success depends in part on our continued ability to attract, retain and motivate highly qualified management. We believe that our future success is highly dependent upon the contributions of our senior management, particularly Robert Bancroft, our Chief Executive Officer, as well as other members of our senior management team. The loss of services of any of these individuals could delay or prevent the successful development of our product pipeline, completion of our planned clinical studies or the commercialization of ABP-450 or any future products we develop.

In addition, we could experience difficulties attracting and retaining qualified employees in the future. For example, competition for qualified personnel in the pharmaceuticals field is intense due to the limited number of individuals who possess the skills and experience required by our industry. We may not be able to attract and retain quality personnel on acceptable terms, or at all. In addition, to the extent we hire personnel from competitors, we may be subject to allegations that they have been improperly solicited or that they have divulged proprietary or other confidential information or that their former employers own their research output.

Our business involves the use of hazardous materials, and we and our third-party manufacturer and supplier must comply with environmental laws and regulations, which can be expensive and restrict how we do business.

Our R&D and manufacturing activities in the future may, and Daewoong’s manufacturing and supplying activities presently do, involve the controlled storage, use and disposal of hazardous materials, including botulinum toxin type-A, a key component of ABP-450, and other hazardous compounds. We and Daewoong are subject to laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. In some cases, these hazardous materials and various wastes resulting from their use are stored at Daewoong’s facilities pending their use and disposal. We and Daewoong cannot eliminate the risk of contamination, which could cause an interruption of Daewoong’s manufacturing processes, our commercialization efforts or our business operations and could cause environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. Although we believe that the safety procedures utilized by Daewoong for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, this may not eliminate the risk of accidental contamination or injury from these materials. In such an event, we may be held liable for any resulting damages and such liability could exceed our resources, and state or federal or other applicable authorities may curtail our use of certain materials and interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent.

Under Sections 382 and 383 of the Code, if a corporation undergoes an “ownership change,” generally defined as a greater than 50 percentage point change (by value) in its equity ownership by one or more 5% shareholders over a rolling three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards, or NOLs, and other pre-change tax attributes, such as research tax credits, to offset its post- change taxable income or income tax liabilities, as applicable, may be limited. As of December 31, 2025 and 2024, the Company had federal net operating loss (“NOL”) carryforwards of $140.5 million and $112.1 million, respectively, which will begin to expire in 2036. The Company had state NOLs of $141.1 million and $140.5 million as of December 31, 2025 and 2024, respectively, which will begin to expire in 2034. As of December 31, 2025 and 2024, the Company has federal R&D credit carryforwards of $7.1 million and $6.9 million, respectively, which will begin to expire in 2039. As of December 31, 2025 and 2024, the Company also has California R&D credit carryforwards of $5.2 million and $5.0 million, respectively, which have an indefinite carryforward period. We may experience ownership changes in the future as a result of subsequent shifts in our stock ownership. As a result, if we earn net taxable income, our ability to use our pre-change NOLs to offset federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to us. Similar rules may apply under state tax laws. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed.

Changes in tax laws may impact our future financial position and results of operations.

New income, sales, use or other tax laws, statutes, rules, regulations or ordinances could be enacted at any time, or interpreted, changed, modified or applied adversely to us, any of which could adversely affect our business operations and financial performance. We are currently unable to predict whether such changes will occur and, if so, the ultimate impact on our business. To the extent that such changes have a negative impact on us or our suppliers, including as a result of related uncertainty, these changes may materially and adversely impact our business, financial condition, results of operations and cash flows.