We are offering a total of    Class A ordinary shares, CHF 0.006 par value, of vVARDIS Holding AG, and the selling shareholders disclosed in this prospectus are offering an additional       Class A ordinary shares of vVARDIS Holding AG. We will not receive any proceeds from the sale of the Class A ordinary shares by the selling shareholders.

The underwriters may also purchase up to    Class A ordinary shares from us and an additional      Class A ordinary shares from the selling shareholders within 30 days to cover over-allotments, if any.

Immediately prior to the completion of this offering, we will convert our existing share capital into two classes of authorized ordinary shares: Class A ordinary shares and Class B voting rights shares. In connection with this conversion, each ordinary share outstanding immediately prior thereto will be converted into either one Class A ordinary share or ten Class B voting rights shares. Following such conversion, each Class A ordinary share and each Class B voting rights share will carry one vote per share. Class A ordinary shares will have a par value of CHF 0.006 per share and Class B voting rights shares will have a par value of CHF 0.0006 per share. As a result, although each share carries one vote, because the Class B voting rights shares have a lower par value, each Class B voting rights share will have ten times the voting power of each Class A ordinary share on a per-par-value (“capital-invested”) basis. The Class B voting rights shares will also be subject to transfer restrictions and mandatory conversion into Class A ordinary shares upon the occurrence of certain events, including upon the occurrence of certain “individual sunset” events, including, but not limited to, such time that (x) a Founder (as defined below) ceases to hold at least 10% of the number of Class B voting rights shares held by such individual immediately following this offering; and (y) a Founder is no longer acting as a member of the executive committee of the Company or serving in an advisory role with the Company or its controlled affiliates, subject, in the case of the “individual sunset” events, to the right of first refusal of the other Founder to purchase such Class B voting rights shares. Class A ordinary shares and Class B voting rights shares will be identical in all other respects. See “Description of Share Capital and Articles of Association.” All of the Class B voting rights shares will be beneficially owned by Haley Abivardi and Goly Abivardi (our “Founders” and each, a “Founder”). Accordingly, following this offering, our Founders will control ordinary shares representing   % of the total voting power of our share capital, assuming no exercise of the underwriters’ option to purchase Class A ordinary shares to cover over-allotments. Accordingly, our Founders will be able to significantly influence any action requiring the approval of shareholders, including the election of our board of directors, the adoption of amendments to our amended and restated articles of association (the “Amended and Restated Articles of Association”) and any significant corporate transaction. For more information about our share capital, see the section titled “Description of Share Capital and Articles of Association.”

We expect that the initial public offering price will be between $   and $   per Class A ordinary share. We intend to list our Class A ordinary shares on the New York Stock Exchange (the “NYSE”) under the symbol “VVVV.”

Neither the U.S. Securities and Exchange Commission (the “SEC”) nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

We are an “emerging growth company” under the U.S. federal securities laws and we have elected to take advantage of certain reduced public company reporting requirements for this prospectus and future filings. Additionally, we are a “foreign private issuer” under applicable rules of the SEC and a “controlled company” within the meaning of the NYSE corporate governance standards. As a result, we may elect to observe reduced public company disclosure and corporate governance requirements. See “Prospectus Summary—Implications of Being an Emerging Growth Company,” “—Implications of Being a Foreign Private Issuer,” and “—Controlled Company Status,” respectively.

Investing in our Class A ordinary shares involves risks. See “Risk Factors” beginning on page 20 of this prospectus.

The underwriters expect to deliver the Class A ordinary shares against payment in New York, New York on or about   , 2026.

Through and including   , 2026 (the 25th day after the date of this prospectus), all dealers effecting transactions in these securities, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealers’ obligation to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.

Neither we, the selling shareholders nor any of the underwriters have authorized anyone to provide you with any information or to make any representations other than those contained in this prospectus or in any free writing prospectus we have prepared and filed with the SEC. We, the selling shareholders and the underwriters take no responsibility for, and can provide no assurance as to the reliability of, any other information that others may give you. This prospectus is an offer to sell Class A ordinary shares only under the circumstances and in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of the Class A ordinary shares. Our business, financial condition, results of operations and future prospects may have changed since such date.

For investors outside of the United States: Neither we, the selling shareholders nor any of the underwriters have done anything that would permit this offering or possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside of the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the Class A ordinary shares and the distribution of this prospectus outside of the United States.

Unless otherwise indicated or the context otherwise requires, all references in this prospectus to “vVARDIS,” “vVARDIS Holding AG,” the “Company,” “we,” “our,” “ours,” “us” or similar terms refer to vVARDIS Holding AG, together with its subsidiaries. References to the “selling shareholders” are to Haley Abivardi and Goly Abivardi.

Our fiscal year ends on December 31 of each year. We present our consolidated financial statements in U.S. dollars. Certain of our subsidiaries maintain their books and records in their local currencies, including CHF, GBP and EUR, which are the primary currencies of the economic environment in which their respective operations are conducted. The results of such subsidiaries are subsequently translated to U.S. dollars.

Unless otherwise indicated, all financial information contained in this prospectus is prepared and presented in accordance with accounting principles generally accepted in the United States (“GAAP”). Our financial information should be read in conjunction with the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements, including the notes thereto, included elsewhere in this prospectus.

The audited consolidated financial statements prepared in accordance with GAAP have been audited by Deloitte AG, as stated in its report included elsewhere in this prospectus.

In this prospectus, we also present certain financial information for the last six months ended June 30, 2026. Such financial information has not been audited, is not required by or presented in accordance with GAAP and has been prepared for illustrative purposes only. It has been derived by subtracting our historical unaudited consolidated financial data for the six months ended June 30, 2025, from our historical consolidated financial data for the year ended December 31, 2025, and then adding our historical interim consolidated financial data for the six months ended June 30, 2026.

Historical financial information, including share and per share amounts, included in this prospectus reflects our capital structure prior to the implementation of the dual-class structure, which will become effective upon the effectiveness of our Amended and Restated Articles of Association immediately prior to the completion of this offering. Accordingly, the historical financial statements included in this prospectus do not reflect the reclassification of our outstanding share capital into Class A ordinary shares and Class B voting rights shares.

All references to “U.S. dollars,” “dollars” or “$” are to the U.S. dollar. All references to “CHF” or “Swiss franc” are to the legal currency of Switzerland.

We use Adjusted EBITDA, a non-GAAP financial measure, to supplement our consolidated financial statements, which are presented in accordance with GAAP. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Non-GAAP Financial Measures” for our definition of this non-GAAP financial measure, information about how and why we use it and a reconciliation to its most directly comparable financial measure calculated in accordance with GAAP.

We have made rounding adjustments to some of the figures included in this prospectus. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that preceded them. With respect to financial information set out in this prospectus, a dash (“—”) signifies that the relevant figure is not available or not applicable, while a zero (“0.0”) signifies that the relevant figure is available but is or has been rounded to zero.

This prospectus includes trademarks, trade names and service marks, certain of which belong to us and others that are the property of other organizations. Solely for convenience, trademarks, trade names and service marks referred to in this prospectus appear without the ®, TM and SM symbols, but the absence of those symbols is not intended to indicate, in any way, that we will not assert our rights, or that the applicable owner will not assert its rights, to these trademarks, trade names and service marks to the

fullest extent under applicable law. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties.

This prospectus includes estimates regarding market and industry data. Unless otherwise indicated, information concerning our total addressable market (“TAM”), serviceable addressable market (“SAM”), industry and the markets in which we operate, including our general expectations, market position and market opportunity, are based on our management’s knowledge and experience in the markets in which we operate, together with currently available information obtained from various sources, including publicly available information, industry reports and publications, surveys, business organizations and other contacts in the markets in which we operate.

The content of such sources, except to the extent specifically set forth in this prospectus, does not constitute a portion of this prospectus and is not incorporated into this prospectus by reference. Governmental and industry publications and other market sources, including those referred to in this prospectus, generally state that the information they include has been obtained from sources believed to be reliable, but that the accuracy and completeness of such information is not guaranteed. Although we have no reason to believe that any of this information or these reports are inaccurate in any material respect and believe and act as if they are reliable, neither we, the underwriters, nor their respective affiliates or agents have independently verified it.

Certain information in this prospectus is based on management estimates, which have been derived from third-party sources, as well as data from our internal research, and are based on certain assumptions that we believe to be reasonable. Except to the extent specifically set forth in this prospectus, the data that we compile internally and our estimates have not been verified by an independent source.

See also “Cautionary Statement Regarding Forward-Looking Statements.”

Our TAM and SAM calculations are based on an estimated total U.S. population of approximately 342 million, based on data from the U.S. Census Bureau and the World Bank. We estimate that approximately 63-65% of the U.S. population visits a dentist at least once per year, based on analyses by the National Center for Health Statistics and the CDC.

For TAM, we apply our prevalence assumptions to the full U.S. population, including the approximately 35% to 37% who do not visit a dentist annually, and assume that early-stage cavity prevalence in non-dental visitors is at least as high as in the dental-visiting population. For SAM, we apply an annual dental visitation rate of approximately 65% to reflect the subset of the population that visits a dentist at least once per year.

Based on our review of clinical and academic literature and data from our partners, we estimate that approximately 75% to 85% of the U.S. population has at least one early-stage cavity. We use this same prevalence range in both our TAM and SAM calculations. This estimate does not refer to the 2.5 billion people globally affected by tooth decay cited elsewhere in this prospectus; that figure reflects cavitated (advanced) cavities assessed under WHO surveillance methodology, whereas our estimate is specific to early-stage, enamel-only cavities detectable through dental X-rays and clinical examination. In developing this range, we considered the following material literature:

We selected Skeie et al. as the primary reference point because it used the most comprehensive detection methodology among the studies we reviewed. Because that study focused on adolescents, we supplemented it with the child and adult studies below to estimate a 75% to 85% range across the broader population. Although the principal studies are European, we believe they are directionally supported in the United States by Autio-Gold et al. and by proprietary data from our AI diagnostic partners and major customers.

We estimate that affected patients have, on average, approximately 4.6 early-stage cavities. Because we are not aware of a large-scale pooled review addressing cavities per patient, we relied on individual studies that assessed all tooth surfaces using both clinical examination and dental X-rays. Key studies informing our estimate include:

We weighted these figures based on the proportion of the U.S. population in each age group using U.S. Census Bureau data, which yielded an estimate of 4.6 early-stage cavities per affected patient. We adjust this figure downward by approximately 9% to reflect that approximately 75% of early-stage cavities occur between adjacent teeth, which we refer to as interproximal, based on data from Martignon et al. (2010), Jacobsen et al. (2019), Isaksson et al. (2013) and Talabani et al. (2015), and that approximately 25% of those interproximal cavities involve both surfaces of the same gap between two teeth, based on data from Yilmaz et al. (2025), Kirthiga et al. (2023), Cho et al. (2021) and Dean et al. (1997). Taken together, this means that approximately 18.75% of early-stage cavities involve both surfaces of the same gap between two teeth. Because a single application of our product is often used to treat both surfaces at once, those dual-surface cavities are counted once for treatment purposes rather than twice. This results in an estimate of approximately 4.2 treatable early-stage cavities per affected patient, which we use in both our TAM and SAM calculations.

We estimate that dentists detect approximately 65% to 69% of early-stage cavities without AI assistance. Our TAM assumes a 100% detection rate, meaning all early-stage cavities are identified. Our SAM applies the lower 65% to 69% detection rate and therefore reflects only cavities that are currently identified and clinically managed.

We derived the 65% to 69% unaided detection range from the ADEPT clinical study (Devlin et al., 2021), in which dentists without AI assistance detected 44.3% of interproximal early-stage cavities compared to 75.8% with AI assistance. Based on these results, we estimate that dentists detect approximately 58% of interproximal early-stage cavities without AI assistance. Interproximal cavities represent approximately 75% of all early-stage cavities and are often missed because they are visible only on dental X-rays. For cavities on other tooth surfaces, which represent approximately 25% of early-stage cavities and are generally identifiable through visual examination, we estimate detection rates of approximately 86%, based on a systematic review of visual cavity detection methods conducted by Macey et al. (2021), to 100%, which we use as a conservative upper bound. Weighting these rates produces an overall unaided detection estimate of approximately 65% to 69%. Applying the prevalence, visitation, detection and number of affected teeth assumptions described in this section to the U.S. population, we estimate a SAM of at least 450 million treatable early-stage cavities.

We estimate that broader adoption of AI-powered diagnostic tools could increase early-stage cavity identification by approximately 30% to 40% relative to unaided clinical assessment. This estimate is further supported by data from FDA 510(k) clearance submissions for two leading AI-powered dental diagnostic solutions, each of which independently observed detection improvements consistent with this range: Overjet Caries Assist (K212519, 2022), in which cavity detection improved from 57.9% to 76.2% with AI assistance (an approximately 32% relative improvement), and Videa Caries Assist (2022), in which the number of missed cavities was 43% lower for dentists using the AI-assisted solution. Because our current SAM does not include any assumed increase in detection from AI adoption, we believe broader AI adoption could expand our market opportunity by more than 30%, particularly if improved detection is accompanied by higher patient treatment acceptance through AI-enabled workflows observed by our partners. However, this potential expansion is not included in our current SAM estimate.

Our pricing assumptions are based on the prices at which we currently sell our products in the United States, whether directly or through distributors. Our estimates assume that dental professionals use our products in accordance with their intended use and recommended application protocols, including one application of Curodont® per early-stage cavity. Actual utilization may differ from these assumptions, including where one application is used to treat cavities on neighboring teeth, which could reduce per-cavity product consumption. See “Risk Factors—Risks Related to Our Business and Industry—The market opportunities for our products may be smaller than we estimate.”

Our TAM and SAM estimates are based on several additional assumptions. They assume no material change in provider behavior based on the availability of new cavity treatment options, except that our discussion of potential AI-driven market expansion is presented separately and is not included in our current SAM. They assume no change in the current regulatory framework applicable to our products, including the classification of Curodont® Repair Fluoride Plus as an OTC drug product under the FDCA. See “—Government Regulation—Regulation of Our Products—United States.”

This prospectus contains forward-looking statements. All statements contained in this prospectus other than statements of historical fact, including statements regarding our future operating results and financial position, our business strategy and plans, market growth and our objectives for future operations, are forward-looking statements. The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “could,” “would,” “project,” “target,” “plan,” “expect,” “predict,” “potential” or the negative of these words or other similar terms or expressions that concern our expectations, strategy, plans or intentions are intended to identify forward-looking statements.

Forward-looking statements contained in this prospectus include, but are not limited to, statements about:

We caution you that the foregoing list may not contain all of the forward-looking statements made in this prospectus.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in the section titled “Risk Factors.” Moreover, we operate in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for us to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this prospectus may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

You should not rely upon forward-looking statements as predictions of future events. The events and circumstances reflected in the forward-looking statements may not be achieved or occur. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, performance or achievements. The forward-looking statements made in this prospectus relate only to events as of the date on which the statements are made. We undertake no obligation to update any of these forward-looking statements for any reason after the date of this prospectus or to conform these statements to actual results or to changes in our expectations, except as required by law.

In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this prospectus, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.

You should read this prospectus and the documents that we reference in this prospectus and have filed with the SEC as exhibits to the registration statement of which this prospectus is a part with the understanding that our actual future results, performance, and events and circumstances may be materially different from what we expect. We qualify all of the forward-looking statements in this prospectus by these cautionary statements.

Investing in our Class A ordinary shares involves a high degree of risk. You should consider carefully the risks and uncertainties described below, together with all of the other information in this prospectus, including the section titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and the accompanying notes included elsewhere in this prospectus before deciding whether to invest in our Class A ordinary shares. The risks and uncertainties described below are not the only ones we face. Additional risks and uncertainties that we are unaware of or that we deem immaterial may also become important factors that adversely affect our business. If any of the following risks actually occur, our business, results of operations, financial condition and future prospects could be materially and adversely affected. In that event, the market price of our Class A ordinary shares could decline, and you could lose part or all of your investment.

This prospectus also contains forward-looking statements that involve risks and uncertainties. See “Cautionary Statement Regarding Forward-Looking Statements.” Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain factors, including the risks facing our company or investments worldwide described below and elsewhere in this prospectus.

Our commercial success depends on increasing awareness of, and achieving and maintaining market acceptance for, our existing and future products, in particular our flagship Curodont® products. Curodont® Repair and Curodont® Repair Fluoride Plus employ a novel peptide-based technology that represents a meaningfully different approach to cavity management than traditional preventative or invasive dental cavity treatments. As a result, while many dental professionals, dental support organizations (“DSOs”), patients and payors may already recognize the clinical benefits of our products, we must continue to expand awareness of our Curodont® technology platform and its role in treating early-stage cavities. This means that we face the challenge of establishing a new category of treatment within the existing, long established clinical practice paradigm. Changing established clinical habits among dental professionals requires sustained investment in education, clinical evidence and key opinion leader advocacy. Although our existing products have recently gained market acceptance in certain of our target markets, in particular in the United States, we cannot predict whether such acceptance will continue to increase or expand into additional markets or whether there will be sufficient awareness of our existing and future products to support our expansion and drive sales. In addition, market acceptance may develop more slowly than we anticipate, particularly in markets where dental reimbursement systems do not cover non-invasive restorative treatments or where awareness of our Curodont® technology platform is limited.

Both patients and dental professionals must be aware of our products and believe that our products offer meaningful clinical benefits over other available alternatives. Because Curodont® Repair and Curodont® Repair Fluoride Plus address early-stage cavities through a non-invasive restorative approach rather than drilling and filling, achieving market acceptance requires dental professionals and DSOs to adopt a different clinical mindset, which can be a slow and resource-intensive process. In particular, we believe our Curodont® technology platform represents a new and differentiated category of treatment for early-stage cavities. As a result, awareness and understanding of our technology among patients, dentists, hygienists, DSOs, payors and other stakeholders may be limited. Many dental professionals have been trained and have practiced for years using traditional preventative and restorative approaches and may be unfamiliar with, skeptical of, or slow to adopt our products. Patients likewise may not be aware that early-stage cavities can be treated through a non-invasive restorative approach rather than drilling and filling and generally rely on recommendations from their dental providers. Accordingly, achieving widespread adoption may require substantial investments in clinical education, training, scientific publications, marketing and evidence generation, and there can be no assurance that such efforts will be successful or result in broad acceptance of our products.

In addition, because our flagship Curodont® products represent a new approach to cavity management rather than an extension of existing preventative or invasive treatment options, dental

professionals may take significant time to adopt our products into their clinical practice, even after becoming aware of them. This may be particularly true for smaller, independent dental offices, which represent a significant portion of our target customer base and which may be more cautious in adopting new treatment modalities than larger practices or DSOs with greater resources to evaluate new technologies. Dentists at these practices may want to observe real-world clinical outcomes in their own patients before broadly incorporating our flagship Curodont® products into their treatment protocols. Because cavity progression and remineralization occur over time, such outcomes may not be apparent until a patient’s next scheduled check-up, which is often six months or more after initial treatment. As a result, the sales cycle for converting awareness into sustained adoption may be longer than we anticipate.

The degree of market acceptance of our products depends on a number of additional factors, some of which may not be entirely within our control, including:

Additionally, even if our products achieve widespread market acceptance, they may not maintain that market acceptance over time if more cost-effective or more favorably received products, services or technologies are introduced. In particular, the development of competing remineralization technologies, next-generation fluoride-based treatments, AI-assisted cavity detection platforms that interface with competing treatment products, or new pharmaceutical or other approaches to cavity prevention and/or treatment could render our products less competitive or commercially obsolete. Failure to achieve or maintain market acceptance and/or market share would limit our ability to generate revenue.

In addition, our customer base includes oral surgeons, dental specialists, general dentists, dental laboratories and other dental organizations, including DSOs, as well as educational, medical and governmental entities and third-party distributors. In 2025 and 2024, most of our revenue came from sales

in the United States. Our success will depend on our ability to increase our market penetration among these customers and expand our customer base across various markets and geographies by enhancing our current product portfolio and developing new products.

Historically, a significant portion of our growth has been driven by sales to DSOs, and we expect DSOs to remain an important component of our sales and distribution strategy going forward. Sales made to DSOs represented approximately 65%, 60% and 60% of our products sold by our distributors in the years ended December 31, 2024 and 2025 and the last six months ended June 30, 2026. As a result, our market penetration and operating results are materially influenced by our ability to establish and maintain relationships with these organizations. The DSO market is competitive and continues to evolve through consolidation, which may increase the purchasing leverage of larger organizations, intensify pricing pressure, lengthen sales cycles, require more favorable commercial terms and increase customer concentration. As DSOs grow larger through consolidation, they may also further centralize purchasing decisions, which could reduce the number of decision-makers we must engage with, lengthen the time required to negotiate and finalize agreements, and increase the impact on our business if we are unable to maintain a relationship with any single, larger DSO. In addition, larger DSOs may have greater leverage to negotiate exclusivity arrangements, rebates, discounts or other concessions that could reduce our margins or limit our ability to do business with competing DSOs or independent dental practices. DSO consolidation and growth is often financed in part through significant leverage, including debt incurred by the DSOs themselves or by their private equity sponsors. As a result, the liquidity and creditworthiness of our DSO customers may be more sensitive to changes in interest rates, credit market conditions and broader economic downturns than that of independent dental practices. In periods of economic uncertainty or tightening credit conditions, highly leveraged DSO customers may face increased difficulty refinancing or servicing their debt, which could result in reduced purchasing, delayed payments or financial distress, any of which could adversely affect our revenue, increase our counterparty credit risk and negatively impact our results of operations.

We also intend to focus our efforts on entering into additional markets. Expansion into new markets may require us to obtain applicable regulatory clearances or approvals on a market-by-market basis, establish local distribution relationships, build key opinion leader networks and navigate reimbursement systems that vary significantly across geographies, many of which do not currently provide reimbursement for minimally invasive restorative dental treatments. We have limited experience operating in certain of these target markets and there can be no assurance that we will succeed in doing so on a cost-effective or timely basis, if at all. As we continue to scale our business, we may find that certain of our products, customers or markets may require a dedicated sales force or sales personnel with different experience than those we currently employ.

As we expand to additional markets, we will be required to obtain or maintain authorizations, registrations, licenses or listings from applicable regulators, or comply with local labeling, language, importer, quality, adverse-event, advertising, reimbursement and post-market requirements. These processes may be lengthy, costly and unpredictable, and marketing authorization, approval or clearance in other jurisdictions does not ensure approval, clearance, registration, listing or reimbursement in other jurisdictions.

There can be no assurance that we will be able to further penetrate our existing markets, that our existing markets will be able to sustain our current and future product offerings and that we will be able to expand into new markets. Any failure to increase penetration in our existing markets or expand into new ones may adversely affect our business, results of operations, financial condition and future prospects.

Historically, a substantial portion of our net revenue has come from a limited number of distributors, including our largest customer Henry Schein, which accounted for 72% and 70% of our sales in 2025 and 2024, respectively. We anticipate that Henry Schein will continue to be our largest distributor for the foreseeable future.

Our distribution agreement with Henry Schein (the “Master Distribution Agreement”) grants exclusive distribution rights of our products in the U.S. dental market throughout the term, subject to Henry Schein

achieving an initial threshold amount of new customers by December 31, 2027 (or, following a cure period, by June 30, 2028) and a second threshold amount of new customers by December 31, 2028. Henry Schein also has exclusive distribution rights in the United Kingdom until December 31, 2026, and nonexclusive distribution rights in jurisdictions outside the United States. The Master Distribution Agreement’s term is currently scheduled to expire on December 31, 2029, and automatically renews for one-year periods, unless terminated by either party in writing at least three months before the end of the initial term or applicable renewal term. There can be no assurance that we will be able to renew or extend the Master Distribution Agreement on commercially reasonable terms, or at all. The Master Distribution Agreement may also be terminated by either party if the other party is in material breach of its obligations under the Master Distribution Agreement and the breaching party fails to cure such material breach within 60 business days of receiving notice thereof, or immediately if the breaching party materially breaches the Master Distribution Agreement for a second time. Under the Master Distribution Agreement our obligations include (i) supplying our products to Henry Schein as requested, (ii) honoring Henry Schein’s exclusivity rights and (iii) maintaining a sales support team and providing product training. If we were to fail to materially honor any of our obligations, Henry Schein would have the right to terminate the agreement. Any dispute under the Master Distribution Agreement or with any of our other distributors could cause us to incur significant costs and could jeopardize our relationship with such distributor. The loss of our distributor relationships, including as a result of the termination of the Master Distribution Agreement, could adversely affect our ability to commercialize and distribute our products in the applicable markets.

We generally do not control the timing or quantity of purchases by our distributors, including Henry Schein, and our distributors are not obligated to purchase minimum quantities of our products. Should our distributors fail to order sufficient quantities of our products, our sole remedy is the termination of their distribution rights. There can be no assurance that Henry Schein or any other distributor will continue to purchase our products at historical levels, increase purchases over time or continue to distribute our products at all. Any significant reduction, delay or discontinuation in purchases by Henry Schein or any other distributor could adversely affect our business, results of operations, financial condition and future prospects.

Additionally, under the Master Distribution Agreement, our products are currently sold at a fixed price until January 1, 2027. As a result, we are unable to pass along any increase in the cost of production until January 1, 2027. Henry Schein is also entitled to the lowest available price to any similarly situated distributor (excluding certain DSO customers), which has the effect of limiting our flexibility to negotiate different prices with other distributors.

Our reliance on third-party distributors also reduces our visibility into end-customer demand and purchasing trends and limits our ability to directly influence sales and marketing activities. Distributors may not devote sufficient time, resources or attention to promoting our products and may prioritize competing products or product lines that they believe offer greater sales opportunities, higher margins or stronger strategic relationships. While we believe our Curodont® products currently receive significant focus and attention from Henry Schein and our other distributors as a result of their growth and market reception, there can be no assurance that this level of prioritization will continue. Many of our distributors, including Henry Schein, distribute products for numerous medical, dental and healthcare product companies, including companies that compete directly with us. If our distributors, including Henry Schein, favor competing products for any reason, including due to pricing considerations, competitive incentives, product performance, strategic priorities, sales force focus or contractual arrangements, our products may receive relatively less marketing support, reduced sales attention or less favorable positioning in the marketplace or our distributors may reduce the breadth of our products they carry or cease to distribute our products entirely. The loss of, or a significant reduction in, distribution through Henry Schein or any of our other key distributors could require us to identify and onboard alternative distributors or expand our direct sales efforts, which could be costly, time-consuming and may not be successful, and could result in a loss of sales and disruption to our business while any such transition is underway.

In addition, our distributors generally maintain significant discretion in determining the timing and level of inventory purchases and stocking decisions. As a result, our quarterly and annual operating results may fluctuate significantly due to changes in distributor inventory levels, purchasing patterns,

ordering cycles or efforts by distributors to reduce existing inventory. Distributors may purchase our products in anticipation of future demand, promotional activities or new product launches, which could artificially inflate sales in a particular reporting period, followed by reduced purchases in subsequent periods as inventory levels normalize. Conversely, distributors may reduce inventory levels or delay purchases during periods of economic uncertainty, weaker market demand or changing customer preferences. Such fluctuations may make our operating results difficult to predict and could contribute to significant volatility in our revenue and financial performance from period to period.

We are also subject to risks arising from the financial condition and operational performance of our distributors and key customers. If any distributor or key customer experiences financial difficulties, liquidity constraints, operational disruptions, restructuring, bankruptcy or other adverse developments, such distributor or key customer may reduce purchases from us, delay payments owed to us or cease operations entirely. In addition, consolidation within the healthcare distribution industry could increase the purchasing leverage of large distributors and intensify pricing pressure, reduce our negotiating leverage and increase customer concentration risks.

Further, because our distributors are often the primary point of contact with dental offices, any failure by our distributors to provide adequate customer support, training, technical assistance or regulatory compliance could negatively affect customer satisfaction and market acceptance of our products, even where such issues are outside our direct control. Any reputational harm resulting from distributor conduct, including noncompliance with applicable healthcare, anti-bribery, anti-kickback, promotional or data privacy laws, could adversely affect our business and expose us to regulatory scrutiny or liability.

We also face risks related to concentration among the end-customers who ultimately purchase our products through our distribution channel. Historically, a significant portion of our products that Henry Schein sells has been purchased by a limited number of DSOs and dental practices. For example, among those sales, Heartland accounted for 31% and 51% during the years ended December 31, 2025 and 2024, respectively. As a result, adverse developments affecting one or more of these key end-customers, including reduced purchasing volumes, changes in clinical or procurement preferences, financial distress or the loss of the relationship entirely, could disproportionately affect demand for our products, even though we do not sell directly to these end-customers and may have limited visibility into, or control over, our distributors’ relationships with them. Because we do not have direct contractual relationships with many of these end-customers, we may have limited ability to anticipate or respond to changes in their purchasing behavior, and our distributors may not have an obligation, or may be unwilling, to share information with us regarding end-customer concentration or purchasing trends. Further consolidation among DSOs, or the loss of or reduction in purchasing by any significant end-customer such as Heartland could adversely affect our business, financial condition, results of operations and future prospects.

As we continue to expand internationally, we expect to increasingly rely on third-party distributors in additional jurisdictions. International distribution arrangements may involve additional risks, including reduced operational oversight, challenges associated with managing geographically dispersed relationships, differing regulatory requirements, import and export restrictions, currency fluctuations and political or economic instability. We may also face difficulties identifying and retaining qualified distributors with the necessary capabilities, relationships and regulatory expertise in new markets. If we are unable to maintain and expand our relationships with existing distributors, identify and onboard additional qualified distributors or effectively manage our distributor network, our business, financial condition, results of operations and future prospects could be adversely affected.

Our future sales will depend in large part on our ability to develop, train, retain and substantially expand our sales force, to increase the scope of our marketing efforts, including into markets and geographies where our presence is currently limited or does not exist, and to maintain and expand our strategic relationships with distributors, suppliers and other stakeholders. Our current customer base is large and diverse and includes oral surgeons, dental specialists, general dentists, dental laboratories and other dental organizations, including DSOs, as well as educational, medical and governmental entities and third-party distributors. As a result, we believe it is necessary to continue to develop a sales force that

includes sales representatives with specific technical backgrounds and industry expertise. Competition for such personnel is intense. We may not be able to attract and retain personnel or be able to continue to build and maintain an efficient and effective sales and marketing force, which could adversely impact sales of our products and their market acceptance and limit our revenue growth and potential profitability.

We currently offer our products through various global and local distributors, in particular Henry Schein. In addition, we have a direct sales force to market and sell our products. Sales and marketing activities in the healthcare space are subject to various rules and regulations. In addition, our marketing messaging can be complex and nuanced, and there may be errors or misunderstandings in our sales force’s communication of such messaging. As we continue to grow our sales and marketing efforts, we face an increased need to continuously monitor and improve our policies, processes and procedures to maintain compliance with a growing number and variety of laws and regulations. To the extent that there is any violation, whether actual, perceived or alleged, of our policies or applicable laws and regulations, we could incur additional training and compliance costs, receive inquiries from third parties or be held liable or otherwise responsible for such acts of noncompliance. Any of the foregoing could adversely affect our business, results of operations, financial condition and future prospects.

We intend to continue to expand and leverage our sales and marketing infrastructure. Identifying, recruiting and training qualified sales and marketing personnel requires significant time, expense and attention. It often takes several months or more before a sales representative is fully trained and productive, depending on the target market or geographies. Our sales force may subject us to higher fixed costs than those incurred by our competitors that utilize independent third parties, which could place us at a competitive disadvantage.

Our ability to increase our customer base and achieve broader market acceptance of our products will depend to a significant extent on our ability to expand our marketing efforts. We plan to dedicate significant resources to our marketing programs. However, marketing activities may not generate medical personnel awareness or increase revenue, and even if they do, any increase in revenue may not offset the costs and expenses we incur in building our brand. If we fail to successfully promote, maintain and protect our brand, we may fail to attract or retain the market acceptance necessary to realize a sufficient return on our brand building efforts, or to achieve the level of brand awareness that is critical for broad use of our products.

As we expand our product offerings and enter into new markets and geographies, we anticipate continued growth in our business operations, particularly in the areas of sales and marketing, research and development, clinical and regulatory affairs, manufacturing and supply chain management, quality assurance, finance, accounting, information technology and legal and compliance. To manage our anticipated growth effectively, we will need to continue to improve and expand our managerial, operational, financial and quality systems and controls, expand our facilities and infrastructure and continue to recruit, train, manage and retain qualified personnel. We may also need to integrate additional third-party manufacturers, distributors, service providers and other external partners into our operations as our business expands. Our inability to manage this growth effectively could adversely affect the quality of our products, our ability to satisfy customer demand, our regulatory compliance and our overall business performance.

Our anticipated growth could place significant strain on our management, personnel, systems and resources. In particular, as a medical products company operating in a highly regulated industry, our growth will require us to maintain and continuously enhance our quality management systems, internal controls, regulatory compliance capabilities and complaint handling, post-market surveillance and documentation processes. As our operations expand geographically and operationally, we may experience difficulties in maintaining consistent standards across our organization and among third-party manufacturers, suppliers and distributors. Failure to maintain effective quality systems or comply with applicable regulatory requirements could result in product defects, product recalls, inspection observations, warning letters, delays in regulatory approvals or clearances, loss of certifications or other enforcement actions by regulatory authorities, including the U.S. Food and Drug Administration (the “FDA”), the European Medicines Agency (the “EMA”) and comparable foreign regulatory agencies.

Our future growth will also depend on our ability to attract, integrate, motivate and retain highly skilled personnel, including personnel with expertise in product development, quality assurance, regulatory affairs, clinical operations, manufacturing, commercialization and finance. Competition for qualified personnel in the medical product and life sciences industries is intense, and we may not be successful in identifying, hiring, training or retaining such personnel on acceptable terms or at all. In addition, many of our employees may need to assume significantly expanded responsibilities as we grow, and our management team may not be able to effectively manage a larger and more complex organization.

As we continue to grow, we may also need to implement additional operational and financial systems, procedures and controls, including enterprise resource planning systems and other information technology infrastructure. These systems enhancements may be costly, time-consuming and disruptive to implement and may not operate as intended. Delays or deficiencies in the implementation of such systems could impair our ability to accurately forecast demand, manage inventory and production, fulfill customer orders on a timely basis, maintain adequate financial reporting and disclosure controls and otherwise support our operations.

In addition, our growth strategy may require substantial capital expenditures and additional operating expenses. If our revenue growth does not meet expectations or if we are unable to manage our costs effectively, our operating results and financial condition could be adversely affected. Rapid growth may also increase the complexity of our operations and increase the risk of operational failures, delays, inefficiencies or internal control deficiencies. Our management may need to divert a disproportionate amount of its attention from day-to-day operations to managing these expansion activities, which could adversely affect our ability to successfully execute our business strategy.

We rely, and expect to continue to rely, on third-party manufacturers, component suppliers, sterilization providers, warehousing and logistics providers and other third parties for the manufacture, processing, coating, sterilization, assembly, packaging, labeling, storage and distribution of our products and product components. Our manufacturing processes involve multiple specialized components and production steps, including, depending on the product and end-market, peptide manufacturing, coating processes, applicator components, fluoride droppers, sterilization activities, blister packaging and finished goods assembly. As we continue to develop and commercialize next-generation products and modified formulations, our manufacturing operations and supply chain may become increasingly complex and subject to additional operational and regulatory requirements.

We currently rely on a single third-party counterparty for certain key aspects of our manufacturing process, including the supply of peptide materials and certain coating and applicator-related manufacturing activities. While peptide materials are currently sourced through a single supplier relationship, that supplier maintains other production locations to which production could be shifted, and qualification processes in such regard are underway. We may not have formal supply agreements with all of these suppliers, and even where agreements exist, they may not require suppliers to allocate sufficient capacity to us or continue supplying us on commercially reasonable terms. There are a limited number of manufacturers with the technical capabilities, regulatory experience and production capacity necessary to manufacture certain of our products and components in accordance with our specifications, applicable regulatory requirements and quality standards. If any such supplier or manufacturer becomes unavailable, fails to meet our specifications, increases prices, delays delivery, experiences capacity constraints or fails an audit or regulatory inspection, qualifying an alternative source could be costly and time-consuming and may require technology transfer activities, validation work, quality audits, stability testing, regulatory notifications or approvals, and we may be unable to identify and qualify replacement manufacturers or suppliers on a timely basis, or at all.

Our reliance on third parties exposes us to risks that we would not face, or that would be reduced, if we manufactured and controlled all operations internally. In particular, we have limited direct control over the operations, quality systems, production schedules, personnel, regulatory compliance and business continuity of our third-party manufacturers, suppliers and service providers. Any failure by these parties to comply with applicable requirements could adversely affect the quality, performance, tolerability, stability/shelf life, availability or regulatory status of our products.

Our third-party manufacturers and suppliers are required to comply with extensive regulatory requirements and standards applicable to healthcare products in the jurisdictions in which our products are manufactured and sold, including current good manufacturing practices (“cGMP”), quality management system requirements, ISO standards, recordkeeping and documentation requirements, traceability obligations and applicable environmental, health and safety laws and regulations. Regulatory authorities, including the FDA, the EMA and Swissmedic, may conduct inspections or audits of our manufacturers’, suppliers’ and warehouse providers’ facilities and operations. Any failure by such parties to comply with applicable regulatory or quality requirements could result in inspection observations, warning letters, import restrictions, delays in regulatory approvals, suspension of manufacturing or distribution activities, product recalls, field corrective actions or the loss, suspension or withdrawal of existing regulatory clearances, certifications or approvals.

Because peptide-based products and related components may be particularly sensitive to process variability, storage conditions and even minor deviations in manufacturing processes, coating procedures, sterilization activities, material composition, environmental controls or transportation and storage conditions could adversely affect product quality, stability/shelf life or performance. The manufacture of our products requires significant technical expertise, specialized equipment, stringent quality controls and sophisticated analytical testing methods. Certain manufacturing defects, contamination events or quality issues may not be detected until after products have been distributed or used by customers.

In addition, changes in manufacturers, manufacturing sites, suppliers, sterilization providers, warehouse operators, raw materials, production processes or quality systems may require additional testing, validation activities, stability studies, regulatory notifications, amendments, certifications, inspections or approvals before modified or replacement products may be commercialized. Delays or failures in qualifying replacement manufacturers or suppliers, including as a result of technology transfer, validation or regulatory requirements, could interrupt product supply, delay commercialization activities or adversely affect our ability to meet customer demand.

Any inability to identify, qualify and transition to alternative manufacturers or suppliers, quality issues, manufacturing failures, supply interruptions or regulatory compliance deficiencies involving our third-party manufacturers, suppliers or service providers could result in product shortages, shipment delays, recalls, adverse event reporting obligations, increased regulatory scrutiny, reputational harm, litigation, liability claims, increased costs or loss of customer confidence. Any such events could adversely affect our business, financial condition, results of operations and future prospects.

To ensure adequate inventory supply and operational efficiency, we must forecast inventory needs, manage procurement activities and coordinate the manufacture and distribution of our products based on estimates of future customer demand. Our ability to accurately forecast demand for our products is subject to significant uncertainty and could be adversely affected by numerous factors, including variability in customer ordering patterns, the timing and success of commercial launches, market acceptance of our products, changes in clinical practice or treatment protocols, pricing and reimbursement developments, competitive product introductions, regulatory developments, macroeconomic conditions and healthcare spending trends. In addition, our limited operating history in certain markets and for certain products may make demand forecasting particularly difficult. Furthermore, our forecasts depend on assumptions regarding the pace and pattern of customer adoption and utilization, including among new customers as compared to existing customers. If new customers adopt or increase utilization more slowly than we expect, or if existing customers adopt or expand utilization faster than new customers or follow different adoption patterns than we anticipate, our forecasts may be inaccurate.

As a medical company, we are also subject to risks associated with long manufacturing lead times, component availability constraints and regulatory and quality requirements applicable to inventory and production processes. If we overestimate customer demand or fail to accurately forecast market adoption of our products, we may accumulate excess or obsolete inventory. Inventory levels in excess of demand may result in inventory write-downs, write-offs or increased storage and handling costs and could adversely affect our gross margins, operating results and cash flows. Certain of our products,

components and raw materials may have limited shelf lives or be subject to specialized storage requirements, which could increase the risk of inventory obsolescence and financial loss. Excess inventory may also divert management attention and working capital resources and impair our ability to efficiently manage our operations.

Conversely, if we underestimate customer demand for our products or fail to maintain appropriate inventory levels, we may experience product shortages, delays in customer shipments or an inability to fulfill orders on a timely basis. Such shortages could arise from inaccurate forecasting, manufacturing disruptions, delays in obtaining raw materials or components, capacity constraints at our manufacturing facilities or third-party manufacturers, quality control issues or interruptions in our supply chain. Any inability to meet customer demand could damage our reputation, reduce customer confidence in our products, harm our relationships with distributors, healthcare providers and other customers and result in lost sales or market share, particularly if customers switch to competing products to the extent available.

In addition, if we experience a significant increase in demand for our products, additional manufacturing capacity, raw materials, components or other supplies may not be available when needed, on acceptable terms or at all. We rely on third-party suppliers and manufacturers for raw materials, components and manufacturing services, and such suppliers and manufacturers may be unable or unwilling to allocate sufficient capacity to satisfy our requirements, particularly during periods of industry-wide supply constraints or increased demand. Many specialized components, including peptides, used in the manufacturing of our products are available only from limited sources, and qualifying alternative suppliers can be time-consuming and costly and may require additional regulatory submissions or approvals. Any interruption or delay in the supply of materials or manufacturing services could impair our ability to manufacture and deliver products in a timely manner.

Moreover, inventory management challenges may become more significant as we continue to expand internationally and commercialize additional products. Managing inventory across multiple jurisdictions and distribution channels increases operational complexity and may require us to maintain higher inventory levels, which could increase costs and expose us to additional risks of excess, obsolete or expired inventory. We may also experience difficulties integrating inventory management systems, coordinating logistics activities or maintaining appropriate internal controls over inventory.

If we are unable to accurately forecast demand for our products or effectively manage our inventory and supply chain operations, our business, financial condition, results of operations and future prospects could be adversely affected.

Our estimates of the addressable market for our products are derived from a variety of sources, including internal estimates and analyses, scientific literature, surveys of clinicians, dental personnel and healthcare professionals and other forms of market research. These estimates may be inaccurate or based on imprecise data. Further, these estimates are based on various assumptions, including the number of people who have a particular disease or condition, the prices at which we and our distributors provide or sell our products in the market, the degree to which provider behavior will change based on the availability of new cavity treatment options, the regulatory framework governing the development, sale and use of our products, including the laws and regulations governing medical devices and OTC drugs which do not include FDA approval or assessment of safety and efficacy under a New Drug Application or Abbreviated New Drug Application processes, the degree of coverage and reimbursement, the cost-containment efforts by payors and customers as well as obtaining necessary clearance or regulatory approvals. For example, our estimates of our TAM and SAM assume that our products are used in accordance with their intended use and recommended application protocols, including one application per early-stage cavity. However, dental professionals may determine to use a single application to treat multiple cavities or otherwise use our products in a manner that differs from these assumptions, in particular with respect to cavities affecting neighboring teeth, which could reduce product utilization and cause the actual market opportunity for our products to be smaller than our estimates. Our estimates also rely on assumptions regarding the number of adults and children who regularly visit dental offices, the prevalence of early-stage cavities among those patients and the estimated number of treatable early-stage cavities per patient. These assumptions are based on a combination of published studies,

industry reports and other third-party sources, some of which were published several years ago. Estimates of patient populations, dental visitation rates, cavity prevalence and the number of potential dental customers may vary among sources, may be based on different methodologies, assumptions or time periods and may not reflect current market conditions. While we believe our assumptions and estimates are reasonable, they may prove to be incorrect and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors. The future growth of the market for our current and future products and services depends on many factors beyond our control, including continued recognition and acceptance of our products by the dental community and the growth, prevalence and costs of competing products. Such further recognition and acceptance may not occur in the near term, or at all. If the addressable market for our products is smaller than our estimates, or if the prices at which we can sell our products are lower than our estimates, our business, results of operations, financial condition and future prospects could be negatively impacted.

We rely, and expect to continue to rely, on third parties, including clinical investigators, research institutions, contract research organizations (“CROs”), consultants and clinical trial sites, to assist in managing, monitoring, conducting and otherwise carrying out clinical studies relating to our products. For example, we rely on participating investigators, study coordinators and site personnel to recruit and enroll patients, comply with study protocols, collect and accurately record clinical data and report adverse events and other study results. As a result of our reliance on these third parties, we have less direct control over the conduct, timing, quality and completion of clinical studies than we would have if we conducted such activities entirely with our own personnel.

Although in certain cases we may be responsible for ensuring that our clinical studies are conducted in accordance with applicable protocols, legal, ethical, scientific and regulatory standards, third parties conducting these studies are not our employees and may have competing priorities or insufficient resources dedicated to our programs. These third parties may fail to comply with contractual obligations, study protocols, regulatory requirements or applicable quality standards, experience staffing shortages or turnover, encounter financial difficulties, fail to devote sufficient time and attention to our studies or otherwise perform inadequately. In addition, communication and coordination with geographically dispersed investigators, study sites and service providers may be challenging and may increase the risk of errors, delays, protocol deviations, inconsistent data collection or other operational difficulties.

Clinical studies involving dental products may present additional operational challenges, including variability in clinical practices among providers, patient adherence and follow-up limitations, differences in standards of care across jurisdictions and challenges associated with generating long-term clinical outcome data. Enrollment and retention of study participants may also be more difficult or slower than anticipated, particularly if competing clinical studies are ongoing, if patients are unwilling to participate or if investigators prioritize other programs over ours.

If the third parties conducting our clinical studies do not successfully carry out their contractual duties or regulatory obligations, fail to meet expected timelines or generate inaccurate, incomplete, inconsistent or unreliable data, our clinical studies may be delayed, suspended, terminated or fail to support regulatory submissions, product claims, expanded indications, reimbursement efforts or future commercialization activities. Regulatory authorities may determine that data generated from our clinical studies are insufficient, unreliable or not collected in accordance with applicable requirements, which could require us to repeat studies, conduct additional studies or delay or prevent regulatory approvals, clearances, certifications or marketing authorizations.

In addition, we and our third-party service providers must comply with applicable laws and regulations governing clinical investigations, including requirements relating to informed consent, patient privacy, recordkeeping, safety reporting and good clinical practice standards. If our third-party service providers fail to comply with these requirements, we may be subject to warning letters, fines, enforcement actions, clinical holds, delays in regulatory submissions or approvals or other regulatory consequences. Any noncompliance or deficiencies identified during regulatory inspections or audits could also adversely affect the acceptability of clinical data generated in our studies.

We compete with many other medical product, dental technology and life sciences companies for access to clinical investigators, trial sites, CROs and other third-party service providers. As a result, these third parties may allocate resources to competing programs or may be unable to dedicate sufficient personnel or capacity to our studies. Some of these third parties may also have relationships with our competitors, which could create conflicts of interest or reduce the attention devoted to our programs.

Further, if any of our relationships with CROs, investigators or other third-party service providers are terminated or disrupted, we may not be able to enter into replacement arrangements on commercially reasonable terms, in a timely manner or at all. Transitioning clinical studies to new service providers may involve additional costs, operational disruptions, delays and the need to repeat certain study activities or data collection efforts.

Delays or failures in the completion of our clinical studies or deficiencies in the clinical data supporting our products could delay or impair our product development efforts, regulatory strategy, commercialization activities, reimbursement initiatives and market acceptance. Any such delays, failures or deficiencies could adversely affect our business, financial condition, results of operations and future prospects.

Expedited, reliable shipping, logistics and warehousing services are essential to our operations and customer satisfaction. We rely on third-party carriers, logistics providers, warehousing vendors and, in certain cases, our distributors to handle storage, fulfillment and last-mile delivery of our products. As a result, we may not have direct control over all aspects of product handling, transportation, tracking and delivery, particularly where fulfillment is performed through distributor networks.

Any disruption, delay or failure in services provided by carriers, logistics providers, warehousing vendors or distributors could adversely affect our ability to fulfill customer orders in a timely manner and may harm our reputation, reduce customer satisfaction and negatively impact demand for our products. These third parties are subject to risks that may be outside of our control, including operational failures, system outages, labor shortages, strikes, increased fuel or transportation costs, capacity constraints, cyber incidents, severe weather events, natural disasters, public health emergencies, geopolitical instability and other force majeure events. Any such disruptions could result in delayed, lost or damaged shipments, which could require costly replacement of products, disrupt customer relationships and increase our operating expenses.

We are also exposed to risks arising from inventory handling and distribution practices of our distributors, including timing of shipments to end customers, local storage conditions and fulfillment processes. Because certain of our sales are fulfilled through distributor inventory rather than direct shipment from us, we may have limited visibility and control over downstream logistics performance, which could amplify the impact of delays, mismanagement or service interruptions within distributor-managed channels.

In addition, warehousing providers and distributors play an important role in inventory management and product distribution. Any performance issues affecting warehousing or distributor-managed inventory, including inventory mismanagement, improper storage conditions, system failures or security breaches, could result in product loss, damage, spoilage or delays in product availability. Such events could require us to replace inventory, incur additional costs or experience disruptions in order fulfillment.

We are also exposed to the risk of increases in shipping, freight and warehousing costs, including costs incurred by distributors that may be passed through to us indirectly or embedded in negotiated pricing arrangements. Significant increases in transportation or storage rates may occur due to inflationary pressures, fuel price volatility, labor costs, carrier pricing policies or capacity constraints within the logistics industry. Due to competitive market conditions and the cost-containment efforts of our customers and distributors, we may be unable to pass such increased costs through to customers in the form of higher prices or fully recover such costs through pricing adjustments. As a result, increases in shipping, warehousing or distributor fulfillment costs could negatively impact our gross margins, operating income and overall profitability.

We rely on commercial courier and express delivery services, as well as distributor logistics networks, to transport samples and other materials to our laboratory and clinical sites in a timely and cost-efficient manner. Any disruption in these services, whether due to labor actions, adverse weather, natural disasters, civil unrest, terrorism, infrastructure failures or other events, could delay our operations, disrupt clinical, research or quality control activities and adversely affect our ability to meet development timelines and customer expectations.

If we are unable to maintain access to reliable shipping, logistics, warehousing and distributor fulfillment services on commercially reasonable terms, or if these providers experience significant operational disruptions, our ability to process and deliver orders on a timely basis could be impaired. Any such impairment could materially adversely affect our business, financial condition, results of operations and prospects.

Our industry is characterized by rapid and ongoing technological and scientific innovation, frequent introductions of new products and services, evolving clinical practices and changing industry standards. As a result, our products may become obsolete or non-competitive more quickly than anticipated. Our future success depends on our ability to anticipate and respond effectively to evolving customer needs, technological developments and scientific advances in a timely and cost-effective manner, while identifying and pursuing new market opportunities as they emerge.

Without the timely development and introduction of new products, enhancements or next-generation technologies, demand for our existing products may decline over time. The success of any new product or product enhancement depends on numerous factors, including our ability to properly identify and anticipate customer needs, successfully commercialize new products in a timely manner, manufacture and deliver products in sufficient quantities and on schedule, and differentiate our offerings from those of competitors. In addition, the success of our products depends on our ability to generate positive clinical outcomes, respond to increasing pressure from healthcare providers, payors and patients to reduce costs and provide adequate training and medical education to support adoption of new technologies.

We invest substantial time and resources in research and development activities, and there can be no assurance that such investments will result in commercially successful products or generate revenues sufficient to offset development costs. Even if we successfully develop and commercialize new products, such products may not achieve market acceptance or may be quickly rendered obsolete by competing technologies, evolving clinical preferences or the introduction of lower-cost or more effective alternatives.

While we believe our products have created a new category for the treatment of early-stage cavities and have the potential to become a new standard of care, we remain subject to competitive pressures from other companies in our industry. Many of these companies have significantly greater financial, technical, manufacturing, marketing and distribution resources than we do. Competitive dynamics in our industry are influenced by product performance, clinical outcomes, tolerability profiles, pricing, reimbursement conditions, practitioner adoption and the strength of quality systems, and shifts in market share can occur rapidly in response to product performance issues, safety concerns, new clinical data or competitive introductions.

In the future, we may also face competition from companies that may introduce private label, generic or lower-cost alternatives that are perceived by customers as functionally equivalent to our products. If such products gain market acceptance or result in overall market price reductions, we may experience downward pricing pressure, reduced margins and loss of market share. In addition, our ability to compete effectively depends on our success in retaining and expanding relationships with customers, continuously improving existing products and developing new offerings that meet evolving clinical and economic requirements.

Our competitors also compete with us for qualified scientific, technical, management and commercial personnel, as well as for access to technologies and intellectual property. As we grow, our need to attract and retain highly qualified personnel will increase, and our inability to do so could impair our research, development and commercialization efforts.

The introduction of new technologies, products or services by competitors, improvements in existing competitive offerings or shifts in clinical practice patterns may reduce demand for our products or make it more difficult for us to compete effectively on performance, convenience, clinical outcomes or price. Any failure to keep pace with industry change or to compete successfully in this highly dynamic environment could materially adversely affect our business, financial condition, results of operations and future prospects.

We operate in multiple geographies and expect to continue expanding our operations into additional markets. Our results of operations and financial condition are subject to a wide range of risks inherent in conducting business across multiple countries and regions, many of which are outside of our control and may be difficult to predict or mitigate. These risks include adverse macroeconomic and market conditions, such as inflation, economic slowdowns, recessionary pressures and volatility in consumer demand. They also include political instability, social unrest, armed conflict and changes in government policies or priorities. Ongoing geopolitical tensions, including conflicts in the Middle East and Ukraine, may further contribute to global economic volatility, disrupt supply chains and logistics networks, and increase costs associated with cross-border trade and operations.

We are exposed to risks arising from divergent and evolving regulatory regimes across jurisdictions, including with respect to medical device regulation, product clearance and approval requirements, manufacturing standards, quality systems requirements, clinical evidence standards, advertising and promotional restrictions, consumer protection rules, data privacy and cybersecurity laws, anti-corruption and anti-bribery requirements, Anti-Money Laundering (AML) and Countering the Financing of Terrorism (CFT) frameworks and employment, labor and immigration laws. Compliance with these requirements may be complex, costly and time-consuming, and may require significant localization of our operations, policies and systems. Failure to comply, or delays in achieving compliance, could result in enforcement actions, fines, product restrictions, suspension of operations, reputational damage or other adverse consequences.

We are subject to U.S., Swiss, EU, U.K. and other sanctions, export control, customs, import, anti-boycott and trade compliance laws. These laws may restrict dealings with certain countries, regions, governments, entities, individuals or end users, and may apply to distributors and other third parties acting on our behalf. Violations could result in fines, penalties, loss of export privileges, contractual liability, reputational harm or restrictions on our ability to sell products in certain markets.

We are also exposed to fluctuations in foreign currency exchange rates, currency controls and the potential volatility of revenues and expenses denominated in different currencies. Adverse movements in exchange rates may impact our reported results, increase the cost of our operations or reduce the value of revenues generated in foreign markets. In addition, hedging strategies may not fully offset such exposures.

Our international operations also subject us to risks related to differing cultural norms, healthcare practices and consumer behaviors, which may affect the acceptance and adoption of our products. Market dynamics, including dental practice structures, patient behavior, reimbursement environments and purchasing practices, may vary significantly across jurisdictions and may differ materially from those in our more established markets. As a result, our products may not achieve the same level of market acceptance in new jurisdictions as in existing markets.

We may also face increased competition in international markets from both local competitors with established relationships and deeper knowledge of local regulatory and commercial environments, and global competitors with greater resources. These competitors may be better positioned to respond to local market conditions or regulatory requirements, which may limit our ability to gain or maintain market share.

Changes in trade policy, tariffs, export controls, sanctions, customs regulations or import/export licensing requirements may also restrict our ability to operate in certain markets, increase costs, delay

product shipments or limit access to key suppliers or distribution channels, any of which may impact our operating results. Changes in immigration laws or policies may also affect our ability and that of our third-party partners to attract and retain qualified personnel in certain jurisdictions, which may impair operational efficiency.

Our international expansion efforts may require significant investment in infrastructure, personnel, regulatory compliance, technology systems and local partnerships. These investments may not generate expected returns, and we may be unable to achieve or sustain profitability in new markets. Expansion may also materially alter our geographic, product and customer mix, which could increase volatility in our results of operations due to differences in regulatory environments, pricing dynamics, credit risk profiles, reimbursement structures, consumer demand patterns and operating costs.

Operating in multiple jurisdictions also increases the complexity of managing our business across different time zones, languages, regulatory frameworks and cultural environments. Failure to effectively manage these complexities, including through adequate local expertise and systems, could result in operational inefficiencies, regulatory noncompliance, reputational harm or financial losses. Any of the foregoing risks could adversely affect our business, financial condition, results of operations and future prospects, particularly as we continue to expand our international footprint.

Haley Abivardi and Goly Abivardi, our Co-Founders and Co-Chief Executive Officers, have been the driving force behind our success since our inception. The unexpected loss of either of our Founders could severely disrupt our operations and significantly impact our ability to continue executing our business strategy with the same level of effectiveness. We believe that their unique experiences as dentists and dental entrepreneurs as well as deep understanding of noninvasive, patient-centric dental care and technology is unparalleled. Finding a successor for either of our Founders with comparable vision and capability to maintain the momentum and direction our Founders have established for us would present a substantial challenge. Furthermore, either of our Founders’ departures could lead to instability within our Company, potentially affecting the morale and productivity of our team, which has been crucial in our rapid growth and innovation. The potential uncertainty surrounding such a leadership transition could also undermine confidence among our customers, partners and investors as well as other stakeholders who are integral to our continued success and expansion. In the highly competitive dental technology industry, any perceived weakening of our leadership could be exploited by our competitors. This could lead to a loss of market share and have a negative impact on our business, results of operations, financial condition and future prospects.

Our success will further depend on our ability to retain senior management and to attract and retain qualified personnel in the future, including sales and marketing professionals, scientists, clinical specialists and other highly skilled personnel. The loss of members of our senior management, sales and marketing professionals, scientists, IT and data experts or clinical and regulatory specialists could result in delays in product development and commercialization and harm our business. Our research and development programs and laboratory operations depend on our ability to attract and retain highly skilled scientists and technicians. We may not be able to attract or retain qualified scientists and technicians due to the competition for such personnel among life science businesses, particularly near our headquarters in Zug, Switzerland. We also face competition from universities and public and private research institutions in recruiting and retaining highly qualified scientific and technical personnel. We may also have difficulties locating, recruiting or retaining qualified sales people. Recruiting and retention difficulties can limit our ability to support our research and development and sales programs.

To induce employees to remain at our company, in addition to salary and cash incentives, we have granted and may continue to grant share-based compensation awards that vest over time. The value to employees of such awards is significantly affected by movements in our share price, and such awards may at any time be insufficient to counteract more lucrative offers from other companies. Despite our efforts to retain valuable employees, members of our management, scientific and development teams may terminate their employment with us on short notice. We do not maintain “key person” insurance policies.

If we are unable to retain our Founders, senior management team and other key employees, or if we fail to attract and retain additional qualified personnel as needed to support our anticipated growth, our business, financial condition, results of operations and future prospects could be adversely affected.

We sell our products to dentists and other healthcare providers, which may receive reimbursement for procedures involving our products from third-party payors, including government healthcare programs, private insurance companies, managed care organizations and other healthcare payors. The availability and level of reimbursement for procedures utilizing our products can significantly affect the adoption, utilization and pricing of our products. Third-party payors may deny or limit reimbursement if they determine that a procedure or product is not medically necessary, cost-effective, experimental or otherwise not eligible for coverage under their reimbursement policies. If reimbursement for procedures involving our products is unavailable, limited or reduced, healthcare providers may be less likely to use our products and demand for our products may decline.

In addition, governmental authorities, third-party payors, DSOs, group purchasing organizations and other healthcare industry participants continue to seek to contain healthcare costs and reduce expenditures. These efforts have resulted, and are expected to continue to result, in increased pricing pressure, limitations on coverage and reimbursement, more restrictive reimbursement policies and increased emphasis on value-based healthcare and cost-effective treatment alternatives. Such measures may reduce the amount healthcare providers are reimbursed for procedures involving our products or otherwise negatively affect utilization of our products.

Coverage and reimbursement policies are complex and frequently changing, and we have limited control over the timing or outcome of reimbursement decisions. In the United States, reimbursement decisions by government agencies and commercial payors may significantly influence the adoption and utilization of medical and dental products. Outside the United States, many countries maintain government-controlled healthcare systems that regulate pricing and reimbursement levels and may impose pricing restrictions, reimbursement caps, mandatory discounts or other limitations that could adversely affect the commercial viability of our products in those markets.

Further, many dental practices in the United States have become affiliated with DSOs or other provider networks that negotiate pricing arrangements with manufacturers and distributors through centralized purchasing and competitive bidding processes. Due to the highly competitive nature of these contracting processes, we may not be able to obtain or maintain favorable contract positions with major DSOs or purchasing organizations. In addition, the increasing purchasing leverage of large DSOs and organized buying groups may result in downward pricing pressure, lower gross margins and reduced sales opportunities.

We also face competition from companies with greater financial, technical, manufacturing and commercial resources than we possess, some of which may offer lower-priced products that dental professionals perceive as acceptable alternatives to our products. Third-party payors and purchasing organizations may use competing products as benchmarks in evaluating pricing and reimbursement decisions relating to our products, which could increase pricing pressure and adversely affect our ability to maintain favorable reimbursement levels and operating margins.

If third-party payors reduce reimbursement levels, impose more restrictive coverage policies, favor lower-cost alternatives or otherwise limit the use of our products, or if healthcare providers become increasingly focused on cost containment, demand for our products could decline and we could experience increased pressure to reduce prices, any of which could materially adversely affect our business, financial condition, results of operations and prospects.

Our gross margins depend on the prices at which we sell products, distributor and other customer discounts and rebates, product mix, manufacturing costs, raw material and component costs, freight and logistics costs, tariffs, inventory reserves, product obsolescence, warranty or replacement costs and the

cost of complying with regulatory and quality requirements. As we expand into additional markets and geographies, enter into additional distributor arrangements, seek broader adoption by DSOs or other large purchasing organizations, or introduce new products, we may experience lower average selling prices or a less favorable product mix. We may be unable to offset increased costs through price increases, particularly where pricing is constrained by distributor contracts, reimbursement limitations, competitive pressures or customer purchasing leverage. Any decline in gross margins could adversely affect our results of operations and ability to achieve profitability.

Because our revenue is generated through third-party distributors, our accounts receivable may be concentrated among a limited number of parties. For example, as of June 30, 2026, and as of December 31, 2025 and 2024, 94%, 68% and 63% of our gross accounts receivable, respectively, related to two distributors. If any significant distributor delays payment, disputes amounts owed, cancels the supply arrangement or becomes insolvent or experiences liquidity constraints, our cash flows and working capital could be adversely affected. We may also be required to increase allowances for doubtful accounts or write off receivables, which could adversely affect our results of operations and financial condition.

If we need to replace an existing distributor, there can be no assurance that a new distributor would allocate sufficient capacity to us in order to meet our requirements or sales demand. If our distributors are unable to fulfill their obligations under their contracts or we are unable to identify alternative distributors, we would encounter higher costs or fail to meet our sales demand, any of which could have a material adverse effect on our reputation or results of operations.

We may be subject to product liability claims arising from the development, clinical testing, marketing and sale of our products. We may be subject to product liability claims if our products are alleged or perceived to cause injury, to be defective or otherwise unsuitable for their intended use, or if they fail to perform as expected in clinical or commercial settings. Such claims may arise from alleged defects in manufacturing or design, failure to provide adequate warnings regarding risks inherent in the use of our products, negligence, strict liability or breach of warranties. We may also be subject to product liability claims even where the alleged harm is attributable to the actions of third parties, including healthcare providers, distributors or the preexisting medical or dental conditions of patients.

The performance and tolerability of our products may also be affected by user error, including improper handling, inadequate training of dental professionals or care collaborators or failure to follow instructions for use. Misuse or off-label use of our products may increase the risk of adverse outcomes and, in turn, increase our exposure to liability claims. In addition, if we sponsor clinical studies in the future, our exposure to product liability risk may increase due to the direct involvement of patients and clinical investigators in controlled study settings.

Product liability claims, regardless of merit, can be expensive, time-consuming and disruptive to defend and may require significant financial and management resources. Even where we are ultimately successful, such claims may divert management attention from our core operations and strategic priorities. If we are unsuccessful in defending against such claims, we may be required to pay substantial damages, enter into costly settlements or be subject to injunctive or regulatory remedies that could restrict or prevent the marketing and sale of our products.

In addition, product liability claims or related adverse events may have a number of negative consequences, including delays in obtaining or maintaining regulatory clearances or approvals, increased regulatory scrutiny or investigations, mandatory or voluntary product recalls or withdrawals, labeling, marketing or promotional restrictions, delays or suspension of clinical studies, and loss of existing or potential customers. Such claims may also harm our reputation, reduce demand for our products, adversely affect our relationships with healthcare providers, distributors and other commercial partners, and negatively impact the trading price of our securities.

We maintain product liability insurance; however, this insurance may not be adequate to cover all liabilities that we may incur, and it may not cover certain types of claims or damages. Product liability

insurance is increasingly expensive and may become more difficult to obtain in the future on commercially reasonable terms, or at all. We may not be able to maintain or obtain sufficient insurance coverage to protect against potential liability claims. If we are required to pay damages or settlements in excess of our insurance coverage, or if such claims are not covered by insurance, we may be required to use our available capital resources, which could materially adversely affect our financial condition and results of operations.

Any product liability claims brought against us, with or without merit, could increase our insurance costs, result in denial of coverage, reduce the availability of future coverage, harm our reputation and materially adversely affect our business, financial condition, results of operations and future prospects.

Purchasing decisions for Curodont® Repair Fluoride Plus, which we currently only market in the United States, may be affected by adverse publicity or negative public perception regarding fluoride. This negative public perception may include publicity regarding the risks, performance, legality or quality of Curodont® Repair Fluoride Plus, fluoride in general or of other products containing fluoride. Negative public perception may also arise from regulatory investigations, regardless of whether those investigations involve us, or negative statements made to the public. We are highly dependent upon patients’ perception of the tolerability and quality of Curodont® Repair Fluoride Plus. Thus, a mere assertion that such product may be harmful could have a material adverse effect on us, regardless of whether such assertion is scientifically supported. Adverse publicity may have an adverse effect on our reputation, results of operations, financial condition or future prospects.

Additionally, if fluoride’s regulatory status were to change in the United States, Europe or elsewhere, we would need to modify how we market Curodont® Repair Fluoride Plus or may need to remove Curodont® Repair Fluoride Plus from the market. While our other Curodont® products, including Curodont® Repair which is currently marketed in select jurisdictions outside of the United States, do not contain fluoride, we may not succeed in marketing Curodont® Repair or any modified version of Curodont® Repair Fluoride Plus not containing fluoride. Such a change in regulatory status may have an adverse effect on our reputation, results of operations, financial condition or future prospects.

Effective internal control over financial reporting and disclosure controls and procedures are critical to our success as a public company. Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements in accordance with applicable accounting principles. Disclosure controls and procedures are designed to ensure that information required to be disclosed in reports filed under the Securities Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is communicated to management as appropriate to allow timely decisions regarding required disclosures.

We have identified material weaknesses in our internal control over financial reporting related to the risk assessment, control environment, information and communication, control activities, and monitoring components of the Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (the “COSO Framework”). A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our financial statements will not be prevented or detected on a timely basis.

Specifically, we identified the following material weaknesses:

These material weaknesses could result in a misstatement of substantially all account balances or disclosures that would result in a material misstatement to our annual or interim financial statements that would not be prevented or detected. As a result of these material weaknesses, we concluded that our internal control over financial reporting was not effective as of December 31, 2025.

We have taken and continue to take steps intended to remediate these material weaknesses and strengthen our internal control environment. During the fourth quarter of the year ended December 31, 2025, we implemented a new ERP system, which provides the foundation for a stronger control environment and supports the implementation of a comprehensive information technology control framework. Since January 1, 2026, in connection with and following the ERP system implementation, we have taken the following actions, with the support of an outside accounting advisory firm:

The actions described above were taken during fiscal year 2026 and had not been implemented, and the related material weaknesses had not been remediated, as of December 31, 2025. The material weaknesses will not be considered remediated until the applicable remediated controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively. We expect this remediation testing to occur in connection with our fiscal year 2026 audit. We cannot at this time predict the success of such efforts or whether such efforts will prevent or avoid potential future material weaknesses.

We cannot assure you that the measures we have taken or may take in the future will be sufficient to remediate the identified material weakness or that we will not identify additional material weaknesses in

the future. As we continue to grow, expand our operations and increase the complexity of our business, our internal control over financial reporting and disclosure controls and procedures may not be adequate to ensure timely and accurate reporting, particularly as we integrate new systems, processes, personnel and third-party service providers.

In addition, as an emerging growth company, we are not currently required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act (“Section 404”). However, we are subject to the management assessment requirements of Section 404 and will be required to begin compliance with the auditor attestation requirements of Section 404 in the future, which will require significant time and resources to implement, document and test our internal control over financial reporting. When we become subject to auditor attestation requirements, our independent registered public accounting firm may identify control deficiencies that were not previously identified by management.

During the course of implementing, documenting and testing our internal control over financial reporting, we may identify additional deficiencies or weaknesses. Any such deficiencies may require us to take further remediation measures, divert management attention and incur significant additional costs. Even if we implement remediation measures, we cannot provide assurance that such measures will be effective in fully remediating existing or future material weaknesses.

A failure to maintain effective internal control over financial reporting or disclosure controls and procedures could result in material misstatements in our financial statements, require restatements of previously issued financial statements, cause delays in the filing of periodic reports, increase compliance costs and subject us to regulatory scrutiny or enforcement action. In addition, any such failure could adversely affect investor confidence in the accuracy and reliability of our financial reporting, which could negatively impact the market price of our securities and materially adversely affect our business, financial condition, results of operations and future prospects.

From time to time, we are involved in various legal, arbitration and administrative proceedings arising in the ordinary course of our business or in connection with extraordinary corporate, tax, regulatory or commercial matters. These proceedings may involve current or former directors, executive officers, employees, shareholders, customers, distributors, suppliers or other third parties, and may include, among other things, product liability claims, contractual disputes, intellectual property disputes, regulatory enforcement matters, privacy and data protection disputes, employment matters, competition and antitrust matters, tax matters and other commercial or governance-related claims. Given the nature and scope of our business as a dental technology company operating across multiple jurisdictions, we expect to continue to be subject to such proceedings and disputes in the future.

In addition, we operate in a highly regulated industry and may from time to time be subject to investigations, inquiries, inspections or enforcement actions by regulatory authorities in Switzerland, the EU, the United States and other jurisdictions in which we operate or commercialize our products. Such matters may relate to, among other things, product performance, manufacturing practices, clinical data, promotional activities, compliance with medical device regulations, quality systems requirements or other regulatory obligations. We may also become involved in disputes with distributors, healthcare providers or commercial partners regarding pricing, reimbursement, supply, exclusivity or other contractual arrangements.

We may also face legal claims or regulatory actions following this offering as a result of our increased visibility as a publicly listed company in the United States and our expanded disclosure, reporting and governance obligations under applicable securities laws and exchange rules. In addition, we may become involved in disputes with or among shareholders relating to corporate governance, capital structure, strategic direction or other matters.

The outcome of legal proceedings is inherently uncertain, particularly where claims involve complex factual or legal issues, novel legal theories, large or indeterminate damages, multiple parties or early-stage allegations. We cannot provide assurance as to the outcome of any such proceedings. An adverse resolution of one or more of these matters could result in monetary damages, settlements, injunctions, fines, penalties, consent decrees or other remedies that could materially adversely affect our business, financial condition, results of operations and future prospects.

Although we may maintain insurance coverage for certain types of claims, such coverage may be insufficient to cover all liabilities or may not be available in respect of all claims. Certain claims may fall outside the scope of our insurance coverage or may exceed applicable policy limits. In addition, insurance coverage may become more costly or difficult to obtain in the future.

Regardless of outcome, litigation and regulatory proceedings may be time-consuming, expensive and disruptive, may require significant management attention and may result in reputational harm. Any such proceedings could adversely affect relationships with customers, distributors, regulators and other stakeholders, and could negatively impact our ability to conduct and expand our business.

While we may in certain cases seek to limit exposure to certain types of claims through contractual arrangements, including arbitration provisions or other dispute resolution mechanisms, there can be no assurance that such provisions will be enforceable in all jurisdictions or in all cases. Changes in applicable law or regulatory interpretation, particularly in the EU, Switzerland, the United States or other jurisdictions in which we operate, could limit the availability or effectiveness of such mechanisms. Any inability to rely on such provisions could increase our exposure to litigation, including collective or group proceedings where permitted under applicable law.

Any of the foregoing could adversely affect our business, financial condition, results of operations and future prospects.

Misconduct, fraud or other illegal or inappropriate activities by our employees, consultants or third-party service providers could have adverse consequences for us. Such conduct may include fraudulent activities, violations of applicable laws, rules or regulations or failure to comply with our internal policies and procedures or those of our partners and counterparties. This risk is heightened by our reliance on third-party service providers for a range of critical functions, including manufacturing, distribution, logistics and technology infrastructure.

In particular, our dependence on third-party manufacturers and distributors exposes us to risks arising from misconduct or noncompliance within their operations, including improper handling of products, failure to adhere to quality or regulatory requirements or other operational deficiencies. Because we do not control these third parties, we have limited ability to prevent or detect such conduct in a timely manner, and we rely on them to maintain appropriate internal controls, compliance systems and oversight mechanisms. Any failure by these third parties to comply with applicable legal or regulatory requirements or our standards could result in product quality issues, regulatory enforcement actions, shipment delays, recalls or other disruptions to our operations.

Any incident of misconduct or noncompliance by our employees or third-party service providers could result in regulatory investigations or enforcement actions, civil litigation, contractual disputes, financial losses, fines or other penalties. In addition, such events could result in increased insurance costs, higher operating expenses and increased cost of capital due to reduced investor and stakeholder confidence.

Beyond the direct financial and operational impacts, such events could also cause significant reputational harm. We believe that our brand is associated with trust, quality and reliability, and any publicized incident involving misconduct, regulatory noncompliance or operational disruption within our supply chain or distribution network could undermine that trust. This may lead to reduced customer confidence, decreased demand for our products, loss of distribution or commercial partners and difficulty in attracting or retaining customers and collaborators. Given the competitive nature of the dental and medical technology industry, even isolated incidents involving misconduct or third-party failures may have a disproportionate adverse impact on our business, financial condition, results of operations and future prospects.

We rely on our employees and on third-party manufacturers, suppliers, distributors, warehousing providers, logistics providers and other service providers for the development, manufacture, storage and

distribution of our products. As a result, our operations may be adversely affected by labor shortages, labor disputes, strikes, work stoppages, union activity, collective bargaining disputes or other labor-related disruptions affecting either our own workforce or the personnel of our third-party business partners, many of which are outside of our control.

As we continue to expand our operations rapidly, scale manufacturing activities and enter new markets and geographies, we may face increased operational complexity, heightened competition for qualified personnel and increased exposure to differing labor laws, employment practices and workforce expectations across jurisdictions. Our continued growth may also place additional strain on our management, operational, manufacturing and commercial infrastructure and increase the risk of workforce disruptions, employee dissatisfaction, turnover or disputes.

Labor disruptions affecting our employees or third-party providers may result in temporary or prolonged interruptions in manufacturing operations, delays in production schedules, reduced productivity, quality control issues, shortages of critical components or finished products, disruptions in warehousing or distribution activities and delays in shipping and fulfillment. Because we may rely on a limited number of manufacturing or distribution partners for certain products, components or geographic regions, any such disruption could have a disproportionate impact on our ability to maintain product supply and meet customer demand.

In addition, labor shortages or disruptions could increase our operating expenses through higher wages, employee benefit costs, contractor costs, retention incentives or costs associated with recruiting and training replacement personnel. Certain jurisdictions in which we or our third-party partners operate may also have employee protection laws, works council requirements, collective bargaining arrangements or other labor regulations that could limit operational flexibility or increase the complexity and cost of workforce management. Any labor-related disruption involving our employees or third-party providers could adversely affect our business, financial condition, results of operations and future prospects.

We maintain insurance coverage as part of our risk management strategy to mitigate certain operational, regulatory and commercial risks. However, our insurance policies are subject to limitations, exclusions and deductibles, and may not cover all claims or losses that we may incur. In addition, the amount of any covered claim may exceed our policy limits.

Insurance costs have generally increased across our industry, and we may face higher premiums, reduced coverage availability or less favorable terms in the future. As our business expands and our risk profile evolves, we may be unable to maintain existing coverage or obtain additional coverage on commercially reasonable terms, or at all.

If we suffer a significant uninsured loss or a loss in excess of our insurance coverage, or if any insurer disputes or denies coverage, we may be required to bear substantial costs directly. Such losses could adversely affect our financial condition, results of operations and liquidity. In addition, significant uninsured or underinsured losses could result in reputational harm and increased scrutiny from regulators, customers, distributors and investors, which could further adversely affect our business and growth prospects. There can be no assurance that our insurance coverage will be sufficient to protect us against all potential liabilities or losses, and any failure to maintain adequate insurance could materially adversely affect our business, financial condition, results of operations and future prospects.

Our reputation and the Curodont® brand are critical to our commercial success. We rely on the trust of dental professionals, distributors and other healthcare providers, as well as positive clinical perception, word-of-mouth referrals, key opinion leader support and scientific credibility, to drive adoption of our products. Any deterioration in this trust could materially and adversely affect demand for our products.

Negative publicity concerning our Company, our products or our industry—whether accurate or not—could harm our reputation and reduce acceptance of our products among current and prospective

customers. Such publicity may arise from a variety of sources, including alleged or actual product quality issues, adverse clinical outcomes, regulatory inquiries or enforcement actions, product recalls or field safety corrective actions, litigation or disputes involving our products, or broader negative perceptions of dental or medical product technologies.

Because we operate in a field where clinical trust and professional recommendation are key drivers of adoption, reputational harm may have an outsized impact on our ability to maintain and expand our customer base. In addition, any actual or perceived concerns regarding tolerability, observed outcomes, durability or clinical performance of our products may be amplified by competitors, industry commentators or media coverage, which could further damage our market position.

The rapid dissemination of information through social media, online forums and other digital channels may exacerbate the impact of any negative publicity, making it more difficult to control or correct inaccurate or misleading information. Once disseminated, such information may persist and continue to influence perceptions even after corrective actions are taken.

Damage to our brand may be difficult and costly to repair, and may require significant time and resources to restore confidence among dental professionals, distributors and other stakeholders. Any sustained or significant reputational harm could result in reduced demand for our products, loss of existing or prospective customers, reduced support from key opinion leaders and distributors, and increased difficulty in achieving market acceptance for new products.

Any of the foregoing could materially adversely affect our business, financial condition, results of operations and prospects.

Our products may be subject to unauthorized resale, diversion, counterfeiting, tampering, sale after expiration or sale through online or other channels outside our authorized distribution network. Such products may be stored or handled improperly, may not perform as intended and may be difficult for us to monitor or remove from the market. Any adverse outcome, complaint or public report involving counterfeit, diverted, expired or improperly resold products could be attributed to us and could harm our reputation, result in regulatory scrutiny, increase product liability exposure and reduce demand for our products, which could negatively impact our business and harm our financial condition.

Our business is subject to a wide range of macroeconomic, geopolitical and systemic risks that are outside our control. Adverse macroeconomic conditions, including recessions, economic slowdowns, inflationary pressures, rising interest rates, currency fluctuations, tightening credit markets and reduced discretionary spending, may negatively impact demand for our products. In particular, because dental procedures are in part discretionary or elective in nature, demand for our products may decline during periods of economic uncertainty or financial stress experienced by dental practices, patients or healthcare systems.

We are also exposed to significant geopolitical risks arising from political instability, armed conflicts, sanctions regimes, trade disputes and evolving government policies in the jurisdictions in which we or our partners operate. Ongoing conflicts, including in the Middle East and Ukraine, as well as broader geopolitical tensions, may contribute to volatility in global markets, disrupt supply chains, increase transportation and input costs, and restrict or delay access to key markets or distribution channels. In addition, changes in tariffs, trade restrictions, export controls or customs regulations could increase the cost of cross-border commerce or limit our ability to source materials, manufacture products or distribute our products internationally. Changes in immigration policies may also impact our ability and that of our third-party partners to attract and retain qualified personnel in certain jurisdictions, which could further affect operational capacity and execution.

Our business is further subject to risks arising from natural disasters, climate-related events, pandemics, outbreaks of infectious disease, civil unrest, terrorist attacks, power outages and other

catastrophic events. Such events may disrupt our operations and those of our third-party manufacturers, suppliers, distributors and logistics providers, leading to delays in production, reduced availability of products and interruptions in supply chains and distribution networks. They may also adversely affect customer behavior, including reduced patient visits to dental offices and delays in elective procedures, which could materially reduce demand for our products.

The COVID-19 pandemic demonstrated that global public health emergencies and related governmental responses can significantly disrupt economic activity, impair global supply chains and materially reduce demand for dental and medical products and services. Future pandemics or similar events could have comparable or more severe effects on our business.

The occurrence or continuation of any of the foregoing macroeconomic, geopolitical or catastrophic events could be sudden, unpredictable and difficult to mitigate. Although we attempt to manage these risks through operational planning and insurance coverage, such measures may not be sufficient to fully offset potential losses. Any of the foregoing could adversely affect our business, financial condition, results of operations and future prospects.

We have made acquisitions in the past and may pursue acquisitions of complementary businesses, products, services, technologies or intellectual property in the future as part of our growth strategy. Such transactions may also include minority investments, joint ventures or other strategic collaborations. However, there can be no assurance that we will identify suitable targets at attractive valuations, complete any such transactions on favorable terms, or at all.

Acquisitions and strategic investments involve a number of inherent risks, many of which may be difficult to assess or quantify prior to completion of a transaction. These risks include, among others, difficulties in integrating the operations, systems, technologies, regulatory compliance frameworks, quality systems, products, personnel and corporate cultures of acquired businesses with our existing operations. Integration challenges may be exacerbated where acquired businesses operate in different jurisdictions, are subject to different regulatory regimes, or rely on different clinical, manufacturing or commercialization models than our own.

We may also face challenges in aligning acquired products or technologies with our existing product portfolio, quality standards and regulatory requirements applicable to medical products, including compliance with applicable EU medical device regulations, Swiss regulatory requirements and FDA standards where applicable. Any failure to successfully integrate or align acquired businesses with these requirements could result in delays in commercialization, regulatory scrutiny, remediation costs or product discontinuations.

Acquisitions may divert significant management attention and resources away from our existing operations, including research and development, clinical activities and commercialization efforts. This diversion may adversely affect our ability to execute on our core business strategy during and following the integration period.

We may also assume known and unknown liabilities in connection with acquisitions, including liabilities relating to product quality, regulatory compliance, clinical data integrity, intellectual property infringement, labor matters, tax matters or litigation. Such liabilities may not be fully covered by indemnification provisions, insurance or other contractual protections, and enforcement of such protections may be limited by applicable law, jurisdictional constraints or the financial condition of the counterparty.

In addition, acquisition agreements may contain representations, warranties and indemnities that are subject to limitations, caps, time restrictions or exclusions, and may not fully protect us from losses arising out of pre-closing or post-closing events. We may also become involved in disputes with sellers regarding indemnification claims or purchase price adjustments.

We may finance acquisitions through the issuance of equity or equity-linked securities, which may be dilutive to existing shareholders, or through debt financing, which may increase our leverage and impose restrictive covenants on our operations. Any such financing arrangements could limit our operational flexibility or increase our cost of capital.

The expected benefits of acquisitions or strategic investments, including anticipated synergies, cost savings, revenue growth or technological enhancements, may not materialize or may take longer than expected to achieve. In some cases, acquired businesses or technologies may underperform, fail to achieve expected market acceptance or require additional investment beyond initial expectations, resulting in impairment charges or write-downs of goodwill or other intangible assets.

Competition for acquisition targets in the dental technology and broader life sciences and medical product sectors is intense, and we may face competition from larger, better capitalized or more established companies, which may limit our ability to complete attractive transactions or increase acquisition costs. If we fail to effectively identify, execute or integrate acquisitions or strategic investments, or if such transactions do not achieve their intended strategic or financial objectives, our business, financial condition, results of operations and prospects could be adversely affected.

Regulators, investors, shareholder advocacy groups, institutional investors, consumers and other stakeholders, particularly in the United States, the EU and Switzerland, have increasingly focused on environmental, social and governance (“ESG”) matters and sustainability-related disclosures by public companies, including companies in the medical product and healthcare sectors. These stakeholders have placed greater emphasis on the environmental and social impacts of corporate operations, including product lifecycle considerations, manufacturing practices, supply chain responsibility, clinical and patient safety standards and broader sustainability commitments.

We may incur significant costs and devote substantial management attention and resources to developing, implementing and maintaining our ESG strategy, policies, internal controls and related disclosure frameworks. This may include tracking and reporting sustainability metrics across our operations and supply chain, engaging with third-party advisors or auditors, and adapting to evolving reporting standards and regulatory requirements. These requirements are expected to continue to develop and may increase in scope, complexity and cost over time.

We are or may become subject to a range of ESG-related disclosure regimes, including requirements under applicable European Union sustainability reporting frameworks, evolving climate-related disclosure rules in the United States and Swiss corporate reporting obligations. These regimes may require detailed disclosures regarding environmental impacts, supply chain practices, workforce policies and governance structures. Compliance with such requirements may be costly, resource-intensive and may require significant enhancements to our data collection systems and internal controls.

In addition, we may be exposed to risks relating to the accuracy, completeness or perceived credibility of ESG-related disclosures. If our ESG or sustainability disclosures, targets or commitments are viewed by regulators, investors, consumers or other stakeholders as incomplete, inconsistent, misleading or insufficiently substantiated, we may face reputational harm, loss of investor confidence or increased scrutiny from regulatory authorities. Any such perception may also lead to litigation or enforcement actions, including claims under securities, consumer protection or other laws alleging misrepresentation or “greenwashing.”

We have established internal ESG goals and initiatives. However, there can be no assurance that we will achieve these objectives, as they may depend on factors outside of our control, including technological limitations, availability of compliant materials, evolving regulatory requirements and macroeconomic conditions. In particular, our ability to meet certain ESG objectives may depend on the practices of third-party manufacturers, suppliers, distributors and other service providers. Any failure, or perceived failure, by these third parties to adhere to applicable ESG-related standards or expectations could adversely affect our reputation and expose us to regulatory, legal or commercial risks.

Given the evolving nature of ESG standards and stakeholder expectations, there is no assurance that our ESG strategy, practices or disclosures will satisfy current or future regulatory requirements or investor expectations. Any failure to do so could materially adversely affect our business, financial condition, results of operations and prospects, as well as our reputation and ability to attract and retain employees, customers and investors.

The global regulatory environment applicable to healthcare products has become increasingly stringent, complex and unpredictable. Our products are subject to regulatory frameworks across the jurisdictions in which they are marketed, including differing requirements imposed by the U.S. Federal Food, Drug and Cosmetic Act (the “FDCA”), the EU Medical Devices Regulation (Regulation (EU) 2017/745) (the “EU MDR”), the Swiss Federal Act on Medicinal Products and Medical Devices (the “Therapeutic Products Act” or the “TPA”), the Swiss Medical Devices Ordinance (the “MedDO”) and other comparable regulatory schemes. These regulations govern, among other things, the development, testing, manufacturing, labeling, packaging, storage, marketing, advertising, promotion, distribution, post-market surveillance and sale of our products.

Regulatory requirements applicable to our products continue to evolve, including as a result of changes to the FDA OTC monograph framework under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), implementation and ongoing interpretation of the EU MDR, evolving Swiss medical device requirements following Switzerland’s third-country status under the EU MDR framework and expanding global healthcare compliance, privacy and data protection obligations. Compliance with these requirements has required, and may continue to require, significant investments in quality systems, personnel, clinical evidence generation, post-market surveillance, regulatory affairs and compliance infrastructure.

The applicable regulatory classification of our products depends on a number of factors, including composition, intended use, mechanism of action, formulation, delivery method, route of administration and product claims. As we continue to expand our product portfolio, develop next-generation products and introduce modified formulations, additional active ingredients, new technologies or alternative delivery methods, the applicable regulatory requirements and pathways may change or become more complex.

In the United States, certain of our products are marketed pursuant to FDA OTC monographs and have not been separately approved under a new drug application (“NDA”) or abbreviated new drug application (“ANDA”). The monograph system establishes conditions, such as active ingredients, uses or indications, doses, routes of administration, labeling and testing, under which certain OTC active ingredients are generally recognized as safe and effective for their intended use. Products that contain these active ingredients and that comply with applicable monograph requirements do not require pre-market approval from the FDA. As a result, when a product, such as Curodont® Repair Fluoride Plus, is marketed following the OTC monograph process, the FDA does not approve it or its labeled intended use under either an NDA or an ANDA to assess its safety and efficacy.

The CARES Act established a process under which the FDA can issue administrative orders that revise or withdraw OTC monograph conditions. OTC monograph requirements continue to be subject to further FDA rulemaking, administrative orders, and guidance. We cannot assure you that the FDA will not issue administrative orders or otherwise take regulatory action that changes the conditions under which our products may be lawfully marketed, including by imposing additional data requirements, restricting permissible ingredients or claims or otherwise modifying applicable requirements. Any such action could require reformulation, relabeling, additional clinical data, changes to manufacturing processes or pre-market approval under the NDA or ANDA pathways, which could disrupt or delay commercialization and increase our costs.

Certain of our products are considered cosmetics regulated by the FDA through the FDCA and the Fair Packaging and Labeling Act. The FDA does not require pre-market clearance for cosmetics, but manufacturers are responsible for ensuring that such products are not adulterated or misbranded. Furthermore, Congress recently passed the Modernization of Cosmetics Regulation Act of 2022

(“MoCRA”), which significantly expands FDA authority to regulate cosmetics. MoCRA provides new FDA authorities related to records access, mandatory recalls, adverse event reporting, facility registration, product listing and safety substantiation of products, and we must comply with these requirements for any cosmetic products that we market in the United States.

In the EU and Switzerland, the EU MDR and MedDO impose rigorous and evolving requirements relating to clinical evidence, post-market surveillance, post-market clinical follow-up, periodic safety reporting, traceability, registration, quality systems and notified body oversight. Compliance with these requirements has required modifications to our quality management systems and technical documentation and may continue to require significant additional resources and expenditures. Limited notified body capacity, increased review timelines and evolving interpretations of EU MDR requirements may delay certification activities, product modifications or commercialization efforts.

Switzerland is not a member of the EU, and the bilateral Mutual Recognition Agreement between Switzerland and the EU has not been updated to encompass the EU MDR. As a result, Switzerland is treated as a third country for EU MDR purposes. As a Swiss-domiciled manufacturer, we must satisfy EU MDR requirements for EU market access and separately comply with Swiss MedDO obligations, including registration requirements and Swissmedic oversight. Because there are currently no Swiss-designated conformity assessment bodies whose certificates are recognized by the EU for CE marking purposes, we are dependent on EU-designated notified bodies for conformity assessments relating to our products marketed as medical devices in the EU and Switzerland. Any inability to obtain, maintain or renew notified body certifications on a timely basis, or any determination by Swissmedic that our products do not satisfy applicable Swiss regulatory requirements, could interrupt or delay commercialization activities.

We cannot guarantee that we will be able to maintain compliance with applicable regulations, and maintaining compliance may be time-consuming, costly and subject to changing interpretations. Regulatory authorities may conduct inspections of our operations and those of our contract manufacturers, distributors and suppliers. Failure to comply with applicable requirements, including quality system requirements, manufacturing standards, labeling and promotional restrictions, post-market surveillance obligations or adverse event reporting obligations, could result in increased regulatory scrutiny, warning letters, import restrictions, product withdrawals, recalls, field safety corrective actions, operating restrictions, suspension of certifications, refusal to permit commercialization of products, injunctions, fines, civil or criminal penalties or other enforcement actions.

Any actual or perceived quality, tolerability, performance, labeling, manufacturing or promotional issue relating to our products could result in increased regulatory scrutiny, voluntary or mandatory recalls, field safety corrective actions, customer notifications, import restrictions, product withdrawals, safety alerts or other enforcement actions. Regulatory authorities, including the Federal Trade Commission (the “FTC”), have increasingly focused on the substantiation of marketing and advertising claims and have commenced enforcement actions against companies for failures to adequately substantiate such claims. As a result, we may face increased scrutiny of our marketing practices, and any determination that our claims are not adequately supported could result in enforcement actions, including fines, injunctions, product relabeling or other corrective measures, as well as increased risk of private litigation, which could adversely affect our business, financial condition and results of operations. Even absent formal enforcement action, adverse event reports, product complaints, safety signals or negative publicity relating to our products may reduce market acceptance, impair relationships with healthcare professionals and distributors and adversely affect our reputation and commercialization efforts.

While we currently have operations in multiple countries, in order to market any of our current or future products in any particular jurisdiction, we must establish and maintain compliance with numerous and varying regulatory requirements on a jurisdiction-by-jurisdiction basis regarding quality, tolerability, performance and efficacy. Regulatory authorization or approval in one jurisdiction does not guarantee authorization or approval in any other jurisdiction. Approval processes vary among countries and can involve additional testing, validation, inspections and administrative review periods. Seeking regulatory clearance, authorization or approval in additional jurisdictions may result in substantial costs, delays and

operational burdens, and we may never obtain or maintain the required approvals or certifications to commercialize products in certain markets. If we fail to obtain or maintain required regulatory clearances, certifications, authorizations or approvals in international markets, our target market and growth opportunities could be materially limited.

Regulatory authorities could in the future disagree with, modify or reassess the regulatory classification or applicable regulatory pathway for our products. Regulatory authorities may also apply differing interpretations to novel biomimetic peptide technologies and other technologies that we may develop or commercialize in the future. For example, a product currently regulated as a medical device in a particular jurisdiction could in the future be determined to be subject to regulation as a medicinal product, drug-device combination product or another regulatory category subject to more burdensome approval, manufacturing, clinical or post-market requirements. The FDA could conclude that Curodont® Repair Fluoride Plus is a combination product utilizing its carrier sponge as a device or could conclude that Curodont® Repair Fluoride Plus is not marketed in full compliance with the applicable OTC monograph but rather may require separate regulatory review and approval by the FDA as a drug through the NDA/ANDA processes, as a medical device, or as a combination product following either the FDA’s drug or medical device approval pathways. Any such reassessment or change in regulatory requirements could significantly increase development and compliance costs, delay commercialization timelines, interrupt existing commercialization activities, require product reformulation or relabeling, subject us to additional post-market surveillance obligations or otherwise adversely affect our business.

Our products may be classified differently across jurisdictions depending on their composition, intended use, mechanism of action, claims and delivery method. A determination that any current or future product is a drug, biologic, combination product, higher-risk medical device or other regulated product category could require additional clinical data, manufacturing controls, quality-system changes, labeling changes, premarket submissions, notified body review, marketing authorization, post-market surveillance or other obligations. Such changes could delay or restrict commercialization, restrict claims, require reformulation or relabeling, increase compliance costs or interrupt sales.

For example, certain of our products are currently regulated as medical devices in some jurisdictions and as OTC drug products or cosmetics in others. Each of these product classes has its own regulatory review pathways in each jurisdiction in which our products are marketed. Future products or modified versions of existing products may be subject to different regulatory frameworks, including those applicable to drug products, medical devices, combination products, cosmetics or products incorporating ancillary medicinal substances. Changes in product composition, mechanism of action, indications, claims, formulation, route of administration or method of delivery may result in additional regulatory requirements, including the need for new or expanded clinical evidence, modified labeling, additional manufacturing or quality system requirements, new regulatory submissions, additional post-market obligations or pre-market approvals.

If the FDA determines that our products or any part of our products are subject to medical device regulatory requirements, we and our contract manufacturers may be required to comply with additional obligations, including but not limited to establishment registration, device listing, medical device reporting requirements and compliance with the new Quality Management System Regulation (the “QMSR”), unless an exemption applies. The FDA adopted the QMSR, effective February 2, 2026, which incorporates ISO 13485:2016 by reference and replaces most elements of the prior Quality System Regulation for medical device manufacturers. Compliance with the QMSR would require additional investments in quality systems, documentation, supplier oversight and operational controls, and failure to comply could expose us to FDA enforcement actions.

Our products may be subject to recalls, safety alerts, field actions or other corrective measures. Regulatory authorities, including the FDA, the EMA, Swissmedic and comparable foreign regulatory authorities, have broad authority to require the recall, withdrawal, correction, suspension or restriction of

commercialized products that are alleged or determined to be unsafe, ineffective, noncompliant or otherwise violative of applicable laws or regulations. Manufacturers may also voluntarily initiate recalls, field safety corrective actions, product withdrawals, safety notices or other corrective measures if a product deficiency or safety concern is identified.

A government-mandated or voluntary recall, correction, removal, field action or safety alert involving our products or services could occur for many reasons, including actual or alleged unacceptable health risks, adverse events, component failures, manufacturing errors, quality control deficiencies, contamination, design defects, software or technical failures, failures in laboratory or testing processes, packaging defects, stability issues, labeling deficiencies, misleading promotional claims, deviations from current good manufacturing practices or quality system requirements, noncompliance with regulatory requirements or other deficiencies or issues, whether caused by us, our suppliers, contract manufacturers, distributors or other third parties.

As our product portfolio expands and we introduce next-generation products, modified formulations, new technologies and alternative delivery methods, the scope and complexity of our post-market obligations and product safety risks may increase. In addition, because certain of our products may be regulated differently across jurisdictions, a recall, safety issue or regulatory action in one jurisdiction could lead to increased scrutiny or parallel regulatory action in other jurisdictions.

Recalls and corrective actions can be particularly costly and disruptive in highly regulated industries such as healthcare and medical products. Regulatory authorities may require us to develop and implement detailed recall or field correction strategies, provide periodic reports regarding the status of corrective actions, conduct customer notifications, maintain extensive records regarding corrections and removals and undertake additional post-market surveillance or remediation activities. Regulatory authorities may also conduct inspections, audits or investigations in connection with recalls or safety events.

Any recall, field action, correction, removal, market withdrawal or safety alert involving our products could divert significant managerial, operational, technical and financial resources, interrupt manufacturing and commercial activities, result in inventory write-offs, increase costs and adversely affect our relationships with healthcare professionals, distributors, regulatory authorities and customers. We may also become subject to product liability claims, contractual disputes, indemnification obligations, litigation, enforcement actions, fines, penalties or other liabilities arising from actual or alleged defects or safety concerns relating to our products.

In addition, even absent a formal recall or enforcement action, adverse event reports, product complaints, safety signals, quality issues or negative publicity relating to our products may reduce market acceptance of our products, impair customer confidence, delay or reduce adoption of new products and harm our reputation. Competitors may also use publicly available recall or safety-related information to market competing products or otherwise attempt to gain commercial advantage.

If we initiate or are required to initiate a recall, correction, removal, field action or other safety-related measure, we could face increased scrutiny by the FDA, the EMA, Swissmedic and other regulatory authorities regarding the quality, safety and regulatory compliance of our products and operations. Such scrutiny could result in warning letters, import restrictions, increased inspections, suspension or withdrawal of certifications or authorizations, operating restrictions, delays in obtaining approvals for new or modified products or other enforcement actions.

Moreover, regulatory requirements governing recalls, adverse event reporting, vigilance reporting and field safety corrective actions are complex and vary across jurisdictions. Any failure or perceived failure by us to timely identify, investigate, report or appropriately respond to product-related issues or safety events could itself result in regulatory enforcement actions, fines, penalties or reputational harm.

Our operations may subject us to healthcare regulation and enforcement by governmental authorities in the United States, Switzerland, the EU, the United Kingdom and other jurisdictions in which we operate or commercialize our products. Various laws and regulations govern reimbursement, payment practices,

interactions with healthcare professionals and healthcare organizations, sales and marketing activities and financial arrangements involving healthcare products and services. These laws and regulations are broad in scope, may be interpreted narrowly by enforcement authorities and are subject to evolving guidance and enforcement priorities.

In particular, numerous U.S. federal and state laws, as well as comparable foreign laws, prohibit payments intended to induce the referral, recommendation, purchase, prescription, order or use of healthcare products or services and may require companies to limit, monitor, disclose or report certain payments and transfers of value to healthcare professionals and healthcare organizations. These laws affect many aspects of our business operations, including our sales, marketing, pricing, discounting, customer support, consulting, education, training and reimbursement support activities. In particular, these laws may limit the kinds of financial arrangements, sales programs and customer engagement initiatives that we may enter into with dentists, dental clinics, distributors, hospitals, universities and other purchasers or users of our products. They also impose additional administrative and compliance burdens on us. In particular, these laws influence, among other things, how we structure our sales offerings, including discount practices, customer support, education and training programs and physician consulting and other service arrangements. These laws prohibit certain marketing initiatives that are commonplace in other industries.

Applicable U.S. healthcare laws and regulations include, among others:

We may also become subject to comparable anti-bribery, anti-kickback, transparency, fraud and abuse, reimbursement and healthcare compliance laws in foreign jurisdictions. In many countries, interactions between medical product companies and healthcare professionals are highly regulated and may be subject to industry codes, disclosure obligations, restrictions on sponsorships and educational activities and limitations on pricing and reimbursement support. In addition, healthcare professionals employed by government-affiliated hospitals, universities or healthcare systems may be considered government officials under applicable anti-corruption laws.

Many of these laws may apply even where there is no intent to violate the law, and enforcement authorities have increasingly interpreted these laws broadly. In addition, violations of the AKS may serve as the basis for liability under the federal False Claims Act. Comparable foreign laws and regulations may apply more broadly to commercial payors and private healthcare arrangements.

Healthcare enforcement activity has increased in recent years, particularly with respect to promotional practices, consulting arrangements, speaker programs, educational grants, discount

arrangements, reimbursement support activities and interactions with healthcare professionals. Our relationships with healthcare providers, distributors and customers may be subject to scrutiny under these laws, and our business practices could be challenged even if we believe they comply with applicable law.

In addition, the availability of coverage and reimbursement for our products by governmental healthcare programs, including Medicare and Medicaid, commercial insurers and other third-party payors may affect market acceptance and commercial adoption of our products. Government authorities and private payors continue to seek ways to reduce healthcare costs and may limit coverage, reduce reimbursement levels, impose pricing pressures or apply additional utilization management controls relating to healthcare products and services. Any reduction in reimbursement or limitation on coverage for our products could adversely affect demand for our products and our ability to commercialize them successfully. In addition, even if our efforts to expand reimbursement coverage for our products are successful, there can be no assurance that such efforts will result in increased utilization. Reimbursement decisions by third-party payors may set reimbursement rates at levels that patients or providers consider insufficient to justify the cost or administrative burden of treatment. Dental professionals may accordingly be reluctant to prescribe or recommend treatments that are not adequately reimbursed, and as a result, our efforts to secure or expand reimbursement coverage may not translate into increased adoption of our products.

Any actual or alleged failure by us, our employees, distributors, agents or other third parties acting on our behalf to comply with applicable healthcare laws and regulations could result in investigations, audits, significant legal expenses, reputational harm and diversion of management resources. If our operations are found to violate any applicable laws or regulations, we could be subject to substantial administrative, civil or criminal penalties, damages, fines, disgorgement, contractual liability, integrity oversight obligations, exclusion from participation in governmental healthcare programs, including Medicare and Medicaid, repayment obligations and operational restrictions, any of which could adversely affect our business, financial condition and results of operations.

Our commercial strategy depends in part on communicating the clinical benefits of our products to dental professionals, distributors, DSOs and patients. Claims regarding mode of action, cavities management, repair, restoration of mineral density, treatment of early-stage cavities, clinical superiority, tolerability, performance, durability, cost-effectiveness or patient outcomes may be subject to scrutiny by the FDA, FTC, state attorneys general, foreign regulatory authorities, self-regulatory bodies, competitors and private plaintiffs. If our claims are alleged or determined to be false, misleading, inadequately substantiated, inconsistent with authorized, cleared, approved or permitted indications, or otherwise noncompliant, we may be required to modify promotional materials, limit claims, conduct additional studies, issue corrective communications, pay fines or damages, defend litigation or investigations, suspend certain marketing activities, or conduct field / corrective actions, recalls, or withdraw product(s) from the market.

We are exposed to the risk that our employees, distributors, agents, contractors, collaborators and other third parties acting on our behalf may engage in misconduct, fraud, unauthorized activities or other improper conduct. Such conduct could include failures to comply with applicable healthcare, anti-corruption, competition, employment, environmental, privacy, reimbursement, fraud and abuse or other laws and regulations, including those governing the marketing, sale, labeling and promotion of healthcare products, interactions with healthcare professionals and government officials, reporting obligations, financial recordkeeping and disclosure requirements.

Because we operate internationally and rely on distributors, commercial partners and other third parties in multiple jurisdictions, including jurisdictions with heightened corruption or enforcement risk, we may face increased exposure to compliance-related risks. In addition, healthcare professionals and employees of public hospitals, universities or healthcare systems in many jurisdictions may be considered government officials for purposes of applicable anti-corruption laws.

We are subject to the U.S. Foreign Corrupt Practices Act (the “FCPA”), the U.K. Bribery Act 2010, and other anti-bribery and anti-corruption laws in the jurisdictions in which we operate. These laws generally prohibit the offering, promising, giving or authorization of improper payments or other benefits, directly or indirectly, to government officials or other parties in order to obtain or retain business or secure an improper advantage. The FCPA also imposes accounting, recordkeeping and internal controls requirements on public companies.

Although we maintain policies, contractual provisions and compliance procedures intended to promote compliance with applicable laws, including a code of conduct, anti-corruption policies and contractual compliance obligations applicable to certain third parties, we cannot assure you that these controls will be effective or that all employees and third parties acting on our behalf will comply with applicable laws and regulations at all times. We have provisions in our Code of Business Conduct and Ethics (the “Code of Ethics”), an anti-corruption policy, certain provisions in some of our agreements with third parties, including our collaborators and distributors, and certain controls and procedures in place that are designed to mitigate the risk of noncompliance with anti-corruption and anti-bribery laws. It is not always possible to identify and deter misconduct, and the precautions we take to detect and prevent improper activities may not be effective in controlling unknown or unmanaged risks.

Any actual or alleged violation of applicable laws or regulations by us or by third parties acting on our behalf could result in investigations, audits, enforcement actions, significant administrative, civil or criminal penalties, damages, fines, disgorgement, reputational harm, operational restrictions, integrity oversight obligations, exclusion from participation in governmental healthcare programs or restrictions on our ability to commercialize products in one or more jurisdictions. Any such events could adversely affect our reputation, international expansion efforts, business, financial condition and results of operations.

Our operations and those of our third-party manufacturers, suppliers, warehousing providers, distributors, logistics providers and other business partners involve the use, storage, transportation, handling and disposal of hazardous substances, chemicals, biological materials and other regulated materials and are subject to environmental, occupational health and safety, chemical control and waste management laws and regulations in multiple jurisdictions. These laws and regulations govern, among other things, emissions, discharges, storage practices, packaging, labeling, worker health and safety, contamination, transportation and disposal activities.

Environmental, health and safety laws and regulations are becoming increasingly stringent and may impose substantial compliance costs, operational restrictions, remediation obligations, reporting requirements, permitting obligations and potential liabilities. Compliance with these requirements may require us and our third-party partners to incur significant costs relating to facilities, equipment, procedures, training, monitoring and recordkeeping.

We cannot eliminate the risk of accidental contamination, injury, exposure, release or other incidents involving hazardous materials or regulated substances. Such events may occur at our facilities or at facilities operated by our third-party manufacturers, suppliers, warehouse operators, transportation providers or other contractors, including during manufacturing, storage, transportation or disposal activities. We may have limited visibility into, or control over, the operations and compliance practices of these third parties.

Any failure by us or our third-party partners to comply with applicable environmental, health and safety requirements could result in governmental investigations, inspections, fines, penalties, remediation obligations, operational disruptions, recalls, supply interruptions, shipment delays, restrictions on the transportation or storage of products, reputational harm or other liabilities. In addition, contamination events, workplace accidents or environmental incidents involving our facilities or supply chain partners could result in litigation, regulatory enforcement actions, property damage, personal injury claims or interruptions to manufacturing and distribution activities.

If a clinical trial subject’s or research participant’s informed consent is challenged or proven invalid, unlawful or otherwise inadequate, our product development efforts may be hindered and we could become involved in legal challenges.

We seek to ensure that all data, biological samples and other research materials that we receive from collaborators, investigators, research institutions, clinical sites and other third parties have been collected from subjects or participants who have provided appropriate informed consent for purposes that extend to our development activities and that such data and samples are appropriately de-identified where required. However, requirements relating to informed consent, secondary use of clinical data and biospecimens and cross-border transfer of health-related data continue to evolve, and regulatory authorities or courts may adopt interpretations that restrict the use of previously collected data or samples.

Because we rely on collaborators and third parties to obtain, document and maintain appropriate consents and to comply with applicable local laws and ethical standards, we cannot assure you that all consents obtained will be valid or sufficient for our intended purposes. Any findings that informed consent was not properly obtained or that applicable legal, ethical or regulatory requirements were not satisfied could restrict our ability to use certain data or samples, delay development activities, result in litigation or regulatory scrutiny.

Any of the foregoing events could adversely affect our business, supply chain, financial condition, results of operations and future prospects.

Healthcare reform efforts in the United States and internationally continue to evolve and may reduce reimbursement levels, impose pricing pressures, increase compliance obligations or otherwise adversely affect the demand for, or commercial viability of, our products. Governments, regulatory authorities and private payors in many jurisdictions continue to implement cost-containment measures and other reforms intended to control healthcare spending, improve quality of care and expand access to healthcare services.

In the United States, federal and state governments, CMS, private insurers and managed care organizations continue to review and assess the cost-effectiveness, coverage and reimbursement of healthcare products and services. Legislative and regulatory changes may affect coverage, reimbursement, pricing, utilization, coding, promotional practices or market access relating to healthcare products. We cannot predict the nature or impact of future healthcare reform initiatives, including future changes to the Affordable Care Act, Medicare, Medicaid or other governmental healthcare programs. Government authorities and private payors may also seek to impose additional pricing controls, reimbursement reductions, utilization management measures or documentation requirements applicable to healthcare products and services.

Outside the United States, many countries, including member states of the EU, the United Kingdom and Switzerland, maintain government-sponsored healthcare systems and centralized or quasi-centralized mechanisms for setting or influencing pricing, reimbursement and market access for healthcare products. In these jurisdictions, pricing and reimbursement approvals may be required before products can be commercialized broadly or achieve meaningful adoption, and governmental authorities may impose conditions, reimbursement caps, tender requirements, reference pricing systems or other restrictions that negatively affect pricing or utilization.

Healthcare reforms and cost-containment measures in the EU and the United Kingdom have included increased scrutiny of healthcare expenditures, efforts to reduce reimbursement levels, expanded pricing controls and greater emphasis on health economic outcomes and comparative effectiveness. In Switzerland, healthcare cost-containment initiatives and reimbursement reforms may similarly affect pricing, utilization and market access for healthcare products and services. Comparable measures have also been implemented or proposed in other jurisdictions in which we operate or may seek to commercialize our products in the future.

In addition, third-party payors may increasingly require evidence of clinical utility, cost-effectiveness and long-term economic benefit in order to support reimbursement decisions or coverage determinations. If our products fail to obtain or maintain adequate reimbursement, favorable coding or broad coverage from governmental healthcare programs, commercial insurers or other third-party payors, healthcare professionals and patients may not use our products, or may reduce utilization of our products, which could adversely affect our revenue and commercial prospects.

Healthcare reform measures and reimbursement restrictions may also increase our operational and compliance burdens, reduce the prices we may charge for our products, limit the commercial opportunities available to us or require us to make significant changes to our business practices. Any such developments could materially adversely affect our business, financial condition, results of operations and future prospects.

Our success depends in part on our ability to obtain, maintain, defend and enforce patents and other forms of intellectual property rights, including trademarks and copyrights, as well as our ability to preserve our trade secrets and to prevent third parties from infringing, misappropriating or otherwise violating our intellectual property and proprietary rights.

Our ability to protect our products, methods and technology from unauthorized use by third parties depends on the extent to which valid and enforceable patents cover them or they are effectively protected as trade secrets. For information regarding our patent portfolio, please see “Business—Intellectual Property.”

The patent position of companies in our field is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. As a result, the ownership, issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. There can be no assurance that our patent rights will not be invalidated or held to be unenforceable, will adequately protect our products, methods or technology or provide any competitive advantage, or that any of our pending or future patent applications will issue as valid and enforceable patents. Our ability to obtain and maintain patent protection for our methods and related products or technology is uncertain due to a number of factors, including that:

While we will endeavor to protect our products, methods and technology with intellectual property rights such as patents, as appropriate, the process of obtaining patents is time-consuming, expensive and sometimes unpredictable, and we may not be able to file, prosecute, maintain, enforce or license all necessary or desirable patent applications at a reasonable cost or in a timely manner or we may elect not to file patent applications for certain products, methods or technology and to instead rely on trade secret protection. For example, we have filed patent applications for Curodont® Protect in the United States, but no such patent applications have issued. With respect to the version of Curodont® Protect that is marketed outside the United States, we have elected to rely on trade secret protection and we have not filed for any patent protection for such product, and therefor we will be unable to rely on patent protection as a means for providing us with any competitive advantage for such product.

In addition, although we enter into nondisclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of our research and development output, such as our employees, corporate collaborators, outside scientific collaborators, contract research organizations or manufacturers, consultants, advisors and other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection. Furthermore, we cannot guarantee that any patents will be issued from any of our pending or future patent applications. The standards applied by the United States Patent and Trademark Office (the “USPTO”) and foreign patent offices in granting patents are not always applied uniformly or predictably. Moreover, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. As such, we do not know the degree of future protection that we will have on our proprietary products, methods or technology. Thus, even if our patent applications issue as patents, they may not issue in a form that will provide us with meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage.

Even if we have or obtain patents, we may still be barred from making, using and selling such products, methods or technology because of the patent rights of others. Others may have filed, and in the future may file, patent applications covering products, methods or technology that are similar or identical to ours, which could materially affect our ability to successfully develop our methods or technology, or to successfully commercialize any products, methods or technology alone or with collaborators. Patent applications in the United States and elsewhere are generally published approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications could have been filed by others without our knowledge. Additionally, pending claims in patent applications which have been published can, subject to certain limitations, be later amended in a manner that could cover our products, methods or technology. These patent applications may predate patent applications filed by us. Furthermore, certain patent applications may remain confidential until a patent issues. It is difficult for industry participants, including us, to identify all third-party patent rights that may be relevant to our products, methods or technology because patent searching is imperfect due to the delay between the filing of a patent application and its publication, differences in terminology among patents, incomplete databases and the difficulty in assessing the meaning of patent claims. We may fail to identify relevant patents or patent applications or may identify pending patent applications of potential interest but incorrectly predict the likelihood that such patent

applications may issue with claims of relevance to our technology. In addition, we may be unaware of one or more issued patents that would be infringed by the manufacture, sale or use of our products, methods or technology, or we may incorrectly conclude that a third-party patent is invalid, unenforceable or not infringed by our activities.

The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our owned patents may be challenged in the courts or patent offices in the United States and abroad. We may be subject to third-party pre-issuance submissions of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant and inter partes review, or interference proceedings and equivalent proceedings in the U.S. and foreign jurisdictions (e.g., opposition proceedings) challenging our patent rights. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our products, methods or technology and compete directly with us, including without payment to us, or result in our inability to manufacture or commercialize our products, methods or technology without infringing third-party patent rights. Moreover, we may have to participate in interference proceedings declared by the USPTO to determine priority of invention or in post-grant challenge proceedings, such as oppositions in a foreign patent office, that challenge our right to obtain patents on our inventions or other features of patentability of our inventions. Such challenges may result in loss of patent rights, loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical products, methods or technology, or limit the duration of the patent protection of our products, methods or technology. Such proceedings also may result in substantial cost and require significant time from our employees and management, even if the eventual outcome is favorable to us. In addition, if the breadth or strength of protection provided by the patents and patent applications we own is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future technology.

In addition, third parties may be able to develop technology that is similar to, or better than, ours in a way that is not covered by the claims of our patents or may have blocking patents that could prevent us from marketing our products or practicing our own patented methods or technology. Moreover, patents have a limited lifespan. In the United States, the default term of a patent expires generally 20 years after it is filed. Thus, the term of a patent, and the protection it affords, is limited. Without patent protection for current or future products, methods or technology, we may face increased competition. Given the amount of time required for the development and testing, and regulatory review where necessary, patents protecting our technology might expire before or shortly after such technology is commercialized. At the same time, given the rapid pace of technological advancement and innovation in our industry, the time needed to obtain patents often renders the protection, once obtained, ineffective if the protected technology has become obsolete or widely adopted while the patent protection was pending or before a patent application was filed. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products, methods or technology similar or identical to that we or our collaborators may develop.

Moreover, certain of our patents and patent applications may in the future be co-owned with third parties. If we are unable to obtain an exclusive license to any such third-party co-owners’ interest in such patents or patent applications, such co-owners may be able to use or license their rights to other third parties, including our competitors, and our competitors could market competing products, methods or technology. In addition, we may need the cooperation of any such co-owners of our patents in order to enforce such patents against third parties, and such cooperation may not be provided to us. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

Competitors and other third parties may infringe, misappropriate or otherwise violate our patents and other intellectual property rights or the patents and other intellectual property rights of our collaborators. The enforcement of such claims can be expensive and time-consuming. In an infringement proceeding, a court may decide that a patent owned by us is invalid or unenforceable or may refuse to stop the other

party from using the technology at issue on the grounds that our owned patents do not cover the technology in question. An adverse result in any litigation proceeding could put one or more of our owned patents at risk of being invalidated, rendered unenforceable or interpreted narrowly in a way that renders them commercially immaterial. In addition, our ability to enforce our patent or other intellectual property rights depends on our ability to detect infringement. It may be difficult to detect infringers who do not advertise the components or methods that are used in connection with their products and services. Moreover, it may be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s product or service sufficient to initiate a lawsuit or other proceeding to obtain relief.

If we were to initiate legal proceedings against any other third party to enforce a patent covering our technology, the defendant could assert that our patent is invalid or unenforceable or is not sufficiently broad to cover the third party’s products or technology. In patent litigation in the United States and Europe, defendants alleging invalidity or unenforceability are common. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, for example, lack of novelty, obviousness, lack of written description or non-enablement. Third parties might allege unenforceability of our patents because during prosecution of the patent an individual connected with such prosecution withheld relevant information or made a misleading statement. Third parties may also raise challenges to the validity of our patent claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include reexamination, post-grant review, inter partes review, interference proceedings, derivation proceedings and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in the revocation of, cancellation of, or amendment to, our patents in such a way that they no longer cover our products, methods or technology. The outcome of proceedings involving assertions of invalidity, non-infringement and unenforceability, including during patent litigation, is unpredictable. With respect to the validity of patents, for example, we cannot be certain that there is no invalidating prior art of which we and the patent examiner were unaware during prosecution, but that an adverse third party may identify and submit in support of such assertions of invalidity. If a defendant were to prevail on a legal assertion of invalidity, non-infringement or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our technology. Such a loss of patent protection could have a material adverse effect on our business. Our patents and other intellectual property rights also will not protect our products, methods or technology if competitors design around our protected products, methods or technology without infringing our patents or other intellectual property rights.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our personnel from their normal responsibilities. There can be no assurance that we will have sufficient financial or other resources to file and pursue infringement claims, which typically last for years before they are concluded. We may or may not choose to pursue litigation or other actions against those that have infringed on our patents, or have used them without authorization, due to the associated expense and time commitment of monitoring and carrying out these activities. In addition, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our ordinary shares and valuation. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or commercialization activities. Uncertainties resulting from patent and other intellectual property litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace, our ability to raise additional funds and could otherwise have a material adverse effect on our business, financial condition, results of operations and prospects.

Our commercial success depends in part upon our ability to develop, manufacture, market and sell our products and use our proprietary methods and technology without infringing, misappropriating or otherwise violating the patents or other intellectual property or proprietary rights of third parties. Litigation

relating to infringement, misappropriation or other violations of patents and other intellectual property rights in our industry is common, including patent infringement lawsuits, trade secret lawsuits, interferences, oppositions, inter partes review, post-grant review and reexamination proceedings before the USPTO, and corresponding international patent offices.

In the future, we may be subject to third-party claims and similar adversarial proceedings or litigation regarding any infringement, misappropriation or other violation by us of patent or other intellectual property rights of third parties. If any such claim or proceeding is brought against us, our collaborators or our third-party service providers, our development, manufacturing, marketing, sales and other commercialization activities could be similarly adversely affected. Even if we believe third-party intellectual property claims are without merit, there is no assurance that a court would find in our favor on questions of ownership, inventorship, infringement, validity, enforceability or priority. A court of competent jurisdiction could hold that third-party patents asserted against us are valid, enforceable and infringed, which could materially and adversely affect our ability to develop, manufacture, market, sell and commercialize any of our products, methods or technology. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. If we are found to infringe any third party’s patents or other intellectual property rights, and we are unsuccessful in demonstrating that such patents or other intellectual property are invalid or unenforceable, we could be required to obtain a license from such third party to continue developing, manufacturing, marketing, selling and commercializing our products, methods or technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be nonexclusive, which would give our competitors and other third parties access to the same technologies licensed to us, and it could require us to make substantial licensing, royalty and other payments. We also could be forced, including by court order, to cease developing, manufacturing, marketing, selling and commercializing the infringing product, method or technology. Further, we may be required to redesign the product, method or technology in a non-infringing manner which may not be commercially, or at all, feasible. In addition, we could be found liable for significant monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent or other intellectual property right. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar material adverse effect on our business, financial condition, results of operations and prospects.

The various markets in which we plan to operate are subject to frequent and extensive litigation regarding patents and other intellectual property rights. It is possible that one or more organizations will hold patent rights to which we will need a license. If those organizations refuse to grant us a license to such patent rights on reasonable terms, we may be unable to develop, manufacture, market, sell and commercialize our products, methods or technology or perform research and development or other activities covered by these patents. Some claimants may have substantially greater resources than we do and may be able to sustain the costs of complex intellectual property litigation to a greater degree and for longer periods of time than we could. In addition, many companies in intellectual property-dependent industries have employed intellectual property litigation as a means to gain an advantage over their competitors. Furthermore, patent holding companies that focus solely on extracting royalties and settlements by enforcing patent rights may target us. As our industry expands and more patents are issued, and as we gain greater visibility and market exposure as a public company, the risk increases that our products, methods and technology may be subject to intellectual property-related claims by third parties.

Even if resolved in our favor, litigation or other legal proceedings relating to intellectual property claims may cause us to incur significant expenses and could distract our personnel from their normal responsibilities. In addition, intellectual property litigation, regardless of its outcome, may cause negative publicity, adversely impact prospective customers, cause product shipment delays or prohibit us from manufacturing, marketing, selling or otherwise commercializing our products, methods and technology. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions

or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our Class A ordinary shares and valuation. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or commercialization activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Uncertainties resulting from patent and other intellectual property litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace, our ability to raise additional funds, and could otherwise have a material adverse effect on our business, results of operations, financial condition and future prospects.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for noncompliance with these requirements.

Obtaining and maintaining a patent portfolio entails significant expense, including application fees, attorneys’ fees, periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and patent applications, which must be paid to the USPTO and various government patent agencies outside of the United States over the lifetime of our owned patents and applications. The USPTO and various non-U.S. government agencies require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process. We may or may not choose to pursue or maintain protection for particular intellectual property in our portfolio. If we choose to forgo patent protection or to allow a patent application or patent to lapse purposefully or inadvertently, our competitive position could suffer. Furthermore, we employ reputable law firms and other professionals to help us comply with the various procedural, documentary, fee payment and other similar provisions we are subject to and, in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. There are situations, however, in which failure to make certain payments or noncompliance with certain requirements in the patent process can result in abandonment or lapse of a patent or patent application, resulting in a partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might have increased or greatly increased ability to enter the market, which would have a material adverse effect on our business, financial condition, results of operations and prospects.

Filing, prosecuting and defending patents in all countries and jurisdictions throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States will likely be less extensive than those in the United States, assuming rights are obtained in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States, even in jurisdictions where we do pursue patent protection. Consequently, we may not be able to prevent third parties from practicing our inventions or using our intellectual property without authorization in all countries outside the United States, even in jurisdictions where we do pursue patent protection, or from selling or importing our technology in and into the United States or other jurisdictions.

We generally apply for patents in those countries where we intend to make, have made, use or offer for sale our products, methods and technology and where we assess the risk of infringement to justify the cost of seeking patent protection. However, we may not seek protection in all countries where we will commercialize our products, methods and technology and we may not accurately predict all the countries where patent protection would ultimately be desirable or valuable. If we fail to timely file a patent application in any such country or major market, we may be precluded from doing so at a later date. Competitors may use our technology in jurisdictions where we do not pursue and obtain patent protection to develop their own products, methods or technology and may export otherwise infringing products, methods or technology to territories where we have patent protection, but where our ability to enforce our

patent rights is not as strong as in the United States. These products, methods or technology may compete with technologies that we or our collaborators may develop, and our patents or other intellectual property rights may not be effective or sufficient to prevent such competition.

In addition, the legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to our industry. As a result, many companies have encountered significant difficulties in protecting and defending intellectual property rights in certain jurisdictions outside the United States. Such issues may make it difficult for us to stop the infringement of our patents, if obtained, or the misappropriation or other violation of our other intellectual property rights. For example, many other countries, including countries in the EU, have compulsory licensing laws under which a patent owner must grant licenses to third parties under certain conditions. In addition, many countries limit the enforceability of patents against third parties, including government agencies or government contractors. In those countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of those patents and could limit our potential revenue opportunities and our ability to prevent wrongful competition using our intellectual property. Accordingly, our efforts to enforce intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we own.

Furthermore, proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, subject our patents to the risk of being invalidated or interpreted narrowly or rendered unenforceable, subject our patent applications to the risk of not issuing or provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded to us, if any, may not be commercially meaningful, while the damages and other remedies we may be ordered to pay such third parties may be significant.

In addition to seeking patent protection for certain aspects of our technology, we also consider trade secrets, including confidential and unpatented know-how, important to the maintenance of our competitive position. We protect trade secrets and confidential and unpatented know-how, in part, by entering into nondisclosure and confidentiality agreements with parties who have access to such knowledge, such as our employees, corporate collaborators, outside scientific collaborators, contract research organizations or manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants that obligate them to maintain confidentiality and assign their inventions to us. We cannot guarantee that we have entered into such agreements with each party that may have or have had access to our trade secrets or proprietary technology and processes or that the assignment agreements that have been entered into are self-executing. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information and/or use it in an unauthorized manner to our disadvantage, including our trade secrets, or claim ownership in intellectual property that we believe is owned by us. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems; however, such systems and security measures may be breached, and we may not have adequate remedies for any breach. In addition, there is a risk of employees inadvertently inputting trade secret information into AI technologies, thereby enabling third parties to access such information. Monitoring unauthorized uses and disclosures of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will be effective. In addition, we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed, used without authorization or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts in the United States and certain foreign jurisdictions are less willing or unwilling to protect trade secrets. As a result, we could lose our trade secrets and third parties could use our trade secrets to compete with our products, methods and technology.

Moreover, our competitors or other third parties may independently develop knowledge, methods and know-how equivalent to our trade secrets or seek to reverse-engineer our technology for which we do not

have patent protection. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third parties, we would have no right to prevent them from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.

We are also subject both in the United States and outside the United States to various regulatory schemes which mandate disclosures to governmental authorities and/or the public, which may include, in whole or in part, trade secrets or confidential commercial information. While we are likely to be notified in advance of any disclosure of such information and would likely object to such disclosure, there can be no assurance that our challenge to the request would be successful. Any of the foregoing could have a material adverse effect on our business, results of operations, financial condition and future prospects.

Many of our employees, consultants and advisors are currently or were previously employed at universities, research institutes or other companies in our industry, including our competitors or potential competitors. Although we try to ensure that our employees, consultants and advisors do not use the proprietary information or know-how of others in their work for us, we may in the future be subject to claims that we or these individuals have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights. Our inability to use such technologies or features would harm our business and may prevent us from successfully commercializing our products, methods and technology. In addition, we may lose personnel as a result of such claims and any such litigation or the threat thereof may adversely affect our ability to hire employees or contract with independent contractors. A loss of key personnel or their work product could hamper or prevent our ability to commercialize our products, methods or technology, which would have a material adverse effect on our business, results of operations, financial condition and prospects. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.

In addition, while it is our policy to require our employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that we regard as our own. The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and we may be forced to bring claims against third parties, or defend claims that they may bring against us, to determine the ownership of what we regard as our intellectual property. Furthermore, individuals executing agreements with us may have preexisting or competing obligations to a third party, such as an academic institution, and thus an agreement with us may be ineffective in perfecting ownership of inventions developed by that individual. Additionally, disputes may arise with employees, consultants or others who develop or generate intellectual property for us in which they deny an obligation to assign the intellectual property to us. Such claims could have a material adverse effect on our business, results of operations, financial condition and future prospects. In addition, if the breadth or strength of protection provided by our owned patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future intellectual property rights.

Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, declared generic, cancelled or determined to be infringing on other marks. As a means to enforce our trademark rights and prevent infringement, we may be required to file trademark claims against third parties or initiate trademark opposition proceedings. This can be expensive, particularly for a company of our size, and time-consuming. In addition, in an infringement proceeding, a court may decide that a trademark of ours is not valid or is unenforceable, or may refuse to stop the other party from using

the trademark at issue. We may not be able to protect our rights to these and other trademarks and trade names or may be forced to stop using these names, which we may need to build goodwill and name recognition with potential collaborators or customers in our markets of interest.

We have certain trademark applications pending in the United States and abroad, but there can be no assurance that these applications will be allowed and not opposed. Even if these applications proceed to registration, third parties may challenge our use or registration of these trademarks in the future. In the event that our trademarks are successfully challenged, we could be forced to rebrand our products, methods or technology, which could result in loss of brand recognition and could require us to devote substantial resources to advertising and marketing new brands. Other companies may be using trademarks that are similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, they may infringe our trademarks and we may not have adequate resources to enforce our trademarks. If we attempt to enforce our trademarks and assert trademark infringement claims, a court may determine that the party against whom we have asserted trademark infringement has superior rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks. Furthermore, there could be potential trade name or trademark infringement claims brought by owners of other trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Failure to maintain our trademark registrations, or to obtain new trademark registrations in the future, could limit our ability to protect our trademarks and impede our marketing efforts in the countries in which we operate. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.

A portion of the products or technologies licensed, developed or distributed by us incorporate so-called “open source” software, and we may incorporate open source software into other products or technologies in the future. Such open source software is generally licensed by its authors or other third parties under open source licenses. Some open source licenses may contain requirements that we disclose source code for modifications we make to the open source software and that we license such modifications to third parties at no cost, as well as other obligations. In some circumstances, distribution of our software in connection with open source software could require that we disclose and license some or all of our proprietary code in that software as well as distribute our products or technologies that use particular open source software at no cost to the user, which could substantially help our competitors develop products or technologies that are similar to or better than ours and otherwise have a material adverse effect on our business, financial condition, results of operations and prospects.

Open source license terms are often ambiguous and such use could inadvertently occur. There is little legal precedent governing the interpretation of many of the terms of certain of these licenses, and the potential impact of these terms on our business may result in unanticipated obligations regarding our products and technologies.

Companies that incorporate open source software into their products have, in the past, faced claims seeking enforcement of open source license provisions and claims asserting ownership of open source software incorporated into their product. If an author or other third party that distributes such open source software were to allege that we had not complied with the conditions of an open source license, we could incur significant legal costs defending ourselves against such allegations. In the event such claims were successful, we could be subject to significant damages or be enjoined from the distribution of our products and technologies.

Changes in either the patent laws or interpretation of the patent laws in the United States could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Assuming that other requirements for patentability are met,

prior to March 2013, in the United States, the first to invent the claimed invention was entitled to a patent, while outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith America Invents Act (the “America Invents Act”) enacted in September 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application in the USPTO after March 2013, but before we do could therefore be awarded a patent covering an invention we made even if we had made the invention before it was made by such third party. This will require us to be cognizant of the time from invention to filing of a patent application and be diligent in filing patent applications. However, circumstances could prevent us from promptly filing patent applications on our inventions. Since patent applications in the United States and most other countries are confidential for a period after filing or until issuance, we cannot be certain that we were the first to either (i) file any patent application on inventions related to our products, methods or technology or (ii) invent any of the inventions claimed in our patents or patent applications.

The America Invents Act also includes a number of significant changes that affect the way patent applications are prosecuted and also may affect patent litigation. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional procedures to challenge the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. Therefore, the America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our owned patent applications and the enforcement or defense of our owned issued patents, all of which could have a material adverse effect on our competitive position, business, financial condition, results of operations and prospects.

In addition, the patent positions of companies in our industry are particularly uncertain. Court rulings may narrow the scope of patent protection available and weaken the rights of patent owners in certain situations. For example, recent U.S. Supreme Court decisions have served to curtail the scope of subject matter eligible for patent protection in the United States, and many software patents have since been invalidated on the basis that they are directed to abstract ideas. Such events have created uncertainty with respect to the validity and enforceability of issued patents. Depending on future actions by the U.S. Congress, federal courts, and USPTO, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce our intellectual property in the future. Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations and prospects.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

Should any of these events occur, they could have a material adverse effect on our business, results of operations, financial condition and future prospects.

As part of our business activities, we and our third-party providers and distributors on our behalf, collect and use a variety of personal data related to different data subjects (e.g., customers, employees, representatives, etc.), such as identity data (including first and last names, job description and GDC number (for U.K. residents only)) and contact data (including email address and phone number). In addition, in connection with the performance of our contractual obligations and upon request from our customers and collaborators, we may access additional data, such as data available in the accounts of customers for support operations or data provided for research and development projects. We rely on third-party vendors and service providers to support various aspects of our business operations. However, these third parties may pose risks related to data security, compliance, and contractual obligations. A breach or failure by a third party to adequately protect our data could have adverse consequences for our business and reputation. Any failure to prevent or mitigate security incidents or improper access to, use, disclosure or other misappropriation of our data or customers’ personal data or the inability to rightfully access any such data could result in significant liability under state (e.g., state breach notification and privacy laws such as the California Consumer Privacy Act (the “CCPA”)), federal (e.g., the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)) and international laws (e.g., the General Data Protection Regulation (the “GDPR”)).The landscape of the laws regulating personal data is constantly evolving, and compliance with these laws requires a flexible privacy framework and substantial resources, and compliance efforts will likely be an increasing and substantial cost in the future. We may be subject to fines, penalties or private actions in the event of noncompliance with such laws. Such incidents may also cause a material loss of revenue from the potential adverse impact to our reputation and brand, affect our ability to retain or attract new users and customers of our products, methods and technology and potentially disrupt our business.

Unauthorized disclosure of sensitive or confidential customer, patient or employee data, including personally identifiable information, whether through a breach of computer systems, systems failure, employee negligence, fraud or misappropriation or otherwise, or unauthorized access to or through our information systems and networks, whether by our employees or third parties (including through the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other

means to affect service reliability and threaten the confidentiality, integrity and availability of information), could result in negative publicity, legal liability and damage to our reputation. Unauthorized disclosure of personally identifiable information could also expose us to sanctions for violations of data privacy laws and regulations around the world. To the extent that any disruption or security incident resulted in a loss of or damage to our, our business partners’, or our customers’ and patients’ data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of our products, methods or technology could be delayed.

As we become more dependent on information technologies to conduct our operations, cyber incidents, including deliberate attacks and attempts to gain unauthorized access to computer systems and networks, including by computer hackers, foreign governments and cyber terrorists, may increase in frequency and sophistication. These threats pose a risk to the security of our systems and networks, the confidentiality and the availability and integrity of our data, and these risks apply both to us (including via our corporate systems and any employees that may be working remotely) and to third parties on whose systems we rely for the conduct of our business. Because the techniques used to obtain unauthorized access, disable or degrade service or sabotage systems change frequently and often are not recognized until after a launch against a target, we and our collaborators may be unable to anticipate these techniques or to implement adequate preventative measures. To the extent AI capabilities improve and are increasingly adopted, they may be used by threat actors to identify vulnerabilities and design increasingly sophisticated cybersecurity attacks. Cybersecurity and privacy vulnerabilities may also be introduced from the use of AI by us, our customers, suppliers and other business partners and third-party providers. We have and may in the future experience security incidents. If we do not allocate and effectively manage the resources necessary to build and sustain the proper technology and cybersecurity infrastructure, we could suffer significant business disruption, data loss or the loss of or damage to intellectual property or other proprietary information. While no security incidents in the past have had a material adverse effect on our business, results of operations, financial condition and future prospects, we cannot predict the impact of any such future events. Further, although we are obligated under certain laws and regulations to ensure that our systems and servers and those of our service providers remain compliant with the relevant legal requirements with respect to data privacy and security, we do not have any control over the operations of the facilities or technology of such providers, including any third-party vendors that collect, process and store personal data on our behalf. Moreover, despite our efforts and the ever-changing threat landscape, the possibility of these events occurring cannot be eliminated entirely and there can be no assurance that any measures we take will prevent cyberattacks or security breaches that could adversely affect our business. Our systems and servers and those of our service providers may be vulnerable to computer viruses or physical or electronic break-ins that our or their security measures may not detect, including via supply chain attacks. Individuals able to circumvent such security measures may misappropriate our confidential or proprietary information, disrupt our operations, damage our computers or otherwise impair our reputation and business. If the information technology systems of our third-party vendors and other contractors and consultants become subject to disruptions or security breaches, we may have insufficient recourse against such third parties. We may need to expend significant resources and make significant capital investments to protect against security breaches or to mitigate the impact of any such breaches and any cybersecurity insurance that we may have in place may not cover such expenses. In addition, to the extent that our systems and servers and those of our service providers experience security breaches that result in the unauthorized or improper use of confidential data, employee data or personal data, we may not be indemnified for any losses resulting from such breaches. There can be no assurance that we or our third-party providers will be successful in preventing cyberattacks or successfully mitigating their effects. If we are unable to prevent or mitigate the impact of such security breaches, our ability to attract and retain new customers, patients and other collaborators could be harmed as they may be reluctant to entrust their data to us, and we could be exposed to litigation and governmental investigations, proceedings and regulatory actions by federal, state and local regulatory entities in the United States and by international regulatory entities, and such events could be deemed breaches of our contractual obligations, all of which could result in significant legal and financial exposure and reputational damages and lead to a potential disruption to our business or other adverse consequences.

We are subject to data privacy and protection laws and regulations that apply to the collection, transmission, storage, use and other processing of personally identifying information or personal data, which among other things, impose certain requirements relating to the privacy, security, transmission and other processing of personal information. The legislative and regulatory landscape for privacy and data protection continues to evolve in jurisdictions worldwide, and there has been an increasing focus on privacy and data protection issues with the potential to affect our business. Failure to comply with any of these laws and regulations could result in enforcement action against us, including fines, imprisonment of company officials and public censure, claims for damages by affected individuals, damage to our reputation and loss of goodwill, any of which could have a material adverse effect on our business, financial condition, results of operations or prospects.

There are numerous U.S. federal and state laws and regulations relating to privacy and security of personal information, including regulations promulgated pursuant to HIPAA, which limits the use and disclosure of protected health information. Determining whether protected health information has been handled in compliance with applicable privacy standards and our contractual obligations can be complex and may be subject to changing interpretation.

Additionally, the CCPA grants comprehensive rights to consumers with respect to data privacy in California. The CCPA includes certain transparency and other requirements to protect personal data and grants California consumers with certain rights regarding their personal data. In addition, California consumers have the right to bring a private right of action in connection with data security incidents involving certain elements of personal data. The CCPA also established the California Privacy Protection Agency to oversee and enforce these requirements.

Numerous states have enacted privacy laws similar to but distinct from the CCPA that have gone or are going into effect, which creates a patchwork of overlapping but different state laws. Health-specific consumer privacy laws have also been passed in multiple states, including Washington and Nevada. These laws and regulations are constantly evolving and may impose limitations on our business. In addition, all 50 U.S. states and the District of Columbia have enacted breach notification laws that may require us to notify patients, employees or regulators in the event of unauthorized access to or disclosure of personal or confidential information experienced by us or our service providers. These laws are not consistent, and compliance in the event of a widespread data breach is difficult and may be costly.

We also may be contractually required to notify customers or other counterparties of a security breach. Although we may have contractual protections with our third-party service providers, contractors and consultants, any actual or perceived security breach could harm our reputation and brand, expose us to potential liability or require us to expend significant resources on data security and in responding to any such actual or perceived breach. Any contractual protections we may have from our third-party service providers, contractors or consultants may not be sufficient to adequately protect us from any such liabilities and losses, and we may be unable to enforce any such contractual protections.

Outside of the United States, certain foreign jurisdictions, including the European Union, have adopted onerous laws and regulations relating to data protection and cybersecurity, including the GDPR, which imposes obligations on companies that process personal information from individuals located in the European Economic Area (the “EEA”). The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal information. The GDPR allows the imposition of substantial penalties in the event of noncompliance, including fines of up to €20 million or up to 4% of total worldwide annual turnover of the preceding fiscal year, whichever is greater. The GDPR also confers a private right of action on data subjects and representative bodies/associations to lodge complaints with supervisory authorities, seek judicial remedies and obtain compensation for damages resulting from violations of the GDPR. While we have taken steps to support compliance with GDPR requirements, due to a high volume of requirements and related supportive documentation that we are obliged to maintain, we may be unsuccessful in implementing all measures required by data protection authorities or courts in interpreting the GDPR.

The GDPR also imposes a broad range of strict requirements on companies with respect to cross-border transfers of personal data out of the EEA, including to the United States. In July 2023, the European Commission adopted an adequacy decision in relation to the new EU-U.S. Data Privacy Framework (the “DPF”) rendering the DPF effective as a GDPR transfer mechanism for personal data transferred from the EEA to the United States by U.S. entities self-certified under the DPF. However, the DPF adequacy decisions do not foreclose, and have faced and are likely to continue to face, legal challenges, and the ongoing legal uncertainty with respect to international data transfers may increase our costs and impair our ability to efficiently process personal data from the EEA. Other data transfer mechanisms such as the Standard Contractual Clauses approved by the European Commission have faced challenges in European courts, may require additional risk analysis and supplemental measures to be used, and may be challenged, suspended or revoked. In addition, the GDPR also provides that EU Member States may partially deviate from the GDPR and impose different obligations from country to country, meaning that we do not operate in a uniform legal landscape in the EU.

Following the United Kingdom’s departure from the EU, the United Kingdom implemented substantively equivalent provisions to the GDPR. Fines for noncompliance with the U.K. GDPR can amount to up to £17.5 million or 4% of annual global revenue, whichever is greater. However, the relationship between the United Kingdom and the EU in relation to certain aspects of data protection law remains unclear, and it is unclear how U.K. data protection laws and regulations will develop in the medium to longer term, and how data transfers to and from the United Kingdom will be regulated in the long term. For example, the U.K. government has passed the Data (Use and Access) Act 2025, which became law on June 19, 2025 (phasing in between June 2025 and June 2026), to reform the U.K. data protection regime. This Data (Use and Access) Act 2025 deviates further from EU data protection regimes than its predecessor law. The United Kingdom’s evolving regulatory landscape and further divergence from the EU framework may lead to additional compliance, legal risk, complexity, costs and overall risk to our handling of personal data, and may require us to adapt our privacy and data security compliance programs to account for increasing legal and regulatory divergence between the United Kingdom and the EU. Coupled with the existing flexibility under the GDPR that allows EU Member States to implement national derogations and apply varying interpretations through their respective authorities, we are exposed to many overlapping but increasingly divergent regimes. With respect to transfers of personal data from the EEA to the United Kingdom, the European Commission has published a decision finding that the United Kingdom ensures an adequate level of data protection. In December 2025, the European Commission adopted a decision to extend the term of the U.K. adequacy decision for six years until December 2031. Other countries have also passed or are considering passing laws requiring local data residency or restricting the international transfer of data.

In Switzerland, where we are headquartered, our processing activities are governed by the revised Federal Act on Data Protection (Datenschutzgesetz or the “revFADP”), which entered into force on September 1, 2023, and aligns Swiss data protection requirements more closely with the GDPR. The revFADP is enforced by the Swiss Federal Data Protection and Information Commissioner (“FDPIC”), who may initiate investigations and recommend corrective measures. Violations of certain revFADP provisions may result in substantial criminal fines on the responsible data controller or processor.

It is possible that these laws may be interpreted and applied in a manner that is inconsistent with our practices and our efforts to comply with the evolving data protection rules may be unsuccessful. If so, this could result in government-imposed fines or orders requiring that we change our practices, which could adversely affect our business. We must devote significant resources to understanding and complying with this changing landscape. Failure to comply with federal, state and international laws regarding privacy and security of personal information could expose us to penalties under such laws. Any such failure by us or our third-party processors to comply with data protection and privacy laws could result in significant government-imposed fines or orders requiring that we change our practices, claims for damages or other liabilities, regulatory investigations and enforcement action, litigation and significant costs for remediation, any of which could adversely affect our business. Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could harm our business, financial condition, results of operations or prospects. See “Business—Government Regulation—Data Privacy.”

We make public statements about our use and disclosure of personal information through our privacy policy, information provided on our internet platform and press statements. These statements may be subject to heightened scrutiny by regulators, consumer protection authorities and other third parties. Although we endeavor to comply with our public statements and documentation, we may be alleged to have failed to do so. The publication of our privacy policy and other statements that provide promises and assurances about data privacy and security can subject us to potential government or legal action if they are found to be deceptive, unlawful, unfair or misrepresentative of our actual practices. Such actions may include investigations, enforcement proceedings, fines, penalties, consent decrees or other remedial measures. Any failure, real or perceived, by us to comply with our posted privacy policies or with any legal or regulatory requirements, standards, certifications or orders or other privacy or consumer protection-related laws and regulations applicable to us could cause our customers to reduce their use of our products, methods or technology and could materially and adversely affect our business, financial condition and results of operations. In many jurisdictions, enforcement actions and consequences for noncompliance can be significant and are rising. In addition, from time to time, concerns may be expressed about whether our products, methods or technology, or our processes compromise the privacy of customers and others. Concerns about our practices with regard to the collection, use and reuse, retention, security, disclosure, transfer and other processing of personal information or other privacy-related or security-related matters, even if unfounded, could damage our reputation and adversely affect our business, financial condition, results of operations and future prospects.

We depend on our information technology systems, some of which are provided and/or managed by third parties, for the efficient functioning of our business, including the distribution of our products as well as for accounting, data storage, compliance, purchasing and inventory management, and our continued growth is dependent on our ability to adapt and upgrade our information technology systems without suffering significant business disruption, data loss or the loss of or damage to intellectual property or other proprietary information. Our information technology systems may fail and are vulnerable to breakdown, breach, interruption or damage from computer viruses, ransomware or other malware, attacks by computer hackers, including sophisticated nation-state and nation-state-supported actors, employee error or malfeasance, theft or misuse, failures during the process of upgrading or replacing software, databases or components thereof, power outages, damage or interruption from fires or other natural disasters, hardware failures, telecommunication failures and user errors, among other adverse events. We could also experience a cybersecurity incident or other security failure, including an inadvertent disclosure of information or unauthorized access to our systems by a third party, which could disrupt our operations, corrupt data or result in the unauthorized access to, disclosure of or loss of confidential information. Technological interruptions would disrupt our operations, including our ability to timely ship and track orders, project inventory requirements, manage our supply chain and otherwise adequately service our customers. Any prolonged or material disruption could impair our ability to meet contractual obligations and may result in financial penalties, loss of customers or reputational harm. In the event we experience significant disruptions, we may be unable to repair our systems in an efficient and timely manner. We believe that our subcontractors and vendors take precautionary measures to prevent problems that could affect our business operations as a result of failure or disruption to their information systems. However, despite our process for conducting due diligence on and contractually requiring security and privacy measures from our material, data-handling subcontractors and vendors, there is no guarantee such efforts will be successful in preventing a disruption, and it is possible that we may be impacted by third-party information-system failures. The occurrence of any information-system failures with our vendors could result in interruptions, delays, loss or corruption of data and cessations or interruptions in the availability of these systems. Accordingly, such events may disrupt or reduce the efficiency of our entire operation and have a material adverse effect on our business, results of operations, financial condition and future prospects.

We use and intend to expand our use of AI, generative AI and ML technologies across various aspects of our business, including research and development, scientific and clinical analysis (including using AI-enabled diagnostic solutions), data analytics, customer engagement (such as our AI-managed call centers), marketing, administrative functions and operational support activities. We also expect that dental professionals and other users of our Curodont® products may increasingly use AI-enabled software tools, including diagnostic imaging, cavity detection, cavities assessment, clinical decision support and treatment planning technologies, in conjunction with our products as part of clinical workflows. Any failure, disruption or degradation of AI-enabled systems, whether used internally or by third parties in connection with our products, could adversely affect our business, results of operations, financial condition and future prospects.

The use of AI and ML technologies, whether by us internally or by third parties in connection with our products, presents significant and evolving operational, legal, regulatory and reputational risks and no assurance can be provided that the usage of such AI tools, solutions and technologies will enhance our network or help our operations become more effective, efficient or profitable. AI systems are highly dependent on the design, integrity and quality of the underlying models and data inputs and may produce inaccurate, incomplete, misleading, biased or otherwise flawed outputs or recommendations. Such technologies and tools may also be adversely impacted by unforeseen defects, technical challenges, data breaches, cybersecurity threats or material performance issues. Any such disruptions could interrupt business processes or lead to system downtime or reduced service availability. In the dental context, AI-enabled diagnostic or treatment planning tools used by dental professionals may incorrectly identify, fail to identify or inaccurately assess cavities, treatment progression, remineralization outcomes or patient conditions. Such errors could contribute to delayed treatment, unnecessary procedures, improper treatment decisions, patient dissatisfaction, adverse clinical outcomes or professional liability claims. Although we do not currently market our products as AI-enabled medical devices and do not control the AI systems used by dental professionals in conjunction with our products, our products could nevertheless become associated with inaccurate or controversial AI-assisted clinical outcomes, which could negatively affect market acceptance, customer trust and our reputation.

Our use of AI could become subject to heightened regulatory scrutiny or additional regulatory obligations. Regulatory authorities globally are increasingly focused on the development, validation, transparency, governance and use of AI systems, particularly in healthcare, medical device and clinical decision-making contexts. Existing and emerging laws and regulations, including the EU Artificial Intelligence Act, GDPR, U.K. GDPR and evolving FDA guidance relating to AI-enabled medical technologies and software, may impose additional obligations, restrictions, testing, monitoring, transparency, documentation, human oversight, cybersecurity, post-market surveillance or reporting requirements on our operations or in connection with our development and marketing of future products. Compliance with such requirements could require significant additional investment and could delay, limit or prevent the development, deployment or commercialization of AI-related capabilities.

The technologies underlying AI and generative AI are rapidly evolving and remain relatively novel in many applications. Generative AI tools may create inaccurate, fabricated, misleading or noncompliant outputs or recommendations that could adversely affect our business operations, communications, scientific activities or customer interactions. If outputs generated or assisted by AI are, or are perceived to be, deficient, unreliable, discriminatory, unethical or otherwise flawed, our reputation and competitive position could be harmed, and we could be exposed to substantial liability.

The use of AI and ML technologies also presents significant data privacy, cybersecurity and intellectual property risks. AI tools may process large volumes of proprietary, sensitive or personal information, including potentially health-related information, and may create risks relating to unauthorized disclosure, misuse, data leakage or cybersecurity incidents. Cybersecurity incidents involving AI systems, including unauthorized access, could disrupt operations or compromise the integrity and availability of systems and data. If our employees, contractors or third-party service providers use third-party AI tools inappropriately or outside approved governance frameworks, confidential information, trade secrets or proprietary data could be exposed or incorporated into external systems in ways that impair our ability to

protect or enforce our intellectual property or contractual rights. AI technologies may also incorporate or generate content that infringes, misappropriates or otherwise violates third-party intellectual property or other rights. To the extent that we do not have sufficient rights to use the data used in, or produced by, the AI tools employed in our business and operations, we may be subject to litigation by the owners of the content or other materials that comprise such data. Further, any content or other output created by us using AI-powered tools may not be subject to copyright or other intellectual property law protection, which may adversely affect our ability to enforce the intellectual property rights in such content. In addition, the use of AI by other companies has resulted in, and our use of AI may in the future result in, data breaches and cybersecurity incidents that implicate the personal information of users of AI powered tools. Any of the foregoing could adversely affect our reputation and expose us to legal liability or regulatory risks, including with respect to third-party intellectual property, privacy, publicity, contractual or other rights.

Governance and oversight challenges may also increase as AI adoption expands across our operations and among third parties with whom we interact. Employees, collaborators, distributors or service providers may use AI tools in ways that are inconsistent with our policies, applicable laws, contractual restrictions, scientific standards or ethical expectations. Such uses may expose us to substantial liability and reputational harm. We may not be able to adequately monitor, control or prevent all such uses. Inadequate governance or oversight could also lead to inconsistent system performance or operational disruptions across different parts of our business.

In addition, public and regulatory scrutiny concerning the ethical use of AI, automated decision-making and the use of AI in healthcare continues to increase. Even if our use of AI complies with applicable laws and internal policies, customers, regulators, patients, healthcare professionals or other stakeholders may object to or criticize our use of AI technologies or perceive such use as insufficiently transparent, reliable or ethical. Any such concerns, whether valid or not, could result in reputational harm, reduced adoption of our products, increased litigation or regulatory exposure and loss of customer trust.

Because AI technologies, regulatory frameworks and market expectations continue to evolve rapidly, it is not possible to predict all of the operational, legal, technological, regulatory, commercial and reputational risks that may arise from our current or future use of AI or from the use of AI-enabled technologies together with our products. Any failure to effectively manage these risks could adversely affect our business, results of operations, financial condition and future prospects.

We have incurred losses since our inception and expect to continue to incur losses for the foreseeable future. For the six months ended June 30, 2026 and 2025 and the years ended December 31, 2025 and 2024, we reported net losses of $27.8 million, $32.1 million, $56.4 million and $34.7 million, respectively. As of June 30, 2026, we had an accumulated deficit of $256.3 million.

We expect to continue to incur significant operating expenses and net losses for the foreseeable future as we continue to invest in the development, commercialization and expansion of our dental products and business. In particular, we expect to continue to devote substantial resources to:

We also expect to incur significant expenses associated with operating as a public company, including expenses related to legal, accounting, compliance, investor relations and other administrative matters.

Our historical operating results should not be considered indicative of future performance. Our net losses and operating expenses may fluctuate significantly from quarter to quarter and year to year due to a variety of factors, including the timing and magnitude of research and development expenses, commercialization activities, regulatory milestones, inventory purchases, manufacturing costs, clinical and regulatory activities, foreign exchange fluctuations and the timing of revenue recognition. As a result, period-to-period comparisons of our results of operations may not be meaningful and should not be relied upon as indicators of future performance.

Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. We may continue to generate losses and negative cash flows as we expand our business and invest in future growth initiatives. If our revenue growth does not meet our expectations, or if our expenses increase more rapidly than anticipated, we may be unable to achieve or maintain profitability. Failure to achieve or sustain profitability could adversely affect our business, financial condition, results of operations and prospects, reduce the value of our ordinary shares and impair our ability to raise additional capital, execute our growth strategy, develop additional products and continue our operations. In such event, investors could lose all or part of their investment.

Since our inception, we have used substantial amounts of cash. The research and development process as well as selling and marketing efforts are capital-intensive and we expect that we will continue to expend substantial resources for the foreseeable future to develop, commercialize and market additional features and applications of our products. In addition, we may also raise capital to expand our business and pursue strategic investments, to take advantage of financing opportunities or for other reasons, including to:

We do not have any committed external source of funds, and additional funds may not be available when we need them or on terms that are acceptable to us. Our ability to raise additional funds will depend on financial, economic and market conditions and other factors, over which we may have no or limited control. Further, as a Swiss company, we have less flexibility to raise capital, particularly in a quick and efficient manner, as compared to U.S. companies. If adequate funds are not available to us on a timely basis or on terms acceptable to us, we may be required to delay, limit, reduce or terminate our research and development, commercialization and growth efforts.

We may seek additional capital through a variety of means, including through public and private equity offerings and debt financings, credit and loan facilities and collaborations. If we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of such equity or convertible debt securities may include liquidation or other preferences that are senior to or otherwise adversely affect your rights as a shareholder. If we raise additional capital through the sale of debt securities or through entering into credit or loan facilities, we may be restricted in our ability to take certain actions, such as incurring additional debt, making capital expenditures, acquiring or licensing intellectual property rights, declaring dividends or encumbering our assets to secure future indebtedness. Such restrictions could adversely impact our ability to conduct our operations and execute our business plan. If we raise additional capital through collaborations with third parties, we may be required to relinquish valuable rights to our intellectual property, technology and products or we may be required to grant licenses for our intellectual property, technology and products on unfavorable terms.

Our ability to continue as a going concern may depend on our ability to raise additional capital, increase revenue and manage expenses. If our auditor expresses doubt about our ability to continue as a going concern, or if investors perceive that our liquidity is insufficient to support our operating plan, the market price of our Class A ordinary shares could be adversely affected.

As of June 30, 2026, we had $84.2 million of total loans. In addition, we may incur additional indebtedness in the future, including in connection with working capital needs, capital expenditures, acquisitions, strategic initiatives or general corporate purposes. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Indebtedness.”

Our level of indebtedness could have significant consequences for our business and investors, including by:

Our ability to make scheduled payments on, service, refinance or repay our indebtedness depends on our future operating performance, cash flows and financial condition, which are subject to prevailing economic, competitive, legislative, regulatory and other factors, many of which are beyond our control. We may be unable to maintain sufficient cash flows from operations or otherwise obtain adequate liquidity to meet our debt service obligations.

If our cash flows and capital resources are insufficient to fund our debt service obligations, we could face substantial liquidity constraints and may be forced to reduce or delay investments, capital expenditures, strategic initiatives or other business activities. We also may be required to sell assets, seek additional debt or equity financing, restructure or refinance our indebtedness or pursue other financing alternatives. Any such measures may not be available on commercially reasonable terms or at all. In addition, the agreements governing our indebtedness may contain, and future financing arrangements may contain, affirmative and negative covenants that restrict our ability to take certain actions, including incurring additional indebtedness, granting liens, making investments, disposing of assets, engaging in mergers or acquisitions, making restricted payments, including dividends or share repurchases, or entering into certain transactions with affiliates. These restrictions could limit our operational and strategic flexibility and impair our ability to respond to changing business and market conditions.

Our indebtedness agreements may also restrict our ability to dispose of assets and may limit the use of proceeds from any such dispositions. As a result, we may not be able to consummate asset sales at favorable valuations, in a timely manner or at all, and any proceeds received may be insufficient to satisfy our debt service obligations.

If we breach any covenants or otherwise default under our indebtedness, the applicable lenders could, subject to any applicable grace periods, declare all outstanding amounts immediately due and payable, terminate commitments to extend further credit and exercise other remedies available to them. Certain of our indebtedness may also contain cross-default or cross-acceleration provisions that could result in other indebtedness becoming immediately due and payable. Any such event could materially adversely affect our liquidity, financial condition, results of operations and ability to continue as a going concern. As described under “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Indebtedness—2030 Term Loans,” we entered into an amendment to the OrbiMed Credit Agreement in April 2026 to obtain a waiver for a covenant violation arising from our failure to satisfy the $5.0 million ordinary-share financing requirement required by the January 2026 amendment to the OrbiMed Credit Agreement and we entered into a further amendment to the OrbiMed Credit Agreement in September 2026 to obtain a waiver for a violation of certain credit-related covenants under the agreement in connection with the liquidation of two subsidiaries as of June 30, 2026. Based on the current status of the liquidation process, we believe it is probable that the applicable covenant violation will be remedied during the waiver period and that we will remain in compliance with the applicable covenant requirements following the expiration of the waiver.

Furthermore, if we require additional capital in the future, there can be no assurance that we will be able to obtain such financing on commercially reasonable terms or at all. Our inability to generate sufficient cash flows to satisfy our debt obligations, or to refinance our indebtedness on acceptable terms or at all, could materially adversely affect our business, financial condition, results of operations and future prospects.

As of June 30, 2026, the net carrying value of our goodwill and intangible assets totaled $42.2 million. Goodwill represents the excess of the purchase price paid over the estimated fair value of the identifiable net assets acquired in a business combination. Under GAAP, goodwill is not amortized but

is instead required to be tested for impairment at least annually and more frequently if events or changes in circumstances indicate that the carrying value of a reporting unit may not be recoverable. Certain of our other intangible assets may also be required to be tested for impairment upon the occurrence of triggering events.

Our goodwill impairment analysis requires significant judgments, estimates and assumptions, including with respect to the identification and valuation of reporting units, estimated future cash flows, long-term growth rates, profitability, discount rates, market multiples and other assumptions used to estimate the fair value of our reporting units and intangible assets. We perform quantitative impairment testing using valuation methodologies that may include discounted cash flow analyses and other market-based approaches. Changes in these assumptions or the occurrence of adverse events could result in impairment charges.

Events and circumstances that could result in impairment include, among other things:

If the estimated fair value of a reporting unit or intangible asset declines below its carrying value, we may be required to record a non-cash impairment charge. Any such impairment charge could be material and could adversely affect our results of operations, net income, shareholders’ equity, financial condition and the trading price of our ordinary shares. Impairment charges may also cause us to fail to meet the expectations of investors, securities analysts or lenders and could negatively affect our ability to obtain financing on acceptable terms or comply with covenants under existing or future indebtedness arrangements.

We have significant carried forward losses, deferred interest expense and other similar tax attributes, most of which are currently unrecognized within our consolidated financial statements, that arise under the tax laws of the jurisdictions in which we operate. It is possible that we will not generate sufficient taxable income in those jurisdictions or otherwise will be unable to fully utilize these losses, deferred interest expense and other tax attributes. In addition, the utilization of our tax attributes to reduce our taxable income may be subject to limitations under the applicable laws of the jurisdictions in which we operate.

For each accounting reporting period, we assess the likelihood of our carried forward losses, deferred interest expense and other similar tax attributes offsetting future taxable income. We only recognize such attributes as assets on our consolidated balance sheet if there is sufficient likelihood that

these tax attributes will be utilized by us in the foreseeable future. The assessment of the recoverability of carried forward losses, deferred interest expense and other similar tax attributes, and therefore the level of deferred tax asset recognition, requires us to exercise judgment based on facts and estimates that may change over time. Accordingly, the value of tax attributes recognized on our consolidated balance sheet for any fiscal period may change over time and may not be indicative of the actual amount of tax attributes that we will be able to utilize in future periods to offset our taxable income. Any limitation on the use of, or the changes to, our tax assets to offset taxable income, including as a result of changes in applicable tax laws or our ownership changes, could result in increased tax liabilities and, as such, could adversely affect our business, financial condition, results of operations and future prospects.

We could be subject to additional tax liabilities due to changes in tax laws, tax audits or our growth, which could affect our profitability and increase our effective tax rate.

We are subject to complex tax laws and regulations of multiple jurisdictions in which we operate, which are subject to uncertain interpretation. Our interpretation and application of these laws and regulations as well as compliance with specific tax filing requirements, payment obligations and transfer pricing regulations require significant judgment and the use of assumptions and estimates. Our effective tax rate and tax filings reflect our interpretation of such tax laws. As a result, we are exposed to the risk that tax authorities in any of these jurisdictions could disagree with our interpretations of the applicable tax laws or our tax calculations’ methodologies, including the classification of our revenues, the pricing of our intercompany transactions or the determinations of the jurisdictions to which profits are attributed. For example, a tax authority could challenge whether our supplies are taxable or exempt for VAT purposes, or could challenge our input VAT recovery methodology. We, including certain of our material subsidiaries, may from time to time be subject to tax audits and other similar proceedings with tax authorities in a number of jurisdictions. In certain cases, the applicable tax authority may challenge one or more tax positions that we have taken. We intend to resolve each of these audits in an efficient manner, including, where appropriate, through arbitration and/or court proceedings. These audits and other similar proceedings, when resolved, could result in additional taxes, including interest and penalties, which could, in turn, adversely affect our business, financial condition, results of operations and future prospects.

Furthermore, our effective tax rate could materially increase as a result of changes in tax law, tax treaties or the interpretation thereof, such as those introducing a tax for credit institutions with liabilities above certain thresholds. Moreover, changes to withholding tax rules, or how they apply to us, may impact our ability to repatriate profits from our operating subsidiaries in various jurisdictions. Our tax liability may also increase significantly if we are required to pay additional taxes (including “minimum” taxes, VAT, other indirect taxes and employment taxes) in any jurisdiction as a result of a growth of our business.

In sum, any changes in tax laws or regulations, or in their interpretation by the relevant authorities, the outcome of any tax audits or changes to our taxation as a result of any expansion or modification of our network, operations or corporate structure, could adversely affect our business, financial condition, results of operations and future prospects.

We are subject to income and other taxes in Switzerland and in the various jurisdictions in which we operate, including the United States, the United Kingdom and certain member states of the EU. Our tax obligations are based on the application of complex and evolving tax laws, regulations and guidance, and are subject to interpretation by the relevant tax authorities. The standard effective corporate income tax rates applicable to us in Switzerland, including in the Canton of Zug, may change from time to time. In addition, tax laws, treaties, regulations and administrative practices in the jurisdictions in which we operate may be modified, amended or applied in a manner that is adverse to us.

Global tax reform initiatives continue to evolve rapidly. In particular, the OECD/G20 Inclusive Framework on Base Erosion and Profit Shifting (“BEPS”), including the implementation of the two-pillar global tax framework, has resulted in significant proposed and enacted changes to international tax rules. Pillar Two establishes a global minimum effective corporate tax rate of 15% for certain multinational enterprise groups and has been implemented, or is in the process of being implemented, in numerous jurisdictions, including Switzerland, EU member states and the United Kingdom. These rules are complex,

continue to evolve and may be subject to differing interpretations by tax authorities across jurisdictions. The adoption, amendment or interpretation of these rules could increase our effective tax rate, result in additional cash tax liabilities, increase our administrative and compliance burdens and require changes to our business operations, legal entity structure, financing arrangements, transfer pricing policies or intercompany arrangements.

In addition, tax authorities around the world have increased their scrutiny of multinational businesses, particularly with respect to transfer pricing, the allocation of income among jurisdictions, the use and ownership of intellectual property, withholding taxes, cross-border financing arrangements, permanent establishment exposure and the pricing of intercompany transactions. In particular, tax authorities may challenge the manner in which we allocate profits among jurisdictions in which we operate, including with respect to intangible assets and the associated DEMPE (Development, Enhancement, Maintenance, Protection and Exploitation) functions. Such challenges could result in additional taxes, interest, penalties, double taxation, adjustments to previously filed tax returns or other adverse tax consequences.

The determination of our worldwide provision for income taxes and other tax liabilities requires significant judgment, and there are many transactions and calculations for which the ultimate tax determination is uncertain. We are regularly subject to tax audits, examinations and assessments in various jurisdictions. The outcome of any such audits or disputes could differ materially from our expectations and could materially adversely affect our financial condition, results of operations and cash flows.

Furthermore, future changes in tax laws or policies, including changes relating to the taxation of cross-border income, research and development incentives, deductions, tax credits, interest deductibility, digital services taxes, tariffs, indirect taxes or withholding taxes, could increase our tax liabilities or otherwise adversely affect our business, financial condition and operating results. Any failure to comply with applicable tax laws and reporting obligations could also result in substantial penalties, reputational harm and additional costs.

In general, we will be a PFIC for any taxable year in which, after the application of certain “look through” rules with respect to our subsidiaries, either (i) 75% or more of our gross income consists of “passive income,” or (ii) 50% or more of the average quarterly value of our assets consist of assets that produce, or are held for the production of, “passive income” (including cash). For purposes of the above calculations, we will be treated as if we hold our proportionate share of the assets of, and receive directly our proportionate share of the income of, any other corporation in which we directly or indirectly own at least 25%, by value, of the shares of such corporation. Passive income includes, among other things, interest, dividends, rents, certain non-active royalties and capital gains.

Based on the expected market price of our Class A ordinary shares following this offering and the composition of our income and assets, including goodwill, we do not expect to be a PFIC for our 2026 taxable year or in the foreseeable future. Even if we determined that we are not a PFIC for a taxable year, there can be no assurance that the IRS will agree with our conclusion or that the IRS would not successfully challenge our position. Our status as a PFIC is a fact-intensive determination that must be made on an annual basis applying principles and methodologies that are in some circumstances unclear, and whether we will be a PFIC in 2026 or any future taxable year is uncertain. Moreover, our PFIC status for any taxable year will depend on the composition of our income and assets and the value of our assets from time to time (which may be determined, in part, by reference to the market price of our Class A ordinary shares, which may fluctuate substantially over time). Accordingly, there can be no assurance that we will not be a PFIC for any taxable year, and our U.S. counsel expresses no opinion regarding our PFIC status in 2026 or any future taxable year. If we are a PFIC for any year during which a U.S. Holder holds Class A ordinary shares, we would continue to be treated as a PFIC with respect to that U.S. Holder for all succeeding years during which the U.S. Holder holds Class A ordinary shares, even if we ceased to meet the threshold requirements for PFIC status, unless the U.S. Holder makes a valid mark-to-market election or QEF election, as described below.

If we are a PFIC for any year during which a U.S. Holder holds Class A ordinary shares, the U.S. Holder may be subject to adverse tax consequences (even if we cease to be a PFIC in subsequent taxable years), including an increased tax liability on dispositions of our Class A ordinary shares or receipt of certain distributions, as well as additional reporting requirements. For a more detailed discussion of the tax consequences of a PFIC classification to U.S. Holders, see the section of this prospectus titled “Taxation—Material U.S. Federal Income Tax Considerations for U.S. Holders—Passive Foreign Investment Company Rules.”

Our reporting currency is the U.S. dollar. However, the functional currencies of our subsidiaries are generally the currencies of the primary economic environments in which they operate. As a result, a significant portion of our revenue, operating expenses, assets and liabilities are denominated in currencies other than the U.S. dollar, including the Swiss franc, Euro and British pound sterling. Accordingly, our consolidated financial statements are affected by fluctuations in exchange rates between the U.S. dollar and the functional currencies of our subsidiaries.

Transactions denominated in currencies other than a subsidiary’s functional currency are remeasured into the applicable functional currency using exchange rates in effect on the transaction dates, and monetary assets and liabilities denominated in nonfunctional currencies are remeasured at period-end exchange rates. Gains and losses arising from such remeasurement are recorded in our consolidated statements of operations and comprehensive loss and may result in significant foreign exchange gains or losses from period to period.

In addition, for subsidiaries whose functional currency is not the U.S. dollar, assets and liabilities are translated into U.S. dollars at exchange rates in effect as of the applicable balance sheet date, while revenues and expenses are translated at average exchange rates during the applicable reporting period. As a result, changes in exchange rates affect the U.S. dollar value of our revenues, expenses, assets, liabilities and equity as reflected in our consolidated financial statements. Foreign currency translation adjustments are recorded as a component of accumulated other comprehensive income (loss) within equity. Accordingly, fluctuations in foreign currency exchange rates could cause our reported results to differ significantly from period to period and could adversely affect the comparability of our financial results.

Exchange rates are subject to significant volatility and are affected by numerous factors outside of our control, including inflation, interest rate changes, monetary policies, trade restrictions, tariffs, geopolitical tensions, political instability, banking and financial market disruptions, sovereign debt concerns, changes in capital controls and general economic and market conditions. In particular, continued global macroeconomic uncertainty and volatility in the financial markets may result in significant fluctuations in the value of the U.S. dollar relative to the currencies in which we conduct business.

An increase in the value of the U.S. dollar relative to foreign currencies could reduce the U.S. dollar value of our foreign-currency-denominated revenues and assets, while a decrease in the value of the U.S. dollar could increase the U.S. dollar value of our foreign-currency-denominated expenses and liabilities. Currency fluctuations may also affect the pricing of our products and services, the competitiveness of our offerings in international markets, the value of intercompany transactions and the costs of operating our international business.

We currently do not maintain a comprehensive foreign currency hedging program to mitigate our exposure to exchange rate fluctuations. Although we may enter into hedging arrangements in the future, any such arrangements may not adequately offset our foreign currency exposure and may themselves expose us to additional risks, including counterparty, liquidity and operational risks. As a result, exchange rate fluctuations may materially adversely affect our business, financial condition, results of operations and future prospects.

While upon the completion of this offering each of our shares carries one vote in our general meeting of shareholders, irrespective of the par value of the shares, our Class A ordinary shares, which are the shares being offered in this offering, have a par value of CHF 0.006 and Class B voting rights shares have a par value of CHF 0.0006. As a result, on a capital-invested basis, each Class B voting rights share has ten times the voting power of each Class A ordinary share. Given the increased voting power of our Class B voting rights shares, our Founders, who, directly or indirectly, are our only Class B shareholders, will hold approximately    % of total combined voting power of our outstanding shares following the completion of this offering (assuming no exercise of the underwriters’ over-allotment option). In addition, entitlements to dividends and other distributions are also calculated based on par value. As a result of our dual class ownership structure, our Founders will be able to exert control over our management and affairs and over matters requiring shareholder approval, including the election of directors and mergers, and indirectly over acquisitions, asset sales and other significant corporate transactions. Further, our Founders will own shares representing approximately    % of the economic interest of our outstanding shares following this offering and, together with our other executive officers, directors and their affiliates, will own shares representing approximately   % of the economic interest and  % of total combined voting power of our outstanding shares following this offering (in each case, assuming no exercise of the underwriters’ over-allotment option). Because of the ten-to-one voting ratio between the Class B voting rights shares and Class A ordinary shares on a capital-invested basis, the holders of Class B voting rights shares collectively will control a majority of the total combined voting power of our outstanding shares and therefore be able to control a substantial number of matters submitted to our shareholders for approval, so long as the outstanding Class B voting rights shares represent the majority of the total voting power of our shares represented at such general meeting. In addition, the Founders entered into a shareholders’ agreement giving them a right of first refusal to purchase Class B voting rights shares that are proposed to be sold or transferred by the other Founder, subject to certain exceptions. This concentrated control will limit your ability to influence corporate matters for the foreseeable future. For example, our Founders will be able to control elections of directors, dividend payments and other distributions, and certain amendments of our articles of association, for the foreseeable future. Additionally, the holders of our Class B voting rights shares may cause us, through the election of the directors, to make strategic decisions or pursue acquisitions that could involve risks to you, are contrary to your expectations or may not be aligned with your interests. This control may materially adversely affect the market price of our Class A ordinary shares. See “Description of Share Capital and Articles of Association—Share Capital—Share Class Structure” and “Description of Share Capital and Articles of Association—Shareholders’ Agreement.”

Our dual class structure may result in a lower or more volatile market price of our Class A ordinary shares, adverse publicity or other adverse consequences. Certain investors, institutional shareholders, proxy advisory firms and corporate governance organizations have expressed concerns regarding dual class and multi-class capital structures, including structures that concentrate voting control in a limited number of shareholders. As a result, some investors may be reluctant to invest in the shares of companies that have dual class capital structures, such as ours, which could adversely affect the trading price and liquidity of our Class A ordinary shares.

In addition, proxy advisory firms, shareholder advocacy groups and certain institutional investors may criticize our corporate governance practices or recommend against voting in favor of our directors and other governance proposals because of our dual class structure. Such groups have, in certain cases, advocated for sunset provisions, one-share-one-vote structures or other changes to governance arrangements at companies with dual class share structures. Any such negative publicity, shareholder activism or adverse voting recommendations could adversely affect the market perception of our company and the value of our Class A ordinary shares.

Although companies with dual class share structures are currently eligible for inclusion in certain major equity indices, including indices maintained by S&P Dow Jones, provided they satisfy the applicable eligibility criteria, index providers may in the future revise their eligibility criteria or policies in a manner that could adversely affect companies with dual class capital structures. In addition, certain index providers, investment funds and other market participants continue to apply governance-based screens or investment criteria that may limit or prohibit investment in companies with dual class structures. To the extent that our dual class structure makes us ineligible for inclusion in certain indices or investment portfolios, or results in reduced demand for our Class A ordinary shares among institutional investors and passive investment vehicles, the trading price, liquidity and market value of our Class A ordinary shares could be adversely affected.

We have been advised by our Co-Founders and Co-CEOs that they are party to several credit facilities for which 10,329,430 of our shares (representing   % of the economic control and   % of the voting control of the Company) are pledged as collateral. CHF 70,000,000 ($88,284,000) of such personal indebtedness was in default from December 2024 until October 5, 2026, when the Co-Founders and Co-CEOs made a partial down payment under one of the credit facilities and the lenders agreed to extend the date for repayment of all outstanding amounts to December 31, 2026 (for which 9,513,333 ordinary shares are pledged as collateral) and CHF 35,000,000 ($44,142,000) of such personal indebtedness matures in September 2027 (subject to a potential six-month extension at the borrowers’ election) (for which 1,996,097 ordinary shares are pledged as collateral).

We have been further advised by our Co-Founders and Co-CEOs that in connection with this offering they intend to refinance CHF 55,000,000 ($69,366,000) of the CHF 60,000,000 ($75,672,000) in indebtedness that currently remains outstanding and is due on December 31, 2026 by using proceeds from additional term loans for which 11,207,471 shares would be pledged as collateral, and which would mature in September 2027 (with respect to CHF 15,000,000 ($18,918,000) (“New Loan A”)), twelve months following funding (with respect to CHF 20,000,000 ($25,224,000) (“New Loan B”)), and 24 months following funding (with respect to CHF 20,000,000 ($25,224,000) (“New Loan C”)), and that they intend to satisfy the remaining CHF 5,000,000 ($6,306,000) in indebtedness due on December 31, 2026 by using all or part of the proceeds from the sale of their Class A ordinary shares in this offering and/or the proceeds from one or more additional term loans (for which additional ordinary shares may be pledged as collateral). Among other terms, New Loan A provides for our Co-Founders and Co-CEOs to pay a structuring fee of CHF 3,600,000 ($4,540,320), payable at maturity, and a commitment fee of CHF 2,000,000 ($2,522,400), payable at funding. Among other terms, New Loan B provides for a make-whole premium pursuant to which, in lieu of interest, our Co-Founders and Co-CEOs would repay to the lender an aggregate amount equal to 140% (if paid within three months) or 160% (if paid after three months) of the loan amount. Among other terms, New Loan C provides for our Co-Founders and Co-CEOs to pay a structuring fee of CHF 3,529,411.76 ($4,451,294.11) and a commitment fee of CHF 1,000,000 ($1,261,200), payable at the latest upon expiry of the lock-up period applicable to our Co-Founders and Co-CEOs. New Loan C also bears interest at a rate of 15% per annum. In addition, New Loan A and New Loan C provide the relevant lender with equity participation rights in an amount corresponding to the excess of the relevant exit value per share determined by reference to specified exit events, including this offering, compared to the base line value per share specified in the applicable loan agreement, which can be settled in shares or in cash at the discretion of our Co-Founders and Co-CEOs at or around the time of maturity of the relevant loan. Assuming an exit value per Class A ordinary share determined in accordance with the relevant loan agreement of $    (the midpoint of the price range set forth on the cover page of this prospectus), the settlement in shares of the equity participation rights under the relevant loan agreements would result in a transfer of up to     shares in the aggregate by our Co-Founders and Co-CEOs to the relevant lenders, following which our Co-Founders and Co-CEOs’ beneficial ownership of our company would be reduced to    % (    % voting control) (or % ( % voting

control). Our Co-Founders and Co-CEOs may incur additional indebtedness, for which additional shares of our Company may be pledged as collateral, to satisfy that remaining indebtedness. In addition, our Co-Founders and Co-CEOs may sell certain of their shares of our Company to satisfy that remaining indebtedness.

The lock-up agreements between the underwriters and our Co-Founders and Co-CEOs includes an exception to allow for the transfer of ordinary shares to such lenders in connection with the exercise by any lender of such lender’s rights under the applicable credit agreement and pledge agreement, and the sale by such entities. The lock-up agreements also permit our Co-Founders and Co-CEOs to refinance existing credit facilities and pledge additional shares.

If our Co-Founders and Co-CEOs are unable to repay the full amount of any such loan when due, it would result in an event of default, which would give the applicable lender the right to foreclose upon all shares pledged under such loan. If that were to occur, the lender could sell such shares at a substantial discount prior to the expiration of the lock-up period. The risk or the perception that a foreclosure may occur may cause the price of our Class A ordinary shares to decline. Additionally, if all of our Co-Founders and Co-CEOs pledged shares were foreclosed upon, our Co-Founders and Co-CEOs’ beneficial ownership of our company would be reduced to   % (   % voting control) (or   % (   % voting control) if the underwriters exercise their over-allotment option in full). Finally, a foreclosure could result in a change of control of the company and a loss of controlled company status under the listing rules of NYSE.

Prior to this offering, there has not been a public market for our Class A ordinary shares. If an active trading market does not develop, you may have difficulty selling any of our Class A ordinary shares that you buy. We cannot predict the extent to which investor interest in our company will lead to the development of an active trading market on the NYSE, or otherwise or how liquid that market might become. The initial public offering price for the Class A ordinary shares will be determined by negotiations between us, the selling shareholders and the underwriters and may not be indicative of prices that will prevail in the open market following this offering. Consequently, you may not be able to sell our Class A ordinary shares at prices equal to or greater than the price paid by you in this offering. In addition to the risks described above, the market price of our Class A ordinary shares may be influenced by many factors, some of which are beyond our control, including:

In addition, the stock market in general has experienced substantial price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of particular companies affected. These broad market and industry factors may materially harm the market price of our Class A ordinary shares, regardless of our operating performance. In the past, following periods of volatility in the market price of certain companies’ securities, securities class action litigation has been instituted against these companies. This litigation, if instituted against us, could adversely affect our business, results of operations, financial condition and future prospects. If a market for our Class A ordinary shares does not develop or is not maintained, the liquidity and price of our Class A ordinary shares could be adversely affected.

The corporate governance rules of the NYSE require listed companies to have, among other things, a majority of independent directors and independent director oversight of executive compensation, nomination of directors and corporate governance matters. As a foreign private issuer, we are permitted to, and we will, follow home country practice in lieu of the above requirements. As long as we rely on the foreign private issuer exemption to certain of the NYSE corporate governance standards, a majority of the directors on our board of directors are not required to be independent directors, our compensation committee is not required to be composed entirely of independent directors and director nominations are not required to be made, or recommended to our full board of directors, by our independent directors or by a nominations committee that consists entirely of independent directors. Therefore, our board of directors’ approach to governance may be different from that of a board of directors consisting of a majority of independent directors, and, as a result, the management oversight of our company may be more limited than if we were subject to all of the NYSE corporate governance standards. We are also subject to certain reduced disclosure obligations as a result of being a foreign private issuer. As such, investors will not have access to the same information as for similar companies that are not foreign private issuers.

In the event we no longer qualify as a foreign private issuer, we intend to rely on the “controlled company” exemption under the NYSE corporate governance rules. A “controlled company” under the NYSE corporate governance rules is a company of which more than 50% of the voting power is held by an individual, group or another company. Following this offering, our Founders will control a majority of the combined voting power of our outstanding share capital, making us a “controlled company” within the meaning of the NYSE corporate governance rules. As a controlled company, we would be eligible to, and, in the event we no longer qualify as a foreign private issuer, we intend to, elect not to comply with certain requirements of the NYSE corporate governance standards, including (i) the requirement that a majority of the board of directors consist of independent directors, (ii) the requirement that we have a compensation committee that is composed entirely of independent directors and (iii) the requirement that our director nominations be made, or recommended to our full board of directors, by our independent directors or by a nominations committee that consists entirely of independent directors. Accordingly, our shareholders will not have the same protection afforded to shareholders of companies that are subject to all of the NYSE corporate governance standards, and the ability of our independent directors to influence our business policies and affairs may be reduced.

We qualify as a foreign private issuer and therefore we are not required to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers. We may no longer be a foreign private issuer as soon as June 30, 2027 (the end of our second fiscal quarter in the fiscal year after this offering), which would require us to comply with all of the periodic disclosure and current reporting requirements of the Exchange Act applicable to U.S. domestic issuers as of January 1, 2028. In order to maintain our current status as a foreign private issuer, either (a) a majority of our outstanding voting securities must be either directly or indirectly owned of record by nonresidents of the United States or (b)(i) a majority of our executive officers or directors may not be United States citizens or residents, (ii) more than 50% of our assets cannot be located in the United States and (iii) our business must be administered principally outside the United States. If we lose this status, we would be required to comply with the Exchange Act reporting and other requirements applicable to U.S. domestic issuers, which are more detailed and extensive than the requirements for foreign private issuers, and would require us to present our financial statements in accordance with GAAP, which could be time-consuming and costly. We may also be required to make changes in our corporate governance practices in accordance with various SEC and stock exchange rules. The regulatory and compliance costs to us under U.S. securities laws if we are required to comply with the reporting requirements applicable to a U.S. domestic issuer may be significantly higher than the cost we would incur as a foreign

private issuer. As a result, we expect that a loss of foreign private issuer status would increase our legal and financial compliance costs and would make some activities highly time-consuming and costly. We also expect that if we were required to comply with the rules and regulations applicable to U.S. domestic issuers, it would be more difficult and expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These rules and regulations could also make it more difficult for us to attract and retain qualified members of our board of directors.

We are an “emerging growth company,” as defined in the JOBS Act, and we intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act. We cannot predict if investors will find our Class A ordinary shares less attractive because we will rely on these exemptions. If some investors find our Class A ordinary shares less attractive as a result, there may be a less active trading market for our Class A ordinary shares and our share price may be more volatile.

In addition, Section 107 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to take advantage of this extended transition period. As a result, our results of operations and financial statements may not be comparable to the results of operations and financial statements of public companies who have adopted the new or revised accounting standards.

In addition, for as long as we are an “emerging growth company” under the JOBS Act, our independent registered public accounting firm will not be required to attest to the effectiveness of our internal control over financial reporting pursuant to Section 404. We could be an emerging growth company for up to five years. See “Summary—Emerging Growth Company Status.” Furthermore, after the date we are no longer an emerging growth company, our independent registered public accounting firm will only be required to attest to the effectiveness of our internal control over financial reporting depending on our market capitalization. Even if our management concludes that our internal controls over financial reporting are effective, our independent registered public accounting firm may still decline to attest to our management’s assessment or may issue a report that is qualified if it is not satisfied with our controls or the level at which our controls are documented, designed, operated or reviewed, or if it interprets the relevant requirements differently from us. In addition, in connection with the implementation of the necessary procedures and practices related to internal control over financial reporting, we may identify deficiencies that we may not be able to remediate in time to meet the deadline imposed by the Sarbanes-Oxley Act for compliance with the requirements of Section 404. Failure to comply with Section 404 could subject us to regulatory scrutiny and sanctions, impair our ability to raise capital, cause investors to lose confidence in the accuracy and completeness of our financial reports and negatively affect our share price.

We will have broad discretion in the application of the net proceeds to us from this offering, including for any of the purposes described in the section titled “Use of Proceeds,” and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine our use of the net proceeds from this offering, our ultimate use may vary substantially from our currently intended use. Investors will need to rely upon the judgment of our management with respect to the use of proceeds. Pending use, we may invest the net proceeds from this offering in short-term, investment-grade, interest-bearing securities, such as money market accounts, certificates of deposit, commercial paper and sovereign debt that may not generate a high yield for our shareholders. We may use a portion of the net

proceeds to acquire complementary businesses, products, services or technologies. At this time, we do not have agreements or commitments to enter into any material acquisitions. If we do not use the net proceeds that we receive in this offering effectively, our business, financial condition, results of operations and prospects could be harmed and the market price of our Class A ordinary shares could decline.

Sales of a substantial number of our Class A ordinary shares in the public market following the completion of this offering, or the perception that these sales might occur, could depress the market price of our Class A ordinary shares and could impair our ability to raise capital through the sale of additional equity securities. Many of our existing equity holders have substantial unrecognized gains on the value of the equity they hold based upon the price of this offering, and therefore they may take steps to sell their shares or otherwise secure the unrecognized gains on those shares. We are unable to predict the timing of or the effect that such sales may have on the prevailing market price of our Class A ordinary shares. All of the Class A ordinary shares sold in this offering will be freely tradable without restrictions or further registration under the Securities Act, except for any shares held by our affiliates as defined in Rule 144 under the Securities Act (“Rule 144”).

We, the selling shareholders, our executive officers and directors, as well as certain other security holders, who currently and collectively own substantially all of our Class A ordinary shares have agreed with the underwriters, subject to certain exceptions, not to dispose of or hedge any of their ordinary shares or securities convertible into ordinary shares during the period from the date of this prospectus continuing through the date 180 days, or 270 days in the case of our Co-Founders and their affiliated entities, after the date of this prospectus, except with the prior written consent of Goldman Sachs & Co. LLC and J.P. Morgan Securities LLC. These agreements are further described in the sections titled “Ordinary Shares Eligible for Future Sale” and “Underwriting.”

10,329,430 shares beneficially owned by our Co-Founders and Co-CEOs are pledged as collateral to secure certain personal loans in an aggregate amount of CHF 105,000,000 ($132,426,000) and we understand that our Co-Founders and Co-CEOs are in discussions with one or more lenders to pledge up to an additional 2,874,137 shares in the aggregate as collateral for additional personal loans in an aggregate amount of up to CHF 55,000,000 ($69,366,000) to refinance in whole or in part existing personal loans of CHF 60,000,000 ($75,672,000) maturing on December 31, 2026. We are not party to these agreements. The lenders for such loans may foreclose upon some or all of these shares at any time. The lock-up agreements between the underwriters and our Co-Founders and Co-CEOs include an exception to allow for the transfer of ordinary shares to such lenders in connection with the exercise by any lender of such lender’s rights under the applicable credit agreement and pledge agreement, and the sale by such entities. If our Co-Founders and Co-CEOs are unable to repay the full amount of any such loan when due, it would result in an event of default, which would give the applicable lender the right to foreclose upon all shares pledged under such loan. A foreclosure upon these 10,329,430 shares or the perception that a foreclosure may occur, may cause the price of our Class A ordinary shares to decline. The lock-up agreements also allow our Co-Founders and Co-CEOs to refinance existing credit facilities and pledge additional shares.

In addition, there will be    Class A ordinary shares issuable upon the exercise of outstanding equity instruments following the completion of this offering and the granting of certain other equity awards following this offering as described elsewhere in this prospectus. We intend to register all of the Class A ordinary shares issuable upon exercise of outstanding equity instruments and other equity incentives we may grant in the future for public resale under the Securities Act. The Class A ordinary shares will become eligible for sale in the public market to the extent such equity instruments are exercised, subject to the lock-up agreements and market stand-off provisions described above, including the exceptions thereto, and compliance with applicable securities laws.

The initial public offering price of our Class A ordinary shares will be substantially higher than the pro forma net tangible book value per Class A ordinary share immediately after this offering. If you purchase

Class A ordinary shares in this offering, you will suffer immediate dilution of $   per Class A ordinary share, or $   per Class A ordinary share if the underwriters exercise their over-allotment option in full, representing the difference between our pro forma net tangible book value per share as of    , 2026, after giving effect to the sale of Class A ordinary shares in this offering and the assumed public offering price of $   per Class A ordinary share, the midpoint of the price range set forth on the cover page of this prospectus. See “Dilution.”

Immediately prior to the completion of this offering, all of our outstanding Class A preferred shares and Class B preferred shares will be converted into Class A ordinary shares as part of the Share Capital Reorganization. The Class A preferred shares and Class B preferred shares will convert at a one-to-one ratio. However, holders of Class B preferred shares have a contractual anti-dilution right to subscribe for additional Class A ordinary shares depending on the initial public offering price, which would further dilute the ownership interest and voting power of investors purchasing Class A ordinary shares in this offering. See “Prospectus Summary—Share Capital Reorganization” and “Prospectus Summary—The Offering.” In addition, prior to the Conversion, the Class A preferred shares and Class B preferred shares carry preferential dividend and liquidation rights that rank senior to the rights of holders of ordinary shares, although such preferential rights will terminate upon the Conversion. See “Description of Share Capital and Articles of Association—Share Capital—Preferred Shares.”

We have never declared or paid any cash dividends on our share capital, and we do not intend to pay any cash dividends in the foreseeable future. Any future proposals at our shareholders’ meeting to pay dividends will be at the discretion of our board of directors after taking into account various factors, including our business prospects, liquidity requirements, financial performance and new product development and subject to approval by the general meeting of shareholders. In addition, payment of future dividends is subject to certain limitations pursuant to Swiss law and our Amended and Restated Articles of Association. See “Description of Share Capital and Articles of Association” and “Dividend Policy.” While shareholders together representing at least 0.5% of the share capital or voting rights may demand that a general meeting of shareholders be called for specific agenda items, including to pay dividends, because of the ten-to-one voting ratio between the Class B voting rights shares and Class A ordinary shares on a capital-invested basis, the holders of Class B voting rights shares collectively will control a majority of the total combined voting power of our outstanding shares and therefore be able to prevent any cash dividend payments for the foreseeable future. Accordingly, investors cannot rely on dividend income from our Class A ordinary shares, and any return on an investment in our Class A ordinary shares will likely depend entirely upon any future appreciation in the price of our Class A ordinary shares, which may never occur.

The trading market for our Class A ordinary shares will rely in part on the research and reports that industry or securities analysts publish about us or our business. We do not currently have and may never obtain research coverage by industry or securities analysts. If no or few analysts commence coverage of us, the trading price of our Class A ordinary shares would likely decrease. Even if we do obtain analyst coverage, if one or more of the analysts covering our business downgrade their evaluations of our Class A ordinary shares, the price of our Class A ordinary shares could decline. If one or more of these analysts cease to cover our Class A ordinary shares, we could lose visibility in the market for our shares, which in turn could cause the price of our Class A ordinary shares to decline.

On August 24, 2026, our shareholders approved the ordinary share capital increase and the creation of a capital range necessary to source the Class A ordinary shares to be sold in this offering. The execution of the share capital increase by our board of directors and the related filings will be made prior to the completion of this offering and, with regard to the Class A ordinary shares to be issued upon any exercise of the underwriters’ option to purchase additional Class A ordinary shares (if any), upon exercise of such option. The issuance of new Class A ordinary shares will become effective upon registration in the commercial register. As with all share capital increases in Switzerland, the shareholders’ resolutions regarding such share capital increases may be challenged in court within two months after such shareholders’ meeting and/or the registration of the capital increases in the commercial register may be blocked temporarily by a preliminary injunction or permanently by order of a competent court. Either action would prevent or delay the completion of this offering.

We are a Swiss corporation. Our corporate affairs are governed by our articles of association and by the laws governing companies, including listed companies, incorporated in Switzerland. The rights of our shareholders and the responsibilities of members of our board of directors may be different from the rights and obligations of shareholders and directors of companies governed by the laws of the United States. In the performance of its duties, our board of directors is required by Swiss law to consider the interests of our Company, our shareholders, our employees and other stakeholders, in all cases with due observation of the principles of reasonableness and fairness. It is possible that some of these parties will have interests that are different from, or in addition to, shareholders’ interests. Swiss corporate law limits the ability of our shareholders to challenge resolutions made or other actions taken by our board of directors in court.

Our shareholders generally are not permitted to file a suit to reverse a decision or an action taken by our board of directors, but are instead only permitted to seek damages for breaches of fiduciary duty. As a matter of Swiss law, shareholder claims against a member of our board of directors for breach of fiduciary duty would have to be brought in the competent courts in Zug, Switzerland, or where the relevant member of our board of directors is domiciled. In addition, under Swiss law, any claims by our shareholders against us must be brought exclusively in the competent courts in Zug, Switzerland. U.S.-style class actions and derivative actions are not available under Swiss law. A further summary of applicable Swiss corporate law is included in this prospectus under “Description of Share Capital and Articles of Association” and “Comparison of Swiss Corporate Law and U.S. Corporate Law.” There can be no assurance that Swiss law will not change in the future, the occurrence of which could adversely affect the rights of our shareholders, or that Swiss law will protect our shareholders in a similar fashion as under U.S. corporate law principles.

Because our Class A ordinary shares will be listed exclusively on the NYSE and not in Switzerland, our shareholders will not benefit from the protection afforded by certain provisions of Swiss law that are designed to protect shareholders in the event of a public takeover offer or a change-of-control transaction. For example, Article 120 of the Swiss Financial Market Infrastructure Act and its implementing provisions require investors to disclose their interest in our company if they reach, exceed or fall below certain ownership thresholds. Similarly, the Swiss takeover regime imposes a duty on any person or group of persons who acquires more than one-third of a company’s voting rights to make a mandatory offer for all of the company’s outstanding listed equity securities. In addition, the Swiss takeover regime imposes certain restrictions and obligations on bidders in a voluntary public takeover offer that are designed to protect shareholders. However, these protections are applicable only to issuers that list their equity securities in Switzerland, and because our Class A ordinary shares will be listed exclusively on the NYSE, they will not be applicable to us. Furthermore, since Swiss law restricts our ability to implement rights

plans or U.S.-style “poison pills,” our ability to resist an unsolicited takeover attempt or to protect minority shareholders in the event of a change-of-control transaction may be limited. Therefore, our shareholders may not be protected to the same degree in a public takeover offer or a change-of-control transaction as are shareholders in a Swiss company listed in Switzerland.

Swiss law reserves for approval by shareholders certain corporate actions over which a board of directors would have authority in certain other jurisdictions. For example, the payment of dividends must be approved by shareholders. Swiss law also requires that our shareholders themselves resolve to, or authorize our board of directors to, increase or decrease our share capital. While our shareholders may authorize our board of directors to issue or cancel shares without additional shareholder approval, Swiss law limits this authorization to 50% of the share capital registered in the commercial register at the time of the authorization. The authorization, furthermore, has a limited duration of up to five years and must be renewed by the shareholders from time to time thereafter in order to be available for raising capital. Additionally, subject to specified exceptions, including exceptions described in our Amended and Restated Articles of Association, Swiss law grants pre-emptive subscription rights to existing shareholders to subscribe for new issuances of equity securities, which may be withdrawn or limited only under certain conditions. Swiss law also does not provide as much flexibility in the various rights and regulations that can attach to different categories of shares as do the laws of some other jurisdictions. These Swiss law requirements relating to our capital management may limit our flexibility, and situations may arise where greater flexibility would have provided benefits to our shareholders. See “Description of Share Capital and Articles of Association” and “Comparison of Swiss Corporate Law and U.S. Corporate Law.”

Under Swiss corporate law, shareholders may receive certain pre-emptive rights to subscribe on a pro-rata basis for issuances of equity securities or other securities that are convertible into equity securities. Due to the laws and regulations in certain jurisdictions, however, shareholders who are not residents of the United States may not be able to exercise such rights unless the Company takes action to register or otherwise qualify the rights offering, including, for example, by complying with prospectus requirements under the laws of that jurisdiction. There can be no assurance that the Company will take any action to register or otherwise qualify an offering of subscription rights or shares under the laws of any jurisdiction other than the United States where the offering of such rights is restricted. If shareholders in such jurisdictions were unable to exercise their subscription rights, their ownership in the Company would be diluted.

We are a corporation organized and incorporated under the laws of Switzerland with registered office and domicile in Zug, Switzerland, and the majority of our assets are located within Switzerland. Moreover, a number of our directors and executive officers are not residents of the United States, and all or a substantial portion of the assets of such persons are or may be located outside the United States. As a result, investors may not be able to effect service of process within the United States upon the Company or upon such persons, or to enforce judgments obtained against the Company or such persons in U.S. courts, including judgments in actions predicated upon the civil liability provisions of the federal securities laws of the United States. There is doubt as to the enforceability in Switzerland of original actions, or in actions for enforcement of judgments of U.S. courts, of civil liabilities to the extent solely predicated upon the federal and state securities laws of the United States. Original actions against persons in Switzerland based solely upon the U.S. federal or state securities laws are governed, among other things, by the principles set forth in the Swiss Federal Act on Private International Law (the “PILA”). This statute provides that the application of provisions of non-Swiss law by the courts in Switzerland shall be precluded if the result is incompatible with Swiss public policy. Also, certain mandatory provisions of Swiss law may be applicable regardless of any other law that would otherwise apply.

The United States and Switzerland currently do not have a treaty providing for the reciprocal recognition and enforcement of judgments, other than arbitration awards, in civil and commercial matters. The recognition and enforcement of a judgment of the courts of the United States in Switzerland are governed by the principles set forth in the PILA. This statute provides in principle that a judgment rendered by a non-Swiss court may be enforced in Switzerland only if:

See “Enforcement of Judgments.”

Our Amended and Restated Articles of Association contain provisions that may have the effect of discouraging, delaying or preventing a change in control of us that shareholders may consider favorable, including transactions in which our shareholders may receive a premium for their shares. Our Amended and Restated Articles of Association, which will become effective immediately prior to the completion of this offering, includes provisions that:

These and other provisions, alone or together, could delay or prevent takeovers and changes in control. See “Description of Share Capital and Articles of Association.” These provisions could also limit the price that investors might be willing to pay in the future for our Class A ordinary shares, thereby depressing the market price of our Class A ordinary shares.

We estimate that the net proceeds to us from the sale of our Class A ordinary shares in this offering will be approximately $   million, based on the assumed initial public offering price of $   per Class A ordinary share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. If the underwriters exercise in full their over-allotment option, we estimate that the net proceeds to us would be approximately $   million, after deducting underwriting discounts and commissions and estimated offering expenses payable by us. We will not receive any proceeds from the sale of the Class A ordinary shares by the selling shareholders.

Each $1.00 increase (decrease) in the assumed initial public offering price per Class A ordinary share would increase (decrease) our net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses payable by us, by $  ($ ). Similarly, each increase (decrease) of 1.0 million Class A ordinary shares offered by us would increase (decrease) the net proceeds to us from this offering by approximately $  ($ ), assuming the assumed initial public offering price of $   per Class A ordinary share remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

The principal purposes of this offering are to create a public market for our Class A ordinary shares and enable access to the public equity markets for us and our shareholders. We intend to use the net proceeds from this offering for general corporate purposes, including working capital, operating expenses and capital expenditures. Pending the use of proceeds from this offering, we intend to invest the net proceeds in short-term, interest-bearing, investment grade securities, certificates of deposit or governmental securities.

The expected use of net proceeds from this offering represents our intentions based upon our current plans and business condition, which could change in the future. We cannot predict with certainty all of the particular uses for the net proceeds of this offering or the amounts that we will actually spend on the uses set forth above. As a result, our management will have broad discretion in applying the net proceeds of this offering, and investors will be relying on our judgment regarding the application of the net proceeds of this offering. See “Risk Factors—Risks Related to This Offering and Ownership of Our Class A Ordinary Shares―We will have broad discretion in the use of the net proceeds to us from this offering and we may not use them effectively.”

We have never declared or paid cash dividends on our ordinary shares. We currently intend to retain any future earnings to fund the operation and expansion of our business, and we do not expect to declare or pay any dividends for the foreseeable future. Any future determination to declare cash dividends will be made at the discretion of our board of directors, subject to applicable laws, and will depend on a number of factors, including our financial condition, results of operations, capital requirements, contractual restrictions, general business conditions and other factors that our board of directors may deem relevant.

Under Swiss law, any dividend must be approved by our shareholders. In addition, our auditors must confirm that the dividend proposal of our board of directors to the shareholders conforms to Swiss statutory law and our Amended and Restated Articles of Association. A Swiss corporation may pay dividends only if it has sufficient distributable profits from the previous or current business year or brought forward from previous business years or if it has distributable reserves, each as evidenced by its audited stand-alone statutory balance sheet prepared pursuant to Swiss law and after allocations to reserves required by Swiss law and its articles of association have been deducted. Distributable reserves are generally booked either as free reserves or as reserves from capital contributions. Distributions out of share capital, which is the aggregate par value of a corporation’s issued shares, may be made only by way of a share capital reduction. See “Description of Share Capital and Articles of Association.”

We currently intend to retain any future earnings and do not expect to pay any dividends in the foreseeable future. See “Risk Factors—Risks Related to Our Class A Ordinary Shares and the Offering―We do not intend to pay dividends for the foreseeable future and, as a result, your ability to achieve a return on your investment will depend on appreciation in the price of our Class A ordinary shares.”

The table below sets forth our cash and cash equivalents and total capitalization as of June 30, 2026:

You should read this table in conjunction with our consolidated financial statements, including the notes thereto, included in this prospectus as well as “Use of Proceeds,” “Summary Financial and Other Information” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

The pro forma number of shares and amounts reflect the following effects of the Conversion:

The pro forma information gives effect to the Conversion as if it had occurred on June 30, 2026. The pro forma information reflects the following significant assumptions and estimates: (i) share capital reflects the aggregate nominal value of the Class A ordinary shares and Class B voting rights shares outstanding upon the Conversion, translated into U.S. dollars at the historical exchange rate implied by the carrying amount of our existing share capital, with the balance of the carrying value of the preferred shares recorded in additional paid-in capital; (ii) pro forma share capital is allocated between our Class A ordinary shares and our Class B voting rights shares in proportion to their respective aggregate nominal values; (iii) no additional Class A ordinary shares are issued to holders of our Class B preferred shares pursuant to their contractual anti-dilution rights, as the number of such shares, if any, depends on the initial public offering price (see footnote (1) above); and (iv) the pro forma number of shares does not give effect to any Class A ordinary shares issuable upon the vesting of RSUs or the exercise of outstanding options and warrants, or reserved for future issuance under our equity incentive plans (see “The Offering”). Because the Conversion is a reclassification within capitalization, total capitalization of $24.6 million is the same on an actual and a pro forma basis. Total capitalization is the sum of total loans, mezzanine equity and total shareholders’ deficit.

A $1.00 increase (decrease) in the assumed initial public offering price of $    per Class A ordinary share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, would increase (decrease) each of our as adjusted cash and cash equivalents, additional paid-in capital and total shareholders’ equity by $   million ($   million), assuming the aggregate number of ordinary shares offered by us in this offering remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase (decrease) of 1.0 million in the aggregate number of Class A ordinary shares offered by us in this offering would increase (decrease) each of our as adjusted cash and cash equivalents, additional paid-in capital and total shareholders’ equity by $   million ($   million), assuming the assumed initial public offering price of $   per Class A ordinary share remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

The selling shareholders identified herein will receive all net proceeds from the secondary offering of the Class A ordinary shares held by them. Therefore, we will not receive any net proceeds from their secondary offering and our total capitalization will not be impacted by such net proceeds received by the selling shareholders.

Other than as noted above, there have been no material changes to our capitalization since June 30, 2026.

If you invest in our Class A ordinary shares in this offering, your ownership interest will be immediately diluted to the extent of the difference between the initial public offering price per Class A ordinary share and the pro forma as adjusted net tangible book value per Class A ordinary share immediately after this offering.

At June 30, 2026, we had a historical net tangible book value of $(101.8) million, corresponding to a net tangible book value of $(2.98) per ordinary share. The historical net tangible book value represents the amount of our total assets less our total liabilities, excluding goodwill and other intangible assets. The historical net tangible book value per ordinary share represents the historical net tangible book value attributable to our ordinary shares divided by 34,186,620, which is the total number of our ordinary shares outstanding as of June 30, 2026. The foregoing gives effect to the 2026 Share Split but does not give effect to the Conversion, and accordingly does not reflect the issuance of any Class A ordinary shares or Class B voting rights shares.

After giving effect to the Conversion, which will be effected immediately prior to the completion of this offering, and assuming the Conversion had occurred on June 30, 2026, our pro forma net tangible book value as of June 30, 2026, would have been $   million. The pro forma net tangible book value attributable to our Class A ordinary shares would have been $   million, corresponding to a pro forma net tangible book value of $   per Class A ordinary share, based on    Class A ordinary shares outstanding after giving effect to the Conversion. Pro forma net tangible book value has been allocated between our Class A ordinary shares and our Class B voting rights shares in proportion to their respective aggregate nominal values, reflecting that ten Class B voting rights shares carry the same aggregate nominal value, and the same economic entitlement, as one Class A ordinary share. See “Prospectus Summary—Share Capital Reorganization.”

After giving further effect to the sale by us of     Class A ordinary shares in this offering, at the assumed initial public offering price of $   per Class A ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us, our pro forma as adjusted net tangible book value as of June 30, 2026 would have been $   million, or $   per Class A ordinary share. This represents an immediate increase in pro forma net tangible book value of $   per Class A ordinary share to our existing shareholders and an immediate dilution in pro forma net tangible book value of $   per Class A ordinary share to investors purchasing Class A ordinary shares in this offering at the initial public offering price.

If you invest in our Class A ordinary shares in this offering, your ownership interest will be diluted to the extent of the difference between the initial public offering price per Class A ordinary share and the pro forma as adjusted net tangible book value per Class A ordinary share immediately after this offering.

The following table illustrates this dilution to investors purchasing Class A ordinary shares in the offering.

The dilution information discussed above is illustrative only and may change based on the actual initial public offering price and other terms of this offering. A $1.00 increase (decrease) in the assumed initial public offering price of $   per Class A ordinary share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, would increase (decrease) our pro forma as

adjusted net tangible book value per Class A ordinary share after this offering by $   ($  ) per Class A ordinary share and increase (decrease) the dilution to investors in this offering by $   ($  ) per Class A ordinary share, in each case assuming the number of Class A ordinary shares, as set forth on the cover page of this prospectus, remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us. Similarly, each increase or decrease of 1.0 million shares in the number of Class A ordinary shares offered by us would increase (decrease) our pro forma as adjusted net tangible book value by approximately $   ($  ) per Class A ordinary share and decrease (increase) the dilution to investors in this offering by approximately $   ($  ) per Class A ordinary share, in each case assuming the assumed initial public offering price of $   per Class A ordinary share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, remains the same, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us.

If the underwriters exercise in full their over-allotment option, our pro forma as adjusted net tangible book value per Class A ordinary share after the offering would be $  , and the dilution per Class A ordinary share to investors in this offering would be $  , in each case, assuming an initial public offering price of $   per Class A ordinary share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, and after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.

The following table summarizes, on the same pro forma basis as of June 30, 2026, the differences between the existing shareholders and the investors purchasing Class A ordinary shares in this offering, with respect to the number of Class A ordinary shares purchased from us, the total consideration paid or to be paid to us, which includes the gross proceeds received from the issuance of our ordinary shares, and the average price per Class A ordinary share paid or to be paid to us at the assumed initial public offering price of $   per Class A ordinary share, which is the midpoint of the price range set forth on the cover page of this prospectus, before deducting underwriting discounts and commissions and estimated offering expenses payable by us: