Form POS AM YD Bio Ltd

As filed with the Securities and Exchange Commission on May 26, 2026.

Registration No. 333-290471

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

POST-EFFECTIVE AMENDMENT NO. 1

to

FORM F-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

YD Bio Limited

(Exact name of registrant as specified in its charter)

12F., No. 3, Xingnan St.,
Nangang Dist.,
Taipei City 115001, Taiwan
+(886) 2382-0330
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Cogency Global Inc.
122 East 42^nd Street, 18^th Floor
New York, NY 10168
(212) 947-7200

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:

Michael J. Blankenship

Winston & Strawn LLP

800 Capitol Street, Suite 2400

Houston, Texas 77002

(713) 651-2600

Approximate date of commencement of proposed sale to the public: As soon as practicable after this registration statement becomes effective.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box: ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

This Post-Effective Amendment No. 1 shall hereafter become effective in accordance with Section 8(c) of the Securities Act of 1933, as amended, on such date as the Securities and Exchange Commission, acting pursuant to Section 8(c) of the Securities Act, may determine.

EXPLANATORY NOTE

This Post-Effective Amendment No. 1 to the Registration Statement on Form F-1 (File No. 333-290471) (as amended, the “Registration Statement”) of YD Bio Limited (the “Registrant” or the “Company”), as originally became effective on November 13, 2025 pursuant to Section 8(a) of the Securities Act of 1933, as amended, is being filed to update the Registration Statement to reflect the Registrant’s recently filed Annual Report on Form 20-F for the fiscal year ended December 31, 2025, filed with the SEC on April 30, 2026, and certain other updated information. No additional securities are being registered under this Post-Effective Amendment No. 1. All applicable registration fees were paid at the time of the original filing of the Registration Statement.

The information in this preliminary prospectus is not complete and may be changed. The selling shareholders may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell, nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED MAY 26, 2026.

PRELIMINARY PROSPECTUS

YD BIO LIMITED

Prospectus for

11,436,270 Ordinary Shares Issuable Upon Exercise of Public Warrants

58,571,199 Ordinary Shares by the Selling Shareholders

3,136,056 Ordinary Shares Issuable upon Exercise of Warrants

This prospectus relates to the issuance by us of up to an aggregate of up to 11,436,270 ordinary shares, par value $0.0001 per share (“Ordinary Shares”), that are issuable upon the exercise of 11,436,270 warrants, each exercisable for one Ordinary Share at an exercise price of $11.50 per share (the “Public Warrants”). 11,500,000 Public Warrants were originally issued in connection with the completion of our business combination with Breeze Holdings Acquisition Corp. (“Breeze”) and YD Biopharma Limited (the “Business Combination”) on August 28, 2025. The Public Warrants are exercisable 30 days after the closing of the Business Combination and will expire five years from the closing of the Business Combination.

This prospectus relates to the resale, from time to time, by the Selling Shareholders of up to 58,571,199 Ordinary Shares and 3,136,056 Ordinary Shares issuable upon exercise of certain outstanding warrants (the “Private Warrants,” and together with the Public Warrants, the “Warrants”), issued to certain of the Selling Shareholders in connection with the Business Combination in exchange for warrants issued by Breeze on November 25, 2020 in connection with a private placement transaction (the “Private Placement Transaction”). 5,425,000 Private Warrants were initially sold pursuant to the Private Placement Transaction with an initial exercise price equal to $11.50 per share, are exercisable 30 days after the closing of the Business Combination, and will expire five years from the closing of the Business Combination.

We are not selling any securities under this prospectus and will not receive any of the proceeds from the sale of our Ordinary Shares by the Selling Shareholders. We will receive proceeds from any cash exercise of the Public Warrants and the Private Warrants, which, if exercised in cash with respect to all of the 11,436,270 Public Warrants would result in $131,517,105 and if exercised in cash with respect to all of the 3,136,056 Private Warrants, would result in gross proceeds to us of a maximum of $36,064,644; however, we cannot predict when and in what amounts or if the Warrants will be exercised and it is possible that the Warrants may expire and never be exercised, in which case we would not receive any cash proceeds. 

The Selling Shareholders may sell the Ordinary Shares offered by this prospectus from time to time on terms to be determined at the time of sale through ordinary brokerage transactions or through any other means described in this prospectus under the caption “Plan of Distribution.” The Ordinary Shares may be sold at fixed prices, at market prices prevailing at the time of sale, at prices related to prevailing market price or at negotiated prices.

We will pay the expenses incurred in registering under the Securities Act, the offer and sale of the Ordinary Shares to which this prospectus relates by the Selling Shareholders, including legal and accounting fees. See “Plan of Distribution” beginning on page 137.

Our Ordinary Shares are listed on the Nasdaq Global Market under the symbol “YDES.” On May 22, 2026, the last sale price for our Ordinary Shares as reported on the Nasdaq Global Market was $4.75 per share.

We are a “smaller reporting company” as defined under the federal securities laws and, as such, have elected to comply with certain reduced public company reporting requirements for this prospectus and may elect to do so in future filings.

Investing in our securities involves a high degree of risk. See the section entitled “Risk Factors” appearing on page 5 of this prospectus for a discussion of information that should be considered in connection with an investment in our securities.

Neither the Securities and Exchange Commission nor any other regulatory body has approved or disapproved of these securities or passed upon the accuracy or adequacy of this prospectus. Any representation to the contrary is a criminal offense.

The date of this prospectus is                , 2026

TABLE OF CONTENTS

You should rely only on the information contained in this prospectus or any amendment or supplement to this prospectus. This prospectus is an offer to sell only the securities offered hereby, but only under the circumstances and in jurisdictions where it is lawful to do so. Neither we nor the Selling Shareholders have authorized anyone to provide you with information different from that contained in this prospectus or any amendment or supplement to this prospectus. Neither we nor the Selling Shareholders take any responsibility for, or can provide any assurance as to the reliability of, any information other than the information in this prospectus or any amendment or supplement to this prospectus. The information in this prospectus or any amendment or supplement to this prospectus is accurate only as of its date, regardless of the time of delivery of this prospectus or any amendment or supplement to this prospectus, as applicable, or any sale of the securities offered by this prospectus. Our business, financial condition, results of operations and prospects may have changed since that date.

For Investors Outside the United States: The Selling Shareholders are offering to sell, and seeking offers to buy, the securities offered by this prospectus only in jurisdictions where offers and sales are permitted. Neither we nor the Selling Shareholders have done anything that would permit this offering or the possession or distribution of this prospectus in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the offering of the securities offered by this prospectus and the distribution of this prospectus outside the United States.

ABOUT THIS PROSPECTUS

This prospectus is part of a registration statement that we filed with the SEC. The Selling Shareholders may, from time to time, sell the securities offered by them described in this prospectus through any means described in the section titled “Plan of Distribution.” We will not receive any proceeds from the sale by the Selling Shareholders of the securities offered by them described in this prospectus.

We may also file a prospectus supplement or post-effective amendment to the registration statement of which this prospectus forms a part that may contain material information relating to these offerings. The prospectus supplement or post-effective amendment may also add, update or change information contained in this prospectus with respect to that offering. If there is any inconsistency between the information in this prospectus and the applicable prospectus supplement or post-effective amendment, you should rely on the prospectus supplement or post-effective amendment, as applicable. Any statement so modified will be deemed to constitute a part of this prospectus only as so modified, and any statement so superseded will be deemed not to constitute a part of this prospectus. Before purchasing any securities, you should carefully read this prospectus, any post-effective amendment, and any applicable prospectus supplement, together with the additional information described under the heading “Where You Can Find More Information” and “Incorporation of Certain Information by Reference.”

This prospectus contains summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed, or will be incorporated by reference as exhibits to the registration statement of which this prospectus forms a part, and you may obtain copies of those documents as described below under “Where You Can Find More Information.” You should assume that the information in this prospectus is accurate only as of the date on the front of the document and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by reference, regardless of the time of delivery of this prospectus or any sale of a security.

The distribution of this prospectus and the issuance of the securities in certain jurisdictions may be restricted by law. Persons outside the United States who come into possession of this prospectus must inform themselves about, and observe any restrictions relating to, the issuance of the securities and the distribution of this prospectus outside the United States. This prospectus does not constitute, and may not be used in connection with, an offer to sell, or a solicitation of an offer to buy, the securities offered by this prospectus by any person in any jurisdiction in which it is unlawful for such person to make such an offer or solicitation.

MARKET AND INDUSTRY DATA

Unless otherwise indicated, information contained in this prospectus or incorporated into this prospectus by reference regarding the Company’s industry and the regions in which it operates, including market research, estimates, and forecasts, is based on information obtained from industry publications and reports and forecasts from third-party sources. In some cases, the Company does not expressly refer to the sources from which this information is derived. This information is subject to significant uncertainties and limitations and is based on assumptions and estimates that may prove to be inaccurate. Neither we nor the Selling Shareholders can guarantee the accuracy or completeness of any such information contained in this prospectus or incorporated into this prospectus by reference. You are therefore cautioned not to give undue weight to this information.

The Company has not independently verified the accuracy or completeness of any such information. Similarly, internal surveys, industry forecasts and market research, which the Company believes to be reliable based upon its management’s knowledge of the industry, have not been independently verified. While the Company believes that the market data, industry forecasts and similar information included in this prospectus are generally reliable, such information is inherently imprecise. In addition, assumptions and estimates of the Company’s future performance and growth objectives and the future performance of its industry and the markets in which it operates are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those discussed under the headings “Risk Factors,” “Cautionary Note Regarding Forward-Looking Statements,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this prospectus.

Summary of Risk Factors:

The following is a summary of certain, but not all, of the risks that could adversely affect our business, operations and financial results. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below, after this summary, and should be carefully considered, together with other information in our other filings with the SEC before making an investment decision in our securities.

Risks Related to Our Business and Operations

Regulatory Risks

Industry and Market Risks

Risks Related to Taiwan

Risks Related to Intellectual Property Rights

General Tax Risk Factors

Risks Related to Ownership of Our Securities  

RISK FACTORS

Investing in our securities includes a high degree of risk. Prior to making a decision about investing in our securities, you should consider carefully the specific factors discussed below, together with all of the other information contained in this prospectus. If any of the following risks actually occurs, our business, financial condition, results of operations and future prospects would likely be materially and adversely affected. This could cause the market price of our Ordinary Shares to decline and could cause you to lose all or part of your investment.

You should consider carefully the following risk factors, together with all of the other information included in this prospectus. If any of the following risks, either alone or taken together, or other risks not presently known to us or that we currently believe to not be significant, develop into actual events, then our business, financial condition, results of operations or prospects could be materially adversely affected. If that happens, the market price of our common stock could decline, and shareholders may lose all or part of their investment.

Risks Related to Our Business and Operations

YD Bio’s future success depends, in part, on its ability to develop new products and new technologies and maintain technologies, facilities and equipment to meet the needs of its customers.

Many of the markets in which YD Bio operates are characterized by rapidly changing technologies. The product, program and service needs of its customers change and evolve regularly. YD Bio’s success in the cancer detection industry depends upon its ability to identify emerging technological trends, develop technologically advanced, innovative and cost-effective products and services and market these products and services to its customers in the U.S. and internationally. In addition, YD Bio’s ability to develop innovative and technologically advanced products depends on continued funding for, and investment in, research and development projects. YD Bio’s success also depends on its continued access to assured suppliers of important technologies and components and its ability to provide the people, technologies, facilities, equipment and financial capacity needed to deliver those products and services with maximum efficiency. YD Bio’s customers and markets also increasingly require it to be agile and efficient, digitally enabled and able to harness integrated digital technologies and capabilities to deliver solutions with the agility and affordability that its customers seek. If YD Bio is unable to continue to develop new products and technologies in a timely fashion, and successfully to effect digital transformation, or if YD Bio fails to achieve market acceptance more rapidly than its competitors, it may be unable to maintain a competitive position and YD Bio’s future success could be materially adversely affected. If it fails to maintain its competitive position, YD Bio could lose a significant amount of future business to its competitors, which also could have a material adverse effect on its ability to generate favorable financial results and maintain market share and on its financial position, results of operations and/or cash flows.

We are dependent on our license agreements with third parties that are critical to our business.

Termination of our current or future partner agreements could cause us to have to negotiate new or amended agreements with less favorable terms or cause us to lose our rights under the original agreements. In the case of a loss of intellectual property rights relating to technology used in our systems, we may not be able to continue to manufacture certain components for our product or for our operations or may experience disruption to our manufacturing processes as we test and re-qualify any potential replacement technology. Even if we retain the licenses, the licenses may not be exclusive with respect to such component design or technologies, which could aid our competitors and have a negative impact on our business.

EG BioMed

We are highly dependent on the intellectual property licensed from EG BioMed, pursuant to which we license DNA methylation analysis technology for application in pancreatic cancer and breast cancer (the “EG BioMed License Agreements”). Other products or services we may develop also may rely on the same technology.

Any disruption or discontinuation of the EG BioMed License Agreements prior to their expiration can have a significant impact on the revenue, cash flow and future viability of YD Bio.

In the event that we default in the payment of any amount when due under the EG BioMed License Agreements, and such amount is not paid within 30 days of notice of nonpayment, EG BioMed may terminate the exclusivity of the licenses or terminate the EG BioMed License Agreements in full. The loss of the licensed rights would prevent us from marketing and selling our DNA methylation analysis technology and any other products or services we may develop based on the same underlying technology. Any termination of the exclusivity of the licenses could damage our competitive position within the marketplace. In addition, the EG BioMed License Agreements impose significant obligations on us. We are required to notify EG BioMed in writing on a quarterly basis of our total sales revenue for sales of the products using EG BioMed’s licensed patents and technology and pay a 7% and 20% product royalty on our total sales revenue each quarter under each license agreement. Additionally, we are required to pay patent application fees (if any) and patent maintenance fees for the licensed patents and technology, and any patents derived from the licensed patents and technology. Accordingly, we could be obligated to pay fees or other amounts to EG BioMed even though we have generated no or limited revenue.  

3D Global

We are also highly dependent on the intellectual property licensed from 3D Global, pursuant to which we have licensed patented and proprietary technology to develop new drugs for dry eye disease, glaucoma, and corneal repair (the “3D Global License Agreement”). In the event that we default in the payment of any amount when due under the 3D Global License Agreement, and such amount is not paid within 30 days of notice of nonpayment, 3D Global may terminate the exclusivity of the license or terminate the agreement in full. Furthermore, if we breach the agreement, including by failing to use our commercially best efforts to achieve the milestones prescribed by the agreement, and we do not cure such breach within the applicable time period, in addition to seeking damages, 3D Global could terminate the agreement. Any termination of the 3D Global License Agreement resulting in the loss of the licensed rights would prevent us from marketing and selling our drugs related to dry eye disease, glaucoma, and corneal repair, and any other products or services we may develop based on the same underlying technology. Any termination of the exclusivity of the license could damage our competitive position within the marketplace.

In addition, the 3D Global License Agreement imposes significant obligations on us. We are required to make milestone payments, patent application fees (if any), patent maintenance fees, and project development fees. Accordingly, we could be obligated to pay fees or other amounts to 3D Global even though we have generated no or limited revenue.

Our third-party manufacturers may not have the manufacturing and processing capacity to meet the production requirements of consumer demand or clinical testing in a timely manner.

YD Bio relies on third-party suppliers for most of the manufacturing necessary to produce its products. The failure of suppliers to supply manufacturing components in a timely manner or on commercially reasonable terms could delay YD Bio’s plans to expand its business and otherwise disrupt production schedules and increase manufacturing costs.

Our capacity to commercialize our products and conduct any clinical trials required for additional regulatory clearances or approvals will depend in part on our ability to manufacture or provide our products on a large scale, at a competitive cost and in accordance with regulatory requirements. We have no direct experience in large-scale product manufacturing, nor do we currently have the internal resources or facilities to manufacture most of our products on a commercial scale. Accordingly, we expect to rely on third party manufacturers. We cannot guarantee that our third-party manufacturers will be able to establish or increase production and processing capacity in a timely or cost-effective manner, or at all. Our third-party manufacturers may encounter delays or other difficulties in establishing or in increasing production or processing capacity at any time that could result in delays in the commercialization of our products, in the distribution of our products, in the clinical trials for our products or in the submissions for additional regulatory clearances or approvals for our products. Any such delays could have an adverse effect on our ability to obtain regulatory clearance or approval for, commercialize and secure sales of our products.

YD Bio needs to expand to succeed, but it may not be able to successfully manage its growth.

For YD Bio to succeed, it needs to experience significant expansion. Although management is experienced in the industry and in operating companies at a similar stage of growth, there can be no assurance that it will achieve this expansion. This expansion, if accomplished, may place a significant strain on YD Bio’s management, operational and financial resources. To manage any material growth, YD Bio will be required to continue to implement operational and financial systems, procedures and controls. It also will be required to expand its finance, administrative and operations staff. There can be no assurance that YD Bio’s current and planned personnel, systems, procedures and controls will be adequate to support its future operations at any increased level. YD Bio’s failure to manage growth effectively could have a material adverse effect on its business, results of operations and financial condition.

The execution of our strategy to drive growth through strategic acquisitions and partnerships is subject to various risks which could adversely affect our business, financial condition, results of operations and our prospects.

YD Bio continues to pursue growth and expansion through strategic acquisition, partnerships and similar transactions. These transactions could be material to our business, financial condition and results of operations. However, there can be no assurance that we will be able to consummate any such transactions on commercially reasonable terms or at all, nor can there be any assurance that the Company will be able to realize the anticipated benefits of such transactions even if consummated.

The identification of suitable acquisition candidates and strategic partners can be difficult, time-consuming, and costly, and we may enter into negotiations for transactions that are not ultimately consummated, diverting significant costs and management’s time and attention. Furthermore, any such transactions we announce could be viewed negatively by partners, investors or other stakeholders, and the process of integrating an acquired company, business, new processes or technology may create unforeseen operating difficulties and expenditures. If we are unable to successfully address any of these risks, our business, results of operations, financial condition and our prospects could be materially adversely affected.

Substantial doubt exists regarding our ability to continue as a going concern, and YD Bio may need additional financing to implement its business plan.

YD Bio continues to expand the scope of its business and product offerings. The development of YD Bio’s business requires, and will continue to require, significant expenditures, a substantial portion of which must be made before any material profits may be realized. YD Bio incurred recurring losses and negative cash flows from operations for the years ended December 31, 2025 and 2024, and will likely continue to experience significant negative cash flow and operating losses until an adequate revenue base is established. These conditions raise substantial doubt about the Company’s ability to continue as a going concern.

Accordingly, YD Bio will require additional funds to satisfy outstanding payables, fund working capital, and implement our business plan. Management plans to finance our cash needs through public or private equity offerings or debt financings and to continue developing strategies for our operations; however, there is no assurance that we will be able to raise additional capital, generate revenues, or achieve profitability. Our consolidated financial statements have been prepared on a going concern basis and do not include any adjustments that might result from the outcome of this uncertainty.

YD Bio may not be able to secure additional debt or equity financing in a timely basis or on favorable terms or at all. Such financing could result in substantial dilution of the equity interests of existing shareholders. YD Bio has no commitments for any additional financing should the need arise. If YD Bio is unable to secure any necessary additional financing, it may need to delay expansion plans, conserve cash, and reduce operating expenses. There is no assurance that any additional financing will be sufficient, that the financing will be available on terms favorable to YD Bio or to existing shareholders and at such times as required, or that YD Bio will be able to obtain the additional financing required for the continued operation and growth of YD Bio’s business. Any debt financing obtained by YD Bio in the future could involve restrictive covenants relating to its capital raising activities and other financial and operational matters, which may make it more difficult for it to obtain additional capital and to pursue business opportunities. If YD Bio raises additional funds through further issuances of equity, convertible debt securities, or other securities convertible into equity, YD Bio’s existing shareholders could suffer significant dilution in their percentage ownership of our company, and any new equity securities it issues could have rights, preferences, and privileges senior to those of holders of its Ordinary Shares. If YD Bio is unable to obtain adequate financing or financing on terms satisfactory to it, when YD Bio requires it, its ability to grow or support its business and to respond to business challenges could be significantly limited.

If we are unable to establish effective sales, marketing, and distribution capabilities or enter into agreements with third parties with such capabilities, we may not be successful in commercializing our cancer blood tests or medical products if and when they are cleared or approved.

We do not have a sales or marketing infrastructure and have limited experience in the sale, marketing, or distribution of our cancer blood tests and medical products. To achieve commercial success for any cancer blood test or medical product for which we obtain marketing clearance or approval, we will need to successfully establish and maintain relationships directly and with third parties to perform sales and marketing functions.

Factors that may inhibit our efforts to commercialize our cancer blood tests or medical products on our own include:

If we do not establish sales, marketing, and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our cancer blood tests or medical products.

If we are unable to convince physicians of the benefits of our proposed cancer blood tests or medical products, we may incur delays or additional expense in our attempt to establish market acceptance.

Broad use of our proposed cancer blood tests and products may require pathology laboratories and physicians to be informed regarding our proposed cancer blood tests and products and their intended benefits. Inability to carry out this physician education process may adversely affect market acceptance of our proposed cancer blood tests or medical products. We may be unable to timely educate physicians regarding our proposed cancer blood tests or medical products in sufficient numbers to achieve our marketing plans or to achieve acceptance of our cancer blood tests or medical products. Any delay in physician education may materially delay or reduce demand for our cancer blood tests or medical products. In addition, we may expend significant funds toward physician education before any acceptance or demand for our proposed cancer blood tests or medical products is created, if at all.

YD Bio may fail to comply with regulations governing to the sales of drugs and medical-related materials.

Pharmaceutical/medical device companies are required to comply with extensive regulations and hold a number of permits and licenses to carry on their business. Our ability to obtain and maintain these regulatory approvals will be subject to additional burdens placed by government regulation from time to time.

The pharmaceutical/medical device industry is heavily regulated by the government authorities, covering the clearance, approval, registration, production, packaging, licensing, distribution, storage, sales and manufacture and promotion of medicinal products and medical devices in various jurisdictions. In recent years, the regulatory framework regarding the pharmaceutical/medical device industry has undergone significant changes as the authorities tend to implement stricter requirements to ensure effect and safety of medicinal products and medical devices, and we expect that such trends will continue in the future. Any changes could lead to higher compliance costs for our current businesses of sales of pharmaceutical products and medical devices, as well as potential delays or obstacles in the successful development and commercialization of our drug/medical device candidates and could reduce the benefits we receive from drug/medical device development and manufacturing. In addition, even if we receive regulatory approval or clearance from competent authorities for any of our pharmaceutical products or medical devices, we will be subject to ongoing obligations and continued regulatory review in order to maintain the clearance or approval, which may result in significant additional expenses if new requirements are implemented. Any failure by us or our collaborators to maintain compliance with applicable laws and regulations or obtain and maintain required licenses and permits may result in administrative fines and/or the suspension or termination of our business activities. We believe our strategy and approach is aligned with the relevant government regulatory requirements and policies, but we cannot ensure that our strategy and approach will continue to be aligned.

A failure of YD Bio’s information technology systems, or an interruption in its operation due to internal or external factors including cyber-attacks, could have a material adverse effect on its business, reputation, financial condition or results of operations.

YD Bio’s operations depend on its ability to protect its information systems, computer equipment, and information databases from systems failures. YD Bio relies on its information technology systems generally to manage the day-to-day operations of its business, operate elements of its manufacturing facility, manage relationships with its customers, fulfill customer orders, and maintain its financial and accounting records. Failure of YD Bio’s information technology systems could be caused by internal or external events, such as incursions by intruders or hackers, computer viruses, cyber-attacks, failures in hardware or software, or power or telecommunication fluctuations or failures.

There have been an increasing number of cyber security incidents affecting companies around the world, which have caused operational failures or compromised sensitive corporate data. Although YD Bio does not believe its systems are at a greater risk of cyber security incidents than other similar organizations, such cyber security incidents may result in: the loss or compromise of customer, financial, or operational data; disruption of billing, collections, or normal operating activities; disruption of electronic monitoring and control of operational systems; and delays in financial reporting and other management functions. Possible impacts associated with a cyber-security incident may include, among others: remediation costs related to lost, stolen, or compromised data; repairs to data processing systems; increased cyber security protection costs; reputational damage; and adverse effects on YD Bio’s ability to comply with applicable privacy and other laws and regulations. The failure of YD Bio’s information technology systems to perform as anticipated for any reason could disrupt its business and result in numerous adverse consequences, including reduced effectiveness and efficiency of operations or increased costs, any of which could have a material adverse effect on its business, operating results and financial condition. Any technology and information security processes and disaster recovery plans YD Bio uses to mitigate its risk to these vulnerabilities may not be adequate to ensure that its operations will not be disrupted should such an event occur.

The success of YD Bio depends upon certain key personnel, including product development and engineering staff.

The success of YD Bio will depend in large part upon the skill and expertise of certain key personnel, including product development and engineering staff. The competition for qualified management and such key personnel is intense. There can be no assurance that any such individuals will continue to be associated with or employed by YD Bio throughout their respective lives. The loss of services of one or more of such key personnel or the inability to hire, train and retain additional such key personnel could delay the development and sale of its products, disrupt its business, and interfere with its ability to execute our business plan. The loss of key personnel could also have a material adverse effect on YD Bio.

The loss of sales, or significant reductions in orders from, any major customers may have a material adverse effect on us.

YD Bio’s top three corporate customers — Novartis, Zuelling and Alcon — accounted for approximately 53.7% of the company’s total revenue for the year ended December 31, 2025. In any one reporting period, our major customers may contribute an even larger percentage of our consolidated sales. The loss, or any significant reduction in orders from, any of these customers, including reductions due to economic, market or competitive conditions or regulatory requirements, would likely have a material adverse effect on our business, financial condition and results of operations. None of our significant customers has entered into an agreement with us requiring it to purchase any minimum quantity of our products.

Attempts to lessen the adverse effect of any loss or reduction of sales through the rapid addition of new customers would be difficult because customers typically require lengthy qualification periods prior to placing volume orders with a new supplier. Our future success will continue to depend upon: our ability to maintain relationships with existing key customers; our ability to attract new customers and satisfy any required qualification periods; and our ability to introduce new products in a timely manner.

YD Bio’s management team has limited experience managing a public company.

The members of YD Bio’s management team have limited or no experience managing a publicly-traded company, interacting with public company investors, and complying with the increasingly complex laws, rules and regulations that govern public companies. There are significant obligations it will now be subject to relating to reporting, procedures and internal controls, and will require significant attention from management and could divert their attention away from the day-to-day management of YD Bio’s business, which could adversely affect its business, financial condition and operating results. YD Bio may not have adequate personnel with the appropriate level of knowledge, experience, and training in the accounting policies, practices or internal controls over financial reporting required of public companies in the U.S. The development and implementation of the standards and controls necessary for YD Bio to achieve the level of accounting standards required of a public company in the U.S. may require costs greater than expected. It is possible that YD Bio will be required to expand its employee base and hire additional employees to support its operations as a public company, which will increase its operating costs in future periods.

Regulatory Risks

Securing FDA clearance or approval of our products and products we may develop, license, or acquire is a complex process requiring substantial time, commitment of resources and expense without any assurance that the FDA will grant such clearance or approval.

We have not yet obtained FDA clearance or approval for any of our cancer detection test products. In March 2025, a U.S. federal district court held that Laboratory Developed Tests (LDTs) performed at the request of a healthcare provider (HCP) (collectively, HCP LDTs) are not medical devices and, as such, the FDA does not have jurisdiction over them. Accordingly, such tests do not currently require FDA clearance or approval. This decision has not been appealed by the government, and the deadline to do so has passed. The March 2025 ruling did not explicitly address DTC LDTs. It is therefore arguable that the court’s order applies only to LDTs for which there is some involvement from a HCP (i.e., HCP LDTs). This means that the FDA may view DTC LDTs as subject to the FDA’s full regulatory oversight and all applicable regulatory requirements.

YD Bio’s commercially available assay is currently offered as an LDT performed solely at the request of a prescribing HCP (i.e., it is not a DTC LDT). On March 31, 2026, the Company and EG BioMed launched the EG Telehealth Platform, an online portal integrated with an independent telehealth physician network. Although this platform allows patients to initiate testing online, all orders will still be reviewed and authorized by a licensed HCP prior to sample collection (i.e., such tests are not DTC LDTs). Should YD Bio eventually receive FDA clearance or approval for our tests, it still does not intend to offer them as fully DTC products, but instead intend to offer them as products that require an order from a licensed HCP (i.e., again, such tests will not be DTC LDTs).

It is possible — though unlikely, given that the government has not appealed the March 2025 ruling, and the deadline to do so has passed — that the FDA could determine that tests initiated by consumers are still subject to the Agency’s regulatory oversight, despite the involvement of a HCP and the March 2025 ruling. In this event, YD Bio may be required to obtain regulatory approval or clearance for its test products.

By statute, all new medical devices are initially placed in Class III. Nonetheless, and based on the FDA’s current practices, YD Bio expects that if it is required to obtain regulatory clearance or approval for its cancer detection tests, such tests will ultimately be regulated as Class II devices, requiring either a 510(k) notification or, more likely, a de novo application. However, it is possible that the FDA may determine that these products should be regulated as Class III medical devices under 21 U.S.C. § 360c (Section 513 of the FDCA). Class III devices are those that sustain or support life, are implanted, or present potential risks of serious illness or injury. These products typically require a PMA to demonstrate safety and effectiveness before they can be marketed. Some of our products may be subject to approval under a PMA, the most stringent FDA premarket medical device scientific and regulatory review process, which requires sufficient valid scientific evidence in addition to general and special controls to assure that it is safe and effective for its intended use(s).

The process of securing FDA PMA approval is complex and requires substantial time, commitment of resources and expense. The process may take many years to complete, and approval may never be obtained. It requires us to demonstrate with substantial evidence, gathered in preclinical and large, complex well-controlled clinical trials, that the planned product is safe and effective for use as intended. We may not conduct such a trial or may not successfully enroll or complete any such trial, if required. Any products we may develop may not achieve the required primary endpoint in the clinical trial and may not receive regulatory approval. We must also demonstrate that the manufacturing facilities, processes, and controls for any products we may develop are adequate.

We may need to seek approval of a de novo classification request from FDA. Under the de novo classification process, a manufacturer whose device is not eligible for a 510(k) Notification or whose device under the FDCA would otherwise be automatically classified into Device Class III and require the submission and approval of a PMA prior to marketing is able to request down-classification of the device to Class I or Class II on the basis that the device presents a low or moderate risk. If the FDA grants the de novo classification request, the applicant will receive authorization to market the device. This device type may be used subsequently as a predicate device for future 510(k) submissions.

Even if our products are not required to obtain a PMA or de novo classification, they may instead require a 510(k) Notification. In the 510(k) clearance process, before a device may be marketed, the FDA must determine that a proposed device is “substantially equivalent” to a legally marketed “predicate” device, which includes a device that has been previously cleared through the 510(k) process, a device that was legally marketed prior to May 28, 1976 (pre-amendments device), a device that was originally on the U.S. market pursuant to an approved PMA and later down-classified, or a 510(k)-exempt device. To be “substantially equivalent,” the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. Clinical data are sometimes required to support substantial equivalence.

There can be no assurance that FDA will ever permit us to market any new product or service that we develop. Also, any regulatory clearance or approval of a product, once obtained, may be withdrawn. If we are unable to successfully obtain or maintain regulatory clearance or approval to sell any products in the U.S. we may develop, our business, financial condition, results of operations and growth prospects could be adversely affected. Furthermore, delays in receipt of clearances or approvals could materially delay or prevent us from commercializing our products and services or result in substantial additional costs that could decrease our profitability. Even if we were to successfully obtain and maintain regulatory clearance or approval for a product, any clearance or approval might contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, or may be subject to burdensome post-approval study or risk management requirements.

FDA can delay, limit, or deny clearance or approval of a future product for many reasons, including but not limited to:

If any products we may develop fail to demonstrate safety and efficacy, or otherwise do not gain regulatory clearance or approval, our business and results of operations will be materially and adversely harmed.

Failure to obtain regulatory approvals in foreign jurisdictions will prevent us from marketing our products internationally.

We intend to seek distribution and marketing partners for one or more of the products we are developing in foreign countries. The approval procedures vary among countries and can involve additional clinical testing, and the time required to obtain approval may differ from that required to obtain FDA clearance or approval. Moreover, clinical studies or manufacturing processes conducted in one country may not be accepted by regulatory authorities in other countries. Clearance or approval by FDA does not ensure clearance or approval by regulatory authorities in other countries, and approval by one or more foreign regulatory authorities does not ensure clearance or approval by regulatory authorities in other foreign countries or by FDA. In addition, a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. The foreign regulatory approval process may include all of the risks associated with obtaining FDA clearance or approval. We may not obtain foreign regulatory approvals on a timely basis, if at all. We may not be able to file for regulatory approvals and even if we file, we may not receive necessary approvals to commercialize our products in any market.

Modifications to our cleared or approved products may require new clearances or approvals, or may require us to cease marketing or recall the modified products until clearances are obtained.

For any product approved pursuant to a PMA, we are required to seek supplemental approval for many types of changes to the approved product, for which we will need to determine whether a PMA supplement or other regulatory filing is needed or whether the change may be reported via the PMA Annual Report. Similarly, any modification to a 510(k)-cleared device that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, design, or manufacture, requires new 510(k) clearance or, possibly, approval of a new PMA. The same is true for a device approved via the de novo pathway; any modification to a device approved via this pathway that could significantly affect its safety or effectiveness, or that would constitute a major change of its intended use, design, or manufacture, may require a new de novo classification or a new 510(k) Notification or even a PMA. If the FDA requires us to seek approvals or clearances for modifications to our previously approved or cleared products, for which we concluded that new approvals or clearances are unnecessary, we may be required to cease marketing or distribution of our products or to recall the modified product until we obtain the approval or clearance, and we may be subject to significant regulatory fines or penalties. Foreign regulatory regimes may have comparable requirements, which present the same or substantially similar risks.

Clinical trials necessary to support regulatory submission will be expensive and could require the enrollment of large numbers of patients. Suitable patients may be difficult to identify and recruit. Delays or failures in our clinical trials will prevent us from expanding our commercial efforts and will adversely affect our business, operating results and prospects.

Initiating and completing clinical trials necessary to support regulatory submission will be time-consuming and expensive and their outcome uncertain. Moreover, the results of early clinical trials are not necessarily predictive of future results, and any product we advance into clinical trials may not have favorable results in early or later clinical trials.

Conducting successful clinical studies could require the enrollment of large numbers of patients, and suitable patients may be difficult to identify and recruit. Patient enrollment in clinical trials and completion of patient participation and follow-up depend on many factors, including the size of the patient population, the nature of the trial protocol, the attractiveness of, or the discomforts and risks associated with, the treatments received by patients enrolled as subjects, the availability of appropriate clinical trial investigators, support staff, and proximity of patients to clinical sites and ability to comply with the eligibility and exclusion criteria for participation in the clinical trial and patient compliance. For example, patients may be discouraged from enrolling in our clinical trials if the trial protocol requires them to undergo extensive post-treatment procedures or follow-up to assess the safety and effectiveness of our products or if they determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks, discomforts or expenditures. Patients may also not participate in our clinical trials if they choose to participate in contemporaneous clinical trials of competitive products. In addition, patients participating in clinical trials may die before completion of the trial or suffer adverse medical events unrelated to investigational products.

Development of sufficient and appropriate clinical protocols to demonstrate safety and efficacy may be required and we may not adequately develop such protocols to support clearance and approval. Further, FDA may require us to submit data on a greater number of patients than it originally anticipated and/or for a longer follow-up period or change the data collection requirements or data analysis for any clinical trials. Delays in patient enrollment or failure of patients to continue to participate in a clinical trial may cause an increase in costs and delays in the approval and attempted commercialization of our products or result in the failure of the clinical trial. FDA may not consider our data adequate to demonstrate safety and efficacy. Such increased costs and delays or failures could adversely affect our business, operating results and prospects.

We expect to depend on clinical investigators, medical institutions, and contract research organizations (“CROs”) to perform the clinical trials. If these parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, or if the quality, completeness, or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or for other reasons, our clinical trials may have to be extended, delayed, or terminated. Many of these factors would be beyond our control. We may not be able to enter into replacement arrangements without undue delays or considerable expenditures. If there are delays in testing or approvals as a result of the failure to perform by third parties, our research and development costs would increase, and we may not be able to obtain regulatory clearance or approval for our current products and any other products we may develop. In addition, we may not be able to establish or maintain relationships with these parties on favorable terms, if at all. Each of these outcomes would harm our ability to market our current products and any other products we may develop, license, or acquire, or to achieve sustained profitability.

The results of our clinical trials may not support our product candidate claims or may result in the discovery of adverse side effects.

Even if any of our clinical trials are completed as planned, it cannot be certain that study results will support product candidate claims or that FDA or foreign regulatory authorities will agree with our conclusions regarding them. Success in pre-clinical evaluation and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior trials and pre-clinical studies. The clinical trial process may fail to demonstrate that our product candidates are safe and effective for the proposed indicated uses, which could cause us to abandon a product candidate and may delay development of others. Any delay or termination of our clinical trials will delay the filing of our product submissions and, ultimately, our ability to commercialize our product candidates and generate revenues. It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part of the product candidate’s profile.

If our clinical studies do not satisfy providers, payors, patients and others as to the reliability and performance of our tests, or any other product or service we may develop and seek to commercialize, we may experience reluctance or refusal on the part of physicians to order, and third-party payors to pay for, such test.

If the validity of an informed consent for a clinical trial of one of our products was to be challenged, we could be subject to fines, penalties, litigation, or regulatory sanctions, or other adverse consequences, including invalidating or requiring us to repeat clinical trials which could negatively affect our business and results of operations.

Our products are the subject of multiple clinical trials, and we anticipate they will continue to be so in the future. We have implemented measures to ensure that data and biological samples that we receive have been collected from, and any procedures that have been performed using our products have been on, subjects who have provided appropriate informed consent. We also act as a sponsor of clinical trials in connection with the development of our tests, which are frequently conducted in collaboration with different parties. We seek to receive approval from an ethical review board, or institutional review board, or “IRB,” for projects that meet the definition of “human subjects research,” which includes review and approval of processes for subject informed consent and authorization for use of personal information or waivers thereof. We could conduct clinical trials in a number of different countries. When we utilize clinical research contractor or partner with other third parties, we rely upon them to comply with the requirements to obtain the subject’s informed consent and to comply with applicable laws and regulations. The collection of data and samples in many different countries results in complex legal questions regarding the adequacy of informed consent and the status of genetic material under a large number of different legal systems. Those informed consents could be challenged and prove invalid, unlawful, or otherwise inadequate for our purposes. Any such findings against us, could force us to stop accessing or using data and samples or servicing or conducting clinical trials, which would hinder our product offerings or development. We could also become involved in legal actions, which could consume our management and financial resources.

Our business and reputation will suffer if we are unable to establish and comply with, stringent quality standards to assure that the highest level of quality is observed in the performance of our tests.

Inherent risks are involved in providing and marketing cancer detection tests and related services. Patients and HCPs rely on us to provide accurate clinical and diagnostic information that may be used to make critical healthcare decisions. As such, users of our tests may have a greater sensitivity to errors than users of some other types of products and services.

We must maintain top service standards and FDA-mandated and other quality controls. Past or future performance or accuracy defects, incomplete or improper process controls, excessively slow turnaround times, unanticipated uses of our tests, or mishandling of samples or test results (whether by us, patients, HCPs, courier delivery services or others) can lead to adverse outcomes for patients and interruptions to our services. These events could lead to voluntary or legally mandated safety alerts relating to our tests or our laboratory facilities and could result in the removal of our products and services from the market or the suspension of our laboratories’ operations. Insufficient quality controls and any resulting negative outcomes could result in significant costs and litigation, as well as negative publicity that could reduce demand for our tests and payers’ willingness to cover our tests. Even if we maintain adequate controls and procedures, damaging and costly errors may occur.

Our current products and any other products we develop that receive regulatory clearance or approval will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and subject us to penalties if we fail to comply with applicable regulatory requirements.

Even after regulatory clearance or approval has been obtained for our products, the cleared or approved product and its manufacturer remain subject to continual review by FDA or non-U.S. regulatory authorities. Our cleared or approved products may be subject to limitations on the indicated uses for which the product may be marketed. Furthermore, future approvals may contain requirements for potentially costly post-marketing follow-up studies to monitor the safety and efficacy of the approved product. There is a risk that FDA may modify or withdraw the clearance or approval of a product if the results of a post-clearance or post-approval study are not satisfactory or are inconsistent with previous studies. We may rely on third parties, such as contract research organizations, medical institutions and clinical investigators to conduct any post-approval studies. We will have limited control over the activities of these third parties and any post-approval studies may be delayed or halted prior to its completion for reasons outside our control.

In addition, we and our cleared or approved products will be subject to extensive and ongoing regulatory requirements by FDA and other regulatory authorities with regard to the labeling, packaging, adverse event reporting, storage, advertising, promotion, and recordkeeping for our products. We and our contract manufacturers also will be required to comply with current good manufacturing practice, or “cGMP,” regulations regarding the manufacture of our products, which include requirements related to quality control and quality assurance as well as the corresponding maintenance of records and documentation. Further, regulatory authorities may need to approve these manufacturing facilities before they can be used to manufacture medical devices and/or other medical products, and these facilities are subject to continual review and periodic inspections by FDA and other regulatory authorities for compliance with cGMP regulations. Operations at these facilities could be interrupted or halted if FDA or other governmental agency deems the findings of such inspections unsatisfactory.

Failure to comply with FDA or other regulatory requirements could result in fines, unanticipated compliance expenditures, recall or seizures of our products, import alerts preventing the importation of products from other countries, total or partial suspension of production or distribution, restrictions on labeling and promotion, termination of ongoing research, disqualification of data for submission to regulatory authorities, enforcement actions, injunctions and criminal prosecution. If we or a third party discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory authority may impose restrictions on that product, the manufacturer or us, including requiring recall of the product from the market or suspension of manufacturing and distribution of the product. We also may voluntarily recall a product. Any recalls could have an adverse effect on our ability to provide our products, which in turn would adversely affect our financial condition.

If we are found to be promoting the use of our devices for unapproved or “off-label” uses or engaging in other noncompliant activities, we may be subject to recalls, import alerts, seizures, fines, penalties, injunctions, adverse publicity, prosecution, or other adverse actions, resulting in damage to our reputation and business.

Our labeling, advertising, promotional materials and user training materials must comply with FDA and other applicable laws and regulations, including the prohibition of the promotion of a medical device for a use that has not been cleared or approved by FDA. Obtaining 510(k) clearance, de novo approval, or PMA approval only permits us to promote our products for the uses specifically cleared or approved by FDA. Use of a device outside its cleared or approved indications is known as “off-label” use. Physicians and consumers may use our products off-label because FDA does not restrict or regulate a physician’s choice of treatment within the practice of medicine nor is there oversight on patient use of over-the-counter devices. Although we may request additional cleared or approved indications for our current products, FDA may deny those requests, require additional expensive clinical data to support any additional indications or impose limitations on the intended use of any cleared or approved product as a condition of clearance. Even if regulatory clearance or approval of a product is granted, such clearance or approval may be subject to limitations on the intended uses for which the product may be marketed and reduce our potential to successfully commercialize the product and generate revenue from the product.

If FDA or another regulatory authority determines that our labeling, advertising, promotional materials, or user training materials, or representations made by our personnel, include the promotion of an off-label use for the medical product, or that we have made false or misleading or inadequately substantiated promotional claims, or claims that could potentially change the regulatory status of the product, the authority could take the position that these materials have misbranded our products and request that we modify our labeling, advertising, or user training or promotional materials and/or subject us to regulatory or legal enforcement actions, including the issuance of an Untitled Letter or a Warning Letter, injunction, seizure, recall, import alert, adverse publicity, civil penalties, criminal penalties, or other adverse actions. It is also possible that other federal, state, or foreign enforcement authorities might take action if they consider our labeling, advertising, promotional, or user training materials to constitute promotion of an unapproved use, which could result in significant fines, penalties, or other adverse actions under other statutory authorities, such as laws prohibiting false claims for reimbursement. In that event, we could be subject to extensive fines and penalties and our reputation could be damaged and adoption of the products would be impaired. Although we intend to refrain from statements that could be considered off-label promotion of our products, FDA or another regulatory agency could disagree and conclude that we have engaged in off-label promotion. In addition, any such off-label use of our products may increase the risk of injury to patients, and, in turn, the risk of product liability claims, and such claims are expensive to defend and could divert our management’s attention and result in substantial damage awards against us.

Clinical laboratories and medical diagnostic companies are subject to extensive and frequently changing federal, state, and local laws. We could be subject to significant fines and penalties if we or our third-party laboratory partners fail to comply with these laws and regulations.

As a provider of clinical cancer detection products and services, we and our third-party laboratory partners are subject to extensive and frequently changing federal, state, and local laws and regulations governing various other aspects of our business. In particular, the clinical laboratory industry is subject to significant governmental certification and licensing regulations, as well as federal and state laws regarding:

We are also required to comply with FDA regulations, including with respect to our labeling and promotion activities. In addition, advertising of our tests is subject to regulation by the Federal Trade Commission, or FTC, and advertising of laboratory services is regulated by certain state laws. Violation of any FDA requirement could result in enforcement actions, such as seizures, injunctions, civil penalties and criminal prosecutions, and violation of any FTC or state law requirement could result in injunctions and other associated remedies, all of which could have a material adverse effect on our business. Most states also have similar regulatory and enforcement authority for devices. Additionally, most foreign countries have authorities comparable to FDA and processes for obtaining marketing approvals. Obtaining and maintaining these approvals, and complying with all laws and regulations, may subject us to similar risks and delays as those we could experience under FDA, FTC and state regulation. We incur various costs in complying and overseeing compliance with these laws and regulations.

Healthcare policy has been a subject of extensive discussion in the executive and legislative branches of the federal and many state governments and healthcare laws and regulations are subject to change. Development of the existing commercialization strategy for our current products has been based on existing healthcare policies. We cannot predict what additional changes, if any, will be proposed or adopted or the effect that such proposals or adoption may have on our business, financial condition and results of operations.

If we or our partners fail to comply with these laws and regulations, we could incur significant fines and penalties, and our reputation and prospects could suffer. Additionally, any such partners could be forced to cease offering our products and services in certain jurisdictions, which could materially disrupt our business.

Many aspects of our business are subject to complex, intertwined, costly and/or burdensome federal health care laws and regulations which may be open to interpretation and be subject to varying levels of discretionary enforcement. If we fail to comply with these laws and regulations, we could face substantial penalties and our business, operations and financial condition could be adversely affected. 

Even though we do not and do not expect to control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party payors, certain federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business. We could be subject to healthcare fraud and abuse and patient privacy regulation by both the federal government and the states in which we conduct our business. The regulations that may affect our ability to operate include, without limitation:

The Patient Protection and Affordable Care Act, as amended by the health Care and Education Affordability Reconciliation Act, or “PPACA,” among other things, amends the intent requirement of the Federal Anti-Kickback Statute and criminal healthcare fraud statutes. A person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. In addition, the PPACA provides that the government may assert that a claim including items or services resulting from a violation of the Federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA.

In 2018, Congress passed Eliminating Kickbacks in Recovery Act, or “EKRA,” as part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act. Similar to the Anti-Kickback Statute, EKRA imposes criminal penalties for knowing or willful payment or offer, or solicitation or receipt, of any remuneration, whether directly or indirectly, overtly or covertly, in cash or in kind, in exchange for the referral or inducement of laboratory testing (among other healthcare services) unless a specific exception applies. However, unlike the Anti-Kickback Statute, EKRA is not limited to services covered by federal or state healthcare programs but applies more broadly to services covered by “healthcare benefit programs,” including commercial insurers. As currently drafted, EKRA potentially expands the universe of arrangements that could be subject to government enforcement under federal fraud and abuse laws. In addition, while the Anti-Kickback Statute includes certain exceptions that are widely relied upon in the healthcare industry, not all of those same exceptions apply under EKRA. Because EKRA is a relatively new law, there is no agency guidance or court precedent to indicate how and to what extent it will be applied and enforced. We cannot assure you that our relationships with HCPs, sales representatives, hospitals, customers, or any other party will not be subject to scrutiny or will survive regulatory challenge under EKRA. 

Recently, the medical device industry has been under heightened scrutiny as the subject of government investigations and regulatory or legal enforcement actions involving manufacturers who allegedly offered unlawful inducements to potential or existing customers in an attempt to procure their business, including arrangements with physician consultants. If our operations or arrangements are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, we may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from the Medicare and Medicaid programs and the curtailment or restructuring of our operations. Any penalties, damages, fines, exclusions, curtailment or restructuring of our operations could adversely affect our ability to operate our business and our financial results. The risk of us being found in violation of these laws is increased by the fact that many of these laws are broad and their provisions are open to a variety of interpretations. Any action against us for violation of these laws, even if we successfully defend against that action and the underlying alleged violations, could cause us to incur significant legal expenses and divert our management’s attention from the operation of our business. If the physicians or other providers or entities with whom we do business are found to be non-compliant with applicable laws, they may be subject to sanctions, which could also have a negative impact on our business. Moreover, achieving and sustaining compliance with applicable federal and state privacy, security and fraud laws may prove costly.

The regulations that govern pricing and reimbursement for new products vary widely from country to country, and may adversely affect the pricing, coverage and reimbursement rates of our products in other countries.

The regulations that govern pricing and reimbursement for new products vary widely from country to country. Some countries require approval of the sale price of a product before it can be marketed. In many countries, the pricing review period begins after marketing clearance or approval is granted. In some foreign markets, pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain regulatory clearance or approval for a product in a particular country, but then be subject to price regulations that delay our commercial launch of the product and negatively impact the revenue we are able to generate from the sale of the product in that country. In addition, to obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product to other available therapies. Adverse pricing limitations may hinder our ability to recoup our investment in our products and any other products, tests, or services we develop, even if our products obtain regulatory approval.

Healthcare reform measures could hinder or prevent our products’ commercial success.

In the U.S., there have been, and we expect there will continue to be, ongoing legislative and regulatory changes to the healthcare system which could affect our future revenue and profitability. Federal and state lawmakers regularly propose and, at times, enact legislation that could result in significant changes to the healthcare system, some of which are intended to contain or reduce the costs of medical products and services. For example, one of the most significant healthcare reform measures in decades, the PPACA, was enacted in 2010. The PPACA contains a number of provisions, including those governing enrollment in federal healthcare programs, reimbursement changes and fraud and abuse measures, all of which will impact existing government healthcare programs. The PPACA, among other things, also could result in the imposition of injunctions.

While the U.S. Supreme Court has repeatedly upheld the constitutionality of most elements of the PPACA, other legal challenges are still pending final adjudication in several jurisdictions. Although efforts in Congress to repeal the PPACA have repeatedly fallen short, there are a number of ongoing legislative initiatives to modify it. At this time, it remains unclear whether there will be any changes made to the PPACA. We cannot assure you that the PPACA, as currently enacted or as amended in the future, will not adversely affect our business and financial results and we cannot predict how future federal or state legislative or administrative changes relating to healthcare reform will affect our business. 

In addition, other legislative changes have been proposed and adopted since the PPACA was enacted. There likely will continue to be legislative and regulatory proposals at the federal and state levels directed at containing or lowering the cost of health care. Medicare reimbursement for all products and services, including ours, remains highly susceptible to threats of automatic reductions triggered by budgetary shortfalls. Such payments are subject to recovery of purported overpayment for several years. We cannot predict the initiatives that may be adopted in the future or their full impact. We cannot predict whether any additional legislative changes will affect our business.

The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of health care may adversely affect:

Further, changes in regulatory requirements and guidance may occur, both in the United States and in foreign countries, and we may need to amend clinical study protocols to reflect these changes. Amendments may require us to resubmit our clinical study protocols to an IRB for reexamination, which may impact the costs, timing or successful completion of a clinical study. In light of widely publicized events concerning the safety risk of certain drug and medical device products, regulatory authorities, members of Congress, the Governmental Accounting Office, medical professionals and the general public have all raised concerns about potential safety issues. These events have resulted in the recall and withdrawal of medical device products, revisions to product labeling that further limit use of products and establishment of risk management programs that may, for instance, restrict distribution of certain products or require safety surveillance or patient education. The increased attention to safety issues may result in a more cautious approach by FDA or other regulatory authorities to clinical studies and the medical device clearance or approval process. Adverse event data from clinical studies may receive greater scrutiny with respect to product safety, which may make FDA or other regulatory authorities more likely to terminate or suspend clinical studies before completion, or require longer or additional clinical studies that may result in substantial additional expense and a delay or failure in obtaining approval or approval for a more limited indication than originally sought.

Given the serious public health risks of high profile adverse safety events with certain products, FDA or other regulatory authorities may require, as a condition of approval, costly risk evaluation and mitigation strategies, which may include safety surveillance, restricted distribution and use, patient education, enhanced labeling, special packaging or labeling, expedited reporting of certain adverse events, preapproval of promotional materials and restrictions on direct-to-consumer advertising.

We face uncertainty related to healthcare reform, pricing, coverage, and reimbursement, which could reduce our revenue.

Healthcare reform laws, including the PPACA and PAMA, are significantly affecting the U.S. healthcare and medical services industry. Recently passed legislation and possible future legal and regulatory changes, including potential repeal or modification of the PPACA, or approval of health plans that allow lower levels of coverage for preventive services, could substantially change the structure and finances of the health insurance system and the methodology for reimbursing medical services, drugs and devices, including our current and future products and services. Healthcare reforms, which may intend to reduce healthcare costs, may have the effect of discouraging third-party payors from covering certain kinds of medical products and services, particularly newly developed technologies, such as our current products, or any other products or services we develop. We cannot predict whether future healthcare reform initiatives will be implemented at the federal or state level or the effect any such future legislation or regulation will have on us. The taxes imposed by new legislation, cost reduction measures and the expansion in the government’s role in the U.S. healthcare industry may result in decreased profits to us, which may adversely affect our business, financial condition and results of operations.

Because Medicare currently covers a significant portion of the patients in the current targeted screening population for our products, any reduction in the CMS reimbursement rate for our products would negatively affect our revenues and our business prospects. There can be no assurance under PAMA that adequate CMS reimbursement rates will initially be assigned or will continue to be assigned to our tests. Further, it is possible that Medicare or other federal payors that provide reimbursement for our tests in the future may later suspend, revoke or discontinue coverage at any time, may require co-payments from patients, or may reduce the reimbursement rates payable to us. Any such action could have a negative impact on our revenues.

Our products may cause serious adverse side effects or even death or have other properties that could delay or prevent their regulatory clearance or approval, limit the commercial desirability of an approved label or result in significant negative consequences following any marketing clearance or approval.

All clinical trials have a substantial risk of failing to meet their safety or effectiveness endpoints. It is impossible to predict when or if our current products, or any other products we develop, license or acquire will prove safe and effective and receive regulatory approval. Undesirable side effects caused by any products we are developing could cause us or regulatory authorities to interrupt, delay or halt any required clinical trials. They could also result in a more restrictive label or the delay or denial of regulatory clearance or approval by FDA or other comparable foreign regulatory authority.

Additionally, after receipt of marketing clearance or approval of any products we may develop, if we or others later identify undesirable side effects or even deaths caused by such products, a number of potentially significant negative consequences could result, including:

Any of these events could prevent us from achieving or maintaining market acceptance of the particular product.

Our medical products may in the future be subject to product recalls that could harm our reputation, business, and financial results.

FDA has the authority to request and/or require the recall of commercialized medical products in the event of material deficiencies or defects in design or manufacture. Manufacturers may, under their own initiative, recall a product if any material deficiency in a medical product is found. A government-mandated or voluntary recall by us or one of our distributors could occur as a result of component failures, manufacturing errors, design or labeling defects or other deficiencies and issues. Recalls of any of our products would divert managerial and financial resources and have an adverse effect on our financial condition and results of operations. FDA requires that certain classifications of recalls be reported to FDA within ten working days after the recall is initiated. Companies are required to maintain certain records of recalls, even if they are not reportable to FDA. We may initiate voluntary recalls involving our products in the future that we determine do not require notification of FDA. If FDA disagrees with our determinations, they could require us to report those actions as recalls. A future recall announcement could harm our reputation with customers and negatively affect its sales. In addition, FDA could take enforcement action for failing to report the recalls when they were conducted. No recalls of our medical products have been reported to FDA.

Our medical products may in the future be subject to import alerts.

FDA has the authority to place products and companies on an import alert if the Agency believes that there has been a violation of FDA laws and/or regulations. Import alerts allow FDA to detain future shipments from another country without testing or otherwise physically examining them. If a company on an import alert attempts to import product, or if a product on an import alert is nonetheless offered for import, the product will be detained and refused entry into the U.S. unless the importer can demonstrate to FDA that the product and/or company is not in violation of FDA laws and regulations.

If our medical products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical device or drug reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.

Under FDA medical device reporting regulations, medical device manufacturers are required to report to FDA information that a device has or may have caused or contributed to a death or serious injury or has malfunctioned in a way that would likely cause or contribute to death or serious injury if the malfunction of the device or one of our similar devices were to recur. Similarly, under FDA drug reporting regulations, drug manufacturers are required to submit to FDA information that a drug has or may have caused an unanticipated experience or side effect that places a patient at risk of, or results in, death or serious injury. If we fail to report these events to FDA within the required timeframes, or at all, FDA could take enforcement action against us. Any such adverse event involving our products also could result in future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action. Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business, and may harm our reputation and financial results.

Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our products.

We face an inherent risk of product liability exposure related to the sale of certain of our products and any other products we develop. The marketing, sale and use of our products could lead to the filing of product liability claims against us if someone alleges product failures, product malfunctions, manufacturing flaws, or design defects resulted in injury to patients. We may also be subject to liability for a misunderstanding of, or inappropriate reliance upon, the information we provide. If we cannot successfully defend ourselves against claims that a product we developed caused injuries, we may incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

In addition, insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Compliance with the HIPAA security, privacy and breach notification regulations may increase our costs.

The HIPAA privacy, security and breach notification regulations, including the expanded requirements under HITECH, establish comprehensive federal standards with respect to the uses and disclosures of protected health information, or “PHI,” by health plans, HCPs and healthcare clearinghouses, in addition to setting standards to protect the confidentiality, integrity and security of PHI. The regulations establish a complex regulatory framework on a variety of subjects, including:

We have implemented practices intended to meet the requirements of the HIPAA privacy, security and breach notification regulations, as required by law. We are required to comply with federal privacy, security and breach notification regulations as well as varying state privacy, security and breach notification laws and regulations, which may be more stringent than federal HIPAA requirements. In addition, for healthcare data transfers from other countries relating to citizens of those countries, we must comply with the laws of those countries. The federal privacy regulations restrict our ability to use or disclose patient identifiable data, without patient authorization, for purposes other than payment, treatment, healthcare operations and certain other specified disclosures such as public health and governmental oversight of the healthcare industry.

HIPAA provides for significant fines and other penalties for wrongful use or disclosure of PHI, including potential civil and criminal fines and penalties. Computer networks are always vulnerable to breach and unauthorized persons may in the future be able to exploit weaknesses in the security systems of our computer networks and gain access to PHI. Additionally, we share PHI with third-parties who are legally obligated to safeguard and maintain the confidentiality of PHI. Unauthorized persons may be able to gain access to PHI stored in such third-parties computer networks. Any wrongful use or disclosure of PHI by us or such third-parties, including disclosure due to data theft or unauthorized access to our or our third-parties computer networks, could subject us to fines or penalties that could adversely affect our business and results of operations. Although the HIPAA statute and regulations do not expressly provide for a private right of damages, we could also incur damages under state laws to private parties for the wrongful use or disclosure of confidential health information or other private personal information.

Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk of fraud, misconduct, or other illegal activity by our employees, independent contractors, consultants, commercial partners, and vendors. Misconduct by these parties could include intentional, reckless and negligent conduct that fails to: comply with the rules and regulations of the CMS, FDA, and other comparable foreign regulatory authorities; provide true, complete and accurate information to such regulatory authorities; comply with manufacturing and clinical laboratory standards; comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or report financial information or data accurately or to disclose unauthorized activities to us. In particular, research, sales, marketing, education, and other business arrangements in the healthcare industry are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing, and other abusive practices, as well as off-label product promotion. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, educating, marketing and promotion, sales and commission, certain customer incentive programs, and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of participant recruitment for clinical studies, which could result in regulatory sanctions and cause serious harm to our reputation. We have adopted a code of business conduct and ethics, but it is not always possible to identify and deter misconduct by employees and third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions. Even if it is later determined after an action is instituted against us that we were not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our actions, and have to divert significant management resources from other matters.

Recent reductions in force across the U.S. federal government may impact our ability to secure necessary meetings to discuss, obtain guidance on, and receive clearances or approvals for our products.

Actions by the Trump administration may fundamentally impact the FDA, CMS, and other federal agencies with jurisdiction over our products. Among other things, the issuance of Executive Order (“EO”) 14192, “Unleashing Prosperity Through Deregulation” (January 31, 2025), EO 14212, “Establishing the President’s Make America Healthy Again Commission” (February 13, 2025), and EO 14219, “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative” (February 21, 2025) could have a significant impact on the manner in which the FDA conducts its operations and engages in regulatory and oversight activities.

For example, on March 27, 2025, the US Department of Health and Human Services (“HHS”), which houses both CMS and the FDA, announced significant restructuring in accordance with EO 14219. Among other changes, HHS announced that it intends to reduce its workforce by approximately 10,000 full-time employees, consolidate 28 existing divisions into 15 new divisions, and centralize certain core functions. Notably, this restructuring plan is in addition to other downsizing efforts at HHS, which in combination, will result in a reduction of force by 20,000 employees.

There is substantial uncertainty regarding how these changes will impact the FDA. HHS has stated that it intends to reduce the FDA’s workforce by 3,500 individuals, which represents approximately 18% of FDA full-time employees. This restructuring could lead to significant disruptions and delays at the FDA, including impeding the agency’s ability to meet with industry participants and provide feedback, review and/or approve submissions, conduct inspections, issue regulatory guidance, or take other actions that facilitate the development, approval, and marketing of regulated products. All of this could adversely affect our business.

Industry And Market Risks

The development of new medical products and services requires significant investments, and we may experience difficulties that delay or prevent its success.

Developing new or improved cancer detection and other medical products and services, and drugs are speculative and risky endeavors. Candidate products and services that may initially show promise may fail to achieve the desired results in larger clinical studies or may not achieve acceptable levels of clinical accuracy. Any test we develop will need to demonstrate a high level of accuracy in clinical studies. If in a clinical study a candidate product or service fails to identify even a small number of cases, the sensitivity rate may be materially and adversely affected, and we may have to abandon the candidate product or service.

We may need to explore a number of different designs, methods or technologies, alter our candidate products or services, and repeat clinical studies before we identify a potentially successful candidate. We may need to acquire, whether through purchase, license or otherwise, technologies owned by third parties, and we may not be able to acquire such technologies on commercially reasonable terms or at all. Product development is expensive, may take years to complete and can have uncertain outcomes. Failure can occur at any stage of the development. If, after development, a candidate product or service appears successful, we may, depending on the nature of the product or service, still need to obtain FDA and other regulatory clearances or approvals before we can market it. FDA’s clearance or approval pathways are likely to involve significant time, as well as additional research, development and clinical study expenditures. There can be no guarantee that FDA would clear or approve any future product or service we may develop. Even if FDA clears or approves a new product or service we develop, we would need to commit substantial resources to commercialize, sell and market it before it could be profitable, and the product or service may never be commercially viable. Additionally, development of any product or service may be disrupted or made less viable by the development of competing products or services.

Commitments to develop new products must be made well in advance of any resulting sales, and technologies and standards may change during development, potentially rendering our products outdated or uncompetitive before their introduction. Our ability to develop products to meet evolving industry requirements and at prices acceptable to our customers will be significant factors in determining our competitiveness. We may expend considerable funds and other resources on the development of our products without any guarantee that these products will be successful. If we attempt to bring, but are not successful in bringing, one or more products to market, whether because we fail to address marketplace demand, fail to develop viable products or otherwise, our results of operations could be seriously harmed.

If we determine that any of our current or future development programs is unlikely to succeed, we may abandon it without any return on our investment into the program. We may need to raise significant additional capital to bring any new products or services to market, which may not be available on acceptable terms, if at all.

Even if our cancer blood tests or medical products receive marketing clearance or approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

Even if our medical products receive marketing clearance or approval, if needed, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, and others in the medical community. If we do not generate significant product revenues, we may not become profitable. The degree of market acceptance of our products and tests, if approved for commercial sale, will depend on a number of factors, including:

If we are unable to address and overcome these and similar concerns, our business and results of operations could be substantially harmed.

We face intense competition in the biotechnology and pharmaceutical industries.

The biotechnology and pharmaceutical industries are intensely competitive. We face direct competition from U.S. and foreign companies focusing on cancer blood tests and pharmaceutical products, which are rapidly evolving. Our competitors include major multinational diagnostic and pharmaceutical companies, specialized biotechnology firms, and universities and other research institutions. Many of these competitors have greater financial and other resources, larger research and development staffs, and more effective marketing and manufacturing organizations than we do. In addition, academic and government institutions are increasingly likely to enter into exclusive licensing agreements with commercial enterprises, including our competitors, to market commercial tests or products based on technology developed at such institutions. Our competitors may succeed in developing or licensing technologies, tests, and products that are more effective or less costly than ours or succeed in obtaining FDA or other regulatory approvals for diagnostic test and medical product candidates before we do. Acquisitions of, or investments in, competing diagnostic, pharmaceutical, or biotechnology companies by large corporations could increase such competitors’ financial, marketing, manufacturing, and other resources.

Our ExoLens product faces significant competition in the glaucoma and dry eye syndrome treatment markets from the following:

The market for our proposed tests and products is competitive and rapidly changing, and new cancer detection technologies which may be developed by others could impair our ability to maintain and grow our business and remain competitive.

The cancer detection, pharmaceutical, and biotechnology industries are subject to rapid and substantial technological change. Developments by others may render our proposed tests or products noncompetitive or obsolete, or we may be unable to keep pace with technological developments or other market factors. Technological competition from diagnostic, pharmaceutical and biotechnology companies, universities, governmental entities, and others diversifying into the field is intense and is expected to increase.

As a company engaged in the development of cancer detection technology with limited revenue generated to date, our resources are limited, and we may experience technical challenges inherent in such technologies. Competitors have developed or are in the process of developing technologies that are, or in the future may be, the basis for competition. Some of these technologies may have an entirely different approach or means of accomplishing similar diagnostic efficacy compared to our proposed tests or products. Our competitors may develop cancer detection technologies that are more effective or less costly than our proposed tests or products and therefore present a serious competitive threat.

The potential widespread acceptance of cancer blood tests or therapies that are alternatives to ours may limit market acceptance of our proposed tests or products, even if commercialized. Many of our targeted diseases and conditions can also be detected by other tests or treated by other medications. These tests and treatments may be widely accepted in medical communities and have a longer history of use. The established use of these competitive technologies may limit the potential for our technologies, formulations, tests, and products to receive widespread acceptance if commercialized.

Negative developments in the field of exosomes could damage public perception of any product candidates that we develop, which could adversely affect our ability to conduct our business or obtain regulatory approvals for such product candidates.

Exosome therapeutics are novel and unproven therapies, with no exosome therapeutic approved to date. Exosome therapeutics may not gain the acceptance of the public or the medical community. To date, other efforts to leverage natural exosomes have generally demonstrated an inability to generate exosomes with predictable biologically active properties or to manufacture exosomes at suitable scale to treat more than a small number of patients. Some studies used natural exosomes without an intended or understood mechanism of action or pharmacology. Other studies included payloads but generated inconclusive results. Our success will depend on our ability to demonstrate that our exosomes can overcome these challenges.

If one of our current or future product candidates is unable to successfully target a certain cell type or pathway and establish proof of concept in a certain disease, it may indicate that we will not be able to apply our technology to other diseases mediated by that cell type or pathway. This may also indicate a decrease in the probability of our success for other targets using the same modality in the same or different cell types, as well as for our engineered exosome approach more generally. Such failures could negatively affect the public or medical community’s perception of our technology and exosome therapeutics in general.

Additionally, our success will depend upon physicians who specialize in the treatment of diseases targeted by our product candidates, if approved, prescribing testing or treatments that involve the use of our product candidates, if cleared or approved, in lieu of, or in addition to, existing treatments with which they are more familiar and for which greater clinical data may be available. Adverse events in clinical trials of our product candidates or in clinical trials of others developing similar products and the resulting publicity, as well as any other adverse events in the field of exosome therapeutics, could result in a decrease in demand for any product that we may develop. These events could also result in the suspension, discontinuation, or clinical hold of, or modification to, our clinical trials. Any future negative developments in the field of exosomes and their use as therapies could also result in greater governmental regulation, stricter labeling requirements and potential regulatory delays in the testing or approvals of our product candidates. Any increased scrutiny could delay or increase the costs of obtaining marketing approval for any of our product candidates.

The sizes of the markets for our current and future products have not been established with precision and may be smaller than we estimate.

Our estimates of the annual total addressable markets for our current products are based on a number of internal and third-party estimates, including, without limitation, the number of patients with pancreatic and breast cancers and precancer, the number of individuals who are at a higher risk for developing cancer, and the assumed prices at which we can sell tests for markets that have not been established. While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors. As a result, our estimates of the annual total addressable market for our current or future products may prove to be incorrect. If the actual number of patients who would benefit from our products, the price at which we can sell our products, or the annual total addressable market for our products is smaller than we have estimated, it may impair our sales growth and have an adverse impact on our business.

Risks Related to Taiwan

Your investment may be adversely affected by the strained relations between Taiwan and China.

Taiwan has a unique international political status. The People’s Republic of China (“PRC”) claims that Taiwan is part of China. Although significant economic and cultural relations have been established during recent years between Taiwan and the PRC, relations have often been strained. The PRC government has refused to renounce the use of military force to gain control over Taiwan. Furthermore, the PRC government passed an Anti-secession Law in March 2005, which authorizes non-peaceful means and other necessary measures should Taiwan move to gain independence from the PRC. Relations between the PRC and Taiwan have at times been strained. Strained relations could result in future military actions or economic sanctions or other disruptive activities undertaken by either government. Past tensions between them have on occasion depressed the market prices of the securities of companies in Taiwan. As the headquarters of our major subsidiary (i.e., Yong Ding Biopharm Co., Ltd.) is based in Taiwan, relations between Taiwan and the PRC and other factors affecting military, political or economic conditions in Taiwan could materially and adversely affect our financial condition and results of operations. There can be no assurance that the present tensions will not worsen, which could have a significant adverse impact on our financial condition, results of operations and future prospects.

Currency fluctuations and restrictions on currency exchange may adversely affect our business. 

Our reporting currency is the U.S. dollar and our operations in Taiwan uses the NTD as the functional currencies. The majority of our revenues derived and expenses incurred are in NTD. We are subject to the effects of exchange rate fluctuations with respect to any of these currencies.

Apart from trade-related or service-related foreign exchange transactions, Taiwanese companies may, without foreign exchange approval, remit foreign currency of up to US$100 million (or its equivalent) to and from Taiwan (or such other amount as determined by the Central Bank of the Republic of China (Taiwan) from time to time at its discretion in consideration of the economic and financial conditions of Taiwan) in each calendar year. The above limits apply to remittances involving either a conversion of NT dollars into a foreign currency or a conversion of foreign currency into NT dollars.

Taiwan government may impose further foreign exchange restrictions in certain emergency situations, including situations where there are sudden fluctuations in interest rates or exchange rates, where Taiwan government experiences extreme difficulty in stabilizing the balance of payments or where there are substantial disturbances in the financial and capital markets in Taiwan. There can be no assurance that these restrictions, if imposed, will not adversely affect, among other things, the Company’s ability to repatriate its and/or its subsidiary’s funds in Taiwan, which may in turn limit our ability to receive and use our revenue effectively.

Due to our major subsidiary’s location in Taiwan, natural disasters and other events outside of our control may seriously disrupt our business operations.

Taiwan is vulnerable to natural disasters and other calamities. Fire, floods, typhoons, earthquakes, nuclear and radiation accidents, power loss, telecommunications failures, break-ins, wars, riots, terrorist attacks or similar events may give rise to server interruptions, breakdowns, system failures or internet failures, which could cause, including but not limit to, the damage or destruction of real or personal property, the loss or corruption of data or malfunctions of software or hardware, disruption of our major subsidiary’s business operation, interruption of ongoing development of the biopharmaceutical products as well as adversely affect our business. Although we have not been adversely affected in the past by natural disasters and other calamities, natural disasters and other events outside of our control in Taiwan in the future could seriously disrupt our business operations.

You may not be able to enforce a judgment of a foreign court in Taiwan.

Our major subsidiary (i.e., Yong Ding Biopharm Co., Ltd.) is a company limited by shares and incorporated under the Taiwan Company Act. Also, all our directors and management, with the exception of our CFO who is located in Hong Kong, are located in Taiwan, and a certain portion of our assets and the assets of such persons are located in Taiwan. As a result, it may be difficult for investors to enforce judgments obtained outside Taiwan against us, our major subsidiary or such persons in Taiwan, including those predicated upon the civil liability provisions of the federal securities laws of the United States.

Any further economic downturn or decline in the growth of the population in Taiwan may materially and adversely affect YD Bio’s financial condition, results of operations and prospects.

YD Bio conducts most of our operations and generates most of our revenues in Taiwan. As a result, any decline in the Taiwan economy or a decline in the growth of the population in Taiwan may materially and adversely affect their financial condition, results of operations and prospects. For example, the global slowdown in technology expenditures has from time to time adversely affected the Taiwan economy, which is highly dependent on the technology industry. There is considerable uncertainty over the long-term effects of the expansionary monetary and fiscal policies that have been adopted by the central banks and financial authorities of some of the world’s leading economies. There have also been concerns over unrest in the Middle East, Africa and Ukraine, which has resulted in higher oil prices and significant market volatility.

As the Company’s business is significantly dependent on economic growth, any uncertainty or further deterioration in economic conditions could have a material adverse effect on the Company’s financial condition and results of operations. YD Bio cannot assure that economic conditions in Taiwan will continue to improve in the future or that our business and operations will not be materially and adversely affected by deterioration in the Taiwan economy.

Uncertainties about the “trade war” between the United States and Mainland China may materially and adversely affect our results of operations.

Changes in U.S. trade policy could trigger retaliatory actions by affected countries, e.g., Mainland China, resulting in ‘trade wars,’ increased costs for goods imported into the United States, which may reduce customer demand for these products if the parties having to pay tariffs increase their prices, or trading partners limiting their trade with the United States. Decreasing demand from our customers or increased prices quoted by our suppliers may materially and adversely affect our future results of operations.

Risks Related to Intellectual Property Rights

YD Bio may incur substantial litigation costs related to intellectual property, and if YD Bio is unable to protect its intellectual property, it may lose its competitive advantage.

YD Bio’s future success depends in part upon its ability to protect its intellectual property. YD Bio’s protective measures, including patents, trademarks, copyrights, trade secret protection and internet identity registrations, may prove inadequate to protect its proprietary rights and market advantage. The right to stop others from misusing its trademarks and service marks in commerce depends, to some extent, on YD Bio’s ability to show evidence of enforcement of its rights against such misuse in commerce. YD Bio’s failure to stop the misuse by others of our trademarks and service marks may lead to its loss of trademark and service mark rights, brand loyalty and notoriety among its customers and prospective customers. The scope of any patent to which YD Bio has or may obtain rights may not prevent others from developing and selling competing products. In addition, YD Bio’s patents may be held invalid upon challenge, or others may claim rights in, or ownership of, its patents. Moreover, YD Bio may become subject to litigation with parties that claim, among other matters, that it infringed on their patents or other intellectual property rights. The defense and prosecution of patent and other intellectual property claims are both costly and time-consuming and could result in a material adverse effect on YD Bio’s business and financial position.

Additionally, any intellectual property infringement claims against YD Bio, with or without merit, could be costly and time-consuming to defend and divert its management’s attention from its business. If YD Bio’s products were found to infringe a third-party’s proprietary rights, it could be forced to enter into costly royalty or licensing agreements in order to be able to continue to sell its products or discontinue use of the protected technology. Such royalty and licensing agreements may not be available on terms acceptable to YD Bio or at all. Rights holders may demand payment for past infringements or force it to accept costly license terms or discontinue use of protected technology or works of authorship.

YD Bio may become involved in litigation regarding patents and other intellectual property rights. Other companies, including its competitors, may develop intellectual property that is similar or superior to its intellectual property, duplicate its intellectual property or design around its patents, and may have or obtain patents or other proprietary rights that would prevent, limit or interfere with its ability to make, use or sell its products. Effective intellectual property protection may be unavailable or limited in some foreign countries in which YD Bio sells or will sell products or from which competing products may be sold.

Unauthorized parties may attempt to copy or otherwise use aspects of YD Bio’s intellectual property and products that we regard as proprietary. YD Bio’s means of protecting its proprietary rights in the U.S. or abroad may prove to be inadequate, and competitors may be able to develop similar intellectual property independently. If its intellectual property protection is insufficient to protect its intellectual property rights, YD Bio could face increased competition in the markets for its products.

Should any of YD Bio’s competitors file patent applications or obtain patents that claim inventions also claimed by it, YD Bio may choose to participate in an interference proceeding to determine the right to a patent for these inventions, because its business could be harmed if it fails to enforce and protect its intellectual property rights. Even if the outcome is favorable, an interference proceeding could result in substantial costs to YD Bio and disrupt its business.

In the future, YD Bio also may need to file lawsuits to enforce its intellectual property rights, to protect its trade secrets or to determine the validity and scope of the proprietary rights of others. Any such litigation, whether successful or unsuccessful, could result in substantial costs and diversion of resources, which could have a material adverse effect on its business, financial condition or results of operations.

Intellectual property rights do not necessarily address all potential threats to our competitive advantage.

The degree of future protection afforded by 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:

Changes in patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our diagnostic tests and therapeutic product candidates.

As is the case with other biopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involves both technological and legal complexity and is therefore costly, time consuming and inherently uncertain. Changes in either the patent laws or interpretation of the patent laws in the U.S. could increase the uncertainties and costs, and may diminish our ability to protect our inventions, obtain, maintain, enforce, and license intellectual property rights and, more generally, could affect the value of our intellectual property or narrow the scope of any owned and licensed patents.

In addition, the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly uncertain. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. Depending on future actions by the U.S. Congress, the U.S. courts, the USPTO and the relevant law-making bodies in other countries, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing owned or licensed patents.

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

Periodic maintenance fees, renewal fees, annuities fees, and various other governmental fees on patents and/or patent applications are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent and/or patent application. The USPTO and various foreign governmental patent agencies also require compliance with a number of procedural, documentary, fee payment, and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees, and failure to properly legalize and submit formal documents. If we or our licensors fail to maintain the patents and patent applications covering our diagnostic tests or therapeutic product candidates, our competitive position would be adversely affected.

Patent terms may be inadequate to protect our competitive position on our diagnostic tests or therapeutic product candidates for an adequate amount of time.

The term of any individual patent depends on applicable law in the country where the patent is granted. In the U.S., provided all maintenance fees are timely paid, a patent generally has a term of 20 years from its application filing date or earliest claimed non-provisional filing date. Extensions may be available under certain circumstances, but the life of a patent and, correspondingly, the protection it affords is limited. Even if we or our licensors obtain patents covering our diagnostic tests and therapeutic product candidates, when the terms of all patents covering a diagnostic test or therapeutic product expire, our business may become subject to competition from our competitors. Given the amount of time required for the development, testing, and regulatory review and approval of new diagnostic test or therapeutic product candidates, patents protecting such candidates may expire before or shortly after such candidates are commercialized. As a result, our owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing diagnostic tests and therapeutic products similar or identical to ours.

Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court or the USPTO.

If we or a licensor initiate legal proceedings against a third party to enforce a patent covering one of our diagnostic tests or therapeutic product candidates, the defendant could counterclaim that the patent covering our diagnostic tests or therapeutic product candidate, as applicable, is invalid and/or unenforceable. In patent litigation in the U.S., defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent. Third parties may also raise similar claims before administrative bodies in the U.S. or abroad, even outside the context of litigation. Such mechanisms include re-examination, inter partes review, post grant review, and equivalent proceedings in foreign jurisdictions (i.e., opposition proceedings). Such proceedings could result in revocation or amendments to our owned or licensed patents in such a way that they no longer cover our diagnostic tests or therapeutic product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our diagnostic tests or therapeutic product candidates. Such a loss of patent protection could have a material adverse impact on our business. 

YD Bio’s efforts to avoid the patent, trademark, and copyright rights of others may not provide notice to it of potential infringements in time to avoid investing in product development and promotion that must later be abandoned if suitable license terms cannot be reached.

There is no guarantee that YD Bio’s use of conventional technology searching and brand clearance searching will identify all potential rights holders. Rights holders may demand payment for past infringements and/or force YD Bio to accept costly license terms or discontinue use of protected technology and/or works of authorship that may include for example photos, videos, and software.

General Tax Risk Factors

Unanticipated changes in effective tax rates or adverse outcomes resulting from examination of YD Bio’s income or other tax returns could adversely affect its financial condition and results of operations.

YD Bio may be subject to income taxes, and its tax liabilities will be subject to the allocation of expenses in differing jurisdictions. YD Bio’s future effective tax rates could be subject to volatility or adversely affected by a number of factors, including:

In addition, YD Bio may be subject to audits of its income, sales and other transaction taxes by taxing authorities. Outcomes from these audits could have an adverse effect on YD Bio’s financial condition and results of operations.

The IRS may not agree that YD Bio should be treated as a non-U.S. corporation for U.S. federal income tax purposes.

Under current U.S. federal income tax law, a corporation is generally considered for U.S. federal income tax purposes to be a tax resident in the jurisdiction of its organization or incorporation. Accordingly, under generally applicable U.S. federal income tax rules, YD Bio, which is incorporated under and governed by the laws of Cayman Islands, would be classified as a non-U.S. corporation (and, therefore, not a U.S. tax resident) for U.S. federal income tax purposes. Section 7874 of the Code, however, contains rules that may cause a non-U.S. corporation to, in certain circumstances, be treated as a U.S. corporation for U.S. federal income tax purposes. If YD Bio were to be treated as a U.S. corporation for U.S. federal income tax purposes, it could be subject to substantial U.S. tax liability, in addition to tax liability in its country of residence, and the gross amount of any dividend payments to its Non-U.S. Holders could be subject to U.S. withholding tax.

As more fully described in the section titled “Material U.S. Federal Income Tax Consequences — Tax Residence of YD Bio for U.S. Federal Income Tax Purposes,” YD Bio is not currently expected to be treated as a U.S. corporation for U.S. federal income tax purposes. However, whether the requirements for such treatment have been satisfied must be finally determined at the completion of the Business Combination, by which time there could be adverse changes to the relevant facts and circumstances. Further, the rules for determining ownership under Section 7874 are complex, unclear and the subject of ongoing regulatory change. Accordingly, there can be no assurance that the IRS would not assert a contrary position to those described above or that such an assertion would not be sustained by a court in the event of litigation.

The IRS may take the position that Section 367(a) of the Code requires a U.S. Holder to recognize gain (but not loss) with respect to the exchange of shares of Breeze Common Stock for Ordinary Shares pursuant to the Merger.

Section 367(a) of the Code generally requires a U.S. holder of stock in a U.S. corporation to recognize gain (but not loss) when such stock is exchanged for stock of a non-U.S. corporation in an exchange that would otherwise qualify for nonrecognition treatment unless certain conditions are met. Although it is currently expected that these conditions were be met, U.S. Holders are cautioned that the potential application of Section 367(a) of the Code to the Merger is complex and depends on factors that cannot be determined until the closing of the Merger and the interpretation of legal authorities and facts relating to the Business Combination. Accordingly, there can be no assurance that the IRS will not take the position that Section 367(a) of the Code applies to cause U.S. Holders to recognize gain as a result of the Merger or that a court will not agree with such a position of the IRS in the event of litigation. U.S. Holders should consult with their own tax advisors regarding the potential application of Section 367(a) of the Code in their particular situation.

If YD Bio were a passive foreign investment company for United States federal income tax purposes for any taxable year, U.S. Holders of Ordinary Shares could be subject to adverse United States federal income tax consequences.

If YD Bio is or becomes a “passive foreign investment company,” or a PFIC, within the meaning of Section 1297 of the Code for any taxable year during which a U.S. Holder (as defined in “Material U.S. Federal Income Tax Consequences — U.S. Holders”) holds Ordinary Shares, certain adverse U.S. federal income tax consequences may apply to such U.S. Holder. PFIC status depends on the composition of a company’s income and assets and the fair market value of its assets from time to time, as well as on the application of complex statutory and regulatory rules that are subject to potentially varying or changing interpretations. YD Bio has not made a determination as to whether it currently is, or in the future may become, a PFIC, but there is a possibility that it may be classified as a PFIC for its taxable year that includes the date of the Merger or in the foreseeable future. There can be no assurance that YD Bio will not be treated as a PFIC for any taxable year.

If YD Bio were treated as a PFIC, a U.S. Holder of Ordinary Shares may be subject to adverse U.S. federal income tax consequences, such as taxation at the highest marginal ordinary income tax rates on capital gains and on certain actual or deemed distributions, interest charges on certain taxes treated as deferred, and additional reporting requirements. Certain elections (including a qualified electing fund (“QEF”) or a mark-to-market election) may be available to U.S. Holders of Ordinary Shares to mitigate some of the adverse tax consequences resulting from PFIC treatment, but U.S. Holders will not be able to make similar elections with respect to the YD Bio Warrants. There is no assurance that YD Bio will provide the information necessary for a U.S. Holder to make a QEF election with respect to the U.S. Holder’s Ordinary Shares.

Risks Related to Ownership of Our Securities

Future sales of a substantial amount of our Ordinary Shares may cause our stock price to decline.

As of December 31, 2025, we had 70,789,261 Ordinary Shares outstanding. We cannot predict when these stockholders may sell their shares or in what volumes. However, the market price of our Ordinary Shares could decline significantly if these stockholders sell a large number of shares into the public market or if the market believes that these sales may occur. We may also issue our Ordinary Shares from time to time as consideration for future acquisitions and investments. In the event any such acquisition or investment is significant, the number of Ordinary Shares that we may issue could in turn be significant. In addition, we may also grant registration rights covering those shares in connection with any such acquisitions and investments.

Our stock price has been and may continue to be volatile and may result in substantial losses.

The market price of our Ordinary Shares has been and may continue to be volatile. The stock market in general has been highly volatile in 2024 and 2025 and may continue to be volatile in the remainder of 2026 and beyond. The volatility in Ordinary Shares price may be unrelated to our operating performance. In addition, the trading price of our Ordinary Shares could be subject to wide fluctuations in response to:

Volatility may also be due to factors beyond our control. This may happen because of the broad market and industry factors, like the performance and fluctuation of the market prices of other companies with business operations located mainly in Asia that have listed their securities in the United States.

The market price for our Ordinary Shares may be volatile and subject to wide fluctuations due to factors such as:

In addition, the securities market has from time to time experienced significant price and volume fluctuations that are not related to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of our Ordinary Shares. Fluctuations in our stock price as a result of any of the foregoing factors may result in substantial losses for investors.

In addition, plaintiffs have often initiated securities class action litigation against a company following periods of volatility in the market price of its securities. We may, in the future, be the target of similar litigation. Securities litigation could result in substantial costs and liabilities and could divert management’s attention and resources.

We are a “controlled company” as defined under the NASDAQ Stock Market Rules. As a result, we may rely on exemptions from certain corporate governance requirements and holders of our Ordinary Shares may not have the same protections generally available to stockholders of other companies listed on stock exchanges in the United States.

Because Dr. Ethan Shen, our CEO and Chairman, holds a majority of the voting power of YD Bio, we are a “controlled company” within the meaning of Nasdaq Listing Rule 5615(c), and our securities may look less attractive to certain investors or otherwise harm the trading price. As a controlled company, we qualify for, and our board of directors may rely upon, exemptions from certain of Nasdaq’s corporate governance requirements, including the requirements that:

Accordingly, to the extent that we choose to rely on one or more of these exemptions, our public shareholders would not be afforded the same protections afforded to the shareholders of other Nasdaq-listed companies that are subject to these corporate governance requirements. We do not currently intend to rely on the “controlled company” exemption under the Nasdaq listing rules. However, we may elect to avail ourselves of these exemptions in the future.

Our Ordinary Shares may be thinly traded and you may be unable to sell at or near ask prices or at all if you need to sell your shares to raise money or otherwise desire to liquidate your shares.

Our Ordinary Shares may be “thinly-traded”, meaning that the number of persons interested in purchasing our Ordinary Shares at or near bid prices at any given time may be relatively small or non-existent. This situation may be attributable to a number of factors, including the fact that we are relatively unknown to stock analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume, and that even if we came to the attention of such persons, they tend to be risk-averse and might be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares until such time as we became more seasoned. Therefore, there may be periods of several days or more when trading activity in our shares is minimal or non-existent, as compared to a seasoned issuer which has a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on the share price. A broad or active public trading market for our Ordinary Shares may not be sustained.

If securities or industry analysts do not publish research or reports about us, or publish negative reports, our share price and trading volume could decline.

The trading market for Ordinary Shares depends, in part, on the research and reports that securities or industry analysts publish about us. We do not have any control over these analysts. If our financial performance fails to meet analyst estimates or one or more of the analysts who cover us downgrade Ordinary Shares or change their opinion, our share price would likely decline. If one or more of these analysts cease coverage of us or fail to regularly publish reports on us, we could lose visibility in the financial markets, which could cause our share price or trading volume to decline.

Because there are no current plans to pay cash dividends on Ordinary Shares for the foreseeable future, you may not receive any return on investment unless you sell Ordinary Shares for a price greater than that which you paid for it.

YD Bio may retain future earnings, if any, for future operations, expansion and debt repayment and has no current plans to pay any cash dividends for the foreseeable future. YD Bio’s board of directors has complete discretion as to whether to distribute dividends, subject to certain requirements of Cayman Islands law. In addition, YD Bio’s shareholders may by ordinary resolution declare a dividend, but no dividend may exceed the amount recommended by our directors. Under Cayman Islands law, a Cayman Islands company may pay a dividend out of either profit or share premium account, provided that in no circumstances may a dividend be paid if this would result in the company being unable to pay its debts as they fall due in the ordinary course of business. Even if YD Bio’s board of directors decides to declare and pay dividends, the timing, amount and form of future dividends, if any, and will depend on, among other things, YD Bio’s results of operations, financial condition, cash requirements, contractual restrictions and other factors that YD Bio’s board of directors may deem relevant. In addition, YD Bio’s ability to pay dividends may be limited by covenants of any existing and future outstanding indebtedness it or its subsidiaries incur. As a result, you may not receive any return on an investment in Ordinary Shares unless you sell your shares for a price greater than that which you paid for it. We currently intend to retain any future earnings for use in our operations and expansion of our business. Accordingly, we do not expect to pay any cash dividends in the foreseeable future but will review this policy as circumstances dictate.

You may face difficulties in protecting your interests, and your ability to protect your rights through U.S. courts may be limited, because YD Bio is incorporated under Cayman Islands law.

YD Bio is an exempted company registered by way of continuation under the laws of the Cayman Islands. YD Bio’s corporate affairs are governed by its memorandum and articles of association, the Companies Act (as revised) of the Cayman Islands and the common law of the Cayman Islands. The rights of shareholders to take action against YD Bio’s directors, actions by YD Bio’s minority shareholders and the fiduciary duties of YD Bio’s directors to YD Bio under Cayman Islands law are to a large extent governed by the common law of the Cayman Islands. The common law of the Cayman Islands is derived in part from comparatively limited judicial precedent in the Cayman Islands as well as from the common law of England, the decisions of whose courts are of persuasive authority, but are not binding, on a court in the Cayman Islands. The rights of YD Bio’s shareholders and the fiduciary duties of YD Bio’s directors under Cayman Islands law are not as clearly established as they would be under statutes or judicial precedent in some jurisdictions in the United States. In particular, the Cayman Islands have a less developed body of securities laws than the United States and provides significantly less protection to investors. In addition, Cayman Islands companies may not have the standing to initiate a shareholder derivative action in a federal court of the United States.

Shareholders of Cayman Islands exempted companies like YD Bio have no general rights under Cayman Islands law to inspect corporate records (other than the memorandum and articles of association and any special resolutions passed by such companies, and the register of mortgages and charges of such companies) or to obtain copies of lists of shareholders of these companies. YD Bio’s directors have discretion under YD Bio’s Second Amended and Restated Memorandum and Articles of Association to determine whether or not, and under what conditions, its corporate records may be inspected by its shareholders, but are not obliged to make them available to its shareholders. This may make it more difficult for you to obtain the information needed to establish any facts necessary for a shareholder motion or to solicit proxies from other shareholders in connection with a proxy contest.

Certain corporate governance practices in the Cayman Islands, which is our home country, differ significantly from requirements for companies incorporated in other jurisdictions such as the United States. Currently, we rely on home country practice with respect to certain corporate governance matters – see details in the risk factor named “Because YD Bio is a foreign private issuer and is exempt from certain Nasdaq corporate governance standards applicable to U.S. issuers, you will have less protection than you would have if it were a domestic issuer” above. Therefore, our shareholders may be afforded less protection than they otherwise would under rules and regulations applicable to U.S. domestic issuers.

As a result of all of the above, YD Bio’s public shareholders may have more difficulty in protecting their interests in the face of actions taken by YD Bio’s management, members of the board of directors or controlling shareholders than they would as public shareholders of a company incorporated in the United States.

We are a foreign private issuer within the meaning of the rules under the Exchange Act, and as such we are exempt from certain provisions applicable to United States domestic public companies.

We are a foreign private issuer within the meaning of the rules under the Exchange Act. As such, we are exempt from certain provisions applicable to United States domestic public companies. For example:

We are required to file an annual report on Form 20-F within four months of the end of each fiscal year. In addition, we will file reports on Form 6-K as a foreign private issuer. However, the information we are required to file with or furnish to the SEC will be less extensive and less timely compared to that required to be filed with the SEC by U.S. domestic issuers. As a result, you may not be afforded the same protections or information that would be made available to you were you investing in a U.S. domestic issuer.

If YD Bio ceases to qualify as a foreign private issuer in the future, it would incur significant additional expenses that could have a material adverse effect on its results of operations.

Because YD Bio is a foreign private issuer and is exempt from certain Nasdaq corporate governance standards applicable to U.S. issuers, you will have less protection than you would have if it were a domestic issuer.

YD Bio’s status as a foreign private issuer exempts it from compliance with certain Nasdaq corporate governance requirements if it instead complies with the statutory requirements applicable to a Cayman Islands exempted company. Certain corporate governance practices in the Cayman Islands may differ significantly from corporate governance listing standards as, except for general fiduciary duties and duties of care, Cayman Islands law has no corporate governance regime which prescribes specific corporate governance standards. Currently, we rely on home country practice with respect to certain corporate governance matters instead of following the Nasdaq listing standards, including (i) Rule 5605(b)(2) of Rule 5600 series of the NASDAQ Stock Market LLC Rules (the “Nasdaq Listing Rules”), pursuant to which the board of directors of a Nasdaq-listing company shall have regularly scheduled meetings at which only independent directors are present; (ii) Rule 5605(d)(2)(A) of the Nasdaq Listing Rules, pursuant to which each member of the compensation committee of a Nasdaq-listing company must be an independent director; (iii) Rule 5605(e)(1) of the Nasdaq Listing Rules, pursuant to which the director nomination of a Nasdaq-listing company should be made by a vote in which only independent directors participate or by a nominations committee comprised solely of independent directors; (iv) Rule 5620(a) of the Nasdaq Listing Rules, pursuant to which each company listing common stock or voting preferred stock, or their equivalents, shall hold an annual meeting of shareholders no later than one year after the end of the fiscal year; (v) Rule 5620(b) of the Nasdaq Listing Rules, pursuant to which each company that is not a limited partnership shall solicit proxies and provide proxy statements for all meetings of shareholders and shall provide copies of such proxy solicitation to Nasdaq; (vi) Rule 5635 of the Nasdaq Listing Rules, pursuant to which each Nasdaq-listing company shall obtain shareholder approval for certain dilutive events, such as (a) certain acquisition of stock or assets of another company; (b) an issuance of shares that will result in a change of control of the company; (c) the establishment or amendment of certain equity based compensation plans and arrangements; and (d) certain transactions (other than a public offering) involving issuances of a 20% or more interest or voting power in the company at a price that is less than the minimum price defined therein; (vii) Rule 5640 requiring the voting rights of existing shareholders of publicly traded shares of a Nasdaq-listing company registered under section 12 of The Securities Exchange Act of 1934 of the United States cannot be disparately reduced or restricted through any corporate action or issuance, which includes without limitation, the adoption of time-phased voting plans, the adoption of capped voting rights plans, the issuance of super-voting stock, or the issuance of stock with voting rights less than the per share voting rights of the existing common stock through an exchange offer; and (viii) Rule 5620(c) of the Nasdaq Listing Rules, pursuant to which that the Company’s memorandum and articles of association shall provide for a quorum of at least 33 1/3 percent of the outstanding shares of the Company’s voting shares. Therefore, our shareholders may be afforded less protection than they otherwise would have under corporate governance listing standards applicable to U.S. domestic issuers.

If YD Bio cannot continue to satisfy the listing requirements and other rules of the Nasdaq Global Market, our securities may be delisted, which could negatively impact the price of its securities and your ability to sell them.

Our Ordinary Shares are approved for listing on the Nasdaq Global Market. We cannot assure you that we will be able to meet the continued listing requirements of the Nasdaq in the future.

In addition, in order to maintain our listing on the Nasdaq Global Market, we will be required to comply with certain rules the Nasdaq Global Market, including those regarding minimum stockholders’ equity, minimum share price, minimum market value of publicly held shares, and various additional requirements. Even if we initially meet the listing requirements and other applicable rules of the Nasdaq Global Market, we may not be able to continue to satisfy these requirements and applicable rules. If we are unable to satisfy the Nasdaq Global Market criteria for maintaining our listing, our securities could be subject to delisting.

If the Nasdaq Global Market delists our securities from trading, we could face significant consequences, including:

We are an “emerging growth company” within the meaning of the Securities Act, and if we take advantage of certain exemptions available to emerging growth companies, this could make it less attractive to investors.

We are an “emerging growth company” within the meaning of the Securities Act, as modified by the JOBS Act. Emerging growth companies are exempt from being required to comply with new or revised financial accounting standards until private companies are required to comply with the new or revised financial accounting standards. This may make comparison of our financial statements with another public company which is not an emerging growth company.

In addition, emerging growth companies are exempt from various reporting requirements that are applicable to other public companies, including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports, and exemptions from the requirements of holding a non-binding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. Because of these reduced regulatory requirements, our shareholders would be left with less information or protection available to shareholders of more mature companies. If some investors find our Ordinary Shares less attractive as a result, which may decrease our share price and increase volatility.

We will incur increased costs as a result of being a public company, particularly after we cease to qualify as an “emerging growth company.”

We will incur significant legal, accounting and other expenses as a public company that we did not incur as a private company. The Sarbanes-Oxley Act of 2002, as well as rules subsequently implemented by the SEC and the Nasdaq Global Market, impose various requirements on the corporate governance practices of public companies.

We are an “emerging growth company,” as defined in the JOBS Act and will remain an emerging growth company until the earlier of (1) the last day of the fiscal year (a) following the fifth anniversary of the completion of initial public offering, (b) in which we have total annual gross revenue of at least $1.235 billion, or (c) in which we are deemed to be a large accelerated filer, which means the market value of our Ordinary Shares that is held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter and we have been publicly reporting for at least 12 months, and (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.

An emerging growth company may take advantage of specified reduced reporting and other requirements that are otherwise applicable generally to public companies. These provisions include exemption from the auditor attestation requirement under Section 404 in the assessment of the emerging growth company’s internal control over financial reporting and permission to delay adopting new or revised accounting standards until such time as those standards apply to private companies. After we are no longer an “emerging growth company,” or until five years following the completion of our initial public offering, whichever is earlier, we expect to incur significant expenses and devote substantial management effort toward ensuring compliance with the requirements of Section 404 and the other rules and regulations of the SEC.

We are obligated to develop and maintain proper and effective internal control over financial reporting. We may not complete our analysis of our internal control over financial reporting in a timely manner, or these internal controls may not be determined to be effective, which may adversely affect investor confidence in our Company and, as a result, the value of our Ordinary Shares.

Upon completion the initial public offering in August 2025, we became a public company in the United States subject to Section 404 of the Sarbanes-Oxley Act of 2002 which requires that we include a report of management on our internal control over financial reporting in our annual report on Form 20-F beginning with our annual report for the fiscal year ending December 31, 2026. In addition, once we cease to be an “emerging growth company” as such term is defined under the JOBS Act, and if the value of our non-affiliated float of our Ordinary Shares exceeds certain amounts, our independent registered public accounting firm must attest to and report on the effectiveness of our internal control over financial reporting. Our management may conclude that our internal control over financial reporting is not effective. Moreover, even if our management concludes that our internal control over financial reporting is effective, our independent registered public accounting firm, after conducting its own independent testing, may issue a report that is qualified if it is not satisfied with our internal 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, because we are a public company, our reporting obligations may place a significant strain on our management, operational and financial resources and systems for the foreseeable future. We may be unable to timely complete our evaluation, testing and any required remediation.

During the course of documenting and testing our internal control procedures, in order to satisfy the requirements of Section 404 of the Sarbanes-Oxley Act of 2002, we may identify other weaknesses and deficiencies in our internal control over financial reporting. In addition, if we fail to maintain the adequacy of our internal control over financial reporting, as these standards are modified, supplemented or amended from time to time, we may not be able to conclude on an ongoing basis that we have effective internal control over financial reporting in accordance with Section 404 of the Sarbanes-Oxley Act of 2002. Generally, if we fail to achieve and maintain an effective internal control environment, we could suffer material misstatements in our financial statements and fail to meet our reporting obligations, which would likely cause investors to lose confidence in our reported financial information. This could in turn limit our access to capital markets and harm our results of operations. Additionally, ineffective internal control over financial reporting could expose us to increased risk of fraud or misuse of corporate assets and subject us to potential delisting from the stock exchange on which we list, regulatory investigations and civil or criminal sanctions.

If the PCAOB Is Unable to Inspect or Investigate Completely Our Independent Registered Public Accounting Firm, Trading in Our Common Stock Could Be Prohibited Under the Holding Foreign Companies Accountable Act.

Our independent registered public accounting firm, MaloneBailey, LLP, is headquartered in the United States and is registered with the Public Company Accounting Oversight Board (the “PCAOB”). The PCAOB conducts regular inspections of registered public accounting firms, including MaloneBailey, LLP, to assess compliance with applicable professional standards. These inspections provide investors with certain benefits, including greater transparency into the quality of our audit procedures and financial reporting.

Historically, prior to our engagement of MaloneBailey, LLP, we used auditors located in jurisdictions where the PCAOB had faced challenges in conducting complete inspections and investigations. However, following our auditor change effective December 24, 2025, when we dismissed ARK Pro CPA & Co and engaged MaloneBailey, LLP for the audit of our financial statements for the fiscal year ending December 31, 2025 (and subsequent periods), our current auditor is fully subject to PCAOB oversight with no current jurisdictional limitations.

Nevertheless, there can be no guarantee that the PCAOB will conduct its regular inspections. If, for any reason, the SEC determines that we have filed audit reports not subject to inspections for two consecutive years, trading of our securities could be prohibited, which would materially and adversely affect the liquidity and value of our common stock, impair your ability to sell or purchase shares, and limit our ability to raise capital.

In addition, any perceived or actual deficiencies in our auditor’s performance, as identified in PCAOB inspections or otherwise (including any historical matters noted in prior inspections of MaloneBailey, LLP unrelated to jurisdictional access), could undermine investor confidence in our financial statements, increase scrutiny from regulators or investors, or require us to incur additional costs to remediate issues or engage alternative auditors. These risks could have a material adverse effect on our business, financial condition, results of operations, and prospects.

If YD Bio fails to implement and maintain an effective system of internal controls, YD Bio may be unable to accurately report its results of operations, meets its reporting obligations or prevent fraud, and investor confidence and the market price of YD Bio’s Ordinary Shares may be materially and adversely affected.

Section 404 of the Sarbanes-Oxley Act requires that YD Bio include a report from management on the effectiveness of YD Bio’s internal control over financial reporting in YD Bio’s annual report on Form 20-F beginning with YD Bio’s second annual report on Form 20-F after becoming a public company. In addition, once YD Bio ceases to be an “emerging growth company” as such term is defined in the JOBS Act, YD Bio’s independent registered public accounting firm must attest to and report on the effectiveness of YD Bio’s internal control over financial reporting.

Moreover, even if YD Bio’s management concludes that YD Bio’s internal control over financial reporting is effective, YD Bio’s independent registered public accounting firm, after conducting its own independent testing, may issue an adverse opinion on the effectiveness of internal control over financial reporting if it is not satisfied with YD Bio’s internal controls or the level at which YD Bio’s controls are documented, designed, operated or reviewed, or if it interprets the relevant requirements differently from YD Bio. In addition, YD Bio may be unable to timely complete its evaluation testing and any required remediation.

During the course of documenting and testing YD Bio’s internal control procedures, in the event that YD Bio identifies weaknesses and deficiencies in YD Bio’s internal control over financial reporting, and fails to maintain the adequacy of its internal control over financial reporting, as these standards are modified, supplemented, or amended from time to time, YD Bio may not be able to conclude on an ongoing basis that it has effective internal control over financial reporting in accordance with Section 404. Generally speaking, if YD Bio fails to achieve and maintain an effective internal control environment, it could result in material misstatements in YD Bio’s financial statements and could also impair YD Bio’s ability to comply with applicable financial reporting requirements and related regulatory filings on a timely basis. As a result, YD Bio’s businesses, financial condition, results of operations and prospects, as well as the trading price of the ordinary shares, may be materially and adversely affected. Additionally, ineffective internal control over financial reporting could expose YD Bio to increased risk of fraud or misuse of corporate assets and subject YD Bio to potential delisting from the stock exchange on which YD Bio lists, regulatory investigations and civil or criminal sanctions. YD Bio may also be required to restate its financial statements from prior periods.

After YD Bio is no longer an “emerging growth company,” YD Bio may incur significant expenses and devote substantial management effort toward ensuring compliance with the requirements of Section 404 and the other rules and regulations of the SEC.

YD Bio’s Public Warrants and Private Warrants are exercisable for Ordinary Shares, which would increase the number of shares eligible for future sales and resale in the public market and result in dilution to our shareholders.

As of May 18, 2026, there were 14,572,326 outstanding Public Warrants and Private Warrants to purchase an aggregate of 14,572,326 Ordinary Shares. These warrants are exercisable. The registration statement covering the Ordinary Shares issuable upon exercise of the Public and private Warrants has been declared effective by the SEC, and accordingly the warrants are currently exercisable for cash, subject to the terms of the warrant agreement. Each Public Warrant and Private Warrant entitles the holder to purchase one of our Ordinary Shares at a price of $11.50 per whole share, subject to adjustment.

Public Warrants and Private Warrants may be exercised only for a whole number of Ordinary Shares. To the extent such Public Warrants and Private Warrants are exercised, additional Ordinary Shares will be issued, which will result in dilution to the then existing shareholders and increase the number of shares eligible for sale and resale in the public market. Sales of substantial numbers of such shares in the public market could adversely affect the market price of our Ordinary Shares.

YD Bio’s warrant agreement designates the courts of the State of New York located in the County of New York or the United States District Court for the Southern District of New York as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by holders of its public warrants, as applicable, which could limit the ability of warrant holders to obtain a favorable judicial forum for disputes with our company.

Our warrant agreement provides that, subject to applicable law, (i) any action, proceeding or claim against us arising out of or relating in any way to the warrant agreement, including under the Securities Act, will be brought and enforced in the courts of the State of New York located in the County of New York or the United States District Court for the Southern District of New York, (ii) in each case we irrevocably submit to such jurisdiction, which jurisdiction shall be the exclusive forum for any such action, proceeding or claim. We will waive any objection to such exclusive jurisdiction and that such courts represent an inconvenient forum.

Notwithstanding the foregoing, these provisions of the warrant agreement will not apply to suits brought to enforce any liability or duty created by the Exchange Act or any other claim for which the federal district courts of the United States of America are the sole and exclusive forum. Any person or entity purchasing or otherwise acquiring any interest in any of our warrants, as applicable, shall be deemed to have notice of and to have consented to the forum provisions in our warrant agreement. If any action, the subject matter of which is within the scope the forum provisions of the warrant agreement, as applicable, is filed in a court other than a court of the State of New York located in the County of New York or the United States District Court for the Southern District of New York (a “foreign action”) in the name of any holder of our warrants, as applicable, such holder shall be deemed to have consented to: (x) the personal jurisdiction of the state and federal courts located in the State of New York in connection with any action brought in any such court to enforce the forum provisions, and (y) having service of process made upon such warrant holder in any such action brought in such court to enforce the forum provisions by service upon such warrant holder’s counsel in the foreign action as agent for such warrant holder.

This choice-of-forum provision may limit a warrant holder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with our company, which may discourage such lawsuits. Warrant holders who are unable to bring their claims in the judicial forum of their choosing may be required to incur additional costs in pursuit of actions which are subject to our choice-of-forum provisions. Alternatively, if a court were to find this provision of our warrant agreement inapplicable or unenforceable with respect to one or more of the specified types of actions or proceedings, we may incur additional costs associated with resolving such matters in other jurisdictions, which could materially and adversely affect our business, financial condition and results of operations and result in a diversion of the time and resources of our management and board of directors.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain statements in this prospectus may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are intended to be covered by the safe harbor provisions created by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including statements that relate to, among others, our plans, objectives and expectations for our business, strategy, operations, financial condition, results of operations, liquidity, certain transactions, regulatory approvals and clinical trials are forward-looking statements. When used in this prospectus, such statements can be identified by terminology such as “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “goal,” “hope,” “if,” “intend,” “likely,” “may,” “mission,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “will” and similar expressions, although not all forward-looking statements contain such identifying words.

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

Forward-looking statements are based on management’s beliefs and assumptions and on information currently available to management. Although we believe that the expectations reflected in forward-looking statements are reasonable, such statements involve known and unknown risks, uncertainties and other factors, many of which are beyond our control, that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by forward-looking statements. These risks and uncertainties include, without limitation:

You should not place undue reliance on forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, we undertake no obligation to update or revise any forward-looking statement, whether as a result of new information, future events and circumstances or otherwise, after the date hereof. You should, however, review the risks, factors and additional discussions related thereto in this prospectus and other filings we file from time to time with the SEC.

USE OF PROCEEDS

We will not receive any proceeds from the sale of Ordinary Shares by the Selling Shareholders.

We will receive proceeds from any cash exercise of the Warrants, which, if exercised in cash with respect to all of the 14,572,326 Ordinary Shares offered hereby, would result in gross proceeds to us of a maximum of $167,581,749 assuming the full exercise of the Warrants.

We intend to use any proceeds received by us from the cash exercise of the Warrants for working capital and general corporate purposes. As of the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to us from the cash exercise of the Warrants. Accordingly, our management will have broad discretion in the timing and application of these proceeds. The holders of the Warrants may exercise the Warrants at their own discretion and at any time until their expiration subject to and in accordance with the terms of the Warrants. As a result, we cannot predict when or if the Warrants will be exercised, and it is possible that the Warrants may expire and never be exercised. In addition, the Warrants are exercisable on a cashless basis if at the time of exercise there is no effective registration statement registering, or the prospectus contained therein is not available for, the issuance of shares of common stock for which the Warrants are exercisable. As a result, we may never receive meaningful, or any, cash proceeds from the exercise of the Warrants.

CAPITALIZATION

The following table sets forth our consolidated capitalization as of December 31, 2025. This table should be read in conjunction with, and is qualified in its entirety by reference to, the Company’s audited consolidated financial statement, including the notes hereto, and the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this prospectus.

DIVIDEND POLICY

We have never declared or paid any cash dividends on our Ordinary Shares, and we do not currently intend to pay any cash dividends on our Ordinary Shares for the foreseeable future. We expect to retain future earnings, if any, to fund the development and growth of our business. Our board of directors has complete discretion in deciding whether to distribute dividends, subject to certain restrictions under Cayman Islands law, namely that our company may only pay dividends out of profits or share premium, and provided always that in no circumstances may a dividend be paid if this would result in our company being unable to pay its debts as they fall due in the ordinary course of business. In addition, our shareholders may by ordinary resolution declare a dividend, but no dividend may exceed the amount recommended by our board of directors. Even if our board of directors decides to pay dividends, the timing, amount and form of future dividends, if any, will depend on, among other things, our future results of operations and cash flow, our capital requirements and surplus, the amount of distributions, if any, received by us from our subsidiaries, our financial condition, contractual restrictions and other factors deemed relevant by our board of directors. Please see the section entitled “Regulations Applicable to YD Bio’s Business” of this prospectus for information on the potential tax consequences of any cash dividends declared.

MARKET INFORMATION

Our Ordinary Shares are currently listed on Nasdaq under the symbol “YDES”. To our knowledge, as of May 18, 2026, there were 25 shareholders of record of our Ordinary Shares, of which 10 were in the United States, including Cede & Co., representing approximately 17% of our total outstanding Ordinary Shares. As of May 22, 2026 the closing sale price of our Ordinary Shares was $4.75 per share. The actual number of shareholders of our Ordinary Shares is greater than the number of record holders and includes holders of our Ordinary Shares whose Ordinary Shares are held in street name by brokers and other nominees.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis provide information that YD Bio’s management believes is relevant to an assessment and understanding of YD Bio’s consolidated results of operations and financial condition. The discussion should be read together with the audited consolidated financial statements and related notes that are included elsewhere in this prospectus. The audited consolidated financial statements included in this prospectus reflect the operations of the combined company following the consummation of the Business Combination on August 28, 2025. Unless the context otherwise requires, references in the discussion in this section to “YD Bio”, “we”, “us” and “our” refer to the business and operations of YD Bio and its consolidated subsidiaries.

The discussion may contain certain “forward-looking statements” based upon the current expectations of YD Bio’s management, which expectations involve risks and uncertainties. We do not undertake to update any forward-looking statements to reflect the impact of circumstances or events that arise after the dates they are made. See the section entitled “Cautionary Note Regarding Forward-Looking Statements.” You should, however, consult further disclosures and risk factors included elsewhere in this prospectus. See the section entitled “Risk Factors.”

Overview

We are a publicly listed biotechnology company focused on regulated diagnostics, life science clinical services, and healthcare product commercialization. Our operations include DNA methylation-based oncology testing programs in the United States conducted under a LDT framework in collaboration with CLIA-certified and CAP-accredited laboratory partners. In addition to our diagnostics activities, we provide regulated life science distribution and clinical trial supply chain services to pharmaceutical and biotechnology companies, including procurement, logistics coordination, and compliance-focused support for clinical development programs. We also maintain ocular health product commercialization operations in the United States and consumer healthcare distribution activities in Asia under applicable regulatory and market requirements. Through our combined diagnostics platform, clinical service infrastructure, and healthcare commercialization capabilities, we seek to develop a scalable operating model designed to support growth across multiple regulated healthcare segments.

Outlook

The Company’s strategic focus is to expand access to early-stage cancer detection through regulated diagnostic frameworks and physician-directed testing models in the United States. Earlier detection may allow healthcare providers to consider a broader range of clinical management approaches; however, patient outcomes depend on individual medical circumstances and treatment decisions. Building upon its diagnostics platform, clinical service infrastructure, and strategic partnerships, the Company intends in 2026 to advance selected assets from validation and platform development toward expanded clinical, regulatory, and commercial execution. These initiatives are expected to proceed on a phased basis and will be subject to regulatory requirements, capital availability, operational capacity, and market conditions. There can be no assurance that such initiatives will be completed within anticipated timelines or achieve expected results.

Accelerating Clinical Development Across Global Programs

Cell Therapy and Exosome Platform: Manufacturing and Regulatory De-risking Completed

YD Bio has achieved comprehensive Chemistry, Manufacturing, and Controls (CMC) development for its Limbal Stem Cell (LSC) platform and LSC-derived exosome products. This includes successful batch testing and qualification of primary LSC cell sources, establishment of scalable cell expansion and cryopreservation methods, and definition of cell specifications. Furthermore, robust exosome expansion, purification, and potency assay methods have been developed, alongside established exosome specifications. Relevant supporting Standard Operating Procedures (SOPs) are finalized, ensuring manufacturing readiness for Investigational New Drug (IND) applications.

The Company plans to continue strengthening its regulatory foundation. The Company has filed Drug Master Files (DMFs) with the U.S. Food and Drug Administration (FDA) for both Limbal Stem Cells and LSC-derived exosomes. Pending FDA approval, this establishes a reusable regulatory framework that significantly reduces program risk and is expected to streamline future IND filings, subject to ongoing regulatory feedback.

3D Global Biotech expects to advance two lead ophthalmology programs utilizing its LSC Exosome platform, each supported by targeted regulatory and clinical milestones, which the timing of these milestones remains uncertain and are subject to preclinical results, manufacturing readiness and regulatory feedback.

U.S. FDA Clinical Programs (Ophthalmology – LSC Exosomes)

Taiwan TFDA Clinical Programs (Exovisse Brand)

These targeted timelines reflect the Company’s plan to transition from platform validation to asset-level clinical execution, with multiple value inflection points anticipated over the next 24 months, subject to preclinical results, manufacturing readiness and regulatory feedback.

Strategic Expansion in Precision Oncology Diagnostics

Through its affiliate EG BioMed, YD Bio operates an online platform for CLIA- and CAP-certified laboratory services across 44 U.S. states and Washington, D.C. and Guam. This platform delivers Laboratory Developed Tests (LDTs) for early detection and monitoring of pancreatic, breast, colorectal, and general gastrointestinal cancers, generating recurring revenue and building critical real-world clinical and molecular datasets.

The Company anticipates that this dual-track approach preserves near-term commercial activity under the LDT framework while pursuing regulatory expansion, subject to FDA approval, to broaden market access and valuation uplift.

Strengthening Intellectual Property and Scientific Leadership

The Company has significantly strengthened its global intellectual property position, creating a high-barrier IP moat. Breast cancer patents have been issued in 28 countries, and pancreatic cancer IP has been issued in the United States, with additional regional issuances in Europe, Asia, and Australia expected in 2026, applications pending; timing and scope remain uncertain. Colorectal and gastrointestinal cancer portfolios are also advancing toward key regional approvals, supporting long-term licensing, strategic partnerships, and enterprise value growth.

The Company plans to further enhance its scientific visibility and academic leadership through presentations at AACR 2026 on breast, GI, and liver cancer data, alongside the publication of full manuscripts on pancreatic and colorectal cancer early detection and monitoring, the timing and scope of which are uncertain.

Strategic Acquisitions Driving Future Growth

The Company has advanced its strategic expansion in early 2026 through two transformative transactions: a non-binding Memorandum of Understanding (MOU) announced on January 6, 2026, to merge with EG BioMed, integrating DNA methylation–driven AI platforms for advanced cancer diagnostics, biomarker analytics, real-world clinical data generation, and AI-enabled drug discovery; and a binding Letter of Intent (LoI) executed on January 20, 2026 (announced January 29, 2026), to acquire Safe Save Medical Cell Sciences & Technology Co., Ltd. (SSMC), bringing proprietary Autologous Dendritic Cells/Tumor Antigens (ADCTA) technology, late-stage immunocell therapies (including Phase III applications in glioblastoma), and capabilities targeting various solid tumors (e.g., ovarian, breast, lung, colorectal, pancreatic) through personalized autologous immune-targeted approaches.

These parties involved in these two transactions—EG BioMed and SSMC—represent the Company’s primary targeted acquisitions for 2026 and form the foundation of an integrated, end-to-end biotechnology ecosystem spanning precision oncology: from early detection and stratification via AI-enhanced molecular diagnostics, to advanced cell therapies, treatment, and longitudinal monitoring.

These two are currently planned or under evaluation for 2026. These strategic initiatives are anticipated to accelerate internal clinical execution, shorten development timelines, and fortify global regulatory readiness—particularly for multinational clinical trials across key regions such as the United States and Asia—subject to customary closing conditions, regulatory approvals, negotiation and execution of definitive agreements, and other factors. However, the Company cannot be certain that the ongoing transactions will close as contemplated or that it will achieve the anticipated synergies, outcomes, or benefits.

The Company plans to pursue IND submissions and clinical initiations beginning in 2026, subject to successful completion of preclinical work, CMC readiness, regulatory feedback, and resource availability; projected timing remains subject to change based on these factors. The Company anticipates multiple near-term inflection points from regulatory filings, clinical initiations, and commercial expansion that together support accelerated value creation through 2027.

EG Telehealth Platform

On March 31, 2026, the Company and EG BioMed launched the EG Telehealth Platform, an online portal integrated with an independent telehealth physician network. This platform is intended to support diagnostic service delivery and future clinical program expansion. This model will aim to ensure that all orders are reviewed and authorized by a licensed HCP prior to sample collection (i.e., such tests will not be DTC LDTs). We will not distribute collection kits or report results directly to consumers without a valid physician order, and we do not intend to pursue a fully DTC pathway at this time, given the clinical complexity of cancer-related testing and current regulatory expectations.

Partnership with YC Biotech

Through the Partnership with YC Biotech, within the next twelve months, we intend to expand our clinical services capabilities through the development of a broader regulatory and clinical project support platform. This includes enhancing our ability to support Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA)–related activities in collaboration with our strategic partners. These activities are expected to be conducted on a project-by-project basis and will depend on market demand, regulatory requirements and operational execution.

Key Factors Affecting Our Performance

YD Bio believes that future success will be dependent on several key factors, including those discussed below. While these areas represent opportunities for us, they also represent challenges and risks that we must successfully address in order to continue the growth of our business and improve our results of operations.

Capabilities Across a Broad Spectrum of Solutions

YD Bio has an extensive suite of solutions ranging from ophthalmology cellular drug development to pancreatic and breast cancer blood tests to nutritional product sales. YD Bio faces competition from well financed biopharma companies and is working to distinguish itself through cutting edge advancements which distinguish its solutions from the competition.

Notable Strategic Partnerships, Offering Validation and Growth Potential

YD Bio is a clinical testing drug supplier for global pharmaceutical companies such as Novartis and Alcon, as well as having licensing partnerships with EG BioMed for pancreatic and breast cancer detection and with 3D Global to develop treatment for eye disorders. The length of the existing licensing partnerships and the establishment of new licensing partnerships will have a direct impact on YD Bio’s future revenues.

Proprietary Technology Supported by Licensing Agreements and IP Portfolio

Multi-decade, exclusive licensing agreements and owned, patented technology provides YD Bio with a significant competitive advantage.

Large and Underserved Markets for Each Solution Showcase Untapped Growth Potential

Projected multi-billion-dollar global market sizes over the next decade predict significant growth potential for YD Bio’s solutions. Entering large and underserved markets requires significant increases in production capacity, business development expenses, IT expenses, marketing expenses, labor costs related to employee headcount, and back-office support.

Strong Leadership Team with Deep Expertise in Biotech and Finance

YD Bio has a founder-led management team with experience in new drug development, medical-grade health product development, pharmacy channel development, and financial management and accounting. Expansion of YD Bio will lead to increased costs from hiring skilled labor with the level of expertise required to execute YD Bio’s expansion plans. The labor pool for expertise of the caliber required to execute YD Bio’s business plan is limited and will likely require significant expenditures related to salary and wages to attract qualified talent to the business.

Production Capacity

YD Bio may be required to make significant capital expenditures to execute its business plan. These capital expenditures would be invested in facilities, production equipment and other expenses to support increases in production. To the extent YD Bio outsources production, its cost of revenue may be higher versus in-house production but may be offset in whole or in part because capital expenditures will be reduced.

Customer Demand

Favorable industry dynamics for early detection testing in pancreatic and breast cancer present YD Bio with numerous growth opportunities. According to Precedence Research, the global breast cancer diagnostics market size was estimated at USD 20.14 billion in 2025 and is projected to reach over USD 40.71 billion by 2034, growing at a CAGR of 8.13% from 2025 to 2034. Other estimates, such as from Grand View Research, place the market at approximately USD 5.86 billion in 2025, projected to reach USD 11.36 billion by 2033 at a CAGR of 8.8% from 2026 to 2033. YD Bio’s licensors are uniquely positioned to address this growing demand given their modular and portable production design and anticipated high return on invested capital.

For pancreatic cancer diagnostics, the global market was estimated at USD 2.87 billion in 2024 according to TechSci Research, and is projected to reach USD 4.32 billion by 2030, growing at a CAGR of approximately 7.05% from 2024 to 2030.

According to Precedence Research, the global glaucoma treatment market was valued at USD 6.51 billion in 2024 and is projected to reach USD 8.66 billion by 2034, growing at a CAGR of 2.86% from 2025 to 2034.

According to Fortune Business Insights, the global dry eye syndrome market (including products) was valued at approximately USD 8.00 billion in 2025 and is projected to grow from USD 8.55 billion in 2026 to USD 15.09 billion by 2034, at a CAGR of around 7.37% during the forecast period. Fact.MR extends this further, projecting the dry eye syndrome treatment market to reach USD 12.2 billion by 2035 at a CAGR of 6.0% from 2025 levels.

These markets underscore strong demand for innovative, efficient diagnostics and treatments, particularly in early detection and management of chronic eye conditions. YD Bio’s technologies align well with these expanding opportunities. 

Commitment to Research and Expenses

According to the agreement entered into with 3D Global in respect of its patent in June 2024, YD Bio is obligated to pay up to $4 million when certain conditions and milestones are satisfied and completed by 3D Global. YD Bio had paid $480,000 to 3D Global for the first stage of development of the 3D Global Patent on development of corneal limbal stem cells (“LSC”) during the year 2024. YD Bio has paid a total of $1,550,000 to 3D Global for the first through third stage of Development of LSC Cell Source and the second stage of Establishment of LSC Master Cell Banks for the year ended December 31, 2025.

Costs of Revenue

Our profitability may be affected by our ability to effectively manage our costs of revenues. Our costs of revenues could be impacted by fluctuations in the price of product costs. If material prices increase, we will have to offset these higher costs either through price increases to our customers or through productivity improvements. Although we are not currently relying on any single-source suppliers for our materials, our ability to control our materials costs is also dependent on our ability to negotiate with our suppliers for a better price and our ability to source products from reliable suppliers in a cost-efficient manner. In addition, we expect that an increase in our sales volume will enable us to lower our costs of revenue through economies of scale and that we will see a reduction in the cost of critical components through enhanced and improved production processes from our suppliers. Our royalty costs will also increase the costs of revenue alongside the increased revenue generated from the sales of licensed products and rendering of licensed services in future.

Regulatory Landscape

The sale and purchase of YD Bio’s products and services are subject to extensive federal, state, local, and foreign government laws. YD Bio is also subject to the rules and regulations of the U.S. Federal Drug Administration and various state and international agencies that control the export, import, distribution, and sale of medical device products and cancer early detection services. Such regulations may adversely affect demand for our products by imposing limitations that increase the costs or limit the availability of our products. To date we have not concluded any clinical trials, nor have we had any product candidate approved for commercial sale. It is possible that we may not be able to commercialize a marketable product candidate.

Results of Operations of YD Biopharma

For the year ended December 31, 2025, change in fair value of warrant liabilities increased by $3.2 million from nil for the year ended December 31, 2024 to $3.2 million, general and administrative expenses increased by $2.5 million from $1.1 million for the year ended December 31, 2024 to $3.6 million, and research and development expenses increased by $1.1 million from $0.5 million for the year ended December 31, 2024 to $1.6 million. For the year ended December 31, 2024, general and administrative expenses increased by $0.9 million from $0.2 million for the year ended December 31, 2023 to $1.1 million, and research and development expenses increased by $0.5 million from nil for the year ended December 31, 2023 to $0.5 million.

The increase from year to year in general and administrative expenses and research and development expense mainly resulted from professional and consultancy service fees related to the Company’s expansion and restructuring, staffing costs to expand our business and expenses related to two licensed patents.

Years Ended December 31, 2025, 2024 and 2023

The following table presents the summarized financial information taken from our consolidated statements of operations for the year ended December 31, 2025, compared with the years ended December 31, 2024 and 2023 (amounts in thousands):

Net Revenue

Revenue for the year ended December 31, 2025 consisted of the following:

Top five individual products by revenue for the year ended December 31, 2025 are as follows:

Revenue for the year ended December 31, 2024 consists of the following:

Top five individual products by revenue for the year ended December 31, 2024:

Revenue for the year ended December 31, 2023 consists of the following:

Top five individual products by revenue for the year ended December 31, 2023:

Net revenue increased by $ 86,457 or 17% to $596,817 for the year ended December 31, 2025, compared to $510,360 for the year ended December 31, 2024. The top 5 individual products by revenue accounted for 41% of the total revenue during the period. The increase in revenue was primarily due to higher sales volumes and a shift in product mix toward lower-priced products, as reflected in the decrease in average selling price. Pharmaceutical sales, particularly Keytruda which increased by approximately $48,598 driven by higher purchase volumes from key customers, along with new product launches, were the primary growth drivers. This growth was partially offset by decreased medical product sales, primarily due to the discontinuation of certain products and reduced orders for PVA eye cleansing tablets as a key customer adjusted its procurement strategy based on end-market feedback. Overall, the revenue change reflects a structural shift from higher-priced medical products toward pharmaceuticals and other lower-priced offerings.

Net revenue increased by $160,229 or 46% to $510,360 for the year ended December 31, 2024, compared to $350,131 for the year ended December 31, 2023. The revenue for the year arises from the sales of drugs, medical and related products, nutritional and supplements products in Taiwan. The top 5 individual products by revenue accounted for 51% of the total revenue during the year. The increase in revenue was primarily due to the increase in sales demand of the medical and related products and drugs to corporate customers during the year resulting from increasing public health awareness, e.g. PVA eye cleansing wipes which contributed $97,512 (19%) of the total revenue for the year. As such, YD Bio expects the demand for medical and related products will continue to grow in the future.

Cost of Revenue

Cost of revenue increased by $74,403 or 21% to $429,407 for the year ended December 31, 2025, compared to $ 355,004 for the year ended December 31, 2024. The cost of revenue consists primarily of purchase costs of products for resales. The increase in cost of revenue was primarily due to the increase in revenue of 17%. The increase in cost of revenue was higher than the increase of net revenue, which was primarily due to the change of sales mix to the products sold with a lower margin during the year. Specifically, the sales mix shifted from higher-margin medical products to drugs and medical peripherals with relatively lower margins, resulting in a decrease in overall gross margin. This impact was partially offset by lower procurement costs for certain products.

Cost of revenue increased by $158,318 or 80% to $355,004 for the year ended December 31, 2024, compared to $196,686 for the year ended December 31, 2023. Our cost of revenue consists primarily of purchase costs of products for resales, and the material costs and subcontracting costs of manufactured nutritional products. The increase in cost of revenue was higher than the increase in net revenue, which was primarily due to the change of sales mix to the products sold with a lower margin during the year.

Gross Profit

Gross Profit increased by $12,054 or 8% to $167,410 for the year ended December 31, 2025, compared to $155,356 for the year ended December 31, 2024. Gross Profit increased by $ 1,911 or 1% to $ 155,356 for the year ended December 31, 2024, compared to $153,445 for the year ended December 31, 2023. The year-over-year changes were primarily due to higher sales volumes and a shift in product mix toward lower-priced products.

Operating Expenses

For the year ended December 31, 2025, our total operating expenses were approximately $5.4 million, reflecting an increase of $3.8 million compared to $1.6 million for the year ended December 31, 2024. The increase was mainly caused by the increase of professional and consultancy service fees related to the Company’s expansion and restructuring costs of $1.1 million, the increase in research and development expenses by $1.1 million related to two licensed patents and know-how, and by the $1.3 million increase in staff costs from the expansion of our business.

For the year ended December 31, 2024, our total operating expenses were $1.6 million, reflecting an increase by $1.5 million compared from $163,292 for the year ended December 31, 2023. The increase was caused by the increase of professional and consultancy services fees related to the Company expansion and restructuring of $0.6 million, the increase in research and development expenses of $0.5 million, and by the $0.1 million increase in staffing costs.

Interest and Other Income, Net

For the year ended December 31, 2025, other income, net decreased by $17,612 or 27% to $46,803 compared to the year ended December 31, 2024, due primarily to the increase in foreign exchange losses of $36,219.

For the year ended December 31, 2025, interest income increased by $68,354 or 579% to $80,162 compared to $11,808 for the year ended December 31, 2024.

For the year ended December 31, 2024, other income, net increased by approximately $35,064 or 119% to $64,415 compared to the year ended December 31, 2023, due primarily to an increase in foreign exchange gain and income from leasing medical equipment. On the other hand, YD Biopharma ceased one of the subleasing arrangements to a drug store in June 2023, and the income generated from the operating lease arrangements for the year ended December 31, 2024 decreased as a result. 

Net (Loss) Income

For the year ended December 31, 2025, the net loss was $8.3 million compared to $1.4 million for the year ended December 31, 2024. The increase in net loss was mainly caused by the increase of change in fair value of warrant liabilities by $3.2 million, professional and consultancy service fees related to the Company expansion and restructuring by $1.1 million, research and development expenses by $1.1 million related to two licensed patents and know-how, and by the $1.3 million increase in staff costs from the expansion of our business.

For the year ended December 31, 2024, we had a net loss of $1,411,559 compared to net income of $13,560 for the year ended December 31, 2023. The net loss was caused by the increase in professional and consultancy services fees related to the Company expansion and restructuring of $0.6 million, increase in research and development expenses of $0.5 million, and a $0.1 million increase in staffing costs.

Liquidity and Capital Resources

YD Bio has operated primarily as a development stage Company since its formation. YD Bio’s net loss increased by $6.9 million or 493% to $8.3 million for the year ended December 31, 2025, compared to $1.4 million for the year ended December 31, 2024, and an accumulated deficit of $10.3 million as of December 31, 2025.

YD Bio’s net loss decrease by $1.4 million or 10510% to $1.4 million for the year ended December 31, 2024, compared to net income of $13,560 for the year ended December 31, 2023, and an accumulated deficit of $1,927,043 as of December 31, 2024.

YD Bio has historically funded operations through private equity offerings, related party debt and financial institution debt.

On August 28, 2025, the Company completed its business combination with Breeze pursuant to the Merger Agreement and Plan of Reorganization, dated September 24, 2024. Concurrently with the closing, YD Bio closed a private investment in public equity (“PIPE”) financing, securing $13.2 million in gross proceeds to support YD Bio’s liquidity and capital resources.

The Company also plans to seek additional equity or debt financings to meet projected working capital, operating, and capital expenditures.

We believe that these financing activities will allow YD Bio to meet both its operating and debt obligations in 2026. During 2026, the Company expects to require approximately $2.4 million to $2.7 million to support its operations on a consolidated basis, including its Taiwan operating subsidiary, U.S. subsidiary, and group-level management expenses. We expect our capital expenditures for 2026 to be in the range of $9 million to $10 million, primarily related to the acquisition of real estate and investments in production facilities. However, our liquidity assumptions may prove to be incorrect, and we could utilize our available financial resources sooner than we currently expect. We also recognize that there can be no assurance that our forecasted plan will be met. Our future capital requirements and the adequacy of available funds will depend on many factors. These conditions and Company’s recurring losses from operations raise substantial doubt about the Company’s ability to continue as a going concern for at least twelve months from April 30, 2026.

We may need to raise additional funds to finance our operations through further equity or equity-linked offerings or debt financing arrangements. If we raise additional funds by issuing equity or equity-linked securities, the ownership of our existing stockholders will be diluted. If we raise additional financing by the incurrence of indebtedness, we will be subject to increased fixed payment obligations and could also be subject to restrictive covenants, such as limitations on our ability to incur additional debt, and other operating restrictions that could adversely impact our ability to conduct our business. YD Bio recognizes that there is no assurance that any such additional financing will be obtained or that the terms of such arrangements will be reasonable. If we are unable to obtain additional funds, we would also take other measures to reduce expenses to offset any shortfall.

Cash and Cash Equivalents

Cash and cash equivalents included cash on hand placed with banks or other financial institutions, which are unrestricted as to withdrawal and use and with an original maturity of three months or less. As of December 31, 2025, YD Bio’s cash was $6.0 million compared to $3.1 million as of December 31, 2024. This increase was primarily due to an equity raise of $13.9 million, offset by deferred offering cost of approximately $3.2 million, professional and consultancy services fees related to the Company expansion and restructuring of $1.5 million, research and development expenses of $1.1 million, payment for purchase of medical products and contact lenses of $ 1.9 million and prepayment for the purchase of office space and parking facilities of $1.5 million.

As of December 31, 2024, YD Bio’s cash was approximately $3.1 million compared to $87,098 as of December 31, 2023. This increase was primarily due to an equity raise of approximately $8.0 million for the year, offset by an acquisition of intangible assets of approximately $2.8 million and deferred offering cost of approximately $0.6 million.

Cash Flows

The following table summarizes YD Bio’s cash flows for the period indicated (in thousands):

Cash Flows Used in Operating Activities

Net cash used in operating activities for the year ended December 31, 2025, was $6.6 million, primarily related to YD Bio’s net loss for the period of $5.1 million (excluding non-cash fair value changes of warrant liabilities) and an increase in inventories of $1.8 million.

Net cash used in operating activities for the year ended December 31, 2024, was $1.2 million, primarily related to YD Bio’s net loss for the year of $1.4 million and offset by an increase in accrued expenses and other liabilities of $175,658.

Net cash used in operating activities for the year ended December 31, 2023, was $55,657, primarily related to an increase in accounts receivable and inventories of $63,858 and $30,570, respectively, offset by a reduction in operating lease liabilities of $47,082.

Cash Flows Used in Investing Activities

Net cash used in investing activities for the year ended December 31, 2025, was $1.4 million, primarily related to prepayment for the purchase of office space and parking facilities of $1,431,658.

Net cash used in investing activities for the year ended December 31, 2024, was approximately $2.9 million, driven by the acquisition of patent-related intangible assets of $2.8 million, and property, plant and equipment.

Net cash used in investing activities during the year ended December 31, 2023, was $290, also driven by the acquisition of property, plant and equipment.

Cash Flows Provided by Financing Activities

Net cash used in financing activities for the year ended December 31, 2025, was approximately $10.9 million, primarily related to an equity raise of $13.9 million, offset by deferred offering costs of $3.2 million.

Net cash provided by financing activities for the year ended December 31, 2024, was approximately $7.1 million, consisting primarily of net proceeds from issuance of common shares by YD Biopharma of $7.8 million, offset by the payment of offering cost related to business combination of $0.6 million.

Net cash provided by financing activities during the year ended December 31, 2023, was $113,887, consisting primarily of proceeds from a shareholder and an affiliate of $146,496, net of a $32,609 repayment of a long-term bank loan.

Commitments and Contingencies  

YD Bio’s commitments include our operating lease liabilities. Other commitments primarily consist of debt obligations, including long-term bank loan, amount due to a shareholder and affiliate.

The following table summarizes our contractual obligations and other commitments for cash expenditures as of December 31, 2025, and the years in which these obligations are due as follows (in thousands):

Pursuant to the agreement entered into with 3D Global in June 2024 relating to the 3D Global Patent, YD Bio is obligated to pay up to $2,450,000 when certain conditions and milestones are satisfied and completed by 3D Global. The Company has paid a total of $1,550,000 to 3D Global for the first through third stage of Development of LSC Cell Source and the second stage of Establishment of LSC Master Cell Banks up to December 31, 2025.

On September 17, 2025, Yong Ding Biopharm Co., Ltd (Subsidiary of YD Bio) entered into a pre-sale real estate contract for the purchase of office space and parking facilities located in Taipei City. The contract covers an office unit and four statutory parking spaces with a total contract price of US$8,890,625 (NT$284,500,000, converted at an exchange rate of approximately 32 NT$/US$).

As of December 31, 2025, the remaining balance of $7,467,812 (NT$ 238,970,000) is to be funded through a combination of internal cash reserves and a potential loan of up to US$6,223,437 (NT$199,150,000) through a designated financial institution.

Off-Balance Sheet Arrangements

As of December 31, 2025, 2024 and 2023, we did not engage in any off-balance sheet arrangements, as defined in the rules and regulations of the Securities and Exchange Commission.

Recently Issued and Adopted Accounting Standards

See Note 3 to YD Bio’s consolidated financial statements, included elsewhere herein, for a full description of recent accounting pronouncements, including the actual and expected dates of adoption and estimated effects on our consolidated results of operations and financial condition, which is incorporated herein by reference.

Research and development costs are expensed as incurred in accordance with ASC 730, Research and Development. The Company incurs research and development costs in the pursuit of new products and improving the formulation of existing products.

Other than as disclosed elsewhere in this Annual Report, we are not aware of any trends, uncertainties, demands, commitments or events that are reasonably likely to have a material effect on our revenues, income from continuing operations, profitability, liquidity or capital resources, or that would cause reported financial information not necessarily to be indicative of future operating results or financial condition.

Significant Accounting Policies

 See Note 3 to YD Bio’s consolidated financial statements, included elsewhere herein.

Subsequent Events

On January 6, 2026, the Company announced its entrance into a non-binding Memorandum of Understanding (MOU) to merge with EG BioMed, a biotechnology company specializing in DNA methylation-based cancer diagnostics and AI-driven biomarker analytics. The proposed merger aims to integrate complementary technologies to create a comprehensive oncology platform encompassing early cancer detection, real-world clinical data generation, and AI-enabled drug discovery. The transaction is expected to close in 2026, subject to customary closing conditions, regulatory approvals, definitive agreements, and other factors. No financial terms were disclosed, and there is no assurance the merger will be completed on the contemplated terms or at all.

On January 16, 2026, the Company announced that YD Biopharma and EG Biomed Limited, two stockholders of the Company whose combined holdings constitute a majority of the Company’s voting rights, delivered a shareholders’ written consent (the “Written Consent”) to the Company’s registered office pursuant to the Company’s governing documents and the applicable laws of the Cayman Islands. According to the Written Consent, four members of the Company’s Board of Directors, Joe Douglas Ramsey, Albert Scott McLelland, Michaela Ann Griggs and Janet Hall, were removed as directors effective December 30, 2025, and two new directors, Dr. Kochi Chang and Dr. Shao-Ta Lu were elected to the Board effective December 30, 2025.

On January 20, 2026, the Company entered into a binding Letter of Intent (LoI) to acquire 100% of the equity interests in Safe Save Medical Cell Sciences & Technology Co., Ltd. (SSMC), a Taiwan-based company focused on innovative autologous dendritic cell/tumor antigen (ADCTA) immunocell therapies, including late-stage clinical assets for glioblastoma and other solid tumors. The total consideration is approximately NT$839,832,000 (equivalent to about US$26.87 million), payable through a combination of newly issued Company shares and cash. Completion is subject to successful due diligence, corporate restructuring of SSMC, regulatory approvals, and other customary conditions. There can be no assurance that the acquisition will be consummated.

On February 24, 2026 (announced February 25, 2026), the Company’s U.S. subsidiary, YD Bio USA, Inc., entered into a Master Strategic Alliance Agreement with YC Biotech Co., Ltd. Under this agreement, YD Bio USA will serve as the exclusive U.S. agent and strategic hub for YC Biotech’s Asian Contract Research Organization (CRO) clients, providing FDA-related regulatory services, including pathway strategy, pre-IND facilitation, meeting representation, inspection readiness and advisory support across IND, NDA, BLA, IDE, 510(k), De Novo and PMA submissions. YC Biotech will lead Asian project sourcing, technical execution and document preparation. This partnership is intended to support the Company’s broader strategy of facilitating U.S. market access for innovative therapies and devices.  

Critical Accounting Policies and Estimates

The preparation of audited financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the audited financial statements, and income and expenses during the periods reported. Actual results could materially differ from those estimates. As of December 31, 2025, there were no critical accounting policies and estimates. 

BUSINESS

History and Development

YD Bio Limited was originally incorporated in Delaware under the name True Velocity, Inc. on February 6, 2024. The Company was re-domesticated and registered by way of continuation as a Cayman Islands exempted company limited by shares on November 14, 2024 and changed its name to YD Bio Limited on November 18, 2024. The Company was re-domesticated solely for the purpose of the transactions contemplated by the Merger Agreement, pursuant to which the Business Combination was completed on August 28, 2025. YD Biopharma was incorporated in the Cayman Islands on March 14, 2024 in connection with the restructuring of Yong Ding Biopharm Co., Ltd., a company incorporated in the Republic of China on April 23, 2013 (“Yong Ding”), upon which YD Biopharma acquired all of the issued an outstanding equity interests of Yong Ding.

Our principal executive office is located at 12F., No. 3, Xingnan St., Nangang Dist., Taipei City 115001, Taiwan, and our phone number is +(886) 2382-0330. Our agent for service in the United States is Cogency Global Inc., whose address is 122 East 42nd Street, 18th Floor, New York, NY 10168.

On August 28, 2025, the Company completed its Business Combination with Breeze and YD Biopharma. As a result of the business combination, both Breeze and YD Biopharma became wholly-owned subsidiaries of the Company. As a direct consequence of the closing of the business combination, the Patent Licensing and Technology Transfer Agreement (the “Agreement”), executed between EG BioMed Co., LTD. and Yong Ding became effective on August 28, 2025. The Agreement grants the Company an exclusive sublicense to the licensed patents and know-how related to methylation analysis technology for breast cancer detection and applications. The Agreement has a term of 20 years and will automatically renew for an additional 5 years unless both parties agree not to renew.

On December 16, 2025, the Company announced an expanded U.S. presence with planned facilities and a U.S. operations center in California intended to accelerate clinical development, regulatory engagement and commercial access for next-generation diagnostics and exosome-based therapeutics. The California operations center is in the site evaluation phase, and the specific host city has not yet been finalized.

On January 06, 2026, the Company announced that the Company has entered a Memorandum of Understanding (the “MOU”) to merge with EG BioMed, a biotechnology company specializing in DNA methylation–based cancer diagnostics and AI-driven biomarker analytics. The proposed merger is intended to build an integrated, data-driven oncology platform spanning early cancer detection, real-world clinical data generation and AI-enabled drug discovery. The MOU is non-binding and there can be no assurance that the parties will enter into definitive agreements, obtain required approvals, or consummate the merger on the terms contemplated or on any particular timeline.

On January 20, 2026, the Company entered a binding letter of intent (the “LOI”) with Safe Save Medical Cell Sciences & Technology Co., Ltd. (“SSMC”), pursuant to which the Company intends to acquire, through an offshore holding company to be established, all of the shares, assets and business of SSMC, for a total consideration of approximately NT$839,832,000. The acquisition is expected to involve a combination of newly issued Ordinary Shares and cash. This acquisition is intended to enhance our R&D capabilities, accelerate our entry into new therapeutic areas, and expand our market reach.

On February 24, 2026, YD Bio USA, Inc. (“YD Bio USA”), a subsidiary of the Company, entered into a Master Strategic Alliance Agreement with YC Biotech Co., Ltd. (“YC Biotech”), pursuant to which the parties established a strategic partnership to create a “Taiwan-U.S. Dual- Core” regulatory platform (the “Partnership”). This partnership is intended to cover a broad range of projects involving the U.S. Food and Drug Administration (the “FDA”), including Investigational New Drug, New Drug Application, and Biologics License Application submissions. Under the Agreement, YD Bio USA will serve as YC Biotech’s exclusive U.S. Agent and formal liaison with the FDA for YC Biotech’s Contract Research Organization clients in Asia, and YC Biotech will lead project acquisition and technical execution for clients with U.S. regulatory requirements and provide support for regulatory submissions. This collaboration is intended to build a scalable platform for future expansion.

Our capital expenditures for the years ended December 31, 2025, 2024, and 2023 amounted to $1.4 million, $2.9 million and $290, respectively. These capital expenditures primarily consisted of prepayment for the purchase of office space and parking facilities, acquisition of patent-related intangible assets, and property, plant and equipment.

We are required to make certain filings with the SEC. The SEC maintains an internet website that contains reports, proxy statements and other information about issuers that file electronically with the SEC at www.sec.gov. We also maintain a website at https://www.ydesgroup.com. The reference to our website is an inactive textual reference only and the information contained in, or that can be accessed through, our website or any other website cited in this Annual Report is not a part thereof.

Business Overview

We are a publicly listed biotechnology company focused on regulated diagnostics, life science clinical services, and healthcare product commercialization. Our operations include DNA methylation-based oncology testing programs in the United States conducted under a LDT framework in collaboration with CLIA-certified and CAP-accredited laboratory partners. In addition to our diagnostics activities, we provide regulated life science distribution and clinical trial supply chain services to pharmaceutical and biotechnology companies, including procurement, logistics coordination, and compliance-focused support for clinical development programs. We also maintain ocular health product commercialization operations in the United States and consumer healthcare distribution activities in Asia under applicable regulatory and market requirements. Through our combined diagnostics platform, clinical service infrastructure, and healthcare commercialization capabilities, we seek to develop a scalable operating model designed to support growth across multiple regulated healthcare segments.

Our business model is centered on developing partnerships with biopharmaceutical companies to transform innovative technologies into commercially viable drugs and cancer detection. Our management team is driving accelerated research and clinical trials under the leadership of Chairman Dr. Ethan Shen, a seasoned biomedical expert with over 30 years of experience, and Chief Medical Officer Dr. Benjamin Zhang, who brings over eight years of expertise in clinical research. For EG BioMed, Chief R&D Officer Dr. Ruo-Kai Lin contributes over 30 years of specialized experience in cancer detection. Additionally, 3D Global Biotech is guided by Chairman and Chief Scientific Officer Dr. Ken Ou, a distinguished professional with over 30 years of experience and a former Dean of the College of Oral Medicine at Taipei Medical University. While we have not yet obtained FDA clearance or approval for any of our cancer detection test products, by leveraging translational medicine expertise of our management team, we accelerate the journey from research to clinical trials, positioning YD Bio as a potential leader in the industry.

We currently market our cancer detection test products exclusively to licensed HCPs, who order testing through EG BioMed’s CLIA-certified and CAP-accredited laboratory. The tests are offered as LDTs and performed solely at the request of a prescribing HCP. Following the recent March 2025 decision by a U.S. federal district court vacating the FDA’s May 2024 final rule on LDT oversight (which the government has not appealed, and the deadline to do so has passed), EG BioMed operates under CLIA regulations, which govern laboratory quality standards for HCP-ordered testing performed within a single certified lab. We have not conducted any clinical trials for the cancer detection test products. Instead, clinical testing has been conducted by EG BioMed, which is intending to pursue FDA approval for these products.

On March 31, 2026, the Company and EG BioMed launched the EG Telehealth Platform, an online portal integrated with an independent telehealth physician network. This platform is intended to support diagnostic service delivery and future clinical program expansion. This model will aim to ensure that all orders are reviewed and authorized by a licensed HCP prior to sample collection (i.e., such tests will not be DTC LDTs). We will not distribute collection kits or report results directly to consumers without a valid physician order, and we do not intend to pursue a fully DTC pathway at this time, given the clinical complexity of cancer-related testing and current regulatory expectations. Any future expansion toward broader access will be guided by FDA authorization (e.g., de novo classification or 510(k) clearance) and supported by evidence of safety, usability, and medical appropriateness. Even if our blood tests receive FDA clearance or approval, we do not intend to offer them as fully DTC products. Instead, we intend to offer them as products that still require an order from a licensed HCP (i.e., such tests will not be DTC LDTs). Notably, current FDA-approved cancer tests — such as Guardant360 and Shield — also require HCP involvement to initiate testing, even when accessed through consumer-facing platforms.

Through the Partnership with YC Biotech, within the next twelve months, we intend to expand our clinical services capabilities through the development of a broader regulatory and clinical project support platform. This includes enhancing our ability to support Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA)–related activities in collaboration with our strategic partners. These activities are expected to be conducted on a project-by-project basis and will depend on market demand, regulatory requirements and operational execution.

Industry Background and Market Trends

Cancer Diagnostics Market

The U.S. cancer diagnostics market was valued at approximately USD 40.44 billion in 2025 and is projected to reach around USD 90.89 billion by 2035, growing at a CAGR of 8.41% from 2026 to 2035, according to Precedence Research.

This expansion is supported by rising demand for early detection, advancements in precision diagnostics, and increasing investments in oncology.

In comparison, Taiwan recorded 138,051 new cancer cases in 2023 according to the Health Promotion Administration (the most recent published annual figure as of late 2025), underscoring a notable cancer burden relative to its population of around 23 million.

According to Precedence Research, the global cancer diagnostics market was valued at USD 170 billion in 2025 and is projected to reach USD 378.44 billion by 2035, expanding at a CAGR of 8.33% (or approximately 8.62% in related summaries) from 2026 to 2035.

Global Market Insights (GMI) provides a similar outlook, estimating the market at USD 171.7 billion in 2025, growing to USD 408.9 billion by 2035 at a CAGR of 9.1% between 2026 and 2035.

Key growth drivers cited across these reports include the increasing global prevalence of cancer, technological advancements in early detection (such as AI-powered imaging, liquid biopsy, and biomarker-based tests), expanded government screening programs, rising healthcare expenditures, and the shift toward personalized medicine.

For a more conservative longer-term view, IMARC Group projects the global cancer diagnostics market to reach USD 326.2 billion by 2033, with a CAGR of 4.88% during 2025–2033.

Pancreatic Cancer Diagnostics Market

The global pancreatic cancer diagnostics market was valued at USD 2.68 billion in 2024 and is expected to grow from USD 3.05 billion in 2025 to nearly USD 9.76 billion by 2034, growing at a CAGR of 13.8% from 2025 to 2034, according to Vision Research Reports (December 2025).

According to Global Market Insights, “The global pancreatic cancer diagnostic market was estimated at USD 2.5 billion in 2024. The market is expected to grow from USD 2.7 billion in 2025 to USD 5 billion in 2034, growing at a CAGR of 7.2%.”

According to Allied Market Research, “The pancreatic cancer diagnostic market was valued at $1.6 billion in 2023, and is estimated to reach $3.2 billion by 2035, growing at a CAGR of 5.9% from 2024 to 2035.”

According to Vision Research Reports and Global Market Insights (via document synthesis), North America continues to account for the largest share due to advanced healthcare infrastructure, high awareness, and rapid adoption of innovative diagnostic technologies such as AI-powered imaging and liquid biopsy. The U.S. is expected to lead in revenue contribution.

According to multiple market research firms including Vision Research Reports, Global Market Insights and Allied Market Research, the projected growth is driven by rising disease incidence, an aging population, increasing demand for early detection, and technological advancements in molecular and biomarker-based diagnostics, AI-powered imaging, and non-invasive liquid biopsy methods. Greater awareness, expanding screening initiatives for high-risk groups, ongoing research efforts, unmet clinical needs, and supportive regulatory environments further contribute to market expansion.

Pancreatic cancer incidence (2025 update): According to the American Cancer Society’s Cancer Facts & Figures 2025, “In 2025, an estimated 67,440 new cases of pancreatic cancer will be diagnosed in the US and 51,980 people will die from the disease.” This accounts for 3.3% of all new cancer cases and 8.4% of cancer deaths in the United States, with a five-year relative survival rate remaining low at approximately 13%.

Globally, the most recent comprehensive figure remains at 510,992 new cases in 2022 (GLOBOCAN / WCRF data). Updated worldwide incidence figures for 2024–2025 have not yet been fully released.

These projections assume continued regulatory support for novel diagnostics, technological progress (especially in early-detection tools), and sustained investment in oncology research across key markets.

Note: Market size estimates vary across research firms due to differences in scope (e.g., pure diagnostics vs. combined therapeutics & diagnostics, or inclusion of advanced genomic/liquid biopsy tests). The higher-growth projection (13.8% CAGR) reflects broader adoption of emerging precision technologies. The original Grand View Research figures (around USD 3.4 billion in 2023 growing to ~USD 4.79 billion by 2030 at ~4.8–6.5% CAGR) remain conservative compared to newer 2025–2034 outlooks.

Breast Cancer Diagnostics Market

According to Grand View Research, the global breast cancer diagnostics market size was estimated at USD 5.86 billion in 2025 and is projected to reach USD 11.36 billion by 2033, growing at a CAGR of 8.8% from 2026 to 2033.

This growth is expected due to increasing breast cancer incidence rates, advancements in imaging and biomarker-based diagnostics, expanded government screening programs, greater adoption of AI-driven diagnostic tools for early detection, rising awareness campaigns, and improved access to healthcare services in emerging regions.

According to Precedence Research, the global breast cancer diagnostics market size was valued at USD 20.14 billion in 2025 and is projected to reach USD 40.71 billion by 2034, growing at a CAGR of 8.13% from 2025 to 2034.

According to Grand View Research, the U.S. breast cancer diagnostics market size was estimated at USD 2.26 billion in 2024 and is expected to reach USD 2.41 billion in 2025, growing to USD 4.53 billion by 2033 at a CAGR of 8.21% from 2025 to 2033.

This projection is based on increased early detection efforts, growing investment in precision medicine and liquid biopsy technologies, expanding insurance coverage for mammography and genetic testing, and continued innovation in digital pathology and AI-assisted diagnostics. YD Bio’s management believes the trend toward personalized medicine and improvements in non-invasive detection methods are expected to further drive market expansion.

These projections assume continued regulatory support, technological advancements, and sustained investment in breast cancer diagnostics and early detection programs.

Breast cancer incidence update: Breast cancer remains the most common cancer among women globally. According to GLOBOCAN 2022 (the most recent comprehensive global data), there were approximately 2.3 million new cases and 670,000 deaths worldwide in 2022. Incidence is rising by about 1% annually in many countries, with projections indicating a substantial increase by 2050 due to population aging and other factors.

In the United States, the American Cancer Society estimates 316,950 new cases of invasive breast cancer and 59,080 cases of ductal carcinoma in situ (DCIS) in 2025, with approximately 42,170 women expected to die from the disease. Breast cancer accounts for nearly 30% of all new female cancer cases in the U.S. (excluding skin cancers). In Taiwan, the most recent available data from the Taiwan Cancer Registry shows 19,756 new cases, highlighting the disease’s significance in the region.

Note on sources and variations: Market size estimates vary across research firms due to differences in scope (e.g., inclusion of imaging only vs. broader biomarker, genetic, and liquid biopsy testing). The figures from Grand View Research (more conservative, focused on core diagnostics) and Precedence Research (broader inclusion of advanced technologies) provide a balanced longer-horizon view. The original BioSpace-reported numbers (USD 4.5 billion in 2023 at 7.2% CAGR) align directionally with these updated outlooks but have been refreshed with more recent publisher data.

Contact Lens and Glaucoma Treatment Markets

The U.S. contact lenses market generated a revenue of USD 5,222.3 million in 2025 and is expected to reach USD 6,975.8 million by 2033, growing at a CAGR of 3.7% from 2026 to 2033, according to Grand View Research.

According to Precedence Research, the U.S. contact lenses market is estimated at USD 9.76 billion in 2025 and is projected to reach approximately USD 17.83 billion by 2034, growing at a CAGR of 6.21% from 2026 to 2035.

The contact lens market is expected to grow due to rising vision correction needs, increasing eye health awareness, advancements in materials and technology (such as silicone hydrogel and daily disposables), and growing demand for cosmetic and specialty lenses globally.

According to Future Market Insights, “The contact lens solution market is set to register USD 1.91 billion in 2025. The industry is expected to grow at 4.3% CAGR from 2025 to 2035 and reach USD 2.90 billion by 2035.”

According to the Centers for Disease Control and Prevention (“CDC”) and industry estimates, as of 2025, approximately 45 million people in the United States — roughly 16% of the adult population — wear contact lenses, with most preferring soft, disposable types, particularly daily disposables. Worldwide, the number of contact lens users continues to grow steadily, driven by increasing refractive errors and lifestyle factors. In Taiwan, the number of contact lens users is projected to reach approximately 945,000 people by 2025 (around 4% of the total population), with steady growth especially in daily disposable lenses and a strong consumer preference for hydrogel-based options.

The U.S. glaucoma treatment market was valued at approximately USD 2.19 billion in 2024 and is projected to reach around USD 2.78 billion by 2034, growing at a CAGR of 2.30% from 2025 to 2034, according to Precedence Research.

According to Precedence Research, “The global glaucoma treatment market was valued at USD 6.51 billion in 2024. It is projected to reach USD 8.66 billion by 2034... expanding at a CAGR of 2.86%.”

YD Bio’s management believes the glaucoma market will grow due to an aging population, rising prevalence of the disease, advancements in treatment options (including minimally invasive surgeries and novel therapeutics), and increased awareness of early detection and management.

Glaucoma prevalence update: according to the CDC and Prevent Blindness America, glaucoma affects approximately 80 million people worldwide, with projections indicating this number will increase to 111.8 million by 2040. In the United States, around 4.22 million people live with glaucoma, with a significant portion experiencing vision loss due to the disease. In Taiwan, there are currently 380,000 to 400,000 individuals under treatment for glaucoma, and the patient population is growing at a rate of about 8% annually.

Note on sources and variations: Market size estimates vary across research firms due to differences in scope (e.g., inclusion of cosmetic lenses, solution products, or broader vision care categories). Precedence Research and Grand View Research provide balanced, longer-horizon views that align directionally with the original Global Market Insights and earlier Precedence figures while offering extended forecasts to 2034/2035. Growth drivers remain consistent, with emphasis on technological advancements, aging populations, and rising awareness.

These projections assume continued regulatory support, technological progress in lens materials and glaucoma therapies, and sustained investment in eye health across key markets.

Dry Eye Market

According to Fortune Business Insights, the global dry eye syndrome market size was valued at USD 8.00 billion in 2025 and is projected to grow from USD 8.55 billion in 2026 to USD 15.09 billion by 2034, exhibiting a CAGR of 7.37% during the forecast period.

According to Fact.MR, the dry eye syndrome treatment market was worth USD 6.8 billion in 2025 and is predicted to grow to USD 12.2 billion by 2035, with a CAGR of 6.0%.

The U.S. dry eye syndrome treatment market size was estimated at USD 2.45 billion in 2024 and is projected to reach USD 2.59 billion in 2025, growing to USD 3.47 billion by 2030 at a CAGR of 6.0% from 2025 to 2030, according to Grand View Research.

YD Bio’s management believes the dry eye disease market will grow due to aging populations, increased screen time, rising awareness, improved diagnostic tools, and advancements in innovative treatments like artificial tears, drugs, and regenerative therapies.

According to a National Health and Wellness Survey, dry eye disease (“DED”) is a widespread ocular condition that affects an estimated 16.4 million adults in the United States (with some estimates of diagnosed and undiagnosed cases reaching 30–49 million). In Taiwan, data from the National Health Insurance system and recent studies indicate a high burden, with over 1.83 million patients seeking medical treatment for DED in earlier years and prevalence notably higher among those over 65 years (around 33.7%), highlighting its growing clinical and public health significance. The data from Taiwan’s National Health Insurance system indicates thatglobally, DED remains one of the most common eye disorders, with prevalence ranging from 5% to 50% and higher rates observed in Asian populations.

These projections assume continued regulatory support, technological advancements in diagnostics and therapeutics, and sustained investment in dry eye disease management and early intervention programs.

Note on sources and variations: Market size estimates vary across research firms due to differences in scope (e.g., treatment-only vs. broader syndrome market, inclusion of devices or pharmaceuticals). Fortune Business Insights provides a higher 2025 base and stronger growth to 2034, while Grand View Research and Fact.MR offer more conservative figures. The original Fortune Business Insights 2024–2032 numbers have been refreshed with the publisher’s more recent data for accuracy. 

Noninvasive Cancer Detection with Circulating Cell-Free DNA (“cfDNA”) Methylation Technology

Our business focuses on developing highly sensitive and specific noninvasive blood tests for the detection of cancers, including pancreatic, breast, and various other types of cancers. We have licensed cfDNA methylation analysis technology from EG BioMed, a company registered in Taiwan and of which Dr. Shen currently owns a 45.34% equity stake. cfDNA are DNA fragments in the bloodstream, released by dying cells, which enables non-invasive diagnostics, including cancer detection, prenatal testing, and organ transplant monitoring through genetic and epigenetic analysis. This technology has the potential to develop derivative products for monitoring and detecting various types of cancer, including lung, colorectal, breast, liver, oral, prostate, thyroid, gastric, and pancreatic cancers. The early detection technology licensed from EG BioMed should have the advantages being non-invasive, user-friendly and accurate.

EG BioMed’s approach to biomarker discovery and validation combines high-throughput commercially available array technology, AI-powered bioinformatics and cross-cohort analysis. By leveraging these innovations, the company aims to strengthen its early pancreatic cancer detection capabilities. 

Our EG BioMed license agreement for pancreatic cancer was entered into on June 25, 2024, and has an initial term of 10 years with an automatic extension period of 5 years, unless both parties agree not to extend. The agreement was amended on September 30, 2024 to increase the licensed period to 20 years from the date of the original agreement, which was automatically extended for an additional 5 years upon the completion of the Business Combination. Under the agreement, we have agreed to develop jointly, with EG BioMed, products using EG BioMed’s patent and technology in the United States. Under the agreement, we agreed to pay EG BioMed a one-time license fee of NTD 60,000,000 (US$1,848,000) and are required to notify EG BioMed in writing on a quarterly basis of our total sales revenue for sales of the products using EG BioMed’s licensed patent and technology and pay a 7% product royalty on our total sales revenue each quarter for the term of the agreement. Additionally, we are required to pay patent application fees (if any) and patent maintenance fees for the licensed patent and technology, and any patents derived from the licensed patent and technology, as well as expenses, costs, taxes and fees incurred during the term of the agreement.

From a small blood sample, we should be able to utilize the DNA methylation analysis technology to detect the methylation level of tumor suppressor genes in circulating tumor DNA (“ctDNA”) in the blood to assess the risk of cancer and facilitate early cancer detection, cancer progression monitoring and post-treatment evaluation. DNA methylation is an epigenetic modification where methyl groups attach to DNA, regulating gene expression without altering the sequence, playing key roles in development, disease and cellular function. This technology, which detects ctDNA released from tumors undergoing apoptosis (programmed cell death that occurs naturally to maintain healthy tissue, remove damaged cells, or during development, playing a critical role in growth, immune responses, and disease prevention) and necrosis (uncontrolled cell death caused by injury, infection or disease, leading to inflammation and tissue damage, often resulting in the release of harmful substances into surrounding areas), as well as circulating cell-free DNA partially released from the tumor environment — including surrounding stromal tissues (the supportive framework of organs, consisting of connective tissues, blood vessels and extracellular matrix, providing structural integrity and facilitating nutrient and waste exchange for functional cells, and immune blood cells near tumor sites) — undergoes gradual DNA methylation alterations both before and after tumor formation. ctDNA is tumor-derived DNA in the bloodstream, used in non-invasive diagnostics to detect, monitor and analyze cancers by identifying genetic mutations and epigenetic alterations.

We believe our technology is emerging as a powerful tool in real-time cancer detection, reflecting the presence and quantity of tumors in the body. cfDNA methylation analysis technology can precisely detect target genes, identify cancer at gene sites with methylation alterations and be used to assess the risk of different cancers. In connection with this process, we are able to utilize EG BioMed’s DNA methylation artificial intelligence (“AI”) cloud database as test results are connected with disease information and treatment plans, which may become a useful tool for the development of new drugs to accurately monitor cancer cell changes.

The use of cfDNA detection technology supports the principles of precision medicine, allowing for tailored treatment strategies based on individual patient needs. The following are applications of cfDNA detection at various stages of breast cancer treatment:

The integration of cfDNA into clinical practice may be able to provide enhanced accuracy in assessment and decision-making, surpassing traditional genetic testing methods and leading to more personalized patient care. 

On July 11, 2024, EG BioMed submitted a de novo application to the FDA for its breast cancer monitoring blood test. Following a meeting with the FDA, EG BioMed withdrew its FDA de novo application and is targeting a new pre-submission by the end of 2027.

Pancreatic Cancer Testing

In 2025, we obtained an exclusive license to utilize patents and technology from EG BioMed in the U.S. for core methylation detection of pancreatic cancer with what we believe will have a high degree of sensitivity, specificity and accuracy. High rates of sensitivity and specificity are essential in cancer detection to ensure early and precise detection of cancer. This allows timely intervention, improving treatment outcomes and survival rates while minimizing unnecessary procedures. Accuracy ensures confidence in the test’s reliability, ultimately optimizing patient care and resource allocation in healthcare systems.

Development of Our Pancreatic Cancer Technology

The pancreatic cancer study was solely designed and conducted by EG BioMed’s research and development team, with no involvement from YD Bio. The study began in 2023 and is currently ongoing. Methylation markers for Zinc Finger Protein 30 (ZFP30), an indicator for pancreatic cancer, were detected in cfDNA in 96% of plasma samples from pancreatic cancer patients, demonstrating a strong area under the curve (AUC) of 0.96. The assay achieved a sensitivity of 93.8% in stages I and II, 100% in stages III and IV, and a specificity of 97.3%. These findings are based on a total of 388 samples, including 50 pancreatic cancer patients and 338 healthy individuals. The EG BioMed Pancreatic Blood Test-E1 was independently developed by EG BioMed’s research team, leveraging proprietary cfDNA methylation biomarkers to detect pancreatic cancer at early stages.

The pancreatic cancer clinical trial was conducted under the approval of Taipei Medical University-Joint Institutional Review Board (TMU-JIRB, IRB ID No.: N202105091). This prospective study enrolled 100 pancreatic cancer patients and 500 healthy individuals to evaluate the OkaiDx Pancreatic Cancer Detection Blood Test using circulating methylated ZFP30 in plasma as a biomarker. The study design ensured a well-defined cohort of pancreatic cancer patients and healthy individuals, with recruitment carried out at Taipei Medical University Hospital, Wan Fang Hospital and Shuang Ho Hospital.

The primary endpoint of the study was to assess the clinical performance of the OkaiDx Pancreatic Cancer Detection Blood Test in detecting pancreatic cancer by evaluating its sensitivity, specificity and overall accuracy. The test’s performance was validated through receiver operating characteristic (ROC) curve analysis, confirming its ability to distinguish pancreatic cancer patients from healthy individuals with high diagnostic reliability. The study adhered to strict inclusion and exclusion criteria, enrolling only treatment-naïve pancreatic cancer patients and healthy individuals.

Throughout the study, no serious adverse events were reported, as the trial involved only non-invasive blood sample collection. Taipei Medical University and its affiliated hospitals served as clinical sites for patient recruitment and sample collection under IRB supervision, but EG BioMed solely designed, managed, and executed the study. While EG BioMed originated as a spin-off from Taipei Medical University, the company now operates independently, holding full ownership of its intellectual property, technology and clinical research initiatives.

The comprehensive statistical analysis using The Cancer Genome Atlas database was performed solely by EG BioMed’s bioinformatics team, utilizing advanced computational methods to validate the methylation biomarker ZFP30 for pancreatic cancer detection. This analysis confirmed the biomarker’s clinical relevance and diagnostic potential.

EG BioMed has not yet conducted clinical trials for pancreatic cancer detection in the U.S. However, the company has initiated U.S.-based sample collection through Bloodworks, which will support future clinical trials and regulatory submissions in the U.S. In addition, EG BioMed has sourced pancreatic cancer specimens from U.S. and Western cohorts through qualified commercial biorepositories, including BioIVT and other reference medicine suppliers. These specimens are obtained under appropriate ethical approvals and are accompanied by available clinical and demographic data, as provided by the respective suppliers.

EG BioMed

Independent U.S. Laboratory; FDA Regulatory Status

Our collaboration with EG BioMed has led to the establishment of an independent laboratory in the U.S. dedicated to pancreatic cancer early detection and monitoring technology that marks a significant expansion of our research and development capabilities. While EG BioMed’s cancer testing products have not yet received approval from the FDA or equivalent regulatory authorities in any jurisdiction, EG BioMed’s lab in the US has obtained a Washington State Medical Test Site (“MTS”) license, which is equivalent to Clinical Laboratory Improvement Amendments (“CLIA”) certification (CLIA#:50D2316600). An MTS license in health allows entities to provide medical testing services, ensuring compliance with regulations, accuracy in diagnostics, and patient safety for laboratories, telehealth, and diagnostic centers.

The Washington State MTS licensure program is exempt from CLIA and, as such, entities that obtain an MTS license do not need to apply separately to CMS to obtain a CLIA number. Instead, once an MTS application is received, the Washington State Department of Health enters the laboratory data into the federal CLIA database to obtain a CLIA number for the relevant facility. As such, when EG BioMed obtained its MTS license, it additionally obtained CLIA Certificate No. 50D2316600. The CLIA certificate held by EG BioMed’s facility indicates that the laboratory meets the regulatory requirements under CLIA to perform high complexity testing.

The College of American Pathologists (“CAP”) accreditation is the standard for clinical laboratories in the United States, recognized for ensuring the high levels of accuracy, reliability and quality in laboratory testing. For EG BioMed’s laboratory, CAP accreditation confirms that all procedures meet rigorous standards for clinical excellence, providing confidence to regulators, physicians and patients that test results are both precise and reproducible. This certification strengthens EG BioMed’s position as a trusted partner in oncology diagnostics and supports YD Bio’s commitment to global best practices.

We hope to work with providers around the world to identify new patients. We also aim to collaborate with clinics in the U.S., as well as hospitals, insurance companies and pharmaceutical companies to identify and follow up with patients as we begin to test and hopefully market and distribute our pancreatic tests and DNA methylation AI cloud services. On February 26, 2025, a pancreatic cancer blood test was added to the test menu of the MTS license held by EG BioMed. As such, using EG BioMed technology, we will be able to design, manufacture and use within the laboratory a pancreatic cancer detection test that can be marketed by EG BioMed’s Washington State laboratory as a HCP LDT. See the section below entitled “Regulations — U.S. Government Regulation and Product Approval — U.S. Regulation of Medical Devices” for more information regarding U.S. regulatory requirements for LDTs.

Pursuant to a March 2025 U.S. federal district court ruling, FDA clearance or approval is not required for LDTs performed at the request of a HCP. On March 31, 2026, the Company and EG BioMed launched the EG Telehealth Platform, an online portal integrated with an independent telehealth physician network. Although this platform allows patients to initiate testing online, all orders will still be reviewed and authorized by a licensed HCP prior to sample collection (i.e., such tests will not be DTC LDTs). Should YD Bio eventually receive FDA clearance or approval for our tests, we still do not intend to offer them as fully DTC products, but instead intend to offer them as products that require an order from a licensed HCP (i.e., again, such tests will not be DTC LDTs). It is possible — though unlikely, given that the government has not appealed the March 2025 ruling, and the deadline to do so has passed — that the FDA could determine that tests initiated by consumers are still subject to the Agency’s regulatory oversight, despite the involvement of a HCP and the March 2025 ruling. In this event, YD Bio may be required to obtain regulatory approval or clearance for its test products.

EG BioMed previously entered into a strategic partnership with a U.S.-based CRO, Arbelos Genomics Inc., in October 2024, to support the regulatory submission process to the FDA for clearance or approval of its pancreatic blood cancer test. If the FDA permits, following the March 2025 court ruling, EG BioMed intends to seek approval for a version of this test that does not strictly fall within the definition of an LDT, i.e., a version of the test that is not developed, validated, and performed within a single laboratory that is certified under the CLIA and meets the regulatory requirements under CLIA to perform high complexity testing. If this were to occur, EG BioMed would seek to obtain this approval either via the de novo classification process or via a PMA. Additionally, and if approval is obtained, YD Bio intends to market (1) the approved version of the pancreatic cancer diagnostic test and (2) the LDT version of the pancreatic cancer diagnostic test (in compliance with the requirements for the test to be deemed an LDT). This is because certain markets and entities may prefer to utilize the product as an FDA approved test, while others may prefer to utilize the product as an LDT. 

An FDA-approved in vitro diagnostic (“IVD”) test can be adopted across all levels of clinical care — from national hospitals and affiliated medical centers to regional clinics — making it highly scalable and widely trusted. Achieving FDA approval involves rigorous clinical validation and comprehensive analytical studies to ensure performance, stability, reproducibility and clinical effectiveness.

FDA-approved tests are often preferred by large hospital networks, government healthcare systems (e.g., Medicare/Medicaid), insurance payers, international regulatory bodies and pharmaceutical partners — entities that prioritize regulatory certainty, legal defensibility and broad reimbursement eligibility.

That said, the pace of innovation in diagnostics is accelerating. LDTs play a vital role in bridging the gap between discovery and regulation. They offer flexibility for ongoing technical refinement and allow early market introduction. This real-world deployment helps identify unmet clinical needs and gather valuable data — laying the groundwork for a more robust, FDA-approved IVD in the future.

LDTs are typically favored by CLIA-certified labs, early adopting clinicians and niche research institutions who value agility, customization and early access to innovation, especially when FDA pathways are too slow or cost-prohibitive.

The selected CRO brings extensive expertise in IVD, with over 15 years of experience and a proven track record of successfully completing nearly 200 trials. The CRO will provide comprehensive project management and support, including regulatory affairs guidance, site selection and initiation, recruitment assistance, clinical monitoring, data management and other critical services.

The FDA classifies medical devices into Class I, Class II, and Class III based on risk. Class I devices, such as bandages and gloves, pose low risk and are subject to minimal regulatory controls, often exempt from premarket review. Class II devices, such as blood pressure monitors, present moderate risk and require general and special controls, including 510(k) premarket clearance to demonstrate substantial equivalence to existing devices. Class III devices, such as pacemakers, pose high risk, sustain or support life, and require an approval under a PMA, which requires the submission of clinical data to ensure safety and effectiveness. The classification ensures patient safety while enabling innovation. EG BioMed submitted an FDA de novo application FDA for its breast cancer blood tests as a Class II medical device.

EG BioMed is actively preparing its pancreatic cancer blood test for regulatory submission and is evaluating expedited pathways, such as the FDA’s Breakthrough Devices Program or Safer Technologies Program (“SteP”) for Medical Devices. The FDA’s Breakthrough Devices Program accelerates the development and review of innovative medical devices that provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. It offers prioritized guidance, faster review timelines, and collaborative feedback, helping patients access cutting-edge technologies sooner while maintaining safety and efficacy standards. The SteP expedites the development and review of medical devices and combination products that significantly improve safety for non-life-threatening conditions. It provides prioritized guidance, efficient regulatory pathways and enhanced interaction with the FDA, promoting access to safer, innovative technologies while ensuring rigorous safety and effectiveness standards. Following its evaluation, the company intends to file a formal request for a pre-submission meeting with the FDA to obtain feedback on the proposed regulatory pathway and clinical trial design.

This partnership and the subsequent regulatory steps mark significant progress in EG BioMed’s mission to advance innovative early detection solutions for pancreatic cancer.

The FDA application was originally prepared by EG BioMed because EG BioMed collected, organized, and managed the clinical data that is included in the application. The collection, organization, and management of the clinical data was completed under the oversight of the Taiwan Institutional Review Board. As a result, EG BioMed, rather than YD Bio, is in the best position to submit the application because it directly manages the clinical data in accordance with regulatory requirements and can best ensure the accuracy of the application. For that reason, EG BioMed is continuing to pursue the application with FDA rather than YD Bio.

EG BioMed has engaged two FDA consultants, Research & Development LLC (“RDI”) and IVD Regulatory Advisors LLC (“IVDRA”), to provide comprehensive support to EG BioMed in preparing and submitting a submission to the FDA to request Breakthrough Device designation. The pre-submission meeting with the FDA is targeted by the end of 2027.

On January 06, 2026, the Company announced that it has entered a non-binding MOU to merge with EG BioMed.

Breast Cancer Testing

Breast cancer is the second leading cancer-related cause in women. According to SEER Cancer Statistics Review, nearly 20 – 30% of patients with early-stage disease develop metastases over the disease course. In clinical practice, detecting recurrence or metastasis in patients with stage II or III breast cancer through blood tests remains a significant challenge. This often necessitates advanced imaging procedures such as CT or MRI scans, or bone scans, which, while accurate, are not convenient for routine clinical needs due to their high cost, limited accessibility and often restricted insurance coverage. In countries like the U.S., where these procedures are expensive and insurance coverage is limited, they are typically reserved for patients presenting overt symptoms rather than being used as a regular monitoring tool.

Current blood tests for breast cancer monitoring lack sufficient sensitivity. According to previous literature, the CA-153 level has a sensitivity of only 60% – 70%. Even the simultaneous use of serum markers CA-153 and carcinoembryonic antigen (CEA) results in diagnosing metastasis in up to 60% – 80% of patients with breast cancer early, while according to our unpublished data, the simultaneous use of both CA-153 and CEA resulted in the early diagnosis of metastasis in less than 50% of patients with breast cancer. We aim to change this by utilizing the DNA methylation analysis technology for which we have an exclusive license from EG BioMed covering EG BioMed’s patent and know-how. The licensed patent has been successfully approved sequentially in Taiwan, Europe, Malaysia, China, Spain, Poland and the U.S. Additionally, the patent is currently under review and defense proceedings in Japan, Korea, Singapore and Australia. The license includes, for example, U.S. patent application No. 17/053,688, titled “Methods for Early Prediction, Treatment Response, Recurrence, and Prognosis Monitoring of Breast Cancer.” On November 6, 2024, the United States Patent and Trademark Office issued an allowance for certain claims under this application. YD Bio is obligated to pay a royalty of 20% of the revenue of the sales or services generated from this technology to EG BioMed on a quarterly basis.

As a result of the Business Combination, the Agreement between EG BioMed and Yong Ding became effective, granting the Company an exclusive sublicense to the licensed patents and know-how related to methylation analysis technology for breast cancer detection and applications. We believe this technology will allow us to develop, market and sell noninvasive tests to diagnose breast cancer with only 8 milliliters of blood for circulating with what we believe to be a high degree of sensitivity, specificity and accuracy.

Development of Our Breast Cancer Testing Technology

The clinical study titled “Development of cell-free methylated DNA markers for tracking treatment response and recurrence of breast cancer patients following treatment” was conducted as an investigator-initiated trial (IIT) at Taipei Medical University under the approval of the Institutional Review Board of Taiwan. The study began in 2016 and continued through 2023, enrolling breast cancer patients from Stage 0 to Stage IV at Taipei Medical University Hospital and Shuang Ho Hospital. The research was supported by grants obtained by Professor Ruo-Kai Lin’s team before EG BioMed was formally established in 2022. Upon its establishment, EG BioMed acquired the intellectual property and technology related to these detection platforms from Taipei Medical University but was not the original sponsor of the trials and was not involved in the execution of the trials. However, EG BioMed has integrated clinical findings into its regulatory and product development strategy.

The breast cancer detection study followed a prospective observational design with longitudinal sample collection at multiple time points, including before surgery, 24 hours after surgery, every three months for the first two years post-treatment, and every six months for the following three years. The study population included 166 participants in a pilot study and 325 participants in the full-scale validation study. Patient samples were collected at Taipei Medical University Hospital and Shuang Ho Hospital, where clinical biomarkers and imaging data, including MRI, CT, ultrasound, CA15-3, and CEA, were obtained. The study was planned to last between seven to ten years, with each participant followed for five years. In the test cohort of 166 breast cancer patients, detection of methylated GCM2 and TMEM240 achieved an accuracy of 97.0%, sensitivity of 81.8%, and specificity of 99.3%. In the validation cohort of 325 patients, the test demonstrated an accuracy of 95.4%, sensitivity of 89.2%, and specificity of 96.9%. The combined detection of these methylated genes significantly outperformed traditional biomarkers, including CA-153 and CEA. The study began in 2017 and is currently ongoing.

The primary endpoint of the study was to assess the ability of the OkaiDx Breast Cancer Monitoring Blood Test to track breast cancer recurrence and progression by detecting circulating methylated GCM2 and TMEM240 in patient plasma. The study aimed to determine the clinical accuracy, sensitivity, and specificity of these markers. Statistical analyses included qPCR cycle threshold (Ct) value calculations, receiver operating characteristic (ROC) curve analysis, area under the curve (AUC) measurements, and the Mann-Whitney U test for mean Cp value comparisons. The trials were statistically powered to evaluate diagnostic performance, with p-values and statistical significance levels documented in study reports.

The study applied strict participant enrollment criteria. Eligible participants were women aged 20 to 75 years diagnosed with breast cancer from Stage 0 to Stage IV. Exclusion criteria included patients under 20 or over 75 years old, patients with physical, sensory, or cognitive disabilities preventing participation, patients with recent intravenous infusions such as blood transfusions that could affect sample integrity, and individuals who failed to provide informed consent.

Since the study focused on non-invasive blood-based biomarker detection, there were no reported serious adverse events related to the sample collection process. Taipei Medical University played a research and clinical support role by providing infrastructure, patient recruitment, sample collection, and IRB oversight. While EG BioMed was established as a technology spin-off from Taipei Medical University, the company operates independently and owns the intellectual property and clinical data derived from these studies.

The comprehensive statistical analysis of biomarker signatures using The Cancer Genome Atlas database was conducted by Professor Ruo-Kai Lin and EG BioMed’s bioinformatics team. The analysis validated the methylation markers GCM2 and TMEM240 as predictors of breast cancer progression and hormone therapy response.

EG BioMed has partnered with Bloodworks to facilitate blood sample collection from healthy individuals in the U.S. Bloodworks will also support the Institutional Review Board (IRB) approval process for part of future U.S.-based clinical studies.

FDA Regulatory Status

In July 2024, EG BioMed submitted a de novo application to the FDA for its breast cancer monitoring blood test. On September 24, 2024, the company received a decision letter detailing several points that were required to be addressed within 180 days. Notably, FDA provided feedback requesting modifications to clinical trial and analytical study design.

The FDA recommended developing a longitudinal study, strengthening sample validation to ensure independent data sets for training and validation, and incorporating U.S. clinical samples that more accurately reflected U.S. demographics. The FDA noted that the study must also include at least 50 progression cases, with a minimum of 25 cases from Stage 2 and 25 from Stage 3, while explicitly excluding Stage 1 and Stage 4 patients from all assays to align with the intended use. To address additional feedback from the FDA, cybersecurity and software validation for the COBAS z480 analyzer must be obtained from Roche, and the Streck cfDNA BCTs 510(k) application must be updated to include precision and accuracy testing for its use in breast cancer blood monitoring.

Following a productive meeting with the FDA, EG BioMed withdrew its pending de novo application. EG BioMed intends to revise the study design, continue clinical sample collection and submit a comprehensive study plan for pre-submission review to the FDA by the end of 2027. Engaging in the pre-submission process with the Agency will help ensure that all experimental designs and preliminary data align with FDA requirements before the next de novo application submission. To assist with this process, EG BioMed has engaged RDI and IVDRA. Nonetheless, there is no assurance that the FDA will accept the additional information submitted by the Company — or it may request further additional information — in which case the breast cancer monitoring blood test would not be granted de novo status. In that case, a PMA may be required.

In the meantime, EG BioMed has established a dedicated testing laboratory in the United States. This independent laboratory, which was first opened in February 2025, is certified under CLIA and meets the regulatory requirements under CLIA and CAP to perform high complexity testing. As such, using EG BioMed technology, we hope to be able to design, manufacture and use within the laboratory, a breast cancer monitoring blood test that can be marketed by EG BioMed’s Washington State laboratory as a HCP LDT.

EG BioMed has additionally engaged IVDRA to assist with developing a submission strategy with the FDA, as well as drafting and reviewing all documents required by the FDA.

Timeline for Bringing Our Pancreatic and Breast Cancer Blood Test Services and Products to Market

While CLIA continues to serve as the primary regulatory framework for HCP-ordered LDTs within a single lab, tests marketed directly to consumers may be treated by the FDA as IVD medical devices subject to broader regulatory requirements, including pre-market review and quality system compliance. As such, we have established regulatory pathways and timelines to obtain FDA authorization prior to the full launch of any direct-to-consumer-initiated offering.

 
See below for the status of selected items on our path to bringing our pancreatic and breast cancer blood test services and products to market: 

Taiwan

USA

EG BioMed conducts comprehensive validation of the cfDNA methylation blood tests to ensure accuracy, specificity, sensitivity, and reproducibility in detecting methylation patterns. Validation of the cfDNA methylation blood tests confirms the reliability of such tests for clinical applications, including cancer diagnosis. To achieve this, EG BioMed conducts a series of analytical assessments, including: