BioSig Technologies - 10-K annual report 2025

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM10-K

☒ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Fiscal Year Ended December 31, 2025

Or

☐TRANSITION REPORT UNDER SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _______ to ______

Commission File Number 001-38659

STREAMEX CORP.

(Exact name of registrant as specified in its charter)

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

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined by Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐ No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

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 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal controls over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant as of June 30, 2025 (the last business day of the registrant’s most recently completed second fiscal quarter) was approximately $190 million.

As of March 27, 2026, there were 97,721,696 shares of the registrant’s common stock outstanding.

Exchangeable Shares and Special Voting Stock:

As of March 27, 2026, there were outstanding 83,420,765 exchangeable shares of BST Sub ULC, a wholly owned subsidiary of the registrant. The exchangeable shares are exchangeable for an equal number of the registrant’s common stock, and carry rights substantially equivalent to the Company’s common stock, including rights to dividends, liquidation preferences, and voting (via a Special Voting Preferred Stock held by a trustee). 

TABLE OF CONTENTS

PART I

Note on Forward-Looking Statements

This Annual Report on Form 10-K (including the section regarding Management’s Discussion and Analysis of Financial Condition and Results of Operations) contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical fact contained in this Annual Report on Form 10-K are forward-looking statements. These forward-looking statements relate to, among other things, our business, financial condition, results of operations, and prospects, including, but not limited to, statements regarding our business strategy and objectives; our expectations concerning the regulatory compliance, and commercialization of our products and services (including our digital asset tokenization platform and the GLDY gold-backed digital token, which has launched and is actively accepting subscriptions); the integration and development of the Streamex business; our future capital needs and financial position, including our ability to raise capital or refinance obligations and the impact on our liquidity; our plans to develop additional tokenized financial products and any expected benefits, adoption, or regulatory approvals related thereto; our anticipated future operating results; and our plans and prospects for sales, marketing, and product expansion in our digital asset segments. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these terms, and similar expressions or variations of such words.

Although forward-looking statements in this Annual Report on Form 10-K reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in, or anticipated by, the forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes include, without limitation, those specifically addressed under the heading “Risk Factors” below, as well as those discussed elsewhere in this Annual Report on Form 10-K, including risks and uncertainties related to (among other things) the technical and market feasibility of digital asset products (such as our GLDY gold-backed token, which has launched, and related tokenization platforms); evolving regulatory requirements applicable to digital assets, token offerings, and related financial services activities; difficulties or delays in integrating acquired businesses or realizing anticipated benefits from such acquisitions; volatility in the market price of gold or other underlying assets; development, clinical validation, and regulatory clearance of medical devices and related software; our ability to manage and finance our operations and repay or refinance indebtedness; our dependence on key personnel; our relationships with strategic partners, third-party custodians, manufacturers, and suppliers; and the outcome of corporate transactions and financing arrangements. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this Annual Report on Form 10-K. We file reports with the Securities and Exchange Commission (“SEC”). The SEC maintains an Internet site (www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC, including us.

We undertake no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this Annual Report on Form 10-K, except as required by law. Readers are urged to carefully review and consider the various disclosures made throughout the entirety of this Annual Report on Form 10-K, including the disclosures under the heading “Risk Factors,” which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.

Unless otherwise mentioned or unless the context requires otherwise, all references in this Annual Report on Form 10-K to the “Company,” “we,” “us,” “our,” “Streamex,” or similar terms refer to Streamex Corp., a Delaware corporation, and its consolidated subsidiaries.

ITEM 1 – BUSINESS

Corporate Structure

Streamex Corp. (formerly BioSig Technologies, Inc.) (“Streamex,” “we,” “us,” or the “Company”) was originally formed as a Nevada corporation in February 2009 and reincorporated in Delaware in April 2011 through a merger with its wholly owned Delaware subsidiary, with the Delaware entity surviving.

On May 28, 2025, the Company completed the acquisition of Streamex Exchange Corporation (“Streamex Exchange”), a corporation incorporated under the laws of British Columbia on April 5, 2024. The acquisition was consummated pursuant to a share purchase agreement dated May 23, 2025, as amended (the “Share Purchase Agreement”).

The Streamex Exchange acquisition was structured through the issuance of exchangeable shares by the Company’s wholly owned British Columbia unlimited liability company subsidiary (“ExchangeCo”). Each exchangeable share is exchangeable, on a one-for-one basis and subject to certain adjustments, for a share of the Company’s common stock. The holders of exchangeable shares would be entitled to exchange such shares for an aggregate of 109,070,039 shares of the Company’s common stock representing up to 75% of the Company’s fully diluted common stock as of the Agreement date. The exchangeable shares carry rights that are substantially equivalent to those of the Company’s common stock. On November 4, 2025, the Company obtained shareholder approval, which removed the conversion cap and allowed holders to exchange the exchangeable shares into the Company’s common stock in accordance with the exchange rights.

On September 12, 2025, the Company changed its name from BioSig Technologies, Inc. to Streamex Corp., and on September 12, 2025, its common stock, listed on The Nasdaq Capital Market, began trading under the ticker symbol “STEX,” replacing the former ticker symbol “BSGM.”

The Company’s principal business is tokenized finance and real-world asset (“RWA”) digitization, conducted through Streamex. The Company also retains a legacy healthcare technology innovation, focused on advanced signal acquisition and analysis through the Company’s PURE EP™ platform.

On November 7, 2018, the Company formed a Delaware subsidiary originally named NeuroClear Technologies, Inc. to pursue additional applications of its signal processing technology outside of cardiac electrophysiology. In March 2020, this subsidiary was renamed ViralClear Pharmaceuticals, Inc. (“ViralClear”). As of December 31, 2025, the Company owned approximately 69.7% of ViralClear’s outstanding equity. See “ViralClear Business Overview” for additional information.

On July 2, 2020, the Company formed another Delaware subsidiary, NeuroClear Technologies, Inc., which was renamed BioSig AI Sciences, Inc. (“BioSig AI”) on May 31, 2023. BioSig AI was established to pursue applications in cardiac and neurological disorders through advanced recordings and analyses of action potentials, including artificial intelligence-enabled diagnostic and therapeutic technologies. As of December 31, 2025, the Company owned approximately 84.5% of BioSig AI’s outstanding equity.

Business Overview

The Company is a technology company with two principal lines of business: (i) Tokenized Asset Finance, focused on digital asset and real-world asset tokenization via our Streamex Exchange platform, and (ii) Biomedical Technology, focused on advanced signal processing solutions in electrophysiology. In 2025, we expanded beyond our historical biomedical business through the strategic acquisition of Streamex Exchange, a developer of blockchain-based financial technology. This acquisition (completed in May 2025) marked our entry into financial technology, specifically the tokenization of real-world assets (“RWAs”), such as precious metals, via secure digital tokens.

Our Streamex Exchange platform (developed by Streamex Exchange prior to its acquisition) is designed as an institutional-grade system that enables the issuance, trading, and custody of digital tokens backed by tangible assets. The initial application of this platform is in the tokenized gold market: we have launched a tokenized gold product called GLDY, which provides investors with a digital token representing fractional interests in a special purpose vehicle domiciled in the Cayman Islands (the “SPV”), which holds physical gold and participates in a gold leasing program. Each GLDY Token corresponds to one troy ounce of gold held by the SPV, with yield features generated through gold leasing activities administered through a Tokenized Yield Partnership Agreement (the “MM Agreement”), by and between the Company and Monetary Metals & Co., a Delaware corporation (“Monetary Metals”). The Company intends to issue other products offering tokenized exposure to metals and other commodities in the future.

With the integration of the Streamex Exchange business, the Company intends to position itself as a leader in financial technology. Our long-term vision is to leverage our expertise in high-fidelity signal processing and secure, scalable transactions to facilitate the digital transformation of real-world assets in a regulated, transparent manner, while continuing to support our advanced medical devices that improve patient care.

Streamex

Streamex developed and is operating an institutional grade technology platform that supports the tokenization of real-world assets, including gold, and other physical commodity asset interests. The Company operates as an infrastructure provider, enabling the issuance, trading, and backend infrastructure for digital tokens backed by tangible commodities, beginning with gold.

Business Model

Nature of Operations

Streamex is a technology focused Company on digital infrastructure for the tokenization and exchange of real-world assets and other commodity-linked financial products. On May 28, 2025, we acquired Streamex Exchange, a software development company based in Vancouver, British Columbia. In connection with this strategic expansion, on September 12, 2025, we changed our corporate name from BioSig Technologies, Inc. to Streamex Corp., and effective September 12, 2025, our common stock began trading on The Nasdaq Capital Market under the ticker symbol “STEX” (formerly “BSGM”).

On May 28, 2025, the Company completed the acquisition of Streamex Exchange pursuant to that certain Share Purchase Agreement dated as of May 23, 2025 (as amended on May 27, 2025, the “Share Purchase Agreement”) by and among the Company, BST Sub ULC, an unlimited liability company organized under the laws of the Province of British Columbia and a wholly owned subsidiary of the Company (“ExchangeCo”), 1540875 B.C. Ltd., a British Columbia company and a wholly owned subsidiary of the Company (“Callco”), the shareholders of Streamex Exchange, and 1540873 B.C. Ltd., as trustee (the “Trustee”) under the exchange rights agreement entered into among the Company, ExchangeCo, Callco, and the Trustee (the “Exchange Rights Agreement”). Streamex Exchange is a software development company based in Vancouver, British Columbia focused on building digital tools and platforms intended to facilitate commodity trading and finance.

These outputs are expected to enable monetization through multiple fee-based and recurring revenue models across the commodity and digital asset lifecycle.

Streamex Potential Revenue Streams

Streamex’s revenue model consists of the following core business lines:

Streamex’s Strategy

Streamex has launched a tokenized gold product called GLDY, tokenized security representing fractional interests in the SPV, which is designed to provide investors with yield on gold leases. This asset is designed to provide accredited and qualified investors with exposure to the spot price of gold through the SPV’s physical gold storage, as well as a yield from the SPV’s gold leasing program. 

Streamex expects to earn revenue through tokenization fees, trading fees, and yield spreads, while operating with minimal direct exposure to commodity price risk.

Growth Strategy

Streamex plans to scale its operations through:

The Company also intends to scale its internal treasury strategy, re-deploying capital across multiple token issuance cycles per year to increase gold-linked asset holdings and maximize capital efficiency.

Technology Platform

Streamex’s proprietary tokenization protocol supports:

The Company seeks to actively develop features such as real-time proof-of-reserves dashboards, physical redemption protocols, and third-party custodial integrations.

BioSig

The Company retains a legacy technology business focused on advanced digital signal processing solutions for electrophysiology. The Company’s PURE EP™ Platform (“PURE EP™”), is designed to deliver real-time, high-fidelity cardiac signal data to electrophysiologists during ablation procedures for the treatment of cardiovascular arrhythmias.

The PURE EP™ Platform enables the acquisition of raw intracardiac signals with minimal noise and interference, supporting improved procedural outcomes and clinical decision-making. By preserving the integrity of complex cardiac signals, PURE EP™ is intended to enhance workflow efficiency and support the treatment of challenging arrhythmias, including ventricular tachycardia (VT) and atrial fibrillation (AF).

In recent quarters, we have shifted our strategic focus from commercial hardware distribution to the research and development of proprietary software algorithms. These algorithms aim to advance the understanding of cardiac tissue characteristics and ablation mechanisms. Data collection efforts began in December 2023 and remain ongoing. A key area of focus is improving the specificity and long-term outcomes of pulsed field ablation (PFA), a rapidly adopted technique in electrophysiology.

As of December 31, 2025, our intellectual property portfolio related to the medical device business includes:

The Company continues to evaluate strategic alternatives for its legacy majority-owned subsidiaries ViralClear Pharmaceuticals, Inc. (“ViralClear”) and BioSig AI Sciences, Inc. (“BioSig AI”).

ViralClear was established to pursue additional applications of PURE EP™ signal processing technology outside of EP. Subsequently it also was developing merimepodib, a broad-spectrum anti-viral agent that showed potential to treat COVID-19. We ceased the development of merimepodib in late 2020 and realigned ViralClear with its original objective. Currently, the business is dormant and ViralClear’s business objectives are being evaluated. As of December 31, 2025, the Company held a majority interest of approximately 69.7% in ViralClear.

BioSig AI was established to pursue clinical needs of cardiac and neurological disorders through recordings and analyses of action potentials. BioSig AI aims to contribute to the advancements of AI-based diagnoses and therapies. BioSig AI was developing AI solutions for the hospital marketplace utilizing structured, semi-structured, and unstructured data. BioSig AI’s business operations have currently been placed on hold. At December 31, 2025, the Company held a majority interest of approximately 84.5% in BioSig AI.

As of December 31, 2025 and 2024, the Company held majority interests of approximately 69.7% and 69.08%, respectively, in ViralClear. As of December 31, 2025 and 2024, the Company held majority interests of approximately 84.5% in BioSig AI.

Recent Developments

GLDY Launch

On February 25, 2026, Streamex officially launched GLDY and opened its platform, app.streamex.com, to accept subscriptions from qualified investors. Investors can view information about GLDY on Streamex’s website, and view data about its deployment at https://app.rwa.xyz/assets/GLDY. Information contained on, or accessible through, these websites is not incorporated by reference into, and does not form a part of, this Annual Report on Form 10-K.

Underwritten Public Offering

On January 26, 2026, the Company closed on an underwritten public offering with Needham & Company, LLC, as representative of the several underwriters (the “Underwriters”), pursuant to which the Company sold and issued to the Underwriters an aggregate of 11,666,667 shares of the Company’s common stock, at $3.00 per share. In addition, on January 27, 2026, the Underwriters fully-exercised their over-allotment option, purchasing an additional 1,750,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The aggregate gross proceeds to the Company from the offering (including the over-allotment option), before deducting the underwriting commissions and other estimated offering expenses, were $40.25 million. The Company used the net proceeds from the Offering to repay prior indebtedness in accordance with our financing strategy, and for working capital and general corporate purposes.

Secured Convertible Debenture Financing

On July 7, 2025, we entered into a Debenture Purchase Agreement (as amended, the “DPA”) with YA II PN, Ltd. (“Yorkville”), pursuant to which we may issue, subject to conditions, up to $50.0 million aggregate principal amount of secured convertible debentures (with an additional $50.0 million option subject to mutual agreement). We issued a $25.0 million first tranche on November 4, 2025 (net proceeds of approximately $22.2 million), of which $12.6 million was allocated to vaulted physical gold, and a $25.0 million second tranche on December 17, 2025 at 96% of principal (before expenses). The November 4, 2025 debenture and the December 17, 2025 debenture mature on November 4, 2027 and December 17, 2027, respectively, the debentures bear interest at 4.00% per annum (increasing to 18.00% upon an event of default until cured), and are convertible into shares of our common stock at a conversion price equal to the lower of (i) $6.016 per share (subject to a one-time downward-only reset) and (ii) 97.0% of the lowest daily VWAP during the three trading days immediately preceding conversion, subject to a $4.00 floor and customary adjustments; conversions are subject to a 4.99% beneficial ownership limitation. We may prepay the debentures prior to maturity, subject to a 10% prepayment premium and a notice period during which Yorkville retains the right to convert, and there can be no assurance that we will be able to issue any additional debentures under the DPA. Pursuant to a registration rights agreement, we filed a resale registration statement on November 19, 2025, which the SEC declared effective on December 10, 2025, to register the shares issuable upon conversion (including interest). On January 22, 2026, we delivered an irrevocable optional prepayment notice; on February 6, 2026, Yorkville converted $15.0 million of principal at $4.00 per share, resulting in the issuance of 3,750,000 shares, and we prepaid the remaining amounts for an aggregate cash payoff of $38.9 million (comprised of $35.0 million principal, $3.5 million prepayment premium, and $403 accrued interest), after which the related security interests were released.

Standby Equity Purchase Agreement

On July 7, 2025, we entered into the SEPA with Yorkville, pursuant to which the Company has the right, but not the obligation, to issue and sell to Yorkville up to $1.0 billion of its common stock, from time to time during the 36-month commitment period under the SEPA, subject to certain terms, limitations and conditions.

On January 22, 2026, we delivered a notice to Yorkville terminating the SEPA, effective as of January 29, 2026. During the term of the SEPA, we did not sell any shares of common stock under the SEPA.

Our Industry

Digital Asset Infrastructure and Real-World Asset Tokenization

The Company operates in the emerging digital financial infrastructure industry, with a focus on the tokenization, issuance, custody, and exchange of real-world assets (“RWAs”), beginning with precious metals such as gold. Real-world asset tokenization refers to the representation of ownership interests in physical or financial assets through blockchain-based digital tokens. These tokens are designed to reflect direct or indirect economic exposure to the underlying asset and may facilitate improved transferability, settlement efficiency, transparency, and programmability relative to traditional financial instruments.

Historically, ownership and financing of physical commodities such as gold have relied on a combination of physical custody arrangements, warehouse receipts, exchange-traded products, and over-the-counter contracts. These structures often involve multiple intermediaries, limited transparency into underlying reserves, manual reconciliation processes, extended settlement cycles, and operational friction. In addition, access to commodity-backed yield products has traditionally been limited to institutional participants or specialized financial vehicles.

Recent advances in distributed ledger technology, cryptographic security, and digital custody frameworks have enabled the development of platforms that seek to modernize commodity ownership and financing by integrating physical asset custody with digital issuance and transfer mechanisms. Tokenized commodity platforms are intended to allow for fractionalized ownership, near-real-time settlement, enhanced auditability, and programmable compliance features, while maintaining linkage to physical assets held in secure custody.

Gold-Backed Digital Assets and Yield Structures

Gold has historically served as a store of value and a monetary asset, particularly during periods of macroeconomic uncertainty, inflation, or geopolitical instability. Demand for gold exposure spans retail, institutional, and sovereign participants and includes both investment and treasury management use cases. Traditional gold investment vehicles include physical bullion, allocated and unallocated accounts, exchange-traded funds, futures contracts, and leasing arrangements. Each of these structures carries varying degrees of counterparty risk, liquidity constraints, settlement complexity, and operational overhead.

Tokenized gold products seek to combine attributes of physical ownership with the operational efficiencies of digital assets. These products may be structured to provide exposure to spot gold prices, enable transferability through blockchain-based systems, and, in certain cases, incorporate yield-generating mechanisms derived from underlying leasing, financing, or structured arrangements. Yield-bearing gold products have historically been limited in accessibility and often require specialized counterparties, minimum investment sizes, or bespoke contractual frameworks.

The Company’s Streamex platform is being developed to support compliant issuance and lifecycle management of tokenized commodity linked products, including gold denominated instruments. accredited, qualified, or institutional investors, as applicable.

Market Evolution and Institutional Adoption

The broader digital asset industry has evolved beyond cryptocurrencies toward infrastructure supporting regulated financial instruments, tokenized securities, and on-chain representations of traditional assets. Financial institutions, commodity market participants, and technology providers are increasingly exploring blockchain-based systems for settlement, custody, collateral management, and issuance of asset-backed products. This evolution has been driven by demand for operational efficiency, improved risk management, enhanced transparency, and reduced settlement times.

Institutional adoption of digital asset infrastructure has accelerated as regulatory clarity, enterprise-grade custody solutions, and compliance tooling have improved. At the same time, market participants continue to face challenges related to interoperability, regulatory uncertainty, counterparty risk, cybersecurity, and scalability. Platforms operating in this industry must address these challenges through robust governance frameworks, secure system architecture, third-party custody arrangements, and comprehensive compliance controls.

Regulatory Environment

The tokenization and digital asset infrastructure industry is subject to an evolving and complex regulatory landscape that varies by jurisdiction. Activities related to the issuance, trading, custody, and settlement of tokenized assets may be subject to regulation under securities laws, commodities laws, anti-money laundering and know-your-customer requirements, and other financial services regulations. Regulatory authorities in multiple jurisdictions continue to evaluate and refine frameworks applicable to digital assets and tokenized financial products.

Compliance with applicable regulatory requirements is a critical component of operating in this industry. Market participants must design systems and products that incorporate appropriate investor eligibility controls, disclosure practices, custody safeguards, and reporting mechanisms. Regulatory developments may impact product design, market access, operating costs, and the timing or feasibility of commercial launches.

Industry Risks and Competitive Landscape

The digital asset and tokenized RWA industry is characterized by rapid technological change, evolving standards, and increasing competition from both established financial institutions and emerging technology firms. Competitors may include digital asset exchanges, commodity trading platforms, fintech companies, and traditional financial services providers developing proprietary blockchain-based solutions.

Risks inherent in the industry include technology failures, cybersecurity incidents, regulatory changes, market volatility, counterparty risk, and uncertainty regarding user adoption.

Our Product

Streamex Digital Asset Infrastructure Business

Through Streamex, the Company operates a digital infrastructure business focused on the tokenization, issuance, and lifecycle management of real world asset (“RWA”) financial products, with an initial emphasis on gold backed and commodity linked instruments. Streamex operates as a technology and infrastructure platform intended to support digital issuance, custody integration, and transactional workflows for asset backed financial products.

The Streamex platform (the “Streamex Platform”) is designed to operate as an infrastructure provider rather than a principal commodity owner or trading counterparty. The platform is intended to enable third-party issuers, institutional participants, and qualified investors to access tokenized representations of real-world assets within applicable regulatory frameworks. Streamex is not designed to take proprietary commodity price exposure and is structured to operate with limited direct exposure to underlying commodity price volatility.

Business Model and Platform Scope

Streamex’s business model is focused on the development and operation of the Streamex Platform, a software based infrastructure solution that supports the digital representation and administration of tokenized RWA products. The platform is intended to support multiple stages of the asset lifecycle, including onboarding, issuance, transfer, settlement, reporting, and redemption, subject to applicable regulatory requirements.

The Streamex Platform is being designed to support:

The Company expects the Streamex Platform to generate revenue primarily through fee based models, including issuance fees, transaction based fees, platform access fees, and other recurring or usage based fees, depending on product structure and market adoption. While subscriptions for GLDY are actively being accepted, Streamex has not yet generated material revenue from its fee models.

Initial Product Focus: Gold-Linked Digital Instruments

In connection with the ongoing development of the Streamex Platform, Streamex has announced the launch of GLDY (“GLDY”), a gold backed tokenized security representing fractional interests in a Cayman Islands exempted company (the “GLDY SPV”), which holds physical gold in custody with an LBMA-accredited custodian and participates in a gold leasing program administered by Monetary Metals. GLDY is currently being offered and sold on the Streamex Platform to accredited and qualified investors.

Gold has historically served as a store of value and a component of institutional and treasury level asset allocation strategies. Traditional gold investment and financing structures often involve operational complexity, limited transparency, and settlement inefficiencies. Tokenized gold structures seek to combine attributes of physical ownership with digital transaction capabilities, including enhanced transparency, transferability, and reporting functionality.

The Streamex Platform is intended to support the issuance and administration of GLDY, as well as any other tokenized RWA products developed in the future, in each case without investors taking direct ownership of, or trading positions in, the underlying assets of such RWA products.

Technology and Development Status

The Streamex Platform incorporates security, access controls, auditability, and data integrity features consistent with enterprise-grade financial infrastructure requirements. The Company continues to invest in platform enhancements, compliance workflows, and third-party integrations to support ongoing operations and future product development.

The Company expects to continue incurring development, compliance, and operating costs related to Streamex as it scales operations, expands product offerings, and supports the issuance and administration of GLDY and future tokenized asset products.

Regulatory Considerations

The tokenization and digital asset infrastructure industry is subject to evolving and complex regulatory requirements that vary by jurisdiction. Activities related to the issuance, transfer, custody, and settlement of tokenized assets may be subject to regulation under securities laws, commodities laws, anti-money laundering and know-your-customer regulations, and other financial services frameworks.

The Company intends for Streamex-supported products to operate within applicable regulatory requirements. However, regulatory interpretations and requirements may change, and such changes could impact product design, timing, operating costs, or the feasibility of commercial launch.

Competitive Landscape and Risks

The digital asset and real-world asset tokenization market is characterized by rapid technological change and increasing competition from both established financial institutions and emerging technology firms. Competitors may include digital asset platforms, fintech companies, commodity market participants, and traditional financial services providers developing proprietary digital infrastructure.

Risks associated with the Streamex business include, but are not limited to, regulatory uncertainty, technology development risk, cybersecurity risk, market adoption risk, integration with third-party service providers, and operational execution risk. There can be no assurance that Streamex will achieve commercial success.

Technology and Development Plan 

The Company’s technology and development activities are focused primarily on digital asset infrastructure for the tokenization and administration of real world assets through the Streamex Platform, a software based digital infrastructure platform intended to support the tokenization, issuance, and lifecycle management of real world asset instruments, including GLDY and other tokenized products that may be developed in the future. Technology development efforts continue to focus on platform enhancements, compliance and regulatory workflows, system security, auditability, and integration with third party custodians and service providers.

The Streamex Platform supports asset onboarding, digital issuance, transaction processing, reporting, and redemption functionality, subject to applicable regulatory requirements. The Company expects to continue incurring development, compliance, and operating costs related to the Streamex Platform as it scales operations and pursues additional product launches.

Customers

The Streamex Platform is now operational and is currently supporting the issuance and administration of GLDY. Accredited and qualified investors are permitted to purchase and hold GLDY. Over time, customers are expected to include institutional participants, qualified investors, and third-party issuers, subject to regulatory requirements.

Competition

The digital asset and real-world asset tokenization market is highly competitive and rapidly evolving. Competitors may include digital asset platforms, fintech companies, commodity market participants, and traditional financial institutions developing proprietary blockchain-based infrastructure. Many potential competitors have substantially greater financial, technical, and operational resources than the Company.

Competition in this market is driven by factors including regulatory compliance capabilities, technology reliability, security, integration with custodians and financial institutions, and market adoption. There can be no assurance that Streamex will be able to compete effectively or achieve commercial success.

Large financial firms are entering the RWA tokenization arena: 

Other RWA tokenization platforms—e.g., Tokeny, Polymesh, and Spydra—span real estate, carbon credit, and commodities segments, reflecting broadening market demand. This evolving landscape validates Streamex’s initiative while highlighting the need for strong competitive positioning.

Suppliers

Streamex has established operational relationships with third-party service providers that are material to its tokenization business. With respect to GLDY, the Company has engaged, either directly or indirectly through its relationships with subsidiaries, affiliates, the GLDY SPV and other third parties, a fund administrator, a gold leasing agent, a gold custodian, and an auditor. The Company relies on an LBMA-accredited custodian for physical gold storage to support the administration of GLDY, and the gold leasing program in which the GLDY SPV participates is administered through the MM Agreement. The success of GLDY and the Company’s broader tokenization operations facilitated via the Streamex Platform depend on the continued performance of these and other key service providers, and any failure, insolvency, or withdrawal of services by any one of these providers could adversely affect the Company’s ability to operate the platform and support its current or future tokenized products.

ViralClear Business Overview

ViralClear Pharmaceuticals, Inc.

ViralClear Pharmaceuticals, Inc. (“ViralClear”) is a majority-owned subsidiary of the Company originally known as NeuroClear Technologies, Inc. The subsidiary was established November 2018 to pursue additional applications of PURE EP™ signal processing technology outside of EP. In March 2020, it was renamed ViralClear in connection with its prior objective to develop merimepodib, a broad-spectrum anti-viral agent that showed potential to treat COVID-19. We had ceased the development of merimepodib in late 2020 and realigned ViralClear with its original objective, however, currently the business is dormant.

BioSig AI Sciences Overview

BioSig AI Sciences, Inc.

On July 2, 2020, the Company formed NeuroClear Technologies, Inc., a Delaware corporation, which was renamed to BioSig AI Sciences, Inc. (“BioSig AI”) on May 31, 2023. The subsidiary was established to pursue clinical needs of cardiac and neurological disorders through recordings and analyses of action potentials. BioSig AI aims to contribute to the advancements of AI-based diagnoses and therapies.

BioSig AI is a medical technology company that was developing AI solutions for the hospital marketplace utilizing structured, semi-structured, and unstructured data. BioSig AI’s business operations have currently been placed on hold due to lack of resources. The Company’s former established technology team with external partners and collaborators were joined to advance the research and development of an artificial intelligence (“AI”) medical device platform.

Intellectual Property

Patents

Our success with our medical device technology depends in large part on our ability to establish and maintain the proprietary nature of our technology. We have retained Sterne Kessler Goldstein & Fox P.L.L.C., a patent firm based in Washington DC, to help develop and execute a strategy for the development of our patent portfolio.

Our owned patent portfolio now includes 46 issued/allowed utility patents (34 utility patents where the Company is at least one of the applicants). Thirty additional U.S. and foreign utility patent applications are pending covering various aspects of our PURE EP System for recording, measuring, calculating and displaying of electrocardiograms during cardiac ablation procedures (30 U.S. and foreign utility patent applications where either the Company, Mayo, or both is at least one of the applicants). We also have one U.S. patent and one U.S. pending application directed to artificial intelligence (AI). We also have 30 issued worldwide design patents, which cover various features of our display screens and graphical user interface for enhanced visualization of biomedical signals (30 design patents where the Company is at least one of the applicants). Finally, we have licenses to 12 (issued/allowed) patents and 7 additional worldwide utility patent applications from Mayo Foundation for Medical Education and Research that are pending (12 issued/allowed patents and 7 applications where only Mayo is the applicant). These patents and applications are generally directed to electroporation and stimulation.

The Company and ViralClear signed three patent and know-how license agreements with Mayo Foundation for Medical Education and Research in November 2019. Under the terms of such agreements, the Company exclusively licensed additional patents and applications of the Mayo Clinic related to novel ways for ablation therapy and to treat autonomic nervous system disease including hardware, software and algorithmic solutions to be integrated into PURE EPtechnology. The Company intends to take the licensed intellectual properties and products, which have been developed by Mayo Clinic over the last decade, through FDA approval, manufacturing, and commercialization. The development program is run under the leadership of Dr. Asirvatham. On March 5, 2021, we announced that the U.S. Patent Office had allowed a utility patent that ViralClear has exclusively licensed from the Mayo Foundation for Medical Education and Research. The patent application number 16,805,017 entitled,“Systems and Methods for Electroporation” was filed on February 28, 2020. The patent describes and claims methods and materials for improving the treatment of hypertension via electroporation of nerves in the renal area. Electroporation is an emerging technique that has demonstrated efficacy in treatments for several critical conditions and is currently being evaluated for the treatments of autonomic nervous disorders, including hyper- and hypotension / syncope.

Trademarks

Our trademark for “BIOSIG TECHNOLOGIES” was registered on April 25, 2017.

Our trademark for “PURE EP” was registered on January 26, 2016.

Our trademark for the standard mark, “BIOSIG” was registered March 19, 2019.

Our trademark for “SEE MORE, CLEARLY” was registered on April 4, 2023.

Our trademark for “WCT+” was registered on February 20, 2024.

In July 2021, we received EU certificates of registration for the following trademarks: “ACCUVIZ”, “WCT+”, and “COMBIO”.

In July 2021, we received UK certificates of registration for the following trademarks: “SMARTFINDER”, “ACCUVIZ”, “WCT+”, and “COMBIO”.

We also have a pending U.S. trademark application for “GLDY,” which has received a Notice of Allowance from the United States Patent and Trademark Office and is used in connection with our digital asset and tokenization platform. Registration of this mark is subject to the filing and acceptance of a Statement of Use.

Government Regulation

Digital Asset Infrastructure and Real-World Asset Tokenization

Streamex operates a technology and infrastructure platform intended to support the tokenization, issuance, custody integration, and lifecycle management of real-world asset (“RWA”) financial products, including commodity-linked digital instruments. As a result, Streamex is subject to an evolving and complex regulatory framework that spans securities, commodities, financial services, anti-money laundering, sanctions, data privacy, and consumer protection laws in the United States and internationally.

U.S. Federal and State Regulation

Depending on product structure, participant roles, and transactional features, Streamex’s activities may be subject to regulation by, among others:

Regulatory classifications applicable to digital assets and tokenized financial instruments remain subject to interpretation and change, and regulatory authorities may adopt new rules, guidance, or enforcement positions that impact Streamex’s business model, product design, operating costs, or ability to conduct certain activities.

Securities and Commodity Law Considerations

Certain tokenized assets supported by the Streamex platform may be deemed “securities” under federal or state securities laws, or “commodities” under the Commodity Exchange Act, depending on their structure, rights, economic characteristics, and manner of distribution. As a result, such products may be subject to registration requirements or exemptions, transfer restrictions, disclosure obligations, resale limitations, and ongoing reporting or compliance obligations.

There can be no assurance that regulatory authorities will agree with Streamex’s characterization of any particular digital asset or transaction, and adverse regulatory determinations could require changes to product structure, limitations on distribution, suspension of offerings, or enforcement actions.

AML, KYC, and Financial Crime Compliance

Streamex is subject to AML, KYC, and counter-terrorist financing requirements under U.S. and international laws and regulations. These requirements include customer identification, transaction monitoring, recordkeeping, suspicious activity reporting, and sanctions screening. Compliance with these obligations may increase operating costs and requires ongoing investment in compliance systems, controls, and personnel.

Failure to comply with applicable AML, sanctions, or financial crime regulations could result in significant civil or criminal penalties, reputational harm, and restrictions on operations.

Data Privacy, Cybersecurity, and Technology Regulation

Streamex’s operations involve the collection, processing, storage, and transmission of sensitive customer, transactional, and financial data. As a result, Streamex is subject to data protection, privacy, and cybersecurity laws and regulations, including U.S. federal and state privacy laws and, where applicable, foreign data protection regimes such as the European Union’s General Data Protection Regulation (“GDPR”).

Cybersecurity incidents, data breaches, or failures of information systems could result in regulatory investigations, enforcement actions, civil liability, and reputational harm.

International Regulation

Streamex intends to operate and support transactions involving participants, assets, or custodians located outside the United States. International activities may subject Streamex to foreign securities, commodities, payments, AML, sanctions, and data protection laws, which vary significantly by jurisdiction and may impose additional licensing, registration, or compliance obligations.

Regulatory requirements in non-U.S. jurisdictions may be inconsistent or conflict with U.S. regulations, increasing compliance complexity and risk.

Regulatory Uncertainty

The regulatory framework applicable to digital assets, tokenization platforms, and blockchain-based financial infrastructure continues to evolve rapidly. Legislative, regulatory, or enforcement developments could materially and adversely affect Streamex’s business, operating results, or strategic plans. Compliance with existing and future regulations may require substantial resources and could limit the development, launch, or scalability of certain products or services.

Legacy Medical Device Regulation

The Company’s legacy PURE EP™ Platform received FDA 510(k) clearance on August 8, 2018. The medical device business remains subject to FDA regulations governing product design and development, testing, manufacturing, labeling and packaging, advertising and promotion, and product sales, distribution, and servicing. Medical devices are also subject to Quality System Regulation (QSR), establishment registration, medical device listing, labeling regulations, and medical device reporting regulations. The Company is evaluating strategic alternatives for the legacy medical device business.

Employees

As of December 31, 2025, we had 6 full-time employees. Additionally, we use 4 consultants as needed to perform various specialized services. None of our employees are represented under a collective bargaining agreement.

Corporate and Other Information

We were originally incorporated in Nevada in February 2009 and, in April 2011, we merged with our wholly owned subsidiary, BioSig Technologies, Inc., a Delaware corporation, with the Delaware corporation continuing as the surviving entity. On September 12, 2025, we changed our name to Streamex Corp. Our principal executive offices are located at 2431 Aloma Avenue Suite 243, Winter Park, Florida 32792, and our telephone number is +1-203-409-5444. Our website addresses are www.streamex.com and https://ir.streamex.com. Information contained on or accessible through our website is not a part of this Annual Report on Form 10-K, and the inclusion of our website address in this Annual Report on Form 10-K is an inactive textual reference only.

We file or furnish electronically with the U.S. Securities and Exchange Commission (the “SEC”) our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements and other information. Our SEC filings are available to the public over the Internet at the SEC’s website at http://www.sec.gov. We make available on our website, under “Investors,” free of charge, copies of these reports as soon as reasonably practicable after filing or furnishing these reports with the SEC.

ITEM 1A – RISK FACTORS

RISK FACTORS

There are numerous and varied risks, known and unknown, that may prevent us from achieving our goals. You should carefully consider the risks described below and the other information included in this Annual Report on Form 10-K, including the consolidated financial statements and related notes. If any of the following risks, or any other risks not described below, actually occur, it is likely that our business, financial condition, and/or operating results could be materially adversely affected. The risks and uncertainties described below include forward-looking statements and our actual results may differ from those discussed in these forward-looking statements.

Risk Factor Summary

Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Annual Report on Form 10-K and our other filings with the SEC before making investment decisions regarding our common stock.

Risks Related to Our Business and Industry

Because we have reverted to a development stage company, we expect to incur operating losses.

We are a development stage company with respect to our principal business, the Streamex digital asset infrastructure and real-world asset tokenization platform. We have not generated material revenue from the Streamex platform and expect to incur substantial additional operating expenses over the next several years as we develop and launch our tokenized gold product (GLDY), other future tokenized asset offerings, and related infrastructure, invest in technology development and compliance capabilities, and build strategic partnerships in the digital asset and commodity finance markets.

We might not succeed at any of these undertakings. If we are unsuccessful at some or all of these undertakings, our business, prospects, and results of operations may be materially adversely affected.

The Company also retains a legacy medical device business focused on the PURE EP™ Platform, which is not a strategic priority and is being evaluated for strategic alternatives. Revenues from this legacy business have not been material, and no assurance can be given that the Company will realize any value from the disposition or continued operation of this business.

Our digital asset and tokenization business is new and unproven, subjecting us to numerous risks and uncertainties.

The Company’s ongoing primary focus will be scaling the Streamex Platform for the tokenization of real-world assets. The development and commercialization of digital tokens backed by physical assets involves significant technical, regulatory, and market uncertainties. The regulatory environment for digital assets and token offerings is rapidly evolving; changes in laws or regulations (or the interpretation of existing laws, including securities, commodities, and money transmission regulations) could impose costly compliance obligations, restrict our business model, or make our any token offering infeasible. Additionally, market acceptance of asset-backed digital tokens (such as GLDY) remains subject to ongoing validation. If we are unable to maintain regulatory compliance, attract users, and establish a liquid market for our tokens, our digital asset initiative may not generate the anticipated benefits, and our business, financial condition, and results of operations could be adversely affected.

Our tokenized gold products and platform may be subject to extensive and evolving regulation, and we may be required to obtain licenses or registrations (including broker-dealer or alternative trading system regulation) that could delay or prevent commercialization.

Digital tokens representing contractual interests in gold or other RWAs may be treated as “securities” and/or “commodities” depending on their structure, the rights conveyed, and how they are offered and traded. As a result, we may be required to rely on offering exemptions, implement transfer restrictions and resale limitations, and ensure that any secondary trading occurs through appropriately regulated venues. In addition, as we expand investor onboarding and platform functionality across jurisdictions, we may face overlapping and potentially conflicting requirements applicable to broker-dealers, alternative trading systems (“ATS”), custodial service providers, and other regulated financial activities. Regulatory scrutiny, new legislation, changing interpretations, or enforcement actions could require changes to our products or platform, limit our ability to operate in certain markets, increase compliance costs, or cause us to suspend or discontinue planned offerings.

Our tokenization strategy depends on third-party custody, reserve verification, and related operational controls that may not be fully implemented or may not operate as expected.

The success of our current and planned tokenized products rely on establishing third-party custody arrangements for underlying assets and the implementation of controls to manage credit risk, reserve verification, auditability, and related controls. With respect to GLDY, gold may be held on an unallocated basis, and there may be no current mechanism to link GLDY balances to physical gold held as individual bullion bars. As a result of these operational hurdles, physical redemption for underlying assets may only be available under certain conditions, We have not yet fully implemented a live proof-of-reserves dashboard or public confirmation of 1:1 gold backing for tokens, and we are in the process of implementing an independent audit process for bullion holdings on a defined timeline. If custody infrastructure, verification processes, or operational safeguards are delayed, incomplete, or fail (including smart-contract or operational safeguards designed to prevent issuance of tokens in excess of gold held), investor confidence, market adoption, and regulatory posture could be adversely affected.

If our tokens are not listed on an exchange and we do not engage market makers or establish liquid trading venues, tokenholders may face significant liquidity and pricing risk.

Our ability to attract investors and support token utility may depend on the availability of liquid secondary markets. Tokens are not currently listed on any exchange, and no market makers are engaged to provide liquidity or price stability. In addition, the transferability, lock-up restrictions, and resale mechanics applicable to tokenized products may be limited or may evolve over time. Limited liquidity could result in wide bid-ask spreads, price volatility, and difficulty exiting positions, which may reduce investor demand and materially adversely affect our business.

We may face operational and governance risks because we may retain centralized control over token smart contracts.

We may retain centralized control over token smart contracts, including upgrade authority. If governance controls, access controls, or change-management processes fail, or if smart contract upgrades are executed improperly, such events could cause operational disruption, unintended token behavior, losses to users, or regulatory scrutiny. These risks could adversely affect trust in our platform and the perceived integrity of our token offerings.

Tokenholders may not have perfected rights to underlying gold and may be treated as unsecured creditors in an insolvency scenario.

Depending on product structure, tokenholders may not have direct legal title to specific bullion bars or a perfected security interest in underlying assets. In an insolvency, recovery of value may depend on third-party custodian arrangements and could subject tokenholders to delays or losses, including the possibility that tokenholders rank as unsecured creditors. Any such outcomes could adversely affect token adoption and our ability to commercialize tokenized products.

Our financial results and the market price may be adversely affected by fluctuations in the price of gold, other precious metals, and the volatility inherent in digital asset markets.

We have deployed and continue to develop the Streamex Platform, a blockchain-based platform for the tokenization of real-world assets (“RWA”). The Streamex Platform has an initial focus on the issuance and administration of GLDY, a gold-backed tokenized security that seeks to provide holders exposure to the spot price of gold. The value proposition of GLDY—and the underlying demand for GLDY from prospective investors—is inherently linked to prevailing and expected future prices of gold.

While we seek to operate as a technology platform and facilitator—earning revenue through token issuance, platform usage, and transaction fees—our exposure to the issuance of GLDY introduces indirect but material risk. If the price of gold declines materially or becomes more volatile, demand for GLDY or gold-backed RWA more generally may decrease, impairing our ability to successfully issue new GLDY, develop future tokenized products, or generate secondary market activity. In addition, lower gold prices may increase counterparty risk among our gold leasing counterparties, potentially leading to defaults or contractual disputes that could harm our reputation and operations. Moreover, Streamex’s tokens are structured as digital assets and are subject to broader volatility and uncertainty inherent in the digital asset and blockchain ecosystem. This includes risks related to token pricing, investor adoption, smart contract execution, liquidity, regulatory scrutiny, cyber threats, and custodial integrity. The performance of our gold tokenization strategy may be further affected by sentiment across the broader digital asset market, regardless of the performance of gold itself.

As Streamex scales its balance sheet and operational footprint in support of its gold strategy, our consolidated financial results may increasingly reflect the performance of this line of business. Accordingly, any sustained disruption in the gold market or deterioration in investor confidence in digital asset–linked products could materially and adversely affect our financial condition, operating results, and the market price.

Our gold-linked tokenization and treasury strategy may expose us to complex liquidity risks across both traditional and digital asset markets, which could adversely affect our financial results.

The issuance and administration of GLDY requires the Company to deploy a capital strategy that ultimately involves the acquisition of physical gold by the GLDY SPV, which is held in custody with professional custodians and deployed into a leasing program administered by Monetary Metals under the MM Agreement. This model seeks to maintain a long gold position and generate yield for holders of GLDY through gold leasing activities. However, this approach introduces liquidity management challenges that may ultimately impact the financial performance of the Company, as the ability of the Streamex Platform to generate fee revenues for the Company is dependent upon the successful issuance and administration of GLDY and other tokenized RWA products that may be offered on the Streamex Platform in the future.

The gold market, while historically liquid, can be subject to temporary dislocations caused by geopolitical events, macroeconomic shocks, or supply chain disruptions. Similarly, emerging token markets—particularly those involving newly issued or bespoke digital assets—often exhibit reduced trading volumes, fragmented order books, and dependence on limited market makers or exchange infrastructure. These structural limitations may prevent timely exits or settlements, or may result in price slippage, widening spreads, or delayed conversions between tokenized assets and fiat currency.

Additionally, gold deployed into leases may not be immediately available for redemption or liquidation. If investor demand softens, market infrastructure fails to scale, or lessees default on their lease obligations, we may face constraints on accessing or redeploying gold-linked assets, reducing liquidity, delaying revenue recognition, and potentially impairing balance sheet efficiency.

These liquidity risks, across both traditional bullion markets and tokenized asset venues, may limit our ability to execute our gold strategy effectively. If we are unable to timely deploy or rotate capital, or if our token products fail to achieve meaningful market traction, our financial results, cash flows, and overall operating performance could be materially and adversely affected.

We operate in the highly competitive gold market, and established market participants with greater resources, regulatory positioning, or brand recognition may outperform us.

Streamex operates within the global gold market, a highly competitive industry dominated by well-established financial institutions, bullion banks, ETF sponsors, precious metals dealers, and newer entrants offering gold-backed digital assets. Many of these participants possess significantly greater financial resources, broader market access, deeper liquidity, established regulatory frameworks, and longstanding relationships with institutional investors and gold leasing counterparties.

We also face emerging competition from blockchain-native platforms offering gold-linked tokens or decentralized finance (DeFi) products that may offer alternative value propositions or pricing advantages. Some of our competitors may already have established physical custody infrastructure, tokenized offerings, or secondary markets in place. In addition, we face competition from traditional gold investment products such as exchange-traded funds (ETFs), futures contracts, and bullion dealers, which are already widely accepted by retail and institutional investors.

If we are unable to successfully differentiate our platform, build user trust, secure high-quality counterparties, or scale liquidity in our tokenized offerings, we may not be able to compete effectively. Any failure to compete successfully could adversely affect our ability to grow our market share, attract capital to our platform, or generate sustainable revenue, which would have a material and adverse effect on our business, financial condition, and results of operations.

Evolving regulatory requirements for gold trading and cross-border transactions may increase our compliance costs and could restrict or delay our operations.

The Company’s tokenization business model, including the infrastructure supporting the issuance and administration of GLDY, spans multiple regulated domains, including securities issuance, commodity-related activities, and digital asset markets, each of which is subject to evolving and potentially conflicting regulatory frameworks across jurisdictions.

In particular, the issuance and leasing activities underlying GLDY involve cross-border elements, which subject the Company to a range of regulatory regimes. These include anti-money laundering (“AML”) and know-your-customer (“KYC”) requirements, securities registration and exemptions, custody and safekeeping standards, and gold traceability obligations, all of which may become more stringent as regulators focus on precious metals and digital asset markets.

Simultaneously, tokenized representations of gold delivery rights are likely to be classified as securities in many jurisdictions, including Canada and the United States, subjecting our platform to securities registration requirements, prospectus exemptions, and potential enforcement action if deemed non-compliant. As we onboard investors, counterparties, and exchanges in different countries, we must assess and adhere to multiple legal frameworks, including those applicable to broker-dealers, alternative trading systems (“ATS”) operators, stablecoin providers, and custodial service providers.

The regulatory environment for tokenized commodities and cross-border digital assets remains fluid. New legislation or guidance from regulators such as the SEC, FINTRAC, FCA, MAS, or IOSCO could impose additional disclosure, reporting, registration, or licensing requirements on our business, including on our smart contracts, custody relationships, or token design. Meeting these evolving obligations may result in significant compliance costs, delays in product rollout, or restructuring of token features.

Failure to anticipate or comply with applicable laws and regulations could limit our ability to offer products in certain jurisdictions, subject us to enforcement actions or fines, or require us to unwind existing transactions. Any such regulatory developments could materially and adversely affect our business, platform scalability, and financial performance.

Our ability to execute our business plan depends on the successful development, deployment, and commercialization of blockchain-based enterprise solutions for tokenized commodities, on-chain commodity markets, and treasury management, which may not materialize as expected. 

Streamex’s business model relies on the development and successful commercialization of blockchain-enabled infrastructure that supports the tokenization of real-world assets—beginning with gold—and the creation of on-chain commodity trading systems and treasury management strategies. Our ability to generate revenue and scale operations depends on the timely and functional integration of multiple technical, legal, and market-facing components, including:

Although the Streamex Platform is currently administering the issuance and trading of GLDY, the systems supporting tokenized commodity flows and digital secondary market infrastructure continue to evolve, and there can be no assurance that our technology will continue to function as intended, meet security or audit standards, or achieve broader market acceptance. Bugs, third-party integration failures, or regulatory developments may materially impair our ability to scale operations or meet investor expectations.

Moreover, widespread commercial acceptance of tokenized commodity assets particularly those not offering direct legal title to physical bullion is uncertain and may depend on user familiarity, platform trust, macroeconomic conditions, and evolving regulatory support. Even if we successfully deploy our core infrastructure, user adoption may lag or institutional counterparties may hesitate to participate in a new digital settlement framework.

If we are unable to successfully design, launch, or scale our blockchain enterprise solutions or if these solutions fail to gain sufficient traction among gold leasing participants, custodians, market makers, or institutional investors our ability to execute our strategic plan and generate sustainable revenue may be material and adversely affected.

Changes in laws and regulations, including increased regulation of blockchain technologies and digital assets, may adversely affect our business, product development, and compliance obligations.

The legal and regulatory environment applicable to blockchain-based platforms, digital asset issuance, and tokenized financial products is rapidly evolving. Streamex’s business involves the creation and distribution of tokenized claims on physical commodities through blockchain infrastructure. This structure intersects with regulatory regimes governing securities, commodities, financial services, payments, data privacy, and cross-border transactions. Any material change in applicable laws, regulatory guidance, or enforcement priorities could adversely affect our operations, increase compliance burdens, or require us to modify, delay, or cancel certain product offerings.

In particular, governments and regulatory agencies globally—including the SEC, the Commodity Futures Trading Commission (CFTC), the Canadian Securities Administrators, and other international bodies—have signaled increased scrutiny over blockchain-based activities. Areas of focus include the classification of digital tokens as securities, the registration of platforms as broker-dealers or ATS, custody and safekeeping standards, and AML compliance. Heightened regulation could also affect how smart contracts are governed, how token transfers are tracked, and how compliance responsibilities are allocated among issuers, custodians, and technology providers.

Changes in applicable law could impose new licensing or registration requirements, require changes to our token architecture, restrict our ability to engage in cross-border token sales, or subject our personnel or counterparties to additional oversight. In addition, regulatory developments may outpace technological adaptation, resulting in uncertainty or fragmentation that inhibits innovation or market adoption.

Complying with new or modified regulatory regimes could require significant legal, operational, and technical resources. Failure to comply—or perceived non-compliance—with applicable regulatory requirements may result in fines, enforcement actions, product delays, reputational harm, or even the inability to operate in certain jurisdictions. Any such developments could materially and adversely affect our business, prospects, and financial condition.

Our platform may fail to achieve market adoption or effectively address key inefficiencies in the traditional gold and commodities markets.

Streamex’s business model is predicated on the belief that blockchain-based tokenization can address long-standing inefficiencies in the gold and broader commodities markets—such as limited access to yield-bearing gold products, lack of real-time settlement infrastructure, illiquidity of gold leasing arrangements, and restricted investor access.

However, there is no assurance that our platform will gain traction among institutional investors, gold leasing participants, traders, or other key market participants.

Many participants in the traditional gold market operate within established commercial relationships, regulatory frameworks, and settlement processes that may be resistant to change or skeptical of blockchain-based alternatives. Institutional investors may be slow to embrace tokenized interests in a gold leasing vehicle, particularly those that do not confer direct legal title to physical bullion. Similarly, traditional gold market participants may prefer established financing models, and existing exchanges may be unwilling to support tokens issued through non-traditional mechanisms.

Even if the technology performs as intended, our platform may fail to differentiate itself meaningfully from other gold-backed token offerings or digital asset infrastructure providers, several of whom already have established user bases, liquidity, and regulatory licenses. Without sustained user engagement and ecosystem development, Streamex may struggle to reach commercial scale or justify its infrastructure investment.

If we are unable to demonstrate compelling advantages over traditional commodity market solutions—or if potential users are unwilling to change entrenched behaviors—our platform may not achieve meaningful adoption, which would materially and adversely affect our business prospects, financial performance, and growth trajectory.

Our gold-focused tokenization strategy will subject us to enhanced regulatory oversight across securities, commodities, and precious metals regimes, which may increase our compliance burdens and limit operational flexibility.

The infrastructure underlying the issuance and administration of GLDY combines elements of traditional commodity holding with gold leasing and blockchain-based digital asset issuance—triggering overlapping regulatory frameworks that are subject to heightened scrutiny from global regulators.

In particular, gold markets are subject to extensive regulation related to sourcing, trading, custody, and leasing. Regulatory bodies such as the London Bullion Market Association (“LBMA”), the Financial Transactions and Reports Analysis Centre of Canada (FINTRAC), the U.S. Department of the Treasury, and various central banks impose rules around gold purity standards, provenance, AML, and sanctions compliance. Our partnerships with bullion custodians, reliance on gold leasing arrangements through Monetary Metals, and participation in global trade flows may trigger reporting, licensing, and inspection obligations under these frameworks.

In parallel, the tokenization of gold-linked instruments is expected to be treated as the issuance of securities in most jurisdictions, subjecting Streamex to securities laws, including prospectus exemptions, resale restrictions, investor suitability rules, and ongoing disclosure obligations. In the U.S., Canada, and elsewhere, regulators have signaled increased oversight of digital asset instruments, especially those that function as investment contracts or derivative-like structures.

Given the nature of our gold strategy—which spans physical commodities, token issuance, and decentralized infrastructure—we anticipate enhanced regulatory oversight from multiple authorities across jurisdictions. This may include periodic audits, product-level reviews, cross-border compliance restrictions, and the potential need for broker-dealer, ATS, or commodity pool operator registrations. In some cases, new or revised rules could require us to alter token design, restrict certain investor types, or suspend offerings in affected jurisdictions.

Complying with these layered regulatory obligations will require significant legal, technical, and financial resources. Failure to meet applicable standards—or regulatory determinations that contradict our structural assumptions—could result in enforcement actions, civil or criminal penalties, loss of licensure, reputational harm, or business disruption. As a result, our gold strategy may expose us to enhanced compliance risks and may materially and adversely affect our ability to operate, scale, or compete effectively.

Discrepancies between token volume entitlements and actual gold holdings may lead to valuation uncertainty, settlement delays, and reputational harm.

The SPV’s gold leasing activities are conducted through a “back-to-back” structure pursuant to agreements with Monetary Metals, whereby the SPV leases gold to a designated series of a Delaware series limited liability company managed by Monetary Metals, which then may commingle the SPV’s gold with gold from other participants and lease it to the ultimate lessee. Accordingly, the Company relies heavily on the performance of its service providers and lease counterparties in ensuring efficient administration of GLDY.

In the context of other tokenized digital assets, settlement risk is exacerbated when settlement finality on-chain does not align with actual asset delivery off-chain. According to the Bank for International Settlements, token arrangements can introduce mismatches between token issuance, asset availability, and transfer finality—raising risk around incomplete settlement.

If Streamex cannot deliver the full gold volumes represented by its tokens—or if deliveries are delayed—tokenholders may experience difficulty redeeming tokens, confront valuation discrepancies, and lose confidence in the platform. Such issues could erode secondary market liquidity, prompt margin or reserve adjustments, and trigger reputational or regulatory scrutiny. Ultimately, these challenges could materially impair our business model, financial condition, and long-term growth potential.

The concentration of our holdings and strategy in gold may amplify the risks inherent in our business model and expose us to adverse market and operational developments.

Streamex’s intended tokenization and treasury strategy may be heavily concentrated in gold. A substantial portion of our revenue model and balance sheet exposure is tied to the successful administration of GLDY and the gold leasing arrangements underlying the GLDY product. While gold is traditionally viewed as a stable store of value, such concentration will enhance our exposure to a single asset class and a narrow set of market and operational risks.

Gold markets are subject to a range of external forces including macroeconomic policy shifts, inflation expectations, interest rate volatility, geopolitical instability, and currency fluctuations. Any adverse developments in these areas—such as sustained declines in gold prices, weakening institutional demand, or tightening of physical delivery infrastructure—could materially impact the perceived value of our tokenized products and reduce investor demand.

Additionally, our reliance on a limited number of gold leasing counterparties and custodial partners to secure, hold, and safeguard the underlying gold creates additional counterparty and operational concentration risks. Any lessee defaults, disputes over lease terms, custodial limitations, or insurance shortfalls could have disproportionate effects on our token programs and financial stability.

Unlike diversified financial institutions or asset managers, Streamex has not yet expanded into other commodities or asset classes, which limits our ability to hedge or offset commodity-specific shocks. Until we achieve broader asset diversification or launch a multi-asset tokenization strategy, our strategic focus on gold will continue to heighten our vulnerability to gold-specific pricing, supply, and market confidence risks.

Such concentration may impair our liquidity, restrict capital rotation, increase volatility in our platform, and reduce investor confidence, all of which could materially and adversely affect our business, financial results, and long-term prospects.

Our gold holdings will be significantly less liquid than cash and cash equivalents and may not serve as a reliable source of liquidity in times of need.

As part of our asset-backed token issuance model, Streamex anticipates holding a portion of its assets in physical gold—whether directly or through special purpose vehicles, with gold held in custody with professional custodians and potentially deployed into gold leases through Monetary Metals. While gold is widely regarded as a store of value, it lacks the immediate liquidity and transactional flexibility of cash or cash equivalents, particularly in a corporate treasury context.

Unlike cash, which can be deployed immediately to satisfy operational expenses, service debt, or meet regulatory obligations, gold holdings may require conversion through third-party custodians, sales in potentially illiquid or volatile markets, or settlement of contractual obligations over extended periods. Additionally, when gold is deployed into leases or held as token reserves, we may face legal or practical constraints on its conversion or redeployment, particularly during times of market stress or when platform users seek redemption or exit en masse.

If the Company encounters liquidity needs that exceed the available cash on hand, the reliance on gold or tokenized gold reserves may limit our ability to respond rapidly. This could impair our capacity to meet obligations, delay strategic execution, or require unfavorable asset liquidations. These risks may be further exacerbated in periods of gold market disruption, reduced token liquidity, or custodial access constraints.

As a result, the presence of gold holdings on our balance sheet should not be viewed as equivalent to cash or near-cash instruments. Our reliance on less liquid assets may materially and adversely affect our financial flexibility and resilience in periods of operational or market stress.

These risks could materially and adversely affect the value, utility, and credibility of our token offerings, and may impair our ability to scale operations or attract institutional participation.

Geopolitical instability, including conflict in the Middle East, could adversely affect gold markets, custody arrangements, cross-border settlement, and demand for our tokenized commodity products.

Our business is exposed to macroeconomic and geopolitical conditions that affect the global precious metals markets, the digital asset ecosystem, and cross-border financial activity. Escalation of armed conflicts, political instability, terrorism, trade restrictions, sanctions programs, shipping disruptions, or broader unrest in the Middle East or other regions could result in increased volatility in gold prices, higher insurance and transportation costs, disruption to bullion supply chains, delays in settlement, reduced market liquidity, or heightened counterparty risk. Public company filings in adjacent sectors, including precious metals and commodity-related issuers, commonly recognize that instability in the Middle East can materially affect commodity prices, trading conditions, logistics, and financial performance. With respect to GLDY specifically, a number of leases that MM has arranged for the SPV are concentrated in the Middle East; therefore, to the extent broader unrest in the Middle East continues, such disruptions may impair the performance of underlying leases and the ability of GLDY to generate yield, which could have a material and adverse effect on our business and growth potential.

Because our Streamex platform supports gold-linked digital products that depend on bullion custody, compliance processes, investor confidence, and the orderly functioning of financial and commodity markets, geopolitical instability may have a disproportionate effect on our business model. Even if we do not maintain direct operations in a conflict zone, geopolitical developments may adversely affect the availability or cost of custody, vaulting, insurance, reserve verification, banking access, fiat settlement, blockchain infrastructure usage, onboarding of institutional participants, or the willingness of investors and counterparties to transact in tokenized commodity products. These developments could also result in abrupt changes in regulatory expectations or market sentiment toward gold-linked or cross-border digital financial products.

In addition, periods of heightened geopolitical stress may produce unusual movements in gold prices or disconnects between spot, forward, and financing markets. Such conditions could impair the economics of our offerings, increase hedging or operational costs, reduce investor demand, cause disruptions in expected redemption or settlement mechanics, and adversely affect the perceived reliability of our platform. Any of these events could materially and adversely affect our business, financial condition, results of operations, and growth prospects.

Our business may be adversely affected by sanctions, export controls, anti-money laundering laws, and heightened regulatory scrutiny relating to Iran and other sanctioned jurisdictions, particularly because our products are linked to physical gold and cross-border financial activity.

Our business involves the development of tokenized gold and other commodity-linked products that depend on bullion sourcing, custody, financing, investor onboarding, and cross-border transfers of value. As a result, we are subject to extensive sanctions, anti-money laundering, know-your-customer, anti-bribery, and related compliance obligations in multiple jurisdictions. Iran-related sanctions administered by the U.S. Department of the Treasury’s Office of Foreign Assets Control (“OFAC”) remain extensive and actively enforced, and OFAC continues to publish Iran-specific guidance and advisories for market participants. OFAC also warns that sanctions evasion can involve the use of physical assets, including gold and other precious metals.

Although we intend to maintain compliance controls designed to prevent dealings involving sanctioned persons, prohibited jurisdictions, or impermissible source-of-gold exposure, there can be no assurance that our controls, or those of our custodians, counterparties, liquidity providers, refiners, brokers, banking partners, or other service providers, will be effective in all circumstances. Gold supply chains and cross-border financial flows can be complex, and counterparties may use intermediaries, transshipment points, omnibus arrangements, digital wallets, structured transactions, or incomplete documentation that make beneficial ownership, source of funds, source of bullion, or sanctions nexus difficult to identify. If bullion, funds, investors, or counterparties associated with our platform are found to have a direct or indirect connection to Iran or other sanctioned persons or jurisdictions, or are alleged to have been involved in sanctions evasion, money laundering, or other illicit activity, we could face investigations, penalties, asset freezes, loss of banking or custody relationships, contractual disputes, reputational harm, or restrictions on our ability to operate.

In addition, compliance expectations applicable to LBMA-standard gold, responsible sourcing programs, and institutional onboarding may become more stringent over time, including with respect to conflict-affected sourcing, audit trails, traceability, and due diligence. Failure by us or our third-party providers to satisfy these expectations could impair our ability to support proof-of-reserves or reserve verification processes, attract institutional customers, maintain custody or liquidity relationships, or expand into additional jurisdictions. Any such development could materially and adversely affect the perceived legitimacy, marketability, and commercial viability of our tokenized gold offerings and our broader business and financial prospects.

The freely transferable nature of tokenized RWA may increase market volatility and limit recourse for tokenholders in the event of disputes or enforcement actions.

The Streamex Platform is intended to be designed so that tokenized RWA can be freely transferable across jurisdictions and market participants, subject to applicable securities law restrictions. While this transferability is intended to promote liquidity and market participation, it also introduces potential risks that may negatively impact tokenholders and the platform.

In particular, the ability to transfer tokens freely may contribute to increased price volatility, especially during periods of market stress, limited secondary market liquidity, or when macroeconomic conditions affect gold pricing or digital asset sentiment. Without the stabilizing effects of centralized pricing, redemption windows, or regulated exchange mechanisms, token values may diverge significantly from the underlying value of the referenced gold, creating dislocation and confusion in the market.

Additionally, the decentralized and pseudonymous nature of blockchain transactions may make it difficult to trace token ownership, enforce contractual rights, or resolve disputes. If a tokenholder experiences a smart contract malfunction, or counterparty breach, the ability to seek legal redress may be limited, particularly where tokens have changed hands multiple times or are held by unidentifiable or offshore counterparties.

Furthermore, the unrestricted nature of transfers may limit Streamex’s ability to monitor or enforce compliance with investor eligibility criteria, sanctions obligations, or secondary trading restrictions, potentially exposing the platform to regulatory risk.

As a result, while transferability is a key feature of our token model, it may also amplify volatility, obscure liability, and limit recourse for holders. These dynamics could undermine investor confidence and materially affect the performance and perception of our tokenized offerings.

Holders of GLDY bear the economic risk of gold price fluctuations and potential non-performance by gold leasing counterparties.

GLDY is designed to provide tokenholders with economic exposure to gold and a gold-denominated yield through the SPV’s gold leasing activities. As such, tokenholders are likely to be fully exposed to fluctuations in the price of gold, which can be volatile and influenced by a wide range of macroeconomic factors including changes in interest rates, central bank policies, inflation expectations, geopolitical events, currency fluctuations, and broader commodity cycles. A decline in gold prices may significantly reduce the market value of the tokens, regardless of the issuer’s performance or platform functionality.

In addition, tokenholders are subject to the credit and operational risk of gold lessees under the SPV’s gold leasing program. If a lessee fails to return leased gold or make required payments-whether due to financial distress, operational failure, fraud, or other events-tokenholders may experience reduced recoveries upon redemption. The SPV relies on Monetary Metals’ diligence, technology, insurance, and risk management practices in sourcing, structuring, and administering gold leases. While leases may include independent insurance coverage, collateral, guarantees, or inspections, these measures vary by lease and may be insufficient to prevent losses.

Furthermore, the value of the tokens may also be affected by perceived risks of non-performance, creating additional market volatility even absent an actual default. This may impair token liquidity, reduce investor confidence, and undermine secondary market activity.

Investors in Streamex’s tokens must be prepared to assume all economic consequences associated with the performance of the underlying gold asset and counterparty obligations. These structural risks could materially and adversely affect tokenholder returns, Streamex’s platform adoption, and our long-term financial performance.

Our ability to build and scale a community of clients and investor end-users for blockchain-enabled financial services and products is uncertain and depends on successful market adoption, product development, and execution of our business strategy.

Streamex’s growth depends on the successful creation and sustained expansion of an engaged ecosystem of users, including institutional investors, gold leasing participants, custodians, liquidity providers, and individual tokenholders. We aim to position our platform as a digital infrastructure layer for the issuance, trading, and settlement of tokenized real-world assets, beginning with gold. However, there is no assurance that we will succeed in attracting and retaining a critical mass of users necessary to support token liquidity, market activity, and platform revenues.

Market adoption of blockchain-based financial services—particularly in the context of real-world commodity assets—remains nascent and subject to skepticism from both traditional finance and regulatory stakeholders. Many investors and institutions are unfamiliar with or cautious toward tokenized instruments, decentralized smart contracts, or cross-border digital asset frameworks. In addition, competing platforms or legacy products may already command greater trust, scale, or regulatory clarity.

Our success also depends on timely and effective product development. Delays in launching smart contracts, integrating with exchanges, securing custodial relationships, or offering user-friendly interfaces may hinder onboarding or reduce retention. Similarly, failure to provide sufficient liquidity, transparency, or user protections could impair adoption and reduce network effects.

If we are unable to effectively execute our business strategy or develop products that meet the expectations of target users, we may not achieve sufficient traction to support our platform. This could materially limit our revenue potential and long-term viability.

Risks Related to Bullion Custody and Token Structure

Streamex’s bullion custody infrastructure, although established, depends on third-party custodians and service providers, and any failure, interruption, or change in those arrangements could adversely affect its business.

Streamex’s business model is predicated in part on the secure custody, verification and administration of physical gold underlying its tokenized asset offerings. As of the date of this Annual Report on Form 10-K Streamex has established its bullion custody infrastructure and has engaged an LBMA-accredited custodian in support of this framework. However, Streamex’s ability to operate its platform and support tokenized gold products will continue to depend on the performance, reliability and ongoing availability of such custodian and any related vaulting, insurance, logistics, verification and other service providers.

Even where custodial arrangements have been established, there can be no assurance that such relationships will continue on favorable terms, remain operational without disruption, or satisfy all future business, legal, regulatory, technological or commercial requirements. Streamex may need to modify, supplement or replace aspects of its custody framework from time to time as a result of changes in market conditions, counterparty requirements, applicable law, regulatory expectations, insurance requirements, or the operational needs of the platform. Any such change may result in delays, increased costs, additional diligence and compliance work, redesign of platform processes or smart contract logic, or other operational burdens.

In addition, the use of third-party custodians and related service providers exposes Streamex to risks that are outside of its direct control, including risks of operational error, insolvency, fraud, cybersecurity incidents, insufficient insurance coverage, asset loss, recordkeeping failures, disputes over title, access interruptions, delays in settlement or transfer, or other service failures. If Streamex’s custody arrangements are disrupted or prove inadequate, Streamex may be unable to issue gold-backed tokens, process redemptions, support reserve verification, or otherwise satisfy obligations to tokenholders and counterparties. Any such event could materially and adversely affect platform adoption, investor confidence, Streamex’s reputation, and its business, financial condition and results of operations.

Although Streamex has engaged an LBMA-accredited custodian, it remains subject to risks associated with reliance on that custodian and with maintaining LBMA-standard bullion custody arrangements.

Streamex’s tokenization model contemplates physical gold being held through a custody framework designed to support bullion integrity, auditability and investor confidence. Streamex has engaged an LBMA-accredited custodian, which it believes strengthens the credibility of its custody arrangements. However, engagement of such a custodian does not eliminate risk.

There can be no assurance that Streamex will be able to maintain its relationship with its LBMA-accredited custodian on acceptable terms, expand that relationship as its business grows, or replace that custodian with another comparable institution in a timely manner if necessary. In addition, LBMA accreditation does not guarantee uninterrupted service, complete protection against operational failures, asset loss, title defects, fraud, insurance gaps, or regulatory concerns. Streamex may also remain dependent on additional counterparties, including sub-custodians, vault operators, insurers, auditors, logistics providers and other infrastructure participants, any of which could create points of failure or delay.

Moreover, if Streamex’s custody arrangements were to cease meeting institutional expectations, or if its LBMA-accredited custodian were to experience service disruptions, reputational issues, regulatory scrutiny, financial distress, or changes in business practices, Streamex’s ability to support third-party audits, proof-of-reserves attestations, institutional onboarding, or access to liquidity venues could be adversely affected. Any such developments could materially and adversely affect the perceived integrity of Streamex’s tokenized gold offerings, investor confidence, platform adoption, and Streamex’s broader business and financial prospects.

Gold may be held on an unallocated basis, and there is no current mechanism to link tokens to individual bullion bars, which may introduce custody, transparency, and redemption risks.

Some or all of the physical gold underlying GLDY tokens may be held on an unallocated basis by third-party custodians, which means the gold is pooled and not specifically assigned to individual tokenholders or even to Streamex in segregated accounts. Unallocated holdings increase reliance on the creditworthiness and operational soundness of the custodian and may expose tokenholders to higher counterparty risk.

Furthermore, Streamex does not currently offer or contemplate a mechanism to link each token to a specific gold bar with a verifiable serial number, refiner, and assay certificate. While Streamex expects to rely on LBMA “Good Delivery” standards to ensure overall bullion integrity, the absence of a traceability layer means tokenholders cannot verify or redeem against individually earmarked bars. This lack of granularity may reduce transparency and auditability, create potential ambiguity in settlement or redemption scenarios, and undermine confidence in the one-to-one relationship between tokens and underlying gold.

In jurisdictions where asset traceability and segregated title are regulatory priorities, these structural limitations may raise compliance concerns or reduce the appeal of Streamex’s offering to institutional participants. Any doubts regarding the adequacy of custody practices or the fidelity of gold backing could adversely impact token valuation, platform credibility, and Streamex’s overall business strategy.

In the event of loss, theft, or damage to the gold, recovery of value may depend entirely on the custodian’s insurance and operational reliability.

Streamex’s business model involves issuing digital tokens backed by physical gold held in custody with third-party vault providers or deployed in gold leases. In the event of a loss, theft, or physical damage to the bullion, Streamex does not directly insure the gold; rather, it expects that insurance coverage will be arranged by the lessee, MM, or the custodian. As a result, any recovery of value would likely depend entirely on the custodian’s insurance policies, their claims process, and the custodian’s ability and willingness to comply with their contractual obligations.

There is no guarantee that insurance coverage by the custodian will be sufficient to cover all losses, that claims will be paid promptly or in full, or that the terms of coverage will address all types of risks. Moreover, Streamex may have limited ability to enforce or benefit from insurance coverage if Streamex is not named as an insured party or beneficiary.

In addition, Streamex is exposed to operational and financial risks related to the custodian itself, including insolvency, internal mismanagement, or cybersecurity incidents. If the custodian fails to safeguard the bullion or fulfill its obligations, tokenholders may face substantial delays in recovery or incur total loss of value.

Such events could severely impact Streamex’s credibility, impair the value of its tokens, and lead to reputational, regulatory, and financial harm.

Streamex retains centralized control over the token smart contracts, including upgrade authority, which may result in operational or governance risks.

Streamex’s gold-backed tokens operate on public blockchain infrastructure, with smart contracts developed and deployed by Streamex. While decentralization is often viewed as a key attribute of blockchain-based assets, Streamex currently intends to retain centralized control over its token smart contracts, including the authority to modify, upgrade, pause, or terminate contract functions.

Although such control is intended to ensure security, regulatory compliance, and flexibility to respond to technical issues or market changes, it also introduces operational and governance risks. Errors or misjudgments in implementing upgrades or exercising control rights could result in unintended consequences, token malfunction, or loss of tokenholder value. Centralized control also increases the risk of insider threats or external compromise, particularly if administrative keys or access credentials are not properly secured.

Moreover, market participants may perceive centralized control as inconsistent with DeFi principles, potentially limiting adoption among investors who prioritize trustless infrastructure. Regulatory authorities may also view such control as indicative of issuer responsibility for the token’s operations and risks, which could heighten Streamex’s compliance obligations under securities, commodities, or consumer protection laws.

These risks could negatively affect the reliability, security, and market acceptance of Streamex’s tokenized products and may adversely impact Streamex’s reputation and financial performance.

There is no live proof-of-reserves dashboard or public confirmation of 1:1 gold backing for tokens at this time.

Transparency around collateralization is essential to building trust in asset-backed digital tokens. As of the date of this Annual Report on Form 10-K, Streamex has not launched a real-time or publicly accessible proof-of-reserves dashboard to confirm that issued gold-backed tokens are fully supported by an equivalent volume of vaulted bullion. In the absence of such a mechanism, tokenholders and market participants must rely solely on Streamex’s internal records and representations.

The lack of independent, real-time validation may raise concerns among investors, counterparties, and regulators regarding the sufficiency and accuracy of the SPV’s gold reserves. This is particularly relevant in the context of blockchain-based financial products, where decentralized verification and transparency are commonly expected.

Failure to implement a robust proof-of-reserves system in a timely manner—or if such a system is perceived as unreliable or insufficiently transparent—could undermine confidence in Streamex’s token issuance practices. This may impair secondary market liquidity, reduce institutional participation, and increase regulatory scrutiny, any of which could materially and adversely affect Streamex’s reputation, token valuation, and business prospects.

Streamex may not prevent issuance of tokens in excess of gold held if smart contract or operational safeguards fail.

A foundational element of Streamex’s business model is to be the issuance of gold-backed tokens intended to represent specific, contractually defined quantities of physical gold. This 1:1 linkage between tokens and gold reserves is designed to ensure trust, transparency, and value integrity. However, the effectiveness of this framework depends on both the proper functioning of smart contract logic and sound internal controls.

If the underlying smart contracts contain flaws, are misconfigured, or are compromised through a security breach, Streamex may unintentionally issue tokens exceeding its actual gold reserves. Similarly, if internal recordkeeping or reconciliation practices fail—whether due to human error, system malfunction, or inadequate oversight—Streamex could lose track of reserve levels or erroneously authorize new issuance.

Such over-issuance could lead to a mismatch between outstanding token volume and the gold actually held in custody, triggering valuation discrepancies, reputational harm, and potential legal liability. Investors may lose confidence in Streamex’s controls, and regulators may view the incident as a failure to comply with securities, commodities, or consumer protection standards.

Failure to prevent or promptly detect issuance errors could materially and adversely affect the price, liquidity, and market acceptance of Streamex’s tokens, and may expose Streamex to enforcement actions, class actions, or contractual claims from impacted tokenholders.

Streamex’s tokenized gold products are expected to be classified as securities exposing Streamex to comprehensive and evolving regulatory obligations across multiple jurisdictions.

Based on the Supreme Court’s Howey test and updated SEC guidance, tokens representing interests in a fund that deploys gold into leases or contractual claims on gold deliveries are likely to meet the definition of an “investment contract” and thus be treated as securities under U.S. law. As confirmed in the Coinbase Global, Inc. S-1 filing, “A particular crypto asset’s status as a ‘security’ … is subject to a high degree of uncertainty”. The SEC has reiterated this position in recent enforcement actions and filings, emphasizing that most tokens involving profit expectations and reliance on centralized efforts—especially those tied to traditional assets like gold—may qualify as securities.

Consequently, Streamex must ensure compliance with stringent regulatory frameworks, including:

Failure to comply could expose Streamex to enforcement actions, civil liabilities, and investor rescission demands. Such outcomes are consistent with SEC regulatory posture in Coinbase, which prompted investigations related to offering alleged unregistered securities tokens, staking programs, and wallet services.

Additionally, SEC staff recently clarified that tokens associated with centralized issuer control, profit-driven marketing, or token-structure authority (e.g., pausing or burning tokens) are more likely to be deemed securities—even absent official guidance—reinforced by “‘reasonable expectation of profit’ plus ‘issuer influence’” principles.

Outside the U.S., jurisdictions including Canada, the EU, and Singapore maintain similar classifications for tokenized assets. While Streamex operates under a Canadian Exempt Market Dealer license, any expansion into the U.S. or other foreign markets could trigger additional registrations or exemptive relief obligations—each accompanied by costs, delays, and shifting legal interpretations.

Should regulatory authorities determine that Streamex’s tokens are unregistered securities—or should new securities rules for tokenized assets be enacted—Streamex could be required to:

Such outcomes could significantly restrict token liquidity, delay platform rollouts, burden operations with compliance costs, and limit Streamex’s ability to scale its gold-token and RWA strategy.

Streamex has not received any no-action relief or regulatory approvals in the United States or other jurisdictions outside Canada, which may subject it to enforcement risk and limit its ability to operate.

As of the date of this Annual Report on Form 10-K, Streamex has not obtained no-action relief, exemptive orders, or other formal regulatory approvals from the SEC, the CFTC, or any other regulatory authority outside Canada. While Streamex currently operates under an exempt market dealer registration in Canada, any offer, sale, or promotion of tokens in other jurisdictions—including the United States—may be deemed to involve the offering of securities, derivatives, or other regulated instruments.

Without such relief or registrations, Streamex could be subject to enforcement actions, civil penalties, or demands for rescission from investors if regulators determine that its operations violate local securities or commodities laws. In the United States, for example, the SEC has pursued enforcement actions against digital asset platforms and issuers that did not register their offerings or trading venues, or that failed to otherwise comply with applicable securities laws. Similarly, the CFTC has taken the position that certain digital asset transactions may fall within its regulatory remit, including under rules applicable to commodity interests, swaps, and futures.

Furthermore, if Streamex were to engage in marketing, issuance, or token transfer activities that are later found to have triggered regulatory obligations outside of Canada, it could face retroactive enforcement, forced platform modifications, investor claims, reputational damage, or operational disruptions.

Until Streamex obtains the necessary authorizations, relief, or determinations from relevant regulatory bodies in key markets, its ability to scale, onboard institutional investors, and operate a cross-border digital asset platform will remain highly constrained.

Onboarding is subject to AML/KYC procedures, but compliance infrastructure and enforcement mechanisms may be evolving or incomplete.

Streamex’s ability to administer token offerings and operate the Streamex Platform is contingent on its implementation of AML and KYC protocols that comply with applicable legal and regulatory requirements. While these controls are operational, they may not yet meet the heightened expectations of global regulators, financial institutions, or institutional investors, and the Company continues to enhance its compliance infrastructure.

Digital asset markets, particularly those involving cross-border transactions and asset-backed tokens, face increasing scrutiny under global AML frameworks such as the Financial Action Task Force recommendations and U.S. Bank Secrecy Act rules. Streamex’s current infrastructure may not yet include fully integrated tools for sanctions screening, politically exposed person flagging, suspicious activity reporting, or automated transaction monitoring.

If Streamex’s AML/KYC controls are deemed insufficient, improperly enforced, or inconsistently applied, Streamex could face enforcement actions, fines, reputational damage, or restrictions on banking, custody, or exchange access. In addition, counterparties, including bullion custodians, market makers, and institutional investors, may decline to engage with Streamex without confidence in the robustness of its compliance program.

Failure to build, maintain, and enforce a comprehensive AML/KYC framework could impede Streamex’s ability to scale operations, access global markets, or establish the credibility necessary to attract and retain users on its tokenization platform.

Tokens are not currently listed on any exchange, and no market makers are engaged to provide liquidity or price stability.

As of the date of this Annual Report on Form 10-K, Streamex’s tokenized products, including its gold-backed tokens, are not listed on any centralized or decentralized exchange, nor has Streamex engaged any market makers to support liquidity or maintain price stability in secondary markets. Without an active trading venue or committed liquidity providers, investors may be unable to sell their tokens on a timely basis or at favorable prices, which could materially impair the perceived and actual value of the tokens.

The absence of listing arrangements may also limit price discovery, widen bid-ask spreads, and increase the risk of abrupt price volatility due to low trading volumes or concentrated holdings. Moreover, without market maker participation, tokens may be more susceptible to manipulation or speculative trading, especially in periods of market stress or heightened interest in gold or commodity-based digital assets.

Further, the listing of tokenized assets on regulated exchanges is subject to a range of legal, operational, and jurisdictional requirements, including but not limited to exchange approvals, securities law compliance, and compatibility with listing standards. There can be no assurance that Streamex will succeed in listing its tokens on any exchange in the near term, or at all.

In the absence of accessible, liquid secondary markets, tokenholders may be unable to exit their positions efficiently, and Streamex may face challenges in achieving broad adoption of its platform among institutional or retail investors seeking tradable, fungible digital asset products.

In the absence of well-defined and enforceable transfer restrictions or lock-up terms, there is an increased risk that tokens may be transferred in violation of applicable securities laws, which could expose Streamex and tokenholders to legal liability, rescission claims, or enforcement actions. Conversely, overly restrictive mechanics could hinder investor participation, reduce market liquidity, or impair the attractiveness of the tokens as financial instruments.

Additionally, resale rules under securities law (e.g., Rule 144 under the Securities Act) may require holding periods, reporting obligations, and affiliate restrictions, none of which can be operationalized without clearly documented and enforceable mechanics.

Until such terms are disclosed and implemented through smart contracts, tokenholder agreements, or platform-level controls, investors face material uncertainty regarding the liquidity, portability, and regulatory treatment of their tokens. This uncertainty could limit institutional interest, raise compliance burdens, and adversely affect Streamex’s ability to execute its digital asset strategy.

In the event the bullion custodian or Streamex ceases operations, tokenholders may suffer losses and may not recover their full holdings.

The administration of GLDY by the Streamex Platform relies heavily on third-party bullion custodians to store and safeguard the physical gold that underpins its tokenized assets. These custodians maintain insurance and adhere to industry best practices. In the event that a bullion custodian ceases operations—whether due to insolvency, regulatory action, negligence, or other disruption—the GLDY SPV may have limited or no ability to promptly retrieve or substitute the underlying gold, which could impair the value or redeemability of the associated tokens.

Streamex itself is a newly formed company with no established operating history and has not yet implemented bankruptcy-remote structures that would insulate tokenholders from the risks of issuer failure. Likewise, MM does not have extensive experience with the implementation of bankruptcy-remote structures such as those that support GLDY. If Streamex or MM were to cease operations or enter insolvency proceedings, tokenholders may be treated as unsecured creditors and subject to delays, write-downs, or total losses in the claims process.

Neither the custodians nor Streamex may be able to guarantee uninterrupted access to the gold reserves or to administer the token rights effectively during such periods of disruption. As a result, tokenholders may face material impairment in value, diminished liquidity, and a lack of clear recourse, which could have a significant adverse effect on the perceived reliability and attractiveness of the Streamex platform.

If we were deemed to be an investment company under the Investment Company Act of 1940, applicable restrictions could significantly limit our business operations and adversely affect our ability to execute our strategy.

The Investment Company Act of 1940 (the “1940 Act”) imposes significant regulatory burdens on entities that meet the definition of an “investment company.” Under Sections 3(a)(1)(A) and 3(a)(1)(C) of the 1940 Act, a company may be deemed to be an investment company if it is or holds itself out as being primarily engaged in the business of investing, reinvesting, or trading in securities or if it owns or proposes to acquire investment securities that comprise more than 40% of the value of its total assets (excluding government securities and cash items) on an unconsolidated basis. Rule 3a-1 under the 1940 Act provides a safe harbor from investment company status, subject to limitations on the proportion of assets and income derived from investment securities.

Streamex is a software development company that intends to develop and commercialize blockchain-based solutions for tokenized commodities, including gold, decentralized trading infrastructure, and blockchain-enabled capital markets products. Our primary business is the development of technology and platforms—not investing in or trading securities. However, given that our business model involves the issuance and management of tokenized assets that may be deemed securities in certain jurisdictions, there is a risk that regulators such as the SEC could take the position that Streamex or a Streamex-affiliated issuer is engaged in investment company activities.

The application of the 1940 Act to digital assets, including tokenized commodities and smart contract-based financial products, is evolving and may raise novel interpretive issues. For example, in 2022 the SEC brought an action against BlockFi Lending LLC, asserting that it was operating as an unregistered investment company due to its securities-based loan portfolio and related activities. Similarly, tokenized gold products or SPVs used in Streamex’s structure—depending on their asset composition, investor rights, and operational model—may raise comparable concerns.

If we were to be deemed an investment company, or if our tokenization activities were construed as causing us to engage in investment company activities under the 1940 Act, we could become subject to significant restrictions, including limitations on leverage, capital structure, affiliated transactions, and the issuance of different classes of securities. Moreover, we may be required to register as an investment company, divest certain operations, or restructure our product lines and legal entities—any of which could have a material adverse effect on our business, financial condition, and prospects.

We intend to conduct our operations and structure our product offerings in a manner designed to comply with available exemptions and to avoid investment company status. However, there can be no assurance that regulators will not challenge our characterization of our business activities or that we will continue to qualify for applicable exemptions. If we were deemed to be an investment company and failed to register as such or to qualify for an exemption, we could be subject to enforcement actions, penalties, and reputational harm. 

Our PURE EP and other product candidates are in continued development and may not be successfully developed or commercialized.

Although our main product candidate, PURE EP, received FDA 510(k) clearance from FDA, we are currently conducting research studies, which may require substantial further capital expenditure, to establish the safety and efficacy data needed to obtain acceptance by the medical community and coverage by third-party payors. The continued development of PURE EP, and/or any other product candidates we may develop, is dependent upon our ability to obtain sufficient additional financing. However, even if we are able to obtain the requisite financing to fund our development program, we cannot assure you that our current or future product candidates will be successfully developed or commercialized. Our failure to develop, manufacture, receive regulatory approval for, or successfully commercialize any of our product candidates could result in the failure of our business and a loss of all of your investment in our company.

We may need to finance our future cash needs through public or private equity offerings, debt financings or corporate collaboration and licensing arrangements. Any additional funds that we obtain may not be on terms favorable to us or our stockholders and may require us to relinquish valuable rights.

Until PURE EP or another product of ours become commercially viable, we will have to fund all of our operations and capital expenditures from cash on hand, public or private equity offerings, debt financings, bank credit facilities or corporate collaboration and licensing arrangements. However, we may need to raise additional funds more quickly if one or more of our assumptions prove to be incorrect or if we choose to expand our product development efforts more rapidly than we presently anticipate. We also may decide to raise additional funds before we require them if we are presented with favorable terms for raising capital.

If we seek to sell additional equity or debt securities, obtain a bank credit facility or enter into a corporate collaboration or licensing arrangement, we may not obtain favorable terms for us and/or our stockholders or be able to raise any capital at all, all of which could result in a material adverse effect on our business and results of operations. The sale of additional equity or debt securities, if convertible, could result in dilution to our stockholders. The incurrence of indebtedness would result in increased fixed obligations and could also result in covenants that would restrict our operations. Raising additional funds through collaboration or licensing arrangements with third parties may require us to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, or to grant licenses on terms that may not be favorable to us or our stockholders. In addition, we could be forced to discontinue product development, reduce or forego sales and marketing efforts and forego attractive business opportunities, all of which could have an adverse impact on our business and results of operations.

We may be unable to develop our existing or future technology.

Our product, the PURE EP, may not deliver the levels of accuracy and reliability needed to make it a successful product in the marketplace, and the development of such accuracy and reliability may be indefinitely delayed or may never be achieved. In addition, we may experience delays in the development of our technology for other reasons, including failure to obtain necessary funding and failure to obtain all necessary regulatory approvals. Failure to develop this or other technology could have an adverse material effect on our business, financial condition, results of operations and future prospects. 

We may experience delays in any phase of the preclinical or clinical development of a product, including during its research and development.

We may experience delays in any phase of the preclinical or clinical development of a product, including during its research and development. The completion of any of these studies may be delayed or halted for numerous reasons, including, but not limited to, the following:

If the preclinical and clinical studies that we are required to conduct to gain regulatory approval are delayed or unsuccessful, we may not be able to market any product that we develop in the future. Preclinical studies and clinical trials are expensive and difficult to design and implement and any delays or prolongation of our preclinical and clinical studies will require additional capital. There is no assurance that we will be able to acquire additional capital to support our studies. The failure to obtain additional capital would have a material adverse effect on the Company.

We have completed one clinical trial of our product. The results of additional clinical studies may not support the usefulness of our technology.

In November 2019, we commenced our first clinical study with PURE EP and completed the clinical trial as of September 2021. Conducting clinical trials is a long, expensive, and uncertain process that is subject to delays and failure at any stage. Clinical trials can take months or years. The commencement or completion of any of our subsequent clinical trials may be delayed or halted for numerous reasons, including:

Results of pre-clinical studies do not necessarily predict future clinical trial results and previous clinical trial results may not be repeated in subsequent clinical trials. We may experience delays, cost overruns and project terminations despite achieving promising results in pre-clinical testing or early clinical testing. In addition, the data obtained from clinical trials may be inadequate to support a device’s approval or clearance, or to demonstrate safety and efficacy to the extent required to obtain third-party coverage and/or reimbursement. The FDA may disagree with our interpretation of the data from our clinical trials, or may find the clinical trial design, conduct, or results inadequate to demonstrate the safety and effectiveness of the product candidate. The FDA may also require additional pre-clinical studies or clinical trials that could further delay clearance or approval of any product candidates we may develop in the future and/or the PURE EP to the extent we seek clearance/approval for different indications than that for which it is currently cleared. If we are unsuccessful in receiving FDA clearance approval of a future product candidate, or a product’s clearance or approval is withdrawn, we would not be able to commercialize the product(s) in the U.S., which could seriously harm our business. Moreover, we face similar risks in other jurisdictions in which we may sell or propose to sell our products.

The medical device industry is subject to stringent regulation and failure to obtain regulatory approval will prevent commercialization of our products.

Medical devices are subject to extensive and rigorous regulation by the FDA pursuant to the Federal Food, Drug, and Cosmetic Act, by comparable agencies in foreign countries and by other regulatory agencies and governing bodies. Under the Federal Food, Drug, and Cosmetic Act and associated regulations, manufacturers of medical devices must comply with certain regulations that cover the composition, labeling, testing, clinical study, manufacturing, packaging and distribution of medical devices. In addition, medical devices must receive FDA clearance or approval before they can be commercially marketed in the U.S., and the FDA may require testing and surveillance programs to monitor the effects of approved products that have been commercialized and can prevent or limit further marketing of a product based on the results of these post-market evaluation programs. The process of obtaining marketing clearance or approval from the FDA for new products could take a significant period of time, require the expenditure of substantial resources, involve rigorous pre-clinical and clinical testing, require changes to the products and result in limitations on the indicated uses of the product. In addition, if we seek regulatory approval in non-U.S. markets, we will be subject to further regulatory approvals that may require additional costs and resources. There is no assurance that we will obtain necessary regulatory approvals in a timely manner, or at all.

To obtain 510(k) clearance for a medical device, a pre-market notification must be submitted to the FDA demonstrating that the device is “substantially equivalent” to a previously cleared “predicate” device. A new device is substantially equivalent to a predicate device “at least as safe and effective” as the predicate. The FDA considers a device substantially equivalent to a predicate if it has the same intended use as the predicate and has either: (i) the same technological characteristics as the predicate or (ii) different technological characteristics from the predicate, but the information submitted to the FDA does not raise new questions of safety or effectiveness or demonstrates that the device is at least as safe and effective as the predicate. 

We received 510(k) clearance to market our current lead product, the PURE EP in the U.S. However, if we intend to market the PURE EP for additional medical uses or indications, we may need to submit additional 510(k) applications to the FDA that are supported by satisfactory clinical trial results specifically for the additional indication. Clinical trials necessary to support 510(k) clearance or PMA approval for any future product candidates, or any new indications for use for our PURE EP, would be expensive and could require the enrollment of large numbers of suitable patients who could be difficult to identify and recruit. Delays or failures in any necessary clinical trials could prevent us from commercializing any modified product or new product candidate and could adversely affect our business, operating results and prospects.

The results of our initial clinical trials may not provide sufficient evidence to allow the FDA to grant us such additional marketing clearances and even additional trials requested by the FDA may not result in our obtaining 510(k) marketing clearance for our product. The failure to obtain FDA marketing clearance for any additional indications for the PURE EP or any other of our future products would have a material adverse effect on our business.

We, and our third-party manufacturer(s), are, and will be, subject to extensive regulation by the FDA.

In addition to the pre-market regulations, once a device is approved or cleared for the applicable indications for use, numerous FDA regulations apply, including but not limited to those relating to manufacturing, labeling, packaging, advertising, and record keeping. Notably, these regulations apply to us, as well as our contract manufacturer(s). Even if regulatory approval or clearance of a product is obtained, the approval or clearance may be subject to limitations on the uses for which the product may be marketed or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the product. Any such requirements could reduce our revenues, increase our expenses, and render the product not commercially viable. If we fail to comply with the applicable regulatory requirements, or if previously unknown problems with any approved commercial products, manufacturers, or manufacturing processes are discovered, we could be subject to administrative or judicially imposed sanctions or other negative consequences, including:

Regulations are constantly changing, and in the future our business may be subject to additional regulations that increase our compliance costs.

We believe we understand the current laws and regulations to which our products will be subject in the future. However, federal, state and foreign laws and regulations relating to the sale of our products are subject to future changes, as are administrative interpretations of regulatory agencies. If we fail to comply with such federal, state or foreign laws or regulations, we may fail to obtain regulatory approval for our products and, if we have already obtained regulatory approval, we could be subject to enforcement actions, including injunctions preventing us from conducting our business, withdrawal of clearances or approvals and civil and criminal penalties. In the event that federal, state, and foreign laws and regulations change, we may incur additional costs to seek government approvals, in addition to the clearance from the FDA in order to sell or market our products. If we are slow or unable to adapt to changes in existing regulatory requirements or the promulgation of new regulatory requirements or policies, we or our licensees may, following approval, lose marketing approval for our products which will impact our ability to conduct business in the future.

The market for our technology and revenue generation avenues for our EP products may be slow to develop, if at all.

The market for our products may be slower to develop or smaller than estimated or it may be more difficult to build the market than anticipated. The medical community may resist our products or be slower to accept them than we anticipate. Revenues from our products may be delayed or costs may be higher than anticipated which may result in our need for additional funding. We anticipate that our principal route to market will be through commercial distribution partners. These arrangements are generally non-exclusive and have no guaranteed sales volumes or commitments. The partners may be slower to sell our products than anticipated. Any financial, operational or regulatory risks that affect our partners could also affect the sales of our products. In the current economic environment, hospitals and clinical purchasing budgets may exercise greater restraint with respect to purchases, which may result in purchasing decisions being delayed or denied. If any of these situations were to occur this could have a material adverse effect on our business, financial condition, results of operations and future prospects.

Our estimate of the size of our addressable EP market may prove to be inaccurate.

While our addressable market size estimate for the EP market was made in good faith and is based on assumptions and estimates we believe to be reasonable, this estimate may not be accurate. If our estimates of the size of our addressable market are not accurate, our potential for future growth may be less than we currently anticipate, which could have a material adverse effect on our business, financial condition, and results of operations.

If we seek to market our EP products in foreign jurisdictions, we may need to obtain regulatory approval in these jurisdictions.

In order to market our products in the European Union and many other foreign jurisdictions, we may need to obtain separate regulatory approvals and comply with numerous and varying regulatory requirements. Approval procedures vary among countries (except with respect to the countries that are part of the European Economic Area) and can involve additional clinical testing. The time required to obtain approval may differ from that required to obtain FDA approval. Should we decide to market our products abroad, we may fail to obtain foreign regulatory approvals on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority, including obtaining CE Mark approval, does not ensure approval by regulatory authorities in other foreign countries or by the FDA. We may be unable to file for, and may not receive, necessary regulatory approvals to commercialize our products in any foreign market, which could adversely affect our business prospects. In addition, a new Medical Device Regulation was published in 2017, which includes additional premarket and post-market requirements, as well as potential product reclassifications or more stringent commercialization requirements that could delay or otherwise adversely affect our clearances and approvals.

The EP market is highly competitive.

There are a number of groups and organizations, such as healthcare, medical device and software companies in the EP market that may develop a competitive offering to our products. The largest companies in the EP market are GE, Johnson & Johnson, Boston Scientific, Siemens, Medtronic, and Abbott. All of these companies have significantly greater resources, experience and name recognition than we possess. There is no assurance that they will not attempt to develop similar or superior products, that they will not be successful in developing such products or that any products they may develop will not have a competitive advantage over our products. Moreover, our product may not be viewed as superior to existing technology or new technology from our competitors and as a result we may not be able to justify expected selling price our product, which may have a material adverse effect on market acceptance of our product. In addition, if we experience delayed regulatory approvals or disputed clinical claims, we may not have a commercial or clinical advantage over competitors’ products that we believe we currently possess. Should a superior offering come to market, this could have a material adverse effect on our business, financial condition, results of operations and future prospects. 

We rely on key officers, consultants and scientific and medical advisors, and their knowledge of our business and technical expertise would be difficult to replace.

We are highly dependent on our officers, consultants and scientific and medical advisors because of their expertise and experience in medical device development. We do not have “key person” life insurance policies for any of our officers. Moreover, if we are unable to obtain additional funding, we will be unable to meet our current and future compensation obligations to such employees and consultants. In light of the foregoing, we are at risk that one or more of our consultants or employees may leave our company for other opportunities where there is no concern about such employers fulfilling their compensation obligations, or for other reasons. The loss of the technical knowledge and management and industry expertise of any of our key personnel could result in delays in product development, loss of customers and sales and diversion of management resources, which could adversely affect our results of operations.

We may fail to attract and retain qualified personnel.

We expect to rapidly expand our operations and grow our sales, research and development and administrative operations. This expansion is expected to place a significant strain on our management and will require hiring a significant number of qualified personnel. Accordingly, recruiting and retaining such personnel in the future will be critical to our success. There is intense competition from other companies, research and academic institutions, government entities and other organizations for qualified personnel in the areas of our activities. Many of these companies, institutions and organizations have greater resources than we do, along with more prestige associated with their names. If we fail to identify, attract, retain and motivate these highly skilled personnel, we may be unable to continue our marketing and development activities, and this could have a material adverse effect on our business, financial condition, results of operations and future prospects.

If we do not effectively manage changes in our business, these changes could place a significant strain on our management and operations.

Our ability to grow successfully requires an effective planning and management process. The expansion and growth of our business could place a significant strain on our management systems, infrastructure and other resources. To manage our growth successfully, we must continue to improve and expand our systems and infrastructure in a timely and efficient manner. Our controls, systems, procedures and resources may not be adequate to support a changing and growing company. If our management fails to respond effectively to changes and growth in our business, including acquisitions, there could be a material adverse effect on our business, financial condition, results of operations and future prospects.

Our strategic business plan may not produce the intended growth in revenue and operating income.

Our strategies ultimately include making significant investments in sales and marketing programs to achieve revenue growth and margin improvement targets. If we do not achieve the expected benefits from these investments or otherwise fail to execute on our strategic initiatives, we may not achieve the growth improvement we are targeting and our results of operations may be adversely affected. We may also fail to secure the capital necessary to make these investments, which will hinder our growth.

In addition, as part of our strategy for growth, we may make acquisitions and enter into strategic alliances such as joint ventures and joint development agreements. However, we may not be able to identify suitable acquisition candidates, complete acquisitions or integrate acquisitions successfully, and our strategic alliances may not prove to be successful. In this regard, acquisitions involve numerous risks, including difficulties in the integration of the operations, technologies, services and products of the acquired companies and the diversion of management’s attention from other business concerns. Although we will endeavor to evaluate the risks inherent in any particular transaction, there can be no assurance that we will properly ascertain all such risks. In addition, acquisitions could result in the incurrence of substantial additional indebtedness and other expenses or in potentially dilutive issuances of equity securities. There can be no assurance that difficulties encountered with acquisitions will not have a material adverse effect on our business, financial condition and results of operations. 

We currently have limited sales, marketing or distribution operations and will need to expand our expertise in these areas.

We currently have limited sales, marketing or distribution operations. We have begun implementing a market development program and are in the process of building such operations in connection with the commercialization of PURE EP, and we are expanding our expertise in sales, marketing and distribution operations for commercial growth. To increase internal sales, distribution and marketing expertise and be able to conduct these operations, we have begun to invest in and will have to invest significant amounts of financial and management resources. In developing these functions ourselves, we could face a number of risks, including:

Our product development program depends upon third-party researchers, including Mayo Clinic, who are outside our control and whose negative performance could materially hinder or delay our pre-clinical testing or clinical trials.

We do not have the ability to conduct all aspects of pre-clinical testing or clinical trials ourselves. We depend upon independent investigators and collaborators, such as commercial third-parties, government, universities and medical institutions, to conduct our pre-clinical and clinical trials under agreements with us. For our first clinical trial for the PURE EP, titled “Novel Cardiac Signal Processing System for Electrophysiology Procedures (PURE EP 2.0 Study)” which commenced in November 2019, we rely on third parties, including TCARF and Mayo Clinic to conduct the patient cases. In addition, we are party to various license agreements with Mayo, pursuant to which we rely on research and development information, materials, technical data, unpatented inventions, trade secrets, know-how and supportive information of Mayo to develop, make, have made, use, offer for sale, sell, and import licensed products. These collaborators are not our employees and we cannot control the amount or timing of resources that they devote to our programs. These investigators may not assign as great a priority to our programs or pursue them as diligently as we would if we were undertaking such programs ourselves. The failure of any of these outside collaborators to perform in an acceptable and timely manner in the future, including in accordance with any applicable regulatory requirements, such as good clinical and laboratory practices, or pre-clinical testing or clinical trial protocols, could cause a delay or otherwise adversely affect our pre-clinical testing or clinical trials, our success in obtaining regulatory approvals and, ultimately, the timely advancement of our development programs. In addition, these collaborators may also have relationships with other commercial entities, some of whom may compete with us. If our collaborators assist our competitors at our expense, our competitive position would be harmed.

If healthcare providers are unable to obtain sufficient reimbursement or other financial incentives from third-party healthcare payers related to the use of our products, their adoption and our future product sales will be materially adversely affected.

Widespread adoption of the PURE EP, and any other products we may develop in the future, by the medical community is unlikely to occur without a financial incentive from third-party payors for the use of these products. Third-party payors include but are not limited to governmental programs such as Medicare and Medicaid, commercial health insurers and private payors, workers’ compensation programs, and other organizations. Currently, the PURE EP does not receive separate reimbursement from any third-party payor. Instead, healthcare providers typically receive reimbursement for the procedure in which our product is used. Future regulatory action by CMS or other governmental agencies, or unfavorable clinical data, among other things, may impact coverage and/or reimbursement policies for procedures performed using our products. If healthcare providers are unable to obtain adequate coverage of, or reimbursement for, procedures performed using our products, or if managed care organizations do not receive improved capitated payments due to more accurate patient risk assessment using our products, we may be unable to sell our products at levels that are sufficient to allow us to achieve and maintain profitability, and our business would suffer significantly. 

We may face risks associated with future litigation and claims.

We may, in the future, be involved in one or more lawsuits, claims or other proceedings. These suits could concern issues including contract disputes, employment actions, employee benefits, taxes, environmental, health and safety, personal injury and product liability matters. Due to the uncertainties of litigation, we can give no assurance that we will prevail on any claims made against us in any such lawsuit. Also, we can give no assurance that any other lawsuits or claims brought in the future will not have an adverse effect on our financial condition, liquidity or operating results.

The risk that we may be sued on product liability claims is inherent in the development and commercialization of medical devices. Specifically, we believe we will be subject to product liability claims or product recalls, particularly in the event of false positive or false negative reports, because we plan to develop and manufacture medical diagnostic products. Once a product is approved for sale and commercialized, the likelihood of product liability lawsuits increases. Product liability claims could be asserted directly by consumers, health-care providers or others. We have obtained product liability insurance coverage; however such insurance may not provide full coverage for our current or future clinical trials, products to be sold, and other aspects of our business. A product recall or a successful product liability claim or claims that exceed our planned insurance coverage could have a material adverse effect on us. In addition, insurance coverage is becoming increasingly expensive and we may not be able to maintain current coverage, or expand our insurance coverage to include future clinical trials or the sale of new products or existing products in new territories, at a reasonable cost or in sufficient amounts to protect against losses due to product liability or at all. A successful product liability claim or series of claims brought against us could result in judgments, fines, damages and liabilities that could have a material adverse effect on our business, financial condition and results of operations. In the event of an award against us during a time when we have no available insurance or insufficient insurance, we may sustain significant losses of our operating capital. We may incur significant expense investigating and defending these claims, even if they do not result in liability. Moreover, even if no judgments, fines, damages or liabilities are imposed on us, our reputation could suffer, which could have a material adverse effect on our business, financial condition and results of operations, as well as impair our reputation in the medical and investment communities.

Our business is subject to cybersecurity risks.

Our operations are increasingly dependent on information technologies and services. Threats to information technology systems associated with cybersecurity risks and cyber incidents or attacks continue to grow, and include, among other things, storms and natural disasters, terrorist attacks, utility outages, theft, viruses, phishing, malware, design defects, human error, and complications encountered as existing systems are maintained, repaired, replaced, or upgraded. Risks associated with these threats include, among other things:

As we expand our digital asset infrastructure and tokenization initiatives, cybersecurity and data protection risks may be heightened. A successful cybersecurity incident could result in service disruption, theft or loss of digital assets, unauthorized access to confidential or personally identifiable information, reputational harm, regulatory scrutiny, litigation, and increased costs to prevent, respond to, or mitigate cybersecurity events. We also have limited control over the information technology systems of third parties with which our systems may connect and communicate, including custodians, compliance service providers, and other vendors, and an incident at a third party could adversely affect us.

Although we utilize various procedures and controls to mitigate our exposure to such risk, cybersecurity attacks and other cyber events are evolving and unpredictable. Moreover, we have no control over the information technology systems of our suppliers, and others with which our systems may connect and communicate. As a result, the occurrence of a cyber incident could go unnoticed for a period time. 

We presently maintain insurance coverage to protect against cybersecurity risks. However, we cannot ensure that it will be sufficient to cover any particular losses we may experience as a result of such cyberattacks. Any cyber incident could have a material adverse effect on our business, financial condition and results of operations.

We may be subject, directly or indirectly, to U.S. federal and state healthcare laws, including fraud and abuse, false claims, and privacy laws and regulations. Prosecutions under such laws have increased in recent years and we may become subject to such litigation and enforcement. If we are unable to, or have not fully complied with such laws, we could face substantial penalties.

We are subject, directly or indirectly, to various U.S. federal and state healthcare laws and regulations. These laws include fraud and abuse laws, such as the federal Anti-Kickback Statute, federal False Claims Act, and federal Foreign Corrupt Practices Act. These laws may impact, among other things, our proposed sales, marketing and education programs. In addition, we may be subject, directly or indirectly, to patient privacy regulations by both the federal government and the states in which we conduct our business. The healthcare laws that may affect our ability to operate include, but are not limited to, the following.

Additionally, we may be subject to state equivalents of each of the healthcare laws described above, among others, some of which may be broader in scope and may apply regardless of the payor. Many U.S. states have adopted laws similar to the federal Anti-Kickback Statute, some of which apply to the referral of patients for healthcare services reimbursed by any source, not just governmental payors, including private insurers. Several states impose marketing restrictions or require medical device companies to make marketing or price disclosures to the state. There are ambiguities as to what is required to comply with these state requirements, and if we fail to comply with an applicable state law requirement, we could be subject to penalties.

Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our future business activities could be subject to challenge under one or more of such laws. In addition, healthcare reform legislation has strengthened these laws. For example, the Affordable Care Act, among other things, amended the intent requirement of the federal Anti-Kickback and criminal healthcare fraud statutes. As a result of such amendment, a person or entity no longer needs to have actual knowledge of these statutes or specific intent to violate them in order to have committed a violation. Moreover, the Affordable Care Act 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 False Claims Act.

Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including penalties, fines and/or exclusion or suspension from federal and state healthcare programs such as Medicare and Medicaid and debarment from contracting with the U.S. government. In addition, private individuals have the ability to bring actions on behalf of the U.S. government under the False Claims Act as well as under the false claims laws of several states.

Efforts to ensure that our business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our existing or future business practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. Any such actions instituted against us could have a significant adverse impact on our business, including the imposition of civil, criminal and administrative penalties, damages, disgorgement, monetary fines, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations. Even if we are successful in defending against such actions, we may nonetheless be subject to substantial costs, reputational harm and adverse effects on our ability to operate our business. In addition, the approval and commercialization of any of our products outside the United States will also likely subject us to non-U.S. equivalents of the healthcare laws mentioned above, among other non-U.S. laws. 

If any of our employees, agents, or the physicians or other providers or entities with whom we do business are found to have violated applicable laws, we may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs, or, if we are not subject to such actions, we may suffer reputational harm for conducting business with persons or entities found, or accused of being, in violation of such laws. Any such events could adversely affect our ability to operate our business and our results of operations.

In addition, to the extent we commence commercial operations overseas, we will be subject to the federal Foreign Corrupt Practices Act and other countries’ anti-corruption/anti-bribery regimes, such as the U.K. Bribery Act. The federal Foreign Corrupt Practices Act prohibits improper payments or offers of payments to foreign governments and their officials for the purpose of obtaining or retaining business. Safeguards we implement to discourage improper payments or offers of payments by our employees, consultants, sales agents or distributors may be ineffective, and violations of the federal Foreign Corrupt Practices Act and similar laws may result in severe criminal or civil sanctions, or other liabilities or proceedings against us, any of which would likely harm our reputation, business, financial condition and results of operations.

We could be adversely affected if healthcare legislation or reform measures substantially change the market for medical care or healthcare coverage in the U.S., negatively affecting our business or revenue for PURE EP or future products.

The Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010, commonly referred to as the “Healthcare Reform Law,” includes a number of rules regarding health insurance, the provision of healthcare, conditions to reimbursement for healthcare services provided to Medicare and Medicaid patients, and other healthcare policy reforms. Through the law-making process, substantial changes have been and continue to be made to the current system for paying for healthcare in the U.S., including changes made to extend medical benefits to certain Americans who lacked insurance coverage and to contain or reduce healthcare costs (such as by reducing or conditioning reimbursement amounts for healthcare services and medical devices, and imposing additional taxes, fees, and rebate obligations on medical device companies). This legislation was one of the most comprehensive and significant reforms ever experienced by the U.S. in the healthcare industry and has significantly changed the way healthcare is financed by both governmental and private insurers. This legislation has impacted the scope of healthcare insurance and incentives for consumers and insurance companies, among others. Additionally, the Healthcare Reform Law’s provisions were designed to encourage providers to find cost savings in their clinical operations. Medical devices represent a significant portion of the cost of providing care. This environment has caused changes in the purchasing habits of consumers and providers and resulted in specific attention to the pricing negotiation, product selection and utilization review surrounding medical devices. This attention may result in our products we may commercialize or promote, including our current commercial products, being chosen less frequently or the pricing being substantially lowered. At this stage, it is difficult to estimate the full extent of the direct or indirect impact of the Healthcare Reform Law on us.

These structural changes could entail further modifications to the existing system of private payors and government programs (such as Medicare, Medicaid, and the State Children’s Health Insurance Program), creation of government-sponsored healthcare insurance sources, or some combination of both, as well as other changes. Restructuring the coverage of medical care in the U.S. could impact the reimbursement for medical devices, including our current commercial products, those we and our development or commercialization partners are currently developing or those that we may commercialize or promote in the future. If reimbursement for our approved medical devices, products we currently commercialize or promote, or any product we may commercialize or promote is substantially reduced or otherwise adversely affected in the future, or rebate obligations associated with them are substantially increased, it could have a material adverse effect on our reputation, business, financial condition or results of operations.

Extending medical benefits to those who currently lack coverage will likely result in substantial costs to the U.S. federal government, which may force significant additional changes to the healthcare system in the U.S. Much of the funding for expanded healthcare coverage may be sought through cost savings. While some of these savings may come from realizing greater efficiencies in delivering care, improving the effectiveness of preventive care and enhancing the overall quality of care, much of the cost savings may come from reducing the cost of care and increased enforcement activities. Cost of care could be reduced further by decreasing the level of reimbursement for medical services or products (including those products currently being developed by us or our development or commercialization partners or any product we may commercialize or promote, including our current commercial products), or by restricting coverage (and, thereby, utilization) of medical services or products. In either case, a reduction in the utilization of, or reimbursement for, any medical device or any product we may commercialize or promote, including our current commercial products, or for which we receive marketing approval in the future, could have a material adverse effect on our reputation, business, financial condition or results of operations. 

Further, the healthcare regulatory environment has seen significant changes in recent years and is still in flux. Legislative initiatives to modify, limit, replace, or repeal the Healthcare Reform Law and judicial challenges have continued for over a decade. However, as of the Supreme Court’s ruling ordering the dismissal of, arguably, the most promising case challenging the Healthcare Reform Law to-date in June 2021, it appears that the Healthcare Reform Law will remain in-effect in its current form for the foreseeable future; however, we cannot predict what additional challenges may arise in the future, the outcome thereof, or the impact any such actions may have on our business. Additionally, the previous Biden administration has introduced various measures in recent years, focusing on healthcare and medical-product pricing, in particular. It remains to be seen how these measures will affect our business and there is uncertainty as to what other healthcare programs and regulations may be implemented or changed at the federal and/or state level in the U.S., but, it is possible that such initiatives could have an adverse effect on our ability to obtain approval and/or successfully commercialize products in the U.S. in the future. For example, any changes that reduce, or impede the ability of healthcare providers to obtain reimbursement for medical procedures in which the products we currently, or intend to, commercialize are used, or that reduce medical procedure volumes, could adversely affect our operations and/or future business plans. The financial impact of U.S. healthcare reform legislation over the next few years will depend on a number of factors, including the policies reflected in implementing regulations and guidance and changes in sales volumes for medical devices affected by the legislation. From time to time, legislation is drafted, introduced and passed in the U.S. Congress that could significantly change the statutory provisions governing coverage, reimbursement, pricing, and marketing of medical device products. In addition, third-party payor coverage and reimbursement policies are often revised or interpreted in ways that may significantly affect our business and our products.

As a smaller reporting company, we are subject to scaled disclosure requirements that may make it more challenging for investors to analyze our results of operations and financial prospects.

Currently, we are a “smaller reporting company,” as defined by Rule 12b-2 of the Exchange Act. As a “smaller reporting company,” we are able to provide simplified executive compensation disclosures in our filings and have certain other decreased disclosure obligations in our filings with the SEC, including being required to provide only two years of audited financial statements in annual reports. Consequently, it may be more challenging for investors to analyze our results of operations and financial prospects.

Furthermore, we are a non-accelerated filer as defined by Rule 12b-2 of the Exchange Act, and, as such, are not required to provide an auditor attestation of management’s assessment of internal control over financial reporting, which is generally required for SEC reporting companies under Section 404(b) of the Sarbanes-Oxley Act. Because we are not required to, and have not, had our auditor’s provide an attestation of our management’s assessment of internal control over financial reporting, a material weakness in internal controls may remain undetected for a longer period.

Global economic uncertainty and financial market volatility caused by political instability, changes in international trade relationships and conflicts could make it more difficult for us to access financing and could adversely affect our business and operations.

Our ability to raise capital is subject to the risk of adverse changes in the market value of our stock. Periods of macroeconomic weakness or recession and heightened market volatility caused by adverse geopolitical developments could increase these risks, potentially resulting in adverse impacts on our ability to raise further capital on favorable terms. The impact of geopolitical tension, such as a deterioration in the bilateral relationship between the U.S. and China or in the ongoing conflicts between Russia and Ukraine, including resulting sanctions, export controls or other restrictive actions that may be imposed by the U.S. and/or other countries against governmental or other entities in, for example, Russia, also could lead to disruption, instability and volatility in global trade patterns, which may in turn impact our ability to source necessary reagents, raw materials and other inputs for our research and development operations. In addition, political developments impacting government spending and international trade, including changes in trade agreements, potential government shutdowns and trade disputes and tariffs, including tariffs that have been or may in the future be imposed by the United States or other countries and future legislation or actions taken by the United States or other countries that restrict trade, and protectionist or retaliatory measures taken by the United States or other countries, may negatively impact markets and cause weaker macroeconomic conditions. Any of the abovementioned factors could affect our business, prospects, financial condition, and operating results. The extent and duration of any political instability and resulting market disruptions are impossible to predict but could be substantial. Any such disruptions may also have the effect of heightening many of the other risks and uncertainties described elsewhere in this “Risk Factors” section.

The U.S. Congress, the Trump administration, or any new administration may make substantial changes to fiscal, tax, and other federal policies that may adversely affect our business.

In 2017, the U.S. Congress and the Trump administration made substantial changes to U.S. policies, which included comprehensive corporate and individual tax reform. In addition, the Trump administration called for significant changes to U.S. trade, healthcare, immigration and government regulatory policy in President Trump’s second term. The transitions between the Trump and Biden presidential terms led to substantial changes in the direction and focus of administrative and regulatory policies. Changes to U.S. policy implemented by the U.S. Congress, the Trump administration or any future administration have impacted and may in the future impact, among other things, the U.S. and global economy, international trade relations, unemployment, immigration, healthcare, taxation, the U.S. regulatory environment, inflation and other areas. Although we cannot predict the impact, if any, of these changes to our business, they could adversely affect our business. Until we know what policy changes are made, whether those policy changes are challenged and subsequently upheld by the court system and how those changes impact our business and the business of our competitors over the long term, we will not know if, overall, we will benefit from them or be negatively affected by them. 

The Company has concluded that there are material weaknesses in its internal control over financial reporting, which, if not remediated, could materially adversely affect its ability to timely and accurately report its results of operations and financial condition. The accuracy of the Company’s financial reporting depends on the effectiveness of its internal controls over financial reporting.

Internal control over financial reporting can provide only reasonable assurance with respect to the preparation and fair presentation of financial statements and may not prevent or detect misstatements. Failure to maintain effective internal control over financial reporting, or lapses in disclosure controls and procedures, could undermine the Company’s ability to provide accurate financial information on a timely basis, which could cause investors to lose confidence in the Company’s disclosures, require significant resources to remediate the deficiency, and expose the Company to legal or regulatory proceedings.

In the course of performing management’s assessment of internal control over financial reporting as of December 31, 2025, management identified the following material weaknesses: (i) inadequate identification, recording and reporting of stock-based compensation, (ii) ineffective review processes over period-end financial disclosure and reporting, including review of IPE (Information Produced by the Entity), (iii) inadequate segregation of duties for transaction posting and processing, and (iv) ineffective review controls over the accounting for business combinations and related financial instruments.

As a result of these material weaknesses, there was a reasonable possibility that material misstatements in the Company’s financial statements could occur and not be prevented or detected on a timely basis. Accordingly, management concluded that the Company’s internal control over financial reporting was not effective as of December 31, 2025.

The Company’s remediation efforts for these material weaknesses are ongoing. Remediation and strengthening of the internal control environment has required, and is expected to continue to require, substantial effort in 2026. The material weaknesses cannot be considered fully remediated until the applicable controls have operated effectively for a sufficient period of time and management has tested and concluded that these controls are operating as designed. The Company cannot provide assurance that the identified material weaknesses will be fully remediated or that additional material weaknesses will not be identified in the future.