QT IMAGING HOLDINGS, INC.
For the period ended Dec 31, 2024. Filed Mar 31, 2025.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 31, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
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Table of Contents
| Page | |
|---|---|
| Cautionary Statement About Forward-Looking Statements | ii |
| Summary of Risk Factors | iv |
| Part I: | |
| Item 1: Business | 1 |
| Item 1A: Risk Factors | 49 |
| Item 1B: Unresolved Staff Comments | 99 |
| Item 1C: Cybersecurity | 96 |
| Item 2: Properties | 100 |
| Item 3: Legal Proceedings | 100 |
| Item 4: Mine Safety Disclosures | 100 |
| Part II | |
| Item 5: Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities | 101 |
| Item 6: Reserved | 101 |
| Item 7: Management’s Discussion and Analysis of Financial Condition and Results of Operations | 101 |
| Item 7A: Quantitative and Qualitative Disclosures About Market Risk | 118 |
| Item 8: Financial Statements and Supplementary Data | F-1 |
| Item 9: Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 111 |
| Item 9A: Controls and Procedures | 111 |
| Item 9B: Other Information | 112 |
| Item 9C: Disclosure Regarding Foreign Jurisdictions that Prevent Inspection | 112 |
| Part III | |
| Item 10: Directors, Executive Officers and Corporate Governance | 113 |
| Item 11: Executive Compensation | 121 |
| Item 12: Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 129 |
| Item 13: Certain Relationships and Related Transactions, and Director Independence | 131 |
| Item 14: Principal Accountant Fees and Services | 135 |
| Part IV | |
| Item 15. Exhibits, Financial Statement Schedules | 136 |
| Signatures | 141 |
i
CAUTIONARY STATEMENT ABOUT FORWARD-LOOKING STATEMENTS
This annual report contains forward-looking statements. All statements, other than statements of present or historical fact included in or incorporated by reference in this annual report, regarding the future financial performance of QT Imaging Holdings, Inc. (the “Company”), as well as the Company’s strategy, future operations, financial position, estimated revenues, and losses, projected costs, prospects, plans and objectives of management are forward-looking statements. When used in this annual report, the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward‑looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations, assumptions, hopes, beliefs, intentions and strategies regarding future events and are based on currently available information as to the outcome and timing of future events. The Company cautions you that these forward-looking statements are subject to all of the risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of the Company, incident to its business.
These forward-looking statements are based on information available as of the date of this annual report, and current expectations, forecasts and assumptions, and involve a number of risks and uncertainties. As a result of a number of known and unknown risks and uncertainties, the Company’s actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include:
the Company’s ability to recognize the anticipated benefits of the Business Combination (as defined below), which may be affected by, among other things, competition and the ability of the Company to grow and manage growth profitably following the closing of the Business Combination;
changes in applicable laws or regulations;
the outcome of any legal proceedings against the Company;
the financial and business performance of the Company, including financial projections and business metrics and any underlying assumptions thereunder;
the Company’s ability to successfully and timely develop, sell and expand its technology and products, and otherwise implement its growth strategy;
risks relating to the Company’s operations and business, including information technology and cybersecurity risks, loss of customers and deterioration in relationships between the Company and its employees;
risks related to increased competition;
risks that the Company experiences difficulties managing its growth and expanding operations;
the impact of geopolitical, macroeconomic and market conditions;
the ability to successfully select, execute or integrate future acquisitions into the business; and
other risks and uncertainties set forth in this annual report in the section entitled “Risk Factors” beginning on page 49.
Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in an evolving environment. Some of these risks and uncertainties may in the future be amplified by events we do not expect or cannot predict. Additionally, new risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. As a result of these factors, the forward‑looking statements in this annual report may not prove to be accurate.
Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained in this annual report, whether as a result of any new information, future events, changed circumstances or
ii otherwise. You should read this annual report completely, and with the understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
iii
SUMMARY OF RISK FACTORS
The below summary of risk factors provides an overview of many of the risks we are exposed to in the normal course of our business activities. As a result, the below summary risks do not contain all of the information that may be important to you, and you should read the summary risks together with the more detailed and complete discussion of risks set forth under the heading “Risk Factors” in Part I, Item 1A of this annual report, as well as elsewhere in this annual report. Additional risks, beyond those summarized below or discussed elsewhere in this annual report, may apply to our activities or operations as currently conducted or as we may conduct them in the future or in the markets in which we operate or may in the future operate.
Consistent with the foregoing, we are exposed to a variety of risks, including risks associated with the following:
Risks Associated with Our Business, Financial Condition and Need for Additional Capital
We have incurred significant operating losses in the past and may never achieve or maintain profitability.
We have a limited operating history with our current offerings, which makes it difficult to evaluate our current and future business prospects and increases the risk of your investment.
If we are unable to attract new customers on a cost-effective basis, our business will be harmed.
We may be unable to successfully execute on our growth initiatives, business strategies, or operating plans.
The forecasts and projections herein are based upon certain assumptions, analyses, and estimates. If these assumptions, analyses, or estimates prove to be incorrect or inaccurate, our actual results may differ materially from those forecasted or projected.
If we fail to attract and retain qualified personnel, our business could be harmed.
Our management team has a limited history working together operating the Company and, as a result, our past results may not be indicative of future operating performance.
Our ability to introduce new products and features is dependent on adequate development resources. If we do not adequately fund our development efforts, we may not be able to compete effectively and our business and operating results may be harmed.
We rely on internet infrastructure, bandwidth providers, data center providers, other third parties, and our own systems for providing solutions to our customers, and any failure or interruption in the services provided by these third parties or our own systems could expose us to litigation and negatively impact our relationships with customers, adversely affecting our brand and our business.
We may not successfully develop or introduce new and enhanced products that achieve market acceptance, or successfully integrate acquired products or services with our existing products, and our business could be harmed and our revenue could suffer as a result.
If we successfully commercially launch the QT Scanner 2000 Model A, (the “QT Breast Scanner”), products under development that are cleared by the U.S. Food and Drug Administration (the “FDA”) and other regulatory agencies, and they do not achieve widespread market acceptance, we will not be able to generate the revenue necessary to support our business.
Recent changes in the United States related to payment policies for imaging procedures could have a negative impact on the utilization of our imaging services.
In order to support the growth of our business, we may need to incur additional indebtedness under our credit facilities or seek capital through new equity or debt financings, which sources of additional capital may not be available to us on acceptable terms or at all.
Risks Associated with Healthcare Industry Shifts and Government Regulation
Our business is subject to extensive pre-market and post-market government regulations and if we fail to comply with present or future regulator requirements that are applicable, it may subject our company to enforcement
iv action by the FDA which may have a material adverse effect our business, financial condition and results of operations.
Our products must be manufactured in accordance with federal, state and foreign regulations as to the methods used in, and the facilities used for, the manufacture of our products and if we, or our third-party manufacturers do not take the necessary steps to comply with applicable regulations, it could result in delays in the delivery of our products which could significantly and negative affect the supply of our products.
. Risks Associated with our Intellectual Property
Our business relies upon a combination of patents and trade secrets to protect the intellection property related to our proprietary technologies and if we are unable to obtain and maintain intellectual property protections it could have an adverse impact on our market competitiveness and business prospects.
Patents have a limited life span and given the amount of time required for the development, testing and regulatory review of products, patents protecting our future products might expire before or shortly after we commercialize these products which could result in us not having sufficient rights to exclude others from commercializing products similar or identical to ours for a sufficient amount of time, and as a result, we may not be able to obtain adequate protection of our patent portfolio.
Risks Associated with Our Management
We are highly dependent on key members of our executive management team and the loss of members of our management team could result in a delay in the implementation of our business plan and plan of operations, which could result in a material adverse effect on our business, result of operations and financial condition.
Most of the members of our management team have limited or no experience managing a publicly traded company and may not successfully or efficiently manage our transition to being a public company subject to regulatory oversight and reporting obligations under U.S. federal securities laws and the scrutiny of our investors and these obligations could divert their attention away from the management of our business, which could affect our business, financial condition,results of operations and prospects.
Risks Associated with Common Stock and Other Securities
It is not currently anticipated that we will pay dividends on shares of common stock, and, consequently, your ability to achieve a return on your investment will depend on appreciation, if any, in the market price of common stock.
Future sales of common stock may depress their stock price.
We could become subject to product liability claims, product recalls, and warranty claims that could be expensive, divert management’s attention and harm our business reputation and financial results.
The public warrants may never be in the money, and they may expire worthless and the terms of the warrants may be amended in a manner adverse to a holder if holders of at least 50% of the then outstanding public warrants approve of such amendment.
We may redeem unexpired public warrants prior to their exercise at a time that is disadvantageous to the warrant holder, thereby making the public warrants worthless.
We may issue additional shares of common stock or preferred stock, including under our equity incentive plan. Any such issuances would dilute the interest of our stockholders and likely present other risks.
Our common stock will no longer be listed on the Nasdaq Global Market which may adversely affect our ability to raise additional financing through the public or private sale of equity securities, the ability of investors to trade our securities and the value and liquidity of our common stock.
Our common stock is now quoted on the OTC Markets OTCQB Venture Market tier which is a volatile market that could depress the market price of our common stock and have an adverse impact on our ability to raise capital in the future for reasons unrelated to our operating performance.
v
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