Sintx Technologies, Inc.: Form 10-Q for the period ended Jun 30, 2026

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our consolidated financial statements for the year ended December 31, 2025 and the notes thereto, along with Management’s Discussion and Analysis of Financial Condition and Results of Operations, included in our Annual Report on Form 10-K for the year ended December 31, 2025, filed separately with the U.S. Securities and Exchange Commission. This discussion and analysis contains forward-looking statements based upon current beliefs, plans, expectations, intentions and projections that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and projections. Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2025, and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q and in other filings with the Securities and Exchange Commission we may make from time-to-time.

Overview

SINTX Technologies is an advanced ceramics company formed in December 1996 that develops, manufactures, and commercializes silicon nitride biomaterials, composites, devices, and related technologies for medical and other high-value applications. SINTX provides biomedical solutions for medical devices specializing in silicon nitride (Si₃N₄) for musculoskeletal and antipathogenic applications. We also manufacture parts made from silicon nitride for customers in the electrical, aerospace and other industrial sectors. SINTX is a global leader in the research, development, and manufacturing of silicon nitride, and its products have been implanted in humans since 2008.

Components of our Results of Operations

We manage our business within one reportable segment, which is consistent with how our management reviews our business, makes investment and resource allocation decisions, and assesses operating performance.

Revenue

Our product revenue is derived from the manufacture and sale of products. These revenue sources primarily include coatings, materials, and components for aerospace and medical device markets, toll processing services, and government contracts and grants. We generally recognize revenue from sales where control transfers at a point in time as the title and risk of loss passes to the customer, which is at the time the product is shipped. In general, our customers do not have rights of return or exchange.

We believe our product revenue will increase as we complete development and obtain regulatory clearance for our product candidates and secure opportunities to manufacture third party products with silicon nitride.

We also derive grant and contract revenue from awards provided by governmental agencies.

Cost of revenue

The expenses that are included in cost of revenue include all in-house manufacturing costs for the products we manufacture.

Gross profit

Our gross profit measures our product revenue relative to our cost of revenue.

Research and development expenses

Our research and development costs are expensed as incurred. Research and development costs consist of engineering, product development, clinical trials, test-part manufacturing, testing, developing and validating the manufacturing process, manufacturing, facility and regulatory-related costs. Research and development expenses also include employee compensation, employee and non-employee stock-based compensation, supplies and materials, consultant services, and travel and facilities expenses related to research and development activities.

We expect to incur additional research and development costs as we continue to develop new medical devices, related product candidates for antipathogenic applications, and other products which may increase our total research and development expenses.

General and administrative expenses

General and administrative expenses consist primarily of salaries, benefits and other related costs, including stock-based compensation for certain members of our executive team and board of directors, and other personnel employed in finance, legal, compliance, administrative, information technology, customer service, executive and human resource departments. General and administrative expenses also include other expenses not part of the other cost categories mentioned above, including facility expenses and professional fees for accounting and legal services.

RESULTS OF OPERATIONS

The following is a tabular presentation of our unaudited condensed consolidated operating results for the three and six months ended June 30, 2026 and 2025 (in thousands):

Revenue

For the three months ended June 30, 2026, total revenue increased $0.3 million, or 199%, compared to the same period in 2025. For the six months ended June 30, 2026, total revenue increased $0.3 million, or 60%, compared to the same period in 2025. When excluding the total revenue decrease of $0.1 million due to the sale of the TA&T subsidiary, the remaining total revenue for the six months ended June 30, 2026 increased by $0.4 million, or 102%.

For the three months ended June 30, 2026, product revenue increased $0.3 million, or 347%, compared to the same period in 2025. For the six months ended June 30, 2026, product revenue increased $0.4 million, or 91%, compared to the same period in 2025. When excluding the product revenue decrease of $0.1 million due to the sale of the TA&T subsidiary, the remaining product revenue for the six months ended June 30, 2026 increased by $0.4 million, or 128%.

During the three months ended June 30, 2026, grant and contract revenue decreased $46,000, or 90%, as compared to the same period in 2025. During the six months ended June 30, 2026, grant and contract revenue decreased $44,000, or 34%, as compared to the same period in 2025. When excluding the grant and contract revenue decrease of $45,000 due to the sale of the TA&T subsidiary, the remaining grant and contract revenue for the six months ended June 30, 2026 increased by $1,000, or 1%.

Revenue trends and strategic focus

Total revenue increased compared with the prior-year periods, primarily reflecting higher product sales from the Company’s operations. Comparability to the prior year was also affected by the divestiture of the TA&T subsidiary during the first quarter of 2025.

Product revenue growth was driven primarily by increased sales within the Company’s OEM technical manufacturing products, reflecting improved customer demand and pricing, together with initial commercial sales of the SiNAPTIC Foot & Ankle Osteotomy Wedge System. These increases were partially offset by lower grant and contract revenue, which can fluctuate based on the timing and scope of funded projects.

The Company continues to support its OEM technical manufacturing product line as an important source of revenue and cash flow. Recent pricing initiatives have improved the profitability of this product line while allowing the Company to continue investing in the commercialization of its proprietary silicon nitride-based biomedical devices, including its orthopedic product portfolio. Management expects the OEM product line and its proprietary medical technology initiatives to remain complementary components of the Company’s long-term growth strategy.

Cost of revenue and Gross profit

For the three months ended June 30, 2026, cost of revenue increased by $0.1 million, or 85%, compared to the same period in 2025. For the six months ended June 30, 2026, cost of revenue increased by $0.1 million, or 21%, compared to the same period in 2025. Cost of revenue increased at a lower rate than revenue primarily due to the Company’s continued focus on higher-margin sales and a favorable sales mix, with improved pricing on certain OEM products, during the current period. Although the Company expects this strategy to continue to support profitability, gross margin may fluctuate from period to period based on product mix, pricing, manufacturing efficiencies, customer demand, and the mix of product and grant and contract revenue.

Research and development expenses

For the three months ended June 30, 2026, research and development expenses decreased by $0.7 million, or 54%, compared to the same period in 2025. The decrease was primarily due to $0.7 million in the reallocation of certain overhead costs to general and administrative expenses (also see explanation below). Other research and development expenses remained consistent during the period.

For the six months ended June 30, 2026, research and development expenses decreased by $1.4 million, or 60%, compared to the same period in 2025. The decrease was primarily due to $1.4 million in the reallocation of certain overhead costs to general and administrative expenses (also see explanation below). Other research and development expenses remained consistent during the period.

Historically, a significant portion of our operations was focused on research and development, resulting in the majority of overhead costs being allocated to research and development. As our focus has shifted toward commercialization, a greater portion of these costs is now classified as general and administrative.

General and administrative expenses

For the three months ended June 30, 2026, general and administrative expenses increased by $0.9 million, or 64%, compared to the same period in 2025. The increase was primarily due to $0.8 million in higher headcount-related costs, including $0.1 million of non-cash stock-based compensation, as well as the reallocation of certain overhead costs of $0.7 million, as discussed above. These increases were partially offset by decreases of $0.2 million in board of directors fees, $0.1 million in non-employee stock-based compensation, $0.1 million in accounting fees, and $0.2 million in other general expenses.

For the six months ended June 30, 2026, general and administrative expenses increased by $2.1 million, or 78%, compared to the same period in 2025. The increase was primarily due to $1.1 million in higher headcount-related costs, including $0.5 million of non-cash stock-based compensation, as well as the reallocation of certain overhead costs of $1.4 million, as discussed above, and $0.1 million in other general expenses. These increases were partially offset by decreases of $0.3 million in non-employee stock-based compensation and $0.2 million in board of directors fees.

Sales and marketing expenses

For the three months ended June 30, 2026, sales and marketing expenses increased by $0.3 million, or 1,200%, compared to the same period in 2025. The increase was primarily due to $0.2 million in higher headcount-related costs, including $34,000 of non-cash stock-based compensation, as well as a $0.1 million increase in other sales and marketing related costs associated with our product launch.

For the six months ended June 30, 2026, sales and marketing expenses increased by $0.6 million, or 1,539%, compared to the same period in 2025. The increase was primarily due to $0.3 million in higher headcount-related costs, including $0.1 million of non-cash stock-based compensation, as well as a $0.3 million increase in other sales and marketing related costs associated with our product launch.

Grant and contract expenses

For the three months ended June 30, 2026, grant and contract expenses decreased by $46,000, or 96%, compared to the same period in 2025, primarily due to the decrease in grant and contract revenue.

For the six months ended June 30, 2026, grant and contract expenses decreased by $44,000, or 44%, compared to the same period in 2025, primarily due to the decrease in grant and contract revenue.

Other income, net

For the three months ended June 30, 2026, other income, net decreased by $0.2 million, or 48%, compared to the same period in 2025, primarily due to a $0.4 million decrease in gain on disposal of equipment, partially offset by a $0.2 million increase from the change in value of derivative liabilities.

For the six months ended June 30, 2026, other income, net increased by $0.1 million, or 30%, compared to the same period in 2025, primarily due to a $0.4 million increase from the change in value of derivative liabilities, partially offset by a $0.3 million decrease in gain on disposal of equipment.

Liquidity and capital resources

The condensed consolidated financial statements have been prepared assuming we will continue to operate as a going concern. To date, our operations have been principally financed from proceeds from the issuance of preferred and common stock and, to a lesser extent, cash generated from product sales. It is anticipated that we will continue to generate operating losses and use cash in operations. Our continuation as a going concern is dependent upon our ability to increase sales, decrease expenses and raise additional funding. We continue to seek opportunities to raise additional funding through equity and/or debt financing. However, such funding is not guaranteed and may not be available to us on favorable terms and may involve restrictive covenants. If we are not able to obtain additional debt or equity financing, the impact on us will be material and adverse.

For the six months ended June 30, 2026, and 2025, we incurred a net loss of $5.5 million and $4.6 million, respectively, and used cash in operating activities of $5.3 million and $3.7 million, respectively. We had an accumulated deficit of $298 million and $292 million as of June 30, 2026, and December 31, 2025, respectively.

The board of directors and management remain aligned in advancing the Company’s strategic direction and business objectives. While we expect to continue generating a significant portion of our revenues from our industrial business product line, management is increasingly concentrating resources on high-growth areas within the healthcare sector where our proprietary materials and technologies—such as silicon nitride—provide a distinct competitive advantage due to their unique strength, durability, and biocompatibility. We believe our established industrial activities provide an important operational and revenue foundation that supports the continued development and commercialization of our medical technologies. Building upon our established advanced materials expertise and FDA 510(k) clearance of the SiNAPTIC Foot & Ankle Osteotomy Wedge System, we are focused on commercializing our medical technologies and advancing additional silicon nitride-based compositions and applications for orthopedic, spinal, wound care, and other medical markets in order to expand our footprint in the medical device sector and support creation of long-term shareholder value.

As part of our ongoing strategic review of our operations aimed at improving operational efficiency and reducing costs, as discussed in Note 2 to the condensed consolidated financial statements, on February 19, 2025, we sold to Tethon all the issued and outstanding shares of TA&T in exchange for the assumption by Tethon of the outstanding liabilities of TA&T.

As discussed in further detail above, in October 2025, we received FDA 510(k) clearance for a new foot and ankle osteotomy wedge system, enabling SINTX’s commercial entry into reconstructive foot and ankle surgery in the United States. We recognized initial revenue from the system during the first and second quarters of 2026. The timing and amount of future revenue will depend on, among other matters, physician adoption, customer ordering patterns, distributor performance, manufacturing capacity and reimbursement and market conditions.

As discussed in Note 9 to the condensed consolidated financial statements, in October 2025, we entered into the 2025 ATM Agreement to sell shares of our common stock from time to time, through an “at the market offering” program, having an aggregate offering price of $6.4 million. Through June 30, 2026, we have sold $1.3 million under the ATM, leaving a remaining balance of $5.1 million available under the ATM. Sales under the ATM depend on market conditions, eligibility to use the registration statement, trading volume and compliance with applicable offering limitations.

As discussed in Note 12 to the condensed consolidated financial statements, in October 2025, we entered into a sublease agreement to lease the SINTX Armor facility, that is expected to save us approximately $1.0 million over the sublease term.

As discussed in Note 9 to the condensed consolidated financial statements, in June 2026, we entered into securities purchase agreements for aggregate proceeds of approximately $4.5 million.

Despite the actions undertaken by management to improve liquidity and operating costs—including the divestiture of non-core operations, implementation of cost and pricing improvement initiatives, commercialization of newly cleared medical products, access to capital through our ATM program, and execution of the Armor facility sublease—management has concluded that substantial doubt remains regarding our ability to continue as a going concern for a period of at least 12 months from the date these condensed consolidated financial statements are issued. Our ability to continue as a going concern will depend on our ability to generate increased revenues, achieve profitability, obtain additional financing, and successfully execute our strategic business objectives. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.

Cash Flows

The following table summarizes, for the periods indicated, cash flows from operating, investing and financing activities (in thousands) – unaudited:

19

Net cash used in operating activities

Net cash used in operating activities was $5.3 million during the six months ended June 30, 2026, compared to $3.7 million used during the same period in 2025, an increase of $1.6 million. The increase was primarily due to an increase in net loss of $0.9 million, combined with net outflow from the change in inventories of $1.4 million, other liabilities of $0.8 million, and accounts receivable of $0.2 million. These changes were partially offset by net inflow from the change in accounts payable and accrued expenses of $1.5 million and non-cash adjustments of $0.2 million.

Net cash used in investing activities

Net cash used in investing activities was $0.1 million during the six months ended June 30, 2026, compared to net cash provided by investing activities of $0.3 million during the same period in 2025, a decrease of $0.4 million, primarily due to a decrease in proceeds from sale of property and equipment.

Net cash provided by financing activities

Net cash provided by financing activities was $4.8 million during the six months ended June 30, 2026, compared to $4.1 million provided during the same period in 2025. The $0.7 million increase was primarily due to an increase in proceeds from issuance of common stock in connection with ATM of $0.8 million, a decrease in repurchases of common stock into treasury of $0.1 million, and a decrease in payment on debt of $0.1 million. These changes were partially offset by a decrease in proceeds from issuance of common stock and warrants of $0.3 million.

Indebtedness

Information with respect to Indebtedness may be found in Note 8 to the condensed consolidated financial statements included in Item 1 of Part I of this report.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

Critical Accounting Estimates

A summary of our significant accounting policies and estimates is discussed in Management’s Discussion and Analysis of Financial Condition and Results of Operations and in Note 1 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2025. There have been no material changes to those policies for the three and six months ended June 30, 2026.

Recent Accounting Pronouncements

Information with respect to Recent Accounting Pronouncements may be found in Note 1 to the condensed consolidated financial statements included in Item 1 of Part I of this report.

This Report includes the certifications of our Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial and Accounting Officer) required by Rule 13a-14 of the Securities Exchange Act of 1934 (the “Exchange Act”). See Exhibits 31.1 and 31.2. This Item 4 includes information concerning the controls and control evaluations referred to in those certifications.

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures, as such term is defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934 (the “Exchange Act”), that are designed to ensure that information required to be disclosed in the reports filed or submitted under the Exchange Act, is recorded, processed, summarized, and reported within the time periods specified by the Commission’s rules and forms. Disclosure controls and procedures include controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act are properly recorded, processed, summarized and reported within the time periods required by the Commission’s rules and forms.

We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial and Accounting Officer), of the effectiveness of the design and operation of these disclosure controls and procedures, as such term is defined in Exchange Act Rule 13a-15(e), as of June 30, 2026. Based on this evaluation, the Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of June 30, 2026, the end of the period covered by this Quarterly Report on Form 10-Q.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the second quarter of 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Information regarding risk factors appears in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 20, 2026. There have been no material changes from the risk factors previously disclosed in the Annual Report on Form 10-K.