株探米国株
エドガーで原本を確認する
false 0001269026 0001269026 2025-11-13 2025-11-13 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): November 13, 2025

 

SINTX Technologies, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-33624   84-1375299

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

1885 West 2100 South

Salt Lake City, UT

  84119
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (801) 839-3500

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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

 

Title of each class:   Trading Symbol(s):   Name of each exchange on which registered:
Common Stock, par value $0.01 per share   SINT   The NASDAQ Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b–2 of the Securities Exchange Act of 1934 (§ 240.12b–2 of this chapter).

 

Emerging growth company ☐

 

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. ☐

 

 

 

 
 

 

Item 2.02. Results of Operations and Financial Condition.

 

On November 13, 2025, SINTX Technologies, Inc. (the “Company”) issued a press release announcing financial results for its quarter ended September 30, 2025. The full text of the press release, which includes information regarding the Company’s use of a non-GAAP financial measure, is furnished as Exhibit 99.1 to this Form 8-K.

 

The information contained in this Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section. Furthermore, the information contained in this Item 2.02 or Exhibit 99.1 shall not be deemed to be incorporated by reference into any registration statement or other document filed pursuant to the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

 

Item 7.01. Regulation FD. Disclosure.

 

The information set forth under Item 2.02 is incorporated by reference as if fully set forth herein.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
99.1   Press Release, dated November 13, 2025
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 
 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  SINTX TECHNOLOGIES, INC.
   
Date: November 13, 2025 /s/ Eric Olson
  Eric Olson
  President and Chief Executive Officer

 

 

 

EX-99.1 2 ex99-1.htm EX-99.1

 

Exhibit 99.1

 

 

 

SINTX Reports Pivotal Third Quarter Business Update and Financial Highlights Driven by FDA Clearance, Product and IP Portfolio Expansions and Increased Operational Efficiencies

 

Company underscores its strengthened liquidity, cost reductions, and first revenue recorded from OsseoSculpt™

 

SALT LAKE CITY, Utah – November 13, 2025 – SINTX Technologies, Inc. (NASDAQ: SINT) (“SINTX” or the “Company”), an advanced ceramics and biomaterials company focused on silicon-nitride–based medical technologies, today provided a business update reporting third quarter financial results in conjunction with the filing the Company’s Form 10-Q for the quarter ended September 30, 2025.

 

During the third quarter and subsequent weeks, SINTX advanced a focused commercialization plan centered on infection-resistant silicon nitride devices and polymer composites, while tightening its operating footprint and strengthening its balance sheet.

 

Business Highlights and Key Milestones

 

FDA 510(k) Clearance: Received U.S. FDA clearance for the SINAPTIC® Foot & Ankle Osteotomy Wedge System, enabling SINTX’s commercial entry into reconstructive foot and ankle surgery in the U.S.
Initial Product Revenue: Recorded first commercial revenue from the private-labeled orthobiologic product OsseoSculpt™, a companion biologic to the SINAPTIC wedge portfolio.
Facility Optimization: Executed a sublease of the Armor facility, estimated to save up to approximately $950,000 in lease costs over the sublease term, further aligning operating resources with its medical device priorities.
Broadened IP Portfolio: United States Patent and Trademark Office (USPTO) issued Notice of Allowance for patent application containing method claims covering the Company’s antipathogenic fabric technology.
Strengthened Liquidity: Raised an additional $4.3 million in gross proceeds through warrant inducement and common stock warrant exercises.

 

Third Quarter 2025 Financial Results:

 

Cash and cash equivalents were $6.25 million on September 30, 2025, compared with $3.60 million on December 31, 2024, reflecting financing activity and disciplined working-capital management.
Revenue of $0.2 million, a decrease as compared to $0.8 million in Q3 2024, primarily related to a reduction in grant revenue recognized compared to the prior period.
Operating expenses of approximately $3.4 million, a decrease of 51% year-over-year.
Operating loss of $3.4 million compared to $6.4 million in Q3 2024.
Net loss of $3.5 million, representing a loss of $1.19 per fully diluted share, compared to net loss of $6.2 million representing a loss of $6.96 per fully diluted share in Q3 2024.
Adjusted EBITDA loss of $2.3 million in Q3 2025 compared to $6.1 million in Q3 2024.

 

“We have aligned SINTX squarely behind near-term commercial milestones with our advanced biomaterial products,” said Eric Olson, President and CEO of SINTX. “The 510(k) clearance for our SINAPTIC foot & ankle wedge system represents a pivotal milestone that validates our technology and establishes a scalable platform for future growth. We believe the decisive actions we have taken to monetize non-core assets, streamline facilities, and maintain prudent access to capital position the Company to execute this strategy effectively. The Company remains focused on advancing clinical leadership into sustainable product revenue opportunities, while building broader commercial utilization around silicon nitride’s unique clinical advantages.”

 

 
 

 

Looking ahead, SINTX’s near-term priorities include: (i) preparing the SINAPTIC wedge system for launch; (ii) expanding clinical and key opinion leader (KOL) engagement in targeted surgical specialties; and (iii) leveraging its material science into adjacent indications — including polymer composites for 3D printed custom and patient specific implants — where silicon nitride’s antipathogenic and bone-affinity attributes can be most impactful. Management also intends to continue evaluating partnering, licensing, and capital formation options that we believe will accelerate market access and enhance shareholder value.

 

For more information on SINTX Technologies or its materials platform, visit www.sintx.com.

 

About SINTX

 

Headquartered in Salt Lake City, Utah, SINTX Technologies, Inc. (NASDAQ: SINT) is an advanced ceramics company that develops, manufactures, and commercializes silicon nitride biomaterials, composites, devices, and related technologies for medical and other high-value applications. With thousands of medical devices implanted since 2008 and nearly two decades of peer-reviewed research, SINTX has established itself as a leader in high-performance biomaterials that enhance clinical outcomes and patient safety. Supported by a strong patent portfolio, U.S.-based manufacturing, and strategic industry partnerships, the company continues to expand its technology platform through innovation and market diversification, including the recently FDA-cleared SINAPTIC® Foot & Ankle Osteotomy Wedge System for reconstructive surgery.

 

Non-GAAP Financial Measures

 

This press release contains adjusted EBITDA, which is a non-GAAP measure defined as net income excluding depreciation and amortization, income tax (benefit) expense, net interest (income) expense, stock-based compensation, change in fair value of contingent consideration, realized gain (loss) on investments, and (gain) loss on disposition of assets. The Company believes that adjusted EBITDA provides useful information to management and investors relating to its results of operations. The Company’s management uses this non-GAAP measure to compare the Company’s performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The Company believes that the use of adjusted EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making. Adjusted EBITDA may differ from similarly titled measures used by other companies and should not be considered in isolation or as a substitute for measures of financial performance prepared in accordance with GAAP. Management uses Adjusted EBITDA solely as a supplemental tool to evaluate operating performance and for internal budgeting and planning purposes.

 

Management does not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recorded in the Company’s financial statements. In order to compensate for these limitations, management presents the non-GAAP financial measure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A reconciliation table of the net income, the most comparable GAAP financial measure to adjusted EBITDA, is included at the end of this release. The Company urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company’s business.

 

 
 

 

Forward-Looking Statements

 

Certain statements in this release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding SINTX Technologies’ commercialization plans and expected timing for the SINAPTIC Foot & Ankle Osteotomy Wedge System; potential surgeon adoption, clinical engagement, and commercial performance; anticipated benefits of facility optimization and financing activities; and the Company’s expectations regarding market opportunities, product development, and shareholder value creation. Forward-looking statements are based on current expectations, estimates, and projections about future events and are often identified by words such as “may,” “will,” “could,” “should,” “would,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “project,” “target,” “seek,” “continue,” and similar expressions. Plans and projections are subject to change based on market conditions, regulatory developments, and other factors beyond the Company’s control. These statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied, including, among others, risks related to commercialization execution, surgeon training and utilization, market acceptance, manufacturing scale-up, supply chain constraints, pricing and reimbursement, competitive products, intellectual property protection, integration of business operations, macroeconomic conditions, and reliance on third-party market estimates. FDA 510(k) clearance does not assure commercial success, and any discussion of potential infection-prevention or bone-affinity attributes of silicon nitride reflects materials-level research and is not part of the cleared indications for this product. Additional risks and uncertainties are described in SINTX’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, available at www.sec.gov. Forward-looking statements speak only as of the date of this release, and SINTX undertakes no obligation to update them, except as required by law.

 

SINTX Contacts:

 

Jack Perkins or Maria Hocut

KCSA Strategic Communications

Sintx@kcsa.com

 

SINTX Technologies, Inc.

801.839.3502

IR@sintx.com

 

 
 

 

SINTX Technologies, Inc.

Condensed Consolidated Balance Sheets - Unaudited

(in thousands, except share and per share data)

 

    September 30,
2025
    December 31,
2024
 
             
Assets                
Current assets:                
Cash and cash equivalents   $ 6,250     $ 3,598  
Account and other receivables, net of allowance for credit losses of $4.2 and $61.0 respectively     120       196  
Prepaid expenses and other current assets     577       475  
Inventories     447       502  
Total current assets     7,394       4,771  
                 
Inventories, net     402       465  
Property and equipment, net     507       922  
Intangible assets, net     150       16  
Goodwill     302       -  
Operating lease right of use asset     2,536       3,159  
Other long-term assets     73       80  
Total assets   $ 11,364     $ 9,413  
                 
Liabilities and Stockholders’ Equity                
Current liabilities:                
Accounts payable   $ 203     $ 299  
Accrued liabilities     1,050       986  
Debt     59       32  
Derivative liabilities     870       208  
Current portion of operating lease liability     384       456  
Other current liabilities     1,781       1  
Total current liabilities     4,347       1,982  
                 
Operating lease liability, net of current portion     2,949       3,537  
Total liabilities     7,296       5,519  
                 
Commitments and contingencies                
                 
Stockholders’ equity:                
Convertible preferred stock Series B, $0.01 par value, 130,000,000 total shares authorized inclusive of all series of preferred; 19 shares issued and outstanding as of September 30, 2025 and December 31, 2024.     -       -  
Convertible preferred stock Series C, $0.01 par value, 130,000,000 total shares authorized inclusive of all series of preferred; 50 shares issued and outstanding as of September 30, 2025 and December 31, 2024.     -       -  
Convertible preferred stock Series D, $0.01 par value, 130,000,000 total shares authorized inclusive of all series of preferred; 180 shares issued and outstanding as of September 30, 2025 and December 31, 2024.     -       -  
                 
Common stock, $0.01 par value, 250,000,000 shares authorized; 3,666,280 and 1,342,853 shares issued and 3,615,856 and 1,342,853 outstanding as of September 30, 2025 and December 31, 2024, respectively.     36       13  
Treasury Stock, 50,424 shares as of September 30, 2025     (133 )     -  
Additional paid-in capital     294,052       285,619  
Accumulated deficit     (289,887 )     (281,738 )
Total stockholders’ equity     4,068       3,894  
Total liabilities and stockholders’ equity   $ 11,364     $ 9,413  

 

 
 

 

SINTX Technologies, Inc.

Condensed Consolidated Statements of Operations - Unaudited

(in thousands, except share and per share data)

 

    Three Months Ended
September 30,
    Nine Months Ended
September 30,
 
    2025     2024     2025     2024  
Product revenue   $ 150     $ 367     $ 541     $ 1,054  
Grant and contract revenue     58       432       187       1,291  
Total revenue     208       799       728       2,345  
Costs of revenue     115       210       455       657  
Gross profit     93       589       273       1,688  
Operating expenses:                                
Research and development     1,264       796       3,618       4,492  
General and administrative     2,102       802       4,836       2,997  
Sales and marketing     59       87       100       589  
Armor exit costs     -       4,457       -       4,457  
Reduction in force     -       407       -       407  
Grant and contract expenses     23       448       122       1,061  
Total operating expenses     3,448       6,997       8,676       14,003  
Loss from operations     (3,355 )     (6,408 )     (8,403 )     (12,315 )
Other income (expenses):                                
Interest expense     (13 )     (9 )     (40 )     (15 )
Interest income     43       24       130       66  
Gain (loss) on disposal of equipment     -       (20 )     327       (8 )
Change in fair value of derivative liabilities     (214 )     173       (166 )     3,459  
Offering costs of derivative liabilities     -       -       -       (550 )
Other income, net     -       1       3       34  
Total other income, net     (184 )     169       254       2,986  
Net loss before income taxes     (3,539 )     (6,239 )     (8,149 )     (9,329 )
Provision for income taxes     -       -       -       -  
Net loss   $ (3,539 )   $ (6,239 )   $ (8,149 )   $ (9,329 )
Deemed dividend related to warrant inducement     (6,719 )     -       (6,719 )     -  
Net loss attributable to common stockholders   $ (10,258 )   $ (6,239 )   $ (14,868 )   $ (9,329 )
                                 
Net loss per share – basic and diluted                                
Basic – net loss   $ (1.19 )   $ (6.96 )   $ (3.38 )   $ (17.30 )
Basic – deemed dividend related to warrant inducement     (2.27 )     -       (2.79 )     -  
Basic – attributable to common stockholders   $ (3.46 )   $ (6.96 )   $ (6.17 )   $ (17.30 )
                                 
Diluted – net loss   $ (1.19 )   $ (6.96 )   $ (3.38 )   $ (19.59 )
Diluted – deemed dividend related to warrant inducement     (2.27 )     -       (2.79 )     -  
Diluted – attributable to common stockholders   $ (3.46 )   $ (6.96 )   $ (6.17 )   $ (19.59 )
                                 
Weighted average common shares outstanding:                                
Basic     2,963,539       896,305       2,411,004       539,252  
Diluted     2,963,539       897,323       2,411,179       656,468  

 

 
 

 

SINTX Technologies, Inc.

GAAP AND NON-GAAP MEASURES

(Unaudited)

 

Reconciliation of net loss to adjusted EBITDA:

 

    Three Months Ended September 30,  
    2025     2024  
Net loss   $ (3,539 )   $ (6,239 )
Interest income, net     (30 )     (15 )
Depreciation and amortization     159       332  
Stock-based compensation     888       10  
Change in fair value of derivative liabilities     214       (173 )
Adjusted EBITDA   $ (2,308 )   $ (6,085 )