UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

 

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

 

For the quarterly period ended September 30,March 31, 20222023

 

OR

 

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

 

Commission File Number 001-33624

 

 

SINTX Technologies, Inc.

(Exact name of registrant as specified in its charter)

 

delaware 84-1375299
(State or other jurisdiction (IRS Employer
of incorporation or organization) Identification No.)

 

1885 West 2100 South, Salt Lake City, UT 84119
(Address of principal executive offices) (Zip Code)

 

(801) 839-3500

(Registrant’s telephone number, including area code)

 

 

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

 

Title of each class Trading Symbols Name of each exchange on which registered
Common Stock SINT The NASDAQ Capital Market

 

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 (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files); Yes ☒ No ☐

 

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

 

Large accelerated filerAccelerated filer
    
Non-accelerated filerSmaller reporting company
    
  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. ☐

 

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

 

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:

 

51,933,0954,050,302 shares of common stock, $0.01 par value, were outstanding at November 9, 2022.May 11, 2023.

 

 

 
 

SINTX Technologies, Inc.

Table of Contents

 

Part I. Financial Information 
Item 1. Financial Statements 
Condensed Consolidated Balance Sheets (unaudited)3
Condensed Consolidated Statements of Operations (unaudited)4
Condensed Consolidated Statements of Stockholders’ Equity (unaudited)5
Condensed Consolidated Statements of Cash Flows (unaudited)6
Notes to Condensed Consolidated Financial Statements (unaudited)7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations2017
Item 3. Quantitative and Qualitative Disclosures About Market Risk2623
Item 4. Controls and Procedures2623
Part II. Other Information 
Item 1. Legal Proceedings2724
Item 1A. Risk Factors2724
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds2724
Item 3. Defaults Upon Senior Securities2724
Item 4. Mine Safety Disclosures2724
Item 5. Other Information2724
Item 6. Exhibits2825
Signatures2926

 

2

SINTX Technologies, Inc.

Condensed Consolidated Balance Sheets - Unaudited

(in thousands, except share and per share data)

        
 September 30,
2022
  December 31,
2021
  March 31, 2023  December 31, 2022 
          
Assets                
Current assets:                
Cash and cash equivalents $4,779  $14,273  $12,626  $6,245 
Account and other receivables, net of allowance  230   102   467   328 
Prepaid expenses and other current assets  667   350   785   344 
Inventories  326   303   388   284 
Other current assets  46   -   25   8 
Total current assets  6,048   15,028   14,291   7,209 
                
Inventories  423   294 
Inventories, net  238   453 
Property and equipment, net  5,493   4,025   5,772   5,691 
Intangible assets, net  27   31   25   26 
Operating lease right of use asset  2,491   2,385   2,241   2,309 
Other long-term assets  81   77   84   85 
Total assets $14,563  $21,840  $22,651  $15,773 
                
Liabilities and Stockholders’ Equity                
Current liabilities:                
Accounts payable $289  $242  $486  $434 
Accrued liabilities  1,554   1,150   1,504   1,618 
Current portion of debt  5   509 
Current portion of related party debt  163   - 
Current portion of long-term debt  117   160 
Derivative liabilities  139   347   2,267   5,126 
Current portion of operating lease liability  720   500   750   738 
Other current liabilities  2   -   2   2 
Total current liabilities  2,872   2,748   5,126   8,078 
                
Debt, net of current portion  393   - 
Related party debt, net of current portion  72   - 
Operating lease liability, net of current portion  1,811   1,898   1,547   1,621 
Long term debt, net of current portion  33   368 
Other long-term liabilities  -   2 
Total liabilities  5,148   4,646   6,706   10,069 
                
Commitments and Contingencies  -   - 
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; 26 shares issued and outstanding as of September 30, 2022 and December 31, 2021.  -   - 
Convertible preferred stock Series C, $0.01 par value, 130,000,000 total shares authorized inclusive of all series of preferred; 50 and 51 shares issued and outstanding as of September 30, 2022 and December 31, 2021 respectively.  -   - 
Stockholders’ equity:        
Convertible preferred stock Series B, $0.01 par value, 130,000,000 total shares authorized inclusive of all series of preferred; 26 shares issued and outstanding as of March 31, 2023 and December 31, 2022.  -   - 
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 March 31, 2023 and December 31, 2022.  -   - 
Convertible preferred stock Series D, $0.01 par value, 130,000,000 total shares authorized inclusive of all series of preferred; 206 shares issued and outstanding as of March 31, 2023 and December 31, 2022.  -   - 
Convertible preferred stock Series E, $0.01 par value, 130,000,000 total shares authorized inclusive of all series of preferred; zero and 1 share issued and outstanding as of March 31, 2023 and December 31, 2022, respectively.  -   - 
Preferred stock value          -   - 
        
Common stock, $0.01 par value, 250,000,000 shares authorized; 24,729,289 and 24,710,574 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively.  247   247 
Common stock, $0.01 par value, 250,000,000 shares authorized; 4,050,236 and 542,145 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively.  40   5 
Additional paid-in capital  267,666   267,364   278,653   268,154 
Accumulated deficit  (258,498)  (250,417)  (262,748)  (262,455)
Total stockholders’ equity  9,415   17,194   15,945   5,704 
Total liabilities and stockholders’ equity $14,563  $21,840  $22,651  $15,773 

The condensed consolidated balance sheet as of December 31, 2021,2022, has been prepared using information from the audited consolidated balance sheet as of that date.

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

3

SINTX Technologies, Inc.

Condensed Consolidated Statements of Operations - Unaudited

(in thousands, except share data)

 

 2022  2021  2022  2021         
 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

  

Three Months Ended

March 31,

 
 2022  2021  2022  2021  2023  2022 
Product revenue $173  $239  $354  $441  $240  $101 
Grant and contract revenue  253   -   442   -   299   28 
Total revenue  426   239   796   441   539   129 
Costs of revenue  89   190   235   324   118   80 
Gross profit  337   49   561   117   421   49 
Operating expenses:                        
Research and development  1,523   1,603   4,651   4,402   2,200   1,653 
General and administrative  1,069   933   2,918   2,791   1,169   856 
Sales and marketing  291   338   1,023   953   310   394 
Grant and contract expenses  247   -   423   - 
Grant expenses  299   26 
Total operating expenses  3,130   2,874   9,015   8,146   3,978   2,929 
Loss from operations  (2,793)  (2,825)  (8,454)  (8,029)  (3,557)  (2,880)
Other income (expenses):                        
Interest expense  (4)  (1)  (12)  (2)  (2)  (8)
Interest income  5   3   8   99   38   2 
Loss on disposal of assets  -   -   (1)  - 
Change in fair value of derivative liabilities  60   481   208   225   4,006   41 
Forgiveness of PPP loan  -   -   -   391 
Other income, net  8   (1)  170   141 
Total other income (expense), net  69   482   373   854 
Offering costs of derivative liabilities  (786)  - 
Other income (net)  8   - 
Total other income, net  3,264   35 
Net loss before income taxes  (2,724)  (2,343)  (8,081)  (7,175)  (293)  (2,845)
Provision for income taxes  -   -   -   -   -   - 
Net loss $(2,724) $(2,343) $(8,081) $(7,175) $(293) $(2,845)
                        
Net loss per share – basic and diluted                        
Basic – net loss $(0.11) $(0.09) $(0.33) $(0.29) $(0.13) $(11.51)
Diluted –net loss $(0.11) $(0.11) $(0.33) $(0.29)
Diluted – net loss $(1.74) $(11.51)
Weighted average common shares outstanding:                        
Basic  24,724,792   24,703,156   24,717,904   24,686,533   2,272,992   247,122 
Diluted  25,086,999   25,069,343   25,084,092   25,097,138   2,558,059   247,122 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

4

SINTX Technologies, Inc.

Condensed Consolidated Statements of Stockholders’ Equity - Unaudited

(in thousands, except share and per share data)

  Shares  Amount  Shares  Amount  Shares  Amount  Capital  Deficit  Equity 
  Preferred B Stock  Preferred C Stock  Common Stock  Paid-In  Accumulated  Total 
  Shares  Amount  Shares  Amount  Shares  Amount  Capital  Deficit  Equity 
Balance as of December 31, 2020  26  $-   51  $-   24,552,409  $245  $266,666  $(241,107) $25,804 
Stock based compensation  -   -   -   -   -   -   36   -   36 
Extinguishment of derivative liability upon exercise of warrant  -   -   -   -   -   -   195   -   195 
Issuance of common stock upon exercise of warrants for cash  -   -   -   -   130,275   2   194   -   196 
Issuance of common stock from the cashless exercise of warrants  -   -   -   -   1,890   -   -   -   - 
Net loss  -   -   -   -   -   -   -   (2,633)  (2,633)
Balance as of March 31, 2021  26   -   51   -   24,684,574��  247   267,091   (243,740)  23,598 
Stock based compensation  -   -   -   -   15,500   -   80   -   80 
Net loss  -   -   -   -   -   -   -   (2,199)  (2,199)
Balance as of June 31, 2021  26   -   51   -   24,700,074   247   267,171   (245,939)  21,479 
Stock based compensation  -   -   -   -   6,000   -   104   -   104 
Net loss  -   -   -   -   -   -   -   (2,343)  (2,343)
Balance as of September 30, 2021  26  $-   51  $-   24,706,074  $247  $267,275  $(248,282) $19,240 
                             
  Preferred Stock  Common Stock  Paid-In  Accumulated  Total 
  Shares  Amount  Shares  Amount  Capital  Deficit  Equity 
Balance as of December 31, 2021  77              -   247,105             2   267,609   (250,416)  17,195 
Stock based compensation  -   -   30   -   102   -   102 
Net loss  -   -   -   -   -   (2,845)  (2,845)
Balance as of March 31, 2022  77  $-   247,135  $2  $267,711  $(253,261) $14,452 

 

  Preferred B Stock  Preferred C Stock  Common Stock  Paid-In  Accumulated  Total 
  Shares  Amount  Shares  Amount  Shares  Amount  Capital  Deficit  Equity 
Balance as of December 31, 2021  26  $-   51  $-   24,710,574  $247  $267,364  $(250,417) $17,194 
Stock based compensation  -   -   -   -   3,000   -   102   -   102 
Net loss  -   -   -   -   -   -   -   (2,845)  (2,845)
Balance as of March 31, 2022  26   -   51   -   24,713,574   247   267,466   (253,262)  14,451 
Stock based compensation  -   -   -   -   6,000   -   88   -   88 
Acquisition of subsidiary  -   -   -   -   -   -   22   -   22 
Net loss  -   -   -   -   -   -   -   (2,512)  (2,512)
Balance as of June 30, 2022  26   -   51   -   24,719,574   247   267,576   (255,774)  12,049 
Balance  26   -   51   -   24,719,574   247   267,576   (255,774)  12,049 
Stock based compensation  -   -   -   -   9,039   -   90   -   90 
Common stock issued on conversion of preferred stock  -   -   (1)  -   676   -   -   -   - 
Net loss  -   -   -   -   -   -   -   (2,724)  (2,724)
Balance as of September 30, 2022  26  $-   50  $-   24,729,289  $247  $267,666  $(258,498) $9,415 
Balance  26  $-   50  $-   24,729,289  $247  $267,666  $(258,498) $9,415 
  Preferred Stock  Common Stock  Paid-In  Accumulated  Total 
  Shares  Amount  Shares  Amount  Capital  Deficit  Equity 
Balance as of December 31, 2022  283  $          -   542,145  $5  $268,154  $(262,455) $5,704 
Beginning balance  283  $          -   542,145  $5  $268,154  $(262,455) $5,704 
Stock based compensation  -   -   15   -   86   -   86 
Common stock issued for cash, net of cash fees  -   -   1,980,000   20   4,437   -   4,457 
Prefunded warrants issued for cash, net of cash fees  -   -   -   -   383   -   383 
Extinguishment of derivative liability upon exercise of warrant  -   -   -   -   5,502   -   5,502 
Issuance of common stock from the exercise of prefunded warrants for cash  -   -   170,000   2   (2)  -   - 
Issuance of common stock from the cashless exercise of warrants  -   -   1,337,600   13   (13)  -   - 
Redemption of preferred stock  (1)  -   -   -   (2)  -   (2)
Issuance of agent warrants  -   -   -   -   108   -   108 
Round up shares issued in reverse split  -   -   20,475   -   -   -   - 
Net loss  -   -   -   -   -   (293)  (293)
Net income (loss)  -   -   -   -   -   (293)   (293) 
Balance as of March 31, 2023  282  $-   4,050,235  $40  $278,653  $(262,748) $15,945 
Ending balance  282  $-   4,050,235  $40  $278,653  $(262,748) $15,945 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

5

SINTX Technologies, Inc.

Condensed Consolidated Statements of Cash Flows - Unaudited

(in thousands)

 

 2022  2021         
 

Nine months Ended

September 30,

  

Three Months Ended

March 31,

 
 2022  2021  2023  2022 
Cash Flow From Operating Activities                
Net loss $(8,081) $(7,175) $(293) $(2,845)
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation expense  237   119   154   68 
Amortization of right of use asset  441   331   183   130 
Amortization of intangible assets  4   3   1   1 
Non-cash interest income  -   (88)
Stock based compensation  280   220   86   102 
Change in fair value of derivative liabilities  (208)  (225)  (3,898)  (41)
Forgiveness of PPP loan  -   (391)
Loss (gain) on disposal of property and equipment  1   (144)
Bad debt expense  (2)  -   (3)  - 
Changes in operating assets and liabilities:                
Trade accounts receivable  66   (140)  (137)  (4)
Prepaid expenses and other current assets  (346)  (177)  (457)  (391)
Inventories  (151)  (203)  110   (27)
Accounts payable and accrued liabilities  25   417   (103)  (54)
Other liabilities  (32)  -   (337)  3 
Payments on operating lease liability  (414)  (294)  (177)  (122)
Net cash used in operating activities  (8,180)  (7,747)  (4,871)  (3,180)
Cash Flows From Investing Activities                
Purchase of property and equipment  (1,109)  (3,210)  (236)  (230)
Proceeds from notes receivable, net of imputed interest  -   1,944 
Cash acquired in acquisition (see Note 2)  303   - 
Proceeds from sale of property and equipment  1   144 
Net cash used in investing activities  (805)  (1,122)  (236)  (230)
Cash Flows From Financing Activities                
Proceeds from issuance of common stock in connection with exercise of warrants  -   196 
Proceeds from issuance of debt  -   510 
Payments on debt  (509)  (5)
Net cash provided by (used in) financing activities  (509)  701 
Net decrease in cash and cash equivalents  (9,494)  (8,168)
Proceeds from issuance of warrant derivative liabilities  6,650   - 
Proceeds from issuance of common stock and prefunded warrants, net of cash fees of $600  4,840   - 
Redemption of Preferred Stock Series E  (2)  - 
Net cash provided by financing activities  11,488   - 
Net increase (decrease) in cash and cash equivalents  6,381   (3,410)
Cash and cash equivalents at beginning of period  14,273   25,351   6,245   14,273 
Cash and cash equivalents at end of period $4,779  $17,183  $12,626  $10,863 
                
Noncash Investing and Financing Activities                
Right-of-Use Assets and assumption of operating lease liability $27  $918 
Extinguishment of derivative liabilities through exercise of warrants  -   195 
Acquisition of subsidiary through assumption of debt (see Note 2)  22   - 
Right of use asset for lease liability $114  $- 
Reduction of derivative liability upon exercise of warrants  5,502   - 
Par value of common stock upon cashless exercise of warrants  13   - 
Par value of common stock upon exercise of prefunded warrants  2   - 
        
Supplemental Cash Flow Information                
Cash paid for interest $32  $-  $2  $25 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

6

SINTX TECHNOLOGIES, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

1. Organization and Summary of Significant Accounting Policies

 

Organization

The condensed consolidated financial statements include the accounts of SINTX Technologies, Inc. (“SINTX”) and its wholly-owned subsidiaries, SINTX Armor, Inc. (“SINTX Armor”) and SINTX TA&T,Technology Assessment and Transfer, Inc. (TA&T), which are collectively referred to as “we” or “the Company”. SINTX was incorporatedis an advanced ceramics company formed in the state of Delaware on December 10, 1996 (and was previously known as Amedica Corporation). The Company, is an OEM advanced ceramics materials company focused on providing solutions in a variety of medical, industrial,biomedical, technical, and antipathogenic applications. SINTX is a 25-year-old company that hasWe have grown over time from focusing primarily on the research, development and developmentcommercialization of medical devices manufactured with silicon nitride for use in human interbody implants to becoming an advanced ceramics company engaged in many differentdiverse fields, including biomedical, technical and this has enabled the Companyantipathogenic applications. This diversification enables us to focus on our core competencies. The core strength of the Company iscompetencies, which are the manufacturing, research, and development of products comprised from advanced ceramicsceramic materials for external partners. We seek to connect with new customers, partners and manufacturers to help them realize the goal of leveraging our expertise in advanced ceramics to create new, innovative products across these sectors. The Company presently manufactures ceramic powders and components in its Salt Lake City and Maryland facilities. The SINTX Salt Lake City facility is FDA and ANVISA registered, ISO 13485:2016 certified, and ASD9100D certified. The Company’s products are primarily sold in the United States.

 

The Company is focused on building revenue generating opportunities in three business industries - antipathogenic, industrial– biomedical, technical (including armor), and biomedicalantipathogenic – thereby connecting with current and new customers, partners and manufacturers to help realize the goal of leveraging expertise in high-tech ceramics to create new, innovative opportunities across these sectors. We expect our continued investment in research and development to provide additional revenue opportunities.

 

The Company’s initial focus was the development and commercialization of products made from silicon nitride for use in spinal fusion and hip and knee replacement applications. SINTX believes it is the first and only manufacturer to use silicon nitride in medical applications primarily focused on spine fusion therapies. Since then, we have developed other applications for our silicon nitride technology as well as utilized our expertise in the use of ceramic materials in other applications. In July 2021, the Company acquired the equipment and obtained certain proprietary know-how rights with which it intendsis using to develop, manufacture, and commercialize protective armor from boron carbide and a composite material of silicon carbide and boron carbide for military, law enforcement and civilian uses. The protective armor operations are housed in SINTX Armor. In June 2022, the Company acquired Technology Assessment and Transfer, Inc. (TA&T),TA&T, a nearly 40-year-old business with a mission to transition advanced materials and process technologies from a laboratory environment to commercial products and services (see Note 2).services.

 

On October 1, 2018, the Company completed the sale of its retail spine business to CTL Medical, a Dallas, Texas-based privately held medical device manufacturer. As a result of the sale, CTL Medical became the exclusive owner of the Company’s portfolio of metal and silicon nitride spine products, as well as access to future silicon nitride spine technologies developed by the Company. The Company’s name, Amedica, was also transferred to CTL Medical, which is now CTL Amedica. The Company serves as CTL’s exclusive OEM provider of silicon nitride products. Manufacturing, R&D, and all intellectual property related to the core, non-spine, biomaterial technology including silicon nitride remains with the Company.

 

On October 30, 2018, the Company amended its Certificate of Incorporation with the State of Delaware to change its corporate name to SINTX Technologies, Inc. The Company also changed its trading symbol on the NASDAQ Capital Market to “SINT”.

 

The Company’s new corporate brand reflects both the Company’s core competence in the research, developmentscience and manufacturingproduction of silicon nitride ceramics and other ceramics, as well as encouraging prospects for the future, as an OEM supplier of spine implants to CTL Amedica, and multiple opportunities outside of spine.

 

7

Basis of Presentation

 

These unaudited condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the United States Securities and Exchange Commission (“SEC”) and include all assets and liabilities of the Company.

 

SEC rules and regulations allow the omission of certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) so long as the statements are not misleading. In the opinion of management, these financial statements and accompanying notes contain all adjustments (consisting of normal recurring adjustments) necessary to present fairly the financial position and results of operations for the periods presented herein. These condensed consolidated financial statements should be read in conjunction with the consolidated audited financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021,2022, filed with the SEC on March 25, 2022.29, 2023. The results of operations for the ninethree months ended September 30, 2022,March 31, 2023, are not necessarily indicative of the results to be expected for the year ending December 31, 2022.2023. The Company’s significant accounting policies are set forth in Note 1 to the consolidated financial statements in its Annual Report on Form 10-K for the year ended December 31, 2021.2022.

Reverse Stock Split

On December 20, 2022, the Company effected a 1 for 100 reverse stock split of the Company’s common stock. The par value and the authorized shares of the common and preferred stock were not adjusted as a result of the reverse stock split. All common stock shares, equivalents, and per-share amounts for all periods presented in these consolidated financial statements have been adjusted retroactively to reflect the reverse stock split.

 

Use of Estimates

 

The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenue and expenses during the period. Actual results could differ from those estimates. As of September 30, 2022,March 31, 2023, the most significant estimate relates to derivative liabilities relating to common stock warrants.

 

Liquidity and Capital Resources

 

The condensed consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern within one year from the date of issuance of these condensed consolidated financial statements.

 

For the ninethree months ended September 30,March 31, 2023, and 2022, and 2021, the Company incurred a net loss of $8.10.3 million and $7.22.8 million, respectively, and used cash in operating activities of $8.24.9 million and $7.73.2 million, respectively. The Company had an accumulated deficit of $258.5262.7 million and $250.4262.5 million as of September 30, 2022,March 31, 2023, and December 31, 2021,2022, respectively. To date, the Company’s 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 the Company will continue to generate operating losses and use cash in operating activities. The Company’s continuation as a going concern is dependent upon its ability to increase sales, and/or raise additional funds through the capital markets. Whether and when the Company can attain profitability and positive cash flows from operations or obtain additional financing is uncertain.

 

The Company is actively generating additional scientific and clinical data to have it published in leading industry publications. WeThe unique features of our advanced ceramic materials are not well known, and we believe the publication of such data would help sales efforts as the Company approaches new prospects. The Company continues to makeis also making additional changes to the sales strategy, including a focus on revenue growth by expanding the use of silicon nitride in other areas outside of spinal fusion applications. The Company has also acquired equipment and certain proprietary know-how for the purpose of developing, manufacturing and commercializing armored plates made from boron carbide and a composite of boron carbide and silicon carbide for military, law enforcement and other civilian uses. We also expect the acquisition of TA&T will further broaden the Company’s sources of revenue.

 

8

The Company has common stock that is publicly traded and has been able to successfully raise capital when needed since the date of the Company’s initial public offering in February 2014. On January 3, 2022, the Company received a notice from Nasdaq Listing Qualifications department (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) stating that the bid price of the Company’s common stock for the last 30 consecutive trading days had closed below the minimum $1.00 per share required for continued listing under Listing Rule 5550(a)(2). The Nasdaq notification letter does not result in the immediate delisting of the Company’s common stock, and the stock will continue to trade uninterrupted on the The Nasdaq Capital Market under the symbol “SINT”. The letter from the Staff further indicated that if the Company did not regain compliance with Rule 5550(a)(2) by July 5, 2022, the Company may be eligible for additional time to regain compliance. On July 6, 2022, the Company received notice from the Staff that the Company was eligible for an additional 180 calendar day period, or until January 2, 2023, to regain compliance. Delisting of the Company’s common shares from The Nasdaq Capital Market may adversely impact its ability to raise capital on the public markets. The Company intends to actively monitor the closing bid price for its common stock and will consider available options to resolve the deficiency and regain compliance with Nasdaq Listing Rule 5550(a)(2).

 

On February 25, 2021, the Company entered into an Equity Distribution Agreement (the(as amended, the “2021 Distribution Agreement”) with Maxim Group LLC (“Maxim”), pursuant to which the Company may sell from time to time, shares of the Company’s common stock having an aggregate offering price of up to $2.0 million through Maxim, as agent.

Subject to the terms and conditions of the 2021 Distribution Agreement, as amended, Maxim will use its commercially reasonable efforts to sell the Sharesshares from time to time, based on our instructions. Under the 2021 Distribution Agreement, Maxim may sell the Shares by any method permitted by law deemed to be an “at-the-market” offering (the “ATM”) as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), including, without limitation, sales made directly on the Nasdaq Capital Market. We have no obligation to sell any shares under the ATM and may at any time suspend offers under the 2021 Distribution Agreement. The Offering will terminate upon the earlier of (i) the sale of shares having an aggregate offering price of $2.0$15.0 million, (ii) the termination by either Maxim or the Company upon the provision of fifteen (15) days written notice, or (iii) February 25, 2023.2024. Under the terms of the 2021 Distribution Agreement, Maxim will be entitled to a transaction fee at a fixed rate of 2.0% of the gross sales price of Shares sold under the 2021 Distribution Agreement. The Company will also reimburse Maxim for certain expenses incurred in connection with the 2021 Distribution Agreement and agreed to provide indemnification and contribution to Maxim with respect to certain liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended. As of September 30, 2022,March 31, 2023, there have been no sales of shares of common stock under the 2021 Distribution AgreementAgreement..Because the company’s public float is less than $75 million, we may not sell securities over a 12-month period in an amount greater than one-third of our public float. In connection with the February 2023 offering, the Company agreed to not make any sales of securities under the ATM for a period of six months from the date of closing the offering, February 10, 2023, until August 10, 2023.

 

On October 17, 2022, the Company closed on the sale of 4,656 Units for gross proceeds of approximately $4.7 million pursuant to the terms of a Rights Offering to holders of the Company’s common stock, Series B and Series C preferred stock and holders of certain outstanding common stock warrants. See Subsequent Events below for a more detailed discussion of the Rights Offering.warrants (See Note 7).

 

AlthoughOn February 10, 2023, the Company is seeking to obtain additional equity and/or debt financing, such funding is not assured and may not be available to the Company on favorable or acceptable terms and may involve significant restrictive covenants. Any additional equity financing is also not assured and, if available to the Company, will most likely be dilutive to its current stockholders. If the Company is not able to obtain additional debt or equity financingclosed on a timely basis, the impact on the Company will be material and adverse.public offering of 2,150,000 units with gross proceeds of approximately $12.0 million (See Note 7).

 

These uncertainties create substantial doubt about our ability to continue as a going concern. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.

Risks Related to COVID-19 Pandemic

The COVID-19 pandemic is affecting the United States and global economies and may affect the Company’s operations and those of third parties on which the Company relies. In response to the spread of COVID-19 and to ensure safety of employees and continuity of business operations, we temporarily restricted access to the Salt Lake City facility, with our administrative employees continuing their work remotely and limited the number of staff in our manufacturing facility. We implemented protective measures such as wearing of face masks, maintaining social distancing, and additional cleaning. Beginning in 2021, we have offered vaccination incentives. While the potential economic impact brought by, and the duration of, the COVID-19 pandemic is difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce the Company’s ability to access capital, which could negatively impact the Company’s short-term and long-term liquidity. The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change. The Company does not yet know the full extent of potential delays or impacts on its business, financing or other activities or on healthcare systems or the global economy as a whole. However, these effects could have a material impact on the Company’s liquidity,Management has concluded existing capital resources will be sufficient to fund operations and business and those offor at least the third parties on which we rely.next 12 months, or through May 2024.

 

9

Grant and Contract Revenue

 

Revenues from grants, contracts, and awards provided by governmental agencies are recorded based upon the terms of the specific grant agreements, which generally provide that revenue is earned when the allowable costs specified in the applicable grant agreement have been incurred.incurred or a milestone has been met. Cash received from federal grants, contracts, and awards can be subject to audit by the grantor and, if the examination results in a disallowance of any expenditure, repayment could be required.

 

Grant, contract, and award receivables relate to allowable amounts expended or otherwise incurred in connection with the terms of a grant or award and for which reimbursement or draw upon the grant funds have not yet taken place.

Correction of an Immaterial Error

During the first quarter 2022, the Company identified an error related to the removal of a loan obligation and the recording of other income for forgiveness of debt totaling approximately $0.5 million, which forgiveness was recorded on November 24, 2021. The Company has determined that the Company should not have removed the loan obligation and recorded approximately $0.5 million of other income in the financial statements as of December 31, 2021, and for the year then ended. The error affected the 2021 net loss attributable to common stockholders and net loss per share—basic and diluted. The error also affected total liabilities and accumulated deficit (and total stockholders’ equity) as of December 31, 2021. The error did not affect 2021 cash flows from operating activities and total cash flow.

In accordance with the SEC Staff Accounting Bulletin (SAB) No. 99, “Materiality,” and SAB No. 108, “Considering the Effects of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements,” the Company evaluated the materiality of the error from qualitative and quantitative perspectives and concluded that the error was immaterial to the March 31, 2022 and December 31, 2021, financial statements. Consequently, only the December 31, 2021, consolidated balance sheet and the December 31, 2021, balance in the statement of stockholders’ equity contained in these financial statements have been restated. The change resulted a reduction of stockholders’ equity of $0.5 million as of December 31, 2021.

New Accounting Pronouncements Not YetRecently Adopted

 

In August 2020, the Financial Statement Accounting Board (the “FASB”) issued ASU 2020-06 which simplifies the accounting for convertible instruments and its application of the derivatives scope exception for contracts in an entity’s own equity. For contracts in an entity’s own equity, the new guidance eliminates some of the current requirements for equity classification such as the requirement that settlement in unregistered shares is permitted. In addition, the new guidance reduces the number of accounting models that require separating embedded conversion features from convertible instruments, including eliminating the requirement to recognize a beneficial conversion feature if the conversion feature is in the money and does not require bifurcation as a derivative liability. As a result, only conversion features accounted for under the substantial premium model and those that require bifurcation will be accounted for separately. The guidance also addresses how convertible instruments are accounted for in the diluted earnings per share calculation and requires enhanced disclosures about the terms of convertible instruments and contracts in an entity’s own equity. The guidance is effective for the Company for annual periods beginning after December 15, 2023, and interim periods within that year, with early adoption permitted. The Company plans to adoptadopted the new standards January 1, 2023. The adoption of this standard will resultallows the Company in the future and, in certain circumstances, to avoid derivative treatment of warrants currently classified as fair value liabilities to be reclassified within stockholder’s equity. We are currently assessing any other impact that adoption will have on our financial position and resultsavoid beneficial conversion treatment of operations.certain convertible preferred shares.

New Accounting Pronouncements Not Yet Adopted

 

The Company has reviewed all other recently issued, but not yet adopted, accounting standards, in order to determine their effects, if any, on its results of operations, financial position or cash flows. Based on that review, the Company believes that no other pronouncements will have a significant effect on its financial statements.

 

2. Business Acquisition

On June 30, 2022, the Company entered into and closed a Stock Purchase Agreement (the “Purchase Agreement”) pursuant to which the Company acquired all of the outstanding shares of common stock of Technology Assessment and Transfer, Inc. (TA&T), a corporation organized under the Laws of the State of Maryland. As a result, TA&T is a wholly owned subsidiary of the Company.

10

The Purchase Agreement sets forth approximately $760,000, including accrued interest, in loan obligations that the Company agreed to assume in connection with the purchase. Further, the Purchase Agreement provides for potential earnout payments to the sellers on the achievement of certain pre-determined gross revenue targets by TA&T for calendar years 2022 and 2023. Earnouts, if any, will be expensed as incurred , as management does not expect the earnouts to be achieved.

The following table summarizes the purchase price allocation (in thousands):

Schedule of Business Acquisition Purchase Price Allocation

    
  June 30, 2022 
Assets    
Current assets    
Cash and cash equivalents $303 
Accounts and other receivables, net of allowance  193 
Prepaid expenses and other receivables, net of allowance  14 
Total current assets  510 
     
Property and equipment, net  599 
Operating lease right of use asset  521 
Other long-term assets  7 
Total assets  1,637 
     
Liabilities and net assets acquired    
Current liabilities    
Accounts payable  105 
Accrued liabilities  241 
Current portion of debt  6 
Current portion of related party debt  242 
Current portion of operating lease liability  179 
Total current liabilities  773 
     
Debt, net of current portion  393 
Related party debt, net of current portion  107 
Operating lease liability, net of current portion  342 
Total liabilities  1,615 
     
Net assets acquired $22 

The following proforma unaudited revenue and net loss are presented as if the acquisition had been included in the consolidated results of the Company for the nine months ended September 30, 2022 (in thousands).

Schedule of Proforma Unaudited Revenue and Net Loss

     
  

Nine Months Ended

September 30, 2022

 
Revenue $1,385 
Net loss $(8,097)

No amounts are included in the condensed consolidated statement of operations relating to TA&T for the six months ended June 30, 2022, as the transaction was closed the end of day June 30, 2022. TA&T’s operations are included in the Company’s condensed consolidated statement of operations beginning July 1, 2022.

3. Basic and Diluted Net LossIncome (Loss) per Common Share

 

Basic net lossincome (loss) per share is calculated by dividing the net lossincome (loss) by the weighted-average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common share equivalents outstanding for the period that are determined to be dilutive. Common stock equivalents are primarily comprised of preferred stock and warrants for the purchase of common stock. For the ninethree months ended September 30, 2022,March 31, 2023, there is no difference in the number of shares and net loss used to calculate basic and diluted shares outstanding because their effect would have been anti-dilutive. The Company had potentially dilutive securities, totaling approximately 2.41.2 million and 1.82.1 million as of September 30,March 31, 2023, and 2022, and 2021, respectively.

 

1110

Below are basic and diluted loss per share data for the three months ended March 31, 2023, which are in thousands except for share and per share data:

Schedule of Basic and Diluted Loss Per Share

  Basic
Calculation
  

Effect of

Dilutive
Warrant
Securities

  Diluted
Calculation
 
Numerator:            
Net loss $(293) $(4,149) $(4,442)
             
Denominator:            
Number of shares used in per common share calculations:  2,272,992   258,067   2,558,059 
             
Net loss per common share:            
Net loss $(0.13) $(1.61) $(1.74)

 

Below are basic and diluted loss per share data for the three months ended September 30,March 31, 2022, which are in thousands except for share and per share data:

 

Schedule of Basic and Diluted Loss Per Share

  Basic
Calculation
  

Effect of

Dilutive
Warrant
Securities

  Diluted
Calculation
 
Numerator:            
Net loss $(2,724) $(60) $(2,784)
Deemed dividend and accretion of a discount  -   -   - 
Net loss attributable to common stockholders $(2,724) $(60) $(2,784)
             
Denominator:            
Number of shares used in per common share calculations:  24,724,792   362,207   25,086,999 
             
Net loss per common share:            
Net loss $(0.11) $-  $(0.11)
Deemed dividend and accretion of a discount  -   -   - 
Net loss attributable to common stockholders $(0.11) $-  $(0.11)

Below are basic and diluted loss per share data for the nine months ended September 30, 2022, which are in thousands except for share and per share data:

  Basic
Calculation
  

Effect of

Dilutive
Warrant
Securities

  Diluted
Calculation
 
Numerator:            
Net loss $(8,081) $(208) $(8,289)
Deemed dividend and accretion of a discount  -   -   - 
Net loss attributable to common stockholders $(8,081) $(208) $(8,289)
             
Denominator:            
Number of shares used in per common share calculations:  24,717,904   366,188   25,084,092 
             
Net loss per common share:            
Net loss $(0.33) $-  $(0.33)
Deemed dividend and accretion of a discount  -   -   - 
Net loss attributable to common stockholders $(0.33) $-  $(0.33)

12

Below are basic and diluted loss per share data for the three months ended September 30, 2021, which are in thousands except for share and per share data:

  Basic
Calculation
  

Effect of

Dilutive
Warrant
Securities

  Diluted
Calculation
 
Numerator:            
Net loss $(2,343) $(480) $(2,823)
Deemed dividend and accretion of a discount  -   -   - 
Net loss attributable to common stockholders $(2,343) $(480) $(2,823)
             
Denominator:            
Number of shares used in per common share calculations:  24,703,156   366,187   25,069,343 
             
Net loss per common share:            
Net loss $(0.09) $(0.02) $(0.11)
Deemed dividend and accretion of a discount  -   -   - 
Net loss attributable to common stockholders $(0.09) $(0.02) $(0.11)

Below are basic and diluted loss per share data for the nine months ended September 30, 2021, which are in thousands except for share and per share data:

 Basic Calculation  

Effect of

Dilutive
Warrant
Securities

  

Diluted

Calculation

  Basic
Calculation
  

Effect of

Dilutive
Warrant
Securities

  Diluted
Calculation
 
Numerator:                        
Net loss $(7,175) $(225) $(7,400) $(2,845) $-  $(2,845)
Deemed dividend and accretion of a discount  -   -   - 
Net loss attributable to common stockholders $(7,175) $(225) $(7,400)
                        
Denominator:                        
Number of shares used in per common share calculations:  24,686,533   410,605   25,097,138   247,122   -   247,122 
                        
Net loss per common share:                        
Net loss $(0.29) $-  $(0.29) $(11.51) $-  $(11.51)
Deemed dividend and accretion of a discount  -   -   - 
Net loss attributable to common stockholders $(0.29) $-  $(0.29)

 

4.3. Inventories

 

Inventories consisted of the following (in thousands):

Schedule of Components of Inventory

              
 September 30,
2022
  December 31,
2021
  March 31,
2023
  December 31,
2022
 
Raw materials $509  $411  $412  $552 
WIP  148   134   125   94 
Finished goods  92   52   89   91 
Inventory net $749  $597  $626  $737 

 

As of September 30, 2022,March 31, 2023, inventories totaling approximately $0.30.4 million and $0.4 million were classified as current and long-term, respectively. As of December 31, 2021, inventories totaling approximately $0.3 million and $0.30.2 million were classified as current and long-term, respectively. Inventories classified as current represent the carrying value of inventories as of September 30, 2022,March 31, 2023, that management estimates will be sold or used by September 30, 2023.March 31, 2024.

 

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5.4. Fair Value Measurements

 

Financial Instruments Measured and Recorded at Fair Value on a Recurring Basis

 

The Company has issued certain warrants to purchase shares of common stock, which are considered derivative liabilities because they have registration rights which could require a cash settlement and are re-measured to fair value at each reporting period in accordance with accounting guidance. Fair value is based on the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date, under a three-tier fair value hierarchy which prioritizes the inputs used in measuring fair value as follows:

 

 Level 1 -quoted market prices for identical assets or liabilities in active markets.
   
 Level 2 -observable prices that are based on inputs not quoted on active markets but corroborated by market data.
   
 Level 3 -unobservable inputs reflecting management’s assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment.

 

The Company classifies assets and liabilities measured at fair value in their entirety based on the lowest level of input that is significant to their fair value measurement. No financial assets were measured on a recurring basis as of September 30, 2022,March 31, 2023, and December 31, 2021.2022. The following tables set forth the financial liabilities measured at fair value on a recurring basis by level within the fair value hierarchy as of September 30, 2022,March 31, 2023, and December 31, 20212022 (in thousands):

Schedule of Financial Liabilities Measured at Fair Value on Recurring Basis by Level Within Fair Value Hierarchy

 Fair Value Measurements as of September 30, 2022  Fair Value Measurements as of March 31, 2023 
Description Level 1  Level 2  Level 3  Total  Level 1  Level 2  Level 3  Total 
Derivative liability                                
Common stock warrants $-  $-  $139  $139  $-  $-  $2,267  $2,267 

 

 Fair Value Measurements as of December 31, 2021  Fair Value Measurements as of December 31, 2022 
Description Level 1  Level 2  Level 3  Total  Level 1 Level 2 Level 3 Total 
Derivative liability                         
Common stock warrants $-  $-  $347  $347  $-  $-  $5,126  $5,126 

 

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The Company did not have any transfers of assets and liabilities between Level 1 and Level 2 of the fair value measurement hierarchy during the ninethree months ended September 30, 2022,March 31, 2023, and 2021.2022. The following table presents a reconciliation of the derivative liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) during the ninethree months ended September 30,March 31, 2023, and 2022 and 2021 (in thousands):

Schedule of Fair Value Measurement Hierarchy of Derivative Liability

 Common Stock
Warrants
 
Balance as of December 31, 2020 $(1,238)
Change in fair value  225 
Exercise of warrants  195 
Balance as of September 30, 2021 $(818)
     Common Stock
Warrants
 
Balance as of December 31, 2021 $(347) $(347)
Change in fair value  208   41 
Balance as of September 30, 2022 $(139)
Issuance of derivatives  - 
Exercise of warrants  - 
Balance as of March 31, 2022 $(306)
    
Balance as of December 31, 2022 $(5,126)
Issuance of derivatives  (6,650)
Exercise of warrants  5,502 
Change in fair value  4,006 
Other  1 
Balance as of March 31, 2023 $(2,267)

 

Common Stock Warrants

 

The Company has issued certain warrants to purchase shares of common stock, which are considered derivative liabilities because they have registration rights which could require a cash settlement and are re-measured to fair value at each reporting period in accordance with accounting guidance. As of September 30, 2022,March 31, 2023, and December 31, 2021,2022, the derivative liability was calculated using the Monte Carlo Simulation valuation.

 

The assumptions used in estimating the common stock warrant liability using the Monte Carlo simulation valuation model as of September 30, 2022,March 31, 2023, and December 31, 20212022 were as follows:

 

Schedule of Assumptions Used in Estimating Fair Value

September 30,March 31,

20222023

December 31,

20212022

Weighted-average risk-free interest rate3.333.60%-4.224.74%0.063.99%-0.974.42%
Weighted-average expected life (in years)0.320.11-2.364.870.07-3.104.80
Expected dividend yield-%-%-%
Weighted-average expected volatility81.9109.2%-121.7141.8%71.5103.6%-126.5243.0%

Other Financial Instruments

 

The Company’s recorded values of cash and cash equivalents, account and other receivables, accounts payable and accrued liabilities approximate their fair values based on their short-term nature. The recorded value of notes payable approximates the fair value as the interest rate approximates market interest rates.

 

6.5. Accrued Liabilities

 

Accrued liabilities consisted of the following (in thousands):

 

Schedule of Accrued Liabilities

  September 30,
2022
  December 31,
2021
 
Payroll and related expense $673  $724 
Accrued payables  321   - 
Other  560   426 
Accrued liabilities $1,554  $1,150 

15

         
  March 31,
2023
  December 31,
2022
 
Payroll and related expense $584  $524 
Accrued payables  307   464 
Other  613   630 
Accrued liabilities $1,504  $1,618 

 

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7.6. Debt

2020 PPP Loan

On April 28, 2020, the Company received funding under a Paycheck Protection Program (“PPP”) loan (the “PPP Loan”) from First State Community Bank (the “Lender”). The principal amount of the PPP Loan was $0.4 million. The PPP was established under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) and is administered by the U.S. Small Business Administration (the “SBA”). Loans made under the PPP may be partially or fully forgiven if the recipient complies with the provisions of the CARES Act, including the use of PPP Loan proceeds for payroll costs, rent, utilities and other expenses, provided that such amounts are incurred during a 24-week period that commenced on April 28, 2020 and at least 60% of any forgiven amount has been used for covered payroll costs as defined by the CARES Act. On January 5, 2021, the Lender provided notice to the Company that the principal amount and accrued interest had been forgiven. The Company removed the PPP Loan obligation and recorded other income for forgiveness of debt totaling $0.4 million. The SBA has until January of 2027 to audit the Company’s compliance with the CARES Act relating to the PPP Loan.

2021 PPP Loan

On March 15, 2021, the Company received funding under the SBA Second Draw Program under the Paycheck Protection Program (“2021 PPP”) (the “2021 PPP Loan”) from the Lender. The principal amount of the 2021 PPP Loan is $0.5 million. The Company received notice on November 24, 2021, that the principal amount and accrued interest had been forgiven. The Company removed the 2021 PPP Loan obligation and recorded other income for forgiveness of debt totaling approximately $0.5 million during the year ended December 31, 2021.

Since receiving the 2021 PPP Loan and learning that the principal amount of the loan and accrued interest had been forgiven, the Company has determined that due to its status as a publicly traded company with common shares trading on the Nasdaq Capital Market it was not eligible to receive a loan under the SBA Second Draw Program under the Paycheck Protection Program. As a result, the Company repaid the loan on June 14, 2022, together with processing fees and interest, which totaled $0.5 million, resulting in no balance outstanding at June 30, 2022 (see Note 1).

Business Loan

 

On July 20, 2021, TA&T (see Note 2), entered into a Loan Authorization and Agreement in the amount of approximately $350,000 (the “Business Loan”). UnderThe Company made a one-time $35,000 buy down payment when acquiring the Business Loan, the Company will make monthly installment payments, including principal and interest, of $1,754. Payments are to begin 18 months from the date of the loan. The balance of principal and interest is payable 30 years from July 20, 2021. The Business Loan bears interest at a rate of 3.75% per annum. The Business Loan is secured by a general security interest in all of the assets of TA&T. The Business Loan contains other standard provisions that are customarybusiness loan was paid in full during the first quarter of loans of this type.2023 and there was no outstanding balance at March 31, 2023.

Related Party Debt

 

TA&T is obligated to repay certain personal loans made by the founders of TA&T to TA&T prior to SINTX’s acquisition of TA&T (the Personal Loans”). The total amount of the Personal Loans at SeptemberJune 30, 2022, the date of acquisition, was approximately $350,000. The Company agreed to repay the outstanding balance of the Personal Loans in (i) 24 equal monthly installments beginning September 1, 2022 and each month thereafter until paid in full as one prior owner’s portion of the Personal Loans totaling $157,000, and (ii) for the other owner’s portion of the Personal Loans totaling $193,000$193,000.. As of September 30, 2022,March 31, 2023, the related party debt had an outstanding balance of $235,000150,000. The outstanding balance is being paid in monthly installments ending August 1, 2024. The related party debt is not collateralized and has no interest raterate.

.

7. Equity

 

Wells Fargo Line of Credit2023 Registered Offering

 

PriorOn February 10, 2023, the Company closed on a public offering of 2,150,000 units, with each unit consisting of one share of common stock, or one pre-funded warrant to SINTX’s acquisitionpurchase one share of TA&T, TA&T entered intoits common stock, one Class C Warrant to purchase one share of common stock, and one half of one Class D Warrant with each whole Class D Warrant entitling the holder to purchase one share of common stock. Each unit was sold at a revolving line of credit with Wells Fargo. As of September 30, 2022, the line of credit with Wells Fargo had an outstanding balancepublic offering price of $47,0005.60. The Class C and Class D Warrants are immediately exercisable at a price of $5.60 per share. The Class C and Class D warrants each have a cashless exercise provision entitling the holders to surrender one Class C Warrant and receive 0.4 shares of common stock and on the surrender of one Class D Warrant the holder is entitled to receive 0.8 shares of common stock. The Class C Warrants expire five years from the date of issuance and the Class D Warrants expire three years from the date of issuance. The shares of common stock (or pre-funded warrants in lieu thereof) and accompanying warrants were only purchasable together in this offering but were issued separately and were immediately separable upon issuance. In addition, the company issued a total of 86,000 common stock warrants to the placement agent, Maxim Group, and the Company’s financial advisor, Ascendiant Capital. Gross proceeds, before deducting offering expenses, totaled approximately $12.0 million. Of the $12.0 million of gross proceeds, approximately $5.4 million were allocated to common stock and prefunded warrants ($4.8 million net of offering costs) and approximately $6.7 million were allocated to derivative liabilities (with approximately $0.7 million of cash offering costs and $0.1 million of agent warrant offering costs recorded as derivative expense).

2022 Rights Offering

 

8.On October 17, 2022, the Company completed a rights offering (the “Rights Offering”) to holders of the Company’s Series B Preferred Shares, Series C Preferred Shares, and warrants issued March 6, 2018, May 8, 2018, May 14, 2018, and February 6, 2020 (collectively, the “Security Holders”) for subscriptions of Equity4,656 rights resulting in gross proceeds to the Company of approximately $4.7 million. Under the Rights Offering, the Company distributed to the Security Holders, at no charge, one non-transferable subscription right for each share of common stock, share of Series B Preferred Stock, share of Series C Preferred Stock, and each participating warrant (on an as-if-converted-to-common-stock basis) held on the record date, September 23, 2022. Each right entitled the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series D Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into shares of SINTX’s common stock at a conversion price equal to $15.102 (the “Conversion Price”), and 66 common stock purchase warrants expiring five years from the date of issuance, which we refer to as the Class A Warrants, and (iii) 66 common stock purchase warrants expiring three years from the date of issuance, which we refer to as the Class B Warrants and, together with the Class A Warrants, the Warrants with each warrant exercisable for one share of common stock at an exercise price of $2.70 per share.

2021 Equity Distribution Agreement

 

On February 25, 2021, the Company entered into an Equity Distribution Agreement (the(as amended, the “2021 Distribution Agreement”) with Maxim Group LLC (“Maxim”), pursuant to which the Company may sell from time to time, shares of the Company’s common stock having an aggregate offering price of up to $2.0 million through Maxim, as agent.

Subject to the terms and conditions of the 2021 Distribution Agreement, as amended, Maxim will use its commercially reasonable efforts to sell the Sharesshares from time to time, based on the Company’sour instructions. Under the 2021 Distribution Agreement, Maxim may sell the Shares by any method permitted by law deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), including, without limitation, sales made directly on the Nasdaq Capital Market. We have no obligation to sell any shares under the 2021 Distribution AgreementATM and may at any time suspend offers under the 2021 Distribution Agreement. The Offering will terminate upon the earlier of (i) the sale of shares having an aggregate offering price of $2.015.0 million, (ii) the termination by either Maxim or the Company upon the provision of fifteen (15) days written notice, or (iii) February 25, 2023. 2024. Under the terms of the 2021 Distribution Agreement, Maxim will be entitled to a transaction fee at a fixed rate of 2.0% of the gross sales price of Shares sold under the 2021 Distribution AgreementAgreement.. The Company will also reimburse Maxim for certain expenses incurred in connection with the 2021 Distribution Agreement and agreed to provide indemnification and contribution to Maxim with respect to certain liabilities under the Securities Act and the Securities Exchange Act of 1934, as amended. As of September 30, 2022March 31, 2023, there have been no sales of shares of common stock under the 2021 Distribution Agreement. Because the company’s public float is less than $75 million, we may not sell securities over a 12-month period in an amount greater than one-third of our public float. In connection with the February 2023 offering, the Company agreed to not make any sales of securities under the ATM for a period of six months from the date of closing the offering, February 10, 2023, until August 10, 2023.

 

On October 17, 2022, the Company closed on the sale of 4,656 Units for gross proceeds of approximately $4.7 million pursuant to the terms of a Rights Offering to holders of the Company’s common stock, Series B and Series C preferred stock and holders of certain outstanding common stock warrants. See Subsequent Events below for a more detailed discussion of the Rights Offering. See Note 13.

1614

9.8. Stock-Based Compensation

 

A summary of the Company’s outstanding stock option activity for the three months ended September 30,March 31, 2023, and 2022 and 2021 is as follows:

 

Schedule of Stock Option Activity

    September 30, 2022        March 31, 2023    
   

Weighted-

Average

 

Weighted-

Average

Remaining

Contractual
Life

  Intrinsic    

Weighted-

Average

 

Weighted-

Average

Remaining

Contractual
Life

  Intrinsic 
 Options  Exercise Price  (Years)  Value  Options  Exercise Price  (Years)  Value 
As of December 31, 2021  833,892  $3.91   8.7   87,553 
As of December 31, 2022  11,909  $234.02   6.9  $             - 
Granted  357,000   0.45   10.0   -   -   -   -   - 
Exercised  -   -   -   -   -   -   -   - 
Forfeited  -   -   -   -   -   -   -   - 
Expired  (3)  139,237.86   -   -   -   -   -   - 
As of September 30, 2022  1,190,889  $2.38   8.4  $- 
Exercisable at September 30, 2022  537,246  $4.64   7.8  $- 
Vested and expected to vest at September 30, 2022  1,105,071  $2.48   8.4  $- 
As of March 31, 2023  11,909  $120.33   7.7  $- 
Exercisable at March 31, 2023  8,303  $330.56   7.6  $- 
Vested and expected to vest at March 31, 2023  9,840  $119.65   7.7  $- 

 

    September 30, 2021        March 31, 2022    
   

Weighted-

Average

 

Weighted-

Average

Remaining

Contractual Life

  Intrinsic    

Weighted-

Average

 

Weighted-

Average

Remaining

Contractual
Life

  Intrinsic 
 Options  Exercise Price  (Years)  Value  Options  Exercise Price  (Years)  Value 
As of December 31, 2020  465,393  $5.53   9.3   - 
As of December 31, 2021  8,339  $391   8.7  $87,553 
Granted  368,500   1.93   10.0   -   3,570   49   10.0   - 
Exercised  -   -   -   -   -   -   -   - 
Forfeited  -   -   -   -   -   -   -   - 
Expired  -   -   -   -   -   -   -   - 
As of September 30, 2021  833,893  $3.98   8.9  $417,164 
Exercisable at September 30, 2021  221,834  $12.26   8.6  $- 
Vested and expected to vest at September 30, 2021  833,893  $3.98   8.9  $417,164 
As of March 31, 2022  11,909  $238   8.9  $114,500 
Exercisable at March 31, 2022  3,872  $602   8.3  $44,652 
Vested and expected to vest at March 31, 2022  11,787  $244   8.9  $117,100 

 

The Company estimates the fair value of each stock option on the grant date using the Black-Scholes-Merton valuation model, which requires several estimates including an estimate of the fair value of the underlying common stock on grant date. The expected volatility was based on an average of the historical volatility of the Company. The expected term was contractual life of option. The risk-free interest rate was based on the U.S. Treasury yield curve in effect at the time of grant for the expected term of the option. The following weighted average assumptions were used in the calculation to estimate the fair value ofCompany did not grant any stock options granted to employees and non-employees during the nine months ended September 30, 2022. During the nine months ended September 30, 2022, the Company granted stock options with an estimated fair valuefirst quarter of approximately $0.2 million.2023.

 

17

Schedule of Assumption used for Fair Value of Option

September 30, 2022
Weighted-average risk-free interest rate1.70%
Weighted-average expected life (in years)5.5
Expected dividend yield-%
Weighted-average expected volatility131.1%

Of the 357,000 options granted during the nine months ended September 30, 2022, 60,000 were to non-executive members of the board of directors. Of the 1,190,88911,909 options outstanding as of September 30, 2022,March 31, 2023, 355,0003,551 were awarded to non-executive members of the board of directors.

 

Unrecognized stock-based compensation as of September 30, 2022,March 31, 2023, is as follows (in thousands):

Schedule of Unrecognized Stock-based Compensation

   

Weighted

Average

    

Weighted

Average

 
 

Unrecognized

Stock-Based

 

Remaining of

Recognition

  

Unrecognized

Stock-Based

 

Remaining of

Recognition

 
 Compensation  (in years)  Compensation  (in years) 
Stock options $431   1.5  $268   1.1 
Stock grants $32   1.7  $53   6.2 

 

10.9. Commitments and Contingencies

 

The Company has executed agreements with certain executive officers of the Company which, upon the occurrence of certain events related to a change in control, call for payments to the executives up to three times their annual salary and accelerated vesting of previously granted stock options.

 

From time to time, the Company is subject to various claims and legal proceedings covering matters that arise in the ordinary course of its business activities. Management believes any liability that may ultimately result from the resolution of these matters will not have a material adverse effect on the Company’s consolidated financial position, operating results or cash flows.

11. Note Receivable

On October 1, 2018, the Company completed the sale of its spine implant business to CTL Medical. The sale included a $6.0 million noninterest bearing note receivable payable over a 36 month term to mature on October 1, 2021. The note receivable included an imputed interest rate of 10%. The note was paid in full in May 2021.

15

 

12.10. Leases

 

The Company has entered into multiple operating leases from which it conducts its business.

 

SINTX

 

With respect to SINTX operations, the Company leases 29,534 square feet of office, warehouse and manufacturing space under a single operating lease.lease. This lease expires at the end of 2024. The lease has two five-year extension optionsoptions..

 

SINTX Armor

 

On August 19, 2021, the Company, on behalf of SINTX Armor, entered into an Industrial Lease Agreement (the “SINTX Armor Lease”) pursuant to which the Company has agreed to lease approximately 10,936 square feet of office and manufacturing space from which SINTX Armor will conduct its operations. The term of the SINTX Armor Lease is 122 months through October 2031.2031.

 

18

TA&T

 

In connection with operation of its business, TA&T has entered into various leases from which it conducts its research, development and manufacturing activities. The leases have various expiration dates ranging from the end of 2022July 2023 through April 2025.

 

Leases with an initial term of 12 months or less are not recorded on the balance sheet. Lease expense is recognized on a straight-line basis over the term of the lease. The Company accounts for lease components separately from the non-lease components. The depreciable life of the assets and leasehold improvements are limited by the expected lease term.

As of September 30, 2022,March 31, 2023, the consolidated operating lease right-of-use assets totaled approximately $2.52.2 million, and the operating lease liability totaled approximately $2.52.3 million. Non-cash operating lease expense during the ninethree months ended September 30,March 31, 2023 and 2022, and 2021, totaled approximately $0.40.2 and $0.30.1 million, respectively. As of September 30, 2022,March 31, 2023, the weighted-average discount rate for the Company’s operating lease was 6.5%.

 

Operating lease future minimum payments together with the present values as of September 30, 2022,March 31, 2023, are summarized as follows:

Schedule of Operating Lease Future Minimum Payments

     
Years Ending December 31, March 31,
2023
 
2023 $654 
2024  897 
2025  269 
2026  190 
2027  131 
Thereafter  539 
Total future minimum lease payments  2,680 
Less amounts representing interests  (383)
Present value of lease liability  2,297 
     
Current-portion of operating lease liability  750 
Long-term portion operating lease liability $1,547 

Years Ending December 31, September 30,
2022
 
2022 $213 
2023  870 
2024  896 
2025  194 
2026  127 
Thereafter  669 
Total future minimum lease payments  2,969 
Less amounts representing interests  (438)
Present value of lease liability  2,531 
     
Current-portion of operating lease liability  720 
Long-term portion operating lease liability $1,811 

13. Subsequent Events

 

Rights Offering

On October 17, 2022, the Company completed a rights offering (the “Rights Offering”) to holders of the Company’s Series B Preferred Shares, Series C Preferred Shares, and warrants issued March 6, 2018, May 8, 2018, May 14, 2018, and February 6, 2020 (collectively, the “Security Holders”) for subscriptions of 4,656 rights resulting in gross proceeds to the Company of approximately $4.7 million. Under the Rights Offering, the Company distributed to the Security Holders, at no charge, one non-transferable subscription right for each share of common stock, share of Series B Preferred Stock, share of Series C Preferred Stock, and each participating warrant (on an as-if-converted-to-common-stock basis) held on the record date, September 23, 2022. Each right entitled the holder to purchase one unit, at a subscription price of $1,000 per unit, consisting of one share of Series D Convertible Preferred Stock with a face value of $1,000 (and immediately convertible into shares of SINTX’s common stock at a conversion price equal to $0.15102 (the “Conversion Price”)), and 2,713 common stock purchase warrants expiring five years from the date of issuance, which we refer to as the Class A Warrants, and (iii) 2,713 common stock purchase warrants expiring three years from the date of issuance, which we refer to as the Class B Warrants and, together with the Class A Warrants, the Warrants with each warrant exercisable for one share of common stock at an exercise price of $0.15102 per share.

1916

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

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, 20212022 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, 2021,2022, 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, 2021,2022, 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

 

We are an advanced materials company that develops and commercializes advanced ceramics for biomedical, industrial,technical, and antipathogenic applications. The core strength of SINTX Technologies is the manufacturing, research, and development of advanced ceramics for external partners.

 

Biomedical Applications: Since itsour inception, SINTX haswe have been focused on medical grade silicon nitride. SINTX silicon nitride products are biocompatible, bioactive, antipathogenic, and have shown superb bone affinity. Spinal implants made from SINTX silicon nitride have been successfully implanted in humans since 2008 in the US, Europe, Brazil, and Taiwan. This established use, along with its inherent resistance to bacterial adhesion and bone affinity – meanmeans that it may also be suitable in other fusion device applications such as hip, kneearthroplasty implants, foot wedges, and dental implants. Bacterial infection of any biomaterial implants is always a concern. SINTX silicon nitride is inherently resistant to bacterial colonization and biofilm formation, making it antibacterial. SINTX silicon nitride products can be polished to a smooth and wear-resistant surface for articulating applications, such as bearings for hip and knee replacements.

 

We believe that silicon nitride has a superb combination of properties that make it suited for long-term human implantation. Other biomaterials are based on bone grafts, metal alloys, and polymers- all of which have well-known practical limitations and disadvantages. In contrast, silicon nitride has a legacy of success in the most demanding and extreme industrial environments. As a human implant material, silicon nitride offers bone ingrowth, resistance to bacterial and viral infection, ease of diagnostic imaging, resistance to corrosion, and superior strength and fracture resistance, among other advantages, all of which claims are validated in our large and growing inventory of peer-reviewed, published literature reports. We believe that our versatile silicon nitride manufacturing expertise positions us favorably to introduce new and innovative devices in the medical and non-medical fields.

 

In June 2022, the Companywe acquired Technology Assessment and Transfer, Inc. (TA&T),TA&T, a nearly 40 year old40-year-old business with a mission to transition advanced materials and process technologies from a laboratory environment to commercial products and servicesservices. TA&T has supplied ceramics for use in several biomedical applications. These products were made via 3D printing and include components for surgical instruments as well as conceptual and prototype dental implants.

 

IndustrialTechnical Applications: It is theour belief of SINTX that itsour silicon nitride has the best combination of mechanical, thermal, and electrical properties of any technical ceramic material. It is a high-performance technical ceramic with high strength, toughness, and hardness, and is extremely resistant to thermal shock and impact. It is also an electrically insulating ceramic material. Typically, it is used in applications where high load-bearing capacity, thermal stability, and wear resistance are required. The Company hasWe have obtained AS9100D certification and ITAR registration to facilitate entry into the aerospace portion of this market.

 

SINTX has recentlyWe entered the ceramic armor market through the purchase of assets from B4C, LLC and a technology partnership with Precision Ceramics USA. SINTX intendsWe intend to develop and manufacture high-performance ceramics for personnel, aircraft, and vehicle armor including a 100% Boron Carbide material for ultimate lightweight performance in ballistic applications, and a composite material made of Boron Carbide and Silicon Carbide for exceptional multi-hit performance against ballistic threats. SINTX hasWe have signed a 10-year lease atfor a building near itsour headquarters in Salt Lake City, UT to house development and manufacturing activities for SINTX Armor.

 

TA&T’s primary area of expertise is material processing and fabrication know howknow-how for a broad spectrum of monolithic ceramic, ceramic composite, and coating materials. Primary technologies include Additive Manufacturing (3D Printing) of ceramics and metals, low costlow-cost fabrication of fiber reinforced ceramic matrix composites (CMCs) and refractory chemical vapor deposited (CVD) coatings, transparent ceramics for ballistic armor and optical applications, and magnetron sputtered (PVD) coatings for lubrication, wear resistance and environmental barrier coatings for CMCs. TA&T also provides a host of services that include 3D printing, PVD-CVD coatings, material processing-CMCs, CIP, PS, HP, HIP, and material characterization for powders and finished parts-TGA/DSC, PSD. SA, Dilatometry, UV-VIS and FTIR transmission, haze and clarity.

 

Antipathogenic Applications: Today, there is a global need to improve protection against pathogens in everyday life. SINTX believes that by incorporating its unique composition of silicon nitride antipathogenic powder into products such as face masks, filters, and wound care devices, it is possible to manufacture surfaces that inactivate pathogens, thereby limiting the spread of infection and disease. The discovery in 2020 that SINTX silicon nitride inactivates SARS-CoV-2, the virus which causes the disease COVID-19, has opened new markets and applications for our material and we have refocused many of our resources on these opportunities.material.

 

SINTXWe presently manufacturesmanufacture advanced ceramic powders and components in our manufacturing facilities based in Salt Lake City, Utah.

17

 

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.

 

20

Revenue

 

We deriveThe majority of our product revenue primarilyis derived from the manufacture and sale of spinal fusion products used in the treatment of spine disorders to CTL, with whom we entered into a 10-year exclusive sales agreement in October 2018. We are currently pursuing other sales opportunities for silicon nitride products outside the spinal fusion application and have shipped new orders for these products. In 2021, we made progress in diversifying our revenue by selling a composite product of silicon nitride and PEEK as well as products for the industrial silicon nitride market, the ceramic armor market, and for the antipathogenic market. The acquisition of TA&T brings revenue from multiple markets that we have previously not participated in. 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 customer does not have rights of return or exchange.

 

We believe our product revenue will increase as we secure opportunities to manufacture third party products with silicon nitride, launch and generate revenue from our ceramic armor products, and as we continue to introduce new products into the market.

 

We 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. We expect our gross profit percentage to decrease as we expand the penetration of our silicon nitride technology platform through OEM and private label partnerships, which offer additional avenues for the adoption of silicon nitride. Prior to the sale of our retail spine implant business, our revenues and gross profits were based on our retail sales. With the focus on OEM and private label partnerships, the margins are lower, thus causing the decrease in our gross profit percentage.

 

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, industrial and ceramic armor products, 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 other personnel employed in finance, 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.

 

2118

RESULTS OF OPERATIONS

 

The following is a tabular presentation of our unaudited condensed consolidated operating results for the three and nine months ended September 30,March 31, 2023 and 2022 and 2021 (in thousands):

 

 

Three Months

Ended September 30,

  $  %  

Nine Months

Ended September 30,

  $  %  

Three Months Ended

March 31,

     
 2022  2021  Change  Change  2022  2021  Change  Change  2023  2022  $ Change  % Change 
Product revenue $173  $239  $(66)  -28% $354  $441  $(87)  -20% $240  $101  $139   138%
Grant and contract revenue  253   -   253   100%  442   -   442   100%  299   28   271   968%
Total revenue  426   239   187   78%  796   441   355   80%  539   129   410   318%
Cost of revenue  89   190   (101)  -53%  235   324   (89)  -27%
Costs of revenue  118   80   38   48%
Gross profit  337   49   288   588%  561   117   444   379%  421   49   372   759%
                                
Operating expenses:                                                
Research and development  1,523   1,603   (80)  -5%  4,651   4,402   249   6%  2,200   1,653   547   33%
General and administrative  1,069   933   136   15%  2,918   2,791   127   5%  1,169   856   313   37%
Sales and marketing  291   338   (47)  -14%  1,023   953   70   7%  310   394   (84)  -21%
Grant and contract expenses  247   -   247   100%  423   -   423   100%
Grant expenses  299   29   273   1050%
Total operating expenses  3,130   2,874   256   9%  9,015   8,146   869   11%  3,978   2,929   1,049   36%
Loss from operations  (2,793)  (2,825)  32   -1%  (8,454)  (8,029)  (425)  5%  (3,557)  (2,880)  (677)  24%
Other income (expense)  69   482   (413)  -86%  373   854   (481)  -56%
Net loss before taxes  (2,724)  (2,343)  (381)  16%  (8,081)  (7,175)  (906)  13%
Other income, net  3,264   35   3,229   9226%
Net income (loss) before income taxes  (293)  (2,845)  2,552   -90%
Provision for income taxes  -   -   -       -   -   -       -   -   -   N/A 
Net loss $(2,724) $(2,343) $(381)  16% $(8,081) $(7,175) $(906)  13%
Net income (loss)  (293)  (2,845)  2,552   -90%

 

Revenue

 

For the three months ended September 30, 2022, and 2021March 31, 2023, total product revenue was relatively unchanged at $0.2 million.increase $0.1 million, or 138% as compared to the same period in 2022. During the quarter ended September 30, 2022 the Company receivedMarch 31, 2023 grant and contract revenue ofincrease $0.3 million. Grant and contract revenue did not exist duringmillion, or 968% as compared to the same period of the prior year.

For the nine months ended September 30, 2022,in 2022. The increases were primarily due to new orders for silicon nitride aerospace components and 2021 total product revenue was relatively unchanged at $0.4 million. During the quarter ended September 30, 2022 the Company received grantgovernment grants and contracts in our Salt Lake City operation as well as commercial and government contract revenue of $0.4 million. Grant and contract revenue did not exist during the same period of the prior year.in our Maryland operation.

 

Cost of Revenue and Gross Profit

 

For the three months ended September 30, 2022, ourMarch 31, 2023, cost of revenue decreasedremained relatively unchanged at $0.1 million. Gross profit increased $0.3 million, or 53%759%, as compared to the same period in 2021.2022. This decrease isincrease was primarily attributed to a decrease in product revenue, and a change in the mix of products being sold. Gross profit increased $0.3 million or 588%. This increase in gross profit is attributed to thean increase in grant and contract revenue. Gross profit margin percentage totaled 79% and 21% for the three months ended September 30 for 2022 and 2021, respectively.

For the nine months ended September 30, 2022, our cost of revenue decreased $0.1 million, or 27%, as compared to the same period in 2021. This decrease is primarily attributed to a decrease in product revenue. Gross profit increased $0.4 million or 379%. This increase in gross profit is attributed to the increase in grant and contract revenue. Gross profit margin percentage totaled 70% and 27% for the nine months ended September 30 for 2022 and 2021, respectively.

 

Research and Development Expenses

 

For the three months ended September 30, 2022,March 31, 2023, research and development expenses increased by $0.1$0.5 million, or 5%33%, as compared to the same period in 2021.2022. This increase was primarily attributable to a generalan increase in productspatent expenses and services due to price inflation.

Forcosts of operations associated with the nine months ended September 30, 2022, research and development expenses increased $0.2 million, or 6%, as compared to the same period in 2021. This increase was primarily attributable to a general increase in products and services due to price inflation.acquisition of TA&T mid-2022.

 

General and Administrative Expenses

 

For the three months ended September 30, 2022,March 31, 2023, general and administrative expenses increased $0.1$0.3 million, or 15%37%, as compared to the same period in 2021.2022. This increase is primarily due to thean increase in patent application expenses.costs for legal expenses, investor relations, and employee recruiting.

 

For the nine months ended September 30, 2022, general and administrative expenses increased $0.1 million, or 5%, as compared to the same period in 2021. This increase is primarily due to the increase in patent application expenses.

2219

Sales and Marketing Expenses

 

For the three months ended September 30, 2022,March 31, 2023, sales and marketing expenses decreased $0.1 million, or 14%-21%, as compared to the same period in 2021. The2022. This decrease is primarily attributable to a decrease in outside consulting services.

For the nine months ended September 30, 2022, sales and marketing expenses increased $0.1 million, or 7%, as compared to the same period in 2021. This increase was primarily attributable to an overall increasedecrease in marketing activities to generate interest in and exposure to the Company’s potential new product lines.costs for outside consulting.

 

Grant and Contract Expenses

 

For the three months ended September 30, 2022, the Company incurredMarch 31, 2023, grant and contract expenses of $0.2 million. The Company had no grant and contract expenses forincreased by $0.3 million, or 1050%, as compared to the same period in 2021 due2022. This increase was primarily attributable to the Company being awarded federala general increase in grant and contract income subsequentrevenue when compared to the third quarter of 2021 (and incurring related grant and contract expense during 2022 and incurring none during 2021).

For the nine months ended September 30, 2022, the Company incurred grant and contract expenses of $0.4 million. The Company had no grant and contract expenses for the same period in 2021 due to the Company being awarded federal grant and contract income subsequent to the third quarter of 2021 (and incurring related grant and contract expense during 2022 and incurring none during 2021).prior year.

 

Other Income, Net

 

For the three months ended September 30, 2022,March 31, 2023, other income decreased $0.4increased $3.2 million, or 86%9226%, as compared to the same period in 2021.2022. This decreaseincrease was primarily due to the incurringother income of a$4.0 million associated with the change in the fair value of the derivative liabilities offset by $0.8 million in the amount of $0.4 million.

For the nine months ended September 30, 2022, other income decreased $0.5 million, or 56%, as compared to the same period in 2021. This decrease was primarily due to other income of $0.4 millionoffering costs associated with the forgiveness of the 2020 PPP Loan in the prior year and a change in interest income of $0.1 million.those derivative liabilities.

 

Liquidity and Capital Resources

 

The condensed consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern within one year from the date of issuance of these condensed consolidated financial statements.

 

For the ninethree months ended September 30,March 31, 2023, and 2022, and 2021, the Company incurred a net loss of $8.1$0.3 million and $7.2$2.8 million, respectively, and used cash in operating activities of $8.1$4.9 million and $7.7$3.2 million, respectively. The Company had an accumulated deficit of $258.5$262.7 million and $250.4$262.5 million as of September 30, 2022,March 31, 2023, and December 31, 2021,2022, respectively. To date, the Company’s 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 the Company will continue to generate operating losses and use cash in operations. The Company’s continuation as a going concern is dependent upon its ability to increase sales, and/or raise additional funds through the capital markets. Whether and when the Company can attain profitability and positive cash flows from operations or obtain additional financing is uncertain.

 

The Company is actively generating additional scientific and clinical data to have it published in leading industry publications. We believe the publication of such data would help sales efforts as the Company approaches new prospects. The Company is also making additional changes to the sales strategy, including a focus on revenue growth by expanding the use of silicon nitride in other areas outside of spinal fusion applications. For instance, results from an independent study demonstrated the potential anti-viral properties of our silicon nitride. We believe that we may be able to apply our silicon nitride powder to personal protection products, such as face masks, gowns and gloves, resulting in inactivation of viruses that come into contact with the items.

 

The Company has common stock that is publicly traded and has been able to successfully raise capital when needed since the date of the Company’s initial public offering in February 2014.

 

On February 10, 2023, the Company closed on a public offering of 2,150,000 units, with each unit consisting of one share of common stock, or one pre-funded warrant to purchase one share of its common stock, one Class C Warrant to purchase one share of common stock, and one half of one Class D Warrant with each whole Class D Warrant entitling the holder to purchase one share of common stock. Gross proceeds, before deducting offering expenses, totaled approximately $12.0 million. Of the $12.0 million of gross proceeds, approximately $5.4 million were allocated to common stock and prefunded warrants ($4.8 million net of offering costs) and approximately $6.7 million were allocated to derivative liabilities (with approximately $0.7 million of cash offering costs and $0.1 million of agent warrant offering costs recorded as derivative expense).

On October 17, 2022, the Company completed a rights offering of units consisting of convertible preferred stock and common stock warrants, resulting in gross proceeds to the Company of approximately $4.7 million, after deducting expenses relating to the offering, including dealer-manager fees and expenses,

On February 25, 2021, the Company entered into an Equity Distribution Agreement (the “2021 Distribution Agreement”) with Maxim Group LLC (“Maxim”), pursuant to which we may sell from time to time, shares of its our common stock, $0.01 par value per share, having an aggregate offering price of up to $2.0 million through Maxim, as agent. No shares have been sold under the 2021 Distribution Agreement as of September 30, 2022.March 31, 2023.

23

 

20

On October 1, 2018, the Company sold the retail spine implant business to CTL Medical. The sale included a $6 million noninterest bearing note receivable payable over a 36-month term. CTL Medical has paid this note in full, and the Company does not expect any future cashflows associated with the note.

 

AlthoughThe Company is not currently seeking to obtain additional equity and/or debt financing. When the Company is seekingdesires to obtainseek such additional equity and/or debt financing, such funding is not assured and may not be available to the Company on favorable or acceptable terms and may involve significant restrictive covenants. Any additional equity financing is also not assured and, if available to the Company, will most likely be dilutive to its current stockholders. If the Company is not able to obtain additional debt or equity financing on a timely basis, the impact on the Company will be material and adverse.

 

These uncertainties create substantial doubt about our abilityManagement has concluded that its existing capital resources will be sufficient to continue as a going concern. The condensed consolidated financial statements do not include any adjustments that might result fromfund operations for at least the outcome of these uncertainties.next 12 months, or through May 2024.

Risks Related to COVID-19 Pandemic

The COVID-19 pandemic is affecting the United States and global economies and may affect the Company’s operations and those of third parties on which the Company relies. In response to the spread of COVID-19 and to ensure safety of employees and continuity of business operations, we temporarily restricted access to the Salt Lake City facility, with our administrative employees continuing their work remotely and limited the number of staff in our manufacturing facility. We implemented protective measures such as wearing of face masks, maintaining social distancing, and additional cleaning. Beginning in 2021, we have offered vaccination incentives. While the potential economic impact brought by, and the duration of, the COVID-19 pandemic is difficult to assess or predict, the impact of the COVID-19 pandemic on the global financial markets may reduce the Company’s ability to access capital, which could negatively impact the Company’s short-term and long-term liquidity. The ultimate impact of the COVID-19 pandemic is highly uncertain and subject to change. The Company does not yet know the full extent of potential delays or impacts on its business, financing or other activities or on healthcare systems or the global economy as a whole. However, these effects could have a material impact on the Company’s liquidity, capital resources, operations and business and those of the third parties on which we rely.

Correction of an Immaterial Error

During the first quarter of 2022 the Company identified an error related to the removal of a loan obligation and the recording of other income for forgiveness of debt totaling approximately $0.5 million, which forgiveness was recorded on November 24, 2021. The Company has determined that the Company should not have removed the loan obligation and recorded approximately $0.5 million of other income in the financial statements as of December 31, 2021, and for the year then ended. The error affected the 2021 net loss attributable to common stockholders and net loss per share—basic and diluted. The error also affected total liabilities and accumulated deficit (and total stockholders’ equity) as of December 31, 2021. The error did not affect 2021 cash flows from operating activities and total cash flow. The December 31, 2021, consolidated balance sheet and the December 31, 2021, balance in the statement stockholders’ equity contained in these financial statements have been restated. The change resulted a reduction of stockholders’ equity of $0.5 million as of December 31, 2021.

Cash Flows

 

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

 

  Nine Months Ended September 30, 
  2022  2021 
Net cash used in operating activities $(8,180) $(7,747)
Net cash provided by (used in) investing activities  (805)  (1,122)
Net cash provided by (used in) financing activities  (509)  701 
Net decrease in cash $(9,494) $(8,168)
  Three Months Ended March 31, 
  2023  2022 
Net cash used in operating activities $(4,871) $(3,180)
Net cash used in investing activities  (236)  (230)
Net cash provided by financing activities  11,488   - 
Net increase (decrease) in cash $6,381  $(3,410)

 

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Net Cash Used in Operating Activities

 

Net cash used in operating activities was $8.1$4.9 million during the ninethree months ended September 30, 2022,March 31, 2023, compared to $7.7$3.2 million used during the ninethree months ended September 30, 2021,March 31, 2022, an increase of $0.4$1.7 million. The increase in the net loss from operations, and related non-cash add backs to the net loss, was $1.2 million from 2023 when compared to 2022. The increase in cash used for operating activities during 20222023 was primarily due to the $1.1 million mentioned above plus changes in the movement of working capital items during 20222023 as compared to the same period in 20212022 as follows: a $0.4$0.3 million increase in cash used in other liabilities, a $0.1 million increase in accounts receivable, a $0.1 million increase in cash used for payments on operating lease liability, a $0.1 million increase in cash used in accounts payable, and a $0.2$0.1 million increase in cash used in prepaid expenses, a $0.1 million increase in cash used in payments on operating lease liability, all offset by a $0.2 million increase in cash provided by accounts receivable, and a $0.1 million decrease in cash used infor inventory.

 

Net Cash Used in Investing Activities

 

Net cash used in investing activities was $0.8$0.2 million during the ninethree months ended September 30,March 31, 2023 and 2022, compared to $1.1 million in cash provided by investing activities during the same period in 2021, a decrease of $0.3 million. The decrease in cash used in investing activities during 2022 wasremaining primarily due to a $2.1 million decrease in cash used to obtain property and equipment, a $0.3 million increase in acquisition net of cash acquired, offset by the decrease in cash received of $1.9 million from the proceeds from notes receivable in 2021 and a $0.2 million decrease in cash received for the sale of property and equipment.unchanged.

 

Net Cash Provided by (Used in) Financing Activities

 

NetThere was $11.5 million in cash used inprovided by financing activities was $0.5 million during the ninethree months ended September 30, 2022,March 31, 2023, compared to $0.7 millionno cash provided by financing activities during the same period in 2021.2022. The $1.2$11.5 million decreaseincrease to net cash provided by financing activities was primarily attributable to $0.5 million in repayment of a PPP loan in the current year, $0.5 millionan increase in proceeds from a PPP loanissuance of warrant derivative liabilities of $6.7 million and $0.2 millionan increase in proceeds from the exerciseissuance of warrants for cash in the prior year.common stock of $4.8 million.

 

Indebtedness

2020 PPP Loan

On April 28, 2020, the Company received funding under a Paycheck Protection Program (“PPP”) loan (the “PPP Loan”) from First State Community Bank (the “Lender”). The principal amount of the PPP Loan was $0.4 million. The PPP was established under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) and is administered by the U.S. Small Business Administration (the “SBA”). Loans made under the PPP may be partially or fully forgiven if the recipient complies with the provisions of the CARES Act, including the use of PPP Loan proceeds for payroll costs, rent, utilities and other expenses, provided that such amounts are incurred during a 24-week period that commenced on April 28, 2020 and at least 60% of any forgiven amount has been used for covered payroll costs as defined by the CARES Act. On January 5, 2021, the Lender provided notice to the Company that the principal amount and accrued interest had been forgiven. The Company removed the PPP Loan obligation and recorded other income for forgiveness of debt totaling $0.4 million. The SBA has until January of 2027 to audit the Company’s compliance with the CARES Act relating to the PPP Loan.

2021 PPP Loan

On March 15, 2021, the Company received funding under the SBA Second Draw Program under the Paycheck Protection Program (“2021 PPP”) (the “2021 PPP Loan”) from the Lender. The principal amount of the 2021 PPP Loan is $0.5 million. The Company received notice on November 24, 2021, that the principal amount and accrued interest had been forgiven. The Company removed the 2021 PPP Loan obligation and recorded other income for forgiveness of debt totaling $0.5 million.

Since receiving the 2021 PPP Loan and learning that the principal amount of the loan and accrued interest had been forgiven, The Company determined that the Company should not have removed the loan obligation and recorded approximately $0.5 million of other income in the financial statements as of December 31, 2021, and for the year then ended. As a result, the Company has repaid the loan together with processing fees and interest.

 

Business Loan

 

On July 20, 2021, TA&T, entered into a Loan Authorization and Agreement in the amount of approximately $350,000 (the “Business Loan”). Under the Business Loan, theThe Company will make monthly installment payments, including principal and interest, of $1,754. Payments are to begin 18 months from the date ofmade a one-time $35,000 buy down payment when acquiring the loan. The balance of principal and interest is payable 30 years from July 20, 2021. The Business Loan bearsbore interest at a rate of 3.75% per annum. The Business Loan iswas secured by a general security interest in all of the assets of TA&T. The Business Loan containscontained other standard provisions that are customary of loans of this type. The business loan was paid in full during the first quarter of 2023 and there was no outstanding balance at March 31, 2023.

 

Related Party Debt

 

TA&T is obligated to repay certain personal loans made by the founders of TA&T to TA&T prior to SINTX’s acquisition of TA&T (the Personal“Personal Loans”). The total amount of the Personal Loans at SeptemberJune 30, 2022 was approximately $350,000. The Company agreed to repay the outstanding balance of the Personal Loans in (i) 24 equal monthly installments beginning September 1, 2022 and each month thereafter until paid in full as one prior owner’s portion of the Personal Loans totaling $157,000, and (ii) for the other owner’s portion of the Personal Loans totaling $193,000, $100,000$193,000. As of which was recorded in accrued liabilities at September 30, 2022.March 31, 2023, the related party debt had an outstanding balance of $150,000. The remaining $249,000outstanding balance is to bebeing paid in 12 equal monthly installments beginning Septemberending August 1, 2022.2024. The related party debt inis not collateralized and has no interest rate.

 

Wells Fargo Line of Credit

 

Prior to SINTX’s acquisition of TA&T, TA&T entered into a revolving line of credit with Wells Fargo. As of September 30,December 31, 2022, the line of credit with Wells Fargo had anno outstanding balance of $47,000.balance.

 

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Off-Balance Sheet Arrangements

 

We do not have any off-balance sheet arrangements, as defined in Item 303(a)(4) of Regulation S-K.

 

Critical Accounting Policies and 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, 2021.2022. There have been no material changes to those policies for the three months ended September 30, 2022.March 31, 2023. The preparation of the consolidated financial statements in accordance with U.S. generally accepted accounting principles requires us to make judgments, estimates and assumptions regarding uncertainties that affect the reported amounts of assets and liabilities. Significant areas of uncertainty that require judgments, estimates and assumptions include the accounting for income taxes and other contingencies as well as valuation of derivative liabilities, asset impairment and collectability of accounts receivable. We use historical and other information that we consider to be relevant to make these judgments and estimates. However, actual results may differ from those estimates and assumptions that are used to prepare our condensed consolidated financial statements.

 

New Accounting Pronouncements

 

See discussion under Note 1, Organization and Summary of Significant Accounting Policies, to the Condensed Consolidated Financial Statements included in Item 1 of Part I of this Quarterly Report on Form 10-Q, for information on new accounting pronouncements.

 

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

 

ITEM 4. CONTROLS AND PROCEDURES

 

This Report includes the certifications of our Chief Executive Officer and Principal Financial 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 principal financial 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 September 30, 2022.March 31, 2023. Based on this evaluation, the Chief Executive Officer concluded that our disclosure controls and procedures were effective as of September 30, 2022,March 31, 2023, the end of the period covered by this Quarterly Report on Form 10-Q.

 

23

There were no changes in our internal control over financial reporting that occurred during the secondfirst quarter of 20222023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

26

PART II

 

ITEM 1. LEGAL PROCEEDINGS

 

We are not aware of any pending or threatened legal proceeding against us that could have a material adverse effect on our business, operating results or financial condition. The medical device industry is characterized by frequent claims and litigation, including claims regarding patent and other intellectual property rights as well as improper hiring practices. As a result, we may be involved in various additional legal proceedings from time to time.

 

Item 1A. Risk Factors

 

Information regarding risk factors appears in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2021,2022, which was filed with the SEC on March 25,29, 2022. There have been no material changes from the risk factors previously disclosed in the Annual Report on Form 10-K.

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

None.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5. OTHER INFORMATION

 

None.

 

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ITEM 6. EXHIBITS

 

Exhibit
Number
Exhibit DescriptionFiled
Herewith
Incorporated by Reference
herein from
Form or
Schedule
Filing
Date

SEC File/

Reg.
Number

4.1Form of Pre-Funded WarrantExhibit 4.14, Form S-1/A02/06/23333-269475
4.2Form of Class C WarrantExhibit 4.13, Form S-1/A02/07/23333-269475
      
4.32.1*+Form of Class D Warrant Stock Purchase AgreementExhibit 4.15, Form S-1/A02/07/23333-269475
  Form 8-K
(Exhibit 2.1)
 07/06/22 
4.4Form of Placement Agent WarrantExhibit 4.16, Form S-1/A02/06/23333-269475
4.5Form of Warrant Agency AgreementExhibit 4.5, Form 8-K02/09/23001-33624
31.1 
10.1Form of Securities Purchase AgreementExhibit 10.1, Form 8-K02/09/23001-33624
10.2Form of Placement Agent AgreementExhibit 10.25, Form S-1/A02/06/23333-26945
31.1Certificate of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002X   
      
31.2Certificate of the Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002X   
      
32Certifications of the Chief Executive Officer and Principal Accounting Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002X   
      
101.INSInline XBRL Instance DocumentX   
      
101.SCHInline XBRL Taxonomy Extension Schema DocumentX   
      
101.CALInline XBRL Taxonomy Extension Calculation Linkbase DocumentX   
      
101.DEFInline XBRL Taxonomy Extension Definition Linkbase DocumentX   
      
101.LABInline XBRL Taxonomy Extension Label Linkbase DocumentX   
      
101.PREInline XBRL Taxonomy Extension Presentation Linkbase DocumentX   
      
104Cover Page Interactive Data File (embedded within the Inline XBRL document)   
*A portion of Exhibit 10.1 has been omitted as it contains information that (i) is not material and (ii) would be competitively harmful if publicly disclosed. 

 

* Schedules and exhibits to this Exhibit have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The Company agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request.

+ A portion of Exhibit 2.1 has been omitted as it contains information that (i) is not material and (ii) would be competitively harmful if publicly disclosed.

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SIGNATURES

 

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, thereunto duly authorized.

 

 SINTX Technologies, Inc.
  
Date: November 14, 2022May 15, 2023/s/ B. Sonny Bal
 B. Sonny Bal
 

Chief Executive Officer

(Principal Executive Officer and Principal Financial Officer)

 

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