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, 2021March 31, 2022

 

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” 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:

 

24,707,57424,710,574 shares of common stock, $0.01 par value, were outstanding at November 8, 2021.May 10, 2022.

 

 

 

 

SINTX Technologies, Inc.

Table of Contents

 

Part I. Financial Information 
Item 1. Financial Statements3
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 Operations1718
Item 3. Quantitative and Qualitative Disclosures About Market Risk2324
Item 4. Controls and Procedures2324
Part II. Other Information 
Item 1. Legal Proceedings2425
Item 1A. Risk Factors2425
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds2425
Item 3. Defaults Upon Senior Securities2425
Item 4. Mine Safety Disclosures2425
Item 5. Other Information2425
Item 6. Exhibits2526
Signatures2627

 

2

 

Part I. Financial Information

Item 1. Financial Statements

 

SINTX Technologies, Inc.

Condensed Consolidated Balance Sheets - Unaudited

(in thousands, except share and per share data)

 

 September 30, 2021  December 31, 2020  March 31,
2022
  December 31,
2021
 
          
Assets                
Current assets:                
Cash and cash equivalents $17,183  $25,351  $10,863  $14,273 
Account and other receivables, net of allowance  182   41   106   102 
Prepaid expenses and other current assets  382   243   721   350 
Inventories  399   99   299   303 
Note receivable  -   1,856 
Total current assets  18,146   27,590   11,989   15,028 
                
Inventories  291   388   325   294 
Property and equipment, net  3,814   471   4,186   4,025 
Intangible assets, net  33   36   30   31 
Operating lease right of use asset  2,513   1,926   2,254   2,385 
Other long-term assets  71   36   99   77 
Total assets $24,868  $30,447  $18,883  $21,840 
                
Liabilities and Stockholders’ Equity                
Current liabilities:                
Accounts payable $169  $194  $490  $242 
Accrued liabilities  1,605   909   833   1,150 
Current portion of long-term debt  59   109 
Debt  524   509 
Derivative liabilities  818   1,238   306   347 
Current portion of operating lease liability  478   403   513   500 
Other current liabilities  24   26   3   - 
Total current liabilities  3,153   2,879   2,669   2,748 
                
Operating lease liability, net of current portion  2,025   1,477   1,763   1,898 
Long term debt, net of current portion  450   287 
Total liabilities  5,628   4,643   4,432   4,646 
                
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, 2021 and December 31, 2020.  -   - 
Convertible preferred stock Series C, $0.01 par value, 130,000,000 total shares authorized inclusive of all series of preferred; 51 shares issued and outstanding as of September 30, 2021 and December 31, 2020.  -   - 
Common stock, $0.01 par value, 250,000,000 shares authorized; 24,706,074 and 24,552,409 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively.  247   245 
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, 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; 51 shares issued and outstanding as of March 31, 2022 and December 31, 2021.  -   - 
Preferred stock value  -   - 
Common stock, $0.01 par value, 250,000,000 shares authorized; 24,713,574 and 24,684,574 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively.  247   247 
Additional paid-in capital  267,275   266,666   267,466   267,364 
Accumulated deficit  (248,282)  (241,107)  (253,262)  (250,417)
Total stockholders’ equity  19,240   25,804   14,451   17,194 
Total liabilities and stockholders’ equity $24,868  $30,447  $18,883  $21,840 

The condensed consolidated balance sheet as of December 31, 2020,2021, 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 
 Three Months Ended
September 30,
  Nine Months Ended
September 30,
  

Three Months Ended

March 31,

 
 2021  2020  2021  2020  2022  2021 
Product revenue $239  $66  $441  $478  $101  $101 
Grant income  28   - 
Total revenue  129   101 
Costs of revenue  190   53   324   382   80   61 
Gross profit  49   13   117   96   49   40 
Operating expenses:                        
Research and development  1,603   1,432   4,402   3,494   1,653   1,595 
General and administrative  933   827   2,791   2,418   856   1,000 
Sales and marketing  338   182   953   450   394   286 
Grant expenses  26   - 
Total operating expenses  2,874   2,441   8,146   6,362   2,929   2,881 
Loss from operations  (2,825)  (2,428)  (8,029)  (6,266)  (2,880)  (2,841)
Other income (expenses):                        
Interest expense  (1)  (1)  (2)  (2)
Interest income  3   78   99   267   2   47 
Change in fair value of derivative liabilities  481   (287)  225   1,750   41   (242)
Offering costs  -   -   -   (1,246)
Interest expense  (8)  - 
Forgiveness of PPP loan  -   -   391   -   -   391 
Other income (expense), net  (1)  200   141   200 
Total other income (expense), net  482   (10)  854   969 
Other income (net)  -   12 
Total other income, net  35   208 
Net loss before income taxes  (2,343)  (2,438)  (7,175)  (5,297)  (2,845)  (2,633)
Provision for income taxes  -   -   -   -   -   - 
Net loss  (2,343)  (2,438)  (7,175)  (5,297)  (2,845)  (2,633)
Deemed dividend related to the beneficial conversion feature and accretion of a discount on series B preferred stock  -   (74)  -   (9,565)
Deemed dividend related to the beneficial conversion feature and accretion of a discount on preferred stock  -   - 
Net loss attributable to common stockholders $(2,343) $(2,512) $(7,175) $(14,862) $(2,845) $(2,633)
                        
Net loss per share – basic and diluted                        
Basic – net loss $(0.09) $(0.11) $(0.29) $(0.39) $(0.12) $(0.11)
Basic - deemed dividend and accretion of a discount on conversion of preferred stock  -   -   -   (0.70)  -   - 
Basic – attributable to common stockholders $(0.09) $(0.11) $(0.29) $(1.09) $(0.12) $(0.11)
                        
Diluted –net loss $(0.11) $(0.11) $(0.29) $(0.49)
Diluted – loss $(0.12) $(0.11)
Diluted - deemed dividend and accretion of a discount on conversion of preferred stock  -   -   -   (0.63)  -   - 
Diluted – attributable to common stockholders $(0.11) $(0.11) $(0.29) $(1.12) $(0.12) $(0.11)
Weighted average common shares outstanding:                        
Basic  24,703,156   22,774,263   24,686,533   13,671,866   24,712,224   24,668,106 
Diluted  25,069,343   22,774,263   25,097,138   15,094,276   24,712,224   24,668,106 

 

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)

 

                                     
  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, 2019  249  $  -   -  $  -   2,434,009  $24  $239,256  $(234,078) $5,202 
Stock based compensation                                    
Stock based compensation, shares                                    
Extinguishment of derivative liability upon exercise of warrant  -   -   -   -   -   -   1,557   -   1,557 
Common stock issued for cash, net of fees                                    
Common stock issued for cash, net of fees, shares                                    
Issuance of common stock from the exercise of warrants for cash  -   -   -   -   100   -   -   -   - 
Issuance of common stock from the cashless exercise of warrants  -   -   -   -   3,128,895   32   (32)  -   - 
Preferred stock issued for cash, net of fees  -   -   9,440   -   -   -   3,112   -   3,112 
Common stock issued on conversion of preferred stock  -   -   (9,208)  -   6,215,742   62   (62)  -   - 
Issuance of agent warrants  -   -   -   -   -   -   168   -   168 
Beneficial conversion feature on issuance of convertible preferred stock  -   -   -   -   -   -   3,111   -   3,111 
Deemed dividend related to the issuance of preferred stock  -   -   -   -   -   -   (3,111)  -   (3,111)
Accretion of convertible preferred stock discount  -   -   -   -   -   -   6,173   -   6,173 
Deemed dividend related to the conversion of preferred stock  -   -   -   -   -   -   (6,173)  -   (6,173)
Net income  -   -   -   -   -   -   -   1,169   1,169 
Balance as of March 31, 2020  249   -   232   -   11,778,746   118   243,999   (232,909)  11,208 
Extinguishment of derivative liability upon exercise of warrant  -   -   -   -   -   -   1,451   -   1,451 
Common stock issued for cash, net of fees  -  ��-   -   -   6,454,381   65   9,583   -   9,648 
Issuance of common stock from the cashless exercise of warrants  -   -   -   -   373,750   3   (3)  -   - 
Issuance of common stock from the exercise of warrants for cash  -   -   -   -   611,868   6   911   -   917 
Common stock issued on conversion of preferred stock  (123)  -   (179)  -   212,168   2   (2)  -   - 
Accretion of convertible preferred stock discount  -   -   -   -   -   -   207   -   207 
Deemed dividend related to the conversion of preferred stock  -   -   -   -   -   -   (207)  -   (207)
Net loss  -   -   -   -   -   -   -   (4,028)  (4,028)
Balance as of June 30, 2020  126   -   53   -   19,430,913   194   255,939   (236,937)  19,196 
Extinguishment of derivative liability upon exercise of warrant  -   -   -   -   -   -   190   -   190 
Stock based compensation  -   -   -   -   -   -   29   -   29 
Common stock issued for cash, net of fees  -   -   -   -   4,915,000   50   10,318   -   10,368 
Issuance of common stock from the cashless exercise of warrants  -   -   -   -   1,890   -   -   -   - 
Issuance of common stock from the exercise of warrants for cash  -   -   -   -   127,650   1   190   -   191 
Common stock issued on conversion of preferred stock  (100)  -   (2)  -   75,606   1   (1)  -   - 
Accretion of convertible preferred stock discount  -   -   -   -   -   -   74   -   74 
Deemed dividend related to the conversion of preferred stock  -   -   -   -   -   -   (74)  -   (74)
Net loss  -   -   -   -   -   -   -   (2,438)  (2,438)
Balance as of September 30, 2020  26  $-   51  $-   24,551,059  $246  $266,665  $(239,375) $27,536 

 Shares  Amount  Shares  Amount  Shares  Amount  Capital  Deficit  Equity 
 Preferred B Stock  Preferred C Stock  Common Stock  Paid-In  Accumulated  Total  Preferred B Stock Preferred C Stock Common Stock Paid-In Accumulated Total 
 Shares  Amount  Shares  Amount  Shares  Amount  Capital  Deficit  Equity  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   26  $-   51  $-   24,552,409  $245  $266,666  $(241,107) $25,804 
Stock based compensation  -   -   -   -   -   -   36   -   36   -   -   -   -   -   -   36   -   36 
Stock based compensation, shares                                    
Extinguishment of derivative liability upon exercise of warrant  -   -   -   -   -   -   195   -   195   -   -   -   -   -   -   195   -   195 
Issuance of common stock upon exercise of warrants for cash  -   -   -   -   130,275   2   194   -   196   -   -   -   -   130,275   2   194   -   196 
Issuance of common stock from the cashless exercise of warrants  -   -   -   -   1,890   -   -   -   -   -   -   -   -   1,890   -   -   -   - 
Net loss  -   -   -   -   -   -   -   (2,633)  (2,633)  -   -   -   -   -   -   -   (2,633)  (2,633)
Balance as of March 31, 2021  26   -   51   -   24,684,574   247   267,091   (243,740)  23,598   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 30, 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)
Net income (loss)  -   -   -   -   -   -   -   (2,343)  (2,343)
Balance as of September 30, 2021  26  $-   51  $-   24,706,074  $247  $267,275  $(248,282) $19,240 

 

  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 
Balance  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 
Balance  26  $-   51  $-   24,713,574  $247  $267,466  $(253,262) $14,451 

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,

 
 2021 2020  2022  2021 
Cash Flow From Operating Activities                
Net loss $(7,175) $(5,297) $(2,845) $(2,633)
Adjustments to reconcile net loss to net cash used in operating activities:                
Depreciation expense  119   54   68   33 
Amortization of right of use asset  331   310   130   107 
Amortization of intangible assets  3   4   1   1 
Non-cash interest income  (88)  (242)  -   (43)
Stock based compensation  220   29   102   36 
Change in fair value of derivative liabilities  (225)  (1,750)  (41)  242 
Offering costs  -   325 
Gain on disposal of equipment  (144)  - 
Forgiveness of PPP loan  (391)  -   -   (391)
Gain on disposal of property and equipment  -   (14)
Changes in operating assets and liabilities:                
Trade accounts receivable  (140)  87   (4)  (26)
Prepaid expenses and other current assets  (177)  (73)  (391)  (555)
Inventories  (203)  104   (27)  (28)
Accounts payable and accrued liabilities  417   (353)  (54)  380 
Other liabilities  3   (3)
Payments on operating lease liability  (294)  (254)  (122)  (98)
Net cash used in operating activities  (7,747)  (7,056)  (3,180)  (2,992)
Cash Flows From Investing Activities                
Purchase of property and equipment  (3,210)  (150)  (230)  (191)
Proceeds from notes receivable, net of imputed interest  1,944   1,528   -   583 
Proceeds from sale of property and equipment  144   -   -   14 
Net cash provided by (used in) investing activities  (1,122)  1,378   (230)  406 
Cash Flows From Financing Activities                
Proceeds from issuance of preferred stock  -   3,112 
Proceeds from issuance of warrant derivative liabilities  -   6,328 
Proceeds from issuance of common stock, net of fees  -   20,015 
Proceeds from issuance of common stock in connection with exercise of warrants  196   1,109   -   196 
Proceeds from issuance of debt  510   406   -   510 
Payments on debt  (5)  (29)
Net cash provided by financing activities  701   30,941   -   706 
Net increase (decrease) in cash and cash equivalents  (8,168)  25,263 
Net decrease in cash and cash equivalents  (3,410)  (1,880)
Cash and cash equivalents at beginning of period  25,351   1,787   14,273   25,351 
Cash and cash equivalents at end of period $17,183  $27,050  $10,863  $23,471 
                
Noncash Investing and Financing Activities                
Right-of-Use Assets and assumption of operating lease liability $918  $- 
Extinguishment of derivative liabilities through exercise of warrants  195   3,197  $-  $195 
Change in par value due to conversion of preferred stock to common stock  -   65 
Issuance of common stock for the cashless exercise of warrants  -   35 
Supplemental Cash Flow Information                
Cash paid for interest $-  $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 subsidiary, SINTX Armor, Inc. (“SINTX Armor”), which are collectively referred to as “we” or “the Company”. SINTX was incorporated 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, armor and antipathogenic applications. SINTX is a 25-year-old company that has grown over time from focusing on the research and development of silicon nitride for use in human interbody implants to becoming an advanced ceramics company engaged in many different fields, which has enabled the business to focus on core competencies. The core strength of the Company is the manufacturing, research, and development of advanced ceramics for external partners. The Company presently manufactures silicon nitride powders and components in its FDA registered, ISO 13485:2016 certified, and ASD9100D certified manufacturing facility. The Company’s products are primarily sold in the United States.

 

The Company is focused on building revenue generating opportunities in fourthree business industries, namely, antipathogenic, armor, industrial (including armor), and biomedical 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 also 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 utilizing our expertise in the use of ceramic materials in other applications as well.applications. In July 2021, the Company acquired the equipment and obtained certain proprietary know-how rights with which it intends to develop, manufacture and commercialize protective armor plates from boron carbide and a composite material of silicon carbide and boron carbide for military, law enforcement and civilian uses (see Note 14)3). The protective armor plate operations will beare housed in SINTX Armor.

 

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 scienceresearch, development and productionmanufacturing 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. In May 2020, the Company dissolved a wholly owned subsidiary ST Sub, Inc. At the time of dissolution, the subsidiary had no assets, liabilities, equity, or operations.

 

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, 2020,2021, filed with the SEC on March 22, 2021.25, 2022. The results of operations for the ninethree months ended September 30, 2021March 31, 2022, are not necessarily indicative of the results to be expected for the year ending December 31, 2021.2022. 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, 2020.2021.

7

 

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, 2021,March 31, 2022, 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, 2022, and 2021, and 2020, the Company incurred a net loss of $7.22.8 million and $2.6 5.3million, respectively, and used cash in operationsoperating activities of $7.73.2 million and $7.13.0 million, respectively. The Company had an accumulated deficit of $248.3253.3 million and $241.1250.4 million as of September 30, 2021March 31, 2022, and December 31, 2020,2021, 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.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. The 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 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. 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.

 

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 February 6, 2020,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 on a rights offering to its stockholdersbelow 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 units, consisting of convertible preferredthe Company’s common stock, and warrants, for gross proceeds of $9.4 million, which excludes underwriting discounts and commissions and offering expenses payable bythe stock will continue to trade uninterrupted on the The Nasdaq Capital Market under the symbol “SINT”. If the Company of approximately $1.2 million. Additionally, during the period of June 2020 through August 2020,does not regain compliance with Rule 5550(a)(2) by July 5, 2022, the Company closed four registered direct offeringsmay be eligible for additional time to regain compliance. Delisting of the Company’s common shares offrom 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 priced at-the-market underand will consider available options to resolve the deficiency and regain compliance with Nasdaq rules, resulting in the issuance of a total of 11,015,000 shares of its common stock for gross proceeds of approximately $20.9 million, before considering issuance costs of approximately $1.6 million (see Note 9)Listing Rule 5550(a)(2).

During the year ended December 31, 2019, the Company entered into an at-the-market (2019 ATM) equity distribution agreement with Maxim Group LLC (“Maxim”) under which the Company could sell, from time to time, shares of common stock having an aggregate offering price of up to $2.5 million. During the year ended December 31, 2020, the Company sold 354,381 shares of common stock under the 2019 ATM, raising approximately $0.8 million before deducting fees to the placement agent and other offering expenses of approximately $0.034 million. As of September 30, 2021, no funding capacity is available under the 2019 ATM. (see Note 9).

 

On February 25, 2021, the Company entered into an at-the-market Equity Distribution Agreement (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 $152.0.0 million through Maxim, as agent. As of September 30, 2021,March 31, 2022, there have been no sales of shares of common stock under the 2021 Distribution Agreement.

 

Management has concluded existing capital resourcesSubject to the terms and conditions of the 2021 Distribution Agreement, Maxim will use its commercially reasonable efforts to sell the Shares 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 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 million, (ii) the termination by either Maxim or the Company upon the provision of fifteen (15) days written notice, or (iii) February 25, 2023. Under the terms of the 2021 Distribution Agreement, Maxim will be sufficiententitled to fund operationsa 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 at leastcertain expenses incurred in connection with the next 12 months, 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 March 31, 2022 there have been no sales of shares of common stock under the 2021 Distribution Agreement.

Although the Company is seeking to obtain additional equity and/or through November 2022.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 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 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.

 

9

Grant Revenue

Revenues from grants 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. Cash received from federal grants 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 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

Subsequent to March 31, 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 $0.5million, 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 Yet Adopted

 

The Company has reviewed all 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.

 

8

2. 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 warrants and optionswarrants for the purchase of common stock. For the three months ended March 31, 2022, 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 1.82.1 million and 1.61.8 million as of September 30,March 31, 2022, and 2021, and 2020, respectively.

10

 

Below are basic and diluted loss per share data for the three months ended September 30, 2021,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 $(2,343) $(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)
Net income (loss) $(2,845) $-  $(2,845)
Deemed dividend and accretion of a discount  -   -   -   -   -   - 
Net loss attributable to common stockholders $(7,175) $(225) $(7,400) $(2,845) $-  $(2,845)
                        
Denominator:                        
Number of shares used in per common share calculations:  24,686,533   410,605   25,097,138   24,712,224   -   24,712,224 
                        
Net loss per common share:                        
Net loss $(0.29) $-  $(0.29)
Net income (loss) $(0.12) $-  $(0.12)
Deemed dividend and accretion of a discount  -   -   -   -   -   - 
Net loss attributable to common stockholders $(0.29) $-  $(0.29) $(0.12) $-  $(0.12)

 

Below are basic and diluted loss per share data for the three months ended September 30, 2020,March 31, 2021, which are in thousands except for share and per share data:

 

 ��Basic Calculation  

Effect of

Dilutive
Warrant
Securities

  Diluted Calculation 
Numerator:            
Net loss $(2,438) $-  $(2,438)
Deemed dividend and accretion of a discount  (74)  -   (74)
Net loss attributable to common stockholders $(2,512) $-  $(2,512)
             
Denominator:            
Number of shares used in per common share calculations:  22,774,263   -   22,774,263 
             
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)

9

Below are basic and diluted loss per share data for the nine months ended September 30, 2020, 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 $(5,297) $(2,073) $(7,370)
Net income (loss) $(2,633) $-  $(2,633)
Deemed dividend and accretion of a discount  (9,565)  -   (9,565)  -   -   -
Net loss attributable to common stockholders $(14,862) $(2,073) $(16,935) $(2,633) $-  $(2,633)
                        
Denominator:                        
Number of shares used in per common share calculations:  13,671,866   1,422,410   15,094,276   24,668,106   -   24,668,106 
                        
Net loss per common share:                        
Net loss $(0.39) $(0.10) $(0.49)
Net income (loss) $(0.11) $-  $(0.11)
Deemed dividend and accretion of a discount  (0.70)  0.07   (0.63)  -   -   -
Net loss attributable to common stockholders $(1.09) $0.03  $(1.12) $(0.11) $-  $(0.11)

 

3. Inventories

 

Inventories consisted of the following (in thousands):

 

Schedule of InventoriesComponents of Inventory

 September 30, 2021  December 31, 2020  March 31,
2022
  December 31,
2021
 
Raw materials $419  $388  $429  $411 
Intermediate Goods  114   - 
WIP  116   97   128   134 
Finished goods  41   2   67   52 
Total Inventories $690  $487 
Inventory net $624  $597 

 

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

 

4. Property and Equipment

11

 

The following is a summary of the components of property and equipment (in thousands):

Schedule of Property and Equipment

  

September 30,

2021

  

December 31,

2020

 
Manufacturing and lab equipment $4,008  $558 
Leasehold improvements  936   941 
Software and computer equipment  696   684 
Furniture and equipment  82   82 
   5,722   2,265 
Less: accumulated depreciation  (1,908)  (1,794)
  $3,814  $471 

Depreciation expense for the nine months ended September 30, 2021, was approximately $0.1  million. Depreciation expense for the year ended December 31, 2020, was approximately $0.1 million.

Of the $4.0 million in manufacturing and lab equipment listed as of September 30, 2021, $2.7 million is related to the purchase of equipment for SINTX Armor. The equipment was being transported to the SINTX Armor facility in Salt Lake City and was not in service as of September 30, 2021 (see Note 14).

 

5. Intangible Assets

Intangible assets consisted of the following (in thousands):

Schedule of Intangible Assets

  September 30,
2021
  December 31,
2020
 
Trademarks $50  $50 
Less: accumulated amortization  (17)  (14)
Intangible assets, net $33  $36 

Amortization expense for the nine months ended September 30, 2021, was approximately $3.0 thousand. Amortization expense for the nine months ended September 30, 2020, was approximately $4.0 thousand.

10

6.4. 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, 2021March 31, 2022, and December 31, 2020.2021. 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, 2021March 31, 2022, and December 31, 20202021 (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, 2021  Fair Value Measurements as of March 31, 2022 
Description Level 1  Level 2  Level 3  Total  Level 1  Level 2  Level 3  Total 
Derivative liability                                
Common stock warrants $-  $-  $818  $818  $-  $-  $306  $306 

 

 Fair Value Measurements as of December 31, 2020  Fair Value Measurements as of December 31, 2021 
Description Level 1  Level 2  Level 3  Total  Level 1  Level 2  Level 3  Total 
Derivative liability                                
Common stock warrants $-  $-  $1,238  $1,238  $-  $-  $347  $347 

12

 

The Company did not have any transfers of assets and liabilities between any levelsLevel 1 and Level 2 of the fair value measurement hierarchy during the ninethree months ended September 30,March 31, 2022, and 2021. 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 three months ended March 31, 2022, and 2021 and 2020 (in thousands).:

Schedule of Fair Value Measurement Hierarchy of Derivative Liability

  Common Stock
Warrants
 
Balance as of December 31, 2019 $(220)
Issuance of derivatives  (6,328)
Change in fair value  1,750 
Exercise of warrants  3,197 
Other, net  1 
Balance as of September 30, 2020 $(1,600)
     
Balance as of December 31, 2020 $(1,238)
Change in fair value  225 
Exercise of warrants  195 
Balance as of September 30, 2021 $(818)

11

  Common Stock
Warrants
 
Balance as of December 31, 2020 $(1,238)
Change in fair value  (242)
Exercise of warrants  195 
Balance as of March 31, 2021 $(1,285)
     
Balance as of December 31, 2021 $(347)
Change in fair value  41 
Balance as of March 31, 2022 $(306)

 

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, 2021March 31, 2022, and December 31, 2020,2021, the derivative liability was calculated using the Monte Carlo Simulation valuation.

 

The assumptions used in estimating the common stock warrant liability as of September 30, 2021March 31, 2022, and December 31, 20202021 were as follows:

Schedule of Assumptions Used in Estimating Fair Value

September 30,March 31,

20212022

December 31,

20202021

Weighted-average risk-free interest rate0.041.63%-0.532.45%0.090.06%-0.270.97%
Weighted-average expected life (in years)0.310.82-3.362.860.630.07-4.103.10
Expected dividend yield-%--%-%
Weighted-average expected volatility70.362.0%%-145.0129.4%138.371.5%-175.6126.5%

 

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.

 

12

7.5. Accrued Liabilities

 

Accrued liabilities consisted of the following (in thousands):

Schedule of Accrued Liabilities

 September 30, 2021  December 31, 2020  March 31,
2022
  December 31,
2021
 
Payroll and related expense $906  $600  $426  $724 
Other  699   309   407   426 
Total accrued liabilities $1,605  $909 
Accrued liabilities $833  $1,150 

13

8.6. 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%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 First State Community Bank (the “Lender”).the Lender. The principal amount of the 2021 PPP Loan is $0.5 million. The Company received notice on November 24, 2021, PPP was established underthat the CARES Actprincipal amount and is administered by the SBA.accrued interest had been forgiven. The 2021 PPP Loan has a five-year term, maturing on March 15, 2026. The interest rate onCompany removed the 2021 PPP Loan is obligation and recorded other income for forgiveness of debt totaling approximately $1.00.5% per annum. million during the year ended December 31, 2021.

 

The Company will not be obligated to make any payments of principal or interest if the Company submits a loan forgiveness application to the Bank within 10 months after the end of the Company’s covered loan forgiveness period (as defined and interpreted by the 2021 PPP Rules) and such loan forgiveness is allowed. Generally, all or a portion ofSince receiving the 2021 PPP Loan may beand learning that the principal amount of the loan and accrued interest had been forgiven, if the Company maintainshas determined that due to its employment and compensation within certain parameters duringstatus as a publicly traded company with common shares trading on the twenty-four (24) week period followingNasdaq Stock 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 will repay the loan origination datetogether with processing fees and the proceeds of theinterest, which totaled $0.5at March 31, 2022 and December 31, 2021 PPP Loan are spent on payroll costs, rent or lease agreements dated before February 15, 2020 and utility payments arising under service agreements in place before February 15, 2020.(see Note 1).

 

13

9.7. Equity

 

2021 Equity Distribution Agreement

 

On February 25, 2021, the Company entered into an Equity Distribution Agreement (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 $152.0.0 million through Maxim, as agent.

 

Subject to the terms and conditions of the 2021 Distribution Agreement, Maxim will use its commercially reasonable efforts to sell the Shares from time to time, based on the Company’s 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 Agreement 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 $15.0 $2.0 million, (ii) the termination by either Maxim or the Company upon the provision of fifteen (15) days written notice, or (iii) February 25, 2022.2023. 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, 2021March 31, 2022 there have been no sales of shares of common stock under the 2021 Distribution Agreement.

2020 Rights Offering

During February 2020, the Company closed on a rights offering capital raise wherein the Company’s holders of common stock, Series C Preferred Stock, and certain outstanding warrants, obtained, at no charge, non-transferable subscription rights to purchase certain units from the Company (“Units”). Each Unit consisted of one share of Series C Convertible Preferred Stock (“Preferred Stock”) and 675 warrants to purchase common stock (“Warrants”). Each Unit sold for $1,000. Each share of the Preferred Stock is convertible, at the Company’s option at any time on or after the first anniversary of the expiration of the rights offering or at the option of the holder at any time, into a number of shares of our common stock equal to the quotient of the stated value of the Preferred Stock ($1,000) divided by the Conversion Price ($1.4814 per share). Each Warrant is exercisable for one share of our common stock at an exercise price of $1.50 per share from the date of issuance through its expiration five years from the date of issuance. The Warrants also contain a cashless exercise provision that allows the holder to receive 70% of the common stock otherwise available under the warrant to the holder electing the cashless exercise provision. The Company issued 9,440 Units, comprised of 6,372,000 Warrants exercisable into shares of our common stock and Preferred Stock convertible into 6,372,350 shares of Common Stock, for gross proceeds of $9.4 million before consideration of issuance costs, associated with the issuance of the Units, with $3.1 million allocated to the Preferred Stock (with no issuance costs allocated to the preferred stock) and $5.1 million, net of issuance costs of approximately $1.2 million, allocated to the Warrants. In association with the Warrants that were recorded as a derivative liability, the Company immediately expensed approximately all $1.2 million of the issuance costs.

During the nine months ended September 30, 2021, Series B Convertible Preferred stockholders of the Company converted 0 shares of Series B Convertible Preferred Stock, and Series C Convertible Preferred stockholders of the Company converted 0 shares of Series C Convertible Preferred Stock.

Also, during the nine months ended September 30, 2021, holders of warrants elected to exercised using both the cashless and for cash options. The cashless exercise option exercised 2,700 warrants, which resulted in the issuance of 1,890 shares of common stock. The for cash option exercised 130,275 warrants, which resulted in the issuance of 130,275 shares of common stock, and the receipt of $0.2 million of cash.

2020 Registered Direct Offerings

During June 2020, the Company closed two registered direct offerings of shares of its common stock, priced at-the-market under Nasdaq rules, resulting in the issuance of a total of 6,100,000 shares of its common stock for gross proceeds of approximately $9.6 million, before considering offering costs of approximately $0.8 million. On June 23, 2020, the Company entered into the first Share Purchase Agreement with certain institutional purchasers, pursuant to which the Company agreed to issue and sell to the purchasers, in a registered direct offering, an aggregate of 3,700,000 shares of common stock, par value $0.01 per share. The shares were sold at a negotiated purchase price of $1.50 per share for aggregate gross proceeds to the Company of approximately $5.5 million, before deducting offering costs. Following the initial registered direct offering, on June 26, 2020, the Company entered into the second Share Purchase Agreement with certain institutional purchasers pursuant to which the Company offered to the purchasers, in a registered direct offering, an aggregate of 2,400,000 shares of common stock, par value $0.01 per share. The shares were sold at a negotiated purchase price of $1.72 per share for aggregate gross proceeds to the Company of approximately $4.1 million, before deducting offering costs.

During July and August 2020, the Company closed two registered direct offerings of shares of its common stock, priced at-the-market under Nasdaq rules, resulting in the issuance of a total of 4,915,000 shares of its common stock for gross proceeds of approximately $11.2 million, before considering offering costs of approximately $0.8 million. On July 16, 2020, the Company entered into a Share Purchase Agreement with certain institutional purchasers, pursuant to which the Company agreed to issue and sell to the purchasers, in a registered direct offering, an aggregate of 1,500,000 shares of common stock, par value $0.01 per share. The shares were sold at a negotiated purchase price of $2.00 per share for aggregate gross proceeds to the Company of $3.0 million, before deducting offering costs. On August 4, 2020, the Company entered into a Share Purchase Agreement with certain institutional purchasers, pursuant to which the Company agreed to issue and sell to the purchasers, in a registered direct offering, an aggregate of 3,415,000 shares of common stock, par value $0.01 per share. The shares were sold at a negotiated purchase price of $2.40 per share for aggregate gross proceeds to the Company of $8.2 million, before deducting offering costs.

14

 

10.8. Stock-Based Compensation

 

A summary of the Company’s outstanding stock option activity for the ninethree months ended September 30,March 31, 2022, and 2021 and 2020 is as follows:

Summary of Stock Option Activity

    September 30, 2021        March 31, 2022    
 Options  Weighted- Average Exercise Price  

Weighted-

Average

Remaining

Contractual Life

(Years)

 

Intrinsic

Value

    

Weighted-

Average

 

Weighted-

Average

Remaining

Contractual Life

  Intrinsic 
As of December 31, 2020  465,393  $5.53   9.3   - $ 
 Options  Exercise Price  (Years)  Value 
As of December 31, 2021  833,892  $3.91   8.7   87,553 
Granted  368,500   1.93   10.0   -   357,000   0.49   10.0   - 
Exercised  -   -   -   -   -   -   -   - 
Forfeited  -   -   -   -   -   -   -   - 
Expired  -   -   -   -   (3)  139,237.86   -   - 
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  1,190,889  $2.38   8.9  $114,500 
Exercisable at March 31, 2022  387,212  $6.02   8.3  $44,652 
Vested and expected to vest at March 31, 2022  1,178,659  $2.44   8.9  $117,100 

 

    September 30, 2020        March 31, 2021    
 Options  Weighted- Average
Exercise Price
  Weighted-Average Remaining Contractual
Life
(Years)
  Intrinsic Value    

Weighted-

Average

 

Weighted-

Average

Remaining

Contractual Life

  Intrinsic 
As of December 31, 2019  377  $7,446.69   5.3  $- 
 Options  Exercise Price  (Years)  Value 
As of December 31, 2020  465,393  $5.53   9.3   - 
Granted  465,017   0.47   10.0   -   368,500   1.93   10.0   - 
Exercised  -   -   -   -   -   -   -   - 
Forfeited  -   -   -   -   -   -   -   - 
Expired  -   -   -   -   -   -   -   - 
As of September 30, 2020  465,394  $5.90   9.6  $746,774 
Exercisable and vested at September 30, 2020  377  $7,446.69   4.6  $- 
As of March 31, 2021  833,893  $3.98   9.4  $698,913 
Exercisable at March 31, 2021  376  $6,977.42   4.1  $- 
Vested and expected to vest at March 31, 2021  833,893  $3.98   9.4  $698,913 

 

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 of options granted to employees and non-employees during the ninethree months ended September 30, 2021.March 31, 2022. During the ninethree months ended September 30, 2021March 31, 2022, the Company granted stock options with an estimated fair value of approximately $0.60.2 million.

15

Schedule of Assumption Used for Fair Valuevalue of Option

September 30, 2021March 31, 2022
Weighted-average risk-free interest rate1.660.73%-0.85%
Weighted-average expected life (in years)5.3-5.910
Expected dividend yield-0%
Weighted-average expected volatility138130%-139132%

 

Of the 368,500357,000 options granted during the ninethree months ended September 30, 2021,March 31, 2022, 60,000were to non-executive members of the board of directors. Of the 833,8931,190,889 options outstanding as of September 30, 2021,March 31, 2022, 295,000355,000 were awarded to non-executive members of the board of directors.

 

Unrecognized stock-based compensation as of September 30, 2021,March 31, 2022, 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 $622   2.1  $609   2.0 
Stock grants $14   1.6  $44   2.1 

 

119. . 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 one halfthree 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.

 

12.10. Note Receivable

 

On October 1, 2018, the Company completed the sale of its spine implant business to CTL Medical. The sale included a $6.0million noninterest bearing note receivable payable over a 36 month term to mature on October 1, 2021.2021. The note receivable included an imputed interest rate of 10%10%. The note was paid in full in May 2021.

 

15

13.11. Leases

 

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

 

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

 

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.

 

16

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, 2021,March 31, 2022, the operating lease right-of-use assets totaled approximately $2.52.3 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, 2022 and 2021, totaled approximately $0.30.1 million.and $0.1 million, respectively. As of September 30, 2021,March 31, 2022, 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, 2021,March 31, 2022, are summarized as follows :follows:

Schedule of Operating Lease Future Minimum Payments

Years Ending December 31, September 30, 2021  March 31,
2022
 
2021 $147 
2022  641  $481 
2023  660   660 
2024  679   680 
2025  123   123 
2026  127 
Thereafter  795   668 
Total future minimum lease payments  3,045   2,739 
Less amounts representing interests  (542)  (463)
Present value of lease liability  2,503   2,276 
        
Current-portion of operating lease liability  478   513 
Long-term portion operating lease liability $2,025  $1,763 

14. Equipment Purchase

As explained in Note 1, on July 20, 2021, the Company acquired the equipment and obtained certain intellectual know how with which it intends to develop, manufacture and commercialize protective armor plates from boron carbide and a composite material of silicon carbide and boron carbide for military, law enforcement and civilian uses. The total purchase price for the assets was $2.75 million, $2.5 million of which was paid at closing and the remaining $250,000 is to be paid upon completion of certain checkpoints.

 

As of September 30, 2021, the assets have not yet been placed in service, nor has the Company recognized any depreciation expense associated with these assets. The intention of the Company is to place these assets into service by early 2022.

1617

 

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, 2020 2021 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, 2020,2021, 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, 2020,2021, and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q and in other filings with the Securities and Exchange Commission we may make from time-to-time.

 

Overview

SINTX Technologies isWe are an OEMadvanced materials company that develops and commercializes advanced ceramics materials company focused on providing solutions in a variety of medical,for biomedical, industrial, armor and antipathogenic applications. SINTX is a 25-year-old company that has grown over time from focusing on the research and development of silicon nitride for use in human interbody implants to becoming an advanced ceramics company engaged in many different fields, which has enabled the business to focus on core competencies. The core strength of the CompanySINTX Technologies is the manufacturing, research, and development of advanced ceramics for external partners. The Company presently manufactures silicon nitride powders and components in its FDA registered, ISO 13485:2016 certified, and ASD9100D certified manufacturing facility.

 

The Company is focused on building revenue generating opportunities in three business industries, antipathogenic, armor, industrial and biomedical, 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 also expect our continued investment in research and development to provide additional revenue opportunities.

Biomedical Applications:Since its inception, we haveSINTX has been focused on development of medical grade silicon nitride for use in applications such as spinal fusion, hip and knee replacement and dental implants. The Company’snitride. SINTX products are biocompatible, bioactive, antipathogenic, and have shown superb bone affinity. Because ofSpinal 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 – mean that it is an ideal material for usemay also be suitable in interbodyother fusion device applications such as hip, knee and dental implants. Bacterial infection of any biomaterial implants is always a concern. OurSINTX 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.

Industrial Applications:It is the belief of the CompanySINTX that its grade of industrial silicon nitride also has the desiredbest combination of mechanical, thermal, and electrical properties for use as aof 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 has obtained AS9100D certification and ITAR registration to facilitate entry into the aerospace portion of this market.

 

Armor solutions utilizing ceramics are commonly used to protect vehicles, personnel, aircraft, and marine vessels due to their lightweight and high hardness. We haveSINTX has recently entered the ceramic armor market through the purchase of assets from B4C, LLC and a technology partnership with Precision Ceramics USA. We willSINTX intends 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 licensed from Precision Ceramics USA, for exceptional multi-hit performance against ballistic threats. SINTX has signed a 10-year lease at a building near its headquarters in Salt Lake City, UT to house development and manufacturing activities for SINTX Armor.

 

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 personal protective equipment,wound care devices, it is possible to manufacture surfaces that inactivate viral particles,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.

 

The CompanySINTX presently manufactures advanced ceramic powders and components in our manufacturing facilities based in Salt Lake City, Utah.

 

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.

 

1718

 

Product Revenue

 

We derive our product revenue primarily 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. 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 CTL increases sales of silicon nitride spinal fusion products, as we secure other 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 revenue from grants and 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 spinal fusionmedical devices, industrial and ceramic armor products, develop armored plates from ceramic, product candidates for total joint replacements, dentalantipathogenic applications, antipathogenic products, 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.

 

1819

RESULTS OF OPERATIONS

 

The following is a tabular presentation of our unaudited condensed consolidated operating results for the three months ended March 31, 2022 and nine month periods ended September 30, 2021 and 2020 (in thousands):

 

 

Three Months

Ended September 30,

  $  %  

Nine Months

Ended September 30,

  $  %  

Three Months Ended

March 31,

     
 2021  2020  Change  Change  2021  2020  Change  Change  2022  2021  $ Change  % Change 
Product revenue $239  $66  $173   262% $441  $478  $(37)  -8% $101  $101  $0   0%
Cost of revenue  190   53   137   258%  324   382   (58)  -15%
Grant revenue  28   -   28   100%
Total revenue  129   101   28   28%
Costs of revenue  80   61   19   31%
Gross profit  49   13   36   277%  117   96   21   22%  49   40   9   23%
                                
Operating expenses:                                                
Research and development  1,603   1,432   171   12%  4,402   3,494   908   26%  1,653   1,595   58   4%
General and administrative  933   827   106   13%  2,791   2,418   373   15%  856   1,000   (144)  -14%
Sales and marketing  338   182   156   86%  953   450   503   112%  394   286   108   38%
Grant expenses  26   -   26   100%
Total operating expenses  2,874   2,441   433   18%  8,146   6,362   1,784   28%  2,929   2,881   48   2%
Loss from operations  (2,825)  (2,428)  (397)  16%  (8,029)  (6,266)  (1,763)  28%  (2,880)  (2,841)  (39)  1%
Other income (expense)  482   (10)  492   4920%  854   969   (115)  -12%
Net loss before taxes  (2,343)  (2,438)  95   -4%  (7,175)  (5,297)  (1,878)  35%
Other income, net  35   208   (173)  -83%
Net income (loss) before income taxes  (2,845)  (2,633)  (212)  8%
Provision for income taxes  -   -   -       -   -   -       -   -   -   N/A 
Net loss $(2,343) $(2,438) $95   -4% $(7,175) $(5,297) $(1,878)  35%
Net income (loss)  (2,845)  (2,633)  (212)  8%

 

Product Revenue

 

For the three months ended September 30,March 31, 2022, and 2021 total product revenue was $0.24 million as compared to $0.07 million inrelatively unchanged at $0.1 million. During the quarter ended March 31, 2022 the Company received grant revenue of $0.03 million. Grant revenue did not exist during the same period 2020, an increase of $0.17 million, or 262%. This increase was largely due to increases in orders from CTL Amedica.

For the nine months ended September 30, 2021, total product revenue was $0.44 million as compared to $0.48 million in the same period 2020, a decrease of $0.04 million, or 8%. This decrease was primarily due to a decrease in orders from CTL Amedica.

prior year.

 

Cost of Revenue and Gross Profit

 

For the three months ended September 30, 2021,March 31, 2022, our cost of revenue increased $0.14 million, or 258%,did not significantly change as compared to the same period in 2020. This increase is primarily attributed to the increase in product revenue, and the associated increase in costs of goods sold. Gross profit increased $0.04 million or 277%. This increase in gross profit is attributed to the increase in product revenue. Gross profit margin percentage totaled 21% and 20% for the three months ended September 30 for 2021 and 2020, respectively.

For the nine months ended September 30, 2021, our cost of revenue decreased $0.06 million, or 15%, as compared to the same period in 2020. Gross profit increased $0.02 million or 22%. The decrease in cost of revenue was directly related to the reduction in revenue. The increase in gross profit is a result of revenue to new customers with higher profit margins when compared to the prior year. Gross profit margin percentage totaled 27% and 20% for the nine months ended September 30 for 2021 and 2020, respectively.

2021.

 

19

Research and Development Expenses

 

For the three months ended September 30, 2021,March 31, 2022, research and development expenses increased $0.2$0.1 million, or 12% as compared to the same period in 2020. This increase was primarily attributable to an overall increase in R&D activity to support the Company’s strategic objective of developing new technologies and related products.

For the nine months ended September 30, 2021, research and development expenses increased $0.9 million, or 26%4%, as compared to the same period in 2020.2021. This increase was primarily attributable to ana general increase in R&D wages for new personnelproducts and outside research activities relatedservices due to testing the anti-viral properties of silicon nitride to support the Company’s strategic objective of developing new technologies and related products.

price inflation.

 

General and Administrative Expenses

 

For the three months ended September 30, 2021,March 31, 2022, general and administrative expenses increaseddecreased $0.1 million, or 13% as compared to the same period in 2020. This increase is primarily due to an increase in insurance costs and fees for outside consultants.

For the nine months ended September 30, 2021, general and administrative expenses increased $0.4 million, or 15%14%, as compared to the same period in 2020.2021. This increasedecrease is primarily due to the increasedecrease in insuranceexternal consulting costs fees for outside consultants and an increase in wages for new personnel.patent application expenses.

20

 

Sales and Marketing Expenses

 

For the three months ended September 30, 2021,March 31, 2022, sales and marketing expenses increased $0.2$0.1 million, or 86%38%, as compared to the same period in 2020.2021. This increase was primarily attributable to an overall increase in marketing activities to generate interest in and exposure to the Company’s potential new product lines.

 

Grant Expenses

For the ninethree months ended September 30, 2021, sales and marketingMarch 31, 2022, the Company incurred grant expenses increased $0.5 million, or 112%, as compared toof less than $0.1 million. The Company had no grant expenses for the same period in 2020. This increase was primarily attributable to an increase in sales and marketing wages for new personnel and an increase in marketing activities to generate interest in and exposure2021 due to the Company’s potential new product lines.Company being awarded federal grant income subsequent to the first quarter of 2021 (and incurring related grant expense during 2022 and incurring none during 2021).

 

Other Income, Net

 

For the three months ended September 30, 2021,March 31, 2022, other income increased $0.5decreased $0.2 million, or 4920%83%, as compared to the same period in 2020.2021. This increasedecrease was primarily due to other income of $0.4 million associated with the forgiveness of the 2020 PPP Loan in the prior year, which was partially offset in the prior year by the incurring of a change in the fair value of the derivative liabilities in the amount of $0.8 million offset by a $0.1 million decrease in interest income and a $0.2 million gain on the reduction of accrued sterilization in the prior year.million.

For the nine months ended September 30, 2021, other income decreased $0.1 million, or 12%, as compared to the same period in 2020. This decrease was primarily due to incurring a change in the fair value of the derivative liabilities in the amount of $1.5 million, a reduction in interest income of $0.2 million offset by offering costs of $1.2 million associated with the February 2020 rights offering and a $0.4 million in PPP loan forgiveness in the prior year.

 

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.

20

For the ninethree months ended September 30,March 31, 2022, and 2021 and 2020,, the Company incurred a net loss of $7.2$2.8 million and a net loss of $5.3$2.6 million, respectively, and used cash in operationsoperating activities of $7.7$3.2 million and $7.1$3.0 million, respectively. The Company had an accumulated deficit of $248.3$253.3 million and $241.1$250.4 million as of September 30, 2021March 31, 2022, and December 31, 2020,2021, 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. The unique features of our silicon nitride material are not well known, and 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 6, 2020, the Company closed on a rights offering to its stockholders of units, consisting of convertible preferred stock and warrants, for gross proceeds of $9.4 million, which excludes underwriting discounts and commissions and offering expenses payable by the Company. Additionally, during the period of June 2020 through August 2020, the Company closed four registered direct offerings of shares of its common stock, priced at-the-market under Nasdaq rules, resulting in the issuance of a total of 11,015,000 shares of its common stock for gross proceeds of approximately $20.9 million, which excludes underwriting discounts and commissions and offering expenses payable by the Company.

During the year ended December 31, 2019, the Company entered into an ATM equity distribution agreement in which the Company could sell, from time to time, shares of common stock having an aggregate offering price of up to $2.5 million. The Company sold 527,896 shares during the year ended December 31, 2019, raising approximately $1.7 million before considering issuance costs. During the year ending December 31, 2020, the Company sold 354,381 shares of common stock, raising approximately $0.8 million before considering issuance costs. As a result of the sales during the first half of 2020 there are no longer any funds available to the Company under the ATM.

 

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 $15.0$2.0 million through Maxim, as agent. No shares have been sold under the 2021 Distribution Agreement as of September 30, 2021.March 31, 2022.

21

 

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.

 

Management has concluded thatAlthough 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 existing capital resourcescurrent 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 sufficient to fund operations for at least the next 12 months, or through November 2022.material and adverse.

 

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 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

 

21

Subsequent to March 31, 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,  Three Months Ended March 31, 
 2021  2020  2022  2021 
Net cash used in operating activities $(7,747) $(7,056) $(3,180) $(2,992)
Net cash provided by (used in) investing activities  (1,122)  1,378   (230)  406 
Net cash provided by financing activities  701   30,941   -   706 
Net cash provided (used) $(8,168) $25,263 
Net decrease in cash $(3,410) $(1,880)

22

 

Net Cash Used in Operating Activities

 

Net cash used in operating activities was $7.7$3.2 million during the ninethree months ended September 30, 2021,March 31, 2022, compared to $7.1$3.0 million used during the ninethree months ended September 30, 2020,March 31, 2021, an increase of $0.6$0.2 million. The increase in cash used for operating activities during 2022 was primarily due to changes in the movement of working capital items during 2022 as compared to the same period in 2021 as follows: a $0.5 million increase in cash used in accounts payable, offset by a $0.2 million decrease in cash used in prepaid expenses. The decrease in the net loss fromfor operations, and related non-cash add backs to the net loss, was $0.8$0.1 million from 20212022 when compared to 2020. The increase in cash used for operating activities during 2021 was primarily due to the $0.8 million mentioned above plus changes in the movement of working capital items during 2021 as compared to the same period in 2020 as follows: a $0.3 million increase in cash used for inventory, $0.1 million increase in cash used for prepaid expenses, and $0.2 million decrease in cash received from accounts receivable, offset by a $0.8 million decrease in cash used for accounts payable.2021.

 

Net Cash Provided by (Used in) Investing Activities

 

Net cash used in investing activities was $1.1$0.2 million during the ninethree months ended September 30, 2021Monarch 31, 2022, compared to cash$0.4 million provided by investing activities of $1.4 million forduring the same period in 2020.2021, a decrease of $0.6 million. The decrease ofin cash provided byin investing activities of $2.5 millionduring 2022 was primarily driven bydue to the changedecrease in property and equipmentcash received of $2.9$0.6 million offset by an increase in cashfrom the proceeds from notes receivable of $0.4 million.in 2021.

Net Cash Provided by Financing Activities

 

NetThere was no cash provided by financing activities was $0.7 million during the ninethree months ended September 30, 2021,March 31, 2022, compared to net cash provided by financing activities of $30.9$0.7 million during the same period in 2020.2021. The $30.2$0.7 million decrease to net cash provided by financing activities was primarily attributable to 2020$0.5 million in proceeds from a offerings including $20.0PPP loan and $0.2 million less in proceeds in the issuance of common stock, $6.3 million less in proceeds from issuance of warrant derivative liabilities, $3.1 million less in proceeds from issuance of preferred stock, and $0.9 million less in proceeds from the issuance of common stock in connection with the exercise of warrants offset by $0.1 millionfor cash in additional proceeds from the issuance of debt related to PPP loans.prior year.

 

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 First State Community Bank (the “Lender”).the Lender. The principal amount of the 2021 PPP Loan is $0.5 million. The Company received notice on November 24, 2021, PPP was established underthat the CARES Actprincipal amount and is administered by the SBA.accrued interest had been forgiven. The 2021 PPP Loan has a five-year term, maturing on March 15, 2026. The interest rate onCompany removed the 2021 PPP Loan is 1.0% per annum.obligation and recorded other income for forgiveness of debt totaling $0.5 million.

 

The Company will not be obligated to make any payments of principal or interest if the Company submits a loan forgiveness application to the Bank within 10 months after the end of the Company’s covered loan forgiveness period (as defined and interpreted by the 2021 PPP Rules) and such loan forgiveness is allowed. Generally, all or a portion ofSince receiving the 2021 PPP Loan may beand learning that the principal amount of the loan and accrued interest had been forgiven, ifThe Company has determined that the Company maintains its employment and compensation within certain parameters during the twenty-four (24) week period followingshould not have removed the loan origination dateobligation and recorded approximately $0.5 million of other income in the proceedsfinancial statements as of December 31, 2021, and for the 2021 PPP Loan are spent on payroll costs, rent or lease agreements dated before February 15, 2020year then ended. As a result, the Company will repay the loan together with processing fees and utility payments arising under service agreements dated before February 15, 2020.interest.

 

2223

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, 2020.2021. There have been no material changes to those policies for the ninethree months ended September 30, 2021.March 31, 2022. The preparation of the condensed 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, 2021.March 31, 2022. Based on this evaluation, the Chief Executive Officer concluded that our disclosure controls and procedures were effective as of September 30, 2021,March 31, 2022, the end of the period covered by this Quarterly Report on Form 10-Q.

 

2324

 

There were no changes in our internal control over financial reporting that occurred during the thirdfirst quarter of 20212022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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, 2020,2021, which was filed with the SEC on March 22, 2021.25, 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.

 

2425

 

ITEM 6. EXHIBITS

 

Exhibit


Number

 Exhibit Description Filed Herewith 

Incorporated by Reference


herein from


Form or


Schedule

 

Filing


Date

 

SEC File/

Reg. Number

2.1*+Asset Purchase Agreement by and among SINTX Technologies, Inc. and B4C, LLC, dated July 20, 2021.

Form 8-K

(Exhibit 2.1)

07/26/21001-33624
3.1Amended and Restated Bylaws of SINTX Technologies, Inc. (effective September 30, 2021)

Form 8-K

(Exhibit 3.1)

10/01/21001-33624
           
10.1*+Industrial Lease Agreement, dated August 19, 2021, by and between SINTX Technologies, Inc. and SLS Industrial Portfolio Owner SLCP, LLC, LLC.31.1 

Form 8-K

(Exhibit 10.1)

08/25/21001-33624
31.1Certificate of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 X      
           
31.2 Certificate of the Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 X      
           
32 Certifications of the Chief Executive Officer and Principal Accounting Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 X      
           
101.INS Inline XBRL Instance Document X      
           
101.SCH Inline XBRL Taxonomy Extension Schema Document X      
           
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document X      
           
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document X      
           
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document X      
           
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document X      
           
104Cover Page Interactive Data File (embedded within the Inline XBRL document)
* 
+PortionsA portion of Exhibit 2.1 and 10.1 havehas been omitted as they containit contains information that (i) is not material and (ii) would be competitively harmful if publicly disclosed.        
*Schedules and exhibits to these Exhibits 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.

 

2526

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 12May 13, 2022, 2021/s/ B. Sonny Bal
 B. Sonny Bal
 

Chief Executive Officer


(Principal Executive Officer and Principal Financial Officer)

 

2627