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 June 30, 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 incorporati ...

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 March 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 incorporat ...

[PART I](index=7&type=section&id=PART%20I) [Business](index=7&type=section&id=Item%201.%20Business) SINTX Technologies specializes in silicon nitride for biomedical, industrial, and antipathogenic applications, focusing on OEM manufacturing and R&D for external partners - SINTX Technologies, a 25-year-old advanced ceramics company, focuses on biomedical, industrial, and antipathogenic applications, shifting to OEM manufacturing and R&D for external partners[28](index=28&type=chunk) - The company's core business utilizes proprietary silicon nitride for **biomedical** (spinal implants, bone growth), **industrial** (aerospace, armor), and **antipathogenic** (SARS-CoV-2 inactivation) applications[29](index=29&type=chunk)[31](index=31&type=chunk)[33](index=33&type=chunk) - Silicon nitride is produced in various forms, including solid, porous, powder, composites, and coatings, enabling diverse applications[37](index=37&type=chunk)[40](index=40&type=chunk) - In 2021, SINTX entered the ceramic armor market by acquiring B4C, LLC assets and establishing SINTX Armor, Inc. for boron carbide and composite armor development[32](index=32&type=chunk)[44](index=44&type=chunk) - The company relies on fourteen U.S. patents, trade secrets, and know-how, with the core patent expiring in June 2022 and newer patents focusing on antibacterial properties[56](index=56&type=chunk)[57](index=57&type=chunk)[60](index=60&type=chunk) - Medical device products are subject to extensive FDA regulation in the U.S., requiring 510(k) clearance or PMA, and international compliance like the EU CE Mark[73](index=73&type=chunk)[74](index=74&type=chunk)[83](index=83&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including persistent net losses, heavy reliance on CTL Medical, intense competition, regulatory hurdles, capital needs, and Nasdaq delisting concerns - The company has a history of net losses, with **$8.8 million** in 2021 and **$7.0 million** in 2020, and an accumulated deficit of **$249.9 million** as of December 31, 2021[109](index=109&type=chunk) - A significant portion of revenue depends on CTL Medical's sales of spinal fusion products, with no minimum purchase obligations under their 10-year agreement[113](index=113&type=chunk)[118](index=118&type=chunk) - The company faces intense competition from larger orthopedic companies like Medtronic, DePuy Synthes, and Stryker, possessing greater financial resources[114](index=114&type=chunk)[115](index=115&type=chunk) - Additional financing is required to fund product development and commercialization; failure to secure it could lead to program delays or elimination[139](index=139&type=chunk) - The company lacks patent protection for the composition of matter of its solid silicon nitride, potentially allowing competitors to develop similar formulations[174](index=174&type=chunk) - On January 3, 2022, Nasdaq issued a delisting notice due to the stock price falling below **$1.00** for 30 consecutive days; failure to comply by July 5, 2022, could result in delisting[197](index=197&type=chunk) [Unresolved Staff Comments](index=45&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - Not applicable[200](index=200&type=chunk) [Properties](index=45&type=section&id=Item%202.%20Properties) SINTX Technologies operates two leased facilities in Salt Lake City, Utah: a 29,534 sq ft corporate/manufacturing site and a 10,936 sq ft Armor business facility - The company leases a **29,534 sq. ft.** corporate office and manufacturing facility in Salt Lake City, UT, with the lease expiring in December 2024[201](index=201&type=chunk) - A separate **10,936 sq. ft.** facility is leased in Salt Lake City, UT, for the Armor business, with its lease expiring in October 2031[201](index=201&type=chunk) [Legal Proceedings](index=45&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is currently not a party to any material legal proceedings[203](index=203&type=chunk) [Mine Safety Disclosures](index=45&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - This item does not apply to the company's business[204](index=204&type=chunk) [PART II](index=46&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=46&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on NASDAQ under 'SINT', experiencing price volatility, with no history or future plans for cash dividends - The company's common stock trades on The NASDAQ Capital Market under the symbol **"SINT"**[207](index=207&type=chunk) Quarterly High and Low Stock Prices (2021) | Quarter | High ($) | Low ($) | | :--- | :--- | :--- | | First | 3.44 | 1.51 | | Second | 2.06 | 1.23 | | Third | 2.04 | 1.22 | | Fourth | 1.36 | 0.59 | - The company has not declared or paid dividends since inception and does not plan to pay cash dividends in the foreseeable future[209](index=209&type=chunk) [Selected Financial Data](index=46&type=section&id=Item%206.%20Selected%20Financial%20Data) This item is not applicable as the company qualifies as a smaller reporting company - Not applicable[210](index=210&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=47&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) SINTX reported an increased net loss of **$8.8 million** in 2021, driven by higher R&D and sales/marketing expenses, with cash decreasing to **$14.3 million**, though management expects sufficient capital through March 2023 Results of Operations (in thousands) | | 2021 | 2020 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Product revenue | $606 | $594 | $12 | 2% | | Gross profit | $157 | $119 | $38 | 32% | | Research and development | $5,886 | $4,808 | $1,078 | 22% | | General and administrative | $3,603 | $3,132 | $471 | 15% | | Sales and marketing | $1,288 | $683 | $605 | 89% | | Loss from operations | $(10,620) | $(8,504) | $(2,116) | 25% | | Net loss | $(8,775) | $(7,029) | $(1,746) | 25% | - R&D expenses increased by **$1.1 million** (**22%**) due to heightened activity in developing new technologies and products[233](index=233&type=chunk) - Sales and marketing expenses rose by **$0.6 million** (**89%**) due to increased efforts to generate interest in potential new product lines[235](index=235&type=chunk) - The company's continuation as a going concern depends on increasing sales or raising additional capital; management believes existing capital is sufficient through March 2023[239](index=239&type=chunk)[245](index=245&type=chunk) Cash Flow Summary (in thousands) | | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,132) | $(9,112) | | Net cash provided by (used in) investing activities | $(1,651) | $1,751 | | Net cash provided by financing activities | $705 | $30,925 | - Cash from financing activities significantly decreased from **$30.9 million** in 2020 to **$0.7 million** in 2021, reflecting reduced capital raising efforts[251](index=251&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=58&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable to the company - Not applicable[276](index=276&type=chunk) [Financial Statements and Supplementary Data](index=58&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section includes audited consolidated financial statements and Tanner LLC's unqualified report, highlighting warrant valuation as a critical audit matter due to complex judgments - The consolidated financial statements are included at the end of the report, beginning on page F-1[277](index=277&type=chunk) - Tanner LLC's independent auditor's report identified the valuation of warrants as derivative liabilities as a Critical Audit Matter due to complex fair value estimation judgments[389](index=389&type=chunk)[390](index=390&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=58&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants regarding accounting and financial disclosure - None[278](index=278&type=chunk) [Controls and Procedures](index=58&type=section&id=Item%209A.%20Controls%20and%20Procedures) As of December 31, 2021, management concluded that the company's disclosure controls and internal control over financial reporting were effective - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2021[280](index=280&type=chunk) - Based on the COSO framework, management determined the company's internal control over financial reporting was effective as of December 31, 2021[285](index=285&type=chunk)[286](index=286&type=chunk) [Other Information](index=59&type=section&id=Item%209B.%20Other%20Information) There is no information to report under this item - None[288](index=288&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.](index=59&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections.) This item is not applicable to the company - None[289](index=289&type=chunk) [PART III](index=60&type=section&id=PART%20III) [Directors, Executive Officers and Corporate Governance](index=60&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The company's five-member Board, with four independent directors and a staggered structure, maintains three independent committees and has adopted a Code of Business Conduct - The Board of Directors comprises five members, including B. Sonny Bal, M.D. as Chairman, President, and CEO[292](index=292&type=chunk) - The Board is divided into three staggered classes, with four of the five directors deemed independent under Nasdaq rules[308](index=308&type=chunk)[309](index=309&type=chunk) - The Board maintains three permanent committees—Audit, Compensation, and Governance and Nominating—all composed of independent directors[310](index=310&type=chunk)[312](index=312&type=chunk) - The company has adopted a Code of Business Conduct, available on its website[321](index=321&type=chunk) [Executive Compensation](index=66&type=section&id=Item%2011.%20Executive%20Compensation) This section details executive compensation, including CEO B. Sonny Bal's **$483,087** total compensation in 2021, 401(k) matching, and change-in-control severance provisions 2021 Summary Compensation Table | Name and Principal Position | Year | Salary ($) | Bonus ($) | Option Awards ($) | Total Compensation ($) | | :--- | :--- | :--- | :--- | :--- | :--- | | B. Sonny Bal, CEO | 2021 | 400,000 | 40,989 | 38,291 | 483,087 | | David O'Brien, COO | 2021 | 300,000 | 25,279 | 28,053 | 370,219 | - Upon a qualifying termination following a change in control, executives receive a lump sum payment equal to two times their highest annual salary (including bonus) and full vesting of all outstanding equity awards[332](index=332&type=chunk) - The company offers a 401(k) plan with a company match on employee contributions[329](index=329&type=chunk) 2021 Non-Employee Director Compensation | Name | Fees Earned or Paid in Cash ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | | David W. Truetzel | 120,500 | 30,520 | 151,020 | | Jeffrey S. White | 40,500 | 30,520 | 71,020 | | Eric A. Stookey | 40,000 | 30,520 | 70,520 | | Mark Froimson | 40,500 | 29,762 | 70,262 | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=71&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 1, 2022, the company had **24,713,574** common shares outstanding, with no known 5% beneficial owners and management collectively owning approximately **2%** - As of March 1, 2022, **24,713,574** shares of common stock were issued and outstanding[352](index=352&type=chunk) - No stockholders are known by the company to beneficially own more than **5%** of its common stock[355](index=355&type=chunk) - All executive officers and directors as a group beneficially own **484,853** shares, representing approximately **2%** of the outstanding common stock[355](index=355&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=72&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company has not engaged in material related party transactions since 2022, excluding standard compensation, and has a policy for Audit Committee review and approval - No material related party transactions have occurred since January 1, 2022, other than standard compensation and indemnification agreements for directors and officers[356](index=356&type=chunk) - The company has a policy requiring Audit Committee review, approval, or ratification of all related party transactions[357](index=357&type=chunk) [Principal Accountant Fees and Services](index=73&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Tanner LLC served as the principal accounting firm, with total fees of **$165,423** in 2021 and **$312,152** in 2020, and all services pre-approved by the Audit Committee Principal Accountant Fees (in thousands) | | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | Audit fees | $127,064 | $163,434 | | Audit related fees | $38,359 | $148,718 | | **Total Fees** | **$165,423** | **$312,152** | - The Audit Committee's charter requires pre-approval of all audit and non-audit services provided by the independent auditors[365](index=365&type=chunk) [PART IV](index=74&type=section&id=PART%20IV) [Exhibits and Financial Statement Schedules](index=74&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section indexes consolidated financial statements and lists all exhibits, including key agreements like the CTL Medical Asset Purchase Agreement and corporate governance documents - This item references the Index to Consolidated Financial Statements, beginning on page F-1[367](index=367&type=chunk) - An extensive list of exhibits is provided, including key agreements like the Asset Purchase Agreement with CTL Medical, corporate governance documents, and financing agreements[370](index=370&type=chunk)[372](index=372&type=chunk)[374](index=374&type=chunk) [Form 10-K Summary](index=80&type=section&id=Item%2016.%20Form%2010-K%20Summary) There is no summary provided under this item - None[376](index=376&type=chunk)

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, 2021 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 incorp ...

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 June 30, 2021 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 incorporati ...

[Part I. Financial Information](index=3&type=section&id=Part%20I.%20Financial%20Information) [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents SINTX Technologies' unaudited condensed consolidated financial statements for Q1 2021 and 2020, including balance sheets, statements of operations, stockholders' equity, and cash flows, with detailed notes on accounting policies and financial disclosures [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(unaudited)) Total assets decreased from **$30.4 million** at December 31, 2020, to **$28.7 million** at March 31, 2021, while total liabilities slightly increased and stockholders' equity decreased | Metric (in thousands) | March 31, 2021 | December 31, 2020 | | :-------------------- | :------------- | :---------------- | | Total Assets | $28,685 | $30,447 | | Total Liabilities | $5,087 | $4,643 | | Total Stockholders' Equity | $23,598 | $25,804 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(unaudited)) SINTX Technologies reported a **net loss of $2.6 million** for Q1 2021, a significant decline from **net income of $1.2 million** in the prior-year period, driven by a 51% decrease in product revenue, increased operating expenses, and sharply lower other income | Metric (in thousands) | 3 Months Ended March 31, 2021 | 3 Months Ended March 31, 2020 | Change ($) | Change (%) | | :-------------------- | :---------------------------- | :---------------------------- | :--------- | :--------- | | Product Revenue | $101 | $207 | $(106) | -51% | | Gross Profit | $40 | $41 | $(1) | -2% | | Total Operating Expenses | $2,881 | $1,895 | $986 | 52% | | Loss from Operations | $(2,841) | $(1,854) | $(987) | 53% | | Other Income, Net | $208 | $3,023 | $(2,815) | -93% | | Net Income (Loss) | $(2,633) | $1,169 | $(3,802) | -325% | | Basic EPS | $(0.11) | $0.19 | $(0.30) | -158% | | Diluted EPS | $(0.11) | $(0.37) | $0.26 | -70% | [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(unaudited)) Total stockholders' equity decreased from **$25.8 million** at December 31, 2020, to **$23.6 million** at March 31, 2021, primarily due to a net loss, partially offset by stock-based compensation and warrant exercises | Metric (in thousands) | December 31, 2020 | March 31, 2021 | Change | | :-------------------- | :---------------- | :------------- | :----- | | Common Stock (shares) | 24,552,409 | 24,684,574 | 132,165 | | Common Stock (amount) | $245 | $247 | $2 | | Additional Paid-In Capital | $266,666 | $267,091 | $425 | | Accumulated Deficit | $(241,107) | $(243,740) | $(2,633) | | Total Equity | $25,804 | $23,598 | $(2,206) | - Stock-based compensation contributed **$36 thousand** to equity, and warrant exercises for cash added **$196 thousand**[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(unaudited)) The company experienced a **net decrease in cash and cash equivalents of $1.9 million** for Q1 2021, compared to a **net increase of $6.4 million** in the prior-year period, primarily due to a significant reduction in cash provided by financing activities | Metric (in thousands) | 3 Months Ended March 31, 2021 | 3 Months Ended March 31, 2020 | Change ($) | | :-------------------- | :---------------------------- | :---------------------------- | :--------- | | Net Cash Used in Operating Activities | $(2,992) | $(3,398) | $406 | | Net Cash Provided by Investing Activities | $406 | $396 | $10 | | Net Cash Provided by Financing Activities | $706 | $9,439 | $(8,733) | | Net Increase (Decrease) in Cash | $(1,880) | $6,437 | $(8,317) | | Cash and Cash Equivalents at End of Period | $23,471 | $8,224 | $15,247 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) These notes provide detailed information supporting the condensed consolidated financial statements, covering the company's organization, significant accounting policies, liquidity, capital resources, and specific financial statement line items [1. Organization and Summary of Significant Accounting Policies](index=9&type=section&id=1.%20Organization%20and%20Summary%20of%20Significant%20Accounting%20Policies) SINTX Technologies, Inc. is an OEM ceramics company focused on developing and commercializing silicon nitride for medical and non-medical applications, serving as an exclusive OEM provider for CTL Medical after selling its retail spine business in 2018 - SINTX Technologies, Inc. (formerly Amedica Corporation) was incorporated in Delaware on **December 10, 1996**[19](index=19&type=chunk) - The company is an OEM ceramics company specializing in silicon nitride for medical and non-medical applications, serving as CTL Amedica's exclusive OEM provider for silicon nitride spinal implants[19](index=19&type=chunk)[22](index=22&type=chunk) - In **October 2018**, the company sold its retail spine business to CTL Medical, retaining manufacturing, R&D, and IP for core silicon nitride biomaterial technology[20](index=20&type=chunk) [2. Basic and Diluted Net Income (Loss) per Common Share](index=12&type=section&id=2.%20Basic%20and%20Diluted%20Net%20Income%20(Loss)%20per%20Common%20Share) For Q1 2021, basic and diluted net loss per share were both **$(0.11)**, with no dilutive effect due to the net loss, contrasting with Q1 2020's basic net income per share of **$0.19** and diluted net loss per share of **$(0.37)** | Metric | 3 Months Ended March 31, 2021 | 3 Months Ended March 31, 2020 | | :-------------------------------- | :---------------------------- | :---------------------------- | | Basic Net Income (Loss) per Share | $(0.11) | $0.19 | | Diluted Net Loss per Share | $(0.11) | $(0.37) | | Basic Weighted Average Shares Outstanding | 24,668,106 | 6,020,889 | | Diluted Weighted Average Shares Outstanding | 24,668,106 | 8,035,392 | - For Q1 2021, there was no difference between basic and diluted shares due to the anti-dilutive effect of the net loss[39](index=39&type=chunk) [3. Inventories](index=13&type=section&id=3.%20Inventories) Total inventories increased slightly from **$487 thousand** at December 31, 2020, to **$515 thousand** at March 31, 2021, with raw materials constituting the largest portion and most inventories classified as long-term | Inventory Type (in thousands) | March 31, 2021 | December 31, 2020 | | :---------------------------- | :------------- | :---------------- | | Raw materials | $407 | $388 | | WIP | $106 | $97 | | Finished goods | $2 | $2 | | Total Inventories | $515 | $487 | - As of March 31, 2021, approximately **$0.1 million** of inventories were current, and **$0.4 million** were long-term[41](index=41&type=chunk) [4. Intangible Assets](index=13&type=section&id=4.%20Intangible%20Assets) Intangible assets, primarily trademarks, remained stable at **$35 thousand** net of accumulated amortization as of March 31, 2021, with consistent amortization expense of approximately **$1.3 thousand** for both periods | Metric (in thousands) | March 31, 2021 | December 31, 2020 | | :-------------------- | :------------- | :---------------- | | Trademarks | $50 | $50 | | Accumulated Amortization | $(15) | $(14) | | Net Intangible Assets | $35 | $36 | - Amortization expense for intangible assets was approximately **$1.3 thousand** for both the three months ended March 31, 2021, and 2020[42](index=42&type=chunk) [5. Fair Value Measurements](index=14&type=section&id=5.%20Fair%20Value%20Measurements) The fair value of common stock warrants, classified as Level 3 derivative liabilities, increased from **$1.238 million** at December 31, 2020, to **$1.285 million** at March 31, 2021, with valuation based on the Monte Carlo Simulation - Common stock warrants are classified as **Level 3 derivative liabilities** and are re-measured to fair value each reporting period[43](index=43&type=chunk)[45](index=45&type=chunk) Derivative Liability (in thousands) | Metric (in thousands) | March 31, 2021 | December 31, 2020 | | :-------------------- | :------------- | :---------------- | | Derivative liability (Common stock warrants) | $1,285 | $1,238 | - The valuation of common stock warrant liability uses the Monte Carlo Simulation, with key assumptions including risk-free interest rates (**0.05%-0.70%** for March 2021) and expected volatility (**137.8%-178.1%** for March 2021)[45](index=45&type=chunk)[46](index=46&type=chunk) [6. Accrued Liabilities](index=16&type=section&id=6.%20Accrued%20Liabilities) Accrued liabilities increased from **$909 thousand** at December 31, 2020, to **$1.086 million** at March 31, 2021, primarily driven by an increase in payroll and related expenses | Accrued Liability Type (in thousands) | March 31, 2021 | December 31, 2020 | | :------------------------------------ | :------------- | :---------------- | | Payroll and related expense | $690 | $600 | | Other | $396 | $309 | | Total Accrued Liabilities | $1,086 | $909 | [7. Debt](index=16&type=section&id=7.%20Debt) The company received forgiveness for its **$0.4 million 2020 PPP Loan** in January 2021 and secured a new **$0.5 million 2021 PPP Loan** in March 2021 with a 1.0% interest rate, maturing in March 2026, which may also be forgiven - The **$0.4 million 2020 PPP Loan** was forgiven on **January 5, 2021**, and recorded as other income[50](index=50&type=chunk) - A new **$0.5 million 2021 PPP Loan** was received on **March 15, 2021**, with a **1.0% interest rate** and a five-year term, potentially eligible for forgiveness[51](index=51&type=chunk)[52](index=52&type=chunk) [8. Equity](index=17&type=section&id=8.%20Equity) In February 2021, the company entered into a new Equity Distribution Agreement to sell up to **$15.0 million** of common stock through an at-the-market offering, and during Q1 2021, issued **130,275 shares** for **$0.2 million** cash from warrant exercises - On **February 25, 2021**, SINTX entered into a new Equity Distribution Agreement to sell up to **$15.0 million** of common stock via an at-the-market offering, with no sales as of March 31, 2021[54](index=54&type=chunk)[55](index=55&type=chunk) - During Q1 2021, **130,275 common shares** were issued from cash warrant exercises, generating **$0.2 million**, and **1,890 shares** from cashless warrant exercises[58](index=58&type=chunk) - In **February 2020**, a rights offering generated **$9.4 million gross proceeds** from units of convertible preferred stock and warrants, and in **June-August 2020**, four registered direct offerings issued **11,015,000 common shares** for **$20.9 million gross proceeds**[56](index=56&type=chunk)[59](index=59&type=chunk)[60](index=60&type=chunk)[61](index=61&type=chunk) [9. Stock-Based Compensation](index=19&type=section&id=9.%20Stock-Based%20Compensation) As of March 31, 2021, the company had **833,893 stock options** outstanding with a weighted-average exercise price of **$3.98**, and granted **368,500 options** in Q1 2021 with an estimated fair value of approximately **$0.6 million** | Metric | March 31, 2021 | December 31, 2020 | | :-------------------------------- | :------------- | :---------------- | | Options Outstanding | 833,893 | 465,393 | | Weighted Average Exercise Price | $3.98 | $5.53 | | Weighted Average Remaining Contractual Life (Years) | 9.4 | 9.3 | - **368,500 stock options** were granted in Q1 2021, with an estimated fair value of approximately **$0.6 million**[62](index=62&type=chunk) Unrecognized Stock-Based Compensation (in thousands) | Unrecognized Stock-Based Compensation (in thousands) | Amount | Weighted Average Remaining Recognition Period (in years) | | :--------------------------------------------------- | :----- | :------------------------------------------------------- | | Stock options | $779 | 2.5 | | Stock grants | $17 | 2.1 | [10. Commitments and Contingencies](index=20&type=section&id=10.%20Commitments%20and%20Contingencies) The company has executive agreements for change-in-control payments and accelerated vesting of stock options, and management believes potential liabilities from ordinary course legal proceedings will not materially affect its financial position - Executive agreements include payments and accelerated stock option vesting upon a change in control[66](index=66&type=chunk) - Management believes potential liabilities from ordinary course legal proceedings will not materially affect financial position, operating results, or cash flows[67](index=67&type=chunk) [11. Note Receivable](index=20&type=section&id=11.%20Note%20Receivable) The company holds a **$6.0 million noninterest-bearing note receivable** from CTL Medical, maturing **October 1, 2021**, with a net carrying value of **$1.3 million** as of March 31, 2021, and expected cash proceeds of **$1.4 million** for the remaining term - A **$6.0 million noninterest-bearing note receivable** from CTL Medical matures on **October 1, 2021**[68](index=68&type=chunk) Note Receivable Metrics (in thousands) | Metric (in thousands) | March 31, 2021 | | :-------------------- | :------------- | | Net Carrying Value | $1,300 | | Expected Cash Proceeds (remaining 7 months) | $1,400 | [12. Leases](index=21&type=section&id=12.%20Leases) The company leases office, warehouse, and manufacturing space under an operating lease extended through 2024, with both the operating lease right-of-use asset and liability approximately **$1.8 million** as of March 31, 2021, and a weighted-average discount rate of **6.5%** - The company leases office, warehouse, and manufacturing space under an operating lease extended through **2024**[70](index=70&type=chunk) Operating Lease Metrics (in thousands) | Metric (in thousands) | March 31, 2021 | | :-------------------- | :------------- | | Operating Lease Right-of-Use Asset | $1,819 | | Operating Lease Liability | $1,782 | | Current Portion of Operating Lease Liability | $413 | | Long-Term Portion of Operating Lease Liability | $1,369 | | Weighted-Average Discount Rate | 6.5% | - Non-cash operating lease expense for Q1 2021 was approximately **$0.1 million**[70](index=70&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of SINTX Technologies' business as an advanced materials company focused on silicon nitride, details its financial results, analyzes Q1 2021 operating performance, and discusses liquidity, capital resources, and COVID-19 impact [Overview](index=22&type=section&id=Overview) SINTX Technologies is an advanced materials company developing and commercializing silicon nitride for medical and non-medical applications, leveraging its unique properties and expanding into new markets beyond spinal fusion, including anti-viral applications - SINTX Technologies develops and commercializes silicon nitride for medical and non-medical applications, highlighting its properties for human implantation (bone ingrowth, infection resistance, strength)[74](index=74&type=chunk) - Independent study showed silicon nitride inactivates **SARS-CoV-2 virus within a minute**, opening opportunities for anti-viral applications in products like face masks, PPE, and high-contact surfaces[75](index=75&type=chunk) - The company is the first to commercialize silicon nitride medical implants and, after selling its spine business to CTL Amedica in 2018, now focuses on OEM and private label partnerships for various markets (e.g., hip/knee replacements, dental, aerospace, antipathogenic applications)[76](index=76&type=chunk)[77](index=77&type=chunk)[78](index=78&type=chunk) [Components of our Results of Operations](index=23&type=section&id=Components%20of%20our%20Results%20of%20Operations) The company operates as a single reportable segment, deriving product revenue primarily from spinal fusion products sold to CTL, with gross profit margins expected to decrease due to a focus on OEM and private label partnerships, and R&D expenses anticipated to increase with new product development - The company operates within **one reportable segment**[81](index=81&type=chunk) - Product revenue is primarily from manufacturing and selling spinal fusion products to CTL under a **10-year exclusive sales agreement**[83](index=83&type=chunk) - Gross profit percentage is expected to decrease due to expansion through OEM and private label partnerships, which offer lower margins than retail sales[86](index=86&type=chunk) - Research and development costs are expensed as incurred and are expected to increase with the development of new products for various applications (e.g., total joint replacements, dental, antipathogenic)[87](index=87&type=chunk)[88](index=88&type=chunk) [Results of Operations](index=25&type=section&id=RESULTS%20OF%20OPERATIONS) For Q1 2021, SINTX Technologies reported a **net loss of $2.6 million**, a significant decline from **net income of $1.2 million** in Q1 2020, primarily due to a **51% decrease in product revenue**, a **52% increase in total operating expenses**, and a **93% decrease in other income** | Metric (in thousands) | 3 Months Ended March 31, 2021 | 3 Months Ended March 31, 2020 | $ Change | % Change | | :-------------------- | :---------------------------- | :---------------------------- | :------- | :------- | | Product Revenue | $101 | $207 | $(106) | -51% | | Costs of Revenue | $61 | $166 | $(105) | -63% | | Gross Profit | $40 | $41 | $(1) | -2% | | Research and Development | $1,595 | $994 | $601 | 60% | | General and Administrative | $1,000 | $764 | $236 | 31% | | Sales and Marketing | $286 | $137 | $149 | 109% | | Total Operating Expenses | $2,881 | $1,895 | $986 | 52% | | Loss from Operations | $(2,841) | $(1,854) | $(987) | 53% | | Other Income, Net | $208 | $3,023 | $(2,815) | -93% | | Net Income (Loss) | $(2,633) | $1,169 | $(3,802) | -325% | - Product revenue decreased by **51%** due to fewer orders from CTL Amedica[92](index=92&type=chunk) - Gross profit remained essentially unchanged despite decreased revenue and costs, attributed to new revenue sources with higher profit margins[93](index=93&type=chunk) - Other income decreased by **93%** primarily due to a **$4.4 million** change in fair value of derivative liabilities in 2020, partially offset by **$0.4 million** from 2020 PPP Loan forgiveness in 2021[98](index=98&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company continues to operate as a going concern, despite incurring a **net loss of $2.6 million** and using **$3.0 million** in cash from operations in Q1 2021, contributing to an accumulated deficit of **$243.7 million**, but management projects sufficient capital for the next 12 months - The company's ability to continue as a going concern relies on increasing sales and/or raising additional capital[101](index=101&type=chunk) - Management believes existing capital resources, including a **$15.0 million Equity Distribution Agreement** and **$1.4 million** from a note receivable, will fund operations for at least the next **12 months** (through May 2022)[105](index=105&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) - The company is actively generating scientific and clinical data to support sales efforts and is expanding its sales strategy beyond spinal fusion to other silicon nitride applications, including potential anti-viral products[102](index=102&type=chunk) [Cash Flows](index=28&type=section&id=Cash%20Flows) Net cash used in operating activities decreased by **$0.4 million** to **$3.0 million** in Q1 2021, while net cash provided by financing activities significantly decreased by **$8.7 million** to **$0.7 million**, mainly due to the absence of large rights offerings seen in Q1 2020 | Cash Flow Activity (in thousands) | 3 Months Ended March 31, 2021 | 3 Months Ended March 31, 2020 | Change ($) | | :-------------------------------- | :---------------------------- | :---------------------------- | :--------- | | Net Cash Used in Operating Activities | $(2,992) | $(3,398) | $406 | | Net Cash Provided by Investing Activities | $406 | $396 | $10 | | Net Cash Provided by Financing Activities | $706 | $9,439 | $(8,733) | - Decrease in cash used in operating activities was primarily due to a **$0.7 million** decrease in cash used in accounts payable, offset by increases in prepaid expenses and accounts receivable[110](index=110&type=chunk) - The significant decrease in financing cash flow was due to **$9.4 million** from rights offerings in 2020, partially offset by **$0.5 million** from a PPP loan and **$0.2 million** from warrant exercises in 2021[112](index=112&type=chunk) [Indebtedness](index=28&type=section&id=Indebtedness) The company's **$0.4 million 2020 PPP Loan** was forgiven in January 2021, and a new **$0.5 million 2021 PPP Loan** was secured in March 2021 with a **1.0% interest rate**, maturing in March 2026, and is also eligible for forgiveness - The **$0.4 million 2020 PPP Loan** was forgiven on **January 5, 2021**[113](index=113&type=chunk) - A new **$0.5 million 2021 PPP Loan** was received on **March 15, 2021**, with a **1.0% interest rate** and a five-year term, subject to forgiveness conditions[114](index=114&type=chunk)[115](index=115&type=chunk) [Off-Balance Sheet Arrangements](index=29&type=section&id=Off-Balance%20Sheet%20Arrangements) The company has no off-balance sheet arrangements as defined by SEC regulations - The company does not have any off-balance sheet arrangements[116](index=116&type=chunk) [Critical Accounting Policies and Estimates](index=29&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) There have been no material changes to the company's critical accounting policies and estimates for Q1 2021, which include judgments and assumptions regarding income taxes, contingencies, valuation of derivative liabilities, asset impairment, and accounts receivable collectability - No material changes to critical accounting policies and estimates for Q1 2021[117](index=117&type=chunk) - Significant estimates include accounting for income taxes, contingencies, valuation of derivative liabilities, asset impairment, and collectability of accounts receivable[117](index=117&type=chunk) [New Accounting Pronouncements](index=29&type=section&id=New%20Accounting%20Pronouncements) Information on new accounting pronouncements is discussed in Note 1 to the Condensed Consolidated Financial Statements - New accounting pronouncements are discussed in **Note 1** of the financial statements[118](index=118&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable to the company - Not applicable[119](index=119&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) The CEO and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2021, with no material changes in internal control over financial reporting during Q1 2021 - Disclosure controls and procedures were effective as of **March 31, 2021**, as concluded by the CEO (principal executive and financial officer)[122](index=122&type=chunk)[136](index=136&type=chunk) - No material changes in internal control over financial reporting occurred during Q1 2021[124](index=124&type=chunk) [Part II. Other Information](index=30&type=section&id=Part%20II.%20Other%20Information) [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not aware of any pending or threatened legal proceedings that could materially affect its business, operating results, or financial condition, though it may be involved in various legal proceedings in the ordinary course of business - No material pending or threatened legal proceedings are known[125](index=125&type=chunk) - The medical device industry is characterized by frequent claims and litigation, and the company may be involved in various additional legal proceedings from time to time[125](index=125&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2020 - No material changes to risk factors from the **2020 Annual Report on Form 10-K**[126](index=126&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report - None[127](index=127&type=chunk) [Item 3. Defaults Upon Senior Securities](index=30&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report - None[128](index=128&type=chunk) [Item 4. Mine Safety Disclosures](index=30&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[129](index=129&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) There is no other information to report under this item - None[130](index=130&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including a Patent License Agreement, Promissory Note, Equity Distribution Agreement, and various certifications - Key exhibits include a Patent License Agreement (**10.1**), Promissory Note (**10.2**), Equity Distribution Agreement (**10.3**), and CEO/PFO certifications (**31.1, 31.2, 32**)[132](index=132&type=chunk) [Signatures](index=32&type=section&id=Signatures) The report was signed on May 13, 2021, by B. Sonny Bal, Chief Executive Officer (Principal Executive Officer and Principal Financial Officer) of SINTX Technologies, Inc. - Report signed by **B. Sonny Bal**, CEO (Principal Executive Officer and Principal Financial Officer) on **May 13, 2021**[136](index=136&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K [X] Annual report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2020 or [ ] Transition report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from _______ to _________ Commission File No. 001-33624 SINTX Technologies, Inc. (Exact name of registrant as specified in its charter) Delaware 84-1375299 (State or other juris ...