Company Overview - SINTX Technologies has successfully implanted spinal implants made from silicon nitride in humans since 2008 across multiple regions including the US, Europe, Brazil, and Taiwan[30]. - The company acquired Technology Assessment and Transfer, Inc. (TA&T) in June 2022, enhancing its capabilities in transitioning advanced materials to commercial products, particularly in biomedical applications[32]. - SINTX has obtained AS9100D certification and ITAR registration to facilitate entry into the aerospace and protective armor markets[33]. - The company has signed a 10-year lease for a facility in Salt Lake City, Utah, to develop and manufacture high-performance ceramics for armor applications[34]. - The company has a total of fifteen issued U.S. patents and numerous pending applications, ensuring a strong intellectual property position[64]. - The company has entered the national stage in multiple countries including Australia, Brazil, Canada, China, Europe, India, Japan, South Korea, and Mexico to seek patent protection for various proprietary technologies related to antifungal applications and silicon nitride methods[74][75][76][77][78][79][80][81]. Product Development and Innovation - SINTX's silicon nitride products have demonstrated superior bone affinity, with in vivo studies showing that the force required to separate silicon nitride from surrounding bone is approximately three times that of PEEK and nearly two times that of titanium[44]. - The company has published over 130 peer-reviewed publications supporting the safety and efficacy of its silicon nitride products[45]. - The company has received NIH grants to develop 3D printed silicon nitride/polymer implantable medical devices, indicating ongoing innovation in product development[52]. - The company is developing female-specific torso plates for body armor, responding to increased demand for ceramic armor due to global conflicts[56]. - The company is developing new manufacturing technologies and product candidates, including ceramic armor products, to expand its product lines[140]. Financial Performance - As of December 31, 2023, the company reported a net loss of $8.3 million, compared to a net loss of $12.0 million for the year ended December 31, 2022, with an accumulated deficit of $270.7 million[127]. - The company had cash and cash equivalents of $3.3 million as of December 31, 2023, and raised approximately $3.7 million from a public offering in February 2024, expected to fund operations through the second quarter of 2024[122]. - The company has incurred substantial net losses since inception, with cash used in operations amounting to $14.1 million in 2023 and $10.3 million in 2022[127]. - The company has not declared or paid dividends since inception, intending to retain earnings for growth[217]. Market and Competition - The main competitors in the medical device market include Medtronic, DePuy Synthes, Stryker, and Zimmer Biomet, which have greater financial and technical resources[87][89]. - The orthopedic market is highly competitive, with major players like Medtronic and Stryker dominating, which presents challenges for the company in gaining market share[132]. - The company faces competition from alternatives to its silicon nitride biomaterial, including PEEK and traditional oxide ceramics, which are produced by competitors like Invibio and CeramTec[86]. - The company has limited market acceptance of its silicon nitride-based products, which may hinder revenue generation and necessitate additional financing[130]. Regulatory Compliance - Regulatory compliance is critical, as medical devices in the U.S. require either 510(k) clearance or PMA approval from the FDA before marketing[90][91]. - The PMA process is complex and can take several years, requiring extensive data to demonstrate safety and effectiveness[94]. - The company must adhere to post-marketing regulations, including compliance with quality system regulations and medical device reporting obligations[96][98]. - The European Union's CE Marking is mandatory for medical devices, certifying compliance with applicable directives for commercial distribution[100]. - The company must comply with various U.S. federal and state laws regarding healthcare fraud and abuse, which are enforced aggressively by agencies such as the U.S. Department of Justice[102]. Risks and Challenges - The company faces risks related to regulatory approvals for its product candidates, which could delay commercialization and revenue generation[123]. - The company is dependent on CTL for the sale of its spinal fusion products, and any failure in CTL's sales efforts could lead to a decline in revenues[131]. - The company relies on a limited number of third-party suppliers for key raw materials, which poses risks related to pricing, availability, and quality[139]. - The company may face significant civil, criminal, and administrative penalties if found in violation of healthcare laws, which could adversely affect its business operations and profits[168]. - The company may face product liability claims that exceed insurance coverage, potentially harming its financial condition and reputation[196]. Strategic Partnerships and Collaborations - The company has structured agreements with surgeons for product design assistance, which may involve royalty payments, but compliance with healthcare laws is critical to avoid regulatory scrutiny[103]. - The company seeks strategic partners for the development and commercialization of biomedical and antipathogenic product candidates, but has not yet secured agreements[141]. - Establishing OEM partnerships is part of the company's strategy, but it may lead to lower profitability and increased compliance costs[142]. Facilities and Operations - The company occupies a 30,764 square foot corporate office and manufacturing facility in Salt Lake City, Utah, with a lease expiring in December 2024[209]. - The company has a second facility of 10,936 square feet for its Armor business, with a lease expiring in October 2031[209]. - The company believes its existing facilities are adequate for current and projected needs for the foreseeable future[211].

Revenue Growth - For the three months ended September 30, 2023, total revenue increased by 59% to $678,000 compared to $426,000 in the same period in 2022[101] - Product revenue for the nine months ended September 30, 2023, increased by 82% to $643,000 compared to $354,000 in the same period in 2022[101] - Grant and contract revenue for the nine months ended September 30, 2023, increased by 145% to $1,082,000 compared to $442,000 in the same period in 2022[103] - Other income for the three months ended September 30, 2023, increased by 514% to $424,000 compared to $69,000 in the same period in 2022[113] Profit and Loss - Gross profit for the three months ended September 30, 2023, increased by 66% to $561,000 compared to $337,000 in the same period in 2022[101] - For the nine months ended September 30, 2023, the company incurred a net loss of $5.9 million, an improvement from a net loss of $8.1 million in the same period of 2022[116] - The accumulated deficit as of September 30, 2023, was $268.4 million, up from $262.5 million as of December 31, 2022[116] Expenses - Research and development expenses for the three months ended September 30, 2023, increased by 66% to $2,525,000 compared to $1,523,000 in the same period in 2022[106] - General and administrative expenses for the nine months ended September 30, 2023, increased by 14% to $3,313,000 compared to $2,918,000 in the same period in 2022[109] - Cash used in operating activities increased to $11.0 million for the nine months ended September 30, 2023, compared to $8.1 million for the same period in 2022, reflecting a $2.8 million increase[126] Financing Activities - The company raised approximately $12.0 million in gross proceeds from a public offering on February 10, 2023, with $5.4 million allocated to common stock and pre-funded warrants[119] - Net cash provided by financing activities was $11.4 million during the nine months ended September 30, 2023, a significant increase from $0.5 million used in financing activities during the same period in 2022[128] Future Outlook and Strategy - The company expects to incur additional research and development costs as it continues to develop new medical devices and products for antipathogenic applications[99] - The acquisition of TA&T in June 2022 is expected to enhance the company's capabilities in transitioning advanced materials to commercial products[86] - The company is focusing on expanding the use of silicon nitride in areas beyond spinal fusion applications, including potential applications in personal protection products[117] - The company is actively generating scientific and clinical data to support sales efforts and is making changes to its sales strategy[117] Cash Flow - The company had a net cash decrease of $26,000 for the nine months ended September 30, 2023, compared to a net cash decrease of $9.5 million in the same period of 2022[124] - The company has an outstanding balance of $72,000 related to personal loans made by the founders, with repayments scheduled to end in August 2024[130] - The company’s ability to continue as a going concern is dependent on its ability to increase sales and/or raise additional funds through capital markets[116] Infrastructure Development - The company has signed a 10-year lease for a building near its headquarters to support the development and manufacturing of ceramic armor products[88]

Revenue Growth - For the three months ended June 30, 2023, product revenue increased by $155,000, or 194%, compared to the same period in 2022, totaling $235,000[93]. - Grant and contract revenue for the three months ended June 30, 2023, increased by $113,000, or 71%, totaling $273,000[94]. - Total revenue for the three months ended June 30, 2023, was $508,000, an increase of $268,000, or 112%, compared to the same period in 2022[93]. - For the six months ended June 30, 2023, total product revenue increased by $294,000, or 162%, totaling $475,000[95]. - Other income for the six months ended June 30, 2023, increased by $4.0 million, or 1305%, compared to the same period in 2022, primarily due to changes in the fair value of derivative liabilities[107]. Expenses - Gross profit for the three months ended June 30, 2023, increased by $230,000, or 132%, totaling $404,000[93]. - Research and development expenses for the three months ended June 30, 2023, increased by $672,000, or 46%, totaling $2,148,000[97]. - General and administrative expenses for the three months ended June 30, 2023, increased by $175,000, or 18%, totaling $1,168,000[99]. - Total operating expenses for the three months ended June 30, 2023, increased by $911,000, or 31%, totaling $3,868,000[93]. Net Loss - The net loss for the three months ended June 30, 2023, was $2,455,000, a decrease of $57,000, or 2%, compared to the same period in 2022[93]. - The company incurred a net loss of $2.7 million for the six months ended June 30, 2023, compared to a net loss of $5.4 million for the same period in 2022[109]. Cash Flow - Net cash used in operating activities was $8.1 million for the six months ended June 30, 2023, an increase of $2.4 million from $5.7 million used in the same period in 2022[118]. - Cash provided by financing activities was $11.5 million for the six months ended June 30, 2023, compared to $0.5 million used in financing activities during the same period in 2022[120]. Funding and Financial Position - The company raised approximately $12.0 million in gross proceeds from a public offering on February 10, 2023[112]. - The company had an accumulated deficit of $265.2 million as of June 30, 2023[109]. - The company’s ability to continue as a going concern is dependent on its ability to increase sales and/or raise additional funds through capital markets[109]. Strategic Focus - The acquisition of TA&T in mid-2022 contributed to increased research and development expenses and grant and contract revenue[97][105]. - The company is focusing on expanding the use of silicon nitride in personal protection products, which may enhance sales efforts[110]. Other Financial Information - The company has an outstanding balance of $107,000 related to personal loans made by the founders, to be repaid in monthly installments until August 2024[122]. - The company does not have any off-balance sheet arrangements as defined in Regulation S-K[125].

Financial Performance - For the three months ended March 31, 2023, total revenue increased to $539,000, a 318% increase compared to $129,000 in the same period in 2022[90] - Product revenue rose to $240,000, reflecting a 138% increase from $101,000 in the same period last year[90] - Grant and contract revenue surged to $299,000, marking a 968% increase from $28,000 in the same period in 2022[90] - Gross profit for the three months ended March 31, 2023, was $421,000, a 759% increase compared to $49,000 in the same period in 2022[90] - The company incurred a net loss of $293,000 for the three months ended March 31, 2023, compared to a net loss of $2.85 million in the same period in 2022[90] Expenses - Research and development expenses increased to $2.2 million, a 33% rise from $1.65 million in the same period last year[90] - General and administrative expenses rose to $1.17 million, a 37% increase from $856,000 in the same period in 2022[90] Other Income - Other income increased significantly to $3.26 million, a 9226% increase compared to $35,000 in the same period in 2022[90] Cash Flow - Net cash used in operating activities was $4.9 million for the three months ended March 31, 2023, an increase of $1.7 million compared to $3.2 million for the same period in 2022[108] - Cash provided by financing activities was $11.5 million for the three months ended March 31, 2023, compared to no cash provided during the same period in 2022[110] - The net cash used in investing activities remained unchanged at $0.2 million for the three months ended March 31, 2023, compared to the same period in 2022[109] Financing and Capital Resources - The Company closed a public offering of 2,150,000 units on February 10, 2023, generating gross proceeds of approximately $12.0 million[102] - The Company completed a rights offering on October 17, 2022, resulting in gross proceeds of approximately $4.7 million[103] - The Company does not currently seek additional equity or debt financing, and any future financing may not be available on favorable terms[105] - Management believes existing capital resources will be sufficient to fund operations for at least the next 12 months, through May 2024[106] Debt and Liabilities - The accumulated deficit as of March 31, 2023, was $262.7 million, slightly up from $262.5 million as of December 31, 2022[99] - The Business Loan of approximately $350,000 was paid in full during the first quarter of 2023, with no outstanding balance as of March 31, 2023[111] - As of March 31, 2023, related party debt had an outstanding balance of $150,000, being repaid in monthly installments until August 1, 2024[112] - The Company does not have any off-balance sheet arrangements[115] Strategic Focus - The company is focusing on expanding the use of silicon nitride in various applications, including personal protection products, to leverage its antiviral properties[100]

Company Overview - SINTX Technologies has successfully implanted spinal implants made from silicon nitride in humans since 2008 across multiple regions including the US, Europe, Brazil, and Taiwan[28]. - The company acquired Technology Assessment and Transfer, Inc. (TA&T) in June 2022, enhancing its capabilities in transitioning advanced materials to commercial products[30]. - SINTX has entered the ceramic armor market through the acquisition of assets from B4C, LLC, and a technology partnership with Precision Ceramics USA, focusing on high-performance ceramics for ballistic applications[32]. - The company operates a 30,000 square foot FDA registered and ISO 13485:2016 certified manufacturing facility, controlling the entire manufacturing process for its silicon nitride products[38]. - The company has published over 130 peer-reviewed publications supporting the safety and efficacy of its silicon nitride products and product candidates[45]. - The company has received three NIH grants in the last fifteen months to develop 3D printed silicon nitride/polymer implantable medical devices, showcasing its commitment to innovation[51]. - The company has eleven issued U.S. patents and eighteen pending U.S. non-provisional patent applications, indicating a strong intellectual property portfolio[62]. - The company has entered into a 10-year manufacturing and supply agreement with CTL for silicon nitride spinal fusion products, which significantly impacts revenue generation[135]. Product Development and Innovation - SINTX's silicon nitride has demonstrated superior osteointegration, with separation force required to detach from surrounding bone being approximately three times that of PEEK and nearly two times that of titanium[43]. - The company believes its silicon nitride is superior to other biomaterials in the spine implant market, promoting bone growth and offering resistance to bacterial and viral infections[41]. - The company has developed silicon nitride interbody spinal fusion devices that exhibit flexural strength over five times that of PEEK and compressive strength over twenty times that of PEEK, indicating superior performance[9]. - The company is developing implants with improved antibacterial characteristics and advanced performance features[81]. - The company is currently manufacturing silicon nitride interbody spinal fusion implants and aims to expand its product lines to include other advanced ceramic products for both medical and non-medical applications[141]. - The company is developing new manufacturing technologies and product candidates, including new ceramic armor products, to enhance commercialization efforts[141]. - The company is addressing the global need for pathogen protection by incorporating silicon nitride into products like face masks and wound care devices, targeting new markets following the discovery of its efficacy against SARS-CoV-2[225]. Market and Financial Performance - As of December 31, 2022, the company reported a net loss of $12.0 million, compared to a net loss of $9.3 million for the year ended December 31, 2021, resulting in an accumulated deficit of $262.5 million[126]. - The company had cash and cash equivalents of $6.2 million as of December 31, 2022, and raised approximately $10.9 million from a public offering in February 2023, which is expected to fund operations through the first quarter of 2025[118]. - The company incurred cash used in operations of $10.3 million for the year ended December 31, 2022, compared to $10.1 million for the year ended December 31, 2021[126]. - The company is dependent on CTL's ability to sell spinal fusion products, which account for a significant percentage of its revenues, and any failure in demand could materially harm its business[135]. - The company has limited committed sources of capital and may require additional financing to continue product development and commercialization efforts[118]. - The company has an accumulated deficit of $262.5 million as of December 31, 2022, indicating ongoing financial challenges[126]. Regulatory and Compliance Challenges - The FDA requires either 510(k) clearance or PMA approval for new medical devices, with a typical 510(k) review taking up to 90 days[85][88]. - The PMA process is more complex and can take several years, requiring extensive data to demonstrate safety and effectiveness[88]. - Compliance with regulatory requirements is critical, with potential sanctions including fines, product recalls, and operating restrictions[96]. - The company is subject to the federal Anti-Kickback Statute, which prohibits remuneration in exchange for referrals or recommendations related to services or products covered by federal healthcare programs[98]. - Recent enforcement efforts by government officials have focused on sales and marketing activities of healthcare companies, leading to significant fines and penalties for violations[99]. - The company must comply with various healthcare laws and regulations, which could expose it to penalties and reputational harm[172]. - The evolving nature of regulatory standards creates uncertainty regarding program profitability, particularly for aircraft engine products[160]. Competitive Landscape - The main competitors in the medical device market include Medtronic, DePuy Synthes, Stryker, and Zimmer Biomet, which have significantly greater resources[80]. - The orthopedic market is highly competitive, with significant challenges from larger, well-established companies, which could impact the company's market share and pricing strategies[131]. - The company faces risks related to competition, including the potential for competitors to develop superior technologies or products[160]. Intellectual Property and Legal Risks - The company has assigned 48 U.S. patents and 2 foreign patents to CTL Medical as part of the sale of its spine implant business[75]. - The company expects to rely on trade secrets and technological innovation to maintain its intellectual property position, which includes confidentiality agreements with partners and employees[77]. - The company has no patent protection for the composition of its solid silicon nitride, allowing competitors to create similar formulations[191]. - The medical device industry is characterized by extensive litigation over intellectual property rights, which could divert management's attention and resources[192]. - There is a risk of claims regarding ownership rights to inventions developed in collaboration with surgeon advisors, which could lead to substantial costs[195]. - SINTX may face product liability claims that exceed insurance coverage, potentially harming its financial condition[201]. Future Outlook and Strategic Initiatives - The company is seeking partnerships to utilize its capabilities in manufacturing products for medical OEM and private label partnerships, targeting markets such as foot and ankle, dental, and maxillofacial[51]. - The company anticipates that future healthcare legislation could reduce patient coverage and increase pricing pressure on its products[184]. - Changes in payment levels by state and federal healthcare programs could adversely impact the company's ability to market and sell its products[110]. - The company invests substantial amounts in research and development to pursue advancements in a wide range of technologies, products, and services[160].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 For the quarterly period ended September 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 incorporation or organization) Identification No.) 1885 West 2100 South, Salt Lake City, UT 84119 (Address of princip ...

Revenue Performance - For the three months ended June 30, 2022, total product revenue was $0.08 million, a decrease of 21% compared to $0.10 million in the same period of 2021[110] - Grant revenue for the three months ended June 30, 2022, was $0.16 million, representing a 100% increase as it did not exist in the same period of the prior year[110] - Total revenue for the three months ended June 30, 2022, was $0.24 million, an increase of 138% compared to $0.10 million in the same period of 2021[110] - Gross profit for the three months ended June 30, 2022, was $0.17 million, a significant increase of 521% from $0.028 million in the same period of 2021[110] - Other income for the three months ended June 30, 2022, increased by $0.11 million, or 65%, compared to the same period in 2021[121] Expenses - Research and development expenses for the three months ended June 30, 2022, increased by $0.27 million, or 23%, compared to the same period in 2021[115] - General and administrative expenses for the three months ended June 30, 2022, increased by $0.10 million, or 16%, compared to the same period in 2021[117] - Sales and marketing expenses for the six months ended June 30, 2022, increased by $0.12 million, or 19%, compared to the same period in 2021[118] - The company incurred grant expenses of $0.15 million for the three months ended June 30, 2022, which did not exist in the same period of 2021[119] Financial Position - For the six months ended June 30, 2022, the company incurred a net loss of $5.4 million, compared to a net loss of $4.8 million for the same period in 2021, representing an increase in loss of approximately 12.5%[124] - The accumulated deficit as of June 30, 2022, was $255.8 million, up from $250.4 million as of December 31, 2021, indicating a continued increase in losses[124] - The company has an accumulated deficit of $255.8 million as of June 30, 2022, raising substantial doubt about its ability to continue as a going concern[130] Cash Flow - The company used cash in operating activities of $5.7 million for the six months ended June 30, 2022, an increase of $0.4 million from $5.3 million used in the same period in 2021[134] - Net cash used in investing activities was $0.3 million for the six months ended June 30, 2022, a decrease of $1.8 million compared to $1.5 million provided in the same period in 2021[135] - Net cash used in financing activities was $0.5 million for the six months ended June 30, 2022, compared to $0.7 million provided in the same period in 2021, a decrease of $1.2 million[136] Future Outlook - The company expects product revenue to increase as it secures opportunities to manufacture third-party products and launches new products into the market[102] - The company is focusing on expanding the use of silicon nitride in areas outside of spinal fusion applications, with potential applications in personal protection products[125] - The company is actively seeking additional equity and/or debt financing, but such funding is not assured and may involve significant restrictive covenants[129] Other Information - The company has an outstanding balance of $48,707 on a revolving line of credit with Wells Fargo as of June 30, 2022[143] - The company has identified an error related to the removal of a loan obligation and recorded approximately $0.5 million of other income, which has been restated in the financial statements[132]

Revenue and Financial Performance - For the three months ended March 31, 2022, total revenue increased by 28% to $0.129 million compared to $0.101 million in the same period of 2021 [92]. - Grant revenue for the three months ended March 31, 2022, was $0.028 million, a 100% increase from zero in the same period of the prior year [93]. - The company incurred a net loss of $2.845 million for the three months ended March 31, 2022, compared to a net loss of $2.633 million in the same period of 2021, representing an 8% increase in loss [102]. - The accumulated deficit as of March 31, 2022, was $253.3 million, up from $250.4 million as of December 31, 2021 [102]. - Net cash used in operating activities was $3.2 million for the three months ended March 31, 2022, compared to $3.0 million for the same period in 2021, an increase of $0.2 million [112]. - The total decrease in cash for the three months ended March 31, 2022, was $3.4 million, compared to a decrease of $1.9 million for the same period in 2021 [111]. Expenses - Research and development expenses increased by $0.058 million, or 4%, to $1.653 million for the three months ended March 31, 2022, primarily due to price inflation [95]. - General and administrative expenses decreased by $0.144 million, or 14%, to $0.856 million for the three months ended March 31, 2022, due to reduced external consulting costs [96]. - Sales and marketing expenses increased by $0.108 million, or 38%, to $0.394 million for the three months ended March 31, 2022, driven by increased marketing activities [98]. Cash Flow and Financing - Net cash used in investing activities was $0.2 million for the three months ended March 31, 2022, a decrease of $0.6 million from $0.4 million provided in the same period in 2021 [113]. - There was no cash provided by financing activities during the three months ended March 31, 2022, compared to $0.7 million in the same period in 2021, a decrease of $0.7 million [114]. - The company identified an error related to the removal of a loan obligation and recorded approximately $0.5 million of other income, which affected the 2021 net loss attributable to common stockholders [110]. - The company received a 2021 PPP Loan of $0.5 million, which was forgiven, but later determined that the loan obligation should not have been removed from the financial statements [116][117]. Market and Product Development - The company is actively pursuing new markets for its silicon nitride products, including applications in personal protection products to inactivate viruses [103]. - SINTX Technologies has entered the ceramic armor market through asset purchases and technology partnerships, focusing on high-performance ceramics for ballistic applications [79]. - The company has a 10-year exclusive sales agreement with CTL for spinal fusion products, which is a key revenue source [83]. COVID-19 Impact - The company implemented protective measures in response to COVID-19, which may impact operations and liquidity [109]. - The company continues to assess the impact of COVID-19 on its operations and financial condition, which remains uncertain [109]. Accounting Policies - Significant accounting policies and estimates have not materially changed for the three months ended March 31, 2022 [120]. - The company has no off-balance sheet arrangements as defined in Regulation S-K [119].

[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)

Revenue Performance - For the three months ended September 30, 2021, product revenue was $0.24 million, an increase of 262% compared to $0.07 million in the same period of 2020[100]. - For the nine months ended September 30, 2021, total product revenue was $0.44 million, a decrease of 8% from $0.48 million in the same period of 2020[101]. - Other income for the three months ended September 30, 2021, increased by $0.5 million, or 4920%, compared to the same period in 2020[111]. Profitability and Loss - Gross profit for the three months ended September 30, 2021, was $0.05 million, representing a gross profit margin of 21%, compared to 20% in the same period of 2020[102]. - The company incurred a net loss of $7.2 million for the nine months ended September 30, 2021, compared to a net loss of $5.3 million for the same period in 2020[115]. - The company had an accumulated deficit of $248.3 million as of September 30, 2021[115]. Expenses - Research and development expenses for the three months ended September 30, 2021, increased by $0.2 million, or 12%, compared to the same period in 2020[105]. - General and administrative expenses for the three months ended September 30, 2021, increased by $0.1 million, or 13%, compared to the same period in 2020[107]. - Sales and marketing expenses for the three months ended September 30, 2021, increased by $0.2 million, or 86%, compared to the same period in 2020[109]. Cash Flow and Financing - Net cash used in operating activities was $7.7 million for the nine months ended September 30, 2021, an increase of $0.6 million compared to the same period in 2020[123]. - Net cash provided by financing activities decreased by $30.2 million to $0.7 million for the nine months ended September 30, 2021, primarily due to reduced proceeds from common stock offerings[125]. - The Company raised $9.4 million from a rights offering on February 6, 2020, and approximately $20.9 million from four registered direct offerings between June and August 2020[117]. - The Company sold 527,896 shares in 2019, raising approximately $1.7 million, and 354,381 shares in 2020, raising approximately $0.8 million[118]. - The Company has a $0.5 million PPP loan with a five-year term, maturing on March 15, 2026, at an interest rate of 1.0% per annum[127]. - Cash flows from investing activities were negative $1.1 million for the nine months ended September 30, 2021, compared to positive cash flows of $1.4 million in the same period in 2020[124]. Future Outlook and Operations - The company expects to incur additional research and development costs as it continues to develop new products, including antipathogenic products and armored plates from ceramic[96]. - The Company is focusing on expanding the use of silicon nitride in personal protection products, which may have anti-viral properties[116]. - The Company has concluded that its existing capital resources will be sufficient to fund operations for at least the next 12 months[120]. - The Company temporarily restricted access to its facility due to COVID-19, implementing protective measures to ensure employee safety[121]. - The Company has no off-balance sheet arrangements as defined in Regulation S-K[130].