Core Viewpoint - SINTX Technologies, Inc. has been awarded a $75,000 phase I SBIR contract by AFWERX to enhance the sinterability of complex-shaped 3D printed silicon nitride, addressing material challenges for high-temperature systems in the Department of the Air Force [1][2]. Group 1: Contract and Partnership - The contract awarded to SINTX's subsidiary, Technology Assessment and Transfer, Inc. (TA&T), is part of a 3-month initiative aimed at improving 3D printing capabilities for silicon nitride [1]. - If successful, TA&T/SINTX aims to secure a phase II contract from AFWERX worth up to $1.25 million over 21 months [2]. Group 2: Technical Focus and Market Strategy - Silicon nitride is recognized for its mechanical, thermal, and dielectric properties, making it suitable for applications in aeroengines and microwave-frequency apertures, which is a strategic focus for SINTX [3]. - The company is leveraging its expertise in ceramic 3D printing and past projects to enter the RF market, aiming to develop innovative capabilities that enhance U.S. defense [3][8]. Group 3: Industry Challenges and Expertise - The current effort addresses the challenges in producing silicon nitride parts that meet application-specific performance and repeatability, highlighting the unique technical difficulties in 3D printing this material compared to others like aluminum oxide [8]. - SINTX's extensive experience with silicon nitride and TA&T's expertise in ceramic 3D printing position the company favorably within the industry to tackle these challenges [8][13].

Core Insights - SINTX Technologies, Inc. has been awarded a $75,000 phase I Small Business Innovation Research (SBIR) contract by AFWERX to enhance the sinterability of complex-shaped 3D printed silicon nitride, addressing material challenges in high-temperature propulsion and guidance systems for the Department of the Air Force [1][7] - The company aims to leverage its extensive experience in silicon nitride manufacturing and ceramic additive manufacturing to enter the RF market, focusing on applications in aerospace and defense [2][3][8] Company Overview - SINTX Technologies is a leader in the manufacturing and supply of silicon nitride components, particularly for spinal fusion devices, and has expanded its focus to include aerospace, defense, and energy applications since 2018 [3][10] - The acquisition of Technology Assessment and Transfer, Inc. (TA&T) in 2022 has enhanced SINTX's capabilities in ceramic additive manufacturing, contributing to its strategic goals [3][10] Industry Context - Silicon nitride is recognized for its superior mechanical, thermal, and dielectric properties, making it suitable for applications in aeroengines and microwave-frequency technologies [2] - The current SBIR effort addresses the challenges of producing silicon nitride parts that meet application-specific performance and repeatability, highlighting the technical difficulties associated with 3D printing this material [8]

Core Insights - SINTX Technologies has entered a 5-year strategic agreement with Myosung Co., Ltd to expand its presence in the Korean market, focusing on technical ceramic products and services [1][2] - The partnership is expected to generate significant new business for SINTX, particularly in the medical technology sector, leveraging Myosung's established reputation and network in Korea [2] Company Overview - SINTX Technologies specializes in advanced ceramics, developing and commercializing materials for medical and technical applications, with a focus on silicon nitride [3] - The company has been a leader in the research and manufacturing of silicon nitride, with products implanted in humans since 2008 [3] - SINTX has utilized strategic acquisitions and alliances to enter new markets and has manufacturing facilities located in Utah and Maryland [3]

SALT LAKE CITY, May 23, 2024 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. (NASDAQ: SINT) today announced that its Board of Directors has declared a 1-for-200 reverse stock split of the company's common stock. The reverse stock split will become effective on May 28, 2024 (the "Effective Date") at 12:01 AM Eastern Time. The company's common stock is expected to begin trading on a split-adjusted basis when the markets open on May 28, 2024 under the current trading symbol "SINT." As a result of the reverse stoc ...

Core Points - SINTX Technologies, Inc. announced a 1-for-200 reverse stock split effective May 28, 2024, to comply with Nasdaq listing requirements [1][2] - The reverse stock split will reduce the number of issued and outstanding shares from approximately 123 million to about 0.6 million [4] - The reverse stock split will not affect the number of authorized shares or the par value of the common stock [2][3] Company Overview - SINTX Technologies specializes in advanced ceramics, focusing on materials and technologies for medical and technical applications [7] - The company is a leader in the research and manufacturing of silicon nitride, with products implanted in humans since 2008 [7] - SINTX has expanded into new markets through strategic acquisitions and alliances, with manufacturing facilities located in Utah and Maryland [7]

Revenue and Profit - For the three months ended March 31, 2024, total revenue increased by $148,000, or 27%, to $687,000 compared to $539,000 in the same period in 2023[96]. - Product revenue rose by $69,000, or 29%, to $309,000, while grant and contract revenue increased by $79,000, or 26%, to $378,000[96][97]. - Gross profit for the quarter was $464,000, reflecting a $43,000 increase, or 10%, from $421,000 in the prior year[96]. Expenses - Cost of revenue increased by $105,000, or 89%, to $223,000, primarily due to the increase in revenue[96][98]. - Research and development expenses decreased by $181,000, or 8%, to $2,019,000, attributed to lower patent and consulting costs[96][99]. - General and administrative expenses decreased by $46,000, or 4%, to $1,123,000, mainly due to reduced employee recruiting costs[96][100]. - Sales and marketing expenses decreased by $64,000, or 21%, to $246,000, primarily due to lower payroll and consulting costs[96][102]. Net Loss - The company incurred a net loss of $886,000 for the three months ended March 31, 2024, compared to a net loss of $293,000 in the same period in 2023, representing a 202% increase in loss[96][106]. Cash Flow - Net cash used in operating activities decreased to $2.7 million for the three months ended March 31, 2024, from $4.9 million in the same period of 2023, a reduction of $2.2 million[118]. - Cash provided by financing activities was $5.3 million for the three months ended March 31, 2024, down from $11.5 million in the same period of 2023, a decrease of $6.2 million[120]. - The Company reported a net increase in cash of $2.4 million for the three months ended March 31, 2024, compared to a net increase of $6.4 million in the same period of 2023[116]. Financing Activities - On March 26, 2024, the company closed a public offering of 28,400,000 shares at a price of $0.047, raising approximately $1.3 million before expenses[110]. - The Company closed a public offering of 2,150,000 units on February 10, 2023, generating gross proceeds of approximately $12.0 million[112]. - The Company allocated approximately $5.4 million of the gross proceeds from the February 2023 offering to common stock and prefunded warrants[112]. - The Company has entered into an Equity Distribution Agreement allowing for the sale of up to $1.1 million in common stock, with $1.0 million raised as of March 1, 2024[114]. Debt and Credit - As of March 31, 2024, the related party debt had an outstanding balance of $26,000, with payments scheduled to end on August 1, 2024[122]. - The Company has no outstanding balance on the Wells Fargo line of credit as of March 31, 2024, and the account has been closed[123]. Other Income - Other income decreased by $953,000, or 29%, to $2,311,000, mainly due to a decrease in non-cash derivative expense[96][104]. Off-Balance Sheet Arrangements - The Company has not made any off-balance sheet arrangements as defined in Item 303(a)(4) of Regulation S-K[124]. Rights Offering - The Company completed a rights offering on October 17, 2022, resulting in gross proceeds of approximately $4.7 million[113].

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]