Core Viewpoint - SINTX Technologies, Inc. has been invited to present at the H.C. Wainwright 27th Annual Global Investment Conference, highlighting its growth strategy and recent financial initiatives aimed at accelerating its strategic objectives [1][3]. Group 1: Conference Participation - The conference is scheduled from September 8–10, 2025, at the Lotte New York Palace Hotel, with SINTX's presentation set for September 9, 2025 [1]. - The event serves as a platform for the company to share its objectives, progress, and engage with institutional investors [2]. Group 2: Company Strategy and Objectives - SINTX plans to outline its growth strategy, near-term milestones, and the impact of its silicon nitride platform in medical device and infection-prevention markets [3]. - Recent financial initiatives, including a warrant inducement plan, are expected to enhance the company's ability to pursue its strategic objectives [3]. Group 3: Company Overview - SINTX Technologies, based in Salt Lake City, Utah, specializes in advanced ceramics for biomedical applications, particularly silicon nitride [5]. - The company has been a leader in the research, development, and manufacturing of silicon nitride, with products implanted in humans since 2008 [5]. - SINTX continues to expand its portfolio through innovation and strategic partnerships across multiple markets [5].

Core Viewpoint - SINTX Technologies, Inc. has entered into agreements for the immediate exercise of outstanding warrants, which will result in the issuance of new unregistered warrants and is expected to generate approximately $3.8 million in gross proceeds for the company [1][4]. Group 1: Warrants and Financial Details - The company announced the exercise of warrants to purchase up to 1,099,431 shares of common stock at an exercise price of $3.32 per share [1]. - In exchange for the immediate exercise of the warrants, the company will issue new unregistered warrants to purchase up to 1,649,147 shares at an exercise price of $4.79 per share, which will be exercisable immediately and expire in five and a half years [3]. - The gross proceeds from the exercise of the warrants and issuance of new warrants are expected to be approximately $3.8 million, prior to deducting placement agent fees and estimated offering expenses [4]. Group 2: Use of Proceeds and Closing Conditions - The company intends to use the net proceeds from the offering for working capital purposes [4]. - The offering is expected to close on or about September 9, 2025, subject to customary closing conditions [4]. Group 3: Company Overview - SINTX Technologies is an advanced ceramics company specializing in biomedical applications of silicon nitride, with products implanted in humans since 2008 [7]. - The company is a global leader in the research, development, and manufacturing of silicon nitride and continues to expand its portfolio across multiple markets through innovation and strategic partnerships [7].

Core Viewpoint - SINTX Technologies has received a Notice of Allowance from the USPTO for its patent on "Antipathogenic Fibrous Materials," which provides broad protection for its silicon nitride-based platform aimed at neutralizing pathogens [1][2][3] Intellectual Property Milestone - The patent secures extensive protection for silicon nitride's use in various applications, including medical devices, surgical care, and healthcare infrastructure, within a global infection-prevention market projected to exceed $30 billion annually [2][4] - This milestone enhances SINTX's intellectual property portfolio, complementing existing patents on antipathogenic face masks and systems for rapid viral inactivation [7][8] Leadership Perspective - The CEO of SINTX emphasizes that this patent could transform silicon nitride into a platform technology for infection prevention, potentially lowering infection risks and healthcare costs while saving lives [3][10] Healthcare Impact - Healthcare-associated infections (HAIs) are a significant challenge, with 1 in 31 U.S. hospital patients affected daily, leading to tens of billions in annual costs [4][5] - Silicon nitride's ability to provide continuous, drug-free pathogen inactivation could lead to substantial savings for hospitals and improved patient outcomes [5][6] Scientific Foundation - The patent builds on over a decade of research demonstrating silicon nitride's antimicrobial properties, including its effectiveness against various coronaviruses [6][7] Commercialization Strategy - SINTX plans to pursue partnerships and licensing agreements to integrate silicon nitride into products like wound dressings and PPE, facilitating rapid market adoption without major infrastructure changes [8][9] Future Outlook - With the patent allowance, SINTX is positioned to accelerate product commercialization and expand its presence in the infection-prevention market, potentially enhancing long-term shareholder value [9][10]

Core Insights - SINTX Technologies has published a peer-reviewed study demonstrating the antiviral efficacy of silicon nitride against various virus strains, including SARS-CoV-2 and MERS-CoV [1][2][4] Company Overview - SINTX Technologies is an advanced ceramics innovator specializing in biomedical applications of silicon nitride (Si₃N₄) and is the only FDA-cleared and ISO-certified silicon nitride manufacturer in the U.S. [3][5][10] - The company is transitioning from a single-product orthopedic implant manufacturer to a platform technology company with broad applications in infection control and medical devices [9] Study Findings - The study showed that alpha-phase silicon nitride (α-Si₃N₄) can reduce infectious SARS-CoV-2 titers by up to 99.97% within 10 minutes, with complete inactivation observed by 30 minutes [4] - When embedded in textile fabric, silicon nitride achieved 97% inactivation, demonstrating broad-spectrum virucidal activity against several SARS-CoV-2 variants and MERS-CoV [4] Market Opportunity - The global infection-prevention and control market is projected to exceed $230 billion by 2032, with the antiviral PPE market estimated to reach over $40 billion by 2030 and the global wound care market forecast to surpass $30 billion by 2030 [6] - SINTX believes its silicon nitride-based products can capture significant market share in these sectors due to their superior safety profile and performance compared to traditional metal-based antimicrobials [6] Advantages of Silicon Nitride - Unlike traditional antimicrobial additives like copper and silver, silicon nitride releases non-toxic reactive nitrogen species that damage viral RNA and proteins without harming surrounding tissue [7] - Potential applications include wound dressings, surgical sutures, face masks, hospital linens, and HEPA filters [8] Strategic Positioning - The publication of the study marks a strategic milestone for SINTX as it seeks partnerships and licensing opportunities to accelerate commercialization of its technology [9]

Core Insights - SINTX Technologies is undergoing a strategic transformation following the acquisition of SiNAPTIC, focusing on accelerating growth in the medical device sector over the next 12 to 24 months [1][2][3] Business Update - The company has made significant progress in its commercialization strategy and has streamlined operations to focus on high-margin, high-growth opportunities in orthopedic and surgical markets [1][4] - SINTX has successfully implanted over 50,000 spinal interbody devices and aims to leverage its differentiated orthopedic and spine technologies for revenue and margin growth [3][4] Leadership and Team Expansion - The acquisition of SiNAPTIC has enhanced SINTX's leadership team with experienced MedTech innovators, improving its commercial capabilities [4][5] - Key appointments include Bryan Scheer, M.D. as Chairman of the Clinical Advisory Board, and Lisa Marie Del Re as Chief Commercial Officer, among others [5] Strategic Focus and Operations - The company has divested non-core assets, including the sale of its Maryland-based subsidiary, to enhance strategic focus [5] - SINTX has exited low-margin OEM manufacturing, which contributed to a slight decrease in revenue during Q2 2025, reflecting a purposeful transition towards more profitable operations [6] Future Growth Strategy - SINTX plans to continue building its scientific foundation and intellectual property portfolio, with recent advancements in composite implant design and antimicrobial ceramics [7][11] - The company is committed to transparency with shareholders as it moves towards commercialization [7]

[Part I. Financial Information](index=3&type=section&id=Part%20I.%20Financial%20Information) This section presents SINTX Technologies' unaudited condensed consolidated financial statements, management's discussion, market risk disclosures, and controls for Q2 2025 [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents unaudited condensed consolidated financial statements, including balance sheets, operations, equity, cash flows, and detailed notes [Condensed Consolidated Balance Sheets (unaudited)](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20(unaudited)) The balance sheets present the company's financial position as of June 30, 2025, and December 31, 2024, showing slight decreases in assets and liabilities, and a minor equity increase Balance Sheet Summary (in thousands) | Balance Sheet Item (in thousands) | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Total assets | $9,195 | $9,413 | $(218) | | Total liabilities | $5,207 | $5,519 | $(312) | | Total stockholders' equity | $3,988 | $3,894 | $94 | [Condensed Consolidated Statements of Operations (unaudited)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20(unaudited)) The statements of operations show increased net losses for Q2 and H1 2025, driven by significant revenue declines and changes in other income/expenses Statements of Operations Summary (in thousands) | Operating Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change (YoY) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (YoY) | | :------------------------------ | :--------------------------- | :--------------------------- | :----------- | :--------------------------- | :--------------------------- | :----------- | | Total revenue | $151 | $859 | $(708) (-82%) | $520 | $1,546 | $(1,026) (-66%) | | Gross profit | $57 | $635 | $(578) (-91%) | $180 | $1,099 | $(919) (-84%) | | Loss from operations | $(2,665) | $(2,710) | $45 (-2%) | $(5,048) | $(5,907) | $859 (-15%) | | Net loss | $(2,318) | $(2,204) | $(114) (5%) | $(4,610) | $(3,090) | $(1,520) (49%) | | Basic Net loss per share | $(0.91) | $(3.49) | $2.58 | $(2.14) | $(8.61) | $6.47 | [Condensed Consolidated Statements of Stockholders' Equity (unaudited)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(unaudited)) The statements detail changes in stockholders' equity, including common stock issuances, stock-based compensation, and net losses, resulting in a slight equity increase from December 31, 2024, to June 30, 2025 Stockholders' Equity Summary (in thousands) | Stockholders' Equity Item (in thousands) | As of Dec 31, 2024 | As of Jun 30, 2025 | Change | | :--------------------------------------- | :----------------- | :----------------- | :----- | | Common Stock Amount | $13 | $26 | $13 | | Additional Paid-In Capital | $285,619 | $290,443 | $4,824 | | Accumulated Deficit | $(281,738) | $(286,348) | $(4,610) | | Total Stockholders' Equity | $3,894 | $3,988 | $94 | - Common stock shares outstanding increased from **1,342,853** as of December 31, 2024, to **2,591,171** as of June 30, 2025, reflecting significant equity issuance activities[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows (unaudited)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20(unaudited)) Cash flow statements show decreased cash used in operating activities, positive investing cash flow, and reduced financing cash flow for the six months ended June 30, 2025 Cash Flow Summary (in thousands) | Cash Flow Activity (in thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (YoY) | | :-------------------------------- | :--------------------------- | :--------------------------- | :----------- | | Net cash used in operating activities | $(3,710) | $(4,948) | $1,238 |\n| Net cash provided by (used in) investing activities | $289 | $(173) | $462 |\n| Net cash provided by financing activities | $4,143 | $6,338 | $(2,195) |\n| Net increase in cash and cash equivalents | $722 | $1,217 | $(495) |\n| Cash and cash equivalents at end of period | $4,320 | $4,557 | $(237) | [Notes to Condensed Consolidated Financial Statements (unaudited)](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) These notes provide detailed disclosures on accounting policies, significant events, and financial instrument valuations, offering context to the condensed consolidated financial statements [1. Organization and Summary of Significant Accounting Policies](index=9&type=section&id=1.%20Organization%20and%20Summary%20of%20Significant%20Accounting%20Policies) SINTX Technologies, an advanced ceramics company, focuses on silicon nitride for medical and agribiotech applications, with unaudited financials noting going concern uncertainty - SINTX Technologies specializes in silicon nitride (Si₃N₄) for medical devices (musculoskeletal, antipathogenic) and agribiotech applications, with products implanted in humans since **2008**[18](index=18&type=chunk)[19](index=19&type=chunk) - The company's Salt Lake City facility is **FDA registered**, **cGMP**, **ANVISA RDC 665 compliant**, and **ISO 9001:2015**, **ISO 13485:2016**, and **ASD9100D certified**[22](index=22&type=chunk) - Management concluded substantial doubt exists about the Company's ability to continue as a going concern for **12 months** from issuance due to net losses and accumulated deficit[28](index=28&type=chunk)[29](index=29&type=chunk)[38](index=38&type=chunk) - SINTX is strategically repositioning to focus on the biomedical sector, transitioning from industrial applications to develop and commercialize innovative silicon nitride medical devices[33](index=33&type=chunk)[34](index=34&type=chunk) - The company implemented a workforce reduction and ceased efforts to make the armor plant operational in August 2024, incurring a **$4.6 million impairment charge** related to the armor plant in **2024**[35](index=35&type=chunk)[36](index=36&type=chunk) [2. Disposition of TA&T](index=12&type=section&id=2.%20Disposition%20of%20TA%26T) On February 19, 2025, SINTX sold its subsidiary TA&T to Tethon Corporation, which assumed TA&T's liabilities, a transaction not qualifying for discontinued operations - SINTX sold its subsidiary TA&T to Tethon Corporation on **February 19, 2025**, in exchange for Tethon assuming TA&T's outstanding liabilities[37](index=37&type=chunk)[42](index=42&type=chunk) TA&T Assets and Liabilities Transferred (in thousands) | TA&T Assets and Liabilities Transferred (in thousands) | February 19, 2025 | | :--------------------------------------------------- | :---------------- | | Total assets sold | $743 | | Total liabilities assumed | $(719) | [3. Basic and Diluted Net Income (Loss) per Common Share](index=14&type=section&id=3.%20Basic%20and%20Diluted%20Net%20Income%20(Loss)%20per%20Common%20Share) Basic and diluted net loss per common share calculations are presented, excluding antidilutive securities from diluted EPS for the periods Net Loss Per Share (Basic and Diluted) | Net Loss Per Share (Basic and Diluted) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Basic Net Loss | $(0.91) | $(3.49) | $(2.14) | $(8.61) | | Diluted Net Loss | $(0.91) | $(3.61) | $(2.14) | $(13.62) | - Approximately **2.1 million** and **0.1 million** potentially dilutive securities were excluded from diluted loss per share calculations as of June 30, 2025, and 2024, respectively, because they were antidilutive[45](index=45&type=chunk) [4. Inventories](index=15&type=section&id=4.%20Inventories) Inventories decreased from **$967 thousand** at December 31, 2024, to **$805 thousand** at June 30, 2025, with approximately half current and half long-term Inventory Breakdown (in thousands) | Inventory Category (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Raw materials | $516 | $629 | | WIP | $162 | $182 | | Finished goods | $127 | $156 | | Total Inventories | $805 | $967 | - As of June 30, 2025, inventories were split approximately **$0.4 million current** and **$0.4 million long-term**[48](index=48&type=chunk) [5. Fair Value Measurements](index=15&type=section&id=5.%20Fair%20Value%20Measurements) Derivative liabilities, primarily common stock warrants, are measured at fair value using Level 3 inputs via Monte Carlo Simulation, decreasing from **$(208) thousand** to **$(160) thousand** from December 2024 to June 2025 - Common stock warrants are classified as derivative liabilities and re-measured to fair value at each reporting period using the **Monte Carlo Simulation valuation model**[49](index=49&type=chunk)[52](index=52&type=chunk) Derivative Liabilities (in thousands) | Derivative Liabilities (in thousands) | December 31, 2024 | June 30, 2025 | Change | | :------------------------------------ | :---------------- | :------------ | :----- | | Common stock warrants | $(208) | $(160) | $48 | Valuation Assumptions | Valuation Assumption | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Weighted-average risk-free interest rate | 3.66-3.92% | 4.12-4.35% | | Weighted-average expected life (years) | 0.09-3.59 | 0.10-4.09 | | Weighted-average expected volatility | 140.00-165.00% | 140.00-210.00% | [6. Accrued and Other Current Liabilities](index=17&type=section&id=6.%20Accrued%20and%20Other%20Current%20Liabilities) Accrued liabilities decreased from **$986 thousand** to **$585 thousand** due to reduced payroll and payables, while other current liabilities increased to **$750 thousand** for Sinaptic Surgical acquisition stock issuance Accrued Liabilities (in thousands) | Accrued Liabilities (in thousands) | June 30, 2025 | December 31, 2024 | Change | | :--------------------------------- | :------------ | :---------------- | :----- | | Payroll and related expense | $215 | $400 | $(185) | | Accrued payables | $10 | $178 | $(168) | | Other | $360 | $408 | $(48) | | Total Accrued Liabilities | $585 | $986 | $(401) | - Other current liabilities increased to **$750 thousand** as of June 30, 2025, primarily due to a deposit for stock issuance related to the acquisition of Sinaptic Surgical[55](index=55&type=chunk) [7. Debt](index=18&type=section&id=7.%20Debt) The Company entered two new insurance premium finance arrangements in March and May 2025, with outstanding balances of **$88 thousand** and **$21 thousand** as of June 30, 2025, and a prior arrangement was fully paid in Q1 2025 - New premium finance arrangements were entered in **March 2025** (D&O insurance, **$145 thousand** financed at **7.45% APR**, **$88 thousand** outstanding) and **May 2025** (general liability, **$21 thousand** financed at **11.15% APR**, **$21 thousand** outstanding)[57](index=57&type=chunk)[58](index=58&type=chunk) - A **June 2024** premium finance arrangement for commercial liability insurance (**$117 thousand** financed at **8.75% APR**) was fully paid in **Q1 2025**[56](index=56&type=chunk) [8. Equity](index=18&type=section&id=8.%20Equity) SINTX completed a **$5.0 million** private placement in February 2025, issuing common stock and warrants, and conducted public offerings in April, March, and February 2024, raising approximately **$1.5 million**, **$1.3 million**, and **$4 million**, with the ATM Agreement suspended - On **February 20, 2025**, the Company closed a private placement for **$5.0 million** gross proceeds, issuing **1,171,189 common shares**, **278,098 pre-funded warrants**, and **1,449,287 common warrants**[59](index=59&type=chunk) - Public offerings in **April 2024** (**$1.5 million** gross proceeds for **358,000 shares**) and **March 2024** (**$1.3 million** gross proceeds for **142,000 shares**) were completed[60](index=60&type=chunk)[62](index=62&type=chunk) - A public offering in **February 2024** raised approximately **$4 million**, involving common units, pre-funded warrant units, Class E warrants, and Class F warrants[63](index=63&type=chunk) - The ATM Agreement was suspended in **March 2024** and had no capacity for further sales as of **June 30, 2025**[64](index=64&type=chunk) [9. Stock-Based Compensation](index=20&type=section&id=9.%20Stock-Based%20Compensation) As of June 30, 2025, **90,032** stock options were outstanding with a weighted-average exercise price of **$20.85** and **9.7 years** remaining life, and **$478 thousand** unrecognized stock-based compensation to be recognized over **1.7 years** Stock Option Activity | Stock Option Activity | As of Dec 31, 2024 | Granted | Expired | As of Jun 30, 2025 | | :-------------------- | :----------------- | :------ | :------ | :----------------- | | Options | 35 | 90,000 | (3) | 90,032 | | Weighted Average Exercise Price | $18,872 | $3.00 | $19,267 | $20.85 | - Unrecognized stock-based compensation for stock grants amounted to **$478 thousand**, with a weighted-average remaining recognition period of **1.7 years** as of **June 30, 2025**[66](index=66&type=chunk) [10. Commitments and Contingencies](index=20&type=section&id=10.%20Commitments%20and%20Contingencies) The Company has agreements with executive officers for payments and accelerated stock vesting upon a change in control and is subject to ordinary course legal proceedings, which management believes will not have a material adverse effect - Executive officers have agreements for payments and accelerated stock vesting upon a change in control[67](index=67&type=chunk) - Management believes any liability from ordinary course legal proceedings will not materially adversely affect the Company's financial position, operating results, or cash flows[68](index=68&type=chunk) [11. Leases](index=22&type=section&id=11.%20Leases) SINTX leases office, warehouse, and manufacturing space under operating leases, with **$2.6 million** in right-of-use assets and **$3.4 million** in liabilities as of June 30, 2025, and TA&T lease facilities were transferred upon disposition - SINTX leases **30,764 square feet** of space under an operating lease expiring in **October 2031**, with a **five-year extension option**[71](index=71&type=chunk) - Operating lease right-of-use assets were approximately **$2.6 million** and operating lease liability was approximately **$3.4 million** as of **June 30, 2025**[75](index=75&type=chunk) Operating Lease Future Minimum Payments (in thousands) | Operating Lease Future Minimum Payments (in thousands) | Amount | | :----------------------------------------------------- | :----- | | 2025 (Remainder) | $326 | | 2026 | $668 | | 2027 | $688 | | 2028 | $709 | | 2029 | $730 | | Thereafter | $1,395 | | Total future minimum lease payments | $4,516 | | Present value of lease liability | $3,420 | [12. Related Party Transactions](index=22&type=section&id=12.%20Related%20Party%20Transactions) During Q2 2025, the Company entered a Research Collaboration Agreement with a majority-owned shareholder company, paying **$500,000** to fund it, with **$163,000** remaining prepaid as of June 30, 2025 - SINTX paid **$500,000** to fund a Research Collaboration Agreement with a company majority-owned by a shareholder, with **$163,000** remaining prepaid as of **June 30, 2025**[77](index=77&type=chunk) [13. Subsequent Events](index=22&type=section&id=13.%20Subsequent%20Events) On **July 1, 2025**, SINTX acquired Sinaptic Surgical, LLC assets and liabilities, issuing warrants for **325,000 common shares** at **$6.30** exercisable upon milestones, and Sinaptic Surgical purchased **216,450 common shares** in a private placement - On **July 1, 2025**, SINTX acquired assets and assumed liabilities of Sinaptic Surgical, LLC, issuing warrants to purchase **325,000 common shares** (exercise price **$6.30**, exercisable upon milestones)[78](index=78&type=chunk) - Sinaptic Surgical purchased **216,450 common shares** at **$3.465 per share** in a private placement[79](index=79&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes SINTX Technologies' financial condition and results, highlighting the strategic shift to biomedical applications, revenue declines, and ongoing liquidity challenges [Overview](index=24&type=section&id=Overview) SINTX Technologies is an advanced ceramics company specializing in silicon nitride for medical and agribiotech applications, focusing on biomedical solutions and recently submitting a 510(k) for osteotomy wedges - SINTX is an advanced ceramics company focused on developing and commercializing silicon nitride materials for medical and agribiotech applications, with products implanted in humans since **2008**[81](index=81&type=chunk) - The company submitted a **510(k) premarket notification** for novel silicon nitride osteotomy wedges in **July 2025**, entering the foot and ankle reconstruction market[82](index=82&type=chunk) - SINTX silicon nitride is noted for its **biocompatibility**, **bone affinity**, **antibacterial properties**, and ability to inactivate pathogens like **SARS-CoV-2**[83](index=83&type=chunk)[84](index=84&type=chunk) [Components of our Results of Operations](index=25&type=section&id=Components%20of%20our%20Results%20of%20Operations) This section outlines SINTX's key financial components, including product and grant revenue, cost of revenue, gross profit, and operating expenses like R&D, G&A, sales & marketing, and grant & contract expenses - Product revenue is derived from manufacturing and selling products like coatings, materials, and components for aerospace and medical devices, and toll processing services[87](index=87&type=chunk) - Grant and contract revenue comes from awards by governmental agencies[88](index=88&type=chunk) - Research and development costs, expensed as incurred, include engineering, product development, clinical trials, and regulatory activities, expected to increase with new medical device development[91](index=91&type=chunk)[92](index=92&type=chunk) [RESULTS OF OPERATIONS](index=26&type=section&id=RESULTS%20OF%20OPERATIONS) SINTX experienced significant revenue declines for product and grant/contract revenue in Q2 and H1 2025 due to strategic repositioning towards proprietary biomedical devices, leading to decreased gross profit and increased net loss Operating Results Summary (in thousands) | Operating Metric (in thousands) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change (YoY) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (YoY) | | :------------------------------ | :--------------------------- | :--------------------------- | :----------- | :--------------------------- | :--------------------------- | :----------- | | Product revenue | $100 | $378 | $(278) (-74%) | $391 | $687 | $(296) (-43%) | | Grant and contract revenue | $51 | $481 | $(430) (-89%) | $129 | $859 | $(730) (-85%) | | Total revenue | $151 | $859 | $(708) (-82%) | $520 | $1,546 | $(1,026) (-66%) | | Gross profit | $57 | $635 | $(578) (-91%) | $180 | $1,099 | $(919) (-84%) | | Net loss | $(2,318) | $(2,204) | $(114) (5%) | $(4,610) | $(3,090) | $(1,520) (49%) | - The decrease in total revenue is primarily due to the Company's strategic repositioning away from non-core, low-margin OEM technical manufacturing contracts towards proprietary silicon nitride-based biomedical devices[97](index=97&type=chunk)[98](index=98&type=chunk) [Liquidity and capital resources](index=28&type=section&id=Liquidity%20and%20capital%20resources) SINTX faces significant liquidity challenges with ongoing net losses and accumulated deficit, leading to substantial doubt about its going concern ability, requiring substantial future capital and active pursuit of potentially dilutive financing - The Company incurred net losses of **$4.6 million** and **$3.1 million** for the six months ended June 30, 2025, and 2024, respectively, and had accumulated deficits of **$286 million** and **$282 million**[110](index=110&type=chunk) - Management concluded substantial doubt exists about the Company's ability to continue as a going concern for **12 months** from the date of issuance[109](index=109&type=chunk)[119](index=119&type=chunk) - SINTX is actively seeking additional equity and/or debt financing to fund operations, R&D, and commercialization, acknowledging potential dilution for current stockholders[111](index=111&type=chunk)[112](index=112&type=chunk) [Cash Flows](index=29&type=section&id=Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities decreased, net cash from investing activities turned positive, and net cash from financing activities decreased year-over-year Cash Flow Summary (in thousands) | Cash Flow Activity (in thousands) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (YoY) | | :-------------------------------- | :--------------------------- | :--------------------------- | :----------- | | Net cash used in operating activities | $(3,710) | $(4,948) | $1,238 | | Net cash provided by (used in) investing activities | $289 | $(173) | $462 | | Net cash provided by financing activities | $4,143 | $6,338 | $(2,195) | | Net increase in cash | $722 | $1,217 | $(495) | - Net cash used in operating activities decreased by **$1.2 million** to **$3.7 million** for H1 2025, driven by a **$1.5 million** decrease in net loss and **$2.9 million** in non-cash adjustments[121](index=121&type=chunk) - Net cash provided by investing activities was **$0.3 million** for H1 2025, a **$0.5 million** increase from H1 2024, primarily due to a **$0.5 million** decrease in property and equipment purchases and a **$0.3 million** increase in proceeds from asset sales[122](index=122&type=chunk) - Net cash provided by financing activities decreased by **$2.2 million** to **$4.1 million** for H1 2025, mainly due to a **$3.4 million** decrease in proceeds from warrant derivative liabilities, partially offset by a **$1.3 million** increase in proceeds from common stock and prefunded warrant issuance[123](index=123&type=chunk) [Indebtedness](index=30&type=section&id=Indebtedness) Information regarding the Company's indebtedness is detailed in Note 7 to the condensed consolidated financial statements - Details on indebtedness are provided in **Note 7** of the financial statements[124](index=124&type=chunk) [Off-Balance Sheet Arrangements](index=30&type=section&id=Off-Balance%20Sheet%20Arrangements) The Company has no off-balance sheet arrangements as defined by SEC regulations - The Company has no off-balance sheet arrangements[125](index=125&type=chunk) [Critical Accounting Policies and Estimates](index=31&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) No material changes occurred to the Company's critical accounting policies and estimates for the six months ended June 30, 2025, as discussed in the prior Annual Report on Form 10-K - No material changes to critical accounting policies and estimates for H1 2025[127](index=127&type=chunk) [Recent Accounting Pronouncements](index=31&type=section&id=Recent%20Accounting%20Pronouncements) Information regarding recent accounting pronouncements is detailed in Note 1 to the condensed consolidated financial statements - Details on recent accounting pronouncements are provided in **Note 1** of the financial statements[128](index=128&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is marked as "Not applicable," indicating no material quantitative or qualitative disclosures about market risk are provided - No quantitative or qualitative disclosures about market risk are applicable for this period[129](index=129&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) The CEO and Principal Financial Officer certified the effectiveness of disclosure controls and procedures as of June 30, 2025, reporting no material changes in internal control over financial reporting during Q2 2025 [Evaluation of Disclosure Controls and Procedures](index=31&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) The Chief Executive Officer concluded that the Company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during Q2 2025 - The Chief Executive Officer concluded that disclosure controls and procedures were effective as of **June 30, 2025**[132](index=132&type=chunk) - No material changes in internal control over financial reporting occurred during **Q2 2025**[133](index=133&type=chunk) [Part II. Other Information](index=32&type=section&id=Part%20II.%20Other%20Information) Part II covers other information not in financial statements, including legal proceedings, risk factors, unregistered equity sales, defaults, mine safety, and exhibits [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The Company is unaware of any pending or threatened legal proceedings that could materially adversely affect its business, operating results, or financial condition, though it may be involved in ordinary course legal proceedings - No pending or threatened legal proceedings are expected to have a material adverse effect on the Company[134](index=134&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) No material changes occurred from the risk factors previously disclosed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes to risk factors from the Annual Report on Form 10-K[135](index=135&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the Company's share repurchase program, which authorized repurchases of up to **$500,000** of common stock, with **20,759 shares** repurchased in April 2025 at **$2.25**, leaving **$366,935.45** remaining [Share Repurchase Program](index=32&type=section&id=Share%20Repurchase%20Program) The Board authorized a share repurchase program for up to **$500,000** of common stock in November 2024, with **20,759 shares** repurchased in April 2025 at **$2.25**, leaving **$366,935.45** remaining as of June 30, 2025 - The Board authorized a share repurchase program for up to **$500,000** of common stock in **November 2024**[136](index=136&type=chunk) Share Repurchase Activity | Period | Total shares purchased | Average price paid per share | Maximum number (or approximate dollar value) of shares that may yet be purchased under the plans or programs | | :---------------- | :--------------------- | :--------------------------- | :--------------------------------------------------------------------------------------------------------- | | 04/01/25 – 04/30/25 | 20,759 | $2.25 | $366,935.45 | | Total | 20,759 | $2.25 | $366,935.45 | [Item 3. Defaults Upon Senior Securities](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities - No defaults upon senior securities were reported[137](index=137&type=chunk) [Item 4. Mine Safety Disclosures](index=32&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is marked as "Not applicable" in the report - Mine safety disclosures are not applicable[138](index=138&type=chunk) [Item 5. Other Information](index=32&type=section&id=Item%205.%20Other%20Information) The Company reported no other information - No other information was reported[139](index=139&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including forms of warrants, asset purchase agreements, and Sarbanes-Oxley Act certifications - Exhibits include Form of Warrant, Form of Asset Purchase Agreement, and certifications (**31.1**, **31.2**, **32**) required by the Sarbanes-Oxley Act[140](index=140&type=chunk) [Signatures](index=34&type=section&id=Signatures) The report is duly signed on behalf of SINTX Technologies, Inc. by Eric Olson, Chief Executive Officer and Principal Financial Officer, on August 14, 2025 - The report was signed by Eric Olson, CEO and Principal Financial Officer, on **August 14, 2025**[143](index=143&type=chunk)

Core Insights - SINTX Technologies has published a peer-reviewed study validating the use of silicon nitride (Si₃N₄) surface coatings on carbon fiber-reinforced polyetherketoneketone (CFR-PEKK) trauma plates, expanding its biomaterial platform into polymer-carbon-ceramic constructs [1][2][3] Group 1: Study Findings - The study demonstrates that SINTX's proprietary process can integrate silicon nitride into 3D-printed continuous carbon fiber PEKK composites without compromising flexural strength or stiffness [2] - Hybrid-manufactured CFR-PEKK trauma plates achieved flexural modulus values within the range of cortical bone (1.7–16.3 GPa), optimizing stress distribution for bone healing [6] - Si₃N₄ surface coatings had no statistically significant effect on flexural modulus or strength, confirmed by standardized four-point bending tests [6] Group 2: Clinical and Market Implications - The integration of silicon nitride with CFR-PEKK positions SINTX to address unmet needs in orthopedic trauma, spine, and custom surgical implants [3] - Si₃N₄'s osteoconductive and antimicrobial properties may enhance clinical outcomes by promoting osseointegration and reducing infection risk, which are critical in trauma and reconstructive surgery [6] - The findings support SINTX's commercialization strategy to develop differentiated implant solutions using hybrid manufacturing and surface bioactivation [5]

Core Insights - SINTX Technologies has submitted a 510(k) premarket notification to the FDA for its silicon nitride osteotomy wedges, marking its entry into the foot and ankle reconstruction market [1][2] - The global foot and ankle fusion market is valued at approximately $750.5 million and is projected to grow to $1.38 billion by 2032 [2] - SINTX's silicon nitride (Si₃N₄) biomaterial has a proven clinical track record with over 50,000 spinal interbody fusion devices implanted since 2008 [2] Clinical Advantages - Si₃N₄ is positioned to address key challenges in orthopedic reconstruction, particularly in infection risk, healing rate, and long-term stability [3] - The material promotes bone cell adhesion, proliferation, and differentiation, enhancing osseointegration and fusion potential [6] - Si₃N₄ inhibits bacterial colonization without additives, crucial for reducing hardware-related infections in foot and ankle procedures [6] Surgical Innovation - SINTX has developed proprietary implant geometries and disposable instrumentation to improve surgical outcomes [4] - The implants are designed in collaboration with leading surgeons to optimize biomechanical correction and ease of insertion [7] - The single-use instrument kits aim to enhance surgical efficiency and reduce intraoperative delays [7] Strategic Launch and Financial Outlook - The FDA submission is supported by over a decade of clinical and preclinical data, including peer-reviewed publications and biocompatibility studies [5] - The company anticipates strong early adoption of its foot and ankle portfolio, which is expected to drive revenue growth through market penetration and increasing procedural demand [8] Value Proposition - The platform is built on a proven material with extensive clinical experience and thoughtful surgical design [10] - The combination of sterile, single-use kits and advanced biomaterial technology aligns with evolving value-based care models [14]

Core Insights - SINTX Technologies has executed a Definitive Agreement to acquire the surgical business assets of SiNAPTIC Holdings, enhancing its product portfolio in the foot and ankle fusion market [1][2] - The acquisition includes all intellectual property and product designs related to six differentiated foot and ankle implant systems, which are expected to accelerate commercial launch activities [2][3] - The global ankle fusion market is valued at approximately $750.5 million and is projected to grow to $1.38 billion by 2032, with a CAGR of 9.1% [2] Company Strategy - The acquisition is seen as transformative for SINTX, shifting the focus from R&D to revenue generation and commercial scale [3] - Key members of the SiNAPTIC executive team will join SINTX, bringing expertise in product development, regulatory strategy, and commercialization [3][4] - SINTX will manufacture all devices under its FDA-registered and ISO-certified quality system, leveraging existing FDA clearances to streamline regulatory approvals [4] Financial Details - SINTX issued $750,000 in common shares at a price of $3.465 per share, representing a 10% premium to the closing price on June 20, 2025, along with performance-based common stock purchase warrants [3] - The warrants are exercisable over five years at a strike price of $6.30, vesting upon achieving specific regulatory and commercial milestones [3] Market Position - The acquisition reflects a shared belief in the potential of silicon nitride ceramic-enhanced implants, aiming to accelerate the development of disruptive products [5] - SINTX has been a leader in the research and development of silicon nitride, with products implanted in humans since 2008 [6]

Core Insights - SINTX Technologies has announced a renewed corporate vision and strategic plan aimed at accelerating the commercialization of its proprietary silicon nitride technologies following a successful recapitalization and leadership restructuring [1][5]. Company Overview - SINTX Technologies is the only FDA-registered producer of implantable silicon nitride and a global leader in advanced ceramics, with a history of innovation dating back to 2008 when it introduced the first FDA-cleared implant material made from medical-grade silicon nitride [1][2][3]. - The company holds 18 issued U.S. patents and has 84 pending applications, positioning itself as an industry leader in silicon nitride technology with applications across various markets, including a $62 billion global orthopedic implant sector [3]. Strategic Initiatives - The company is focusing on developing next-generation hybrid biomaterials that combine the biological performance of silicon nitride with the flexibility of polymers like PEEK and PEKK, targeting applications in spine, oral/maxillofacial, cranio-maxillofacial, and oncologic reconstruction [4][5]. - SINTX is pursuing strategic partnerships and licensing opportunities to expand its technology reach, with initiatives including joint ventures in orthopedics, wound care, and agribiotech, as well as monetizing its extensive patent portfolio [5][8]. Commitment to Stakeholders - The company emphasizes its commitment to transparency, disciplined execution, and long-term value creation for all stakeholders, expressing gratitude for the support from shareholders and partners [6].