SINT 10-K & 10-Q changes, risk factors and insider trading
Sintx Technologies, Inc. · Nasdaq · Surgical & Medical Instruments & Apparatus · CIK 1269026 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “Building and managing an in-house sales and distribution organization subjects us to significant operational, financial, and execution risks.”
New heading “Cybersecurity risks and failures of our information technology systems could disrupt our operations, compromise confidential information, and materially adversely affect our business.”
New heading “We may be required to generate clinical or additional supporting data for certain product candidates, which could increase costs and delay commercialization.”
New heading “Our relationships with healthcare providers, distributors, and third-party payers are subject to complex healthcare fraud and abuse, transparency, and privacy laws, and noncompliance could result in significant penalties and reputational harm.”
New heading “Changes in tax laws or their interpretation could adversely affect our business and the value of our securities.”
New heading “Changes in healthcare laws, regulations, and reimbursement policies may increase our costs, delay regulatory review, and adversely affect pricing and demand for our products.”
Removed heading “Cyber security risks and the failure to maintain the integrity of company, employee or guest data could expose us to data loss, litigation and liability, and our reputation could be significantly harmed.”
Removed heading “We may be required to conduct clinical trials to support regulatory approval of some of our product candidates. We have little experience conducting clinical trials, they may proceed more slowly than anticipated, and we cannot be certain that our product candidates will be shown to be safe and effective for human use.”
Removed heading “Our current and future relationships with third-party payers and current and potential customers in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm administrative burdens and diminished profits and future earnings.”
Removed heading “Proposed legislation in the U.S. Congress, including changes in U.S. tax law, and the recently enacted Inflation Reduction Act of 2022 may adversely impact us and the value of common shares, pre-funded warrants, and Warrants.”
Removed heading “Recently enacted and future legislation may increase the difficulty and cost for us to obtain and monitor regulatory approval or clearance of our product candidates and affect the prices we may obtain for our products.”
Largest changes
“Our current and future relationships with third-party payers and current and potential customers in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm administrative burdens and diminished profits and future earnings.”see in full comparison
“We are subject to evolving federal, state, and international data privacy and cybersecurity laws and regulations, as well as contractual obligations with third parties, which require us to safeguard information and, in certain circumstances, provide notice of data breaches. Compliance with these requirements may increase our costs, and any failure to comply could result in regulatory investigations, litigation, fines, or other liabilities.”see in full comparison
“A successful cyberattack or other security incident could result in the loss, theft, corruption, or unauthorized disclosure of confidential information; disruption of manufacturing or supply chain operations; delays in product development or commercialization; financial loss; and reputational harm. Ransomware or other attacks affecting our manufacturing systems could interrupt production or distribution of our medical products. In addition, a material cybersecurity incident could impair our ability to maintain effective internal control over financial reporting.”see in full comparison
“We collect and third parties collaborating on our clinical trials collect and retain large volumes of data, including personally identifiable information regarding clinical trial participants and others, for business purposes, including for regulatory, research and development and commercialization purposes, and our collaborators’ various information technology systems enter, process, summarize and report such data. We also maintain personally identifiable information about our employees. The integrity and protection of our company, employee and clinical data is critical to our business. …”see in full comparison
“These laws are complex and subject to evolving interpretations. Our compliance efforts may require substantial resources, and we cannot assure that our business arrangements, or those of our distributors or customers, will not be challenged by governmental authorities. If our operations or relationships are found to violate applicable laws, we could be subject to significant civil, criminal, or administrative penalties, including fines, damages, exclusion from participation in government healthcare programs, contractual damages, reputational harm, and the restructuring of our operations. …”see in full comparison
“Our relationships with healthcare providers, distributors, and third-party payers are subject to complex healthcare fraud and abuse, transparency, and privacy laws, and noncompliance could result in significant penalties and reputational harm.”see in full comparison
Full comparison: every changed paragraph (115)
We
currently have limited committed sources of
capital capital, and we have limited liquidity. Our cash and cash equivalents as of December 31, 20242025
were was $3.6$4.1 million. In FebruaryOctober 20252025, we closed
the publicCompany offeringentered ofinto $5.0an millionAt ofThe unitsMarket consistingOffering ofAgreement to sell shares of its common stock, Pre-funded Warrants, and common stock purchase warrants,from
resulting in net proceedstime to ustime, through an “at the market offering” or “ATM” program, having an aggregate offering price of approximately $3.4 $6.4
million. WeThere expectis ourpresently current$6.0 cashmillion andavailable cashcapacity equivalents will be sufficient
to fund our operations throughunder the second quarter of 2026.ATM. We will require substantial future capital in order to continue to continueoperating
operating our business, conduct the research and development and regulatory clearance and approval activities necessary to bring our
products to
market, and to establish effective marketing and sales capabilities. Our existing capital resources are not sufficient to
enable us to
fund the completion of the development and commercialization of all of our product candidates.
We
cannot determine with certainty the duration
and completion costs of the current or future development and commercialization of our product
candidates for spinal fusion, joint replacement
and coated metals or if, when, or to what extent we will generate revenues from the commercialization and sale of any of these product candidates
candidates for which we obtain regulatory approval. We may never succeed in achieving regulatory approval for certain or all of these
product candidates.
The duration, costs and timing of clinical trials and development of our spinal fusion, joint replacement and coated
metal product candidates
will depend on a variety of factors, including:
A
change in the outcome of any of these variables
with respect to the development of spinal fusion, joint replacement or coated metalour product candidates could mean a significant change
in the costs and timing associated with the development of these product candidates.
To
the extent thatthe weCompany raiseraises additional capital
through the saleissuance of equity or convertible debt securities, yourexisting stockholders
may experience dilution in their ownership interestinterests. willIn likely be diluted, andaddition, the terms of any such securities may include liquidation, conversion,
liquidationdividend, or other preferencespreferential rights that are senior to or otherwise adversely affect yourthe rights asof aholders stockholder.of the Company’s
common stock. Debt financing, if available, may involve agreements
that include covenants limiting or restricting our ability to take
specific actions such as incurring additional debt, making capital
expenditures or declaring dividends. If we raise additional funds
through collaboration and licensing arrangements with third parties,
we may have to relinquish valuable rights to our technologies or
products or grant licenses on terms that are not favorable to us. Any
of these events could adversely affect our ability to achieve our
product development and commercialization goals and have a material
adverse effect on our business, financial condition and results of
operations.
We
have incurred net losses since our inception
and anticipate that we will continue to incur substantial net losses for the foreseeable future. We
may never achieve or sustain profitability.
We
have incurred substantial net losses since
our inception. For the years ended December 31, 20242025 and 20232024, we incurred a net loss of $11.0
$10.4 million and $8.3$11.0 million, respectively,
and used cash in operations of $8.6 million and $14.1$8.6 million, respectively. We have
an accumulated deficit of $281.7$292.1 million and $270.7$281.7 million
as of December 31, 20242025 and 20232024, respectively. Our losses have resulted
principally from costs incurred in connection with our sales
and marketing activities, research and development activities,
manufacturing activities, general and administrative expenses associated
with our operations, impairments on intangible assets and
property and equipment, interest expense, loss on extinguishment of debt and
offering costs. Even if we are successful in launching
new products into the market, we expect tomay continue to incur substantiallosses losses
for the foreseeable future as we continue to manufacture products for
CTL Medical and other OEM customers and invest in research and developdevelopment and
seek regulatory approvals for our product candidates.
While we are focused on improving margins and controlling costs and believe our new product initiatives may improve our operating
results over time, we cannot predict when, or if, we will achieve profitability.
We
believe we are the first and only company
to use silicon nitride in medical applications. To date, however, we have had limited acceptance
of our silicon nitride-based products
and prior to the disposition of our spine implant business to CTL, our product revenue was derived substantially from our non-silicon
nitride products. In order to succeed in our goal of becoming a leading advanced ceramics company, we must increase
market awareness
of our silicon nitride interbody fusion products, including our spinal fusion productsimplants inand conjunctionfoot withand CTL,ankle wedge systems,
and develop and launch new biomedical, industrial, and
antipathogenic products. If we fail in any of these endeavors or experience delays
in pursuing them, we will not generate revenues as
planned and will need to curtail operations or seek additional financing earlier than
otherwise anticipated.
Our current
biomedical products and our
future products may not beachieve acceptedmarket byacceptance hospitalsor andcommercial surgeons and may not become commercially successful.success.
Following the sale of our spine implant business, we rely in part on third-party distribution partners to commercialize certain silicon nitride spinal fusion products that we manufacture. If these partners are unable to effectively market and sell such products or increase demand, our revenues would be adversely affected.
More broadly, our ability to generate meaningful revenue depends on market acceptance of our silicon nitride-based technologies by surgeons, hospitals, and other healthcare providers. Although we received FDA clearance for our first spinal fusion products in 2008, we have not achieved significant market share in the interbody spinal fusion market.
Our newer offerings, including the SiNAPTIC® foot and ankle wedge system, and any future products for which we obtain regulatory clearance or approval, may likewise fail to gain sufficient clinical adoption.
Market acceptance depends on numerous factors, including clinical outcomes, supporting data, reimbursement coverage and levels, pricing, surgeon familiarity, and competition from alternative biomaterials. If our products do not achieve adequate market acceptance, our business, results of operations, and financial condition would be materially adversely affected.
With the sale of our spine implant business to
CTL we are now largely dependent on the efforts of CTL to sell the spinal fusion products that we manufacture and then sell to CTL. If
CTL is not able to sell such products or is unable to increase demand for such products, then our revenues will decline. Since obtaining
regulatory clearance from the FDA for our first silicon nitride spinal fusion products in 2008, we have not been able to obtain significant
market share of the interbody spinal fusion market, and CTL may not obtain such market share in the future. Even if we receive regulatory
clearances or approvals for our other product candidates in development, these product candidates may not gain market acceptance among
customers.
Our
products and any product candidates that
we may introduce into the market may not enable us to overcome the competitive advantages of
these large and dominant orthopedic companies.
In addition, even if we successfully introduce additional product candidates incorporating
our silicon nitride biomaterial into the market,
emerging and small innovative companies may seek to increase their market share and
they may eventually possess competitive advantages,
which could adversely impact our business. Our competitors may also employ pricing
strategies that could adversely affect the pricing
of our products and pricing in the spinal fusion and total joint replacement market generally.products.
Moreover, numerous companies are developing and commercializing alternative biomaterials and surface technologies that may compete with our silicon nitride-based products in terms of safety, performance, cost, and clinical acceptance. These include advanced metals, modified polymer implants (such as enhanced PEEK formulations), ceramic-coated or oxidized metal devices, additive manufacturing solutions, and other proprietary materials designed to improve osseointegration, durability, or antimicrobial properties. For example, certain competitors have developed ceramic-coated or treated metal implants intended to address limitations associated with traditional metal devices, which may compete directly with our silicon nitride and silicon nitride-coated product offerings. Competitive materials and technologies are being advanced not only in spinal applications but also in extremity and other orthopedic segments, including foot and ankle procedures in which our SiNAPTIC® foot and ankle wedge system and potential future extremity products may compete. If competing technologies demonstrate comparable or superior clinical outcomes, are supported by more extensive clinical data, achieve broader surgeon adoption, or are offered at more competitive prices, our ability to gain or maintain market share across our product portfolio could be adversely affected.
Moreover, many other companies are seeking to
develop new biomaterials and products which may compete effectively against our products in terms of performance and price. For example,
Smith & Nephew has developed a ceramic-coated metal, known as Oxinium, which may overcome certain of the limitations of metal joint
replacement products and could directly compete with our silicon nitride and silicon nitride-coated product candidates.
In
order to control the quality, cost and availability
of our silicon nitride products, we developed our own manufacturing capabilities.
We operate a 31,00030,764 square foot facility which is certified
under the ISO 13485 medical device manufacturing standard for medical devices
and operates under the FDA’s quality systems regulations,
or QSRs. All operationsoperations, with the exception of raw material production production,
are performed at this facility.
While we currently manufacture silicon nitride spinal fusion implants that are commercialized through third-party distribution arrangements, our long-term growth depends on expanding our product portfolio across orthopedic, extremity, and other medical applications, as well as selected non-medical markets. This includes continued commercialization of our SiNAPTIC® foot and ankle wedge system and the development of additional silicon nitride-based products incorporating our advanced ceramic technologies.
To succeed in these efforts, we must continue product development and testing, scale and optimize manufacturing processes, obtain necessary regulatory clearances and approvals, establish or expand distribution and strategic partner relationships, and enhance our sales and marketing capabilities. We are also pursuing opportunities in non-medical applications, including advanced ceramic armor and other industrial technologies, which involve different market dynamics, customer requirements, and competitive landscapes.
Product development and commercialization involve substantial technical, regulatory, financial, and market risks. We may encounter delays in development timelines, increased costs, manufacturing challenges, regulatory obstacles, or slower-than-expected market adoption. There can be no assurance that any of our current or future product candidates will achieve regulatory clearance or approval, be successfully commercialized, or generate meaningful revenue. If we are unable to successfully expand and commercialize our product lines, or if commercialization is delayed, our revenues and growth prospects would be adversely affected, and we may need to reduce operations or seek additional capital sooner than anticipated.
Although we are currently manufacturing silicon
nitride interbody spinal fusion implants for CTL, in order to be successful, we will need to expand our product lines to include other
advanced ceramic products for both medical and non-medical applications. Therefore, we are developing new manufacturing technologies
and new product candidates including our new ceramic armor products. To succeed in our commercialization efforts, we must effectively
continue product development and testing, find new strategic partners, obtain regulatory clearances and approvals, and enhance our sales
and marketing capabilities. Because of these uncertainties, there is no assurance that we will succeed in bringing any of our current
or future product candidates to market. If we fail in bringing our product candidates to market, or experience delays in doing so, we
will not generate revenues as planned and will need to curtail operations or seek additional financing earlier than otherwise anticipated.
We will depend
rely on one or moreboth strategic
partners and our own commercialization capabilities to develop and commercializemarket our biomedical and antipathogenic product candidates, and if our strategic partnersthese
efforts are unable
to execute effectively on our agreements with them,unsuccessful, we may nevernot becomeachieve profitable.profitability.
We currently utilize a combination of third-party commercialization arrangements and internal capabilities to develop, manufacture, and market our biomedical and antipathogenic product offerings. For certain product lines, including silicon nitride spinal fusion implants, we rely on distribution or strategic partners for commercialization. At the same time, following our acquisition of the SiNAPTIC® foot and ankle wedge system and related assets, we are undertaking direct commercialization efforts for that product line and may elect to do so for additional products in the future.
Our success will depend on the effectiveness of both these third-party relationships and our internal commercialization infrastructure. Where we rely on strategic partners, we are dependent on their ability to successfully market and distribute our products, manage customer relationships, and allocate sufficient resources to our product lines. Where we pursue commercialization independently, we must continue to build and manage sales and marketing capabilities, establish and maintain effective distribution channels, manage certified and validated commercial-scale manufacturing operations, conduct product development and testing, and obtain and maintain required regulatory clearances and approvals.
There can be no assurance that we will be able to successfully execute on either our partnered or direct commercialization strategies. If our strategic partners fail to perform as expected, if we are unable to effectively build and scale our internal commercialization capabilities, or if we experience delays or increased costs in these efforts, we may not generate revenues as anticipated and may need to curtail operations or seek additional financing sooner than expected.
Building and managing an in-house sales and distribution organization subjects us to significant operational, financial, and execution risks.
In connection with the commercialization of the SiNAPTIC® foot and ankle wedge system and potentially other future products, we are developing internal sales, marketing, and distribution capabilities. Establishing and managing an effective in-house commercial organization requires substantial time, capital, and management resources, and we have limited prior experience operating a direct sales force at scale.
We must recruit, train, and retain experienced sales representatives, including those with established relationships in the foot and ankle and broader orthopedic markets. Competition for qualified sales personnel in the medical device industry is intense, particularly for individuals with existing surgeon relationships and experience calling on hospitals, ambulatory surgery centers, and group purchasing organizations. We may be unable to attract or retain such personnel on acceptable terms, and turnover among sales representatives could disrupt customer relationships and delay revenue growth.
In addition, we may utilize independent distributors in certain territories, which introduces risks related to managing distributor performance, aligning incentives, negotiating pricing and commission structures, and maintaining consistent branding and compliance practices. Distributors may represent competing products and may not prioritize our products. Poor distributor performance or disputes over commercial terms could adversely affect sales.
Direct commercialization also requires us to manage inventory forecasting, warehousing, logistics, instrument tray deployment, and consignment arrangements. Inaccurate demand forecasting, slow inventory turnover, product returns, or obsolescence could result in write-downs and negatively impact gross margins. Furthermore, the need to maintain inventory and instrument sets in the field may increase our working capital requirements and cash burn, particularly during the early stages of market adoption.
If we are unable to effectively build, manage, and scale our internal sales and distribution infrastructure, or if the associated costs exceed our expectations, our commercialization efforts may be delayed or less successful than anticipated, which could materially adversely affect our business, results of operations, financial condition, and liquidity.
We are seeking strategic partners to develop
and commercialize our biomedical and antipathogenic product candidates. We will be reliant on our strategic partners to develop and commercialize
these product candidates, although we have not yet entered into an agreement with any strategic partner to develop products and may be
unable to do so on agreeable terms. In order to succeed in our joint commercialization efforts, we and any future partners must execute
effectively on all elements of a combined business plan, including continuing to establish sales and marketing capabilities, manage certified,
validated and effective commercial-scale manufacturing operations, conduct product development and testing, and obtain regulatory clearances
and approvals for our product candidates. If we or any of our strategic partners fail in any of these endeavors, or experience delays
in pursuing them, we will not generate revenues as planned and will need to curtail operations or seek additional financing earlier than
otherwise anticipated.
If
hospitals and other healthcare providers
are unable to obtain coverage or adequate reimbursement for procedures performed withusing our medical
products, it is unlikely our products will
bemay widelynot used.achieve widespread adoption.
The commercial success of our medical products, including our silicon nitride spinal implants, the SiNAPTIC® foot and ankle wedge system, and any future orthopedic or other medical devices we develop, depends in part on the availability of coverage and adequate reimbursement from governmental and private third-party payers. Hospitals and other healthcare providers that purchase and use our products generally rely on Medicare, Medicaid, private insurers, and other payers to reimburse all or a portion of the costs of the procedures in which our products are used, typically under bundled or fixed payment rates. If coverage is unavailable or reimbursement levels are insufficient, providers may be unwilling to use our products.
Coverage and reimbursement policies vary among payers and may be influenced by determinations made by the Centers for Medicare & Medicaid Services (CMS). Private payers frequently follow CMS coverage and payment decisions, and adverse determinations at the federal or state level could negatively affect reimbursement by other payers. In addition, payers may deny reimbursement if they determine that a procedure was not medically necessary, was not cost-effective, or involved a use not approved or cleared by the FDA.
The U.S. healthcare system continues to face significant cost-containment pressures. Government and private payers periodically revise payment methodologies and may reduce reimbursement rates or impose value-based purchasing and pay-for-performance measures that increase pricing pressure on hospitals and, indirectly, on medical device manufacturers. As a result, hospitals and other providers may seek to reduce the prices they pay for our products or limit adoption of products perceived as more costly than alternatives.
Hospitals and clinics often participate in group purchasing organizations (GPOs), which negotiate pricing arrangements with selected vendors. If we are unable to secure contracts with key GPOs or otherwise persuade providers to purchase our products outside of existing contracts, our ability to achieve meaningful market penetration could be adversely affected.
Internationally, reimbursement systems and pricing controls vary by country, and many jurisdictions impose price ceilings or other restrictions on medical devices. Failure to obtain favorable reimbursement or pricing approvals in international markets could limit adoption of our products outside the United States.
Adverse changes in coverage, reimbursement levels, or healthcare policy, whether in the United States or internationally, could materially adversely affect our business, results of operations, and financial condition.
In the United States, the commercial success
of our spinal products will depend, in part, on the extent to which governmental payers at the federal and state levels, including Medicare
and Medicaid, private health insurers and other third-party payers provide coverage for and establish adequate reimbursement levels for
procedures utilizing our products. Because we typically receive payment directly from the companies for whom we manufacture, we do not
anticipate relying directly on payment from third-party payers for our products. However, hospitals and other healthcare providers that
purchase orthopedic products manufactured by us from our customers for treatment of their patients generally rely on third-party payers
to pay for all or part of the costs and fees associated with our products as part of a “bundled” rate for the associated
procedures. The existence of coverage and adequate reimbursement for our products and the procedures performed with them by government
and private payers is critical to market acceptance of our existing and future products. Neither hospitals nor surgeons are likely to
use our products if they do not receive adequate reimbursement for the procedures utilizing our products.
Many private payers currently base their reimbursement
policies on the coverage decisions and payment amounts determined by the Centers for Medicare and Medicaid Services, or CMS, which administers
the Medicare program. Others may adopt different coverage or reimbursement policies for procedures performed with our products, while
some governmental programs, such as Medicaid, have reimbursement policies that vary from state to state, some of which may not pay for
the procedures performed with our products in an adequate amount, if at all. A Medicare national or local coverage decision denying coverage
for one or more of our products could result in private and other third-party payers also denying coverage for our products. Third-party
payers also may deny reimbursement for our products if they determine that a product used in a procedure was not medically necessary,
was not used in accordance with cost-effective treatment methods, as determined by the third-party payer, or was used for an unapproved
use. Unfavorable coverage or reimbursement decisions by government programs or private payers underscore the uncertainty that our products
face in the market and could have a material adverse effect on our business.
Many hospitals and clinics in the United States
belong to group purchasing organizations, which typically incentivize their hospital members to make a relatively large proportion of
purchases from a limited number of vendors of similar products that have contracted to offer discounted prices. Such contracts often
include exceptions for purchasing certain innovative new technologies, however. Accordingly, the commercial success of our products may
also depend to some extent on our ability to either negotiate favorable purchase contracts with key group purchasing organizations and/or
persuade hospitals and clinics to purchase our product “off contract.”
The healthcare industry in the United States
has experienced a trend toward cost containment as government and private payers seek to control healthcare costs by paying service providers
lower rates. While it is expected that hospitals will be able to obtain coverage for procedures using our products, the level of payment
available to them for such procedures may change over time. State and federal healthcare programs, such as Medicare and Medicaid, closely
regulate provider payment levels and have sought to contain, and sometimes reduce, payment levels. Private payers frequently follow government
payment policies and are likewise interested in controlling increases in the cost of medical care. In addition, some payers are adopting
pay-for-performance programs that differentiate payments to healthcare providers based on the achievement of documented quality-of-care
metrics, cost efficiencies, or patient outcomes. These programs are intended to provide incentives to providers to deliver the same or
better results while consuming fewer resources. As a result of these programs, and related payer efforts to reduce payment levels, hospitals
and other providers are seeking ways to reduce their costs, including the amounts they pay to medical device manufacturers. We may not
be able to sell our implants profitably if third-party payers deny or discontinue coverage or reduce their levels of payment below that
which we project, or if our production costs increase at a greater rate than payment levels. Adverse changes in payment rates by payers
to hospitals could adversely impact our ability to market and sell these products and negatively affect our financial performance.
In international markets, medical device regulatory
requirements and healthcare payment systems vary significantly from country to country, and many countries have instituted price ceilings
on specific product lines. We cannot assure you that our products will be considered cost-effective by international third-party payers,
that reimbursement will be available or, if available, that the third-party payers’ reimbursement policies will not adversely affect
our ability to sell our products profitably. Any failure to receive regulatory or reimbursement approvals would negatively impact market
acceptance of our products in any international markets in which those approvals are sought.
There is no assurance that federal or state healthcare
reform will not also adversely affect our business and financial results, and we cannot predict how future federal or state legislative,
judicial or administrative changes relating to healthcare reform will affect our business.
A
pandemic, epidemic or outbreak of an
infectious disease in the United States or elsewhere may adversely affect our business.business, operations,
and financial condition.
Future outbreaks of infectious diseases or other public health emergencies in the United States or internationally could disrupt global and domestic economies, financial markets, and healthcare systems. Such events may result in reduced access to capital markets, increased market volatility, and constraints on our ability to raise additional financing on acceptable terms, or at all.
Public health crises may also disrupt our operations and those of our suppliers, manufacturers, and distribution partners. Travel restrictions, workforce shortages, quarantines, government-mandated shutdowns, or supply chain interruptions could delay product development, manufacturing, regulatory activities, or commercialization efforts. In addition, hospitals and healthcare providers may postpone elective or non-urgent procedures during periods of healthcare system strain, which could reduce demand for our orthopedic and other medical products.
The extent and duration of any future pandemic or public health emergency and its impact on our business would depend on numerous factors beyond our control, including the severity of the outbreak, governmental responses, and the resilience of global supply chains and healthcare systems. Any such event could materially adversely affect our business, results of operations, financial condition, and liquidity.
A significant outbreak in the future of contagious
diseases, such as COVID-19, could result in a widespread health crisis that could adversely affect the economies and financial markets
of many countries, resulting in an economic downturn. As a result, our ability to raise additional funds, if necessary, may be adversely
impacted by risks, or the public perception of the risks, related to the recent outbreak of COVID-19. Furthermore, the third parties
we engage, or seek to engage, with respect to OEM manufacturing relationships, and, for supply and development activities, may be adversely
impacted by risks, or the public perception of the risks, related to the recent outbreak of COVID-19, which may delay OEM relationships,
and, product development opportunities, and increase our costs.
The
members of our current senior management
team may not be able to successfully implement our strategy. In addition, we have not entered into employment agreements, other than
change-in-control severance agreements, with any of the members of our senior management team. There are no assurances that the
services services
of any of these individuals will be available to us for any specified period of time. The successful integration of our senior
management management
team, the loss of members of our senior management team, engineering team and key external advisors, or our inability to attract
or retain
other qualified personnel or advisors could have a material adverse effect on our business, financial condition and results
of operations.
We may not have sufficient number of qualified personnel to effectuate our business strategystrategy, which could have a material
adverse effect
on our business, financial condition and results of operations.
Cybersecurity risks and failures of our information technology systems could disrupt our operations, compromise confidential information, and materially adversely affect our business.
We rely on information technology systems and digital infrastructure to operate our business, including systems used for financial reporting, manufacturing operations, supply chain management, inventory control, sales and distribution activities, research and development, and communications with customers, suppliers, employees, and other third parties. We collect, process, and store sensitive information, including proprietary business information, intellectual property, employee data, and limited customer-related information.
Our systems, and those of our third-party service providers, distributors, and manufacturing partners, may be vulnerable to cybersecurity threats, including unauthorized access, ransomware attacks, phishing schemes, malware, business email compromise, insider misconduct, and other cyber incidents. The frequency and sophistication of cyberattacks have increased in recent years, particularly against healthcare and manufacturing companies.
A successful cyberattack or other security incident could result in the loss, theft, corruption, or unauthorized disclosure of confidential information; disruption of manufacturing or supply chain operations; delays in product development or commercialization; financial loss; and reputational harm. Ransomware or other attacks affecting our manufacturing systems could interrupt production or distribution of our medical products. In addition, a material cybersecurity incident could impair our ability to maintain effective internal control over financial reporting.
We are subject to evolving federal, state, and international data privacy and cybersecurity laws and regulations, as well as contractual obligations with third parties, which require us to safeguard information and, in certain circumstances, provide notice of data breaches. Compliance with these requirements may increase our costs, and any failure to comply could result in regulatory investigations, litigation, fines, or other liabilities.
Although we maintain cybersecurity policies, procedures, and technical safeguards designed to protect our systems and data, these measures may not be sufficient to prevent all incidents. Any significant cybersecurity breach or disruption could materially adversely affect our business, results of operations, financial condition, and liquidity.
Cyber security risks and the failure to
maintain the integrity of company, employee or guest data could expose us to data loss, litigation and liability, and our reputation
could be significantly harmed.
We collect and third parties collaborating on
our clinical trials collect and retain large volumes of data, including personally identifiable information regarding clinical trial
participants and others, for business purposes, including for regulatory, research and development and commercialization purposes, and
our collaborators’ various information technology systems enter, process, summarize and report such data. We also maintain personally
identifiable information about our employees. The integrity and protection of our company, employee and clinical data is critical to
our business. We are subject to significant security and privacy regulations, as well as requirements imposed by government regulation.
Maintaining compliance with these evolving regulations and requirements could be difficult and may increase our expenses. In addition,
a penetrated or compromised data system or the intentional, inadvertent or negligent release or disclosure of data could result in theft,
loss or fraudulent or unlawful use of company, employee or clinical data which could harm our reputation, disrupt our operations, or
result in remedial and other costs, fines or lawsuits.
We
design, manufacture and service products
that incorporate advanced technologies; the introduction of new products and technologies involves risks
risks, and we may not realize the degree
or timing of benefits initially anticipated; competition may reduce our revenues and segment
share and limit our future opportunities.
Management's Discussion & Analysis (MD&A)
Removed heading “SINTX Core Business”
Removed heading “Insurance Premium Finance Arrangements”
Largest changes
“On June 11, 2024, the Company received formal notice from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has evidenced compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”). The Company remains subject to a “Mandatory Panel Monitor,” as that term is defined in Listing Rule 5815(d)(4)(B), for a period of one year from June 11, 2024. …”see in full comparison
“Goodwill represents the excess of the purchase price over the fair market value of identifiable net assets. Goodwill is not amortized, but rather is tested at the reporting unit level at least annually for impairment or more frequently if triggering events or changes in circumstances indicate impairment. Initially, qualitative factors are considered to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount. …”see in full comparison
“While management has implemented plans intended to mitigate these conditions, we have concluded that substantial doubt exists about the Company’s ability to continue as a going concern for 12 months from the date these consolidated financial statements are issued. The consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.”see in full comparison
“Based on the decrease in expenditures from the reduction in force, sale of TA&T and the increase in cash on February 20, 2025, SINTX management has determined that there is no uncertainty of the Company’s ability to continue as a going concern through at least March 19, 2026 and further analysis of this matter is not deemed necessary for the year ended December 31, 2024.”see in full comparison
“On February 20, 2025, entered into a private placement transaction pursuant to a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional and accredited investors for aggregate gross proceeds of $5.0 million, before deducting fees to the placement agent and other expenses payable by the Company in connection with the Private Placement. The Company intends to use the net proceeds from the Private Placement for general corporate purposes and working capital. H.C. Wainwright & Co. …”see in full comparison
Full comparison: every changed paragraph (68)
SINTX Technologies is an advanced ceramics company formed in December 1996 that develops, manufactures, and commercializes silicon nitride biomaterials, composites, devices, and related technologies for medical and other high-value applications. SINTX provides biomedical solutions for medical devices specializing in silicon nitride (Si₃N₄) for musculoskeletal and antipathogenic applications. We also manufacture parts made from silicon nitride for customers in the electrical, aerospace and other industrial sectors. SINTX is a global leader in the research, development, and manufacturing of silicon nitride, and its products have been implanted in humans since 2008.
SINTX Technologies is an advanced ceramics company
formed in December 1996, focused on providing solutions in a variety of biomedical, technical, and antipathogenic applications. We have
grown from focusing primarily on the research, development and commercialization of medical devices manufactured with silicon nitride
to becoming an advanced ceramics company engaged in diverse fields, including biomedical, technical and antipathogenic applications.
This diversification enables us to focus on our core competencies which are the manufacturing, research, and development of products
comprised from advanced ceramic materials for external partners. We seek to connect with new customers, partners and manufacturers to
help them realize the goal of leveraging our expertise in advanced ceramics to create new, innovative products across these sectors.
SINTX Core Business
Revenue
Product revenue decreased $0.5 million, or 41%, compared to the same period in 2024. Grant and contract revenue decreased $1.4 million, or 82%, compared to the same period in 2024.
Product Revenue, GrantRevenue
trends and Contractstrategic Revenuefocus
The decrease in total revenue was primarily due to the Company’s ongoing strategic repositioning away from non-core, low-margin OEM technical manufacturing contracts that did not support long-term profitability. This planned reduction in OEM-related revenue is consistent with our corporate shift toward commercializing proprietary silicon nitride-based biomedical devices, which we believe offer stronger margins, a more defensible competitive position, and better long-term value for shareholders.
While this strategic realignment has led to a decline in reported revenue, we believe it is a necessary step in positioning the Company for sustainable growth. During this transitional period, we continue to invest in the development and regulatory advancement of silicon nitride-based orthopedic and surgical implants, as evidenced by the recently received 510(k) clearance for osteotomy wedges used in foot and ankle fusion procedures. Additionally, we entered into a private label agreement to supply OsseoSculpt™, a next-generation biologic designed to complement the foot and ankle osteotomy wedges. We began recognizing commercial revenue from OsseoSculpt™ in the second half of 2025. We believe that these products will serve as key revenue drivers in 2026.
Total product revenue remained relatively flat
when comparing the years ended December 31, 2024 and 2023. During the year ended December 31, 2024, the Company grant and contract revenue
increased $0.2 million or 17% as compared to the same period in 2023.
Costs Cost
of Revenue and Gross Profit
Cost of revenue decreased $0.3 million, or 31%, compared to the same period in 2024, while gross profit decreased $1.6 million, or 78%, for the same period. These decreases were primarily due to the decrease in revenue mentioned above.
Cost of revenue remained relatively flat when
comparing the years ended December 31, 2024 and 2023. Gross profit increased $0.2 million, or 13%, as compared to the same period in
2023. This increase was primarily attributed to an increase in grant and contract revenue and a shift in product mix to more profitable
products.
Research
and development expenses decreased $3.5
$0.6 million, or -40%, as12%, compared to the same period in 2023.2024. This decrease was primarily attributabledue to a decrease
in inpayroll related costs, patent expenses,
employee wages, product prototypes, and toolingoutside expenses.consulting costs, partially offset by an increase in costs related
to a research agreement.
General and administrative expenses decreased
$0.2increased $2.2 million, or -5%, as 55%,
compared to the same period in 2023.2024. This decreaseincrease is primarily due to aincreased decreasestock-based in employee wagescompensation and recruitingother headcount related
expenses.costs, and fees paid to departing members of the board of directors, partially offset by lower legal expenses and outside consulting costs.
Sales
and marketing expenses decreased $0.5$0.4 million,
or -46%, as61%, compared to the same period in 2023.2024. This decrease was primarily attributabledue to a reduction decreases
in employeepayroll wagesrelated costs and an overall
decrease in costs for outside consulting.consulting costs.
Armor
exit costs increaseddecreased $4.6 million, or 100%,
as compared to the same period in 2023.2024. This increasedecrease was primarily attributable to an increase inthe asset impairment
costs at the SINTX
Armor facility.
Reduction
in force expenses increaseddecreased $0.4 million,
or 100%, as compared to the same period in 2023.2024. This increasedecrease was primarily attributable to payroll
expenses related to severance and
accrued vacation payouts.
Grant
and contract expenses increaseddecreased $0.2$1.1 million,
or 15%, as88%, compared to the same period in 2023.2024. This increasedecrease was primarily attributabledue to athe general increase decrease
in grant and contract
revenue whenassociated compared towith the priorsale year.of the TA&T subsidiary.
Other
income income(expense), net decreased $2.1$2.7 million, or -41%,
as88%, compared to the same period in 2023.2024. This decrease was primarily due to a $3.6
million decrease in the change in the fair value of thederivative derivative
liabilitiesliabilities, partially offset by $0.5 million change in thederivative amountliabilities
offering costs, a $0.3 million gain on disposal of $2.8property million,and equipment associated with SINTX Armor, and a $0.1 million increase in
interest gain on disposal of assets offset by $0.8 million in offering
costs on derivative liabilities in 2023 with no corresponding amount in 2024.income.
To
date, the Company’sour operations have
been principally financed from proceeds from the issuance of preferred and common stock and, to a lesser extent,
cash generated from
product sales. ItWe is anticipatedexpect that the Companywe will continue to generate operating losses and use cash in operations. TheOur Company’scontinuation
continuation as a going concern is dependent upon its ability to increase sales, decrease expenses and/ raise additional funding. WhetherIt is uncertain when,
andif whenever, thewe Company canwill attain profitability and positive cash flows from operations or obtain additional financing is uncertain.financing.
The Company is actively generating additional
scientific and clinical data to have it published in leading industry publications. We believe the publication of such data would help
sales efforts as the Company approaches new prospects. The Company is also making additional changes to the sales strategy, including
a focus on revenue growth by expanding the use of silicon nitride in other areas outside of spinal fusion applications.
The Company has common stock that is publicly
traded and has been able to successfully raise capital when needed since the date of the Company’s initial public offering in February
2014.
On February 20, 2025, entered into a private
placement transaction pursuant to a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional and
accredited investors for aggregate gross proceeds of $5.0 million, before deducting fees to the placement agent and other expenses payable
by the Company in connection with the Private Placement. The Company intends to use the net proceeds from the Private Placement for general
corporate purposes and working capital. H.C. Wainwright & Co. (“Wainwright”), acted as the exclusive placement agent
for the Private Placement, which closed on February 25, 2025. As part of the Private Placement, the Company issued (i) 1,171,189 shares
of the Company’s common stock, par value $0.01 per share (“Common Stock”), (ii) pre-funded warrants to purchase 278,098
shares of Common Stock (the “Pre-Funded Warrants”) with an exercise price of $0.0001 per share, and (iii) warrants to purchase
1,449,287 shares of Common Stock (the “Common Warrants,” together with the Pre-Funded Warrants, the “Warrants”)
(the Warrants, together with the Shares and Warrant Shares (as defined below), the “Securities”) with an exercise price of
$3.32 per share. The purchase price per share of Common Stock and the associated Common Warrant was $3.45 and the purchase price per
Pre-Funded Warrant and associated Common Warrant was $3.4499. The Common Warrants are exercisable immediately and expire five-and one-half
years from issuance. The Pre-Funded Warrants are exercisable immediately and terminate when exercised in full.
On February 2, 2024, the Company closed on a
public offering of 80,000 units, with each unit consisting of one share of its common stock, or one pre-funded warrant to purchase one
share of its common stock, one Class E Warrant with each warrant entitled to purchase one share of common stock, and one Class F Warrant
with each warrant entitled to purchase one share of common stock. Each unit was sold at a public offering price of $50.00 resulting in
gross proceeds to the Company of $4 million before deducting offering fees and expenses. The Class E and Class F Warrants were immediately
exercisable at a price of $50.00 per share. The Class E Warrants expire five years from the date of issuance and the Class F Warrants
expire eighteen months from the date of issuance. Of the $4.0 million of gross proceeds, approximately $0.6 million were allocated to
common stock and prefunded warrants ($0.5 million net of offering costs) and approximately $3.4 million were allocated to derivative
liabilities (with approximately $0.5 million of cash offering costs and $0.1 million of agent warrant offering costs recorded as derivative
expense).
On February 10, 2023, the Company closed on a
public offering of 10,750 units, with each unit consisting of one share of common stock, or one pre-funded warrant to purchase one share
of its common stock, one Class C Warrant to purchase one share of common stock, and one half of one Class D Warrant with each whole Class
D Warrant entitling the holder to purchase one share of common stock. Gross proceeds, before deducting offering expenses, totaled approximately
$12.0 million. Of the $12.0 million of gross proceeds, approximately $5.4 million were allocated to common stock and prefunded warrants
($4.8 million net of offering costs) and approximately $6.7 million were allocated to derivative liabilities (with approximately $0.7
million of cash offering costs and $0.1 million of agent warrant offering costs recorded as derivative expense).
On March 26, 2024, the Company closed on a public
offering of 142,000 shares of the Company’s common stock, (the “March 26 Offering”). Each Share was sold at a public
offering price of $9.40. The aggregate proceeds to the Company from the March 26 Offering were approximately $1.3 million before deducting
placement agent fees and other estimated offering expenses payable by the Company.
On April 5, 2024, the Company closed on a public
offering of 358,000 shares of the Company’s common stock, (the “April 5 Offering”). Each Share was sold at a public
offering price of $4.20. The aggregate proceeds to the Company from the April 5 Offering were approximately $1.5 million before deducting
placement agent fees and other offering expenses payable by the Company.
On October 17, 2022, the Company completed a
rights offering of units consisting of convertible preferred stock and common stock warrants, resulting in gross proceeds to the Company
of approximately $4.7 million, after deducting expenses relating to the offering, including dealer-manager fees and expenses, On February 25, 2021, the Company entered into
an Equity Distribution Agreement (the “ATM Agreement”) with Maxim Group LLC (the “Agent”), as sales agent, as
amended on January 10, 2023 and October 12, 2023 , pursuant to which the Company could offer and sell shares of the Company’s common
stock, par value $0.01 pershare (the “Shares”), initially up to an aggregate offering price of $15,000,000, from time to
time in an at-the-market public offering.
On March 22, 2024, the company suspended sales
under the ATM Agreement and terminated the continuous offering. On July 11, 2024, the Company filed a Prospectus Supplement with the
SEC adjusting the amount available for sale under the ATM Agreement to $3.1 million and shortly thereafter begin offering and selling
Shares under the ATM Agreement to the public. During the year ended December 31, 2024, 602,357 Shares were sold under the ATM Agreement
for gross proceeds of approximately $3.7 million. Because the Company is subject to General Instruction I.B.6 of Form S-3, it is restricted
from selling securities in a public primary offering with a value exceeding one-third of its public float (the market value of our common
stock held by our non-affiliates) in any 12-month period so long as its public float remains below $75.0 million. As of December 31,
2024, there was no capacity to offer and sell Shares under the ATM Agreement.
On June 11, 2024, the Company received formal
notice from The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has evidenced compliance with the $1.00 minimum bid price
requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Rule”).
The Company remains subject to a “Mandatory Panel Monitor,” as that term is defined in Listing Rule 5815(d)(4)(B), for a
period of one year from June 11, 2024. If, within the one-year period, the Company fails to satisfy the minimum $1.00 closing bid price
threshold for 30 consecutive business days, Nasdaq will issue a delist determination rather than provide the Company with a grace period
to regain compliance with the Bid Price Rule. In that event, the Company would have the opportunity to request a new hearing to address
the deficiency.
We
continue areto actively seekingseek opportunities to raise
additional funding through equity and/or debt financing. However, such funding is not guaranteed
and may not be available to the Company on favorable
or acceptable terms and may involve significant restrictive covenants. Any additional equity financing, if availableavailable, to the Company,will
will most likely be dilutive to its current stockholders. If thewe Company isare not able to obtain additional debt or equity financing on
a timely basis,financing, the impact on
our thecompany Companyand business will be material and adverse.
The Board of Directors, together with management,
is performing an ongoing evaluation of the Company’s business strategy and focus. On August 1, 2024, the board of directors appointed
Eric Olson to the office of Chief Executive Officer and President to lead the evaluation process.
The
board Companyof hasdirectors, implementedtogether awith changemanagement, remains focused on advancing our business strategy and focus. Our strategic emphasis is
focused on utilizing our technology in strategic
emphasis tomaking advancements in the medical devicebiomedical sector. Historically engaged in both industrial and biomedical
applications, SINTXwe is
prioritizinghave prioritized the development and commercialization of innovative medical devices, leveraging our expertise in advanced
ceramics and biomaterials.
Such aThis renewed focus would alignaligns with a commitment to improving patient outcomes through the creation of products
designed for surgical,
orthopedic, and other specialized medical applications. We wouldare concentrateconcentrating our resources on high-growth areas
within the healthcare
sector where our proprietary materials and technologies—such as silicon nitride—provide a distinct
competitive advantage
due to their unique strength, durability, and biocompatibility.
Through
this transformation, SINTX’sas demonstrated by the recent FDA 510(k) clearance of our SiNAPTIC® Foot & Ankle Osteotomy Wedge System,
our aim
would beis to deliver meaningful innovations to the medical community. Our current research and development pipeline is centered on medical-grade
devices that incorporate antimicrobial properties, enhanced imaging capabilities, and durability under physiological conditions, which
are critical for orthopedic implants, spinal fusion devices, and other surgical tools. IfAs we transition our focus away from industrial
applications, applications,
we anticipate this strategic shift will enable us to better serve the medical sector, address critical unmet needs, and
position SINTX
as a leading provider in the medical device market. By focusing on partnerships and collaborations with healthcare institutions
and industry
leaders, SINTXwe isbelieve that we are positioned to expand itsour footprint in the medical device sector and drive shareholder value
through sustainable, high-impact
innovations, however, such a transition has not been approved by the Board of Directors, nor can such approval or successful transition
be assured.innovations.
On
August 8, 2024, the Boardboard of Directorsdirectors approved
a plan to implement a Company-wide reduction in the workforce. This decision iswas part
of the Company’san ongoing strategic review
of itsour operations aimed at improving operational efficiency and reducing costs. The reduction in force reduced the number of employees
of the Company from 40 to 23. During the year ended December 31, 2024, the Company recorded expenses of approximately $407,000 associated
with the reduction in workforce.
On
August 12, 2024, the Boardboard of Directors of
the Companydirectors approved a plan to cease efforts to make the armor plant operational. This decision was made
to streamline operations and
focus on core business areas that align with the Company’sour long-term strategic goals. The armor plant hashad not been
fully operational
since the acquisition of the armor equipment in July 2021 and hashad been completely shut down since October 2023 due
to the malfunctioning
of the sintering furnace. In connection with this decisiondecision, the Companywe incurred an impairment charge of approximately $4.6
million during
the year ended December 31, 2024. This charge primarily relates to the write-down of certain long-lived assets associated
with the armor
plant to their estimated fair value.
The Company’s insurance carrier has determined
that a covered loss occurred when the sintering furnace malfunctioned, and coverage is available for the Company’s repair of the
sintering furnace. However, the Company’s efforts to fully repair the damaged furnace continue to be delayed. Management will work
with the insurance company to continue to fund the repair of the furnace. When the furnace is fully repaired, management intends to sell
the furnace, and related equipment, to a third party. However, the full repair and sale of the furnace, and related equipment, cannot
be assured. Therefore, in the calculation of the $4.6 million impairment charge, management has assumed no proceeds
will be received from a potential sale of the furnace and related equipment.
Sale of TA&T
On
February 19, 2025, we entered into an Entity
Acquisition Agreement (the “Agreement”) with Tethon Corporation (“Tethon”),
pursuant to which the Company sold
to Tethon all of the issued and outstanding shares of Technology Assessment and Transfer, Inc. (“TA&T”), a wholly owned
subsidiary of the Company, in exchange for the assumption by Tethon
of the outstanding liabilities of TA&T (the “Sale”).T.
In October 2025, we received FDA 510(k) clearance for a new foot and ankle osteotomy wedge system, enabling SINTX’s commercial entry into reconstructive foot and ankle surgery in the United States. Revenue is expected to begin during the first half of 2026.
In October 2025, we entered into the 2025 ATM Agreement to sell shares of its common stock from time to time, through an “at the market offering” program, having an aggregate offering price of $6.4 million was filed with the SEC. As of December 31, 2025, there is $6.0 million remaining balance on the 2025 ATM Agreement.
In October 2025, we entered into a sublease agreement to lease the SINTX armor facility to a third party, which is expected to save the Company approximately $1.0 million over the sublease term.
While management has implemented plans intended to mitigate these conditions, we have concluded that substantial doubt exists about the Company’s ability to continue as a going concern for 12 months from the date these consolidated financial statements are issued. The consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.
Based on the decrease in expenditures from the reduction
in force, sale of TA&T and the increase in cash on February 20, 2025, SINTX management has determined that there is no uncertainty
of the Company’s ability to continue as a going concern through at least March 19, 2026 and further analysis of this matter is not
deemed necessary for the year ended December 31, 2024.
Net cash used in operating activities was $8.6 million in 2025, compared to $8.6 million used in 2024, remaining consistent year over year.
Net cash used in operating activities was $8.6
million in 2024, compared to $14.1 million used in 2023, a decrease of $5.5 million. The decrease in the net loss from operations, and
related non-cash add backs to the net loss, was $3.4 million from 2024 when compared to 2023. The decrease in cash used for operating
activities during 2024 was primarily due to the $3.4 million mentioned above plus changes in the movement of working capital items during
2024 as compared to the same period in 2023 as follows: a $0.9 million decrease in cash used in accounts receivable, a $0.7 million decrease
in cash used for prepaids, a $0.6 million decrease for inventory, a $0.4 million decrease in cash used in other liabilities, and a $0.2
million decrease in cash used for payments on operating lease liability, all offset by a $0.7 million increase in cash used in accounts
payable and accrued liabilities.
Net Cash Provided by (Used in) Investing Activities
Net
cash usedprovided inby investing activities was $0.2
$0.9 million during 2024,2025, compared to $0.5$0.2 million used in investing activities during the
same period in 2023,2024, aan decreaseincrease of $0.3$1.1 million.
The decreaseincrease in cash usedprovided inby investing activities during 20242025 was primarily due
to a$0.8 million in proceeds from the acquisition of Sinaptic Surgical, $0.5 million decrease in purchase of property and equipment and
$0.3 million increase in proceeds from notesthe receivable,
offset by $0.2 million increase in purchasesale of property and equipment.equipment, partially offset by a $0.5 million decrease in proceeds from
notes receivable.
Net
cash provided by financing activities was $8.2 million during 2025, compared to $9.1 million provided by financing activities during
the same period in 2024, a decrease of $0.9 million. The $0.9 million decrease to net cash provided by financing activities was
$9.1 million during 2024, compared to $11.7 million provided by financing activities during the same period in 2023, a decrease of $2.6
million. This decrease was primarily
attributable to a decrease in proceeds from issuance of warrant derivative liabilities of $3.3$3.4 million,
an increaseand a decrease in paymentsproceeds on debtfrom
issuance of $0.2common stock and prefunded warrants of $1.7 million, partially offset by a $0.9 million increaseincreases in proceeds from the exercise of warrants,
net of cash fees, and deposit for stock issuance (in other current liabilities) of $3.6 million, proceeds from issuance of common stock.stock
in connection with ATM, net of fees of $0.3 million, and proceeds from issuance of warrants in connection with exercise of warrants of
$0.2 million.
Information with respect to our indebtedness may be found in Note 7 to the consolidated financial statements included in Part II, Item 8 of this Annual Report, which is incorporated by reference.
Business Loan
On July 20, 2021, TA&T, entered into a Loan
Authorization and Agreement in the amount of approximately $350,000 (the “Business Loan”). The Company made a one-time $35,000
buy down payment when acquiring the loan. The Business Loan bore interest at a rate of 3.75% per annum. The Business Loan was secured
by a general security interest in all of the assets of TA&T. The Business Loan contained other standard provisions that are customary
of loans of this type. The business loan was paid in full during the first quarter of 2024 and there was no outstanding balance at December
31, 2024.
Insurance Premium Finance Arrangements
In March 2024, in connection with securing Director
and Officer professional liability insurance, the Company entered into a Premium Finance Arrangement to extend the premium payment out
for a period of 10 months. The Company paid a total of $40,000 up front toward the insurance premium and financed approximately $238,000.
The Company will make 10 equal payments under the terms of the Premium Finance Agreement. The Premium Finance Agreement bears interest
at an annual percentage rate of 8.510%. The Director and Officer professional liability insurance debt was paid in full during the fourth
quarter of 2024 and there was no outstanding balance at December 31, 2024.
In June 2024, in connection with securing commercial
liability insurance, the Company entered into a Premium Finance Arrangement to extend the premium payment out for a period of 10 months.
The Company paid a total of $26,000 up front toward the insurance premium and financed approximately $117,000. The Company will make
10 equal payments under the terms of the Premium Finance Agreement. The Premium Finance Agreement bears interest at an annual percentage
rate of 8.75%. As of December 31, 2024, there was an outstanding balance of $32,000.
Information with respect to our related party transactions may be found in Note 14 to the consolidated financial statements included in Part II, Item 8 of this Annual Report, which is incorporated by reference.
We have not entered
into any transactions since January 1, 2021 to which we have been a party, in which the amount involved in the transaction exceeded the
lesser of $120,000 or one percent of the average of our total assets at year-end for the last two completed fiscal years, and in which
any of our directors, executive officers or, to our knowledge, beneficial owners of more than 5% of our common stock, on an as converted
basis, or any member of the immediate family of any of the foregoing persons had or will have a direct or indirect material interest,
other than equity and other compensation, termination, change in control and other arrangements.
Our
business is generally not seasonal in nature.
The majority of our product revenue is derived from the manufacture and sale of spinal
fusion products, used in the treatment of spine
disorders, to CTL Medical. We also retained CTL Medical to act as our exclusive broker
to offer for sale, and sell, our manufacturing
services to third party developers of spinal implants and spinal devices that incorporate
silicon nitride technology, which has a remaining
term ofthrough 3-years.2028. CTL Medical’s sales generally consist of products that are in
stock with them or maintained at hospitals or with
their sales distributors. Accordingly, we do not have a backlog of sales orders.
New
Accounting Pronouncement, Not Yet AdoptedPronouncements
Information with respect to new accounting pronouncements may be found in Note 1 to the consolidated financial statements included in Part II, Item 8 of this Annual Report, which is incorporated by reference.
What changed in the latest 10-Q
Risk Factors
Information regarding risk factors appears in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on March 20, 2026. There have been no material changes from the risk factors previously disclosed in the Annual Report on Form 10-K.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
Largest changes
Net cash used in operating activities wassee in full comparison$2.5$5.3 million during thethreesix months endedMarchJune31,30, 2026, compared to$1.3$3.7 million used during the same period in 2025, an increase of$1.2$1.6 million. The increase was primarily due to an increase in net loss of$0.5$0.9 million, combinedcombinedwithincreasesnet outflow from the change in inventories of$0.4$1.4 million,change in fair value of derivativeother liabilities of$0.3$0.8 million, and accounts receivableof$0.2 million and decreases in non-cash adjustmentsof $0.2million for non-employee stock based compensation and $0.1 million in impairment cost.million. These changes were partially offset byannetincreaseinflow from the change in accounts payable and accrued expenses of$0.5$1.5 millioninandemployeenon-cashstockadjustmentsbasedofcompensation.$0.2 million.
We do not have any off-balance sheetsee in full comparisonarrangements, as defined in Item 303(a)(4) of Regulation S-K.arrangements.
For the three months endedsee in full comparisonMarchJune31,30, 2026, general and administrative expenses increased by$1.2$0.9 million, or92%,64%, compared to the same periodperiodin 2025. The increase was primarily due to$1.1$0.8 million in higher headcount-related costs, including$0.4$0.1 million of non-cash stock-basedstock-basedcompensation, as well as the reallocation of certain overhead costs of$0.5$0.7 million, as discussed above. These increases were partially offset by decreases of $0.2 million in board of directors fees, $0.1 million in non-employee stock-based compensation, $0.1 million inimpairmentaccountingcost recognized in 2025,fees, and$0.1$0.2 million in other general expenses.
“For the three months ended June 30, 2026, cost of revenue increased by $0.1 million, or 85%, compared to the same period in 2025. For the six months ended June 30, 2026, cost of revenue increased by $0.1 million, or 21%, compared to the same period in 2025. Cost of revenue increased at a lower rate than revenue primarily due to the Company’s continued focus on higher-margin sales and a favorable sales mix, with improved pricing on certain OEM products, during the current period. …”see in full comparison
“For the six months ended June 30, 2026, general and administrative expenses increased by $2.1 million, or 78%, compared to the same period in 2025. The increase was primarily due to $1.1 million in higher headcount-related costs, including $0.5 million of non-cash stock-based compensation, as well as the reallocation of certain overhead costs of $1.4 million, as discussed above, and $0.1 million in other general expenses. These increases were partially offset by decreases of $0.3 million in non-employee stock-based compensation and $0.2 million in board of directors fees.”see in full comparison
Net cash provided by financing activities wassee in full comparison$0.2$4.8 million during thethreesix months endedMarchJune31,30, 2026, compared to$4.3$4.1 million provided during the same period in 2025. The$4.0$0.7 milliondecrease to net cash provided by financing activitiesincrease was primarily due toaandecreaseincrease in proceeds from issuance of common stockand prefunded warrants of $4.4 million, partially offset by an increase in proceeds from issuanceof common stockin connection with ATM of$0.3$0.8million andmillion, a decrease in repurchases of common stock into treasury of $0.1 million, and a decrease in payment on debt of $0.1 million. These changes were partially offset by a decrease in proceeds from issuance of common stock and warrants of $0.3 million.
Full comparison: every changed paragraph (36)
Our
product revenue is derived from the manufacture and sale of products. These revenue sources primarily include coatings, materials, and
components for aerospace and medical device markets, toll processing services, and government contracts and grants. We generally recognize
revenue from sales where control transfers at a point in time as the title and risk of loss passes to the customer, which is at the time
the product is shipped. In general, our customercustomers doesdo not have rights of return or exchange.
The
following is a tabular presentation of our unaudited condensed consolidated operating results for the three and six months ended MarchJune
31,30, 2026 and 2025 (in thousands):
For
the three months ended MarchJune 31,30, 2026, total revenue
increased $0.3 million, or 199%, compared to the same period in 2025. For the six months ended June 30, 2026, total revenue increased
$0.3 $11,000,million, or 3%,60%, compared to the same period in 2025. When excluding the
total revenue decrease of $109,000$0.1 million due to the sale of
the TA&T subsidiary, the remaining total revenue for the six months ended June 30, 2026 increased by $120,000,$0.4 million, or
46%. 102%.
For
the three months ended MarchJune 31,30, 2026, product
revenue increased $0.3 million, or 347%, compared to the same period in 2025. For the six months ended June 30, 2026, product revenue
increased $9,000,$0.4 million, or 3%,91%, compared to the same period in 2025. When excluding the
product revenue decrease of $64,000$0.1 million due to
the sale of the TA&T subsidiary, the remaining product revenue for the six months ended June 30, 2026 increased by $73,000,$0.4 million, or
32%.128%.
During
the three months ended MarchJune 31,30, 2026, grant and contract revenue increaseddecreased $2,000,$46,000, or 3%,90%, as compared to the same period in 2025. During
the six months ended June 30, 2026, grant and contract revenue decreased $44,000, or 34%, as compared to the same period in 2025. When
excluding the grant and contract revenue decrease of $45,000 due to the sale of the TA&T subsidiary, the remaining grant and contract
revenue for the six months ended June 30, 2026 increased by $47,000,$1,000, or 142%.1%.
Total revenue increased compared with the prior-year periods, primarily reflecting higher product sales from the Company’s operations. Comparability to the prior year was also affected by the divestiture of the TA&T subsidiary during the first quarter of 2025.
Product revenue growth was driven primarily by increased sales within the Company’s OEM technical manufacturing products, reflecting improved customer demand and pricing, together with initial commercial sales of the SiNAPTIC Foot & Ankle Osteotomy Wedge System. These increases were partially offset by lower grant and contract revenue, which can fluctuate based on the timing and scope of funded projects.
Total
revenue for the period was relatively consistent with the prior year, reflecting a combination of underlying growth in the Company’s
continuing operations and the impact of changes to its business portfolio.
Revenue
from ongoing product lines and customer activities increased compared to the prior year period, driven by growth in the Company’s
spine-related product offerings and continued demand within its OEM technical manufacturing business. In addition, activity under grant
and contract programs contributed to period-over-period variability.
These
increases were partially offset by the absence of revenue associated with the Company’s former TA&T subsidiary, which was divested
in Q1 2025.
The
Company continues to support its OEM technical manufacturing operationsproduct line as aan important source of revenue and cash flow,flow. withRecent recent,pricing
initiatives meaningful
pricinghave actions improvingimproved the profitability of this segment.product Atline thewhile same time,allowing the Company remainsto focusedcontinue oninvesting in the long-term commercialization
of its proprietary silicon nitride-based biomedical devices, including its orthopedic product portfolio. Management expects the OEM product line
and its proprietary medical technology initiatives to remain complementary components of the Company’s long-term growth strategy.
For the three months ended June 30, 2026, cost of revenue increased by $0.1 million, or 85%, compared to the same period in 2025. For the six months ended June 30, 2026, cost of revenue increased by $0.1 million, or 21%, compared to the same period in 2025. Cost of revenue increased at a lower rate than revenue primarily due to the Company’s continued focus on higher-margin sales and a favorable sales mix, with improved pricing on certain OEM products, during the current period. Although the Company expects this strategy to continue to support profitability, gross margin may fluctuate from period to period based on product mix, pricing, manufacturing efficiencies, customer demand, and the mix of product and grant and contract revenue.
For
the three months ended March 31, 2026, cost of revenue decreased by $10,000, or 4%, compared to the same period in 2025, primarily due
to a continued focus on higher-margin sales.
For
the three months ended MarchJune 31,30, 2026, research and development expenses decreased by $0.8$0.7 million, or 67%,54%, compared to the same
period period
in 2025. The decrease was primarily due to a $0.3$0.7 million reduction in headcount-related costs and $0.5 million due to the reallocation
of certain overhead costs to general and
administrative expenses.expenses Historically,(also asee significantexplanation portionbelow). of our operations was focused on
research and development, resulting in the majority of overhead costs being allocated toOther research and development.development Asexpenses ourremained focusconsistent hasduring shiftedthe
toward commercialization, a greater portion of these costs is now classified as general and administrative.period.
For the six months ended June 30, 2026, research and development expenses decreased by $1.4 million, or 60%, compared to the same period in 2025. The decrease was primarily due to $1.4 million in the reallocation of certain overhead costs to general and administrative expenses (also see explanation below). Other research and development expenses remained consistent during the period.
Historically, a significant portion of our operations was focused on research and development, resulting in the majority of overhead costs being allocated to research and development. As our focus has shifted toward commercialization, a greater portion of these costs is now classified as general and administrative.
For
the three months ended MarchJune 31,30, 2026, general and administrative expenses increased by $1.2$0.9 million, or 92%,64%, compared to the same
period period
in 2025. The increase was primarily due to $1.1$0.8 million in higher headcount-related costs, including $0.4$0.1 million of non-cash
stock-based stock-based
compensation, as well as the reallocation of certain overhead costs of $0.5$0.7 million, as discussed above. These increases
were partially
offset by decreases of $0.2 million in board of directors fees, $0.1 million in non-employee stock-based
compensation, $0.1 million in impairmentaccounting cost recognized in 2025,fees, and
$0.1 $0.2 million in other general expenses.
For the six months ended June 30, 2026, general and administrative expenses increased by $2.1 million, or 78%, compared to the same period in 2025. The increase was primarily due to $1.1 million in higher headcount-related costs, including $0.5 million of non-cash stock-based compensation, as well as the reallocation of certain overhead costs of $1.4 million, as discussed above, and $0.1 million in other general expenses. These increases were partially offset by decreases of $0.3 million in non-employee stock-based compensation and $0.2 million in board of directors fees.
For
the three months ended MarchJune 31,30, 2026, sales and marketing expenses increased by $0.4$0.3 million, or 1,895%,1,200%, compared to the same period
in 2025. The increase was primarily due to $0.2 million in higher headcount-related costs, including $0.1 million$34,000 of non-cash stock-based
compensation, as well as a $0.2$0.1 million increase in other sales and marketing related costs associated with our product launch.
For the six months ended June 30, 2026, sales and marketing expenses increased by $0.6 million, or 1,539%, compared to the same period in 2025. The increase was primarily due to $0.3 million in higher headcount-related costs, including $0.1 million of non-cash stock-based compensation, as well as a $0.3 million increase in other sales and marketing related costs associated with our product launch.
For
the three months ended MarchJune 31,30, 2026, grant and contract expenses increaseddecreased by $2,000,$46,000, or 4%,96%, compared to the same period in 2025,
primarily primarily
due to the increasedecrease in grant and contract revenue.
For the six months ended June 30, 2026, grant and contract expenses decreased by $44,000, or 44%, compared to the same period in 2025, primarily due to the decrease in grant and contract revenue.
For
the three months ended MarchJune 31,30, 2026, other incomeincome, increasednet decreased by $0.3$0.2 million, or 324%,48%, compared to the same period in 2025, primarily
due to a $0.3$0.4 million decrease in gain on disposal of equipment, partially offset by a $0.2 million increase in other income from the change in value
of derivative liabilities.
For the six months ended June 30, 2026, other income, net increased by $0.1 million, or 30%, compared to the same period in 2025, primarily due to a $0.4 million increase from the change in value of derivative liabilities, partially offset by a $0.3 million decrease in gain on disposal of equipment.
For
the threesix months ended MarchJune 31,30, 2026, and 2025, we incurred a net loss
of $2.8$5.5 million and $2.3$4.6 million, respectively, and used cash in
operating activities of $2.5$5.3 million and $1.3$3.7 million, respectively.
We had an accumulated deficit of $295$298 million and $292 million as
of MarchJune 31,30, 2026, and December 31, 2025, respectively.
The
board of directors and management remain aligned in advancing the Company’s strategic direction and business
objectives. While
we expect to continue generating a significant portion of our revenues from our
industrial business operations,product line, management is increasingly
concentrating resources on high-growth areas within the healthcare sector where
our proprietary materials and technologies—such
as silicon nitride—provide a distinct competitive advantage due to their unique
strength, durability, and biocompatibility. We
believe our established industrial activities provide an important operational and revenue
foundation that supports the continued development
and commercialization of our medical technologies. Building upon our established advanced
materials expertise and recent FDA 510(k) clearance
of the SiNAPTIC Foot & Ankle Osteotomy Wedge System, we are focused on commercializing
our medical technologies and advancing additional
silicon nitride-based compositions and applications for orthopedic, spinal, wound care,
and other medical markets in order to expand
our footprint in the medical device sector and support creation of long-term shareholder value creation.value.
As
discussed in further detail above, in October 2025, we received FDA 510(k)
clearance for a new foot and ankle osteotomy wedge system,
enabling SINTX’s commercial entry into reconstructive foot and ankle
surgery in the United States. Revenue wasWe recognized initial revenue from the system during Q1the 2026first and issecond expectedquarters to increase throughoutof 2026. The timing and amount
of future revenue will depend on, among other matters, physician adoption, customer ordering patterns, distributor performance, manufacturing
capacity and reimbursement and market conditions.
As
discussed in Note 9 to the condensed consolidated financial statements,
in October 2025, we entered into the 2025 ATM Agreement to sell
shares of our common stock from time to time, through an “at the
market offering” program, having an aggregate offering price
of $6.4 million. Through MarchJune 31,30, 2026, we have sold $0.7$1.3 million
under the ATM, leaving a remaining balance of $5.7$5.1 million available
under the ATM. Subsequent to March 31, 2026, we sold an additional $0.5 millionSales under the ATM.ATM depend on market conditions, eligibility to use the registration statement, trading volume and
compliance with applicable offering limitations.
As discussed in Note 9 to the condensed consolidated financial statements, in June 2026, we entered into securities purchase agreements for aggregate proceeds of approximately $4.5 million.
Despite the actions undertaken by management to improve liquidity and operating costs—including the divestiture of non-core operations, implementation of cost and pricing improvement initiatives, commercialization of newly cleared medical products, access to capital through our ATM program, and execution of the Armor facility sublease—management has concluded that substantial doubt remains regarding our ability to continue as a going concern for a period of at least 12 months from the date these condensed consolidated financial statements are issued. Our ability to continue as a going concern will depend on our ability to generate increased revenues, achieve profitability, obtain additional financing, and successfully execute our strategic business objectives. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties.
Net
cash used in operating activities was $2.5$5.3 million during the threesix months ended MarchJune 31,30, 2026, compared to $1.3$3.7 million used during
the same period in 2025, an increase of $1.2$1.6 million. The increase was primarily due to an increase in net loss of $0.5$0.9 million,
combined combined
with increasesnet outflow from the change in inventories of $0.4$1.4 million, change in fair value of derivativeother liabilities of $0.3$0.8 million, and accounts receivable of
$0.2 million and decreases in non-cash adjustments of $0.2 million for non-employee stock based compensation and $0.1 million in impairment
cost.million. These changes were partially offset by annet increaseinflow
from the change in accounts payable and accrued expenses of $0.5$1.5 million inand employeenon-cash stockadjustments basedof compensation.$0.2 million.
Net
cash used in investing activities was $7,000$0.1 million during the threesix months ended MarchJune 31,30, 2026, compared to $63,000net cash provided by investing
activities of $0.3 million during the same period
in 2025, a decrease of $56,000,$0.4 million, primarily due to a decrease in purchasesproceeds from sale
of property and equipment.
Net
cash provided by financing activities was $0.2$4.8 million during the threesix months ended MarchJune 31,30, 2026, compared to $4.3$4.1 million provided
during the same period in 2025. The $4.0$0.7 million decrease to net cash provided by financing activitiesincrease was primarily due to aan decrease
increase in proceeds from issuance of common stock and prefunded warrants of $4.4 million, partially offset by an increase in proceeds from issuance
of common stock in connection with ATM of $0.3$0.8 million andmillion, a decrease in repurchases of common stock into treasury of $0.1 million, and a decrease in
payment on debt of $0.1 million. These changes were partially offset by a decrease in proceeds from issuance of common stock and
warrants of $0.3 million.
We
do not have any off-balance sheet arrangements, as defined in Item 303(a)(4) of Regulation S-K.arrangements.
Critical
Accounting Policies and Estimates
A
summary of our significant accounting policies and estimates is discussed in Management’s Discussion and Analysis of Financial
Condition and Results of Operations and in Note 1 to our consolidated financial statements included in our Annual Report on Form
10-K 10-K
for the year ended December 31, 2025. There have been no material changes to those policies for the three and six months ended
June March 31,30, 2026.
SINT insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 0 Form 4 filings and open-market sales in 0 filings. Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-04-13 | Elmore Robert Ryan |
Grant/award | 4,910 | $2.89 | $14.2K |
Well-known investors holding SINT (13F)
| Investor | Quarter | Shares | Reported value | % of their 13F | Change vs prior quarter |
|---|---|---|---|---|---|
| Citadel Advisors (Ken Griffin) | 2026-06-30 | 31,930 | $59.7K | 0.0% | New position |