AIMD 10-K & 10-Q changes, risk factors and insider trading
Ainos, Inc. (also AIMDW) · Nasdaq · Computer Peripheral Equipment, Nec · CIK 1014763 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
New heading “AI Nose is a developing platform, and we may be unable to successfully generate meaningful revenue.”
New heading “The market for AI-enabled scent digitization and SmellTech solutions may not develop as we expect.”
New heading “AI Nose may fail to achieve acceptable accuracy, reliability, or performance across use cases and environments.”
New heading “Our AI Nose platform may contain undetected errors, defects, or limitations that could impair adoption or result in liability.”
New heading “The performance of AI Nose depends on data collection and model training, which may be insufficient or ineffective.”
New heading “Customers may be unwilling or unable to integrate AI Nose into existing systems or workflows.”
New heading “Expansion into industrial and other non-healthcare environments may expose AI Nose to new and unforeseen risks.”
New heading “Our AI Nose platform is highly technical and may contain undetected errors, which could cause harm to our reputation and adversely affect our business.”
New heading “Our reliance on third-party components and cloud infrastructure could disrupt AI Nose operations, and any errors, disruption, performance problems, or failure in their or our operational infrastructure could adversely affect our business, financial condition, and results of operations.”
New heading “We rely on the availability of licenses to third-party technology that may be difficult to replace or that may cause errors or delay implementation of our software and services should we not be able to continue or obtain a commercially reasonable license to such technology.”
New heading “Issues in the use of AI in our software may result in reputational harm or liability.”
Removed heading “Our stock price has in the past and may in the future fail to meet minimum requirements for continued listing on the Nasdaq Capital Market. Our ability to publicly or privately sell equity securities and the liquidity of our common stock could be adversely affected if we are delisted from the Nasdaq Capital Market or if we are unable to transfer our listing to another stock market.”
Largest changes
“Our stock price has in the past and may in the future fail to meet minimum requirements for continued listing on the Nasdaq Capital Market. Our ability to publicly or privately sell equity securities and the liquidity of our common stock could be adversely affected if we are delisted from the Nasdaq Capital Market or if we are unable to transfer our listing to another stock market.”see in full comparison
“Our AI Nose platform is highly technical and complex and, when deployed, may contain errors or defects. Despite testing, some errors in our products and services may only be discovered after they have been installed and used by customers. Any errors or defects discovered in our AI Nose platform after commercial release could result in failure to achieve market acceptance, loss of revenue or delay in revenue recognition, loss of customers, and increased service and warranty cost, any of which could adversely affect our business, operating results and financial condition. …”see in full comparison
“Our reliance on third-party components and cloud infrastructure could disrupt AI Nose operations, and any errors, disruption, performance problems, or failure in their or our operational infrastructure could adversely affect our business, financial condition, and results of operations.”see in full comparison
“Our products may include intellectual property licensed from third parties. It may be necessary in the future to renew licenses relating to various aspects of these software or to seek new licenses for existing or new software or other products. There can be no assurance that the necessary licenses would be available on commercially acceptable terms, if at all. Third parties may terminate their licenses with us for a variety of reasons, including actual or perceived failures or breaches of security or privacy, or reputational concerns, or they may choose not to renew their licenses with us. …”see in full comparison
“On July 15, 2024, the Company received a deficiency letter from the Nasdaq Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that, for the last 30 consecutive business days, the closing bid price for the Company’s common stock has been below the minimum $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). …”see in full comparison
“The performance of AI Nose depends on data collection and model training, which may be insufficient or ineffective.”see in full comparison
Full comparison: every changed paragraph (49)
We
are focused on product development and have generated $20,321$123,360 and $256nil in revenues from petAI supplementsNose salesrelated product, and $408$797 and $102,256 in$20,321
revenues from COVIDpet 19 antigen rapid test kitssupplements, in 2024the years ended December 31, 2025 and 2023,2024, respectively. We expect to continue to incur operating losses until
we are able to commercialize or license our other products. These operating losses have adversely affected and are likely to continue
to adversely affect our working capital, total assets and stockholders’ equity. We have generated operating losses of $13,841,204$13,990,408
and $13,206,396$13,841,204 in the years ended December 31, 20242025 and 2023,2024, respectively. As of December 31, 20242025 and 2023,2024, we had cumulative losses
of $52,749,316$67,520,328 and $37,886,155,$52,749,316, respectively. We expect to make substantial expenditures and incur increasing operating costs in the
future and our accumulated deficit will increase significantly as we expand development and clinical trial activities for our product
candidates. Because of the risks and uncertainties associated with product development, we are unable to predict the extent of any future
losses, whether we will ever generate significant revenues or if we will ever achieve or sustain profitability.
We
are a company primarily focused on product development and our product revenues may not be sufficient to fund our operations. Until,
and if, we deploy AI Nose at scale or receive approval from the TFDA, FDA and other regulatory authorities for our POCT and VELDONA product
candidates, our revenues generated from
these products may be limited. We had cash and cash equivalents of approximately $3.9$417 million thousand
as of December 31, 2024,2025, and we will need to
continue to seek capital from time to time to capitalize the development and commercialization
of our product candidates and to acquire
and develop other product candidates. Our actual capital requirements will depend on many factors.
For instance, our business or operations
may change in a manner that would consume available funds more rapidly than anticipated and
substantial additional funding may be required
to maintain operations, fund expansion, develop new or enhanced products, acquire complementary
products, business or technologies or
otherwise respond to competitive pressures and opportunities, such as a change in the regulatory
environment or a change in disease treatment
modalities. If we experience unanticipated cash requirements, we may need to seek additional
sources of financing, which may not be available
on favorable terms, if at all.
We
may be unable to access the capital marketsmarkets, and even if we can raise additional funding, we may be required to do so on terms that are
dilutive to you.
AI Nose is a developing platform, and we may be unable to successfully generate meaningful revenue.
AI Nose is an artificial intelligence–based scent digitization platform that is still under development and early commercialization. Although we have conducted pilot deployments and early-stage commercial implementations, we have not yet established a significant history of large-scale commercial adoption, recurring revenue, or long-term customer retention for AI Nose. As a result, our ability to predict demand, pricing, renewal rates, and long-term profitability for this platform is limited.
The commercialization of AI Nose may require substantial additional investment in product development, hardware, software, personnel, customer support, and sales and marketing. There can be no assurance that these investments will result in increased adoption or revenue. If AI Nose fails to achieve meaningful market acceptance or if commercialization efforts are delayed or unsuccessful, our business, operating results, and financial condition could be adversely affected.
The market for AI-enabled scent digitization and SmellTech solutions may not develop as we expect.
The market for AI-powered scent detection, classification, and interpretation remains nascent. Potential customers may not recognize scent as a valuable data modality or may choose not to adopt SmellTech solutions. If this market fails to develop, develops more slowly than expected, or adopts alternative technologies, demand for AI Nose may be limited. In addition, the size, growth rate, and long-term demand for this market are difficult to predict. Customers may choose to rely on traditional sensing technologies, alternative analytical methods, or internal processes rather than adopting AI Nose. If the market for AI-enabled scent digitization fails to develop, develops more slowly than we expect, or evolves in a way that does not favor our platform, our ability to grow AI Nose–related revenue could be materially limited.
AI Nose may fail to achieve acceptable accuracy, reliability, or performance across use cases and environments.
AI Nose integrates sensor hardware, software, cloud connectivity, and artificial intelligence models, and its performance depends on numerous variables, including environmental conditions, data quality, calibration, and model training. The platform may not perform as expected in all environments or applications, including healthcare-adjacent or industrial settings, and may require additional development, retraining, or customization to achieve acceptable results.
Our AI Nose platform may contain undetected errors, defects, or limitations that could impair adoption or result in liability.
Due to the complexity of the AI Nose platform, errors, defects, or limitations may not be identified until after deployment. These issues may arise from hardware components, software code, data processing pipelines, model training methodologies, or interactions with third-party systems. In some cases, errors may only become apparent after extended use or under specific conditions. Any such defects or failures could result in inaccurate outputs, operational disruptions, or customer dissatisfaction. In addition, errors in AI Nose outputs could expose us to warranty claims, contractual disputes, or other legal liabilities. Addressing these issues may require significant resources and may not fully mitigate the impact on customer confidence or market perception.
The performance of AI Nose depends on data collection and model training, which may be insufficient or ineffective.
AI Nose relies on the collection and labeling of scent and volatile organic compound data to train and improve its artificial intelligence models. We may face challenges in obtaining sufficient quantities of high-quality, representative data across diverse environments and use cases. Data collected from limited deployments may not adequately reflect broader operating conditions.
If the data used to train or refine AI Nose models is incomplete, biased, or otherwise inadequate, the platform’s performance may be limited or inconsistent. In addition, collecting, storing, and managing scent data may be time-consuming and costly. Any inability to effectively build or maintain suitable datasets could adversely affect the accuracy, scalability, and commercial viability of AI Nose.
Customers may be unwilling or unable to integrate AI Nose into existing systems or workflows.
AI Nose is designed to integrate with customer infrastructure, operational processes, and third-party systems. Customers may face technical, operational, regulatory, or cost-related barriers to adoption. Integration challenges, deployment complexity, or the need for additional customization may reduce adoption or delay commercial rollout.
Expansion into industrial and other non-healthcare environments may expose AI Nose to new and unforeseen risks.
While AI Nose was initially developed in healthcare-related settings, we are expanding its use into industrial and other environments. These environments may present conditions, requirements, or risks that differ materially from earlier use cases, including increased expectations for reliability, safety, or uptime. Failures or performance issues in such environments could have more significant operational or financial consequences.
Our AI Nose platform is highly technical and may contain undetected errors, which could cause harm to our reputation and adversely affect our business.
Our AI Nose platform is highly technical and complex and, when deployed, may contain errors or defects. Despite testing, some errors in our products and services may only be discovered after they have been installed and used by customers. Any errors or defects discovered in our AI Nose platform after commercial release could result in failure to achieve market acceptance, loss of revenue or delay in revenue recognition, loss of customers, and increased service and warranty cost, any of which could adversely affect our business, operating results and financial condition. In addition, we could face claims for product liability, tort, or breach of warranty. The performance of our products and services could have unforeseen or unknown adverse effects on the networks over which they are delivered as well as on third-party applications and services that utilize our products and services, which could result in legal claims against us, harming our business. Furthermore, we expect to provide implementation, consulting, and other technical services in connection with the implementation and ongoing maintenance of AI Nose, which typically involves working with sophisticated software, computing systems, and communications systems. Defending a lawsuit, regardless of its merit, is costly and may divert our management’s attention and adversely affect the market’s perception of us and our products and services. In addition, if our business liability insurance coverage proves inadequate or future coverage is unavailable on acceptable terms or at all, our business, operating results and financial condition could be adversely impacted.
We
are early in our development efforts of somePOCT ofand our productVELDONA candidates, and our business is dependent on the successful development of our
our current and future productPOCT and VELDONA candidates. If we are unable to advance our current or future product candidates through clinical
trials, trials,
obtain marketing approval and ultimately commercialize any product candidates we develop, or experience significant delays in
doing so,
our business will be materially harmed.
Our
productPOCT and VELDONA candidates are in different stages of clinical development. Our current and future product candidates may never achieve
expected expected
levels of efficacy or an acceptable safety profile. Our use of clinically validated targets to pursue treatments does not guarantee
efficacy efficacy
or safety or necessarily reduce the risk that our current or future product candidates will not achieve expected levels of efficacy
or or
an acceptable safety profile.
The
success of our business, including our ability to finance our Company and generate revenue from products in the futurefuture, will depend heavily
on the successful development and eventual commercialization of our productPOCT and VELDONA candidates, which may never occur. Our current productPOCT
and VELDONA candidates,
and any future productPOCT and VELDONA candidates we develop, will require additional nonclinical and clinical development,
management of clinical, nonclinical
and manufacturing activities, marketing approval in the United States and other markets, obtaining
sufficient manufacturing supply for
both clinical development and commercial production, building of a commercial organization, and substantial
investment and significant
marketing efforts before we generate any revenues from product sales.
The
success of our current and future productPOCT and VELDONA candidates will depend on many factors, which may include the following:
If
we are not successful with respect to one or more of these factors in a timely manner or at all, we could experience significant delays
or an inability to successfully obtain regulatory approval of or commercialize the productPOCT and VELDONA candidates we develop, which would
materially materially
harm our business. If we do not receive marketing approvals for our current or future productPOCT and VELDONA candidates, we may
not be able to continue
our operations. Even if regulatory approvals are obtained, we may never be able to successfully commercialize
any products. Accordingly,
we cannot provide assurances that we will be able to generate sufficient revenue through the sale of productsPOCT
and VELDONA to continue our business.
To
obtain the requisite regulatory approvals to commercialize any of our productPOCT and VELDONA candidates, we must demonstrate that our products
are safe
and effective in humans and animals with respect to our veterinary drug candidates. Clinical trials are expensive and can take
many years
to complete, and their outcomes are inherently uncertain. We may experience delays in completing current and future clinical
trials. trials.
We may also experience numerous unforeseen events prior to, during, or as a result of our nonclinical studies or clinical trials
that that
could delay or prevent our ability to receive marketing approval or commercialize the productPOCT and VELDONA candidates we develop, including:
We
could encounter delays if a current or future clinical trial is suspended or terminated by us, by the TFDA, FDA or other regulatory authorities
and/or review boards. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct
the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations
or trial site by the TFDA, FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues,
failure to demonstrate a benefit from using a product, changes in governmental regulations or administrative actions or lack of adequate
funding to continue the clinical trial. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical
trials may also ultimately lead to the denial of marketing approval of our productPOCT and VELDONA candidates.
If
we experience termination or delays in the completion of any clinical trial of our productPOCT and VELDONA candidates, the commercial prospects
of our
product POCT and VELDONA candidates will be harmed, and our ability to generate product revenues from any of these product candidates
may be delayed.
In addition, any delays in completing our clinical trials will likely increase our costs, slow down our productPOCT and VELDONA
candidate development
and approval process and impact our ability to commence product sales and generate revenues. Significant clinical
trial delays could
also allow our competitors to bring products to market before we do, shorten any periods during which we may have
the exclusive right
to commercialize our product candidates, impair our ability to commercialize our productPOCT and VELDONA candidates and
harm our business and results
of operations.
Any
current or future productPOCT and VELDONA candidates, including medical device products, we may develop and the activities associated with their
development development
and commercialization, including their design, testing, manufacture, recordkeeping, labeling, storage, approval, advertising,
promotion, promotion,
sale, and distribution, are subject to comprehensive regulation by the FDA and other regulatory authorities in the United
States and
by comparable authorities in Taiwan and other countries. Failure to obtain marketing approval for a product candidate will
prevent us
from commercializing the product candidate in a given jurisdiction. It is possible that some of our current or future productPOCT
and VELDONA candidates
will not obtain regulatory approval in the jurisdiction we are targeting. We have limited experience in filing
and supporting the applications
necessary to gain marketing approvals, but we expect to rely on third-party CROs or regulatory consultants
to assist us in this process.
Securing regulatory approval requires the submission of extensive applications to the various regulatory
authorities. ProductPOCT and VELDONA candidates
we develop may not be effective or may prove to have adverse characteristics that may preclude
our obtaining marketing approval or prevent
or limit commercial use.
Even
if a current or future product candidate, including AI Nose, POCT and VELDONA, receives marketing approval, it may fail to achieve the
degree degree
of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial
success.
The
regulations that govern marketing approvals, pricing and reimbursement for new products vary widely from country to country. Some countries
require approval of the sale price of a product before it can be marketed. In many countries, the pricing review period begins after
marketing approval is granted. As a result, we might obtain marketing approval for a product candidate in a particular country,country but then
be subject to price regulations that delay our commercial launch of the product candidate. Adverse pricing limitations may hinder our
ability to recoup our investment in one or more product candidates, even if our product candidates obtain marketing approval. Our ability
to successfully commercialize any product candidates, whether as a single agent or in combination, will also depend in part on the extent
to which coverage and reimbursement for these product candidates and related treatments is available from government authorities, private
health insurers and other organizations. Government authorities and third-party payors, such as private health insurers and health maintenance
organizations, and establish reimbursement levels. It is difficult to predict at this time what government authorities and third-party
payors may decide with respect to coverage and reimbursement for our programs (if approved).
Our reliance on third-party components and cloud infrastructure could disrupt AI Nose operations, and any errors, disruption, performance problems, or failure in their or our operational infrastructure could adversely affect our business, financial condition, and results of operations.
AI Nose depends on third-party hardware components, cloud service providers, and connectivity. Interruptions, changes in service terms, outages, or failures of these third parties could impair the performance or availability of AI Nose, delay deployments, or increase costs, any of which could adversely affect customer relationships and adoption. We may have limited ability to control or influence the performance, security, or reliability of these third parties.
Our systems and the third-party systems upon which we and our customers rely are also vulnerable to damage or interruption from catastrophic occurrences such as earthquakes, floods, fires, power loss, telecommunication failures, cybersecurity threats, terrorist attacks, natural disasters, public health crises, geopolitical and similar events, or acts of misconduct. Despite any precautions we may take, the occurrence of a catastrophic disaster or other unanticipated problems at our or our third-party vendors’ hosting facilities, or within our systems or the systems of third parties upon which we rely, could result in interruptions, performance problems, or failure of our infrastructure, technology, or software, which may adversely impact our business. In addition, our ability to conduct normal business operations could be severely affected. In the event of significant physical damage to one of these facilities, it may take a significant period of time to achieve full resumption of our services, and our disaster recovery planning may not account for all eventualities. In addition, any negative publicity arising from these disruptions could harm our reputation and brand and adversely affect our business.
We may experience, disruptions, failures, data loss, outages, and other performance problems with our infrastructure and cloud-based offerings due to a variety of factors, including infrastructure changes, introductions of new functionality, human or software errors, employee misconduct, capacity constraints, denial of service attacks, phishing attacks, computer viruses, malicious or destructive code, or other security-related incidents, and our disaster recovery planning may not be sufficient for all situations. If we experience disruptions, failures, data loss, outages, or other performance problems, our business, financial condition, and results of operations could be adversely affected.
A failure to maintain our relationships with our third-party providers (or obtain adequate replacements), and to receive services from such providers that do not contain any material errors or defects, could adversely affect our ability to deliver effective products and solutions to our customers and adversely affect our business and results of operations.
We rely on the availability of licenses to third-party technology that may be difficult to replace or that may cause errors or delay implementation of our software and services should we not be able to continue or obtain a commercially reasonable license to such technology.
Our products may include intellectual property licensed from third parties. It may be necessary in the future to renew licenses relating to various aspects of these software or to seek new licenses for existing or new software or other products. There can be no assurance that the necessary licenses would be available on commercially acceptable terms, if at all. Third parties may terminate their licenses with us for a variety of reasons, including actual or perceived failures or breaches of security or privacy, or reputational concerns, or they may choose not to renew their licenses with us. In addition, we may be subject to liability if third-party software that we license is found to infringe, misappropriate, or otherwise violate intellectual property or privacy rights of others. The loss of, or inability to obtain, certain third-party licenses or other rights or to obtain such licenses or rights on favorable terms, or the need to engage in litigation regarding these matters, could result in product roll-backs, delays in product releases until equivalent technology can be identified, licensed or developed, if at all, and integrated into our software, and may have a material adverse effect on our business, financial condition, and results of operations. Moreover, the inclusion in our software of software or other intellectual property licensed from third parties on a nonexclusive basis could limit our ability to differentiate our software from products of our competitors and could inhibit our ability to provide the current level of service to existing customers.
In addition, any data that we license from third parties for potential use in our software may contain errors or defects, which could negatively impact the analytics that our customers perform on or with such data. This may have a negative impact on how our software is perceived by our current and potential customers and could materially damage our reputation and brand.
Changes in or the loss of third-party licenses could lead to our software becoming inoperable or the performance of our software being materially reduced resulting in our potentially needing to incur additional research and development costs to ensure continued performance of our software or a material increase in the costs of licensing, and we may experience decreased demand for our software.
Issues in the use of AI in our software may result in reputational harm or liability.
AI is enabled by or integrated into AI Nose and is a significant and potentially growing element of our business. As with many developing technologies, AI presents risks and challenges that could affect its further development, adoption, and use, and therefore our business. AI algorithms may be flawed. Datasets may be insufficient, of poor quality, or contain biased information. Inappropriate or controversial data practices by data scientists, engineers, and end-users of our systems could impair the acceptance of AI solutions. The rapid evolution of AI and its evolving regulatory landscape may also require additional resources to develop, test and maintain our platforms and products to help ensure that AI is implemented appropriately in order to minimize unintended or harmful impact, which may be costly and may not produce the benefits and results that we expect. If the recommendations, forecasts, or analyses that AI applications assist in producing are deficient or inaccurate, we could be subjected to competitive harm, potential legal liability, and brand or reputational harm. Some AI scenarios present ethical issues. Though our technologies and business practices are designed to mitigate many of these risks, if we enable or offer AI solutions that are controversial because of their purported or real impact on human rights, privacy, employment, or other social issues, we may experience brand or reputational harm.
Research
and development of drug candidates such as VELDONA is extremely expensive and complexcomplex, and itsit’s difficult to evaluate the likelihood
of the
outcome of clinical trials, regulatory approvals, and our business and future prospects.
An
active trading market for our common stock may not developdevelop, and the market price of our common stock and warrants could be volatile.
We
do not intend to pay dividends for the foreseeable futurefuture, and, as a result, our ability to achieve a return on your investment will
depend depend
on appreciation in the price of our common stock.
Our
stock price has in the past and may in the future fail to meet minimum requirements for continued listing on the Nasdaq Capital Market.
Our ability to publicly or privately sell equity securities and the liquidity of our common stock could be adversely affected if we are
delisted from the Nasdaq Capital Market or if we are unable to transfer our listing to another stock market.
On
July 15, 2024, the Company received a deficiency letter from the Nasdaq Listing Qualifications Department (the “Staff”) of
The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that, for the last 30 consecutive business days, the closing
bid price for the Company’s common stock has been below the minimum $1.00 per share required for continued listing on The Nasdaq
Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). The Nasdaq deficiency letter
has no immediate effect on the listing of the Company’s common stock, and its common stock will continue to trade on The Nasdaq
Capital Market under the symbol “AIMD” at this time. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has
been given 180 calendar days, or until January 13, 2025, to regain compliance with the Minimum Bid Price Requirement. If at any time
before January 13, 2025, the bid price of the Company’s common stock closes at $1.00 per share or more for a minimum of 10 consecutive
business days, the Staff will provide written confirmation that the Company has achieved compliance. If the Company does not regain compliance
with the Minimum Bid Price Requirement by January 13, 2025, the Company may be afforded a second 180 calendar day period to regain compliance.
To qualify, the Company would be required to meet the continued listing requirement for market value of publicly held shares and all
other initial listing standards for The Nasdaq Capital Market, except for the Minimum Bid Price Requirement. In addition, the Company
would be required to notify Nasdaq of its intent to cure the deficiency during the second compliance period. If the Company meets these
requirements, Nasdaq will inform the Company that it has been granted an additional 180 calendar days. However, if it appears to Staff
that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq will provide notice that
the Company’s securities are subject to delisting. The Company intends to monitor the closing bid price of its common stock and
may, if appropriate, consider available options to regain compliance with the Minimum Bid Price Requirement. However, there can be no
assurance that the Company will be able to regain compliance with the Minimum Bid Price Requirement or will otherwise be in compliance
with other Nasdaq Listing Rules. On July 19,2024 the Company filed a Form 8-K with the SEC disclosing the herein matters.
On
January 14, 2025, the Company received written notification from Nasdaq notifying the Company that it had received another 180-day extension,
until July 14, 2025, to regain compliance with the Minimum Bid Price Requirement.
Management's Discussion & Analysis (MD&A)
New heading “Advancement of AI Nose toward early commercialization.”
New heading “Progress in healthcare-adjacent and senior care applications.”
New heading “Progress in VELDONA® therapeutic programs.”
New heading “Shift toward industrial and infrastructure-oriented applications.”
New heading “Data-driven platform development.”
New heading “Senior care and healthcare-adjacent opportunities.”
New heading “VELDONA® program management.”
New heading “Strategy Outlook”
Removed heading “Contractual Obligations and Commitments”
Largest changes
R&D expenses for the years ended December 31,see in full comparison20242025 and20232024 were$8,413,923$7,749,772 and$7,317,388,$8,413,923, respectively. Theincreasedecrease$1,096,535of $664,151 (15%8%) was due toincreaseddecreased staffing expenditures (including share-based compensation) and co-researchexpenses,expenses but offset byaandecreaseincrease inimpairmentpatentlossapplicationand&materialmaintenance expenses. We expect that our R&D expensesrelated to clinical trialswill continue to grow as we further develop AI Nose programsVOC POCTand VELDONA drugcandidates and increase the pace of clinical trials previously delayed during the COVID-19 pandemic.candidates.
“As part of our robotics-related expansion, we initiated pilot deployments of AI Nose across seven operational sites in Japan through a collaboration with a Japanese service robotics partner. These pilots are designed to evaluate real-world performance in continuous monitoring and facility operations and to generate deployment data supporting further model refinement and commercial scaling.”see in full comparison
“In August 2024, we announced that our VOC co-development program, initiated in 2023, with Nisshinbo Micro Devices Inc. (“NISD”) and Taiwan Inabata Sangyo Co. (“Taiwan Inabata”) achieved several key milestones. First, we have developed a solution targeting the elderly care market. Second, we marked a key milestone in expanding AI Nose application in industrial use-case, with our solution delivering 79% accuracy in 22 different volatile organic compounds (VOCs) in semiconductor factories. …”see in full comparison
“The financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred net operating losses and has an accumulated deficit as of December 31, 2025 of $67,520,328 and expects to incur additional losses and negative operating cash flows for at least the next twelve months. The Company’s ability to meet its obligations is dependent upon its ability to generate sufficient cash flows from operations and future financing transactions. …”see in full comparison
“In semiconductor manufacturing environments, we secured an initial commercial order totaling approximately $2.1 million over three years from a leading semiconductor packaging and testing customer, supporting deployment of 1,400 AI Nose system. We also entered into a commercial arrangement with a semiconductor engineering and systems integration partner that includes a contracted minimum order commitment of 600 AI Nose units targeting deployment in front-end wafer fabrication environments, expanding AI Nose’s reach upstream within the semiconductor value chain. …”see in full comparison
Full comparison: every changed paragraph (78)
Ainos, Inc. (the “Company”), incorporated in the State of Texas in 1984, is a dual-platform company advancing artificial intelligence–based smelltech technologies and immune therapeutics. Our primary strategic focus is the commercialization of our proprietary scent digitization platform, AI Nose, while we also continue to develop therapeutic assets based on our low-dose oral interferon program, VELDONA®. Please refer to “Business” in Part I, Item 1 for description of our business.
Ainos,
Inc. (the “Company”), incorporated in the State of Texas in 1984, is a diversified healthcare company focused on the development
of novel point-of-care testing (the “POCT”), therapeutics based on very low-dose interferon alpha (the “VELDONA”),
and synthetic RNA-driven preventative medicine. Our products pipeline include commercial-stage VELDONA Pet supplements, clinical-stage
VELDONA human therapeutics and telehealth-friendly POCTs powered by the AI Nose technology platform. Please refer to “Business”
in Part I, Item 1 for description of our business.
The
following highlights major corporate milestonesdevelopments in 20242025 that wemanagement believebelieves willadvanced servethe as catalysts for us to developcommercialization and commercializescaling of our
productplatform pipeline over the next several yearstechnologies:
Advancement of AI Nose toward early commercialization.
During 2025, we accelerated the transition of the AI Nose platform from development-stage validation to early-stage commercialization, with a focus on industrial and infrastructure-oriented applications. We expanded our industrial ecosystem through additional system integrators, distribution channels, and early customers, enabling pilot and initial commercial deployments across semiconductor manufacturing, robotics, and smart manufacturing environments.
In semiconductor manufacturing environments, we secured an initial commercial order totaling approximately $2.1 million over three years from a leading semiconductor packaging and testing customer, supporting deployment of 1,400 AI Nose system. We also entered into a commercial arrangement with a semiconductor engineering and systems integration partner that includes a contracted minimum order commitment of 600 AI Nose units targeting deployment in front-end wafer fabrication environments, expanding AI Nose’s reach upstream within the semiconductor value chain. In validation activities conducted in Japanese semiconductor facilities, AI Nose achieved approximately 80% classification accuracy across more than 20 volatile organic compounds, supporting environmental monitoring, anomaly detection, and process awareness. These deployments generated structured scent data used to refine models and support broader commercialization.
As part of our robotics-related expansion, we initiated pilot deployments of AI Nose across seven operational sites in Japan through a collaboration with a Japanese service robotics partner. These pilots are designed to evaluate real-world performance in continuous monitoring and facility operations and to generate deployment data supporting further model refinement and commercial scaling.
Progress in healthcare-adjacent and senior care applications.
In parallel with industrial deployments, we continued to advance healthcare-adjacent applications of AI Nose, including senior care–oriented use cases that leverage non-invasive and continuous sensing for hygiene monitoring. We also continued to evaluate performance and usability in women’s health applications.
Progress in VELDONA® therapeutic programs.
For VELDONA®, we continued to focus on selected rare, autoimmune, and infectious disease indications with unmet medical needs, including oral warts in HIV-seropositive patients, Sjögren’s syndrome, and feline chronic gingivostomatitis (FCGS). During 2025, we advanced clinical preparation and ongoing studies in Taiwan for these indications and maintained discussions with potential partners regarding out-licensing opportunities. Subject to regulatory review and study progress, we currently expect key clinical and partnering milestones to occur over the 2026–2027 timeframe. We also marketed Veldona Pet supplement in Taiwan on a limited scale.
In
December 2024, we announced the signing of a Memorandum of Understanding (MOU) with Taiwan Tanabe Seiyaku Co., Ltd. (“Taiwan Tanabe”),
a subsidiary of Mitsubishi Tanabe Pharma Corporation in Japan. The parties may work under the terms of the MOU to further define the
partnership for manufacturing and Taiwan market promotion of our Sjögren’s syndrome drug based on VELDONA.
In
September 2024, we announced a plan to conduct a Taiwan clinical study for VELDONA in 2025 on treating human immunodeficiency virus (HIV)-related
oral warts. We also announced a plan to conduct a Taiwan clinical study in 2025 for VELDONA on treating Sjögren’s syndrome.
We were also granted an invention patent in Taiwan and has filed for global patent protection under the Patent Cooperation Treaty (PCT)
for treatment and prevention of coronavirus infection based on VELDONA.
In
August 2024, we announced that our VOC co-development program, initiated in 2023, with Nisshinbo Micro Devices Inc. (“NISD”)
and Taiwan Inabata Sangyo Co. (“Taiwan Inabata”) achieved several key milestones. First, we have developed a solution targeting
the elderly care market. Second, we marked a key milestone in expanding AI Nose application in industrial use-case, with our solution
delivering 79% accuracy in 22 different volatile organic compounds (VOCs) in semiconductor factories. We secured an exclusive, perpetual
license of 10 invention patents and patent applications related to gas sensors and medical devices, covering the U.S., Germany, China,
Japan and Taiwan.
In
June 2024, we announced that our Taiwan clinical studies for Ainos Flora have tested 75 cases with meaningful insights, laying ground
for development of second-generation Ainos Flora intended to be optimized for at-home testing. We have implemented CUDA to accelerate
development.
In
May 2024, we initiated a Taiwan clinical study to evaluate VELDONA’s clinical efficacy in treating feline chronic gingivostomatitis
(“FCGS”), a chronic painful oral disease characterized by inflammation or abnormal proliferation in the oral cavity.
Our business activities in 2025 were shaped primarily by our strategic emphasis on scaling the AI Nose platform and managing healthcare-related programs in a selective and capital-efficient manner.
Shift toward industrial and infrastructure-oriented applications.
We continued to prioritize the expansion of AI Nose into industrial environments where continuous sensing, anomaly detection, and operational monitoring are critical. Partner-led deployments in semiconductor manufacturing, robotics, and smart manufacturing settings allowed us to validate the platform under demanding real-world conditions and to begin establishing commercial pathways through existing industrial ecosystems. The pace of adoption, partner execution, and customer conversion may affect our near-term results.
Data-driven platform development.
AI Nose deployments generate Smell ID data across diverse environments. We use this data to refine models, improve classification performance, and broaden the range of detectable patterns. We believe this data-driven feedback loop strengthens the long-term scalability of the platform, although the benefits may not be immediately reflected in revenue.
Senior care and healthcare-adjacent opportunities.
In senior care and hospital-adjacent environments, we continued to evaluate use cases where non-invasive and continuous sensing may support hygiene monitoring and environmental control. These efforts remain exploratory and are influenced by regulatory pathways, partner engagement, and operational validation.
VELDONA® program management.
For VELDONA®, we focused on selected indications with unmet medical needs, including oral warts in HIV-seropositive patients, Sjögren’s syndrome, and feline chronic gingivostomatitis. In 2025, we advanced ongoing and planned clinical studies in Taiwan while continuing to pursue strategic partnerships and out-licensing opportunities. Clinical outcomes, regulatory progress, and partner interest may affect the timing and direction of these programs.
Strategy Outlook
Our strategy centers on scaling AI Nose as a SmellTech platform that digitizes scent as a machine-readable data modality. Following initial industrial validation in 2025, our priorities include expanding partner-led deployments, increasing scent data volume to refine the smell language model, and advancing commercialization through a combination of hardware sales and service-based offerings. In parallel, we plan to manage healthcare-related programs, including VELDONA®, in a selective and capital-efficient manner, with an emphasis on partnerships and out-licensing.
We
have pivoted away from sale of COVID-19 antigen rapid test kits, which were the main source of our revenues in 2023. In 2024 our business
activities focused on sales and marketing of VELDONA Pet, advancing our lead VOC POCT candidate, Ainos Flora, co-developing VOC sensing
platform with our Japan partners, as well as advancing clinical studies and pursuing out-licensing of VELDONA human drug candidates.
Through
our marketing of VELDONA Pet, we gathered insights into the behavior of pet owners. These insights have influenced our choice to allocate
resources toward developing animal drugs. We identified a market opportunity in FCGS, a cat oral disease currently facing limited treatment
options. In 2024, we started a clinical study in Taiwan for our FCGS program. Its success could impact our business plan.
For
our VELDONA human drug development, we prioritize HIV oral warts and Sjogren’s syndrome due to limited treatment options for these
conditions. In 2024, we prepared for clinical studies in Taiwan expected to commence in 2025. We have also progressed in out-licensing
our drug candidates through a MOU with Taiwan Tanabe. These developments may affect our business.
We
believe that consumers have become increasingly familiar with at-home tests, and people may seek additional at-home tests to manage other
infections. Home self-testing have become increasingly available for other infections such as vaginal infections or sexually transmitted
infections (STIs). We believe this new user behavior, supported by a variety of telehealth platforms, will facilitate consumer adoption
of our other POCT product candidates. Our lead candidate Ainos Flora is under clinical studies and we plan to explore strategic relationships
to commercialize the product. The result of clinical studies and our success in exploring strategic relationships, and the likelihood
of regulatory approvals, may affect our business, at least in the near-term.
We
are co-developing a VOC sensing platform, powered by AI Nose technology, with our Japanese partners. This project underscores our commitment
to digitizing smell by pioneering VOC sensing’s potential across diverse industries, thereby broadening our addressable market.
Under this program, we are developing solutions for the elderly care market and for industrial use-case. The progress may affect our
business, at least in the near-term.
As
of December 31, 2024, we had available cash and cash equivalents of $3,892,919. We anticipate business revenues and further potential
financial support from external sources to fund our operations over the next twelve months. We have based this estimate on assumptions
that may prove to be incorrect, and we could exhaust our available capital resources sooner than we expect. See “Liquidity and
Capital Resources” for additional information. To finance our continuing operations, we will need to raise additional capital,
which cannot be assured.
On May 31, 2024, the Company entered into an At-the-Market Offering Agreement, or sales agreement, with H.C. Wainwright & Co., LLC (“Wainwright”), pursuant to which the Company may issue and sell, from time to time, shares of its common stock. The aggregate market value of Shares eligible for sale in the Offering and under the ATM Agreement will be subject to the limitations of General Instruction I.B.6 of Form S-3 to the extent required under such instruction. The prospectus supplement filed with the SEC on July 11, 2024 is offering Shares having an aggregate offering price of $1,840,350.
On September 5, 2025, the Company filed a prospectus supplement to amend the Prospectus to update the amount of shares the Company is eligible to sell pursuant to such prospectus. The Company increased the amount of shares of Common Stock it may offer and sell under the Sales Agreement to an aggregate offering price of up to $874,496 from time to time through Wainwright. Pursuant to General Instruction I.B.6 of Form S-3, in no event will we sell securities in a public primary offering with a value exceeding one-third of our public float in any 12-month calendar period so long as our public float remains below $75.0 million.
As of December 31, 2025, the Company sold 734,214 shares of common stock under At-the-Market Offering Agreement, resulting in net proceeds of approximately $2,008,721.
During the period from January 1, 2026 to March 30, 2026, the Company sold 283,336 shares of common stock under the At-the-Market Offering Agreement, resulting in net proceeds of approximately $601,600.
On March 12, 2025, the Company entered into an amendment to the Convertible Note (the “Convertible Note Amendment”) with Li-Kuo Lee to extend the maturity date to May 13, 2025. On April 30, 2025, the Company repaid the full principal with accrued interest aggregate amount of $1,132,650.
On
May 03, 2024, The Company entered into Convertible Note and Warrant Purchase Agreement with the ASE Test, Inc. (“ASE”), a
shareholder of Ainos KY, for the issuance of convertible promissory notes with 6% compound interest in the aggregate principal amount
of $9,000,000 (collectively the “Notes”) convertible into shares of common stock, par value $0.01 per share, of the Company,
payable three (3) years from May 03, 2024 as well as the issuance of warrants for the purchase of up to 500,000 shares of Common Stock
at a price per share of $4.50, exercisable until May 03, 2029. As of December 31, 2024, the Company received the full amount of the payment.
On
August 2, 2024, the Company retired its remaining senior secured convertible debt (the “Note”) with Lind Global Fund II LP,
an institutional investment fund managed by The Lind Partners (together the “Investor”), as a result of conversions by the
Investor and payments by the Company, which aggregates at a total of approximately US$1.67 million. The repayment was made with $1,439,754
in cash and $224,842 through the issuance of 382,384 shares of Common Stock, valued at $0.588 per share.
On
August 16, 2024, the Company repaid the remaining note payable principal amount of $42,000 with accrued interest to i2China Management
Group, LLC (“i2China”).
On
October 7, 2024, the Company repaid the remaining note payable principal amount of $270,000 with accrued interest to Ainos KY, the controlling
shareholder of the Company.
The
Company reported $20,729$124,157 of revenues for the year ended December 31, 2024,2025, as compared to $122,112$20,729 for the year ended December 31, 2023
from the sales of in Taiwan.2024. The decreaseincrease of revenue in 20242025 was primarily caused by a change in product mix; the Company generated $123,360
and nil in revenues from AI Nose related programs, and $797 and $20,321 from pet supplements, and nil and $408 in revenues from COVID-19
Antigen Rapid Test Kits in lower sales volume2025 and was2024, offset
byrespectively. theThe exchangeCompany ratehas fluctuations.ceased Weselling generated $20,321 and $256 in revenues from pet supplements and $408 and $102,256 in revenues from
COVID-19 Antigen Rapid Test KitsKit insince 2024first andquarter
of 2023, respectively.2024.
The
cost of revenues relating to product sales for the year ended December 31, 20242025 was $52,595$21,246 compared to $375,845$52,595 for the year ended December
31, 2023.2024. The decrease of cost of revenues was primarily caused by the declineaforementioned change in salesproduct volume of COVID-19 Antigen Rapid Test Kits.mix.
The
share-based compensation expense and the depreciation expense for manufacturing in the year ended December 31, 20242025 and 20232024 were $9,032nil
and $80,655,$9,032, respectively. When excluding these non-cash cost,costs, cost of revenue decreased to $43,563$21,246 during the year ended December 31,
20242025 compared to $295,190$43,563 for the same period in 2023.2024.
Gross
profit (loss) from product sales for the year ended December 31, 20242025 was $31,866$102,911 as compared to $253,733$(31,866) for the year ended December
31, 2023.
2024. The gross lossprofit was due to athe lowaforementioned saleschange volumein forproduct newly launched products, and a lower cost of revenue.mix.
When
excluding these non-cash costs, gross profit (loss) decreasedincreased to $(22,834)$102,911 during the year ended December 31, 20242025 compared to $(173,07822,834)
for for
the same period in 2023.2024.
R&D
expenses for the years ended December 31, 20242025 and 20232024 were $8,413,923$7,749,772 and $7,317,388,$8,413,923, respectively. The increasedecrease $1,096,535of $664,151 (15%8%) was
due to increaseddecreased staffing expenditures (including share-based compensation) and co-research expenses,expenses but offset by aan decreaseincrease in impairmentpatent
lossapplication and& materialmaintenance expenses. We expect that our R&D expenses related to clinical trials will continue to grow as we further develop AI Nose programs
VOC POCT and VELDONA drug candidates and increase the pace of clinical trials previously delayed during the COVID-19 pandemic.candidates.
The
share-based compensation expense and the depreciation and amortization expense in 20242025 and 20232024 were $5,600,037$5,260,915 and $5,252,730,$5,600,037, respectively.
When excluding these non-cash expenses, R&D expenses increaseddecreased to $2,488,857 in 2025 from that of $2,813,886 in 2024 from that of $2,064,658 in 2023 primarily caused
by increasingdecreased inco-development non-exclusive use of certain patents related to VOC and POCT technologies.expenses.
SG&A
expenses were $5,395,415$6,343,547 and $5,635,275$5,395,415 for the years ended December 31, 20242025 and 2023,2024, respectively. The $239,860$948,132 (4%18%) slightincrease decreasewas
was due to decreasedincrease professionalin expenses,staffing expenditures (including share-based compensation), public relations and investor relations fees, and advertising
expense, but offset by decreased professional expenses and D&O insurance expenses, but offset
by staffing expenditures (including share-based compensation).expenses.
The
share-based compensation expense and the depreciation and amortization expense in 20242025 and 20232024 were $2,824,743$3,942,820 and $2,886,216,$2,824,743, respectively.
When excluding these non-cash expenses, SG&A expenses slightslightly decreased to $2,400,727 in 2025 compared to $2,570,672 in 2024 compared to $2,749,059 in 2023 mainly
due to decreased professional expenses, expenditures to public relations and investor relations fees,expenses and D&O insurance expenses.
The
Company’s operating loss was $13,841,204$13,990,408 and $13,206,396$13,841,204 during the years ended December 31, 20242025 and 2023,2024, respectively, reflecting
a $634,808$149,204 slight increase in operating losses between the years. We incurred a gross loss in product sales but reduced the professional expense
and material expenses in 2024. We continued to invest resources to execute our growth strategy and
product roadmap to improve our profitability.
TheInterest
interest expense was $616,467$711,903 and $144,193$616,467 during the years ended December 31, 20242025 and 2023,2024, respectively. The increase in interest
expense was
due to accrued interest for compounded convertible notes issued in May 20242024, bearingfor awhich higherthe interestface ratevalue as compared with those interest
bearing debtsincreases in 2023.the second year due
to the compounding feature.
Net
loss was $14,863,161$14,771,012 in 20242025 compared to $13,770,549$14,863,161 in 2023,2024, resulting in a $1,092,612$92,149 (8%1%) increaseslight decrease in net loss attributable to
common common
stockholders due to the increasedecrease in non-exclusiveco-research use of certain patents related to VOCexpenses and POCTD&O technologies despite offset by the decrease
in professionalinsurance expenses.
Net
cash used in operating activities increaseddecreased by $1,113,599$1,193,570 during the year of 20242025 compared to the year of 2023.2024. The increasedecrease in cash
used in operations primarily resulted from our net loss for the year of 20242025 due to swiftincrease product but offset byin cash inflow contributed
by the operating
assets and liabilities.
Net
cash used in investing activities during the year of 20242025 was $125,292$2,223 compared to $101,525$125,292 during the year of 2023.2024. The increasedecrease was due
due to increase in refundable deposits and other noncurrent assets offset by decrease in purchase of property and equipment.
Cash
received from financing activities were $8,025,746$1,008,461 and $4,923,673$8,025,746 during the years of 20242025 and 2023,2024, respectively. The $3,102,073$7,017,285 increasedecrease
was primarily reflected by the following:
As disclosed in Note 6 (Debt) to our accompanying financial statements, we repaid $1,000,000 to retire the Lee Note transaction in April 2025.
As discussed in Note (At The Market) to our accompanying financial statements, we received $2,008,721 in proceeds from ATM transactions in 2025.
On
May 31, 2024, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”), with H.C. Wainwright &
& Co., LLC or the Agent, pursuant to which the Company may issue and sell, from time to time, shares of its Common Stock, depending on
on market demand, with the Agent acting as the sales agent or principal (the “ATM Offering”). Sales of the Common Stock may
be made by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities
Act of 1933, as amended (the “Securities Act”),Act, including, without limitation, sales made directly on or through the Nasdaq
Capital Market. The Agent will use its commercially
reasonable efforts to sell the Shares requested by the Company to be sold on its
behalf, consistent with the Agent’s normal trading
and sales practices, under the terms and subject to the conditions set forth
in the ATM Agreement. The Company has no obligation to sell
any of the Shares. The Company may instruct the Agent not to sell the Shares
if the sales cannot be effected at or above the price designated
by the Company from time to timetime, and the Company may at any time suspend
sales pursuant to the ATM Agreement.
What changed in the latest 10-Q
Risk Factors
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “Component supply and manufacturing.”
New heading “Interest Expense”
New heading “Results of Operations for first half of the year Ended June 30, 2026 (“H1 2026”) and June 30, 2025 (“H1 2025”):”
New heading “Revenues, Cost and Gross Loss”
New heading “Research and Development (R&D) Expenses”
New heading “Selling, General and Administrative (SG&A) Expenses”
New heading “Interest Expense”
Removed heading “Interest Expense and Issuance Cost of Convertible Note”
Largest changes
“Results of Operations for first half of the year Ended June 30, 2026 (“H1 2026”) and June 30, 2025 (“H1 2025”):”see in full comparison
“The commercialization of AI Nose depends on the timely availability of components, electronic parts, and other materials from third-party suppliers. Changes in component availability, lead times, pricing, or broader supply chain conditions could increase costs, delay customer deployments, and adversely affect our commercialization activities, operating results, and financial condition.”see in full comparison
Full comparison: every changed paragraph (45)
During the first half of 2026, the Company continued to advance AI Nose deployment, validation, and research activities across semiconductor manufacturing, industrial infrastructure, and healthcare-related environments. These activities included work relating to environmental monitoring, equipment and facility safety, emergency care environments, and research involving the analysis of exhaled breath patterns. These efforts remain at varying stages of deployment, validation, research, and commercialization.
We continue to prioritize AI Nose activities across industrial environments, including semiconductor manufacturing, robotics, smart manufacturing, and hospital infrastructure settings. Recent progress includes initial commercial activity in backend semiconductor manufacturing, front-end semiconductor validation efforts through industry partners, robotics-related development initiatives and activities in hospital infrastructure environments. During the first half of 2026, the Company continued AI Nose deployment and validation activities across certain facility monitoring, safety, ventilation, equipment, and chemical handling applications. These activities remain at varying stages of deployment, validation, and commercialization. The timing and extent of partner execution, customer adoption, and conversion of pilot and initial commercial activities into broader commercial arrangements may affect the timing of revenue and our near-term operating results.
Component supply and manufacturing.
The commercialization of AI Nose depends on the timely availability of components, electronic parts, and other materials from third-party suppliers. Changes in component availability, lead times, pricing, or broader supply chain conditions could increase costs, delay customer deployments, and adversely affect our commercialization activities, operating results, and financial condition.
As part of our ongoing deployment and validation activities, we continue to develop AI Nose capabilities across different operating conditions and application environments. These efforts include the detection and interpretation of gas signal variations and the potential application of such capabilities in anomaly detection, environmental sensing, and operational monitoring. We are also developing AI Nose for near-threshold detection scenarios, meaning the detection of signal variations at or near traditional detection thresholds. If validated, such capabilities may support certain early-stage anomaly detection applications. We continue to develop these near-threshold detection capabilities with a focus on reliability, repeatability, and scalability across different environments, which remain subject to ongoing validation. Expanded deployments may provide additional conditions for evaluating system performance and environmental pattern recognition.
AI Nose deployments are expected to generate Smell ID data across different operating environments, and we continue to use this data to refine models, improve classification performance, and expand the range of detectable patterns. Continued deployment of AI Nose is also expected to result in further accumulation of scent-related data, which may support model improvement, broaden detectable patterns, and enhance system adaptability across different operating environments. During the first half of 2026, the Company expanded data-generation activities across industrial and healthcare-related settings, including environmental signals, facility conditions, and exhaled breath patterns. While we expect these efforts to support ongoing performance improvements, the timing and extent to which they contribute to broader commercial adoption or commercial outcomes may vary, and their benefits may take time to be reflected in revenue or operating results.
We continue to develop AI Nose applications in senior care and other healthcare-adjacent settings, including environments where non-invasive and continuous sensing may support hygiene monitoring, environmental control, and hospital operations. During the first half of 2026, the Company expanded research and validation activities in hospital infrastructure, emergency care, and exhaled breath analysis. These activities remain research- and validation-stage and are not intended to provide individual patient diagnosis. The timing and extent of these activities may be affected by regulatory requirements, partner engagement, operational validation, and resource allocation decisions.
As
of MarchJune 31,30, 2026, we had available cash and cash equivalents of $2,841,422.$1,422,912. We anticipate business revenues and external financing options,
if necessary, to fund our operations over the next twelve months. We have based this estimate on assumptions that may prove to be incorrect,
and we could exhaust our available capital resources sooner than we expect. See “Liquidity and Capital Resources” for additional
information. To finance our continuing operations, we will need to raise additional capital, which cannot be assured.
During
the first quarterhalf of the year 2026, we advanced AI Nose-related activities within industrial applications, with a focus on semiconductor
and robotics
environments. These activities included
As previously disclosed, on March 27, 2026, the Company entered into a loan agreement with ASE Test, Inc., pursuant to which ASE Test, Inc. agreed to lend the Company an aggregate principal amount of NT$90 million (approximately US$2,812,940) (the “Loan”). The Loan was scheduled to mature on March 27, 2027. On July 10, 2026, the parties agreed to extend the maturity date of NT$62 million (approximately US$1,937,800) of the outstanding principal amount of the Loan to July 31, 2027. The maturity date of the balance of the loan, an aggregate principal amount of NT$28 million (approximately US$875,140), remains March 27, 2027.
Results
of Operations for Quarter Ended MarchJune 31,30, 2026 (“Q1Q2 2026”) and MarchJune 31,30, 2025 (“Q1Q2 2025”):
The Company reported $152 and $4,663 in revenue in Q2 2026 and Q2 2025, respectively. The decrease of revenue in Q2, 2026 was primarily caused by lower sales volume on VELDONA pet supplements during the reporting period, as the Company shifts operational focus to AI Nose platform.
The
Company reported $161 and $106,207 in revenue in Q1 2026 and Q1 2025, respectively. The decrease of revenue in Q1, 2026 was primarily
caused by lower sales volume on AI Nose related programs in healthcare adjacent applications. This decrease was partly attributable to
a strategic shift in focus from healthcare-adjacent applications toward industrial deployments, which are currently at earlier stages
of commercialization. The Company generated nil and $105,942 in revenues from AI Nose related programs, and $161 and $265 from pet supplements
in Q1 2026 and Q1 2025, respectively.
The
cost of revenue related to product sales in Q1Q2 2026 was $763$53 compared to $18,233$937 in Q1Q2 2025. The decrease in cost of revenue was caused by
by the aforementioned lower produce volume for AIVELDONA Nosepet related programssupplements during the reporting period.
Gross
profit from product sales in Q1Q2 2026 was $602 gross loss$99 as compared to $87,974$3,726 gross profit from product sales in Q1Q2 2025. The decrease
in gross profit was due to aforementioned lower sale volume.
R&D
expenses in Q1Q2 2026 and Q1Q2 2025 were $1,689,860$1,850,409 and $1,724,084,$1,911,800, respectively. The decrease of $34,224$61,391 (2%3%) was due to reduced expenses
in share-based compensation and expenses associated with co-research for technology partially offset by increased staffing expenditures and experimental material
fees. We expect
that our R&D investments may continue to grow as we further develop our technologies.
SG&A
expenses were $593,185$2,548,776 and $1,526,761$1,837,613 in Q1Q2 2026 and Q1Q2 2025, respectively, reflecting a decreaseincrease of $933,576$711,163 (61%39%) due to a significant
decreaseincrease in share-based compensation,compensation furtherand professional fees, offset by a decrease in D&Oadvertisement insurance feefees and SECpublic reportingrelations relatedand investor
relations fees.
The
share-based compensation expense and the depreciation and amortization expense in Q1Q2 2026 and Q1Q2 2025 were $12,808$2,018,095 and $901,800$1,309,358
respectively. respectively.
When excluding these non-cash expenses, SG&A expenses decreasedincreased to $580,377$530,681 in Q1Q2 2026 compared to $624,961$528,255 in Q1Q2 2025.
The
Company’s operating loss was $2,283,647$4,399,086 and $3,162,871$3,745,687 in Q1Q2 2026 and Q1Q2 2025, respectively, reflecting a $879,224$653,399 (28%17%) decreaseincrease
in operating loss between the reporting periods. We continued to invest resources to execute our growth strategy and product roadmap
to improve our profitability.
Interest Expense
Interest
Expense and Issuance Cost of Convertible Note
In
Q1Q2 2026, interest expense was $176,876$200,162 compared to $180,445$177,957 in Q1Q2 2025. The decreaseincrease in interest expense was due to the company paid
off Lee’s convertible note, resulting in a reductionnew loan agreement
in the principalfirst amountquarter of the convertibleyear note outstanding.2026.
Net
loss was $2,459,800$4,594,731 in Q1Q2 2026 compared to $3,286,022$4,084,990 in Q1Q2 2025, resulting in an $826,222$509,741 (25%12%) decreaseincrease in net loss attributable to
our shareholders of common stock. The net loss was due to expanding operating expense as we continued to invest resources to execute
our growth strategy and product roadmap to improve our profitability.
Results of Operations for first half of the year Ended June 30, 2026 (“H1 2026”) and June 30, 2025 (“H1 2025”):
Revenues, Cost and Gross Loss
The Company reported $313 and $110,870 in revenue in H1 2026 and H1 2025, respectively. The decrease of revenue in H1, 2026 was primarily caused by lower sales volume on AI Nose related programs in healthcare adjacent applications. This decrease was partly attributable to a strategic shift in focus from healthcare-adjacent applications toward industrial deployments, which are currently at earlier stages of commercialization. The Company generated nil and $105,942 in revenues from AI Nose related programs, and $313 and $4,928 from pet supplements in H1 2026 and H1 2025, respectively.
The cost of revenue related to product sales in H1 2026 was $816 compared to $19,170 in H1 2025. The decrease in cost of revenue was caused by the aforementioned lower produce volume for AI Nose related programs during the reporting period.
Gross loss from product sales in H1 2026 was $503 as compared to $91,700 gross profit from product sales in H1 2025. The decrease in gross profit was due to aforementioned lower sale volume.
Research and Development (R&D) Expenses
R&D expenses in H1 2026 and H1 2025 were $3,540,269 and $3,635,884, respectively. The decrease of $95,615 (3%) was due to reduced expenses in share-based compensation and expenses associated with co-research for technology partially offset by increased staffing expenditures and experimental material fees. We expect that our R&D investments may continue to grow as we further develop our technologies.
The share-based compensation expense and depreciation and amortization expense in H1 2026 and H1 2025 were $2,342,023 and $2,402,213, respectively. When excluding these non-cash expenses, R&D expenses decreased to $1,198,246 in H1 2026 from $1,233,671 in H1 2025.
Selling, General and Administrative (SG&A) Expenses
SG&A expenses were $3,141,961 and $3,364,374 in H1 2026 and H1 2025, respectively, reflecting a decrease of $222,413 (7%) due to a significant decrease in share-based compensation and public relations and investor relations fees, offset by an increase in professional related fees.
The share-based compensation expense and the depreciation and amortization expense in H1 2026 and H1 2025 were $2,030,903 and $2,211,158 respectively. When excluding these non-cash expenses, SG&A expenses decreased to $1,111,058 in H1 2026 compared to $1,153,216 in H1 2025.
Operating Loss
The Company’s operating loss was $6,682,733 and $6,908,558 in H1 2026 and H1 2025, respectively, reflecting a $225,825 (3%) decrease in operating loss between the reporting periods. We continued to invest resources to execute our growth strategy and product roadmap to improve our profitability.
Interest Expense
In H1 2026, interest expense was $377,038 compared to $358,402 in H1 2025. The increase in interest expense was due to the company processing a new loan agreement in the first quarter of the year 2026.
Net Loss
Net loss was $7,054,531 in H1 2026 compared to $7,371,012 in H1 2025, resulting in an $316,481 (4%) decrease in net loss attributable to our shareholders of common stock. The net loss was due to expanding operating expense as we continued to invest resources to execute our growth strategy and product roadmap to improve our profitability.
As
of MarchJune 31,30, 2026 and December 31, 2025, the Company had available cash of $2,841,422$1,422,912 and $417,353, respectively.
The
following table summarizes our cash flow during the threesix months ended MarchJune 31,30, 2026 and 2025:
Cash
used in operating activities decreased by $241,157$143,246 during the first quarterhalf of the year 2026 compared to the first quarterhalf of the year 2025.
Our net
loss for the first quarterhalf of the year 2026 decreased by $826,222$316,481 primarily due to the company expandinglower operating expense. The operating
cash cash
outflow as a result of changes in operating assets and liabilities was mainly attributable to:
Cash
provided (used) for investing activities were $79$7,297 and $20,587($18,045) during the first quarterhalf of the year 2026 and the first quarterhalf of the year
2025, respectively. The
decrease increase was due to a reduction in refundable deposits and other noncurrent assets and decrease in purchases
of property and equipment
and increase in proceeds from disposal of property and equipment.
Cash
provided by (used in) financing activities were $3,414,540 and $14,605$(280,902) during the first quarterhalf of the year 2026 and the first quarterhalf of
the year 2025, respectively.
The $3,399,935$3,695,442 increase was primarily reflected by the following:
AIMD insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 7 Form 4 filings (1 insider, 9 trade dates, 10,879 shares, about $21.3K) and open-market sales in 4 filings (3 insiders, 3 trade dates, 198,090 shares, about $387.9K). Net open-market shares: -187,211 (purchases minus sales); net value about -$366.6K.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 |
|---|---|---|---|---|---|
| 2026-06-05 | Chiang Yao-Chung |
Open-market purchase | 3,500 | $2.05 | $7.2K |
| 2026-06-03 | Chiang Yao-Chung |
Open-market purchase | 2,000 | $2.13 | $4.3K |
| 2026-05-28 | Chiang Yao-Chung |
Open-market purchase | 250 | $2.30 | $575 |
| 2026-05-27 | Chiang Yao-Chung |
Open-market purchase | 2,000 | $2.00 | $4.0K |
| 2026-05-26 | Lee Ting-Chuan |
Open-market sale | 109,988 | $1.90 | $209.0K |
| 2026-05-26 | Taiwan Carbon Nano Technology Corp |
Open-market sale | 41,000 | $2.36 | $96.8K |
| 2026-05-26 | Tsai Chun-Jung |
Open-market sale | 27,718 | $1.87 | $51.8K |
| 2026-05-22 | Tsai Chun-Jung |
Open-market sale | 1,082 | $1.55 | $1.7K |
| 2026-05-22 | Lee Ting-Chuan |
Open-market sale | 9,302 | $1.57 | $14.6K |
| 2026-05-21 | Lee Ting-Chuan |
Open-market sale | 9,000 | $1.56 | $14.0K |
| 2026-05-19 | Chiang Yao-Chung |
Open-market purchase | 2,200 | $1.68 | $3.7K |
| 2026-05-18 | Chiang Yao-Chung |
Open-market purchase | 500 | $1.65 | $825 |
| 2026-05-05 | Chiang Yao-Chung |
Open-market purchase | 129 | $1.70 | $219 |
| 2026-04-30 | Chiang Yao-Chung |
Open-market purchase | 200 | $1.68 | $336 |
| 2026-04-29 | Chiang Yao-Chung |
Open-market purchase | 100 | $1.75 | $175 |
| 2026-04-15 | Tsai Chun-Jung |
Grant/award | 330,000 | $1.61 | $531.3K |
| 2026-04-15 | Tsai Chun-Hsien |
Grant/award | 300,000 | $1.61 | $483.0K |
| 2026-04-15 | Lee Ting-Chuan |
Grant/award | 570,000 | $1.61 | $917.7K |
Well-known investors holding AIMD (13F)
None of the 59 investors we track reported a position in their latest 13F.