ITEM 1A. RISK FACTORS 8
ITEM 1B. UNRESOLVED STAFF COMMENTS 33
ITEM 1C. CYBERSECURITY 33
ITEM 2. DESCRIPTION OF PROPERTY 33
ITEM 3. LEGAL PROCEEDINGS 33
ITEM 4. MINE SAFETY DISCLOSURES 33
ITEM 6. [RESERVED] 35
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 43
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 43
ITEM 9A. CONTROLS AND PROCEDURES 43
ITEM 9B. OTHER INFORMATION 43
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 43
PART III 44
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE 44
ITEM 11. EXECUTIVE COMPENSATION 47
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES 52
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES 53
PART
I
FORWARD-LOOKING
STATEMENTS
This
Annual Report on Form 10-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933,
as amended (the Securities Act) and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act) and, as such, may
involve unknown risks, uncertainties and assumptions.
Forward-looking
statements are those that predict or describe future events or trends and that do not relate solely to historical matters. You can generally
identify forward-looking statements as those statements containing the words “anticipate,” “believe,” “plan,”
“estimate,” “expect,” “intend,” “may,” “will,” “would,” “could,”
“should,” “might,” “potential,” “continue” or other similar expressions.
There
are a number of important risks and uncertainties that could cause our actual results to differ materially from those indicated by forward-looking
statements. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should
not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions
and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements
included in this Annual Report on Form 10-K, particularly in the section entitled “Risk Factors” in Part I, Item 1A that
could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements
do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make.
You
should read this Annual Report on Form 10-K and the documents that we have filed as exhibits to this Annual Report on Form 10-K completely
and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements
contained in this Annual Report on Form 10-K are made as of the date of this Annual Report on Form 10-K, and we do not assume any obligation
to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable
law.
As
used in this Annual Report on Form 10-K, “Ainos” “the Company,” “we,” “us,” and “our”
refer to Ainos, Inc. and our consolidated subsidiaries, except where the context otherwise requires.
ITEM
1. BUSINESS.
Overview
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®.
Our
core technology platform, AI Nose, is an AI-based electronic olfaction system that integrates gas sensor arrays with proprietary artificial
intelligence models, which we refer to as a smell language model (“SLM”), to digitize scent and volatile organic compound
(“VOC”) signals into Smell ID, a machine-readable data format. AI Nose is initially developed in healthcare-related settings,
including point-of-care testing (“POCT”). These early healthcare applications shaped the platform’s sensor architecture,
data models, and system calibration.
Building
on this foundation, we are expanding the application of AI Nose into industrial environments, where we believe real-time environmental
sensing, anomaly detection, and operational monitoring are important. Current and planned use cases include industrial applications across
semiconductor manufacturing, robotics, and smart manufacturing settings. We believe the underlying scent digitization architecture of
AI Nose is adaptable across a range of industrial and non-industrial verticals, and we continue to evaluate additional application opportunities
based on partner engagement and deployment experience.
We
are advancing the AI Nose platform through partner-led deployments, with a strategy focused on platform scalability, data-driven performance
improvement, and integration into existing industrial ecosystems. Our approach emphasizes expanding the role of scent as a machine-readable
data modality alongside vision and sound, while maintaining flexibility to address diverse operational requirements.
Separately,
we continue to develop VELDONA®, our low-dose oral interferon platform, targeting selected rare, autoimmune, and infectious disease
indications. Our VELDONA® programs include candidates for the treatment of oral warts in HIV-positive patients, Sjögren’s
syndrome, and feline chronic gingivostomatitis (“FCGS”). We have conducted research and development activities related to
VELDONA® since our inception.
Our
Technologies
AI
Nose Platform (AI-Powered Scent Digitization SmellTech)
AI
Nose is our core artificial intelligence–based scent digitization SmellTech platform designed to enable machines to detect, classify,
and interpret scent and volatile organic compound (“VOC”) signals in real time. While artificial intelligence has broadly
adopted vision and sound as primary data modalities, smell remains a largely underrepresented perception layer for machines. We are developing
AI Nose to address this gap by translating complex scent signals into a structured, machine-readable data format.
Our
targeted revenue sources include sales of AI Nose hardware systems and recurring service-based offerings associated with our SmellTech
platform.
AI
Nose differs from conventional gas sensors in that it is positioned as a connected, trainable SmellTech sensing platform rather than
a single-purpose detection component. The system combines portable sensor hardware capable of parts-per-billion–level sensitivity
with cloud connectivity and proprietary artificial intelligence models. This architecture enables centralized data aggregation, remote
model updates, and performance refinement over time. Unlike fixed-function sensors calibrated for specific compounds, AI Nose is designed
to support ongoing training and adaptation as additional scent data are collected across deployments.
The
AI Nose platform integrates gas sensor arrays with our proprietary artificial intelligence models, which we refer to as smell language
model (“SLM”), to digitize scent signals into Smell ID, a structured digital data format designed to support computational
analysis, comparison, and learning across applications and environments. The SLM is designed to classify and contextualize scent data
and to enable learning across different operating conditions using a trainable data framework. Through continued development of the SLM,
we are working to treat scent data as an AI-native data asset that can be applied across multiple use cases and deployment models.
AI
Nose was initially developed in healthcare-related environments, including point-of-care testing (“POCT”) and healthcare
monitoring use cases such as ventilator-associated pneumonia, women’s vaginal health, and selected sexually transmitted infections.
These early applications required reliable operation in variable clinical settings and influenced the design of the platform’s
sensor architecture, signal processing pipeline, data labeling methodology, and model training framework. Development in healthcare settings
also contributed to calibration, quality control, and validation processes that are applicable across other operating environments. Based
on this foundation, AI Nose is designed to detect and analyze target VOC patterns with parts-per-billion sensitivity within short time
frames, supporting non-invasive and timely monitoring applications.
Building
on this healthcare foundation, we have expanded the application of AI Nose into industrial environments, where continuous environmental
sensing, anomaly detection, and operational monitoring are important. Current and targeted industrial applications include deployments
across semiconductor manufacturing, robotics, and smart manufacturing settings. In these environments, AI Nose is designed to function
as a modular sensing component supporting safety-related detection, process awareness, and environmental monitoring.
During
2025, we expanded the AI Nose industrial ecosystem through collaborations supporting pilot deployments. These deployments generate real-world
scent data across diverse operating conditions, which we use to refine models, improve classification performance, and broaden the range
of detectable patterns. We believe this process creates a data-driven feedback loop, whereby increased deployment generates additional
Smell ID data that supports ongoing model improvement and broader applicability of the platform. As part of our industrial commercialization
efforts, in 2025 we secured an initial commercial deployment under a multi-year subscription agreement with a leading semiconductor packaging
and testing company involving AI Nose within manufacturing environments.
In
addition to industrial applications, we continue to evaluate healthcare-adjacent use cases, including senior care, women’s vaginal
health, selected sexually transmitted infections, and environmental control and monitoring in hospital operations, where non-invasive
and continuous sensing capabilities may support monitoring and safety-related applications.
To
support the continued development and scaling of the AI Nose platform, we operate ScentAI Inc. (“ScentAI”), a wholly owned
subsidiary focused on advancing the SLM algorithm, with Ainos focusing on hardware, deployment, and data generation.
Point-of-Care
Testing (POCT)
Our
point-of-care testing (“POCT”) development activities incorporate multiple detection approaches, including volatile organic
compound (“VOC”) sensing, lateral flow immunochromatographic assays, and nucleic acid–based methods. Current POCT development
efforts emphasize applications that leverage VOC sensing capabilities derived from the AI Nose platform. While initially developed for
ventilator-associated pneumonia, our planned POCT pipeline also includes applications in senior care hygiene monitoring, women’s
vaginal health, and selected sexually transmitted infections. We continue to evaluate lateral flow and nucleic acid technologies for
selected disease indications as part of our broader technology portfolio.
VELDONA®
(Low-Dose Oral Interferon Platform)
VELDONA®
is our low-dose oral interferon alpha formulation delivered to the oral cavity and designed to modulate immune responses through the
oral mucosa. Interferons are naturally occurring proteins produced by host cells in response to pathogens and play a role in immune signaling.
The VELDONA® formulation is intended to enable immune modulation at low doses, with the objective of reducing the risks and side
effects commonly associated with higher-dose interferon therapies.
Since
our inception, we have conducted research and development of low-dose oral interferon across human and animal health applications. To
date, we have completed 68 human clinical studies evaluating low-dose oral interferon alpha, including Phase 1, Phase 2, and Phase 3
studies. Of these, 63 were Phase 2 trials that evaluated safety, tolerability, and potential therapeutic effects across multiple indications.
In
addition, we have conducted 28 preclinical and animal studies evaluating low-dose oral interferon across a range of species. These studies
assessed immune-related effects and explored potential applications in both companion and production animals. Results from these studies
shaped our understanding of oral mucosal delivery and systemic immune modulation.
Our
current VELDONA® development programs focus on selected rare, autoimmune, and infectious disease indications. These include candidates
for the treatment of oral warts in HIV-seropositive patients, Sjögren’s syndrome, and feline chronic gingivostomatitis (“FCGS”).
The U.S. Food and Drug Administration has granted orphan drug designation for our VELDONA® formulation as a potential treatment for
oral warts in HIV-seropositive patients.
We
are advancing clinical studies in Taiwan to further evaluate VELDONA® in HIV-seropositive patients, Sjögren’s syndrome,
and FCGS indications, subject to enrollment progress. We intend to primarily pursue out-licensing and partnership opportunities to advance
the further development and commercialization of the VELDONA® assets. In parallel, we commercialized VELDONA® Pet supplements
in Taiwan to support companion animal health.
Product
Portfolio and Pipeline
An
integral part of our operating strategy is to advance commercially viable products while expanding the deployment of the AI Nose platform
through partnerships and system integrations.
● VELDONA® Pet supplements, launched in Taiwan.
From
time to time, we evaluate our development priorities based on available resources, partner engagement, and market conditions. Our current
focus emphasizes scaling the AI Nose platform and expanding its commercial footprint across industrial and infrastructure-oriented environments,
while continuing to advance selected healthcare and therapeutic programs.
Our
Business Model
We
structure our operations to emphasize capital efficiency through a combination of geographic footprint, outsourced manufacturing, and
third-party commercial relationships, as described below.
Geographic
footprint. We operate our research and development and certain operating functions primarily in Taiwan as part of a capital-efficient
operating model. Taiwan is a significant hub in the global technology supply chain and offers access to a skilled workforce, including
engineers, researchers, and healthcare professionals. We believe our presence in Taiwan supports our current commercialization activities
by enabling close coordination with manufacturing partners, distributors, and customers in the region. We also believe that maintaining
operations in Taiwan in the near term enables us to access technical and scientific talent while managing operating costs, supporting
the development of high-quality and cost-effective products.
Outsourced
Manufacturing. We rely on an outsourced manufacturing model, which we believe allows us to manage capital efficiently and maintain
operational flexibility. We outsource the manufacturing of our AI Nose hardware products and point-of-care testing (POCT) product candidates
to Taiwan Carbon Nano Technology Corp. (TCNT). We outsource the manufacturing of our VELDONA® human-use drug candidates to Swiss
Pharmaceutical Co., Ltd., a Taiwan-based pharmaceutical manufacturer. We outsource the manufacturing of our VELDONA® pet supplement
products to third-party manufacturers in Taiwan, including TCNT.
Commercial
Relationships. We work with third parties to support the commercialization of our products across different markets and applications.
We maintain relationships with companies including Inabata & Co. Ltd. and its Taiwan subsidiary, Taiwan Inabata Sangyo Co., Topco
Scientific Co., Ltd., Trusval Technology Co., Ltd., Solomon Technology Corporation, Kenmec Mechanical Engineering Co., Ltd., and Topmed
International Biotech Co., Ltd.
Intellectual
Property
We
seek to protect our technology and competitive position through a combination of patents, trade secrets, proprietary know-how, and other
intellectual property rights. Our intellectual property portfolio includes issued patents and pending patent applications covering aspects
of our core technologies, including AI Nose sensing technologies, point-of-care testing, and interferon-based therapeutics. The issued
patents within our portfolio have expiration dates ranging from 2026 through 2046, depending on jurisdiction and the specific patent
grant. We also rely on contractual protections, including confidentiality and non-disclosure agreements with employees, collaborators,
and other third parties, to safeguard proprietary information. We continue to evaluate opportunities to expand and strengthen our intellectual
property portfolio as our technologies evolve. We also license certain patents and patent applications related to AI Nose, point-of-care
testing and other technologies pursuant to certain agreements with our affiliated companies as disclosed in Part III, Item 13.
Employees
As
of December 31, 2025, we had 41 full-time employees, of whom 20 were engaged in research and development. Most of our employees are based
in Taiwan. None of our employees are represented by a labor union or are party to a collective bargaining agreement. We plan to continue
to expand our workforce in research and development, sales and marketing, and general operations to support our business programs.
Additional
Information
Under
our former name, Amarillo Biosciences, Inc., we completed an initial public offering on the Nasdaq SmallCap Market in August 1996 and
have traded on the U.S. over-the-counter market since October 1999. On October 31, 2013, we filed a voluntary petition for reorganization
under Chapter 11 of the United States bankruptcy code. We emerged from bankruptcy on January 23, 2015. We established a Taiwan branch
office in 2017. We renamed as Ainos, Inc in April 2021.
On
August 9, 2022, our common stock and warrants began trading on the Nasdaq Capital Market under the trading symbols “AIMD”
and “AIMDW,” respectively. We effectuated a 1-for-15 reverse stock split of our common stock on August 8, 2022, and a 1-for-5
reverse stock split on December 14, 2023, and a 1-for-5 reverse stock split on June 30, 2025.
Our
annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and all amendments to those reports are available
free of charge on the Company’s website at www.ainos.com as soon as reasonably practicable after such material is electronically
filed with, or furnished to, the Securities and Exchange Commission.
Government
Regulation
Our
AI Nose platform products incorporate electronic components and may include wireless communication capabilities, which may subject them
to regulatory requirements governing radio frequency emissions, electromagnetic compatibility, and wireless device certification in jurisdictions
where they are manufactured, marketed, or operated. In the United States, such devices are regulated by the Federal Communications Commission
(“FCC”). In Taiwan, devices with radio frequency functionality may be subject to certification by the National Communications
Commission (“NCC”). In Japan, wireless devices may be regulated under the Radio Law administered by the Ministry of Internal
Affairs and Communications (“MIC”). Applicable requirements depend on device configuration and functionality, and compliance
may require testing, certification, and labeling prior to commercialization in certain markets
Our
drug and medical device product candidates are subject to regulatory oversight by governmental authorities responsible for protecting
public health and safety. In the United States, medical and diagnostic technologies may be regulated by the U.S. Food and Drug Administration
(“FDA”), which oversees clinical testing, product approval, and post-market surveillance. Internationally, our product candidates
may also be subject to review and approval by regulatory authorities in the jurisdictions, including the Taiwan Food and Drug Administration
(“TFDA”) and other comparable agencies. As of December 31, 2025, our medical device product candidates are in development
stage and have not been approved to sell by the FDA, the TFDA or other comparable agencies. Our VELDONA drug candidates, currently under
clinical studies in Taiwan for HIV oral warts, Sjogren Syndrome, have not been approved to sell by the FDA, TFDA and other comparable
agencies.
Our
VELDONA veterinary product candidates are subject laws and regulations in Taiwan including, but not limited to, the Veterinary Drugs
Control Act, Enforcement Rules under the Veterinary Control Act, Guidelines of Good Manufacture Practice for Veterinary Drug Manufacturers,
and Taiwan Regulations for Pet Foods and Supplements. The laws and regulations govern, among other things, product design and development,
pre-clinical and clinical testing, quality testing, manufacturing, packaging, labeling, storage, record keeping and reporting, clearance
or approval, marketing, sales and distribution, promotion and advertising, import and export and post-marketing surveillance. As of December
31, 2025, our VELDONA FCGA candidate, a veterinary application of our VELDONA drug, has not been approved to sell by TFDA.
Compliance
with applicable regulatory requirements may require time and financial resources and may affect commercialization of certain products.
Failure to comply with applicable regulations could result in fines, suspension of operations, or other regulatory actions.
ITEM
1A. RISK FACTORS.
Investors
should carefully consider the following discussion of significant factors, events, and uncertainties that make an investment in our securities
risky. The events and consequences discussed in these risk factors could, in circumstances we may or may not be able to accurately predict,
recognize, or control, have a material adverse effect on our business, growth, reputation, prospects, financial condition, operating
results (including components of our financial results), cash flows, liquidity, and stock price. These risk factors do not identify all
risks that we face; our operations could also be affected by factors, events, or uncertainties that are not presently known to us or
that we currently do not consider to present significant risks to our operations. In addition, the global economic climate amplifies
many of these risks.
Risks
related to our limited operating history, financial position, and need for additional capital
We
have a history of operating losses that are expected to continue for the foreseeable future, and we are unable to predict the extent
of future losses, or whether we will generate significant revenues or achieve or sustain profitability.
We
are focused on product development and have generated $123,360 and nil in revenues from AI Nose related product, and $797 and $20,321
from pet supplements, in the years ended December 31, 2025 and 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 $13,990,408
and $13,841,204 in the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025 and 2024, we had cumulative losses
of $67,520,328 and $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
believe that our cash on hand, along with the anticipated net proceeds from products sales and additional financing, will enable us to
fund our operations over the short and medium terms based on our current plan. We are dependent on obtaining, and are continuing to pursue,
necessary funding from outside sources, including obtaining additional funding from the issuance of securities in order to continue our
operations. Without adequate funding, we may not be able to meet our obligations. The successful commercialization of any of our products
will require us to perform a variety of functions, including:
● continuing to undertake preclinical and clinical development;
● engaging with payors and other pricing and reimbursement authorities;
We
have generated very little revenue from product sales and may never become profitable.
Our
ability to generate product sales and achieve profitability depends on our ability, alone or with collaborative partners, to successfully
complete the development of, and obtain the regulatory approvals necessary to commercialize our current and future product candidates.
Our product candidates will require additional clinical, manufacturing, and non-clinical development, regulatory approval, commercial
manufacturing arrangements, establishment of a commercial organization, significant marketing efforts, and further investment before
we generate significant product sales.
We
cannot assure you that we will meet our timelines for our development programs, which may be delayed or not completed for a number of
reasons. Our ability to generate future revenues from product sales depends heavily on our, or our collaborators’ ability to successfully:
● address competing technological and market developments;
● implement internal systems and infrastructure, as needed;
● attract, hire, and retain qualified personnel.
Even
if one or more of our current and future product candidates are approved for commercial sale, we anticipate incurring significant costs
associated with commercializing any approved product candidate. Our expenses could increase beyond our expectations if we are required
by the TFDA, the FDA or other regulatory authorities to perform clinical and other studies in addition to those that we currently anticipate.
If we are required to conduct additional clinical trials or other testing of our product candidates that we develop beyond those that
we currently expect, if we are unable to successfully complete clinical trials of our product candidates or other testing, if the results
of these trials or tests are not positive or are only modestly positive, or if there are safety concerns, we may be delayed in obtaining
marketing approval for our product candidates, not obtain marketing approval at all, or obtain more limited approvals. Even if we are
able to generate revenues from the sale of any approved product candidates, we may not become profitable and may need to obtain additional
funding to continue operations.
Even
if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to
become and remain profitable would decrease the value of the Company and could impair our ability to raise capital, maintain our research
and development efforts, expand our business or continue our operations. A decline in the value of our Company also could cause you to
lose all or part of your investment.
We
need to raise additional capital to operate our business. If we fail to obtain the capital necessary to fund our operations, we will
be unable to continue or complete our product development.
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 $417 thousand
as of December 31, 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.
However,
we may not be able to secure funding when we need it or on favorable terms. If we cannot raise adequate funds to satisfy our capital
requirements, we will have to delay, scale-back or eliminate our research and development activities, clinical studies or future operations,
we may be unable to complete planned nonclinical studies and clinical trials or obtain approval of our product candidates from the TFDA
and FDA and other regulatory authorities. In addition, we could be forced to discontinue product development, reduce or forego sales
and marketing efforts and attractive business opportunities, reduce overhead, or discontinue operations. We may also be required to obtain
funds through arrangements with collaborators, which arrangements may require us to relinquish rights to certain technologies or products
that we otherwise would not consider relinquishing, including rights to future product candidates or certain major geographic markets.
We may further have to license our technology to others. This could result in sharing revenues which we might otherwise retain for ourselves.
Any of these actions may harm our business, financial condition and results of operations.
The
amount of capital we may need depends on many factors, including the progress, timing and scope of our product development programs;
the progress, timing and scope of our nonclinical studies and clinical trials; the time and cost necessary to obtain regulatory
approvals; the time and cost necessary to further develop manufacturing processes and arrange for contract manufacturing; our
ability to enter into and maintain collaborative, licensing and other commercial relationships; and our partners’ commitment
of time and resources to the development and commercialization of our products.
We
may be unable to access the capital markets, and even if we can raise additional funding, we may be required to do so on terms that are
dilutive to you.
The
capital markets have been unpredictable in the recent past for unprofitable companies such as ours. The amount of capital that a company
such as ours is able to raise often depends on variables that are beyond our control. As a result, we cannot assure you that we will
be able to secure financing on terms attractive to us, or at all. If we are able to consummate a financing arrangement, the amount raised
may not be sufficient to meet our future needs. If adequate funds are not available on acceptable terms, or at all, our business, results
of operations, financial condition and our continued viability will be materially adversely affected.
Our
operating results may fluctuate significantly, which will make our future results difficult to predict and could cause our results to
fall below expectations.
Our
quarterly and annual operating results may fluctuate significantly, which will make it difficult for us to predict our future results.
These fluctuations may occur due to a variety of factors, many of which are outside of our control and may be difficult to predict, including:
● the scalability of our product sales, which is difficult to predict
● the timing and status of enrollment for our clinical trials;
The
cumulative effects of these factors could result in large fluctuations and unpredictability in our quarterly and annual operating results.
As a result, comparing our operating results on a period-to-period basis may not be meaningful. Investors should not rely on our past
results as an indication of our future performance.
Risks
related to product development and regulatory process
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 POCT and VELDONA candidates, and our business is dependent on the successful development of our
current and future POCT and VELDONA candidates. If we are unable to advance our current or future product candidates through clinical
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
POCT and VELDONA candidates are in different stages of clinical development. Our current and future product candidates may never achieve
expected levels of efficacy or an acceptable safety profile. Our use of clinically validated targets to pursue treatments does not guarantee
efficacy or safety or necessarily reduce the risk that our current or future product candidates will not achieve expected levels of efficacy
or an acceptable safety profile.
The
success of our business, including our ability to finance our Company and generate revenue from products in the future, will depend heavily
on the successful development and eventual commercialization of our POCT and VELDONA candidates, which may never occur. Our current POCT
and VELDONA candidates, and any future POCT 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.
As
a company, we have limited experience in preparing, submitting and prosecuting regulatory filings. We have no prior experience in developing
or securing regulatory approvals for veterinary drugs or treatments. If we do not receive regulatory approvals for current or future
product candidates, we may not be able to continue our operations. Even if we successfully obtain regulatory approval to market a product
candidate, our revenue will depend, in part, upon the size of the markets in the territories for which we gain regulatory approval and
have commercial rights, as well as the availability of competitive products, third-party reimbursement and adoption by physicians.
We
plan to seek regulatory approval to commercialize our product candidates both in the United States and in select foreign countries. While
the scope of regulatory approval in other countries is generally similar to that in the United States, in order to obtain separate regulatory
approval in other countries we must comply with numerous and varying regulatory requirements of such countries. We may be required to
expend significant resources to obtain regulatory approval and to comply with ongoing regulations in these jurisdictions.
The
success of our current and future POCT and VELDONA candidates will depend on many factors, which may include the following:
● successful enrollment and completion of clinical trials;
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 POCT and VELDONA candidates we develop, which would
materially harm our business. If we do not receive marketing approvals for our current or future POCT 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 POCT
and VELDONA to continue our business.
Clinical
product development involves a lengthy and expensive process, with uncertain outcomes. We may experience delays in completing, or ultimately
be unable to complete, the development and commercialization of our current and future product candidates, which could result in increased
costs to us, delay or limit our ability to generate revenue and adversely affect our business, financial condition, results of operations
and prospects.
To
obtain the requisite regulatory approvals to commercialize any of our POCT 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. We may also experience numerous unforeseen events prior to, during, or as a result of our nonclinical studies or clinical trials
that could delay or prevent our ability to receive marketing approval or commercialize the POCT 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 POCT and VELDONA candidates.
If
we experience termination or delays in the completion of any clinical trial of our POCT and VELDONA candidates, the commercial prospects
of our 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 POCT 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 POCT and VELDONA candidates and
harm our business and results of operations.
Any
of these occurrences may harm our business, financial condition and prospects significantly. Delays in clinical product development present
material uncertainty and risk with respect to our clinical trials, business, and financial condition.
We
and our collaboration partners have conducted and intend to conduct clinical trials for selected product candidates at sites outside
the United States, and for any of our product candidates for which we seek approval in the United States, the FDA may not accept data
from trials conducted in such locations or may require additional U.S.-based trials.
We
and our collaboration partners have conducted and plan to continue to conduct, clinical trials outside the United States, including in
Taiwan. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of these data is subject
to certain conditions imposed by the FDA. There can be no assurance that the FDA will accept data from trials conducted outside of the
United States. If the FDA does not accept the data from any clinical trials that we or our collaboration partners conduct outside the
United States, it would likely result in the need for additional clinical trials, which would be costly and time-consuming and delay
or permanently halt our ability to develop and market these or other product candidates in the United States. In other jurisdictions,
for instance, in Taiwan, there is a similar risk regarding the acceptability of clinical trial data conducted outside of that jurisdiction.
Our
long-term prospects depend in part upon discovering, developing and commercializing additional products, including POCT and VELDONA candidates,
which may fail in development or suffer delays that adversely affect their commercial viability.
Our
future operating results are dependent on our ability to successfully discover, develop, obtain regulatory approval for and commercialize
product candidates, including POCT and VELDONA candidates, beyond those we currently have in development. The success of a product candidate
is unknown and initial product development success may not result in a viable commercial product. The product development process may
require changes in manufacturing methods and formulation/design or additional validation testing. We may also make changes as we work
to optimize our manufacturing processes, but we cannot be sure that even minor changes in our processes will result in products that
are safe and effective or that will be approved for commercial sale. If a product candidate fails to develop as expected, or we experience
additional and/or unforeseen development costs and/or delays, we could face additional costs and/or loss of expected future revenue,
which would adversely affect our current financial position and future prospects may be adversely affected.
Even
if we complete the necessary nonclinical studies and clinical trials, the marketing approval process is expensive, time consuming and
uncertain, which may prevent us or any of our future collaboration partners from obtaining approvals for the commercialization of our
current product candidates and any other product candidate we develop.
Any
current or future POCT and VELDONA candidates, including medical device products, we may develop and the activities associated with their
development and commercialization, including their design, testing, manufacture, recordkeeping, labeling, storage, approval, advertising,
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 POCT
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. POCT 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.
The
process of obtaining marketing approvals, in Taiwan, the United States and other jurisdictions, is expensive, may take many years, if
approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity, and novelty
of the product candidates involved. Changes in marketing approval policies during the development period, changes in or the enactment
of additional statutes or regulations, or changes in regulatory review for each submitted product application, may cause delays in the
approval or rejection of an application. The FDA and comparable authorities in other countries may refuse to accept any application or
may decide that our data are insufficient for approval and require additional nonclinical, clinical or other studies. Any marketing approval
we ultimately obtain may be limited or subject to restrictions or post-approval commitments. If we experience delays in obtaining marketing
approval or if we fail to obtain marketing approval of any current or future product candidates we may develop, the commercial prospects
for those product candidates may be harmed, and our ability to generate revenues will be materially impaired.
Even
if a current or future product candidate, including AI Nose, POCT and VELDONA, receives marketing approval, it may fail to achieve the
degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial
success.
If
any current or future product candidate we develop receives marketing approval, whether as a single agent or in combination with other
therapies, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, and others in the
medical community, or such participants may prefer existing treatment options. If the product candidates we develop, including medical
device products, do not achieve an adequate level of market acceptance, we may not generate expected levels of revenues associated with
such products, which may prevent those products from becoming profitable. The degree of market acceptance of any product candidate, if
approved for commercial sale, will depend on a number of factors, including:
● efficacy and potential advantages compared to alternative tools;
● convenience and ease of use;
● the willingness of the target market to adopt new technologies; and
● the strength of marketing and distribution support.
The
total addressable market opportunity for our current and future products may be much smaller than we estimate.
Our
estimates of the total addressable market for our product candidates are based on internal and third-party estimates as well as a number
of significant assumptions. Market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on
assumptions and estimates. These estimates, which have been derived from a variety of sources, including market research and our own
internal estimates, may prove to be incorrect. Further, the continued development of, and approval or authorizations for, vaccines and
therapeutic treatments may affect these market opportunity estimates. Our market opportunity may also be limited by new products that
enter the market. If any of our estimates prove to be inaccurate, the market opportunity for platform and products could be significantly
less than we estimate. If this turns out to be the case, our potential for growth may be limited and our business and future prospects
may be materially adversely affected.
We
may not obtain approval for our product candidates in any jurisdictions.
Approval
of a product candidate in one jurisdiction by a regulatory authority, such as the TFDA or FDA, does not ensure approval of such product
candidate by regulatory authorities in other countries or jurisdictions. Commercialization of our product candidates will be subject
to the regulatory requirements governing marketing authorization in the jurisdiction in which they are sold.
Approval
procedures vary among jurisdictions and can involve requirements and administrative review periods different from, and more onerous than,
those in Taiwan and the United States, including additional nonclinical studies or clinical trials. In many countries outside Taiwan
and United States, a product candidate must be approved for reimbursement before it can be approved for sale in that country. In some
cases, the price that we intend to charge for any product candidates, if approved, is also subject to approval. For example, obtaining