Ainos, Inc.

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.

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.