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Ainos, Inc.

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Business Summary

Ainos, Inc. is a dual-platform company advancing artificial intelligence-based smelltech technologies and immune therapeutics. Its primary strategic focus is the commercialization of its proprietary scent digitization platform, AI Nose, while it also continues to develop therapeutic assets based on its low-dose oral interferon program, VELDONA. The company operates in the nascent market for AI-enabled scent digitization and SmellTech solutions, which remains under development and early commercialization. The company is expanding AI Nose from initial healthcare-related settings, including point-of-care testing, into industrial environments such as semiconductor manufacturing, robotics, and smart manufacturing. Separately, Ainos continues to develop VELDONA, its low-dose oral interferon platform, targeting selected rare, autoimmune, and infectious disease indications, including oral warts in HIV-positive patients, Sjögren's syndrome, and feline chronic gingivostomatitis.

The company faces competition in its various markets. In the pet health supplement industry, it competes on the basis of product quality, brand awareness, and price against larger incumbents with greater financial resources. In the point-of-care testing market, it competes against established lab companies such as Quest Diagnostics, Inc. and Laboratory Corporation of America, as well as other companies developing molecular, antigen, and antibody tests. The company's competitive advantages include its proprietary AI Nose platform, which integrates gas sensor arrays with a proprietary smell language model to digitize scent signals into a machine-readable data format called Smell ID. Ainos also holds intellectual property, including issued patents and pending patent applications covering AI Nose sensing technologies, point-of-care testing, and interferon-based therapeutics, with expiration dates ranging from 2026 through 2046. The U.S. Food and Drug Administration has granted orphan drug designation for its VELDONA formulation as a potential treatment for oral warts in HIV-seropositive patients.

Ainos generates revenue through sales of AI Nose hardware systems and recurring service-based offerings associated with its SmellTech platform, as well as sales of VELDONA Pet supplements. The company structures its operations for capital efficiency through a geographic footprint in Taiwan, outsourced manufacturing, and third-party commercial relationships. It relies on an outsourced manufacturing model, outsourcing AI Nose hardware and POCT product candidates to Taiwan Carbon Nano Technology Corp., VELDONA human-use drug candidates to Swiss Pharmaceutical Co., Ltd., and VELDONA pet supplement products to third-party manufacturers in Taiwan, including TCNT. The company works with third parties for commercialization, maintaining relationships with companies including Inabata & Co. Ltd., Topco Scientific Co., Ltd., Trusval Technology Co., Ltd., Solomon Technology Corporation, Kenmec Mechanical Engineering Co., Ltd., and Topmed International Biotech Co., Ltd.

The company's core technology platform, AI Nose, is an AI-based electronic olfaction system that integrates gas sensor arrays with proprietary artificial intelligence models, referred to as a smell language model, to digitize scent and volatile organic compound signals into Smell ID, a machine-readable data format. AI Nose was initially developed in healthcare-related settings, including point-of-care testing and healthcare monitoring use cases such as ventilator-associated pneumonia, women's vaginal health, and selected sexually transmitted infections. Building on this foundation, the company is expanding AI Nose into industrial environments, with current and planned use cases including semiconductor manufacturing, robotics, and smart manufacturing. During 2025, the company 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. The company also operates ScentAI Inc., a wholly owned subsidiary focused on advancing the SLM algorithm, with Ainos focusing on hardware, deployment, and data generation.

The company's VELDONA program is a low-dose oral interferon alpha formulation delivered to the oral cavity, designed to modulate immune responses. Since its inception, the company has completed 68 human clinical studies evaluating low-dose oral interferon alpha, including Phase 1, Phase 2, and Phase 3 studies, of which 63 were Phase 2 trials. In addition, it has conducted 28 preclinical and animal studies evaluating low-dose oral interferon across a range of species. Current VELDONA development programs focus on candidates for the treatment of oral warts in HIV-seropositive patients, Sjögren's syndrome, and feline chronic gingivostomatitis. The company also commercialized VELDONA Pet supplements in Taiwan to support companion animal health. For the year ended December 31, 2025, the company generated $123,360 in revenues from AI Nose related product and $797 from pet supplements, compared to nil and $20,321 respectively in 2024. The company has ceased selling COVID-19 Antigen Rapid Test Kits since the first quarter of 2024.

During 2025, the company accelerated the transition of the AI Nose platform from development-stage validation to early-stage commercialization. It 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 systems. It 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. In validation activities conducted in Japanese semiconductor facilities, AI Nose achieved approximately 80% classification accuracy across more than 20 volatile organic compounds. The company initiated pilot deployments of AI Nose across seven operational sites in Japan through a collaboration with a Japanese service robotics partner. On the financing side, the company entered into an amendment to the Convertible Note with Li-Kuo Lee to extend the maturity date to May 13, 2025, and on April 30, 2025, repaid the full principal with accrued interest aggregate amount of $1,132,650 . As of December 31, 2025, the company sold 734,214 shares of common stock under the At-the-Market Offering Agreement, resulting in net proceeds of approximately $2,008,721 . The company also issued 1,160,000 shares of its common stock in exchange for 116,000,000 newly issued shares of ScentAI Inc., and issued 950,000 shares to the company's directors and employees as special stock awards.

For the year ended December 31, 2025, the company reported total revenues of $124,157 , compared to $20,729 in 2024. Cost of revenues was $21,246 in 2025 versus $52,595 in 2024, resulting in a gross profit of $102,911 in 2025 compared to a gross loss of $31,866 in 2024. Operating expenses totaled $14,093,319 in 2025, up from $13,809,338 in 2024. The company reported an operating loss of $13,990,408 in 2025 versus $13,841,204 in 2024. Net loss was $14,771,012 in 2025 compared to $14,863,161 in 2024. Basic and diluted net loss per share was $3.46 in 2025 versus $7.82 in 2024. As of December 31, 2025, the company had cash and cash equivalents of $417,353 and an accumulated deficit of $67,520,328 .

Business Outlook

The company's primary growth vector is the scaling of the AI Nose platform as a SmellTech platform that digitizes scent as a machine-readable data modality. Following initial industrial validation in 2025, 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. The company 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 systems. It 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. In validation activities conducted in Japanese semiconductor facilities, AI Nose achieved approximately 80% classification accuracy across more than 20 volatile organic compounds. The company initiated pilot deployments of AI Nose across seven operational sites in Japan through a collaboration with a Japanese service robotics partner.

A second growth vector is the advancement of VELDONA therapeutic programs. The company continues 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. During 2025, the company 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, the company currently expects key clinical and partnering milestones to occur over the 2026–2027 timeframe. The company also marketed Veldona Pet supplement in Taiwan on a limited scale.

The filing does not contain specific margin or cost trajectory targets with exact figures.

The company plans to continue to expand its workforce in research and development, sales and marketing, and general operations to support its business programs. As of December 31, 2025, the company had 41 full-time employees, of whom 20 were engaged in research and development. Most employees are based in Taiwan. The company relies on an outsourced manufacturing model, outsourcing AI Nose hardware products to Taiwan Carbon Nano Technology Corp., VELDONA human-use drug candidates to Swiss Pharmaceutical Co., Ltd., and VELDONA pet supplement products to third-party manufacturers in Taiwan, including TCNT.

The company expects that research and development expenses will continue to grow as it further develops AI Nose programs and VELDONA drug candidates. For the year ended December 31, 2025, R&D expenses were $7,749,772 . The company expects that selling, general and administrative expenses and research and development expenses will continue to increase as its internal sales force moves forward its product development and commercialization roadmaps. The company may also have cash requirements related to capital expenditures to support the planned growth of its business, including investments in corporate facilities and equipment. The company has not declared or paid any cash dividends on its capital stock in 2025 and does not intend to pay any cash dividends in the foreseeable future. As of December 31, 2025, the company sold an aggregate of 734,214 shares of common stock under the ATM facility and received $2,008,721 in net proceeds. 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 .

The company faces significant headwinds and constraints. It has a history of operating losses that are expected to continue for the foreseeable future, generating 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, the company had cash and cash equivalents of approximately $417,000 and will need to continue to seek capital to fund operations. The company has generated very little revenue from product sales, with $124,157 in total revenues for 2025. The market for AI-enabled scent digitization and SmellTech solutions remains nascent, and potential customers may not recognize scent as a valuable data modality. The company's AI Nose platform is still under development and early commercialization, and it has not yet established a significant history of large-scale commercial adoption, recurring revenue, or long-term customer retention. The company's POCT and VELDONA candidates are in different stages of clinical development and may never achieve regulatory approval or commercial success. The company also faces risks related to reliance on third-party manufacturers, including TCNT, an affiliate, and Swiss Pharmaceutical Co., Ltd.

Risk Factors

The company has a history of operating losses that are expected to continue, with operating losses of $13,990,408 and $13,841,204 in 2025 and 2024, respectively, and an accumulated deficit of $67,520,328 as of December 31, 2025. It had cash and cash equivalents of only $417,353 as of December 31, 2025, and will need to raise additional capital to fund operations, with no assurance that financing will be available on acceptable terms. The company has generated very little revenue from product sales, totaling $124,157 in 2025, and may never become profitable. The AI Nose platform is still under development and early commercialization, with no significant history of large-scale commercial adoption, and the market for AI-enabled scent digitization may not develop as expected. The company's POCT and VELDONA candidates are in early stages of clinical development and require substantial additional investment, regulatory approvals, and successful clinical trials before commercialization, with no guarantee of success. The company relies on a single third-party manufacturer, TCNT, an affiliate, for AI Nose hardware products, creating concentration risk.

Management Priorities

Management's message emphasizes the strategic shift toward scaling the AI Nose platform as a SmellTech platform that digitizes scent as a machine-readable data modality, following initial industrial validation in 2025. Key themes 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. Management also plans to manage healthcare-related programs, including VELDONA, in a selective and capital-efficient manner, with an emphasis on partnerships and out-licensing. The company expects key clinical and partnering milestones for VELDONA to occur over the 2026–2027 timeframe. Management's strategic priorities for the period ahead are: (1) scaling the AI Nose platform and expanding its commercial footprint across industrial and infrastructure-oriented environments, (2) continuing to advance selected healthcare and therapeutic programs, and (3) managing capital efficiently through a combination of geographic footprint, outsourced manufacturing, and third-party commercial relationships.

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 7, MD&A — Results of Operations
  2. [2] Item 7, MD&A — Results of Operations
  3. [3] Item 7, MD&A — Results of Operations
  4. [4] Item 7, MD&A — Key Developments in 2025
  5. [5] Item 7, MD&A — Key Developments in 2025
  6. [6] Item 7, MD&A — Key Developments in 2025
  7. [7] Item 7, MD&A — Key Developments in 2025
  8. [8] Item 7, MD&A — Key Developments in 2025
  9. [9] Item 7, MD&A — Key Developments in 2025
  10. [10] Item 7, MD&A — Recent Financing
  11. [11] Item 7, MD&A — At The Market Offering Agreement
  12. [12] Item 7, MD&A — At The Market Offering Agreement
  13. [13] Item 5, Market for Registrant's Common Equity — Recent Sales of Unregistered Securities
  14. [14] Item 8, Note 7 — Stockholders' Equity
  15. [15] Item 5, Market for Registrant's Common Equity — Recent Sales of Unregistered Securities
  16. [16] Item 7, MD&A — Results of Operations
  17. [17] Item 7, MD&A — Results of Operations
  18. [18] Item 7, MD&A — Results of Operations
  19. [19] Item 7, MD&A — Results of Operations
  20. [20] Item 7, MD&A — Results of Operations
  21. [21] Item 7, MD&A — Results of Operations
  22. [22] Item 7, MD&A — Results of Operations
  23. [23] Item 7, MD&A — Results of Operations
  24. [24] Item 7, MD&A — Results of Operations
  25. [25] Item 7, MD&A — Results of Operations
  26. [26] Item 7, MD&A — Results of Operations
  27. [27] Item 7, MD&A — Results of Operations
  28. [28] Item 8, Note 11 — Net Loss per Common Share
  29. [29] Item 8, Note 11 — Net Loss per Common Share
  30. [30] Item 7, MD&A — Liquidity and Capital Resources
  31. [31] Item 7, MD&A — Going Concern
  32. [32] Item 7, MD&A — Key Developments in 2025
  33. [33] Item 7, MD&A — Key Developments in 2025
  34. [34] Item 7, MD&A — Key Developments in 2025
  35. [35] Item 7, MD&A — Key Developments in 2025
  36. [36] Item 7, MD&A — Key Developments in 2025
  37. [37] Item 7, MD&A — Key Developments in 2025
  38. [38] Item 1, Business — Employees
  39. [39] Item 1, Business — Employees
  40. [40] Item 7, MD&A — Research and Development Expenses
  41. [41] Item 7, MD&A — At The Market Offering Agreement
  42. [42] Item 7, MD&A — At The Market Offering Agreement
  43. [43] Item 8, Note 14 — Subsequent Events
  44. [44] Item 8, Note 14 — Subsequent Events
  45. [45] Item 1A, Risk Factors — Risks related to our limited operating history
  46. [46] Item 1A, Risk Factors — Risks related to our limited operating history
  47. [47] Item 1A, Risk Factors — We need to raise additional capital
  48. [48] Item 7, MD&A — Results of Operations
  49. [49] Item 1A, Risk Factors — Risks related to our limited operating history
  50. [50] Item 1A, Risk Factors — Risks related to our limited operating history
  51. [51] Item 1A, Risk Factors — Risks related to our limited operating history
  52. [52] Item 1A, Risk Factors — We need to raise additional capital
  53. [53] Item 7, MD&A — Results of Operations
  54. [54] Item 8, Consolidated Statements of Operations
  55. [55] Item 8, Consolidated Statements of Operations
  56. [56] Item 8, Consolidated Statements of Operations
  57. [57] Item 8, Consolidated Statements of Operations
  58. [58] Item 8, Note 11 — Net Loss per Common Share
  59. [59] Item 8, Note 11 — Net Loss per Common Share
  60. [60] Item 8, Consolidated Statements of Operations
  61. [61] Item 8, Consolidated Statements of Operations
  62. [62] Item 8, Consolidated Statements of Operations
  63. [63] Item 8, Consolidated Statements of Operations
  64. [64] Item 8, Consolidated Balance Sheets
  65. [65] Item 8, Consolidated Balance Sheets
  66. [66] Item 8, Consolidated Balance Sheets
  67. [67] Item 8, Consolidated Balance Sheets
  68. [68] Item 8, Consolidated Statements of Cash Flows
  69. [69] Item 8, Consolidated Statements of Cash Flows
  70. [70] Item 8, Consolidated Statements of Operations
  71. [71] Item 8, Consolidated Statements of Operations
  72. [72] Item 8, Consolidated Statements of Operations
  73. [73] Item 8, Consolidated Statements of Operations
  74. [74] Item 8, Note 9 — Share-Based Compensation
  75. [75] Item 8, Note 9 — Share-Based Compensation
  76. [76] Item 8, Consolidated Statements of Cash Flows
  77. [77] Item 8, Consolidated Statements of Cash Flows
  78. [78] Item 8, Note 8 — Revenue
  79. [79] Item 8, Note 8 — Revenue

Analysis on 6/21/2026