Tillkännagivande • Nov 12

Ainos, Inc. Announces Institutional Review Board Approval for Sjögren’S Syndrome Clinical Study

Ainos, Inc. announced that it has received Institutional Review Board (IRB) approval from Shuang Ho Hospital, affiliated with Taipei Medical University (IRB Approval No.: TMU-JIRB No.: N202408042), for its clinical trial of VELDONA®? in treating Sjogren's syndrome. Ainos plans to commence a site initiation visit (SIV) for the study around April 2025, subject to regulatory approvals. The study aims to further assess the potential of VELDONA®® in improving salivary gland function and alleviating symptoms of dryness. Ainos previously conducted eight clinical studies in the U.S., including three Phase 3 trials, showing that VELDONA® significantly increases unstimulated whole salivary flow. Clinical Trial Design and Objectives: The study will be conducted at Shuang Ho Hospital under the oversight of the Department of Allergy, Immunology, and Rheumatology. Its primary endpoint is to evaluate the efficacy of VELDONA in improving salivary flow and alleviating dryness symptoms in patients with primary Sjögren's syndrome. The trial follows an open-label design (Protocol Title: An open-label study to evaluate the efficacy of VELDONA® in patients with primary Sjögren's syndrome) and will recruit 24 patients for a 24- to 48-week treatment period, based on the diagnostic criteria established by the American and European Rheumatology Associations in 2016. Secondary endpoints include: Assessing improvements in dryness symptoms using the European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI); Measuring changes in disease activity using the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI); Evaluating eight specific dryness symptoms, including oral and ocular dryness, using the Visual Analog Scale (VAS); Conducting nuclear medicine imaging to compare pre- and post-treatment salivary gland function. Clinical Trial Timeline and Progress: The trial is managed by ComboTrial Consultancy Ltd. under Good Clinical Practice (GCP) standards. Following the IRB approval from Shuang Ho Hospital (TMU-JIRB No.: N202408042), Ainos plans to submit to Taiwan'sFood and Drug Administration (TFDA) by the end of December 2024 and anticipates to complete all approvals by first quarter 2025, with the SIV scheduling for April 2025. Patient recruitment will span six months, with the First Patient First Visit (FPFV) anticipated for May 2025, the Last Patient Last Visit (LPLV) by the end of November 2025, and study completion by the end of December 2026. Ainos has previously conducted three clinical trials in the U.S. evaluating VELDONA® for Sjögren's syndrome. Results indicate the product has the potential to significantly improve oral dryness symptoms without serious adverse reactions. First Study: A total of 241 patients participated in a 24-week double-blind, placebo-controlled study, where patients were randomly assigned to receive either a placebo or 150 IU of HBL IFNa three times daily. Results showed a significant increase in unstimulated whole salivary flow (p<0.05) in the HBL IFNa group, with no other significant treatment effects observed. There were no reports of serious adverse reactions or deaths during the study, and no statistically significant difference in the incidence or severity of adverse events between the treatment and placebo groups. Second Study: In a similar 24-week double-blind, placebo-controlled study with 256 patients, the difference in salivary flow between the treatment and placebo groups was assessed. Results indicated a trend toward increased unstimulated whole salivary flow in the 150 IU HBL IFNa treatment group (p<0.10), although this did not reach statistical significance. The incidence and severity of adverse events were comparable between the treatment and placebo groups. Third Study: A 48-week open-label safety study was conducted with 288 patients, all of whom received 150 IU HBL IFNa three times daily. By the end of the treatment period, patients reported significant improvement in oral dryness and comfort (p<0.0001), with significant improvements observed in all eight symptom scores (p<0.05). No treatment-related serious adverse reactions were noted, and the safety analysis indicated no clinically significant changes.

Tillkännagivande • Oct 08

Ainos, Inc. Advances Healthcare and Industrial Innovations with AI Nose and VELDONA Technologies

Ainos, Inc. announced that it continues to push the boundaries of global smart healthcare and immunotherapy innovation. With its AI Nose and VELDONA® low-dose oral interferon technologies, Ainos is not only spearheading advancements in medical technology but also demonstrating significant potential for industrial safety and automation applications. The Company's excellent research and development progress aligns with its strategic plans, with certain projects being completed ahead of schedule, showcasing Ainos' exceptional ability in both technology deployment and commercialization. AI-Powered Electronic Nose Technology: Breakthroughs in Healthcare and Industrial Applications AI Nose, Ainos' AI-powered digital nose technology simulates human olfaction by detecting volatile organic compounds ("VOCs"). Currently, AI Nose can detect 22 different gases with a 79% accuracy, proving its broad potential in both medical and industrial markets. Healthcare Applications: AI Nose holds revolutionary significance in early disease diagnosis, particularly in respiratory diseases and telemedicine. By analyzing the composition of exhaled breath, the technology can quickly identify abnormalities, assisting with patient stratification, and reducing the need for invasive diagnostic procedures. Additionally, Ainos has developed Ainos Flora, designed to detect vaginal infection and certain sexually transmitted infections ("STIs") in women. The second-generation Ainos Flora, optimized for home-use, is expected to begin clinical trial preparations by the end of 2024, advancing women's health technology. Industrial and Environmental Safety Applications: AI Nose, an AI-powered digital nose technology, can monitor harmful chemicals in real-time, safeguarding workers and reducing the risk of industrial accidents. As Industry 4.0 continues to evolve, this technology is set to play a pivotal role in automated factories and environmental monitoring systems. Product Development for Long-Term Care Institutions: Ainos, in collaboration with its Japanese partners, has developed a specialized AI-powered electronic nose solution for long-term elderly care institutions. Trial production is expected to begin by the end of 2024, with real-world applications in elderly care facilities soon to follow, proliferating the adoption of smart healthcare solutions. Human-Like Sensing for Robots: Enhancing the Future of Robotics: The future of humanoid robots hinges on their ability to possess human-like sensory capabilities, including vision, hearing, smell, taste, and sound processing. While many robots are already equipped with advanced vision and auditory technologies, the lack of a sense of smell limits their ability to fully perceive their environment. Ainos' AI-powered electronic nose will enable robots to detect gas leaks, hazardous chemicals, or abnormal odors, significantly enhancing their autonomy and safety. The application of AI-powered electronic nose technology extends beyond industrial automation. In the future, the company envision robots equipped with olfactory capabilities collaborating with humans in a broader range of scenarios, creating new value in various fields. These robots will better understand and respond to their surroundings, helping humans improve efficiency in dangerous, complex, or labor-intensive tasks. the company believe Ainos' expertise and achievements in AI-powered electronic nose technology will drive a leap forward in robotics, paving the way for a new era of human-robot collaboration. VELDONA® Low-Dose Oral Interferon Technology: A New Approach to Treating Viral and Immune Diseases Ainos' VELDONA® low-dose oral interferon technology demonstrates significant potential in treating various viral and immune-related diseases. Innovative Treatments for Viral Diseases: VELDONA® offers a breakthrough treatment for viral diseases such as COVID-19 and influenza by modulating the immune system, inhibiting viral replication, and reducing the severity of illness with fewer side effects. Immune-Related Diseases: Sjögren's Syndrome: VELDONA® has shown promising results in clinical trials for treating Sjögren's syndrome, an autoimmune disease characterized by dry mouth and eyes. By regulating immune responses and reducing inflammation, VELDONA® significantly improves patients' quality of life. Potential in the Veterinary Market: VELDONA® has also shown success in the veterinary field, particularly in treating feline chronic gingivostomatitis ("FCGS"). Clinical trials are already underway in Taiwan, with the potential to penetrate the rapidly growing global pet healthcare market upon success. Major Breakthrough in HIV-Related Oral Warts Treatment and FDA Orphan Drug Designation Ainos' VELDONA® treatment has achieved a breakthrough in the treatment of human immunodeficiency virus ("HIV")-related oral warts and has received Orphan Drug Designation from the U.S. Food and Drug Administration ("FDA"). This development is expected to significantly enhance the quality of life for HIV patients. Clinical Progress: Ainos is in the process of initiating clinical trials for HIV-related oral warts. Prior clinical trial results indicate that VELDONA® can significantly reduce the size and number of oral warts while enhancing patients' oral health. Significance of FDA Orphan Drug Designation: This designation strengthens VELDONA®'s market potential as a treatment for a rare disease. It offers market exclusivity, tax incentives, and research and development support, accelerating its global commercialization. Key Collaborations and Developments in 2023-2024 Since 2023, Ainos formed key partnerships to further drive the application and commercialization of its technologies. Collaboration with a Swiss pharmaceutical company to accelerate the global commercialization of VELDONA® for human pharmaceutical markets. Partnership with Topmed International Biotech to promote VELDONA® pet health supplements, with plans to expand into global markets. Joint development of a VOC sensing platform with Nisshinbo Micro Devices and Taiwan'sInabata Sangyo Co., with applications in telemedicine, automotive, industrial monitoring, and environmental safety, strengthening Ainos' position in the AI-powered electronic nose market. Agreement with Taiwan'sCarbon Nano Technology Co. to co-develop VOC and POCT technologies, accelerating the promotion of smart healthcare solutions.

Räntetäckningsgrad	n/a
Kontanter	US$1.42m
Eget kapital	US$3.28m
Summa skulder	US$16.28m
Totala tillgångar	US$19.56m

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/09/13 08:17
Aktiekurs vid dagens slut	2026/09/11 00:00
Intäkter	2026/06/30
Årlig intjäning	2025/12/31

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Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

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Ainos (NASDAQ:AIMD) Has Debt But No Earnings; Should You Worry?

Ainos (NASDAQ:AIMD) Is Carrying A Fair Bit Of Debt

Ainos Receives a Deficiency Letter from Nasdaq Regarding Non-Compliance with the Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital Market Pursuant to Nasdaq Listing Rule 5550(a)(2)

We Think Ainos (NASDAQ:AIMD) Has A Fair Chunk Of Debt

Ainos Regains Compliance with Nasdaq Minimum Bid Price Requirement

Here's Why Ainos (NASDAQ:AIMD) Can Afford Some Debt

Recent updates

Second quarter 2026 earnings released: US$0.63 loss per share (vs US$0.99 loss in 2Q 2025)

New major risk - Market cap size

Director recently sold US$209k worth of stock

First quarter 2026 earnings released: US$0.41 loss per share (vs US$1.04 loss in 1Q 2025)

New major risk - Market cap size

Ainos (NASDAQ:AIMD) Has Debt But No Earnings; Should You Worry?

New major risk - Market cap size

Ainos, Inc., Annual General Meeting, Nov 07, 2025

Ainos (NASDAQ:AIMD) Is Carrying A Fair Bit Of Debt

First quarter 2025 earnings released: US$0.21 loss per share (vs US$0.57 loss in 1Q 2024)

Full year 2024 earnings released: US$1.56 loss per share (vs US$3.36 loss in FY 2023)

Ainos, Inc. Announces Institutional Review Board Approval for Sjögren’S Syndrome Clinical Study

Third quarter 2024 earnings released: US$0.33 loss per share (vs US$0.73 loss in 3Q 2023)

Ainos, Inc. Advances Healthcare and Industrial Innovations with AI Nose and VELDONA Technologies

Ainos, Inc. Receives IRB Approval from National Taiwan University Hospital for HIV-Oral Warts Clinical Trial

Ainos Announces Plan to Initiate Taiwan Clinical Study for Veldona as Potential Treatment of Oral Warts in HIV-Positive Patients

Ainos, Inc. Unveils AI Nose Breakthrough that Revolutionizes Smart Manufacturing Factory Automation and Manufacturing Safety

Ainos, Inc., Annual General Meeting, Sep 27, 2024

Second quarter 2024 earnings released: US$0.49 loss per share (vs US$0.58 loss in 2Q 2023)

Ainos, Inc Enrolls First Subject for Clinical Study of VELDONA-Based Animal FCGS Drug

Ainos Receives a Deficiency Letter from Nasdaq Regarding Non-Compliance with the Minimum Bid Price Requirement for Continued Listing on the Nasdaq Capital Market Pursuant to Nasdaq Listing Rule 5550(a)(2)

Ainos, Inc. Unveils Critical Progress in Ainos Flora Clinical Trials and Next-Gen Plans Powered by NVIDIA CUDA

Ainos, Inc. to Initiate Clinical Study of New Potential VELDONA-Based Animal Drug, Expanding VELDONA's Potential Market

First quarter 2024 earnings released: US$0.57 loss per share (vs US$0.63 loss in 1Q 2023)

New major risk - Shareholder dilution

We Think Ainos (NASDAQ:AIMD) Has A Fair Chunk Of Debt

Full year 2023 earnings released: US$3.36 loss per share (vs US$5.14 loss in FY 2022)

Ainos, Inc. Submits Clinical Hold Complete Response to US FDA to Resolve the Deficiencies on Investigational New Drug Phase Ii Trial of Its Veldona Formulation Against Mild Covid-19 Symptoms

New minor risk - Shareholder dilution

Ainos Regains Compliance with Nasdaq Minimum Bid Price Requirement

Ainos, Nisshinbo Micro Devices and Inabata Initiate Phase 2 of VOC Co-Development Powered by Ai Nose, Accelerating the Digitalization of Smell

Ainos, Inc. Announces Resignation of John Junyong Lee as Chief Legal Counsel and Corporate Secretary

Less than half of directors are independent

Ainos, Inc. Announces Positive Data Reports from its Clinical Studies for VELDONA as Potential Treatment of Oral Warts in HIV-Seropositive Patients, an Orphan Drug Designated by the FDA

Ainos, Inc., Annual General Meeting, Dec 08, 2023

Here's Why Ainos (NASDAQ:AIMD) Can Afford Some Debt

Second quarter 2023 earnings released: US$0.12 loss per share (vs US$0.20 loss in 2Q 2022)

Staff of Nasdaq Determines Ainos is Eligible for an Additional 180 Calendar Day Period, or Until January 2, 2024, to Regain Compliance with Its Minimum Bid Price Requirement

Ainos, Inc. Completes VELDONA Pet Line-Up by Launching New VELDONA Pet Shiny and Slim in Push Towards $20 Million Revenue Target

Ainos, Inc. Announces Chief Financial Officer Changes

Here's Why Ainos (NASDAQ:AIMD) Can Afford Some Debt

First quarter 2023 earnings released: US$0.13 loss per share (vs US$0.22 loss in 1Q 2022)

Full year 2022 earnings released: US$1.03 loss per share (vs US$0.52 loss in FY 2021)

Ainos Receives Non-Compliance Notice From Nasdaq

Ainos, Inc Publishes Preclinical Data Demonstrating its VELDONA Formulation's Potential as Treatment Candidates for the Most Common Medical Conditions for Companion Animals

Third quarter 2022 earnings released: US$0.51 loss per share (vs US$0.12 loss in 3Q 2021)

Less than half of directors are independent

Ainos, Inc. Pursues Licensing Partners to Accelerate Five Candidates of Its Low-Dose Oral Interferon Formulation Veldona to Phase 3 Trials and Commercialization

Ainos Announces Positive Results from Additional Preclinical Study of Its Low-Dose Oral Interferon Formulation Against New Variant Virus - Omicron

Ainos rises 50% on positive data from animal study trial of Veldona to treat COVID-19

Ainos stock rises on FDA filing for starting phase 2 trial of Veldona for COVID-19

Second quarter 2022 earnings released: US$0.014 loss per share (vs US$0.09 loss in 2Q 2021)

Amarillo Biosciences GAAP EPS of -$0.01, revenue of $636.62M

Ainos, Inc. has completed a Composite Units Offering in the amount of $3.315 million.

Less than half of directors are independent

Ainos Announces Positive Results from Preclinical Studies of Its Low-Dose Oral Interferon Formulation Against Covid-19

Ainos, Inc. Announces Executive Changes

Ainos, Inc. announced delayed 10-Q filing

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