Arizona Tribune - Ainos Reports Breakthrough Interim Results in VELDONA Clinical Trial for FCGS, Signaling New Era in Companion Animal Immunotherapy

SAN DIEGO, CALIFORNIA / ACCESS Newswire / May 19, 2025 / Ainos, Inc. (Nasdaq:AIMD)(Nasdaq:AIMDW) ("Ainos"), a pioneer of low-dose oral interferon therapeutics, today announced compelling interim results from its ongoing veterinary clinical trial using low-dose interferon VELDONA for treating Feline Chronic Gingivostomatitis ("FCGS"), a chronic inflammatory conditions in cats. The interim results demonstrate meaningful improvements in inflammation and a consistent reduction in steroid dependency, indicating strong commercial and scientific potential for a novel class of immunotherapy in companion animals.

The randomized, controlled trial aims to enroll 30 cats, divided into high- and low-dose treatment groups, to assess pre- and post-treatment inflammation scores, corticosteroid usage, and safety. The focus is on chronic inflammatory diseases such as feline gingivostomatitis-an area where effective long-term treatments remain limited and largely reliant on steroids.

To date, three cats have completed treatment, with a fourth currently in progress. All cases have shown clear clinical improvements and strong tolerability:

• Case 1 (5-year-old cat, severe oral inflammation):

  • Inflammation score reduced from 19 to 17 (10.5% improvement)

  • Previous treatment with a French high-dose injectable interferon treatment was ineffective

  • Steroid dose successfully reduced from 0.8mg/kg/day to 0.5mg/kg/day with stable condition

• Case 2 (14-year-old cat, chronic inflammation):

  • Score reduced from 16 to 12.3 (23.1% improvement)

  • Steroid therapy was fully discontinued two months after treatment; condition remains stable

• Case 3 (index case):

  • Score reduced from 9 to 5 (44.4% improvement)

  • Steroids discontinued post-treatment; no relapse observed

No significant side effects were observed in any case. The results also suggest a steroid-sparing effect, which is critical for improving long-term outcomes in aging or chronically ill pets.

Dr. Albert Yu, Technical Director of Pharmaceuticals at Ainos, commented: "We are witnessing a potential paradigm shift in treating chronic inflammatory diseases in companion animals. Our interferon therapy not only shows efficacy in reducing inflammation but also opens the door to steroid-free or steroid-reduced treatment strategies, which could significantly elevate animal welfare worldwide."

A High-Growth Market with Global Opportunity

According to Global Market Insights, the global pet dental market is projected to reach nearly $13 billion by 2030, driven by increasing focus on preventive care and growing awareness about pet dental health. By leveraging its proprietary interferon technology, Ainos is positioning itself at the forefront of this expanding market-potentially establishing a first-mover advantage in animal interferon therapy.

We believe these early clinical signals reinforce Ainos' leadership in translational biotech and help lay the foundation for future commercial strategies, including partnerships, licensing, and regulatory engagements across major veterinary markets.

About Ainos, Inc.

Headquartered in San Diego, California, Ainos, Inc. develops disruptive medical and healthcare solutions based on its proprietary AI Nose and VELDONA® technologies. The name "Ainos" combines "AI" and "Nose" to signify the Company's commitment to enabling AI with the ability to smell and individuals to live healthier. The Company's clinical-stage product pipeline includes AI-driven, telehealth-friendly POCT solutions powered by AI Nose, VELDONA® human and animal oral therapeutics, and human orphan drugs. To learn more, visit https://www.ainos.com. Follow Ainos on X, formerly known as Twitter, (@AinosInc) and LinkedIn to stay up-to-date.

Forward-Looking Statements

Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements are based on management's current assumptions and expectations of future events and trends, which affect or may affect the Company's business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, among other things, our expectation that we will incur net losses for the foreseeable future; our ability to become profitable; our ability to raise additional capital to continue our product development; our ability to accurately predict our future operating results; our ability to advance our current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates we develop; the ability to obtain and maintain regulatory approval of our product candidates; delays in completing the development and commercialization of our current and future product candidates; developing and commercializing additional products, including diagnostic testing devices; our ability to compete in the marketplace; compliance with applicable laws, regulations and tariffs, and factors described in the Risk Factors section of our public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.

Contact Information
Feifei Shen
[email protected]

SOURCE: Ainos, Inc.

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