Ainos Reports Statistically Significant Interim Efficacy Results from VELDONA Clinical Trial in Feline Chronic Gingivostomatitis (FCGS)

Rhea-AI Summary

Ainos (NASDAQ:AIMD) reported statistically significant interim efficacy from its open-label VELDONA trial in feline chronic gingivostomatitis (FCGS). In six treated cats, mean oral inflammation improved ~38% at Week 6 and ~45% at Week 14, with 66.7% of subjects achieving ≥30% improvement.

Safety signals were absent: liver and renal labs remained stable and VELDONA was well tolerated. Enrollment continues to 12 subjects to assess dose response and durability.

Positive

• Mean oral inflammation −38% at Week 6
• Mean oral inflammation −45% at Week 14 (sustained benefit)
• 66.7% of subjects achieved ≥30% clinically meaningful improvement
• No clinically significant safety signals; labs remained stable

Negative

• Interim results based on only 6 of 12 planned subjects
• Open-label design with no control group
• Uneven dosing cohorts: 4 vs 2 subjects per dose

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Open-Label Study Demonstrates Durable Reduction in Oral Inflammation with Favorable Tolerability Profile at Interim Analysis

HOUSTON, TEXAS / ACCESS Newswire / February 17, 2026 / Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos" or the "Company"), a SmellTech platform company digitizing scent as a native data language for artificial intelligence, today announced interim results from its ongoing open-label, multi-dose clinical trial evaluating VELDONA, a low-dose oral interferon alpha formulation, for the treatment of Feline Chronic Gingivostomatitis (FCGS), a severe, chronic inflammatory oral disease in companion animals.

The study is designed to enroll 12 client-owned cats diagnosed with FCGS across two dosing cohorts (6,000 IU and 12,000 IU administered orally three times per week for six weeks). The interim analysis includes the first six treated subjects. Enrollment remains ongoing.

Interim Efficacy Results

The primary disease activity assessment utilized the Stomatitis Disease Activity Index (SDAI; range 0-30), a composite score integrating:

• Veterinary assessment of oral inflammation

• Body weight changes

• Owner-reported activity and feeding behavior

At Week 6:

• The majority of subjects demonstrated reductions in total SDAI scores.

• Directional improvement in overall disease activity was observed across the cohort.

• No clinically significant rebound was observed through Week 14 follow-up.

Local oral inflammation scores demonstrated consistent and statistically significant improvement:

• 6 of 6 cats showed lower oral inflammation scores at Week 6 compared to baseline.

• Mean improvement reached approximately 38% at Week 6.

• 66.7% of subjects achieved ≥30% clinically meaningful improvement.

• Wilcoxon signed-rank testing demonstrated statistical significance (p < 0.05).

At Week 14 follow-up, mean improvement in oral inflammation increased to approximately 45%, suggesting sustained benefit after completion of the six-week treatment course.

Notably, one subject that did not undergo full-mouth dental extraction achieved measurable clinical improvement during interferon therapy, supporting a therapeutic effect independent of surgical recovery and consistent with an immunomodulatory mechanism.

Ainos plans to continue enrollment toward the full 12-subject target and further evaluate dose-response relationships, durability of effect, and safety outcomes in the complete dataset.

Safety and Tolerability

Comparative hematology and serum biochemistry analyses between baseline (Week 0) and Week 6 demonstrated:

• Liver enzymes (ALP, ALT, AST) remained within normal limits.

• Renal function markers (BUN, creatinine) remained stable without dose-related deterioration.

• No persistent leukocyte abnormalities or evidence of immunosuppression were observed.

• No dose-related toxicity trends were observed.

VELDONA™ was well tolerated in all six subjects, with no clinically significant safety signals identified in this interim analysis.

Study Overview

• Design: Open-label, multi-dose clinical study

• Population: Client-owned cats diagnosed with FCGS

• Dosing: 6,000 IU (n=4) or 12,000 IU (n=2), administered orally three times weekly for six weeks

• Setting: Five subjects underwent full-mouth dental procedures prior to treatment; one subject received dental cleaning only

Clinical and Market Context

FCGS is a debilitating, immune-mediated condition characterized by chronic oral inflammation, pain, and reduced quality of life. Current management often relies on invasive dental extractions and symptomatic therapies, with variable outcomes. An effective, non-invasive immunomodulatory approach could represent a meaningful advancement in companion animal care.

The global pet dental health market size is projected to reach USD 12.70 billion by 2030, growing at a CAGR of 7.57% from 2025 to 2030, according to Grand View Research.

About Ainos, Inc.

Ainos, Inc. (NASDAQ:AIMD) is a dual-platform AI and biotech company pioneering smelltech and immune therapeutics. Its AI Nose platform and smell language model (SLM) digitize scent into Smell ID, a machine-readable data format, powering intelligent sensing across robotics, smart factories, and healthcare. The company also develops VELDONA^®, a low-dose oral interferon targeting rare, autoimmune, and infectious diseases. Ainos, a fusion of "AI" and "Nose," is redefining machine perception for the sensory age. 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.

Investor Relations Contact

Feifei Shen
Email: IR@ainos.com

SOURCE: Ainos, Inc.

View the original press release on ACCESS Newswire

FAQ

What interim efficacy did Ainos (AIMD) report for VELDONA in FCGS on Feb 17, 2026?

VELDONA showed statistically significant reductions in oral inflammation, with mean improvement ~38% at Week 6. According to the company, the cohort of six cats reached ~45% mean improvement by Week 14, suggesting sustained benefit after treatment.

How many cats were included in the VELDONA interim analysis for AIMD and what are enrollment plans?

The interim analysis included six treated cats from a planned 12-subject study. According to the company, enrollment is ongoing to reach the full 12-subject target to evaluate dose response and durability.

What safety findings did Ainos (AIMD) report for VELDONA at interim analysis?

VELDONA was well tolerated with no clinically significant safety signals identified in six subjects. According to the company, liver enzymes and renal markers remained within normal limits and no persistent leukocyte abnormalities were observed.

What dosing regimens were used in the VELDONA FCGS study reported by AIMD?

The study used oral interferon alpha at 6,000 IU or 12,000 IU three times weekly for six weeks. According to the company, dosing cohorts in the interim dataset were four cats at 6,000 IU and two cats at 12,000 IU.

Does the interim VELDONA data suggest benefit independent of dental extraction for AIMD?

Yes; one subject that did not undergo full-mouth dental extraction showed measurable clinical improvement during therapy. According to the company, this supports a potential immunomodulatory effect separate from surgical recovery.