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
Key Figures
Market Reality Check
Peers on Argus
AIMD was down 3.8% while peers showed mixed moves: INBS +4.58%, NVNO +2.51%, ALUR, NXL, and TRIB modestly negative. Only NXL appeared in momentum scanners, moving down, suggesting today’s setup looked stock-specific rather than a coordinated sector trade.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Aug 04 | Regulatory approval | Positive | +0.4% | TFDA approval to initiate VELDONA study for primary Sjögren's syndrome. |
| May 19 | Veterinary interim data | Positive | -2.9% | Interim VELDONA data in FCGS cats showing notable inflammation reductions. |
| Sep 24 | Analyst report | Positive | +2.5% | Water Tower Research report on upcoming VELDONA Sjögren’s trial in Taiwan. |
| Sep 23 | Study planning | Positive | +1.1% | Announcement of Taiwan VELDONA study plan for Sjögren’s syndrome patients. |
| Sep 20 | Trial announcement | Positive | -5.7% | New VELDONA trial for HIV+ oral warts with orphan drug designation noted. |
Clinical-trial headlines have usually been positive but produced mixed reactions, with a slight negative average move and a balance of aligned and divergent price responses.
Over recent years, Ainos has repeatedly highlighted its VELDONA clinical program across multiple indications, including Sjögren’s syndrome, FCGS in companion animals, and oral warts in HIV+ patients. Prior updates often described regulatory progress in Taiwan and positive efficacy or design details. Market reactions to these clinical-trial announcements have been mixed, with both gains and declines around news. Today’s interim FCGS data fits into this broader pattern of ongoing VELDONA development across human and veterinary indications.
Historical Comparison
Over the last five clinical-trial updates, AIMD’s average move was -0.91%. Today’s -3.8% reaction to new VELDONA FCGS data was more negative than prior same-tag news.
Clinical-trial news has traced a progression from planning and regulatory clearance in Taiwan to interim efficacy data across multiple VELDONA indications, including Sjögren’s syndrome, FCGS, and HIV-related oral warts.
Market Pulse Summary
This announcement details statistically significant interim efficacy and favorable tolerability for VELDONA in FCGS, with all 6 cats showing improved oral inflammation and mean gains of about 38% at Week 6 and 45% by Week 14. It builds on Ainos’ broader VELDONA clinical portfolio across human and veterinary indications. Investors may monitor completion of the planned 12-cat trial, dose–response analyses, and additional data readouts against the backdrop of a projected USD 12.70 billion pet dental health market by 2030.
Key Terms
stomatitis disease activity index medical
interferon alpha medical
wilcoxon signed-rank technical
hematology medical
cagr financial
AI-generated analysis. Not financial advice.
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
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
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?
How many cats were included in the VELDONA interim analysis for AIMD and what are enrollment plans?
What safety findings did Ainos (AIMD) report for VELDONA at interim analysis?
What dosing regimens were used in the VELDONA FCGS study reported by AIMD?
Does the interim VELDONA data suggest benefit independent of dental extraction for AIMD?
