Ainos, Inc. announced that it has submitted the clinical hold complete response to the U.S. Food and Drug Administration for conducting a Phase II trial of its low-dose oral interferon (IFN)-alpha formulation, VELDONA®, for treatment of mild COVID-19 symptoms. If approved, the Company's Phase II trial is expected to involve a multicenter, parallel, randomized study conducted in Taiwan to evaluate the efficacy of VELDONA® in subjects with mild COVID-19 symptoms during the third quarter of 2024. Ainos' recently-commenced VELDONA® manufacturing process fully complies with both Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice ("PIC/S GMP") and the U.S.FDA's Current Good Manufacturing Practice regulations. The updated Chemistry, Manufacturing, and Controls ("CMC") information indicates that the stability of VELDONA® can exceed the minimum shelf life of biologicals.

Ainos intends to submit a number of additional IND applications during the second half of 2024, including Phase II/III studies for treatment of oral warts in HIV-seropositive patients (designated an orphan drug by the U.S. FDA), and Phase II/III studies for Sjögren's syndrome. Ainos continues to build on its prior studies on influenza and the common cold. Given VELDONA®'s promising results to date, the Company is optimistic that it may become a potential treatment for mild COVID-19 symptoms in the future.

Ainos plans to expand its VELDONA® platform for treatment of other viral infections, as a key component of its long-term strategy to enhance and realize the value of this unique compound. Ainos' low-dose oral VELDONA® formulation is designed to enhance a patient's immune response and boost their ability to fight viral infections, while also potentially reducing the side effects and risks caused by high-dose interferons and other small molecule drugs. The Company's previous studies have demonstrated that VELDONA® could inhibit respiratory virus infection, including influenza A. Human studies have shown that IFNa given orally is effective against viral and autoimmune diseases, without the side effects associated with high-dose injections of IFNa.

To date, 68 clinical trials have been conducted with low-dose oral IFNa. Nearly 6,000 patients with one of 16 different disease indications and/or healthy volunteers participated in these trials, including a total of 4,600 subjects exposed to IFNa at a dose level ranging from three to 2,000 international units given daily for up to five years. The safety of orally administered IFNa has been consistently demonstrated in these trials.