Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos", or the "Company"), a diversified medtech company focused on the development of novel point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that it is pursuing out-licensing opportunities for five new drug candidates for its low-dose oral interferon-alpha ("IFNα") formulation, VELDONA. Ainos has completed Phase 2 trials for the five new drug candidates and will work with potential partners to accelerate the candidates to Phase 3 trials and eventual commercialization of VELDONA. 

The following five indications have completed Phase 2 trials. Ainos aims to enter out-licensing agreements to advance VELDONA to Phase 3 trials and commercialization.

• Sjögren's syndrome (US IND No. 5700)

• Aphthous Stomatitis (US IND No. 5126)

• Chemotherapy-induced Stomatitis (US IND No. 5587)

• Influenza (Australian ACTRNACTRN12609000976280)

• Common Cold (US IND No. 5244)

The Company's product is delivered into the oral cavity as a lozenge in low (nanogram) doses. Human studies have shown that IFNα given orally is effective against viral and autoimmune diseases, without the side effects associated with high-dose injections of IFNα. Ainos has cumulatively spent nearly $40 million on developments related to the oral use of IFNα (VELDONA formulation), not including the expected expenses on clinical trials and manufacturing VELDONA. To date, 68 clinical trials have been conducted with low-dose oral IFNα. Sixty-three studies were Phase 2 trials, and three Phase 1 and two Phase 3 studies have also been conducted. 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 IFNα at a dose level ranging from three to 2,000 international units given daily for up to five years. The safety of orally administered IFNα has been consistently demonstrated in these trials.

Interferons are proteins made by host cells in response to the presence of pathogens such as viruses, bacteria, parasites, or tumor cells. They allow for communication between cells to trigger the protective defenses of the immune system that eradicate pathogens or tumors. Of the nine different families of human interferon that have been identified, interferon-alpha is the most widely studied. The US FDA has approved the use of IFNα in mega doses given by injection for treating a number of cancers, as well as Hepatitis B and C.

Ainos's low-dose oral VELDONA formulation is designed to enhance autoimmunity to resist virus damage, potentially reducing side effects and risks caused by high-dose interferon and other small molecule drugs.

Positive effects of oral VELDONA treatment have been noted across a wide range of disease indications, including:

• In Sjögren's syndrome (SS) (US IND No. 5700), after 48 weeks of treatment the clinical results showed increased unstimulated whole saliva and improvement in mouth dryness and seven other SS symptoms.

• In Aphthous Stomatitis (US IND No. 5126), the clinical results showed clearance of existing lesions and reduced severity of new lesions.

• In Chemotherapy-induced Stomatitis (US IND No. 5587), the clinical results showed reduced severity during repeat chemotherapy.

• In Influenza (Australian ACTRNACTRN12609000976280), the clinical results showed reduced incidence of moderate to severe symptoms; remission of sore throat, fever and head congestion; and significantly reduced influenza-like illness rate in three subgroups: 50 year and older, those vaccinated against seasonal flu, and males.

• In Common Cold (US IND No. 5244), the clinical results showed immediate reduction of malaise and sore throat after 6 hours from initial treatment.

Chun-Hsien Tsai, Ainos' Chairman of the Board, President, and Chief Executive Officer, commented, "Low-dose oral interferon-alpha treatments have shown a promising array of potential applications through Phase 2 clinical trials. We have recently carried out studies that demonstrate VELDONA's effectiveness in protecting against symptoms associated with COVID-19 and prevention and treatment of influenza. By exploring out-licensing opportunities for our five VELDONA new drug candidates, we plan to accelerate commercialization of our VELDONA technology as rapidly as possible."