Ainos Signs MoU for Contract Clinical Trials to Conduct Clinical Study of Potential New Animal Drug Based on VELDONA

Ainos and SIDSCO will cooperate to accelerate the development of new animal drugs based on Ainos’ VELDONA® low-dose oral interferon

Upcoming clinical study will investigate VELDONA®’s safe use and efficacy for the treatment of feline chronic gingivostomatitis (FCGS) via oral mucosal administration

SAN DIEGO, CA / ACCESSWIRE / November 6, 2023 / Ainos, Inc. (NASDAQ:AIMD, AIMDW) (“Ainos”, or the “Company”), a diversified healthcare company focused on the development of AI-powered point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced that it had signed a Memorandum of Understanding (“MoU”) with SIDSCO Biomedical Co., Ltd. (“SIDSCO”).

The MoU is an important step in Ainos’ strategy to expand its product line into the global pet care market. Under the agreement, Ainos and SIDSCO (collectively, the “Parties”) will jointly explore the feasibility of VELDONA®/Cytoprotein contract clinical trials. Ainos intends to conduct animal clinical trials for veterinary investigational medicines in conjunction with SIDSCO, and will provide the technical knowledge, funding, and assistance required for the project.

Ainos’ low-dose oral interferon alpha (“IFNα”) formulation, VELDONA®, is a human interferon first approved for sale by the Texas Department of Health in 1985 for the treatment of cats with feline leukemia and dogs with canine parvovirus. In 28 previous studies performed by Ainos, VELDONA® was found to exhibit systemic effects in mice, cats, dogs, ferrets, chickens, rats, guinea pigs, horses, calves/cows, and particularly pigs. VELDONA® has aided in boosting feed conversion efficiency and fighting deadly viral infections in these species, including canine parvovirus, equine herpesvirus, feline coronavirus, and others. These studies demonstrate that VELDONA® has a therapeutic or preventive effect via the oral mucosa. At the same time, VELDONA® modulates systemic and mucosal immunity without serious side effects.

Previous studies have confirmed that feline interferon administered to the local oral mucosa can improve the clinical symptoms of pain in cats and the degree of inflammation in the affected area, and no serious adverse drug reactions occurred during the trial period. The experience of many veterinarians using over-the-counter medications has also shown that many cases of feline chronic gingivostomatitis (FCGS) have been significantly improved through the use of interferons. It can be seen that interferon has a good effect on chronic gingivostomatitis in cats, and it has no adverse effects when used in combination with other drugs. The results of the Agricultural Science and Technology Research Institute’s potency and cytotoxicity tests on VELDONA® using feline macrophages (fcwf-4) confirmed its antiviral efficacy and established an effective and safe dosage. Ainos’ upcoming clinical trial, expected to be held in cooperation with SIDSCO at Mercy Animal Medical Center, will investigate VELDONA®’s safe use and efficacy for the treatment of FCGS in cats via oral mucosal administration.

FCGS is characterized by severe inflammation of the gingiva, buccal mucosa, and caudal oral mucosa. There are two types of FCGS. Type 1 includes cases with alveolar and labial/buccal mucositis/stomatitis only, while Type 2 covers cases with caudal mucositis/stomatitis, with or without alveolar and labial/buccal mucositis/stomatitis. The exact cause of FCGS is still unknown. It seems that cats with FCGS have a hyperimmune reaction to plaque, bacteria, viruses, or environmental factors which leads to excessive inflammation. FCGS is a common condition, with a reported prevalence ranging from 0.7% to 12.0%.

The most favorable clinical control for resolution of oral inflammation is via partial or full mouth complete tooth extractions. Dental extractions have been shown to cure FCGS in 55% of cases, markedly improve symptoms in 35% of cases, and have no effect in 10% of cases. Refractory FCGS requires lifelong medication, including immunosuppressants such as corticosteroids or cyclosporine, or immunomodulators such as Feline Interferon Omega. However, due to the potential deleterious side-effects of long-term corticosteroid administration, these should only be used as needed for symptomatic alleviation during the acute phase.

Currently, medical management of FCGS remains highly variable and often depends on comorbidities in each individual case. Generally, existing medical therapies for FCGS include antibiotics, antihistamines, and immunosuppressants, such as corticosteroids or cyclosporine, which are often first-line treatments for affected animals. However, these immunosuppressants have serious long-term side effects, including type 2 diabetes and opportunistic infections. Currently, there are no medications for animals that do not respond to anti-inflammatory or immunosuppressive treatments, and there are no ideal long-term solutions available to pet owners.

A report compiled by Grand View Research shows that the global pet dental health market is projected to grow at a CAGR of 6.2%, reaching US$9.98 billion by 2030. The canine market segment accounted for the largest revenue share at over 55.0%, and the feline market segment is anticipated to expand at a CAGR of 6.9%.

Cat ownership in the United States is estimated at 85.5 million, suggesting that as many as 10.3 million cats have FCGS. Companion animal ownership continues to rise in the United States, especially among young people. About 35% of American households own a cat. In addition to Taiwan, Ainos is actively working to take advantage of larger market opportunities with sales in Asia and the United States.

Ainos’ upcoming clinical trial is expected to be sent to the United States’ Internal Animal Care and Use Committee (IACUC) for review in December this year. The clinical trial is a small-scale field pre-trial. It is expected to start accepting cases in the first quarter of next year, and to complete admission of 15-30 cats in the second quarter. If the results of this trial meet the expected efficacy requirements, the Company will submit a formal application to Taiwan’s Bureau of Prevention and Inspection of the Ministry of Agriculture for animal new drug field trials. This would represent a significant step forward in the process of obtaining an animal new drug license. Ainos plans to conduct the upcoming clinical study in cooperation with SIDSCO at Mercy Animal Medical Center.

Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented, “We are thrilled to be taking this significant step in the further advancement of VELDONA® within the pet health space. The global pet care market is massive, estimated at $223 billion in 2021, making this the perfect time for us to expand our VELDONA® portfolio to include a potential treatment option for one of the most common ailments among domestic cats. By signing this MoU with SIDSCO, we are intent on accelerating the drug development process, and we believe our collaboration will bring substantial benefits to both parties. We remain steadfast in our commitment to providing pet owners with safe and effective solutions to safeguard their animals’ health, and I look forward to our team working side-by-side with SIDSCO to make this goal a reality.”

About Ainos, Inc.

Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on the development of novel point-of-care testing (“POCT”), low-dose VELDONA® interferon therapeutics, and synthetic RNA-driven preventative medicine. The company’s products include VELDONA® clinical-stage human therapeutics, VELDONA® Pet cytoprotein health supplements, and telehealth-friendly POCTs powered by its AI Nose technology platform. The lead POCT candidate, Ainos Flora, is intended to be a telehealth-friendly POCT for women’s health and certain common sexually transmitted infections (“STIs”). To learn more, visit https://www.ainos.com.

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About SIDSCO Biomedical Co., Ltd

SIDSCO, which stands for Scientific Integration Design Service Corporation, is a Taiwanese contract research organization (CRO) founded in 2018. SIDSCO focuses on providing systematic and customized preclinical experimental integration outsourcing services, which include experiment design, material preparation, experiment execution, report writing, and evidence counseling. SIDSCO is fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC), and has been certified for both OECD GLP and TFDA GLP. Visit https://www.biosidsco.com for more information.

About Mercy Animal Medical Center

Founded in 1998, Mercy Animal Medical Center’s mission is to safeguard animals’ medical care and to educate pet owners about better animal health. It currently employs 60 specialized veterinarians to diagnose and treat a wide range of pets, including rabbits, rodents, snakes, lizards, turtles, parrots, sugar gliders, raccoons, hedgehogs, and more. It is equipped with advanced instruments and benefits from professional collaboration with specialized departments, ensuring that every patient receives the most appropriate medical care. Mercy Animal Center is affiliated with Jong-Shing Animal Hospital. Visit http://www.jsah.com.tw/home for more information.

Forward-Looking Statements

This press release contains “forward-looking statements” about Ainos within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as “anticipate,” “believe,” “estimate,” “approximate,” “expect,” “intend,” “plan,” “predict,” “project,” “target,” “future,” “likely,” “strategy,” “foresee,” “may,” “guidance,” “potential,” “outlook,” “forecast,” “should,” “will” or other similar words or phrases. Similarly, statements that describe the Company’s objectives, plans or goals are, or may be, forward-looking statements. Forward-looking statements are based only on the Company’s current beliefs, expectations, and assumptions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control. The Company’s actual results may differ materially from those indicated in the forward-looking statements.

Important factors that could cause the Company’s actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release include, among others, the cost of production and sales potential of the planned drug treatments announced in this press release; the Company’s dependence on projected revenues from the sale of COVID-19 test kits and its VELDONA® Pet line of supplements ; the Company’s limited cash and history of losses; the Company’s ability to achieve profitability; the Company’s ability to raise additional capital to continue the Company’s product development; the ability to accurately predict the future operating results of the Company; the ability to advance Ainos’ current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates the Company develops; the ability to obtain and maintain regulatory approval of Ainos’ product candidates; delays in completing the development and commercialization of the Company’s current and future product candidates, which could result in increased costs to the Company, delay or limit the ability to generate revenue and adversely affect the business, financial condition, results of operations and prospects of the Company; intense competition and rapidly advancing technology in the Company’s industry that may outpace its technology; customer demand for the products and services the Company develops; the impact of competitive or alternative products, technologies and pricing; disruption in research and development facilities; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company’s operations; potential cybersecurity attacks; increased requirements and costs related to cybersecurity; the Company’s ability to realize the benefits of third party licensing agreements; the Company’s ability to obtain and maintain intellectual property protection for Ainos product candidates; compliance with applicable laws, regulations and tariffs; continued listing on and compliance with the applicable regulations of the Nasdaq Capital Market; and the Company’s success in managing growth. A more complete description of these risk factors and others is included in the “Risk Factors” section of Ainos’ Annual Report on Form 10-K for the year ended December 31, 2022 and other reports filed with the U.S. Securities and Exchange Commission (“SEC”), many of which risks are beyond the Company’s control. In addition to the risks described above and in the Company’s reports filed with the SEC, other unknown or unpredictable factors also could cause actual results to differ materially from the projections, forecasts, estimates and expectations discussed in this press release.

The forward-looking statements made in this press release are expressly qualified in their entirety by the foregoing cautionary statements. Ainos undertakes no obligation to, and expressly disclaims any such obligation to, publicly update or revise any forward-looking statement to reflect changed assumptions, the occurrence of anticipated or unanticipated events or changes to the future results over time or otherwise, except as required by law.

Investor Relations Contact

ICR, LLC
Robin Yang
Tel: +1 646-224-6971
Email: Ainos.IR@icrinc.com

SOURCE: Ainos, Inc.

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