Study to evaluate clinical effectiveness of low-dose oral interferons in treating chronic gingivostomatitis in cats, building upon VELDONA's history in animal health since 1985

Clinical trials are expected to run for approximately ten months from May 24, 2024.

SAN DIEGO, CA / ACCESSWIRE / May 15, 2024 / Ainos, Inc. (NASDAQ:AIMD, AIMDW) ("Ainos", or the "Company"), a diversified healthcare company focused on the development of novel point-of-care testing, low-dose interferon therapeutics, and synthetic RNA-driven preventative medicine, today announced the initiation of a clinical study for a new potential VELDONA®-based drug for pet disease. The study is aimed at evaluating the clinical efficacy of low-dose oral interferons in treating feline chronic gingivostomatitis ("FCGS"), a serious and chronic painful oral disease characterized by inflammation or abnormal proliferation in the oral cavity.

This marks another meaningful step in the Company' s strategy for expanding its product line into the global pet care market, which follows the Memorandum of Understanding Ainos signed last year with SIDSCO Biomedical Co., Ltd. The clinical trials are expected to run for approximately ten months from May 24, 2024 to March 31, 2025.

Current research suggests that FCGS results from multiple factors, including dental diseases, viral and bacterial pathogens, and environmental conditions, with a reported prevalence ranging between 0.7% and 12%. Despite the frequency of the disease, there are no safe long-term pharmaceutical treatments available to date.

Ainos' VELDONA®, a low-dose oral interferon alpha ("IFNα") formulation, was initially approved by the Texas Department of Health in 1985 for treating feline leukemia in cats and canine parvovirus in dogs. Ainos has conducted 28 studies, in which VELDONA® demonstrated systemic effects across various animal species including mice, cats, dogs, ferrets, chickens, rats, guinea pigs, horses, calves/cows, and particularly, pigs. These studies highlight the therapeutic or preventive capabilities in VELDONA® through oral mucosa, alongside systemic and mucosal immunity modulation without serious side effects.

Previous studies have confirmed that interferon administered through the oral mucosa can modulate partial immune system in experimental animals. Furthermore, interferon administered is shown by imaging to be prominently distributed in the lymph nodes of the head and neck, and in some cases, even reaching the lymphatic system surrounding the mesentery. Since the FCGS belongs to diseases of immune system dysregulation, partial oral mucosal administration not only modulates the disordered immune system but also avoids the associated systemic side effects of interferon use, such as immunogenicity and bone marrow suppression.

Ainos's study will involve a randomized, controlled trial with 30 cats divided into two groups: one receiving low doses (6000 IU/time) of the treatment and the other for high doses (12000 IU/time). The main objective is to demonstrate significant health assessment improvements made by both pet owners and veterinarians before and after the treatment. The trials will also evaluate the potential in reducing dosage and frequency of steroids or other immunosuppressive drugs.

Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented "Animal health has been an important part of VELDONA's development history since 1985, we're excited to take another significant step in advancing VELDONA® in the pet health sector. With the burgeoning growth of the pet care market, there's never been a better time for us to study a potential treatment and broaden our VELDONA® offerings to address one of the most prevalent issues among cats. We are dedicated to expediting the animal drug development process through this pioneering clinical study, and we will remain steadfast in our commitment to providing safe and efficient solutions for our animal companions."

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 STIs. To learn more, visit https://www.ainos.com.

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Safe Harbor Statement

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 products announced in this press release; the Company's dependence on projected revenues from the sale of current or future products ; 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 accuracy of third-party market research data, 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, 2023, 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. Any forward-looking statements contained in this press release represent Ainos' views only as of today and should not be relied upon as representing its views as of any subsequent date. 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

Feifei Shen
Email: IR@ainos.com

SOURCE: Ainos, Inc.