Ainos Announces Master Services Agreement with Swiss Pharmaceutical, Ltd. for Drug Testing, Manufacturing, and Packaging for its VELDONA Product Candidates

Rhea-AI Summary

Ainos, Inc. (NASDAQ:AIMD, AIMDW) has announced a Master Service Agreement with Swiss Pharmaceutical Co., Ltd. to test, manufacture, and package its VELDONA product candidates. This agreement aligns with Ainos' plans to submit an IND application for a Phase 2 study to the FDA by year-end. Additionally, Ainos is pursuing clinical trials for VELDONA against COVID-19 and has plans for further studies on thrombocytopenia and Sjögren's syndrome in 2023. This partnership aims to enhance Ainos' manufacturing capabilities and streamline its clinical trial preparations.

Positive

• Partnership with Swiss Pharma enhances manufacturing capabilities for clinical trials.
• Plans to submit IND application for Phase 2 study by the end of the year.
• Continued development of VELDONA for various diseases including COVID-19.

Negative

• None.

SAN DIEGO, CA / ACCESSWIRE / August 17, 2022 / Ainos, Inc. (NASDAQ:AIMD, 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 it has signed a Master Service Agreement with Swiss Pharmaceutical Co., Ltd. (Taiwan) ("Swiss Pharma"). Pursuant to the agreement, Swiss Pharma will test, manufacture, and package the Company's VELDONA "GMP Clinical Batch" and "GMP Commercial Batch" product candidates for the Company's planned clinical trials under both Pharmaceutical Inspection Co-operation Scheme Good Manufacturing Practice ("PIC/S GMP") and U.S. Food & Drug Administration ("U.S. FDA") Current Good Manufacturing Practice regulations.

The Company plans to submit an Investigational New Drug ("IND") application for a Phase 2 Study to the U.S. FDA by the end of this year.

Following previous results from preclinical studies of its VELDONA formulation against COVID-19 in June 2022, Ainos initiated "A Multicenter, Randomized, Parallel, Phase II Study to Evaluate the Efficacy of VELDONA® in Patients with Mild COVID-19" in Taiwan.

The Company's prior studies of its VELDONA, interferon-based drug platform, have focused on various viral infections. The Company has previously conducted promising clinical studies on influenza (https://onlinelibrary.wiley.com/doi/10.1111/irv.12094) and the common cold (https://clinicaltrials.gov/ct2/show/NCT00895947?term=Amarillo+Biosciences%2C+Inc.&draw=2&rank=3). The Company plans to further its VELDONA program with the initiation of a Phase 2 study for thrombocytopenia and Phase 3 study for Sjögren's syndrome in 2023.

Chun-Hsien Tsai, Chairman and Chief Executive Officer of Ainos, commented, "Our relationship with Swiss Pharma forms a strong foundation for our plans to develop VELDONA product candidates. We anticipate our relationship with Swiss Pharma will enable us to effectively increase our manufacturing capabilities for VELDONA for our clinical trials, including testing, quality inspection, labeling, and packaging."

About Ainos, Inc.

Headquartered in San Diego, California, Ainos, Inc. is a diversified medtech company engaged in developing innovative medical technologies for point-of-care testing and safe and novel medical treatment for a broad range of disease indications. In addition to its proprietary therapeutics using low-dose non-injectable interferon, Ainos is committed to developing a comprehensive healthcare business portfolio encompassing medical devices and consumer healthcare products. While prioritizing the commercialization of medical devices as part of its diversification strategy, Ainos has also expanded its product portfolio to include Volatile Organic Compounds (VOC) and COVID-19 POCTs. Leveraging its patents related to VOC technologies and COVID-19 POCT products, the Company seeks to expedite the commercialization of its medical device pipeline, beginning with Ainos-branded COVID-19 POCT product candidates.

About Swiss Pharmaceutical Co., Ltd (Taiwan)

Swiss Pharma was established in the 1950s with a mission to develop and manufacture quality pharmaceutical products, and operates with a commitment to continuous improvement and advancement. Headquartered in Tainan City, Taiwan, Swiss Pharma currently has over 400 employees and annual revenue of US$30 million. Its facilities have been PIC/S GMP certified by the Taiwan Food and Drug Administration and inspected by the U.S. Food and Drug Administration.

Throughout its history, Swiss Pharma has innovated products covering a wide range of therapeutic areas and dosage forms, and continues to invest a significant amount of resources in developing new products and expanding manufacturing capabilities.

Forward-Looking Statements

This press release contains 'forward-looking statements' 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 words such as "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict," "project," 'target," "future," "seek," "likely," "strategy," "may," "should," "will," and similar references to future periods. Forward-looking statements are based only on our 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 our control. Our actual results may differ materially from those indicated in the forward-looking statements.

Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others, the following: the cost of production and sales potential of the planned drug treatments announced in this press release; the impact of final approvals from the U.S. Food and Drug Administration (the "FDA") or other regulatory bodies for the planned drug treatments including the availability of emergency use authorization; the Company's limited cash and history of losses; the Company's ability to achieve profitability; 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; the Company's ability to manufacture any products it develops; general economic conditions and events and the impact they may have on the Company and its potential customers, including but not limited to the impact of Covid-19; the Company's ability to obtain adequate financing in the future; the impact of promulgation and implementation of regulations by the World Health Organization, the FDA and by other governmental authorities with functions similar to those of the FDA on the Company's operations and technologies; lawsuits and other claims by third parties or investigations by various regulatory agencies governing the Company's operations; the Company's ability to secure regulatory approvals for its products; and our success in managing the risks involved in the foregoing items. Readers should also review the risks and uncertainties listed in our Annual Report on Form 10-K for the year ended December 31, 2021 and other reports we file with the U.S. Securities and Exchange Commission.

Any forward-looking statement made by us in this press release speaks only as of the date on which such statement is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Relations Contact

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

SOURCE: Ainos, Inc.

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FAQ

What is the Master Service Agreement between Ainos and Swiss Pharma?

Ainos has signed a Master Service Agreement with Swiss Pharmaceutical Co., Ltd. to test, manufacture, and package its VELDONA product candidates for clinical trials.

What are the plans for Ainos' VELDONA product candidates?

Ainos plans to submit an Investigational New Drug application for a Phase 2 study to the FDA by the end of 2022 and is conducting clinical trials for COVID-19.

When will Ainos initiate its Phase 2 study for thrombocytopenia?

Ainos plans to further its VELDONA program with a Phase 2 study for thrombocytopenia in 2023.

What are the key developments announced by Ainos in 2022?

In 2022, Ainos announced a partnership with Swiss Pharma and plans for multiple clinical trials including for COVID-19 and further studies in other diseases.