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With Orphan Drug Designation, Ainos' VELDONA Has Compelling Opportunity to Improve Quality of Life for HIV Patients

By: Newsfile

Boston, Massachusetts--(Newsfile Corp. - September 19, 2023) - The U.S. Food and Drug Administration (FDA) has granted Ainos' (NASDAQ: AIMD) VELDONA Orphan Drug Designation (ODD) for the treatment of oral warts in HIV-seropositive patients. VELDONA is Very Low-Dose Oral Interferon Alpha, Ainos' proprietary oral lozenge formulation of Interferon alpha (IFN-) that has been extensively tested in preclinical and 68 human clinical studies, including three Phase 1, 63 Phase 2, and three Phase 3 studies, several which have been conducted in the U.S.

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Key Takeaways:

  • An estimated 24,000 HIV-seropositive Americans suffer from chronic oral warts.
  • Orphan Drug Designation fosters the development of new medicines to treat or prevent rare diseases and disorders, as well as provides tax credits, reduced FDA application fees, and guaranteed market exclusivity upon approval.
  • Ainos plans to seek a pre-IND meeting with the U.S. FDA, with plans to advance VELDONA into a Phase 3 study for oral warts. We estimate in excess of a $1 Billion global market opportunity for the company.

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About Ainos, Inc.

Ainos Inc. (AIMD) is a NASDAQ-listed 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"). 

The company is headquartered in San Diego, CA, and has substantial operations in Taiwan. As of December 31, 2022, Ainos had 43 full-time employees, 27 dedicated to R&D, primarily located in Taiwan. Ainos has constructed its infrastructure to be capital-efficient by choosing Taiwan as the R&D and operating center. Taiwan is a key global technology supply chain center home to many high-caliber engineers, scientists,  and healthcare professionals. Maintaining operations in Taiwan allows Ainos to access top-quality talent while staying capital-efficient, further enhancing the company's ability to offer quality, affordable, consumer-friendly products. In total, the company owns 63 patents, of which 50 are active patents, and 13 are pending patent approval.

Important Disclosures: Horizon Insights ("Horizon") is a team of former buy-side, sell-side, and investment banking analysts. A member of the Horizon team prepared this report. Horizon hereby certifies that the views expressed in this report accurately reflect the personal views about the subject securities and issuers. We also certify that no part of our compensation was, is, or will be directly or indirectly related to the recommendations or views expressed in this report. We believe the information used to create this report has been obtained from reliable sources. Still, Horizon can neither guarantee nor represent the completeness or accuracy of the information herewith. Such information and the opinions expressed are subject to change without notice. Because of individual financial or investment objectives and/or financial circumstances, this report should not be construed as advice designed to meet the particular investment needs of any investor. Investing involves risk. Reports are not to be construed as an offer or solicitation of an offer to buy or sell the securities herein mentioned.

Fees For Services: Horizon has not received compensation for investment banking services from the issuers of the securities covered in this report. Horizon has received compensation from the issuer directly for providing non-investment banking services to this issuer, which includes the preparation of this report, investor relations services, and consultancy on business development and overall corporate strategy. Horizon expects to receive additional compensation for such services provided to this issuer in the future. The fees for these services vary per client and are subject to the number and types of services contracted. 


Source: Horizon Insights

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