Ainos to Begin Clinical Trial of HIV Treatment at Taiwan Hospital

Ainos set for clinical trial of HIV treatment at Taiwan hospital By Investing.com

SAN DIEGO - Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW), a healthcare company specializing in AI-driven diagnostics and low-dose interferon therapies, has announced plans to initiate a clinical study of its VELDONA® formulation at the National Taiwan University Hospital. The U.S. FDA has granted Orphan Drug Designation for VELDONA® as a potential treatment for oral warts in HIV-positive patients. The study, set to begin in November 2024, will assess the efficacy of VELDONA®, an oral interferon-alpha formulation, in HIV-positive individuals undergoing antiretroviral therapy. Forty participants will be enrolled and randomized to receive either a placebo or VELDONA® in a double-blind trial for 24 weeks. The primary goal of the study is to measure the reduction in the surface area of oral warts, with a successful response defined as a 75% or greater reduction. Secondary objectives include a 50% reduction in wart size and patient self-assessments of oral health. Previous U.S. trials involving 77 HIV-positive patients showed significant reductions in oral wart surface area for those treated with VELDONA®. These promising results have led to the upcoming study, which will be conducted in accordance with Good Clinical Practice guidelines by Bestat Pharmaservices Corporation, a TFDA-certified Contract Research Organization. The Infectious Disease Department at National Taiwan University Hospital, overseeing nearly 4,000 HIV-positive patients, will conduct the study. Patient enrollment is expected to take one year, with the study completion anticipated in July 2026. HIV-related oral warts present a significant treatment challenge, with limited options currently available. Ainos hopes that VELDONA® will offer a new, effective solution for managing this condition, potentially improving the quality of life for those affected. Ainos, based in San Diego, California, continues to develop its product pipeline, including VELDONA® for both human and animal oral therapeutics, orphan drugs, and AI-powered point-of-care testing solutions. This clinical study announcement is based on a press release statement and aims to provide new treatment options for individuals living with HIV, a virus that affected approximately 39.9 million people globally in 2023. In other recent news, Ainos, Inc., a healthcare company, has secured a patent in Taiwan for its antiviral drug, VELDONA®, aimed at treating and preventing coronavirus infections. Additionally, the company's AI Nose technology has achieved a 79% accuracy rate in detecting volatile organic compounds in Japanese semiconductor factories. This development is expected to enhance safety and efficiency in the industrial sector. Ainos has also acquired exclusive licenses for 10 invention patents from Taiwan Carbon Nano Technology, valued at approximately $5.4 million. This strategic move is anticipated to bolster the company's AI Nose and point-of-care testing technologies. Furthermore, Ainos has extended its product development agreement with Taiwan Carbon Nano Technology for an additional three months, allowing continued non-exclusive access to their patents. Despite these advancements, Ainos faces a potential delisting from the Nasdaq due to its stock price falling below the required minimum bid price. The company has been given a grace period until January 13, 2025, to regain compliance. These are some of the recent developments at Ainos, Inc. InvestingPro Insights As Ainos, Inc. (NASDAQ:AIMD) prepares to initiate a crucial clinical study for its VELDONA® formulation, current financial metrics from InvestingPro offer insights into the company's market performance. With a market capitalization of just $4.04 million, Ainos is indeed a niche player in the healthcare industry, as reflected by its specific focus on AI-driven diagnostics and therapies. InvestingPro Data indicates a challenging financial landscape for Ainos, with a revenue of only $0.07 million for the last twelve months as of Q2 2024, and a significant revenue decline of 97.73% during the same period. Additionally, the company's gross profit margin stands at a concerning -316.61%, underscoring the "InvestingPro Tip" that Ainos suffers from weak gross profit margins. The stock price has also seen substantial volatility. The price has fallen by 22.2% over the last month, and by an even more stark 87.74% over the last year, which aligns with the "InvestingPro Tip" that the stock has fared poorly over the last month and is trading near its 52-week low. Investors and interested parties can find further analysis and a total of 12 "InvestingPro Tips" for Ainos, Inc. on the InvestingPro platform, which may provide additional context to the company's financial health and stock performance as it advances its clinical trials. The "InvestingPro Fair Value" estimate for AIMD stands at $0.56, offering a glimpse into the potential valuation of the company's stock as it navigates the challenges ahead. The upcoming study for VELDONA® could be a pivotal moment for Ainos, potentially impacting both its product pipeline success and its financial recovery. As the company moves forward with its clinical trials, these financial insights will be crucial for investors monitoring Ainos's ability to capitalize on its innovative healthcare solutions.

Ainos Announced Plan to Initiate Taiwan Clinical Study for VELDONA as Potential Treatment of Oral Warts in HIV-Seropositive Patients, an Orphan Drug Designated by the FDA

<p><i><strong>Ainos Plans To Conduct the Study at National Taiwan University Hospital, a Premier Taiwanese Medical Center for HIV Management</strong></i></p><p><i><strong>The U.S. FDA Have Granted Orphan Drug Designation (ODD) for the Company's VELDONA^&reg; Low-Dose Oral Interferon Formulation as a Potential Treatment for Oral Warts in HIV-Positive Patients</strong></i></p> SAN DIEGO, CA, September 17, 2024 (Newswire.com) - Ainos, Inc. (NASDAQ:AIMD)(NASDAQ:AIMDW) ("Ainos" or the "Company"), an innovative healthcare company focused on advanced AI-driven point-of-care testing (POCT) and low-dose interferon therapeutics, is pleased to announce that its plans to initiate a clinical study for very low-dose interferon alpha (VELDONA) on treating Human immunodeficiency virus (HIV)-related oral warts at the National Taiwan University Hospital. The study aims to evaluate the efficacy of VELDONA, a low-dose oral interferon-alpha formulation, in treating oral warts in HIV-positive patients undergoing combination antiretroviral therapy. VELDONA has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for this indication, offering new hope to HIV-positive individuals suffering from oral warts. Overview of the Clinical Study This clinical study will be conducted by the Infectious Disease Department at National Taiwan University Hospital, one of Taiwan's 25 designated medical centers for HIV management. The hospital oversees nearly 4,000 HIV-positive patients, approximately 11.2% of Taiwan's total HIV cases. The study will enroll 40 participants who will be randomized in a 1:3 ratio to receive either a placebo or VELDONA in a double-blind trial. Participants will take VELDONA or a placebo sublingually every day for 24 weeks. The primary objective of the study is to evaluate the reduction in oral warts' surface area. A successful response is defined as a reduction of 75% or more in the surface area of oral warts compared to baseline, while a non-responsive result indicates less than 75% reduction. The secondary objectives include evaluating oral wart surface area reduction by 50% or more, as well as participant self-assessments through questionnaires comparing oral health to baseline conditions. The study's Principal Investigator (PI) will also objectively assess the participants' oral conditions. This clinical study will be conducted in accordance with Good Clinical Practice (GCP) guidelines by Bestat Pharmaservices Corporation, a TFDA-certified Contract Research Organization (CRO). The study is expected to begin in November 2024, with the first patient visit (FPFV) anticipated in November. Patient enrollment is projected to take one year, with the last patient visit (LPLV) expected in May 2026, and study completion anticipated in July 2026. Protocol of the study is currently being reviewed for Investigational Review Board ("IRB") approval by National Taiwan University Hospital and Taiwan Food and Drug Administration (TFDA). Data from Prior Studies Ainos has conducted one pilot study and two phase 2 trials in the U.S. involving 77 HIV-positive patients with multiple oral warts. In these trials, patients were randomized to receive either VELDONA or a placebo, taking the medication three times daily for 24 weeks. After treatment, patients receiving VELDONA® showed significant reductions in oral wart surface area, with decreases of over 75%, and in some cases up to 99%. Overview of HIV Human Immunodeficiency Virus (HIV) is the virus responsible for causing AIDS, with two main types: HIV-1 and HIV-2. HIV-1 is the dominant strain worldwide and is the primary cause of AIDS in most countries. HIV-2, found predominantly in West Africa, is less virulent and less likely to progress to AIDS. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), in 2023, there were approximately 39.9 million people living with HIV worldwide, with 1.3 million new infections and about 630,000 AIDS-related deaths. In Taiwan, there were around 35,500 individuals living with HIV and 940 reported new cases in 2023. There were 666 new reported cases in August 2024. Challenges in Treating HIV-Related Oral Warts Currently, treatment options for HIV-related oral warts are limited, and no established pharmacological therapies exist for this condition. Only a few case reports mention the use of drugs such as cidofovir, bleomycin, cimetidine, podophyllum, or intralesional interferon-alpha injections. Surgical removal is possible but comes with the risk of recurrence. Ainos believes that VELDONA has the potential to be a safe and effective treatment for oral warts in HIV-positive individuals, offering a meaningful improvement in their quality of life. "We are excited by the data we've gathered so far and are optimistic about the potential of VELDONA to benefit many HIV-positive patients. Oral warts can significantly affect daily activities such as eating and speaking, as well as a person's appearance. We are hopeful that VELDONA will become an important option for those seeking relief from these symptoms," said Chun-Hsien (Eddy) Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos About Ainos, Inc. Headquartered in San Diego, California, Ainos is a diversified healthcare company focused on novel AI-powered point-of-care testing (POCT) and low-dose interferon therapeutics (VELDONA). The Company's clinical-stage product pipeline includes VELDONA human and animal oral therapeutics, human orphan drugs, and telehealth-friendly POCT solutions powered by its AI Nose technology platform. The name "Ainos" is a combination of "AI" and "Nose" to reflect the Company's commitment to empowering individuals to manage their health more effectively with next-generation AI-driven POCT solutions. To learn more, visit https://www.ainos.com. Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. 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 public filings 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 filings 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.