Interferon alfa(Viragen, Inc.)

Interferon (IFN) is a type of crucial cytokine, capable of directly participating in the antiviral immune response of epithelial cells, mediating the natural immune response to induce the expression of Interferon Stimulated Genes (ISG), hence, swiftly establishing the body's natural immune defense line against viral infections.  Based on the structural characteristics, receptor binding, and biological activity of interferon, human interferons can be divided into three types: Type I, II, and III interferons. Their genes are located on human chromosomes 9p21-22, 12q24.1, and 19q13.13, respectively. Among the three types of human interferons, Type I interferons mainly include IFN-α, IFN-β, and other 20 subtypes, Type II interferons only consist of IFN-γ, and Type III interferons comprise four subtypes including IL-29 (IFN-λ1). Most cells infected by viruses can produce Type I interferon, the secreted IFN-α/β can bind to a common receptor on neighboring uninfected cells, and initiate a paracrine signaling cascade response. Type I and Type III interferons are considered classical antiviral interferons, with alpha interferons being the main subtype used in clinical antiviral treatment. These mainly include subtypes like alpha-1b, alpha-2b, alpha-2a, etc. Recent studies indicate that Type III interferons have a significant relationship with mucosal immunity, while IFN-gamma also exhibits strong virus inhibitory characteristics. Regulatory Mechanisms of Interferons● Classic JAK-STAT signaling pathway The signaling pathway triggered within the cell after type I and II receptors bind to their respective IFNs is very similar, which is the JAK-STAT signaling pathway. Interferon receptors and Type I & II interferons activate the classic JAK-STAT pathwayType I IFN binding to the IFN-α/β receptor can phosphorylate and activate two members of the JAK family: TYK2 (Tyrosine Kinase 2) and JAK1 (Janus Kinase 1). These kinases further phosphorylate STAT1α (STAT91), STAT1β (STAT84), and STAT2 (STAT113). These three activated STATs dissociate from the receptor and bind to the intracellular protein p48, and then this complex enters the cell nucleus and directly binds to the upstream regulatory region (ISREs) of IFN-sensitive genes, thereby regulating the expression of specific genes. Typically, type I and III interferon signals form STAT1-2 heterodimers and ISGF3 complexes by activating TYK2 and JAK1, while type II interferon signals induce the formation of STAT1 homodimers by activating JAK1 and JAK2.  ● PI3K/AKT/mTOR signaling pathway In addition to activating the JAK–STAT signaling pathway, interferons also have an activating effect on the PI3K/AKT/mTOR signaling pathway. The activating effect of Type I Interferon on the PI3K/AKT/mTOR pathwayThe activation of the PI3K/AKT/mTOR pathway depends on JAK1/TYK2, which phosphorylates IRS1 (insulin receptor substrate 1) and IRS2 (insulin receptor substrate 2). The phosphorylation of IRS1 and IRS2 leads to the activation of PI3K, which subsequently activates the target of mammalian mTORC1 (rapamycin complex 1). MTORC1 activates RPS6kB (ribosomal protein S6 kinase, also known as p70s6 kinase), then phosphorylates RPS6 (ribosomal protein S6), leading to the initiation of mRNA translation. Furthermore, mTORC1 also regulates the phosphorylation of EIF4EBP1 (eukaryotic initiation factor 4E binding protein 1), the phosphorylation of EIF4EBP1 leads to the inactivation of EIF4EBP1, causing the dissociation of EIF4E (eukaryotic translation initiation factor E), thereby initiating the translation of dependent mRNA. Type I interferons also activate mTORC2 (rapamycin-insensitive complex 2), which is necessary for the phosphorylation of RPS6KB, RPS6, and EIF4BP1. Biological Activities of Type III Interferons1) Antiviral Function Type I interferon is the key antiviral defense and modulation factor in the immune system. On the one hand, it directly activates immune cells; on the other hand, it can indirectly inhibit the replication process of viruses. It can also activate natural killer cells and macrophages, thereby promoting the activation of dendritic cells, while at the same time inducing CD4+ subtype T lymphocytes and T helper cells to produce a large amount of type I interferon on distinct effect cells, protecting CD8+ cells and preventing induced antibody cell death.  2) Antibacterial Function The antibacterial function of interferons is mainly manifested in IFN-γ. IFN-γ can decrease bacterial iron supply by down-regulating transferrin receptor, or inhibit intracellular bacterial propagation directly by inducing production of endogenous NO. It can also increase the phagocytic body of monocytes and macrophages, lysosome, to dissolve bacteria. By these means, it achieves the function of eliminating bacteria. 3) Anti-parasitic Activity The anti-parasitic activity of interferon is primarily manifested in IFN-γ. IFN-γ can activate macrophages (Mφ), and the activated Mφ can express high levels of inducible nitric oxide synthase (iNOS) which catalyzes the production of NO from L-arginine. NO has inhibitory and killing effects on inoculated pathogens. 4) Involvement in Immune Regulation IFN-γ can affect the expression of the Fc receptor for IgG, which facilitates macrophages' phagocytosis of antigens, NK cells' lysis of target cells and the activation of T and B lymphocytes, enhancing the body's immune response. IFN-γ can increase the expression of MHC class II molecules on the surface of macrophages, enhancing their antigen presentation capabilities. 5) Antitumor Activity IFN-γ is produced by T lymphocytes stimulated by specific antigens. It is the main macrophage-stimulating factor in the body, it resists acid, can activate effector cells, enhances the activity of natural killer cells, macrophages, and tumor-infiltrating lymphocytes, promotes monocyte circulation, increases the expression of antigens and antibodies on the surface of immune cells, stimulates the production of cellular factors such as IL-2, tumor necrosis factor, interferon-α, etc. It inhibits tumor cell division and induces the production of antiviral proteins.

SAN DIEGO, CA / ACCESSWIRE / August 15, 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 its unaudited financial results for the second quarter ended June 30, 2022. Second Quarter 2022 Financial Highlights Revenues were US$636,627 in the second quarter of 2022, up 213.6% from US$202,992 in the same period of 2021. Gross profit was US$317,664, representing a gross margin of 49.9% in the second quarter of 2022. Chun-Hsien Tsai, Chairman of the Board, President, and Chief Executive Officer of Ainos, commented, "We are pleased to announce our first quarterly results as a Nasdaq-listed company with significant year-over-year revenue growth and promising operational milestones. This has been a momentous year for us, our partners, and our shareholders. Receiving approval for our COVID-19 Antigen Self-Test to be sold in Taiwan and the positive preclinical study results for our VELDONA interferon formulation demonstrates the strength of our product portfolio as we strive to fulfill our mission to develop a telehealth-enabled future for precision medicine. Our Nasdaq uplisting is an exciting new chapter in our development, providing us with wider access to capital, raising our corporate profile, and positioning us to deliver greater and more sustainable value for our shareholders. With our low-cost operations and cutting-edge technology, the building blocks for our future growth as a diversified medtech company are firmly in place." Hui-Lan Wu, Chief Financial Officer of Ainos, commented, "Increased sales of our COVID-­19 Antigen Rapid Test Kits during the second quarter drove robust year-over-year 213.6% top-line growth. With the additional capital provided by our recent uplisting, we are well positioned to meet our product development targets, capture emerging market opportunities, and generate long-term growth for our shareholders. Looking ahead, we will continue to commercialize our medical device pipeline while expanding and strengthening our innovative product portfolio." Second Quarter 2022 Financial Results Revenues Revenues increased by 213.6% to US$636,627 in the second quarter of 2022 from US$202,992 in the same period of 2021, mainly driven by the increased product sales of the Ainos COVID­-19 Antigen Rapid Test Kits in Taiwan. Cost of Revenues Cost of revenues was US$318,963 in the second quarter of 2022, compared with US$69,508 in the same period of 2021, mainly driven by the increase in associated cost of product sales of the Ainos COVID-­19 Antigen Rapid Test Kits. Gross Profit Gross profit was US$317,664, representing 49.9% of sales in the second quarter of 2022. Total Operating Expenses Total operating expenses increased by 163.0% to US$2,261,960 in the second quarter of 2022 from US$860,030 in the same period of 2021, mainly attributable to increased research and development expenses. The increase in research and development expenses reflects the Company's ongoing investments in research and development, in line with its product development plans. Net Loss Net loss attributable to common stock shareholders was US$1,954,032 in the second quarter of 2022, compared with US$749,774 in the same period of 2021. Balance Sheet As of June 30, 2022, the Company had cash and cash equivalents of US$1,753,877, compared with US$1,751,499 as of December 31, 2021. Recent Developments On June 21, 2022, the Company announced it has begun marketing the Ainos COVID-19 Antigen Self-Test Kit under an Emergency Use Authorization that was issued by the Taiwan Food and Drug Administration on June 13, 2022 to Taiwan Carbon Nano Technology Corporation, the manufacturer and product co-developer of the test in conjunction with Ainos. Ainos is the exclusive master sales and marketing agent for the COVID-19 Antigen Self-Test Kit. On June 27, 2022, the Company announced the topline results from its COVID-19 antiviral efficacy study in hamsters. The available results show that its low-dose oral interferon alpha formulation, VELDONA, has a protective effect on lungs infected with the SARS-CoV-2 virus by regulating the immune response, thus expediting recovery of infected animals. The Company is preparing application documents for U.S. FDA Phase 2/3 clinical trials. On August 12, 2022, the Company announced the closing of its previously announced underwritten public offering of 780,000 units at a public offering price of $4.25 per unit. Each unit issued in the offering consisted of one share of common stock and one warrant to purchase one share of common stock at an exercise price of $4.25. The common stock and warrants were immediately separable and were issued separately. The common stock and warrants began trading on the Nasdaq Capital Market on August 9, 2022, under the symbols "AIMD" and "AIMDW," respectively. Ainos received gross proceeds of approximately $3.3 million, before deducting underwriting discounts and commissions and other estimated offering expenses. About Ainos, Inc. Headquartered in San Diego, California, Ainos, Inc. (f/k/a Amarillo Biosciences, 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 three issued patents for 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. 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 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 Ainos, Inc. Condensed Consolidated Statements of Operations (Unaudited) Three months ended June 30, Six months ended June 30, 2022 2021 2022 2021 Revenues $ 636,627 $ 202,992 $ 723,828 $ 205,113 Cost of revenues (318,963 ) (69,508 ) (360,042 ) (70,757 ) Gross profit 317,664 133,484 363,786 134,356 Operating expenses Research and development expenses 1,634,856 - 3,212,310 - Selling, general and administrative expenses 627,104 860,030 1,178,834 1,383,011 Total operating expenses 2,261,960 860,030 4,391,144 1,383,011 Operating loss (1,944,296 ) (726,546 ) (4,027,358 ) (1,248,655 ) Non-operating income and expenses, net Loss on sale of fixed assets - (2,247 ) - (2,247 ) Interest expense, net (18,796 ) (20,981 ) (35,483 ) (32,879 ) Other income, net 9,060 - 8,914 - Total non-operating income and expenses, net (9,736 ) (23,228 ) (26,569 ) (35,126 ) Net loss (1,954,032 ) (749,774 ) (4,053,927 ) (1,283,781 ) Basic and diluted net loss per average share available to common shareholders $ (0.01 ) $ (0.01 ) $ (0.03 ) $ (0.02 ) Weighted average common shares outstanding - basic and diluted 144,379,308 124,644,759 144,379,308 83,583,583 Ainos, Inc. Condensed Consolidated Balance Sheets (Unaudited) June 30, December 31, 2022 2021 Assets Current assets: Cash and cash equivalents $ 1,753,877 $ 1,751,499 Inventory 670,507 - Other current assets 1,274,512 466,198 Total current assets 3,698,896 2,217,697 Intangible assets, net 35,086,424 37,329,191 Property and equipment, net 1,503,025 1,187,702 Other assets 124,697 87,571 Total assets $ 40,413,042 $ 40,822,161 Liabilities and Stockholders' Equity Current liabilities: Convertible notes payable $ 3,376,526 $ 3,376,526 Notes payable 1,013,405 213,405 Accrued expenses and others current liabilities 2,598,468 1,004,868 Payables - related party - 26,000,000 Total current liabilities 6,988,399 30,594,799 Long term liabilities: Convertible notes payable - noncurrent 27,400,000 - Operating lease liabilities - noncurrent 18,323 30,255 Total long term liabilities 27,418,323 30,255 Total liabilities 34,406,722 30,625,054 Stockholders' equity Preferred stock, $0.01 par value; 10,000,000 shares authorized; none issued Common stock, $0.01 par value; 300,000,000 shares authorized as of June 30, 2022 and December 31, 2021; 144,379,308 shares issued and outstanding as of June 30, 2022 and December 31, 2021 1,443,793 1,443,793 Additional paid-in capital 18,943,316 18,856,430 Accumulated deficit (14,162,843 ) (10,108,916 ) Translation adjustment (217,946 ) 5,800 Total stockholders' equity 6,006,320 10,197,107 Total liabilities and stockholders' equity $ 40,413,042 $ 40,822,161 SOURCE: Ainos, Inc. 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