SAN DIEGO, Feb. 01, 2024 (GLOBE NEWSWIRE) -- 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 that Jack Lu, the Company's Director of Corporate Development, will present live at the Small-Cap Growth Virtual Investor Conference, hosted by VirtualInvestorConferences.com, on February 7, 2024. DATE: February 7 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q _____________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File No. 0-20791 _____________________________________________ AINOS, IN ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from____to____ Commission File No. 0-20791 AINOS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from____to____ Commission File No. 0-20791 AINOS, INC. (Exact name of registrant as specified in its charter) Texas 75-1974352 (State or other jurisdiction of (IRS ...

U.S. Securities and Exchange Commission Washington, D.C. 20549 FORM 10-K ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 [Fee Required] For the Fiscal Year Ended December 31, 2022 ☐ Transition Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 [No Fee Required] Commission File Number 0-20791 AINOS, INC. (Exact name of registrant as specified in its charter) | Texas | 75-1974352 | | --- | --- | | (State or other jurisdiction of incorporation or orga ...

PART I: FINANCIAL INFORMATION [Financial Statements](index=2&type=section&id=ITEM%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for the period ended June 30, 2022, show a significant increase in revenue driven by COVID-19 test kit sales, offset by a substantial rise in operating expenses, leading to a larger net loss and a decrease in stockholders' equity, while cash remained stable due to financing activities [Condensed Consolidated Balance Sheets](index=2&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Financial Metric | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Total Assets** | **$40,413,042** | **$40,822,161** | | Total Current Assets | $3,698,896 | $2,217,697 | | Intangible Assets, net | $35,086,424 | $37,329,191 | | **Total Liabilities** | **$34,406,722** | **$30,625,054** | | Total Current Liabilities | $6,988,399 | $30,594,799 | | Total Long Term Liabilities | $27,418,323 | $30,255 | | **Total Stockholders' Equity** | **$6,006,320** | **$10,197,107** | - Total liabilities increased primarily due to the addition of **$27.4 million** in non-current convertible notes payable as of June 30, 2022, which were not present at the end of 2021[6](index=6&type=chunk) - Total stockholders' equity decreased from **$10.2 million** to **$6.0 million**, driven by a net loss of **$4.05 million** for the six-month period, which increased the accumulated deficit[7](index=7&type=chunk)[13](index=13&type=chunk) [Condensed Consolidated Statements of Operations](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) | Metric (Six Months Ended June 30) | 2022 | 2021 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $723,828 | $205,113 | +252.9% | | Gross Profit | $363,786 | $134,356 | +170.8% | | Research and Development Expenses | $3,212,310 | $0 | N/A | | Total Operating Expenses | $4,391,144 | $1,383,011 | +217.5% | | Operating Loss | ($4,027,358) | ($1,248,655) | +222.5% | | Net Loss | ($4,053,927) | ($1,283,781) | +215.8% | | Basic and Diluted Net Loss Per Share | ($0.03) | ($0.02) | +50.0% | - The significant increase in net loss for the first six months of 2022 was primarily driven by the introduction of **$3.2 million** in Research and Development expenses, which were not incurred in the same period of 2021[8](index=8&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Cash Flow Activity (Six Months Ended June 30) | 2022 | 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($1,619,153) | ($42,926) | | Net cash used in investing activities | ($424,557) | ($23,276) | | Net cash provided by financing activities | $2,189,875 | $650,595 | | **Cash and cash equivalents at end of period** | **$1,753,877** | **$606,638** | - Financing activities in H1 2022 provided **$2.19 million** in cash, primarily from **$1.4 million** in convertible notes and **$0.8 million** in other notes payable, which was significantly higher than the **$0.65 million** raised in H1 2021[16](index=16&type=chunk) - The company executed significant non-cash activities, including issuing a **$26 million** convertible note for an asset purchase in 2022 and issuing **$20 million** in stock for patent acquisition in 2021[16](index=16&type=chunk) [Notes to Financial Statements](index=5&type=section&id=Notes%20to%20Financial%20Statements) The notes detail the company's shift towards commercializing medical devices, particularly point-of-care tests (POCTs), highlighting a going concern uncertainty dependent on future financing and profitability, significant current ($4.4M) and non-current ($27.4M) debt primarily from convertible notes, extensive related-party transactions, and key subsequent events including a Nasdaq public offering, a 1-for-15 reverse stock split, and the conversion of over $30 million in debt to equity in August 2022 - The company is prioritizing the commercialization of medical devices, including Volatile Organic Compounds (VOC) POCTs and COVID-19 POCTs, acquired through intellectual property from its majority shareholder, Ainos KY[17](index=17&type=chunk) - The company's ability to continue as a going concern is dependent on obtaining necessary financing to fund working capital and achieving future profitable operations[20](index=20&type=chunk)[21](index=21&type=chunk) - As of June 30, 2022, the company had **$27.4 million** in non-current convertible notes, including a **$26 million** note issued to Ainos KY for an asset purchase and **$1.4 million** in 'March 2027 Convertible Notes'[26](index=26&type=chunk)[27](index=27&type=chunk)[28](index=28&type=chunk) - Subsequent to the quarter end, in August 2022, the company completed a public offering on Nasdaq, executed a 1-for-15 reverse stock split, and converted approximately **$30.4 million** of convertible notes into common stock[39](index=39&type=chunk)[40](index=40&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=9&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic shift to commercializing point-of-care test (POCT) devices, leveraging intellectual property from its majority shareholder, noting significant revenue growth from COVID-19 test kits in Taiwan, but also a substantial increase in R&D expenses leading to sharp rises in operating and net losses for both the second quarter and first half of 2022 compared to 2021, with liquidity supported by cash reserves, test kit sales, debt financing, and a subsequent public offering in August 2022 providing additional net proceeds of approximately $2.1 million [Overview and Strategy](index=10&type=section&id=Overview%20and%20Strategy) - The company is prioritizing the commercialization of medical devices, particularly POCTs, as part of a diversification strategy away from its historical focus on low-dose oral interferon[48](index=48&type=chunk) - The product portfolio includes COVID-19 Antigen and Nucleic Acid tests, VOC POCTs (Ainos Flora, Ainos Pen, CHS430), Very Low-Dose Oral Interferon Alpha (VELDONA), and a Synthetic RNA (SRNA) platform[49](index=49&type=chunk)[50](index=50&type=chunk)[51](index=51&type=chunk) - The general strategy for 2022 is to conduct clinical trials in Taiwan, use the data to apply for TFDA and FDA approval, and then partner with third-party distributors for marketing[54](index=54&type=chunk) [Results of Operations](index=11&type=section&id=Results%20of%20Operations) | Metric (Three Months Ended June 30) | Q2 2022 | Q2 2021 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $636,627 | $202,992 | +213.6% | | Gross Profit | $317,664 | $133,484 | +138.0% | | R&D Expenses | $1,634,856 | $0 | N/A | | Operating Loss | ($1,944,295) | ($726,546) | +167.6% | | Net Loss | ($1,954,032) | ($749,774) | +160.6% | | Metric (Six Months Ended June 30) | H1 2022 | H1 2021 | Change (%) | | :--- | :--- | :--- | :--- | | Revenues | $723,828 | $205,113 | +252.9% | | Gross Profit | $363,786 | $134,356 | +170.8% | | R&D Expenses | $3,212,310 | $0 | N/A | | Operating Loss | ($4,027,358) | ($1,248,655) | +222.5% | | Net Loss | ($4,053,927) | ($1,283,781) | +215.8% | - The increase in operating and net losses in 2022 is mainly attributable to new R&D expenses for product development initiatives, including amortization of intellectual property, staffing, and co-development research[62](index=62&type=chunk)[64](index=64&type=chunk)[67](index=67&type=chunk) [Liquidity and Capital Resources](index=12&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2022, the company had cash and cash equivalents of **$1,753,877**, nearly unchanged from **$1,751,499** at year-end 2021[70](index=70&type=chunk) - Net cash used in operating activities increased significantly to **$1.62 million** in H1 2022 from **$43k** in H1 2021, due to higher operating expenses from increased staffing and R&D investment[71](index=71&type=chunk)[72](index=72&type=chunk) - The company raised **$2.19 million** from financing activities in H1 2022, primarily through **$1.4 million** in convertible notes and **$0.8 million** in non-convertible notes[74](index=74&type=chunk) - Following the quarter, the company received net proceeds of approximately **$2.1 million** from its public offering in August 2022 and converted over **$30 million** in debt to equity[76](index=76&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=13&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," Ainos, Inc. is not required to provide the information for this item - The company is not required to provide quantitative and qualitative disclosures about market risk because it qualifies as a "smaller reporting company"[78](index=78&type=chunk) [Controls and Procedures](index=13&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of June 30, 2022, and the company is actively implementing a remediation plan for previously identified deficiencies in internal control over financial reporting, which includes increasing staff resources, delegating responsibilities, and establishing more robust review processes for financial reports - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2022[78](index=78&type=chunk) - The company is implementing a remediation plan for deficiencies in internal control over financial reporting identified as of December 31, 2021[79](index=79&type=chunk) - Remediation efforts in H1 2022 include hiring additional accounting staff, delegating reporting roles, and establishing a multi-level executive review process for all disclosures and financial reports before filing[80](index=80&type=chunk) PART II: OTHER INFORMATION [Legal Proceedings](index=14&type=section&id=ITEM%201.%20Legal%20Proceedings) As of the date of this report, the company was not aware of any material legal proceedings or claims involving the company - The company reports no material legal proceedings or claims as of the filing date[82](index=82&type=chunk) [Risk Factors](index=14&type=section&id=ITEM%201A.%20Risk%20Factors) There have been no material changes to the risk factors previously disclosed in the company's Form 10-K/A filed on April 15, 2022 - No material changes to risk factors have occurred since the annual report filing on April 15, 2022[83](index=83&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=14&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company details several unregistered sales of securities, primarily convertible notes, including a $26 million convertible note issued to majority shareholder Ainos KY for an asset purchase, additional working capital advances from Ainos KY, and $1.4 million in convertible notes issued pursuant to Regulation S, all of which were subsequently converted into common stock in August 2022 in connection with the company's public offering - On January 30, 2022, the company issued a **$26 million** convertible promissory note (the "APA Convertible Note") to Ainos KY as payment for an asset purchase[83](index=83&type=chunk) - The company received working capital advances from Ainos KY, including **$3 million** in convertible notes in 2021 and an **$800,000** non-convertible note in March 2022[85](index=85&type=chunk)[86](index=86&type=chunk) - In March and April 2022, the company issued a total of **$1.4 million** in convertible notes (the "March 2027 Convertible Notes") pursuant to Regulation S[87](index=87&type=chunk)[88](index=88&type=chunk) - In August 2022, the APA Convertible Note, the March 2027 Convertible Notes, and **$3 million** of other convertible notes were all converted into shares of common stock[84](index=84&type=chunk)[85](index=85&type=chunk)[89](index=89&type=chunk) [Defaults Upon Senior Securities](index=15&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - None[89](index=89&type=chunk) [Exhibits](index=15&type=section&id=ITEM%206.%20Exhibits) This section provides an index of all exhibits filed with the report, including corporate governance documents, material agreements such as a Convertible Note Purchase Agreement, and certifications from the CEO and CFO - The exhibit index lists key documents filed with the 10-Q, including the CEO and CFO certifications (Exhibits 31.1, 31.2, 32.1, 32.2) and a Convertible Note Purchase Agreement with ASE Test, Inc. (Exhibit 10.1)[90](index=90&type=chunk)[91](index=91&type=chunk)

PART I - FINANCIAL INFORMATION [ITEM 1. Financial Statements](index=2&type=section&id=ITEM%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Ainos, Inc. for the three months ended March 31, 2022 and 2021, including the balance sheets, statements of operations, comprehensive loss, stockholders' equity (deficit), and cash flows, along with accompanying notes detailing the company's organization, financial condition, and significant transactions [Condensed Consolidated Balance Sheets](index=2&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a slight decrease in total assets from December 31, 2021, to March 31, 2022, primarily due to a significant reclassification of related party payables to non-current convertible notes, which dramatically reduced current liabilities while increasing long-term liabilities Condensed Consolidated Balance Sheets (Unaudited) | Item | March 31, 2022 | December 31, 2021 | | :----------------------------------- | :------------- | :---------------- | | **Assets** | | | | Cash and cash equivalents | $1,871,349 | $1,751,499 | | Inventory | $337,805 | $- | | Total current assets | $3,023,059 | $2,217,697 | | Intangible assets, net | $36,214,023 | $37,329,191 | | Total assets | $40,736,264 | $40,822,161 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $5,729,516 | $30,594,799 | | Convertible notes payable - noncurrent | $26,900,000 | $- | | Total long term liabilities | $26,924,152 | $30,255 | | Total liabilities | $32,653,668 | $30,625,054 | | Total stockholders' equity | $8,082,596 | $10,197,107 | | Total liabilities and stockholders' equity | $40,736,264 | $40,822,161 | [Condensed Consolidated Statements of Operations](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company experienced a significant increase in revenue and gross margin in Q1 2022 compared to Q1 2021, primarily driven by sales of COVID-19 Antigen Rapid Test Kits. However, a substantial increase in research and development expenses led to a much larger operating and net loss Condensed Consolidated Statements of Operations (Unaudited) | Item | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Revenues | $87,200 | $2,121 | | Cost of revenues | $(41,078) | $(1,249) | | Gross margin | $46,122 | $872 | | Research and development expenses | $1,577,454 | $- | | Selling, general and administrative expenses | $551,730 | $522,981 | | Total operating expenses | $2,129,184 | $522,981 | | Operating loss | $(2,083,062) | $(522,109) | | Interest expenses, net | $(16,687) | $(11,897) | | Net loss | $(2,099,895) | $(534,006) | | Basic and diluted net loss per average share | $(0.01) | $(0.01) | | Weighted average common shares outstanding | 144,379,308 | 42,066,172 | [Condensed Consolidated Statements of Comprehensive Loss](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) The comprehensive loss for Q1 2022 significantly increased compared to Q1 2021, primarily due to the higher net loss and a negative translation adjustment Condensed Consolidated Statements of Comprehensive Loss (Unaudited) | Item | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Net loss | $(2,099,895) | $(534,006) | | Other comprehensive loss: | | | | Translation adjustment | $(58,059) | $- | | Comprehensive loss | $(2,157,954) | $(534,006) | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=3&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20%28Deficit%29) Stockholders' equity decreased from December 31, 2021, to March 31, 2022, mainly due to the net loss incurred during the period and a negative translation adjustment, partially offset by share-based compensation Condensed Consolidated Statements of Stockholders' Equity (Deficit) (Unaudited) | Item | Balance at Dec 31, 2021 | Share-based compensation | Net loss | Translation Adjustment | Balance at Mar 31, 2022 | | :------------------------------------ | :---------------------- | :----------------------- | :--------- | :--------------------- | :---------------------- | | Common Shares | 144,379,308 | - | - | - | 144,379,308 | | Common Stock Amount | $1,443,793 | - | - | - | $1,443,793 | | Additional Paid-in Capital | $18,856,430 | $43,443 | - | - | $18,899,873 | | Accumulated Deficit | $(10,108,916) | - | $(2,099,895) | - | $(12,208,811) | | Other comprehensive loss (Translation adjustment) | $5,800 | - | - | $(58,059) | $(52,259) | | Total Stockholders' Equity (Deficit) | $10,197,107 | $43,443 | $(2,099,895) | $(58,059) | $8,082,596 | [Condensed Consolidated Statements of Cash Flows](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash and cash equivalents increased slightly in Q1 2022, with significant cash used in operating and investing activities being offset by substantial cash provided by financing activities, primarily from convertible and other notes payable Condensed Consolidated Statements of Cash Flows (Unaudited) | Item | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(1,389,889) | $(211,737) | | Net cash used in investing activities | $(135,899) | $- | | Net cash provided by financing activities | $1,644,884 | $198,869 | | Net change in cash | $119,096 | $(12,868) | | Cash and cash equivalents at beginning of period | $1,751,499 | $22,245 | | Cash and cash equivalents at end of period | $1,871,349 | $9,377 | | Issuance of convertible notes for payables - related party | $26,000,000 | $- | [Notes to Financial Statements](index=4&type=section&id=Notes%20to%20Financial%20Statements) The notes provide crucial context to the financial statements, detailing the company's business transformation towards medical devices, its going concern status, significant debt issuances (including related party convertible notes), and subsequent events like additional convertible note offerings [1. Organization and Business](index=4&type=section&id=1.%20Organization%20and%20Business) Ainos, Inc. is a Texas corporation focused on developing medical technologies for point-of-care (POCT) testing and novel medical treatments. The company is diversifying from its historical pharmaceutical R&D in low-dose interferon to prioritize commercialization of medical devices, including VOC and COVID-19 POCTs, leveraging intellectual property acquired from its majority shareholder, Ainos KY - **Ainos, Inc.** is engaged in developing medical technologies for **point-of-care (POCT)** testing and medical treatments[15](index=15&type=chunk)[91](index=91&type=chunk) - The company is prioritizing the commercialization of medical devices, expanding its portfolio into **Volatile Organic Compounds (VOC) POCTs** and **COVID-19 POCTs** through intellectual property acquisition from its majority shareholder, **Ainos KY**[15](index=15&type=chunk)[91](index=91&type=chunk) [2. Basis of presentation](index=4&type=section&id=2.%20Basis%20of%20presentation) The unaudited consolidated financial statements are prepared in accordance with GAAP for interim financial information, including only normal recurring adjustments. The operating results for Q1 2022 are not indicative of the full year's expected results - Financial statements are unaudited and prepared in accordance with **GAAP** for interim information, with only normal recurring adjustments included[16](index=16&type=chunk)[92](index=92&type=chunk) - Operating results for **Q1 2022** are not necessarily indicative of the full year ending **December 31, 2022**[16](index=16&type=chunk)[92](index=92&type=chunk) [3. Financial Condition](index=4&type=section&id=3.%20Financial%20Condition) The company's financial statements are prepared on a going concern basis, but it has not achieved sustained operating income and relies on related-party convertible debt and equity financings. The ability to continue operations is dependent on securing necessary financing and achieving future profitability, raising substantial doubt about its ability to continue as a going concern - The company has not achieved sustained operating income and is funded primarily by related-party convertible debt and equity financings[17](index=17&type=chunk)[93](index=93&type=chunk) - The ability to continue as a **going concern** is dependent on obtaining necessary financing and achieving future profitable operations, which raises **substantial doubt**[18](index=18&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk) [4. Common Stock](index=5&type=section&id=4.%20Common%20Stock) As of March 31, 2022, Ainos, Inc. had 144,379,308 shares of common stock issued and outstanding, with additional shares reserved for conversion of convertible debt, RSUs, stock options, and warrants. The company has $26.9 million in outstanding convertible notes that can convert to common stock at 80% of the public offering price upon national exchange listing - As of **March 31, 2022**, **144,379,308 shares** of common stock were **issued and outstanding**[19](index=19&type=chunk)[95](index=95&type=chunk) - A total of **163,987,550 shares** of common stock were either issued or reserved for various conversions and issuances[19](index=19&type=chunk)[95](index=95&type=chunk) - **Outstanding convertible notes** totaling **$26.9 million** are convertible into common stock at **80%** of the public offering price upon **national exchange listing**[19](index=19&type=chunk)[95](index=95&type=chunk) [5. Preferred Stock](index=5&type=section&id=5.%20Preferred%20Stock) The company has 10,000,000 shares of preferred stock authorized, but no shares were outstanding as of March 31, 2022 - **10,000,000 shares** of preferred stock are authorized, but none were outstanding as of **March 31, 2022**[20](index=20&type=chunk)[96](index=96&type=chunk) [6. Current Convertible Notes Payable and Other Notes Payable](index=5&type=section&id=6.%20Current%20Convertible%20Notes%20Payable%20and%20Other%20Notes%20Payable) Current convertible and other notes payable increased to $4,389,931 as of March 31, 2022, from $3,589,931 at December 31, 2021. This increase includes new non-convertible notes from Ainos KY and an extension of maturity dates for existing convertible notes from Ainos KY to February 28, 2023 Current Convertible Notes Payable and Other Notes Payable | Category | As of 12/31/2021 | Additions | Payments | As of 3/31/2022 | Accrued Interest (3/31/2022) | | :------------------------------------ | :--------------- | :-------- | :------- | :-------------- | :--------------------------- | | Total convertible notes payable - related parties | $3,376,526 | $- | $- | $3,376,526 | $39,540 | | Non-convertible notes payable - related party | $129,405 | $800,000 | $- | $929,405 | $1,489 | | Non-convertible notes payable - non-related party | $84,000 | $- | $- | $84,000 | $3,527 | | **Total convertible and non-convertible notes** | **$3,589,931** | **$800,000** | **$-** | **$4,389,931** | **$44,556** | | Total interest expense (Q1 2022) | | | | $15,883 | | | Total interest expense (Q1 2021) | | | | $11,897 | | - On **March 17, 2022**, the due dates for **$3,000,000** in **convertible notes** from **Ainos KY** were extended to **February 28, 2023**[21](index=21&type=chunk)[97](index=97&type=chunk) - On **March 11, 2022**, a **non-convertible note** of **$800,000** was approved in favor of **Ainos KY**, with a **1.85%** interest rate and a **maturity date** of **February 28, 2023**[22](index=22&type=chunk)[98](index=98&type=chunk) [7. Non-Current Convertible Notes Payable](index=6&type=section&id=7.%20Non-Current%20Convertible%20Notes%20Payable) Non-current convertible notes payable increased significantly to $26,900,000 as of March 31, 2022, from $0 at December 31, 2021. This includes a $26,000,000 non-interest bearing APA Convertible Note issued to Ainos KY for an asset purchase, due in January 2027, and $900,000 in additional convertible notes issued in Q1 2022 with similar terms Non-Current Convertible Notes Payable | Item | March 31, 2022 | December 31, 2021 | | :------------------------------------ | :------------- | :---------------- | | Non-current convertible notes payable | $26,900,000 | $- | - A **$26,000,000 non-interest bearing Convertible Promissory Note (APA Convertible Note)** was issued to **Ainos KY** on **January 30, 2022**, for an asset purchase, due **January 30, 2027**[24](index=24&type=chunk)[100](index=100&type=chunk) - An additional **$900,000** in **convertible notes** were issued in **Q1 2022** with similar **non-interest bearing** terms and a **March 30, 2027 maturity**[25](index=25&type=chunk)[26](index=26&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk) [8. Related Party Transactions](index=6&type=section&id=8.%20Related%20Party%20Transactions) Significant related party transactions in Q1 2022 include the acquisition of intellectual property and equipment from Ainos KY for $26,000,000, paid via a convertible promissory note. Related parties also provided working capital through convertible and non-convertible notes totaling $4,355,931 as of March 31, 2022. The company also incurred costs for COVID-19 test kits and co-development expenses with TCNT, a product co-developer - The company acquired intellectual property assets and equipment from **Ainos KY** for **$26,000,000**, paid by issuing an **APA Convertible Note**[26](index=26&type=chunk)[102](index=102&type=chunk) - **Convertible and non-convertible notes payable** from related parties totaled **$4,355,931** as of **March 31, 2022**[27](index=27&type=chunk)[103](index=103&type=chunk) - Incurred **$386,412** for **COVID-19 antigen rapid test kits** and **$167,422** in development expenses under a co-development agreement with **TCNT**[27](index=27&type=chunk)[28](index=28&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk) [9. Subsequent Events](index=7&type=section&id=9.%20Subsequent%20Events) Subsequent to the quarter end, on April 11, 2022, the company issued a $500,000 convertible note to ASE Test Inc., a minority owner of Ainos KY, due March 30, 2027, with conversion terms similar to other convertible notes - On **April 11, 2022**, a **$500,000 convertible note** was issued to **ASE Test Inc.**, a minority owner of **Ainos KY**, due **March 30, 2027**[29](index=29&type=chunk)[105](index=105&type=chunk) - The **ASE Note** is convertible into common stock at **80%** of the public offering price upon **national exchange listing**[29](index=29&type=chunk)[105](index=105&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=7&type=section&id=ITEM%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of Ainos, Inc.'s business, its product portfolio, the impact of COVID-19, and a detailed analysis of its financial performance for Q1 2022 compared to Q1 2021, highlighting increased revenues from COVID-19 test kits but also significantly higher R&D expenses leading to increased net losses. It also discusses the company's liquidity and capital resources, emphasizing reliance on external financing and future commercialization plans [Overview](index=7&type=section&id=Overview) Ainos, Inc. is transitioning its focus from traditional pharmaceutical R&D to the commercialization of medical devices, particularly Point-of-Care (POCT) tests for VOCs and COVID-19, leveraging acquired intellectual property. The company aims to generate multiple revenue streams and expects significant expenses for product development and commercialization, relying on business revenues and external funding to achieve profitability - **Ainos, Inc.** is developing medical technologies for **POCT** testing and medical treatments, shifting focus from low-dose interferon therapeutics to medical devices[35](index=35&type=chunk)[111](index=111&type=chunk) - The company acquired **significant intellectual property** from **Ainos KY** to expand its product portfolio into **VOC** and **COVID-19 POCTs**, aiming to expedite commercialization[36](index=36&type=chunk)[112](index=112&type=chunk) - The operating strategy involves creating multiple revenue streams through commercializing its product portfolio, leveraging intellectual property, and seeking strategic relationships[39](index=39&type=chunk)[115](index=115&type=chunk) [Our portfolio of products](index=8&type=section&id=Our%20portfolio%20of%20products) Ainos, Inc.'s product portfolio includes COVID-19 Antigen Rapid Test Kits (marketed in Taiwan under EUA) and Nucleic Acid Tests, VOC POCT devices (Ainos Flora for vaginal health and Ainos Pen for breath analysis), CHS430 for ventilator-associated pneumonia, Very Low-Dose Oral Interferon Alpha (VELDONA) for viral infections, and Synthetic RNA (SRNA) technology for a potential COVID-19 mRNA vaccine - **COVID-19 Antigen Rapid Test Kit** and Cloud-based Test Management Apps: Marketed in Taiwan under **EUA**, manufactured by **TCNT**[37](index=37&type=chunk)[113](index=113&type=chunk) - **COVID-19 Nucleic Acid Test**: Color-changing assay compatible with PCR machines, delivering results within **40 minutes**, with portable equipment options[38](index=38&type=chunk)[114](index=114&type=chunk) - **VOC POCT – Ainos Flora**: Non-invasive test for female vaginal health and STDs, designed for rapid, discreet, point-of-care or home self-testing[38](index=38&type=chunk)[114](index=114&type=chunk) - **VOC POCT – Ainos Pen**: Cloud-connected, multi-purpose portable breath analyzer for monitoring oral, gastrointestinal, liver, and renal health[39](index=39&type=chunk)[115](index=115&type=chunk) - **VOC POCT – CHS430**: Non-invasive testing for ventilator-associated pneumonia within **10 minutes**, with **Ainos** as the **exclusive sales agent**[39](index=39&type=chunk)[115](index=115&type=chunk) - **Very Low-Dose Oral Interferon Alpha ("VELDONA")**: IFN-α formulation for broad treatment applications, including a strategic relationship with InnoPharmax, Inc. for CICCT for **COVID-19** and other viral infections[39](index=39&type=chunk)[115](index=115&type=chunk) - **Synthetic RNA ("SRNA")**: Developing a technology platform in Taiwan, initially focused on a potential **COVID-19 mRNA vaccine platform**[39](index=39&type=chunk)[115](index=115&type=chunk) [Impact of COVID-19 on Our Business](index=9&type=section&id=Impact%20of%20COVID-19%20on%20Our%20Business) The COVID-19 pandemic has provided a growth opportunity for Ainos, Inc., with substantially all Q1 2022 operating revenue derived from sales of its COVID-19 antigen rapid test kits in Taiwan. The company anticipates continued demand for rapid testing and aims to expand its market reach, while acknowledging potential future impacts of the pandemic on its operations - **Substantially all Q1 2022 operating revenue** came from sales of **Ainos COVID-19 antigen rapid test kits** in Taiwan[45](index=45&type=chunk)[121](index=121&type=chunk) - The company believes affordable, easy-to-use, rapid **COVID-19** testing will remain in demand in the short-term[45](index=45&type=chunk)[121](index=121&type=chunk) - The company is monitoring the pandemic's potential future impact on its business, financial condition, and operations[46](index=46&type=chunk)[122](index=122&type=chunk) [Results of Operations for Quarter Ended March 31, 2022 ("Q1 2022") and March 31, 2021 ("Q1 2021")](index=9&type=section&id=Results%20of%20Operations%20for%20Quarter%20Ended%20March%2031%2C%202022%20%28%22Q1%202022%22%29%20and%20March%2031%2C%202021%20%28%22Q1%202021%22%29) In Q1 2022, Ainos, Inc. saw a significant increase in revenue and gross profit due to COVID-19 test kit sales, a shift from liposomal nutraceuticals. However, a substantial rise in R&D expenses, primarily from intellectual property amortization and co-development, led to a 299% increase in operating loss and a 293% increase in net loss compared to Q1 2021 Key Financial Results (Q1 2022 vs. Q1 2021) | Item | Q1 2022 | Q1 2021 | Change ($) | Change (%) | | :------------------------------------ | :-------- | :-------- | :--------- | :--------- | | Revenues | $87,200 | $2,121 | $85,079 | 4011% | | Cost of revenues | $41,078 | $1,249 | $39,829 | 3189% | | Gross profit | $46,122 | $872 | $45,250 | 5189% | | Research and Development Expenses | $1,577,454 | $- | $1,577,454 | N/A | | Selling, General and Administrative Expenses | $551,730 | $522,981 | $28,749 | 6% | | Operating Loss | $(2,083,062) | $(522,109) | $(1,560,953) | 299% | | Interest Expense | $(16,687) | $(11,897) | $(4,790) | 40% | | Net Loss | $(2,099,895) | $(534,006) | $(1,565,889) | 293% | - Revenue in **Q1 2022** was primarily from sales of **Ainos COVID-19 Antigen Rapid Test Kits**, a shift from liposomal nutraceuticals sold in **Q1 2021**[47](index=47&type=chunk)[123](index=123&type=chunk) - **Increased R&D expenses** were mainly due to amortization of intellectual property assets, staffing, and co-development research[48](index=48&type=chunk)[124](index=124&type=chunk) [Liquidity and Capital Resources](index=9&type=section&id=Liquidity%20and%20Capital%20Resources) Ainos, Inc. had $1,871,349 in cash as of March 31, 2022. Cash used in operating activities increased significantly due to higher net loss and negative working capital, while cash provided by financing activities also increased substantially from convertible and other notes payable. The company anticipates funding operations for the next twelve months through cash reserves, business revenues from COVID-19 test kits, stock sales, and debt financing, but acknowledges the need for additional capital and the uncertainty of achieving profitability Cash Flow Summary (Q1 2022 vs. Q1 2021) | Item | Q1 2022 | Q1 2021 | | :------------------------------------ | :------------ | :-------- | | Net cash used in operating activities | $(1,389,889) | $(211,737) | | Net cash used in investing activities | $(135,899) | $- | | Net cash provided by financing activities | $1,644,884 | $198,869 | - **Cash used in operating activities increased** due to higher net loss and negative working capital, driven by increased inventory and other current assets for a potential public offering[53](index=53&type=chunk)[129](index=129&type=chunk) - Financing activities provided **significant cash**, primarily from proceeds of **convertible notes payable ($850,000)** and **notes payable ($800,000)**, including a **$26,000,000 noninterest-bearing convertible note** for an asset purchase[54](index=54&type=chunk)[55](index=55&type=chunk)[130](index=130&type=chunk)[131](index=131&type=chunk) - Near-term liquidity requirements include expenses for clinical trials, debt repayment, regulatory clearances, and marketing for **POCT** devices and the **CICCT** program, with plans to invest in **VELDONA** and **SRNA** development in **2023** and beyond[56](index=56&type=chunk)[132](index=132&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=10&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Ainos, Inc. is not required to provide quantitative and qualitative disclosures about market risk - As a '**smaller reporting company**,' **Ainos, Inc.** is exempt from providing quantitative and qualitative disclosures about market risk[58](index=58&type=chunk)[134](index=134&type=chunk) [ITEM 4. Controls and Procedures](index=10&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of March 31, 2022. The company has also implemented a remediation plan for internal control over financial reporting deficiencies identified in 2021, including increasing staff resources, delegating responsibilities, and establishing executive review processes for financial reporting [Disclosure Controls and Procedures](index=10&type=section&id=Disclosure%20Controls%20and%20Procedures) The company's management, with CEO and CFO participation, evaluated and concluded that disclosure controls and procedures were effective as of March 31, 2022, ensuring timely and accurate reporting of information required under the Exchange Act - **Disclosure controls and procedures** were evaluated and deemed **effective** as of **March 31, 2022**[58](index=58&type=chunk)[134](index=134&type=chunk) - These controls are designed to ensure information required for **SEC** reports is recorded, processed, summarized, and reported timely[58](index=58&type=chunk)[134](index=134&type=chunk) [Internal Control Over Financial Reporting](index=10&type=section&id=Internal%20Control%20Over%20Financial%20Reporting) Following identified deficiencies in internal controls over financial reporting as of December 31, 2021, Ainos, Inc. initiated a remediation plan in Q1 2022. This plan includes increasing accounting staff, clearly delegating reporting roles, establishing an executive review team for narrative disclosures and financial reports, and approving final EDGAR/IXBRL files - **Deficiencies in internal control over financial reporting** were identified as of **December 31, 2021**, and a **remediation plan** was implemented in **Q1 2022**[59](index=59&type=chunk)[135](index=135&type=chunk) - **Remediation efforts** include increasing staff resources, delegating roles and responsibilities for reporting, and establishing executive review teams for disclosures and final filings[60](index=60&type=chunk)[136](index=136&type=chunk) - The company plans to continue implementing its **remediation plan** and further increase internal corporate resources throughout **2022**[61](index=61&type=chunk)[137](index=137&type=chunk) PART II - OTHER INFORMATION [ITEM 1. Legal Proceedings](index=11&type=section&id=ITEM%201.%20Legal%20Proceedings) Ainos, Inc. is not currently aware of any material legal proceedings or claims against the company as of the report date, though it may be involved in various lawsuits in the ordinary course of business - As of the report date, the company was not aware of any **material legal proceedings or claims**[62](index=62&type=chunk)[138](index=138&type=chunk) [ITEM 1A. Risk Factors](index=11&type=section&id=ITEM%201A.%20Risk%20Factors) There are no material changes to the risk factors previously disclosed in the company's Form 10-K/A filed on April 15, 2022 - **No material changes** to risk factors were reported compared to the **Form 10-K/A** filed on **April 15, 2022**[63](index=63&type=chunk)[139](index=139&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=11&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Ainos, Inc. engaged in several unregistered sales of equity securities and related transactions. This includes the issuance of a $26,000,000 non-interest bearing convertible promissory note to Ainos KY for an asset purchase, working capital advances from Ainos KY totaling $3,000,000 (convertible notes with extended maturity) and $800,000 (non-convertible note), and an aggregate of $900,000 in convertible notes issued to other purchasers under Regulation S - Issued a **$26,000,000 non-interest bearing APA Convertible Note** to **Ainos KY** on **January 30, 2022**, as payment for intellectual property and equipment[63](index=63&type=chunk)[139](index=139&type=chunk) - Received **$3,000,000** in working capital advances from **Ainos KY** in **2021** via **convertible notes**, with **maturity dates extended** to **February 28, 2023**[64](index=64&type=chunk)[140](index=140&type=chunk) - Received an **$800,000 non-convertible working capital advance** from **Ainos KY** in **March 2022**, due **February 28, 2023**[65](index=65&type=chunk)[141](index=141&type=chunk) - Issued **$900,000** in aggregate **convertible notes** under **Regulation S** to various purchasers, including a **$50,000 note** to the **CFO's daughter** and **$850,000** to other investors, all **non-interest bearing** and due **March 30, 2027**[66](index=66&type=chunk)[67](index=67&type=chunk)[142](index=142&type=chunk)[143](index=143&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=12&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - **No defaults upon senior securities** were reported[68](index=68&type=chunk)[144](index=144&type=chunk) [ITEM 4. Mine Safety Disclosures](index=12&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Ainos, Inc - **Mine Safety Disclosures** are **not applicable** to the company[68](index=68&type=chunk)[144](index=144&type=chunk) [ITEM 5. Other Information](index=12&type=section&id=ITEM%205.%20Other%20Information) No other information was reported under this item - **No other information** was reported[68](index=68&type=chunk)[144](index=144&type=chunk) [ITEM 6. Exhibits](index=12&type=section&id=ITEM%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including organizational documents, common stock certificates, asset purchase agreements, various convertible and non-convertible notes, employment agreements, and certifications - The exhibit list includes **Restated Certificate of Formation**, **Amended and Restated Bylaws**, **Specimen Common Stock Certificate**, **Amended and Restated Asset Purchase Agreement**, **Convertible Promissory Notes**, **Non-Convertible Note**, **Note Extension Agreement**, **Employment Agreements**, and various certifications (e.g., **31.1**, **31.2**, **32.1**, **32.2**)[69](index=69&type=chunk)[70](index=70&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk)[75](index=75&type=chunk)[145](index=145&type=chunk)[146](index=146&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk)[149](index=149&type=chunk)[150](index=150&type=chunk)[151](index=151&type=chunk) [Signatures](index=14&type=section&id=Signatures) The report is signed by Chun-Hsien Tsai, Chairman of the Board, President, and Chief Executive Officer, and Hui-Lan Wu, Chief Financial Officer, on May 16, 2022 - The report was signed by **Chun-Hsien Tsai** (Chairman, President, CEO) and **Hui-Lan Wu** (CFO) on **May 16, 2022**[76](index=76&type=chunk)[152](index=152&type=chunk)

U.S. Securities and Exchange Commission Washington, D.C. 20549 FORM 10-K (Mark One) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 [Fee Required] For the Fiscal Year Ended December 31, 2021 ☐ Transition Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934 [No Fee Required] Commission File Number 0-20791 AINOS, INC. | --- | --- | |----------------------------------------------------------------------------|-------------------------------------------- ...

PART I: FINANCIAL INFORMATION [ITEM 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Ainos, Inc.'s unaudited financial statements detail significant changes from the Ainos KY Transaction, including increased assets, cash, and operating losses [Balance Sheets](index=3&type=section&id=Balance%20Sheets) Balance Sheet Highlights (Unaudited) | Metric | September 30, 2021 | December 31, 2020 | | :--------------------------------- | :------------------- | :------------------ | | Cash and cash equivalents | $706,931 | $22,245 | | Total current assets | $884,814 | $76,413 | | Patents, net | $19,011,337 | $180,628 | | Total assets | $19,993,626 | $260,290 | | Total current liabilities | $2,821,977 | $1,098,568 | | Total liabilities | $2,857,266 | $1,098,568 | | Total stockholders' equity (deficit) | $17,136,360 | $(838,278) | [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) Statements of Operations (Unaudited) - Three Months Ended September 30 | Metric | 2021 | 2020 | | :------------------------------------- | :----------- | :------- | | Revenues | $363,052 | $192 | | Cost of revenues | $103,638 | $123 | | Gross margin | $259,414 | $69 | | Research and development expenses | $646,798 | $- | | Selling, general and administrative expenses | $795,958 | $321,153 | | Total operating expense | $1,442,756 | $321,153 | | Operating loss | $(1,183,342) | $(321,084) | | Net loss | $(1,160,110) | $(323,285) | Statements of Operations (Unaudited) - Nine Months Ended September 30 | Metric | 2021 | 2020 | | :------------------------------------- | :----------- | :------- | | Revenues | $568,164 | $15,876 | | Cost of revenues | $174,395 | $11,221 | | Gross margin | $393,769 | $4,655 | | Research and development expenses | $646,798 | $389 | | Selling, general and administrative expenses | $2,178,969 | $1,001,893 | | Total operating expense | $2,825,767 | $1,002,282 | | Operating loss | $(2,431,998) | $(997,627) | | Net loss | $(2,443,891) | $(1,002,130) | [Statements of Stockholders' Equity (Deficit) – Three Months](index=5&type=section&id=Statements%20of%20Stockholders%27%20Equity%20%28Deficit%29%20%E2%80%93%20Three%20Months) Stockholders' Equity (Deficit) - Three Months Ended September 30 | Metric | September 30, 2021 | September 30, 2020 | | :------------------------------------- | :------------------- | :------------------- | | Common Stock Shares Outstanding | 142,442,215 | 40,916,351 | | Common Stock Par Value | $1,424,422 | $409,164 | | Additional Paid-in Capital | $24,369,245 | $4,586,068 | | Accumulated Deficit | $(8,664,145) | $(5,771,762) | | Total Stockholders' Equity (Deficit) | $17,136,360 | $(776,530) | - Net loss for the three months ended September 30, 2021, was **$(1,160,110)**[10](index=10&type=chunk)[183](index=183&type=chunk) [Statements of Stockholders' Equity (Deficit) – Nine Months](index=6&type=section&id=Statements%20of%20Stockholders%27%20Equity%20%28Deficit%29%20%E2%80%93%20Nine%20Months) Stockholders' Equity (Deficit) - Nine Months Ended September 30 | Metric | September 30, 2021 | December 31, 2020 | | :------------------------------------- | :------------------- | :------------------ | | Common Stock Shares Outstanding | 142,442,215 | 42,066,172 | | Common Stock Par Value | $1,424,422 | $420,661 | | Additional Paid-in Capital | $24,369,245 | $4,961,315 | | Accumulated Deficit | $(8,664,145) | $(6,220,254) | | Total Stockholders' Equity (Deficit) | $17,136,360 | $(838,278) | - Issuance of stock for Patent assets contributed **$20,000,000** to additional paid-in capital in 2021[12](index=12&type=chunk)[185](index=185&type=chunk) - Net loss for the nine months ended September 30, 2021, was **$(2,443,891)**[12](index=12&type=chunk)[185](index=185&type=chunk) [Condensed Statements of Cash Flows](index=7&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Condensed Statements of Cash Flows (Unaudited) - Nine Months Ended September 30 | Metric | 2021 | 2020 | | :------------------------------------------ | :----------- | :----------- | | Net cash used in operating activities | $(569,150) | $(244,967) | | Net cash flows used in investing activities | $(43,340) | $(1,891) | | Net cash provided by financing activities | $1,290,129 | $85,000 | | Net change in cash and cash equivalents | $677,639 | $(325,272) | | Cash and cash equivalents at end of period | $706,931 | $83,767 | - Non-cash transaction: Stock issued for acquisition of patents amounted to **$20,000,000** in 2021[14](index=14&type=chunk)[187](index=187&type=chunk) [Notes to Financial Statements](index=8&type=section&id=Notes%20to%20Financial%20Statements) - Ainos, Inc. is a diversified healthcare company focused on R&D and sales/marketing of pharmaceutical and biotech products, operating through Pharmaceutical, Medical Devices, and Preventive Medicine Divisions[15](index=15&type=chunk)[16](index=16&type=chunk)[17](index=17&type=chunk)[188](index=188&type=chunk)[189](index=189&type=chunk)[190](index=190&type=chunk) - The company's financial condition significantly improved as of September 30, 2021, with total stockholder's equity increasing to **$17,136,360** from a negative **$838,278** at December 31, 2020, and cash increasing to **$706,931** from **$22,245**, largely due to the Ainos KY Transaction and sales of the Ainos Covid-19 Test Kit[21](index=21&type=chunk)[22](index=22&type=chunk)[194](index=194&type=chunk)[195](index=195&type=chunk) Convertible and Other Notes Payable (Principal Balance) | Payee | September 30, 2021 | December 31, 2020 | | :-------------------------------- | :------------------- | :------------------ | | Dr. Stephen T. Chen (Related Party) | $1,019,193 | $805,001 | | Ainos KY (Affiliated Company) | $981,000 | $0 | | i2China Management Group LLC | $185,000 | $148,000 | | **Total** | **$2,185,193** | **$953,001** | *Note: $45,875 in interest on matured, unpaid amounts for related party notes was waived during Q3 2021* - Significant related party transactions include financial support from Ainos KY (**$981,000** convertible note), inventory purchases from TCNT (**$173,657**), product co-development with TCNT (**$117,386** in costs), product sales to ASE Technology Holding (**$185,376**), and common stock issued as compensation to Dr. Stephen T. Chen and Bernard Cohen (**$36,500** total)[33](index=33&type=chunk)[34](index=34&type=chunk)[35](index=35&type=chunk)[36](index=36&type=chunk)[37](index=37&type=chunk)[206](index=206&type=chunk)[207](index=207&type=chunk)[208](index=208&type=chunk)[209](index=209&type=chunk)[210](index=210&type=chunk) - Subsequent events include engaging PricewaterhouseCoopers (PWC) for audit and advisory services, Board approval of new committees (Compensation, Audit), employee stock plans, director compensation policy, and corporate governance policies, and engaging former CEO Dr. Stephen T. Chen as a consultant for the pharmaceutical division[38](index=38&type=chunk)[39](index=39&type=chunk)[40](index=40&type=chunk)[211](index=211&type=chunk)[212](index=212&type=chunk)[213](index=213&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=11&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes Ainos, Inc.'s financial condition and operational results, highlighting its medtech transformation and the impact of the Ainos KY Transaction [Overview](index=11&type=section&id=OVERVIEW) - Ainos, Inc. is a Texas corporation engaged in the discovery and development of pharmaceuticals, medical devices, and preventative medicine, with offices in the US and Taiwan[42](index=42&type=chunk)[215](index=215&type=chunk) - The company operates three business divisions: Pharmaceutical (low-dose oral interferon alpha research), Medical Devices (insulin pump, COVID-19, and VOC diagnostics), and a restructured Preventive Medicine (sRNA-based therapeutics)[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk)[216](index=216&type=chunk)[217](index=217&type=chunk)[218](index=218&type=chunk) - Ainos is undergoing a 'medtech transformation' driven by the COVID-19 pandemic, focusing on telehealth-enabled diagnostics and sRNA's potential in pharmaceutical innovation, aiming to leverage its AI Nose platform for volatile organic compound (VOC) diagnostics and personalized medicine ('Smell ID')[46](index=46&type=chunk)[48](index=48&type=chunk)[219](index=219&type=chunk)[221](index=221&type=chunk) - The Ainos KY Transaction (April 15, 2021) involved the acquisition of intellectual properties valued at approximately **$20 million**, including VOC AI algorithms, digital nose technology, and POCT diagnostics for various diseases, and provided financial and management resources[49](index=49&type=chunk)[50](index=50&type=chunk)[222](index=222&type=chunk)[223](index=223&type=chunk) [Our Business Divisions and Product Lines](index=13&type=section&id=Our%20Business%20Divisions%20and%20Product%20Lines) - The Pharmaceutical Division's VELDONA platform focuses on low-dose non-injectable interferon alpha (IFN-α) for thrombocytopenia and Sjögren's syndrome, leveraging over thirty years of clinical data and planning to resume late-stage clinical trials in late 2022[59](index=59&type=chunk)[60](index=60&type=chunk)[61](index=61&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk)[64](index=64&type=chunk)[65](index=65&type=chunk)[66](index=66&type=chunk)[67](index=67&type=chunk)[68](index=68&type=chunk)[69](index=69&type=chunk)[70](index=70&type=chunk)[71](index=71&type=chunk)[232](index=232&type=chunk)[233](index=233&type=chunk)[234](index=234&type=chunk)[235](index=235&type=chunk)[236](index=236&type=chunk)[237](index=237&type=chunk)[238](index=238&type=chunk)[239](index=239&type=chunk)[240](index=240&type=chunk)[241](index=241&type=chunk)[242](index=242&type=chunk)[243](index=243&type=chunk)[244](index=244&type=chunk) - The Medical Device Division develops cloud-connected Point-of-Care Testing (POCT) diagnostics, including the Ainos COVID-19 Antigen Test Kit (launched in Taiwan, CE mark for Europe, with smartphone-based management apps), and VOC-based POCTs like Ainos Flora (vaginal health/STDs), Ainos Pen (multipurpose breathalyzer), and CHS430 VAP Rapid Test (ventilator-associated pneumonia detection)[72](index=72&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk)[81](index=81&type=chunk)[82](index=82&type=chunk)[83](index=83&type=chunk)[84](index=84&type=chunk)[85](index=85&type=chunk)[86](index=86&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk)[89](index=89&type=chunk)[90](index=90&type=chunk)[91](index=91&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk)[94](index=94&type=chunk)[95](index=95&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk)[245](index=245&type=chunk)[246](index=246&type=chunk)[247](index=247&type=chunk)[248](index=248&type=chunk)[249](index=249&type=chunk)[250](index=250&type=chunk)[251](index=251&type=chunk)[252](index=252&type=chunk)[253](index=253&type=chunk)[254](index=254&type=chunk)[255](index=255&type=chunk)[256](index=256&type=chunk)[257](index=257&type=chunk)[258](index=258&type=chunk)[259](index=259&type=chunk)[260](index=260&type=chunk)[261](index=261&type=chunk)[262](index=262&type=chunk)[263](index=263&type=chunk)[264](index=264&type=chunk)[265](index=265&type=chunk)[266](index=266&type=chunk)[267](index=267&type=chunk)[268](index=268&type=chunk)[269](index=269&type=chunk)[270](index=270&type=chunk) - The Preventive Medicine Division is establishing an sRNA technology platform for 2nd generation COVID-19 mRNA vaccines (short-term) and therapeutic RNA drugs for inflammatory diseases and cancers (long-term), focusing on R&D and strategic partnerships[98](index=98&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk)[101](index=101&type=chunk)[271](index=271&type=chunk)[272](index=272&type=chunk)[273](index=273&type=chunk)[274](index=274&type=chunk) [Manufacturing and Intellectual Property](index=20&type=section&id=Manufacturing%20and%20Intellectual%20Property) - Ainos operates an asset-light manufacturing model, primarily partnering with Taiwan Carbon Nano Technology Corporation (TCNT) for POCT products, leveraging TCNT's ISO and GMP certifications[102](index=102&type=chunk)[103](index=103&type=chunk)[275](index=275&type=chunk)[276](index=276&type=chunk) - The company owns eleven issued patents and two pending, with license rights in Japan and China for two patents. Newly acquired patents from the Ainos KY transaction include gas sensors and medical ventilators for pneumonia detection, forming the basis for next-generation rapid test kits[104](index=104&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk)[277](index=277&type=chunk)[278](index=278&type=chunk)[279](index=279&type=chunk) [Regulatory Environment](index=20&type=section&id=Regulatory%20Environment) - Products with health claims in the U.S. require FDA approval, involving rigorous preclinical testing, clinical trials, IND submission, NDA approval, and manufacturing inspections. Alternative paths like 505(b)(2) and Orphan Drug Designation may be pursued[108](index=108&type=chunk)[109](index=109&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk)[281](index=281&type=chunk)[282](index=282&type=chunk)[283](index=283&type=chunk)[284](index=284&type=chunk) - Medical devices require FDA clearance via Premarket Notification 510(k) (for substantial equivalence) or Premarket Approval (PMA) for new or Class III devices, which is a more stringent scientific review process[112](index=112&type=chunk)[113](index=113&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk)[285](index=285&type=chunk)[286](index=286&type=chunk)[287](index=287&type=chunk)[288](index=288&type=chunk)[289](index=289&type=chunk) - Foreign regulations also govern clinical trials and commercial sales, with varying approval processes and requirements, and changes in these policies could impact the company's operations[117](index=117&type=chunk)[118](index=118&type=chunk)[290](index=290&type=chunk)[291](index=291&type=chunk) [Employees and Consultants](index=22&type=section&id=Employees%20and%20Consultants) - As of September 30, 2021, the company had **27 employees**, a significant increase from **4** in 2020, with R&D employees comprising approximately **33%** of the total workforce. The company plans to further increase R&D human resources[119](index=119&type=chunk)[292](index=292&type=chunk) - Key personnel retained post-Ainos Transaction include Lawrence Lin (EVP Operations) and John Junyong Lee (Chief Legal Counsel and Corporate Secretary)[122](index=122&type=chunk)[295](index=295&type=chunk) [Results of Operation for Quarter Ended September 30, 2021 and 2020](index=22&type=section&id=Results%20of%20Operation%20for%20Quarter%20Ended%20September%2030%2C%202021%20and%202020) Financial Performance - Three Months Ended September 30 | Metric | 2021 | 2020 | | :------------------------------------- | :----------- | :------- | | Revenues | $363,052 | $192 | | Cost of revenues | $103,638 | $123 | | Gross margin | $259,414 | $69 | | Research and development expenses | $646,798 | $- | | Selling, general and administrative expenses | $795,958 | $321,153 | | Operating loss | $(1,183,343) | $(321,084) | | Net loss | $(1,161,110) | $(323,285) | - Revenue growth was primarily driven by sales of the Ainos Covid-19 Test Kit, with **64%** sold through distribution channels[120](index=120&type=chunk)[293](index=293&type=chunk) - Increased R&D expenses were due to Covid-19 Test Kit development, AI Nose pen mold, expanded R&D staffing, and amortization of acquired intellectual properties[120](index=120&type=chunk)[124](index=124&type=chunk)[293](index=293&type=chunk)[297](index=297&type=chunk) - Increased SG&A expenses were associated with marketing the Ainos Covid-19 Test Kit, Ainos KY Transaction expenses, employee salaries, and professional service fees[127](index=127&type=chunk)[300](index=300&type=chunk) [Results of Operation for the Nine months Ended September 30, 2021 and 2020](index=23&type=section&id=Results%20of%20Operation%20for%20the%20Nine%20months%20Ended%20September%2030%2C%202021%20and%202020) Financial Performance - Nine Months Ended September 30 | Metric | 2021 | 2020 | | :------------------------------------- | :----------- | :----------- | | Revenues | $568,164 | $15,876 | | Cost of revenues | $174,395 | $11,221 | | Gross margin | $393,769 | $4,655 | | Research and development expenses | $646,798 | $389 | | Selling, general and administrative expenses | $2,178,969 | $1,001,893 | | Operating loss | $(2,431,998) | $(997,627) | | Net loss | $(2,443,891) | $(1,002,130) | - Revenue growth was primarily from sales of the Ainos Covid-19 Test Kits, with **62%** sold through distribution channels[131](index=131&type=chunk)[304](index=304&type=chunk) - R&D costs increased significantly due to patent purchases under the Ainos KY Transaction and new product development and research expenses[131](index=131&type=chunk)[304](index=304&type=chunk) - SG&A expenses rose due to increased marketing for the Ainos Covid-19 Test Kit, Ainos KY Transaction expenses, higher employee salaries, and professional service fees[132](index=132&type=chunk)[305](index=305&type=chunk) [Liquidity and Capital Resources](index=24&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity and Capital Resources | Metric | September 30, 2021 | September 30, 2020 | December 31, 2020 | | :-------------------------- | :------------------- | :------------------- | :------------------ | | Cash | $706,931 | $83,767 | $22,245 | | Working Capital Deficit | $1,937,163 | $919,880 | $1,022,155 | - The company anticipates business revenues and potential financial support from Ainos KY to fund operations for the next twelve months but may need to raise additional capital through equity or debt if necessary[136](index=136&type=chunk)[309](index=309&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Ainos, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is exempt from providing market risk disclosures as it qualifies as a 'smaller reporting company'[137](index=137&type=chunk)[310](index=310&type=chunk) [ITEM 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management confirmed effective disclosure controls and internal financial reporting as of September 30, 2021, with no material COVID-19 impact - Disclosure controls and procedures were evaluated as effective at the reasonable assurance level as of September 30, 2021[138](index=138&type=chunk)[311](index=311&type=chunk) - Management concluded that internal control over financial reporting was effective at the reasonable assurance level as of September 30, 2021[139](index=139&type=chunk)[312](index=312&type=chunk) - No material impact on internal controls over financial reporting was experienced due to the COVID-19 work-from-home arrangements[140](index=140&type=chunk)[313](index=313&type=chunk) PART II: OTHER INFORMATION [ITEM 1. Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings) Ainos, Inc. is not currently aware of any material legal proceedings or claims against it as of the report date - As of the report date, the company was not aware of any material legal proceedings or claims against it[141](index=141&type=chunk)[314](index=314&type=chunk) [ITEM 1A. Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors) Ainos, Inc. faces significant business risks including intense competition, operational strains, new product challenges, supply chain vulnerabilities, and regulatory changes - The company faces intense competition in the pharmaceutical and medical device industries from entities with greater resources, requiring continuous innovation and successful commercialization[145](index=145&type=chunk)[146](index=146&type=chunk)[318](index=318&type=chunk)[319](index=319&type=chunk) - Expansion into innovative biotechnologies, digital health, and point-of-care testing places significant strain on management, operational, financial, and R&D resources[147](index=147&type=chunk)[320](index=320&type=chunk) - Risks include limited experience in new market segments, potential for customer non-adoption, and challenges in international operations due to local economic/political conditions, government regulation, and foreign currency restrictions[148](index=148&type=chunk)[149](index=149&type=chunk)[321](index=321&type=chunk)[322](index=322&type=chunk) - Business growth relies on complex commercial agreements and strategic alliances, which require substantial resources and are subject to risks if partners' offerings are unsuccessful or new agreements cannot be secured[150](index=150&type=chunk)[151](index=151&type=chunk)[323](index=323&type=chunk)[324](index=324&type=chunk) - The company is vulnerable to supply risks, particularly for interferon (due to the former producer ceasing manufacturing) and the Ainos Covid-19 Test Kit (exclusive reliance on TCNT)[152](index=152&type=chunk)[153](index=153&type=chunk)[325](index=325&type=chunk)[326](index=326&type=chunk) - Evolving government regulations for biologics, pharmaceuticals, and medical devices in multiple jurisdictions could lead to increased costs, liabilities, and adverse impacts on business operations[154](index=154&type=chunk)[327](index=327&type=chunk) - The company may be subject to claims, litigation, and government investigations, which could result in legal costs, operational disruption, and reputational damage[155](index=155&type=chunk)[156](index=156&type=chunk)[328](index=328&type=chunk)[329](index=329&type=chunk) - The future impact of the COVID-19 outbreak on the company's operations is highly uncertain and cannot be predicted[157](index=157&type=chunk)[330](index=330&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=28&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds were reported for the period - No unregistered sales of equity securities or use of proceeds were reported[330](index=330&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=28&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities were reported for the period - No defaults upon senior securities were reported[330](index=330&type=chunk) [ITEM 4. Mine Safety Disclosures](index=28&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Mine safety disclosures are not applicable to Ainos, Inc.'s operations - Mine safety disclosures are not applicable to the company[330](index=330&type=chunk) [ITEM 5. Other Information](index=28&type=section&id=Item%205.%20Other%20Information) This section details CEO and CFO compensation, Board adoption of new corporate governance policies, and amendments to company bylaws - Employment offer letters were executed for CEO Chun-Hsien Tsai (monthly salary of NTD **250,000**, approx. **$8,929**, plus bonus) and CFO Hui-Lan Wu (monthly salary of NTD **230,000**, approx. **$8,214**, plus bonus)[157](index=157&type=chunk)[158](index=158&type=chunk)[330](index=330&type=chunk)[331](index=331&type=chunk) - The Board adopted several corporate governance policies on August 20, 2021, including Rules and Procedures of Board of Directors Meetings, Corporate Governance Policies, and Charters for the Audit and Compensation Committees[159](index=159&type=chunk)[332](index=332&type=chunk)[333](index=333&type=chunk) - Amendments to the company's Bylaws were approved, specifically Article II, Section 10 regarding director compensation, and the corporate name was updated to 'Ainos, Inc.' from 'AMARILLO CELL CULTURE COMPANY, INCORPORATED'[160](index=160&type=chunk)[333](index=333&type=chunk) [ITEM 6. Exhibits](index=29&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed or incorporated by reference in the 10-Q report, including corporate organizational documents, certifications, and various board policies - Exhibits include the Restated Certificate of Formation, amended Bylaws, Specimen Common Stock Certificate, CEO and CFO certifications, and various Board policies (e.g., Rules and Procedures of Board of Directors Meetings, Corporate Governance Policies, Audit Committee Charter, Compensation Committee Charter, Insider Trading Policy, Code of Business Conduct and Ethics)[160](index=160&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk)[165](index=165&type=chunk)[166](index=166&type=chunk)[167](index=167&type=chunk)[168](index=168&type=chunk)[169](index=169&type=chunk)[170](index=170&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk)[333](index=333&type=chunk)[334](index=334&type=chunk)[335](index=335&type=chunk)[336](index=336&type=chunk)[337](index=337&type=chunk)[338](index=338&type=chunk)[339](index=339&type=chunk)[340](index=340&type=chunk)[341](index=341&type=chunk)[342](index=342&type=chunk)[343](index=343&type=chunk)[344](index=344&type=chunk)[345](index=345&type=chunk) [Signatures](index=31&type=section&id=Signatures) The report is officially signed by the Chairman of the Board and Chief Executive Officer, Chun-Hsien Tsai, and the Chief Financial Officer, Hui-Lan Wu, on November 15, 2021 - The report was signed by Chun-Hsien Tsai, Chairman of the Board and Chief Executive Officer, and Hui-Lan Wu, Chief Financial Officer, on November 15, 2021[173](index=173&type=chunk)[346](index=346&type=chunk)