Ainos, Inc 10-Q/A for FY2023 Q3
Ainos, Inc. (AIMD)
About this 10-Q/A
Ainos, Inc filed this 10-Q/A on February 15, 2024, covering the quarter ended September 30, 2023 (FY2023 Q3).
Headline figures
Quarter ended September 30, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $24.49K
- down 98.6% from $1.76M a year earlier
- Net loss
- $2.98M
- compared with a net loss of $7.82M a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________________________________
FORM
_____________________________________________
(Mark One)
For the quarterly period ended
or
For the transition period from __________ to __________
Commission File No.
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(Exact name of registrant as specified in its charter) |
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(State or other jurisdiction of incorporation or organization) |
| (IRS Employer Identification No.) |
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(Address and telephone number, including area code, of registrant's principal executive offices) | ||
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Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
| Trading Symbol(s) |
| Name of each exchange on which registered |
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| The | ||
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| The |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
☒ | Smaller reporting company | ||
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| Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)
AINOS, INC.
INDEX
| 2 |
| Table of Contents |
PART I - FINANCIAL INFORMATION
ITEM 1. Financial Statements
Ainos, Inc.
Condensed Balance Sheets
(Unaudited)
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| September 30, |
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| December 31, |
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| 2023 |
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| 2022 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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Accounts receivable (including amounts of related party of nil and $ |
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Inventory, net |
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Other current assets |
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Total current assets |
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Intangible assets, net |
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Property and equipment, net |
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Other assets |
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Total assets |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Contract liabilities |
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Convertible notes payable, related party |
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Other notes payable, related party |
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Accrued expenses and others current liabilities |
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Total current liabilities |
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Convertible notes payable - noncurrent (including amounts of related party of $ |
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Senior secured convertible notes measured at fair value |
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Other notes payable, related party - noncurrent |
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Other long-term liabilities |
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Total liabilities |
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Commitments and contingencies |
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Stockholders' equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
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Translation adjustment |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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See accompanying notes to condensed financial statements.
| 3 |
| Table of Contents |
Ainos, Inc.
Condensed Statements of Operations
(Unaudited)
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| Three months ended September 30, |
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| Nine months ended September 30, |
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| 2023 |
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| 2022 |
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| 2023 |
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| 2022 |
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Revenues (including amounts of related party of $21,224 and $1,506,225 for the three months ended September 30, 2023 and 2022, and $33,765 and $1,988,150 for the nine months ended September 30, 2023 and 2022, respectively) |
| $ |
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| $ |
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| $ |
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| $ |
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Cost of revenues (including amounts of related party of $39,523 and $732,765 for the three months ended September 30, 2023 and 2022, and $86,158 and $1,603,169 for the nine months ended September 30, 2023 and 2022, respectively) |
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Gross (loss) profit |
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Operating expenses: |
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Research and development expenses (including amounts of related party of $135,606 and $115,912 for the three months ended September 30, 2023 and 2022, and $287,802 and $490,082 for the nine months ended September 30, 2023 and 2022, respectively) |
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Selling, general and administrative expenses |
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Total operating expenses |
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Loss from operations |
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Non-operating (expenses) income, net: |
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Interest expense |
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Other income, net |
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Issuance cost of convertible note measured at fair value |
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Total non-operating (expenses) income, net |
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Net loss before income taxes |
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Provision for income taxes |
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Net loss |
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Net loss per common share - basic and diluted |
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Weighted-average shares used in computing net loss per common share-basic and diluted |
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See accompanying notes to condensed financial statements.
| 4 |
| Table of Contents |
Ainos, Inc.
Condensed Statements of Comprehensive Loss
(Unaudited)
|
| Three months ended September 30, |
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| Nine months ended September 30, |
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| 2023 |
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| 2022 |
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| 2023 |
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| 2022 |
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Net loss |
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| $ | ( | ) |
| $ | ( | ) |
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Other comprehensive loss: |
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Translation adjustment |
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Comprehensive loss |
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) |
See accompanying notes to condensed financial statements.
| 5 |
| Table of Contents |
Ainos, Inc. | ||||||||||||||||||||||||||||||||
Condensed Statements of Stockholders’ Equity | ||||||||||||||||||||||||||||||||
For the three months ended September 30, 2023 and 2022 (Unaudited) | ||||||||||||||||||||||||||||||||
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| Preferred Stock |
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| Common Stock |
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| Additional Paid-in |
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| Accumulated |
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| Accumulated Other Comprehensive |
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| Total Stockholders’ |
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| Shares |
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| Amount |
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| Shares |
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| Amount |
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| Capital |
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| Deficit |
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| Loss |
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| Equity |
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Balance at June 30, 2023 |
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| $ |
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| $ | ( | ) |
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Warrants issued in connection with secured convertible note payable |
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| - |
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| - |
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Share-based compensation |
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| - |
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Net loss |
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| - |
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Translation adjustment |
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| - |
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Balance at September 30, 2023 |
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| $ |
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Balance at June 30, 2022 |
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| $ |
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Issuance of stock upon offering, net of issuance cost |
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Conversion of convertible notes payable to common stock |
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Share-based compensation |
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| - |
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Net loss |
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| - |
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| - |
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Translation adjustment |
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| - |
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Balance at September 30, 2022 |
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| $ |
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| $ |
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| $ |
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See accompanying notes to condensed financial statements.
| 6 |
| Table of Contents |
Ainos, Inc. | ||||||||||||||||||||||||||||||||
Condensed Statements of Stockholders’ Equity | ||||||||||||||||||||||||||||||||
For the nine months ended September 30, 2023 and 2022 (Unaudited) | ||||||||||||||||||||||||||||||||
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| Preferred Stock |
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| Common Stock |
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| Additional Paid-in |
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| Accumulated |
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| Accumulated Other Comprehensive |
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| Total Stockholders’ |
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| Shares |
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| Amount |
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| Amount |
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| Capital |
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| Deficit |
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| Loss |
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| Equity |
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Balance at December 31, 2022 |
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Issuance of stock in exchange of vehicle |
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Conversion of convertible notes payable to common stock |
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Issuance of stock to settle vested RSUs |
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Warrants issued in connection with senior secured convertible note payable |
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Share-based compensation |
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Net loss |
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Translation adjustment |
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Balance at September 30, 2023 |
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| $ |
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Balance at December 31, 2021 |
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| $ |
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Issuance of stock upon offering, net of issuance cost |
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Conversion of convertible notes payable to common stock |
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Share-based compensation |
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Net loss |
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Translation adjustment |
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Balance at September 30, 2022 |
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| $ |
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| $ |
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| $ |
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| $ | ( | ) |
| $ | ( | ) |
| $ |
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See accompanying notes to condensed financial statements.
| 7 |
| Table of Contents |
Ainos, Inc.
Condensed Statements of Cash Flows
(Unaudited)
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| Nine months ended September 30, |
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| 2023 |
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| 2022 |
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Cash flows from operating activities: |
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Net loss |
| $ | ( | ) |
| $ | ( | ) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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Loss on inventory write-downs |
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Share-based compensation expense |
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Issuance cost of convertible note measured at fair value |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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Inventory |
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Other current assets |
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Accrued expenses and other current and long-term liabilities |
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Operating lease liabilities |
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Contract liabilities |
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Net cash used in operating activities |
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Cash flows from investing activities: |
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Purchase of property and equipment |
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Increase in refundable deposits |
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Net cash used in investing activities |
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Cash flows from financing activities |
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Proceeds from convertible notes payable |
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Proceeds from convertible notes payable, related party |
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Proceeds from other notes payable, related party |
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Proceeds from senior secured convertible notes payable |
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Repayments of convertible notes payable, related party |
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Repayments of other notes payable, related party |
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Net proceeds from Uplisting in Nasdaq |
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Payments of issuance cost of convertible note measured at fair value |
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Net cash provided by financing activities |
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Effect from foreign currency exchange |
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Net increase in cash and cash equivalents |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period |
| $ |
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| $ |
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Supplemental cash flow information: |
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Cash paid for interest |
| $ |
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| $ |
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Noncash financing and investing activities |
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Purchase of equipment and intangible assets by issuing convertible notes payable to a related party |
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| $ |
| ||
Conversion of convertible notes payable to common stock and accrued interest waived or converted by convertible note holders |
| $ |
|
| $ |
| ||
Issuance of common stock in exchange of motor vehicle |
| $ |
|
|
|
| ||
Payable for purchase of equipment |
| $ |
|
| $ |
| ||
See accompanying notes to the condensed financial statements.
| 8 |
| Table of Contents |
Ainos, Inc.
Notes to Condensed Financial Statements
(Unaudited)
1. Description of Business
Organization and Business
Ainos, Inc. (the “Company”), incorporated in the State of Texas, is a diversified healthcare company focused on the development of novel point-of-care testing (the “POCT”), therapeutics based on very low-dose interferon alpha (the “VELDONA”), and synthetic RNA-driven preventative medicine. The Company’s products include VELDONA clinical-stage human therapeutics, VELDONA Pet cytoprotein supplements, and telehealth-friendly POCTs powered by its AI Nose technology platform.
The Company’s POCT platforms aim to provide connected, rapid and convenient testing of a broad range of health conditions. Building on its extensive research and development on VELDONA, the Company is focused on commercializing a suite of VELDONA-based products including VELDONA Pet cytoprotein supplements and human related VELDONA therapeutics.
In 2021 and 2022, the Company acquired intellectual property from controlling shareholder, Ainos Inc., a Cayman Islands corporation (“Ainos KY”), and continues to expand its product portfolio into POCTs. Pivoting from the sales of COVID-19 POCT, the Company is commercializing POCTs that detect volatile organic compounds (the “VOC”) emitted by the body, powered by the Company’s AI Nose technology platform. The Company’s lead VOC POCT candidate, Ainos Flora, aims to quickly and easily test female vaginal health and certain common sexually transmitted infections (the “STIs”).
Underwritten Public Offering
The Company’s registration statement related to its underwritten public offering (the “Offering”) was declared effective on August 8, 2022, and the Company’s common stock and warrants began trading on the Nasdaq Capital Market (the “Nasdaq”) on August 9, 2022 under the trading symbols “AIMD” and “AIMDW”, respectively. The Company completed its underwritten public offering of an aggregated
In connection with the Offering, the Company’s board of directors on April 29, 2022 and its shareholders on May 16, 2022 approved a
The Company filed a Certificate of Amendment to its Restated Certificate of Formation with the Secretary of State of Texas on August 8, 2022 that effectuated the Reverse Stock Split.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (the “GAAP”) and pursuant to the accounting disclosure rules and regulations of the Securities and Exchange Commission (the “SEC”) regarding interim financial reporting. Certain information and note disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. Therefore, these condensed financial statements should be read in conjunction with the financial statements and notes included in the Company’s audited financial statements as of and for the year ended December 31, 2022 contained in the Annual Report on Form 10-K filed with the SEC on April 3, 2023.
In the opinion of management, the accompanying condensed financial statements reflect all normal recurring adjustments necessary to present fairly the financial position, results of operations, and cash flows for the interim periods. The results for the three and nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for any subsequent quarter, the year ending December 31, 2023, or any other period.
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| Table of Contents |
There have been no material changes to the Company’s significant accounting policies as described in the audited financial statements as of December 31, 2022.
Use of Estimates
The preparation of condensed financial statements in conformity with GAAP requires management to make certain estimates, judgments, and assumptions that affect the reported amounts of assets and liabilities and disclosures as of the date of the condensed financial statements and the reported amounts of revenues and expenses during the reporting period. The Company bases its estimates on various factors, including historical experience, and on various other assumptions that are believed to be reasonable under the circumstances, when these carrying values are not readily available from other sources. Significant items subject to estimates and assumptions include useful lives of property and equipment, valuation of stock option, warrants and convertible notes measured at fair value, and impairment testing of intangible assets. Actual results may differ from these estimates.
Liquidity
As of September 30, 2023, the Company had cash and cash equivalents of $
For the nine months ended September 30, 2023, the Company generated a net loss of $
The financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred net operating losses in every year since inception and has an accumulated deficit as of September 30, 2023 of $
Segments
Operating segments are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the chief operating decision maker (the “CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company’s Chief Executive Officer is the Company’s CODM. The CODM reviews financial information prepared on the basis of accounting policy disclosed in its annual financial statement for purposes of making operating decisions, allocating resources, and evaluating financial performance of the Company. As such, the Company has determined that it operates as one operating segment.
Impairment of Intangible Assets
The Company reviews its definite-lived intangibles and other long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be fully recoverable. When such events occur, management determines whether there has been impairment by comparing the anticipated undiscounted future net cash flows to the carrying value of the asset or asset group. If impairment exists, the assets are written down to their estimated fair value. No impairment of definite-lived intangible and long-lived assets was recorded for the three and nine months ended September 30, 2023 and 2022.
| 10 |
| Table of Contents |
Fair Value Option
ASC 825-10, Financial Instruments, provides a fair value option (the “FVO”) election that allows companies an irrevocable election to use fair value as the initial and subsequent accounting measurement attribute for certain financial assets and liabilities. ASC 825-10 permits entities to elect to measure eligible financial assets and liabilities at fair value on an ongoing basis. Unrealized gains and losses on items for which the FVO has been elected are reported in earnings, except for the effect of changes in own credit, which are recognized in other comprehensive income/loss. The decision to elect the FVO is determined on an instrument-by-instrument basis, must be applied to an entire instrument and is irrevocable once elected. Assets and liabilities measured at fair value pursuant to ASC 825-10 are required to be reported separately from those instruments measured using another accounting method.
The Company elected to account for the senior secured convertible notes issued to Lind Global Fund II LP (the “Lind Note”) using FVO, which allows for valuing the Lind Note at fair value in its entirety versus bifurcation of the embedded derivatives (see Note 5). The fair value of the Lind Note is determined using a binomial lattice valuation model, which is widely used for valuing convertible notes. The significant assumptions used in the model is volatility of the Company's common stock. If different assumptions are used, the fair value of the convertible notes and the change in estimated fair value could be materially different. A significant increase in the volatility of the market price of the Company’s common stock, in isolation, would result in a significantly higher fair value; and a significant decrease in volatility would result in a significantly lower fair value.
Recent Accounting Pronouncements Adopted
On January 1, 2023, the Company adopted Accounting Standards Update (the “ASU”) 2016-13 (the “ASU 2016-13”), Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which the Financial Accounting Standards Board (the “FASB”) issued in June 2016. The new standard changes the accounting for credit losses for financial assets and certain other instruments, including trade receivables and contract assets that are not measured at fair value through net income. Under legacy standards, the Company recognizes an impairment of receivables when it was probable that a loss had been incurred. Under the new standard pursuant to ASU 2016-13, the Company is required to recognize estimated credit losses expected to occur over the estimated life or remaining contractual life of an asset (which includes losses that may be incurred in future periods) using a broader range of information including reasonable and supportable forecasts about future economic conditions. The guidance is effective for smaller reporting companies (the “SRC”) as defined by the SEC for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years with early adoption permitted. The Company’s adoption of this new guidance did not have a material impact on the Company’s financial statements and related disclosure.
On January 1, 2023, the Company early adopted ASU 2020-06 (the “ASU 2020-06”), Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. ASU 2020-06 as issued by FASB in August 2020 removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception, and it also simplifies the diluted earnings per share calculation in certain areas. ASU 2020-06 is effective for SRC’s fiscal years beginning after December 15, 2023, including interim periods within those fiscal years, with early adoption permitted. The Company’s early adoption of this new guidance did not have a material impact on its financial statements and related disclosures.
Accounting Standards Issued but Not Yet Adopted
No other new accounting pronouncement issued or effective has had, or is expected to have, a material impact on the Company’s financial statements.
3. Cash and Cash Equivalents
As of September 30, 2023 and December 31, 2022, cash and cash equivalents consist of cash on hand and cash in bank which is potentially subject to concentration of credit risk. Such balance is maintained at financial institutions that management determines to be of high-credit quality. Cash accounts at each institution are insured by the Federal Deposit Insurance Corporation in the U.S.A or Central Deposit Insurance Corporation in Taiwan up to certain limits. At times, such deposits may be in excess of the insurance limit. The Company has not experienced any losses on its deposits.
| 11 |
| Table of Contents |
4. Inventory
Inventory stated at cost, net of reserve, consisted of the following:
|
| September 30, |
|
| December 31, |
| ||
|
| 2023 |
|
| 2022 |
| ||
Raw materials |
| $ |
|
| $ |
| ||
Work in process |
|
|
|
|
|
| ||
Finished goods |
|
|
|
|
|
| ||
Total |
| $ |
|
| $ |
| ||
Inventory write-downs to estimated net realizable values were $
The Company identified certain raw material that could be used for research and development of new POCT products and reclassified $
As of September 30, 2023 and December 31, 2022, the inventory consisted of $
5. Convertible Notes Payable and Other Notes Payable
As of September 30, 2023 and December 31, 2022, the respective notes payable were as follows:
|
| September 30, 2023 |
|
| December 31, 2022 |
| ||
Convertible notes payable, related party – current (Chen Note) |
| $ |
|
| $ |
| ||
Other notes payable, related party - current |
|
|
|
|
|
| ||
Other notes payable, related party - noncurrent |
|
|
|
|
|
| ||
March 2025 Convertible Notes, related party – noncurrent (ASE Note) |
|
|
|
|
|
| ||
March 2025 Convertible Notes – noncurrent (Lee Note) |
|
|
|
|
|
| ||
Senior secured convertible notes payable (Lind Note) - fair value |
|
|
|
|
|
| ||
|
| $ |
|
| $ |
| ||
The Company received funding in the form of convertible promissory note from Dr. Stephen T. Chen, the former Chief Executive Officer or Chen (the “Chen Note”), in 2016 for the purpose of supporting working capital. The Chen Note was payable on demand and was convertible into common stock of the Company at the conversion
The other notes payable were issued to Ainos KY, the controlling shareholder of the Company, in exchange for $
All of the aforementioned convertible promissory notes and other notes payable are unsecured and due upon maturity. Holders of convertible notes have the option to convert some or the entire unpaid principal and accrued interest to common stock of the Company.
| 12 |
| Table of Contents |
March 2025 Convertible Notes
On March 13, 2023, the Company entered into two convertible promissory note purchase agreements pursuant to Regulation S of the Securities Act of 1933, as amended, in the total principal amount of $
Convertible Note Issued to ASE Test, Inc. (the “ASE Note”)
Pursuant to the one of the aforementioned agreements,
Convertible Note Issued to Li-Kuo Lee (the “Lee Note”)
The Company issued a convertible note in the principal amount of $
The March 2025 Convertible Notes will mature in two years from the issuance dates, bearing interest at the rate of
The total interest expense of convertible notes payable, other notes payable and March 2025 Convertible Notes for the three and nine months ended September 30, 2023 were $
Senior Secured Convertible Notes Payable
On September 25, 2023, the Company entered into a securities purchase agreement (the “SPA”) with Lind Global Fund II LP (the “Lind”). The SPA provides for loans in an aggregate principal amount of up to $
Following the earlier to occur of (i) 90 days from the date of the SPA or (ii) the date the resale Registration Statement is declared effective by the SEC, the Lind Note is convertible into shares of the Company’s common stock at the option of Lind at any time with the conversion price at lower of $
From an accounting perspective, the Lind Note is considered a debt host instrument embedded with issuer’s call and investor’s contingent puts, and is issued at substantial discount. The Company elects the fair value option (the “FVO”) to account for the Lind Note at fair value and mark to market each quarter.
The Company has granted to Lind a senior security interest in all of the Company’s right, title, and interest in, to and under all of the Company’s property, subject to certain exceptions as set forth in the SPA. The issuance cost related to the first tranche of $
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| Table of Contents |
6. Stockholders’ Equity
Common Stock
During the nine months ended September 30, 2023, the Company issued
As a result of the Lind private placement, the Company reserved up to
Warrants
As of September 30, 2023 and December 31, 2022, warrants issued and outstanding in connection with financing are summarized as below:
|
| September 30, |
|
| December 31, |
| ||
(In number of shares) |
| 2023 |
|
| 2022 |
| ||
Lind Warrant with exercise price of $0.90 |
|
|
|
|
| - |
| |
Public warrant with exercise price of $4.25 |
|
|
|
|
|
| ||
Private warrant with exercise price of $4.675 |
|
|
|
|
|
| ||
Private warrant with exercise price of $1.65 |
|
|
|
|
| - |
| |
Total |
|
|
|
|
|
| ||
As discussed in Note 5, the Company issued the Lind Warrants on September 28, 2023 in connection with the private placement of the Lind Note. The Company further issued
As disclosed in Note 1, the Company issued public warrants together with common stocks in connection with its underwritten public offering effective August 8, 2022. The Company further issued private warrants to Maxim Group LLC, as representative of the underwriter pursuant to an underwriting agreement. Each warrant has a contractual term
The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the instruments’ specific terms and applicable authoritative guidance in ASC 480, Distinguishing Liabilities from Equity (the “ASC480), and ASC 815, Derivatives and Hedging (the “ASC 815”). The assessment considers whether the instruments are free standing financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the instruments meet all of the requirements for equity classification under ASC 815, including whether the instruments are indexed to the Company’s own common shares and whether the instrument holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent period end date while the instruments are outstanding. Management has concluded that the warrants issued in connection with the underwritten public offering and the private placement of Lind Note qualify for equity accounting treatment and are recorded as additional paid-in capital.
In addition, the warrant issued by the Company to i2China in 2020 in exchange for consulting services is accounted for under ASC 718, Compensation – Stock Compensation (see Note 8).
As of September 30, 2023, none of the warrants have been exercised nor have expired.
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7. Revenue
Revenue is recognized upon shipment of products based upon contractually stated pricing at standard payment terms within 30 days. The revenue generated by product sales is recognized at point in time. For the three and nine months ended September 30, 2023 and 2022, the Company generated revenue solely from sales of COVID-19 Antigen Rapid Test Kits in the Taiwan market. There was no revenue recognized from performance obligation satisfied or partially satisfied in prior periods, nor were there any unsatisfied performance obligations related to the sales of COVID-19 Test Kits as of September 30, 2023 and December 31, 2022.
The Company started to manufacture and ship out VELDONA Pet cytoprotein supplements to on-line and off-line distribution channels during the three months ended September 30, 2023. $
8. Share-Based Compensation
2023 Stock Incentive Plan
The Company effectuated an amendment to its 2021 Stock Incentive Plan, now restated as the Company 2023 Stock Incentive Plan (the “2023 SIP” or “Plan”) which includes, among other things, a change in the number of reserved shares under the Plan. Under the 2023 SIP, subject to a change in capital structure or a change in control, the aggregate number of shares which may be issued or transferred pursuant to awards under the Plan will be equal to up to twenty percent (20%) of shares of outstanding common stock of the Company existing as of December 31st of the previous calendar year (the “Plan Share Reserve”). Upon the effectiveness of the 2023 SIP on June 14, 2023, the aggregate number of shares which may be issued pursuant to awards under the Plan is
2021 Stock Incentive Plan
On September 28, 2021, the Company’s board of directors, and on May 16, 2022, its shareholders approved the 2021 Stock Incentive Plan (the “2021 SIP”). During the period from January 1, 2023 up to the date that the prior plan was superseded by the 2023 SIP, no shares were granted under the 2021 SIP.
2021 Employee Stock Purchase Plan
On September 28, 2021, the Company’s board of directors, and on May 16, 2022, its shareholders approved the 2021 Employee Stock Purchase Plan (the “2021 ESPP”). As of September 30, 2023, no shares were issued under the 2021 ESPP.
Restricted Stock Units (“RSUs”)
RSUs entitle the recipient to be paid out an equal number of common stock shares upon vesting. The fair value of RSUs is based on market price of the underlying stock on the date of grant. A summary of the Company’s RSUs activity and related information for the three and nine months ended September 30, 2022 and for the three and nine months ended September 30, 2023 were as follows:
|
| 2023 |
|
| 2022 |
| ||||||||||
|
| Number of Shares |
|
| Weighted-Average Grant Date Fair Value Per Share |
|
| Number of Shares |
|
| Weighted-Average Grant Date Fair Value Per Share |
| ||||
Unvested balance at January 1 |
|
|
|
| $ |
|
|
| - |
|
| $ |
| |||
RSUs granted |
|
| - |
|
| $ |
|
|
| - |
|
| $ |
| ||
RSUs vested |
|
| ( | ) |
| $ |
|
|
| - |
|
| $ |
| ||
RSUs forfeited |
|
| ( | ) |
| $ |
|
|
| - |
|
| $ |
| ||
Unvested balance at March 31 |
|
|
|
| $ |
|
|
| - |
|
| $ |
| |||
RSUs granted |
|
| - |
|
| $ |
|
|
| - |
|
| $ |
| ||
RSUs vested |
| *( | ) |
| $ |
|
|
| - |
|
| $ |
| |||
RSUs forfeited |
|
| ( | ) |
| $ |
|
|
| - |
|
| $ |
| ||
Unvested balance at June 30 |
|
|
|
| $ |
|
|
| - |
|
| $ |
| |||
RSUs granted |
|
| 4,351,000 |
|
| $ |
|
|
| 621,332 |
|
| $ |
| ||
RSUs vested |
|
| - |
|
| $ |
|
| **( | ) |
| $ |
| |||
RSUs forfeited |
|
| ( | ) |
| $ |
|
|
| - |
|
| $ |
| ||
Unvested balance at September 30 |
|
|
|
| $ |
|
|
|
|
| $ |
| ||||
*
**
| 15 |
| Table of Contents |
Stock Options and Warrants
During the three and nine months ended September 30, 2023 and 2022, no shares were granted, forfeited, expired or exercised. As of September 30, 2023, there were
Share-Based Compensation Expense
Shared-based compensation expense for the three and nine months ended September 30, 2023 were $
As of September 30, 2023, the total unrecognized compensation cost related to outstanding RSUs, stock options and warrants was $
9. Income Taxes
The Company did not record a federal, state, or foreign income tax provision or benefit for the three or nine months ended September 30, 2023 and 2022 due to the expected loss before income taxes to be incurred for the years ended December 31, 2023 and 2022, as well as the Company’s continued maintenance of a full valuation allowance against its net deferred tax assets due to its historical deficit.
10. Net Loss per Common Share
The following table sets forth the computation of the basic and diluted net loss per share attributable to common stockholders:
|
| Three Months Ended September 30, |
|
| Nine Months Ended September 30, |
| ||||||||||
|
| 2023 |
|
| 2022 |
|
| 2023 |
|
| 2022 |
| ||||
Net loss attributable to common stockholders, basic and diluted |
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) |
Weighted-average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Net loss per share attributable to common stockholders, basic and diluted |
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) |
| $ | ( | ) |
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| Table of Contents |
The following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding because they would be anti-dilutive:
|
| Three Months Ended September 30, |
|
| Nine Months Ended September 30, |
| ||||||||||
|
| 2023 |
|
| 2022 |
|
| 2023 |
|
| 2022 |
| ||||
Option and RSUs to purchase common stock |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Warrants to purchase common stock |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Convertible notes to purchase common stock |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Total potential shares |
|
|
|
|
|
|
|
|
|
|
|
| ||||
11. Related Party Transactions
The following is a summary of related party transactions that met our disclosure threshold:
Asset Purchase Agreement
Ainos KY and the Company entered into an Asset Purchase Agreement dated as of November 18, 2021 (the “Asset Purchase Agreement”), as modified by an Amended and Restated Asset Purchase Agreement dated as of January 29, 2022 (the “Amended Asset Purchase Agreement”).
Pursuant to the Asset Purchase Agreement, the Company acquired certain intellectual property assets and certain manufacturing, testing, and office equipment for a total purchase price of $
Working Capital Advances
The proceeds of the Chen Note, KY Note and ASE Note (see Note 5) were used for working capital advances. The total interest expense incurred in related to the notes for the three and nine months ended September 30, 2023 were $
Purchase and Sales
Ainos COVID-19 Test Kits Sales and Marketing Agreement with Ainos KY
On June 14, 2021, the Company entered into an exclusive agreement with Ainos KY to serve as the master sales and marketing agent for the Ainos COVID-19 Antigen Rapid Test Kit and COVID-19 Nucleic Acid Test Kit which were developed and manufactured by Taiwan Carbon Nano Technology Corporation (the “TCNT”), a controlling shareholder of Ainos KY (the “Sales and Marketing Agreement”). On June 7, 2021, the Taiwan Food and Drug Administration (the “TFDA”) approved emergency use authorization (the “EUA”) to TCNT for the Ainos COVID-19 Antigen Rapid Test Kit sold and marketed under the “Ainos” brand in Taiwan. On June 21, 2022, the Company began marketing the Ainos SARS-CoV-2 Antigen Rapid Self-Test (together with Ainos COVID-19 Antigen Rapid Test Kit, the “COVID-19 Antigen Rapid Test Kits”) under a separate EUA issued by the TFDA to TCNT on June 13, 2022.
The Company incurred costs associated with manufacturing COVID-19 Antigen Rapid Test Kits by TCNT pursuant to the Sales and Marketing Agreement, totaling nil and $
Manufacturing Service Agreement with TNCT for the VELDONA Pet cytoprotein supplements
On August 28, 2023, the Company entered into a manufacturing service agreement with TCNT, together with another third-party vendor, to manufacture pet supplement products. The Company incurred costs totaling $
As of September 30, 2023 and December 31, 2022, the accounts payable to TCNT were $
| 17 |
| Table of Contents |
COVID-19 Antigen Rapid Test Kits Sales
The Company sold COVID-19 Antigen Rapid Test Kits to affiliates of ASE Test Inc., totaling $
Product Co-development Agreement
Pursuant to a five-year Product Co-development Agreement effective on August 1, 2021 (the “Product Co-Development Agreement”) with TCNT, the development expenses incurred were $
Miscellaneous
On April 26, 2023, the Company issued a total of
The Company engaged Ms. Chien-Hsuan Huang as a medical device development consultant in September 2022 for one year. Ms. Huang is the spouse of one of the members of the board of directors of the Company. The R&D expense was $
12. Commitments and Contingencies
The Company operates in an industry characterized by extensive patent litigation. Competitors may claim that the Company’s products infringe upon their intellectual property. Resolution of patent litigation or other intellectual property claims is typically time consuming and costly and can result in significant damage awards and injunctions that could prevent the manufacture and sale of the affected products or require the Company to make significant royalty payments in order to continue selling the affected products. As of September 30, 2023, there were no such commitments or contingencies.
13. Subsequent Events
On October 11, 2023, the board of directors of the Company approved
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| Table of Contents |
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The unaudited condensed financial statements and this Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2022 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Form 10-K for the period ended December 31, 2022 (the “2022 Annual Report”). In addition to historical information, this discussion and analysis contains 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, or the Exchange Act. These forward-looking statements are subject to risks and uncertainties, including those set forth under “Part I. Item 1A. Risk Factors” in our 2022 Annual Report, “Part II. Item 1A. Risk Factors” in this Quarterly Report, and elsewhere in this Quarterly Report, that could cause actual results to differ materially from historical results or anticipated results.
When used in this Quarterly Report, all references to “Ainos,” the “Company,” “we,” “our” and “us” refer Ainos, Inc.
Overview
Ainos, Inc. (the “Company”, “we” or “us”), incorporated in the State of Texas, is a diversified healthcare company focused on the development of novel point-of-care testing (POCT), therapeutics based on very low-dose interferon alpha (VELDONA), and synthetic RNA-driven preventative medicine. Our products and product candidates include VELDONA clinical-stage human therapeutics, VELDONA Pet cytoprotein supplements, and telehealth-friendly POCTs.
The Company’s POCT platforms are designed to provide rapid and convenient testing of a broad range of health conditions. Building on its extensive research and development on VELDONA, the Company is focused on commercializing a suite of VELDONA-based products including VELDONA Pet cytoprotein supplements and human related VELDONA therapeutics.
In 2021 and 2022, the Company acquired intellectual property from controlling shareholder, Ainos Inc., a Cayman Islands corporation (“Ainos KY”), and continues to expand its product portfolio into POCTs. Pivoting from the sales of COVID-19 POCT, the Company is commercializing POCTs that detect volatile organic compounds (VOC) emitted by the body, powered by the Company’s AI Nose technology platform. The Company’s lead VOCT POCT candidate, Ainos Flora, aims to quickly and easily test female vaginal health and certain common sexually transmitted infections (STIs).
Our Portfolio of Products
Our portfolio of products or product candidates is currently comprised of the following:
| · | COVID-19 Antigen Rapid Test Kit. We currently market and sell COVID-19 antigen rapid test kits in Taiwan under emergency use authorization (“EUA”) issued by the Taiwan Federal and Drug Administration (“TFDA”) for healthcare professional use and for self-test use. We market the test kits under the Ainos brand name. The kit is manufactured by TCNT, our product co-developer. |
|
|
|
| · | VOC POCT – Ainos Flora. Our Ainos Flora device, powered by the Company’s proprietary AI Nose technology (“AI Nose”) is currently under clinical study in Taiwan. The device is intended to perform a non-invasive test for female vaginal health and certain common STIs within a few minutes. A companion app is also being developed that enables users to conveniently manage test results. We believe Ainos Flora provides connected, convenient, discreet, rapid testing in a point-of-care setting. |
|
|
|
| · | VOC POCT – Ainos Pen. Our Ainos Pen device is designed to be a cloud-connected, multi-purpose, portable breath analyzer that is intended to monitor health conditions within minutes, powered by AI Nose. We expect consumers to be empowered to share their test results with their physicians through in-person and telehealth medical consultations. |
|
|
|
| · | VOC POCT – CHS430. The CHS430 device, powered by AI Nose, is intended to provide non-invasive testing for ventilator-associated pneumonia within few minutes, as compared to current standard of care invasive culture tests that typically take more than two days to provide results. We plan to be the exclusive sales agent for CHS430, pursuant to our Product Co-Development Agreement with our co-developer, TCNT, who will manufacture the product. |
|
|
|
| · | Very Low-Dose Oral Interferon Alpha (“VELDONA”). VELDONA is a low-dose oral interferon alpha (“IFN-α”) formulation based on nearly four decades of the Company’s research on IFN-α’s broad treatment applications. Our pipeline candidates under development for human indications include thrombocytopenia, Sjögren’s syndrome, aphthous stomatitis, chemotherapy-induced stomatitis, common cold, oral warts for human immunodeficiency virus (HIV) seropositive patients, influenza, and oral treatment for COVID-19. The United States Food and Drug Administration (the “U.S. FDA”) have granted Orphan Drug Designation (“ODD”) for the Company’s VELDONA formulation as a potential treatment for oral warts in HIV-seropositive patients. We intend to explore various business opportunities, including out-licensing, to advance these indications.
VELDONA Pet. Leveraging our VELDONA technology, we have launched five VELDONA Pet cytoprotein health supplements for pet dogs and cats. Our VELDONA Pet product line is formulated to address a variety of health issues in dogs and cats, including skin, gum, emotion, discomfort caused by allergies, eye, and weight-related issues. We are currently marketing in Taiwan and plan to develop sales and marketing opportunities in other Asian regions and the U.S.A. |
|
|
|
| · | Synthetic RNA (“SRNA”). We are developing a SRNA technology platform in Taiwan with a long-term goal of developing next-generation precision treatments and rapid tests. |
| 19 |
| Table of Contents |
An integral part of our operating strategy is to create multiple revenue streams through commercializing our product portfolio and leveraging our intellectual property patents. Our recent launch of VELDONA Pet, a series of health supplements for pet dogs and cats based on VELDONA formulation, is our latest effort to execute the diversification strategy.
In the near-term, we are prioritizing sales and marketing of VELDONA Pet, commercializing our lead VOC POCT candidate, Ainos Flora, and pursuing out-licensing of our VELDONA human drug candidates. We are currently marketing VELDONA Pet in Taiwan and intend to explore commercial opportunities in other Asian regions and the U.S.A. We have contracted with Topmed International Biotech Co. to market VELDONA Pet in Taiwan in certain offline channels. Our customers have shared insights into the shopping habits of Taiwanese pet owners, and we have aligned our strategies accordingly. We have begun selling VELDONA Pet on certain Taiwanese e-commerce platforms. Offline, we are expanding opportunities in channels such as pet supply stores, chain drugstores and convenience stores. We have introduced new packaging for VELDONA Pet, making it more convenient for consumers to “grab and go” from their nearest stores. To meet anticipated demand, we plan to expand capacity with our contract manufacturers.
As of September 30, 2023, we had available cash and cash equivalents of $2,370,963. We anticipate business revenues and further potential financial support from external sources to fund our operations over the next twelve months. We have based this estimate on assumptions that may prove to be incorrect, and we could exhaust our available capital resources sooner than we expect. See “Liquidity and Capital Resources” for additional information. To finance our continuing operations, we will need to raise additional capital, which cannot be assured.
Substantially all of our operating revenue has come from the sale of COVID-19 test kits in Taiwan under emergency use authorization. Going forward, we expect to generate sales revenue from VELDONA Pet, at least in the near-term.
We believe that post COVID-19, consumers have become increasingly familiar with at-home tests. Moving forward, people may seek additional at-home tests to manage other infections as quickly as possible. Home self-testing have become increasingly available for other infections such as vaginal infections or STIs. We believe this new user behavior, supported by a variety of telehealth platforms, will facilitate consumer adoption of our other POCT product candidates.
Results of Operations for Quarter Ended September 30, 2023 (“Q3 2023”) and September 30, 2022 (“Q3 2022”):
|
| Three months ended September 30, |
|
| Change |
| ||||||||||
|
| 2023 |
|
| 2022 |
|
| Amount |
|
| % |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Revenues |
| $ | 24,489 |
|
| $ | 1,757,774 |
|
| $ | (1,733,285 | ) |
| (99 | %) | |
Cost of revenues |
|
| (87,873 | ) |
|
| (1,176,032 | ) |
|
| 1,088,159 |
|
| (93 | %) | |
Gross (loss) profit |
|
| (63,384 | ) |
|
| 581,742 |
|
|
| (645,126 | ) |
| (111 | %) | |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Research and development expenses |
|
| 1,710,265 |
|
|
| 1,834,786 |
|
|
| (124,521 | ) |
| (7 | %) | |
Selling, general and administrative expenses |
|
| 902,017 |
|
|
| 6,569,227 |
|
|
| (5,667,210 | ) |
| (86 | %) | |
Total operating expenses |
|
| 2,612,282 |
|
|
| 8,404,013 |
|
|
| (5,791,731 | ) |
| (69 | %) | |
Loss from operations |
|
| (2,675,666 | ) |
|
| (7,822,271 | ) |
|
| 5,146,605 |
|
| (66 | %) | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Non-operating (expenses) income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Interest expense |
|
| (44,267 | ) |
|
| (9,821 | ) |
|
| (34,446 | ) |
|
| 351 | % |
Other income, net |
|
| 5,054 |
|
|
| 10,336 |
|
|
| (5,282 | ) |
| (51 | %) | |
Issuance cost of convertible note measured at fair value |
|
| (260,967 | ) |
|
| - |
|
|
| (260,967 | ) |
|
| - |
|
Total non-operating (expenses) income, net |
|
| (300,180 | ) |
|
| 515 |
|
|
| (300,695 | ) |
| (584 | %) | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before income taxes |
|
| (2,975,846 | ) |
|
| (7,821,756 | ) |
|
| 4,845,910 |
|
| (62 | %) | |
Provision for income taxes |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
Net loss |
| $ | (2,975,846 | ) |
| $ | (7,821,756 | ) |
| $ | 4,845,910 |
|
| (62 | %) | |
| 20 |
| Table of Contents |
Revenues, Cost and Gross Profit (Loss)
The Company reported $24,489, and $1,757,774 in revenue in Q3 2023 and Q3 2022, respectively, from product sales of Ainos COVID-19 Antigen Rapid Test Kits in Taiwan. The decrease of revenue in Q3 2023 reflected a slowdown of COVID-19 infection in Taiwan which resulted in a decrease in selling price and sales volume.
The cost of revenue related to product sales in Q3 2023 was $87,873 compared to $1,176,032 in Q3 2022. The decrease in cost of revenue was due to a decrease in sales volume but offset by an increase in inventory loss.
Gross (loss) profit from product sales in Q3 2023 was $(63,384) as compared to $581,742 in Q3 2022. The gross loss was due to a decrease in sales volume and selling price as well as recognition of inventory loss in Q3 2023.
Research and Development (R&D) Expenses
R&D expenses in Q3 2023 and Q3 2022 were $1,710,265 and $1,834,786, respectively. The decrease of $124,521 (7%) was due to decreased expenses associated with clinical trial fees and professional expenses, which were offset by an increase in staffing expenditures (including share-based compensation). We expect that our R&D expenses related to clinical trials will continue to grow as we further develop VOC POCT and VELDONA drug candidates and increase the pace of clinical trials previously delayed during the COVID-19 pandemic.
The share-based compensation expense and the depreciation and amortization expense in Q3 2023 and Q3 2022 were $1,263,665 and $1,206,419, respectively. When excluding these non-cash expenses, R&D expenses slightly decreased to $446,600 in Q3 2023 from $628,367 in Q3 2022 due to limitations on recruiting patients for clinical trials for VOC POCT and human related VELDONA drug candidates.
Selling, General and Administrative (SG&A) Expenses
SG&A expenses were $902,017 and $6,569,227 in Q3 2023 and Q3 2022, respectively, reflecting a decrease of $5,667,210 (86%) due to a significant decrease in share-based compensation for which the Company granted fully vested RSUs to officers and the total amount of compensation expense was fully recognized in Q3 2022. RSUs granted to officers and employees of the Company require a service period of 3 years and therefore, the total amount of the compensation expense was amortized over the service period.
The share-based compensation expense and the depreciation and amortization expense in Q3 2023 and Q3 2022 were $269,934 and $6,079,389, respectively. When excluding these non-cash expenses, SG&A expenses slightly increased to $632,083 in Q3 2023 compared to $489,838 in Q3 2022.
Operating Loss
The Company’s operating loss was $2,675,666 and $7,822,271 in Q3 2023 and Q3 2022, respectively, reflecting a $5,146,605 (66%) decrease in operating loss between the reporting periods. We incurred a gross loss in product sales. We continued to invest resources to execute our growth strategy and product roadmap to improve our profitability.
Interest Expense and Issuance Cost of Convertible Note
In Q3 2023, interest expense was $44,267 compared to $9,821 in Q3 2022. The increase in interest expense was due to accrued interest for convertible notes issued in March 2023 bearing a higher interest rate compared to 2022.
On September 28, 2023, the Company closed the Lind Note transaction and incurred an issuance cost including investor and placement agent fees, as well as legal fees. $260,967 of the issuance cost was expensed for the first tranche of funding received and closed by the Company.
Net Loss
Net loss was $2,975,846 in Q3 2023 compared to $7,821,756 in Q3 2022, resulting in a $4,845,910 (62%) decrease in net loss attributable to our shareholders of common stock. The net loss was due to a gross loss in product sales post COVID-19 pandemic.
| 21 |
| Table of Contents |
Results of Operations for the Nine Months Ended September 30, 2023 (“first nine months of 2023”) and September 30, 2022 (“first nine months of 2022”):
|
| Nine months ended September 30, |
|
| Change |
| ||||||||||
|
| 2023 |
|
| 2022 |
|
| Amount |
|
| % |
| ||||
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Revenues |
| $ | 102,208 |
|
| $ | 2,481,602 |
|
| $ | (2,379,394 | ) |
| (96 | %) | |
Cost of revenues |
|
| (244,538 | ) |
|
| (1,536,074 | ) |
|
| 1,291,536 |
|
| (84 | %) | |
Gross (loss) profit |
|
| (142,330 | ) |
|
| 945,528 |
|
|
| (1,087,858 | ) |
| (115 | %) | |
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
Research and development expenses |
|
| 5,080,335 |
|
|
| 5,047,096 |
|
|
| 33,239 |
|
|
| 1 | % |
Selling, general and administrative expenses |
|
| 2,282,631 |
|
|
| 7,748,060 |
|
|
| (5,465,429 | ) |
| (71 | %) | |
Total operating expenses |
|
| 7,362,966 |
|
|
| 12,795,156 |
|
|
| (5,432,190 | ) |
| (42 | %) | |
Loss from operations |
|
| (7,505,296 | ) |
|
| (11,849,628 | ) |
|
| 4,344,332 |
|
| (37 | %) | |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-operating (expenses) income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
| (93,852 | ) |
|
| (45,304 | ) |
|
| (48,548 | ) |
|
| 107 | % |
Other income, net |
|
| 14,067 |
|
|
| 19,250 |
|
|
| (5,183 | ) |
| (27 | %) | |
Issuance cost of convertible note measured at fair value |
|
| (260,967 | ) |
|
| - |
|
|
| (260,967 | ) |
|
| - |
|
Total non-operating (expenses) income, net |
|
| (340,752 | ) |
|
| (26,054 | ) |
|
| (314,698 | ) |
|
| 1,208 | % |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before income taxes |
|
| (7,846,048 | ) |
|
| (11,875,682 | ) |
|
| 4,029,634 |
|
| (34 | %) | |
Provision for income taxes |
|
| - |
|
|
| - |
|
|
| - |
|
|
| - |
|
Net loss |
| $ | (7,846,048 | ) |
| $ | (11,875,682 | ) |
| $ | 4,029,634 |
|
| (34 | %) | |
Revenues, Cost and Gross Profit (Loss)
The Company reported $102,208 of revenues for the nine months ended September 30, 2023, as compared to $2,481,602 for the nine months ended September 30, 2022 from product sales of Ainos COVID-19 Antigen Rapid Test Kits in Taiwan. The decrease of revenue in first nine months of 2023 reflected a slowdown of COVID-19 infection in Taiwan resulting in a decrease in selling price and sales volume.
The cost of revenue relating to product sales for the nine months ended September 30, 2023 was $244,538 compared to $1,536,074 for the nine months ended September 30, 2022. The decrease of cost of revenue was due to a decrease in sales volume but offset by an increase of approximately $120,931 in inventory loss and approximately $23,143 in idle manufacturing capacity.
Gross (loss) profit from product sales for the nine months ended September 30, 2023 was $(142,330) as compared to $945,528 for the nine months ended September 30, 2022. The gross loss was due to a decrease in sales volume and selling price as well as recognition of inventory loss and idle capacity cost in first nine months of 2023.
Research and Development (R&D) Expenses
R&D expenses for the nine months ended September 30, 2023 and 2022 were $5,080,335 and $5,047,096, respectively. The slight increase $33,239 (1%) was due to increased expenses associated with the consumption of R&D material and staffing expenditures (including share-based compensation), but offset by a decrease in clinical trial fees. We expect that our R&D expenses related to clinical trials will continue to grow as we further develop VOC POCT and VELDONA drug candidates and increase the pace of clinical trials previously delayed during the COVID-19 pandemic.
The share-based compensation expense and the depreciation and amortization expense during the first nine months of 2023 and the first nine months of 2022 were $3,669,081 and $3,498,385, respectively. When excluding these non-cash expenses, R&D expenses slightly decreased to $1,411,254 during the first nine months of 2023 from $1,548,711 during the first nine months of 2022 due to a decrease in clinical trial fees due to delays caused by the COVID-19 pandemic.
| 22 |
| Table of Contents |
Selling, General and Administrative (SG&A) Expenses
SG&A expenses were $2,282,631 and $7,748,060 for the nine months ended September 30, 2023 and 2022, respectively. The $5,465,429 (71%) decrease was largely due to decreased expenses associated with share-based compensation as the Company granted RSUs that were immediately vested to officers in the third quarter of 2022 and fully recorded the total compensation expense in the same period.
When excluding share-based compensation, depreciation and amortization expenses, SG&A expenses slightly increased to $1,685,202 during the first nine months of 2023 compared to $1,523,223 during the first nine months of 2022 mainly due to increased expenditures to maintain the listing requirement as a public company after uplisting in August 2022.
Operating Loss
The Company’s operating loss was $7,505,296 and $11,849,628 during the first nine months of 2023 and the first nine months of 2022, respectively, reflecting a $4,344,332 (37%) decrease in operating losses between the reporting periods. We incurred a gross loss in product sales. We continued to invest resources to execute our growth strategy and product roadmap to improve our profitability.
Interest Expense and Issuance Cost of Convertible Note
During the first nine months of 2023, interest expense was $93,852 compared to $45,304 during the first nine months of 2022. The increase in interest expense was due to accrued interest for convertible notes issued in March 2023 offset by a decrease of interest expense as a result of settlement of convertible notes during the first nine months of 2023.
On September 28, 2023, the Company closed the Lind Note transaction and incurred an issuance cost including investor and placement agent fees, as well as legal fees. $260,967 of the issuance cost was expensed for the first tranche of funding received and closed by the Company.
Net Loss
Net loss was $7,846,048 during the first nine months of 2023 compared to $11,875,682 during the first nine months of 2022, resulting in a $4,029,634 (34%) decrease in net loss attributable to our shareholders of common stock. The net loss was due to the gross loss in product sales post COVID-19 pandemic, concurrent with the launch of our VELDONA Pet supplements.
Liquidity and Capital Resources
As of September 30, 2023 and December 31, 2022, the Company had available cash of $2,370,963 and $1,853,362, respectively.
The following table summarizes our cash flow during the nine months period ended September 30, 2023 and 2022:
|
| Nine months ended September 30, |
| |||||
|
| 2023 |
|
| 2022 |
| ||
Net cash used in operating activities |
|
| (3,321,754 | ) |
|
| (2,420,637 | ) |
Net cash used in investing activities |
|
| (117,528 | ) |
|
| (665,079 | ) |
Net cash provided by financing activities |
|
| 4,023,974 |
|
|
| 3,850,799 |
|
Operating activities:
Cash used in operating activities increased by $901,117 during the first nine months of 2023 compared to the first nine months of 2022. Our net loss for the first nine months of 2023 decreased by $4,029,634 primarily due to a gross loss from COVID-19 antigen test kit sales as a result of slow-down of COVID-19 infection in Taiwan. The operating cash outflow as a result of changes in operating assets and liabilities was mainly attributable to:
| · | No cash out expenses including share-based compensation, depreciation and amortization, and loss on inventory write-downs decreased approximately by $5,313,000; |
| · | Working capital injected into accounts receivable, inventories and other current assets increased by approximately $992,000; and |
| · | Working capital injected into accrued expenses, operating lease liabilities, contract liabilities and other current and long-term liabilities decreased by approximately $870,000. |
| 23 |
| Table of Contents |
Investing activities
Cash used for investing activities during the first nine months of 2023 was $117,528 compared to $665,079 during the first nine months of 2022 due to lower levels of R&D equipment and office facility acquisition as major investments had been made in 2022.
Financing activities
Cash received from financing activities were $4,023,974 and $3,850,799 during the first nine months of 2023 and the first nine months of 2022, respectively. The $173,175 increase was primarily reflected by the following:
| · | Repayment of convertible notes and other notes payable increased $556,621; |
| · | Proceeds from convertible notes and other notes payable financing increased by $2,510,000; and |
| · | Proceeds from uplisting decreased by $1,780,204. |
As disclosed in Note 5 (Convertible Notes Payable and Other Notes Payable) to our accompanying condensed financial statements we received $3 million in proceeds from the March 2025 convertible note financing and $2 million in proceeds from the Lind Note transaction in September 2023. Meanwhile, we made partial cash payment of the KY Note and Chen Note during the first nine months of 2023.
In the near-term, we expect an increase in the pace of clinical trial spending to advance our VOC POCT and VELDONA drug candidates and expect to invest more in R&D activities. We also plan to allocate sales and marketing efforts for VELDONA Pet.
The Company anticipates that cash reserves, business revenues, and potential debt financing through convertible and non-convertible notes will fund the Company’s operations over the next twelve months. There can be no assurance that we will be successful in our efforts to make the Company profitable. If those efforts are not successful, the Company may raise additional capital through the issuance of equity securities, debt financings or other sources to further implement its business plan. However, if such financing is not available when needed and at adequate levels, the Company will need to reevaluate its operating plan.
Critical Accounting Policies and Significant Management Estimates
Our management’s discussion and analysis of our financial condition and results of operations are based on our unaudited condensed financial statements, which have been prepared in accordance with the accounting principles generally accepted in the United States, or U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, and expenses.
We evaluate our estimates and judgments, including those related to inventory valuation, useful lives of property and equipment, valuation of stock option, warrants and convertible note, and impairment testing of intangible assets, on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
There have been no material changes to our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis - Critical Accounting Policies and Significant Management Estimates” of our 2022 Annual Report, except for those accounting subjects discussed in the Notes, if any, to the unaudited condensed financial statements included in this Quarterly Report on Form 10-Q.
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined in Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise required under this Item 3.
ITEM 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, have evaluated our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on the evaluation of our disclosure controls and procedures, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of September 30, 2023.
Changes in Internal Control over Financial Reporting
There were no changes in our internal controls over financial reporting during the period covered by this Quarterly Report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
| 24 |
| Table of Contents |
PART II - OTHER INFORMATION
ITEM 1. Legal Proceedings
From time to time, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. As of the date of this report, we were not aware of any material legal proceedings involving the Company.
ITEM 1A. Risk Factors
This Quarterly Report contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed in this Quarterly Report. Factors that could cause or contribute to these differences include, but are not limited to, those discussed below and elsewhere in this Quarterly Report.
You should carefully consider the risk factors disclosed in our 2022 Annual Report, together with all other information in this Quarterly Report, including our unaudited condensed financial statements and notes thereto, and in our other filings with the Securities and Exchange Commission. If any such risks, including the risk set out below, or other risks not presently known to us or that we currently believe to not be significant, develop into actual events, then our business, financial condition, results of operations or prospects could be materially adversely affected. If that happens, the market price of our common stock could decline, and stockholders may lose all or part of their investment.
Information on risk factors can be found in Part I, Item 1A (Risk Factors) of our 2022 Annual Report. There have been no material changes from the risk factors previously disclosed in our 2022 Annual Report, other than the risk factor set forth below.
All of our assets, subject to certain exceptions, have been pledged as security for the Lind Note and if we default on our obligations, we may suffer adverse consequences, including foreclosure on our assets.
In connection with the Lind Note transaction we signed a security agreement whereby all of our assets, subject to certain exceptions, have been pledged as collateral to secure our obligations thereunder. If we default on our obligations, Lind may have the right to foreclose upon and sell, or otherwise transfer, the collateral subject to their security interests or their superior claim. In such event, we may be forced to sell our investments or take other actions to raise funds to repay our outstanding obligations in order to avoid foreclosure and these could significantly impair our ability to effectively operate our business in the manner in which we intend to operate. As a result, we could be forced to curtail or cease clinical trials or commercialization of products.
ITEM 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities
Recent Sales of Unregistered Equity Securities
None in this quarter.
Issuer Purchase of Equity Securities
Not applicable.
Use of Proceeds of Registered Securities
Not applicable.
ITEM 3. Defaults Upon Senior Securities
None
ITEM 4. Mine Safety Disclosures
Not applicable
ITEM 5. Other Information
None
| 25 |
| Table of Contents |
ITEM 6. Exhibits
EXHIBIT INDEX
|
|
|
| INCORPORATED BY REFERENCE | ||||||||
EXHIBIT NUMBER |
| DESCRIPTION |
| FILED WITH THIS FORM 10-Q |
| FILING DATE WITH SEC |
| FORM |
| EXH # |
| HYPERLINK TO FILINGS |
|
|
|
|
|
| |||||||
| Restated Certificate of Formation of the Company, dated April 15, 2021 |
|
| 4/21/2021 |
| 8-K |
| 3.1 |
| Restated Certificate of Formation of the Company, dated April 15, 2021 | ||
| Certificate of Amendment to the Restated Certificate of Formation, dated August 8, 2022 |
|
| 8/12/2022 |
| 8-K |
| 3.1 |
| Certificate of Amendment, dated August 8 2022 | ||
| Amended and Restated Bylaws of the Company, effective September 28, 2022 |
|
| 10/4/2022 |
| 8-K |
| 3.2 |
| Amended and Restated Bylaws, effective September 28, 2022 | ||
|
|
| 4/3/2023 |
| 10-K |
| 4.1 |
| Form of Common Stock Certificate | |||
|
|
| 8/2/2022 |
| S-1/A |
| 4.1 |
| Form of Warrant | |||
|
|
| 8/2/2022 |
| S-1/A |
| 4.3 |
| Form of Warrant Agency Agreement | |||
| Form of Placement Agent Warrant with Maxim Partners LLC/Brookline |
|
|
| 9/29/2023 |
| 8-K |
| 4.1 |
| Maxim Partners LLC/Brookline Placement Agent Warrant | |
|
|
|
| 9/29/2023 |
| 8-K |
| 4.2 |
| Lind Global Fund II Convertible Note | ||
|
|
|
| 9/29/2023 |
| 8-K |
| 4.3 |
| Lind Global Fund II LP Common Stock Purchase Warrant | ||
| Ainos NISD Inabata Codevelopment Agreement - August 9, 2023, Appendix 1 and 2 redacted |
| x |
| 8/9/2023 |
| 8-K |
| 10.1 |
|
| |
| Ainos KY Promissory Note Extension Agreement - August 17, 2023 |
|
|
| 8/22/2023 |
| 8-K |
| 10.2 |
| Ainos KY Agreement | |
| Promissory Note Extension Agreement with I2 China - August 17, 2023 |
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| 8/22/2023 |
| 8-K |
| 99.1 |
| Promissory Note Agreement i2China | |
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| 9/29/2023 |
| 8-K |
| 10.1 |
| Lind Global Fund II LP Financing | ||
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| 9/29/2023 |
| 8-K |
| 10.2 |
| Lind Global Fund II LP SPA | ||
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| 9/29/2023 |
| 8-K |
| 10.3 |
| Maxim Partners Placement Agency Agreement | ||
| Certification of Chief Executive Officer Pursuant to Rule 13a- 14(a) / 15d – 14(a) |
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| Certification of Chief Financial Officer Pursuant to Rule 13a- 14(a) / 15d – 14(a) |
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100 |
| XBRL – Related Documents |
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101.INS |
| XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the XBRL document. |
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101.SCH |
| XBRL Taxonomy Extension Schema Document |
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101.CAL |
| XBRL Taxonomy Extension Calculation Linkbase |
| x |
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101.DEF |
| XBRL Taxonomy Extension Definition Linkbase |
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101.LAB |
| XBRL Taxonomy Extension Label Linkbase |
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101.PRE |
| XBRL Taxonomy Extension Presentation Linkbase |
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104.1 |
| Cover Page Interactive Data File |
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The exhibits listed in the Exhibit Index are filed or incorporated by reference as part of this filing.
| 26 |
| Table of Contents |
SIGNATURES
Pursuant to the requirements of Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| AINOS, INC. |
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Date: November 9, 2023 | By: | /s/ Chun-Hsien Tsai |
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| Chun-Hsien Tsai, Chairman of the Board, President, and Chief Executive Officer |
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Date: November 9, 2023 | By: | /s/ Meng-Lin Sung |
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| Meng-Lin Sung, Chief Financial Officer |
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| 27 |
EXHIBIT 10.1
APPENDIX I AND II HAVE BEEN REDACTED FROM THIS AGREEMENT PURSUANT TO
SEC REGULATION S-K ITEM 601(b) BECAUSE THEY ARE BOTH (I) NOT MATERIAL AND (II)
THE TYPE OF INFORMATION THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL
CO-DEVELOPMENT AGREEMENT
This co-development agreement (this “Agreement”) is made and entered into as of August 9, 2023 (the “Effective Date”), in Taiwan, by and between Nisshinbo Micro Devices Inc., having an office at 3-10, Nihonbashi Yokoyama-cho, Chuo-ku, Tokyo 103-8456, Japan (“NISD”), Ainos, Inc. having an office at 8880 Rio San Diego Drive Suite 800 San Diego, CA 92108 U.S.A. (“Ainos”) and Taiwan Inabata Sangyo Co., Ltd., having an office at 178, 2F, Sec. 2, Gongdao Wu Rd., Hsinchu City 300, Taiwan (R.O.C.) (“Inabata”), with respect to the transaction that NISD outsources the Development (as defined below) to Ainos. NISD, Ainos and Inabata are referred to individually as a “Party” and collectively as the “Parties”.
RECITALS
The Parties share a vision of building the future of volatile organic compound (VOC) sensing in applications including but not limited to telehealth, automotives, industrials, and environmental safety;
The Parties fully commit to enable the shared vision by codeveloping technologies and leveraging Ainos’s artificial intelligence (AI) algorithm and digital nose technologies built with over 50 active and pending patents, 10 years of R&D in digital nose sensing, and deep-learning algorithm and cloud-based big data analysis
1. Definition
1.1. “Development” means as described in the Appendix.
1.2. “Deliverables” means as described in the Appendix I.
1.3. “Industrial Property Right” means the intellectual property right, including patent right, utility model right, design right and other industrial property right, for which filing system is prepared by the law of applicable country, including a right to obtain the industrial property right.
1.4. “Invention” means the invention, idea, creation or other which may be filed as Industrial Property Right.
1.5. “Background Technology” means the intellectual property including, but not limited to, Invention, copyright of software, and know-how, which is owned by Ainos on the Effective Date and will be used for performance of the Development.
2. Development
2.1. NISD outsources the Development and Ainos undertakes the Development.
2.2. Ainos shall perform the Development with due care of prudent manager.
2.3. NISD may instruct the standards for the performance of Development if it deems necessary, and Ainos shall comply with such standards to the extent commercially reasonable.
2.4. Ainos shall periodically, or upon a request of NISD, report the progress of the Development and the Parties shall cooperate to arrange the progress.
2.5. Ainos shall not subcontract the Development to a third party without the prior written approval of NISD. In case where Ainos subcontracts part of the Development to the third party after obtaining the approval of NISD, Ainos shall impose the obligations equivalent to those herein on such third party in advance.
2.6. Ainos shall not use the intellectual property rights of a third party, including but not limited to open source software, in the Deliverables without the prior written approval of NISD.
2.7. Inabata shall support delivery of the Deliverables and payment therefor as well as communication between NISD and Ainos.
3. Delivery
3.1. Ainos shall deliver the Deliverables in accordance with the terms described in the Appendix I such as the delivery date, place, etc.
3.2. If Ainos recognizes the possibility of delay of delivery, Ainos shall notify NISD of the reason and rescheduled date, and comply with the instruction of NISD.
3.3. The risk of loss or damage of the Deliverables shall be transferred to NISD at the time delivered to the delivery place unless the cause of loss or damage is attributable to Ainos.
4. Inspection
4.1 NISD shall inspect the Deliverables for acceptance upon the delivery subject to the preceding section within term described in the Appendix I and acceptance of the Deliverables will be completed upon passing the inspection. If any notification is not provided to Ainos during the aforementioned period, the Deliverables shall be deemed as passing the inspection.
4.2. In the case where non-conformance is discovered in the Deliverables, NISD may request to take necessary measures such as removal of non-conformance. In such case, Ainos shall, at its cost and expense, perform such necessary measures by the date specified by NISD.
4.3. After necessary measures are performed for the non-conforming Deliverables pursuant to the preceding subsection, NISD shall re-inspect the Deliverables subject to the subsection 4.1 and acceptance of such Deliverables will be completed upon passing the re-inspection.
4.4. The title to the Deliverables shall pass to NISD at the time the acceptance is completed pursuant to the subsection 4.1 or 4.3.
5. Payment
NISD shall pay the amount described in the Appendix I to Ainos in consideration of all of works under this Agreement (performance of the Development, title to the Deliverables and copyrights, and license of the Background Technology).
6. Lent Item
6.1. NISD may lend the item (the “Lent Item”) to Ainos, if NISD deems it necessary to perform the Development. The terms of lending, including whether with charge or not, shall be determined by consultation between the NISD and Ainos in good faith.
6.2. Ainos shall use reasonable efforts to keep the Lent Item in good custody. Ainos shall not use the Lent Items for the purpose other than those specified by NISD, and disclose, reproduce, modify, disassemble, analysis, reverse-engineer, assign, relend, license or otherwise dispose the Lent Items without the approval of NISD.
6.3. Upon the request of NISD, or the termination of this Agreement, Ainos shall, at its costs and expenses, return or dispose the Lent Items (including their reproductions) following the instruction of NISD.
7. Propriety of Rights
7.1. The ownership of the Invention made by the employee of Ainos with respect to the Deliverables in the course of the Development and the Industrial Property Right based on such Invention shall be assigned as follows:
(a) In case developed based on or with reference to the document, technical instruction or advice or other information provided by NISD, the NISD and Ainos will share the ownership in proportion of contribution to such Invention; or
(b) Otherwise, Ainos will retain the ownership independently, provided that Ainos shall not claim any additional royalty fee for the Deliverables (including mass-produced products).
7.2 Notwithstanding the foregoing, the data that NISD would obtain with using of the Deliverables and the processed data of them shall be shared between NISD and Ainos.
7.3 Ainos shall not sell the products incorporating the algorithm developed for the Development or substantially the same as that to a third party.
8. License of Background Technology
8.1. Notwithstanding the provision of the subsection 7.1, the Background Technology and the intellectual property rights thereof shall be withheld by Ainos.
8.2. Ainos shall grant to NISD the non-exclusive, non-transferable, perpetual and irrevocable rights to use the Background Technology for manufacture (including have manufactured) and sale of its products incorporating components deriving from the Deliverable subject to payment of the royalty as described in the Appendix I.
8.3. If Ainos corrects the problem in the Background Technology, Ainos shall provide NISD with such correction.
9. Warranty
9.1. In case that the latent non-conformance is discovered in the Deliverables within one (1) year after the acceptance of the Deliverables, Ainos shall promptly undertake, at its own costs, the removal of non-conformance, burden of the expense for removal by NISD or other necessary measures subject to the instruction of NISD, unless such non-conformance arises out of the causes of NISD.
9.2. Where the third party incurs damage in connection with the Deliverables, and the cause of such damage is suspected of arising out of the non-conformance of Deliverable, Ainos shall cooperate for the investigation into the cause and negotiate burden of indemnification and other matters with good faith.
9.3. Where the non-conformance in the Deliverables attributable to Ainos causes the third party to incur the damage, Ainos shall compensate such damage. In such case, Ainos may offer to NISD the consultation for scope of damage derived from the non-conformance and amount of compensation.
9.4. Where a claim is brought or a dispute arises for the Deliverables as infringing the intellectual property rights of the third party, Ainos shall resolve it at its cost and responsibility, and indemnify the damages incurred by NISD, its customer and other relevant entity or person, unless such infringement directly caused by:
(a) Lent Item or material provided or design or specification designated by NISD;
(b) modification or addition to the Deliverables by NISD;
(c) combination of the Deliverables with other components;
(d) use of the Deliverables for the purpose other than usually intended.
10. Confidentiality
10.1. The Parties shall strictly keep the confidential information, which is technological information and business secret of the other party learnt in course of the Development and relevant consultation, including the data obtained with using of the Deliverables and the fact of execution of this Agreement, in confidential and shall not disclose or divulge to the third party or use for the purpose other than to subject of this Agreement. The obligation under this section shall be imposed to its officers and employees.
10.2. The provision in this section shall not be applied to the information that,
(a) is known at the time of receipt;
(b) is or becomes known to the public through no fault of the receiving Party;
(c) is hereafter received from a third party having the right to disclose it without an obligation of confidentiality;
(d) is developed by the receiving Party independently of the technological information or business secret of the disclosing Party; or
(e) is required to be disclosed under the applicable laws, regulations, rulings or orders of regulatory agency (including stock exchange).
11. Termination
11.1. This Agreement shall be automatically terminated without notice to the Party if any of the following events occurs to such Party:
(a) Failure to cure the breach of this Agreement within ten (30) days or such longer period to be designated by the other Party after receiving a written notice from the other Party requesting to cure the breach;
(b) General assignment by the Party for the benefit of creditors;
(c) Insolvency of the party; or,
(d) Institution of voluntary or involuntary proceedings by or against the Party in bankruptcy or under insolvency laws, or for corporate reorganization, or for a receivership, or for the dissolution of the Party.
11.2 The termination based on the preceding subsection shall not be detrimental to the rights of the terminating Party to demand compensations from the other Party for the damages caused by the termination or the aforementioned causes for termination.
12. Term
12.1. This Agreement shall become effective on the Effective Date and expire end of Development term described in the Appendix I or completion of payment whichever comes later, provided that the Parties may extend such term upon written agreement.
12.2. The provisions of sections from 7 to 10 and 13 shall survive any expiration or termination of this Agreement.
13. Miscellaneous
13.1. The Parties shall not assign, succeed or pledge the rights or obligations arising out of this Agreement, in whole or in part, unless obtaining prior written approval of the other Party.
13.2. The Parties shall comply with the applicable export regulations in any country and the Export Control Regulation of U.S.A, if applicable. If requested by the other Party to report or submit the documents necessary to examine whether transferable or not, the Party shall promptly report or submit such documents.
13.3. This Agreement shall be governed by, and interpreted in accordance with, the laws of Japan, without regard to the choice of laws provisions thereof.
13.4. All disputes or disagreements arising between the parties out of or in connection with this Agreement shall be settled in arbitration under the rules of International Chamber of Commerce. The place of arbitration shall be Tokyo, Japan, if initiated by Ainos, or California, U.S.A., if initiated by NISD. The determination of the arbitrator shall be final and binding upon the parties and shall be enforceable by any court of competent jurisdiction.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their authorized representatives on the date first above written.
| Nisshinbo Micro Devices Inc.
By:________________________________
Name: Kazuaki Komiyama
Title: Executive Managing Officer | Ainos, Inc.
By:_________________________________
Name: Tsai, Chun Hsien
Title: Chairman & CEO |
| Taiwan Inabata Sangyo Co., Ltd.
By:_________________________________
Name: Tung, Cheng Chung
Title: Chairman & CEO |
Appendix I
[REDACTED]
Appendix II
[REDACTED]
EXHIBIT 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO RULE 13A- 14(A) / 15D – 14(A)
UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES OXLEY ACT OF 2002
I, Chun-Hsien Tsai, certify that:
| 1. | I have reviewed this report on Form 10-Q of Ainos, Inc.; |
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| 2. | Based on my knowledge, this report does not contain any untrue statement of material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the periods covered by this report; |
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| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
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| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
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| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
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| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
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| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
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| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
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| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize, and report financial information; and |
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| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: November 9, 2023 | /s/ Chun-Hsien Tsai |
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| Chun-Hsien Tsai, Principal Executive Officer (Chairman of the Board, President, and Chief Executive Officer) |
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EXHIBIT 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO RULE 13A- 14(A) / 15D – 14(A)
UNDER THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES OXLEY ACT OF 2002
I, Meng-Lin Sung, certify that:
| 1. | I have reviewed this report on Form 10-Q of Ainos, Inc.; |
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| 2. | Based on my knowledge, this report does not contain any untrue statement of material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the periods covered by this report; |
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| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
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| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
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| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
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| (b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
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| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
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| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
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| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize, and report financial information; and |
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| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: November 9, 2023 | /s/ Meng-Lin Sung |
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| Meng-Lin Sung, Principal Financial Officer (Chief Financial Officer) |
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EXHIBIT 32.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Ainos, Inc. on Form 10-Q for the period ended September 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), the undersigned, in the capacity and on the date indicated below, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:
| 1. | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
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| 2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company. |
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| AINOS, INC. |
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| Date: November 9, 2023 | By: | /s/ Chun-Hsien Tsai |
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| Chun-Hsien Tsai, Principal Executive Officer (Chairman of the Board, President, and Chief Executive Officer) |
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EXHIBIT 32.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Ainos, Inc. on Form 10-Q for the period ended September 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), the undersigned, in the capacity and on the date indicated below, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
| 1. | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
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| 2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company. |
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| AINOS, INC. |
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| Date: November 9, 2023 | By: | /s/ Meng-Lin Sung |
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| Meng-Lin Sung, Principal Financial Officer (Chief Financial Officer) |
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