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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|
|
|
For
the quarterly period ended June 30, 2024 |
|
|
|
or |
|
|
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|
|
|
For
the transition period from____to____ |
|
|
|
Commission
File No. 001-41461 |
AINOS,
INC.
(Exact
name of registrant as specified in its charter)
texas |
|
75-1974352 |
(State
or other jurisdiction
of
incorporation or organization) |
|
(IRS
Employer
Identification
No.) |
8880
Rio San Diego Drive, Ste. 800, San Diego, CA 92108 (858) 869-2986
(Address
and telephone number, including area code, of registrant’s principal executive offices)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.01 per share |
|
AIMD |
|
The
Nasdaq Stock Market LLC |
Warrants
to purchase Common Stock |
|
AIMDW |
|
The
Nasdaq Stock Market LLC |
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. ☒ Yes ☐ No
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).
☒ Yes ☐ No
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 ☐ |
Non-accelerated
filer ☒ |
Smaller
reporting company ☒ |
|
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) ☐ Yes ☒ No
7,663,022
shares of common stock, par value $0.01 per share, outstanding as of August 2, 2024
AINOS,
INC.
INDEX
PART
I - FINANCIAL INFORMATION
ITEM
1. Financial Statements
Ainos,
Inc.
Condensed
Balance Sheets
(Unaudited)
| |
June 30, 2024 | | |
December 31, 2023 | |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 8,014,098 | | |
$ | 1,885,628 | |
Accounts receivable | |
| 9 | | |
| 455 | |
Inventory, net | |
| 166,322 | | |
| 167,593 | |
Other current assets | |
| 291,166 | | |
| 419,521 | |
Total current assets | |
| 8,471,595 | | |
| 2,473,197 | |
Intangible assets, net | |
| 26,028,058 | | |
| 28,283,208 | |
Property and equipment, net | |
| 691,100 | | |
| 876,572 | |
Other assets | |
| 348,634 | | |
| 208,827 | |
Total assets | |
$ | 35,539,387 | | |
$ | 31,841,804 | |
| |
| | | |
| | |
Liabilities and Stockholders’ Equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Contract liabilities | |
$ | 106,502 | | |
$ | 112,555 | |
Convertible notes payable, (including amounts of related party of $ 2,000,000 and nil as of June 30, 2024 and December 31, 2023, respectively) | |
| 3,000,000 | | |
| - | |
Convertible notes payable | |
| 3,000,000 | | |
| - | |
Senior secured convertible notes measured at fair value - Current | |
| 1,585,761 | | |
| - | |
Other notes payable, related party | |
| 312,000 | | |
| 42,000 | |
Accrued expenses and others current liabilities | |
| 738,936 | | |
| 1,182,283 | |
Total current liabilities | |
| 5,743,199 | | |
| 1,336,838 | |
Senior secured convertible notes measured at fair value | |
| - | | |
| 2,651,556 | |
Convertible notes payable - noncurrent (including amounts of related party of $9,000,000 and $2,000,000 as of June 30, 2024 and December 31, 2023, respectively) | |
| 9,000,000 | | |
| 3,000,000 | |
Convertible notes payable | |
| 9,000,000 | | |
| 3,000,000 | |
Other notes payable, related party - noncurrent | |
| - | | |
| 270,000 | |
Other long-term liabilities | |
| 83,912 | | |
| 135,829 | |
Total liabilities | |
| 14,827,111 | | |
| 7,394,223 | |
Commitments and contingencies | |
| - | | |
| - | |
Stockholders’ equity: | |
| | | |
| | |
Preferred stock, $0.01 par value; 50,000,000 shares authorized; none issued and outstanding as of June
30, 2024 and December 31,2023, respectively | |
| - | | |
| - | |
Common stock, $0.01 par value; 300,000,000 shares authorized as of June 30, 2024 and December 31, 2023, 7,388,674 and 4,677,787 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively | |
| 73,887 | | |
| 46,778 | |
Common stock to be issued 270 shares and 162,337 shares as of June 30, 2024 and December 31, 2023, respectively | |
| 3 | | |
| 1,623 | |
Additional paid-in capital | |
| 65,414,761 | | |
| 62,555,808 | |
Accumulated deficit | |
| (44,395,987 | ) | |
| (37,886,155 | ) |
Accumulated other comprehensive loss - translation adjustment | |
| (380,388 | ) | |
| (270,473 | ) |
Total stockholders’ equity | |
| 20,712,276 | | |
| 24,447,581 | |
Total liabilities and stockholders’ equity | |
$ | 35,539,387 | | |
$ | 31,841,804 | |
See
accompanying notes to condensed financial statements.
Ainos,
Inc.
Condensed
Statements of Operations
(Unaudited)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenues | |
$ | - | | |
$ | 28,555 | | |
$ | 20,729 | | |
$ | 77,719 | |
Cost of revenues (including amounts of related party of nil for the three months ended June 30, 2024 and 2023, and nil and $46,635 for the six months ended June 30, 2024 and 2023, respectively) | |
| (25,373 | ) | |
| (55,817 | ) | |
| (52,127 | ) | |
| (156,665 | ) |
Gross loss | |
| (25,373 | ) | |
| (27,262 | ) | |
| (31,398 | ) | |
| (78,946 | ) |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development expenses (including amounts of related party of $386,507 and $761,700 for the three and six months ended June 30, 2024, and $74,733 and $152,196 for the three and six months ended June 30, 2023, respectively) | |
| 1,978,756 | | |
| 1,671,187 | | |
| 4,063,404 | | |
| 3,370,070 | |
Selling, general and administrative expenses | |
| 1,044,880 | | |
| 618,149 | | |
| 2,074,298 | | |
| 1,380,614 | |
Total operating expenses | |
| 3,023,636 | | |
| 2,289,336 | | |
| 6,137,702 | | |
| 4,750,684 | |
Loss from operations | |
| (3,049,009 | ) | |
| (2,316,598 | ) | |
| (6,169,100 | ) | |
| (4,829,630 | ) |
| |
| | | |
| | | |
| | | |
| | |
Non-operating (expenses) income, net: | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (118,759 | ) | |
| (40,311 | ) | |
| (167,455 | ) | |
| (49,585 | ) |
Issuance cost of senior secured convertible note measured at fair value | |
| - | | |
| - | | |
| (138,992 | ) | |
| - | |
Fair value change for senior secured convertible note | |
| (66,844 | ) | |
| - | | |
| (98,412 | ) | |
| - | |
Other income, net | |
| 39,590 | | |
| 7,182 | | |
| 64,127 | | |
| 9,013 | |
Total non-operating expenses, net | |
| (146,013 | ) | |
| (33,129 | ) | |
| (340,732 | ) | |
| (40,572 | ) |
| |
| | | |
| | | |
| | | |
| | |
Provision for income taxes | |
| - | | |
| - | | |
| - | | |
| - | |
Net loss | |
$ | (3,195,022 | ) | |
$ | (2,349,727 | ) | |
$ | (6,509,832 | ) | |
$ | (4,870,202 | ) |
Net loss per common share - basic and diluted | |
$ | (0.49 | ) | |
$ | (0.58 | ) | |
$ | (1.06 | ) | |
$ | (1.21 | ) |
Weighted-average shares used in computing net loss per common share-basic and diluted | |
| 6,519,014 | | |
| 4,019,030 | | |
| 6,145,148 | | |
| 4,010,666 | |
See
accompanying notes to condensed financial statements.
Ainos,
Inc.
Condensed
Statements of Comprehensive Loss
(Unaudited)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three months ended June 30, | | |
Six months ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Net loss | |
$ | (3,195,022 | ) | |
$ | (2,349,727 | ) | |
$ | (6,509,832 | ) | |
$ | (4,870,202 | ) |
Other comprehensive (loss) income: | |
| | | |
| | | |
| | | |
| | |
Translation adjustment | |
| (44,646 | ) | |
| (53,867 | ) | |
| (109,915 | ) | |
| (43,806 | ) |
Comprehensive loss | |
$ | (3,239,668 | ) | |
$ | (2,403,594 | ) | |
$ | (6,619,747 | ) | |
$ | (4,914,008 | ) |
See
accompanying notes to condensed financial statements.
Ainos,
Inc.
Condensed
Statements of Stockholders’ Equity
For
the three months ended June 30, 2024 and 2023
(Unaudited)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
| |
Loss | | |
Equity | |
| |
| | |
| | |
Common Stock | | |
Additional | | |
| | |
Accumulated
Other | | |
Total | |
| |
Preferred Stock | | |
Common Stock | | |
- to be issued | | |
Paid-in | | |
Accumulated | | |
Comprehensive | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
Balance at March 31, 2024 | |
| - | | |
$ | - | | |
| 6,144,506 | | |
$ | 61,445 | | |
| 270 | | |
$ | 3 | | |
$ | 64,154,052 | | |
$ | (41,200,965 | ) | |
$ | (335,742 | ) | |
$ | 22,678,793 | |
Conversion of convertible notes into common stock | |
| - | | |
| - | | |
| 1,244,168 | | |
| 12,442 | | |
| - | | |
| - | | |
| 838,335 | | |
| - | | |
| - | | |
| 850,777 | |
Share-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 422,374 | | |
| - | | |
| - | | |
| 422,374 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,195,022 | ) | |
| - | | |
| (3,195,022 | ) |
Translation adjustment | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (44,646 | ) | |
| (44,646 | ) |
Balance at June 30, 2024 | |
| - | | |
$ | - | | |
| 7,388,674 | | |
$ | 73,887 | | |
| 270 | | |
$ | 3 | | |
$ | 65,414,761 | | |
$ | (44,395,987 | ) | |
$ | (380,388 | ) | |
$ | 20,712,276 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at March 31, 2023 | |
| - | | |
$ | - | | |
| 4,002,320 | | |
$ | 40,023 | | |
| - | | |
$ | - | | |
$ | 59,126,074 | | |
$ | (26,636,081 | ) | |
$ | (191,592 | ) | |
$ | 32,338,424 | |
Issuance of stock to settle vested RSUs | |
| - | | |
| - | | |
| 25,306 | | |
| 253 | | |
| - | | |
| - | | |
| (253 | ) | |
| - | | |
| - | | |
| - | |
Issuance of stock in exchange of vehicle | |
| - | | |
| - | | |
| 12,231 | | |
| 122 | | |
| - | | |
| - | | |
| 48,437 | | |
| - | | |
| - | | |
| 48,559 | |
Conversion of convertible notes payable to common stock | |
| - | | |
| - | | |
| 18,666 | | |
| 187 | | |
| - | | |
| - | | |
| 274,602 | | |
| - | | |
| - | | |
| 274,789 | |
Share-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 137,159 | | |
| - | | |
| - | | |
| 137,159 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (2,349,727 | ) | |
| - | | |
| (2,349,727 | ) |
Translation adjustment | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (53,867 | ) | |
| (53,867 | ) |
Balance at June 30, 2023 | |
| - | | |
$ | - | | |
| 4,058,523 | | |
$ | 40,585 | | |
| - | | |
$ | - | | |
$ | 59,586,019 | | |
$ | (28,985,808 | ) | |
$ | (245,459 | ) | |
$ | 30,395,337 | |
See
accompanying notes to condensed financial statements.
Ainos,
Inc.
Condensed
Statements of Stockholders’ Equity
For
the six months ended June 30, 2024 and 2023
(Unaudited)
| |
| | |
| | |
| | |
| | |
Common Stock | | |
Additional | | |
| | |
Accumulated
Other | | |
Total | |
| |
Preferred Stock | | |
Common Stock | | |
- to be issued | | |
Paid-in | | |
Accumulated | | |
Comprehensive | | |
Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Loss | | |
Equity | |
Balance at December 31, 2023 | |
| - | | |
$ | - | | |
| 4,677,787 | | |
$ | 46,778 | | |
| 162,337 | | |
$ | 1,623 | | |
$ | 62,555,808 | | |
$ | (37,886,155 | ) | |
$ | (270,473 | ) | |
$ | 24,447,581 | |
Issuance of stock to settle vested RSUs | |
| - | | |
| - | | |
| 133,964 | | |
| 1,340 | | |
| 270 | | |
| 3 | | |
| (1,343 | ) | |
| - | | |
| - | | |
| - | |
Conversion of senior secured convertible note payable to common stock | |
| - | | |
| - | | |
| 2,414,586 | | |
| 24,146 | | |
| - | | |
| - | | |
| 2,015,061 | | |
| - | | |
| - | | |
| 2,039,207 | |
Related party used computer equipment | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,428 | ) | |
| - | | |
| - | | |
| (4,428 | ) |
Warrants issued in connection with senior secured convertible note payable | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 1,586 | | |
| - | | |
| - | | |
| 1,586 | |
Issuance of common stock | |
| - | | |
| - | | |
| 162,337 | | |
| 1,623 | | |
| (162,337 | ) | |
| (1,623 | ) | |
| - | | |
| - | | |
| - | | |
| - | |
Share-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 848,077 | | |
| - | | |
| - | | |
| 848,077 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (6,509,832 | ) | |
| - | | |
| (6,509,832 | ) |
Translation adjustment | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (109,915 | ) | |
| (109,915 | ) |
Balance at June 30, 2024 | |
| - | | |
$ | - | | |
| 7,388,674 | | |
$ | 73,887 | | |
| 270 | | |
$ | 3 | | |
$ | 65,414,761 | | |
$ | (44,395,987 | ) | |
$ | (380,388 | ) | |
$ | 20,712,276 | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance at December 31, 2022 | |
| - | | |
$ | - | | |
| 4,002,320 | | |
$ | 40,023 | | |
| - | | |
$ | - | | |
$ | 58,905,242 | | |
$ | (24,115,606 | ) | |
$ | (201,653 | ) | |
$ | 34,628,006 | |
Balance | |
| - | | |
$ | - | | |
| 4,002,320 | | |
$ | 40,023 | | |
| - | | |
$ | - | | |
$ | 58,905,242 | | |
$ | (24,115,606 | ) | |
$ | (201,653 | ) | |
$ | 34,628,006 | |
Issuance of stock to settle vested RSUs | |
| - | | |
| - | | |
| 25,306 | | |
| 253 | | |
| - | | |
| - | | |
| (253 | ) | |
| - | | |
| - | | |
| - | |
Issuance of stock in exchange of vehicle | |
| - | | |
| - | | |
| 12,231 | | |
| 122 | | |
| - | | |
| - | | |
| 48,437 | | |
| - | | |
| - | | |
| 48,559 | |
Conversion of convertible notes payable to common stock | |
| - | | |
| - | | |
| 18,666 | | |
| 187 | | |
| - | | |
| - | | |
| 274,602 | | |
| - | | |
| - | | |
| 274,789 | |
Share-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 357,991 | | |
| - | | |
| - | | |
| 357,991 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,870,202 | ) | |
| - | | |
| (4,870,202 | ) |
Translation adjustment | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (43,806 | ) | |
| (43,806 | ) |
Balance at June 30, 2023 | |
| - | | |
$ | - | | |
| 4,058,523 | | |
$ | 40,585 | | |
| - | | |
$ | - | | |
$ | 59,586,019 | | |
$ | (28,985,808 | ) | |
$ | (245,459 | ) | |
$ | 30,395,337 | |
Balance | |
| - | | |
$ | - | | |
| 4,058,523 | | |
$ | 40,585 | | |
| - | | |
$ | - | | |
$ | 59,586,019 | | |
$ | (28,985,808 | ) | |
$ | (245,459 | ) | |
$ | 30,395,337 | |
See
accompanying notes to condensed financial statements.
Ainos,
Inc.
Condensed
Statements of Cash Flows
(Unaudited)
| |
2024 | | |
2023 | |
| |
Six months ended June 30 | |
| |
2024 | | |
2023 | |
Cash flows from Operating Activities: | |
| | | |
| | |
Net loss | |
$ | (6,509,832 | ) | |
$ | (4,870,202 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 2,398,696 | | |
| 2,423,274 | |
Loss on inventory write-downs | |
| - | | |
| 57,474 | |
Share-based compensation expense | |
| 848,077 | | |
| 357,991 | |
Issuance cost of senior secured convertible note measured at fair value | |
| 138,992 | | |
| - | |
Change in fair value of senior secured convertible note | |
| 98,412 | | |
| - | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| 446 | | |
| 192,161 | |
Inventory | |
| 1,271 | | |
| 10,814 | |
Other current assets | |
| 128,355 | | |
| (55,990 | ) |
Accrued expenses and other current and long-term liabilities | |
| (573,309 | ) | |
| (693,975 | ) |
Net cash used in operating activities | |
| (3,468,892 | ) | |
| (2,578,453 | ) |
Cash flows from Investing Activities: | |
| | | |
| | |
Purchase of property and equipment | |
| (10,276 | ) | |
| (71,262 | ) |
Increase in refundable deposits and others | |
| (109,516 | ) | |
| - | |
Net cash used in investing activities | |
| (119,792 | ) | |
| (71,262 | ) |
Cash flows from Financing Activities: | |
| | | |
| | |
Proceeds from convertible notes payable- noncurrent | |
| - | | |
| 1,000,000 | |
Proceeds from convertible notes payable, related party | |
| 9,000,000 | | |
| 1,500,000 | |
Proceeds from senior secured convertible notes payable | |
| 875,000 | | |
| - | |
Repayment of other notes payable, related party | |
| - | | |
| (200,000 | ) |
Repayment of convertible notes payable, related party | |
| - | | |
| (114,026 | ) |
Payments of issuance cost of senior secured convertible note measured at fair value | |
| (97,500 | ) | |
| - | |
Net cash provided by financing activities | |
| 9,777,500 | | |
| 2,185,974 | |
Effect from foreign currency exchange | |
| (60,346 | ) | |
| (28,651 | ) |
Net increase (decrease) in cash and cash equivalents | |
| 6,128,470 | | |
| (492,392 | ) |
Cash and cash equivalents at beginning of year | |
| 1,885,628 | | |
| 1,853,362 | |
Cash and cash equivalents at end of year | |
$ | 8,014,098 | | |
$ | 1,360,970 | |
| |
| | | |
| | |
Supplemental Cash Flow Information | |
| | | |
| | |
Cash paid for interest | |
$ | 39 | | |
$ | 3,122 | |
| |
| | | |
| | |
Noncash financing and investing activities: | |
| | | |
| | |
Conversion of convertible notes payable to common stock and accrued interest waived by convertible notes holders | |
$ | - | | |
$ | 274,789 | |
Conversion of senior secured convertible notes to common stock | |
$ | 2,039,207 | | |
$ | - | |
Issuance of common stocks in exchange of vehicle | |
$ | - | | |
$ | 48,559 | |
Account payable to purchase equipment | |
$ | - | | |
$ | 5,848 | |
See
accompanying notes to the condensed financial statements.
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 in 1984, 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. Our product pipeline includes commercial-stage VELDONA Pet cytoprotein supplements, clinical-stage
VELDONA human and animal therapeutics and telehealth-friendly POCTs powered by the AI Nose technology platform.
We
have historically involved in the research and development of therapeutics based on VELDONA. Building on our research and development
on VELDONA since inception, we are focused on commercializing a suite of VELDONA-based product candidates.
In
2021 and 2022, we acquired certain types of intellectual property from our controlling shareholder, Ainos Inc., a Cayman Island corporation
(“Ainos KY”), to expand product portfolio into POCTs aimed to provide connected, rapid, and convenient testing for a broad
range of health conditions. Pivoting from the sales of COVID-19 POCT, we aim to commercialize POCTs that detect volatile organic compounds
(the “VOC”) emitted by the body, powered by our AI Nose technology platform. Our lead VOC POCT candidate, Ainos Flora, aims
to test female vaginal health and certain common sexually transmitted infections (the “STIs”) quickly and easily.
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.
Reverse
Stock Splits
In
connection with the Offering, the Company’s board of directors on April 29, 2022 and its shareholders on May 16, 2022 approved
a 1-for-15 reverse stock split of the Company’s common stock that became effective on August 9, 2022. Further, to comply with Nasdaq’s
minimum $1.00 per share continued listing rules, the Company filed a Certificate of Amendment to its Restated Certificate of Formation
on November 27, 2023, to apply for another reverse stock split of the Company’s common stock at a ratio of 1-for-5 which was effectuated
on December 14, 2023 after receiving required approvals.
The
par value of $0.01 and authorized shares of the Company’s common stock remains the same and were not adjusted as a result of the
reverse stock splits. All issued and outstanding common stock, restricted stock units (RSUs), outstanding convertible notes, warrants
and options to purchase common stock and per share amounts contained in the financial statements have been retroactively adjusted to
give effect to the reverse stock splits for all periods presented.
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, 2023 contained in the Annual Report on Form 10-K filed with the
SEC on March 8, 2024.
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 six months
ended June 30, 2024 are not necessarily indicative of the results to be expected for any subsequent quarter, the year ending December
31, 2024, or any other period.
There
have been no material changes to the Company’s significant accounting policies as described in the audited financial statements
as of December 31, 2023.
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 June 30, 2024, the Company had cash and cash equivalents of $8,014,098. The Company plans to finance its operations and development
needs with its existing cash and cash equivalents, additional equity and/or debt financing arrangements, and expected near-term revenue
primarily from the sale of VELDONA Pet cytoprotein supplements to support the Company’s clinical trial activities, largely in connection
with Ainos Flora and human related VELDONA therapeutics. There can be no assurance that the Company will be able to obtain additional
financing on terms acceptable to the Company, on a timely basis, or at all.
For
the six months ended June 30, 2024, the Company generated a net loss of $6,509,832.
The Company expects to continue incurring development expenses for the next twelve months as the Company advances Ainos Flora and VELDONA
therapeutics for humans through clinical development until regulatory approval is received and the sales and marketing of the products
is authorized.
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 since inception and has an accumulated deficit
as of June 30, 2024 of $44,395,987 and expects to incur additional losses and negative operating cash flows for at least the next twelve
months. The Company’s ability to meet its obligations is dependent upon its ability to generate sufficient cash flows from operations
and future financing transactions. Management expects the Company will continue as a going concern for at least one year from the issuance
of these financial statements.
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 six months ended June 30, 2024 and 2023.
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 June 30, 2024 and December 31, 2023, cash and cash equivalents consisted 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. Accounts are guaranteed
by the Federal Deposit Insurance Corporation (FDIC) up to $250,000. As of June 30, 2024 and December 31, 2023, the Company had approximately
$4,281,890 and $1,557,487 in excess of FDIC insured limits, respectively. The Company maintains cash in state-owned banks in Taiwan.
In Taiwan, the insurance coverage of each bank is NTD$3,000,000 (approximately USD$93,750). As of June 30, 2024 and December 31, 2023,
the Company had approximately $3,358,000and
$0 cash in excess of the insured amount, respectively. The Company has not experienced any losses in such accounts.
4.
Inventory
Inventory
stated at cost, net of reserve, consisted of the following:
Schedule of Inventory
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Raw materials | |
$ | 87,047 | | |
$ | 92,708 | |
Work in process | |
| 1,142 | | |
| 1,208 | |
Finished goods | |
| 78,133 | | |
| 73,677 | |
Total | |
$ | 166,322 | | |
$ | 167,593 | |
Inventory
write-downs to estimated net realizable values were nil for the three and six months ended June 30, 2024, compared to $14,694 and $57,474
for the three and six months ended June 30, 2023.
5.
Convertible Notes Payable and Other Notes Payable
As
of June 30, 2024 and December 31, 2023, the respective notes payable were as follows:
Schedule of Notes Payable
| |
June 30, 2024 | | |
December 31, 2023 | |
Other notes payable, related party – current | |
$ | 312,000 | | |
$ | 42,000 | |
Other notes payable, related party - noncurrent | |
| - | | |
| 270,000 | |
March 2025 Convertible Notes, related party – noncurrent (ASE Note) | |
| - | | |
| 2,000,000 | |
March 2025 Convertible Notes, related party –current (ASE Note) | |
| 2,000,000 | | |
| - | |
March 2025 Convertible Notes – noncurrent (Lee Note) | |
| - | | |
| 1,000,000 | |
March 2025 Convertible Notes –current (Lee Note) | |
| 1,000,000 | | |
| - | |
Senior secured convertible notes payable (Lind Note) - fair value | |
| 1,585,761 | | |
| 2,651,556 | |
May 2027 Convertible Notes, related party – noncurrent (ASE Note) | |
| 9,000,000 | | |
| - | |
Notes payable | |
$ | 13,897,761 | | |
$ | 5,963,556 | |
The
other notes payable were issued to Ainos KY, the controlling shareholder of the Company, in exchange for $800,000 in cash to support
working capital of the Company in March 2022 (the “KY Note”). The Company paid off $530,000 of the KY Note during the year
ended December 31, 2023. The Company did not repay the KY Note during the three and six months ended June 30, 2024. Another note payable
was issued to i2China Management Group, LLC (“i2China”) in exchange for consulting services in 2020 (the “i2China Note”)
which remains outstanding for the amount of $42,000 as of June 30, 2024. Both the KY Note and the i2China Note bear an interest rate
of 1.85% per annum. On August 17, 2023, the Company entered into extension agreements with Ainos KY and i2China to extend the maturity
of the KY Note and i2China Note to March 31, 2025 and September 1, 2024, respectively.
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.
May
2027 Convertible Notes and Warrant Purchase Agreement
On
May 03, 2024, The Company entered into Convertible Note and Warrant Purchase Agreement with the ASE Test, Inc. (“ASE”), a
shareholder of Ainos KY, for the issuance of convertible promissory notes with 6% compound interest in the aggregate principal amount
of $9,000,000 (collectively the “Notes”) convertible into shares of common stock, par value $0.01 per share, of the Company,
payable three (3) years from May 03, 2024 as well as the issuance of warrants for the purchase of up to 500,000 shares of Common Stock
at a price per share of $4.50, exercisable until May 03, 2029. As of June 30, 2024, the Company received the full amount of the payment.
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 $3,000,000 with the following investors (the “March 2025 Convertible
Notes” or “Notes”).
Convertible
Note Issued to ASE Test, Inc. (the “ASE Note”)
Pursuant
to the one of the aforementioned agreements, ASE Test, Inc., a shareholder of Ainos KY, committed to pay a total aggregate amount of
$2,000,000 to the Company in exchange for convertible promissory note(s) in three tranches in the amounts of $1,000,000 (the “First
Tranche”), $500,000 (the “Second Tranche”), and $500,000 (the “Third Tranche”) conditioned, among other
things, on the Company achieving certain business milestones. As of June 30, 2024, the Company received the full amount of the payment.
Convertible
Note Issued to Li-Kuo Lee (the “Lee Note”)
The
Company issued a convertible note in the principal amount of $1,000,000 to an unrelated party, Li-Kuo Lee, in exchange of $1,000,000
in cash. As of June 30, 2024, the Company received the full amount of the payment.
The
March 2025 Convertible Notes will mature in two years from the issuance dates, bearing interest at the rate of 6% compounded interest
per annum. At any time after the issuance and before the maturity date, the Notes are convertible into the common stock of the Company
at the conversion price of $7.50 per share, subject to anti-dilutive adjustment as set forth in the Notes. Unless previously converted,
the Company shall repay the outstanding principal amount plus all accrued and unpaid interest on the maturity date. The Notes shall be
an unsecured general obligation of the Company.
The
total interest expense of convertible notes payable, other notes payable, March 2025 Convertible Notes and May 2027 Convertible Notes
and Warrant Purchase Agreement for the three and six months ended June 30, 2024 were $117,828 and $164,214 compared with the same period
in year 2023 were $37,991and $44,924. As of June 30, 2024 and December 31, 2023, the unpaid accrued interest expense was $303,153 and
$138,939, respectively.
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 $10,000,000 under various tranches to fund
clinical trials, commercial product launch and working capital of the Company. The Lind Note does not bear any interest and matures on
March 28, 2025..
In
2023, the Company issued and sold to Lind, in a private placement, (a) a senior secured convertible promissory note in the aggregate
principal amount of $3,540,000 (the “Lind Note”) and (b) warrants to purchase 691,244 shares of common stock at an exercise
price of $4.50 per share of common stock (the “Lind Warrant”) for a cash amount of $3,000,000. As of June 30, 2024, the Company
received the full amount of the funding.
Subject
to the satisfaction of certain conditions, the Company has the right to request additional tranches of funding from Lind in the aggregate
amount not to exceed $7.0 million (the “Increased Funding Amount”). Lind will receive additional warrants to purchase a number
of shares of common stock based on a formula set forth in the Securities Purchase Agreement. Such warrants will expire after five years
from the date of issuance and may be exercised on a cashless basis.
On
January 23, 2024, the Company received an Increased Funding Amount of up to $1.75 million, with $875,000 funded at closing and $875,000
to be funded subject to an effective registration statement and other conditions specified in the Securities Purchase Agreement, and
amended the Initial Note to, among other amendments, increase the principal amount to $4,235,000 (the Initial Note as so amended, the
“Note”). In connection with additional funding, the Company issued Lind a warrant to purchase 1,021,400 shares at an exercise
price of $2.16 per share (the “Second Lind Warrants and together with the First Lind Warrants, the “Lind Warrants”).
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 $7.50 per share, subject to adjustment, or 90% of the average of the three lowest daily VWAP of the common stock during
the 20 trading days prior to conversion, subject to certain adjustments.
As
of June 30, 2024, the converted principal amount from the SPA was $2,752,170 and the aggregate principal amount was $1,785,330.
From
an accounting perspective, the Lind Note is considered a debt host instrument embedded with an 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. As of June 30, 2024, the fair value of the Lind Note was $1,585,761. For
the three and six months ended June 30, 2024, the change in the fair value of the Lind Note was recorded in the Statements of Operations
in the amount of $66,844 and $98,412 respectively. No portion of the change in fair value was related to changes in credit risk of the
Company which would be charged to other comprehensive loss if any. 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 amendment of $875,000 of the Lind Note, including a commitment fee charged
by Lind, placement agent fee and warrants, and legal fees is $138,992, which is expensed off due to FVO election. $169,344 of the remaining
insurance cost related to the future funding of $6,125,000 offered by the SPA is deferred as other assets on the balance sheet and will
be expensed upon each closing or when the Company does not expect to complete the remaining funding.
6.
Stockholders’ Equity
Preferred
Stock
The
Company increased authorized shares of preferred stock from 10,000,000 shares to 50,000,000 shares upon the filing of an amendment to
the Company’s Certificate of Formation with the Secretary of State of Texas on November 27, 2023. No shares of preferred stock
were issued and outstanding as of June 30, 2024 and December 31, 2023.
Common
Stock
During
the three months ended June 30, 2024, the Company issued an additional 1,244,168 shares of common stock as a result of delivering conversion
of the Lind’s Note. As of June 30, 2024, there were 7,388,674 shares of common stock legally issued and outstanding.
As
a result of the Lind private placement, the Company reserved up to 3,749,535 shares of common stock to be issued upon exercise of conversion
of the Lind Note and warrants issued in connection with the private placement.
Warrants
As
of June 30, 2024 and December 31, 2023, warrants issued and outstanding in connection with financing are summarized as below:
Schedule of Warrants Issued and Outstanding
| |
June 30, | | |
December 31, | |
(In number of shares) | |
2024 | | |
2023 | |
ASE Warrant with exercise price $4.5 | |
| 500,000 | | |
| - | |
Lind Warrant with exercise price from $2.16 to $4.50 | |
| 1,201,944 | | |
| 691,244 | |
Public warrant with exercise price of $21.25 | |
| 179,400 | | |
| 179,400 | |
Representative’s warrant with exercise price of $23.375 | |
| 7,800 | | |
| 7,800 | |
Placement agent warrant with exercise price of $8.25 | |
| 20,666 | | |
| 16,000 | |
Total | |
| 1,909,810 | | |
| 894,444 | |
As
mentioned in Note 5, in connection with Convertible Note and Warrant Purchase Agreement with the ASE, the Company issued warrants to
ASE for purchase of up to 500,000 shares of Common Stock at a price per share of $4.50, exercisable until May 03, 2029.
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 20,666 shares of warrants with an exercise price of $8.25 per share to the placement agent as the agent
fee. Each warrant has a contractual term of 5 years and can be exercised for the purchase of one share of common stock of the Company.
The carrying amount of the Lind Warrant is nil after allocating proceeds to the Lind Note measured at fair value. The fair value of the
placement agent warrant is estimated as $21,479 using the Black-Scholes Model.
As
disclosed in Note 1, the Company issued public warrants together with common stock 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 of 5 years, expiring on August 8, 2027, and can be exercised for the
purchase of one share of common stock of the Company.
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 June 30, 2024, none of the warrants have been exercised nor have expired.
7.
Revenue
Revenue
is recognized upon shipment of products based upon contractually stated pricing at standard payment terms within 30 to 60 days. The revenue
generated by product sales is recognized at point in time.
The
Company generated revenue from sales of COVID-19 Antigen Rapid Test Kits in the Taiwan market for the three and six months ended June
30, 2023. 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 June 30, 2024 and December 31, 2023.
The
Company generated revenue from sales of VELDONA Pet cytoprotein supplements in the Taiwan market through on-line platforms that were
recognized after the expiration of right of return which was offered for a limited time. Revenue from sales through off-line distribution
channels was recognized based on the amount of consideration that we expected to receive, reduced
by estimates for return allowances, promotional discounts, and fees. $106,502 of contract liabilities was recorded for the cash
received in advance from distribution channels as of June 30, 2024.
Return
Allowances
Return
allowances, which reduce revenue and cost of sales, are estimated using historical experience. Liabilities for return allowances are
included in “Accrued expenses and others current liabilities”.
Variable
consideration
We
record revenue from customers in an amount that reflects the transaction price we expect to be entitled to after transferring control
of those goods. From time to time, we offer product sales promotions such as discounts. Variable consideration is estimated at contract
inception only to the extent that it is probable that a significant reversal of revenue will not occur.
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 871,075 shares
of common stock, including shares that remained available for grant under the 2021 Stock Incentive Plan. As of June 30, 2024, 870,200
shares have been granted under the 2023 SIP.
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 June 30, 2024, 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
six months ended June 30, 2024 and for the three and six months ended June 30, 2023 were as follows:
Schedule
of Restricted Stock Units
| |
2024 | | |
2023 | |
| |
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 | |
| 954,306 | | |
$ | 4.39 | | |
| 160,000 | | |
$ | 12.08 | |
RSUs granted | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
RSUs vested | |
| (133,964 | ) | |
$ | 5.74 | | |
| (5,866 | ) | |
$ | 55.50 | |
RSUs forfeited | |
| (5,950 | ) | |
$ | 3.46 | | |
| (7,600 | ) | |
$ | 7.15 | |
Unvested balance at March 31 | |
| 814,392 | | |
$ | 4.18 | | |
| 146,534 | | |
$ | 10.60 | |
RSUs granted | |
| - | | |
| | | |
| - | | |
| | |
RSUs vested | |
| - | | |
| | | |
| (20,220 | ) | |
$ | 6.69 | |
RSUs forfeited | |
| (4,410 | ) | |
$ | 4.16 | | |
| (6,970 | ) | |
$ | 6.38 | |
Unvested balance at June 30 | |
| 809,982 | | |
$ | 4.18 | | |
| 119,344 | | |
$ | 11.51 | |
Stock
Options and Warrants
During
the three and six months ended June 30, 2024 and 2023, no shares were granted, forfeited, expired or exercised. As of June 30, 2024,
there were 7,332 shares in the form of stock options and 6,034 shares in the form of warrants outstanding, and 5,111 shares of the options
and 6,034 shares of the warrants are vested and exercisable.
Share-Based
Compensation Expense
Shared-based
compensation expense for the three and six months ended June 30, 2024 ware $422,374 and $848,077 compared to the three and six months
ended June 30, 2023 amount of $137,159 and $357,991.
As
of June 30, 2024, the total unrecognized compensation cost related to outstanding RSUs, stock options and warrants was $2,486,290, which
the Company expects to recognize over a weighted-average period of 1.86 years.
9.
Income Taxes
The
Company did not record a federal, state, or foreign income tax provision or benefit for the three and six months ended June 30, 2024
and 2023 due to the expected loss before income taxes to be incurred for the years ended December 31, 2024 and 2023, 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:
Schedule
of Basic and Diluted Net Loss Per Share
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Net loss attributable to common stockholders, basic and diluted | |
$ | (3,195,022 | ) | |
$ | (2,349,727 | ) | |
$ | (6,509,832 | ) | |
$ | (4,870,202 | ) |
Weighted-average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted | |
| 6,519,014 | | |
| 4,019,030 | | |
| 6,145,148 | | |
| 4,010,666 | |
Net loss per share attributable to common stockholders, basic and diluted | |
$ | (0.49 | ) | |
$ | (0.58 | ) | |
$ | (1.06 | ) | |
$ | (1.21 | ) |
The
following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding because
they would be anti-dilutive:
Schedule
of Computations of Diluted Weighted Average Shares Outstanding
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Option and RSUs to purchase common stock | |
| 817,314 | | |
| 126,676 | | |
| 817,314 | | |
| 126,676 | |
Warrants to purchase to common stock | |
| 1,915,844 | | |
| 193,234 | | |
| 1,915,844 | | |
| 193,234 | |
Convertible note to purchase common stock | |
| 4,223,245 | | |
| 374,533 | | |
| 4,223,245 | | |
| 374,533 | |
Total potential shares | |
| 6,956,403 | | |
| 694,443 | | |
| 6,956,403 | | |
| 694,443 | |
11.
Related Party Transactions
The
following is a summary of related party transactions that met our disclosure threshold:
Working
Capital Advances
The
proceeds of the 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 six months ended June 30, 2024 were $101,777 and $132,855 compared to $22,637 and $26,057, for the three
and six months ended June 30, 2023. As of June 30, 2024 and December 31, 2023, unpaid accrued interest expenses were $220,488 and $87,632,
respectively.
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 for the three and six months ended June 30, 2024compared with the amount for the three and six months ended June 30, 2023
of nil and $46,635 respectively.
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 nil for the three and six months ended June 30, 2024.
As
of June 30, 2024 and December 31, 2023, the accounts payable to TCNT were nil and $323, respectively; and prepayment for COVID-19 Antigen
Rapid Test Kits were $21,872 and $27,208, respectively.
COVID-19
Antigen Rapid Test Kits Sales
The
Company sold COVID-19 Antigen Rapid Test Kits to affiliates of ASE Test Inc., totaling nil for the three and six months ended June 30,
2024 compared with the three and six months ended June 30, 2023 amount of $12,541 and $12,541, respectively. As of June 30, 2024, and
December 31, 2023, the accounts receivable to aforementioned related parties were nil, respectively.
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 $101,244 and $191,838 for the three and six months ended June 30,2024, respectively, compared
to $74,733 and $152,196 for the three and six months ended June 30, 2023, respectively. The fee for non-exclusive use of patents were
$285,263 and $569,862 for the three and six months ended June 30, 2024 and nil for the three and six months ended June 30, 2023, respectively.
Advance payment $138,615 and $ 26,511 as of June 30, 2024 and December 31, 2023, respectively.
Miscellaneous
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 board of directors of the Company. The R&D expense was nil for the three and six months ended June 30, 2024 and $19,618
and $39,344 for the three and six months ended June 30, 2023, respectively.
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 June 30, 2024,
there were no such commitments or contingencies.
13.
Subsequent Events
Related
Party Transaction
As
part of the Addendum Agreement entered into on July 8, 2024 as disclosed in Note 11, TCNT will provide non-exclusive use of certain patents
related to VOC and POCT technologies for a monthly fee of $95,000 (plus 5% indirect tax), with negotiable payment terms for extend another
three months from July 2024 to September 2024.
Additional
Conversion of the Senior Secured Convertible Notes Payable (Lind Note)
On
July 3, 2024, Lind converted a total of $200,000 of the principal amount of Lind Note into 274,348 shares of common stock.
The remaining principal amount of the Lind Note was $1,585,330 after the conversion.
Repayment
of the Senior Secured Convertible Notes Payable (Lind Note)
On
August 2, 2024, the Company has retired its remaining senior secured convertible debt (the “Note”) with Lind Global Fund II
LP, an institutional investment fund managed by The Lind Partners (together the “Investor”), as a result of conversions by
the Investor and payments by the Company, which aggregates at a total of approximately US$1.67 million.
Nasdaq
Deficiency Notice
On
July 15, 2024 the Company received a deficiency letter from the Nasdaq Listing Qualifications Department (the “Staff”) of
The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that, for the last 30 consecutive business days, the closing
bid price for the Company’s common stock has been below the minimum $1.00 per share required for continued listing on The Nasdaq
Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). The Nasdaq deficiency letter
has no immediate effect on the listing of the Company’s common stock, and its common stock will continue to trade on The Nasdaq
Capital Market under the symbol “AIMD” at this time.
In
accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been given 180 calendar days, or until January 13, 2025, to regain
compliance with the Minimum Bid Price Requirement. If at any time before January 13, 2025, the bid price of the Company’s common
stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, the Staff will provide written confirmation that
the Company has achieved compliance.
If
the Company does not regain compliance with the Minimum Bid Price Requirement by January 13, 2025, the Company may be afforded a second
180 calendar day period to regain compliance. To qualify, the Company would be required to meet the continued listing requirement for
market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, except for the Minimum Bid
Price Requirement. In addition, the Company would be required to notify Nasdaq of its intent to cure the deficiency during the second
compliance period. If the Company meets these requirements, Nasdaq will inform the Company that it has been granted an additional 180
calendar days. However, if it appears to Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise
not eligible, Nasdaq will provide notice that the Company’s securities are subject to delisting.
The
Company intends to monitor the closing bid price of its common stock and may, if appropriate, consider available options to regain compliance
with the Minimum Bid Price Requirement. However, there can be no assurance that the Company will be able to regain compliance with the
Minimum Bid Price Requirement or will otherwise be in compliance with other Nasdaq Listing Rules.
On
July 19,2024 the Company filed a Form 8-K with the SEC disclosing the herein matters.
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, 2023 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, 2023 (the “2023 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 2023 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 to Ainos, Inc.
Overview
Ainos,
Inc. (the “Company”), incorporated in the State of Texas in 1984, 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. Our product pipeline includes commercial-stage VELDONA Pet cytoprotein supplements, clinical-stage
VELDONA human and animal therapeutics and telehealth-friendly POCTs powered by the AI Nose technology platform.
We
have historically involved in the research and development of therapeutics based on VELDONA. Building on our research and development
on VELDONA since inception, we are focused on commercializing a suite of VELDONA-based product candidates.
In
2021 and 2022, we acquired certain types of intellectual property from controlling shareholder, Ainos Inc., a Cayman Island corporation
(“Ainos KY”), to expand product portfolio into POCTs aimed to provide connected, rapid, and convenient testing for a broad
range of health conditions. Pivoting from the sales of COVID-19 POCT, we aim to commercialize POCTs that detect volatile organic compounds
(the “VOC”) emitted by the body, powered by our AI Nose technology platform. Our lead VOC POCT candidate, Ainos Flora, aims
to test female vaginal health and certain common sexually transmitted infections (the “STIs”) quickly and easily.
Our
Pipeline
An
integral part of our operating strategy is to create multiple revenue streams through sales of commercially ready products, out-licensing
or forming strategic relationships to develop and commercialize our products. As of June 30, 2024, we have commercialized the following
products:
|
● |
COVID-19
Antigen Rapid Test Kit. As the first commercialized products we sell, we have marketed COVID-19 antigen rapid test kits in Taiwan
under emergency use authorization (“EUA”) issued by the Taiwan Federal and Drug Administration (“TFDA”) to
TCNT, the product manufacturer. We have pivoted away from this business and have ceased selling the product since the first quarter
of 2024. |
|
|
|
|
● |
VELDONA
Pet. VELDONA Pet is cytoprotein supplement 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 currently sell VELDONA Pet in Taiwan. |
From
time to time, we assess our development plan based on available resources and market dynamics. Our current pipeline of the products,
which are under development, includes the following:
|
● |
VELDONA
human and animal drugs. Our programs include oral warts for human immunodeficiency virus (HIV) seropositive patients, Sjögren’s
syndrome common cold, influenza We have conducted Phase 2 studies for these programs. The United States Food and Drug Administration
(the “U.S. FDA”) have granted orphan drug designation for our VELDONA formulation as a potential treatment for oral warts
in HIV-seropositive patients. In the second quarter of 2024 we announced a plan to initiate a clinical study for feline chronic gingivostomatitis
(FCGS), a cat oral disease, as an effort to explore VELDONA’s opportunity as an animal drug. |
|
|
|
|
● |
VOC
POCT – Ainos Flora. Ainos Flora, powered by AI Nose, 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 aims to enable users to conveniently manage
test results. We believe Ainos Flora can provide connected, convenient, discreet, rapid testing in a point-of-care setting. We are
conducting clinical study in Taiwan and exploring strategic opportunities to commercialize the product. To further optimize the product
for at-home testing, we are developing a next generation Ainos Flora device that implements compute unified device architecture (CUDA),
a parallel computing platform for accelerated computing on graphical processing units. |
|
|
|
|
● |
VOC
platform – NISD co-development. We are co-developing a VOC sensing platform with Nisshinbo Micro Devices Inc. (“NISD”)
and Taiwan Inabata Sangyo Co. (“Taiwan Inabata”). The platform under development is intended to be used in applications
including telehealth, automotive, industrial, and environmental safety. |
|
|
|
|
● |
VOC
POCT – Ainos Pen. The device is intended 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 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. |
|
|
|
|
● |
Synthetic
RNA (“SRNA”). We plan develop a SRNA technology platform in Taiwan with a long-term goal of developing next-generating
precision treatments and rapid tests. |
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 near-term development plans encompass advancing our flagship VOC POCT candidate, Ainos Flora,
and co-developing a VOC sensing platform with our partners. At the same time, we will advance clinical studies and actively pursue the
out-licensing of VELDONA human drug candidates and we are developing opportunities in the animal drug market.
As
of June 30, 2024, we had available cash and cash equivalents of $8,014,098. 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.
Our
operating revenue previously came from the sale of COVID-19 test kits in Taiwan under emergency use authorization, since the expiration
of EUA to TCNT, the company ceased the sale of the Ainos COVID-19 antigen rapid test kits in first quarter of 2024. The company began
to generate sales revenue from VELDONA Pet in the third quarter of 2023. In Taiwan, we are primarily selling VELDONA Pet on certain e-commerce
platforms.
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 has 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 June 30, 2024 (“Q2 2024”) and June 30, 2023 (“Q2 2023”):
| |
Three months ended June 30, | | |
Change | |
| |
2024 | | |
2023 | | |
Amount | | |
% | |
| |
| | |
| | |
| | |
| |
Revenues | |
$ | - | | |
$ | 28,555 | | |
$ | (28,555 | ) | |
| (100 | )% |
Cost of revenues | |
| (25,373 | ) | |
| (55,817 | ) | |
| 30,444 | | |
| (55 | )% |
Gross loss | |
| (25,373 | ) | |
| (27,262 | ) | |
| 1,889 | | |
| (7 | )% |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development expenses | |
| 1,978,756 | | |
| 1,671,187 | | |
| 307,569 | | |
| 18 | % |
Selling, general and administrative expenses | |
| 1,044,880 | | |
| 618,149 | | |
| 426,731 | | |
| 69 | % |
Total operating expenses | |
| 3,023,636 | | |
| 2,289,336 | | |
| 734,300 | | |
| 32 | % |
Loss from operations | |
| (3,049,009 | ) | |
| (2,316,598 | ) | |
| (732,411 | ) | |
| 32 | % |
| |
| | | |
| | | |
| | | |
| | |
Non-operating (expenses) income, net: | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (118,759 | ) | |
| (40,311 | ) | |
| (78,448 | ) | |
| 195 | % |
Issuance cost of senior secured convertible note measured at fair value | |
| - | | |
| - | | |
| - | | |
| - | |
Fair value change for senior secured convertible note | |
| (66,844 | ) | |
| - | | |
| (66,844 | ) | |
| - | |
Other income, net | |
| 39,590 | | |
| 7,182 | | |
| 32,408 | | |
| 451 | % |
Total non-operating expenses, net | |
| (146,013 | ) | |
| (33,129 | ) | |
| (112,884 | ) | |
| 341 | % |
| |
| | | |
| | | |
| | | |
| | |
Net loss before income taxes | |
| (3,195,022 | ) | |
| (2,349,727 | ) | |
| (845,295 | ) | |
| 36 | % |
Provision for income taxes | |
| - | | |
| - | | |
| - | | |
| | |
Net loss | |
$ | (3,195,022 | ) | |
$ | (2,349,727 | ) | |
$ | (845,295 | ) | |
| 36 | % |
Revenues,
Cost and Gross Loss
The
Company reported nil and $28,555 in revenue in Q2 2024 and Q2 2023, respectively, from product sales of VELDONA pet cytoprotein supplements
and Ainos COVID-19 Antigen Rapid Test Kits in Taiwan respectively. The Company launched its VELDONA pet cytoprotein supplement products
in the third quarter of 2023; due to the expiration of EUA, the company ceased the sale of the Ainos COVID-19 antigen rapid test kits
in the first quarter of 2024. There are few sales volume in 2024 Q2 but offset by exchange rate fluctuations.
The
cost of revenue related to product sales in Q2 2024 was $25,373 compared to $55,817 in Q2 2023. The
decrease in cost of revenue was due to the decrease in sales volume.
The
share-based compensation expense and the depreciation expense for manufacturing in Q2 2024 and Q2 2023 were $4,516 and $24,366, respectively.
When excluding these non-cash cost, cost of revenue decreased to $20,857 in Q2 2024 compared to $31,451 in Q2 2023.
Gross
loss from product sales in Q2 2024 was $25,373 as compared to $27,262 gross loss from product sales in Q2 2023. The decrease in gross
loss was due to low sales volume for newly launched products, and a reduced cost of revenue.
When
excluding these non-cash costs, gross loss increased to $20,857 in Q2 2024 compared to $2,896 gross loss in Q2 2023.
Research
and Development (R&D) Expenses
R&D
expenses in Q2 2024 and Q2 2023 were $1,978,756 and $1,671,187, respectively. The increase of $307,569 (18%) was due to increased expenses
associated with co-research for technology and product, as well as staffing expenditures (including share-based compensation), which
were offset by a decrease in professional expense. 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 Q2 2024 and Q2 2023 were $1,276,777 and $1,210,429,
respectively. Excluding these non-cash expenses, R&D expenses increased to $701,979 in Q2 2024 from $460,758 in Q2 2023.
Selling,
General and Administrative (SG&A) Expenses
SG&A
expenses were $1,044,880 and $618,149 in Q2 2024 and Q2 2023, respectively, reflecting an increase of $426,731 (69%) due to a significant
increase in staffing expenditures (including share-based compensation) and professional expenses and Nasdaq and SEC filing fees. 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 Q2 2024 and Q2 2023 were $338,669 and $121,025, respectively.
Excluding these non-cash expenses, SG&A expenses increased to $706,211 in Q2 2024 compared to $497,124 in Q2 2023.
Operating
Loss
The
Company’s operating loss was $3,049,009 and $2,316,598 in Q2 2024 and Q2 2023, respectively, reflecting a $732,411 (32%) increase
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
In
Q2 2024, interest expense was $118,759 compared to $40,311 in Q2 2023. The increase in interest expense was due to accrued
interest for convertible notes issued in May 2024.
Net
Loss
Net
loss was $3,195,022 in Q2 2024 compared to $2,349,727 in Q2 2023, resulting in a $845,295 (36%) increase in net loss attributable to
our shareholders of common stock. The net loss was due to an expanding operating expense. We continued to invest resources to execute
our growth strategy and product roadmap to improve our profitability.
Results
of Operations for Six Months Ended June 30, 2024 (“H1 2024”) and June 30, 2023 (“H1 2023”):
| |
Six months ended June 30, | | |
Change | |
| |
2024 | | |
2023 | | |
Amount | | |
% | |
| |
| | |
| | |
| | |
| |
Revenues | |
$ | 20,729 | | |
$ | 77,719 | | |
$ | (56,990 | ) | |
| (73 | )% |
Cost of revenues | |
| (52,127 | ) | |
| (156,665 | ) | |
| 104,538 | | |
| (67 | )% |
Gross loss | |
| (31,398 | ) | |
| (78,946 | ) | |
| 47,548 | | |
| (60 | )% |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development expenses | |
| 4,063,404 | | |
| 3,370,070 | | |
| 693,334 | | |
| 21 | % |
Selling, general and administrative expenses | |
| 2,074,298 | | |
| 1,380,614 | | |
| 693,684 | | |
| 50 | % |
Total operating expenses | |
| 6,137,702 | | |
| 4,750,684 | | |
| 1,387,018 | | |
| 29 | % |
Loss from operations | |
| (6,169,100 | ) | |
| (4,829,630 | ) | |
| (1,339,470 | ) | |
| 28 | % |
| |
| | | |
| | | |
| | | |
| | |
Non-operating (expenses) income, net: | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (167,455 | ) | |
| (49,585 | ) | |
| (117,870 | ) | |
| 238 | % |
Issuance cost of senior secured convertible note measured at fair value | |
| (138,992 | ) | |
| - | | |
| (138,992 | ) | |
| - | |
Fair value change for senior secured convertible note | |
| (98,412 | ) | |
| - | | |
| (98,412 | ) | |
| - | |
Other income, net | |
| 64,127 | | |
| 9,013 | | |
| 55,114 | | |
| 611 | % |
Total non-operating expenses, net | |
| (340,732 | ) | |
| (40,572 | ) | |
| (300,160 | ) | |
| 740 | % |
| |
| | | |
| | | |
| | | |
| | |
Net loss before income taxes | |
| (6,509,832 | ) | |
| (4,870,202 | ) | |
| (1,639,630 | ) | |
| 34 | % |
Provision for income taxes | |
| - | | |
| - | | |
| - | | |
| | |
Net loss | |
$ | (6,509,832 | ) | |
$ | (4,870,202 | ) | |
$ | (1,639,630 | ) | |
| 34 | % |
Revenues,
Cost and Gross Loss
The
Company reported $20,729 and $77,719 in revenue in H1 2024 and H1 2023, respectively, from product sales of VELDONA pet cytoprotein supplements
and Ainos COVID-19 Antigen Rapid Test Kits in Taiwan respectively. The Company launched its VELDONA pet cytoprotein supplement products
in the third quarter of 2023; due to the expiration of EUA, the company ceased the sale of the Ainos COVID-19 antigen rapid test kits
in the first quarter of 2024.
The
cost of revenue related to product sales in H1 2024 was $52,127 compared to $156,665 in H1 2023. The
decrease in cost of revenue was due to the decrease in sales volume.
The
share-based compensation expense and the depreciation expense for manufacturing in H1 2024 and H1 2023 were $9,032 and $48,354, respectively.
When excluding these non-cash cost, cost of revenue decreased to $43,095 in H1 2024 compared to $108,311 in H1 2023.
Gross
loss from product sales in H1 2024 was $31,398 as compared to $78,946 gross loss from product sales in H1 2023. The decrease in gross
loss was due to low sales volume for newly launched products, and a lower cost of revenue.
When
excluding these non-cash costs, gross loss decreased to $22,366 in H1 2024 compared to $30,592 gross loss in H1 2023.
Research
and Development (R&D) Expenses
R&D
expenses in H1 2024 and H1 2023 were $4,063,404 and $3,370,070, respectively. The increase of $693,334 (21%) was due to increased expenses
associated with co-research for technology and product and staffing expenditures (including share-based compensation), which were offset
by a decrease in professional expense. 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 H1 2024 and H1 2023 were $2,561,120 and $2,405,414,
respectively. When excluding these non-cash expenses, R&D expenses increased to $1,502,284 in H1 2024 from $964,656 in H1 2023.
Selling,
General and Administrative (SG&A) Expenses
SG&A
expenses were $2,074,298 and $1,380,614 in H1 2024 and H1 2023, respectively, reflecting an increase of $693,684 (50%) due to a significant
increase in staffing expenditures (including share-based compensation) and professional expenses. 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 H1 2024 and H1 2023 were $676,622 and $327,495, respectively.
When excluding these non-cash expenses, SG&A expenses increased to $1,397,676 in H1 2024 compared to $1,053,119 in H1 2023.
Operating
Loss
The
Company’s operating loss was $6,169,100 and $4,829,630 in H1 2024 and H1 2023, respectively, reflecting a $1,339,470 (28%) increase
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
H1 2024, interest expense was $167,455 compared to $49,585 in H1 2023. The increase in interest expense was due to accrued
interest for convertible notes issued in May 2024.
On
January 23, 2024, the Company received an Increased Funding Amount and incurred an issuance cost including investor and placement agent
fees, as well as legal fees. $138,992 of the issuance cost was expensed for the amendment of funding received and closed by the Company.
Net
Loss
Net
loss was $6,509,832 in H1 2024 compared to $4,870,202 in H1 2023, resulting in a $1,639,630 (34%) increase in net loss attributable to
our shareholders of common stock. The net loss was due to an expanding operating expense. We continued to invest resources to execute
our growth strategy and product roadmap to improve our profitability.
Liquidity
and Capital Resources
As
of June 30, 2024 and December 31, 2023, the Company had available cash of $8,014,098 and $1,885,628, respectively.
The
following table summarizes our cash flow during the three months period ended June 30, 2024 and 2023:
| |
Six months ended June 30, | |
| |
2024 | | |
2023 | |
Net cash used in operating activities | |
| (3,468,892 | ) | |
| (2,578,453 | ) |
Net cash used in investing activities | |
| (119,792 | ) | |
| (71,262 | ) |
Net cash provided by financing activities | |
| 9,777,500 | | |
| 2,185,974 | |
Operating
activities:
Cash
used in operating activities decreased by $890,439 during the H1 of 2024 compared to the H1 of 2023. Our net loss for the H1 of 2024
increased by $1,639,630 primarily due to increase of operating expenses. The operating cash outflow as a result of changes in operating
assets and liabilities was mainly attributable to:
|
● |
Non-cash
expenses including share-based compensation, depreciation and amortization, loss on inventory write-downs, issuance cost of secured
convertible note, and change in fair value of senior secured convertible note increased approximately by $645,500; |
|
● |
Working
capital injected into accounts receivable, inventories and other current assets decreased by approximately $17,000; and |
|
● |
Working
capital injected into accrued expenses, operating lease liabilities, contract liabilities and other current and long-term liabilities
increased by approximately $120,600. |
Investing
activities
Cash
used for investing activities were $119,792 and $71,262 during the H1 of 2024 and the H1 of 2023, respectively. The increase was due
to increase in refundable deposits and other noncurrent assets offset by decrease in purchase of property and equipment.
Financing
activities
Cash
provided by financing activities were $9,777,500 and $2,185,974 during the H1 of 2024 and the H1 of 2023, respectively. The $7,591,526
increase was primarily reflected by the following:
|
● |
Repayment
of convertible notes and other notes payable decreased by $314,026; |
|
● |
Proceeds
from convertible notes and other notes payable financing increased by $7,375,000; and |
|
● |
Payments
of issuance cost of senior secured convertible note measured at fair value increased by $97,500. |
As
disclosed in Note 5 (Convertible Notes Payable and Other Notes Payable), to our accompanying condensed financial statements we received
$875,000 in proceeds from the Lind Note transaction in January 2024.
As
disclosed in Note 5 (Convertible Notes Payable and Other Notes Payable), to our accompanying condensed financial statements we received
$9,000,000 in proceeds from the ASE Note transaction in May 2024.
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 may also increase our sales and marketing efforts.
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 2023 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 June 30, 2024.
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.
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 2023 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 2023 Annual Report. There have been no material changes from the
risk factors previously disclosed in our 2023 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 issuance of the Lind Note, 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
During the three months ended June 30, 2024, we did not issue any securities that were either (a) unregistered pursuant
to the Securities Act or (b) not previously disclosed in a Current Report on Form 8-K.
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
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 |
3.1 |
|
Amended and Restated Bylaws of Ainos, Inc. |
|
|
|
6/20/2024 |
|
8-K |
|
3.1 |
|
Amended and Restated Bylaws of Ainos, Inc. |
4.1 |
|
Voting Deed, dated as of May 3, 2024, by and among Ainos, Inc., a Cayman Islands company, and ASE Test, Inc. |
|
|
|
5/6/2024 |
|
8-K |
|
4.1 |
|
Voting Deed, dated as of May 3, 2024, by and among Ainos, Inc., a Cayman Islands company, and ASE Test, Inc. |
4.2 |
|
Convertible Promissory Note, dated as of May 3, 2024, issued by Ainos, Inc. in favor of ASE Test, Inc. in the principal amount of US$9,000,000. |
|
|
|
5/6/2024 |
|
8-K |
|
4.2 |
|
Convertible Promissory Note, dated as of May 3, 2024, issued by Ainos, Inc. in favor of ASE Test, Inc. in the principal amount of US$9,000,000. |
4.3 |
|
Common Stock Warrant, dated as of May 3, 2024, issued by Ainos, Inc. to ASE Test, Inc. |
|
|
|
5/6/2024 |
|
8-K |
|
4.3 |
|
Common Stock Warrant, dated as of May 3, 2024, issued by Ainos, Inc. to ASE Test, Inc. |
10.1 |
|
Convertible Note and Warrant Purchase Agreement, dated May 3, 2024, by and between Ainos, Inc. and ASE Test, Inc. |
|
|
|
5/6/2024 |
|
8-K |
|
10.1 |
|
Convertible Note and Warrant Purchase Agreement, dated May 3, 2024, by and between Ainos, Inc. and ASE Test, Inc. |
10.2 |
|
English Translation of Second Addendum to the Product Development Agreement, dated July 8, 2024 |
|
|
|
7/12/2024 |
|
8-K |
|
10.1 |
|
English Translation of Second Addendum to the Product Development Agreement |
31.1 |
|
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350 Section 302 of the Sarbanes-Oxley Act of 2002 |
|
x |
|
|
|
|
|
|
|
|
31.2 |
|
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350 Section 302 of the Sarbanes-Oxley Act of 2002 |
|
x |
|
|
|
|
|
|
|
|
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 |
|
x |
|
|
|
|
|
|
|
|
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 |
|
x |
|
|
|
|
|
|
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|
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101.INS |
|
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|
101.SCH |
|
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Taxonomy Extension Schema Document |
|
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104.1 |
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Cover
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x |
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|
|
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|
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. |
|
|
|
Date:
August 05, 2024 |
By:
|
/s/
Chun-Hsien Tsai |
|
|
Chun-Hsien
Tsai, Chairman of the Board, President, and Chief Executive Officer |
|
|
|
Date:
August 05, 2024 |
By: |
/s/
Hsin-Liang Lee |
|
|
Hsin-Liang
Lee, Chief Financial Officer |
EXHIBIT 31.1
SECTION 302 CERTIFICATION
I, Chun-Hsien Tsai, certify that:
1. I have reviewed this report
on Form 10-Q of Ainos, Inc.;
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;
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;
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:
(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;
(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;
(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
(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):
(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
(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: August 05, 2024 |
/s/ Chun-Hsien Tsai |
|
Chun-Hsien Tsai, Principal Executive Officer |
|
(Chairman of the Board, President, and Chief Executive Officer) |
EXHIBIT 31.2
SECTION 302 CERTIFICATION
I, Hsin-Liang Lee, certify that:
1. I have reviewed this report
on Form 10-Q of Ainos, Inc.;
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;
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;
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:
(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;
(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;
(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
(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):
(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
(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: August 05, 2024 |
/s/ Hsin-Liang Lee |
|
Hsin-Liang Lee, Principal Financial Officer |
|
(Chief Financial Officer) |
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 June 30, 2024 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
2. The information contained in the Report fairly
presents, in all material respects, the financial condition and results of operation of the Company.
|
AINOS, INC. |
|
|
|
Date: August 05, 2024 |
By: |
/s/ Chun-Hsien Tsai |
|
|
Chun-Hsien Tsai, Principal Executive Officer |
|
|
(Chairman of the Board, President, and Chief Executive Officer) |
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 June 30, 2024 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
2. The information contained in the Report fairly
presents, in all material respects, the financial condition and results of operation of the Company.
|
AINOS, INC. |
|
|
|
Date: August 05, 2024 |
By: |
/s/ Hsin-Liang Lee |
|
|
Hsin-Liang Lee, Principal Financial Officer |
|
|
(Chief Financial Officer) |
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Condensed Balance Sheets (Unaudited) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 8,014,098
|
$ 1,885,628
|
Accounts receivable |
9
|
455
|
Inventory, net |
166,322
|
167,593
|
Other current assets |
291,166
|
419,521
|
Total current assets |
8,471,595
|
2,473,197
|
Intangible assets, net |
26,028,058
|
28,283,208
|
Property and equipment, net |
691,100
|
876,572
|
Other assets |
348,634
|
208,827
|
Total assets |
35,539,387
|
31,841,804
|
Current liabilities: |
|
|
Contract liabilities |
106,502
|
112,555
|
Convertible notes payable |
3,000,000
|
|
Senior secured convertible notes measured at fair value - Current |
1,585,761
|
|
Other notes payable, related party |
312,000
|
42,000
|
Accrued expenses and others current liabilities |
738,936
|
1,182,283
|
Total current liabilities |
5,743,199
|
1,336,838
|
Senior secured convertible notes measured at fair value |
|
2,651,556
|
Convertible notes payable |
9,000,000
|
3,000,000
|
Other notes payable, related party - noncurrent |
|
270,000
|
Other long-term liabilities |
83,912
|
135,829
|
Total liabilities |
14,827,111
|
7,394,223
|
Commitments and contingencies |
|
|
Stockholders’ equity: |
|
|
Preferred stock, $0.01 par value; 50,000,000 shares authorized; none issued and outstanding as of June 30, 2024 and December 31,2023, respectively |
|
|
Common stock, $0.01 par value; 300,000,000 shares authorized as of June 30, 2024 and December 31, 2023, 7,388,674 and 4,677,787 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively |
73,887
|
46,778
|
Common stock to be issued 270 shares and 162,337 shares as of June 30, 2024 and December 31, 2023, respectively |
3
|
1,623
|
Additional paid-in capital |
65,414,761
|
62,555,808
|
Accumulated deficit |
(44,395,987)
|
(37,886,155)
|
Accumulated other comprehensive loss - translation adjustment |
(380,388)
|
(270,473)
|
Total stockholders’ equity |
20,712,276
|
24,447,581
|
Total liabilities and stockholders’ equity |
$ 35,539,387
|
$ 31,841,804
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v3.24.2.u1
Condensed Balance Sheets (Unaudited) (Parenthetical) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Defined Benefit Plan Disclosure [Line Items] |
|
|
Convertible notes payable current |
$ 3,000,000
|
|
Convertible notes payable noncurrent |
$ 9,000,000
|
$ 3,000,000
|
Preferred stock, par value |
$ 0.01
|
$ 0.01
|
Preferred stock, shares authorized |
50,000,000
|
50,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0.01
|
$ 0.01
|
Common stock, shares authorized |
300,000,000
|
300,000,000
|
Common stock, shares issued |
7,388,674
|
4,677,787
|
Common stock, shares outstanding |
7,388,674
|
4,677,787
|
Common stock to be issued |
270
|
162,337
|
Related Party [Member] |
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
Convertible notes payable current |
$ 2,000,000
|
|
Convertible notes payable noncurrent |
$ 9,000,000
|
$ 2,000,000
|
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v3.24.2.u1
Condensed Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Revenues |
|
$ 28,555
|
$ 20,729
|
$ 77,719
|
Cost of revenues (including amounts of related party of nil for the three months ended June 30, 2024 and 2023, and nil and $46,635 for the six months ended June 30, 2024 and 2023, respectively) |
(25,373)
|
(55,817)
|
(52,127)
|
(156,665)
|
Gross loss |
(25,373)
|
(27,262)
|
(31,398)
|
(78,946)
|
Operating expenses: |
|
|
|
|
Research and development expenses (including amounts of related party of $386,507 and $761,700 for the three and six months ended June 30, 2024, and $74,733 and $152,196 for the three and six months ended June 30, 2023, respectively) |
1,978,756
|
1,671,187
|
4,063,404
|
3,370,070
|
Selling, general and administrative expenses |
1,044,880
|
618,149
|
2,074,298
|
1,380,614
|
Total operating expenses |
3,023,636
|
2,289,336
|
6,137,702
|
4,750,684
|
Loss from operations |
(3,049,009)
|
(2,316,598)
|
(6,169,100)
|
(4,829,630)
|
Non-operating (expenses) income, net: |
|
|
|
|
Interest expense |
(118,759)
|
(40,311)
|
(167,455)
|
(49,585)
|
Issuance cost of senior secured convertible note measured at fair value |
|
|
(138,992)
|
|
Fair value change for senior secured convertible note |
(66,844)
|
|
(98,412)
|
|
Other income, net |
39,590
|
7,182
|
64,127
|
9,013
|
Total non-operating expenses, net |
(146,013)
|
(33,129)
|
(340,732)
|
(40,572)
|
Net loss before income taxes |
(3,195,022)
|
(2,349,727)
|
(6,509,832)
|
(4,870,202)
|
Provision for income taxes |
|
|
|
|
Net loss |
$ (3,195,022)
|
$ (2,349,727)
|
$ (6,509,832)
|
$ (4,870,202)
|
Net loss per common share - basic |
$ (0.49)
|
$ (0.58)
|
$ (1.06)
|
$ (1.21)
|
Net loss per common share - diluted |
$ (0.49)
|
$ (0.58)
|
$ (1.06)
|
$ (1.21)
|
Weighted-average shares used in computing net loss per common share-basic |
6,519,014
|
4,019,030
|
6,145,148
|
4,010,666
|
Weighted-average shares used in computing net loss per common share-diluted |
6,519,014
|
4,019,030
|
6,145,148
|
4,010,666
|
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v3.24.2.u1
Condensed Statements of Operations (Unaudited) (Parenthetical) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
Cost of revenue |
$ 25,373
|
$ 55,817
|
$ 52,127
|
$ 156,665
|
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1,978,756
|
1,671,187
|
4,063,404
|
3,370,070
|
Related Party [Member] |
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
Cost of revenue |
|
|
|
46,635
|
Research and development expense |
$ 386,507
|
$ 74,733
|
$ 761,700
|
$ 152,196
|
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- DefinitionThe aggregate cost of goods produced and sold and services rendered during the reporting period.
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3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Net loss |
$ (3,195,022)
|
$ (2,349,727)
|
$ (6,509,832)
|
$ (4,870,202)
|
Other comprehensive (loss) income: |
|
|
|
|
Translation adjustment |
(44,646)
|
(53,867)
|
(109,915)
|
(43,806)
|
Comprehensive loss |
$ (3,239,668)
|
$ (2,403,594)
|
$ (6,619,747)
|
$ (4,914,008)
|
X |
- DefinitionAmount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.
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v3.24.2.u1
Condensed Statements of Stockholders' Equity (Unaudited) - USD ($)
|
Preferred Stock [Member] |
Common Stock [Member] |
Common Stock To Be Issued [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
AOCI Attributable to Parent [Member] |
Total |
Balance at Dec. 31, 2022 |
|
$ 40,023
|
|
$ 58,905,242
|
$ (24,115,606)
|
$ (201,653)
|
$ 34,628,006
|
Balance, shares at Dec. 31, 2022 |
|
4,002,320
|
|
|
|
|
|
Conversion of convertible notes payable to common stock |
|
$ 187
|
|
274,602
|
|
|
274,789
|
Conversion of convertible notes payable to common stock, shares |
|
18,666
|
|
|
|
|
|
Share-based compensation |
|
|
|
357,991
|
|
|
357,991
|
Net loss |
|
|
|
|
(4,870,202)
|
|
(4,870,202)
|
Translation adjustment |
|
|
|
|
|
(43,806)
|
(43,806)
|
Issuance of stock to settle vested RSUs |
|
$ 253
|
|
(253)
|
|
|
|
Issuance of stock to settle vested RSUs, shares |
|
25,306
|
|
|
|
|
|
Issuance of stock in exchange of vehicle |
|
$ 122
|
|
48,437
|
|
|
48,559
|
Issuance of stock in exchange of vehicle, shares |
|
12,231
|
|
|
|
|
|
Balance at Jun. 30, 2023 |
|
$ 40,585
|
|
59,586,019
|
(28,985,808)
|
(245,459)
|
30,395,337
|
Balance, shares at Jun. 30, 2023 |
|
4,058,523
|
|
|
|
|
|
Balance at Mar. 31, 2023 |
|
$ 40,023
|
|
59,126,074
|
(26,636,081)
|
(191,592)
|
32,338,424
|
Balance, shares at Mar. 31, 2023 |
|
4,002,320
|
|
|
|
|
|
Conversion of convertible notes payable to common stock |
|
$ 187
|
|
274,602
|
|
|
274,789
|
Conversion of convertible notes payable to common stock, shares |
|
18,666
|
|
|
|
|
|
Share-based compensation |
|
|
|
137,159
|
|
|
137,159
|
Net loss |
|
|
|
|
(2,349,727)
|
|
(2,349,727)
|
Translation adjustment |
|
|
|
|
|
(53,867)
|
(53,867)
|
Issuance of stock to settle vested RSUs |
|
$ 253
|
|
(253)
|
|
|
|
Issuance of stock to settle vested RSUs, shares |
|
25,306
|
|
|
|
|
|
Issuance of stock in exchange of vehicle |
|
$ 122
|
|
48,437
|
|
|
48,559
|
Issuance of stock in exchange of vehicle, shares |
|
12,231
|
|
|
|
|
|
Balance at Jun. 30, 2023 |
|
$ 40,585
|
|
59,586,019
|
(28,985,808)
|
(245,459)
|
30,395,337
|
Balance, shares at Jun. 30, 2023 |
|
4,058,523
|
|
|
|
|
|
Balance at Dec. 31, 2023 |
|
$ 46,778
|
$ 1,623
|
62,555,808
|
(37,886,155)
|
(270,473)
|
24,447,581
|
Balance, shares at Dec. 31, 2023 |
|
4,677,787
|
162,337
|
|
|
|
|
Share-based compensation |
|
|
|
848,077
|
|
|
848,077
|
Net loss |
|
|
|
|
(6,509,832)
|
|
(6,509,832)
|
Translation adjustment |
|
|
|
|
|
(109,915)
|
(109,915)
|
Issuance of stock to settle vested RSUs |
|
$ 1,340
|
$ 3
|
(1,343)
|
|
|
|
Issuance of stock to settle vested RSUs, shares |
|
133,964
|
270
|
|
|
|
|
Conversion of senior secured convertible note payable to common stock |
|
$ 24,146
|
|
2,015,061
|
|
|
2,039,207
|
Conversion of senior secured convertible note payable to common stock, shares |
|
2,414,586
|
|
|
|
|
|
Related party used computer equipment |
|
|
|
(4,428)
|
|
|
(4,428)
|
Warrants issued in connection with senior secured convertible note payable |
|
|
|
1,586
|
|
|
1,586
|
Issuance of common stock |
|
$ 1,623
|
$ (1,623)
|
|
|
|
|
Issuance of common stock, shares |
|
162,337
|
(162,337)
|
|
|
|
|
Balance at Jun. 30, 2024 |
|
$ 73,887
|
$ 3
|
65,414,761
|
(44,395,987)
|
(380,388)
|
20,712,276
|
Balance, shares at Jun. 30, 2024 |
|
7,388,674
|
270
|
|
|
|
|
Balance at Mar. 31, 2024 |
|
$ 61,445
|
$ 3
|
64,154,052
|
(41,200,965)
|
(335,742)
|
22,678,793
|
Balance, shares at Mar. 31, 2024 |
|
6,144,506
|
270
|
|
|
|
|
Conversion of convertible notes payable to common stock |
|
$ 12,442
|
|
838,335
|
|
|
850,777
|
Conversion of convertible notes payable to common stock, shares |
|
1,244,168
|
|
|
|
|
|
Share-based compensation |
|
|
|
422,374
|
|
|
422,374
|
Net loss |
|
|
|
|
(3,195,022)
|
|
(3,195,022)
|
Translation adjustment |
|
|
|
|
|
(44,646)
|
(44,646)
|
Balance at Jun. 30, 2024 |
|
$ 73,887
|
$ 3
|
$ 65,414,761
|
$ (44,395,987)
|
$ (380,388)
|
$ 20,712,276
|
Balance, shares at Jun. 30, 2024 |
|
7,388,674
|
270
|
|
|
|
|
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v3.24.2.u1
Condensed Statements of Cash Flows (Unaudited) - USD ($)
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Cash flows from Operating Activities: |
|
|
Net loss |
$ (6,509,832)
|
$ (4,870,202)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation and amortization |
2,398,696
|
2,423,274
|
Loss on inventory write-downs |
|
57,474
|
Share-based compensation expense |
848,077
|
357,991
|
Issuance cost of senior secured convertible note measured at fair value |
138,992
|
|
Change in fair value of senior secured convertible note |
98,412
|
|
Changes in operating assets and liabilities: |
|
|
Accounts receivable |
446
|
192,161
|
Inventory |
1,271
|
10,814
|
Other current assets |
128,355
|
(55,990)
|
Accrued expenses and other current and long-term liabilities |
(573,309)
|
(693,975)
|
Net cash used in operating activities |
(3,468,892)
|
(2,578,453)
|
Cash flows from Investing Activities: |
|
|
Purchase of property and equipment |
(10,276)
|
(71,262)
|
Increase in refundable deposits and others |
(109,516)
|
|
Net cash used in investing activities |
(119,792)
|
(71,262)
|
Cash flows from Financing Activities: |
|
|
Proceeds from convertible notes payable- noncurrent |
|
1,000,000
|
Proceeds from convertible notes payable, related party |
9,000,000
|
1,500,000
|
Proceeds from senior secured convertible notes payable |
875,000
|
|
Repayment of other notes payable, related party |
|
(200,000)
|
Repayment of convertible notes payable, related party |
|
(114,026)
|
Payments of issuance cost of senior secured convertible note measured at fair value |
(97,500)
|
|
Net cash provided by financing activities |
9,777,500
|
2,185,974
|
Effect from foreign currency exchange |
(60,346)
|
(28,651)
|
Net increase (decrease) in cash and cash equivalents |
6,128,470
|
(492,392)
|
Cash and cash equivalents at beginning of year |
1,885,628
|
1,853,362
|
Cash and cash equivalents at end of year |
8,014,098
|
1,360,970
|
Supplemental Cash Flow Information |
|
|
Cash paid for interest |
39
|
3,122
|
Noncash financing and investing activities: |
|
|
Conversion of convertible notes payable to common stock and accrued interest waived by convertible notes holders |
|
274,789
|
Conversion of senior secured convertible notes to common stock |
2,039,207
|
|
Issuance of common stocks in exchange of vehicle |
|
48,559
|
Account payable to purchase equipment |
|
$ 5,848
|
X |
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v3.24.2.u1
Description of Business
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Description of Business |
1.
Description of Business
Organization
and Business
Ainos,
Inc. (the “Company”), incorporated in the State of Texas in 1984, 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. Our product pipeline includes commercial-stage VELDONA Pet cytoprotein supplements, clinical-stage
VELDONA human and animal therapeutics and telehealth-friendly POCTs powered by the AI Nose technology platform.
We
have historically involved in the research and development of therapeutics based on VELDONA. Building on our research and development
on VELDONA since inception, we are focused on commercializing a suite of VELDONA-based product candidates.
In
2021 and 2022, we acquired certain types of intellectual property from our controlling shareholder, Ainos Inc., a Cayman Island corporation
(“Ainos KY”), to expand product portfolio into POCTs aimed to provide connected, rapid, and convenient testing for a broad
range of health conditions. Pivoting from the sales of COVID-19 POCT, we aim to commercialize POCTs that detect volatile organic compounds
(the “VOC”) emitted by the body, powered by our AI Nose technology platform. Our lead VOC POCT candidate, Ainos Flora, aims
to test female vaginal health and certain common sexually transmitted infections (the “STIs”) quickly and easily.
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.
Reverse
Stock Splits
In
connection with the Offering, the Company’s board of directors on April 29, 2022 and its shareholders on May 16, 2022 approved
a 1-for-15 reverse stock split of the Company’s common stock that became effective on August 9, 2022. Further, to comply with Nasdaq’s
minimum $1.00 per share continued listing rules, the Company filed a Certificate of Amendment to its Restated Certificate of Formation
on November 27, 2023, to apply for another reverse stock split of the Company’s common stock at a ratio of 1-for-5 which was effectuated
on December 14, 2023 after receiving required approvals.
The
par value of $0.01 and authorized shares of the Company’s common stock remains the same and were not adjusted as a result of the
reverse stock splits. All issued and outstanding common stock, restricted stock units (RSUs), outstanding convertible notes, warrants
and options to purchase common stock and per share amounts contained in the financial statements have been retroactively adjusted to
give effect to the reverse stock splits for all periods presented.
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- DefinitionThe entire disclosure for the business description and basis of presentation concepts. Business description describes the nature and type of organization including but not limited to organizational structure as may be applicable to holding companies, parent and subsidiary relationships, business divisions, business units, business segments, affiliates and information about significant ownership of the reporting entity. Basis of presentation describes the underlying basis used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.24.2.u1
Summary of Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
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, 2023 contained in the Annual Report on Form 10-K filed with the
SEC on March 8, 2024.
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 six months
ended June 30, 2024 are not necessarily indicative of the results to be expected for any subsequent quarter, the year ending December
31, 2024, or any other period.
There
have been no material changes to the Company’s significant accounting policies as described in the audited financial statements
as of December 31, 2023.
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 June 30, 2024, the Company had cash and cash equivalents of $8,014,098. The Company plans to finance its operations and development
needs with its existing cash and cash equivalents, additional equity and/or debt financing arrangements, and expected near-term revenue
primarily from the sale of VELDONA Pet cytoprotein supplements to support the Company’s clinical trial activities, largely in connection
with Ainos Flora and human related VELDONA therapeutics. There can be no assurance that the Company will be able to obtain additional
financing on terms acceptable to the Company, on a timely basis, or at all.
For
the six months ended June 30, 2024, the Company generated a net loss of $6,509,832.
The Company expects to continue incurring development expenses for the next twelve months as the Company advances Ainos Flora and VELDONA
therapeutics for humans through clinical development until regulatory approval is received and the sales and marketing of the products
is authorized.
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 since inception and has an accumulated deficit
as of June 30, 2024 of $44,395,987 and expects to incur additional losses and negative operating cash flows for at least the next twelve
months. The Company’s ability to meet its obligations is dependent upon its ability to generate sufficient cash flows from operations
and future financing transactions. Management expects the Company will continue as a going concern for at least one year from the issuance
of these financial statements.
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 six months ended June 30, 2024 and 2023.
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.
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.24.2.u1
Cash and Cash Equivalents
|
6 Months Ended |
Jun. 30, 2024 |
Cash and Cash Equivalents [Abstract] |
|
Cash and Cash Equivalents |
3.
Cash and Cash Equivalents
As
of June 30, 2024 and December 31, 2023, cash and cash equivalents consisted 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. Accounts are guaranteed
by the Federal Deposit Insurance Corporation (FDIC) up to $250,000. As of June 30, 2024 and December 31, 2023, the Company had approximately
$4,281,890 and $1,557,487 in excess of FDIC insured limits, respectively. The Company maintains cash in state-owned banks in Taiwan.
In Taiwan, the insurance coverage of each bank is NTD$3,000,000 (approximately USD$93,750). As of June 30, 2024 and December 31, 2023,
the Company had approximately $3,358,000and
$0 cash in excess of the insured amount, respectively. The Company has not experienced any losses in such accounts.
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- DefinitionThe entire disclosure for cash and cash equivalent footnotes, which may include the types of deposits and money market instruments, applicable carrying amounts, restricted amounts and compensating balance arrangements. Cash and equivalents include: (1) currency on hand (2) demand deposits with banks or financial institutions (3) other kinds of accounts that have the general characteristics of demand deposits (4) short-term, highly liquid investments that are both readily convertible to known amounts of cash and so near their maturity that they present insignificant risk of changes in value because of changes in interest rates. Generally, only investments maturing within three months from the date of acquisition qualify.
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v3.24.2.u1
Inventory
|
6 Months Ended |
Jun. 30, 2024 |
Inventory Disclosure [Abstract] |
|
Inventory |
4.
Inventory
Inventory
stated at cost, net of reserve, consisted of the following:
Schedule of Inventory
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Raw materials | |
$ | 87,047 | | |
$ | 92,708 | |
Work in process | |
| 1,142 | | |
| 1,208 | |
Finished goods | |
| 78,133 | | |
| 73,677 | |
Total | |
$ | 166,322 | | |
$ | 167,593 | |
Inventory
write-downs to estimated net realizable values were nil for the three and six months ended June 30, 2024, compared to $14,694 and $57,474
for the three and six months ended June 30, 2023.
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v3.24.2.u1
Convertible Notes Payable and Other Notes Payable
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
Convertible Notes Payable and Other Notes Payable |
5.
Convertible Notes Payable and Other Notes Payable
As
of June 30, 2024 and December 31, 2023, the respective notes payable were as follows:
Schedule of Notes Payable
| |
June 30, 2024 | | |
December 31, 2023 | |
Other notes payable, related party – current | |
$ | 312,000 | | |
$ | 42,000 | |
Other notes payable, related party - noncurrent | |
| - | | |
| 270,000 | |
March 2025 Convertible Notes, related party – noncurrent (ASE Note) | |
| - | | |
| 2,000,000 | |
March 2025 Convertible Notes, related party –current (ASE Note) | |
| 2,000,000 | | |
| - | |
March 2025 Convertible Notes – noncurrent (Lee Note) | |
| - | | |
| 1,000,000 | |
March 2025 Convertible Notes –current (Lee Note) | |
| 1,000,000 | | |
| - | |
Senior secured convertible notes payable (Lind Note) - fair value | |
| 1,585,761 | | |
| 2,651,556 | |
May 2027 Convertible Notes, related party – noncurrent (ASE Note) | |
| 9,000,000 | | |
| - | |
Notes payable | |
$ | 13,897,761 | | |
$ | 5,963,556 | |
The
other notes payable were issued to Ainos KY, the controlling shareholder of the Company, in exchange for $800,000 in cash to support
working capital of the Company in March 2022 (the “KY Note”). The Company paid off $530,000 of the KY Note during the year
ended December 31, 2023. The Company did not repay the KY Note during the three and six months ended June 30, 2024. Another note payable
was issued to i2China Management Group, LLC (“i2China”) in exchange for consulting services in 2020 (the “i2China Note”)
which remains outstanding for the amount of $42,000 as of June 30, 2024. Both the KY Note and the i2China Note bear an interest rate
of 1.85% per annum. On August 17, 2023, the Company entered into extension agreements with Ainos KY and i2China to extend the maturity
of the KY Note and i2China Note to March 31, 2025 and September 1, 2024, respectively.
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.
May
2027 Convertible Notes and Warrant Purchase Agreement
On
May 03, 2024, The Company entered into Convertible Note and Warrant Purchase Agreement with the ASE Test, Inc. (“ASE”), a
shareholder of Ainos KY, for the issuance of convertible promissory notes with 6% compound interest in the aggregate principal amount
of $9,000,000 (collectively the “Notes”) convertible into shares of common stock, par value $0.01 per share, of the Company,
payable three (3) years from May 03, 2024 as well as the issuance of warrants for the purchase of up to 500,000 shares of Common Stock
at a price per share of $4.50, exercisable until May 03, 2029. As of June 30, 2024, the Company received the full amount of the payment.
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 $3,000,000 with the following investors (the “March 2025 Convertible
Notes” or “Notes”).
Convertible
Note Issued to ASE Test, Inc. (the “ASE Note”)
Pursuant
to the one of the aforementioned agreements, ASE Test, Inc., a shareholder of Ainos KY, committed to pay a total aggregate amount of
$2,000,000 to the Company in exchange for convertible promissory note(s) in three tranches in the amounts of $1,000,000 (the “First
Tranche”), $500,000 (the “Second Tranche”), and $500,000 (the “Third Tranche”) conditioned, among other
things, on the Company achieving certain business milestones. As of June 30, 2024, the Company received the full amount of the payment.
Convertible
Note Issued to Li-Kuo Lee (the “Lee Note”)
The
Company issued a convertible note in the principal amount of $1,000,000 to an unrelated party, Li-Kuo Lee, in exchange of $1,000,000
in cash. As of June 30, 2024, the Company received the full amount of the payment.
The
March 2025 Convertible Notes will mature in two years from the issuance dates, bearing interest at the rate of 6% compounded interest
per annum. At any time after the issuance and before the maturity date, the Notes are convertible into the common stock of the Company
at the conversion price of $7.50 per share, subject to anti-dilutive adjustment as set forth in the Notes. Unless previously converted,
the Company shall repay the outstanding principal amount plus all accrued and unpaid interest on the maturity date. The Notes shall be
an unsecured general obligation of the Company.
The
total interest expense of convertible notes payable, other notes payable, March 2025 Convertible Notes and May 2027 Convertible Notes
and Warrant Purchase Agreement for the three and six months ended June 30, 2024 were $117,828 and $164,214 compared with the same period
in year 2023 were $37,991and $44,924. As of June 30, 2024 and December 31, 2023, the unpaid accrued interest expense was $303,153 and
$138,939, respectively.
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 $10,000,000 under various tranches to fund
clinical trials, commercial product launch and working capital of the Company. The Lind Note does not bear any interest and matures on
March 28, 2025..
In
2023, the Company issued and sold to Lind, in a private placement, (a) a senior secured convertible promissory note in the aggregate
principal amount of $3,540,000 (the “Lind Note”) and (b) warrants to purchase 691,244 shares of common stock at an exercise
price of $4.50 per share of common stock (the “Lind Warrant”) for a cash amount of $3,000,000. As of June 30, 2024, the Company
received the full amount of the funding.
Subject
to the satisfaction of certain conditions, the Company has the right to request additional tranches of funding from Lind in the aggregate
amount not to exceed $7.0 million (the “Increased Funding Amount”). Lind will receive additional warrants to purchase a number
of shares of common stock based on a formula set forth in the Securities Purchase Agreement. Such warrants will expire after five years
from the date of issuance and may be exercised on a cashless basis.
On
January 23, 2024, the Company received an Increased Funding Amount of up to $1.75 million, with $875,000 funded at closing and $875,000
to be funded subject to an effective registration statement and other conditions specified in the Securities Purchase Agreement, and
amended the Initial Note to, among other amendments, increase the principal amount to $4,235,000 (the Initial Note as so amended, the
“Note”). In connection with additional funding, the Company issued Lind a warrant to purchase 1,021,400 shares at an exercise
price of $2.16 per share (the “Second Lind Warrants and together with the First Lind Warrants, the “Lind Warrants”).
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 $7.50 per share, subject to adjustment, or 90% of the average of the three lowest daily VWAP of the common stock during
the 20 trading days prior to conversion, subject to certain adjustments.
As
of June 30, 2024, the converted principal amount from the SPA was $2,752,170 and the aggregate principal amount was $1,785,330.
From
an accounting perspective, the Lind Note is considered a debt host instrument embedded with an 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. As of June 30, 2024, the fair value of the Lind Note was $1,585,761. For
the three and six months ended June 30, 2024, the change in the fair value of the Lind Note was recorded in the Statements of Operations
in the amount of $66,844 and $98,412 respectively. No portion of the change in fair value was related to changes in credit risk of the
Company which would be charged to other comprehensive loss if any. 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 amendment of $875,000 of the Lind Note, including a commitment fee charged
by Lind, placement agent fee and warrants, and legal fees is $138,992, which is expensed off due to FVO election. $169,344 of the remaining
insurance cost related to the future funding of $6,125,000 offered by the SPA is deferred as other assets on the balance sheet and will
be expensed upon each closing or when the Company does not expect to complete the remaining funding.
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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Stockholders’ Equity
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
Stockholders’ Equity |
6.
Stockholders’ Equity
Preferred
Stock
The
Company increased authorized shares of preferred stock from 10,000,000 shares to 50,000,000 shares upon the filing of an amendment to
the Company’s Certificate of Formation with the Secretary of State of Texas on November 27, 2023. No shares of preferred stock
were issued and outstanding as of June 30, 2024 and December 31, 2023.
Common
Stock
During
the three months ended June 30, 2024, the Company issued an additional 1,244,168 shares of common stock as a result of delivering conversion
of the Lind’s Note. As of June 30, 2024, there were 7,388,674 shares of common stock legally issued and outstanding.
As
a result of the Lind private placement, the Company reserved up to 3,749,535 shares of common stock to be issued upon exercise of conversion
of the Lind Note and warrants issued in connection with the private placement.
Warrants
As
of June 30, 2024 and December 31, 2023, warrants issued and outstanding in connection with financing are summarized as below:
Schedule of Warrants Issued and Outstanding
| |
June 30, | | |
December 31, | |
(In number of shares) | |
2024 | | |
2023 | |
ASE Warrant with exercise price $4.5 | |
| 500,000 | | |
| - | |
Lind Warrant with exercise price from $2.16 to $4.50 | |
| 1,201,944 | | |
| 691,244 | |
Public warrant with exercise price of $21.25 | |
| 179,400 | | |
| 179,400 | |
Representative’s warrant with exercise price of $23.375 | |
| 7,800 | | |
| 7,800 | |
Placement agent warrant with exercise price of $8.25 | |
| 20,666 | | |
| 16,000 | |
Total | |
| 1,909,810 | | |
| 894,444 | |
As
mentioned in Note 5, in connection with Convertible Note and Warrant Purchase Agreement with the ASE, the Company issued warrants to
ASE for purchase of up to 500,000 shares of Common Stock at a price per share of $4.50, exercisable until May 03, 2029.
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 20,666 shares of warrants with an exercise price of $8.25 per share to the placement agent as the agent
fee. Each warrant has a contractual term of 5 years and can be exercised for the purchase of one share of common stock of the Company.
The carrying amount of the Lind Warrant is nil after allocating proceeds to the Lind Note measured at fair value. The fair value of the
placement agent warrant is estimated as $21,479 using the Black-Scholes Model.
As
disclosed in Note 1, the Company issued public warrants together with common stock 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 of 5 years, expiring on August 8, 2027, and can be exercised for the
purchase of one share of common stock of the Company.
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 June 30, 2024, none of the warrants have been exercised nor have expired.
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- DefinitionThe entire disclosure for equity.
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v3.24.2.u1
Revenue
|
6 Months Ended |
Jun. 30, 2024 |
Revenue Recognition and Deferred Revenue [Abstract] |
|
Revenue |
7.
Revenue
Revenue
is recognized upon shipment of products based upon contractually stated pricing at standard payment terms within 30 to 60 days. The revenue
generated by product sales is recognized at point in time.
The
Company generated revenue from sales of COVID-19 Antigen Rapid Test Kits in the Taiwan market for the three and six months ended June
30, 2023. 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 June 30, 2024 and December 31, 2023.
The
Company generated revenue from sales of VELDONA Pet cytoprotein supplements in the Taiwan market through on-line platforms that were
recognized after the expiration of right of return which was offered for a limited time. Revenue from sales through off-line distribution
channels was recognized based on the amount of consideration that we expected to receive, reduced
by estimates for return allowances, promotional discounts, and fees. $106,502 of contract liabilities was recorded for the cash
received in advance from distribution channels as of June 30, 2024.
Return
Allowances
Return
allowances, which reduce revenue and cost of sales, are estimated using historical experience. Liabilities for return allowances are
included in “Accrued expenses and others current liabilities”.
Variable
consideration
We
record revenue from customers in an amount that reflects the transaction price we expect to be entitled to after transferring control
of those goods. From time to time, we offer product sales promotions such as discounts. Variable consideration is estimated at contract
inception only to the extent that it is probable that a significant reversal of revenue will not occur.
|
X |
- DefinitionThe entire disclosure for deferred revenues at the end of the reporting period, and description and amounts of significant changes that occurred during the reporting period. Deferred revenue is a liability as of the balance sheet date related to a revenue producing activity for which revenue has not yet been recognized. Generally, an entity records deferred revenue when it receives consideration from a customer before achieving certain criteria that must be met for revenue to be recognized in conformity with GAAP.
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v3.24.2.u1
Share-Based Compensation
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Share-Based Compensation |
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 871,075 shares
of common stock, including shares that remained available for grant under the 2021 Stock Incentive Plan. As of June 30, 2024, 870,200
shares have been granted under the 2023 SIP.
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 June 30, 2024, 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
six months ended June 30, 2024 and for the three and six months ended June 30, 2023 were as follows:
Schedule
of Restricted Stock Units
| |
2024 | | |
2023 | |
| |
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 | |
| 954,306 | | |
$ | 4.39 | | |
| 160,000 | | |
$ | 12.08 | |
RSUs granted | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
RSUs vested | |
| (133,964 | ) | |
$ | 5.74 | | |
| (5,866 | ) | |
$ | 55.50 | |
RSUs forfeited | |
| (5,950 | ) | |
$ | 3.46 | | |
| (7,600 | ) | |
$ | 7.15 | |
Unvested balance at March 31 | |
| 814,392 | | |
$ | 4.18 | | |
| 146,534 | | |
$ | 10.60 | |
RSUs granted | |
| - | | |
| | | |
| - | | |
| | |
RSUs vested | |
| - | | |
| | | |
| (20,220 | ) | |
$ | 6.69 | |
RSUs forfeited | |
| (4,410 | ) | |
$ | 4.16 | | |
| (6,970 | ) | |
$ | 6.38 | |
Unvested balance at June 30 | |
| 809,982 | | |
$ | 4.18 | | |
| 119,344 | | |
$ | 11.51 | |
Stock
Options and Warrants
During
the three and six months ended June 30, 2024 and 2023, no shares were granted, forfeited, expired or exercised. As of June 30, 2024,
there were 7,332 shares in the form of stock options and 6,034 shares in the form of warrants outstanding, and 5,111 shares of the options
and 6,034 shares of the warrants are vested and exercisable.
Share-Based
Compensation Expense
Shared-based
compensation expense for the three and six months ended June 30, 2024 ware $422,374 and $848,077 compared to the three and six months
ended June 30, 2023 amount of $137,159 and $357,991.
As
of June 30, 2024, the total unrecognized compensation cost related to outstanding RSUs, stock options and warrants was $2,486,290, which
the Company expects to recognize over a weighted-average period of 1.86 years.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.2.u1
Income Taxes
|
6 Months Ended |
Jun. 30, 2024 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
9.
Income Taxes
The
Company did not record a federal, state, or foreign income tax provision or benefit for the three and six months ended June 30, 2024
and 2023 due to the expected loss before income taxes to be incurred for the years ended December 31, 2024 and 2023, as well as the Company’s
continued maintenance of a full valuation allowance against its net deferred tax assets due to its historical deficit.
|
X |
- DefinitionThe entire disclosure for income tax.
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v3.24.2.u1
Net Loss per Common Share
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
Net Loss per Common Share |
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:
Schedule
of Basic and Diluted Net Loss Per Share
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Net loss attributable to common stockholders, basic and diluted | |
$ | (3,195,022 | ) | |
$ | (2,349,727 | ) | |
$ | (6,509,832 | ) | |
$ | (4,870,202 | ) |
Weighted-average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted | |
| 6,519,014 | | |
| 4,019,030 | | |
| 6,145,148 | | |
| 4,010,666 | |
Net loss per share attributable to common stockholders, basic and diluted | |
$ | (0.49 | ) | |
$ | (0.58 | ) | |
$ | (1.06 | ) | |
$ | (1.21 | ) |
The
following potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding because
they would be anti-dilutive:
Schedule
of Computations of Diluted Weighted Average Shares Outstanding
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Option and RSUs to purchase common stock | |
| 817,314 | | |
| 126,676 | | |
| 817,314 | | |
| 126,676 | |
Warrants to purchase to common stock | |
| 1,915,844 | | |
| 193,234 | | |
| 1,915,844 | | |
| 193,234 | |
Convertible note to purchase common stock | |
| 4,223,245 | | |
| 374,533 | | |
| 4,223,245 | | |
| 374,533 | |
Total potential shares | |
| 6,956,403 | | |
| 694,443 | | |
| 6,956,403 | | |
| 694,443 | |
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v3.24.2.u1
Related Party Transactions
|
6 Months Ended |
Jun. 30, 2024 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
11.
Related Party Transactions
The
following is a summary of related party transactions that met our disclosure threshold:
Working
Capital Advances
The
proceeds of the 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 six months ended June 30, 2024 were $101,777 and $132,855 compared to $22,637 and $26,057, for the three
and six months ended June 30, 2023. As of June 30, 2024 and December 31, 2023, unpaid accrued interest expenses were $220,488 and $87,632,
respectively.
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 for the three and six months ended June 30, 2024compared with the amount for the three and six months ended June 30, 2023
of nil and $46,635 respectively.
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 nil for the three and six months ended June 30, 2024.
As
of June 30, 2024 and December 31, 2023, the accounts payable to TCNT were nil and $323, respectively; and prepayment for COVID-19 Antigen
Rapid Test Kits were $21,872 and $27,208, respectively.
COVID-19
Antigen Rapid Test Kits Sales
The
Company sold COVID-19 Antigen Rapid Test Kits to affiliates of ASE Test Inc., totaling nil for the three and six months ended June 30,
2024 compared with the three and six months ended June 30, 2023 amount of $12,541 and $12,541, respectively. As of June 30, 2024, and
December 31, 2023, the accounts receivable to aforementioned related parties were nil, respectively.
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 $101,244 and $191,838 for the three and six months ended June 30,2024, respectively, compared
to $74,733 and $152,196 for the three and six months ended June 30, 2023, respectively. The fee for non-exclusive use of patents were
$285,263 and $569,862 for the three and six months ended June 30, 2024 and nil for the three and six months ended June 30, 2023, respectively.
Advance payment $138,615 and $ 26,511 as of June 30, 2024 and December 31, 2023, respectively.
Miscellaneous
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 board of directors of the Company. The R&D expense was nil for the three and six months ended June 30, 2024 and $19,618
and $39,344 for the three and six months ended June 30, 2023, respectively.
|
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- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.24.2.u1
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
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 June 30, 2024,
there were no such commitments or contingencies.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.2.u1
Subsequent Events
|
6 Months Ended |
Jun. 30, 2024 |
Subsequent Events [Abstract] |
|
Subsequent Events |
13.
Subsequent Events
Related
Party Transaction
As
part of the Addendum Agreement entered into on July 8, 2024 as disclosed in Note 11, TCNT will provide non-exclusive use of certain patents
related to VOC and POCT technologies for a monthly fee of $95,000 (plus 5% indirect tax), with negotiable payment terms for extend another
three months from July 2024 to September 2024.
Additional
Conversion of the Senior Secured Convertible Notes Payable (Lind Note)
On
July 3, 2024, Lind converted a total of $200,000 of the principal amount of Lind Note into 274,348 shares of common stock.
The remaining principal amount of the Lind Note was $1,585,330 after the conversion.
Repayment
of the Senior Secured Convertible Notes Payable (Lind Note)
On
August 2, 2024, the Company has retired its remaining senior secured convertible debt (the “Note”) with Lind Global Fund II
LP, an institutional investment fund managed by The Lind Partners (together the “Investor”), as a result of conversions by
the Investor and payments by the Company, which aggregates at a total of approximately US$1.67 million.
Nasdaq
Deficiency Notice
On
July 15, 2024 the Company received a deficiency letter from the Nasdaq Listing Qualifications Department (the “Staff”) of
The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that, for the last 30 consecutive business days, the closing
bid price for the Company’s common stock has been below the minimum $1.00 per share required for continued listing on The Nasdaq
Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). The Nasdaq deficiency letter
has no immediate effect on the listing of the Company’s common stock, and its common stock will continue to trade on The Nasdaq
Capital Market under the symbol “AIMD” at this time.
In
accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been given 180 calendar days, or until January 13, 2025, to regain
compliance with the Minimum Bid Price Requirement. If at any time before January 13, 2025, the bid price of the Company’s common
stock closes at $1.00 per share or more for a minimum of 10 consecutive business days, the Staff will provide written confirmation that
the Company has achieved compliance.
If
the Company does not regain compliance with the Minimum Bid Price Requirement by January 13, 2025, the Company may be afforded a second
180 calendar day period to regain compliance. To qualify, the Company would be required to meet the continued listing requirement for
market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, except for the Minimum Bid
Price Requirement. In addition, the Company would be required to notify Nasdaq of its intent to cure the deficiency during the second
compliance period. If the Company meets these requirements, Nasdaq will inform the Company that it has been granted an additional 180
calendar days. However, if it appears to Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise
not eligible, Nasdaq will provide notice that the Company’s securities are subject to delisting.
The
Company intends to monitor the closing bid price of its common stock and may, if appropriate, consider available options to regain compliance
with the Minimum Bid Price Requirement. However, there can be no assurance that the Company will be able to regain compliance with the
Minimum Bid Price Requirement or will otherwise be in compliance with other Nasdaq Listing Rules.
On
July 19,2024 the Company filed a Form 8-K with the SEC disclosing the herein matters.
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v3.24.2.u1
Summary of Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
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, 2023 contained in the Annual Report on Form 10-K filed with the
SEC on March 8, 2024.
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 six months
ended June 30, 2024 are not necessarily indicative of the results to be expected for any subsequent quarter, the year ending December
31, 2024, or any other period.
There
have been no material changes to the Company’s significant accounting policies as described in the audited financial statements
as of December 31, 2023.
|
Use of Estimates |
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 |
Liquidity
As
of June 30, 2024, the Company had cash and cash equivalents of $8,014,098. The Company plans to finance its operations and development
needs with its existing cash and cash equivalents, additional equity and/or debt financing arrangements, and expected near-term revenue
primarily from the sale of VELDONA Pet cytoprotein supplements to support the Company’s clinical trial activities, largely in connection
with Ainos Flora and human related VELDONA therapeutics. There can be no assurance that the Company will be able to obtain additional
financing on terms acceptable to the Company, on a timely basis, or at all.
For
the six months ended June 30, 2024, the Company generated a net loss of $6,509,832.
The Company expects to continue incurring development expenses for the next twelve months as the Company advances Ainos Flora and VELDONA
therapeutics for humans through clinical development until regulatory approval is received and the sales and marketing of the products
is authorized.
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 since inception and has an accumulated deficit
as of June 30, 2024 of $44,395,987 and expects to incur additional losses and negative operating cash flows for at least the next twelve
months. The Company’s ability to meet its obligations is dependent upon its ability to generate sufficient cash flows from operations
and future financing transactions. Management expects the Company will continue as a going concern for at least one year from the issuance
of these financial statements.
|
Segments |
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 |
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 six months ended June 30, 2024 and 2023.
|
Fair Value Option |
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 |
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 |
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.
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Inventory (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Inventory Disclosure [Abstract] |
|
Schedule of Inventory |
Inventory
stated at cost, net of reserve, consisted of the following:
Schedule of Inventory
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Raw materials | |
$ | 87,047 | | |
$ | 92,708 | |
Work in process | |
| 1,142 | | |
| 1,208 | |
Finished goods | |
| 78,133 | | |
| 73,677 | |
Total | |
$ | 166,322 | | |
$ | 167,593 | |
|
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v3.24.2.u1
Convertible Notes Payable and Other Notes Payable (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
Schedule of Notes Payable |
As
of June 30, 2024 and December 31, 2023, the respective notes payable were as follows:
Schedule of Notes Payable
| |
June 30, 2024 | | |
December 31, 2023 | |
Other notes payable, related party – current | |
$ | 312,000 | | |
$ | 42,000 | |
Other notes payable, related party - noncurrent | |
| - | | |
| 270,000 | |
March 2025 Convertible Notes, related party – noncurrent (ASE Note) | |
| - | | |
| 2,000,000 | |
March 2025 Convertible Notes, related party –current (ASE Note) | |
| 2,000,000 | | |
| - | |
March 2025 Convertible Notes – noncurrent (Lee Note) | |
| - | | |
| 1,000,000 | |
March 2025 Convertible Notes –current (Lee Note) | |
| 1,000,000 | | |
| - | |
Senior secured convertible notes payable (Lind Note) - fair value | |
| 1,585,761 | | |
| 2,651,556 | |
May 2027 Convertible Notes, related party – noncurrent (ASE Note) | |
| 9,000,000 | | |
| - | |
Notes payable | |
$ | 13,897,761 | | |
$ | 5,963,556 | |
|
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v3.24.2.u1
Stockholders’ Equity (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
Schedule of Warrants Issued and Outstanding |
As
of June 30, 2024 and December 31, 2023, warrants issued and outstanding in connection with financing are summarized as below:
Schedule of Warrants Issued and Outstanding
| |
June 30, | | |
December 31, | |
(In number of shares) | |
2024 | | |
2023 | |
ASE Warrant with exercise price $4.5 | |
| 500,000 | | |
| - | |
Lind Warrant with exercise price from $2.16 to $4.50 | |
| 1,201,944 | | |
| 691,244 | |
Public warrant with exercise price of $21.25 | |
| 179,400 | | |
| 179,400 | |
Representative’s warrant with exercise price of $23.375 | |
| 7,800 | | |
| 7,800 | |
Placement agent warrant with exercise price of $8.25 | |
| 20,666 | | |
| 16,000 | |
Total | |
| 1,909,810 | | |
| 894,444 | |
|
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v3.24.2.u1
Share-Based Compensation (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Restricted Stock Units |
Schedule
of Restricted Stock Units
| |
2024 | | |
2023 | |
| |
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 | |
| 954,306 | | |
$ | 4.39 | | |
| 160,000 | | |
$ | 12.08 | |
RSUs granted | |
| - | | |
$ | - | | |
| - | | |
$ | - | |
RSUs vested | |
| (133,964 | ) | |
$ | 5.74 | | |
| (5,866 | ) | |
$ | 55.50 | |
RSUs forfeited | |
| (5,950 | ) | |
$ | 3.46 | | |
| (7,600 | ) | |
$ | 7.15 | |
Unvested balance at March 31 | |
| 814,392 | | |
$ | 4.18 | | |
| 146,534 | | |
$ | 10.60 | |
RSUs granted | |
| - | | |
| | | |
| - | | |
| | |
RSUs vested | |
| - | | |
| | | |
| (20,220 | ) | |
$ | 6.69 | |
RSUs forfeited | |
| (4,410 | ) | |
$ | 4.16 | | |
| (6,970 | ) | |
$ | 6.38 | |
Unvested balance at June 30 | |
| 809,982 | | |
$ | 4.18 | | |
| 119,344 | | |
$ | 11.51 | |
|
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v3.24.2.u1
Net Loss per Common Share (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
Schedule of Basic and Diluted Net Loss Per Share |
Schedule
of Basic and Diluted Net Loss Per Share
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Net loss attributable to common stockholders, basic and diluted | |
$ | (3,195,022 | ) | |
$ | (2,349,727 | ) | |
$ | (6,509,832 | ) | |
$ | (4,870,202 | ) |
Weighted-average number of shares used in computing net loss per share attributable to common stockholders, basic and diluted | |
| 6,519,014 | | |
| 4,019,030 | | |
| 6,145,148 | | |
| 4,010,666 | |
Net loss per share attributable to common stockholders, basic and diluted | |
$ | (0.49 | ) | |
$ | (0.58 | ) | |
$ | (1.06 | ) | |
$ | (1.21 | ) |
|
Schedule of Computations of Diluted Weighted Average Shares Outstanding |
Schedule
of Computations of Diluted Weighted Average Shares Outstanding
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Option and RSUs to purchase common stock | |
| 817,314 | | |
| 126,676 | | |
| 817,314 | | |
| 126,676 | |
Warrants to purchase to common stock | |
| 1,915,844 | | |
| 193,234 | | |
| 1,915,844 | | |
| 193,234 | |
Convertible note to purchase common stock | |
| 4,223,245 | | |
| 374,533 | | |
| 4,223,245 | | |
| 374,533 | |
Total potential shares | |
| 6,956,403 | | |
| 694,443 | | |
| 6,956,403 | | |
| 694,443 | |
|
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v3.24.2.u1
Summary of Significant Accounting Policies (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Accounting Policies [Abstract] |
|
|
|
|
|
Cash and cash equivalents |
$ 8,014,098
|
|
$ 8,014,098
|
|
$ 1,885,628
|
Net loss |
(3,195,022)
|
$ (2,349,727)
|
(6,509,832)
|
$ (4,870,202)
|
|
Accumulated deficit |
(44,395,987)
|
|
(44,395,987)
|
|
$ (37,886,155)
|
Impairment of intangible assets, definite-lived |
$ 0
|
$ 0
|
$ 0
|
$ 0
|
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Cash and Cash Equivalents (Details Narrative)
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2024
TWD ($)
|
Dec. 31, 2023
USD ($)
|
Dec. 31, 2023
TWD ($)
|
Cash and Cash Equivalents [Abstract] |
|
|
|
|
Cash FDIC insured amount |
$ 250,000
|
|
|
|
Excess of FDIC insured limits |
4,281,890
|
|
$ 1,557,487
|
|
Cash CDIC insured amount |
$ 93,750
|
$ 3,000,000
|
|
|
Excess of CDIC insured limits |
|
$ 3,358,000
|
|
$ 0
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v3.24.2.u1
Schedule of Inventory (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Inventory Disclosure [Abstract] |
|
|
Raw materials |
$ 87,047
|
$ 92,708
|
Work in process |
1,142
|
1,208
|
Finished goods |
78,133
|
73,677
|
Total |
$ 166,322
|
$ 167,593
|
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v3.24.2.u1
Schedule of Notes Payable (Details) - USD ($)
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Short-Term Debt [Line Items] |
|
|
Other notes payable, related party – current |
$ 312,000
|
$ 42,000
|
May 2027 Convertible Notes, related party – noncurrent (ASE Note) |
9,000,000
|
3,000,000
|
March 2025 Convertible Notes –current (Lee Note) |
3,000,000
|
|
Senior secured convertible notes payable (Lind Note) - fair value |
|
2,651,556
|
Notes payable |
13,897,761
|
5,963,556
|
Senior Secured Convertible Notes [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Senior secured convertible notes payable (Lind Note) - fair value |
1,585,761
|
2,651,556
|
Related Party [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Other notes payable, related party – current |
312,000
|
42,000
|
Other notes payable, related party - noncurrent |
|
270,000
|
May 2027 Convertible Notes, related party – noncurrent (ASE Note) |
9,000,000
|
2,000,000
|
March 2025 Convertible Notes –current (Lee Note) |
2,000,000
|
|
Related Party [Member] | March 2025 Convertible Notes [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
May 2027 Convertible Notes, related party – noncurrent (ASE Note) |
|
2,000,000
|
March 2025 Convertible Notes –current (Lee Note) |
2,000,000
|
|
Related Party [Member] | 2027 Convertible Notes [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
May 2027 Convertible Notes, related party – noncurrent (ASE Note) |
9,000,000
|
|
Nonrelated Party [Member] | March 2025 Convertible Notes One [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
May 2027 Convertible Notes, related party – noncurrent (ASE Note) |
|
1,000,000
|
March 2025 Convertible Notes –current (Lee Note) |
$ 1,000,000
|
|
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v3.24.2.u1
Convertible Notes Payable and Other Notes Payable (Details Narrative) - USD ($)
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1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
May 03, 2024 |
Jan. 23, 2024 |
Dec. 31, 2023 |
Sep. 25, 2023 |
Aug. 17, 2023 |
Mar. 13, 2023 |
Mar. 31, 2022 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Short-Term Debt [Line Items] |
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|
|
|
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Outstanding debt amount |
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$ 42,000
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|
|
|
|
$ 312,000
|
|
$ 312,000
|
|
$ 42,000
|
Warrants issued |
|
|
894,444
|
|
|
|
|
1,909,810
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|
1,909,810
|
|
894,444
|
Proceeds from convertible notes payable |
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|
|
|
|
|
|
|
|
$ 1,000,000
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|
Fair value change for senior secured convertible note |
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|
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$ (66,844)
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(98,412)
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Issuance cost of senior secured convertible note measured at fair value |
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(138,992)
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Lind Global Fund II LP [Member] |
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Short-Term Debt [Line Items] |
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Conversion price per share |
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$ 7.50
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Convertible Note and Warrant Purchase Agreement [Member] |
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Short-Term Debt [Line Items] |
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Issuance of convertible promissory notes, percentage |
6.00%
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|
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Increased funding amount |
$ 9,000,000
|
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Conversion price per share |
$ 0.01
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Convertible Note and Warrant Purchase Agreement [Member] | Common Stock [Member] |
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Short-Term Debt [Line Items] |
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Issuance of warrants shares of common stock |
500,000
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Price per share, exercisable |
$ 4.50
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Convertible Note and Warrant Purchase Agreement [Member] | Common Stock [Member] | Maximum [Member] |
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Short-Term Debt [Line Items] |
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Issuance of warrants shares of common stock |
500,000
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KY Note [Member] |
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Short-Term Debt [Line Items] |
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Proceeds from notes payable |
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$ 800,000
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Repayments of notes payable |
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$ 530,000
|
Maturity date |
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Mar. 31, 2025
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I Two China Note [Member] |
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Short-Term Debt [Line Items] |
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Outstanding debt amount |
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$ 42,000
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$ 42,000
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|
|
Interest rate percentage |
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1.85%
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1.85%
|
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Maturity date |
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|
Sep. 01, 2024
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March 2025 Convertible Notes [Member] | Convertible Promissory Note Purchase Agreements [Member] |
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Short-Term Debt [Line Items] |
|
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|
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Convertible notes payable |
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|
$ 3,000,000
|
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ASE Note [Member] | Convertible Promissory Note Purchase Agreements [Member] |
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Short-Term Debt [Line Items] |
|
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Convertible notes payable |
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|
2,000,000
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|
|
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Tranche one |
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|
1,000,000
|
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Tranche two |
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500,000
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Tranche three |
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$ 500,000
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Lee Note [Member] | Convertible Promissory Note Purchase Agreements [Member] |
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Short-Term Debt [Line Items] |
|
|
|
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|
|
|
|
|
|
|
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Interest rate percentage |
|
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|
|
6.00%
|
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|
|
|
|
|
Conversion price per share |
|
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$ 7.50
|
|
|
|
|
|
|
Convertible notes payable |
|
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|
|
|
$ 1,000,000
|
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|
|
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Maturity date |
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|
two years from the issuance dates
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Interest expense |
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|
|
$ 117,828
|
$ 37,991
|
$ 164,214
|
$ 44,924
|
|
Unpaid accrued interest expense |
|
|
$ 138,939
|
|
|
|
|
303,153
|
|
303,153
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|
138,939
|
Senior Secured Convertible Notes Payable [Member] | Securities Purchase Agreement [Member] | Lind Global Fund II LP [Member] |
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Short-Term Debt [Line Items] |
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Maturity date |
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|
Mar. 28, 2025
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Increased funding amount |
|
$ 875,000
|
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|
|
|
|
|
|
|
|
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Convertible notes payable |
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|
$ 3,540,000
|
|
|
|
|
2,752,170
|
|
2,752,170
|
|
$ 3,540,000
|
Aggregate principal amount |
|
|
|
$ 10,000,000
|
|
|
|
1,785,330
|
|
1,785,330
|
|
|
Warrants issued |
|
1,021,400
|
691,244
|
|
|
|
|
|
|
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|
691,244
|
Warrants exercise price |
|
$ 2.16
|
$ 4.50
|
|
|
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|
$ 4.50
|
Conversion amount is cash |
|
|
$ 3,000,000
|
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|
|
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|
|
|
|
|
Convertible notes payable additional funding |
|
|
$ 7,000,000.0
|
|
|
|
|
6,125,000
|
|
6,125,000
|
|
$ 7,000,000.0
|
Proceeds from convertible notes payable |
|
$ 1,750,000
|
|
|
|
|
|
|
|
|
|
|
Convertible notes payable |
|
|
|
|
|
|
|
$ 1,585,761
|
|
$ 1,585,761
|
|
|
Remaining insurance cost |
|
169,344
|
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AmendedInitial Note [Member] | Securities Purchase Agreement [Member] | Lind Global Fund II LP [Member] |
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|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Convertible notes payable |
|
$ 4,235,000
|
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v3.24.2.u1
Schedule of Warrants Issued and Outstanding (Details) - shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Class of Warrant or Right [Line Items] |
|
|
Total |
1,909,810
|
894,444
|
ASE Warrant [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Total |
500,000
|
|
Lind Warrant [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Total |
1,201,944
|
691,244
|
Public Warrant [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Total |
179,400
|
179,400
|
Representative Warrant [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Total |
7,800
|
7,800
|
Placement Agent Warrant [Member] |
|
|
Class of Warrant or Right [Line Items] |
|
|
Total |
20,666
|
16,000
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v3.24.2.u1
Stockholders’ Equity (Details Narrative) - USD ($)
|
6 Months Ended |
|
|
|
|
Jun. 30, 2024 |
May 03, 2024 |
Dec. 31, 2023 |
Nov. 27, 2023 |
Nov. 26, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Preferred stock shares authorized |
50,000,000
|
|
50,000,000
|
50,000,000
|
10,000,000
|
Preferred stock shares issued |
0
|
|
0
|
|
|
Preferred stock shares outstanding |
0
|
|
0
|
|
|
Additional common stock shares issued |
$ 1,244,168
|
|
|
|
|
Common stock shares issued |
7,388,674
|
|
4,677,787
|
|
|
Common stock shares outstanding |
7,388,674
|
|
4,677,787
|
|
|
Common stock shares reserved |
3,749,535
|
|
|
|
|
Warrants expired |
0
|
|
|
|
|
Placement Agent Warrant [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Warrant issued |
20,666
|
|
|
|
|
Exercise price |
$ 8.25
|
|
|
|
|
Warrants contractual term |
5 years
|
|
|
|
|
Fair value of warrants |
$ 21,479
|
|
|
|
|
Private Warrant [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Warrants contractual term |
5 years
|
|
|
|
|
Convertible Note and Warrant Purchase Agreement [Member] | Common Stock [Member] |
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
Warrant issued |
|
500,000
|
|
|
|
Price per share, exercisable |
|
$ 4.50
|
|
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Schedule of Restricted Stock Units (Details) - Restricted Stock Units (RSUs) [Member] - $ / shares
|
3 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Number of Shares, Beginning |
814,392
|
954,306
|
146,534
|
160,000
|
Weighted-Average Grant Date Fair Value Per Share, Beginning |
$ 4.18
|
$ 4.39
|
$ 10.60
|
$ 12.08
|
Number of Shares, RSUs granted |
|
|
|
|
Weighted-Average Grant Date Fair Value Per Share, RSUs granted |
|
|
|
|
Number of Shares, RSUs vested |
|
(133,964)
|
(20,220)
|
(5,866)
|
Weighted-Average Grant Date Fair Value Per Share, RSUs vested |
|
$ 5.74
|
$ 6.69
|
$ 55.50
|
Number of Shares, RSUs forfeited |
(4,410)
|
(5,950)
|
(6,970)
|
(7,600)
|
Weighted-Average Grant Date Fair Value Per Share, RSUs forfeited |
$ 4.16
|
$ 3.46
|
$ 6.38
|
$ 7.15
|
Number of Shares, Ending |
809,982
|
814,392
|
119,344
|
146,534
|
Weighted-Average Grant Date Fair Value Per Share, Ending |
$ 4.18
|
$ 4.18
|
$ 11.51
|
$ 10.60
|
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Share-Based Compensation (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 14, 2023 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
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|
|
|
|
Aggregate number of shares granted |
|
|
|
|
871,075
|
Form of stock options |
7,332
|
|
7,332
|
|
|
Shares of the options vested |
5,111
|
|
5,111
|
|
|
Shares of the options vested and exercisable |
6,034
|
|
6,034
|
|
|
Shared-based compensation expense |
$ 422,374
|
$ 137,159
|
$ 848,077
|
$ 357,991
|
|
Unrecognized compensation cost, Stock options and warrants |
$ 2,486,290
|
|
$ 2,486,290
|
|
|
weighted-average period in years |
|
|
1 year 10 months 9 days
|
|
|
Warrant [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Warrants outstanding |
6,034
|
|
6,034
|
|
|
2023 Stock Incentive Plan [Member] |
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
Aggregate number of shares granted |
870,200
|
|
870,200
|
|
|
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v3.24.2.u1
Schedule of Basic and Diluted Net Loss Per Share (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Earnings Per Share [Abstract] |
|
|
|
|
Net loss attributable to common stockholders, basic and diluted |
$ (3,195,022)
|
$ (2,349,727)
|
$ (6,509,832)
|
$ (4,870,202)
|
Weighted-average number of shares used in computing net loss per share attributable to common stockholders, basic |
6,519,014
|
4,019,030
|
6,145,148
|
4,010,666
|
Weighted-average number of shares used in computing net loss per share attributable to common stockholders, diluted |
6,519,014
|
4,019,030
|
6,145,148
|
4,010,666
|
Net loss per share attributable to common stockholders, basic |
$ (0.49)
|
$ (0.58)
|
$ (1.06)
|
$ (1.21)
|
Net loss per share attributable to common stockholders, diluted |
$ (0.49)
|
$ (0.58)
|
$ (1.06)
|
$ (1.21)
|
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Schedule of Computations of Diluted Weighted Average Shares Outstanding (Details) - shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potential shares |
6,956,403
|
694,443
|
6,956,403
|
694,443
|
Stock Options And Restricted Stock Units [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potential shares |
817,314
|
126,676
|
817,314
|
126,676
|
Warrant [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potential shares |
1,915,844
|
193,234
|
1,915,844
|
193,234
|
Convertible Debt Securities [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Total potential shares |
4,223,245
|
374,533
|
4,223,245
|
374,533
|
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Related Party Transactions (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Related Party Transaction [Line Items] |
|
|
|
|
|
Unpaid accrued interest expenses |
$ 220,488
|
|
$ 220,488
|
|
$ 87,632
|
Cost of revenue |
25,373
|
$ 55,817
|
52,127
|
$ 156,665
|
|
Revenues |
|
28,555
|
20,729
|
77,719
|
|
Development expenses incurred |
1,978,756
|
1,671,187
|
4,063,404
|
3,370,070
|
|
Research and development expense |
|
19,618
|
|
39,344
|
|
COVID 19 Antigen Rapid Test Kits Sales [Member] |
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
Revenues |
|
12,541
|
|
12,541
|
|
Manufacturing Service Agreement [Member] |
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
Incurred costs |
|
|
|
|
|
Manufacturing Service Agreement [Member] | COVID 19 Antigen Rapid Test Kits Sales [Member] |
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
Accounts payable |
|
|
|
|
323
|
Accounts receivable |
21,872
|
|
21,872
|
|
27,208
|
Product Co Development Agreement [Member] |
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
Development expenses incurred |
101,244
|
74,733
|
191,838
|
152,196
|
|
Advance payment |
|
|
138,615
|
|
26,511
|
Product Co Development Agreement [Member] | Patents [Member] |
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
Non exclusive use of patents fee |
285,263
|
|
569,862
|
|
|
Related Pary [Member] |
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
Interest expense incurred related party |
101,777
|
22,637
|
132,855
|
26,057
|
|
Related Party [Member] |
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
Cost of revenue |
|
|
|
46,635
|
|
Accounts receivable |
|
|
|
|
|
Development expenses incurred |
386,507
|
74,733
|
761,700
|
152,196
|
|
Related Party [Member] | Sales and Marketing Agreement [Member] |
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
Cost of revenue |
|
|
|
$ 46,635
|
|
X |
- DefinitionCarrying value as of the balance sheet date of liabilities incurred (and for which invoices have typically been received) and payable to vendors for goods and services received that are used in an entity's business.
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v3.24.2.u1
Subsequent Events (Details Narrative) - USD ($)
|
Jul. 08, 2024 |
Jul. 03, 2024 |
Aug. 02, 2024 |
Jul. 15, 2024 |
Jun. 30, 2024 |
Dec. 31, 2023 |
Subsequent Event [Line Items] |
|
|
|
|
|
|
Remaining principal amount |
|
|
|
|
$ 13,897,761
|
$ 5,963,556
|
Subsequent Event [Member] | Common Stock [Member] |
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
Stock issued price per share |
|
|
|
$ 1.00
|
|
|
Subsequent Event [Member] | Lind Financing [Member] |
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
Principal amount converted, value |
|
$ 200,000
|
|
|
|
|
Principal amount converted, shares |
|
274,348
|
|
|
|
|
Remaining principal amount |
|
$ 1,585,330
|
|
|
|
|
Subsequent Event [Member] | Lind Financing [Member] | Director [Member] |
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
Remaining principal amount |
|
|
$ 1,670,000
|
|
|
|
Voc And Poct Technologies [Member] | Subsequent Event [Member] | Patents [Member] |
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
Monthly fee for patent |
$ 95,000
|
|
|
|
|
|
Indirect tax |
5.00%
|
|
|
|
|
|
X |
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